(15) Assessment of The Issues on Understanding and Use of Biologics in Clinical Practice and Their Regulations

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1060

Presenting Author(s)

Imelda G. Pe�a, DrPH
– Professor, University of the Philippines Manila, University of the Philippines Manila, Manila, Philippines

Co-Author(s)

Bryan Paul I. Bulatao, MS Pharmacy Industrial Pharmacy
– Assistant Professor, University of the Philippines Manila, Manila, Philippines

Background: Despite the rising trend of biologics, their use as drugs cannot be optimized if costs due to their manufacture and regulation and the limited knowledge among healthcare professionals on biologics for clinical decision-making, would restrict further research and development, including access to patients. Henceforth, issues on their use and regulations need to be assessed and addressed through a recommended action plan for eventual promotion of better patient health outcomes.

Objectives: The study aimed to:
1. assess the issues about biologics, including biosimilars, used in clinical practice, in terms of understanding their use, manufacture and regulation among various stakeholders; and
2. formulate an action plan on recommended activities to help address the identified issues about biologics .

Methods: A descriptive qualitative study design was used among (a) pharmacists, nurses and doctors from government and privately-owned hospitals, (b) community pharmacists, with work relevant to biologics; and (c) section head in Philippine FDA involved in regulation and pharmacovigilance of biologics . Prior to study participation, informed consent was signed individually.

Focus group discussions were conducted for each group of participants. These covered concepts on biologics and biosimilars, their method of manufacture, regulation and professional / clinical practices. Also, key informant interviews were conducted among section heads of the FDA on the registration of biologics and biosimilars, other regulatory issues , as well as possible action plans to address regulatory issues.

Thematic analyses were done to organize their responses so that issues or gaps on biologics and biosimilars can be identified.

Results: Fifteen (15) healthcare professionals participated in the study, comprising 47% pharmacists, 33% doctors and 20% nurses.
The issues and gaps on biologics and biosimilars identified include cost, switching/substitution, lack of awareness, unsafe handling and storage, variations in prescribing practices, poor implementation of regulation, lack of training on biologics for regulators and poor reporting of adverse drug reactions. Action plans include seminars and trainings on the proper use of biologics for healthcare professionals; pharmacovigilance and evaluation of biosimilarity for regulators; and patient education on essential information about biologics to understand their effects and the value of handling these products.

Conclusions: This study highlighted concrete needs-based action points to address the gaps on the use of biologics and biosimilars for the promotion of patient safety with optimum therapeutic outcomes.