Adverse Drug Reactions: How Monitoring Medicines Keeps Patients Safe

Adverse drug reactions (ADRs) are unwanted effects of medicines that can sometimes be serious. Pharmacovigilance is the system that helps us detect, understand, and prevent these reactions.

Here, I explain in simple words what researchers found when they looked at all the ADRs reported in one Indian hospital over a year.

Background
Medicines are used by almost everyone during their lifetime. Sometimes medicines can cause side effects in some people. Some of these side effects are mild, but some can be harmful or even life‑threatening. Many side effects are avoidable, but for that we need to know what possible side effects can happen and how they can be prevented. Pharmacovigilance is a programme that focuses on how these side effects occur, how to detect them, and how to prevent them.

What the researchers did
They analysed side effects (ADRs) that had already been reported from January 2022 to December 2022. This observational study was conducted in an ADR monitoring centre in ESIC Medical College & Hospital, Faridabad. The details were collected according to patient and drug characteristics, causes, types, seriousness, and severity of the ADRs. The data were recorded in ADR reporting forms, and the cause (causality) was assessed using the WHO‑UMC causality assessment scale.

What they found
F
rom all the departments, 282 ADR reports were obtained. Of these, 28 reactions were serious and required hospitalisation, and 254 were non‑serious. ADRs were more common in people aged 21–60 years (about 78%). The causality assessment found that about 91% of the side effects were probably due to the medicines, and about 8% were possibly due to the medicines or some other reason. Most of the side effects were due to antibiotics.

Why it matters

These findings are important:

• Helps doctors and pharmacists be more careful when prescribing and monitoring those medicines
• Highlights the importance of reporting ADRs to improve patient safety and detect rare or new reactions.
• To help decrease illness and hospitalisations due to side effects.

Note that it is a single‑centre, one‑year study, so results may not be the same everywhere

Have you ever experienced a side effect from a medicine?

Do you think patients are told enough about side effects when they receive their medicines?

Source:

Title: The Pattern of Adverse Drug Reaction Reporting at a Regional Pharmacovigilance Center in North India: A Retrospective Observational Study

https://pmc.ncbi.nlm.nih.gov/articles/PMC12505011/

MBH/AB

The fact that antibiotics were responsible for the majority of these ADRs is a significant clinical signal. It highlights the urgent need for better ‘at-the-counter’ education.
To answer the question: No, patients are rarely told enough. Most are given a strip of tablets without being warned about specific red flags to watch for. This study proves that pharmacovigilance isn’t just about filing forms; it’s about translating that WHO-UMC causality data into real-world counseling. If 91% of these cases were ‘probably’ drug-related, many were likely preventable with better patient awareness and monitoring.

1 Like

Exactly, programmes like antimicrobial stewardship needs to implement in every hospital @pimplenidhi

What I have noticed is that there is not much awareness of working knowledge of ADR case reporting in general population as well as healthcare workers. So many cases remain unresolved. Also, in hospitals with high patient load, time constraint plays a major role in medical misinformation, which leads to increased incidents of ADRs.

1 Like

ADR reporting should be increased with valid information in it @drpriyanshisingh

1 Like

Agreed. Filing accurate ADR report in turn saves many patient lives.

1 Like

Very well explained. I think many patients are still not fully aware of the possible side effects of medications, and monitoring ADR’s is not widely understood. It really requires more awareness. As mentioned, many ADR’S are linked to antibiotics, which also highlights the growing concern of increased antibiotics use and resistance.

ADRs are very important to understand by every patient because just like one has to know the use of a medicine before taking it, they equally have to know about the adverse effects which are associated with it.

Most patients don’t report ADRs but we have to create more awareness regarding that and moniter the ADRs associated with every medicine use.