The importance of adverse event reporting

We are all familiar with side effects of drugs. Worldwide this term has been replaced by “Adverse Event” (AE), a broader umbrella that included a lot of things apart from side effects.

US FDA and International Conference on Harmonisation guideline (ICH E2) both defined AE as any untoward incidence the patient experiences after administration of the drug. Whether the incidence is actually related to the drug does not matter, that call will be made by physicians, manufacturers or Drug Administration Authority processing the AE.

For example, we are often told about common AEs like, vertigo, dizziness, nausea, vomiting etc. However, you might be surprised to know that if someone takes a drug and then fall from the stairs or is involved in an accident it is also considered an AE, since we do not know at the time whether the drug has factored into the incident anyway. Taking the medication while pregnant, even though it has not led to an untoward event, is also reportable as an AE.

But why should we report AE? Because we do not know everything about the drug at the clinical trial stage and therefore need to enhance our knowledge for the health of the patients as the drug circulates in the market. Every drug carries some risk, and all potential treatments are tested before being approved. ² However, clinical trials can only provide limited information since they have a time restriction and do not account for long term AEs.

Also, the patient population in clinical trials is very carefully selected to comply with the regulations, excluding certain types of patients who might take the drug in real world. This often includes groups, like elderly, pregnant or lactating mothers, immunocompromised people, those with liver or kidney disease. But they may still take the drug when it is marketed.

That is why it is important to report any AE when we are taking the drug in real life. We, the consumers can play a very crucial role to improve the safety of a drug by providing information. It will eventually help to detect important issues that were not captured during the trial phase and help to mitigate subsequent risk to the patients.

It is required that to facilitate AE reporting, manufacturers must clearly mention how to report in the drug labels. Anyone can report the AE, it can be the patient, physician, pharmacist, relative or friend of the patient or anyone else. for reporting, it is important to know what happened, what was the drug and who suffered from it.

But what to report? Well, anything that makes you suspicious. It does not matter whether the AE is well known or listed on the drug label, or the physician told you this could happen. If it happens, it is best to report it. Every report counts.

What will happen after the report? If the Drug Administration Authority sees a certain pattern with the reports, they may ask the manufacturer to update the drug label and take additional steps to reduce the risks of taking the drug.

Bangladesh has a structured AE management system. In 2018. Directorate General of Drug Administration (DGDA) launched the National Guideline on the Pharmacovigilance System in Bangladesh developed with support from Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Adverse Drug Reaction Monitoring (ADRM) Cell of the DGDA serves as the coordinating body for the AE reporting and management.

According to section 5.3 of the guideline, patients are requested to report to an HCP at a health facility, or does not have immediate access to a Health Care Provider or facility, he or she can report to a community health worker or directly to the ADRM Cell. For reporting go to dgda.gov.bd. Under e-services there is a tab for AE reporting.

Imtiaz Ahmed completed his MBBS from Dhaka Medical College.
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