Patient Centricity in Pharmacovigilance

INTRODUCTION

Pharmacovigilance (PV) is becoming increasingly prominent as a science, also its role in effective patient care and public health is emerging. 

The past decade has seen remarkable growth in patient engagement in health care, to point that the term “Patient centricity” has been introduced steadily in all patient-related activities. 

This is particularly true in clinical research, where patients have shifted from passive enrolled subjects to active participants. The significance and impact of the patient perspective in drug safety reporting is now apparent.

Patient-centeredness and patient safety have become fundamental to today’s interactive and responsive healthcare systems. The focus on patients has become a recognized feature not only of high-quality health care, but also of high-quality drug development. As patients become increasingly interested in their health and in healthcare, they support the maximum of ‘‘Nothing about me, without me”.

In this evolutionary scenario, pharmacovigilance has not been a primary testing ground for patient engagement. It is an area where only health care professionals are competent to deal with adverse events and associated risks; on the other hand, patients have not been encouraged to play a more active role on this issue. 

The most important objective of pharmacovigilance has been to detect and report serious side effects, a task well performed by today's state-of-the-art pharmacovigilance systems designed to ensure patient safety and an early response to any alert.

Much effort has been invested in developing new methodologies for collecting the patient perspective along the clinical trial journey, Patients’ perspectives incorporation into pharmacovigilance (PV):

• ADR reporting 

• Signal detection and evaluation 

• Risk management, 

• Medication error assessment 

• Benefit–risk assessment and risk communication.

Effective patient centric PV model is entrenched in 6 stepladders;

One of the key approaches in patient centric PV is raising patient awareness. Social media can also serve as an effective digital tool for the risk assessment & communication for PV Professionals within the companies to directly connect and engage with patient, costumers and HCPs.

Encouraging Factors and barriers in ADR Reporting;

Why Did Patients report?	Why Did Patients not report?
ADR were serious Worried about their situation Wanted to share the experience Wanted actions to be taken Want extra information ADR was not mentioned in the leaflet Heard about possibility of reporting Family member assist them to report	Side effect was not serious Side effect was expected or known Discouraged by GP Misguided Lack of personal feedback

Methodologies

Seven database were considering to identify relevant publication related to patients’ participation on ADRs reporting.

• Google Scolar

• Science Direct-Elsevier

• SOPUS

• Medline

• Academic search complete “EBSCO”

• Health and Medical Complete ProQuest

Technologies

Modern pharmacovigilance solutions combine information while rationalizing scientific and regulatory processes. These new tools help safety leaders target patients, utilize new data sources and enhance collaboration with stakeholders.

CONCLUSION

The exact way to encourage direct patient reporting in PV is to provide more value to the words of patient and work on better ways to involve them more in the process.

The importance of patient direct reports can be summed up as follows:

• They give more and better context than indirect reports from professionals

• They generally describe the impact on people’s lives, which clinicians rarely note

• Indirect and direct reports complement each other, producing multicultural knowledge

• Knowledge of ADRs and their significance collects faster in drug safety societies

• Patients become active contributors in their care

• Patients learn how to manage their medicines and to connect better with experts.

Five questions guiding the way to actual patient-centricity;

1. Why do we work in healthcare?

2. Do you know everything you need to know about your patients?

3. Do we really want to engage in a dialogue with patients?

4. Are we ready to offer value (beyond the drug) to the patient?

5. Do you know why, or when, a patient would want to engage with you?

References:

1. Supriya Desai; “Patient centricity in pharmacovigilance: new directions and new horizons for transformation”, Pharmacovigilance review, Volume 8/4, 2015

2. Meredith Y; “The Patient’s Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization”, Drug Saf (2016) 39:779–785

3. Hager Ali Saleh; “Patient-centered pharmacovigilance: A review”, Tropical Journal of Pharmaceutical Research January 2018; 17 (1): 179-188

4. Kelly Traverso; “Moving to Patient-Centric Pharmacovigilance”, Journal of clinical studies, 12(4) (Suppl1): S73–S77, 2013

Krina Unadkat

M. Pharmacy-Pharmacology

Kanabar.krina7@gmail.com