DOH STANDARD ON

REPORTING MEDICATION
ERRORS
March 2019

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Document
DOH Standard on Reporting Medication Errors
Title:
Document
DOH/Standard/RME/1.1 Version 1.1
Ref. Number:
Approval Effectiveness
March 2019 April 1, 2019
Date: Date:
Revision
April 2022
History:
Drug and Medical Products Department, Healthcare Licensing
For Further
and Medical Education Division,
Advice
pharmacovigilance@doh.gov.ae
Contact:

All Healthcare Professionals and Healthcare Providers in the

Applies To
Emirate of Abu Dhabi

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DOH Standard on Reporting Medication Errors

Table of Contents
1. Purpose ......................................................................................................................... 4
2. Scope ............................................................................................................................ 4
3. Abbreviations and Definitions ...................................................................................... 4
4. Duties of Healthcare Providers and Healthcare Professionals ,,.................................. 7
5. ME Reporting: Service Specifications ........................................................................... 8
6. Enforcement and Sanctions ......................................................................................... 9
7. Appendix 1: Medication Error Reporting Form ........................................................ 10
8. Appendix 2: Types of Medication Errors ................................................................... 11
9. Appendix 3: NCC MERP Index for Categorizing Medication Errors ......................... 12

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1. Purpose
The purpose of this Standard is to:
1.1. Define Healthcare Professionals’ responsibility in detecting, reporting,
evaluating, and preventing medication errors (ME), as part of the “Culture of
Safety” that should be adopted by Healthcare Providers for promoting the
development and use of Continuous Quality Improvement (CQI) system to
detect and document, evaluate, report and prevent ME.

2. Scope
The Standard applies to all Healthcare Professionals and Healthcare Providers in the
Emirate of Abu Dhabi.

3. Abbreviations and Definitions

ME Medication Error

DOH Department of Health

CQI Continuous Quality Improvement

NCC MERP National Coordinating Council for Medication Error Reporting and
Prevention

Medication A medication error is any preventable event that may cause or lead
Error1 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 labeling, packaging, and
nomenclature, compounding, dispensing, distribution,
administration, education, monitoring, and use.

Near miss2 An error that has the potential to cause an adverse event (patient
harm) but fails to do so because of chance or because it is
intercepted.

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Unsafe Any circumstance that increase the probability of a patient safety
condition3 event; includes a defective or deficient input to or environment of a
care process that increases the risk of an unsafe act, care process
failure or error, or patient safety event. An unsafe condition does not
involve an identifiable patient.

Impairment of the physical, emotional or psychological function or

Harm structure of the body and/or pain resulting therefrom.

Healthcare An individual who provides clinical professional services within a

Professional named healthcare profession.

Any person who operates a healthcare facility or in selected instance,

Healthcare who proposes to do so.
Provider4 For these purposes:
 ‘person’ means any individual or legal entity,
 that person ‘operates’ a healthcare facility if he carries on the
business of providing healthcare services at the facility or,
where healthcare services are not provided as part of a
business, otherwise has the ultimate responsibility for the
management of the facility.

Non- Non-punitive action means there will be no disciplinary action taken

punitive against an employee for a medication error that is reported as per
actions the timeframe outlined in the standard. Under this standard, nothing
will be placed in the employees’ permanent employee record or
used during the performance appraisal process. Continuing
education, remedial training or an individualized action plan is not
considered punitive or disciplinary action.

Any information gathered through audits of medical records,

patients’ complaints, intentional acts by the employee, wrongful /
unlawful consumption of medications /controlled substances by the
employee making the error, employees who knowingly fail to report
a medication error are considered exceptions to non-punitive
actions.

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 Anonymous for the purpose of this document means that providing
information about the person involved in the error is optional.
Anonymous However, identity of the facility or the professional reporting the
error to DOH must be known for follow up purposes.

Culture of The product of individual and group beliefs, values, attitudes,

Safety5,6 perceptions, competencies, and patterns of behavior that determine
the organization’s commitment to quality and patient safety.
"Culture of safety" encompasses the following key features:
•acknowledgment of the high-risk nature of an organization's
activities and the determination to achieve consistently safe
operations.
•a blame-free environment where individuals are able to report
errors or near misses without fear of reprimand or punishment
•encouragement of collaboration across ranks and disciplines to seek
solutions to patient safety problems.
Chain Pharmacies under common control or ownership.
Pharmacies
Root Cause Process for identifying the basic or causal factors that underlie
Analysis variation in performance and that may have caused or contributed
to an adverse event. It focuses primarily on systems and processes,
not on individual performance. It progresses from special causes in
clinical processes to common causes in organizational processes and
systems and identified potential improvements that would decrease
the likelihood of recurrence.

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4. Duties of Healthcare Providers and Healthcare Professionals 7,8,9

4.1. All Healthcare Providers must develop organizational policies on medicine

management that include but is not limited to reporting, evaluating and
preventing MEs; along with the procedures for identifying, tracking,
documenting, ensuring corrective actions and reporting MEs to DOH.

4.2. Health care providers should continuously monitor medication error incidents,
identify trends in medication error incidents and perform root cause analysis
when necessary to identify ways of improving the medication use process and
prevent future occurrence of errors.

4.3. Healthcare providers should also develop long term monitoring plans to ensure
the effectiveness of changes in practice following medication error incidents.

4.4. It is imperative for chain pharmacies to develop quality assurance programs

aimed at monitoring, tracking and evaluating medication errors.

4.5. Pharmacies should also develop and follow procedures designed to prevent
recurrences and submit ME reports to DOH as per the timeframe outlined in
the Standard.

4.6. All Healthcare Providers and Professionals must report all types of MEs (Refer to
Appendix 2 for list).

4.7. All errors or unanticipated events associated with the medication system or
steps in the medication use process such as selection and procurement,
ordering and transcribing, preparing and dispensing, administration or
monitoring shall be reported as medication errors using the available
electronic/ manual reporting tools (4.2, 4.3, Appendix 1).

4.8. Unsafe conditions and near misses, errors that have been detected and
corrected through intervention by another Healthcare Professional or patient
before actual medication administration, should also be reported.

4.9. MEs must be classified according to the severity of the outcome using NCC
MERP harm score (Appendices 3 and 4) or any other international harm
classification system.

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4.10. ME incidents associated with permanent patient harm, required intervention
to sustain life or associated with patient death shall be reported within 48
hours of identifying and documenting the error. All other errors associated
with no harm or temporary harm should be reported on a monthly basis to
DOH (refer to error categories in Appendices 3 and 4).

4.11. Healthcare Providers are required to provide training that ensure their staff
understand ME classifications, including the types of errors and the severity
level of harm.

4.12. Healthcare Providers must ensure that Healthcare Professionals are reporting
MEs and following policies and procedures.

5. ME Reporting: Service Specifications

5.1. The online reporting form is the preferred means of reporting. It is available in
the E-notification tool and could be accessed through DOH website, under
pharmacovigilance e-service via the following link:
https://bpmweb.haad.ae/notifications/Pharmacovigilance/AdverseReaction.aspx

5.2. PDF fillable reporting form is also available on DOH website via:
https://www.haad.ae/HAAD/LinkClick.aspx?fileticket=of9cfrBnV4Y%3d&tabid=1
399 The form should be filled and sent to DOH pharmacovigilance program by
email: pharmacovigilance@doh.gov.ae or fax: +971-2-419-3668.

5.3. Applicable sections of the ME reporting form should be filled in as complete as

possible. If more than one patient was affected by the same ME, separate
reports for the same incident must be completed and submitted. Additional
pages may be attached if more space is required.

5.4. DOH will acknowledge the receipt of ME reports. Any follow up of reported ME
case should be made by mentioning the ‘unique report number’ provided to
the reporter.

5.5. Any information related to the identity of the patient and/or the reporter of the
medication error shall be protected to the fullest extent of UAE laws and
regulations.

5.6. Medication error reporting will be anonymous and non-punitive. There will be
no disciplinary action taken against an employee for a medication error that is
reported as per the timeframe outlined in the standard.

5.7. Enquiries on ME reporting can be directed to DOH pharmacovigilance program

via Phone: 02 419 3576/ 3496, email: pharmacovigilance@doh.gov.ae or fax:
+971-2-419-3668.

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6. Enforcement and Sanctions

6.1. DOH-licensed Healthcare Providers and Healthcare Professionals must comply

with the terms and requirements of this Standard. DOH may impose sanctions
in relation to any breach of requirements under this Standard in accordance
with the Complaints, Investigations, Regulatory Action and Sanctions Policy,
Chapter IX, Healthcare Regulator Manual.

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7. Appendix 1: Medication Error Reporting Form

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8. Appendix 2: Types of Medication Errors10
Type Definition
Inappropriate patient behavior regarding adherence to a prescribed
Compliance error
medication regimen.
Deteriorated drug Administration of a drug that has expired or for which the physical or
error chemical dosage form integrity has been compromised.

A discrepancy between a prescription and the medicine that the pharmacy

delivers to the patient or distributes to the ward on the basis of the
Dispensing error11
prescription; including the dispensing of a medicine with inferior
pharmaceutical or informational quality.
Administration to the patient of a dose that is greater than or less than the
Improper dose amount ordered by the prescriber or administration of duplicate doses to
error the patient i.e. one or more dosage units in addition to those that were
ordered.

Failure to review a prescribed regimen for appropriateness and detection of

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

The failure to administer an ordered dose to a patient before the next

Omission error
scheduled dose, if any.
Incorrect drug selection (based on indications, drug allergies,
contraindications, etc.), dose, dosage form, quantity, route, concentration,
rate of administration, or instructions for use of drug product ordered or
Prescribing error
authorized by physician (or other legitimate prescriber), illegible
prescriptions or medication orders that lead to errors that reach the
patient.
Unauthorized Administration of medication not authorized by a legitimate prescriber for
drug error the patient.
Wrong
administration Inappropriate procedure or improper technique in the administration of a
technique error drug.

Wrong dosage Administration to the patient of a drug product in a different dosage form
form error than ordered by the prescriber.
Wrong drug
preparation error Drug product incorrectly formulated or manipulated before administration.

Administration of medication outside a pre-defined time interval from its

Wrong time error scheduled administration time (this interval should be established by each
individual health care facility).
Other medication Any medication error that does not fall into one of above defined
error categories.

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 9. Appendix 3: NCC MERP Index for Categorizing Medication Errors

Source: The Institute of Safe Medication Practices. Available at: http://www.ismp.org , accessed August
2018

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Appendix 4: NCC MERP Index for Categorizing Medication Errors Algorithm

Source: The Institute of Safe Medication Practices. Available at: http://www.ismp.org, accessed August
2018

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References

1. The National Coordinating Council for Medication Error Reporting and Prevention. What is a
medication error? New York, NY: National Coordinating Council for Medication Error Reporting
and Prevention; 2015. (http://www.nccmerp.org/ about-medication-errors, accessed
August2018).
2. WHO draft guidelines for adverse event reporting and learning systems. Available at
http://apps.who.int/iris/bitstream/handle/10665/69797/WHO-EIP-SPO-QPS-05.3-
eng.pdf?sequence=1, accessed September 2018.
3. The Hospital Quality Institute, Definitions. Available at: http://www.chpso.org/definitions
Accessed September 2018.
4. Refer to DOH Healthcare Providers’ Manual, Chapter II.
https://www.haad.ae/HAAD/LinkClick.aspx?fileticket=WgyfUYNJTY0%3d&tabid=1276
5. Tenets of a Safety Culture,
https://www.jointcommission.org/assets/1/6/SEA_57_infographic_11_tenets_safety_culture.pdf ,
Accessed October 2018
6. Culture of Safety, (August 2018), Available at: https://psnet.ahrq.gov/primers/primer/5/Culture-
of-Safety, Accessed October 2018.
7. Patient safety work shop ‐Learning from Error. WHO publications document.
WHO/IER/PSP/2008.09.
8. Medication Errors: Technical Series on Safer Primary Care; © World Health Organization 2016.
Available at; http://apps.who.int/iris/bitstream/handle/10665/252274/9789241511643-
eng.pdf?sequence=1
9. Reporting and learning systems for medication errors: the role of pharmacovigilance Centres; ©
World Health Organization 2014. Available at;
http://apps.who.int/medicinedocs/documents/s21625en/s21625en.pdf
10. American Society of Hospital Pharmacists. ASHP guidelines on preventing medication errors in
hospitals. Am J Hosp Pharm. 1993; 50:305–14.
11. Medication errors: the importance of safe dispensing; (Ka-Chun Cheung), Br J Clin Pharmacol.
2009 Jun; 67(6): 676–680.

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