I eagerly write for you this April 2016 edition of Oviya MedSafe’s newsletter which aspires to provide an overview of the relevance of Pharmacovigilance in Patient Support Programmes and Market Research Programmes, with emphasis on the capabilities and experience of Oviya MedSafe in this niche super-specialty segment within the larger discipline of Drug Safety.
The Guidance Notes for Patient Safety and Pharmacovigilance in Patient Support Programmes released by the Association of the British Pharmaceutical Industry (ABPI) on 09-May-2011 (which is now being revised in light of the new pharmacovigilance legislation) states that a Patient Support Programme (PSP) is a service for direct patient or patient-carer interaction/engagement designed to help management of medication and/or disease outcomes or to provide healthcare professionals with support for their patients. Section VI.C.2.2.11 of the Good Pharmacovigilance Practices (GVP) Module VI (Revision 1, 08-Sep-2014) defines a PSP as an organised system where a Marketing Authorisation Holder (MAH) receives and collects information relating to the use of its medicinal products.
According to section VI.C.2.2.11 of the GVP, a Market Research Programme (MRP) is defined as a systematic collection, recording and analysis by a MAH of data and findings about its medicinal products, relevant for marketing and business development. While both PSPs and MRPs are not formal studies driven by structured protocols and may not always be product-specific, the main difference between a MRP and a PSP is that a MRP does not usually take interest on the individual identities of the respondents which is not the case with a PSP. Further, although follow-up may be possible in a MRP, consent to follow-up is not explicitly sought for or provided as a routine. It could be much more challenging in a MRP rather than a PSP to medically confirm a reported adverse event. A MRP can be classified as Qualitative or Quantitative and also as Primary or Secondary.
PSPs are rolled out by MAHs with the prime motive of helping patients and/or Healthcare Professionals (HCPs) better manage disease and optimize treatment. Identifying adverse events is not an objective of PSPs and in fact, PSPs are usually not designed to be organised data collection schemes. However, it is crucial that Patient Safety is a priority in PSPs and the MAH should be able to meet ethical, legal and regulatory obligations including pharmacovigilance requirements. According to a presentation on the European Medicines Agency’s (EMA) website, the objectives of most PSPs fall under one of the below-mentioned three categories:
To support patients and help them take their medications as prescribed (compliance/adherence);
To help patients understand their condition and provide advice on managing disease, such as lifestyle (exercise or diet) & disease education; and
To provide a service or financial assistance or reimbursement support for patients (which are also known as patient assistance programs).
Adverse event reports identified from PSPs and MRPs should generally be considered as Solicited Reports (with some exceptions as explained in GVP Module VI.B.1.2). To manage information on suspected Adverse Drug Reactions (ADRs) identified from PSPs and MRPs, MAHs should have the same mechanisms in place as for all other solicited reports (as detailed in GVP Module VI.C.2.2.2). Valid Individual Case Safety Reports (ICSRs) should be reported as solicited reports in accordance with the electronic reporting requirements provided in GVP Module VI.C.22.214.171.124. Due to this reason, it is important for the MAH to seek the reporter’s causality assessment. If the reporter’s causality is missing, the MAH is obliged to provide their own causality assessment.
The United States Food & Drug Administration (US FDA) too states in its Compliance Program Guidance Manual (Chapter 53 – Section D.1.b and Section G) that adverse event reports originating from PSPs should be handled as safety information obtained from a postmarketing study.
The Pharmaceutical Information & Pharmacovigilance Association (PIPA), in a presentation on its website, clarifies that reporting of suspected ADRs in the form of ICSRs is not required if such information is identified during secondary review of data previously collected from consumers or HCPs for other purposes (secondary data). However, such information should be summarised as part of any interim safety analysis and in the final study report unless the protocol provides for different reporting. PIPA emphasizes that MAHs should have a structured contract with PSP vendors who must be trained in identifying adverse events and reporting them. If a Safety Data Exchange Agreement (SDEA) is in place, all the parties to the agreement must be made aware of their adverse event reporting obligations in the context of the concerned PSP. The common inspection findings pertaining to pharmacovigilance of PSPs include failing to report suspected ADRs, lack of awareness of the pharmacovigilance team and/or the Qualified Person for Pharmacovigilance (QPPV) of PSPs, lack of or inadequate agreements with PSP vendors, failure to train vendors, lack of reconciliation activities and lack of audits or other monitoring methods. Hence, it is vital on the part of the MAH to ensure that such obvious misses are avoided when PSPs are conceived and/or executed.
We at Oviya MedSafe are well-positioned in terms of our expertise and track record in managing safety data derived from PSPs and MRPs. Right from helping a MAH in putting together a pharmacovigilance plan for a prospective PSP/MRP to analyzing and/or performing quality checks of data collated from a PSP or MRP with the target of screening the data for adverse events, Oviya MedSafe can take care of all the pharmacovigilance obligations a MAH is expected to fulfil, on behalf of the MAH. Needless to mention, we will be able to leverage our ICSR-processing services coupled with our 21 CFR Part 11 & E2B compliant drug safety software database support, as required, to electronically report suspected ADRs to the competent authorities. It will be our pleasure to support you with any such business needs you may have at the moment or foresee in future.
I wish to share some recent updates on the vibrantly progressing pharmacovigilance scenario in India, further to what I had elucidated in Oviya MedSafe’s March 2016 newsletter. I was privileged to be invited to speak at the 5th Anniversary Celebrations of the Indian Pharmacopoeia Commission’s commitment as the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) on 14-Apr-2016 at New Delhi on the topic ‘Industry Engagement in PvPI’, during which I put forward my suggestions on how the pharmaceutical industry could work with the PvPI for further advancements to come through in Indian Pharmacovigilance. The significant outcomes of the meeting were a proposal of the Government of India to make PvPI an autonomous Centre of Excellence and the formal launch of the Medical Device Adverse Event Reporting (MDAE) Form for the Materiovigilance Programme of India (MvPI).
I also had the opportunity to participate in the 2nd Interactive Session on Challenges and Issues in ADRs reporting by Pharmaceuticals Industries to PvPI organized by PvPI on 29-April-2016 at IPC, Ghaziabad. The well-promoted meeting which brought together members from the industry, PvPI and the Central Drugs Standard Control Organization (CDSCO) resulted in a call for an India-specific ‘Good Pharmacovigilance Practices’ guidance document for the industry.
Given these developments, it is obvious that the task of integrating and streamlining the opinions and expectations of all stakeholders of Indian pharmacovigilance assumes significant relevance. I am glad to announce that the forthcoming Indian Pharmacovigilance Day 2016 conference to be organized at Mumbai on 29-July-2016 by Italy-based EasyB srl, who are well-known for their Pharmacovigilance Day series of events in Europe, is tailored towards addressing this pressing need of the domain in India. I am proud that I would be chairing this conference which will have expert speakers from the industry, health authorities, research bodies, academia and healthcare delivery centres. The conference is now open for registration and I take this opportunity to solicit your active participation to make it a grand success.
While on the topic of conferences, I would like to gently remind you to register for the fast-approaching DIA conference ‘Innovations in Pharmacovigilance – the era of e-PV‘ which is to be held at Mumbai on 13th & 14th May 2016, if you have not already. As a member of the Program Committee, I feel that the final agenda of the conference has come out quite well and I am particularly thrilled to be moderating a panel discussion titled ‘Destination India – PV Outsourcing’ on 14-May-2016 between 14:45 and 15:30 hours, with my esteemed colleagues from other pharmacovigilance service-providers as panellists. I look forward to meeting many of you at these forthcoming events.
Signing off now to meet you later through our May 2016 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,