Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Sobel, Rachel E.; Bate, Andrew; Marshall, James H.; Haynes, Kevin; Selvam, Nandini; Nair, Vinit; Daniel, Gregory W.; Brown, Jeffrey S.; Reynolds, Robert F.

doi:10.1002/pds.4392

Cited by 16 publications

(17 citation statements)

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“…HCPs who took the time to complete to this survey were likely to be better informed about or have greater interest in pharmacovigilance than those who did not respond; the majority of respondents were from one of the many countries surveyed). Other study designs and frameworks to assess effectiveness of aRMMs should be considered in future evaluation work [34][35][36].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

et al. 2019

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Background Voriconazole is an extended-spectrum antifungal agent approved for the treatment and prophylaxis of invasive aspergillosis and other serious fungal infections. In 2014, additional risk minimization measures (aRMM) consisting of a Healthcare Professional (HCP) Question and Answer (Q&A) Brochure, HCP Checklist, and Patient Alert Card were implemented on a rolling basis across the European Union (EU) to mitigate three key risks with voriconazole: phototoxicity, squamous cell carcinoma (SCC) of the skin, and hepatotoxicity. The risks of phototoxicity and hepatotoxicity have been documented in the Summary of Product Characteristics (SmPC) since voriconazole was first approved in the EU in 2002. However, the risk of SCC of the skin was a more recent addition to the SmPC (added in 2010). Objectives We evaluated the effectiveness of the aRMM, as per EU Good Pharmacovigilance Practices Module XVI, via a survey of HCPs. Methods An online survey was conducted among specialty care HCPs in 10 EU countries who had received by mail aRMM tools 12 months previously. Survey questions evaluated HCPs' receipt and utilization of aRMM tools, and knowledge of the three risks. Results Of 27,396 HCPs invited to participate, 332 eligible respondents completed the survey (response rate: 447/26,735; 1.7%). In total, 19.6% of respondents recalled receiving the HCP Q&A Brochure, 22.6% the HCP Checklist, and 25.9% the Patient Alert Card. HCPs had a high level of knowledge of phototoxicity and hepatotoxicity; however, knowledge of SCC was lower. Knowledge of the three risks and self-reported risk minimization behavior was slightly improved in those who had read the HCP Q&A Brochure compared with those who had not. Conclusion The effectiveness of the voriconazole aRMM cannot be meaningfully inferred from the results due to the low survey response rate. The assessment indirectly points to the SmPC or other resources being the main source of risk information for HCPs. Engaging HCPs before designing and implementing an aRMM program is crucial to ensure an effective and focused program. (EU PAS registration number: EUPAS12624).

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Section: Discussionmentioning

confidence: 99%

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

et al. 2019

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“…Active surveillance of healthcare databases is conducted through the Sentinel System to inform FDA decisions. Although the Sentinel System has been criticized for not realizing its vision [ 71 ], it allows independent assessment of the effectiveness of FDA safety advisories [ 72 ]. Overall, the US approach to active pharmacovigilance is distinctive in that it does not rely exclusively on industrial sponsors, revealing its independence (Table 1 ).…”

Section: Results: International Approaches To Pharmacogovernancementioning

confidence: 99%

Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence

2018

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BackgroundAs a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members include regulators and pharmaceutical industry trade associations in the European Union, the United States and Japan. In this paper we explore the manner in which state interdependence fosters the conditions for regulatory harmonization by tracing the underlying parallels between ICH and member state pharmacogovernance to clarify emergent patterns in regulatory policy convergence.ResultsA shift to the life cycle approach to pharmaceutical regulation corresponded with international convergence in pre-market standards as emphasis shifted to post-market standards where convergence remains unresolved. Transnational pharmacogovernance was found to concentrate regulatory authority within a co-regulatory model of bilateral negotiation with pharmaceutical trade associations in defining safety and efficacy standards. Given a context of state interdependence, parallels were found between transnational and ICH member pharmacogovernance modes that guide policy development. Divergent modes of state regulatory governance that re-calibrate perceptions of risk and risk mitigation were found to coincide with post-market policy dissonance.ConclusionAlthough interdependence fostered harmonization in pre-market standards and aligned with increased focus on post-market approaches, the confluence of divergent state governance modes and perceptions of risk may inspire improvisation in post-market standards. As the ICH expands to an ensemble with a greater global reach, further research is needed to clarify the manner in which interdependence shapes transnational pharmacogovernance and the conditions that foster policy convergence in the public interest.Electronic supplementary materialThe online version of this article (10.1186/s12992-018-0402-5) contains supplementary material, which is available to authorized users.

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“…The study also compared the occurrence of hypocalcemia between patients prescribed denosumab and those prescribed a similar drug. A similar type of study was recently conducted by utilizing the sentinel database …”

Section: Pilot Study 2: Impact Of a Dear Healthcare Professional Lettmentioning

confidence: 99%

The utilization and challenges of Japan's MID‐NET^® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

Yamada

Itoh

Fujimura

et al. 2019

Pharmacoepidemiology and Drug

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Purpose To examine the potential role of Medical Information Database Network (MID‐NET®), a newly established Japanese medical information database network, in postmarketing drug safety assessments through the characterization of its advantages and limitations in five pilot studies. Methods The pilot studies were designed to address three major objectives in postmarketing drug safety assessments, ie, the examination of actual drug utilization, the impact of safety‐related regulatory actions, and drug‐associated risks. The five studies were conducted on the following topics: (a) utilization of codeine‐containing products and its relationship with respiratory depression, (b) impact of a Dear Healthcare Professional letter on hypocalcemia incidence associated with denosumab (Ranmark®) use, (c) risk of acute myocardial infarction associated with antidiabetic drug use, (d) risk of glucose metabolism disorders associated with atypical antipsychotic drug use, and (e) prospective monitoring of abnormal laboratory test results during new drug prescriptions. Results The pilot studies were successfully conducted and demonstrated the value of MID‐NET® in postmarketing drug safety assessments. In particular, the ability to utilize laboratory test results as objective clinical indicators is a major advantage of this database. Potential limitations include a relatively small sample size and a lack of patient‐level data linkages among hospitals. Conclusions MID‐NET® was confirmed to be a valuable database for postmarketing drug safety assessments. The use of laboratory test results to define clinical outcomes may allow more objective and accurate analyses to be conducted. These studies furthered our understanding of the characteristics of MID‐NET®, including its advantages and limitations.

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Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Abstract: This analysis demonstrated the ability to use Sentinel tools to assess the effectiveness of a label change and accompanying communication at the population level and suggests an influence on subsequent dispensing behavior.

Cited by 16 publications

References 20 publications

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence

The utilization and challenges of Japan's MID‐NET^® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

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Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System's analytic tools

Abstract: This analysis demonstrated the ability to use Sentinel tools to assess the effectiveness of a label change and accompanying communication at the population level and suggests an influence on subsequent dispensing behavior.

Cited by 16 publications

References 20 publications

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

Evaluation of the Effectiveness of Additional Risk Minimization Measures for Voriconazole in the EU: Findings and Lessons Learned from a Healthcare Professional Survey

Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence

The utilization and challenges of Japan's MID‐NET® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

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Product

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About

The utilization and challenges of Japan's MID‐NET^® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies