Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach

Esther Vries, Elisabeth Bakker, Remy D. C. Francisca, Stijn Croonen, Petra Denig and Peter G. M. Mol ()
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Esther Vries: University Medical Center Groningen, University of Groningen
Elisabeth Bakker: University Medical Center Groningen, University of Groningen
Remy D. C. Francisca: Dutch Medicines Evaluation Board
Stijn Croonen: Dutch Medicines Evaluation Board
Petra Denig: University Medical Center Groningen, University of Groningen
Peter G. M. Mol: University Medical Center Groningen, University of Groningen

Drug Safety, 2022, vol. 45, issue 4, No 6, 369-378

Abstract: Abstract Introduction The implementation of new drug safety information and Direct Healthcare Professional Communications (DHPCs) in hospitals is important for patient safety. Objectives The aim of this study was to gain insight into which procedures and practices are in place to handle new drug safety information and particularly DHPCs in the Dutch hospital setting. Methods We first conducted focus groups including medical specialists and hospital pharmacists, focusing on handling of drug safety information at the individual and organisational level. A survey was then developed and distributed among hospital pharmacists in all Dutch hospitals to quantify the existence of specific procedures and committees to handle drug safety information and DHPCs. Results Eleven specialists and 14 pharmacists from six hospitals participated in focus groups. Drug safety information was usually considered before drugs were included in formularies or treatment protocols. Furthermore, drug safety information was consulted in response to patients experiencing adverse events. DHPCs were mostly dealt with by individual professionals. DHPCs could lead to actions but this was very uncommon. Completed surveys were received from 40 (53%) of the hospitals. In 32 (80%), the hospital pharmacy had procedures to deal with new drug safety information, whereas in 11 (28%) a hospital-wide procedure was in place. Drug safety was considered in committees concerning drug formulary decisions (69%) and antibiotic policies (63%). DHPCs were assessed by a hospital pharmacist in 50% of the hospitals. Conclusions Drug safety information was used for evaluation of new treatments and in response to adverse events. Assessment of whether a DHPC requires action was primarily an individual task.

Date: 2022
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DOI: 10.1007/s40264-022-01149-4

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