What is Pharmacovigilance?
Pharmacovigilance also known as drug safety, refers to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problem. Here ‘adverse effects’ refer to any untoward medical occurrence which happens to either a patient or a subject in a clinical investigation when a pharmaceutical product has been given to them. This includes any signs which are unfavorable and unexpected for the patient or subject, including any abnormal laboratory findings. Information received via pharmacovigilance agreements (PVAs) from patients and healthcare providers, as well as other sources such as the medical literature, plays a critical role in providing the necessary information for undertaking pharmacovigilance. In fact, in order to market or to test a pharmaceutical product, most countries have mandated the requirement for adverse event data received by the license holder (usually a pharmaceutical company). This data is required to be submitted to the local drug regulatory authority. In this article, our experts examine the importance of pharmacovigilance in healthcare.
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Importance of Pharmacovigilance
Clinical Trial Regulation
One of the importance of pharmacovigilance is that it facilitates clinical trial regulation. The recent years have witnessed a skyrocketing increase in clinical trials in the United States alone. Furthermore, the increase in the complexity of clinical trials is leaving regulators with several challenges to face. Clinical trials are mostly contracted to clinical research organizations and patient recruitment agencies. These agencies act as intermediaries between the sponsors of the study, the investigators, and the patients. The importance of pharmacovigilance can also be established from the fact that it enables improved and more rapid changes in labeling or even withdrawal of a new drug from the market. Furthermore, a standardized reporting system for safety concerns arising during clinical trials can be established. Pharmacovigilance also plays a vital role in ensuring patient safety and strict compliance with prescribed regulatory requirements that would substantially improve standards of clinical trials.
Monitoring Post-Marketing Safety
A part of the process of evaluating drug safety should ideally take place in the post-marketing phase. Safety monitoring is not only limited to the cases of new drugs or significant therapeutic advances. The importance of pharmacovigilance is notable in the introduction of generic medicines, and in the review of the safety profile of older medicines already available, where new safety issues may have arisen. Spontaneous reporting is a cornerstone of pharmacovigilance in the regulatory environment is indispensable for signal detection. The need for more active surveillance has also become increasingly clear in recent years. Without reliable and authentic information on utilization and the extent of consumption, spontaneous reports do not make it possible to determine the frequency of an ADR related to a product or its safety.
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Promotional Activities
There has been an increased spending in direct to consumer advertising by pharmaceutical manufacturers. This results in national regulations on advertising to become ineffective. Several websites now enable buying and selling of prescription drugs such as benzodiazepines without controls. These developments in communication have a significant impact on the safety of medicine. Such issues suggest the need for more thorough monitoring of drug safety and scrutiny of advertising. This highlights the importance of pharmacovigilance.
