Recently, the Supreme Court declined to mandate that doctors provide patients with a detailed explanation of potential risks and side effects associated with prescribed drugs. The Court held that the requirement would be impractical for general medical practitioners to implement consistently, highlighting that such a policy change would affect their ability to handle daily patient volume.
The petition requested that doctors include a written note or slip in the local language for patients, detailing all potential adverse effects of prescribed medications. The petitioner emphasised that patients should have full awareness of drug risks to ensure informed consent. It was argued that, while pharmacists provide medication information within packaging, no equivalent obligation exists for doctors to inform patients directly of such risks.
The counsel for the petitioner argued that a significant portion of patient harm stems from uncommunicated adverse effects of medications. He contended that informed consent requires doctors to disclose contraindications and side effects of prescribed drugs. Further, the counsel proposed that doctors could provide a printed proforma summarising these effects, making it easier for patients to understand risks without overburdening doctors’ schedules.
The Apex Court bench comprising Justice BR Gavai and Justice KV Viswanathan, carefully evaluated the practicality of implementing mandatory drug risk disclosures by doctors. Justice Gavai noted that requiring general practitioners to explain the risks and side effects of each prescribed medication to every patient would significantly reduce the number of patients they could treat daily, limiting their capacity to manage regular patient inflow effectively. He highlighted the logistical challenges, particularly in high-demand healthcare settings where doctors see dozens of patients each day, explaining that doctors might only be able to attend 10-15 patients daily under such a requirement. This, the Court noted, would create further strain on the healthcare system and could lead to overcrowded pharmacies, impacting patient experience and healthcare access.
In response to the petitioner’s suggestion for a standard printed proforma summarizing medication risks, Justice Gavai observed that individual treatment plans are highly specific, with patients often receiving tailored combinations of medications. A standard proforma might not account for these individual differences, reducing the effectiveness of this approach. He also referred to doctors’ existing responsibilities under the Consumer Protection Act, noting that any additional requirement might further burden their role, especially given that they are already under consumer scrutiny. Justice Viswanathan, exploring potential alternatives, suggested that pharmacies display a general notice board in local languages, advising patients to read medication packaging carefully for information on risks and side effects. He observed that this approach might be a balanced solution, allowing patients to stay informed while avoiding an impartial, time-intensive burden on doctors. This notice board could encourage patient awareness without comprising the efficiency of healthcare delivery.
Ultimately, the Top Court emphasised that such changes in patient communication standards might be more appropriately addressed through legislative policy. It noted that the Delhi High Court had previously dismissed a similar petition by the same petitioner, observing that setting disclosure standards for doctors is a matter best suited for legislative bodies rather than the judiciary, given the broader implications for healthcare administration. Thus, the petition was dismissed.
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