Policy Analysis on the Regulation of Off-label Uses of Medication
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Abstract
Objective: To review the literature on laws, policies and measures in regulating off-label use of medications in foreign countries, analyze policies and formulate policy proposals to regulate off-label use of medications in Thailand. Method: This study was a documentary research by searching for research papers from electronic databases such as Medline and Google Scholar since the inception of the databases until December 2018. Results: From 39 identified research articles, there were various regulating measures of off-label use to reduce the risk among medication users including legal implementation, issuing standard treatment guidelines, implementing professional ethics, creating motivation in conducting research in off-label use, use of reimbursement mechanisms in health insurance system, providing information to patients, and the development of drug registration systems for off-label use. All measures involved all stakeholders ranging from regulatory agencies on drug system, pharmaceutical manufacturers, health care institutions, professional organizations, prescribers, and patients. Policy recommendations for appropriate measures in Thailand were the measures on health technology assessment together with the use of empirical evidence for selecting drugs with off-label uses and potential impact on patients’ access, reimbursement measures in the health insurance system, development of standard treatment guidelines, provision of information to patients by physician, allowing patients to participate in making decision on treatment with off-label use, and measures to encourage manufacturers to research and register for additional new indications found in research. Conclusion: Measures for regulating off-label use of medication include legal measures, measure to increase relevant research, reimbursement mechanism in the health insurance system, ethical measures for professional practitioners and measures on development of drug registration systems.
Article Details
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
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