The Adverse Drug Reaction (ADR) / Adverse Event Following Immunisation (AEFI) Reporting Manual for health care providers (HCPs), First Edition, was released in August 2021 as a standalone manual.
Prior to this release, the requirements and procedures for submission of ADR and AEFI reports by HCPs were embedded as part of the Malaysian Pharmacovigilance Guideline.
The requirement outlined in the manual aims to improve the quality and standard of ADR and AEFI reporting by HCPs in Malaysia. Health care providers encompass medically qualified persons, such as doctors, dentists, pharmacists, nurses, and other allied healthcare professionals.
The manual comprises three parts:
- Part 1 gives an introduction to pharmacovigilance and provides the legal basis, objectives and impact of ADR/AEFI monitoring.
- Part 2 is on the scope, principles, impact and mechanism of ADR reporting.
- Part 3 is on the scope, principles, impact and mechanism of AEFI reporting. The cause-specific categorisation of AEFI and AEFI investigation is detailed here.
The manual also provides information for health care providers on what, when and how to report ADRs and AEFIs to the National Pharmaceutical Regulatory Agency (NPRA).
The NPRA strives to ensure the safety of medicines through pharmacovigilance activities which include continuous ADR and AEFI monitoring and screening of drug alerts and early signals of previously unrecognised risks and harms of medicines.
Pharmacovigilance is essentially a risk management process for medicines. No medicine is absolutely without risks even after it has been approved and licensed for use by regulators.
With detection of early signals and safety alerts, further studies can then be conducted to establish if the adverse drug reaction is caused by the medicine.
In the National Centre for Adverse Drug Reactions Monitoring Annual Report 2018, a total of 26,110 adverse events reports were received by the National Centre, of which 983 were AEFI reports.
Most of the reports were submitted by Ministry of Health (MOH) pharmacists (68.14 per cent) and MOH doctors (16.47 per cent). Pharmaceutical companies’ submission accounted for 9.94 per cent, and general practitioners and private sector specialists’ submissions only accounted for a mere 2.05 per cent.
The low number of reports from general practitioners/private sector specialists could be due to lack of awareness of the function and purpose of ADR and AEFI reporting; not knowing how and where to report; not certain if the ADR and AEFI is due to the medicine; or if the ADR/AEFI is serious enough to warrant a report; or too busy to report such ADRs and AEFIs.
Much work therefore is needed to increase awareness of the need to report ADRs and AEFIs by health care providers who are in the private sector.
With the implementation of the National Covid-19 Immunisation Programme (PICK), vaccine safety surveillance has become an important area of concern for both health care providers and the regulators.
No vaccine is perfectly safe, and adverse reactions may occur following vaccination due to the vaccine itself or to the process of immunisation that occur in the body.
The manual states that “All adverse event following immunisation should be reported”, and this would include both serious and non-serious AEFI. This should not be taken lightly as vaccines are generally given to the healthy as a preventive measure.
Although non-serious AEFI does not pose a potential risk to the recipient of the vaccines, it should be reported, because these reactions may signal a potentially larger issue with the vaccine, or the immunisation process.
Vaccine safety monitoring includes not just adverse events following immunisation reports, but would also include adverse events reports associated with improper storage, transport, handling, preparation and administration of a vaccine.
The manual states that any suspected vaccine-related death cases must be reported to NPRA and relevant parties within 24 hours of first knowledge of the event. It provides clear details on the investigation process related to suspected vaccine related deaths.
Although the manual is intended for health care providers, it also includes a Consumer Side Effect Reporting Form (ConSERF) for consumers or patients who wish to report any adverse drug events directly to the NPRA.
As frontliners who are usually the first to know of adverse drug events encountered by patients, health care providers play an important role in the continuous safety monitoring of medicines.
With the ADR and AEFI information collected, the NPRA can then analyse and perform signal detection to identify previously unrecognised drug effects, assess the risks and benefits of drug products and improve the safe use of these products for the general public.
Rosalind Chiam is a pharmacist with past work experiences in pharmacovigilance and clinical research.
- This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.