GUIDELINE ON

MEDICATION ERROR
REPORTING SYSTEM
(MERS)

Pharmaceutical Services Programme

Ministry of Health Malaysia
 GUIDELINE ON
MEDICATION ERROR
REPORTING SYSTEM
(MERS)

Pharmaceutical Services Programme

Ministry of Health Malaysia
GUIDELINE ON MEDICATION ERROR REPORTING SYSTEM

Second Edition

2019

All rights reserved. This is a publication of the Pharmacy Practice

and Development Division, Ministry of Health Malaysia. Enquiries
are to be directed to the address below. Permission is hereby
granted to reproduce information contained herein provided that
such reproduction be given due acknowledgement and shall not
modify the text.

Pharmacy Practice and Development Division

Pharmaceutical Services Programme
Ministry of Health Malaysia
Lot 36, Jalan Profesor Diraja Ungku Aziz,
46200 Petaling Jaya,
Selangor, Malaysia.
Tel : 603-78413200
Fax : 603-79682222
Website : www.pharmacy.gov.my
 GUIDELINE ON MEDICATION ERROR
REPORTING SYSTEM (MERS)

Publication date July 2019

Summary Medication Error Reporting System (MERS) is a

national reporting system which was introduced
by the Pharmaceutical Services Programme,
Ministry of Health Malaysia since 2009. It
serves as a platform to encourage healthcare
professionals to report any medication error
encountered.

This guideline describes the management of

medication error and the step-by-step process
on how to fill and submit report to the
Medication Error Reporting System (MERS).

Replaces 1) Guideline On Medication Error Reporting

Document First Edition July 2009
2) Medication Error Reporting System
(MERS) User Manual 2017

Author Medication Safety Section

Pharmacy Practice and Development Division
Pharmaceutical Services Programme
Ministry of Health Malaysia

Applies to All government and private healthcare facilities

Audience Healthcare professionals

Updated Date February 2021

Review Date February 2023

 CONTENT
Content
1. Acknowledgement
2. Introduction
3. Definitions

4. About this guideline

• Purpose of This Guideline
• Scope of Reporting
• Reporting Medium

5. Management of Medication Error

• Reporting Medication Error
• Analysis and Monitoring of Medication Error
• Establishing Error Preventive Strategies
• Dissemination of Information
• Quality Improvement Programme
• Adopt Just Culture

6. Medication Error Reporting System (Online)

• User Guide I : User Registration (Reporter)
• User Guide II: Forget Password/ Unblock Account
• User Guide III : Create Medication Error Report
• User Guide IV : Amend Report (Enquiry)

7. Medication Error Reporting System (Manual)

8. Appendices
• Flow Chart (MERS Online)
• Guide For Categorizing Medication Errors
• Types of Medication Error
• Case Examples
• Medication Error Reporting Form (Manual)
 ACKNOWLEDGEMENT

First and foremost we like to express our sincere gratitude to the

authors and individuals involved directly or indirectly for their valuable
and constructive comments in the establishment of this guidelines.

We wish to thanks all Medication Safety Liaison Officers in the state

level for their support and efforts towards promoting and improving
medication safety practice in the hospitals and health clinics.

Not to forget, our extend appreciation to all the healthcare personnel

in the hospitals and health clinics for their commitment, teamwork and
initiative in ensuring safe medication practice.

Last but not least, we would like to acknowledge and thanks to all
healthcare professionals for their constant reporting medication errors
and every efforts taken to prevent medication errors in their facilities.

Pharmaceutical Services Programme

Ministry of Health Malaysia
EDITORIAL MEMBERS

1. Munira Binti Muhammad

Deputy Director (Quality Use of Medicine)
Pharmacy Practice and Development Division

2. Norhayati Binti Musa

Senior Principal Assistant Director
Pharmacy Practice and Development Division

3. Siew Lee Jin

Senior Principal Assistant Director
Pharmacy Practice and Development Division

4. Ong Su Hua
Senior Principal Assistant Director
Pharmacy Practice and Development Division

5. Lee Shal Ling

Senior Principal Assistant Director
Pharmacy Practice and Development Division

6. Nur Hazwani Binti Md Tahir

Principal Assistant Director
Pharmacy Practice and Development Division

7. Noor Syuhaidah Binti Radzuan

Principal Assistant Director
Pharmacy Practice and Development Division
INTRODUCTION
 INTRODUCTION

Medication safety is one of the vital components in patient safety.

Unfortunately medication errors do occur and often go undetected.
Some medication errors may result in serious patient morbidity and
mortality. Error detection through an active management and effective
reporting system discloses medication error and encourage safe
practice. Hence, Medication Error Reporting System also known as
MERS was introduced in 2009 as a mechanism tool and platform for
monitoring medication errors at the national level. The reporting
system will encourage all healthcare professionals to report any
medication errors encountered. In 2013, MERS was upgraded to
online system to provide easier access on reporting and sharing the
lesson learnt from incident that happened.

The primary objective of medication error reporting is to obtain

information and maintain a database on the occurrence of all
medication errors related to medication use in prescribing, dispensing,
administration, monitoring and others process involved in medication
management system. The reports which submitted through MERS will
be analysed to establish risk reduction strategies and promote safe
medication use.

Findings from MERS will provide important knowledge that can be

used as a guide in developing strategies, policies and action plan to
strengthen the current healthcare system. This system requires a
collective effort from various parties and a change in the way of
management of medication errors. We need to be able to discuss
errors openly, encourage reporting of errors and maintain a culture
that is non-punitive and blamelessness.

All the report submitted will maintain confidentiality with regards to the
identity of patients and the healthcare professionals involved.
DEFINITIONS
DEFINITIONS

Medication Error
Any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in the
control of the health care professional, patient, or consumer.

Such events may be related to professional practice, health care

products, procedures, and systems, including prescribing, order
communication, product labelling, packaging, and nomenclature,
compounding, dispensing, distribution, administration, education,
monitoring, and use.

Actual Error
• Medication error occurred and reached the patient.

• If the error is detected by the patient, it is considered as

actual error.

Near Miss
• Medication error that has the potential to cause an adverse
event (patient harm) but did not reach the patient because of
chance or because it is intercepted in the medication use
process.

• If the healthcare personnel detected and corrected the error

BEFORE it reaches the patient, it is considered as near
miss.

References
1. World Health Organization (WHO)
2. United States National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)
3. Agency for Healthcare Research and Quality (AHRQ)
ABOUT THIS GUIDELINE
 PURPOSE OF THIS GUIDELINE
1. This guideline serves as a reference for healthcare
professionals on how to report medication errors.
2. To emphasize on the quality reporting of medication errors

SCOPE OF REPORTING
• Medication Error Reporting System (MERS) is used to report all
medication errors (including near miss and actual error)
involving any medicine used both in public and private
healthcare facilities.
• Cases that shall not be reported to MERS include:
a) Administrative errors
e.g. no countersign for List A medications, doctor signed
prescription without official chop and prescribed medication
which is not available in the facility’s formulary.
b) Doctor prescribed drug that the patient is allergic to without
previous patient history. In this case, please report to the
National Centre for Adverse Drug Reactions Monitoring.
c) Pharmacist’s intervention due to treatment optimization
(e.g. suggest to increase the insulin dose because the
blood glucose is not well-controlled with the current dose).

REPORTING MEDIUM
Medication error reports can be submitted online or manually.
a) ONLINE
Submit reports through https://mers.pharmacy.gov.my
b) MANUAL
Refer Appendices : Medication Error (ME) Report Form

1. Reporters are encouraged to submit reports online.

2. The manual reporting form is to be submitted to the person-
in-charge for medication error reporting in the facility.
3. If your facility is not listed in the system, especially the
private healthcare facilities, kindly e-mail to
mers@moh.gov.my.
 MANAGEMENT OF
MEDICATION ERROR
 MANAGEMENT OF MEDICATION ERROR

1) REPORTING MEDICATION ERROR

- Detect and report any medication error encountered.

- Reportable events include both actual errors and the errors

that have been detected and corrected before reach the
patient.

- Document and report immediately after detected the error in

accordance to the standard process/ work flow of the
facilities.

2) ANALYSIS AND MONITORING OF MEDICATION ERROR

- Analyse medication error reports regularly and the findings

are shared with all the staff.

- Conduct root cause analysis (RCA) to identify the root

cause of the error and action(s) to eliminate it (refer to
Guidelines on Implementation Incident Reporting &
Learning System 2.0 for Ministry of Health Malaysia
Hospital First Edition 2017)

3) ESTABLISHING ERROR PREVENTIVE STRATEGIES

- Establish Patient/ Medication Safety committee to discuss

all patient safety related issues.

- Establish/ Implement error prevention strategies that focus

on system design/ safe behavioural practices and are
monitored continuously.

- Include medication safety elements in the ward check list/

pharmacy visit list/ audit.
 MANAGEMENT OF MEDICATION ERROR

4) DISSEMINATION OF INFORMATION

- Organize continuous education/learning sessions to share

all the medication errors and the error preventive strategies
among the staff.

5) QUALITY IMPROVEMENT PROGRAMME

- Record and analyse all the drug selection, preparation,

labelling and filling errors identified during routine checking
processes for the quality improvement activities in the
facility (e.g. establishing policies/protocols/guidelines, staff
awareness and education).

6) ADOPT JUST CULTURE

- Adopt JUST CULTURE model of shared accountability for

safe system design and behavioural changes supported by
the high level managements. Just culture encourages
individuals to speak up and to report a medication error,
allows for the proper judgement of the medication error and
provides learning opportunities for all healthcare
professionals.

- There is a visible commitment on patient safety goals within

the organization (e.g. specific medication safety indicators/
objectives are included in the facility's plan).

- Facility adopts no-blame culture in managing medication

error.

- There is a good cooperation among healthcare

professionals in order to work together and provide better
care for patients.
MEDICATION ERROR
REPORTING SYSTEM
(ONLINE)
Who can report?
Only healthcare professionals can register to the online
Medication Error Reporting System (MERS) and submit a
report.

How to report?
1. Go to https://mers.pharmacy.gov.my.
2. Log in using your username and password. If you
haven’t registered to the system, kindly do so and
follow User Guide I: Registration.
3. Fill in the form and submit.

How to complete the reporting form?

The medication error reporting form contains 6 parts:

Part A : Error Details
Part B : Location and Error Outcome
Part C : Patient’s Particulars
Part D : Product Details
Part E : Attachment
Part F : Reporter’s Details

For the step-by-step guide, kindly refer to:

• User Guide I : User Registration (Reporter)
• User Guide II : Forget Password/ Unblock Account
• User Guide III : Create Medication Error Report
• User Guide IV : Amend Report (Enquiry)
 MEDICATION ERROR
REPORTING SYSTEM
(ONLINE)

User Guide I : User Registration (Reporter)

 User Guide I : User Registration (Reporter)

1. Go to https://mers.pharmacy.gov.my

2. Click on the link as shown below.

 User Guide I : User Registration (Reporter)

3. Fill in all the particulars.

Address, Tel no, Fax no

will be autofilled after
selecting the facility

A VALID & ACTIVE

email address

Please fill at least 8

characters (combination of
letters + numbers or symbol)
Example: P@ssword1234

Please remember the security

question and answer. You may need to
use it to retrieve your password later.
 User Guide I : User Registration (Reporter)

4. Click SUBMIT button after all the particulars are completely filled.

5. Message would appear upon successful registration.

6. Once registered successfully, key in your username and password.

Fill in the username

and password.

Click Login

1. If your facility is not listed, kindly e-mail to

mers@moh.gov.my along with your facility’s details.
2. Please use a valid and active email
3. Avoid using IC number for user ID
4. Registration for user other than reporter such as
Reporter HQ, Verifier, JKN Viewer will be done by
Pharmacy Practice & Development Division, MOH.
Kindly e-mail to mers@moh.gov.my.
 MEDICATION ERROR
REPORTING SYSTEM
(ONLINE)
User Guide II: Forget Password/ Unblock Account
 User Guide II : Forgot Password / Unblock Account

Forget Password

1. If you forgot your password, click on the ‘ forgot password’ .

2. In order to obtain your password, you need to fill in your email, security
question and answer. Make sure you remember the security question
and answer. Then, click SUBMIT.

3. If all the details are correct, the system will automatically send a new
password to your registered email.
 User Guide II : Forgot Password / Unblock Account

Notification e-mail:

Default password
generated by the
system

4. You may now log in using the user ID and the default password.

Fill in your username

and your new password
given by the system

Click Login

5. You may change your password in the [User Profile] > [Change
Password].

Fill in the old and

new password
then click save.
 User Guide II : Forgot Password / Unblock Account

Unblock Account

User access will be blocked if failed to log in after

3 attempts.

1. If your account has been blocked, kindly contact the administrator

through email mers@moh.gov.my to reset your password.

2. E-mail details:

Title: To unblock MERS user account

Information to be included:
a) Full name of the user/ Name registered for that account
b) Username
c) Facility name
d) E-mail address
 MEDICATION ERROR
REPORTING SYSTEM
(ONLINE)
User Guide III : Create Medication Error Report
 User Guide III : Create Medication Error Report

1. Go to https://mers.pharmacy.gov.my

2. Log in with your Username and Password

Fill in the username

and password.

Click Login
 User Guide III : Create Medication Error Report

3. Click on Menu [Create ME Report]

4. A pop-up window will appear. Choose either:

a) OWN FACILITY (if you are reporting for your own facility).

By choosing “Own Facility”, the column location of facility and all

the reporter’s details will be auto-filled based on the user profile.
b) ON BEHALF (if you are reporting for other facilities)

By choosing “On Behalf”, you need to fill in the location of facility

and the reporter’s details.

For example, when a medication error occurred at Klinik Kesihatan A,

reporter who is using PKD HQ account to report a medication error
need to choose “On Behalf” instead of “Own Facility”.

Please choose the exact location of facility where the error occurred
(Klinik Kesihatan A).
 User Guide III : Create Medication Error Report

Part A: Error Details

* 1. Date of Event
Date when the error happened, not the date when the error was
reported.

* 2. Time of Event
Time when the error occurred.

* 3. Description of error
What happened? Sequence of event? When error was detected?
(no need to include the name of the personnel who did the error /
patient’s information).

Type of medication error, e.g.

prescribing error/ dispensing The error
error/ administration error involved

Prescribing error (wrong frequency). Doctor

prescribed Tab Metformin 500mg QID
instead of Tab Metformin 500mg BD. Error
detected before dispensing.

Brief description Briefly describe who

of the error detected the error

Examples:

1. Dispensing error (wrong drug). Pharmacist dispensed Tab

Akurit-2 instead of Tab Akurit-4. Patient had taken T Akurit-2
for 2 weeks.

2. Administration error (wrong patient). Nurse wrongly

administered 50ml of Metronidazole to patient A who is
allergic to Metronidazole instead of Patient B. Error detected
by the specialist during ward round.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

* 4. Contributing factor
Indicate the possible error cause(s) and contributing factor(s).
Multiple options may be selected.
* 5. Category made the initial error
Who started the initial error?

Examples:

Process in which Category made the initial error

the error occurs (under normal circumstances)

Prescribing Specialist, MO, HMO, AMO, Dentist, Nurse

Dispensing Pharmacist, PRP, PA, PA(Trainee)

Administration Specialist, MO, HMO, AMO, Nurse,

Nurse(Trainee)
Data Entry Specialist, MO, HMO, AMO, Dentist,
Pharmacist, PRP, PA, PA(Trainee)
Monitoring Specialist, MO, HMO, AMO, Dentist,
Pharmacist, PRP, PA, PA(Trainee)
Registration Registration counter staff (e.g. PRA)

Preparation of Drugs Pharmacist, PRP, PA, PA(Trainee), Nurse

Documentation Pharmacist, PRP, PA, PA(Trainee), Nurse

6. Category also involved in the error

Who also involved causing the error to occur?

* 7. Category detected the error

Who detected the error?

8. Recommendation/ Remedial action taken

Describe the corrective / preventive action taken to avoid the
occurrence of similar errors.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Part B: Location and Error Outcome

* 9. Location of Facility
Facility where the error occurred.
Agency Type State District Facility

If your facility is not listed in the system, kindly e-mail to

mers@moh.gov.my.

* 10. Location of Event

Location where the error occurred (not where the error detected).
Location of event is related to the process in which the error occur.

Examples:

Process in which the Location of event

error occurs
Prescribing Clinic/ Ward/ A&E
Dispensing Pharmacy
Administration Clinic/ Ward/ A&E
Data entry Clinic/ Ward/ A&E/ Pharmacy
Monitoring Clinic/ Ward/ A&E
Registration Registration counter
Preparation of Drugs Clinic/ Ward/ A&E/ Pharmacy
Documentation Clinic/ Ward/ A&E/ Pharmacy

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Part B: Location and Error Outcome

* 11. In which process did the error occur.

(Note: You may select more than 1 option given).
Examples:

Location of event In which process did the error occur

Prescribing, Dispensing, Administration,
Ward
Others
A&E Prescribing, Administration, Others

Clinic Prescribing, Administration, Others

Pharmacy Data Entry, Labelling, Filling, Dispensing

Others Registration

* 12 Did the error reach the patient?

• Yes, if medication reaches the patient
• No, if medication didn’t reach the patient
• An “error of omission” does reach the patient

* 13.Was the incorrect medication, dose or dosage form

administered to or taken by the patient?
• Yes, if the incorrect medication reaches the patient and is
administered
• No, if the incorrect medication reaches the patient but not
administered

* 14. Error Outcome Category

In selecting the patient outcome category, select the highest level
severity that applies during the course of the event. For example, if
a patient suffers a severe anaphylactic reaction (Category H) and
requires treatment (Category F) but eventually recovers
completely, the event should be coded as Category H.

Select only one of the medication error categories or

subcategories, whichever best fits the error that is being reported.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Error Outcome Category

NO ERROR

Category A Circumstances or events that have the capacity to cause

error.
Example: Illegible handwriting, use of abbreviation, incorrect
storage of medication/ mix up drugs

ERROR, NO HARM
[Note: Harm is defined as temporary or permanent impairment of the physical, emotional, or psychological
function or structure of the body and/or pain resulting therefrom requiring intervention.]

Category B An error occurred but the error did not reach the patient (An
“error of omission” does reach the patient).
Example: Error detected before dispensing to the patient.

Category C An error occurred that reached the patient but did not cause
patient harm.

Medication reaches the patient and is administered.

Medication reaches the patient but not administered.
Example:
a) Pharmacist dispensed incorrect medication to ward.
Nurse administer the incorrect medication to patient.
b) Pharmacist dispensed incorrect medication to the patient.
The patient realized that the medicine is incorrect and
return it back to the pharmacy.

Category D An error occurred that reached the patient and required

monitoring to confirm that it resulted in no harm to the patient
and/or required intervention to preclude harm.
Example: Other patient's profile was accidentally placed
inside the patient's file which has led to wrong medications
prescribed during previous visit. MO was informed. Close
glucose monitoring was planned for this patient. The blood
glucose level was reported as mild elevation only.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Error Outcome Category

ERROR, HARM
Root cause analysis (RCA) reports are required and should be attached
(Refer 20.)

Category E An error occurred that may have contributed to or resulted in

temporary harm to the patient and required intervention.

Category F An error occurred that may have contributed to or resulted in

temporary harm to the patient and required initial or prolonged
hospitalisation.

Category G An error occurred that may have contributed to or resulted in

permanent patient harm.

Category H An error occurred that required intervention necessary to

sustain life.

ERROR, DEATH

An error occurred that may contributed to or resulted in the

Category I
patient's death.
Reference: © 2001 National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

Note

Please refer the direct result on the patient (e.g. death, type of harm, additional patient
monitoring) which stated in the medication error report (No.15) and Guide For Categorizing
Medication Errors to determine the severity of the error outcome.

* 15. Describe the direct result on the patient (e.g. death, type of harm,
additional patient monitoring).
Example: No harm, harm (please specify, e.g. tachycardia/ bradycardia/
seizure attack), additional patient monitoring includes, vital signs
monitoring, sign & symptoms of toxicity, blood glucose monitoring, TDM
level monitoring, Glasgow coma scale, etc.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Part C: Patient’s Particulars

16. Patient’s particulars: age, gender and diagnosis.

Click on the Patient’s Particulars tab and complete the form, then
click save. Patient’s particulars are optional fields but reporters are
encouraged to fill in these particulars.

Part D: Product Details

17.1 & 17.2 Generic Name ± Brand Name

* i) Tick the “Generic Name” and type in the first few alphabets, then
choose from the dropdown list.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

OR ii) Choose a Brand Name of the product from the dropdown list and
the Generic Name will be auto filled (Brand name is optional).

1. Generic name is MANDATORY.

2. Brand name is OPTIONAL. If the brand name is
not listed, please untick the brand name and
proceed with other product particulars.
3. If you wish to add in any product in the system,
kindly e-mail the product details to
mers@moh.gov.my.

17.3 Dosage Form

Type in the first few alphabets in the dosage form column, then choose
from the dropdown list.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

17.4 Dose, Frequency, Duration, Route

Fill in the dose, frequency, duration, route column. Then, click SAVE.

What if the error involved more than one product?

Click on ‘Add another product’ button if more than one product is involved
and repeat the above steps.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

17.5 Is the error involved similar packaging?

If similar packaging is involved, click YES and fill in the details
(17.5.1, 17.5.2, 17.5.3). Then, click ADD.

Examples:
a) Incorrect drug

b) Incorrect frequency

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Examples:
c) Incorrect patient

d) Incorrect dosage form

e) Incorrect dose

f) Incorrect quantity

g) Polypharmacy

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Examples:

h) Omission (*not filled/not prescribed/not served)

i) Illegible handwriting

Part E: Attachment
18. Relevant materials such as product label, copy of prescription/ order.
19. Attachment for error description.
20. Attachment for recommendations/ Root Cause Analysis (RCA).

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

To upload the attachment, click on the ‘Choose File’ button and choose
your file.

Click and choose your file.

Once uploading process is 100%, the attachment name will be written

on the section where you attach your file/photo as shown below.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

If file size is exceed 20MB, the system will notify as shown below

1. Supporting file type: png, jpeg, MS Word,

MS Powerpoint, pdf.
2. Make sure your file size not exceed 20MB.
3. Kindly upload the relevant attachment based on the
question.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Part F: Reporter’s Details

* 21. Reporter’s Details

a) For individual account, the reporter’s details will be auto-filled.

b) For centralised account (Reporter HQ), the reporter’s details will

be blank. Kindly fill in all particulars.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

Click SUBMIT once all the tabs are completely filled.

“ME Report has been successfully sent” notification will appear, displaying
your submission details. The report can be retrieved from ME Report Status >
New Submission.

Fields marked with * are compulsory fields.

 User Guide III : Create Medication Error Report

The report will be processed after submission. A notification e-mail will

be sent to the reporter for clarification and amendments if necessary.
The report can be retrieved from ME Report Status> Enquiry. (Kindly
refer to User Manual 4: Amend Report (Enquiry)).

Report that have been saved but have not submitted will be keep as
DRAFT. (ME Report Status> Draft)

Medication Error Report Status

Report Status Action to be taken Action by

Draft ME Report saved but not submitted yet Reporter

(Maximum 10 drafts).
Reporter have to complete the ME report
and SUBMIT.

New Submission ME Report have been submitted. Verifier

Reporter is allowed to edit ME report
during this phase.

Enquiry ME Report is not verified and return to Reporter

reporter for feedback and amendment.
Reporter must edit , save and SUBMIT the
ME report.

Amendment Report have been edited, awaiting Verifier

verification.

Verified Report have been verified, awaiting Approver

approval.
ME Report is not approved/endorsed and
return to reporter for clarification/
Return to reporter amendment. Reporter

Reporter must edit , save and SUBMIT the

ME report.
Approved Report have been approved, awaiting Endorser
endorsement.

Endorsed Report have been endorsed. -

Fields marked with * are compulsory fields.

MEDICATION ERROR
REPORTING SYSTEM
(ONLINE)
User Guide IV : Amend Report (Enquiry)
 User Guide IV : Amend Report (Enquiry)

Medication Error Report Status

Report Status Action to be taken Action by
Draft ME Report saved but not submitted yet. Reporter
Reporter have to complete the ME report
and SUBMIT.
New Submission ME Report have been submitted. Verifier
Reporter is allow to edit ME report during
this phase.
Enquiry Report is not verified/ not approved/ not Reporter
endorsed and return to reporter for
feedback and amendment.
Reporter must edit , save and SUBMITT
the ME report
Amendment Report have been edited, awaiting Verifier
verification.
ME Report is not approved/endorsed and
return to reporter for clarification/
Return to reporter amendment. Reporter

Reporter must edit , save and SUBMIT

the ME report.

A notification e-mail will be sent to the reporter for

clarification and amendments if necessary. Thus, please
ensure the registered e-mail address is valid.

1) Click on the link in the e-mail to access the report to make amendment(s).

Click on this link to

access the report.
 User Guide IV : Amend Report (Enquiry)

2) You will be directed to the MERS home page. Log in the system and you
will be directed to the report. Your details must match with the reporter’s
account, if not, your access will be denied.

OR Alternatively, you can also access the report by choose form the menu
bar [ME Report Status]> [Enquiry] after you log in to your account.
 User Guide IV : Amend Report (Enquiry)

3. Read the remarks and click EDIT to amend report

4. Click EDIT tab at the bottom of the page to make the necessary
amendment(s).

Edit

5. Click SAVE after making every changes/amendments.

Save
 User Guide 4 : Amend Report (Enquiry)

Example:

Notification for report not approved/ not endorsed.

MEDICATION ERROR
REPORTING SYSTEM
(MANUAL)
 Who can report?
Only healthcare professionals can submit report to
Medication Error Reporting System (MERS).

How to report?
Fill in the Medication Error Reporting Form (refer
appendices) and submit to the following address:

Medication Safety Section

Pharmacy Practice and Development Division
Ministry of Health Malaysia
Lot 36, Jalan Universiti,
46200 Petaling Jaya,
Selangor.

How to fill in the Medication Error Reporting Form?

* No 1-5 Describe the error occurred (date, time, type of facility,

location of event and the brief description).

Fields marked with * are compulsory fields.

* 6. In which process did the error occur.
(Note: You may select more than 1 option given).

Examples:

Location of event In which process did the error occur

Prescribing, Dispensing, Administration,
Ward
others
A&E Prescribing, Administration, others

Clinic Prescribing, Administration, others

Pharmacy Data Entry, Labelling, Filling, Dispensing

Others Registration

* 7. Did the error reach the patient?

• Yes, if medication reaches the patient
• No, if medication didn’t reaches the patient
• An “error of omission” does reach the patient

* 8.Was the incorrect medication, dose or dosage form

administered to or taken by the patient?
• Yes, if medication reaches the patient and is administered
• No, if medication reaches the patient but not administered

* 9. Describe the direct result on the patient (e.g. death, type of harm,
additional patient monitoring).
Example: Additional patient monitoring includes, vital signs
monitoring, sign & symptoms of toxicity, blood glucose monitoring,
TDM level monitoring, Glasgow coma scale, etc.

Fields marked with * are compulsory fields.

* 10. Error Outcome Category
In selecting the patient outcome category, select the highest level
severity that applies during the course of the event. For example, if
a patient suffers a severe anaphylactic reaction (Category H) and
requires treatment (Category F) but eventually recovers
completely, the event should be coded as Category H.

Select only one of the medication error categories or

subcategories, whichever best fits the error that is being reported.

NO ERROR

Category A Circumstances or events that have the capacity to cause

error.
Example: Illegible handwriting, use of abbreviation,
incorrect storage of medication/ mix up drugs

ERROR, NO HARM
[Note: Harm is defined as temporary or permanent impairment of the physical, emotional, or
psychological function or structure of the body and/or pain resulting therefrom requiring intervention.]

Category B An error occurred but the error did not reach the patient (An
“error of omission” does reach the patient).
Example: Error detected before dispensing to the patient.

Category C An error occurred that reached the patient but did not cause
patient harm.

Medication reaches the patient and is administered.

Medication reaches the patient but not administered.
Example:
a) Pharmacist dispensed incorrect medication to ward.
Nurse administered the incorrect medication to patient.
b) Pharmacist dispensed incorrect medication to the
patient. The patient realised that the medicine was
incorrect and returned it back to the pharmacy.
Fields marked with * are compulsory fields.
Category D An error occurred that reached the patient and required
monitoring to confirm that it resulted in no harm to the
patient and/or required intervention to preclude harm.
Example: Other patient's profile was accidentally placed
inside the patient's file which has lead to wrong
medications prescribed during previous visit. MO was
informed. Close glucose monitoring was planned for this
patient. The blood glucose level was reported as mild
elevation only.

ERROR, HARM
Root cause analysis (RCA) reports are required and should be attached
(Refer 20.)

Category E An error occurred that may have contributed to or resulted

in temporary harm to the patient and required intervention.

Category F An error occurred that may have contributed to or resulted

in temporary harm to the patient and required initial or
prolonged hospitalisation.

Category G An error occurred that may have contributed to or resulted

in permanent patient harm.

Category H An error occurred that required intervention necessary to

sustain life.

ERROR, DEATH

An error occurred that may contributed to or resulted in the

Category I
patient's death
Reference: © 2001 National Coordinating Council for Medication Error Reporting and Prevention

* 11. Contributing Factor(s)

What caused the described error to occur?
(Note: You may select more than 1 option given).

Fields marked with * are compulsory fields.

* 12. Category made the initial error
Who started the initial error?

Examples:

Process in which Category made the initial error

the error occurs (under normal circumstances)

Prescribing Specialist, MO, HMO, AMO, Dentist, Nurse

Dispensing Pharmacist, PRP, PA, PA(Trainee)

Administration Specialist, MO, HMO, AMO, Nurse,

Nurse(Trainee)
Data Entry Specialist, MO, HMO, AMO, Dentist,
Pharmacist, PRP, PA, PA(Trainee)
Monitoring Specialist, MO, HMO, AMO, Dentist,
Pharmacist, PRP, PA, PA(Trainee)
Registration Registration counter staff (e.g. PRA)

Preparation of Drugs Pharmacist, PRP, PA, PA(Trainee), Nurse

Documentation Pharmacist, PRP, PA, PA(Trainee), Nurse

13. Category also involved in the error

Who also involved causing the error to occur?

* 14. Category detected the error

Who detected the error occurred?

Fields marked with * are compulsory fields.

 15. Patient’s particulars: age, gender and diagnosis.
Patient’s particulars are optional fields but reporters are encouraged
to fill these particulars.

* 16. Product details. (Fill in the relevant column).

Fill in 16.5-16.7 if the error involved similar packing.

17. Attachment.

You are encouraged to attach the relevant materials such as product

label, copy of prescription/ order/ Root Cause Analysis (RCA) report as
supporting documents.

18. Recommendation/ Remedial action taken

Describe the corrective / preventive action taken to avoid the
error so it would not occur

Fields marked with * are compulsory fields.

 APPENDICES

• Flow Chart (MERS Online)

• Guide For Categorizing Medication Errors
• Types of Medication Error
• Case Examples
• Medication Error Reporting Form (Manual)
Flow Chart (MERS Online)
Guide For Categorizing Medication Errors

Classification of Medication Error Severity

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

** An error of omission does reach the patient

YES

Did the error YES

contribute to or
Category C result in patient Category I
death?

NO NO

Did the
Was intervention NO NO error require initial YES
to preclude harm or Was the patient Category E Category F
harmed? or prolonged
extra monitoring hospitalization
required ?

YES
YES YES

Did the
error require an NO
Category D intervention necessary Was the harm
to sustain life ? temporary ?

YES
NO

Was the harm YES

permanent ? Category G

NO

Category H

© 2001 National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)
Types of Medication Error

Type Definition

Incorrect drug product selection (based on indications,

contraindications, known allergies, existing drug
therapy, and other factors), dose, dosage form,
quantity, route, concentration, rate of administration, or
a. Prescribing Error
instructions for use of a drug product ordered or
authorized by physician (or other legitimate prescriber);
illegible prescriptions or medication orders that lead to
errors that reach the patient

The failure to administer an ordered dose to a patient

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

Administration of medication outside a predefined time

interval from its scheduled administration time (this
c. Wrong time error
interval should be established by each individual health
care facility

Unauthorised Dispensing or administration to the patient of

d.
drug error medication not authorised by a legitimate prescriber

Dispensing or administration to the patient of a dose

that is greater than or less than the amount ordered by
the prescriber or administration of duplicate doses to
e. Dose error
the patient, i.e. one or more dosage units in addition to
those that were ordered or prescribing more or less
than standard dose defined in practice

Dispensing or administration to the patient of a drug

Dosage-form
f. product in a different dosage form than that ordered
error
by the prescriber
Types of Medication Error

Type Definition

Drug-preparation Drug product incorrectly formulated or manipulated

g.
error before administration

Route of
Use of wrong route of administration of the correct
h. administration
drug.
error

Administration- Inappropriate procedure or improper technique in

i.
technique error the administration of a drug other than wrong route

Dispensing or administration of a drug that has

Deteriorated drug
j. expired or for which the physical or chemical
error
dosage-form integrity has been compromised

Failure to review a prescribed regimen for

appropriateness and detection of problems, or
k. Monitoring error failure to use appropriate clinical or laboratory data
for adequate assessment of patient response to
prescribed therapy

Inappropriate patient behaviour regarding

l. Compliance error
adherence to a prescribed medication regimen

Other medication Any medication error that does not fall into one of
m.
error the above predefined categories
 Case Examples
Near
Reach/ Taken/
Location Process of Miss/
No Scenario Not Not
of event error Actual
Reach Taken
Error

Prescribing error detected by the

Ward/
pharmacy staff before dispense Not Not Near
1 Clinic/ Prescribing
the medication to the patient at Reach Taken Miss
A&E
the dispensing counter.

Ward/ Prescribing
Prescribing error detected by the Not Actual
2 Clinic/ & Reach
patient at the dispensing counter. Taken Error
A&E Dispensing

Prescriber did not prescribe the

Ward/
medication that is indicated for Not Not Near
3 Clinic/ Prescribing
the patient. Error detected by the Reach Taken Miss
A&E
pharmacy staff before dispensing.

Prescriber did not prescribe the

Ward/
medication that is indicated for Not Actual
4 Clinic/ Prescribing Reach
the patient. Error detected by the Taken Error
A&E
patient at the dispensing counter.

Prescriber did not prescribe the

Ward/
medication that is indicated for Prescribing Taken/
Clinic/ Actual
5 the patient. Error detected by the & Reach Not
A&E Error
patient and return to the Dispensing Taken
pharmacy for clarification.

Pharmacy
Medication error detected by the Data entry/
> Out- Not Not Near
6 pharmacy staff at the dispensing Labelling/
patient Reach Taken Miss
counter. Filling
Pharmacy

Pharmacist enter wrong drug in

the computerized system. Label Pharmacy
Data entry
printed out wrongly and the > Out- Not Not Near
7 & Labelling
pharmacist assistant filled the patient Reach Taken Miss
& Filling
drug based on the wrong label. Pharmacy
Error detected before dispensing.

Pharmacy Data entry/

Medication error detected by the > Out- Labelling/ Not Actual
8 Reach
patient at the dispensing counter. patient Filling/ Taken Error
Pharmacy Dispensing
 Case Examples

Taken Near
Reach/
Location of Process of / Miss/
No Scenario Not
event error Not Actual
Reach
Taken Error

Wrong medication dispensed

Pharmacy> Taken/
to the patient and patient Actual
9 Outpatient Dispensing Reach Not
return to the pharmacy for error
Pharmacy Taken
clarification.

Wrong medication/ dosage

supplied by the in-patient
Pharmacy>
pharmacy and the error Not Not Near
10 In- patient Dispensing
detected by nurse / doctor / Reach Taken miss
Pharmacy
pharmacist before / during
drug administration.

Medication not filled by the Pharmacy>

Filling & Not Not Near
11 pharmacy and the error In-patient
Dispensing Reach Taken miss
detected by nurse Pharmacy

Wrong medication/ dosage Taken/

Actual
12 given to the patient and the Ward Administration Reach Not
Error
error detected by the patient Taken

Medication not supplied by the

pharmacy and the error Pharmacy>
Not Not Near
13 detected by nurse during In-patient Dispensing
Reach Taken Miss
administration. Patient didn’t Pharmacy
missed the dose.

Medication not supplied by the Pharmacy>

Dispensing & Not Actual
14 pharmacy and patient missed In-patient Reach
Administration Taken Error
the dose. Pharmacy

Medication not served in the Not Actual

15 Ward Administration Reach
ward. Taken Error
 MEDICATION ERROR (ME) REPORT FORM MERS reference no:

ME/ref/
Pharmaceutical Services Programme Reporters do not necessarily have to provide any individual identifiable health information, including names of practitioners,
Ministry of Health Malaysia names of patients, names of healthcare facilities, or dates of birth (age is acceptable)
www.pharmacy.gov.my
Tel: 03-78413200 Fax: 79682268

1 Date of event: dd/mm/yy 2 Time of event: hh/mm (24 hr)

3 Type of Facility: *Government/ Private 4 Location Ward (Please specify: Medical/Pead/Ortho/…….…………………………)

of event: Clinic (Please specify: Outpatient/Specialist/Dental/….……………….....)
Hospital Clinic Pharmacy Pharmacy (Please specify: Inpatient/Outpatient/Satellite/A&E/..………..)
A&E
Others: _______________________
Others (Please specify:…………………………………..…………………..)
5 Please describe the error. Include description/ sequence of events and work environment (e.g. change of shift, short staffing, during peak hours).
If more space is needed, please attach a separate page.

6 In which process did the error occur? 7 Did the error reach the YES 9 Describe the direct result on the patient (e.g.
Prescribing Data Entry System patient? NO death, type of harm, additional patient
Filling Labelling monitoring e.g. BP, HR, glucose level etc.).
8 Was the incorrect medication,
Dispensing Administration YES
dose or dosage form
Others (Please specify) : administered to or taken by NO
____________________________ the patient?
10 Please tick the appropriate Error Outcome Category (Select one)

A Potential Error, circumstances/ events have E Treatment/ intervention required - caused temporary harm
potential to cause incident F Initial/ prolonged hospitalization - caused temporary harm
B Actual Error – did not reach patient (near miss) G Caused permanent harm
C Actual Error - caused no harm H Near death event
I Death
D Additional monitoring required - caused no harm
Reference: © 2001 National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)

11 Indicate the possible error cause(s) and contributing factor(s).

Staff factors Task and technology Work and environment
Inexperienced personnel Failure to adhere to work procedure Heavy workload
Inadequate knowledge Use of abbreviations Peak hour
Distraction Illegible prescriptions Stock arrangements/ storage problem
Medication related Patient information/ record unavailable/ inaccurate Others (please specify):
Sound alike medication Wrong labeling/ instruction on dispensing envelope ……………………………………………
Look alike medication or bottle/ container …....................................................….
Look alike packaging Incorrect computer entry
For question 12-14, please fill each box with one of the following option.
a. Specialist g. Nurse (Trainee) l. Patient/ Caregiver
b. Medical Officer (MO) h. Assistant Medical Officer (AMO) m. Dentist
c. Houseman Medical Officer (HMO) i. Assistant Medical Officer (AMO Trainee) n. Others (Please specify:
d. Pharmacist j. Pharmacist Assistant
e. Provisional Registered Pharmacist (PRP) ………………..…………………..)
f. Nurse k. Pharmacist Assistant (Trainee)
12 Which category made the initial error?
13 Other category also involved in the error?
14 Which category discovered the error or recognised the potential error?
15 If available, please provide patient's particulars (Do not provide any patient identifiers).
Age: *years/ months/ days Gender: Male Female Diagnosis: ___________________________________________
16 Product Details: Please complete the following for the product(s) involved. Kindly attach a separate page for additional products.

Product Description Product # 1 (intended) Product # 1(error)

16.1 Generic Name (Active Ingredient)

16.2 Brand / Product Name

16.3 Dosage Form

16.4 Dose, frequency, duration, route

If error involved similar product packaging, please fill in 16.5-16.7.
Product Description Product # 1 (intended) Product # 1(error)

16.5 Manufacturer

16.6 Strength / Concentration

16.7 Type and Size of Container

* Please delete where not applicable

17 Reports are most useful when relevant materials such as 18 Suggest any recommendations, or describe policies or procedures you
product label, copy of prescription/order, etc., can be instituted or plan to institute to prevent future similar errors. If available,
reviewed. Can these materials be provided? kindly attach investigational report e.g. Root Cause Analysis (RCA).
No
Yes, Please specify
________________________________________
_________________________________

Reporter’s Details

Name : For official use :

Profession : Date report received :

Facility and Address : dd/mm/yy

Postcode : Ref. No.

E-mail : ME Type

Telephone number : Fax Number : ME Category

(Fold here)

Medication Safety
Is Everyone’s Responsibility

(Fold here)

NO STAMP REQUIRED

SETEM POS TIDAK DIPERLUKAN

REPLY PAID / JAWAPAN BERBAYAR

MALAYSIA
No. Lesen : BRS 0915 SEL

Medication Safety Section

Pharmacy Practice and Development Division
Pharmaceutical Services Programme
Ministry of Health Malaysia
P.O. Box 924, Jalan Sultan,
46790 Petaling Jaya, Selangor.