Express Pharma

Monitoring product safety beyond clinical trials – Industry practices


Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe, details on the need to foster adherence to good pharmacovigilance practices within the industry to ensure its future progress

Medicinal product safety monitoring is an ongoing activity that starts long before a product is introduced into the market and continues until the product remains available in the market. In clinical trials, only a few hundreds to thousands of carefully selected people get involved for a fixed period of time. The safety data from clinical trials may therefore not necessarily suffice to assess how safe the product would be in the long-term when it will be used by millions of consumers in the real world. A medicinal product may appear to be safe and well-tolerated in the pre-marketing phases which may result in it gaining marketing approval too but the real safety profile of the product will be understood only after it has been used by large numbers of patients over a longer period of time and in different parts of the world. For this to happen, it is imperative for product safety data to be collected, organized, analysed and reported in a proper manner in the post-approval scenario also.

The term ‘Pharmacovigilance’, defined by the World Health Organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, is generally used in the context of safety monitoring beyond clinical trials. While the pharma industry is not the only stakeholder of pharmacovigilance, it is the primary stakeholder that is mandated by regulation to monitor the safety of the medicinal products it manufactures and/or markets. Although regulations may significantly vary between countries, they are usually derived from overarching guidelines which have garnered considerable acceptance across the globe. This article aims to provide an overview of the various pharmacovigilance processes in vogue in the industry without specific reference to the regulations of any particular country/region.

Pharmacovigilance system in the industry

Once a medicinal product is approved for marketing, it is the responsibility of the manufacturer/marketer to implement a pharmacovigilance system within their organisation. In addition, they must pr

oactively assess and manage the risks associated with the product throug

Figure – 1

hout the lifecycle of the product.

In the post-marketing scenario, the following processes are followed for purposes of regulatory compliance in the context of pharmacovigilance:

Adverse Event (AE) Handling

Collection of safety information

Pharmacovigilance commences with collection of safety information from various sources such as patients, consumers, healthcare professionals, company partners/ employees, e-mails, phones, fax, letters, journal publications, clinical trials, surveys of patients or healthcare providers, regulatory reports, social media, etc. Published medical and scientific literature articles are particularly considered as important sources of safety information and therefore a periodic (usually monthly) search and review of literature databases is mandated by the pharmacovigilance requirements in many countries. These sources will also give information like frequency of adverse drug reactions (ADRs), patients with highest risk of ADRs, effects in chronic and long-term use, drug-drug interactions, drug-food interactions, misuse or abuse of drug products, medication errors, etc. Each of these reports needs to be evaluated for its causal association with the product and needs to be communicated to the appropriate regulatory agencies either as an Individual Case Safety Reports or as part of Aggregate Reports within the specified timelines.

Individual Case Safety Reports

Individual Case Safety Report (ICSR) is a format and content that is used for the reporting of one or more suspected adverse reactions in relation to a medicinal product that occurs in a single patient at a specific point of time. One of the fundamental principles of single case reporting is the determination of validity. During the triage phase, the case report will be checked for validity against the four minimum criteria: an identifiable p

Figure – 2
Figure – 2

atient, an identifiable reporter, a suspect drug, and an adverse event. If any of these elements are missing or unknown, the case report will not be qualified as valid. Hence, it is the responsibility of the company to take up the appropriate measures to find out the missing data element. Once the missing element is found, the case report will be qualified as valid. Further, the seriousness and expectedness assessments will play a major role in determining the reportability of ICSR