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10006756
Patient Support Program in Pharmacovigilance: Foster Patient Confidence and Compliance
Abstract:
The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or online chat centers, etc. The PSP has a crucial role in terms of customer acquisition and retention strategies. During the conduct of these programs, Marketing Authorisation Holder (MAH) may receive information related to concerned medicinal products, which is usually reported by patients or involved HCPs. This information may include suspected adverse reaction(s) during/after administration of medicinal products. Hence, the MAH should design PSP to comply with regulatory reporting requirements and avoid non-compliance during PV inspection. The emergence of wireless health devices is lowering the burden on patients to manually incorporate safety data, and building a significant option for patients to observe major swings in reference to drug safety. Therefore, to enhance the adoption of these programs, MAH not only needs to aware patients about advantages of the program, but also recognizes the importance of time of patients and commitments made in a constructive manner. It is indispensable that strengthening the public health is considered as the topmost priority in such programs, and the MAH is compliant to Pharmacovigilance (PV) requirements along with regulatory obligations.

References:

[1] ABPI Guidance notes for Patient Safety and Pharmacovigilance in Patient Support Programs. May 2011.
[2] EMA. GVP Guideline on good pharmacovigilance practices (GVP), Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1) EMA/873138/2011 Rev 1; 06 June 2013.
[3] FDA. Compliance Program Guidance Manual. Chapter 53 - Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products.15 December 2012.
[4] WHO. Adherence to long term strategies-Evidence from Action. 2003.
[5] PIPA. Patient Support Programs. What every PIPA member needs to know. 20 November 2014.
[6] EMA. Management of safety data from Patient Support Programs and Market research Programs. 06 June 2013.
[7] RAPS. Gaffney, A. EMA investigation into Adverse Event reporting failures finds no new risks. 06 November 2013.
[8] EMA. GVP Guideline on good pharmacovigilance practices (GVP), Module III – Pharmacovigilance inspections EMA/119871/2012 Rev 1; 08 September 2014.
[9] MHRA. Pharmacovigilance Inspection Metrics Report. April 2011 to March 2012.
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