The Patient’s Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization

Abstract

Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and processes they implement to achieve this end effectively and efficiently, promise to become distinguishing factors in the highly competitive biopharmaceutical industry landscape. Key PointsPatient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development.Recent patient-centric regulatory and related initiatives are transforming the form and function of the pharmacovigilance function within the biopharmaceutical industry.To meet this patient-centric imperative successfully, pharmacovigilance departments will need to develop a more patient-centered culture, use a frameworkdriven approach to patient engagement and become proficient in a range of patient-centered competencies.

The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

“…Recent developments in pharmacovigilance emphasize the importance of the patient's perspective in drug safety . Aspects of the contribution of patient reporting to pharmacovigilance go beyond a quantitative contribution and include more information on quality of life, severity of the ADR, and circumstances of use …”

“…Recent developments in pharmacovigilance emphasize the importance of the patient's perspective in drug safety. 13 Aspects of the contribution of patient reporting to pharmacovigilance go beyond a quantitative contribution and include more information on quality of life, severity of the ADR, and circumstances of use. [14][15][16] Even though attitudes toward patient reporting are generally positive, 14,17 most information on the contribution of patient reports to signals is theoretical or anecdotal, 14,16,17 and there is still a limited amount of information available that actually quantify the contribution of patient reports to signal detection for a spontaneous reporting system.…”

Harnessing social media data for pharmacovigilance: a review of current state of the art, challenges and future directions

“…Nonetheless, a need for patient-centricity is increasingly recognised by highprofile institutional drug safety stakeholders (Council for International Organizations of Medical Sciences (CIOMS), European Medicines Agency (the ), Food and Drug Administration (FDA), Innovative Medicines Initiative (IMI), etc. ), who have developed a series of regulatory guidances and launched initiatives in this direction across the entire value chain of pharmacovigilance [129]. Experts stress the need for strong and systematic processes for selection, validation and study implementation [130].…”

“…As practices and legal requirements vary across countries, the need for a concrete policy framework on the further use of social media as a new valid type of data sources for pharmacovigilance is emphasised [130]. Smith and Benattia [129] further stress the need for an internal revision of the form and function of pharmacovigilance within the biopharmaceutical industry.…”

“…Principal research area [62,63,86,[127][128][129][130]133] New regulatory paradigms for the incorporation of social data into pharmacovigilance systems for de novo signal detection or to complement and enrich primary data sources to better understand the strengths and limitations of social media in post-market safety surveillance and establish best practices [62]. With regard to the four points (key tasks, see Sect.…”