Impact of Safety-Related Regulatory Action on Drug Use in Ambulatory Care in the Netherlands

Piening, Sigrid; Reber, K.; Wieringa, Jaap E.; Straus, Sabine M. J. M.; Graeff, de Pieter; Haaijer‐Ruskamp, Flora; Mol, Peter G. M.

doi:10.1038/clpt.2011.308

Cited by 28 publications

(27 citation statements)

References 32 publications

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“…In these cases, national competent authorities (NCAs) inform HCPs about these risks and the actions that they should take to minimise or manage them. Research, however, has shown that the safety advice in communications from regulators is not always followed [ 3 – 5 ]. Before HCPs can act on a safety issue, they first need to become aware of it.…”

Section: Introductionmentioning

confidence: 99%

Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

et al. 2018

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IntroductionNational competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs.ObjectiveThe objective was to assess and compare general practitioners’ (GPs’), cardiologists’, and pharmacists’ familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues.MethodsGPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their awareness of safety issues that had recently been communicated and involved the following drugs: combined hormonal contraceptives, diclofenac, valproate, and ivabradine. Those HCPs who were aware of the specific safety issues were subsequently asked to indicate the source through which they had become aware of them. Differences between professions in familiarity with DHPCs and awareness were tested using a Pearson χ2 test per country and post hoc Pearson χ2 tests in the case of statistically significant differences.ResultsOf the 3288 included respondents, 54% were GPs, 40% were pharmacists, and 7% were cardiologists. The number of respondents ranged from 67 in Denmark to 916 in Spain. Most respondents (92%) were familiar with DHPCs, with one significant difference between the professions: pharmacists were more familiar than GPs in Italy (99 vs 90%, P = 0.004). GPs’ awareness ranged from 96% for the diclofenac issue to 70% for the ivabradine issue. A similar pattern was shown for pharmacists (91% aware of the diclofenac issue to 66% of the ivabradine issue). Cardiologists’ awareness ranged from 91% for the ivabradine issue to 34% for the valproate issue. Overall, DHPCs were a common source through which GPs (range: 45% of those aware of the contraceptives issue to 60% of those aware of the valproate issue), cardiologists (range: 33% for the contraceptives issue to 61% for the valproate issue), and pharmacists (range: 41% for the contraceptives issue to 51% for the ivabradine issue) had become aware of the specific safety issues, followed by information on websites or in newsletters.ConclusionsGPs, cardiologists, and pharmacists were to a similar extent (highly) familiar with DHPCs, but they differed in awareness levels of specific safety issues. Cardiologists were less aware of safety issues associated with non-cardiology drugs even if these had cardiovascular safety concerns. This implies that additional strategies may be needed to reach specialists when communicating safety issues regarding drugs outside their therapeutic ar...

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Section: Introductionmentioning

confidence: 99%

Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

et al. 2018

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“…Evaluating safety‐related regulatory action on drug use is important for effective regulatory action in the future. In recent times, medical information databases (MIDs) have been used to evaluate the safety and effectiveness of drugs, including the effect of safety‐related regulatory action …”

Section: What Is Known and Objectivementioning

confidence: 99%

“…In recent times, medical information databases (MIDs) have been used to evaluate the safety and effectiveness of drugs, including the effect of safetyrelated regulatory action. [8][9][10][11] .…”

Section: What Is K Nown and Objec Tivementioning

confidence: 99%

Evaluating the impact of regulatory action on denosumab‐induced hypocalcaemia in Japan

et al. 2019

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What is known and Objective Since its introduction in April 2012, denosumab has been administered to approximately 7,300 patients as of August 2012, and 32 cases of serious hypocalcaemia after denosumab administration, including two deaths, have been reported in Japan. A Dear Healthcare Professional Letter of Rapid Safety Communication (‘Blue letter’) was released to warn about the risks of hypocalcaemia associated with denosumab. The goal of this study therefore was to measure the impact of regulatory action on denosumab‐induced hypocalcaemia in Japan by using an electronic medical information database (MID). Methods We used two different aggregated data sets based on MIDs (data sets one and two). The patients studied were those who were newly prescribed denosumab or zoledronic acid between April 2012 and September 2014. We assessed four indicators: (a) the proportion of patients with calcium supplementation at the initial denosumab treatment, (b) the proportion of patients who underwent a serum calcium test, (c) the average number of serum calcium tests performed and (d) the prevalence of hypocalcaemia. All indices were aggregated by every 3 months. To evaluate the impact of regulatory action, we used difference in difference (DID) analysis. Results and Discussion The proportion of patients with calcium supplementation at the initial denosumab treatment increased year by year in both data sets. The average number of serum calcium tests increased year by year in data set two. There was a significant difference in the prevalence of hypocalcaemia in data set two. This suggests that the estimate of impact of the regulatory action may vary according to the database. In DID analysis, however, significant influences of the regulatory action on combination use with a calcium supplement were detected in both data sets. What is New and Conclusion There was a significant influence on combination use of denosumab with vitamin D and/or calcium supplement in both data sets. That there was no apparent increase in the prevalence of denosumab‐induced hypocalcaemia, suggests that the regulatory action had an impact in the clinical setting studied. Such regulatory actions may play an important role in the promotion of drug safety.

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“…In addition, many regulatory authorities publish these safety issues on their website. However, it is apparent from previous studies that new safety issues do not always reach the HCP nor affect clinical behaviour [17, 18]. It is also recognised that patients need to be informed about the safety issues of drugs that are prescribed to them [19].…”

Section: Introductionmentioning

confidence: 99%

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study

et al. 2016

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IntroductionA mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage.ObjectiveOur aim was to reveal the factors that may influence healthcare professionals (HCPs) and patients to use an app for two-way risk communication.MethodsFocus group discussions and face-to-face interviews were conducted in the Netherlands, Spain and the UK. Patients with type 2 diabetes mellitus, patients with a rare disease or their caregivers and adolescents with health conditions were eligible to participate. HCPs included pharmacists, paediatricians, general practitioners, internists, practice nurses and professionals caring for patients with a rare disease. Patients and HCPs were recruited through various channels. The recorded discussions and interviews were transcribed verbatim. The dataset was analysed using thematic analysis and arranged according to the Unified Theory of Acceptance and Use of Technology.ResultsSeven focus group discussions and 13 interviews were conducted. In total, 21 HCPs and 50 patients participated. Identified factors that may influence the use of the app were the type of feedback given on reported ADRs, how ADR reports are stored and the type of drug news. Also mentioned were other functions of the app, ease of use, type of language, the source of safety information provided through the app, security of the app, layout, the operating systems on which the app can be used and the costs.ConclusionsFurther research is needed to assess associations between user characteristics and the direction (positive or negative) of the factors potentially influencing app use.Electronic supplementary materialThe online version of this article (doi:10.1007/s40264-016-0494-x) contains supplementary material, which is available to authorized users.

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Impact of Safety-Related Regulatory Action on Drug Use in Ambulatory Care in the Netherlands

Cited by 28 publications

References 32 publications

Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

Safety Communication Tools and Healthcare Professionals’ Awareness of Specific Drug Safety Issues in Europe: A Survey Study

Evaluating the impact of regulatory action on denosumab‐induced hypocalcaemia in Japan

Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study

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