Effectiveness of the Crizotinib Therapeutic Management Guide in Communicating Risks, and Recommended Actions to Minimize Risks, Among Physicians Prescribing Crizotinib in Europe
- 37 Downloads
To support a positive benefit/risk profile for crizotinib, additional risk minimization measures (RMMs) included a patient information brochure (PIB) and a therapeutic management guide (TMG) to inform patients and physicians in Europe about the risks associated with crizotinib. This study evaluated the effectiveness of the TMG in communicating risks associated with crizotinib.
A cross-sectional survey was conducted among crizotinib-prescribing physicians in ten European countries. The survey included questions on awareness, receipt, and use of the crizotinib TMG and PIB, and on knowledge of crizotinib risks and actions to minimize risks.
A total of 3978 invitations were sent to potential crizotinib-prescribing physicians, and 98 crizotinib prescribers completed the survey. Over three-quarters (78%) of responding physicians acknowledged awareness of the TMG or PIB. Among physicians who received the TMG and PIB, 78% acknowledged reading the TMG, and 86% acknowledged giving the PIB to their patients. Knowledge of risks listed in the TMG was 97% for vision disorders, 94% for hepatotoxicity, 89% for both interstitial lung disease (ILD)/pneumonitis and corrected QT (QTc) prolongation, 69% for neutropenia/leukopenia, and 68% for bradycardia. Knowledge of recommendations to minimize risks was 74% for ILD/pneumonitis, 64% for vision disorders, 42% for neutropenia and leukopenia, 41% for QTc prolongation, 35% for hepatotoxicity, and 23% for bradycardia.
Most responding physicians were aware of, received, and read the crizotinib RMMs, and were aware of the crizotinib key risks. Knowledge of recommendations to minimize these risks revealed some gaps. The study results indicate the crizotinib RMMs were reasonably effective in communicating the crizotinib risks.
Compliance with Ethical Standards
This study, including preparation of the manuscript, was funded by Pfizer Inc.
Conflict of Interest
Philippe Huot-Marchand and Terri Madison are employees of Mapi, an ICON plc company, which received funding from Pfizer Inc. to conduct this study and to develop this manuscript. Kui Huang, Jingping Mo, and Keith Wilner are employees of Pfizer Inc., which commercializes crizotinib in Europe.
The final protocol and any amendments were reviewed and approved by an independent Ethics Committee for each site affiliated with physicians who participated in the survey from Belgium and Italy. Ethics approval for this healthcare provider survey was not required in the other participating countries.
Formal written informed consent was also not required for this physician survey; however, consent to participate in the survey was documented at the beginning of the survey questionnaire.
- 2.International Agency for Research on Cancer. Cancer fact sheets. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed 1 Dec 2017.
- 3.Cancer Research UK. http://www.cancerresearchuk.org/about-cancer/lung-cancer/stages-types-grades/types. Accessed 1 Dec 2017.
- 4.Howlader N, Noone AM, Krapcho M et al (eds) SEER cancer statistics review, 1975–2013, National Cancer Institute. Based on November 2015 SEER data submission, posted to the SEER website, April 2016. Bethesda. http://seer.cancer.gov/csr/1975_2013/.
- 6.European Medicines Agency. Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005), 2005. https://www.emwa.org/Documents/Freelancer/riskmanagement/rmp%20guidelines.pdf. Accessed 12 Sept 2018.
- 7.European Commission. Volume 9A of the rules governing medicinal products in the European Union, guidelines on pharmacovigilance for medicinal products for human use, 2008. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf. Accessed 12 Sept 2018.
- 8.European Commission. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, directive 2001/83/EC on the Community code relating to medicinal products for human use, 2010. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF. Accessed 12 Sept 2018.
- 9.European Medicines Agency. Guideline on good pharmacovigilance practices. Module XVI—risk minimisation measures: selection of tools and effectiveness indicators, 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/03/WC500224576.pdf. Accessed 8 Dec 2017.
- 16.Montero D. Regulatory initiatives for measuring the impact of risk minimisation measures; Dec 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2016/12/WC500218546.pdf. Accessed 21 Nov 2017.
- 18.van der Sar JM, de Vries ST, Mol PGM, On behalf of SCOPE Work Package 6. European healthcare professionals’ familiarity with and perceived usefulness of safety communications on medicines. http://www.scopejointaction.eu/_assets/files/WP6-HCP-Survey-Report(1).pdf. Accessed 12 Sept 2018.
- 19.Regulatory initiatives for measuring the impact of risk minimisation measures. EMA Workshop, 5–6 December 2016. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2016/12/WC500218533.pdf. Accessed 8 Dec 2017.