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Targeting Outpatient Drug Safety

Recommendations of the Dutch HARM-Wrestling Task Force

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Abstract

Background: Two Dutch observational studies (HARM[Hospital Admissions Related to Medication] and IPCI [Integrated Primary Care Information]) have shown that approximately 5% of all unplanned hospital admissions are associated with adverse drug events (ADEs), of which 40–46% are potentially preventable. These studies prompted the initiation of a Dutch multidisciplinary task force, which was assigned to reduce the number of prescriber-related hospital admissions related to medications (HARMs) in a quick-win way.

Objective: The aim of the study was to identify the most relevant ADEs and to develop a limited number of recommendations for concrete interventions, which should be feasible and relatively easy to convert into computerized drug safety alerts.

Method: To identify the major ADEs, crude data of HARM and IPCI were reanalysed and compared with different international studies, followed by structured literature searches for further characterization of the identified ADEs, their risk factors and potential risk-reduction strategies. Based on this information, the Task Force drew up general and drug-specific recommendations. As the recommendations of the Task Force are a mixture of evidenceand expert-based risk-reducing strategies, they have been graded in accordance with the GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodology.

Results: Seven pharmacologically predictable ADEs associated with ten drug classes were responsible for more than half of all potentially preventable hospital admissions in the IPCI and HARM studies, which was comparable to the results of international studies. Gastrointestinal and other bleedings were the most frequent ADE, followed by disturbances of diabetes mellitus control, electrolyte disturbances, fractures, renal insufficiency and heart failure. Nine general and 34 drug-specific recommendations were developed.

Conclusions: As HARMs constitute a significant public health problem, the Task Force underlines the need to implement its recommendations as soon as possible. They do not replace existing guidelines, but reinforce, complement and fine-tune existing Dutch and international guidelines. Further research is still required to assess the cost consequences and cost effectiveness of some recommendations, and to monitor the implementation of the recommendations and their effect on the incidence of potentially preventable HARMs.

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Acknowledgements

This study was prepared on behalf of the HARM-Wrestling Task Force: P.A.G.M De Smet, Pharmacist/Clinical Pharmacologist, PharmD, PhD (Chair); P.M.L.A. van den Bemt, PhD, Hospital Pharmacist (member of the HARM study group and the Dutch Association of Hospital Pharmacists); H. Buurma, PhD, Community Pharmacist (member of the Royal Dutch Association for the Advancement of Pharmacy); F. Boersma, PhD, Nursing Home Physician (member of the Dutch Association for Nursing Home Physicians); H. Folmer, MSc, General Practitioner (member of the Dutch National Society of General Practitioners); J.L.M. van Klundert,MSc,MD (Senior Advisor of the Dutch Order of Medical Specialists); M.E.A.P. Kokenberg, MSc, Pharmacist (Secretary of the preparatory group); R.J. van Marum, PhD, Clinical Geriatrician/Clinical Pharmacologist (member of the Dutch Geriatrics Society); M. Sturkenboom, PharmD, PhD, Pharmacist/Clinical Epidemiologist (member of the IPCI study group).

On behalf of all authors, the corresponding author (Peter A.G.M. De Smet) gives permission to publish this article in Drug Safety and to exploit all subsidiary rights.

All authors declare that there were no competing interests.

Peter De Smet contributed to conception and study design. Patricia van den Bemt and Miriam Sturkenboom provided access to the anonymized crude data of the HARM and IPCI studies. Margaretha Warle′-van Herwaarden and Peter De Smet combined these into a single database and used it for further analysis. Peter De Smet collected and aggregated the background literature. The Task Force (including Patricia van den Bemt, Miriam Sturkenboom, Margaretha Warle′-van Herwaarden, Cees Kramers and Peter De Smet) interpreted the data and developed the recommendations. All authors contributed to the drafting of the manuscript and approved the final version of the report.

This multidisciplinary consensus was funded by the Dutch Ministry of Health, Welfare and Sport. This played no role in the design and conduction of the study, or in the collection, management, analysis and interpretation of the data, or review or approval of the manuscript.

We would like to thank the other members of the Task Force (H. Buurma, F. Boersma, H. Folmer, J.L.M. van Klundert, M.E.A.P. Kokenberg and R.J. van Marum). Furthermore, we would like to thank A.M. Linssen for her assistance in creating a schematic overview of the guidelines for secondary prevention of arterial thrombosis, and M. Roukens for her correction of typographic errors on the final report.

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Authors and Affiliations

  1. IQ Healthcare, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

    Margaretha F. Warlé-van Herwaarden

  2. Department of Pharmacology and Toxicology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands

    Cees Kramers

  3. Pharmacoepidemiology Unit, Department of Medical Informatics and Epidemiology and Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands

    Miriam C. Sturkenboom

  4. Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, the Netherlands

    Patricia M.L.A. van den Bemt

  5. Department of Pharmacoepidemiology and Pharmacotherapy, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands

    Patricia M.L.A. van den Bemt

  6. IQ Healthcare, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, 6525 EZ, Nijmegen, the Netherlands

    Peter A.G.M. De Smet

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  1. Margaretha F. Warlé-van Herwaarden
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Correspondence to Peter A.G.M. De Smet.

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Herwaarden, M.F.Wv., Kramers, C., Sturkenboom, M.C. et al. Targeting Outpatient Drug Safety. Drug Saf 35, 245–259 (2012). https://doi.org/10.2165/11596000-000000000-00000

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