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

Author

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  • Meredith Y. Smith

    (Amgen Inc.)

  • Isma Benattia

    (Amgen Inc.)

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.

Suggested Citation

  • Meredith Y. Smith & Isma Benattia, 2016. "The Patient’s Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization," Drug Safety, Springer, vol. 39(9), pages 779-785, September.
  • Handle: RePEc:spr:drugsa:v:39:y:2016:i:9:d:10.1007_s40264-016-0426-9
    DOI: 10.1007/s40264-016-0426-9
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    Cited by:

    1. A. Cecilia Jimenez-Moreno & Eline Overbeeke & Cathy Anne Pinto & Ian Smith & Jenny Sharpe & James Ormrod & Chiara Whichello & Esther W. Bekker-Grob & Kristin Bullok & Bennett Levitan & Isabelle Huys &, 2021. "Patient Preferences in Rare Diseases: A Qualitative Study in Neuromuscular Disorders to Inform a Quantitative Preference Study," The Patient: Patient-Centered Outcomes Research, Springer;International Academy of Health Preference Research, vol. 14(5), pages 601-612, September.
    2. Cristiano Matos & Gerda Weits & Florence Hunsel, 2019. "The Role of European Patient Organizations in Pharmacovigilance," Drug Safety, Springer, vol. 42(4), pages 547-557, April.
    3. Cedric Bousquet & Bissan Audeh & Florelle Bellet & Agnès Lillo-Le Louët, 2018. "Comment on “Assessment of the Utility of Social Media for Broad-Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEB-RADR Project”," Drug Safety, Springer, vol. 41(12), pages 1371-1373, December.
    4. Katherine Chinchilla & Cristiano Matos & Victoria Hall & Florence Hunsel, 2021. "Patient Organizations’ Barriers in Pharmacovigilance and Strategies to Stimulate Their Participation," Drug Safety, Springer, vol. 44(2), pages 181-191, February.

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