Eszter Palffy, David John Lewis.
Abstract
Patient Support Programmes (PSPs) are used by the pharmaceutical industry to provide education and support to consumers to overcome the challenges they face managing their condition and treatment. Whilst there is an increasing number of PSPs, limited information is available on whether these programmes contribute to safety signals. PSPs do not have a scientific hypothesis, nor are they governed by a protocol. However, by their nature, PSPs inevitably generate adverse event (AE) reports.
Introduction
PSPs are not designed to investigate a scientific hypothesis nor, typically, are they governed by a protocol, hence these programmes are not safety-oriented. However, by their nature, these programmes generate potentially reportable suspected Adverse Drug Reactions (ADRs). Additionally, patients too can report AEs via these programmes that may contain valuable information.
Methods:
The research was conducted in POPsys, to gather all POPs for sacubitril/valsartan created by the company. Following the confirmation of PSPs for the selected innovative product, research was commissioned in ARGUS to identify all adverse event reports emanating from these PSPs. The extracted data were analysed to identify signals raised and validated from the cohort of sacubitril/valsartan PSPs by reviewing changes of the CDS from the first version (CDS at launch) to the current one. Additionally, the line listing was analysed to review the acceptance and adherence information from a patient perspective.
Discussion
Due to the nature of certain PSPs and the possibility of frequent interactions with patients, the chance of receiving AEs may be high. The collection of AEs is an important element of pharmacovigilance that contributes to signal detection and risk minimisation. In order to identify new safety signals and conduct correct risk minimisation activities, data must be of good quality and must be collected using the most appropriate methods to allow proper assessment of the safety signals.
Acknowledgments:
We would like to acknowledge the advice and guidance from Dr John Talbot at the University of Hertfordshire during the planning and conduct of this research.
Citation: Palffy E, Lewis DJ (2024) Real-World evidence revelations: The potential of patient support programmes to provide data on medication usage. PLoS ONE 19(2): e0295226. https://doi.org/10.1371/journal.pone.0295226
Editor: Masoud Behzadifar, Lorestan University of Medical Sciences, ISLAMIC REPUBLIC OF IRAN
Received: November 2, 2022; Accepted: November 19, 2023; Published: February 8, 2024.
Copyright: © 2024 Palffy, Lewis. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: The minimal data set that was used for the research is provided as a Supporting Information file. Further data is output from the Novartis database and access will be granted on reasonable request. The best point of contact is the QPPV group mailbox required under European Law as the central contact point for safety enquiries which is constantly monitored 24/7/365. eu-eea.qp@novartis.com.
Funding: The author(s) received no specific funding for this work.
Competing interests: The authors have declared that no competing interests exist.
