NPRA: Guide for ADR Reporters

GUIDE FOR ADR REPORTERS

DEFINITIONS:
(i) Time to onset of reaction: time interval between first dose (initiation) of the drug until first sign
of the ADR.
(ii) Initial report: First submission of report to NPRA of a particular patient involving a particular
ADR.
(iii) Follow-up report: Submission of further reports related to the same case to inform of additional
information not mentioned previously or which occurred after the initial report. Please mention
the date of initial report for reference.

1) IMPROVING THE QUALITY OF REPORTS

(Ref: MADRAC Bulletin August 2013)

The list below contains the frequently asked questions that NPRA poses to reporters during follow-
up. You are encouraged to use this checklist to ensure your report is as complete as possible before
submitting it.

*Important Note:
Please fill every section in the ADR form, stating ‘none/nil’ if applicable. Even a dash would do.

Is your report complete?

A Checklist for ADR reporters

Frequently missing information √

Any history of allergy (including drugs, food, etc.)?

Any concomitant medications? (Please state ‘nil’ if none)

Date started and stopped for each medication
Please state ‘cont’ for any medication still continued after the ADR

Any underlying illnesses?

The specific indication of the suspected drug

(e.g.: ‘pneumonia due to S. Pneumoniae’- not ‘infection’ or ‘antibiotic’).

If the ADR reappeared after reintroducing drug (rechallenge), please describe

the rechallenge fully (dose given, timing, brand used, etc.).
Was any treatment given for the ADR, or if suspected drug was stopped, what
alternative was given and patient’s response? (Please describe)
What is the latest/ current outcome for the patient? (e.g. recovered) If possible,
follow-up patient periodically until final outcome is known. A follow-up report
may be sent in to update the final outcome of the patient.

Description of the specific type and location of skin reaction? (Use the
Cutaneous ADR form available on the NPRA website at [Link])

Do keep your own record of details enabling you to contact the patient/ trace
the case notes later on if necessary (e.g. IC number, patient name and phone
number).
DISCLAIMER: The list above is not exhaustive and additional information requested may vary depending on
safety issues that arise.

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 NPRA: Guide for ADR Reporters

Additional information necessary for specific ADR cases

(Ref: MADRAC Bulletin December 2013)

ADR cases involving: Additional information Rationale

Indication of suspected drug (as
specific as possible)
e.g.: ‘pneumonia due to S. To increase quality of reports
All reports Pneumoniae’- not ‘infection’ or submitted to WHO and assist
‘antibiotic’; causality assignment
‘lower back pain’- not ‘painkiller’ or
‘NSAID’
To distinguish ADR from drug
Paediatric patients Body weight
toxicity/ inefficacy
Specific description of reaction
(type and location of rash)
For more accurate causality
Skin reactions - attach the Cutaneous ADR
assignment
classification form available on the
NPRA website at [Link]
Serious skin reactions Designation of doctor who Diagnosis should be confirmed by a
(e.g. SJS, TEN, DRESS) provided final diagnosis dermatologist
Name and MAL number of both
Brand-switching To identify brand/ batch problems
brands involved
Drug use in pregnancy,
To increase available data on such
post-delivery, Please mention this in the
cases, where clinical trials are not
breastfeeding or off-label ‘Relevant Medical History’ section
carried out
use
Suspected Drugs:
Allopurinol 1. Specific indication
- Allopurinol is not indicated for the
2. Category of prescriber
treatment of asymptomatic
3. Renal function of patient
hyperuricaemia.
4. If prescribed for asymptomatic
- Approved prescriber category:
hyperuricaemia:
A/KK
- Name, address and tel. no.
of primary prescriber
Antibiotics Please state if patient was given
To avoid risk of patient being given
an ADR/ allergy card and
the same drug repeatedly
counselling
Antidiabetics Baseline and latest blood glucose
readings
Antihypertensive agents Baseline and latest blood pressure
To differentiate ADRs from disease
readings
exacerbations
Corticosteroid Indication (e.g. asthma, SLE)

ADR cases involving: Additional information Rationale

Antineoplastic agents - List concomitant medication
- Premedication(s) and
Presence of concomitant medication
administration time
will affect causality assignment
Noradrenaline Other concomitant inotropes and
medication
Paracetamol
To identify ADRs due to the
State the colouring agent and
excipient rather than active
Oral Antihistamines flavouring agent
ingredient
Statin causing skin Specify if reaction is related to To identify specific type of skin
reaction photosensitivity reaction
Vancomycin Rate of infusion and dose To distinguish ADR from side effect
of drug
*SJS: Stevens-Johnson syndrome; TEN: Toxic epidermal necrolysis;
DRESS: Drug reaction with eosinophilia and systemic symptoms

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 NPRA: Guide for ADR Reporters

2) LABORATORY TESTING FOR SUSPECTED ADULTERATED PRODUCTS

(REGISTERED PRODUCTS ONLY)

The NPRA may conduct laboratory testing to identify adulterants in registered product samples, including
traditional products and health supplements.

In order for laboratory testing to be conducted, a sufficient amount of sample and certain information are
required. The following is a simple guide on sending product samples for laboratory testing when an adverse
drug reaction occurs and adulteration is suspected.

1. Fill in the adverse drug reaction (ADR) reporting form for healthcare professionals [or Consumer Side
Effect Reporting Form (ConSERF) for consumers who wish to report directly to the NPRA]. Please include
as many details as possible to ensure the report is useful.

Important details:
 Name and contact details of patient
 Details of the ADR
 Details of any concomitant medicines/ other products taken and underlying illnesses
 Product name and label
 Where it was obtained
 Indication for which the patient was taking the product
 Suspected adulterant (e.g. antihistamine, steroid) based on product indication and ADR
 Name and contact details of reporter

2. Submit the completed form together with the product sample. Preferably samples should be sent in the
original packaging, or at least with clear pictures of the product from all angles. This is because the label
information may be required for further investigations (e.g. to identify fake products).

Please send as much sample quantity as possible. The quantities listed below are for the screening of one
suspected adulterant only. Therefore, the quantity should be multiplied based on the number of suspected
adulterants.

Minimum quantities required for testing of one suspected adulterant are as follows:

Minimum sample quantity required for laboratory testing for adulterants

Dosage Form Minimum amount for Total amount for
one test confirmatory result
Tablet/ Capsule/ Pill 10g or 20 dosage forms 30g or 60 dosage forms
Liquid 40ml/ 40g 120ml/ 120g
Powder 10g 30g
Cream 10g 30g
Candy 10 candies 30 candies

3. Please contact us if you have any questions:

Pharmacovigilance Section,
Centre of Compliance & Quality Control,
National Pharmaceutical Regulatory Agency (NPRA),
Ministry of Health Malaysia.

Tel: 03-7883 5447/5450

Email: fv@[Link]

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 NPRA: Guide for ADR Reporters

3) VIGIACCESS™ BY THE WHO

(Ref: MADRAC Bulletin April 2015)

Access information on global ADR reports at

[Link]
Wondering if there have previously been any similar ADR reports for a particular drug?
Looking for general ADR data for your presentation?
Check VigiAccess™.
™
VigiAccess is a public gateway that allows anyone to access information on reported cases of adverse events
related to over 150,000 medicines and vaccines, as sourced from the WHO international database of ADRs
® ®
(VigiBase ). VigiBase currently contains data on over 10 million reports dating back to 1968, from more than
120 countries which participate in the WHO Programme for International Drug Monitoring.

However, it is important to note that information on suspected ADR should NOT be interpreted as meaning
that the medicinal product in question, or the active substance(s), generally causes the observed effect or is
unsafe for use. Any robust conclusion with regard to benefits and risks of a specific medicinal product always
requires detailed evaluation and scientific assessment of all available data. The balance between benefit
and risk of a specific medicinal product also varies between individual patients.

™
VigiAccess presents search results by active ingredient(s), with a breakdown by type of ADR, geographical
distribution, age group, patient sex, and the number of reports per year. Great care has been taken to ensure
privacy of the patient and reporter is protected.

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 NPRA: Guide for ADR Reporters

4) ADR REPORTS INVOLVING ANTITUBERCULOSIS DRUGS

(Ref: MADRAC Bulletin December 2015)

The NPRA has received hundreds of ADR reports involving the four anti-TB drugs (isoniazid,
rifampicin, pyrazinamide, and ethambutol), of which almost 80% reported the use of combination
products containing all four drugs in one tablet. However, very few reports detailed the stepwise
rechallenge of anti-TB drugs which was performed after the ADR occurred. Information on
rechallenge and final outcome of the patient is vital to compare the safety profiles between brands,
combination products and single active ingredient products.

Besides making sure that the report is completely filled in, here are several points to ponder when
reporting adverse events for anti-TB drugs:

The NPRA thanks you for reporting suspected ADRs. These reports are an essential part of
ensuring the safe use of medicines as well as the safety of patients in Malaysia. If you have any
questions, please contact us at 03-7883 5447/5450 or send an email to fv@[Link].

Last reviewed: 5 Dec 2022