n December 2023, one of the often-flashed headlines on daily newspapers and online news portals (both print and digital) in India concerned an adverse drug reaction (ADR) reported by the Indian Pharmacopoeia Commission (IPC) in their monthly Drug Safety Alert. This report was based on preliminary analysis of ADRs from the Pharmacovigilance Programme of India (PvPI) database. Surprisingly, this was neither a hitherto-unknown effect of the drug in question nor was there any new evidence implying a sudden increase in incidence, in either qualitative or quantitative terms, of the said ADR.

Even so, this issue quickly spiraled into significant disquiet among patient safety proponents and stakeholders throughout India, as the widespread and repetitive coverage generated anxiety in the minds of many patients who had been taking the drug for quite some time and assumed that it was risk-free.

While there can be no doubt that patients have the right to be aware of the benefits and risks of the treatments advised to them, it is also important to remember that exaggeration of the risks is as detrimental to the patients as overstating the benefits. Rampant spread of negative remarks on a drug may enhance the hesitancy of medical practitioners in prescribing the drug and tempt patients to question their trust in the treatment prescribed to them or to avoid seeking treatment due to their heightened fear of ADRs (“side effects” in common parlance). This highlights that the responsibility of pharmacovigilance professionals is not just to manage ADR data but to enlighten the public on the benefit-risk profile of a drug and its dynamic nature, in an objective manner.

While media can be a valuable partner in meeting this responsibility, closer examination of the chain of events in this situation lays out key points to ponder.

First, while the ADR was indeed received by the PvPI, these reports never mentioned the number of patients who developed the reported event. They also did not include “the denominator”: more specifically, the total number of patients who consumed the drug during the reporting period.

Further, the drug manufacturers and the prescribing doctors all agree that this event is “expected,” albeit extremely rare, according to the reference safety information. There is no information in the Drug Safety Alert on any newly identified high-risk groups who are prone to develop this event, nor does it propose any new precautions that must be taken to avoid the occurrence of this event or to reduce its impact should it occur.

Given these facts, it seems intriguing to explore why this information was cause for public debate, especially when the IPC has stated that these findings are based on “preliminary analyses” of the PvPI data.

The role of media must be scrutinized here. Consideration of all these facts leads to these questions:

• Was this really “news”?
• Was this really prepared and intentionally distributed to the media, or was it a communication meant for medical practitioners and pharmaceutical companies that inadvertently fell into the hands of the media?
• In their zeal for being transparent in the public domain about the outcomes of their analyses (albeit interim), did they overlook the point that it may have been more helpful to keep this safety data confidential until they could share something more definitive with prescribers and patients?
• Should the IPC establish a secure portal to share the results of preliminary analyses (such as these Monthly Drug Safety alerts) with access restricted to clearly defined stakeholders instead of posting it on their website with full public access?
• Should the media be held accountable by organizations such as the Press Council of India for exaggerating known rare adverse events associated with drugs?
• Should the media be trained in and sensitized to the roles of drug regulations and regulators?
• If this kind of journalism based on insufficient scientific information continues, would it not be possible for any media outlet (with an ulterior motive) to target any medicinal product by selectively quoting and broadcasting its known but rare risks for the sake of being the first to publish?

Although this public disquiet and discontent were an unintended consequence of what one hopes was a well-meant attempt to promote patient safety in India, it was not without its advantages. The emergence of this issue in the public renewed the interest of all stakeholders in pharmacovigilance, which had not been in the public forefront since debate on the safety of COVID-19 vaccines during the pandemic.

The manufacturers of the concerned product publicly stated their confidence in the robustness of the pharmacovigilance systems in their organizations. The confidence that they demonstrated in their ability to address this issue in a scientific manner underlines the importance of pharmacovigilance not only as a regulatory obligation but also as a marker of their integrity. This step could inspire other drug manufacturers who have not yet set up pharmacovigilance systems to realize the benefits of proper and adequate investments in their pharmacovigilance function, which is sometimes seen as a “spending department” that does not contribute to their organization’s revenue growth.

We would be wise to remember that such occasions turn out to be opportunities for both healthcare professionals and consumers to understand that medicinal products can seldom be classified as all “good” or all “bad.” One needs to use their gray matter to shed light on these gray areas.

It is also prudent to bear in mind that such specific Drug Safety Alerts and their accompanying request to report such ADRs to the authorities also create the risk of conditioning healthcare professionals and/or consumers to only look for the same or similar events. This could potentially lead to hyper-reporting of these events due to observer bias, or to missing these same events when they happen with other drugs.

The media can contribute to increased public understanding of safeguards on drug and patient safety through unbiased, objective reporting based on science instead of pre-conceived agendas.

May this future not be far off!