Rational Approaches to the Regulation of Nonprescription Medicines

In recent years, self-medication products have undergone a dramatic change due to the advent of herbal medicines and increasing societal preferences towards greater individual control over the use of medicines. Hence, this area is beginning to receive much attention from regulatory authorities, academia and professional/industry/trade organizations. This dissertation presents a comprehensive analysis of the classification of nonprescription medicines and Rx-to-OTC switch criteria/policy in the United States, United Kingdom, Canada, Japan and Australia. A new approach to investigating US FDA's overall switch regulatory policies through the combined application of case-history evaluations, electronic survey questionnaire and telephone interviews has been utilized. This investigation was conducted in three phases. Phase-1 involved information retrieval and a critical review of existing literature, phase-2 applied switch case history analyses pertinent to US FDA and phase-3 measured the attitudes/opinions of the academic/professional community and key opinion leaders in nonprescription medicines across the US, Canada, UK and Australia on important questions. The subject matter of this dissertation is of enormous current interest in the global nonprescription medicines arena. The significance of the results presented in this dissertation is amplified as this area has received little academic attention and this is perhaps the first comprehensive treatment of this subject. Overall, inferences based on the information elicited have been summarized to provide data-based responses to questions of global interest in the self-medication arena. This information is especially valuable to the US FDA as they are currently seeking public comment. Data shows that the OTC regulatory model in the United States may be improved. Evidence indicates that principles upon which approaches for improvement of the US regulatory system must be based should include: an objective evaluation of pharmacist class of OTC medicines, development of effective consumer education tools, increase in regulation of non-traditional OTC medicines, acknowledge that not all disease conditions and drug classes are suitable for self-treatment, a collaborative approach by FDA towards switching that includes all stakeholders is more favored, decisions on switch petitions must be case-specific without a presumptive basis and public health benefit must be the paramount evaluation criterion.* *This dissertation includes a CD that is compound (contains both a paper copy and a CD as part of the dissertation). The CD requires the following applications: Adobe Acrobat; Microsoft Office; Internet browser.

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