The goal of ‘Action on Patient Safety: High 5s’ is to solve five highly important patient safety problems in five countries within five years by implementing international validated standard operation procedures
Albrecht Eisert PhD
Hospital Pharmacy, University Medical Center Aachen, Germany
Michael Baehr PhD
Hospital Pharmacy, University Medical Center Hamburg Eppendorf (UKE), Germany
Martin J Hug PhD
Hospital Pharmacy, University Medical Center Freiburg, Germany
Ulrich Jaehde PhD
Department of Clinical Pharmacy, Institute of Pharmacy, University of Bonn, Germany
The implementation of strategies to prevent medication errors is one of the main objectives of clinical pharmacists all over Europe. A number of recommendations are available: implement computerised physician order entry (CPOE); deliver medication as unit doses; use barcoding at point of care; put the pharmacist closer to bedside.(1) In 2006, the World Health Organization (WHO) World Alliance for Patient Safety launched the project Action on Patient Safety: High 5s, the goal of which was to solve five highly important patient safety problems in five countries within five years by implementing international validated standard operation procedures (SOPs).
Up to now, only two SOPs are under development, one of which deals with medication reconciliation (MedRec). MedRec aims to ensure that there is no loss of information on the medication when a patient is admitted to, or transferred or discharged from a hospital. Reasons for changes (that is, for example, stopping, pausing, dose modification), which are made at any interface of care, must be documented and be traceable.
Although it is known that a huge number of preventable medication errors occur at these interfaces as a result of insufficient communication,(2) MedRec as a tool to prevent errors is widely unknown in European, and especially in German, hospitals. Reasons are diverse: the process is complex and, if not supported by a suitable computer program, staff-intensive; there is no professional guild definitively responsible for that task; and there is no appropriate German term – ‘medication reconciliation’ was, and still is, untranslatable.
The High 5s MedRec SOP
The High 5s MedRec SOP is based on the recommendations of the institute for safe Medication Practices Canada(3) and its campaign Safer Healthcare Now!(4) The project focuses on non-elective patients older than 65 years of age. The SOP comprises three steps(5):
- Creating the best possible medication history (BPMH) from at least two sources. An accurate and complete list of all medications taken prior to admission is the result of BPMH
- Creating of the admission medication orders (AMO) on basis of the BPMH
- Comparison of AMO and BPMH while all discrepancies need to be documented.
The BPMH, initial reconciliation and communication of discrepancies to the prescriber should be completed as soon as possible within 24 hours following the decision to admit the patient.
Four quality indicators are defined to measure the efficacy of the MedRec process:
- Percentage of patients with medications reconciled within 24 hours of the decision to admit the patient (MR1)
- The mean number of outstanding undocumented intentional medication discrepancies per patient (MR2)
- The mean number of outstanding unintentional medication discrepancies per patient (MR3)
- Percentage of patients with at least one outstanding unintentional discrepancy (MR4).
Before implementation of the SOP, baseline data as a comparison marker have to be collected. These data reflect all types of discrepancy that exist prior to implementation of the MedRec process.
Introduction in Germany
The MedRec SOP will be implemented in Australia, The Netherlands, France and Germany. Australia, The Netherlands and France have already begun to implement the SOP, whereas German participants still struggle with special preconditions of their respective healthcare system.(6) One of the main questions is which healthcare professional should complete the BPMH. The ‘getting started kit’ states: ‘To the extent possible, a pharmacist should be involved in gathering or validating the patient’s list of current medications (BPMH) and the comparison of that list with medication orders.'(9) To this end, however, clinical pharmacy is not properly established in Germany and a number of other European countries, and few clinical pharmacists are available in hospitals.
In addition, only few hospitals in Germany have introduced CPOE systems or an electronic medication administration record (eMAR). A comprehensive electronic medical record combined with a completely paperless workflow is only introduced in Hamburg (UKE). Integrated software to reconcile medication is not usually available.
Another problem is that outpatients can get their medication from any pharmacy of their choice. Therefore, there is no data basis to receive precise information about the medication history. Creating the BPMH in Germany is much more complicated than, for example, in The Netherlands, where a patient’s dedicated pharmacy can supply a comprehensive medication list.
There was much discussion within the German High5s team about the general use of formal MedRec process with respect to patient safety. Could patient safety be increased by focusing on discrepancies when home medication may contain errors that can result in adverse drug events (ADE)? Is it necessary to involve a clinical pharmacist to detect these errors and to adjust the AMO?
The German High 5s team comprises seven hospitals, three of which (Aachen, Freiburg and Hamburg) are University medical centres. The latter decided to set up a concerted scientific study led by University Medical Center Aachen to investigate the added value of clinical pharmacists performing the MedRec process in combination with a comprehensive medication survey.
Added value of clinical pharmacists
According to the High 5s SOP, the MedRec process is only a formal check of the home medication and AMO with the focus on minimising discrepancies.(7) Potential existing medication errors, such as contraindications, interactions and incorrect dosing in home medication as well as in AMO, are not taken into consideration.
Although there is evidence that MedRec can reduce discrepancies,(7) few studies have evaluated whether such a reduction has an impact on patient safety. According to Vira and colleagues, 60% of patients had at least one unintended discrepancy, 18% of which were classified as clinically relevant.(8) Tam et al showed that 11–59% of discrepancies were judged as clinically significant.(9) But critics argue that only unimportant errors with little impact on patient safety are found.(8)
By contrast, there is profound evidence that a comprehensive medication survey can significantly reduce medication-related problems: Bertsche,(10) for example, showed that the incidence of QT interval prolongations could be reduced by 64% and the incidence of hypokalaemia by 80%, respectively.
Our study will be conducted using a multicentre sequential trial design. In the first phase, a baseline survey will be carried out according to High 5s MedRec SOP. In the second phase (interventional phase), a comprehensive medication survey will be performed by a clinical pharmacist within the MedRec process. In addition to the discrepancies of the MedRec SOP, all drug-related problems (DRP) will be recorded. DRP will cover drug–drug interactions, contraindications, dosage adjustments in case of organ dysfunctions, and compliance to guidelines.
All discrepancies and DRPs that are detected in the interventional phase will be discussed with the responsible physicians to adapt and optimise the patient’s therapy.
An evaluation of the clinical relevance of all found discrepancies and detected DRP will be performed after data collection for both phases.
Patients taking high-risk drugs will be observed throughout their entire hospital stay with respect to the occurrence of adverse drug events (ADEs) to work out a recommendation on whether MedRec and/or a comprehensive medication survey should be introduced in the standard care process.
ADEs are the most common causes of injuries and deaths in the health system.(11) If a comprehensive medication survey demonstrates a significant reduction in the rate of ADEs, an effect on patient safety will be proved. As a result, clinical pharmacists would necessarily have to be involved to perform this process as a standard of patient care.
The implementation of the High 5s Medication Reconciliation SOP in Germany is a special challenge because of some infrastructural deficiencies, and particularly the low number of clinical pharmacists available to support the process is a problem. The MedRec SOP describes a formal check of discrepancies between home medication and admission medication orders. The defined quality indicators do not take into consideration that home medication to a significant extent is erroneous. If clinical pharmacists perform a comprehensive medication survey in addition to the SOP, ADEs should be reduced and patient safety should be increased. To evaluate this hypothesis, a scientific study was initiated which will be carried out in the University medical centres in Aachen, Freiburg and Hamburg as a multi-centre study. The aim is to show the added value of involving clinical pharmacists in an extended and modified MedRec process.
- The implementation of medication reconciliation (MedRec) is a strategy to solve one of five highly important patient safety problems within the World Health Organization’s High 5s project.
- MedRec aims to ensure that there is no loss of information at transition of care.
- The MedRec process is not yet implemented in the German healthcare system because of special preconditions, especially the low number of clinical pharmacist in hospitals.
- While Med Rec. is only a formal check of the home medication, potential existing medication errors such as contraindications, interactions, incorrect dosing etc, are not taken into consideration.
- Therefore, a scientific study was initiated to explore if a higher level of patient safety can be achieved by adding a pharmacist led comprehensive medication survey to the common MedRec process.
- The Audit Commission. A spoon full of sugar. Medicines management in NHS hospitals. http://archive.audit-commission.gov.uk/auditcommission/sitecollectiondocuments/AuditCommissionReports/NationalStudies/nrspoonfulsugar.pdf (accessed 15 April 2013).
- Mehrmann L. Arzneimittelversorgung an intersektoralen Schnittstellen. Problemfelder und Best-Practice-Ansätze. Berlin. ÄZQ. www.aezq.de/mdb/edocs/pdf/schriftenreihe/schriftenreihe37.pdf (accessed 15 April 2013).
- Institute for Safe Medication Canada (ISMP Canada). Medication reconciliation (MedRec). www.ismp-canada.org/medrec/ (accessed 15 April 2013)
- Canadian Patient Safety Institute (CPSI). Safer Healthcare Now! www.saferhealthcarenow.ca/EN/Pages/default.aspx (accessed 15 April 2013).
- www.high5s.org/pub/Manual/TrainingMaterials/MR_Getting_Started_Kit.pdf (accessed 15 April 2013).
- Fishman L. Sicherstellen der richtigen Medikation bei Übergängen im Behandlungsprozess. Krankenhauspharmazie 2012;33:514–8.
- Van der Schrieck-de Loos E, Van Groenestijn A. High 5’s Medication Reconciliation SOP. International Standard Operating Procedure for Medication Reconciliation in the Netherlands. KIZ J Qual Saf Healthcare August 2011;21(4):26–9.
- Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge Qual Saf Health Care 2006;15:122–6.
- Tam VC et al. Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review. CMAJ 2005;173(5):510–22.
- Bertsche T et al. Prevention of adverse drug reactions in intensive care patients by personal intervention based on an electronic clinical decision support system. Intensive Care Med 2010;36(4):665–72.
- Action on Patient Safety. High 5s, Version 1.0 (03.09.2010).