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
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 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?
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 Incorrect drug product
error 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 Administration of
error medication outside a
predefined time interval
from its scheduled
administration time

Unauthorised/ Dispensing or
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

Dosage form Dispensing or administration

error to pt of a drug product in diff
dosage form than that
ordered by prescriber
Drug Drug product incorrectly
preparation formulated or manipulated
error before dispensing or
administration

Route of Wrong route of

administration administration of the correct
error drug

Administration Inappropriate procedure or

technique error improper technique in the
administration of a drug
other than wrong route
Deteriorated Dispensing or administration
drug error of a drug that has expired or
the physical or chemical
dosage form integrity has
changed

Monitoring Failure to review a prescribed

error regimen for appropriateness
& detection of problems, or
failure to use appropriate
clinical or lab data for
adequate assessment of pt
response to prescribed
therapy
Compliance Inappropriate patient
error behavior regarding
adherence to a prescribed
medication regimen

Other Any medication error that

medication does not fall into one of the
error 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

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 Classification of Medication Error Severity
events that have the
capacity to cause
error NO ERROR
Category A Potential error, Circumstances/events have
potential to cause incident
ERROR, NO HARM
NO Did an actual
Category A error occur? Category B Actual Error – did not reach patient
Category C Actual Error – caused no harm
YES Category D Additional monitoring required – caused no
harm
ERROR HARM
Category B NO Did the error reach
the patient? * Category E Treatment/Intervention required –caused
temporary harm
Category F Initial/prolonged hospitalization –caused
YES temporary harm
Category G Caused permanent harm
Did the error YES
Category C contribute to or Category
Category I H Near death event
result in patient
death? ERROR, DEATH
NO NO Category I Death

Was intervention Did

Anthe
errorerror
of omission does reach the
NO Was the patient NO patient
require initial or YES Category F
to preclude Category E
harmed? prolonged
harm or extra hospitalization
monitoring required
? YES
YES YES
Did the
Category D error require an NO Was the harm
intervention necessary temporary ?
to sustain life ?
YES
NO

Was the harm YES

permanent ? Category G

All ME reports should be sent to :

NO
Medication Safety Centre
Category H
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

Tel : 03-
MedSC 7841 3200
Fax: 03-
P.O Box 924, 79682268 Online
Jln Sultan Sistem pengurusan
farmasi
46790 Petaling Jaya
State Facility
Johor Hosp Sultanah Aminah
Hosp Sultan Ismail
Hosp Batu Pahat
Klinik Pesakit Luar Johor Baru
KK Pontian
Melaka Hospital Melaka
KK Jasin

Negeri Hosp Tunku Jaafar,Seremban

Sembilan Hosp TA Najihah,K Pilah
KK Seremban
KK Tampin
Selangor Hosp Selayang
HTAR,Klang
KK Kelana Jaya
WPKL/ Hosp Putrajaya
Putrajaya KK Pantai

Perak 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 - Zentel
 Sertraline - Stellazine
 lansoprazole - pantoprazole
 bisoprolol - metoprolol
 bisoprolol - carvedilol
 Lovastatin - 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