Patient Centricity in Pharmacovigilance: New Directions and New Horizons for Transformation
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patient centricity in pharmacovigilance: new directions and new horizons for transformation Supriya Desai he importance of Patient-centric innovation will be at the heart pharmacovigilance (PV) as a of the transformation of PV over the next science, critical to both effective couple of decades and this will likely forever change PV as we know it today. But are we patient care in clinical practice and public T really prepared to implement patient-centric health is growing. Patient-centeredness approaches in PV? What steps are required to and patient safety have emerged as core bring safety to patients, as opposed to elements in today’s interactive and bringing patients to safety? responsive healthcare systems. As patients take more interest in their Patient-centred health and healthcare, they support the implementation in PV maxim of ‘‘Nothing about me, without In Europe, the EU Directive 2010/84/EU and EU me’’ and expect caregivers to engage in Regulation No. 1235/2010 provide shared decision making, so that the recommendations, developed by the patients’ voice is always included. European Patients’ Forum, for patient-centred implementation for PV. These recommendations are intended to lead to a Patients usually report adverse drug reactions strong, open and transparent PV system that (ADRs) to their doctors. However, since only ensures the confidence of patients, healthcare 5% of doctors are estimated to participate in PV, traditional mechanisms may not be professionals (HCPs) and regulators alike and represents a step forward for safe, high efficient in ensuring adequate safety 3,4 reporting. Data from studies indicate that quality and patient-centred healthcare . systems which enable direct recording of patient concerns may identify new drug safety The Directive 2010/84/EU amends the signals earlier than professional reporting definition of ADRs to include medication 1 errors and misuse as part of ADR reporting to systems alone . This emphasises that the Supriya Desai MD, PGDBM is a patients’ role in actively reporting ADRs is key help collect more information on the real-life Clinical Research and to building a better PV ecosystem. working of medicines, when used in different Pharmacovigilance (PV) circumstances by different people. Products, Executive with over 16 years of experience in clinical practice Public health programmes and responsible subject to additional monitoring (e.g. products and in various leadership roles in media coverage aimed at increasing access to with new active substances, biologics) need to the healthcare industry including clinical research, drug safety and drug information has led patients in many be identified by a black symbol with a PV. In her current role as Medical countries to take greater responsibility for standard explanatory sentence on the Director and Practice Head at packaging indicating that the medicine is Sciformix, she provides scientific their own health. This is reflected in the and operational leadership to a creation of patient charters, patients’ bills of under additional monitoring, what such global medical team (across rights 2 and patient advocacy groups. For monitoring means and the reasons behind it, India, Philippines and US); without creating unwarranted alarm so that involved in medical review example, patients with HIV/AIDS have been activities across instrumental in creating international patients do not stop their treatment pharmacovigilance, safety awareness of disease impact, improving unnecessarily. This transparency is paramount writing, signal management and allied safety surveillance access to therapies and communication of to ensure patients’ trust in the functioning of activities, spanning diverse associated medication risks. the PV system. therapeutic areas. PharmacoVigilance Revıew • Volume 8 Number 4 • November 2015 7 The shift from pure safety analysis to benefit– centres. Medical concepts need to be risk evaluation and thereby the overall comprehensively communicated in an implementation approach for an effective understandable and accessible format to patient-centric PV model is entrenched in four patients. Involvement of patient organisations main steps; namely to educate, encourage, as experts for development of safety engage and enable patients, as outlined in information as well as for set-up and Figure 1 . development of the national web portals on medicines is critical. Step 1: Education and encouragement The growing commercial relevance of emerging markets coupled with lower levels One of the key approaches in patient-centric of patient awareness in these regions poses a PV is raising patient awareness regarding the specific challenge and would likely limit the importance of reporting ADRs and continually success of patient-centric measures in a global highlighting the critical role they can play in PV environment. In this context, involving PV, right from safety reporting through risk HCPs like pharmacists, nurses or physicians communication. builds upon existing relationships between Targeted educational initiatives include providers and patients and helps activate their training programmes to directly train patients to participate in safety reporting consumers and patients regarding adverse activities. Reported information can be acted event (AE) reporting systems, as well as train upon by the HCP or reported to other HCPs, investigator site teams, patient organisations as appropriate and provides a mechanism for and HCPs. Dissemination of product safety providers to report complementary clinical summaries, benefit–risk data and risk information or enable linkage to a medical management plan summaries for public record. Direct appreciation and recognition for consumption on a real-time basis is important patient efforts to report AEs with possible and can be through company websites, provision of some incentives (non-monetary) national web portals and patient information to patients and consumers would further encourage ADR reporting. Step 2: Engage purposefully and enable proactively ADRs are estimated as the fifth largest cause ()*+"&$' of deaths in hospitals 4, yet only around 10% to 25% of all ADRs are reported. Underreporting of ADRs is a serious issue, which undermines the evaluation of safety of medicines. Direct patient participation in reporting drug-related problems can increase the efficiency of the PV system and compensate for some of the shortcomings of systems based on HCP reports only 5. (%0"0$' !"#$%&'' (%",-$' The Directive 2010/84/EU [Article 102(b)] proposes guidance encouraging direct patient reporting of ADRs, via appropriate measures including web-based and alternative formats to the national competent authorities (NCAs). Studies show that patient reports are more valuable compared to HCP reports as patients often report earlier, perceive the impact and (%+.*/"0$' severity of reactions differently and give more detailed descriptions, including specific circumstances in which the reaction occurred. In certain situations, like ADRs resulting from Figure 1: Implementation model for patient- prescribing errors or off-label use of centric pharmacovigilance. medications and ADRs of intimate nature, 8 PharmacoVigilance Revıew • Volume 8 Number 4 • November 2015 direct reporting by patients would enable practice records and pharmacy registries collection of such crucial safety data to ensure within national health systems (containing better medication safety 6. confirmed patient-level health and treatment information) would provide the ability to link Patient-reported outcomes (PROs) are data validated patient information (around elements directly reported by patients about diagnosis, co-morbidities, allergies and other experiences with healthcare, symptoms, treatments) for analysis of aggregated safety functional status, or quality of life 7. The Patient data, and help better understand the etiology Reported Outcomes Safety Event Reporting of rare reactions and possible correlation of (PROSPER) Consortium comprises of industry, patient-related genomic data with specific regulatory authority, academic, private sector safety issues 10 . and patient representatives interested in the area of patient reported outcomes of adverse Social media offers another novel channel for events (PRO-AEs). This consortium has put driving patient-centric PV. Most social media forth specific guidance for improved safety activities for PV by companies are focused on reporting by better incorporation of the screening of social media sites to ensure patient’s ‘voice’ and perspectives into adequate safety reporting. Easy, convenient collection of safety data, so that the safety reporting of AEs via simple patient-friendly profile and benefit–risk balance of new and mobile applications (deployed on mobiles, existing medicines is better defined 8. smartphones), monitoring of company- managed websites, health forums and Effective involvement of patients in the AE monitoring of safety data reported on social reporting process is possible by use of novel media sites like Facebook and Twitter are ADR reporting tools and processes like ADR useful in this context 11 . online forms, mobile applications and through local pharmacies. Further, patient involvement Patient engagement in the PV process can in set-up and user-testing of the reporting only be considered truly complete when the systems ensures that the system is fit-for- patients and the public are involved in the purpose and user-friendly. Developing risk management and communication guidelines