French 
Specific projects
Public Health in Pharmaceutical Practice
The Council of Europe offers a platform for member states to engage in specific health and social policy making. In 1958, 18 member states of the Council of Europe concluded an agreement to promote the integration of disabled persons in society and to promote public health protection.
The Council of Europe Committee of Experts on Pharmaceutical Questions, supervised by the Public Health Committee CD-P-SP, has drawn the attention of governments to medication errors and solutions in Resolution ResAP(2001)2 concerning the pharmacist's role in the framework of health security. In addition to medication safety and prevention of medication errors, it tackles also issues arising from medicines from uncontrolled channels, poorly regulated internet sales and counterfeit medicines as well as the legal classification of medicines as regards their supply.
In 2003, the Committee of Experts on Pharmaceutical Questions created the Expert Group on Safe Medication Practices to review medication safety and to prepare recommendations to specifically prevent adverse events caused by medication errors in European health care. Its members are all health professionals who are committed to the cause.
The Expert group contributed to the provisions dealing with medication safety in Recommendation Rec(2006)7 and co-operated with the Council of Europe Committee of Experts on Management of Safety and Quality in Health Care (SP-SQS) which prepared recommendations on management of patient safety and prevention of adverse events in health care.
Recommendation Rec(2006)7 on the management of safety and quality in health care - prevention of adverse events in health care – a system approach was adopted by the Committee of Ministers on 24 May 2006. Governments are asked to recognise medication safety as a priority, promoting Europe-wide standards for safe medication practices and to compile and share data and strategies for prevention and risk minimisation.
Counterfeit medicines:
Rapid Alert System (RAS) - Form adapted to the exchange of information on counterfeit medicines
The Rapid Alert Procedure on quality defects of authorised medicines, currently used jointly by the Pharmaceutical Inspection Convention/Pharmaceutical Cooperation Scheme (PIC/S) and by the European Medicines Agency (EMEA), can be used as well for transmitting alerts on counterfeit medicines. Experience has shown that it is difficult to use the existing alert form, since it focuses only on authorised medicines, whereas counterfeit notifications describe two medicines with different characteristics:
- the counterfeit medicine and
- the counterfeit genuine product.
Therefore, it was proposed to complement the existing Rapid Alert System with a new form, set up specifically for the exchange of information on counterfeit medicines.
The Committee of Experts on Pharmaceutical Questions’ Ad hoc Group on Counterfeit Medicines developed such a new form (link) in 2004, which was further optimised at the EU Medicines Enforcement Officers’ meeting (EMEO) in May 2005.
This form represents an optimised tool for sharing and transmitting information on counterfeit medicines in an easy and systematic way. It may serve at the same time as a check list for the compilation of information which might be of relevance for decisions on concrete measures to protect public and/or animal health.
NB: The proposed form offers a medium to include different information which is important in combating counterfeit medicines at the time they come up on the market. Some more detailed information may not be available or authorised for release at an early stage in case of a suspect counterfeit medicine. In this case, the authority issuing the notification is requested to include all information which can be shared.
Raising awareness and commitment
Seminar “Counteract the counterfeiters! Limiting the risks of counterfeit medicines to Public Health in Europe by adequate measures and mechanisms”, 21-23 September 2005
International conference “Europe against counterfeit medicines”, 23-24 October 2006, Moscow, Russian Federation
Medication Safety:
Preventing medication errors in Europe through the implementation of a medication safety culture - a priority of the Council of Europe work programme
The development of guidelines on common standards on definitions and reporting systems to improve medication safety and to prevent medication errors by reporting, analysing and learning mutually from medication errors is vital.
The Committee of Experts on Pharmaceutical Questions carried out a survey on medication errors between 2001 and 2002. Its results were presented at a multidisciplinary expert meeting on medication safety in The Hague in November 2002. The outcome provided the basis for the plan of activities of the Council of Europe Expert Group on Safe Medication Practices. Click here for Proceedings.
The meeting brought forward a consensus that medication errors must be recognised as an important system-based public health issue and outlined approaches to safe medication practices which should be multidisciplinary and include patients, professionals and their organisations.
For the Consensus document established by the participants of the expert meeting on medication safety on 22 November 2002, click here for the English version, French version, German version, Spanish version, Russian version.
Creation of a better medication safety culture in Europe: building up safe medication practices:
“…Regiments for the good of my patients…and never do harm to anyone” (Hippocratic Oath)
Patient safety is a fundamental principle in health care as reflected in the Hippocratic Oath and a crucial component of health care quality management. However, medication errors occur, either in hospitals, at the doctors’, pharmacies or at home. Unfortunately, sometimes, patients get hurt as a consequence. Medication errors have to be considered a significant public health issue worldwide: Alongside breast cancer, car accidents and AIDS, medication errors are a killer.
Council of Europe to publish comprehensive report on building safe medication practices in Europe
New! The Council of Europe Expert Group on Safe Medication Practices has now finalised its report on how to provide a multidisciplinary and integrated approach to safe medication practices. The Secretariat of the Partial Agreement in the Social and Public Health Field announces the launch of the report “Creation of a better medication safety culture in Europe: Building up safe medication practices” on the web in a preliminarily version (PDF).
Link to the Medication Safety Report
(available as from 19 March 2007)
This outstanding report primarily concentrates on preventable harms from medicines and represents the first international report on this topic with a special focus on Europe. In particular, this work charts how these harms can be prevented by improvements in culture, systems and products. Human factor, bar codes and labelling, EU and national medicines regulations, good medicine information practices as well as the role of patients, their families and health care professionals are the keys to minimise harms from medicines.
The report analyses causes of medication errors from the perspectives of patients, carers, prescribing doctors, dispensing pharmacists and nurses. It gives recommendations on how to improve the safety of the labelling of medicines in day-to-day use and to foster safer medicine information practices.
In addition, the report supplies certain tools
- a glossary of terms related to patient and medication safety for reporting systems for which currently no harmonised approach exists and which allows reporting across borders;
- an assessment tool for regulators, industry and health professionals on how to evaluate whether labels and packaging of medicines may cause medication errors;
- best practices for the prevention of medication errors for promotion and training purposes.
New! Scientific terms may have very specific meanings and standard dictionaries are not always the best source to find the correct definitions. We would like to invite member states to send us their contributions to and translations of this glossary or any other contributions to the report.
Contact: Mailbox under construction. For the time being, please fax your contributions to +33 3 88 41 27 26
In order to enhance these unique tools, we will present complementary bilingual versions of the glossary of terms and other national contributions on our new virtual bookshelf.
Please find here the English-Georgian and Albanian versions as a starting point.
Link to the virtual bookshelf.
(This section will be continually under development.)
Medicines and the Internet:
The Committee recognised the need to take action to avoid that certain practices related to “Medicines and the Internet” (illicit importation and illegal distance sales) may compromise the quality, safety and efficacy of medicinal products on the market.
- See “Publications”: Resolution ResAP(2001)2 concerning the pharmacist’s role in the framework of health security.
- See “Regular information exchange”: Selling and advertising of medicines on the Internet.
- "User-oriented Guidance": the Committee decided to develop a simple user-oriented, easily available and accessible information guide to help citizens to select amongst the overflow of
- information on medicinal products,
- appropriate modes of prescription and
- distribution of medicinal products.
Objectives - Principles - Project description - Timetable - Letters to partners - Information tool
"Core message of user-oriented guidance" agreed by the Committee of experts on Pharmaceutical Questions in October 2003.
National implementation: links to authorities and national versions (translations):
Possible implementation routes and tools - Partners and collaborators - Follow-up
