The importance of Pharmacovigilance (PV) as a science, critical to effective patient care in clinical practice and public health is growing. Even as the PV practice has evolved considerably over the last decade, the primary objectives of PV, remain essentially the same with focus on improving patient care and public health and safety in relation to the use of medicines, assessing benefit-risk of medicines, encouraging safe, rational and effective use of medications and promoting understanding, education and training in PV for effective communication to the public(1).
Today, the PV industry is compelled to look beyond day-to-day challenges, to meet increased patient expectations and the demands of modern public health. The need for innovation in PV is critical as we find ourselves in the era of pro-active pharmacovigilance, patient empowerment and ever-growing influence of social media.
One of the key imperatives in this direction is to rethink the existing traditional safety reporting methods and systems and shift view to more patient-centric approaches in every aspect of the PV continuum. There is a need to effectively engage and directly listen to safety concerns of patients, consumers (safety reporting and follow-up) and obtain the right safety data to enable effective benefit-risk analysis. In parallel, it is necessary to focus on open collaboration, transparency and proactively disseminate and share new safety information (relevant product-related risks and concerns) with patients to create and reinforce public trust (risk communication).
Patient-centeredness and patient safety have emerged as core elements in today’s interactive and responsive healthcare systems. As patients become more involved in their health and healthcare, they support the maxim of ‘‘Nothing about me, without me’’ and expect caregivers to engage in shared decision making, so that what matters to the patient is always included.
Observations and reports made by a health professional are an interpretation of a description originally provided by the patient, together with objective measurements. Only a patient knows the actual benefit and harm of a medicine taken. The patients’ central role in actively reporting adverse drug reactions is key to building a better PV system. Patients are in the best position to report a reaction, as they have a unique personal knowledge and experience of the effects of the medication they take, on their body as well as their daily lives. Patients are able to give more details on the circumstances surrounding the reaction, their reports are more nuanced and descriptive in nature, often yielding important new information concerning reactions.
Patients usually report adverse reactions to their doctor to enable onward reporting to the PV center. However, since only 5% of doctors are estimated to participate in any PV system, this process is not efficient in ensuring that the patient’s concerns are being recorded. There are studies indicating that systems for direct recording of patient concerns may identify new drug safety signals earlier than the professional reporting systems alone(2).
The ready availability of safer and more effective medicines of good quality inspires confidence and trust among patients. PV is an essential part of public programs that underpin the reliable availability of sound medicines and it needs to be understood, supported and promoted at the highest levels. For this, it is necessary for information about drug safety programs to be easily available to the public so that the central role of the patient in the rational and safe use of medicines is understood.
Public health programs and responsible media coverage aimed at increasing access to drug information have led to patients in many countries take greater responsibility for their own health, for the decisions they make and in the wider involvement of patients in decisions. This is reflected, in the creation of patient charters and patients’ bills of rights(3) and in the work of patient advocacy groups. For example, patients with HIV/AIDS have been instrumental in creating international awareness of disease impact, improving access to therapies and communication of associated medication risks.
The public has in recent years increasingly influenced HCP prescribing and patterns of drug use accompanied by greater public awareness, due to increased reach of the media and internet. However, available information is not always reliable or scientifically valid. Direct advertising to the consumer of prescription medicines has become commonplace in many countries. With this information patients feel more empowered to make their own therapeutic decisions, without assistance from HCPs. The result has been increasing self-medication, over-prescribing by doctors on patients’ demand and misuse of medications(3, 4). Variations in the way medicines are used can potentially alter their safety profiles and this needs to be investigated further. Further, it needs to be determined how access to drug information can influence patient safety, including patients’ perception of safety and the level of harm patients are prepared to accept for different medicines. The outcome of such research would make possible a better formulation of policies with a view to reducing patient risk(5).
The recommendations and guidance from the PROPSER consortium underline the importance of patient-centric approaches across the entirety of the PV life cycle. Based on the clinical relevance of ‘real world’ data, PRO-AEs have the potential to contribute important new knowledge about the beneﬁts and risks of medicinal products, communicated through the voice of the patient(6). Additionally, recent PV legislation from regulatory authorities in the EU and the USA(7, 8) calls for the inclusion of patient-reported information in safety monitoring as well as involvement of patients in risk management and communication processes.
The convergence of the patient-centric era and the age of big data, fueled by the phenomenal success and reach of the internet and social media has completely changed the nature of the relationships between companies, patients, physicians and treatments and opened up new avenues for the industry to engage with patients in a language and via a medium that they understand. For the patients, technological advancements have made it easier to be an active participant in the PV process. For the industry, patient-centric technological tools can enable monitoring of safety data in real-time, making it an early indicator of potential safety issues for further investigation and help generate more robust product safety profiles.
Despite these changes and increased attention on the perceived value of patient centric approaches, their full potential is yet to be realized in PV. Current safety reporting and risk assessment and communication processes remain heavily dependent on HCPs, despite known limitations like under-reporting and discordant perspectives between patient and HCP reports.
The PV industry has reached a tipping point. Adopting patient-centric approaches and partnering with patients and public for reporting, analysis and communication of safety data to successfully deliver safe drugs for future generations seems to be the way forward. PV organizations that address these imperatives will be better positioned over the long term to ensure patient safety and add real value back to the patients by enhancing product benefit-risk profiles. Patient centric innovation will be at the heart of the transformation of PV over the next couple of decades and this will likely forever change PV as we know it today.
But are we really prepared to implement patient-centric approaches in PV? How can we leverage the reach of social media, internet and technology to incorporate the patients’ “voice” and perspectives into the PV practice? How can we improve patient involvement in the risk management process? What steps are required to bring safety to patients, as opposed to bringing patient to safety? These are some of the questions that we need to deliberate upon before the “Patient” truly becomes the epicenter of all PV activities in the future.
- Effective communications in Pharmacovigilance. The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily, 24-27 September 1997.
- Egberts GPG, Smulderes M, De Konig FHP et al. Can adverse drug reactions be detected earlier?: a comparison of reports by patients and professionals. British Medical Journal 1996; 313: 530- 31.
- De Vries CS, Duggan CA, Tromp TFJ, de Jong-van den Berg LTW. Changing prescribing in the light of tolerability concerns: How is this best achieved? Drug Safety 1999 Sep; 21(3): 153-160.
- Schwartz RK, Soumerai SB, Avorn J. Physician motivation for non-scientific drug prescribing. Social Science and Medicine 1997; 44(4): 541-8.
- Sachs L, Tomson G. Medicines and culture- a double perspective on drug utilization in a developing country. Social Science and Medicine 1992; 34 (3): 307-315.
- Anjan K. Banerjee, Sally Okun, I. Ralph Edwards et al. Drug Saf (2013) 36:1129–114. Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium Guidance.
- EPF Guidance on Pharmacovigilance April 2012. http://www.eu-patient.eu/globalassets/policy/pharmaceuticalpackage/pharmacovigilance-recommendations-for-patient-centred-implementation.pdf. Accessed Jun 28, 2015.