Pharmacovigilance: A primary business processes for pharmaceutical companies

Pharmacovigilance is a key part of the core business of every pharmaceutical company. Their business depends upon, and their responsibility is to, ensuring patients in need have optimal access to the right medicines, that use in the wrong patients is avoided as much as possible, through optimizing the benefit risk balance of their products. To this end a company should ensure quality, should know all about the safety and efficacy based on reliable data, ensure new information on any of the aspects which could impact the benefit-risk balance is recognized and responded to appropriately, provide correct information about these aspects of a product to all stakeholders, and not market a product which has a negative benefit-risk balance.

Although the key activity of the pharmacovigilance department concerns the collection of post-marketing safety information, in particular reports of adverse events which may be associated with use of the product, the role of the pharmacovigilance department in integrating new data on quality, efficacy and safety on an ongoing basis in signal analyses, periodic benefit risk evaluation reports (PBRER, or periodic safety update reports (PSUR)), risk management plans (RMP), and other aggregate reports, clearly is much broader. It is a coordinating and collaborating role which requires collection of information from numerous other groups within the company, but also communication about concerns and conclusions with multiple internal and external partners / stakeholders.

Regulatory authorities clearly subscribe to the above view and thus require and regularly will verify compliance of companies with the legal requirements with respect to collection, analyses and exchange of new benefit risk information. They do this by assessing information submitted to them by companies on a routine basis or on recognition of safety issues, by requiring regular independent audits of the company pharmacovigilance system, and through announced and unannounced inspections. Penalties for non-compliance are severe, ranging from warning letters, through public naming and shaming, up to very high financial penalties and even criminal prosecution.

In the public perception the pharmaceutical industry too often just wants to sell products, irrespective of risks, resulting in sometimes rating the industry at a similar low level as the tobacco industry, lawyers, and politicians. Confidence of the public in the information provided by industry on quality, efficacy and safety of their products is key to good compliance, and thus is key to optimizing the benefit risk balance of the products they use. At the same time optimizing the benefit-risk balance of the products is key to gaining public confidence. Besides the cost of legal claims, the damage to the perception of a company, who continued to sell a product with a negative benefit risk balance past the time at which such a conclusion could be reasonably reached, can continue to hit the sales of all that company’s other products for many years.

Thus the importance of accepting pharmacovigilance as a key business process and responsibility within a pharmaceutical company, and ensuring all their staff are aware of and support this key process, can be summarized in three letters:

SSS: Selling Safety Sells.