Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Distribution restrictions (Re-switch of OTC medicines) in Germany and in other selected countries ***
Dr. Claudia Karin Wagner (Abschlußjahr: 2010)
Language: English
Medicines available without a prescription are called non-prescription or Over-The-Counter (OTC) medicines. There are many different non-prescription medicines, many of which have been available for a long time, have long track records of safety and efficacy. The non-prescription medicines are bound for the self-medication. Examples are use in cases of mild to moderate pain, cough and cold. Other non-prescription products are newer and started out as prescription medicines, which have been switched to non-prescription medicines; examples are Triptans for migraine and antihistamines for hay fever. In despite of a long period of security, OTC medicines contain potential risks:
- rare but severe adverse effects
- incorrect self-diagnosis and incorrect choice of therapy
- failure to recognize or self-diagnose contraindications, interactions, warnings and precautions
- inadequate or excessive dosage
- excessively prolonged use
- risk of dependence and abuse.
The United States hold a two class system: Prescription and non-prescription. In some other countries such as Germany, the United Kingdom and Australia, there is a graduation in the level of availability of non-prescription products. There can be some sub-divisions such as a Behind-The-Counter (where there is need for pharmacist assistance), pharmacy (self selection) or Free-To-Sale (also called General-Sale-List through any retail outlet).
If a potential risk of an OTC medicine occurs, there are several possibilities to limit the sales of the medicine. Either the drug will be switched to prescription completely (re-switch from non-prescription to prescription status) or there is a re-switch to a more restricted drug class in those countries that have more sub-divisions of the non-prescription status. Further options are limitations of package size, dosage or dosage strength, which are called partial re-switches.
The collaborative care is a new type of sales limitations, for which a doctor is making the first diagnosis. If the medical conditions do not change, the patient can medicate himself.
The present master thesis reviews the re-switches mainly in Germany, following the situation in other countries such as the United States of America, the United Kingdom and Australia will be described. Furthermore, examples of actual decided and planned re-switches in Germany will be described and discussed.
Pages: 58,
Annex: pages: 2