The Increasing Importance of Patient Reported Outcomes and the Patient Voice in Drug Safety

DIA Global Forum
June 2016
Author: Supriya Desai, Sciformix Corporation

Over the past few years there has been a paradigm shift in the overall approach to pharmacovigilance from that of pure safety analysis to overall benefit-risk evaluation of products. Furthermore, patient centeredness and patient safety have emerged as core elements in today’s interactive and responsive health care systems.This has been coupled with a growing awareness to obtain more real world data directly from patients.

Studies show that patient reports are more valuable compared to healthcare professional (HCP) reports as patients, 1) often report earlier, 2) perceive the impact and severity of reactions differently and, 3) give more detailed descriptions—including specific circumstances like prescribing errors, off-label use, and ADRs (adverse drug reactions) of an intimate nature1. Patient reported outcomes of adverse events (PRO-AEs) offer one way to improve the quantity and/or quality of safety information. This brings real world data forward, thereby enabling improved benefit-risk assessment of pharmaceutical products.

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