MEDICATION SAFETY RESEARCH IN THE DIVISION OF SOCIAL PHARMACY, UNIVERSITY OF HELSINKI, FINLAND Professor Marja Airaksinen 3rd Nordic Social Pharmacy and Health Services Research Conference November 1-2, 2007, Copenhagen
WORKING GROUP Carita Linden, Tuula Teinilä, Terhi Toivo, Seija Kivilompolo, Minna Väänänen, Anna-Riia Terzibanjan, Taina Mäntyranta, Anne Lehtonen, Pirjo Pennanen, Raisa Laaksonen, Marjorie Weiss, Tana Wuliji, Tim Chen, Alan Lyles, Marja Airaksinen Networking organisations Council of Europe Ministry of Social Affairs and Health National Centre for Pharmacotherapy Development National Authority for Medicolegal Affairs University of Bath, UK International Pharmaceutical Federation (FIP) University of Sydney, Australia University of Baltimore, USA
HOW DID IT ALL START?
COUNCIL OF EUROPE Founded in 1949 46 member states 800 mln Europeans Seat: Strasbourg, France
PATIENT SAFETY TWO WORKING GROUPS OF COUNCIL OF EUROPE Patient safety Council of Europe, Committee of Health: Committee of Experts on Management of Safety and Quality in Health Care Prevention of Adverse Events in Health Care, a System Approach (SP-SQS) Medication Safety Council of Europe and WHO Euro: Expert Group on Safe Medication Practices (worked under Committee of Experts on Pharmaceutical Questions)
COUNCIL OF EUROPE Creation of a better medication safety culture in Europe: Building up safe medication practices (2007) Top level actions recommended to European health care organisations Available online: http://www.coe.int/t/e/social_cohesion/soc%2dsp/medic ation%20safety%20culture%20report%20e.pdf
CREATING A SAFETY CULTURE WHAT DOES IT MEAN?
SYSTEM APPROACH WHAT DOES IT MEAN?
Human Error - the Swiss Cheese (Reason)
Preventive Actions for Medication Errors: Medication Review Swiss Cheese Model Manufacturer Regulatory Specialist GPs Authority Pharmacist Nurse Patient Manufacturer Regulatory Specialist GPs Authority Pharmacist Nurse Patient Medication Review Source: Chen, Airaksinen, Lyles 2006
CONCEPTUAL FRAMEWORK (Product Safety vs. Process Safety) MEDICATION SAFETY Quality and Safety of Pharmacotherapy PRODUCT SAFETY Adverse Drug Reactions (ADRs) Marketing authorization Pharmacovigilance FDA, EMEA, NAMs, TGA PROCESS SAFETY Medication Errors System approach (Reason) Reporting/monitoring Local, national, international level Source: Medication Safety Coordination Group under the National Center for Pharmacotherapy Development ROHTO 2006
MEDICATION ERROR: DEFINITION 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 labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring, and use. (NCC MERP, 1998)
Recommendations: Medication safety Establish medication error reporting systems Establish and use a common terminology Create a culture of safety at local, national and international levels Set up a nationally recognised focal point for safe medication practices
Recommendations: Medication safety Packaging and labelling should be subject to human factor assessment Dispensing label should become mandatory Use of INN names Access to quality drug information (professionals and patients) Concordance and empowerment Education
COMPLETED STUDIES AND ONGOING PROJECTS Finnish Glossary of Terms Related to Patient and Medication Safety (http://www.rohto.fi/doc/t28-2006-verkko.pdf) Inventory of medication error reporting systems and their usefulness in identifying safety risks Local and national systems, systems in different countries Attitudes towards safety culture and implementation of safety culture in hospital and community settings
COMPLETED STUDIES AND ONGOING PROJECTS Studies on preventive actions Primary and secondary care Collaborative medicines management and medication review procedures Incidence of drug-drug interactions in outpatients Mechanisms to error prevention with high alert medications
COMPLETED STUDIES AND ONGOING PROJECTS Methods development learning about the process leading to severe medication errors Using official investigation documentation as a material for a modified Root Cause Analysis
谢谢! THANK YOU!