Creation of a better medication safety culture in Europe




НазваниеCreation of a better medication safety culture in Europe
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Creation of a better medication safety culture in Europe: 

Building up safe medication practices


Expert Group on Safe Medication Practices (P-SP-PH/SAFE)


(2006)


The views expressed in this report do not necessarily reflect the offical opinions of the

Council of Europe

Contents

Executive summary 5

Aim of the report 5

Seriousness of the problem in European health care 6

Introduction 10

Summary of Chapter 1 - From patient safety to medication safety 12

1.1. International efforts for improving patient safety 13

1.2. Medication safety: an unrecognised issue 14

Summary of Chapter 2 - Medication safety: what do we know 16

2.1. Incidence of adverse drug events 17

2.2. Incidence of preventable adverse drug events 19

2.3. Incidence of medication errors 20

2.4. Costs of preventable adverse drug events 22

Chapter I - Learning from medication errors 23

I.1 Medication error reporting systems (MERS) 26

I.1.1 Objectives of MERS 26

I.1.2 Reporting at each level of the health care system 27

I.2 Providing conditions for reporting medication errors 29

I.2.1 Characteristics of reporting systems 29

I.2.2 Facts to be reported to MERS 30

I.2.3 How to report to MERS 30

I.3 Analysing reported medication errors 31

I.3.1 Requirements for analysing medication errors 31

I.3.2 Elements of a medication error taxonomy 33

I.3.3 Feedback from reported medication error 41

I.4 Sharing information on analysed errors at a supranational European level 44

Chapter II - Assessing safe medication practices 47

II.1.1. Assessing medication errors and adverse drug events 48

II.1.2. Preventable adverse drug event early detection 51

II.1.3. Selecting methods to detect and measure medication safety 54

II.2. Evaluating safe medication practice initiatives 56

II.2.1. Auditing the safety of medication practices 56

II.2.2. Self-assessment of the safety of medication practices 58

II.3. Annual safe medication practice reports 59

Chapter III - Improving the safety of naming, labelling and packaging of medicines marketed in Europe 63

III. 1. Tackling medication errors related to the naming, labelling and packaging of medicines 65

III.1.1. Primacy of safety in design and assessment of naming, label information and packaging 65

III.1.2. Background to the recommendations 66

III.2. Improving the safety of medicines names 67

III.2.1. Medicines names and medication errors 67

III.2.2. How is the name of a medicinal product established? 68

III.2.3. Recommendations to improve the safety of medicines names 70

III.2.4. Safe practices related to medicines names 72

III.3. Improving the safety of label information and packaging of medicines 74

III.3.1. Label information and packaging as sources of medication errors 74

III.3.2. Recommendations to improve the design of label information and packaging with a view to medication safety 76

III.3.3. Pre-marketing safety assessment of label information and packaging 83

III.3.4. Safety practices to minimise errors related to label information and packaging 84

III.4. Post-marketing monitoring: sharing medicinal product safety concerns at European level 87

III.4.1. National medication error reporting centres and drug regulatory authorities 87

III.4.2. Need for co-ordination at supranational European level 88

III.5. Electronic identification of medicines to improve medication safety 89

III.5.1. Reducing medication errors with machine readable codes across the medication use system 89

III.5.2. Standardising the ‘name field’ in databases 92

Chapter IV - Improving the safety of the medication use system 92

Introduction: making use of medicines safer 94

IV.1. Best practices for preventing medication errors 97

IV.2. Safer selection and procurement of medicines 99

IV.3 Safer prescribing of medicines 100

IV.3.1. Adapting safer therapeutic decisions to individual patient needs 100

IV.3.2. Safer writing of prescriptions 101

IV.3.3. Electronic prescribing and alerts 102

IV.4. Safer validation of the prescriptions 103

IV.4.1. Pharmacists review of prescriptions 103

IV.5. Safer preparation of injectable medicines 104

IV.6. Safer dispensing of medicines 105

IV.6.1. Safer hospital drug distribution systems 105

IV.7. Safer storage of medicines 109

IV.7.1. Storing medicines safely 109

IV.7.2. Restricting storage of high risk medicines 109

IV.8. Safer administering medicines 111

IV.8.1 Safety checking before administration 111

IV.8.2. Electronic systems to assist medicine administration 112

IV.8.3. Documenting drug administration 113

IV.9. Safer monitoring of medicine therapy 113

IV.9.1. Reconciliation of medicine histories 113

IV.9.2. Monitoring of medicine therapy 114

IV.9.3. Using pharmacists to minimise adverse drug events and medication errors 115

IV.9.4. Computer adverse drug events detection and alerts 116

Chapter V - Safer medicine information practices 119

V.1. Medicines information and medication safety 121

V.1.1. Medication errors caused by poor medicine information practices 121

V.1.2. Assessing the safety of medicine information practices 122

V.2. Safe medicine information for patients 125

V.2.1. Patients’ needs 125

V.2.2. Medicines information sources for patients 127

V.2.3. Recommendations for safer medicine information for patients 136

V.3. Safe medicine information for health care professionals 137

V.3.1. Health professionals’ needs to meet patients’ needs 137

V.3.2. Medicine information sources for health professionals 142

V.3.2.3. Customer-specific medicine information: medicine information centres (DICs) 145

V.3.3. Medicines information flow: an example of a system failure 146

V.3.4. Recommendations for safer medicine information for health professionals 148

Appendices 155

Appendix 1 155

Recommendation Rec(2006)7 by the Committee of Ministers to member states on management of patient safety and prevention of adverse events in health care 155

Appendix to Recommendation Rec(2006)7 157

A. Prerequisites 157

B. Cultures of safety/environment 158

C. Assessment of patient safety – The role of indicators 161

D. Data sources – Reporting systems 162

E. Medication safety – A specific strategy to promote patient safety 165

F. Human factors 167

G. Patients’ empowerment and citizens’ participation 168

H. Patient safety education 169

I. Research agenda 170

J. Legal framework 171

K. Implementation of the patient safety policy 172

Appendix 2 175

Council of Europe Committee of Experts on Pharmaceutical Questions Expert Group on Safe Medication Practices – Vision statement 175

Appendix 3 177

Glossary of terms related to patient and medication safety 177

Appendix 4 193

European evidence on medication errors 193

1. European studies on adverse drug events 193

2. Medication administration errors observation studies 194

Appendix 5 198

Existing Medication Error Reporting Systems 198

1. MERS Outside Europe 199

2. Existing national MERS in Europe 203

Appendix 6

Safety assessment template on label information and packaging 209

Appendix 7 239

Information on dispensing labels 239

1. Information elements 239

2. Examples of European dispensing labels 240

Appendix 8 245

Machine readable codes 245

1. The GS1Global Trade Item Number (GTIN) 245

2. Barcodes 246

3. Radio Frequency Identification (RFID) 247

Appendix 9 249

Key list of standard and best practices for preventing medicines errors and improving medication safety 249

List of authors 255

List of tables 256

List of figures 257

Bibliography 258

Council of Europe documents 258

National and international official documents 258

General references 263



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