ArticleBMJ open2020
Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
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Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- How does the Content and Dissemination of Communications on the Risks of Medicines Affect Prescriber Awareness, Knowledge, and Behaviour: A Systematic Review.Drug safety · 2026Pooled it
- Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis.BMJ quality & safety · 2022Pooled it
- Article
- Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland.Pharmaceutical medicine · 2025Article
- Safety Warnings on the Same Harmful Effects of Medicines: A Comparison of Four National Regulators.Pharmaceutical medicine · 2025Article
- Dear Doctor Letters regarding citalopram and escitalopram: guidelines vs real-world data.European archives of psychiatry and clinical neuroscience · 2023Article
- [Effect of the direct healthcare professional communication on citalopram and escitalopram drug utilization for inpatient treatment of anxiety disorders].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2022Article
- Handling of New Drug Safety Information in the Dutch Hospital Setting: A Mixed Methods Approach.Drug safety · 2022Article
- Direct healthcare professional communications: A quantitative assessment study.Pharmacology research & perspectives · 2021Observational
- Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies.Pharmacology research & perspectives · 2020Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess whether direct to healthcare professional communications (DHPCs) are of sufficient quality to be applicable in clinical practice and study how the quality differs according to safety concerns and type of monitoring.
designRetrospective cohort study.
settingDHPCs containing monitoring instructions were identified among all DHPC issued in Denmark between 2007 and 2018.
interventionQuality of information of monitoring instructions was assessed according to the Systematic Information for Monitoring (SIM) score. Associations between different characteristics of instructions and the SIM score were compared with analysis of variance and the post hoc test Tukey's honestly significant difference if significant.
resultsIn total, 297 DHPCs were issued, of which 97 contained 134 monitoring instructions. For 95% of these DHPCs the European Medicines Agency was involved. The average SIM score was 2.6±1.6 (ranging 0-6) and only 47% were considered of sufficient quality (SIM score ≥3). In addition, even fewer (11%) instructions were considered a 'adequate instruction' which also reported about facts and risks. Differences between quality of information according to type of monitoring were observed, specifically between clinical monitoring (average SIM score 1.9) and biomarker monitoring (physical average SIM score 2.9, p=0.029 and laboratory average SIM score 3.4, p<0.0001).
conclusionsMonitoring instructions were found not to be of sufficient quality to be applicable in clinical practice according to the SIM score. Our study concludes the need for further research and regulatory steps to ensure improve quality of information in safety communications.
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