Draft EU Guidance on Medication Errors Revision after PSQCWG and PRAC consultation PSQCWG meeting Brussels, 11 February 2015 Presented by Dr. Thomas Goedecke Senior Scientific Officer, Regulatory Affairs and Best Evidence Department An agency of the European Union
Outline Feed-back on consultation: Guide I: Good practise guide on recording, coding, reporting and assessment of medication errors, developed by PMG 1 (Lead: Thomas Goedecke, EMA); Guide II: Good practise guide risk minimisation and prevention of medication errors, developed by PMG 2 (Lead: Kathryn Ord, UK); Addendum of Guide II: Risk minimisation strategies for high strength/fixed dose combination insulins, developed by PRAC drafting group (Co-Leads: Menno van der Elst, NL and Thomas Goedecke, EMA); Purpose of this presentation: Detailed feed-back on PSQCWG members comments Feed-back on PRAC position Agreement on the next steps 1
Comments received PSQCWG (18 Dec 14 18 Jan 15) Guide I: Ministry of Health Italy, Comité Permanent des Médecins Européens (CPME), National School of Public Health Romania, Agency for Quality and Accreditation in Health Care and Social Welfare Croatia; Drug Commission of the German Medical Association (AkdÄ); Pharmacovigilance Risk Assessment Committee (PRAC) (9 Dec 14 20 Jan 15) Guide I: IE, NL, ES, HR, SE, UK; Guide II: DE, SE, UK; Addendum: SE, DE; Patient/HCP expert consultation Addendum: H. Lebanova (PGEU), W. Wientjens (IDF-Europe), J.M. Otero (ISMP-España), C. Kirke (Tallaght Hospital Ireland), M. Lundberg (FEND), J. Wilkinson (PGEU); 2
Guide I Key issues addressed from previous round Conceptual definition for medication errors: Medication error is a failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Endorsed by national Competent Authorities (NCAs) of IE, NL, ES, HR, SE, UK; DE, AkdÄ and CPME support broader definition including acts of omission/commission; Endorsed by PRAC Plenary Feb 15; Collaboration NCA-PSO: NL proposal that national Patient Safety Organisation (PSO) informs NCA of medication errors associated with adverse drug reaction(s) (ADR) as single reports brought to PSO s attention to allow further processing in EudraVigilance; 3
Guide I PSQCWG comments Definition ME (4.3): Definition too narrow, at pharmacy distribution faulty IT systems also cause errors. A distinction to devices (pumps, robots, etc.) should be made. Omissions are the most serious medication errors (for example omission of anti-coagulants), therefore the last part of the definition should not be deleted. Acts of omissions/commissions were included in previous definition, however MS felt this would cause problems at national level with regard to reporting obligations and potential liability issues, therefore PRAC agreed on a narrow definition. The provided examples for errors of omission (e.g. failure to monitor blood glucose levels when switching patients from a standard to a high dose insulin product) and errors of commission (e.g. wrong dose administered) are considered prescribing errors. These examples have been deleted. 4
Guide I PSQCWG comments continued Definition Adverse Event (4.1): Adverse event is often referred to as "medication related adverse event" - to make a difference to other kind of adverse events (falls, infections, wrong side surgery). We suggest the document should made the distinction between «adverse events» and «medication related adverse events». Text amended accordingly. Definition Adverse Drug Reaction (4.2): I wouldn t say that it's an adverse effect if, as in offlabel use, the possible negative effects are taken into account from the very beginning.. This definition of ADR is provided in DIR and GVP VI.A.2.1, so can not be changed. Root cause analysis (4.4): Different methods are used in analysis of errors and root cause analysis is not always the most appropriate method. Suggestion to change to systems analysis. Text amended accordingly. Further discussion needed on the term system analysis ; 5
Guide I PSQCWG comments continued Parameters to follow-up (table 2): List too long and clinical staff nor hospital administrative staff will have time. List is a recommendation for ICSR senders (MAH, NCA) for case followup as appropriate, and not a requirement for HCPs as initial reporter. Collaboration NCA PSO (6.2): The Italian Ministry of Health proposes to add: Where a national system for reporting patient safety incidents exists a formal agreement have to be signed by the two bodies, NCA and PSO, in order to allow the exchange of information. A statement has been added. Role of patients/hcp (6.3): Intentional formulation" is clearly unsufficient to guarantee reporting cf. the CIRS experience (Critical Incident Reporting System) in the many fields where it is used.? Further clarification required 6
Guide I PRAC position on errors at monitoring stage ME are unintended mistakes in the processes of prescribing, dispensing, preparation, administering or monitoring (drug treatment process); Some NCAs consider that monitoring errors are out of scope of this regulatory guidance; PRAC decision to delete monitoring from guide I at Plenary Feb 15; Introduction: Medication errors generally refer to unintended mistakes in the processes of prescribing, dispensing, administering or monitoring of medicinal products in clinical practice. Scope: The primarily scope is to support the recording, reporting and assessment of suspected adverse reactions (serious and non-serious) associated with an error in the prescribing, dispensing, preparation, administration or monitoring of a medicinal product... Def. potential ME: The term potential medication error refers to... This includes all possible mistakes in the prescribing, dispensing, administration, preparation or monitoring of a medicinal product by all persons who are involved in the medication process. Special situations: Coding at different stages of medication error - Medication errors can be a series of events as shown in figure 2 at prescribing, dispensing, preparation, administration or monitoring stage. 7
Guide II Input on examples for root cause analysis Chapter 5.2.5.2 describes the basic steps of root cause analysis: Identification of the problem (including details of what happened, when, where and in what situation, and what the impact of the event is on stakeholders) Identification of causes of the problem (describe the processes that led to the problem and identify the stages at which error could have or did occur) Identification of solutions (identify possible or potential solutions from sources of error in the process) Could PSQCWG members provide practical examples where conduct of RCA has resulted in effective risk minimisation and prevention of medication errors with authorised medicines? 8
Next steps PSQCWG orientation Is PSQCWG content with the proposed next steps: Feb 15: EU regulatory network written consultation (PRAC, CHMP, CMDh, COMP) 18 Feb 15: Consultation and approval by the Implementation Group (IG) of Member States and EMA pharmacovigilance governance structure 17 Mar 15: ERMS approval of final draft for public consultation Apr-May 15: Public consultation Sep 15: Final guidance for publication 9
Thank you for your attention Further information thomas.goedecke@ema.europa.eu European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact Follow us on @EMA_News