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Appendix E. Medication safety – A specific strategy to promote patient safety
The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,
Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may be pursued in particular by the adoption of common rules in the health field;
Considering that access to safe health care is the basic right of every citizen in all member states;
Recognising that although error is inherent in all fields of human activity, it is however possible to learn from mistakes and to prevent their reoccurrence and that health-care providers and organisations that have achieved a high level of safety have the capacity to acknowledge errors and learn from them;
Considering that patients should participate in decisions about their health care, and recognising that those working in health-care systems should provide them with adequate and clear information about potential risks and their consequences, in order to obtain their informed consent to treatment;
Recalling that Article 2 of the Council of Europe’s Convention on Human Rights and Biomedicine (ETS No. 164) establishes the primacy of the human being over the sole interest of society or science, and recalling its Article 3 on the equitable access to health care of appropriate quality;
Considering that the methodology for the development and implementation of patient-safety policies crosses national boundaries and that their evaluation requires substantial resources and expertise and should be shared;
Recalling its Recommendations Nos. R (97) 5 on the protection of medical data, R (97) 17 on the development and implementation of quality improvement systems (QIS) in health care, and R (2000) 5 on the development of structures for citizen and patient participation in the decision-making process affecting health care, and its Resolution ResAP(2001)2 concerning the pharmacist’s role in the framework of health security, which explicitly suggests working in partnership with other health professionals;
Noting the relevance of the World Health Organisation (WHO) “Health for All” targets for the European Region (target 2) and of its policy documents on improving health and quality of life and having regard to its Health Assembly Resolution 55.18 (2002) on “Quality of care: patient safety”, which recognises the need to promote patient safety as a fundamental principle of all health systems;
Considering that patient safety is the underpinning philosophy of quality improvement and that all possible measures should therefore be taken to organise and promote patient-safety education and quality of health-care education;
Considering that the same principles of patient safety apply equally to primary, secondary and tertiary care and to all health professions as well as to health promotion, prevention, diagnosis, treatment, rehabilitation, and other aspects of health care;
Recognising the need to promote open co-ordination of national and international regulations concerning research on patient safety,
Medication safety – A specific strategy to promote patient safety
See Appendix E (pdf-file) of Recommendation Rec(2006)7 of the Council of Europe
NOTE: text markers added to increase readability (not applied in the original).
1. The use of medicines represents the most frequent health-care intervention in developed countries. Medication errors are the most common single preventable cause of adverse events and European health authorities should consider them as an important public health issue.
2. Medication safety comprises both adverse drug reactions and medication errors. A clear distinction has to be made between them. In a recent World Health Organisation (WHO) report adverse drug reactions (pdf-file) (pharmacovigilance) were linked to product safety, whereas medication errors were linked to the safety of health-care services.
3. A medication error is defined as follows: “Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labelling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use (see here (pdf-file)).
4. The following key dimensions in the care provision should be taken into account in order to prevent medication errors:
a. the organisation and structures used within health care that govern the prescription, dispensing, administration, and monitoring of medication use;
b. the patient-safety culture in health care that promotes the understanding of activities that may have a high risk of undesirable outcomes with the use of medication, in the overall care process;
c. the use of indicators that can establish a baseline for the actual incidence of undesirable events;
d. the level of understanding among staff of the necessary and ongoing observations that need to be made to prevent or minimise the likelihood of errors in medication use.
5. A recognised national focal point for safe medication practices should be designated in each country in a collaborative and complementary way with pharmacovigilance systems for reporting medication errors, analysing causes and disseminating information on risk reduction and prevention.
6. European health authorities should recognise medication safety as a priority, promoting Europe-wide standards for safe medication practices and share and disseminate data and strategies for prevention and risk reduction between countries.
7. The nature, causes, frequency and clinical consequences of medication errors in hospitals and home-care settings in Europe should be assessed.
8. The improvement of the system of medication use requires the prevention of medication errors at every stage, including:
a. improvement of packaging and labelling of medicines as well as proprietary and non-proprietary nomenclature, in co-operation with European regulators and the industry;
b. safer selection and procurement of medicines, including a medication-error-risk assessment of drugs and medical devices during formulary and purchasing decisions;
c. safer storage of medicines in clinical areas in hospitals, where unit-based floor stock should be restricted, and home-care settings;
d. safer prescribing of medicines, helped by the availability of complete patient records, electronic prescribing, decision support and clinical pharmacy services;
e. safer medicine preparation, by minimising the preparation in clinical areas and supplying ready-to-use medicines;
f. safer dispensing of medicines, enhancing the ability to intercept medication errors, and reducing dispensing errors by the use of automated dispensing systems;
g. safer administration of medicines, through clear and legible labelling of medicines up to the point of care, bar-coding, minimising the storage of high-risk medicines and the use of standardised procedures;
h. safer monitoring of medicines based on regular medication reviews and the proactive detection of adverse drug events;
i. independent, updated and accessible information on medicines must be available to health-care providers and patients, and considered with patient information when prescribing, dispensing, and administering medication;
j. patients’ and citizens’ education for safer medicine use, considering patients as active partners in their care;
k. safer communication about medicines for individual patients between health-care providers.
9. In this context, reference is made to an ongoing project of the Committee of experts on pharmaceutical questions (P-SP-PH) on safe medication practices (see pdf-file.
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