Resolving Problems Experienced by Involving Patients in the Development of Pharmaceutical Products at Post-Launch Stage of Pharmaceutical Product Development

Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

Abstract:

Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL