Assist. Prof. Dr. Mohamed Awad Mousnad,

B.Pharm (Hons), M.Sc, PhD, RPh

Assistant professor of Pharmacy Practice at International University of Africa (IUA), Khartoum

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Certificate Course in Global Health Pharmacy, Khartoum, Sudan

22nd – 24th of December, 2017.

Introduction

Overview of drug utilisation

Methods used in drug utilisation studies

Drug classification systems

Identifying Problems with Medicine Use

Drug utilization Challenges and Opportunities in

developing countries

Presentation outlines

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Introduction

Pharmacy profession has shifted from product oriented to patient and service oriented professional.

A number of new disciplines were developed such as pharmaceutical care, clinical pharmacy, Pharmacoeconomics and Pharmacoepidemiology.

Pharmacotherapy ( safety, efficacy, cost components and quality of life measures)

Pharmacoepidemiology is the study of the use of, and effects of, drugs in large numbers of people (Strom, 1994)

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No discussion on the historical development of

pharmacoepidemiology will be complete without referring

to the history of drug utilisation.

DUS – Europe

DUR –USA

In last decades, studies were mostly of a descriptive

nature

Recently, social and behavioural aspects become involved

to achieve a higher quality of drug use.

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Introduction cont.

Introduction cont.

Terms

Epidemiology ―the study of the distribution and determinants of

health-related states and events in the population, and the

application of this study to control health problems‖.

Clinical pharmacology ―the study of effect of drugs in

humans.‖

Pharmacoepidemiology ―the study of the utilization and effects

of drugs in large numbers of people.‖

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Disease

Drug Population

Clinical pharmacology

Pharmaco-epidemiology

Epidemiology Public Health

Relationship between Clinical pharmacology , Epidemiology and

Pharmacoepidemiology

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Medicines are part of everyday life.

Frequently little is known about :-

How many drugs people take ?

What sort of drugs are taken ?

How much the drugs cost?

Who influences the way drugs are prescribed and

How the drugs are actually taken ?

Drug utilisation aims to answer these questions.

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Overview of drug utilisation

Definition of drug utilisation

The World Health Organisation (WHO) defined Drug

utilisation as: "The marketing, distribution,

prescription, and use of drugs in society, with special

emphasis on the resulting medical, social, and

economic consequences"

(WHO,2003)

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Overview of drug utilisation cont.

Levels of drug utilisation

Drug utilisation can be studied at different levels depending

on the purpose of the study and the facilities and

information available.

Each drug utilisation study must also be related to a

specific time period (for example, a year, a quarter, a month

or a day) and to a specific unit of the population.

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Overview of drug utilisation cont.

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Basic levels of drug utilisation research

First level Second level Drug All drugs

Groups of drugs

Single drugs/products

Area/sources Country/countries

Region(s)

Pharmacy/pharmacies

Health insurance system(s)

Hospitals/hospital wards/hospital beds

Physician(s)

Patient(s)

Levels of therapy Wholesale/overall pattern

Prescriptions

Patient compliance/non-compliance

Unit of measurement Cost , Quantity, DDD

(Adapted from lunde, et al., 1979)

A systems view of drug utilisation

In any setting, drug utilisation can be viewed as an evolving

management system applied to an underlying health care

system.

Each system typically consists of input, process and output

components.

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Overview of drug utilisation cont.

Output

for example, a specified percentage of decreased costs,

hospitalisations or drugs per patient.

Input

The health care system and available data structure).

Process

The establishment of criteria, the application therefore,

intervention strategies and finally evaluation.

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Overview of drug utilisation cont.

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INPUT

PROCESS

OUTPUT

CRITERIA

APPLICATION

INTERVENTION

EVALUATION

OUTCOMES

Process

Ongoing feedback

ffffffffffffffffffffff

eedfeefeedback

and modification

(Adapted from Jones, 1991)

Systems View of Drug Utilisation

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1. Methods used in qualitative studies;

2. Studies on prescription habits;

3. Studies on patient compliance;

4. Studies on drug effects;

5. Studies on patients' knowledge about drugs;

6. Descriptive studies, determinants of drug

utilisation and impact of drug use; and

7. Consumption studies.

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Methods used in drug utilisation studies cont.

Common language.

For international, regional, national, country comparison of

drug utilization trends.

The system allow easy comparison after collected the

utilization data in uniform way.

( WHO,2003)

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Classification systems in drug utilization

Only three classification well-known world wide in drug

utilization practice:-

1- Anatomical Therapeutic (AT) classification

Developed by the European Pharmaceutical Medicine

Market Research Association (EphMRA).

used worldwide by International Medical Statistics (IMS)

for providing the medicine industry with market research

statistics

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Classification systems in drug utilization cont.

2-Anatomical Therapeutic Chemical (ATC)

classification

Developed in Norway in the early 1970s

Based on the EPhMRA classification

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Classification systems in drug utilization cont.

3-American Society of Health-System Pharmacists

(ASHP) Classification System

is more commonly used in North America;

it is a pharmacological/therapeutic classification

system.

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Classification systems in drug utilization cont.

ATC classification

Anatomical

Therapeutic

Chemical

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Classification systems in drug utilization cont.

Main purpose of ATC

To serve as a tool for presenting drug utilization research in order to improve quality of drug use.

An international language for grouping of drugs.

Recommended by the WHO Headquarters as the international standard for drug utilization studies

(WHO, 2008)

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Classification systems in drug utilization cont.

Currently, guidelines for the ICD-10 section,

preferably using an internationally widespread and

recommended standard system such as the ATC

( WHO,2009) 24

Classification systems in drug utilization cont.

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ATC system main groups

A Alimentary tract and metabolism

B Blood and blood forming organs

C Cardiovascular system

D Dermatologicals

G Genito urinary system and sex hormones

H Systemic hormonal preparations, excl. sex hormones and insulins

J Antiinfectives for systemic use

L Antineoplastic and immunomodulating agents

M Musculo-skeletal system

N Nervous system

P Antiparasitic products, insecticides and repellents

R Respiratory system

S Sensory organs

V Various

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Structure of the ATC system A ALIMENTARY TRACT AND METABOLISM

(1st level, anatomical main group)

A10 DRUGS USED IN DIABETES

(2nd level, therapeutic subgroup)

A10B BLOOD GLUCOSE LOWERING DRUGS,

INSULINS (3rd level, pharmacological subgroup)

A10BA BIGUANIDES

(4th level, chemical subgroup)

A10BA02 METFORMIN

(5th level, chemical substance)

(ATC INDEX WITH DDDs, 2008)

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Indicator study methods

Use data collected at the individual level patient, health

facility

Aggregate data methods

Use routine data (e.g., stock records)

In-depth investigation of medicine use

Prescription audit, patient record review

Drug use evaluation (DUE)

Qualitative methods to understand causes of a medicine

use problem

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Indicator Studies Methods

Irrational medicine use is widespread and results in—

Poor patient outcome

High cost of inappropriate medicine use

Increased risk of ADRs

Increased risk of antimicrobial resistance

Measuring medicine use problems is the first step to

improving use

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A major function of a DTC in Hospitals is to identify

medicine use problems and to implement corrective

measures

Performing an indicator study is useful method to—

Identify medicine use problems at the individual patient

level

Monitor medicine use by prescribers

Evaluate the impact of interventions

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WHO/INRUD indicators in primary health care

Prescribing indicators

Patient care indicators

Facility indicators

Hospital indicators

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Aggregate data methods

A major function of a DTC is to identify medicine use problems and to implement corrective measures

Aggregate methods are a useful way to gain an overview of medicine use problems using routine data not collected at the individual patient level.

Examples of a aggregate data methods include—

DDD

VEN analysis

ABC analysis

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Defined daily dose (DDD)

The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults.

(WHO Collaborating Centre for Drug Statistics Methodology,2008)

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The DDD

should not be considered as a

―correct dose‖ but as an

international compromise

based on review of available documentation

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Unit of measurement cont.

Most frequently used methods

DDDs

DDD/1000 inhabitants/day (DID)

DDD/100 bed days

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Unit of measurement cont.

DDD calculations

No. of DDDs = Q*Strength/DDD value

DDD/1000 inhabitants/day = Q*Strength*1000/Total sample size*DDD

(WHO Collaborating Centre for Drug Statistics Methodology,2008)

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Unit of measurement cont.

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Some DDD examples :-

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Sales of agents used for hypertension in Norway 1973 - 2006

0

50

100

150

200

250

300

1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003 2005

DD

D/1

00

0 i

nh

ab

ita

nts

/da

y

ACE-inhibitors + angiotensin II antagonists (C09)

Calcium channel blockers (C08)

Beta blocking agents (C07)

Diuretics (C03)

Antihyperteinsives (C02)

Solveig Sakshaug, 2008

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Consumption of antibacterials in primary care in 26

European countries 2002

0

5

10

15

20

25

30

35

FR GR LU PT IT BE SK HR PL IS IE ES FI BG CZ SI SE HU NO UK DK DE LV AT EE NL

DD

D p

er

10

00 in

h.

per

da

y

Others

J01B+J01G+J01X

Sulfonamides and

trimethoprim

J01E

Quinolones

J01M

Macrolides, Lincosam.,

Streptogramins

J01F

Tetracyclines

J01A

Cephalosporins

J01D

Penicillins

J01C

Goossens H. et al, 2005

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Challenges

Priority that the health sector receives in the budget in

developing countries ( developed countries 6-12 % GDP).

Regulatory efforts and national drug policies.

Lack of appropriate statistics on medicine.

limitations in funding of drug utilization research.

Lack access to evidence-base publications

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Opportunities

Drug utilization studies identify and analyze problems

related to prescribing, dispensing, and ingestion of

medicines, monitor changes in utilization patterns, and

evaluate the impact of interventions to change medication

use.

Number of approaches were developed according to the

purpose and information needs of policy makers,

manufacturers, program managers, practitioners, and

consumers.

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Availability of international standardized indicators are

enabling drug utilization studies in developing and

transitional countries. Many strategies could be proposed,

tested, and implemented to improve the quality of

medication use.

The increasing availability of computerized databases.

The increasing availability of software (modelling )

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Thank you