Importance of adverse event reportingJanuary 6, 2020
Pharmacovigilance – the science of detecting, assessing and understanding drug safety – has a vital role to play in the prevention of adverse drug reactions (ADRs). Regulatory authorities (RA) are responsible for monitoring and assessing risks and benefits during the life cycle of the drug, all the way from clinical trials to the post-marketing phase, when the drug may be used for new indications, in new populations or via new routes.Despite scientific and technological advances, ADRs continue to be a major challenge. Between 2008 and 2017, US FDA Adverse Event (AE) Reporting System recorded > 10 million AEs – including 5.8 million serious events and 1.1 million fatal ones. ADRs lead to 100,000 deaths annually and are the fourth leading cause of death in the USA. As the Indian population is 4 times that of US, it can be estimated that about 400,000 Indians succumb to fatal ADRs every year.
Prevention of ADRs and protection of patients depend on the recognition and reporting of AEs by patients and prescribers to the pharma industry and/or RA, and review and recommendations by RA. In a European survey of 6,931 patients, 84% reported no or less-than-good-knowledge of drug research and development, and only 25% reported good/very good knowledge of safety. The patients perceive prescription drugs to be high on benefits and low on risks, and attribute ADRs to patient sensitivity or actions by the physician rather than to improper manufacturing, testing, or regulation. This situation becomes complex, as the patients get inaccurate information on drug safety from clinical trial publications, which gloss over the complexity of information, and use simplified language, e.g., drug was safe and effective in the clinical trial.
The success of post-marketing drug safety studies depends on the quantity and quality of signals generated from AEs reported by physicians. An Indian survey (Dr Desai et al 2011) reported that 97.3% of physicians felt that reporting of ADR was important for improving patient safety, but only 20-50% were aware of which ADRs to report and only 15% had ever reported ADRs. Reasons for underreporting ADRs by prescribers (Dr Inman – 7 Deadly Sins, 1996) are: 1) Financial – a lack of reward for reporting 2) Legal – fear of litigation 3) Complacency – all serious ADRs already documented when the drug was approved for marketing 4) Diffidence – report ADR only if certain 5) Indifference – a single report can’t make a difference 6) Ignorance – only serious ADRs should be reported, and 7) Lethargy – lack of time or disinterestedness.
The onus of making efforts to reduce the risks associated with drugs lies with the pharma industry and the RA. The industry should take proactive steps to bring transparency in product safety communications and create an awareness amongst patients and prescribers. The Indian RA should educate patients and prescribers through regular real-time communication on the safety of drugs, make AE reporting easy through email or an app, and protect reporting physicians. Indian RA should also work in co-ordination with international RAs to take prompt action – warning, change of label, or withdrawal of the drug – when drug safety becomes a concern, and ensure strict compliance with regulations recommendations from the industry.
Writer is a consultant on clinical research & development from Mumbai.