The Thalidomide scandal in the 1960s brought about industry-wide changes that entailed a plethora of stricter rules mandated by the government and relevant government agencies. Since the United States Food and Drug Administration (USFDA) didn’t fully regulate drug approval and monitoring prior to the discovery of the teratogenic effects of Thalidomide, thousands of patients were, unfortunately, prescribed the drug. It exposed the US pharmaceutical industry’s lack of safety standards during clinical trials and after the drug is approved and released to the public. With mounting pressure due to public scrutiny, amendments were applied to the existing 1938 Food, Drug, and Cosmetic Act, which took effect the following year. The amendments consequently required new drugs to be proven safe and effective by the manufacturers, and the FDA must approve of a new drug application before a drug could be advertised.
In order to ensure drug efficacy and safety, there should be continued efforts to monitor and assess the information available, even after the product has already reached the “end of its life cycle”. Pharmacovigilance shouldn’t just be restricted to drug discovery, clinical trials, marketing and distribution. It’s a process that extends even after the expiration of a drug’s patent and the instance a patient experiences latent adverse drug reactions (ADRs).
Latency of abnormal reactions is a real cause of concern. Most of the time, patients are caught off-guard and relevant authorities are not made aware of subsequent events, leading to mortality and further morbidity. Limiting the necessary surveillance and implementation of reactive measures to just the drug discovery and development phases will, subsequently, be more detrimental to public health and more costly to pharmaceutical companies in the long run. An effective system needs to be implemented to deliver services that are in accordance with the current regulations to make sure that they maintain their presence at every stage of a drug’s life cycle. Since reactions to specific or all of the components of a drug can sometimes manifest several years after the patient consumes it, there is a need to make sure that signal detection is continuously being practiced to support the monitoring of reports for abnormal responses and take immediate action to prevent progression of undesired effects.
When a drug’s safety and efficacy are proven during clinical trials, it doesn’t automatically mean that ADRs won’t occur or persist in the future and may affect not only the patients, but also the next generation. Such was the case for Diethylstilbestrol (DES), which was prescribed in the US from 1938-1971 (CDC), and was discovered to put a patient at higher risk of developing a rare form of cancer called Clear Cell Adenocarcinoma (CCA). The primary goal of scientists and regulators is to detect and observe any adverse drug events (ADEs) that may take place; and since the majority of those are identified after the marketing period is over and the drug is already being distributed for public consumption, they should also carefully monitor the data from the post-marketing phase and respond to the findings accordingly.
The application of Pharmacoepidemiology, in this context, is crucial to the drug safety monitoring process due to its continual surveillance of a larger population exposed to the drug in real conditions in order to study its use, safety, and effectiveness. It can help in discovering ADRs in the long run as it can recognize patterns arising from larger groups of data.
Want to explore this and other drug safety topics further? Why not join experts and decision-makers at the Pharmacovigilance Strategy Meeting 2019 on the 22nd of May (Wednesday) at the Intercontinental San Francisco.
Research Analyst, Proventa International