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Rx -to- OTC switch increased access and lowered cost of topical adapalene.
Arch Dermatol Res
May 2024
Department of Dermatology, George Washington University Medical Faculty Associates, George Washington University School of Medicine and Health Sciences, 2150 Pennsylvania Ave NW Fl. 2 South, Washington, DC, 20037, USA.
Topical adapalene gel is an effective and well tolerated acne treatment that transitioned from prescription to over-the-counter (OTC) availability in 2016. Historically, prescription to OTC transitions have lowered costs to patients and payers and increased access to medications. This study used sales and prescriber data to assess access to topical retinoid therapies and their costs in the pre- and post- Rx-to-OTC transition.
View Article and Find Full Text PDFSelf-care and minor ailments: The view from Canada.
Explor Res Clin Soc Pharm
March 2024
College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
This manuscript offers a glimpse into the Canadian healthcare system, emphasizing the prevalence and management of minor ailments through self-care practices. The first section outlines the strengths and challenges of the healthcare system, including access issues and escalating costs. The second section explores self-care in Canada, outlines the Self-Care Readiness Index, and Canadians' proactive management of common conditions through self-care activities, including the use of over-the-counter (OTC) medicines.
View Article and Find Full Text PDFReal-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM.
Clin Ther
March 2024
Sanofi, Neuilly-sur-Seine, France. Electronic address:
Purpose: We studied under which circumstances and to what extent Real-World Data (RWD) and Real-World Evidence (RWE) were used in regulatory decisions when switching products from Prescription-only (Rx) to Over-the-Counter (OTC) status with the aim of extracting learnings that could be applied in future switches.
Methods: Sanofi commissioned Clarivate Analytics to identify switches from Rx to OTC in the European Union (centrally by the European Medicines Agency [EMA] and in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]), in the United States by the Food and Drug Administration (FDA), and in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) as far back as data were available in the public domain, mainly Health Authority webpages. They covered the period from and including 2022 and went as far back as they could find data in their proprietary database or in the public domain; for the EMA back to 2008, the US FDA back to 2001, the UK MHRA back to 1991, and the German BfArM for the period 2013-2022.
A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches.
Ther Innov Regul Sci
September 2023
Haleon, 184 Liberty Corner Rd, Warren, NJ, 07059-6796, USA.
Objectives: This evaluation assesses the quantity, uniqueness, and innovative nature of the past 20 years of Rx-to-OTC (RTO) switches, where a current prescription (Rx) product is reclassified for over-the-counter (OTC) status. Broadening access to more OTC drugs with well-established safety and efficacy could help to reduce healthcare expenditure and address public health challenges.
Methods: The FDA-maintained RTO switch list website was accessed to generate the primary dataset.
Regulatory, safety and economic considerations of over-the-counter medicines in the Indian population.
Discov Health Syst
May 2023
Medical Affairs, Haleon (Formerly GSK Consumer Healthcare Pte Ltd.), 10th Floor, One Horizon Center, Golf Course Road, DLF Phase 5, Gurugram, Haryana 122002 India.
Background And Purpose Of Review: Over-the-counter (OTC) medication has been an integral component of an established health care system but their easy accessibility might pose significant risks. This review has attempted to highlight the present scenario of OTC utilization in India, regarding standard practices followed globally. An attempt has also been made to highlight the lifecycle of a prescription and OTC medicine and the benefits and regulatory process involved in the prescription-to-OTC switch.
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