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Medication safety in Vietnamese hospitalsNguyen, Huong

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Medication safety in Vietnamese hospitals

A focus on medication errors and safety culture

Nguyen Huong Thao

Paranimfen: Susana Monteiro Doti Martono

Nguyen Huong Thao

Medication safety in Vietnamese hospitals: A focus on medication errors and safety culture

Thesis Groningen University – With summary in English, Dutch, and Vietnamese

Cover design: Tran Thao Nguyen, Nguyen Thi Thu (Ho Chi Minh city, Vietnam)

Layout, typesetting and printing: Michal Slawinski, thesisprint.eu

ISBN: (book) 978-90-367-7218-1 ISBN: (electronic version) 978-90-367-7217-4

Printing of this thesis was financially supported by the Graduate School for Health Research SHARE, the Groningen Graduate School of Science (GGSS), the University of Groningen (RuG), and the Nuffic project (NPT VNM 240).

© 2014 Nguyen Huong Thao. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage or retrieval system, without written permission of the author. The copyright of previously published chapters of this thesis remains with the publisher or journal.

Medication safety in Vietnamese hospitals

A focus on medication errors and safety culture

PhD thesis

to obtain the degree of PhD at the University of Groningen on the authority of the

Rector Magnificus Prof. E. Sterken and in accordance with

the decision by the College of Deans.

This thesis will be defended in public on

Monday 3 November 2014 at 16.15 hours

by

Nguyen Huong Thaoborn on 5 August 1977

in Binh Phuoc, Vietnam

SupervisorsProf. K. TaxisProf. F.M. Haaijer-RuskampProf. J.R.B.J. Brouwers

Co-supervisorDr. T.D. Nguyen

Assessment committeeProf. B.D. FranklinProf. H.V. HogerzeilProf. J.G.W. Kosterink

Table of contents

Chapter 1 9

General Introduction

Chapter 2 23

Indicators of quality use of medicines in South-East Asian countries: A systematic reviewTropical Medicine & International Health, 2012 Dec;17(12):1552-1566

Chapter 3 51

Errors in medication preparation and administration in Vietnamese hospitals: An observational studySubmitted

Chapter 4 71

Errors in preparation and administration of insulin in two urban Vietnamese hospitals: An observational studyNursing Research, 2014 Jan-Feb;63(1):68-72

Chapter 5 85

The effect of a clinical pharmacist-led training programme on intravenous medication errors: A controlled before and after studyBMJ Quality & Safety, 2014 Apr;23(4):319-324

Chapter 6 103

Nurses’ perception of patient safety culture and its association with medication errors: A cross-sectional survey in Vietnamese hospitalsSubmitted

Chapter 7 119

General Discussion and Future Perspectives

Addendum 133

SummarySamenvatting (Dutch summary)Tóm tắt (Vietnamese summary)AcknowledgmentsList of PublicationsCurriculum VitaePrevious Dissertations of SHARE

Chapter 1


11

Background

Medication safety in developing countries

Medication safety is an issue worldwide (Jha et al. 2010; Jha et al. 2013). It is estimated that more than half of all medicines over the world are prescribed, dispensed or sold inappropriately (WHO 2010). In high-income countries, this has been recognized a long time ago and a lot of efforts are dedicated to improve medication safety (Institute of Medicine 1999; Stelfox et al. 2006). Much less is known about medication safety in low- and middle-income countries (Jha et al. 2010). One of the few large studies in such countries found that 2.5% to 18.4% of hospital admissions were associated with an adverse event and about 30% of those resulted in the death of the patient which was much higher than those in high-income countries. Poor health system infrastructure, inadequately trained healthcare staff, and insufficient safety culture probably contributed to this (Wilson et al. 2012).

Vietnam

In South-East Asia, health and related matters have recently emerged as a focus of global health (Acuin et al. 2011; Chongsuvivatwong et al. 2011; Coker et al. 2011; Dans et al. 2011; Kanchanachitra et al. 2011). The region is dealing with the chal-lenge of an increase in non-communicable diseases and of a growing demand for high quality health care. However, the quality use of medicines or explicit methods to measure quality has not been addressed so far. Vietnam is a relatively small country located in the region and borders Laos, Cambodia and China (Central Intelligence Agency 2014). After the implementation of reform policy (Đổi mới) in late 1980’s, Vietnam has had a rapid growth in economy (Giang 2011; U.S. Government 2011; United Nations Statistics Division 2014). Along with that, there were remarkable improvements in the nation’s health such as an increased life expectancy and a significantly decreased child mortality rate (Giang 2011; Nguyen & Hoang 2013). However, there are still many health-related challenges including a rising burden of illness (with non-communicable diseases replacing infectious diseases as a major cause of death), an ageing pop-ulation, inequities in access to healthcare services, and insufficient capacity of healthcare system (Giang 2011; U.S. Government 2011; Nguyen & Hoang 2013; WHO 2011; Nhung et al. 2013). There is a growing demand of better medical

12

Chapter 1

care and concerns about quality and safety of healthcare services (Giang 2011; U.S. Government 2011). Ensuring affordability and quality is a national priority and much effort of managers and policy makers has been invested to support this, especially concerning rational use of medicines. Two examples: all pharmacies are asked to comply with standards of Good Pharmacy Practice and a Drug and Therapeutics committee is required in every hospital (Vietnam Ministry of Health 2011; Vietnam Ministry of Health 2013). Unfortunately, such regulations have not worked sufficiently (Nguyen et al. 2013). In recent years, the practice of clinical pharmacy has started, but the roles and activities of clinical pharmacists are still invisible in the health system. Improvements are needed to promote quality and safety of health care (Vietnam Ministry of Health, Department of Drug Adminis-tration 2009; Vietnam Ministry of Health 2012; Vo et al. 2013).

Measuring quality and safety of medicines

In order to improve quality and safety of health care, the first step should be to explore the extent of the current problems, so that strategies for improvement can be targeted to these specific problems. In the area of medicine use, regular moni-toring with quality indicators has been recommended to evaluate and improve quality (Quick et al. 1997). Second, the wider context, underlying and associ-ated factors of such problems have to be explored. In practice, combining differ-ent approaches is often suggested to get better insight into the current problems, and as such, increases the likelihood of success in improving quality and safety of patient care (Quick et al. 1997; Garrouste-Orgeas et al. 2012).

Indicators are explicitly defined and measureable items related to the structure, process or outcome of care (Berg et al. 2005; Kerr & Fleming 2007; Campbell et al. 2003; Mainz 2003; Majeed et al. 2007). In the area of quality of medicine use, indicators have been used as a tool for policy-makers and healthcare managers to assess and monitor the extent of rational medicine use, to compare differences across facilities, districts or regions, to analyse changes over time and to evaluate interventions (Quick et al. 1997; Majeed et al. 2007; Hogerzeil 1995; Laing et al. 2001). The first set of indicators measuring quality use of medicines and prescribing behaviour in health facilities was developed over three decades ago by the WHO in collaboration with the International Network for Rational Use of Drugs (INRUD) (Hogerzeil et al. 1993; WHO 1993). These indicators are widely accepted as an objective standard method to assess rational use of medi-cines and have been used in over 30 countries, mainly in the developing world (Laing et al. 2001; WHO 2004; WHO 2009). After that, indicators addressing the

13


pharmaceutical situation of countries including rational medicine use (WHO 2007b) and the use of medicines at household level (WHO 2007a; WHO 2011) were also published. Apart from the widely used WHO indicators, measures of quality use of medicines for specific diseases like asthma or diabetes have been developed and applied in developed countries (Martirosyan et al. 2010; To et al. 2010). As highlighted above, little is known about quality use of medicines in Vietnam as well as in South-East Asia, especially whether existing indicators are suitable for the current medical challenges.

For much of this thesis a specific area of quality indicators has been chosen, medication errors, more specifically, medication administration errors in the hos-pital setting (Ross et al. 2000; Krahenbuhl-Melcher et al. 2007). Medication errors may cause serious harms during hospitalization as they are associated with injury as well as additional hospital stays and costs. Further, such errors can cause fear in patients and in healthcare providers, especially nurses (Institute of Medicine 1999). Medication administration errors have been defined as deviations in prepa-ration and administration medications from the doctor’s prescriptions, the hospi-tal policies and procedures or the manufacturer’s instructions (Berdot et al. 2013; Keers et al. 2013b). Several approaches are used to study medication administration errors, among which, observation technique is considered as the “gold standard” (Barker & McConnell 1962; Barker et al. 2002; Flynn et al. 2002). There have been numerous studies on medication administration errors using observation method conducted worldwide, mainly in developed countries including the United States, the United Kingdom and the Netherlands (Berdot et al. 2013; Keers et al. 2013b). Two recent systematic reviews show median error rates between 8% and 10% (excluding time errors) (Berdot et al. 2013; Keers et al. 2013b). Two small scale studies, each including about one thousand preparations and administrations, have been carried out in a Malaysian hospital (Chua et al. 2010; Chua et al. 2009). Error rates were around 8% which is comparable to the median error rate reported recently (Keers et al. 2013b).

Various factors have been reported influencing medication errors such as knowledge/experience of staff and organizational culture (Keers et al. 2013a). Medication characteristics, for example, administration route and drug class have also been identified as error-related factors (Keers et al. 2013b; Chua et al. 2009). However, the majority of studies included only a limited number of factors using univariable analysis and/or did not take into account possible interactions between them. Also, the clinical relevance of errors was not investigated in all studies.

Many different technology-based interventions (for instance, “closed-loop systems” with bar-coded drug administration) have been suggested to reduce medication administration errors (Duckers et al. 2009; Pham et al. 2012). How-

14

Chapter 1

ever, differences in local practice, resource and culture mean that lessons learnt from other nations are not always applicable. Although technology-based inter-ventions have the potential to reduce medication errors, their implementation is not simple. New risks may occur, if the implementation is not carried out ade-quately. Moreover, technology-based interventions require considerable invest-ments that are not available in many institutions in lower-income countries such as Vietnam. The benefits of clinical pharmacists in improved quality, safety and efficiency of patient care have been acknowledged a while ago, mainly in high-income countries (Kaboli et al. 2006). A recent study conducted in Chile reported the success of clinical pharmacist’s interventions in reducing medication errors (Romero et al. 2013). This strengthens the evidence about the role of clinical phar-macists even in a resource-restricted setting (i.e. a lower-income country). More studies about effective interventions in similar settings are needed. As mentioned earlier, in Vietnam, the concept of clinical pharmacy has just been introduced recently and the performance of clinical pharmacist is less recognized. This sug-gests that clinical/hospital pharmacists should more actively participate in and share the responsibility of medical care, so that they can prove the advantages of clinical pharmacy services. One of the most feasible services which clinical phar-macists could start is enhancing quality use of medicines, for example promoting the appropriateness of medication administration, since they are known as experts in the therapeutic use of medications.

It has been widely accepted that a medication error is not only caused by human factors, but also affected by the working environment. One of the various system factors reported influencing medication errors is safety culture in an orga-nization (Keers et al. 2013a). Safety culture refers to how patient safety is perceived and implemented within an organization, and the structures and processes in place to support this (The Health Foundation 2011). Establishing a culture of safety has a high priority in healthcare in developed countries (Chassin & Loeb 2011). Usually, safety culture is measured as a guide for quality improvement efforts using surveys such as the safety attitudes questionnaire (Colla et al. 2005; Pronovost & Sexton 2005; Halligan & Zecevic 2011). There have been studies reporting the association between safety culture and hospital morbidity, adverse events or readmission rates (Valentin et al. 2013; Singer et al. 2009; Hofmann & Mark 2006; Clarke 2006; Pro-novost et al. 2005). Other studies have found no relationship between safety culture and patient outcomes (Rosen et al. 2010; Bosch et al. 2011). Limited evidence from low- and middle-income countries shows that there is a deficiency of safety culture and this is compromising patient safety (Jha et al. 2010; Wilson et al. 2012). Little work has been done showing the link between safety culture and medication errors (Hofmann & Mark 2006; Vogus & Sutcliffe 2007). Medication errors in these studies

15


were investigated using medical records (Hofmann & Mark 2006) or error report-ing (Vogus & Sutcliffe 2007). These methods are known to underestimate the rate of medication administration errors due to underreporting/lack of documentation of type of errors in medical records (Flynn et al. 2002). More studies investigating the relationship between safety culture and medication administration error rates are needed to identify appropriate approaches to improve medication safety of this step in the process of drug use.

Rationale and objectives of this dissertation

This dissertation focuses on medication safety in South-East Asian countries, especially in Vietnam. Measuring safety e.g. by using indicators is a first step, but little is known about the extent of using indicators of quality use of medicines in South-East Asia. This forms the start of this thesis. The focus of the other parts of this thesis is on administration errors on hospital wards as a specific type of indicator of the quality use of medicines in the hospital setting. The extent of the problem (i.e. how many errors occur?) and the wider context (i.e. what are factors contributing to errors including the safety culture?) are studied as well as the effects of an intervention to improve medication safety. This thesis has been inspired by the wish to gain more insight into medication safety issues in Vietnamese hospitals and contribute to the development of the role of the clinical pharmacist in improving medication safety (which has been also the global aim of the Nuffic project under which this thesis has been funded). Therefore, the objectives of this thesis are: 1. To identify studies explicitly using indicators of quality use of medicines in the

South-East Asian region answering the following three research questions: (i) which indicators have been used; (ii) what is known about the validity, reliabil-ity and feasibility of the existing indicators; and (iii) what are the main results based on the commonly used indicators?

2. To determine the prevalence and potential clinical outcome of medication preparation and administration errors in two Vietnamese hospitals and to identify associated factors in a multifactorial model.

3. To measure the effect of a clinical pharmacist-led training programme on clini-cally relevant errors in intravenous medication preparation and administration in a Vietnamese hospital.

4. To measure nurses’ perception of safety culture in two public hospitals in Viet-nam and to assess the association between this perception and the prevalence of intravenous medication errors.

16

Chapter 1

Outline of this dissertation

Chapter 2 systematically reviews studies explicitly using indicators of quality use of medicines in the South-East Asian region focusing on which indicators have been used and the validity, reliability and feasibility of the existing indicators. Addition-ally, the main results based on commonly used indicators are summarized.

Chapter 3 determines the prevalence and potential clinical outcome of medication preparation and administration errors in two urban public hospitals in Vietnam and identifies factors associated with errors.

Chapter 4 investigates the prevalence, type and potential clinical outcomes of errors in preparation and administration of insulin in two urban public Vietnam-ese hospitals.

Chapter 5 assesses the effect of an educational training programme on clinically relevant errors in intravenous medication preparation and administration in a Vietnamese hospital.

Chapter 6 presents the results of a survey on nurses’ perception of safety culture across two public hospitals in Vietnam and an investigation of whether there is an association between safety culture and the prevalence of intravenous medication errors.

Finally, Chapter 7 summarizes and discusses the main findings of the thesis as well as proposes implications for clinical practice and future research.

17


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Chapter 2

Indicators of quality use of medicines

in South-East Asian countries:

A systematic review

Nguyen HT, Wirtz VJ, Haaijer-Ruskamp FM, Taxis K

Tropical Medicine & International Health, 2012 Dec;17(12):1552-1566

25

Abstract

Objectives: To identify indicators of quality use of medicines used in South-East Asian region.

Methods: A systematic review was conducted searching MEDLINE, Embase and The International Network for Rational Use of Drugs (INRUD) and The World Health Organization (WHO) website. Original studies or reports carried out in the South-East Asian region, explicitly using indicators to measure quality use of medicines, and published between January 2000 and July 2011 were included.

Results: A total of 17 studies conducted in 7 out of 11 countries in South-East Asia were included. WHO indicators focusing on general medication use in health facilities were most widely used (10 studies). Twelve studies used non-WHO indicators for measuring quality use of medicines in clinical areas (geriatrics and obstetrics) or specific diseases, such as diarrhoea and pneumonia. In five stud-ies, WHO indicators were used along with non-WHO indicators. There was little information available about validity, reliability and feasibility of the non-WHO indicators. The majority of indicators measured process rather than structure or outcome. There were very few indicators addressing non-communicable diseases.

Conclusions: A limited number of studies have been published explicitly using indicators of quality use of medicines across South-East Asia. Importantly, exist-ing indicators need to be complemented with valid, reliable and feasible indicators related to non-communicable diseases, particularly those with a high financial burden to meet the current medical challenges in the region.

Keywords: quality indicator, South-East Asia

27

Indicators of quality use of medicines in South-East Asian countries

Introduction

WHO (2010) estimated that more than half of all medicines over the world were prescribed, dispensed or sold inappropriately. Examples of irrational use of medi-cines include use of too many medicines per patient (Hajjar et al. 2007), inap-propriate use of antimicrobials (Werner et al. 2011) and failure to prescribe in accordance with clinical guidelines (Ko et al. 2010). Over three decades ago, the WHO in collaboration with the International Network for Rational Use of Drugs (INRUD) developed a set of indicators measuring quality use of medicines and prescribing behaviour in health facilities (Hogerzeil et al. 1993; WHO 1993). These indicators are widely accepted as an objective standard method to assess rational use of medicines and have been used in over 30 countries, mainly in the develop-ing world (Laing et al. 2001; WHO 2004, 2009). Another set of WHO indicators addresses the pharmaceutical situation of countries including rational medicine use (WHO 2007b). Finally, more recently, WHO has published a set of indicators for the use of medicines at household level (WHO 2007a, 2011). Apart from the widely used WHO indicators, measures of quality use of medicines for specific diseases like asthma or diabetes have been developed and applied in developed countries (Martirosyan et al. 2010; To et al. 2010). Indicators are a tool for policy-makers and healthcare managers to assess and monitor the extent of rational medi-cine use, to compare differences across facilities, districts or regions, to analyse changes over time and to evaluate interventions (Hogerzeil 1995; Quick et al. 1997; Laing et al. 2001; Majeed et al. 2007).

South-East Asia is a region consisting of eleven countries – Brunei, Sin-gapore, Malaysia, Thailand, the Philippines, Indonesia, Vietnam, Laos, Cam-bodia, Myanmar and East Timor (PubMed definition). These countries have a common history, geography and position as a major crossroad of trade and the movement of goods and services. Recently, a set of papers discussed health and related matters in South-East Asian countries as an emerging focus for global health (Acuin et al. 2011; Chongsuvivatwong et al. 2011; Coker et al. 2011; Dans et al. 2011; Kanchanachitra et al. 2011). The region is dealing with the chal-lenge of an increase in non-communicable diseases associated with population ageing. The health systems are a mix of traditional medical practices and the use of new medical technologies and pharmaceutical products, presenting problems in terms of safety and quality. In addition, there is a rising demand for high-quality health care because of increasing educational levels and wealth as well as a growing consciousness of human rights in societies with a developing democratic environ-ment. Although this series of papers addressed some aspects of quality of health care and challenges related to health insurance coverage, it did not address the

28

Chapter 2

quality use of medicines or explicit methods to measure quality, neither could we identify any other reviews on this topic. It remains unknown whether existing indicators are suitable for the current medical challenges. In this systematic review, we aimed to identify studies explicitly using indicators of quality use of medicines in the South-East Asian region answering the following three research questions: (i) which indicators have been used; (ii) what is known about the validity, reli-ability and feasibility of the existing indicators; and (iii) what are the main results based on the commonly used indicators.

Methods

Search strategies

A systematic literature review was conducted according to the PRISMA instruc-tions (Moher et al. 2009), using PubMed (MEDLINE) and Embase databases with relevant keywords: ‘quality indicators, health care’, ‘quality indicator(s)’, ‘safety indicator(s)’, ‘indicator(s)’, ‘medication errors’, ‘drug monitoring’, ‘adverse drug reaction reporting systems’, ‘drug reporting system(s)’, ‘medical audit’, ‘quality assur-ance, health care’, ‘rational use’, ‘pharmaceutical preparations’, ‘medication’, ‘drug(s)’, ‘pharmaceutical sector’, ‘asia, southeastern’, ‘southeastern asia’, ‘southeast asia’, and individual country names as MeSH terms and free-text words or combinations. We also performed searches in the INRUD bibliography (The International Network for Rational Use of Drugs: http://www.inrud.org) and in the WHO (http://www.who.int) website with the keyword ‘indicator(s)’. The searches were restricted by published date between January 2000 and July 2011, but not for languages.

Duplicated studies were eliminated. All remaining titles and abstracts were independently screened and selected by two authors (H.T.N and K.T). Disagreements were resolved through discussion. Studies deemed relevant at the first screening were retrieved in full-text format and screened for further eligibility. Related articles and the reference lists of reviewed articles were searched for additional studies.

Inclusion criteria

We included original studies or reports that (i) were carried out in South-East Asian region, (ii) explicitly used indicators to measure quality use of medicines including prescribing, dispensing and utilization of medicines, adopted from

29


official sources/sets (e.g. WHO documents) or clearly defined indicators (namely unambiguous descriptions and clear definitions of variables to be measured, explicit definition of the population to be included and the setting to which they apply) (Hearnshaw et al. 2001; Campbell et al. 2003; Hepler & Segal 2003), and (iii) were published between January 2000 and July 2011.

Exclusion criteria

We excluded studies that (i) used exclusively other methods to describe/measure rational use of medicines rather than using indicators and (ii) did not provide suf-ficient details in methods and results sections, thus failing to answer research ques-tions.

Data abstraction

The following information was extracted: first author, publication year, country, design, study level (for example: national, provincial or hospital), setting and objec-tive of study, number and description of indicators used. For studies including mul-tiple indicators, we only included indicators addressing quality use of medicines and excluded those relating to other aspects of care (for instance, access to or qual-ity of medicines). The first author extracted the data and the last one checked this.

Data analysis

For each indicator of quality use of medicines, several parameters were deter-mined. To access the original source of the indicators, we checked whether indica-tors were developed by the WHO or not. The latter were named non-WHO indica-tors. Similar indicators were grouped together. We classified indicators according to the dimension of quality of care as structure (defined as the capacity to pro-vide high quality of care), process (referred to the actions of healthcare providers, such as prescribing, dispensing, etc.) or outcome (including recovery, restoration of functionality, knowledge about therapy and survival of patients) indicators as described by Donabedian (Donabedian 2005), irrespective of the category defined in the original source, from which they were selected.

WHO indicators were developed by appropriate methods, well tested in many countries and applied in various studies in a standard way: the face and con-

30

Chapter 2

tent validity, reliability and feasibility of those indicators have been proven (WHO 1993, 2006a, 2007a, 2009; Brudon et al. 1999). All other indicators were evaluated on the information provided in the studies and additional documents cited in the original papers as follows (Martirosyan et al. 2010):

— Content validity: indicators were based on the literature review or evidence-based clinical guidelines.

— Face validity: indicators were assessed and accepted by a group of experts or profes-sionals in the field.

— Feasibility: feasibility of calculation of indicators was demonstrated or defended in the view of available data.

— Reliability: indicators yield the same outcome when measured by different persons at different times.

The main results of most commonly used indicators

Results of commonly used indicators in the reviewed articles were extracted and aggregated if there were at least three results from different countries. We included the results of both WHO and non-WHO indicators if their contents were compa-rable and presented aggregated data as a range for each indicator.

Results

In total, 696 potentially relevant articles were identified (PubMed: 376, Embase: 308, INRUD: 9 and WHO: 3). Of those, 19 original studies met the inclusion criteria and were included in our analysis. Three papers (Stenson et al. 2001a, b; Syhakhang et al. 2001) were from a serial publication relating to the same PhD research project and are referred to as one study by Syhakhang (Syhakhang 2002). No relevant studies were identified from searching the related articles and the ref-erence lists of included studies. As a result, 17 different studies were included for review.

The greatest number of studies was carried out in Laos (five studies). Others were conducted in Singapore (three studies), Cambodia (two studies), Thailand (two studies), the Philippines (two studies), Vietnam (two studies) and Malaysia (one study). The studies were performed at different levels: national (12 studies), regional (one study), provincial (three studies) and hospital (one study) using two major designs: to describe the situation of medication use (10 studies) or to assess practice improvement/impact of a certain intervention (seven studies) (Table 1).

31


Tabl

e 1.

Des

crip

tion

of st

udie

s usin

g in

dica

tors

of q

ualit

y us

e of

med

icin

es

No

Ref

eren

ceC

ount

rySt

udy

leve

lSt

udy

sett

ing

Stud

y de

sign

Stud

y ob

ject

ive

Num

ber &

des

crip

tion

of

indi

cato

r(s)

use

dSo

urce

of

indi

cato

r(s)

1(P

apha

ssa-

rang

et a

l. 20

02)

Lao

PDR

Nat

iona

lPh

arm

aceu

tical

se

ctor

in g

ener

al

(Nat

iona

l dru

g po

licy

(ND

P))

Inte

rven

tion

(Im

plem

enta

tion

of N

DP/

regu

lato

ry

inte

rven

tion)

To a

sses

s the

impa

ct o

f th

e N

atio

nal D

rug

Polic

y pr

ogra

m to

get

evi

denc

e fo

r re

visin

g th

e po

licy.

Twen

ty n

ine

indi

cato

rs co

mpr

ising

15

indi

cato

rs fo

r mon

itorin

g N

atio

nal

Dru

g Po

licy

(ND

P), 1

0 G

ood

Phar

ma-

cy P

ract

ice

(GPP

) ind

icat

ors,

and

othe

r fo

ur m

easu

ring

the

know

ledg

e of

ND

P an

d its

com

pone

nts.

Som

e of

them

re

late

d to

disp

ensin

g an

d pr

escr

ibin

g pr

actic

es. I

t is i

mpo

ssib

le to

kno

w th

e ex

act n

umbe

r of i

ndic

ator

s mea

surin

g qu

ality

use

of m

edic

ines

sinc

e th

e fu

ll lis

t of i

ndic

ator

s was

not

repo

rted

in

the

stud

y.

1, 2

2(S

tens

on et

al

. 200

1a;

Sten

son

et

al. 2

001b

; Sy

hakh

ang

et a

l. 20

01;

Syha

khan

g 20

02)*

Lao

PDR

Prov

inci

alPu

blic

and

priv

ate

phar

mac

ies (

in

Sava

nnak

het

prov

ince

)

Inte

rven

tion

(Reg

ulat

ory

inte

-rv

entio

n:in

spec

tions

, inf

or-

mat

ion,

dist

ribut

ion

of d

ocum

ents

and

sa

nctio

ns)

To d

escr

ibe

the

qual

ity

of th

e pr

ivat

e ph

arm

acy

serv

ices

in co

mpa

rison

with

th

at o

f pub

lic p

harm

acy

rega

rdin

g to

asp

ects

of g

ood

phar

mac

y pr

actic

es a

nd

ratio

nal u

se o

f dru

g an

d to

as

sess

the

effec

tiven

ess o

f go

vern

men

t reg

ulat

ion.

Twel

ve in

dica

tors

cove

ring

aspe

cts o

f G

ood

Phar

mac

y Pr

actic

e (G

PP) a

nd

ratio

nal u

se o

f dru

gs (R

UD

). A

mon

g th

ose,

eigh

t ass

esse

d pr

escr

ibin

g an

d di

spen

sing

prac

tices

and

two

rela

ted

to fa

cilit

y.

1, 2

3(W

ahlst

rom

et

al.

2003

)La

o PD

RN

atio

nal

Prov

inci

al h

o-sp

itals

(man

age-

men

t of m

alar

ia,

diar

rhoe

a an

d pn

eum

onia

)

Inte

rven

tion

(Int

rodu

ctio

n of

ST

Gs,

audi

t, fe

ed-

back

& d

iscus

sions

)

To e

valu

ate

the

effec

ts o

f an

educ

atio

nal i

nter

vent

ion

to

impr

ove

trea

tmen

t pra

ctic

es

of th

ree

com

mon

dise

ases

in

clud

ing

mal

aria

, dia

rrho

ea

and

pneu

mon

ia.

Thre

e in

dica

tors

add

ress

ing

diag

nost

ic

and

trea

tmen

t of m

alar

ia, d

iarr

hoea

an

d pn

eum

onia

in a

ccor

danc

e to

st

anda

rd tr

eatm

ent g

uide

lines

. Eac

h ha

d so

me

com

pone

nts r

elat

ing

to

med

icat

ion

use.

2

32

Chapter 2

No

Ref

eren

ceC

ount

rySt

udy

leve

lSt

udy

sett

ing

Stud

y de

sign

Stud

y ob

ject

ive

Num

ber &

des

crip

tion

of

indi

cato

r(s)

use

dSo

urce

of

indi

cato

r(s)

4(K

eoha

vong

et

al.

2006

)La

o PD

RN

atio

nal

Publ

ic h

ealth

faci

li-tie

s (pr

ovin

cial

and

di

stric

t hos

pita

ls an

d he

alth

cent

ers)

Des

crip

tive

To e

valu

ate

the

ratio

nal u

se

of d

rug

(RU

D) p

atte

rns w

ith

a fo

cus o

n pr

escr

ibin

g an

d di

spen

sing

prac

tices

.

Four

teen

indi

cato

rs m

easu

ring

pres

cri-

bing

and

disp

ensin

g pr

actic

es.

1

5(V

ang

et a

l. 20

06)

Lao

PDR

Nat

iona

lD

rug

and

Ther

a-pe

utic

s Com

mit-

tees

(DTC

s) in

cen-

tral

and

pro

vinc

ial

hosp

itals

Inte

rven

tion

(aud

it, fe

edba

ck &

di

scus

sions

)

To a

sses

s DTC

s per

form

an-

ce, t

o ev

alua

te im

prov

e-m

ents

of a

n ed

ucat

iona

l in

terv

entio

n an

d to

mon

itor

subs

eque

nce

prac

tices

.

Eigh

t ind

icat

ors f

or a

sses

sing

DTC

pe

rfor

man

ce. O

f whi

ch, o

ne in

dica

tor

rela

ted

to q

ualit

y us

e of

med

icin

es. T

en

indi

cato

rs fo

r RU

D a

nd o

ther

thre

e fo

r adh

eren

ce to

Sta

ndar

d Tr

eatm

ent

Gui

delin

es.

1, 2

6(M

amun

et

al. 2

004)

Sing

apor

e N

atio

nal

Ger

iatr

ics/

Nur

sing

Hom

esD

escr

iptiv

eTo

iden

tify

the

prev

alen

ce

of p

olyp

harm

acy

and

inap

-pr

opria

te m

edic

atio

n us

e in

nu

rsin

g ho

mes

.

Two

indi

cato

rs fo

r nur

sing

hom

e ca

re

com

prisi

ng p

olyp

harm

acy

and

inap

-pr

opria

te m

edic

atio

n us

e.

2

7(C

hong

et

al. 2

006)

Sing

apor

e N

atio

nal

(Ins

titut

io-

nal)

Inst

itute

of M

enta

l H

ealth

Inte

rven

tion

(Im

plem

enta

tion

of

Nat

iona

l tre

atm

ent

prog

ram

me)

To e

valu

ate

the

qual

ity o

f ca

re b

efor

e an

d aft

er th

e im

plem

enta

tion

of e

arly

ps

ycho

sis in

terv

entio

n pr

o-gr

amm

e (E

PIP)

.

Thirt

een

proc

ess i

ndic

ator

s cov

erin

g di

ffere

nt d

omai

ns o

f car

e. O

f whi

ch,

seve

n re

late

d to

trea

tmen

t with

med

i-ca

tion.

2

8(C

hong

et

al. 2

008)

Sing

apor

e N

atio

nal

Poly

clin

ics (

spec

ia-

list o

utpa

tient

cli-

nics

of g

over

nmen

t ho

spita

ls)

Inte

rven

tion

(Aud

it &

feed

back

)To

ass

ess t

he im

pact

of

Sing

apor

e N

atio

nal A

sthm

a Pr

ogra

m o

n dr

ug p

resc

rip-

tion

patte

rn.

One

indi

cato

r foc

usin

g on

dru

g pr

e-sc

ribin

g fo

r ast

hma.

2

9(C

hare

onku

l et

al.

2002

)C

ambo

dia

Prov

inci

alH

ealth

cent

ers

(prim

ary

heal

th

care

)

Des

crip

tive

To id

entif

y dr

ug u

se

prob

lem

s and

to e

valu

ate

pres

crib

ing

and

disp

ensin

g pr

actic

e co

mpa

red

to d

esi-

red

natio

nal g

uide

lines

.

Eigh

teen

indi

cato

rs fo

r eva

luat

ing

qu-

ality

use

of m

edic

ines

in g

ener

al a

nd in

so

me

spec

ific d

iseas

es (d

iarr

hoea

and

ac

ute

resp

irato

ry in

fect

ion)

.

1, 2

33


No

Ref

eren

ceC

ount

rySt

udy

leve

lSt

udy

sett

ing

Stud

y de

sign

Stud

y ob

ject

ive

Num

ber &

des

crip

tion

of

indi

cato

r(s)

use

dSo

urce

of

indi

cato

r(s)

10(U

chiy

ama

et a

l. 20

06)

Cam

bodi

aN

atio

nal

Ant

i-tub

ercu

losis

(T

B) d

rug

man

a-ge

men

t (pu

blic

he

alth

faci

litie

s and

pr

ivat

e ph

arm

a-ci

es)

Des

crip

tive

To a

sses

s ant

i-TB

drug

m

anag

emen

t of s

ervi

ce

prov

ider

s, ou

t-pa

tient

s an

d dr

ug st

orek

eepe

rs; t

o do

cum

ent p

ract

ices

of a

nti-

-TB

drug

s in

the

publ

ic a

nd

priv

ate

sect

or in

the

conc

ept

of p

rocu

rem

ent,

avai

labi

lity

and

pric

e.

Six

indi

cato

rs fo

cusin

g on

ant

i-tub

er-

culo

sis d

rug

man

agem

ent.

Of w

hich

, tw

o re

late

d to

pre

scrib

ing

prac

tice

of

serv

ice

prov

ider

s, an

d kn

owle

dge

of

TB o

ut-p

atie

nts.

2

11(L

iabs

uetr

a-ku

l et a

l. 20

08)

Thai

land

Regi

onal

(S

outh

ern

Thai

land

)

Obs

tetr

ic u

nits

(u

nive

rsity

, reg

io-

nal a

nd p

rovi

ncia

l ho

spita

ls)

Des

crip

tive

To e

valu

ate

the

qual

ity o

f ca

re fo

r con

ditio

ns o

f sev

ere

pre-

ecla

mps

ia/e

clam

psia

ob

stru

cted

labo

r, an

d po

st-

part

um h

emor

rhag

e in

the

5 so

uthe

rnm

ost p

rovi

nces

of

Thai

land

.

Eigh

teen

indi

cato

rs fo

r ass

essin

g qu

ality

of o

bste

tric

car

e, of

whi

ch se

ven

indi

cato

rs co

ncer

ning

dru

g us

e.

2

12(K

anch

ana-

phib

ool e

t al

. 200

9)

Thai

land

Hos

pita

lPu

blic

tert

iary

ho

spita

lD

escr

iptiv

eTo

ass

ess t

he q

ualit

y of

di

abet

es c

are.

Seve

n in

dica

tors

com

pass

ing

qual

ity o

f di

abet

es c

are,

of w

hich

onl

y on

e re

late

d to

med

icat

ion

use

for p

reve

ntio

n of

co

mpl

icat

ions

.

2

13(F

alke

nber

g et

al.

2000

)V

ietn

amN

atio

nal

Phar

mac

eutic

al

sect

or in

gen

eral

. D

escr

iptiv

e To

ass

ess t

he V

ietn

ames

e ph

arm

aceu

tical

sect

or

rega

rdin

g th

e st

anda

rd o

f th

e dr

ug q

ualit

y co

ntro

l sy

stem

, ava

ilabi

lity

of d

rugs

an

d ra

tiona

l use

of e

ssen

tial

drug

s in

the

priv

ate

and

publ

ic se

ctor

s.

Ten

indi

cato

rs fo

r mon

itorin

g na

tiona

l dr

ug p

olic

y (N

DP)

. Of w

hich

, fou

r co-

verin

g th

e fie

ld o

f rat

iona

l use

of d

rugs

.

1

34

Chapter 2

No

Ref

eren

ceC

ount

rySt

udy

leve

lSt

udy

sett

ing

Stud

y de

sign

Stud

y ob

ject

ive

Num

ber &

des

crip

tion

of

indi

cato

r(s)

use

dSo

urce

of

indi

cato

r(s)

14(C

halk

er

2001

)V

ietn

amPr

ovin

cial

Com

mun

e H

ealth

St

atio

ns (p

rimar

y he

alth

car

e)

Inte

rven

tion

(Con

ditio

nal e

quip

-m

ent d

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35


Four studies used indicators to assess the pharmaceutical sector: one mea-sured financial access to essential medicines including only one indicator relating to medication dispensing (Saleh & Ibrahim 2005), while the other three investi-gated also geographical access to essential medicines, quality and rational use of medicine (Falkenberg et al. 2000; Paphassarang et al. 2002; Batangan & Juban 2009a). Another four studies described overall medicine use patterns comprising prescribing and dispensing practices or assessed the impact of an intervention on these issues in various health facilities (health centres, hospitals and pharmacies) (Chareonkul et al. 2002; Syhakhang 2002; Keohavong et al. 2006; Vang et al. 2006). Indicators were applied in different clinical areas including geriatrics and obstet-rics as well as in specific diseases comprising malaria, diarrhoea, pneumonia, psy-chosis, asthma, tuberculosis, and diabetes in seven studies (Wahlstrom et al. 2003; Mamun et al. 2004; Chong et al. 2006, 2008; Uchiyama et al. 2006; Liabsuetr-akul et al. 2008; Kanchanaphibool et al. 2009). One study evaluated the effective-ness of an intervention in the utilisation of antibiotics (Chalker 2001). Finally, one study described medication use in households (Batangan & Juban 2009b) (Table 1).

WHO indicators

About half of the studies (10 studies, 59%) applied indicators developed by the WHO with some studies slightly modifying the indicators to fit the specific contexts (Paphassarang et al. 2002; Syhakhang 2002; Vang et al. 2006; Batangan & Juban 2009a, b). For instance, Vang et al. (2006) had scored indicators based on a 10-point scale instead of using percentages or absolute numbers as recommended by the WHO. Prescribing and dispensing practices at facility level were assessed by using indicators of quality use of medicines in health facilities (WHO 1993). Those indi-cators were developed a long time ago, updated various times and incorporated into the package for assessing country pharmaceutical situation (WHO 2007b). The use of medicines at home was measured by using another set of WHO indicators for the household survey (WHO 2007a). Most of the studies using WHO indicators measured processes, only few focused on structures and outcomes (Appendix 1).

Non-WHO indicators

Twelve studies used non-WHO indicators, which were developed either by a national organization or by the authors themselves. In five studies, non-WHO indicators were used along with the WHO indicators (Chalker 2001; Chareonkul et al. 2002;

36

Chapter 2

Paphassarang et al. 2002; Syhakhang 2002; Vang et al. 2006). Those indicators were categorised into four groups: (i) rational medicine use in general, (ii) quality of pharmacy practice (Good Pharmacy Practice (GPP) indicators), (iii) rational medi-cine use in specific clinical areas or diseases (Clinical area/disease-oriented indica-tors) and (iv) other aspects involving medication use (Appendix 2).

Table 2. Evaluation of non-WHO indicators of quality use of medicines*

Indicators Evaluation

Content validity

Face validity Feasibility Reliability

1. Rational medicine use in general

Antibiotic use (Chalker 2001) - - ± -

Medicine use in hospital (Vang et al. 2006) - + ± -

Patient care and facility (Chareonkul et al. 2002) - - ± -

2. Good pharmacy practice (GPP) indicators

(Syhakhang 2002; Paphassarang et al. 2002) + + + +

Facility specific indicators

Dispensing indicators

3. Clinical area/disease-oriented indicators

Geriatrics (Mamun et al. 2004) + - ± -

Obstetrics (Liabsuetrakul et al. 2008) + - ± -

Malaria, diarrhoea and pneumonia

(Chareonkul et al. 2002) + - ± -

(Vang et al. 2006; Wahlstrom et al. 2003) + + ± +

Asthma (Chong et al. 2008) - - ± -

Diabetic (Kanchanaphibool et al. 2009) + - ± -

Psychosis (Chong et al. 2006) + - ± -

Tuberculosis (TB) (Uchiyama et al. 2006) + - ± -

4. Others

National Drug Policy (NDP) (Paphassarang et al. 2002) - - ± -

Drug and Therapeutics Committee (DTC) (Vang et al. 2006) + - ± -

(+), Positive information; (-), No/ambiguous information; (±), Limited information.

* List of non-WHO indicators used in the included studies is provided in Appendix 2.

37


Few non-WHO indicators sets were judged to be face and content valid and reliable (Table 2). These indicators were developed based on experts’ consen-sus and related to available literature or standard treatment guidelines and tested within local contexts. For instance, Good Pharmacy Practice (GPP) indicators were developed by the Lao Food and Drug Department and tested for reliability in pharmacies (Paphassarang et al. 2002; Syhakhang 2002); or indicators assess-ing adherence to standard treatment guidelines of malaria, diarrhoea and pneu-monia were developed in the Lao National Drug Policy (NDP) implementation programme and tested by the Department of Curative Medicine in a hospital (Wahlstrom et al. 2003). Most studies described indicators that were based on existing literature and/or clinical guidelines, and these were judged to have content validity. Four studies did not provide any data or reported ambiguous messages on the process of developing and testing the indicators (Chalker 2001; Chare-onkul et al. 2002; Paphassarang et al. 2002; Chong et al. 2008), so content and face validity could not be determined. All of the non-WHO indicators reported results and were therefore assumed to be feasible within the context of the specific study, except for the indicators assessing adherence to Lao standard treatment guidelines of malaria, diarrhoea and pneumonia as they were used in two distinct studies (Wahlstrom et al. 2003; Vang et al. 2006). However, the feasibility of all of these indicators on a larger scale was not tested. The exception was the Lao GPP indica-tor study which confirmed the feasibility of the indicators as they were regularly used for inspection of pharmacies in Laos (Paphassarang et al. 2002; Syhakhang 2002) (Table 2). Most of the non-WHO indicators identified were process, fol-lowed by structure and outcome indicators (Appendix 2).

Summary results of most commonly used indicators of quality use of medicines

Only a limited number of studies used indicators that allow comparison of results across countries. Among the identified indicators, the most prominent ones were indicators addressing prescribing and dispensing/patient care practices of health-care providers (Table 3).

Rational medicine use in general was measured in seven studies. The overall results showed wide variation for all indicators involved, often with about twofold differences. For example, the number of medicines per prescription ranged from 1.4 to 3.8. The percentage of medicines prescribed from the essential medicine list was encouraging in some health facilities with a percentage of nearly 100.0, but still

38

Chapter 2

poor in other studied sites (56.0%). The most extreme difference was the percentage of encountering an injection, which was 1.3% in Laos (Paphassarang et al. 2002) and 32.0% in Vietnam (Falkenberg et al. 2000).

Table 3. Results of most commonly used indicators in South-East Asia

Indicators Results#

General prescribing indicators

Average number of medicines per encounter/prescription/patient (Syhakhang 2002; Paphassarang et al. 2002; Falkenberg et al. 2000; Batangan & Juban 2009a; Chareonkul et al. 2002; Keoha-vong et al. 2006)

1.4–3.8

Percentage of medicines prescribed by generic name (Syhakhang 2002; Batangan & Juban 2009a; Chareonkul et al. 2002; Keoha-vong et al. 2006)

35.0–99.8

Percentage of encounters/patients with an antibiotic prescribed (Sy-hakhang 2002; Paphassarang et al. 2002; Batangan & Juban 2009a; Chareonkul et al. 2002; Keohavong et al. 2006; Chalker 2001)

13.1–66.0*

Percentage/number of encounters/patients with an injection prescribed (Syhakhang 2002; Paphassarang et al. 2002; Falken-berg et al. 2000; Batangan & Juban 2009a; Chareonkul et al. 2002; Keohavong et al. 2006)

1.3–32.0

Percentage of medicines prescribed from essential medicines list or formulary (Syhakhang 2002; Paphassarang et al. 2002; Batangan & Juban 2009a; Chareonkul et al. 2002; Keohavong et al. 2006)

56.0–99.7

Prescribing indicators for treatment simple diarrhoea in children under age 5

Percentage of patients prescribed Oral Rehydration Salts/Solutions (ORS) (Paphassarang et al. 2002; Batangan & Juban 2009a; Chareon-kul et al. 2002; Keohavong et al. 2006)

60.0–100.0*

Percentage of patients prescribed antibiotics (Paphassa-rang et al. 2002; Batangan & Juban 2009a; Chareonkul et al. 2002; Keohavong et al. 2006)

22.0–81.3*

Percentage of patients prescribed anti-diarrhoeal/antispasmodic drugs (Paphassarang et al. 2002; Falkenberg et al. 2000; Batangan & Juban 2009a; Keohavong et al. 2006)

0.0–30.0

Dispensing/patient care indicators

Percentage of medicines dispensed/received/administered (Saleh & Ibrahim 2005; Batangan & Juban 2009a; Chareonkul et al. 2002; Keohavong et al. 2006)

84.8–100.0

Percentage of medicines adequately labeled (Batangan & Juban 2009a; Chareonkul et al. 2002; Keohavong et al. 2006)

0.0–97.1

Patients’ knowledge of correct dosage/how to take medicines (Batangan & Juban 2009a; Chareonkul et al. 2002; Keoha-vong et al. 2006)

55.0–80.0

# Due to small number of studies, only ranges are presented.

* Included the results of non-WHO indicators whose contents were comparable to those of WHO indicators.

39


Appropriateness of medicine use for treatment of a specific disease, that is, diarrhoea, in children under 5-year old was addressed in five studies. The findings varied between 60.0 and 100.0%, 22.0-81.3% and 0.0-30.0% of patients with simple diarrhoea prescribed oral rehydration salts/solutions (ORS), antibiotics and antidiar-rhoea/antispasmodic drugs, respectively.

Quality of medication dispensing or patient care was assessed in four studies. Most patients (55.0-80.0%) knew how to take medicines in the majority of cases (84.8-100.0%) studied. However, labelling medicines broadly varied from not being labelled at all to almost adequate.

Discussion

A total of 17 studies conducted in seven countries in South-East Asia using indi-cators of quality use of medicines were included in this review. WHO indicators mainly focusing on general medication use in health facilities were most frequently used. New indicators for measuring quality use of medicines in specific clinical areas/diseases have been developed with little information on their validity, reli-ability and feasibility. The majority of indicators identified measured process, fol-lowed by structure and outcome.

We did not find studies from Brunei, Indonesia, Myanmar and East Timor. Furthermore, with the exception of Laos, only few studies were performed in each country. One of the reasons may be that these are mainly developing countries (except for Singapore) where electronic medical records and insurance data are often absent and monitoring of medicine use is not undertaken (Holloway & van Dijk 2011). Also, scientific journals may not be interested in publishing studies on routine monitoring of drug utilization. Based on the limited data, quality use of medicines in South-East Asia was suboptimal and varied greatly. Some of the comparisons are restricted because target values for indicators are not available or depend on local practices. In view of the sparse data, it was not feasible to conduct statistical analy-sis. We found that between 1.4 and 3.8 medicines were prescribed per encounter, which is only partly in line with the range of 2.0-2.7 identified in a recent large study (WHO 2009). A value of two was suggested to be adequate (Chareonkul et al. 2002; Batangan & Juban 2009a), but five studies reported a value of more than two (Falken-berg et al. 2000; Chareonkul et al. 2002; Paphassarang et al. 2002; Syhakhang 2002; Keohavong et al. 2006). The percentage of prescriptions with an antibiotic or with an injection also varied widely; a threshold of not more than 30% has been recom-mended for injection (WHO 1993). Differences could be because of disease patterns, health policies (e.g. effort to improve prescribing pattern) and culture. For example,

40

Chapter 2

the rate of injections per prescription in the study by Falkenberg was probably high, because many patients, especially in mountainous areas, expected injections of vita-mins (Falkenberg et al. 2000). Medicine use for the treatment of a disease (in children under 5-year old) was also suboptimal: not all patients with simple diarrhoea were prescribed ORS, but were given antibiotics and antidiarrhoea/antispasmodic drugs. These results were in line with the findings of a recent study at global level (WHO 2009). The most frequently used indicators were the ones developed by the WHO, especially the core set of indicators (WHO 1993). This is a well-accepted, highly standardized simple tool for fast and reliably assessing general medicine use, rec-ommended for application in any medicine use study. The indicators for common specific diseases (including acute diarrhoea, acute respiratory infection and malaria) described in the annex (WHO 1993) were not used. Studies addressing the latter used indicators from other sources or developed their own (Falkenberg et al. 2000; Chareonkul et al. 2002; Paphassarang et al. 2002; Keohavong et al. 2006; Batangan & Juban 2009a). Three studies used WHO indicators for monitoring national drug poli-cies (NDP) including indicators for rational use of medicines (Falkenberg et al. 2000; Paphassarang et al. 2002; Saleh & Ibrahim 2005). The two sets of indicators men-tioned previously were further developed and incorporated into the WHO pack-age of indicators for assessing, monitoring and evaluating country pharmaceutical situations (WHO 2006b), which were applied in two studies (Keohavong et al. 2006; Batangan & Juban 2009a). Only one study used WHO indicators for the household survey to measure quality use of medicines at home (Batangan & Juban 2009b), pos-sibly because this set is rather new (WHO 2007a, 2011).

More studies are needed using WHO indicators to assess quality use of medi-cines in the region to fill the gap in knowledge as highlighted previously. However, current WHO indicators do not address the recent changes of the health situation in the region with increasing chronic diseases and ageing population. They should be complemented with indicators related to non-communicable diseases, particularly those with a high financial burden. Encouragingly, there are some studies measuring quality use of medicines in specific medical fields (geriatrics and obstetrics) or in spe-cific diseases (psychosis, asthma, tuberculosis, diabetes). However, they were mostly used in the context of a single study with insufficient information to assess their valid-ity and reliability (Mamun et al. 2004; Chong et al. 2006, 2008; Uchiyama et al. 2006; Liabsuetrakul et al. 2008; Kanchanaphibool et al. 2009). Indicators should be devel-oped using appropriate methods, for example, RAND (Campbell et al. 2003). Stan-dard sets of valid and reliable indicators should be used in studies evaluating medica-tion use to generate consistent data to facilitate the comparison across countries or regions. Indicators can then serve as a tool to revise medicine policies and to develop strategies for enhancing quality use of medicines at both national and regional levels.

41


Most indicators were process indicators rather than structure or outcome indicators. This is not surprising as most indicators assessed rational use of medi-cines, which is by definition a process indicator (Mainz 2003; Donabedian 2005). In general, structures are often readily formulated and easily measured, but are not always associated with better processes that yield the desired health outcomes. There is more evidence that process indicators are linked with outcome, but even this is not true for all situations (Sidorenkov et al. 2011). Furthermore, the process of care is in the control of healthcare providers and reflects their quality of care provision. Process indicators are therefore well suited to identify areas of possible change and to evaluate interventions. Outcomes are not always direct measures of the quality of health care provided and are likely to be influenced by patient-related factors (e.g. severity of the disease, patient age) and may take a very long time to occur (e.g. mor-tality or target blood pressure in hypertension) (Mainz 2003; Donabedian 2005).

Strengths and limitations of the review

There is no defined keyword for “indicator(s) of quality use of medicines”. We combined all potentially relevant MeSH terms and free-text terms. We found no additional studies searching the related articles or screening the lists of references of included studies, indicating we have included the studies that met our inclusion criteria, in correspondence with the aim of the study. Secondly, we excluded studies on rational use of medicines in which the authors did not use the concept of indica-tor explicitly, for example Chuc et al. (2001) or Ayuthya et al. (2003). A complete overview of rational use of medicines in South-East Asia was outside the scope of the present study. Thirdly, there are inconsistencies in the definition of South-East Asia in the literature. The WHO has divided this area into two subregions, South-East Asia consisting of Indonesia, Myanmar, Thailand and East Timor and Western Pacific encompassing Brunei, Cambodia, Laos, Malaysia, the Philippines, Singapore and Vietnam. Others included ten countries as members of ASEAN organisation, which excludes East Timor (Chongsuvivatwong et al. 2011). We considered South-East Asia as a region covering eleven countries, ten ASEAN members and East Timor, using the PubMed categorisation. Lastly, we did not search for unpublished papers or grey literature because of feasibility and resources. In an attempt to seek relevant locally published studies, one of the authors (H.T.N, Vietnamese) carried out a manual search of the relevant pharmaceutical and medical journals published in Vietnamese, but no studies were identified.

In conclusion, a limited number of studies have been carried out using indi-cators of quality use of medicines across South-East Asia. WHO indicators focus-

42

Chapter 2

ing on general medication use in health facilities were mainly used. Non-WHO indicators often lacked information on validity, reliability and feasibility. As far as results could be compared between studies, suboptimal quality use of medicine is indicated. Most importantly, existing indicators need to be complemented with valid, reliable and feasible indicators related to non-communicable diseases, par-ticularly those with a high financial burden to meet the current medical challenges in the region.

Acknowledgments

H.T.N received a scholarship from the Netherlands Organization for International Cooperation in Higher Education.

43


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WHO (2007b) WHO Operational Package for Assessing, Monitoring and Evaluating Country Pharmaceuti-

cal Situations, Guide for Coordinators and Data Collectors. World Health Organization, Geneva.

WHO (2009) Medicines Use in Primary Care in Developing and Transitional Countries – Fact Book Sum-

marizing Results from Studies Reported Between 1990 and 2006. World Health Organization,

Geneva.

WHO (2010) Medicines: rational use of medicines, Fact sheet No. 338, May 2010. http://www.who.int/

mediacentre/factsheets/fs338/en/index.html [Accessed 5 October 2011].

WHO (2011) Development of WHO TCM household medicines access survey. http://www.whoccpp.org/

methods/tcm_household_survey.asp [Accessed 20 December 2011].

47


Appendix 1. List of WHO indicators used in reviewed articles

Type of indicators St Pr Ot References

Indicators of quality use of medicines at health facility level 2 17 1

Prescribing indicators in generalAverage number of medicines per encounter/prescription/patient Percentage of medicines prescribed by generic name Percentage of encounters/patients with an antibiotic prescribed Percentage/number of encounters/patients with an injection prescribed Percentage of medicines prescribed from essential medicines list or formulary Number of medicines from the national essential medicines list, out of the 50 best-selling medicines in the private sector Percentage of prescription medicines bought with no prescription

××××

×

×

×

(Keohavong et al. 2006; Paphassarang et al. 2002; Syhakhang 2002; Vang et al. 2006; Cha-reonkul et al. 2002; Chalker 2001; Fal-kenberg et al. 2000; Saleh & Ibrahim 2005; Batangan & Juban 2009a)

Prescribing indicators for specific diseases Simple diarrhoea in children under age 5Percentage of patients prescribed oral rehydration salts/solutions (ORS) Percentage of patients prescribed antibioticsPercentage of patients prescribed anti-diarrhoeal/antispasmodic drugs Mid/moderate pneumonia in children under age 5Percentage of patients prescribed first-line antibiotics Percentage of patients prescribed more than one antibiotic Non-pneumonia (flu) in patients of any agePercentage of patients prescribed antibiotics

×

××

××

×

Dispensing/patient care indicatorsAverage consultation timeAverage dispensing timePercentage of medicines dispensed/received/administered Percentage of medicines adequately labeled Patients’ knowledge of correct dosage/how to take medicines

××××

×

Facility indicatorsAvailability of copy of essential medicines list or formulary Availability of standard treatment guidelines at public health facilities

××

Indicators of quality use of medicines at household level 0 0 1

Rational use of medicines at home * × (Batangan & Juban 2009b)

St, structure; Pr, process; Ot, outcome; The classification of structure, process and outcome indicators based

on the aspect of care as described by Donabedian.

* It was not reasonable to list individual indicators; Full lists of indicators used in original articles were not

shown; only indicators relating to quality use of medicines were reported.

48

Chapter 2

Appendix 2. List of non-WHO indicators used in reviewed articles


1. Rational medicine use in general 1 6 1

Antibiotic useAntibiotic dose (% of patients receiving an adequate antibiotic dose) ×

(Chalker 2001)

Medicine use in hospitalMedicine in hospitalClear writing Traditional medicineRational use of antibioticRational use of injection

×××××

(Vang et al. 2006)

Patient care and facilityPercentage patients confirmation of medicine instructionUse pictogram (plastic bag) ×

×(Chareonkul et al. 2002)

2. Good pharmacy practice (GPP) indicators 2 3 0

Facility specific indicators Order in the pharmacy Essential materials available in the pharmacy Dispensing indicators Labelling Mixing of medicines Information/percentage of informed customers

××

×××

(Paphassarang et al. 2002; Sy-hakhang 2002)

3. Clinical area/disease-oriented indicators 0 23 1

GeriatricsPolypharmacy (an order of ≥ 5 medications per resident) Inappropriate medication use (based on established criteria by Beers MH and Strand LM )

××

(Mamun et al. 2004)

Obstetrics Seizure treatment and prophylaxis with magnesium sulphateAntihypertensive treatment was given when blood pressure ≥ 160/110 mm HgRespiratory rate and tendon reflexes monitored in women treated with magnesium sulphateIntravenous access and hydration was achieved in women with obstructed laborAntibiotic prophylaxis was given during caesarean deliveryIntravenous access achieved and crystalloids and/or colloids should be infused in women with postpartum haemorrhageAdministration of uterotonics was recorded

××

×

×

××

×

(Liabsuetrakul et al. 2008)

Malaria, diarrhoea and pneumonia Indicator for in/out patient treatment of malaria in adherence to standard treatment guideline (STG)Indicator for in/out patient treatment of pneumonia in adherence to STGIndicator for in/out patient treatment of diarrhoea in adherence to STGPercentage of children <5 with ARI given antibiotics

×

×××

(Vang et al. 2006; Chareon-kul et al. 2002; Wahlstrom et al. 2003)

49



AsthmaPreventer (corticosteroid inhalers) – reliever (short-acting beta agonist inhalers) prescription ratio in asthma treatment

×(Chong et al. 2008)

DiabeticAntiplatelet therapy to prevent cardiovascular disease in diabetic patients over age 40 year old

×(Kanchanaphi-bool et al. 2009)

Psychosis Patients hospitalised for an acute episode of psychosis and prescribed an antipsychotic medication on dischargePatients treated with antipsychotic medication for at least three months and received a medication adjustment following persistent psychotic symptoms or antipsychotic-related side effectsPatients discontinued from antipsychotic medications and have a do-cumented plan for recognizing and responding to signs of relapsePatients who had at least four medications or psychotherapy visits with a psychiatrist within a year from first visitPatients treated with antipsychotic medication and evaluated for medication side effect within three months of prescriptionPatients who had either one inpatient admission or two outpatient visits for psychosis within a 12-month period and received education about their prescribed medications and side effectsPatients prescribed oral antipsychotic drugs, reported medication non-compliance and received depot maintenance therapy

×

×

×

×

×

×

×

(Chong et al. 2006)

Tuberculosis (TB)Percentage of smear-positive TB patients who received correct TB drugs in correct dosagesPercentage of new smear-positive TB out-patients with correct knowledge of TB treatment

×

×

(Uchiyama et al. 2006)

4. Others 2 0 0

National Drug Policy (NDP)The use of standard treatment guidelines (STGs)Drug and Therapeutics Committee (DTC)DTC drug information

×

×

(Vang et al. 2006; Paphassa-rang et al. 2002)

St, structure; Pr, process; Ot, outcome; The classification of structure, process and outcome indicators based

on the aspect of care as described by Donabedian.

Full lists of indicators used in original articles were not shown; only indicators relating to quality use of

medicines were reported.

Chapter 3

Errors in medication preparation

and administration

in Vietnamese hospitals:

An observational study

Nguyen HT, Nguyen TD, Doan TMD, van den Heuvel ER, Haaijer-Ruskamp FM, Taxis K

Submitted

53

Abstract

Background: Evidence from developed countries showed that medication errors are common and harmful. Little is known about medication errors in resource-restricted settings, including Vietnam.

Objectives: To determine the prevalence and potential clinical outcome of medi-cation preparation and administration errors, and to identify factors associated with errors.

Design and setting: This was a prospective study conducted on six wards in two urban public hospitals in Vietnam.

Methods: Data of preparation and administration errors of oral and intravenous medications was collected by direct observation, 12 hours per day on 7 consecutive days, on each ward. Multivariable logistic regression was applied to identify factors contributing to errors.

Results: In total, 2060 out of 5271 doses had at least one error. The error rate was 39.1% (95% confidence interval 37.8%–40.4%). Experts judged potential clini-cal outcomes as minor, moderate, and severe in 72 (1.4%), 1806 (34.2%) and 182 (3.5%) doses. Factors associated with errors were drug characteristics (administra-tion route, complexity of preparation, drug class; all p values < 0.001), and adminis-tration time (drug round, p = 0.023; day of the week, p = 0.024). Several interactions between these factors were also significant. Nurse experience was not significant. Higher error rates were observed for intravenous medications involving complex preparation procedures and for anti-infective drugs. Slightly lower medication error rates were observed during afternoon rounds compared to other rounds.

Conclusions: Potentially clinically relevant errors occurred in more than a third of all medications in this large study conducted in a resource-restricted setting. Educational interventions, focusing on intravenous medications with complex preparation procedure, particularly antibiotics, are likely to improve patient safety.

Keywords: hospital, medication errors, observation, patient safety, Vietnam

55

Errors in medication preparation and administration in Vietnamese hospitals

Introduction

Medication errors are a global issue, especially prescribing and administration errors (Krahenbuhl-Melcher et al. 2007; Ross et al. 2000). Drug administration is important because the possibilities to prevent or correct errors at this stage are lim-ited. A recent review showed a median error rate of 8% in medication preparation and administration (Keers et al. 2013). Most of these studies have been carried out in developed countries. In such countries, patient safety issues have been recognised a long time ago and efforts to increase medication safety such as implementation of electronic prescribing systems, barcoding, and involving clinical pharmacists at the ward level are on-going (Duckers et al. 2009).

Little is known about patient safety in resource-restricted settings, i.e. devel-oping and transitional countries (Jha et al. 2010). One of the few large studies found that 2.5% to 18.4% of hospital admissions were associated with an adverse event and about 30% of those resulted in the death of the patient which was much higher than those in developed countries (Wilson et al. 2012). Poor health system infrastructure and inadequately trained healthcare staff probably contributed to this. Two small scale studies on medication errors, each including about one thousand preparations and administrations, have been carried out in a Malaysian hospital (Chua et al. 2010; Chua et al. 2009). Error rates were around 8%, which is comparable to the median error rate reported by Keers et al. (2013). More evidence is needed from other resource-restricted settings. Especially, studies with a larger sample size which allow investigation of factors contributing to errors to identify appropriate approaches to prevent errors. In this study, we determined the prevalence and potential clinical outcome of medication preparation and administration errors in two Vietnamese hospitals and identified associated factors in a multifactorial model.

Methods

Study design and setting

This prospective study, using an observation-based approach, took place on six wards in two major public hospitals in a large city in Vietnam. In each hospital we studied an intensive care unit (ICU) and a post-surgery (PS) ward, in hospital A we also studied one general internal medicine (GIM) and in hospital B one trauma unit (TU).

Commonly used medications were kept at the ward. The remainder of the medications was dispensed from the pharmacy department every morning for the

56

Chapter 3

weekdays, and on Friday morning additionally for the weekend. Orders for medi-cations were written by doctors onto the patient’s medical records. Nurses tran-scribed prescriptions either manually into inpatient drug charts (paper, hospital A) or entered them into the patients’ electronic drug use records in a computer and printed out the drug regimen for each patient (hospital B). All medications were prepared and administered by nurses referring to these charts. Medication prepara-tions were undertaken either in a separate room or on a dedicated trolley. Every drug administration on the ward was recorded in the nurse chart and on a disclosure form at the patient’s bedside which was attached to the patient’s medical record on discharge. Clinical pharmacists were not available at ward level.

Data collection

Data were collected between March and June 2011 by four pharmacy students (two in each hospital) using direct observation (Dean & Barber 2001). The students were trained for about a week in observation technique by lectures on medication error research as well as ward-based observations by a senior researcher to ensure all observers used the same definition of an error. A one-day observation pilot was conducted on each study ward prior to commencement of the main study to help the observers get familiar with medications and procedures of the study wards. This also helped nursing staff get comfortable with someone being around and minimized the Hawthorne effect (Allan & Barker 1990).

At the beginning of each drug round, the observer asked the nurse in charge for permission to observe. Nurses were told that the observer was a pharmacy stu-dent who wanted to learn more about ward-based drug preparation and administra-tion. The observer followed the nurses during all intravenous and oral drug prepara-tion and administration. Data were collected 12 hours per day (7 am–7 pm) on seven consecutive days (Monday–Sunday) on each ward. Details of drug preparation and administration were recorded on the pre-specified data collection forms. Nurses’ and patients’ identity was anonymised and kept confidential. For ethical reasons, the observer intervened in case of potentially serious medication errors about to reach the patient in a non-judgmental manner. These errors were also included in the analysis. After each round of observation, the observer went through all the observa-tion notes and compared the information observed with the doctor’s orders to detect any discrepancies. All collected data was revised by a senior researcher to ensure the validity and reliability of the data. Disagreements were resolved through discussion.

The study was approved by Medical Ethics Committee and Management Board of the study hospitals.

57


Definitions

Medication errors were defined as deviations in preparation and administration of oral or intravenous medications from the doctor’s prescriptions, the hospital poli-cies and procedures or the manufacturer’s instructions (Chua et al. 2009; Taxis & Barber 2004). Medication errors were classified into the following categories, simi-lar to that used by other authors (Wirtz et al. 2003; Tissot et al. 2003): wrong drug, wrong dose, wrong dosage-form, deteriorated drug, wrong preparation technique, omission, unordered drug, and wrong administration technique. An error could be classified in one category only (Table 1).

Table 1. Types of medication errors

Type of errors Definition

Prep

arat

ion

Wrong drug Preparation of a drug which differs from that prescribed

Wrong dose Preparation of a dose that is higher than, or less than, the amo-unt prescribed (± 10%)

Wrong dosage-form

Formulation of drug deviates from that prescribed

Deteriorated drug Preparation of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised

Wrong preparation technique

Inappropriate procedure or improper technique in the prepara-tion of a drug (compared to the manufacturer’s instructions or hospital policy, including wrong diluent, wrong solvent, wrong volume, possible incompatibility)

Adm

inist

ratio

n

Omission Failure to administer an ordered dose to a patient

Unordered drug Administration to the patient of non-prescribed medication

Wrong administration technique

Inappropriate procedure or improper technique in the admini-stration of a drug (rate, incompatibility, route, dose (± 10%) if prepared with correct dose)A rate error was identified if administration took less than 3 or more than 5 min (for a bolus dose) or 15% shorter/longer than the required infusion time (for an infusion dose).An incompatibility error was determined if there was incompa-tibility information available in at least one of four documents including the Handbook on Injectable Drugs, 15th edition (Trissel 2009), AHFS Drug Information 2009 (American Society of Health-System Pharmacists 2009), Vietnam National Drug Formulary, 2nd edition (Vietnam Ministry of Health 2009) and the manufacturer’s instructions.

58

Chapter 3

Potential clinical outcomes of errors

A 10-point validated scale between zero (labelled as no harm) and 10 (death) was used to assess the clinical outcomes of drug errors. Four healthcare professionals (one doctor, one nurse, and two pharmacists) scored the potential clinical outcome of each medication with one or more errors (i.e. erroneous dose). The mean score was calculated, a value below 3 suggested a minor outcome, of 3–7 a moderate outcome, and above 7 a severe outcome (Dean & Barber 1999).

Data analysis

We calculated the overall error rate (with 95% confidence interval) as percentage by dividing the number of doses with one or more errors (i.e., erroneous doses) by the sum of given doses plus omitted doses, which were called total opportunities for errors (TOEs), then multiplying it by 100. The rate of each error type was calculated by dividing the number of errors of that particular type by the sum of given doses plus omitted doses, then multiplying it by 100.

Multivariable logistic regression was performed to explore factors associated with errors. Independent variables were characteristics of drug (ATC – Anatomical Therapeutic Chemical – class, complexity of preparation, and administration route), administration time (day of the week, drug round) and experience of nurse in charge, corrected for hospital, ward, and observer. The following definitions were used: medications were grouped using the ATC/WHO classification (http://www.whocc.no/atc_ddd_index), less commonly used medications, i.e. frequency around 5% or lower, were grouped as others. A medication preparation was defined as follows: simple preparations did not involve any manipulations, e.g. this included drawing up an injectable solution with a syringe. Complex oral preparations included manipula-tions such as crushing tablets or opening capsules and dissolving them. Complex intravenous preparations included manipulations of one or more steps such as recon-stituting a medication. Administration route were either intravenous (including short IV injections, bolus, and infusions) or oral. According to study wards/hospitals, there were five drug rounds a day: morning (7 am–11 am), lunch (11 am–2 pm), afternoon (2 pm–5 pm), evening (5 pm–9 pm), and night (after 9pm till 7am next day). So, our observation time (7 am to 7 pm) included four drug rounds. Nurse experience was classified into four groups: ≤ 1, > 1–2, > 2–6, and > 6 working years. We also included interactions terms (i.e. the effect of a specific factor was modified by the others) into the model. Backward elimination using the likelihood ratio test was applied to test for the effects of interactions and variables. The level of significance was set at 0.05.

59


Data were analyzed using SPSS statistical package (SPSS 20.0, SPSS Inc., IBM Corporation, Somers, NY, USA).

Results

A total of 6232 medications were prescribed during the study period. Among those, 5271 (84.6%) drug preparations and administrations involving 327 patients were included: 2996 in hospital A and 2275 in hospital B (Table 2).

Prevalence and potential clinical outcomes of errors

In total, 2060 out of 5271 doses had at least one error, affecting 92.4% (302 out of 327) patients. The error rate was 39.1% (95% confidence interval (CI) 37.8%–40.4%). Among those, 336 doses had 2 errors and 8 had 3 errors. Overall, 2412 errors were identified. There were 945 doses given earlier (< -1 hour) or later (> +1 hour) than the defined time, but these were not included as errors. Experts judged potential clinical outcomes as minor, moderate, and severe in 72 (1.4%), 1806 (34.2%) and 182 (3.5%) doses.

Most frequent errors were wrong administration technique (23.5%), followed by wrong preparation technique, omission, and wrong dose (15.7%, 2.3%, and 1.8%, respectively). There were no wrong dosage-form errors (Table 2).

Table 2. Frequencies of error types (n = 2412 errors out of 2060 erroneous doses)

Hospital A Hospital BTotal Rate

(%)Error type ICU PS GIM ICU PS TU

Wrong drug 2 0 55 3 2 2 64 1.2

Wrong dose 8 7 10 26 24 18 93 1.8

Wrong dosage-form 0 0 0 0 0 0 0 0.0

Deteriorated drug 5 0 0 0 4 0 9 0.2Wrong preparation technique 316 40 88 104 201 81 830 15.7

Omission 2 1 60 21 0 39 123 2.3

Unordered drug 1 8 12 7 13 15 56 1.1Wrong administration technique 257 212 191 136 265 176 1237 23.5

Total 591 268 416 297 509 331 2412

ICU: intensive care unit, PS: post-surgery, GIM: general internal medicine, TU: trauma unit.

60

Chapter 3

The observers intervened twice to prevent errors from occurring: one involved a mixture of 10 IU fast-acting insulin and 10 mL KCl 10% in glucose 5% to the wrong patient, the other was the wrong dose of midazolam (50 mg instead of 25 mg) which was about to be added to an infusion bag.

Factors associated with errors

Using backward elimination of interactions and variables in the logistic regres-sion analysis, corrected for hospital, ward, and observer, we observed that errors were associated with characteristics of the drug (administration route, complexity of preparation, ATC class, all p values < 0.001), and administration time (drug round, p = 0.023; day of the week, p = 0.024). All two-way interactions between administration route, complexity of preparation, and ATC class were significant (all p values < 0.001). There was also a significant interaction between ATC class and drug round (p = 0.007). Nurse’s experience was not significant.

To give more insight into the data, tables 3–5 describe error rates stratified by significant factors and interactions.

Much higher error rates were observed for intravenous medications than for oral ones (73.2% vs. 11.8%), and for complex preparation procedures than for simple ones (58.0% vs. 25.9%). Higher error rates were observed for intravenous medications involving complex preparation procedures than for simple intrave-nous ones (90.2% vs. 53.9%). This was consistent for most drug classes (Table 3).

In terms of drug class, the highest error rates (79.6%) were observed for anti-infective drugs (ATC class J). Probably because most of them were complex intravenous medications (724 out of 955). Low error rates were observed for car-diovascular drugs (ATC class C), but again, high error rates were observed for complex preparation procedures and intravenous administrations of cardiovascu-lar medications (Table 3).

61


Table 3. Number of included doses (n) and error rates (%) stratified by drug class, administration route and preparation procedure

Administration route Oral IntravenousTotal

Preparation procedure Simple Complex Simple Complex

n % n % n % n % n %

ATC class

A 731 9.4 370 21.1 72 91.7 187 92.5 1360 28.4

B 106 17.0 97 7.2 531 33.0 101 77.2 835 33.3

C 418 10.0 188 18.1 66 84.8 71 98.6 743 27.2

J 59 10.2 2 0.0 170 63.5 724 89.2 955 79.6

N 437 5.5 84 11.9 180 63.9 70 95.7 771 28.0

Others 255 20.4 182 3.3 79 91.1 91 96.7 607 35.9

Total 2006 10.5 923 14.6 1098 53.9 1244 90.2 5271 39.1

ATC: Anatomical Therapeutic Chemical

Medication errors seemed to be similar for all days of the week with error rates ranging from 36.0% to 42.0%. This could be explained by different charac-teristics of drugs used among days of the week. For example, about half of medi-cations (50.2%) prepared and administered on Mondays was simple oral. When stratifying the data by administration route and preparation procedure, almost all error rates were higher on Mondays compared to other days (Table 4).

Table 4. Number of included doses (n) and error rates (%) stratified by day of the week, administration route and preparation procedure

Administration route Oral IntravenousTotal

Preparation procedure Simple Complex Simple Complex

n % n % n % n % n %

Day of the week

Sunday 271 7.0 124 15.3 147 53.1 201 91.5 743 40.4

Monday 317 13.2 54 24.1 128 56.3 133 93.2 632 39.7

Tuesday 276 10.1 134 11.9 147 48.3 162 88.9 719 36.0

Wednesday 252 11.1 176 15.9 182 56.6 195 91.8 805 42.0

Thursday 314 10.2 165 10.9 181 51.9 190 86.8 850 36.4

Friday 298 10.7 139 13.7 167 54.5 169 87.6 773 37.5

Saturday 278 10.8 131 16.8 146 56.8 194 91.8 749 41.8

Total 2006 10.5 923 14.6 1098 53.9 1244 90.2 5271 39.1

62

Chapter 3

Slightly fewer errors occurred during afternoon rounds than at other times of the day. This was not consistent across all drug classes. For example, error rates of anti-infective medications (ATC class J) were similar across drug rounds (Table 5).

Table 5. Number of included doses (n) and error rates (%) stratified by drug class and drug round

Drug round Morning Lunch Afternoon Evening Total

n % n % n % n % n %

ATC class

A 618 32.2 253 31.6 404 18.6 85 37.6 1360 28.4

B 354 34.5 207 40.1 212 25.9 62 29.0 835 33.3

C 308 26.6 144 29.2 232 26.3 59 28.8 743 27.2

J 482 80.1 203 80.8 199 80.9 71 69.0 955 79.6

N 269 22.7 168 36.3 231 29.0 103 26.2 771 28.0

Others 248 39.1 111 28.8 190 31.6 58 50.0 607 35.9

Total 2279 41.6 1086 42.5 1468 32.6 438 39.3 5271 39.1

ATC: Anatomical Therapeutic Chemical

Discussion

Our study on six wards in two Vietnamese hospitals showed that in more than a third of all medication preparations and administrations potentially clinically rel-evant errors occurred. Errors were associated with drug characteristics (intravenous medications, complex preparation procedures, anti-infectives), and administration time (drug round and day of the week), but not associated with nursing experience.

The error rate of 39.1% (37.8%–40.4%) identified in our study is relatively high. Previous studies using similar methodology including oral and injectable medications found error rates (without time errors) between 7.5% and 33% (Chua et al. 2009; Tissot et al. 2003; Berdot et al. 2012; van den Bemt et al. 2002). Our higher error rate may be partly due to observing a high proportion of intravenous medications. This was 44% in our study whereas between 9% (Berdot et al. 2012) and 26% (Chua et al. 2009) intravenous/injectables were observed in other studies. In addition, the other studies did not include all days of the week (Chua et al. 2009; Tissot et al. 2003; Berdot et al. 2012; van den Bemt et al. 2002). Furthermore, there may have been subtle differences in the definition of a medication error. We were strict about criteria of preparation technique errors, where mixing/shaking errors

63


were included (for example a dose of ceftriaxone 1 g was incompletely dissolved in 10 mL sterile water because of insufficient shaking) while other authors did not clearly specify this. In contrast to the previous studies, the majority of erroneous doses in our study were judged to be potentially clinically significant and only few were considered minor. However due to different methods used to assess clinical outcome these data are difficult to compare.

In line with a recent review on intravenous medication errors (McDow-ell et al. 2010) we observed frequently administration technique, preparation tech-nique, omission and dose errors. About half of errors were wrong administration technique and most of these were rate errors involving bolus medications, which should have been given within 3–5 minutes according to the Vietnam National Drug Formulary (Vietnam Ministry of Health 2009). The second most common error involved preparation technique where nurses did not shake or mix properly while reconstituting intravenous medications or used the wrong volume of sol-vent/diluent. For oral medications, the most frequent preparation technique errors were crushing tablets or capsules that should not have been crushed, for example, sustained or extended release dosage-forms or coated tablets. Most omission and dose errors involved oral medications which were unavailable or where nurses misinterpreted/mistranscribed the prescriptions. In around 40% of dose errors, half the dose or twice the dose was given. For example, two tablets of alpha chy-motrypsin were given in the morning instead of administering this in two doses (morning and evening) as the doctor intended. This was probably due to ambigu-ous prescriptions: alpha chymotrypsin 1 tablet × 2. We did not find this type of error being reported in other studies.

Intravenous administration route had a bigger effect on error occurrence compared to oral one. The potential for errors increased when the (intravenous) medication involved a complex preparation process. This was in line with a previous study on intravenous medications showing that multiple step preparations involved more errors than simple ones (Taxis & Barber 2003). A recent review estimated that removing the reconstitution step (complex preparations) by providing prepared injections (simple preparations) would reduce the overall error rate from 73% to 17% (McDowell et al. 2010). Anti-infective drugs for systemic use were shown as the most error-prone medications as most antibiotics observed involved complex preparation procedures. We also found an association between administration time and errors. The risk for errors was higher at all times during the day except the after-noon round. A reason for this may be that the afternoon was the least busy time of the day for the nurses. For instances, in the morning nurses also had to take blood samples, transcribe prescriptions and during lunch and evening rounds, they had to give out meals. Underlying this could be frequent interruptions of staff during busy

64

Chapter 3

times on the wards (Westbrook et al. 2010) or the number of patients a nurse has to take care of (Tissot et al. 2003; Berdot et al. 2012). Day of the week was a significant term which remained in the final logistic regression model, but it was not easy to identify the most risky day for errors. This is probably due to unequal distribution of medications observed in terms of drug characteristics (i.e. administration route, preparation procedure, and ATC class) across days of the week. For example, a higher proportion of simple oral medications was prepared and administered on Monday (50.2%) compared to other days. When administration route and prepa-ration procedure were kept constant, Monday turned out to be an error-prone day. This has been reported in another study (van den Bemt et al. 2002).

Nursing experience was not significant, irrespective of administration route as well as type of preparation. In contrast, an Australian study on intravenous medications found that each year of experience, up to 6 years, reduced the risk of error by 11% (Westbrook et al. 2011). Maybe in Australia, nurses are continuously trained after graduation, while in Vietnam continuing education for healthcare professionals, including nurses, is a concept introduced recently (Vietnam Min-istry of Health 2008). Nurses may have learnt from the senior ones and they have little opportunities to update knowledge and practice. Alternatively, senior nurses may be better than junior ones, but because of more responsibilities they may have to carry out several tasks simultaneously and may be interrupted more often which is associated with errors (Westbrook et al. 2010).

A range of different measures are recommended for error reduction includ-ing improving the competence of healthcare professionals, controlling working environment, and enhancing the safety culture (Barber et al. 2003). Preparation technique errors could be reduced by providing medications, particularly intra-venous ones, with simple preparations such as ready to use medications which either prepared by pharmaceutical company or pharmacy department (McDow-ell et al. 2010). Administration technique errors, especially rate errors, could be eliminated by using (smart) infusion pumps (Lemoine & Hurst 2012). However, in the context of resource limited settings, the implementations of such interven-tions may be too costly and unfeasible. Nurse experience had no impact on the error rate. Guidelines seemed to be absent or not up to date on the study wards. This would suggest starting improvements by introducing an educational train-ing programme for nurses targeting the most error-prone medications (intrave-nous medication involving complex preparation procedures) as well as providing guidelines. A recent review confirmed that education, protocols and guidelines are a successful approach to reduce medication error rates (Manias et al. 2012). This would be in line with patient safety research from resource restricted set-

65


tings identifying inadequate training of clinical staff and lack of protocol/policy as important factors (Wilson et al. 2012). Errors were likely to occur during busy drug rounds (all drug rounds except afternoon). This would suggest that working patterns and/or system of medication management should be adapted to assign comparable workload for every drug round (Manias et al. 2012), and to minimize interruptions (Trossman 2010; Freeman et al. 2013), or to have dedicated nurses who are responsible for medication administrations, but research on the latter is inconclusive so far (Pathak 2008; Greengold et al. 2003). As a first step to foster a culture of safety, clinical/hospital pharmacists could discuss the errors and pre-vention strategies with ward staff. This would stimulate interests and concerns in patient safety, and create a comfortable environment to learn from errors. In later stages, implementation of an (non-punitive) error reporting system would be rec-ommended. In spite of underestimation, this system has been indicated as a valu-able tool for preventing future errors (Pierson et al. 2007).

In contrast to most previous studies on administration errors, we studied a large number of variables and interactions between these variables as potential factors contributing to errors. For instance, Chua et al. (2009) used χ2 test to find the effect of administration route and drug round. But an imbalance, e.g. more intravenous medications given during a particular round, will not be taken into account in univariable analysis. For example our descriptive data showed no dif-ferences in error rates between days of the week. Only after stratification, we found higher error rates on Mondays. Surprisingly, we found a number of significant interactions. This suggested that the complexity of clinical practice should be taken into account and confirmed the necessity of controlling for other factors, known or suspected to have an impact on errors, while evaluating potential factors. These findings have not been reported in the literature.

We used direct observation to detect errors which is recognized as the “gold standard” (Dean & Barber 2001; Flynn et al. 2002). The observation rate was high (84.6%) and observations were only missed in some cases, for example, if there was more than one nurse preparing/administering drugs at the same time or in cases where observation was inappropriate for seriously ill patients. It should be noted that part of the evening rounds and night shifts were not included. Therefore, the error rate during the night remains unknown. Almost all patients (92.4%) experi-enced at least one medication error during their hospital stay. As with all observa-tion based studies, we did not collect data on the real consequences of errors, but if only a fraction of the 3.5% potentially severe cases result in actual harm, there would be many patients affected, given the fact that about one thousand medica-tions were administered per week on each ward.

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Chapter 3

Conclusions

In this large study of medication preparation and administration errors in a resource-restricted setting, we found that potentially clinically relevant errors occurred in more than a third of all medications. Administration technique, preparation tech-nique, omission, and dose errors were most commonly encountered. Interventions, probably starting with education focusing on intravenous medications with complex preparation procedure, particularly antibiotics, are needed to improve patient safety.

Acknowledgments

The authors would like to thank all the students who participated in the data collec-tion. We also thank the four health professionals who assessed the clinical relevance of the data.

The authors acknowledge that this study was supported by the Netherlands Organization for International Cooperation in Higher Education (NUFFIC).

Conflict of interest

The authors have no conflicts of interest to disclose.

67


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Lemoine JB & Hurst HM (2012) Using smart pumps to reduce medication errors in the NICU. Nursing

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Chapter 4

Errors in preparation and administration

of insulin in two urban Vietnamese hospitals:

An observational study

Nguyen HT, Nguyen TD, Haaijer-Ruskamp FM, Taxis K

Nursing Research, 2014 Jan-Feb;63(1):68-72

73

Abstract

Background: Medication errors involving insulin are common, particularly during the administration stage, and may cause severe harm. Little is known about the prevalence of insulin administration errors in hospitals, especially in resource-restricted settings, where the burden of diabetes is growing alarmingly.

Objectives: The aim of this study was to determine the prevalence, type and poten-tial clinical outcome of errors in preparation and administration of insulin in resource-restricted setting hospitals.

Methods: This study was conducted on six wards in two urban public hospitals in Vietnam using a direct observation method. Details of insulin preparation and administration were collected by pharmacy students 12 hours per day on 7 con-secutive days on each ward. Potential clinical outcome was judged by a panel of four experts using a validated scale.

Results: The error rate was 28.8% (95% confidence interval 23.1%–35.2%, n = 66 out of 229 insulin doses), all with potentially moderate/severe outcome. Higher error rates were observed for infusion doses than for subcutaneous ones (80.0% vs. 22.5%, p < 0.01). Incorrect time, incorrect preparation/administration technique, and omis-sions were mostly encountered.

Discussion: Interventions suitable for resource-restricted settings need to be devel-oped and tested to improve insulin preparation and administration, probably start-ing with education and providing information, especially infusion doses.

Keywords: diabetes mellitus, insulin, medication errors, nursing care, Vietnam

75

Errors in preparation and administration of insulin in two urban Vietnamese hospitals

Introduction

Medication errors involving insulin are common and may cause severe harms or even death (National Patient Safety Agency 2010b). It has been reported that about one third of fatal medical errors are related to insulin therapy (Anonymous 2005). Insulin-related errors were more frequently observed during the adminis-tration stage (61%) compared with prescribing (17%) and dispensing (10%; Cous-ins et al. 2011). Errors are clinically important because insulin requires accurate dosing and timely administration as well as careful monitoring (Walden 2010). So far, most evidence of insulin-related errors is from national incident reporting sys-tems from developed countries. Omitted, delayed, incorrect insulin product, and incorrect dose were the most common insulin-related adverse drug events (Cous-ins et al. 2011; Pennsylvania Patient Safety Advisory 2010). Omitted or delayed doses expose patients to longer periods of unanticipated hyperglycemia and could have serious consequences (National Patient Safety Agency 2010a). An incorrect dose or incorrect insulin product could lead to hypoglycemia or hyperglycemia (Cousins et al. 2011).

Although time consuming, direct observation of medication preparation and administration is considered the “gold standard” method to investigate the preva-lence and type of medication administration errors (Flynn et al. 2002). A recent review article showed that there are a considerable number of observation-based studies on medication administration errors in hospitals (Keers et al. 2013), but little knowledge specifically about insulin errors. Studies are particularly needed from resource-restricted settings, that is, developing and transitional countries, where the burden of diabetes is growing alarmingly. In such countries, attention for patient safety is insufficient because of poor health system infrastructure and inadequately trained healthcare staff (Wilson et al. 2012).

In Vietnam, it is estimated that 2.5% of people older than age 20 years experience diabetes mellitus type 2 (Beran 2008). The number of diabetes cases is expected to double in the next 20 years (Shaw et al. 2010). In general, diabetes care is not standardized, and currently, there is no national treatment guideline. Patients with diabetes are treated at home with oral glucose lowering medica-tions and/or insulin and have regular checkups in hospital outpatient clinics. They should be admitted to the hospital if they are having uncontrolled high blood glu-cose, complications, or comorbidities. Those patients may need to use insulin as an additional treatment, to switch from oral medications to insulin or to increase the insulin dose depending on the patient’s condition. Between 10% and 33% of hospitalized patients with diabetes were reported to use insulin (Beran 2008). In Vietnam, insulin is available in various types such as rapid-, short-, intermedi-

76

Chapter 4

ate-, and long-acting insulin (Beran 2008). In this study, the aim is to determine the prevalence, type, and potential clinical outcome of errors in preparation and administration of insulin in hospitals.

Methods

Setting

The study was conducted in two large public hospitals in a large city in Vietnam. Both are provincial general hospitals: hospital A has 700 beds, and hospital B has 1000 beds. In each hospital, an intensive care unit and a postsurgery ward were studied. In hospital A, one general internal medicine was studied, and in hospital B, one trauma unit was studied. Insulin doses were indicated by doctors and writ-ten in the patients’ medical records. Nurses transcribed prescriptions, including insulin, either manually on inpatient drug charts (paper, hospital A) or entered them into the patients’ electronic drug use records in a computer and printed out the drug regimen for each patient (hospital B). Nurses prepared and administered medications referring to these charts. Every medication administration on the ward was recorded in the nurse chart. Most nurses held an Associate’s Degree in Nursing. In each shift, each nurse was assigned three to six patients. Clinical phar-macists were not available at ward level. Commonly used insulins were stored in refrigerators on the wards.

Data collection

Data were collected between March and June 2011 – 12 hours per day for 7 con-secutive days on each ward – by four pharmacy students using the direct observa-tion method (Dean & Barber 2001). The students were trained for about a week through lectures and ward-based observations by a senior researcher to ensure all observers used the same definition of an error. Agreement between observ-ers was not performed. A 1-day pilot observation was conducted on each study ward – before the main study – to help the observers get familiar with the study wards. This also helped nursing staff get comfortable with the presence of observ-

77


ers (Allan & Barker 1990). The observers followed the nurses during preparation and administration and recorded all details of insulin doses. For ethical rea-sons, the observers intervened in case they were aware of a severe error reaching the patient (e.g., giving an unordered dose to a patient). These errors were also included in the analysis. Nurses were asked for permission to observe – but were not informed about the true purposes of the study – to minimize any bias, which might be caused by being observed. They were told that the observer was a phar-macy student who wanted to learn more about ward-based drug preparation and administration. Results were reported to the nurses after completion of the study. A follow-up educational intervention was designed (Nguyen et al. 2014).

Medication errors were defined as deviations in drug preparation and administration from the doctors’ prescriptions, the hospital policies and pro-cedures, or the manufacturers’ instructions (Chedoe et al. 2012). Medication errors were classified into nine categories: incorrect drug, incorrect dose, incor-rect dosage form, deteriorated drug, incorrect preparation technique, omission, unordered drug, incorrect time (including early and delayed), and incorrect administration technique (including incorrect route and incorrect administration rate; Table 1; (American Society of Hospital Pharmacists 1993; Barker et al. 2002; Wirtz et al. 2003). Potential clinical outcome of a dose with error(s) was judged by four experts (one doctor, one nurse, and two pharmacists) – who had at least 5 years working experience in the hospitals – using a validated scale between 0 (labeled as no harm) and 10 (death). A mean score below 3 suggested minor out-come, between 3 and 7 suggested a moderate outcome, and above 7 suggested a severe outcome (Chedoe et al. 2012).

The study was approved by the medical ethics committee and the manage-ment board of the study hospitals.

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Chapter 4


Error Definition

Incorrect drug Preparation of a drug that differs from the prescribed one.

Incorrect dose Preparation of a dose that is higher than, or less than, the amount prescribed (± 10%).

Incorrect dosage form

Formulation of drug deviates from the one prescribed.

Deteriorated drug Preparation of a drug that has expired or for which the physical or chemical dosa-ge-form integrity has been compromised.

Incorrect prepara-tion technique

Inappropriate procedure or improper technique in the preparation of a drug (com-pared with manufacture’s instruction or hospital policy, including wrong diluent, wrong solvent, wrong volume, and possible incompatibility).

Omission Failure to administer an ordered dose to a patient.

Unordered drug Administration to the patient of nonprescribed medication.

Incorrect time Administration to the patient of a medication at a different time from the prescri-bed or predefined time including early (less than -1 hour) and delayed (greater than +1 hour) doses.

Incorrect admini-stration technique

Inappropriate procedure or improper technique in the administration of a drug (rate, incompatibility, route, dose [± 10%] if preparation with correct dose). A rate error was identified if the administration took less than 3 or more than 5 minutes (for a bolus dose) or 15% shorter/longer than the period that the medication was supposed to be infused (for an infusion dose). An incompatible error was determined if there was incompatible information available in at least one of three documents including Handbook on Injectable Drugs 15th edition (Trissel 2009), AHFS Drug Information (McEvoy et al. 2009), and manufacturers’ instructions.

Data analysis

Descriptive analysis was performed using SPSS statistical package (SPSS 20.0, SPSS Inc., IBM Corporation, Somers, NY). The overall error rate (with 95% confidence interval) was calculated by dividing the number of doses with one or more errors (i.e., erroneous doses) by the sum of given doses plus omitted doses, then multiply-ing it by 100. The rate of each error type was calculated by dividing the number of errors of that particular type by the sum of given doses plus omitted doses, then multiplying it by 100. Differences in error rates between infusion and subcutane-ous doses were tested by chi-square test. Significant level was set at p < 0.05.

79


Results

Table 2. Error frequencies and examples

Error n %a Example

Incorrect drug 1 0.4 A dose of 20 IU of short-acting insulin was given instead of 20 IU of combined insulin (short- and long-acting insulin).

Incorrect dose 1 0.4 A dose of 15 IU of combined insulin was given instead of 25 IU as prescribed.

Incorrect dosage form

0 0.0

Deteriorated drug 0 0.0

Incorrect prepara-tion technique

17 7.4 A dose of 5 IU of short-acting insulin and 10 mL of KCl 10% was prepared with 500 mL of NaCl 0.9%/glucose 5% instead of 500 mL of NaCl 0.9% as prescribed. The nurse did not mix the solution sufficien-tly when preparing the medication.

Omission 6 2.6 A dose of 10 IU of combined insulin was omitted.

Unordered drug 2 0.9 A patient received an infusion dose of 5 IU of short-acting insulin and KCl 10% 10 mL in 500 mL of glucose 5%, which were prescribed for another patient.

Incorrect time:early (less than -1 hour)

17 7.4 A dose of 10 IU of combined insulin was given to patient at 1 pm inste-ad of 4 pm as prescribed.

Incorrect time:delayed (greater than +1 hour)

24 10.5 A patient was prescribed combined insulin of 10 IU twice a day (8 am and 6 pm). The morning dose was given 2 hours late; the evening dose was given on time.

Incorrect admini-stration technique

7 3.1 A dose of 5 IU of short-acting insulin and 10 mL of KCl 10% in 500mL of NaCl 0.9%/glucose 5% was given in 5 hours instead of 8 hours and 30 minutes as prescribed.

Note. There were 75 errors in 66 of 229 insulin doses. IU = International Unit.

a Rate as a percent of 229 insulin doses.

Overall, 229 insulin doses (204 subcutaneous and 25 infusions) were included. Of which, 66 doses had at least one error, that is, an error rate of 28.8% (95% confidence interval 23.1%–35.2%). Fifty-eight doses (23.5%) were judged to have potentially moderate outcome, and eight doses (3.5%) were judged to have potentially severe outcome. Higher error rates were observed for infusion doses than for subcutaneous ones (80.0% vs. 22.5%, p < 0.01). Seven doses involved two errors, and one involved three errors; so in total, 75 errors were identified. More than half of all errors were incorrect time errors (54.7%), followed by incorrect preparation technique (22.7%), incorrect administration technique (9.3%), and omission (8.0%). There were no incorrect dosage forms or deteriorated drug errors (Table 2).

80

Chapter 4

Discussion

Errors occurred in about one third of all insulin doses with omitted, delayed, incor-rect drug and incorrect dose being the most frequent. This is in line with studies of insulin-related adverse drug events in the United Kingdom and in the United States (Cousins et al. 2011; Pennsylvania Patient Safety Advisory 2010). Omitted or delayed doses (encountered in 40% of all errors) expose patients to longer periods of unanticipated hyperglycemia and could have serious consequences (National Patient Safety Agency 2010a). An incorrect dose or incorrect drug (insulin prod-uct) could lead to hypoglycemia or hyperglycemia (Cousins et al. 2011). A high number of doses given too early – even 3 hours earlier than the scheduled time – was also observed. This could lead to hypoglycemia, which may have severe con-sequences, such as confusion, fainting or even seizures, coma, and death. Particu-larly high error rates were associated with infusions (80.0%), mainly preparation and administration technique errors. This is not surprising as infusions require more manipulations than subcutaneous doses. Hence, there were more opportuni-ties for errors in infusions.

Education is probably the first feasible step to achieve improvements (Chedoe et al. 2012). Providing posters at work stations and on insulin-storing refrigerators and attaching alert stickers to insulin products were successful to reduce fatal insulin dosing errors (Dooley et al. 2011). A broad range of other sug-gestions have been published but not formally evaluated. This includes providing wards with guidelines emphasizing potential insulin-related errors and highlight-ing the danger of such errors, particularly omitted and delayed doses (National Patient Safety Agency 2010a). Using insulin passports – small booklets providing patient information and records of the patient’s current insulin products (National Patient Safety Agency 2011) – and/or having dedicated nurses (or diabetes spe-cialist team) responsible for insulin (Walden 2010) has been recommended for reducing errors, such as incorrect insulin product, incorrect dose, and omitted/unordered doses. Other recommendations include having nurses double check medication, making use of centralized preparation of doses in the pharmacy department, changing the supply system to ensure timely medicine supply, and making policies to promote safety culture (National Patient Safety Agency 2010a; Grissinger 2003). Technological interventions, such as electronic prescribing, bar-coded administration, and the use of smart pumps, may also be powerful to prevent incorrect drug, incorrect dose, unordered drug, and rate errors (Pham et al. 2012; Lemoine & Hurst 2012). But such solutions are not feasible in a resource-restricted

81


setting. In practice, successful implementation of quality improvement strategies needs a multidisciplinary team with strong leadership endorsed by hospital man-agers (Hughes 2008).

As in other observation-based studies (Keers et al. 2013), information about the actual harms of errors were not collected. However, the error rate was high, and all erroneous doses were considered having potentially clinically moderate or severe outcomes. This may be because of the constraints of the resource-restricted setting, such as poor health system infrastructure and inadequately trained health-care staff (Wilson et al. 2012). Errors are preventable, so any harm arising from these incidents is too much. This suggested an urgent need of feasible strategies to improve insulin preparation and administration. Cost-effective interventions suitable for resource-restricted settings need to be developed and tested, probably starting with education and providing information.

Acknowledgments

The authors would like to thank all the students who participated in the data col-lection. We also thank the four health professionals who assessed the clinical rel-evance of the data.




82

Chapter 4

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hospitals. American Journal of Hospital Pharmacy 50, 305-314.

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Beran D (2008) Report on the rapid assessment protocol for insulin access in Vietnam 2008. International

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Report-Vietnam.pdf [Accessed 30 January 2013].

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cational intervention on medication preparation and administration errors in neonatal intensive

care. Archives of Disease in Childhood-Fetal and Neonatal Edition 97, F449-F455.

Cousins D, Rosario C & Scarpello J (2011) Insulin, hospitals and harm: a review of patient safety incidents

reported to the National Patient Safety Agency. Clinical Medicine (London, England) 11, 28-30.



Dooley MJ, Wiseman M, McRae A et al. (2011) Reducing potentially fatal errors associated with high

doses of insulin: a successful multifaceted multidisciplinary prevention strategy. BMJ Quality &

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macy and Therapeutics 28, 628.

Hughes RG (2008) Tools and strategies for quality improvement and patient safety. In: Patient safety and

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Society of Health-System Pharmacists Inc., Bethesda (MD), USA.

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National Patient Safety Agency (2010a) Rapid Response Report NPSA/2010/RRR009: Reducing harm from

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Agency. http://www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=66720 [Accessed 30 Janu-

ary 2013].

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tion of insulin – Supporting information. UK: National Patient Safety Agency. http://www.nrls.npsa.

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319-324.

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Journal of Diabetes Nursing, 14, 258-263.





Chapter 5

The effect of a clinical pharmacist-led

training programme

on intravenous medication errors:

A controlled before and after study

Nguyen HT, Pham HT, Vo DK, Nguyen TD, van den Heuvel ER, Haaijer-Ruskamp FM, Taxis K

BMJ Quality & Safety, 2014 Apr;23(4):319-324

87

Abstract

Background: Little is known about interventions to reduce intravenous medication administration errors in hospitals, especially in low- and middle-income countries.

Objective: To assess the effect of a clinical pharmacist-led training programme on clinically relevant errors during intravenous medication preparation and adminis-tration in a Vietnamese hospital.

Methods: A controlled before and after study with baseline and follow-up mea-surements was conducted in an intensive care unit (ICU) and a post-surgical unit (PSU). The intervention comprised lectures, practical ward-based teaching sessions and protocols/guidelines, and was conducted by a clinical pharmacist and a nurse. Data on intravenous medication preparation and administration errors were col-lected by direct observation 12 h/day for seven consecutive days. Generalised esti-mating equations (GEE) were used to assess the effect of the intervention on the prevalence clinically relevant erroneous doses, corrected for confounding factors.

Results: 1204 intravenous doses were included, 516 during the baseline period (236 on ICU and 280 on PSU) and 688 during the follow-up period (407 on ICU and 281 on PSU). The prevalence of clinically relevant erroneous doses decreased sig-nificantly on the intervention ward (ICU) from 64.0% to 48.9% (p < 0.001) but was unchanged on the control ward (PSU) (57.9% vs. 64.1%; p = 0.132). GEE analysis showed that doses on the intervention ward were 2.60 (1.27–5.31) times less likely to have clinically relevant errors (p = 0.013).

Conclusions: The pharmacist-led training programme was effective, but the error rate remained relatively high. Further quality improvement strategies are needed, including changes to the working environment and promotion of a safety culture.

Keywords: hospital, intervention study, medication errors, patient safety

89

The effect of a clinical pharmacist-led training programme on intravenous medication errors

Introduction

Intravenous therapy is associated with higher rates of medication admin-istration errors compared to orally administered medications (Shane 2009; Nguyen et al. 2013). In Vietnam, about three quarters of all intravenous doses were erroneous (Nguyen et al. 2013), which is considerably higher than error rates in other settings reported in a recent review (Keers et al. 2013). Most intra-venous medication administration errors occur during reconstitution and injec-tion (McDowell et al. 2010). Intravenous errors have been shown to be related to insufficient knowledge of practical procedures, deviations from protocols/guidelines and nurses’ experience (Taxis & Barber 2003a; Taxis & Barber 2004a; Stavroudis et al. 2010; Westbrook et al. 2011). This suggests that educational inter-ventions targeting the specific error-prone stages could be useful to improve med-ication safety. Such interventions have shown a reduction in medication errors in high-income countries (Ford et al. 2010; Chedoe et al. 2012; Manias et al. 2012). Technical interventions, such as advanced infusion pumps and bar code technol-ogy, have also been suggested as methods to help reduce medication administra-tion errors (Duckers et al. 2009; Pham et al. 2012); however, large scale implemen-tation of such tools will be difficult in low- and middle-income countries.

In low- and middle-income countries, patient safety is still a neglected area, with little known about medication errors. Health system infrastructures are weak and there is a poor safety culture. Inadequate training of clinical staff and lack of protocols/policy have been identified as important factors compro-mising patient safety (Jha et al. 2010; Wilson et al. 2012). The effect of educa-tion on medication preparation and administration errors has rarely been studied in lower-income countries. An exception is a recent study in an intensive care unit (ICU) in Chile. A considerable reduction in various types of medication errors was found after a multifaceted intervention was implemented, including the participation of a clinical pharmacist in clinical rounds, standardisation of medication use, training, and the introduction of a medication error reporting system (Romero et al. 2013). However, lessons learnt from high-income nations are not always applicable. In the context of limited resources, the implementation of expensive technology-based interventions is not feasible. Education, therefore, could be considered as the first practical step to improve patient safety. The aim of this study is to measure the effect of a clinical pharmacist-led training pro-gramme on clinically relevant errors during intravenous medication preparation and administration in a Vietnamese hospital.

90

Chapter 5

Methods

Setting

The study took place in a major public hospital in Vietnam. The pharmacy service in the hospital was based on ward stock supply. Commonly used medications were kept on the ward, while other medications were dispensed from the pharmacy department every morning for weekdays, and on Friday morning for the weekend. Medications prescribed by the doctors were noted on the patient’s medical record and then entered into the computerised drug use record for each patient by nurses who printed out the patient’s drug regimen. This print-out was used as the infor-mation source for preparing and administering drugs. Medication preparation was carried out in a separate room. Every drug administration on the ward was recorded on the nurse chart and disclosure form at the patient’s bedside, which was attached to the patient’s medical record on discharge. No clinical pharmacists were attached to the wards. The majority of nurses held a baccalaureate degree (2 years’ training). Continuing education for healthcare professionals, including nurses, has only been introduced recently in Vietnam. Hence, nurses in the study hospital received further training infrequently (less than once a year). The study was conducted on an ICU and a unit caring for critical ill patients after surgery (a post-surgical unit, PSU). Nurses worked in shifts. On each shift, a nurse took care of three or four patients and gave about 18-20 intravenous doses. During the baseline period, no written instruc-tions for preparing drugs were available on the wards.

Study design

This is a prospective controlled before and after study with baseline and follow-up mea-surements using the direct observation method (Dean & Barber 2001), conducted in two critical care units: an ICU (the intervention ward), and a PSU (the control ward).

Definition

Medication errors were defined as deviations in drug preparation and administra-tion from the doctor’s prescription, hospital policies and procedures or the manufac-turer’s instructions (Taxis & Barber 2004b; Chua et al. 2009). Medication errors were further classified into eight categories (Table 1) (Tissot et al. 2003; Wirtz et al. 2003).

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The clinical relevance of each dose with one or more errors was judged by a panel of four experienced healthcare professionals (one doctor, one nurse, and two pharmacists) using a validated scale between 0 (labelled as no harm) and 10 (death). Assessors were blinded regarding ward and period. Mean scores below 3 suggested a minor outcome, scores of 3–7 a moderate outcome, and scores above 7 a severe outcome (Dean & Barber 1999). The last two outcomes were considered clinically relevant. This method has been used in similar studies (Chedoe et al. 2012; Taxis & Barber 2003b; Barber et al. 2009).


Type of errors Definition

Prep

arat

ion

Wrong drug Preparation of a drug which differs from that prescribed

Wrong dose Preparation of a dose that is higher than, or less than, the amount prescribed (± 10%)

Wrong dosage form

Formulation of drug deviates from that prescribed

Deteriorated drug Preparation of a drug that has expired or for which the physical or chemical dosage-form integrity has been compromised

Wrong preparation technique

Inappropriate procedure or improper technique in the preparation of a drug (compared to the manufacturer’s instructions or hospital po-licy, including wrong diluent, wrong solvent, wrong volume, possible incompatibility)

Adm

inist

ratio

n

Omission Failure to administer an ordered dose to a patient

Unordered drug Administration to the patient of non-prescribed medication

Wrong administration technique

Inappropriate procedure or improper technique in the administration of a drug (rate, incompatibility, route, dose (± 10%) if prepared with correct dose)A rate error was identified if administration took less than 3 or more than 5 min (for a bolus dose) or 15% shorter/longer than the required infusion time (for an infusion dose).An incompatible error was determined if there was incompatibility information available in at least one of four documents including the Handbook on Injectable Drugs, 15th edition (Trissel 2009), AHFS Drug Information 2009 (American Society of Health-System Pharmacists 2009), Vietnam National Drug Formulary, 2nd edition (Vietnam Ministry of Health 2009) and the manufacturer’s instructions.

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Intervention

Our previous study revealed that the most frequent errors were wrong administra-tion technique and wrong preparation technique (Nguyen et al. 2013). An educa-tional training programme to correct these two common errors was developed by a clinical pharmacist and the chief nurse in the study hospital. For example, wrong preparation technique was targeted through lectures, practice sessions and written guidelines by addressing reconstitution, compatibility and the correct preparation technique, such as the selection of appropriate diluents/solvents.

The intervention was carried out during 2 weeks in May 2012 in the prepa-ration room of the intervention ward and was repeated twice to ensure the full participation of all nurses. The programme consisted of the following:1. Classroom lectures: two 30-min teaching sessions with PowerPoint presentation

covering reconstitution, compatibility, administration rate and drug preparation and administration techniques were given by the clinical pharmacist.

2. Practice-based education: one 45-min practical session covering the preparation and administration of commonly used medications and including discussion of patient cases was carried out by the chief nurse.

3. Two posters on recommended practice for safe preparation and administration and emphasising the adverse consequences of inappropriate procedures, were attached to the wall of the preparation area. Written guidelines on the preparation and ad-ministration of commonly used intravenous drugs were made available on the ward during and after the intervention period. The posters and guidelines were prepared by the clinical pharmacist and the chief nurse.

Outcome

The prevalence of doses with clinically relevant error(s) was calculated.

Sample size

The sample size was estimated using the approximate formula for normality of proportion where the effect of the intervention is controlled for a possible change in event rate over time (Agresti 1996). The level of significance was set at 0.05 and

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the power was set at 0.8. The baseline clinically relevant error rate found in our previous study was about 70% (Nguyen et al. 2013). The estimated sample size was 177 intravenous doses per ward in each period in order to detect an absolute reduction in the error rate of at least 20% on the intervention ward.

Data collection

Medication errors were measured 2 weeks before (baseline, in April 2012) and 3 weeks after the educational programme was fully implemented (follow-up, in June 2012). Two observers were allocated to each ward (four observers in total). They collected data using direct observation of nurses (Dean & Barber 2001) for 12h each day (7:00–19:00) on seven consecutive days (Monday-Sunday) on each ward during each period. The observers were senior pharmacy students who were trained by an experienced observer for 1 week through lectures, discussions of medication errors from previous studies, and practice observations. A 1-day pilot observation was conducted on the study wards prior to the commencement of the main study to ensure all observers used the same definition of an error. All observation data were reviewed by the experienced observer. Also, the pilot study helped observers become familiar with ward routines (staff, medications, devices, schedules of drug rounds) and staff to feel comfortable with their presence in order to minimise the Hawthorne effect (Allan & Barker 1990).

The observation procedure was described previously (Chedoe et al. 2012). Briefly, the observers asked nurses for permission to observe, followed the nurses during drug preparation and administration, and recorded details of all intra-venous doses. Nurses were not informed about the true purpose of the study to minimise any bias which might be caused by that awareness. The observers were blinded to the intervention and were asked to minimise conversation with nurses and avoid the word ‘error’ during the observation process. For ethical reasons, the observers intervened if they became aware of a severe error potentially affect-ing a patient. These errors were also included in the analysis. After each round of observation, the observers reviewed all observation notes and compared the information with the doctor’s prescriptions, hospital policies and procedures, the manufacturer’s instructions and available literature to detect any discrepancies.

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Data analysis

The prevalence of clinically relevant errors was calculated by dividing the number of doses with clinically relevant errors by the number of opportunities for errors, which is the sum of given doses plus omitted doses (ie, prescribed but not given). Differences in the prevalence of clinically relevant errors between both periods were determined using Pearson’s χ² statistic. CIs were calculated using standard methods (Agresti 1996).

The impact of the intervention programme on medication errors was esti-mated with generalised estimating equations (GEE) using an exchangeable work-ing correlation matrix. A cumulative logit link function was applied for the ordinal variable of clinical relevance of error (ie, no error, minor error or moderate/severe error). The cluster variable was patient within ward. The analysis was controlled for drug characteristics (type of preparation, type of intravenous (IV) administration (ie, as a short IV/bolus dose or as an infusion), and ATC class (Anatomical Thera-peutic Chemical) according to the ATC/WHO classification (http://www.whocc.no/atc_ddd_index)), administration time (day of the week, drug round), ward, observer on the ward and period (ie, time effect) to eliminate possible imbalances between wards and periods. The interaction term between ward and period in the model represents the intervention effect.

Data were analysed using SPSS statistical package V.20.0 (SPSS, IBM, Somers, New York, USA).

Results

A total of 516 intravenous doses were included during the baseline period (236 on ICU and 280 on PSU) and 688 during the follow-up period (407 on ICU and 281 on PSU). The most frequently observed medications belonged to the blood/blood forming and anti-infective classes. The most common errors were wrong adminis-tration technique and wrong preparation technique (Table 2).

Examples of errors are given in online supplement appendix 1. On the intervention ward (ICU), the prevalence of clinically relevant errors decreased significantly from 64.0% to 48.9% (p < 0.001, χ² test). On the control ward (PSU), there was no change in the prevalence of clinically relevant errors (57.9% vs 64.1%; p = 0.132, χ² test) (Table 3).

http://www.whocc.no/atc_ddd_index

http://www.whocc.no/atc_ddd_index

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Table 2. Prevalence as percentage (95% CI) of different error types observed during baseline and follow-up periods*

Error type ICU (intervention ward) PSU (control ward)

Baseline (n=236)

Follow-up (n=407)

Baseline (n=280)

Follow-up (n=281)

Wrong drug 0.4 (0.0 to 1.2) 0.0 0.4 (0.0 to 1.1) 0.0

Wrong dose 11.4 (7.3 to 15.4)# 2.2 (0.8 to 3.6)# 6.1 (3.3 to 8.9) 4.6 (2.2 to 7.0)

Wrong dosage form 0.0 0.0 0.0 0.0

Deteriorated drug 7.2 (3.9 to 10.5)# 0.7 (0.0 to 1.5)# 2.1 (0.4 to 3.8)# 0.0#

Wrong prepara-tion technique 28.4 (22.6 to 34.2)# 14.0 (10.6 to 17.4)# 14.3 (10.2 to 18.4)# 26.3 (21.2 to 31.4)#

Omission 1.3 (0.1 to 2.7) 0.2 (0.0 to 0.6) 1.4 (0.0 to 2.8) 3.9 (1.6 to 6.2)

Unordered drug 2.1 (0.3 to 3.9) 2.7 (1.1 to 4.3) 4.3 (1.9 to 6.7)# 0.7 (0.0 to 1.7)#

Wrong admini-stration technique 44.9 (38.6 to 51.2) 46.9 (42.1 to 51.7) 61.4 (55.7 to 67.1) 54.1 (48.3 to 59.9)

*The sum of error rates exceeds the overall prevalence of errors as more than one type of error could be as-

sociated with each dose.

#Significant difference between baseline and follow-up (based on 95% CIs).

ICU, intensive care unit; PSU, post-surgical unit.

Table 3. Prevalence (95% CI) of clinically relevant errors

Ward Period Number of doses No error Minor error Clinically relevant

error

ICUBaseline 236 32.6% (26.6 to 38.6) 3.4% (1.1 to 5.7)# 64.0% (57.9 to 70.1)#

Follow-up 407 41.5% (36.7 to 46.3) 9.6% (6.7 to 12.5)# 48.9% (44.0 to 53.8)#

PSUBaseline 280 27.1% (21.9 to 32.3) 15.0% (10.8 to 19.1) 57.9% (52.1 to 63.7)

Follow-up 281 26.7% (21.5 to 31.9) 9.2% (5.8 to 12.6) 64.1% (58.5 to 69.7)

#Significant difference between baseline and follow-up (based on 95% CIs).

ICU, intensive care unit (the intervention ward); PSU, post-surgical unit (the control ward).

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The GEE analysis showed that drug characteristics (type of preparation, p < 0.001; type of intravenous administration, p < 0.001; and ATC class, p = 0.038) were all significant, but administration time (day of the week, p = 0.853; drug round, p = 0.438), observer on the ward (p = 0.295), and period (p = 0.274) were not. Ward was significant (p = 0.004) and the OR for the interaction term between ward and period (ie, intervention effect) was 2.60 (1.27–5.31), indicating that the educational programme was significantly effective in reducing clinically relevant errors (p = 0.013).

Discussion

The training programme was effective, with intravenous doses on the interven-tion ward being 2.6 times less likely to have clinically relevant medication errors as compared with pre-intervention/baseline. However, the overall error rate remained high, with about half of all intravenous doses having a potentially clinically relevant error. This may partly be due to the wards chosen for study, as the ICU has been reported to be an error-prone environment due to critically ill patients, heavy workload and complex clinical care (Bracco et al. 2001; Valen-tin et al. 2009). A study in a Chilean ICU evaluating an intervention with a simi-lar educational component, also showed a considerable reduction in error rates. However, the results are difficult to compare in more detail because of the many differences between the two studies (eg, the Chilean researchers also included pre-scribing errors, did not have a control group, etc) (Romero et al. 2013). There is a lack of other research on intravenous medication errors in resource-restricted settings for comparison with our results.

In line with previous studies evaluating educational interventions (Ford et al. 2010; Chedoe et al. 2012; Manias et al. 2012) the training programme was effective. However, poor medication safety is still a big problem. Preparation errors (including wrong dose, deteriorated drug, wrong preparation technique) were successfully reduced, but administration errors were approximately similar in both periods (Table 2), although administration procedures were part of the training programme. These mistakes mainly concerned bolus doses which were injected in less than 1 min instead of 3-5 min (examples are given in online sup-plementary appendix 1). Such errors might be related to contextual factors, such as workload (eg, many doses had to be given in a limited time), which are not changed by education. However, they might be reduced by other measures, for example, changes in working procedures (taking more time for drug administra-tion, using short infusions to administer some medications) (Cousins et al. 2005).

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In addition, promoting a safety culture around medication, including drug prepa-ration and administration, may be relevant. This could be achieved by increasing awareness of errors by emphasising the risks of inappropriate practice including fast drug administration, and introducing error reporting (Barber et al. 2003; Pier-son et al. 2007; National Patient Safety Agency 2010).

Other strategies including technical interventions (implementation of elec-tronic prescribing system, bar-code medication administration) and ready-to-use products (which are not always available for all medications) have been recom-mended to prevent medication errors (McDowell et al. 2010; Pham et al. 2012). However, little is known about which of these interventions are most successful in a specific setting. There is a need to balance evidence from research and experi-ence in the local context (ie, whether the intervention is feasible and accepted by nursing/local staff) (Hughes 2008). More importantly, in the restricted-resource settings, the cost of an initiative is an important factor.

Clinical pharmacists have been shown to improve the quality of patient care, for instance by reducing medication errors and (potential) adverse drug events (Kaboli et al. 2006; Brown et al. 2008; Abbasinazari et al. 2012; Mueller et al. 2012). Our study strengthens the evidence for the relevance of clinical pharmacy in a resource-restricted setting such as Vietnam. The success of our intervention was due not only to the pharmacist, but also to the willingness and efforts of the ward staff, especially the nurses. This underlines the importance of a collaborative approach. In practice, successful implementation of quality improvement strate-gies needs a multidisciplinary team with strong leadership endorsed by hospital managers (Hughes 2008).

A rigorous study design (ie, a quasi-experimental design with a control group) and sophisticated data analysis were used. Potential imbalances between the two wards and two periods in drug characteristics (type of preparation, type of intravenous administration (ie, as a short IV/bolus doses or as an infusion), and ATC class) and administration time (day of the week, drug round) were taken into account in the analysis. The time effect (ie, changes over time) was controlled by the effect of period. During the post-intervention period, more patients were admitted to the ICU (intervention ward), and hence a higher number of intravenous doses was observed. Several studies suggested that a higher workload is associated with a higher error rate (Tissot et al. 2003; Berdot et al. 2012), whereas we found a lower medication error rate. We are confident that the educational intervention produced the effect found in the study setting. We therefore recommend conducting this train-ing programme in similar settings as a first step to improving medication safety.

Our study has some limitations. Observers were blinded as to the true nature of the study, but they may have learnt from nurses on the intervention ward about

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the training sessions. We included “observer” in our statistical model, but this was not significant and so we believe that this has not influenced our results. As in other observation-based studies on medication errors (Keers et al. 2013), informa-tion about the actual harms arising from errors was not collected. Furthermore, we have not investigated the long term effect of the training programme (ie, if the change was maintained over time). There is a risk that healthcare providers return to baseline practice, so on-going efforts are needed, for example, to keep materials (guidelines/protocols) updated (Fan et al. 2010). Further research examining how often the training programme should be repeated is required.

Conclusions

The pharmacist-led training programme was effective in reducing clinically rel-evant intravenous medication errors, but the error rate remained relatively high. Further quality improvement strategies are needed and should include other approaches such as changes in the working environment and the promotion of a safety culture.

Acknowledgments

The authors thank all pharmacy students for participating in the data collection. We also thank the four health professionals who assessed the clinical relevance of the data.

Funding

This study was supported by NUFFIC (The Netherlands Organisation for Interna-tional Cooperation in Higher Education). The funder had no role in study design, data collection, analysis and interpretation, preparation of the manuscript, and decision to submit the paper.

Competing interests

None.

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Ethics approval

The study was approved by the medical ethics committee, management board and ward managers of Gia Dinh Hospital in Ho Chi Minh city, Vietnam.

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Chapter 6

Nurses’ perception of patient safety culture

and its association with medication errors:

A cross-sectional survey

in Vietnamese hospitals

Nguyen HT, Nguyen NH, Haaijer-Ruskamp FM, Taxis K

Submitted

105

Abstract

Background: Establishing a culture of safety is a high priority in healthcare in high-income countries. Limited evidence from low- and middle-income countries shows that there is a deficiency of safety culture and this is compromising patient safety.

Objectives: To measure nurses’ perception of safety culture across two public hos-pitals in Vietnam and to assess the association between this perception and the prevalence of intravenous medication errors.

Methods: A cross-sectional survey was conducted on six wards in two urban public hospitals in Vietnam using the safety attitudes questionnaire (SAQ). Data of intravenous medication errors was collected by direct observation, 12 hours per day on 7 consecutive days, on each ward. Descriptive statistics were used to calculate frequencies/percentages and means with standard deviations. Spearman rank correlation was used to test the relationship between subscales, selected items and the prevalence of intravenous medication errors.

Results: A total of 172 (out of 189, 91%) nurses returned the questionnaires. Over-all, subscale scores were between 46.1 ± 29.5 and 92.2 ± 15.6. The percentage of nurses holding positive attitudes ranged from 17.1% to 100.0%. Teamwork climate and working condition were the most positively perceived domains (i.e., consis-tently high scores across wards and high percentages of nurses being positive). The domains of perception of management and job satisfaction were also perceived relatively positively. Stress recognition and safety climate were the least positively conceived domains. The prevalence of intravenous medication errors was high across wards with about two thirds of doses involving clinically relevant error(s). There were no significant correlations between the prevalence of medication errors and any of the subscales of the SAQ. A significant correlation between difficulty of discussing errors and the prevalence of errors was found (rs = -0.986, p < 0.001).

Conclusions: Nurses in two urban Vietnamese hospitals had concerns about the safety climate and only few recognized stress as a factor which could affect their performance. To improve safety culture these factors should be addressed first. Safety culture was not directly linked to intravenous medication error rates.

Keywords: Safety culture, nurses’ perception, medication errors, Vietnam

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Nurses’ perception of patient safety culture and its association with medication errors

Introduction

Safety culture is receiving growing attention in the health care sector. In a hospi-tal, safety culture can be understood as how patient safety is perceived, structured and implemented in the organization (The Health Foundation 2011). Establishing a culture of safety has been a high priority in healthcare in high-income countries (Chassin & Loeb 2011). Usually, safety climate is measured as a diagnostic indi-cator for safety culture using surveys such as the safety attitudes questionnaire (Colla et al. 2005; Pronovost & Sexton 2005; Halligan & Zecevic 2011). A relation-ship between safety culture (or climate) and hospital morbidity, adverse events and readmission rates has been reported in various studies (Pronovost et al. 2005; Clarke 2006; Hofmann & Mark 2006; Singer et al. 2009; Valentin et al. 2013). Other studies have found no relationships between safety culture and patient out-comes (Rosen et al. 2010; Bosch et al. 2011). Limited evidence from lower-income countries shows that there is a deficiency of safety culture and this is compromis-ing patient safety (Jha et al. 2010; Wilson et al. 2012).

Medication administration errors occur frequently in hospitals, in particular with intravenous medication administration (Berdot et al. 2013; Keers et al. 2013). We found that about two thirds of intravenous doses were erro-neous in a study in a large urban hospital in Vietnam. An educational interven-tion was only partly successful in reducing the errors (Nguyen et al. 2014). Some evidence is available linking safety culture with medication errors (Hofmann & Mark 2006; Vogus & Sutcliffe 2007). A cross-sectional survey of nursing staff in 42 hospitals throughout the US found that fewer medication errors occurred in units with higher safety climate (Hofmann & Mark 2006). Another study carried out in 78 nursing units across various states of the US determined that safety climate had a negative relationship with reported medication errors (Vogus & Sutcliffe 2007). In these studies medication errors were investigated using medical records (Hofmann & Mark 2006) and error reporting (Vogus & Sutcliffe 2007). These methods are known to underestimate the rate of medication administration errors due to underreporting/lack of documentation of type of errors in medical records (Flynn et al. 2002). More studies investigating the relationship between safety culture and medication administration error rates are needed, to identify appropriate approaches to improve medication safety of this step in the process of drug use. In clinical practice, nurses carry out most of the medication admin-istrations. Furthermore, their perceptions of safety appear to contribute the most

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to unit safety culture (Huang et al. 2007; Huang et al. 2010) and appear to be more related to patient safety outcomes compared to perceptions of other staff (Singer et al. 2009).

The aims of this study were (1) to measure nurses’ perception of safety cul-ture in two public hospitals in Vietnam and (2) to assess the association between this perception and the prevalence of intravenous medication errors.

Methods

Setting and sample

This was a cross-sectional survey in two urban public hospitals in Vietnam. In each hospital we studied an intensive care unit (ICU) and a post-surgery (PS) ward, in hospital A we also studied one general internal medicine (GIM) and in hospital B one trauma unit (TU). Data were collected between January and June 2012. The study was conducted in collaboration with the pharmacy departments and approved by Medical Ethics Committee and Management Board of the study hospitals. A pharmacy student and two clinical pharmacists (one in each hospital) contacted the head nurses of the study wards and asked for permission to distrib-ute survey packages, each including a cover letter and a questionnaire. Surveys were handed to ward nurses during the weekly ward meeting. All nurses work-ing for at least one year on the study wards were invited to participate (n=189). Nurses were encouraged to return the completed questionnaires on the same day. In case nurses were too busy, the questionnaires were collected a few days later. Nurses’ responses were anonymous and informed consent was assumed when the questionnaires were completed and returned. A small gift of about 1.50 euro was offered to nurses who returned the questionnaire.

Safety culture was measured with the safety attitudes questionnaire (SAQ) – short form (available at: https://med.uth.edu/chqs/files/2012/05/SAQ-Short-Form-2006.pdf). This is one of the most frequently used measures, with robust psy-chometric properties (Sexton & Thomas 2003; Sexton et al. 2006; Jackson et al. 2010). The SAQ has 36 items and covers six domains: teamwork climate, safety climate, job satisfaction, stress recognition, perception of management (measured at both unit

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and hospital level), and working condition. The definitions of subscales have been described previously (Sexton & Thomas 2003; Sexton et al. 2006). For example, the subscale of teamwork climate was defined as perceived quality of collaboration between personnel. One researcher translated the SAQ from English into Vietnam-ese. The clarity was tested by ten volunteer nurses working outside the study wards. Amendments were made according to their suggestions. The questionnaire was then translated back to English by another researcher. Minor differences in wording and/or phrasing were found and revised to ensure the content was the same as the original version. For each item, the Likert response scale, ranking from 1 = disagree strongly, 2 = disagree slightly, 3 = neutral, 4 = agree slightly to 5 = agree strongly was used. Questions about demographic characteristics were added.

On each ward, data on intravenous medication errors were collected for 12 h each day (7:00–19:00) on seven consecutive days (Monday-Sunday) as part of a larger study on the prevalence of medication errors (Nguyen et al. 2013). We used the disguised observation technique as described previously (Nguyen et al. 2014). Briefly, the observers (pharmacy students) asked nurses for permission to observe, followed the nurses during drug preparation and administration, and recorded details of all intravenous doses. Nurses were not informed about the true purpose of the study to minimize any bias which might be caused by that awareness. The observers were asked to minimize conversa-tion with nurses and avoid the word ‘error’ during the observation process. For ethical reasons, the observers intervened if they became aware of a severe error potentially affecting a patient. These errors were included in the analysis. After each round of observation, the observers reviewed all observation notes and compared the information with the doctors’ prescriptions, hospital policies and procedures, the manufacturer’s instructions and available literature to detect any discrepancies. Intravenous medication administration errors were defined as deviations in intravenous drug preparation and administration from the doctor’s prescriptions, the hospital policies and procedures or the manufacturer’s instruc-tions (Taxis & Barber 2004; Chua et al. 2009). The potential clinical relevance of medication errors was judged by a panel of four experienced healthcare profes-sionals using a validated scale between zero (labeled as no harm) and 10 (death) (Dean & Barber 1999). Clinically relevant intravenous medication administra-tion errors were defined as having a mean score of 3 or higher (Taxis & Barber 2003; Barber et al. 2009; Chedoe et al. 2012).

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Data analysis

After reversing two items (2 and 11) with negative wording, we calculated the score of each subscale for each nurse (by taking the average of each set of items). A higher score suggests more positive attitude to the specific domain. The scores were then transformed to a 100-point scale by subtracting 1 from the mean and multiplying by 25. For each ward, we calculated means of subscales and the percentage of nurses having positive perception, i.e. score of 75 or higher, which is equal to “agree slightly” or “agree strongly” (Chaboyer et al. 2013).

The prevalence of clinically relevant errors per ward was calculated by dividing the number of doses with clinically relevant error(s) by the number of opportunities for errors, which is the sum of given doses plus omitted doses (i.e. prescribed but not given).

Data were analyzed using SPSS statistical package (SPSS 20.0, SPSS Inc., IBM Corporation, Somers, NY, USA). A significant level of 0.05 was used. Reliabil-ity of subscales was assessed using Cronbach’s alpha (α). Descriptive statistics were used to calculate frequencies/percentages and means with standard deviations. Spearman’s rank correlation was used to test the relationship between subscales and the prevalence of intravenous medication errors at ward level. Furthermore, we used Spearman’s rank correlation to test the relationship between the three items from the questionnaire which referred specifically to medication/medical errors and the prevalence of intravenous medication errors. The three items were:

— Item 8: “Medical errors are handled appropriately in this clinical area.” — Item 11: “In this clinical area, it is difficult to discuss errors.” — Item 13: “The culture in this clinical area makes it easy to learn from the errors of others.”

Results

Participants

In total, 172 (out of 189, 91%) nurses returned the questionnaires. The reasons for not participating in the survey were sick/maternity leave or being on holiday. Most of them were long-term employees (76.2%) involved in direct patient care (85.5%) with a median of 5-years working experience. During each shift, each nurse was assigned around 4 patients (Table 1).

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Table 1. Demographic characteristics of nurses responding to the Safety Attitudes Questionnaire (SAQ)

Characteristics n %

Hospital A 90 52.3

B 82 47.7

Gender Female 156 90.7

Male 16 9.3

Position Direct patient care 147 85.5

Administration/management function 25 14.5

Employment condition Permanent 131 76.2

Contract 41 23.8

Working type Rotating three shifts 75 43.6

Fixed shift (office hour only) 25 14.5

Fixed shift and occasional night shifts 72 41.9

Age Median 28.0 (24.0–34.8)

Experience years Median 5 (2–10)

Number of patients/ nurse/shift Median 4 (3–6)

Results of safety culture-related domains and intravenous medication errors

The internal consistency of the subscales was acceptable with Cronbach’s alpha rang-ing from 0.61 to 0.91 (Table 2). Overall, subscale scores were moderate (46.1 ± 29.5) to high (92.2 ± 15.6). The percentage of nurses holding positive attitudes ranged from 17.1% to 100.0%. Teamwork climate and working condition were the most positively perceived domains (i.e. consistently high scores across wards (means were in ranges of 72.3–83.3, and 68.5–88.5, respectively) and a large percentage of nurses having positive perceptions). In contrast, stress recognition and safety climate were the least positively conceived domains, i.e. having the lowest/second lowest scores on five out of six wards. Between 17.1% and 57.1% of nurses acknowl-edged that stress would influence their performance. On four out of six wards, only around a quarter of nurses had positive attitudes about safety climate (i.e. perceived a strong and proactive organizational commitment to safety), but the range was wide, 21.2% to 81.3%. The scores of the two remaining domains (perception of management and job satisfaction) were in the middle with a tendency of being positive, i.e. scores ranging around 60 to approximately 90 (Table 2).

112

Chapter 6

Tabl

e 2.

Res

ults

of s

ubsc

ales

pre

sent

ed a

s mea

n (M

) with

stan

dard

dev

iatio

n (S

D) a

nd p

erce

ntag

e of

nur

ses w

ith p

ositi

ve p

erce

ptio

n (%

),

Cro

nbac

h’s a

lpha

(α),

and

prev

alen

ce o

f int

rave

nous

(IV

) med

icat

ion

erro

rs (%

)

Team

wor

k cl

imat

e(α

= 0.

61)

Safe

ty cl

imat

e(α

= 0.

73)

Job

satis

fact

ion

(α =

0.82

)St

ress

reco

gniti

on(α

= 0.

87)

Perc

eptio

n

of m

anag

emen

t(α

= 0.

91)

Wor

king

cond

ition

(α =

0.83

)IV

m

edic

atio

n er

rors

(%)

M (S

D)

%M

(SD

)%

M (S

D)

%M

(SD

)%

M (S

D)

%M

(SD

)%

Hos

pita

l A

ICU

(n =

38)

74.8

(9.7

)60

.564

.7 (1

5.7)

21.1

72.0

(19.

2)68

.455

.9 (2

8.0)

42.1

69.6

(14.

2)47

.474

.8 (1

5.7)

73.7

76.0

PS (n

= 35

)72

.3 (1

4.7)

51.4

57.0

(15.

9)25

.762

.9 (1

4.1)

45.7

48.8

(22.

8)17

.160

.0 (2

4.8)

37.1

73.8

(17.

0)65

.767

.8

GIM

(n =

17)

77.2

(8.1

)58

.872

.9 (7

.0)

29.4

87.1

(10.

6)10

0.0

66.9

(15.

7)47

.182

.6 (8

.7)

100.

075

.5 (7

.5)

94.1

76.0

Hos

pita

l B

ICU

(n =

38)

81.1

(13.

3)81

.675

.5 (1

5.6)

60.5

80.9

(18.

5)89

.546

.1 (2

9.5)

36.8

72.7

(17.

1)47

.477

.4 (1

9.1)

68.4

67.9

PS (n

= 28

)76

.5 (8

.2)

64.3

68.0

(12.

0)25

.068

.6 (1

5.5)

42.9

69.0

(23.

6)57

.165

.7 (1

1.3)

21.4

68.5

(14.

9)50

.070

.5

TU (n

= 16

)83

.3 (9

.0)

93.8

78.1

(14.

6)81

.392

.2 (1

5.6)

93.8

51.2

(44.

6)50

.087

.9 (1

5.7)

93.8

88.5

(15.

2)87

.571

.1

Rang

e72

.3–8

3.3

51.4

–93.

857

.0–7

8.1

21.1

–81.

362

.9–9

2.2

42.9

–100

.046

.1–6

9.0

17.1

–57.

160

.0–8

7.9

21.4

–100

.068

.5–8

8.5

50.0

–94.

1

113


The prevalence of intravenous medication errors was high across wards with about two thirds of doses involving clinically relevant error(s) (Table 2).

Relationship between subscales, selected items and prevalence of intravenous medication errors

There were no significant correlations between the prevalence of medication errors on the different wards and any of the subscales of the SAQ. The Spearman’s rank correlation coefficients (rs) were between 0.203 and 0.580, p > 0.05. There was a sig-nificant correlation between item 11 (“In this clinical area, it is difficult to discuss errors.”) and the prevalence of errors (rs = -0.986, p < 0.001). The scores ranged between 3.24 and 4.09 (the lower the score the more difficult to discuss errors, reversed score). On the wards where nurses found it more difficult to discuss errors, more errors were made. About a third of nurses were either neutral or found it dif-ficult to discuss errors on their wards (34.3%, ranging from 11.4%–52.9%).

Discussion

Our survey of safety attitudes in two Vietnamese urban hospitals showed that nurses were positive about teamwork and working condition and relatively sat-isfied with management and their own job. They had concerns about the safety climate and relatively few recognized stress as a factor which could affect their performance. We observed a high prevalence of intravenous medication errors, but error rates were not correlated with safety attitudes at ward level. There was one exception, higher error rates were observed on wards where nurses found it more difficult to discuss errors.

We found that global scores and percentages of nurses having positive attitudes to safety domains were approximately the same as the ranges that have been reported previously (Huang et al. 2010; Lee et al. 2010; Profit et al. 2012). However, the overall patterns of safety attitudes are in contrast to studies from Western/developed countries where lower scores were observed for perception of management and working condition and higher scores for safety climate and stress recognition (Huang et al. 2007; Huang et al. 2010; Chaboyer et al. 2013; Profit et al. 2012), but similar to a recent study from Taiwan (Lee et al. 2010). This may partly be explained by differences in traditional values between Asian and Western countries (Wagner et al. 2013). More work has to be done to explore this issue and examine the practical relevance of possible differences. For example, if culture specific interventions are needed to change safety attitudes. Efforts to

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improve safety culture should focus on safety climate and stress recognition. There is limited evidence that poor safety climate can be improved by leadership walk-rounds or comprehensive unit-based safety programs (Morello et al. 2013). Ward/hospital managers should help nursing staff, especially those working in critical care units (ICUs and PSs), to recognize that stress can have a negative impact on performance (Huang et al. 2007). Crew resource-management training has been successful for this in the past (Haller et al. 2008).

We observed differences in safety attitudes between wards, but these were not related to intravenous medication error rates. This is in contrast to a few pre-vious studies which found that a better safety culture was related to fewer medica-tion errors (Hofmann & Mark 2006; Valentin et al. 2013; Vogus & Sutcliffe 2007). Studies are difficult to compare as previous studies investigated medication errors using record review (Hofmann & Mark 2006) or incident reporting (Vogus & Sutcliffe 2007). As has been already highlighted, both methods underestimate the prevalence of medication administration errors. Our finding is also in contrast with some other studies showing a relationship between safety culture and patient outcomes/adverse outcomes (Pronovost et al. 2005; Clarke 2006; Hofmann & Mark 2006; Singer et al. 2009; Valentin et al. 2013; Wang et al. 2013). There may be several reasons to explain our findings. First, safety culture is a complex con-cept and we used the SAQ which is a commonly used measure. Other aspects of safety culture not covered by the SAQ may be more important with respect to medication errors. An indication for this is the fact that we found a relationship for one item of the SAQ. Wards where nurses were able to discuss errors had lower error rates. Further, theoretical work is needed to investigate which aspects of safety attitude are (if at all) related to medication errors. Secondly, in the analysis we did not adjust for possible confounding factors such as workload, complex-ity of patient conditions or nurse-related factors. These factors are known either to affect the medication error rates (Tissot et al. 2003; Berdot et al. 2012) or to moderate the relationship between safety climate and medication errors/adverse events (Hofmann & Mark 2006; Wang et al. 2013). However, we did stratify the data by type of preparation (i.e. simple vs. complex), but no significant correla-tions were found (data not shown). A larger study including more wards allowing more sophisticated analysis is needed.

Our study contributes to the body knowledge of patient safety in lower-income countries (Jha et al. 2010; Wilson et al. 2012). This study is one of the first measurements of nurses’ perception of safety attitudes in resource-restricted setting hospitals using a robust psychometric instrument, the SAQ. We obtained a very good response rate (91%) which is higher than recommended (Sexton & Thomas 2003; Sexton et al. 2006). We found that the SAQ had acceptable reli-

115


ability with Cronbach’s α above 0.70 (except for teamwork climate, α=0.61) (Huang et al. 2007; Chaboyer et al. 2013), but further psychometric testing is required with larger samples to test the validity of the instrument in Vietnam. Results in non-urban hospitals and other clinical specialties may be different due to different staffing levels and training of staff. The SAQ can then be used for benchmarking for internal/external comparisons, preparation and evaluation of national/regional patient safety policies.

Conclusions

Nurses in two urban Vietnamese hospitals had concerns about the safety climate and only few recognized stress as a factor which could affect their performance. To improve safety culture these factors should be addressed first. Safety culture was not directly linked to intravenous medication error rates.

Acknowledgments

The authors would like to thank all the students who participated in the data col-lection. We also thank the four health professionals who assessed the clinical rel-evance of the data.




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Chapter 7


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Summary of the results

Patient safety in health care in low- and middle-income countries receives recently more attention, but is still a relatively neglected area with little knowledge about medication safety (Jha et al. 2010; Wilson et al. 2012). Our research addressed quality use of medications in South-East Asia by reviewing indicators assess-ing prescribing, dispensing and utilization of medicines. These indicators were infrequently used and the results indicated a sub-optimal quality use of medi-cines and raised the need of new valid, reliable and feasible indicators, especially for non-communicable diseases (Chapter 2). The extent and associated factors of medication preparation and administration errors in the specific setting of Viet-namese urban public hospitals were explored. Potentially clinically relevant errors occurred in a third of all medication preparations and administrations. Errors were likely to occur in intravenous medications, especially involving complex preparation procedures. Administration time (drug round and day of the week) was also associated with errors, but nursing experience was not (Chapter 3). In a sub-study we investigated errors involving insulin, because these carry a high risk of harm (i.e. a high-alert medication). We found that one or more errors occurred in about one-third of insulin doses. All erroneous doses were consid-ered having potentially clinically moderate to severe outcomes (Chapter 4). Clini-cally relevant intravenous medication errors could be reduced by an educational training programme focusing on the most common types of errors such as wrong preparation/administration technique (Chapter 5). Despite the high level of med-ication problems, nurses were neutral or even positive in their perception of safety culture in their hospitals, and only few recognized stress as a factor which could affect their performance. They did have concerns about safety climate. Therefore it is not surprising that perception of safety culture was not correlated to medication errors in general. Only one item appears to be relevant, intravenous medication error rates were associated with difficulty of discussing errors (Chapter 6).

Methodology of detecting and scoring the severity of medication administration errors

Direct observation was used to detect medication administration errors. This technique was developed about fifty years ago by Barker and McConnell (1962); since then it has been recognized as the “gold standard” (Dean & Barber 2001; Flynn et al. 2002) and used in various studies (Keers et al. 2013; Berdot et al. 2013). Briefly, a trained observer asked the nurse in charge for permission to observe,

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followed the nurse, and noted down all details of medication preparations and administrations. The notes were compared with doctors’ prescriptions, hospital policies/procedures or manufactures’ instructions to detect any discrepancies which were defined as medication errors. The observation method is considered superior to other approaches for investigating medication errors such as anony-mous self-reports, incident reports (including voluntary reports), the critical inci-dent technique, chart review, as it is more sensitive in detecting errors, is indepen-dent of people’s willingness to report or awareness of errors occurrence (Barker & McConnell 1962; Flynn et al. 2002; Barker et al. 2002). Observation explores people’s actual behaviour rather than what they intend to do or think they do as do many other methods.

A main limitation of direct observation is the Hawthorne effect (i.e. effect of the observer on the person being observed) (Allan & Barker 1990). It has been confirmed that the person being observed would get familiar with the observer after a while and return to his/her usual behaviour (Allan & Barker 1990). In our study we tried to neutralize such effects by including a one-day observation pilot on each study ward before starting the main study. This helped the observers get familiar with ward routines (staff, medications, devices, schedules of drug rounds) and nursing staff get comfortable with someone being around (Allan & Barker 1990). We kept the study “disguised”, i.e. nurses were asked for permission to observe, but were not informed about the true purposes of the study. They were told that the observer was a pharmacy student who wanted to learn more about ward-based drug preparation and administration. In this respect, it is important to emphasize that nurses’ and patients’ identities were anonymized and kept con-fidential. The observers only intervened in case of potentially serious medication errors in a non-judgmental manner. Using pharmacy students fits well with local context. The staff, especially nurses in the study hospitals were used to students (nursing, medical and pharmacy) being around. It would have been more difficult to explain the presence of hospital pharmacists or outside researchers. Also, the observers showed their willingness to learn from nursing staff about clinical/prac-tical issues in medication preparation and administration by talking informally with nurses when they had completed the observation. This created a friendly and comfortable environment between the observer and the observed. In addition, data were collected on seven consecutive days which should further reduce the Hawthorne effect as nurses become more familiar with the observers. To finally overcome observer bias, we carefully trained the pharmacy students for one week

123


prior to starting the study. This ensured that observers used the same definition of an error. Moreover, all data were revised by the experienced researcher. In the light of education, observation of drug administration rounds could be integrated in the curriculum of nursing, medical, and pharmacy schools/universities to teach students practical issues of medication safety.

Another limitation of the observation approach, the limited time frame of data collection, is more difficult to overcome, because of the labour intensive nature of the observation technique. We collected data for one week on each ward, covering six wards in total. Among observation based studies this is a rather large study (Keers et al. 2013; Berdot et al. 2013). However, within such a short time frame it is unlikely to study rare events. This means that complementary study methods should be employed to study such events, for example incident reporting (see clinical implications).

Different methods have been used to study the clinical impact of errors (Keers et al. 2013). We used a valid and reliable method for scoring severity of medication errors developed by Dean & Barber (1999). Briefly, four healthcare professionals (one doctor, one nurse, and two pharmacists) who had at least 5 years working experience in the hospitals scored the potential clinical outcome of each medication with one or more errors (i.e. erroneous dose) using a 10-point scale between zero (no harm) and 10 (death). The mean score was calculated, a value below 3 suggested a minor outcome, of 3-7 a moderate outcome, and above 7 a severe outcome (Dean & Barber 1999). The method is quick and does not require the knowledge about actual patient’s harm. The raters do not need to be trained as they are experienced healthcare professionals. This method has been used in previous studies on medication errors (Taxis & Barber 2003; Chedoe et al. 2012). The majority of potentially clinically relevant errors were considered as moderate and few were judged to be of minor or severe outcome. This pattern is somehow in contrast to previous studies where relatively more cases were judged to be minor (Taxis & Barber 2003; Chedoe et al. 2012). A possible explanation for this is that difference in culture may affect the view on (consequences of) medication errors. For example, a study validating this scoring method in German setting found that the German healthcare professionals gave lower mean scores compared to the UK ones (Taxis et al. 2002), implying German raters judged the cases in general as less harmful than did their UK peers. In the Asian culture, people may tend to have neu-tral judgments, avoid extreme opinions which may yield adverse effects on intra-group harmony and in-group solidarity (Wagner et al. 2013; Fujita et al. 2013).

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Implications for future research

Interventions to reduce medication errors

Educational interventions have shown a reduction in medication errors in high-income countries (Chedoe et al. 2012; Ford et al. 2010; Manias et al. 2012) and in lower-income countries as well (Romero et al. 2013). Our training programme focusing on the most error-prone stages (i.e. reconstitution and injection) strengthens the evidence for the impact of educational intervention on reducing clinically relevant intravenous medication errors in a resource-restricted setting (a Vietnamese hospital) (Nguyen et al. 2014b). This suggests that the educational programme could be employed as a first practical step to improving medication safety in similar settings. However, the long term effect of the education has not been investigated so far. There is a risk that healthcare providers return to baseline practice, so on-going efforts are needed, e.g. to keep materials (guidelines/proto-cols) updated (Fan et al. 2010). Further research examining how often the training programme has to be repeated is needed. In addition, the error rate remained high after implementation of the training programme suggests further investiga-tions of other interventions to reduce medication errors. This should focus on errors involving high-alert medications as insulin. For instance, researchers can test the impact of employing dedicated nurses responsible for insulin prepara-tion and administration (Walden 2010) or the effect of using additional labels for distinguishing insulin products (Dooley et al. 2011). The evidence-base for many of interventions to improve medication safety is weak and cost effectiveness has not been evaluated in the context of resource-restricted settings. This needs to be addressed in future research.

Safety culture

Building a culture of safety has been recommended as a crucial aspect of any high reliability organization in health care (Chassin & Loeb 2011). In the trend of grow-ing attention to patient safety, hospitals are encouraged to measure safety culture regularly as the first step to promote patient safety (Pronovost et al. 2005; National Patient Safety Agency 2009), usually using staff attitude surveys (Colla et al. 2005; Pronovost & Sexton 2005; Halligan & Zecevic 2011). Among several available tools, the safety attitudes questionnaire (SAQ) developed by University of Texas with robust psychometric properties (Sexton & Thomas 2003; Sexton et al. 2006;

125


Jackson et al. 2010) is one of the most widely tested, well validated and frequently used measures (The Health Foundation 2011). It covers six domains: teamwork climate, safety climate, job satisfaction, stress recognition, perception of man-agement, and working condition (Sexton & Thomas 2003; Sexton et al. 2006). The SAQ has been used in various settings to establish benchmarks, to evaluate safety improvement interventions (Colla et al. 2005; The Health Foundation 2011; Chaboyer et al. 2013; Meurling et al. 2013; Profit et al. 2012). We selected this tool for our study as it is relatively short, easy to complete and can be adapted to various contexts (The Health Foundation 2011). Furthermore, based on previous studies, it is more likely to show a link between safety culture scores and patient and staff outcomes compared to other tools (The Health Foundation 2011).

Our assessment of nurses’ perception of safety culture should be considered as one of the first baseline measurements in a resource-restricted setting. We hope that our study sparks discussions of safety culture in other similar health care orga-nizations/hospitals, and interventions/strategies/policies to promote safety culture should be designed, tested and monitored. Moreover, the fact that we did not find a correlation between medication errors and safety culture (Chapter 6) does not mean that this is not there. The relationship may be either indirect or more complex. For instance, the association between safety climate and medication errors has been shown to be moderated by the complexity of patient conditions (Hofmann & Mark 2006). Furthermore, safety culture measured by the SAQ is a broad concept encom-passing other medical safety issues rather than medication errors. Nurses in our study were quite optimistic about safety culture in their hospitals in spite of the high prevalence of medication errors. So, it is understandable that perception of safety culture was not correlated to medication errors. Further theoretical work is needed to investigate which aspects of safety attitude are (if at all) related to medication errors.

Implications for clinical practice

Role of the clinical pharmacist in improving medication safety in hospitals

Clinical pharmacists in hospitals have been shown to be able to reduce medication errors and (potential) adverse drug events (Kaboli et al. 2006; Brown et al. 2008; Abbasinazari et al. 2012; Mueller et al. 2012). Recent studies strengthen the evi-dence of the relevance of clinical pharmacy also in resource-restricted settings (Romero et al. 2013; Nguyen et al. 2014b). In Vietnam, the practice of clinical

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pharmacists has just started recently and their roles in the healthcare system are not well recognized so far (Vo et al. 2013). The role of the pharmacist has been expand-ing from dispensing medications to providing services about medication manage-ment to support rational drug use and to promote patient safety (Vo et al. 2013). With the development of more and more complex medications (new agents, vari-ous dosage-forms and usages), it is likely that this role will continue growing to support other healthcare providers and receivers to make optimal use of avail-able resources and to achieve expected therapeutic outcomes. Our study showed that the clinical pharmacist-led intervention was successful, but there is still room for improvement of medication safety (the error rate remained high after the intervention). Furthermore, our assessment of safety culture suggested that there should be regular discussions about medication errors among healthcare profes-sionals. The pharmacists should implement educational activities as discussed above, but in addition initiate the following measures (Klopotowska et al. 2011; Klopotowska et al. 2010; Pierson et al. 2007):

— Periodic assessment (audits) of the medication safety in a quality assurance program based on observation sheets.

— Multidisciplinary ward-based discussions of medication errors (clinical case conferences).

— Implementation of a (medication) error reporting system, especially to tackle rare and serious events.

Information from all of the above initiatives could be used to develop fur-ther tailor-made interventions. However, unfortunately little is known about which of these interventions are most successful in a specific setting. There is a need to balance evidence from research and experience in the local context (i.e. whether the intervention is feasible and accepted by nursing/local staff) (Hughes 2008). In prac-tice, successful implementation of quality improvement strategies needs a multidis-ciplinary team (was successful in our own study) with strong leadership endorsed by hospital managers (Hughes 2008). In this respect, hospitals should consider a comprehensive approach to manage the quality of care, which put people, process and products together in order to get optimal healthcare outcomes. In other words, these efforts should lead into the implementation of a quality control group in the hospital (Chang et al. 2010; Wang et al. 2013). This group should involve relevant people with different expertise, maybe the best solution for hospitals with scarce resources is to optimize the function of Drug and Therapeutic committee which is already established in most (if not all) hospitals. A clinical/hospital pharmacist should be a member of this multidisciplinary medical team and have the lead for medication safety and shared responsibility for overall safe patient care.

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Sufficient attention to/more research on non-communicable diseases in South-East Asian countries

Health and related matters in South-East Asian countries are an emerging focus for global health. The region is dealing with an increasing burden of non-com-municable diseases including diabetes and a rising demand for high quality health care (Acuin et al. 2011; Chongsuvivatwong et al. 2011; Coker et al. 2011; Dans et al. 2011; Kanchanachitra et al. 2011). So far, attention to patient safety is insufficient due to poor health system infrastructure and inadequately trained healthcare staff (Wilson et al. 2012). Our systematic review revealed sub-optimal quality use of medicines in South-East Asia and the need of valid and reliable indi-cators focusing on non-communicable diseases (Nguyen et al. 2012). In addition, high prevalence of errors involving insulin therapy was observed in the hospital setting. About a third of insulin doses was used in errors with potentially moderate/severe outcome (Nguyen et al. 2014a). These findings stress that medication use in non-communicable diseases in the South-East Asia needs attention. A start could be to develop/adopt adequate guidelines (e.g. WHO guideline) for this area (WHO 2012; American Diabetes Association 2014). For example in Vietnam, a national or hospital treatment guideline for diabetes should be developed to promote appro-priate prescribing (Beran 2008). Changes in quality of care could be monitored by using/adopting existing valid and reliable quality indicators related to diabe-tes mellitus and cardiovascular diseases, particularly the ones relevant to the local practice and culture to assess/monitor medicine use and quality of care (Martiro-syan et al. 2010). As non-communicable diseases require long-term treatment and patient involvement, it is relevant to investigate patient adherence and/or to test/promote a patient education programme encouraging adherence to therapy and appropriate medicine use (Murray et al. 2007; Holloway & van Dijk 2011).

Conclusions

Interest in medication safety has grown remarkably since publication of the report To Err is Human (Stelfox et al. 2006). There have been numerous stud-ies on medication errors conducted worldwide. The majority of evidence about (preventing) medication preparation and administration errors is from developed countries such as in the USA, in the UK or in the Netherlands (Keers et al. 2013; Berdot et al. 2013). In such countries, patient safety issues have been recognized a long time ago and efforts to increase medication safety such as implementation of electronic prescribing systems, barcoding, and involving clinical pharmacists at

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the ward level are on-going (Duckers et al. 2009). Much less is known about medi-cation errors in resource-restricted settings including Vietnam. Because of differ-ences in local practice, resource and culture, lessons learnt from other nations are not always applicable, especially the interventions employing expensive technol-ogy-based approaches. Every country seems to need some studies on assessing the safety of medication use and tailor-made strategies to improve the situation.

Medication safety in South-East Asian countries including Vietnam remains a neglected area with a limited number of studies explicitly using quality indicators, but those few studies show a sub-optimal quality use of medicines. We found that about one-third of all medications prepared and/or administered were erroneous including high-alert medications as insulin. Our educational training programme was effective in reducing clinically relevant intravenous medication errors, especially the most common types of errors such as wrong preparation technique. Nurses perceived safety culture in general as neutral to slightly positive, but had concerns about safety climate and were rarely aware that stress may influ-ence their performance. Medication error rates were associated with difficulty of discussing errors, but there was no correlation between safety culture domains and medication errors rates.

We hope that our results will trigger research on medication safety includ-ing non-communicable diseases and prompt managers and healthcare providers in Vietnam and similar countries in South-East Asia to review their own processes and systems to improve medication use.

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Addendum

Summary

Samenvatting (Dutch summary)

Tóm tắt (Vietnamese summary)

Acknowledgments

List of Publications

Curriculum Vitae

Previous Dissertations of SHARE

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Summary

Medication safety is an issue worldwide. It is estimated that more than half of all medicines over the world are prescribed, dispensed, sold or consumed inappro-priately (Chapter 1). In high-income countries, this has been recognized a long time ago and a lot of efforts are dedicated to improve medication safety. Much less is known about medication safety in low- and middle-income countries. A recent study in those countries indicated that 2.5% to 18.4% of hospital admis-sions were associated with an adverse event and about 30% of those resulted in the death of the patient (Chapter 1). This was much higher than results reported from high-income countries. Interventions such as electronic prescribing systems, barcoded medication administration, training healthcare providers, providing guidelines and involving clinical pharmacists at the ward level have shown signifi-cant improvements. Differences in local practice, resource and culture mean that lessons learnt from other nations are not always applicable. Therefore, research in low- and middle-income countries providing information on the extent and nature of the problem may contribute significantly to develop strategies for improvement in such a context. In this thesis, we focus on South-East Asia and in particular on Vietnam. In this region, there is a growing demand of better medical care driven by concerns about quality, affordability and safety of healthcare services. So far, the quality use of medicines or explicit methods to measure quality in South-East Asian countries have been addressed insufficiently. As a (relatively small) country located in the region, Vietnam has to deal with such healthcare-related challenges. Ensuring affordability and quality of the healthcare system is a national priority, and managers and policy makers have made efforts to support this, especially con-cerning rational use of medicines (Chapter 1).

The aim of the studies described in this dissertation was to gain more insight into medication safety in South-East Asian countries, especially in Viet-nam. Increasingly, pharmacists in Vietnamese hospitals have a clinical role. There-fore, special attention was paid to the role of the clinical pharmacist in improving medication safety in a Vietnamese setting. The thesis aimed:1. To identify studies explicitly using indicators of quality use of medicines in the

South-East Asian region answering the following three research questions: (i) which indicators have been used; (ii) what is known about the validity, reliabil-ity and feasibility of the existing indicators; and (iii) what are the main results based on the commonly used indicators (Chapter 2)?

2. To determine the prevalence and potential adverse clinical outcome of medica-tion preparation and administration errors in two Vietnamese hospitals and to identify associated factors in a multifactorial model (Chapter 3 & 4).

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3. To measure the effect of a clinical pharmacist led training programme on clini-cally relevant errors in intravenous medication preparation and administration in a Vietnamese hospital (Chapter 5).

4. To measure nurses’ perception of safety culture in two public hospitals in Viet-nam and to assess the association between this perception and the prevalence of intravenous medication errors (Chapter 6).

The thesis started with a study on indicators of quality use of medicines in South-East Asia (Chapter 2). We performed a systematic review using the most common databases (MEDLINE and Embase) and websites (The International Net-work for Rational Use of Drugs (INRUD) and The World Health Organization (WHO)). In total, seventeen original studies or reports explicitly using indica-tors assessing prescribing, dispensing and utilization of medicines and published between January 2000 and July 2011 were included. The studies were carried out in 7 out of 11 countries across the South-East Asian region. The majority of indicators measured the process rather than structure or outcome. The most frequently used indicators were WHO indicators focusing on general medication use in health facilities. The others were indicators measuring quality use of medicines in clinical areas (geriatrics and obstetrics) or specific diseases, such as diarrhoea and pneu-monia. There were very few non-WHO indicators addressing non-communicable diseases. Little information was available about validity, reliability and feasibility of the non-WHO indicators. The review identified that indicators of quality use of medicines were infrequently used in the region. As far as can be concluded from the information, quality use of medicines is clearly sub-optimal.

In order to explore the medication safety problem in a resource-restricted setting such as Vietnam, the next two chapters (Chapter 3 & 4) focused on inves-tigating medication administration errors on hospital wards. In Chapter 3, the extent of the problem (How many errors occur? What is the clinical relevance of the errors? What are the factors contributing to the errors?) was studied using the “gold standard” approach, i.e. the direct observation technique. Potential adverse clinical outcome was judged by a panel of four experts using a validated scale. The data was prospectively collected on six wards in two urban public hospitals in Vietnam, 12 hours per day on 7 consecutive days, on each ward. A relatively high error rate of 39.1% (2060 out of 5271 doses) was identified. Most frequent errors were incorrect administration technique, followed by incorrect preparation technique, omission, and incorrect dose. No incorrect dosage-form errors were observed. The majority of the errors were judged having potentially clinically moderate to severe adverse outcomes. Multivariable logistic regression analysis showed that errors were likely to occur in intravenous medications, especially

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involving complex preparation procedures. Administration time (drug round and day of the week) was also associated with errors, but nursing experience was not. Chapter 4 is a sub-study investigating the prevalence, type and potential adverse clinical outcomes of errors involving insulin, a high-alert medication. The study was conducted using the same approach in the same setting as the study described in Chapter 3. In total, 229 insulin doses were observed. In about one-third of the insulin doses, at least one error occurred and all erroneous doses were considered potentially clinically relevant. Higher error rates were observed in infusion doses which require more complex preparation procedures than subcutaneous doses. Incorrect time, incorrect preparation/administration technique, and omissions were mostly encountered. The results from both studies suggested that educational interventions, focusing on intravenous medications with complex preparation procedures are likely to improve patient safety.

In Chapter 5, the effect of an educational training programme led by a clinical pharmacist on clinically relevant errors during intravenous medica-tion preparation and administration in a Vietnamese hospital was assessed. This was a controlled before and after study with baseline and follow-up measurements conducted in two critical care units: an intensive care unit (ICU – the interven-tion ward) and a post-surgical unit (PSU – the control ward). The intervention package included lectures, practical ward-based teaching sessions and provision of protocols/guidelines. The intervention was implemented by a clinical pharmacist in collaboration with the chief nurse of the study hospital. Data on intravenous medication preparation and administration errors was collected by direct observa-tion 12 hours per day for seven consecutive days on each ward, each period. A total of 1204 intravenous doses were included, 516 during the baseline period (236 on ICU and 280 on PSU) and 688 during the follow-up period (407 on ICU and 281 on PSU). An analysis using generalized estimating equations determined that the educational intervention was effective in reducing clinically relevant errors. It was more than twice less likely to have an erroneous dose (p=0.013) on the interven-tion ward. However, the error rate remained relatively high. This implied a need of further quality improvement strategies, including changes to the working environ-ment and promotion of a safety culture.

Establishing a culture of safety is a high priority in healthcare in high-income countries. The limited evidence from low- and middle-income countries shows that there is a deficiency in safety culture and this is compromising patient safety (Chapter 1). In Chapter 6 we performed a cross-sectional survey on nurses’ perception of safety culture across six wards in two urban public hospitals in Viet-nam and investigated whether there is an association between safety culture and the prevalence of intravenous medication errors. The safety culture was explored

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using the safety attitudes questionnaire (SAQ), one of the most common mea-sures. Data on intravenous medication errors was taken from the study described in Chapter 3. In about two-thirds of intravenous doses, clinically relevant error(s) occurred. The analysis of 172 eligible returned questionnaires showed that nurses were quite optimistic in their perception of safety culture in their hospitals. Team-work climate and working condition were the most positively perceived domains. Only few recognized stress as a factor which could affect their performance in spite of the high prevalence of medication errors. Therefore it is not surprising that there were no correlations between perception of safety culture and medication errors. Only one item appears to be relevant, intravenous medication error rates were associated with difficulty of discussing errors.

Finally, the main findings of the thesis were summarized and discussed in Chapter 7. The thesis shows that there is still room for improvement and further investigations on strategies to enhance medication safety including promoting safety culture are needed. We would recommend tailor-made interventions involv-ing a multidisciplinary team with strong leadership endorsed by hospital manag-ers. Maybe the most feasible short term solution for scarce resources is to optimize the function of the Drug and Therapeutics committee which is already established in most (if not all) hospitals. Furthermore, the results indicated the need for more research on quality use of medications in non-communicable diseases in the South-East Asian countries. We hope that our studies will inspire researchers, managers and health care professionals in Vietnam and other countries in South-East Asia to review their own processes and systems to improve medication use.

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Medicatieveiligheid is wereldwijd een probleem. Er zijn schattingen dat de helft van alle medicatie op de wereld op een onjuiste manier wordt voorgeschreven, afgeleverd, verkocht of gebruikt (Hoofdstuk 1). In de rijke landen is dit probleem al jaren geleden gesignaleerd en worden er verschillende projecten ontwikkeld om de medicatieveiligheid te verbeteren. In midden- en laag-inkomen landen is er veel minder bekend over de medicatieveiligheid. Een recent onderzoek laat zien dat in deze landen bij 2,5% tot 18,4% van de ziekenhuisopnames ongewenste gebeurtenissen (adverse events) optreden. Daarvan is ongeveer 30% van de patiën-ten overleden, mogelijk ten gevolge van deze gebeurtenissen (Hoofdstuk 1). Deze cijfers zijn veel hoger dan in de rijke landen. Verschillende projecten hebben laten zien, dat verbeteringen mogelijk zijn. Voorbeelden zijn interventies zoals elektro-nische voorschrijfsystemen, gebruik maken van barcodes bij geneesmiddeltoe-dieningen, scholing van personeel, richtlijnen en meewerken van (ziekenhuis-)apothekers op afdelingen. Maar deze interventies zijn niet altijd goed toepasbaar in laag-inkomen landen, onder andere door een verschil in lokale uitvoerbaar-heid, cultuur en beschikbare middelen. Onderzoek in laag-inkomen landen kan dan ook een belangrijke bijdrage leveren aan de vermindering van het probleem door beter inzicht te krijgen in de oorzaak van de problemen en daarnaast bijpas-sende strategieën te ontwikkelen.

Dit proefschrift is gericht op Zuidoost- Azië en met name Vietnam. In deze regio bestaat een toegenomen vraag naar goede medische zorg veroorzaakt door bezorgdheid over de kwaliteit, betaalbaarheid en veiligheid van zorginstellingen. Op dit moment zijn er in Zuidoost- Azië onvoldoende gegevens beschikbaar over de kwaliteit van medicatiegebruik. Als (relatief klein) land in deze regio is het een uitdaging voor Vietnam om hiermee om te gaan. Betaalbare zorg van goede kwali-teit te bieden is een nationale prioriteit en beleidsmakers investeren veel om dit doel te bereiken, met specifiek aandacht voor het juiste gebruik van geneesmiddelen (Hoofdstuk 1).

Het doel van dit proefschrift is om meer inzicht te krijgen in de medica-tieveiligheid in Zuidoost- Azië, met name in Vietnam. Omdat de apotheker in Vietnamese ziekenhuizen in toenemende mate een klinische rol heeft is er veel aandacht besteed aan de rol van de “clinical pharmacist” in de verbetering van de medicatieveiligheid in Vietnamese ziekenhuizen. Het proefschrift heeft de vol-gende deelvragen:1. Overzicht te geven van onderzoeken die gebruik maken van indicatoren om de

kwaliteit van medicatiegebruik in Zuidoost-Azië in kaart te brengen, waar-bij antwoorden worden gegeven op de volgende vragen: (i) welke indicatoren

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worden gebruikt; (ii) wat is bekend over de validiteit, betrouwbaarheid en de uitvoerbaarheid van de beschreven indicatoren; en (iii) wat zijn de belangrijk-ste resultaten van deze veel gebruikte indicatoren (Hoofdstuk 2)?

2. Het vaststellen van de prevalentie van potentieel klinische uitkomsten van fou-ten tijdens het bereiden en toedienen van medicatie in twee Vietnamese zie-kenhuizen. En met behulp van een multifactorieel model de factoren bepalen die hierop van invloed zijn. (Hoofdstuk 3 & 4).

3. Meten van het effect van een scholingsprogramma van een klinisch apotheker op klinisch relevante fouten gedurende het klaarmaken en toedienen van intra-veneuze medicatie in een Vietnamees ziekenhuis (Hoofdstuk 5).

4. Het meten van de beleving van verpleegkundigen over de veiligheidscultuur in twee ziekenhuizen in Vietnam en de associatie hiervan met de prevalentie van medicatiefouten met intraveneuze medicatie (Hoofdstuk 6).

Het proefschrift begint met een beschrijving van medicatieveiligheid met de nadruk op de kwaliteit van medicijngebruik en een duidelijke en betrouwbare methode om deze kwaliteit te meten. Hiervoor is een systematische review uitge-voerd in Hoofdstuk 2, waarbij de databases (MEDLINE en Embase), de websites van The International Network for Rational Use of Drugs (INRUD) en de Wereld-gezondheidsorganisatie (WHO) zijn gebruikt. In totaal zijn 17 onderzoeken en rapporten, uitgevoerd in 7 landen in Zuidoost- Azië, meegenomen in de analyse. Deze onderzoeken zijn gepubliceerd tussen januari 2000 en juli 2010 en beschre-ven expliciet indicatoren om de kwaliteit van het voorschrijven, afleveren en het gebruik van medicijnen in kaart te brengen.

De meerderheid van de indicatoren beschreven het proces in plaats van de structuur of uitkomsten. De meest gebruikte indicatoren waren de WHO-indica-toren met een focus op medicatiegebruik in het algemeen in zorginstellingen. De andere indicatoren waren indicatoren, waarbij de kwaliteit van medicatiegebruik in een specifieke kliniek (geriatrie, obstetrie) of specifieke ziekten, zoals diarree en pneumonie werden beschreven. Daarnaast waren er nog een paar niet WHO indicatoren welke niet-overdraagbare ziekten bespraken. Er was weinig informatie beschikbaar over de validiteit, betrouwbaarheid en de uitvoerbaarheid van de niet WHO indicatoren. Uit de beschikbare informatie komt naar voren dat de kwaliteit van geneesmiddelgebruik duidelijk suboptimaal is.

Om het probleem van de medicatieveiligheid in onderontwikkelde landen, zoals Vietnam, te onderzoeken is in Hoofdstuk 3 & 4 gefocust op toedieningsfou-ten op verpleegafdelingen in het ziekenhuis. In Hoofdstuk 3 wordt de omvang van het probleem (hoeveel fouten zijn er, wat is de klinische relevantie van de fouten en welke factoren dragen bij aan de totstandkoming van de fouten) onderzocht


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door middel van directe observatie, dat als de gouden standaard onderzoeksme-thode voor dit soort problemen geldt. De klinische relevantie van de mogelijke bijwerkingen werd door 4 experts beoordeeld met een gevalideerde schaal. De data zijn prospectief gedurende 12 uur, op 7 achtereenvolgende dagen op 6 afdelingen in 2 openbare ziekenhuizen in Vietnam verzameld. Het aantal fouten was 39,1% (2060 van 5271 doseringen). Veel voorkomende fouten waren: verkeerd voorge-schreven medicatie, gevolgd door een verkeerde bereiding, vergeten medicatie en verkeerde doseringen. Fouten in verkeerde doseringsvormen zijn niet waargeno-men. Het merendeel van de fouten had potentieel matig tot ernstig negatieve gevol-gen. De multivariabele logistische regressie toonde aan dat fouten meer optraden bij intraveneuze medicatie, met name wanneer de bereiding uit meerdere stap-pen bestond. De toedieningstijden (geneesmiddelronde, dag van de week) bleken samen te hangen met de kans op fouten. Er was geen samenhang met de ervaring van de verpleegkundige. Hoofdstuk 4 is een deelonderzoek waarbij is gekeken naar de prevalentie, het type en klinische uitkomsten bij fouten met insuline. In dit onderzoek is dezelfde strategie gebruikt als bij het onderzoek zoals beschreven in Hoofdstuk 3. In totaal zijn 229 doseringen met insuline onderzocht. In ongeveer een derde van de insuline doseringen zat tenminste één fout en alle fouten waren geclassificeerd als mogelijk klinisch relevant. De kans op fouten was hoger indien het middel via een infuus werd toegediend, omdat hier ingewikkeldere bereidings-tappen voor nodig zijn dan bij subcutane toedieningen. Verkeerde tijd, verkeerde bereiding/toediening techniek en vergeten doseringen kwamen veelvuldig voor. De resultaten van beide onderzoeken laten zien dat scholing, waarbij de nadruk ligt op het klaarmaken van intraveneuze medicatie, een bijdrage kan leveren aan het verbeteren van de medicatieveiligheid.

In Hoofdstuk 5 wordt een onderzoek naar het effect van een scholingspro-gramma door een klinisch apotheker op klinisch relevante fouten tijdens het klaar-maken en toedienen van intraveneuze medicatie in het ziekenhuis beschreven. Dit was een gecontroleerd onderzoek waarbij een voor en na meting is gedaan op twee afdelingen met een intensieve behandeling, een ‘intensive care’ afdeling (de inter-ventie afdeling) en een ‘recovery afdeling’ (controle). De interventie bestond uit voordrachten, praktische scholing op de afdelingen en het opstellen van protocol-len en richtlijnen. De interventie werd georganiseerd door een klinisch apotheker in samenwerking met de hoofdverpleegkundige van het ziekenhuis. De fouten van het klaarmaken en toedienen van intraveneuze medicatie werden onderzocht door middel van observaties gedurende 12 uur, op 7 achtereenvolgende dagen, op elke afdeling en in elke periode. In totaal zijn 1204 intraveneuze toedieningen meege-nomen in het onderzoek, 516 gedurende de voormeting (236 op de IC en 280 op de recovery) en 688 gedurende de follow- up periode (407 op de IC en 281 op de


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recovery). Statistische analyse (met generalized estimating equations) toont aan dat het scholingsprogramma het aantal klinische relevante fouten reduceert. Op de controle afdeling was de kans twee keer zo groot om een foute dosering te krijgen dan op de interventie afdeling (p = 0.013). Echter bleef het foutpercentage nog steeds hoog. Dit benadrukt de behoefte voor verdere verbetering van de kwaliteit, waarbij ook aandacht is voor de werkomgeving en de veiligheidscultuur.

Rijke landen leggen veel nadruk op het behouden van een goede veilig-heidscultuur. In laag- en midden-inkomen landen blijkt de veiligheidscultuur tekort te komen in vergelijking met de westerse landen (Hoofdstuk 1). In Hoofd-stuk 6 wordt een cross-sectioneel onderzoek beschreven naar de beleving van ver-pleegkundigen van de veiligheidscultuur op 6 afdelingen in twee openbare zieken-huizen in Vietnam. In dit onderzoek werd onderzocht of er een verband bestaat tussen de veiligheidscultuur en het optreden van mediatiefouten bij intraveneuze toedieningen. De veiligheidscultuur werd onderzocht aan de hand van een van de meest gebruikte vragenlijsten, de veiligheid attitudes vragenlijst. Voor het meten van de intraveneuze medicatiefouten werd gebruik gemaakt van de data uit het in Hoofdstuk 3 beschreven onderzoek. Bij ongeveer twee derde van de intraveneuze doseringen zijn klinisch relevante fouten geconstateerd. Uit de 172 ingevulde vra-genlijsten kwam naar voren dat de verpleegkundigen optimistisch gestemd zijn over de veiligheidscultuur in hun ziekenhuis. Slechts enkele verpleegkundigen gaven stress aan als factor voor het mogelijk ontstaan van medicatiefouten. Er was dan ook geen verband tussen de veiligheidscultuur en het optreden van intrave-neuze medicatiefouten. Verpleegkundigen die op afdelingen werkten met hogere fout-percentages vonden het moeilijker om fouten te bespreken.

De belangrijkste resultaten van dit proefschrift zijn samengevat in Hoofd-stuk 7. Er is nog steeds ruimte voor verbetering. Een verdere ontwikkeling van verbeter-strategieën is dan ook zeker van groot belang. Daarbij verdient het aan-beveling om meer aandacht te besteden aan de veiligheidscultuur en maatregelen ontwikkeld door een multidisciplinair team met steun van de ziekenhuismana-gers. De beste oplossing zou kunnen zijn om de farmacotherapiecommissie, die in (bijna) alle ziekenhuizen aanwezig is, te optimaliseren. Daarnaast laten de resultaten ook zien dat er behoefte is aan meer onderzoek naar de kwaliteit van medicatiegebruik in niet-overdraagbare ziekten in Zuidoost-Azië. We hopen dat dit proefschrift andere onderzoekers zal inspireren om meer onderzoek te doen naar de medicatieveiligheid en daarnaast managers en zorgverleners zal aanzet-ten tot het verbeteren van hun eigen processen en systemen om de kwaliteit van medicijngebruik te verbeteren.


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Sử dụng thuốc an toàn là một mối quan tâm hàng đầu trên toàn thế giới. Ước tính trên toàn cầu có hơn một nửa lượng thuốc được kê toa, phân phối, bán hay sử dụng không hợp lý (Chương 1). Ở các nước có thu nhập cao, vấn đề sử dụng thuốc an toàn đã được nhìn nhận từ rất lâu, và nhiều giải pháp nhằm nâng cao chất lượng sử dụng thuốc đã được thiết lập. Ở các nước có thu nhập thấp và trung bình, vấn đề này ít được quan tâm. Một nghiên cứu gần đây ở các nước này cho thấy từ 2,5% đến 18,4% các trường hợp nhập viện có liên quan đến một biến cố không mong muốn, và 30% trong số đó gây ra tử vong cho bệnh nhân (Chương 1). Các con số này lớn hơn rất nhiều so với các kết quả ghi nhận được từ các nước có thu nhập cao. Một số can thiệp như sử dụng hệ thống kê toa điện tử, sử dụng mã vạch trong thực hiện thuốc, đào tạo nhân viên y tế, cung cấp các hướng dẫn về sử dụng thuốc và tham gia của dược sĩ lâm sàng tại khoa điều trị đem đến những cải thiện đáng kể. Tuy nhiên, những giải pháp này không phải lúc nào cũng áp dụng được ở tất cả các nước do có sự khác biệt về thực hành lâm sàng, nguồn lực và văn hóa. Do đó, nghiên cứu về sử dụng thuốc an toàn ở các nước có thu nhập thấp và trung bình giúp cung cấp thông tin về quy mô và bản chất của vấn đề, có thể đem đến những đóng góp quan trọng cho việc xây dựng các chiến lược cải thiện sử dụng thuốc thích hợp. Trên cơ sở đó, luận án này được thực hiện, tập trung vào nghiên cứu hiện trạng sử dụng thuốc trong khu vực Đông Nam Á, đặc biệt là ở Việt Nam. Trong những năm gần đây, nhu cầu chăm sóc sức khỏe của người dân trong khu vực ngày càng tăng về cả loại hình cũng như chất lượng điều trị. Bên cạnh đó, chi phí và tính an toàn của các dịch vụ y tế cũng được quan tâm nhiều hơn. Tuy vậy, chất lượng sử dụng thuốc cũng như các phương pháp cụ thể để đo lường chất lượng chưa được quan tâm đúng mức. Là một nước (tương đối) nhỏ trong khu vực, Việt Nam cũng phải đối mặt với những thách thức y tế này. Đảm bảo tính hợp lý về chi phí và chất lượng của hệ thống y tế là một trong những ưu tiên mang tính chất quốc gia. Các cấp quản lý cũng đã và đang nỗ lực rất nhiều để thực hiện điều này, đặc biệt là những vấn đề liên quan đến sử dụng thuốc hợp lý (Chương 1).

Mục tiêu của các nghiên cứu mô tả trong luận án này là thu được những hiểu biết sâu sắc hơn về sử dụng thuốc an toàn ở các nước trong khu vực Đông Nam Á, cụ thể là ở Việt Nam. Hơn nữa, luận án đặc biệt chú ý đến vai trò của dược sĩ lâm sàng trong việc nâng cao an toàn sử dụng thuốc tại Việt Nam. Các mục tiêu cụ thể của luận án bao gồm:1. Xác định các nghiên cứu được tiến hành trong khu vực Đông Nam Á có sử

dụng các chỉ số đo lường chất lượng sử dụng thuốc một cách rõ ràng, để trả lời ba câu hỏi sau: (i) các chỉ số nào đã được sử dụng; (ii) thông tin gì đã biết

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về tính hợp lệ (validity), độ tin cậy (reliability), và tính khả thi (feasibility) của các chỉ số hiện hành; và (iii) kết quả thu được từ các chỉ số được sử dụng nhiều nhất là gì (Chương 2)?

2. Xác định tỷ lệ và hậu quả lâm sàng tiềm tàng của các sai sót trong chuẩn bị và thực hiện thuốc tại hai bệnh viện ở Việt Nam; đồng thời xác định các yếu tố ảnh hưởng đến sai sót bằng một mô hình phân tích đa yếu tố (Chương 3 & 4).

3. Đánh giá hiệu quả của một chương trình đào tạo do dược sĩ lâm sàng chủ trì đối với những sai sót quan trọng trên lâm sàng, xảy ra trong quá trình chuẩn bị và thực hiện thuốc tiêm truyền tại một bệnh viện ở Việt Nam (Chương 5).

4. Đo lường nhận thức của điều dưỡng về văn hóa an toàn (safety culture) tại hai bệnh viện ở Việt Nam, và khảo sát mối tương quan giữa nhận thức của điều dưỡng và tỷ lệ sai sót trong sử dụng thuốc tiêm truyền (Chương 6).

Mở đầu luận án là một nghiên cứu về các chỉ số đo lường chất lượng sử dụng thuốc ở Đông Nam Á (Chương 2). Chúng tôi thực hiện một nghiên cứu tổng quan có hệ thống (systematic review) dựa trên các cơ sở dữ liệu (MEDLINE và Embase), và các trang web (the International Network for Rational Use of Drugs (INRUD) và the World Health Organization (WHO)) thông dụng nhất. Chúng tôi ghi nhận, trong khoảng từ tháng 01/2000 đến 07/2011, có tổng cộng 17 báo cáo/nghiên cứu ban đầu (original studies) có sử dụng các chỉ số một cách rõ ràng để đánh giá việc kê toa, phân phối và sử dụng thuốc. Các nghiên cứu này được tiến hành tại 7 trong số 11 nước thuộc khu vực Đông Nam Á. Các chỉ số chủ yếu đo lường quá trình hơn là cơ cấu tổ chức hay kết quả của việc chăm sóc sức khỏe. Phần lớn các chỉ số được sử dụng là các chỉ số do Tổ Chức Y Tế Thế Giới xây dựng (tạm gọi là các chỉ số WHO: WHO indicators). Các chỉ số này đo lường chất lượng sử dụng thuốc tại các cơ sở y tế một cách tổng quát. Phần còn lại là các chỉ số do các quốc gia hay các tác giả của nghiên cứu ban đầu tự xây dựng (tạm gọi là các chỉ số không WHO: non-WHO indicators). Các chỉ số này đo lường chất lượng sử dụng thuốc trong các lĩnh vực lâm sàng (như lão khoa hay sản khoa) hay các bệnh lý cụ thể (như tiêu chảy hay viêm phổi). Trong đó, có một vài chỉ số đánh giá sử dụng thuốc trong các bệnh không truyền nhiễm (non-communicable diseases). Tuy nhiên, có rất ít thông tin để đánh giá về tính hợp lệ, độ tin cậy và tính khả thi của các chỉ số không WHO. Nghiên cứu tổng quan này cho thấy việc sử dụng các chỉ số đo lường chất lượng sử dụng thuốc trong khu vực còn hạn chế. Từ những thông tin ghi nhận được, có thể kết luận rằng chất lượng sử dụng thuốc chưa được tối ưu.

Để tìm hiểu kỹ hơn về thực trạng sử dụng thuốc an toàn tại các cơ sở có nguồn lực hạn chế như Việt Nam, hai chương tiếp theo (Chương 3 & 4) tập trung vào nghiên cứu các sai sót trong quá trình chuẩn bị và thực hiện thuốc tại các khoa lâm sàng. Trong Chương 3, quy mô của vấn đề (Chẳng hạn như có bao nhiêu sai


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sót xảy ra? Hậu quả lâm sàng của những sai sót này như thế nào? Các yếu tố nào ảnh hưởng đến sai sót?) được nghiên cứu bằng phương pháp quan sát trực tiếp, một phương pháp được xem là “tiêu chuẩn vàng” (“gold standard”). Hậu quả lâm sàng tiềm tàng của các sai sót được đánh giá bởi một nhóm bao gồm bốn chuyên gia dựa trên một thang đo đã được thẩm định. Đây là một nghiên cứu tiến cứu, được tiến hành tại sáu khoa lâm sàng thuộc hai bệnh viện công lập tại một thành phố ở Việt Nam. Tại mỗi khoa, dữ liệu được thu thập 12 giờ mỗi ngày, trong 7 ngày liên tiếp. Một tỷ lệ sai sót tương đối cao, 39,1% (2060 sai sót xảy ra ở 5271 liều thuốc sử dụng), đã được xác định. Các sai sót thường gặp là sai kỹ thuật thực hiện thuốc, tiếp theo là sai kỹ thuật chuẩn bị thuốc, bỏ sót và sai liều. Sai sót về dạng bào chế chưa được ghi nhận. Đa phần các sai sót được đánh giá là có hậu quả lâm sàng tiềm tàng từ trung bình đến nghiêm trọng. Phân tích hồi quy logistic đa biến cho thấy sai sót có nhiều khả năng xảy ra ở các thuốc tiêm truyền, đặc biệt là các thuốc đòi hỏi một quá trình chuẩn bị phức tạp. Sai sót cũng bị ảnh hưởng bởi thời điểm sử dụng thuốc (như sáng/chiều hay các ngày khác nhau trong tuần), nhưng không bị ảnh hưởng bởi kinh nghiệm của điều dưỡng. Chương 4 là một nghiên cứu nhằm xác định tỷ lệ, các loại và hậu quả lâm sàng tiềm tàng của sai sót trong việc sử dụng insulin, một thuốc được xem là cần phải cảnh giác cao. Nghiên cứu này cũng sử dụng phương pháp quan sát trực tiếp và được tiến hành tại các khoa lâm sàng như đã mô tả ở Chương 3. Tổng cộng, có 229 liều insulin được quan sát. Trong khoảng một phần ba các liều đó, có ít nhất một sai sót xảy ra ở mỗi liều. Đáng tiếc thay, tất cả các sai sót đều được đánh giá là có hậu quả (tiềm tàng) quan trọng trên lâm sàng. Chúng tôi cũng nhận thấy tỷ lệ sai sót cao hơn ở các liều insulin tiêm truyền, vì các liều này đòi hỏi một quá trình chuẩn bị phức tạp, so với các liều insulin tiêm dưới da. Các sai sót như sai thời điểm sử dụng thuốc, sai kỹ thuật chuẩn bị/thực hiện thuốc, bỏ sót thường hay xảy ra nhất. Kết quả từ hai nghiên cứu này gợi ý rằng các can thiệp bằng cách đào tạo/tập huấn, tập trung vào các thuốc tiêm truyền đòi hỏi một quá trình chuẩn bị phức tạp, có khả năng nâng cao an toàn sử dụng thuốc cho bệnh nhân.

Nghiên cứu trong Chương 5 đánh giá hiệu quả của một chương trình đào tạo, do dược sĩ lâm sàng chủ trì, đối với các sai sót quan trọng trên lâm sàng xảy ra trong quá trình chuẩn bị và thực hiện thuốc tiêm truyền tại một bệnh viện Việt Nam. Đây là một nghiên cứu với thiết kế trước – sau, có nhóm chứng (a con-trolled before and after study). Hiệu quả của can thiệp được đánh giá dựa trên sự thay đổi về tỷ lệ sai sót sau can thiệp so với trước can thiệp. Nghiên cứu được tiến hành tại hai khoa chăm sóc đặc biệt: Khoa chăm sóc tích cực (Intensive care unit – ICU) – khoa can thiệp, và khoa hậu phẫu (Post-surgical unit – PSU) – khoa chứng. Can thiệp bao gồm bài giảng lý thuyết, thực hành tại khoa, và cung cấp các quy trình/hướng dẫn về chuẩn bị và thực hiện thuốc tiêm truyền. Chương


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trình đào tạo được thực hiện bởi một dược sĩ lâm sàng phối hợp với điều dưỡng trưởng của bệnh viện nơi tiến hành nghiên cứu. Tại mỗi khoa, dữ liệu được thu thập bằng phương pháp quan sát trực tiếp 12 giờ/ngày, trong 7 ngày liên tiếp/mỗi giai đoạn (trước/sau can thiệp). Tổng cộng có 1204 liều thuốc tiêm truyền được ghi nhận: 516 liều trước can thiệp (236 tại khoa ICU và 280 tại khoa PSU) và 688 liều sau can thiệp (407 tại khoa ICU và 281 tại khoa PSU). Phương pháp phân tích với phương trình ước lượng tổng quát (generalized estimating equations – GEEs) được sử dụng để đánh giá hiệu quả của can thiệp, kết quả cho thấy chương trình đào tạo có hiệu quả trong việc giảm thiểu các sai sót quan trọng trên lâm sàng đến hơn hai lần (p=0,013). Tuy nhiên, tỷ lệ sai sót sau can thiệp vẫn còn cao. Điều này gợi ý các chiến lược nâng cao chất lượng sử dụng thuốc tiếp theo cần được phát triển toàn diện hơn nữa, chẳng hạn như bao gồm cả cải thiện môi trường làm việc và đề cao văn hóa an toàn.

Xây dựng văn hóa an toàn là một trong những ưu tiên hàng đầu của các tổ chức chăm sóc sức khỏe ở các nước có thu nhập cao. Trong khi đó, dữ liệu về văn hóa an toàn ở các nước thu nhập thấp và trung bình thì khan hiếm hơn. Tuy nhiên, các bằng chứng ít ỏi này cũng đã cho thấy có sự khiếm khuyết về văn hóa an toàn, và điều đó gây tổn hại không nhỏ đến sự an toàn của bệnh nhân (Chương 1). Trong Chương 6, chúng tôi thực hiện một khảo sát cắt ngang về nhận thức của điều dưỡng đối với văn hóa an toàn tại sáu khoa lâm sàng của hai bệnh viện công lập tại một thành phố ở Việt Nam. Đồng thời, chúng tôi cũng khảo sát mối tương quan giữa văn hóa an toàn và tỷ lệ sai sót trong sử dụng thuốc tiêm truyền. Nhận thức của điều dưỡng được khảo sát bằng bảng câu hỏi về thái độ an toàn (the safety attitudes questionnaire – SAQ). Đây là một công cụ đáng tin cậy và được sử dụng nhiều nhất trong các nghiên cứu đánh giá văn hóa an toàn. Dữ liệu về sai sót trong sử dụng thuốc tiêm truyền được thu thập bằng phương pháp quan sát trực tiếp (là một phần của nghiên cứu được mô tả ở Chương 3). Chúng tôi nhận thấy, trong khoảng hai phần ba các liều thuốc sử dụng có ít nhất một sai sót quan trọng trên lâm sàng xảy ra ở mỗi liều. Trong khi đó, kết quả phân tích từ 172 bảng câu hỏi hợp lệ cho thấy điều dưỡng khá lạc quan về văn hóa an toàn tại bệnh viện họ đang công tác. Hai lĩnh vực được nhận thức tích cực nhất là không khí làm việc nhóm và điều kiện làm việc. Mặc dù tỷ lệ sai sót là tương đối cao, nhưng chỉ có rất ít điều dưỡng nhận thức được căng thẳng là một yếu tố ảnh hưởng đến hiệu quả công việc. Chúng tôi chưa phát hiện ra mối tương quan nào giữa nhận thức về văn hóa an toàn và sai sót trong sử dụng thuốc. Mối tương quan duy nhất được xác định là tỷ lệ sai sót tỷ lệ với sự khó khăn khi thảo luận về sai sót.

Cuối cùng, các phát hiện chính của luận án được tóm tắt và bàn luận ở Chương 7. Các nghiên cứu trong luận án này cho thấy nhiều vấn đề cần phải được cải thiện, cũng như cần có nhiều nghiên cứu sâu rộng hơn về chiến lược nâng cao


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an toàn sử dụng thuốc, ví dụ như xây dựng và đề cao văn hóa an toàn. Chúng tôi khuyến cáo nên có các can thiệp phù hợp với điều kiện của từng cơ sở y tế. Tốt nhất các can thiệp nên được thực hiện bởi một đội ngũ đa ngành nghề và được sự ủng hộ của ban lãnh đạo bệnh viện. Có lẽ giải pháp tốt nhất và khả thi nhất cho các cơ sở có nguồn lực hạn chế là tối ưu hóa hoạt động của Hội đồng thuốc và điều trị trong bệnh viện. Hơn thế nữa, kết quả nghiên cứu cũng chỉ ra cần có nhiều nghiên cứu hơn về chất lượng sử dụng thuốc trong các bệnh không truyền nhiễm ở các nước Đông Nam Á. Chúng tôi hy vọng rằng các phát hiện trong luận án này sẽ ít nhiều tạo động lực cho các nhà nghiên cứu có nhiều khám phá hơn về sử dụng thuốc an toàn ở các cơ sở tương tự. Chúng tôi cũng mong các kết quả này có thể gợi ý phần nào cho các cấp quản lý và đội ngũ nhân viên y tế tại Việt Nam cũng như các nước khác trong khu vực nhìn nhận lại hệ thống và cách thức thực hành lâm sàng của cơ sở, để từ đó đề ra những giải pháp tích cực cho việc nâng cao chất lượng và an toàn trong sử dụng thuốc.


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Acknowledgments

Five years ago, I was excited having had the privilege to work on this PhD program. But I also had a number of concerns. I really had no clue about what the chal-lenges would be and whether I would be able to overcome the biggest one: doing and completing such a project. And today I am very glad to share with you the results of my hard work, which is far beyond my best expectations. But I would not have been able to come so far without all the encouragement and support from a number of people who helped me since the beginning until the end of this long journey, to whom I owe great appreciation and gratitude.

First of all, I owe my deepest gratitude to my supervisors, Prof. dr. Katja Taxis, Prof. dr. F.M. Haaijer-Ruskamp, Prof. dr. J.R.B.J. Brouwers and Prof. dr. Nguyen Tuan Dung.

This thesis would not have been possible without the intellectual support, patience and motivation from my principal supervisor, Prof. dr. Katja Taxis. Dear Katja, you are a very special person to me: a noble friend, a knowledgeable advi-sor and a great teacher. You always somehow showed me how to turn compli-cated research issues into a lot easier, simpler and manageable ones. I had always felt comfortable and reassured at the same time after each discussion with you. Throughout these years, you taught me so much on how to motivate people, which is what I am currently doing not only at my university, as a lecturer, and hopefully as a PhD supervisor in the future, but also at home, as a wife and a mother. Every time that I came and visited you, I felt very much at home because of the cozy atmosphere and the lovely moments with you both and your cute children.

I am extremely grateful to Prof. dr. F.M. Haaijer-Ruskamp for countless constructive discussions and for the wise advice throughout all the phases of this research project. Dear Flora, to be honest with you, I often felt a bit pressured before each of our meeting because I was aware of tough questions or critical com-ments that you would give. It all paid off in the end and I realize now how valuable these moments were and how lucky I was to work with you. You taught me how to think logically, critically and comprehensively, not only at academic level but also at a more personal level.

I would like to express a great “thank you” to Prof. dr. J.R.B.J. Brouwers. Dear Koos, thank you for offering me the opportunity to have the interview for this project and to award me with the scholarship that made this PhD possible. You were one of the first people helping me out at the very first days of my life in Groningen. Not only you supported me continuously and wonderfully throughout

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this research project, but you also helped me understand more about the phar-macy services in Dutch hospitals. These were really useful complements to my knowledge on clinical practice of the hospital pharmacist.

Many thanks to Prof. dr. Nguyen Tuan Dung for the invaluable encouragement and support during the time I was conducting my research and writing this thesis at the University of Medicine and Pharmacy, Ho Chi Minh City. My dear respectful teacher, you have inspired me a lot with your passion for conducting research.

My special thanks go also to Prof. dr. B.D. Franklin, Prof. dr. H.V. Hogerzeil and Prof. dr. J.G.W. Kosterink who were willing to participate in my assessment committee. Thank you so much for making time to read my manuscript as well as your kind considerations which allowed me to finalize this thesis.

I would especially like to acknowledge the Dutch government and the Nuffic project (NPT VNM 240) for the financial support. Thank you Wiebe Zijlstra, Herman Woerdenbag, Geertje Holtrop, Margreet van der Giezen, Gonny Lakerveld and Ivita Kops for assisting and relieving me from all administrative hurdles, and for your constant support during my PhD.

I am very grateful to all my co-authors for their valuable contributions and time, particularly to Veronika Wirtz for her thoughtful guidance on my very first paper. I would also like to express my sincere thanks to Edwin van den Heuvel. Dear Edwin, I would have never managed all the data analyses without your sup-port. Moreover, a word of thankfulness I would like to send to Truus van Ittersum for her kind advice about literature search and thesis preparation.

Furthermore, I would like to express my appreciation to all the Profes-sors, the teaching staff and my PhD colleagues from the Department of Clinical Pharmacology (UMCG), the Department of Pharmacoepidemiology and Phar-macoeconomics, and the Department of Pharmacotherapy and Pharmaceutical Care. Thank you all for the useful suggestions during dRUGs and Brainstorm meetings! Also thank you for being nice and caring, making me feel really com-fortable at work.

I would like to send a special “thank you” to Bert Bijker, Jens Bos, Sipke Visser and Jugo Pavlovic for your patient and valuable technical support! I also want to extend my appreciation to our secretary, Jannie Schoonveld. Dear Jannie, thank you so much for all the arrangements you have made for me, from the begin-ning until the very last steps of my PhD.

A huge “thank you” to my fellow postgraduate students and colleagues, Susana Monteiro, Silvia Ravera, Timothy Broesamle, Marlies Geurts, Irene Lako,

Acknowledgments

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Hoa Vu, Josta de Jong, Fenneke Hasselt, Hao Wang, Doti Martono, Aizati Athirah, Lisette Berm, Hoa Le, Hong Anh Tu, Hao Tran, Thang Nguyen, Lan Nguyen, Mehraj Parouty, Jelena Stevanovic… for your kindness, friendship and encouragements.

I am also grateful to the nurses, pharmacists and doctors at the study hos-pitals. Thank you for the great collaborations as well as for giving permission to observe your work. And of course, a word of thankfulness to my hard-working students who helped with data collection, and also to the four experts who partici-pated in the assessment of the data.

I would like to express my special “thank you” to Susana, Silvia, Hoa, Marl-ies, Irene, Tim, Kevin and Carlos for being such great friends, able to understand my feelings without too many words. Thank you very much for being beside me and for sharing all the ups and downs with me. You all made my life in Gronin-gen much better. I will keep in mind all the cherished moments we shared, the memorable coffees, drinks, lunches and dinners we had together. We will cer-tainly keep in touch.

A word of deep appreciation goes to my wonderful paranymphs, Susana and Doti. Thank you very much for preparing all the defense-related issues and for sharing the stressful moments with me. I believe that my big day would not have been successful without your support. I am really indebted to Karin Larmené who did an excellent translation of the summary of this research into Dutch.

A very special “thank you” goes to my Vietnamese friends (and their part-ners) in Groningen, especially to those who showed me how to enjoy the process of doing a PhD. Thank you for all the unforgettable time we had together. I am really happy that I have met you and that I have shared with you all a considerable part of my life.

I could not thank enough my nice colleagues at the Department of Clini-cal Pharmacy of the University of Medicine and Pharmacy, in Ho Chi Minh City, for sharing the difficulties of my daily life and for strongly pushing me towards the defense of this dissertation.

Last but not least, I would also like to thank all of my family, especially my par-ents, my husband and our lovely daughter for the endless love and encouragements.

Thank you! Bedankt! Cám ơn!

Ho Chi Minh City, August 2014Nguyen Huong Thao

Acknowledgments

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From this thesis

Nguyen HT, Wirtz VJ, Haaijer-Ruskamp FM, Taxis K. Indicators of quality use of medicines in South-East Asian countries: A systematic review. Tropical Medicine & International Health, 2012 Dec;17(12):1552-1566.

Nguyen HT, Nguyen TD, Haaijer-Ruskamp FM, Taxis K. Errors in preparation and administration of insulin in two urban Vietnamese hospitals: An observational study. Nursing Research, 2014 Jan-Feb;63(1):68-72.

Nguyen HT, Pham HT, Vo DK, Nguyen TD, van den Heuvel ER, Haaijer-Ruskamp FM, Taxis K. The effect of a clinical pharmacist-led training programme on intrave-nous medication errors: A controlled before and after study. BMJ Quality & Safety, 2014 Apr;23(4):319-324.

Other publications

Nguyen HT, Vo VL, Ngo VT, Tran H. Flavonoids from pericarpium of Citri reticu-latae Blanco in the South of Vietnam. Vietnam Pharmaceutical Journal, 2001 (In Vietnamese).

Nguyen HT, Nguyen TTL, Phan TD, Nguyen TD. Clinical monitoring and evaluat-ing gentamicin concentration at Cho Ray hospital, Ho Chi Minh city. Vietnam Medi-cal Journal, 2005 (In Vietnamese).

Nguyen HT, Phan TD. Clinical efficacy of erythropoietin in the treatment of anemia in patients with chronic renal failure. Medical Journal of Ho Chi Minh city, 2006 (In Vietnamese).

http://www.ncbi.nlm.nih.gov/pubmed/22974440

http://www.ncbi.nlm.nih.gov/pubmed/22974440

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Presentations

Nguyen HT, Nguyen TD, van den Heuvel ER, Haaijer-Ruskamp FM, Taxis K. Errors in medication preparation and administration in Vietnamese hospitals. Presented at the FIGON, Dutch Medicines Days 2012, 1-3 October, Lunteren, the Nether-lands and at the 41st ESCP symposium on Clinical Pharmacy 2012, 29-31 October, Bacelona, Spain.

Nguyen HT, Nguyen TD, van den Heuvel ER, Haaijer-Ruskamp FM, Taxis K. The effect of a clinical pharmacist-led training programme on intravenous preparation and administration errors in a Vietnamese hospital. Presented at the 18th Congress of the EAHP 2013, 13-15 March, Paris, France.

Nguyen HT, Nguyen TD, van den Heuvel ER, Haaijer-Ruskamp FM, Taxis K. Med-ication safety in Vietnamese hospitals: Current context and strategies for improve-ment. Presented at the 13th Asian Conference on Clinical Pharmacy (ACCP) 2013, 13-15 September, Hai Phong, Vietnam (Invited symposium presentation).


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Curriculum Vitae

Nguyen Huong Thao was born on 5th August, 1977 in Binh Phuoc, Vietnam. She gained a bachelor degree in pharmacy from University of Medicine and Pharmacy at Ho Chi Minh city (1999) and continued her postgraduate study with a four-year internship program specialized in clinical pharmacy (2000), which was qualified as a master program in clinical pharmacy (2009). Since 2001 she works as a lecturer. From 2001 to 2009, she participated in several research projects of the department of Clinical Pharmacy (University of Medicine and Pharmacy at Ho Chi Minh city), mainly focusing on therapeutic drug monitoring (TDM) and drug use evaluation. In November 2009, she started a PhD project at the department of Pharmacother-apy and Pharmaceutical Care (University of Groningen). The research is part of the Nuffic project on Strengthening Clinical Pharmacy in Vietnam (NPT VNM 240), and aims to investigate the quality of medication preparation and administration in Vietnamese hospitals and to develop suitable interventions to improve medica-tion safety in such setting. During this time, she also had some teaching activities of both University of Groningen and University of Medicine and Pharmacy at Ho Chi Minh city. Her teaching responsibilities include applied pharmacotherapy and medication safety as well as the supervision of research projects of bachelor and master students.

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This thesis is published within the Research Institute SHARE (Science in Healthy Ageing and Health caRE) of the University Medical Center Groningen/University of Groningen. Further information regarding the institute and its research can be obtained from our internetsite: www.share.umcg.nl More recent theses can be found in the list below.((co-) supervisors are between brackets)

2014

Suwantika AA. Economic evaluations of non-traditional vaccinations in middle-income countries: Indonesia as a reference case(prof MJ Postma, dr K Lestari)

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Dekker H. Teaching and learning professionalism in medical education(prof J Cohen-Schotanus, prof T van der Molen, prof JW Snoek)

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Mahmood SI. Selection of medical students and their specialty choices(prof JCC Borleffs, dr RA Tio)

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