The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

Møllebæk, Mathias; Kaae, Susanne; Bruin, Marie L. De; Callréus, Torbjörn; Jossan, Sukhwinder; Hallgreen, Christine Erikstrup

doi:10.1016/j.sapharm.2018.06.015

Cited by 17 publications

(22 citation statements)

References 42 publications

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“…21 A recent review by Møllebaek et al reported that lack of clinical applicability and insufficient information about evidence were found to be limiting factors for the usability of DHPCs. 12 Other have used the SIM score to capture quality of monitoring instructions to healthcare professions although in SmPC. 14 15 While all found that only a minority of instruction could be considered clinically applicable, differences in the quality can be observed.…”

Section: Discussionmentioning

confidence: 99%

Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

et al. 2020

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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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Section: Discussionmentioning

confidence: 99%

Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

et al. 2020

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“…36,90 Perceived commercial influence on regulators can reduce trust in messaging and cause reputational damage to regulators, 91 although healthcare professionals appear to prefer receiving safety advisories from regulatory authorities rather than pharmaceutical companies. 63,83,92 No. Multiteam approach.…”

Section: Risk Communication Capability and Monitoring Effectivenessmentioning

confidence: 99%

“…Finally, healthcare professionals are less likely to trust communications disseminated by industry. 63,92,135 Legislation does not bind the TGA to consult or collaborate with industry for the development or dissemination of safety warnings, nor does it provide the TGA with any authority over DHPCs issued by companies. There is some evidence that TGA informally negotiates with and advises industry in a collaborative manner on preparing and disseminating DHPCs.…”

Section: Legal Authority and The Role Of Industrymentioning

confidence: 99%

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

Bhasale

Sarpatwari

Bruin

et al. 2020

Clin Pharma and Therapeutics

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In the wake of the withdrawal of the nonsteroidal anti-inflammatory drug rofecoxib, regulators worldwide reconsidered their approach to postmarket safety. Many have since adopted a "life cycle" approach to regulation of medicines, facilitating faster approval of new medicines while planning for potential postmarket safety issues. A crucial aspect of postmarket safety is the effective and timely communication of emerging risk information using postmarket safety advisories, commonly issued as letters to healthcare professionals, drug safety bulletins, media alerts, and website announcements. Yet regulators differ in their use of postmarket safety advisories. We examined the capacity of regulators in the United States, Europe, Canada, and Australia to warn about postmarket safety issues through safety advisories by assessing their governance, legislative authority, risk communication capabilities, and transparency.

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“…However, most evaluations of DHPCs are restricted to an assessment of process and outcome indicators. They do not assess which factors between the distribution of the DHPC and resulting prescription behavior explain the success or failure of a DHPC 17 …”

Section: Introductionmentioning

confidence: 99%

“…They do not assess which factors between the distribution of the DHPC and resulting prescription behavior explain the success or failure of a DHPC. 17 The objectives of this study are to identify factors that determine, firstly, whether and how a target audience recognizes DHPCs when it receives them and, secondly, whether and in what aspects DHPCs are considered useful in clinical practice. The overarching purposes are to provide input to the development of future DHPCs and to explore the value of formative, user-centered evaluation.…”

Section: Introductionmentioning

confidence: 99%

Why do general practitioners disregard direct to healthcare professional communication? A user‐oriented evaluation to improve drug safety communication

Møllebæk

Kaae

2020

Basic Clin Pharma Tox

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Post‐approval drug risks are a significant public health problem. A central instrument to mitigate them in the European Union is direct to healthcare professional communications (DHPC), typically a letter sent from the manufacturer to prescribers. However, evaluations show that DHPCs have limited impact on prescribing behavior. Which factors influence prescribers’ lack of adoption of DHPCs remains unknown. This article presents a think‐aloud reading study of 17 Danish general practitioners’ reading aloud a 2013 DHPC about new oral anticoagulants, interjecting their immediate reactions and associations to daily clinical routines concurrently. We found that interviewees inferred more from the DHPC than risk information. It was perceived to be commercially biased, which generally discouraged reading despite learning new safety information. DHPCs were also disregarded because they are isolated from routinely used clinical information sources. Furthermore, DHPCs were perceived as pre‐emptive acts of legal defence aiming to relocate responsibility from the manufacturer onto prescribers. In conclusion, the study indicates that certain DHPCs may be disregarded because of the perceived motivations that prescribers attribute to the DHPC senders. While the specific letter itself was deemed unsatisfactory, its legitimacy among prescribers remains the central challenge. Further integration with trusted and established information structures is also needed.

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The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

Cited by 17 publications

References 42 publications

Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

Are monitoring instructions provided in direct healthcare professional communications (DHPCs) of sufficient quality? A retrospective analysis of DHPCs sent out between 2007 and 2018

Postmarket Safety Communication for Protection of Public Health: A Comparison of Regulatory Policy in Australia, Canada, the European Union, and the United States

Why do general practitioners disregard direct to healthcare professional communication? A user‐oriented evaluation to improve drug safety communication

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