Healthy Skepticism Library item: 10410

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Publication type: Journal Article

Bergmann JF.
Self-medication: from European regulatory directives to therapeutic strategy.
Fundam Clin Pharmacol 2003 Jun; 17:(3):275-80
http://www.blackwell-synergy.com/doi/abs/10.1046/j.1472-8206.2003.00141.x

Abstract:

Self medications are drugs which can be used without a physician’s advice or supervision. There is a clear emerging patient demand for efficient drugs available without prescription. This review summarizes the regulatory rules regarding the status of self-medication drugs in Europe and describes some situations where specific clinical trials are needed for a new drug to be registered as a self medication. These drugs not only have to offer a very positive safety profile but also a well-established level of efficacy. A nonprescription drug can only be proposed in situations where the patient himself can make a self-assessment of the medical condition and its follow-up. These products must be safe even in the event of incorrect use and must offer clear and complete information contributing to a proper use, i.e. a definition of situations where a physician’s advice is necessary. For registration as an ‘over-the-counter’ drug, specific efficacy trials may be conducted in real self-medication situation especially when the target populations, the dosage or the indications in self medication are not the same as those evaluated previously when the drug in question had prescription status. Specific pharmacovigilance is needed and the patient, pharmacist and physician encouraged to report any adverse events. A safety survey may be necessary in some situations such as insomnia or emergency contraception. It is important for the patient, pharmacist and public health in general to distinguish the efficient and safe self medications from the nonvalidated, nonevaluated alternative medicines.

Keywords:
Clinical Trials Drug Labeling/standards Drugs, Non-Prescription/standards* European Union Legislation, Drug* Patient Education Product Surveillance, Postmarketing Self Medication*/adverse effects