[Self-medication: Is regulation needed...from whom?]. / Automédication: faut-il une politique? Laquelle? Table Ronde no 3 de Giens. XV.

The participants attending the 1999 French Clinical Pharmacological meeting in Giens eventually reached a consensus about the necessity to set up a clear policy regarding self-medication products in France. Despite a wish by French people to take more responsibility for their own health care, self-medication products' use and development in France have been held back for many years for the reasons reported below. However, self-medication could be developed while respecting or even improving public health care by applying the following key principles: (1) the acknowledgement of a consensual definition. 'A self-medication drug is a drug (the guarantees for which are provided by marketing authorization approval and dispensation and advice of a pharmacist) specifically suitable for use without any physician's prescription'; (2) the advertising of self-medication products to the general public is authorized; (3) the safe use of self-medication products is linked to the selected indications and the relevance of the information provided to the general public; (4) the self-medication drug approval procedure could be simplified, managed by a specific AFSSAPS unit; (5) the role of the pharmacist involved, as well as suitable pharmacovigilance, is mentioned; (6) more than 1000 previously marketed drugs without any clear status, the so called 'grey zone drugs', should be taken into consideration. According to the participants at the meeting, it is possible to set up a new clear and dynamic policy for self-medication products in France in conformity with EU requirements.

Telematics applications to support the role of the community pharmacists as self-medication advisors. TESEMED Consortium.

One of the applications developed within the EU-funded projects TESEMED and TESEMED-II is a program for the information and continuous training of community pharmacists, with the aim to empower them as advisors of the citizens about self-medication topics. Several programs are being developed on the basis of ad-hoc developed protocols about minor ailments (currently, cold and flu, haemorrhoids, constipation and cough). Each program includes three modules: a hypertextual version of the protocol, an interactive scheme of it, and an educational tool called Encounter Simulator, that trains the pharmacist about the protocol by means of simulated pharmacist-customer interactions. The testing of these applications with 84 community pharmacists offers positive results in terms of expectations, program characteristics and perceived usefulness.

Over-the-counter drugs. The issues.

Self-medication is recognised today as an important part of health-care systems. Empirical studies worldwide show that most consumers use self-medication preparations in a safe and proper way. Because of this, a liberal regulatory environment, concerning, in particular, the change from prescription to nonprescription status, seems appropriate. This must be combined with a comprehensive information package in consumer-oriented language. The characteristics for self-medication medicines which were developed by WHO might provide guidance for the national policies in that area.