Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study

Landsberg, W.; Al-Dakkak, Imad; Coppin-Renz, Antonia K; Geis, Uli; Peters-Strickland, Timothy; Heumen, Emiel van; Rahman, Mirza I.

doi:10.1007/s40264-018-0662-2

Cited by 16 publications

(20 citation statements)

References 16 publications

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“…> 20 patients), slightly higher proportions reported receipt and utilization of the aRMM tools compared with prescribers who treated ≤ 20 patients with voriconazole. This observation is consistent with the finding reported by Landsberg and colleagues [38]. We note that prescriber's general medical experience may affect aRMM awareness and utilization differently than specific experience of treating patients with voriconazole.…”

Section: Potential Reasons Behind Low Utilization Of Armm Toolssupporting

confidence: 93%

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: Potential Reasons Behind Low Utilization Of Armm Toolssupporting

confidence: 93%

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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“…In our study, most patient respondents reported receiving the PIB (77%), of which 93% reported reading it. Our results are similar to results reported in the limited number of studies identified in the literature that directly evaluated the effectiveness of RMMs with patients . Specifically, levels of receipt/reading of patient‐directed RMMs in other studies were as follows: 88%/93% (Landsberg et al), 93%/86% (Enger et al), and 89%/86% (Brandenburg et al).…”

Section: Discussionsupporting

confidence: 88%

“…Our results are similar to results reported in the limited number of studies identified in the literature that directly evaluated the effectiveness of RMMs with patients . Specifically, levels of receipt/reading of patient‐directed RMMs in other studies were as follows: 88%/93% (Landsberg et al), 93%/86% (Enger et al), and 89%/86% (Brandenburg et al). Awareness of the side effects and precautions for use of crizotinib, and reasons for contacting the physician was high for vision‐, hepatic‐, and dizziness‐related items, with knowledge levels ranging from 61% to 85%.…”

Section: Discussionsupporting

confidence: 88%

“…Awareness of the side effects and precautions for use of crizotinib, and reasons for contacting the physician was high for vision‐, hepatic‐, and dizziness‐related items, with knowledge levels ranging from 61% to 85%. However, fewer than half of respondents knew crizotinib was associated with “chest discomfort or irregular heartbeat,” “slow in heart rate,” or “breathing problems.” Knowledge levels in our study were similar or higher to those reported by Landsberg et al, where knowledge levels of risks associated with aripiprazole ranged from 46% to 69% and knowledge levels of behaviors in case these risks occur was 56%‐69% . Similarly, a study that evaluated knowledge levels of precautions for use for, and risks associated with, varenicline reported patient knowledge levels of 19%‐82% .…”

Section: Discussionsupporting

confidence: 87%

“…Despite improvements in overall survival for patients with ALK‐positive NSCLC who are treated with crizotinib, patients diagnosed with NSCLC, in general, have an average life expectancy of ranging from 10 to 26.7 months, and this may have contributed to the relatively low response rate. The response rate was not as low as the other EU‐based survey we found in the literature, where only 16 patients/caregivers participated in the survey conducted by Landsberg et al Enger et al reported a response rate of 18%, however, this US‐based study allowed identification of specific patients receiving varenicline from a large healthcare claims database whereas in Europe, a similar approach is not allowed due to stringent European privacy regulations. Similarly, due to the restricted distribution Risk Evaluation and Mitigation Program in place for lenalidomide and thalidomide, Brandenburg et al were able to fully identify all US‐based patients receiving these medicines, yet still reported a relatively low response rate of 3.8%.…”

Section: Discussionmentioning

confidence: 64%

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Effect of the patient information brochure in communicating the risks associated with crizotinib treatment to patients with non‐small cell lung cancer (NSCLC) in Europe

Huang

Madison²,

Wehler

et al. 2020

Pharmacology Res & Perspec

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Crizotinib (XALKORI®) is indicated for anaplastic lymphoma kinase‐positive and ROS1‐positive advanced non‐small cell lung cancer. This study evaluated the distribution of the crizotinib patient information brochure (PIB) in Europe and patient knowledge of the key messages in the PIB. A cross‐sectional survey was conducted in 10 European countries among patients who received crizotinib to ascertain whether each patient received and read the PIB, and his/her knowledge of its key messages on hepatotoxicity, interstitial lung disease/pneumonitis, QTc prolongation, bradycardia, and vision disorders. Of the 341 patients contacted, 40 responded (11.7%), and 39 patients were eligible. A total of 77% of respondents acknowledged receiving the PIB, of which, 93% reported reading it. Knowledge of the individual side effects ranged from 36% to 85%, and precautions for use ranged from 56% to 67%. Understanding the reasons for calling a physician ranged from 54% to 85%. Knowledge of each of the 6 key side effects was greater among readers of the PIB compared to non‐readers or respondents who did not recall receiving the PIB. Approximately three‐quarters of survey respondents recalled receiving the crizotinib PIB and respondents who read the PIB were more knowledgeable of the key side effects of crizotinib than those who did not read or receive. Caution should be taken in generalizing these results because of the potential for selection bias and small sample size. These survey results suggest that the crizotinib PIB may be an effective risk communication tool for crizotinib‐treated patients in Europe.

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Assessment of colistimethate sodium (COLOBREATHE) risk minimization measures implemented in the European Union: A cross‐sectional study

Kaplan

Patino

Rainville

et al. 2019

Pharmacoepidemiology and Drug

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Purpose: To assess the effectiveness of additional risk minimization measures (aRMMs) implemented in Europe for colistimethate sodium (CMS) among healthcare professionals (HCPs) and patients/caregivers following safety concerns regarding incorrect use of CMS delivered via Turbospin inhaler. Methods:A cross-sectional study was conducted among HCPs and patients/caregivers in . Knowledge of the educational materials was assessed regarding common side effects, correct use of CMS and Turbospin inhaler, and capsule breakage. Awareness, receipt, and utilization of the aRMMs were also evaluated. Results: Among 124 HCPs surveyed, the majority acknowledged awareness (86.2%), receipt (91.0%), and utilization (81.6%) of the CMS educational materials and were knowledgeable about the common CMS side effects (93.2%). Most HCPs correctly answered most questions regarding the proper use of CMS (>90%), yet only half knew how to correctly use the Turbospin inhaler (53.2%). Knowledge about capsule breakage was moderate (67.5%). Of the 29 patients/caregivers surveyed, almost half were aware of the educational materials (48.1%); of these, 69.2% received and used the materials. Most patients/caregivers were knowledgeable about the common CMS side effects (81.5%) and proper CMS use (>85%); however, knowledge about correct Turbospin inhaler use and potential for capsule breakage was moderate to low (48.1% and 37.9%, respectively). Conclusions: HCPs and patients/caregivers have good knowledge about the common side effects associated with CMS. However, knowledge of correct use of the Turbospin inhaler and capsule breakage was moderate to low. K E Y W O R D S colistimethate sodium, pharmacoepidemiology, risk minimization measures, survey, Turbospin inhaler

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Effectiveness Evaluation of Additional Risk Minimization Measures for Adolescent Use of Aripiprazole in the European Union: Results from a Post-Authorization Safety Study

Cited by 16 publications

References 16 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

Effect of the patient information brochure in communicating the risks associated with crizotinib treatment to patients with non‐small cell lung cancer (NSCLC) in Europe

Assessment of colistimethate sodium (COLOBREATHE) risk minimization measures implemented in the European Union: A cross‐sectional study

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