Masterarbeit

Rx-to-OTC switch – Comparison of the Current Regulatory Approaches in Germany, in the UK, and in the USA ***

Dr. Thorsten Henning (2009)

Language: English

Prescription (Rx) medicinal products shown to be safe and effective for direct consumer use (over-the-counter, OTC) could be reclassified by Rx-to-OTC switches from Rx to OTC (self-medication) status in Germany, the UK, and the USA.

The WHO defined characteristics of self-medication in a particular guideline from 2000 as "the use of medicinal products by the consumer to treat self-recognised disorders or symptoms, or the intermittent or continued use of a medication prescribed by a physician for chronic or recurring disease or symptoms. The customer must perform a number of tasks normally carried out by a physician treating a patient with an Rx medicine: The customer has to recognise accurately the symptoms, setting the therapeutic goals, selection of a product to be used, decide what is the appropriate dosage and dosage schedule, taking into account the persons medical history, contraindication, concomitant diseases and concurrent medication, and monitoring the treatment response. The provision of the medicinal product in self-medication form with appropriate warning instructions may provide at least as great a measure of safety for the user."

This master thesis will discuss the procedural issues of Rx-to-OTC switches in Germany, the UK, and the USA, and will analyse factors that are important in a successful Rx-to-OTC switch in these three countries. The “Rx-to-OTC switch philosophy” of each country will be discussed.

Pages: 48