MEDICATION SAFETY MEDICATION SAFETY UNITUNIT

Pharmacy Practice and Pharmacy Practice and DevelopmentDevelopment Division Division

Ministry of Health MalaysiaMinistry of Health Malaysia

Unit formed in 2007Unit formed in 2007 PersonnelPersonnel

1 pharmacist U48 (2007)1 pharmacist U48 (2007)

1 pharmacist U41 1 pharmacist U41

(April 2008)(April 2008)

OBJECTIVESOBJECTIVES

To establish a medication error To establish a medication error reporting systemreporting system

To create a medication error To create a medication error databasedatabase

To promote medication safety To promote medication safety awareness awareness

To provide training programmes on To provide training programmes on medication safetymedication safety

SECRETARIATSECRETARIAT

Medication Safety Committee, Medication Safety Committee, Pharmaceutical Services DivisionPharmaceutical Services Division

Medication Safety Technical Medication Safety Technical Advisory Committee (MedSTAC)Advisory Committee (MedSTAC)

Pharmacovigilance on Safety of Pharmacovigilance on Safety of Vaccines Vaccines

Medication Medication Error Error

Reporting Reporting SystemSystem

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in control of the healthcare professional, patient or consumer

NCCMERP, US

MEDICATION ERROR . . .

Maybe related to professional practice, healthcare products, procedures and systems including:

prescribing, order communication, product labeling, packaging, compounding, dispensing, distribution, administration, monitoring and use

Medication errors can be committed (or contributed to) by

Anyone who handles medicine

Physicians/doctors, dentists, pharmacists, other healthcare providers, patients, caregivers etc

Human ErrorHuman Error

Error is inevitable because of human Error is inevitable because of human limitationslimitations

- Limited memory capacityLimited memory capacity- Limited mental processing capacityLimited mental processing capacity- Negative effects of fatigue and other Negative effects of fatigue and other

physiological stressorsphysiological stressors

Traditionally, culture is individual responsibility and blame

Typical response in a punitive environment:

-Attention focused on least manageable ( the person)

-Pressure to cover up mistakes

-Increasing likelihood of error to recur

Look at systems involved in Look at systems involved in medication error medication error

Why? Why?

and not Who?and not Who?

Why report?Why report?Enable the healthcare providers & Enable the healthcare providers &

institutions to learn aboutinstitutions to learn about

• potential risks Risks hidden in the processes used

• actual errors Errors that occur during patient care

• causes of errors Underlying weaknesses in systems & processes that explain why errors happened

• prevention Ways of preventing recurrent events

What to report?What to report?

Risks that can lead to errors or near Risks that can lead to errors or near missesmisses

Sound-alike names or look alike Sound-alike names or look alike packagespackages

Ambigous product labelsAmbigous product labels Use of error prone abbreviationsUse of error prone abbreviations Error-prone functions in cpoe Error-prone functions in cpoe

systemssystems

Pharmacy interventions/ errors detected Pharmacy interventions/ errors detected by prescribers, nurses or patients inby prescribers, nurses or patients in

Prescribing errorsPrescribing errors

Dispensing errorsDispensing errors

Administration errorsAdministration errors

What not to reportWhat not to report

Administrative errorsAdministrative errors Examples:Examples:

• no prescribers stampno prescribers stamp• no countersignature for category no countersignature for category

A medicines A medicines • Medicines not stocked/ nil in stockMedicines not stocked/ nil in stock

• Other units using certain drugs eg. Other units using certain drugs eg. MO A&E using Tramal which is for MO A&E using Tramal which is for specialist clinicspecialist clinic

Types of Medication ErrorsTypes of Medication Errors

Prescribing Prescribing errorerror

Incorrect drug product Incorrect drug product selection (based on selection (based on indications, CI,known indications, CI,known allergies, existing drug allergies, existing drug therapy), dose,dosage therapy), dose,dosage form, quantity, route or form, quantity, route or rate of administration, rate of administration, conc, or instructions for conc, or instructions for use authorised by use authorised by physician; illegible Rx or physician; illegible Rx or med orders that lead to med orders that lead to errorserrors

Omission Omission errorerror

The failure to administer The failure to administer an ordered dose to a an ordered dose to a patient before the next patient before the next ordered dose or failure to ordered dose or failure to prescribe a drug product prescribe a drug product that is indicated.that is indicated.

The failure to administer The failure to administer an ordered dose excludes an ordered dose excludes patient’s refusal and patient’s refusal and clinical decision or other clinical decision or other valid reason not to valid reason not to administer.administer.

Wrong time Wrong time errorerror

Unauthorised/ Unauthorised/ wrong drug wrong drug errorerror

Administration of Administration of medication outside a medication outside a predefined time interval predefined time interval from its scheduled from its scheduled administration timeadministration time

Dispensing or Dispensing or administration to the administration to the patient of medication not patient of medication not authorised by a legitimate authorised by a legitimate prescriberprescriber

Dose errorDose error Dispensing or Dispensing or administration to pt of a administration to pt of a dose that is > or< than dose that is > or< than amount ordered by amount ordered by prescriber or administration prescriber or administration of multiple doses to ptof multiple doses to pt

Dosage form Dosage form errorerror

Dispensing or Dispensing or administration to pt of a administration to pt of a drug product in diff dosage drug product in diff dosage form than that ordered by form than that ordered by prescriber prescriber

Drug Drug preparation preparation errorerror

Drug product incorrectly Drug product incorrectly formulated or manipulated formulated or manipulated before dispensing or before dispensing or administrationadministration

Route of Route of administration administration error error

Wrong route of Wrong route of administration of the administration of the correct drugcorrect drug

Administration Administration technique technique errorerror

Inappropriate procedure or Inappropriate procedure or improper technique in the improper technique in the administration of a drug administration of a drug other than wrong routeother than wrong route

Deteriorated Deteriorated drug errordrug error

Dispensing or administration Dispensing or administration of a drug that has expired or of a drug that has expired or the physical or chemical the physical or chemical dosage form integrity has dosage form integrity has changedchanged

Monitoring Monitoring errorerror

Failure to review a Failure to review a prescribed regimen for prescribed regimen for appropriateness & detection appropriateness & detection of problems, or failure to use of problems, or failure to use appropriate clinical or lab appropriate clinical or lab data for adequate data for adequate assessment of pt response to assessment of pt response to prescribed therapyprescribed therapy

Compliance Compliance errorerror

Inappropriate patient Inappropriate patient behavior regarding behavior regarding adherence to a prescribed adherence to a prescribed medication regimenmedication regimen

Other Other medication medication errorerror

Any medication error that Any medication error that does not fall into one of the does not fall into one of the above predefined typesabove predefined types

MEDICATION ERROR (ME) REPORTING FLOW CHART

Medication Error encountered

Fill ME form

Send ME report to Medication Safety Centre (MedSC)

Grading of ME report

Register ME report

Record and compile for further action

Check

ME

form

Check ME

form

Contact reporter for details

Incomplete

Complete

Responsibility

Reporter

Reporter

MedSC

NMEC

MedSC

MedSC

Acknowledge report received to reporter

Guideline on Medication Error Reporting 18

NMEC MembersNMEC Members Senior Director of Pharmaceutical Senior Director of Pharmaceutical

Services,MOH – ChairpersonServices,MOH – Chairperson Director of Pharmacy Practice and Director of Pharmacy Practice and

Development,MOH – alternate ChairpersonDevelopment,MOH – alternate Chairperson A representative from the Medical A representative from the Medical

Development Division,MOHDevelopment Division,MOH 14 others appointed by Director General of 14 others appointed by Director General of

HealthHealth A physician from MOH hospitalA physician from MOH hospital A hospital pharmacist from MOHA hospital pharmacist from MOH

A physician from a university hospitalA physician from a university hospital A pharmacist from any local university with A pharmacist from any local university with

expertise in clinical pharmacy practice expertise in clinical pharmacy practice A physician from the APHMA physician from the APHM A hospital pharmacist from the Malaysian A hospital pharmacist from the Malaysian

Armed Forces Armed Forces A Family Medicine Specialist from MOH A Family Medicine Specialist from MOH A rep from the Malaysian Medical A rep from the Malaysian Medical

AssociationAssociation

A rep from the Federation of Private A rep from the Federation of Private Medical Practitioners AssociationMedical Practitioners Association

A rep from the Community Pharmacy A rep from the Community Pharmacy Chapter, MPSChapter, MPS

A rep from the Private Hospital A rep from the Private Hospital Pharmacy Chapter, MPSPharmacy Chapter, MPS

A rep from the Malaysian Dental A rep from the Malaysian Dental AssociationAssociation

A rep from the Malaysian Nursing BoardA rep from the Malaysian Nursing Board A rep from the Malaysian Medical A rep from the Malaysian Medical

Assistants BoardAssistants Board

TOR National Medication Error Committee (NMEC) Members

1.To study and grade the ME reports received

2.To propose remedial actions in relation to medication errors

3.To actively promote medication error reporting in Malaysia

18. Medication Error (ME) Reporting Form

MEDICATION ERROR (ME) REPORTING FORM Reporters do not necessarily have to provide any individual identifiable health information, including names of practitioners, names of patients, names of healthcare facilities, or dates of birth (age is acceptable)

1. Date of event Time of event Place /Location of event 2. Please describe the error. Include description/sequence of events, type of staff involved, and work environment (e.g. change of shift, short staffing, during peak hours). If more space is needed, please attach a separate page. 3. Did the error reach the patient? (Tick appropriate box) Yes No

4. Was the incorrect medication, dose or dosage form administered to or taken by the patient? (Tick appropriate box) Yes No

4 .1 Circle the appropriate Error Outcome Category (select one – see Guide for details) A B C D E F G H I

4 .2 Describe the direct result on the patient (e.g., death, type of harm, additional patient monitoring).

5. Indicate the possible error cause(s) and contributing factor(s) (e.g., abbreviation, similar names, distractions, etc). 6. What category of staff or healthcare provider made the initial error? 7. Indicate if other provider (s) were also involved in the error (category of staff perpetuating error)

Front

ME Report FormME Report Form

Date and time of eventDate and time of event Type of facilityType of facility Private/ government Private/ government

hospital/clinic/pharmacyhospital/clinic/pharmacy Location of event:Location of event: - ward- ward - pharmacy- pharmacy - A& E- A& E - OT/ ICU etc- OT/ ICU etc

Description of event - sequence of events - work environment (peak hour,

change of shift) - details (what? how? of the

incident) Attach separate page if more space is

needed

In which process error occur In which process error occur Prescribing/Dispensing/Administration Prescribing/Dispensing/Administration / Others/ Others

Did error reach patient Y/NDid error reach patient Y/N Incorrect med, dose or dosage Incorrect med, dose or dosage

administered or taken by patientadministered or taken by patient

Describe direct result on patient eg. death, admission into hospital,

drugs prescribed to treat error

Did an actual error occur?

Category C

Circumstances or events that have the capacity to cause

error

Did the error reach the patient? *

Did the error contribute to or result in patient death?

Was the patient harmed?

Did the error require an intervention necessary

to sustain life ?

Did the error require initial or prolonged hospitalization

Was the harm temporary ?

Was the harm permanent ?

Category H

Category G

Category E Category FWas intervention to

preclude harm or extra monitoring required ?

Category B

Category A

Category I

Category D

NO

NO

NO

NO

NO

NO

NO

YES

YES

YES

YES

YES

NO

YES

YES

NO

YES

YES

Classification of Medication Error SeverityClassification of Medication Error Severity

NO ERRORNO ERROR

Category ACategory A Potential error, Circumstances/events have potential to Potential error, Circumstances/events have potential to cause incidentcause incident

ERROR, NO HARMERROR, NO HARM

Category BCategory B Actual Error – did not reach patientActual Error – did not reach patient

Category CCategory C Actual Error – caused no harmActual Error – caused no harm

Category DCategory D Additional monitoring required – caused no harmAdditional monitoring required – caused no harm

ERROR HARMERROR HARM

Category ECategory E Treatment/Intervention required –caused temporary Treatment/Intervention required –caused temporary harmharm

Category FCategory F Initial/prolonged hospitalization –caused temporary harmInitial/prolonged hospitalization –caused temporary harm

Category GCategory G Caused permanent harmCaused permanent harm

Category HCategory H Near death eventNear death event

ERROR, DEATHERROR, DEATH

Category ICategory I DeathDeath

An error of omission does reach the An error of omission does reach the patientpatient

All ME reports should be sent to :

Medication Safety Centre

Pharmaceutical Services Division , Ministry of Health P.O. Box 924, Jalan Sultan, 46790 Petaling Jaya, Selangor.

Fax: 03-79682268

© 2001 NCCMERP. All rights reserved

19. GUIDE FOR CATEGORIZING MEDICATION ERRORS

Possible contributing factor (s)

Example: - Sound alike or look alike drug - Look alike packaging - Different strength of same drug - Unclear instruction on Rx - Illegible handwriting

Category of staff made initial error?

Other category involved Category of staff,provider or

individual who discovered the error/potential error

Example: Doctor, pharmacist, staff nurse, pharmacist assistant, asst medical officer, PRP, trainee MA or SN

Patient’s particulars Do not provide patient’s name Info needed = age, M or F, diagnosis

Product 1 intended (prescribed)/ error

brand name, generic name, dose, freq,duration, route

similar packaging- manufacturer, dosage form, strength, container type

Relevant materials can be providedRelevant materials can be provided

- copy of Rx, label of product, - copy of Rx, label of product, picture of product involvedpicture of product involved

Recommendations/ preventive Recommendations/ preventive actions takenactions taken

Reporter’s detailsReporter’s details

P.O Box 924,

Jln Sultan

46790 Petaling Jaya

Tel : 03-

7841 3200

Fax: 03-

79682268 Online

Sistem pengurusan farmasi

ME

MedSC

StateState FacilityFacility

JohorJohor Hosp Sultanah AminahHosp Sultanah Aminah

Hosp Sultan IsmailHosp Sultan Ismail

Hosp Batu PahatHosp Batu Pahat

Klinik Pesakit Luar Johor BaruKlinik Pesakit Luar Johor Baru

KK PontianKK Pontian

MelakaMelaka Hospital MelakaHospital Melaka

KK JasinKK Jasin

Negeri Negeri SembilanSembilan

Hosp Tunku Jaafar,SerembanHosp Tunku Jaafar,Seremban

Hosp TA Najihah,K PilahHosp TA Najihah,K Pilah

KK SerembanKK Seremban

KK TampinKK Tampin

SelangorSelangor Hosp SelayangHosp Selayang

HTAR,KlangHTAR,Klang

KK Kelana JayaKK Kelana Jaya

WPKL/ WPKL/ PutrajayaPutrajaya

Hosp PutrajayaHosp Putrajaya

KK PantaiKK Pantai

PerakPerak Hospital Raja Permaisuri Hospital Raja Permaisuri Bainun, IpohBainun, Ipoh

Hosp Teluk IntanHosp Teluk Intan

KK GreentownKK Greentown

KK SetiawanKK Setiawan

Hospital Kuala LumpurHospital Kuala Lumpur

Two months duration ( July- August)Two months duration ( July- August) Number of reports received Number of reports received

= 779= 779 Category A = 42 ( 5.4 %)Category A = 42 ( 5.4 %)

Category B = 714 (91.7 %)Category B = 714 (91.7 %)

Category C = 6 (0.8 %)Category C = 6 (0.8 %)

Category D = 10 (1.3 %)Category D = 10 (1.3 %)

Category E = 2 (0.2%)Category E = 2 (0.2%)

Category F = 5 (0.6 %) Category F = 5 (0.6 %)

Sound-alike drugsSound-alike drugs

Zantac - ZentelZantac - Zentel Sertraline - StellazineSertraline - Stellazine lansoprazole - pantoprazolelansoprazole - pantoprazole bisoprolol - metoprololbisoprolol - metoprolol bisoprolol - carvedilolbisoprolol - carvedilol Lovastatin - simvastatinLovastatin - simvastatin

T. Pyridostigmine 60mg 5x/day was T. Pyridostigmine 60mg 5x/day was prescribed to myasthenia gravis patientprescribed to myasthenia gravis patientStaff Nurse served once daily doseStaff Nurse served once daily dose Patient condition worsened - muscle Patient condition worsened - muscle weakness and shortness of breath weakness and shortness of breath worsenedworsenedError detected by doctor and the staff Error detected by doctor and the staff nurse was told to follow dosing time 8am, nurse was told to follow dosing time 8am, 1pm, 6pm, 11pm and 4am1pm, 6pm, 11pm and 4am

Possible error causes: Staff Nurse Possible error causes: Staff Nurse misunderstood the prescription because misunderstood the prescription because very seldom the encounter 5x daily very seldom the encounter 5x daily dosagedosage

ERROR CATEGORY - F

ERROR CATEGORY - EERROR CATEGORY - E Patient was prescribed T. Lithium 300mg Patient was prescribed T. Lithium 300mg

BD x 3/12 but was supplied with T. Lithium BD x 3/12 but was supplied with T. Lithium 600mg BD x 3/12600mg BD x 3/12

Patient had giddiness, diarrhoea, loss of Patient had giddiness, diarrhoea, loss of weight, tremor. Went to A&E twice.weight, tremor. Went to A&E twice.

Staff who made the initial error: Pharm Staff who made the initial error: Pharm Asst.Asst.

Contributing factors: Poor compliance to Contributing factors: Poor compliance to work procedure – no counterchecking of work procedure – no counterchecking of dispensed medicine with prescriptiondispensed medicine with prescription

Remedial action: Remedial action: • Medication & labelling of instruction Medication & labelling of instruction

must be countercheckedmust be counterchecked• Staff involved counseledStaff involved counseled• Staff deployment during peak hourStaff deployment during peak hour

A 44 year old male with Dengue haemorrhagic A 44 year old male with Dengue haemorrhagic fever in ICUfever in ICU

Prescribed IV Piperacillin-tazobactam 2.25g qid by Prescribed IV Piperacillin-tazobactam 2.25g qid by specialist using abbreviation pip-tazo specialist using abbreviation pip-tazo

Medication supplied by pharmacy assistant : IV Medication supplied by pharmacy assistant : IV Piperacillin 4 mg Piperacillin 4 mg

3 doses were administered to patient by staff nurse3 doses were administered to patient by staff nurseError discovered by pharmacist Error discovered by pharmacist Fortunately no harm to patient Fortunately no harm to patient

ERROR CATEGORY - D

Error Reduction StrategiesError Reduction Strategies

Alerts eg a new drug with confusing Alerts eg a new drug with confusing labellabel

Share ‘lessons learned’ to avoid Share ‘lessons learned’ to avoid similar mistakes similar mistakes

Disseminate new methods adopted Disseminate new methods adopted by facilities to prevent errorsby facilities to prevent errors

Provide information to healthcare Provide information to healthcare stakeholdersstakeholders

Drug Safety AlertDrug Safety Alert

Pharmacy websitePharmacy website

Medication Safety NewsletterMedication Safety Newsletter

Call for medication safety relatedCall for medication safety related

ArticlesArticles

Activities eg 5SActivities eg 5S

WorkshopsWorkshops

CPE /CPD sessionsCPE /CPD sessions

CartoonsCartoons

PicturesPictures

TERIMA KASIHTERIMA KASIH