The Enigma of Pharmacovigilance of Patient Support Programs: A Survey of Marketing Authorization Holders in Europe

Abstract

Background: Pharmacovigilance of patient support programs (PSPs) has been the subject of debate, legislation, and guidance, and regulatory inspections over the last half-a-dozen years. PSPs often involve direct contact between patients or caregivers and health care professionals and are sponsored by marketing authorization holders (MAHs). PSPs have no scientific hypothesis under study, and are not governed by a protocol. Adverse events and suspected adverse reactions are expected to arise. Management of safety data is governed by a patchwork of incongruous guidelines worldwide, leaving room for varying interpretations.

Methods: A survey of MAHs was conducted to inquire about methods, techniques and scope of pharmacovigilance activities concerning PSPs and similar organized data collection systems. The survey was conducted over a 6-week period by contacting pharmacovigilance operations managers in a broad range of MAHs.

Results: The survey was completed by 18 of 35 MAHs. The vast majority of MAHs (94%) conduct market research. Patient support programs were sponsored or supported by 89% of the respondents, with 67% of MAHs sponsoring or supporting disease management programs or social media resources.

Conclusion: Pharmaceutical industry responses to the challenge of pharmacovigilance of patient support programs are varied. In general there has been a consistent response to the European pharmacovigilance regulations and the accompanying guidance introduced in June 2012. As evidenced by the following survey results, many companies have adopted a risk-based approach first assessing each PSP for probability of AE generation, and then setting up a contract and processes to ensure appropriate collection, collation, and assessment of reports of suspected adverse reactions. At the same time, the survey results indicate that many companies are not as mature in their oversight of PSPs. The authors recommend collaboration within the industry to define and agree to industry standard approaches for oversight of PSPs and the adoption of evidence-based simplification of the current regulatory guidelines concerning safety monitoring and reporting, as the current burden is onerous, and over a period of several years has not yielded any information on medically important new risks. Specifically, the authors recommend the formation of a CIOMS Expert Working Group to spearhead this industry collaboration to find a better path forward.

Keywords: adverse events; enforcement; guidelines; patient support programs; quality assurance; regulations.