MEDICATION SAFETY UNIT

Pharmacy Practice and Development Division Ministry of Health Malaysia

Unit formed in 2007  Personnel 1 pharmacist U48 (2007) 1 pharmacist U41 (April 2008)

OBJECTIVES

To establish a medication error reporting system To create a medication error database To promote medication safety awareness To provide training programmes on medication safety

SECRETARIAT
Medication Safety Committee, Pharmaceutical Services Division  Medication Safety Technical Advisory Committee (MedSTAC)  Pharmacovigilance on Safety of Vaccines

Medication Error Reporting System

MEDICATION ERROR . . . 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

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 Error

Error is inevitable because of human limitations Limited memory capacity Limited mental processing capacity Negative effects of fatigue and other physiological stressors

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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 medication error Why?

and not Who?

Why report?
Enable the healthcare providers & institutions to learn about

potential risks actual errors causes of errors prevention

Risks hidden in the processes used Errors that occur during patient care Underlying weaknesses in systems & processes that explain why errors happened Ways of preventing recurrent events

What to report?
Risks that can lead to errors or near misses  Sound-alike names or look alike packages  Ambigous product labels  Use of error prone abbreviations  Error-prone functions in cpoe systems

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

Prescribing errors Dispensing errors Administration errors

What not to report

Administrative errors Examples: • no prescribers stamp • no countersignature for category A medicines • Medicines not stocked/ nil in stock • Other units using certain drugs eg. MO A&E using Tramal which is for specialist clinic

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

Omission error The failure to administer an

ordered dose to a patient before the next ordered dose or failure to prescribe a drug product that is indicated. The failure to administer an ordered dose excludes patient’s refusal and clinical decision or other valid reason not to administer.

Wrong time error

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

Dispensing or Unauthorised/ administration to the wrong drug patient of medication not error authorised by a legitimate prescriber

Dose error

Dispensing or administration to pt of a dose that is > or< than amount ordered by prescriber or administration of multiple doses to pt Dispensing or administration to pt of a drug product in diff dosage form than that ordered by prescriber

Dosage form error

Drug preparation error

Drug product incorrectly formulated or manipulated before dispensing or administration

Wrong route of Route of administration administration of the correct drug error Administration Inappropriate procedure or technique error improper technique in the administration of a drug other than wrong route

Deteriorated drug error

Dispensing or administration of a drug that has expired or the physical or chemical dosage form integrity has changed Failure to review a prescribed regimen for appropriateness & detection of problems, or failure to use appropriate clinical or lab data for adequate assessment of pt response to prescribed therapy

Monitoring error

Compliance error

Inappropriate patient behavior regarding adherence to a prescribed medication regimen

Other medication error

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

NMEC Members
 

  

Senior Director of Pharmaceutical Services,MOH – Chairperson Director of Pharmacy Practice and Development,MOH – alternate Chairperson A representative from the Medical Development Division,MOH 14 others appointed by Director General of Health A physician from MOH hospital A hospital pharmacist from MOH

 

   

A physician from a university hospital A pharmacist from any local university with expertise in clinical pharmacy practice A physician from the APHM A hospital pharmacist from the Malaysian Armed Forces A Family Medicine Specialist from MOH A rep from the Malaysian Medical Association

  

A rep from the Federation of Private Medical Practitioners Association A rep from the Community Pharmacy Chapter, MPS A rep from the Private Hospital Pharmacy Chapter, MPS A rep from the Malaysian Dental Association A rep from the Malaysian Nursing Board A rep from the Malaysian Medical Assistants 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 Err

M

Reporters do not necessa practitioners, names of p

Front

ME Report Form
 

Date and time of event Type of facility Private/ government hospital/clinic/pharmacy Location of event: - ward - pharmacy - A& E - 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 Prescribing/Dispensing/Administration / Others Did error reach patient Y/N Incorrect med, dose or dosage administered or taken by patient Describe direct result on patient eg. death, admission into hospital, drugs prescribed to treat error

 

19. GUIDE FOR CATEGORIZING MEDICATION ERRORS
Circumstances or events that have the capacity to cause error Classification of Medication Error Severity NO ERROR Category A Potential error, Circumstances/events have potential to cause incident Actual Error – did not reach patient Actual Error – caused no harm Additional monitoring required – caused no harm Treatment/Intervention required –caused temporary harm Initial/prolonged hospitalization –caused temporary harm Caused permanent harm Near death event Death

Category A

NO

Did an actual error occur?

ERROR, NO HARM Category B Category C Category D ERROR HARM Category E Category F

YES Category B NO
Did the error reach the patient? *

YES Category C NO
Was intervention to preclude harm or extra monitoring required ? Did the error contribute to or result in patient death?

YES

Category G Category Category I H ERROR, DEATH Category I

NO NO
Was the patient harmed?

Category E

NO

An error of omission does reach the Did the error YES patient require initial or Category F prolonged hospitalization

YES

YES
Did the error require an intervention necessary to sustain life ?

YES NO
Was the harm temporary ?

Category D

YES
Was the harm permanent ?

NO YES
Category G

NO
Category H

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.

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 provided - copy of Rx, label of product, picture of product involved Recommendations/ preventive actions taken Reporter’s details

ME

MedSC
P.O Box 924, Jln Sultan 46790 Petaling Jaya

Tel : 037841 3200 Fax: 0379682268 Online Sistem pengurusan farmasi

State Johor

Facility Hosp Sultanah Aminah Hosp Sultan Ismail Hosp Batu Pahat Klinik Pesakit Luar Johor Baru KK Pontian Hospital Melaka KK Jasin Hosp Tunku Jaafar,Seremban Hosp TA Najihah,K Pilah KK Seremban KK Tampin

Melaka Negeri Sembilan

Selangor

WPKL/ Putrajaya Perak

Hosp Selayang HTAR,Klang KK Kelana Jaya Hosp Putrajaya KK Pantai Hospital Raja Permaisuri Bainun, Ipoh Hosp Teluk Intan KK Greentown KK Setiawan Hospital Kuala Lumpur

Two months duration ( July- August)  Number of reports received = 779  Category A = 42 ( 5.4 %) Category B = 714 (91.7 %) Category C = 6 (0.8 %) Category D = 10 (1.3 %) Category E = 2 (0.2%) Category F = 5 (0.6 %)

Sound-alike drugs
Zantac  Sertraline  lansoprazole  bisoprolol  bisoprolol  Lovastatin

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Zentel Stellazine pantoprazole metoprolol carvedilol simvastatin

ERROR CATEGORY - F T. Pyridostigmine 60mg 5x/day was prescribed to myasthenia gravis patient Staff Nurse served once daily dose Patient condition worsened - muscle weakness and shortness of breath worsened Error detected by doctor and the staff nurse was told to follow dosing time 8am, 1pm, 6pm, 11pm and 4am Possible error causes: Staff Nurse misunderstood the prescription because very seldom the encounter 5x daily dosage

ERROR CATEGORY - E

Patient was prescribed T. Lithium 300mg BD x 3/12 but was supplied with T. Lithium 600mg BD x 3/12 Patient had giddiness, diarrhoea, loss of weight, tremor. Went to A&E twice. Staff who made the initial error: Pharm Asst. Contributing factors: Poor compliance to work procedure – no counterchecking of dispensed medicine with prescription Remedial action: • Medication & labelling of instruction must be counterchecked • Staff involved counseled • Staff deployment during peak hour

ERROR CATEGORY - D
A 44 year old male with Dengue haemorrhagic fever in ICU Prescribed IV Piperacillin-tazobactam 2.25g qid by specialist using abbreviation pip-tazo Medication supplied by pharmacy assistant : IV Piperacillin 4 mg 3 doses were administered to patient by staff nurse Error discovered by pharmacist Fortunately no harm to patient

Error Reduction Strategies

Alerts eg a new drug with confusing label Share ‘lessons learned’ to avoid similar mistakes Disseminate new methods adopted by facilities to prevent errors Provide information to healthcare stakeholders

Drug Safety Alert

Pharmacy website

Medication Safety Newsletter
Call for medication safety related Articles Activities eg 5S Workshops CPE /CPD sessions Cartoons Pictures

TERIMA KASIH

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