DDReg Pharma

DDReg Pharma

ISoP: The Need for Patient Engagement in Pharmacovigilance

Pharmacovigilance is paramount for the well-being of patients exposed to pharmaceutical products. To ensure the effectiveness of pharmacovigilance systems professionals from various scientific disciplines contribute in diverse manner. Several organizations collaborate to ensure best global pharmacovigilance practices for patient safety. Among these key organizations is the International Society of Pharmacovigilance (ISoP) that is dedicated to patient safety in healthcare systems worldwide. ISoP provides a platform for professionals with different expertise and skill sets to collaborate and share knowledge.

Patient-Centered Ecosystems

Healthcare systems have been increasingly acknowledging the importance of patient-centered care, as scientific knowledge evolves. These systems prioritize engaging and empowering patients. Patient-centered ecosystems emphasize the value of decision-making recognizing patients as participants in their healthcare journey. Patients should be actively involved in conversations regarding their treatment choices, sharing information and honoring their preferences.

Patient involvement in healthcare is a valuable idea. Challenges may arise in incorporating such methods. Sometimes patients may hesitate to participate in their healthcare decisions. Similarly, healthcare professionals may also feel hesitant to involve patients due to factors like patient preferences and lack of knowledge. Limited and incomplete access to records can create obstacles to patient engagement.

It is important to adopt a strategy in order to tackle these obstacles and establish a healthcare system that focuses on the needs of patients, especially regarding the utilization of medications and medical equipment. Patients should be encouraged to actively engage in different aspects of healthcare, including research reporting pertaining to any negative reactions to drugs and managing their potential risks. The ISoP recognizes the significance of involving patients in pharmacovigilance

Strategies of the ISoP Patient Engagement Group

  1. The goal of the ISoP Patient Engagement Group (PatEG) SIG is to foster collaboration between healthcare professionals and patients promoting communication and information exchange.
  2. In order to ensure effective practices, PatEG SIG is creating guidelines and frameworks for involving patients in pharmacovigilance.
  3. PatEG SIG stays updated on the developments in engagement techniques and technologies to make well-informed decisions.
  4. The digitalization of healthcare has brought several advantages. However, It also presents challenges, particularly in areas like remote monitoring, telehealth and access to medical records.
  5. PatEG SIG plays a role in promoting engagement in pharmacovigilance by encouraging their participation, across various aspects of medicine including development, regulations and safety measures.


Through vast research, it has been observed that patient engagement in pharmacovigilance plays an important role in ensuring patient safety and an effective healthcare system. ISoP established PatEG SIG, a group with a special interest in facilitating patient engagement. Such practices lead to informed therapeutic choices and enhancement of patient safety.

DDReg recognizes the need for and importance of patient-centred ecosystems for effective patient engagement in pharmacovigilance. Through it’s extensive network across the globe, DDReg ensures regional patient engagement and efficient adverse event reporting to drive pharmacovigilance and drug safety surveillance. Read the previous blog on AMDF’s approach to Ensuring the Safety of Donated Devices.

References and Further Reading

  • Younus, Manal M., Mayada Alkhakany, Priya Bahri, Angela Caro, Hadir Rostom, Helen Byomire Ndagije, and Mohamed A. Elhawary. “The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed.” Drug Safety(2023): 1-5.
  • Smith, Meredith Y., and Isma Benattia. “The patient’s voice in pharmacovigilance: pragmatic approaches to building a patient-centric drug safety organization.” Drug Safety39 (2016): 779-785.