References
- Rubino A, Artime E. A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006–2015. Expert Opin Drug Saf. 2017;16:877–884.
- Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, et al. Risk minimization activities of centrally authorized products in the EU: a descriptive study. Drug Saf. 2012;35:299–314.
- European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) - Module XVI – risk minimisation measures: selection of tools and effectiveness indicators (Rev 2). 2017. [cited 2019 April 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools_en-3.pdf
- European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module VIII – post-authorisation safety studies (Rev 3). 2017. [cited 2019 April 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pdf
- The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). EU PAS register guide. 2017. [cited 2019 April 15]. Available from: http://www.encepp.eu/publications/documents/EUPASRegisterGuide.pdf
- The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The European Union electronic register of post-authorisation studies (EU PAS register). [cited 2019 April 15]. Available from: http://www.encepp.eu/encepp_studies/indexRegister.shtml
- The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). FAQ - EU PAS register. 2017. [cited 2019 April 15]. Available from: http://www.encepp.eu/encepp_studies/documents/FAQ_EUPASRegister.pdf
- Gridchyna I, Cloutier A-M, Nkeng L, et al. Methodological gaps in the assessment of risk minimization interventions: a systematic review. Pharmacoepidemiol Drug Saf. 2014;23:572–579.
- Keddie S. A descriptive study of additional risk minimization measures included in risk management plans reviewed by the United Kingdom Regulatory Authority. Pharmaceut Med. 2013;27:25–34.
- Banerjee AK, Zomerdijk IM, Wooder S, et al. Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation. Drug Saf. 2014;37:33–42.
- Agyemang E, Bailey L, Talbot J. Additional Risk minimisation measures for medicinal products in the European Union: a review of the implementation and effectiveness of measures in the United Kingdom by one marketing authorisation holder. Pharmaceut Med. 2017;31:101–112.
- Vora P, Artime E, Soriano-Gabarró M, et al. A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic register of post-authorization studies. Pharmacoepidemiol Drug Saf. 2018;27:695–706.
- The American Association for Public Opinion Research. Standard definitions: final dispositions of case codes and outcome rates for surveys. 9th edition. AAPOR. 2016.
- Draugalis JR, Coons SJ, Plaza CM. Best practices for survey research reports: a synopsis for authors and reviewers. Am J Pharm Educ. 2008;72:11.
- Higgins JPT, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses testing for heterogeneity. BMJ. 2003;327:557–560.
- Zomerdijk IM, Trifirò G, Sayed-Tabatabaei FA, et al. Additional risk minimisation measures in the EU - are they eligible for assessment? Pharmacoepidemiol Drug Saf. 2013;22:1046–1053.
- Goedecke T, Morales DR, Pacurariu A, et al. Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations. Br J Clin Pharmacol. 2018;84:419–433.
- Artime E, Vora P, Asiimwe A, et al. Sampling methods used and country selection in survey studies evaluating the effectiveness of risk minimisation measures in the European Union. Pharmacoepidemiol Drug Saf. 2017;26(S2):425–426.
- Andersson ML, Böttiger Y, Bastholm-Rahmner P, et al. Evaluation of usage patterns and user perception of the drug–drug interaction database SFINX. Int J Med Inform. 2015;84:327–333.
- International Society of Pharmacoepidemiology and Drug Safety. Whitepaper - Evaluating the effectiveness of additional risk minimisation measures via surveys in Europe: challenges and recommendations. 2016. [cited 2019 April 15]. Available from: https://pharmacoepi.org/pub/?id=f46953df-de69-31e7-8f74-725bd7fa685f
- Smith MY, Andrea RB, Priya BB, et al. The RIMES statement: a checklist to assess the quality of studies evaluating risk minimization programs for medicinal products. Drug Saf. 2018;41:389–401.
- European Medicines Agency. Annex 2 to the guide on methodological standards in pharmacoepidemiology - methods for pharmacovigilance impact research. 2017. [cited 2019 April 15]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools_en-3.pdf
- Bennett C, Khangura S, Brehaut JC, et al. Reporting guidelines for survey research: an analysis of published guidance and reporting practices. PLoS Med. 2011;8:1–11.
- Kelley K, Clark B, Brown V, et al. Good practice in the conduct and reporting of survey research. Int J Qual Heal Care. 2003;15:261–266.
- Frisk P, Aggefors K, Cars T, et al. Introduction of the second-generation direct-acting antivirals (DAAs) in chronic hepatitis C: a register-based study in Sweden. Eur J Clin Pharmacol. 2018;74:971–978.
- Forslund T, Raaschou P, Hjemdahl P, et al. Usage, risk, and benefit of weight-loss drugs in primary care. J Obes. 2011;2011:1–7.
- Troncoso A, Diogène E. Dabigatran and rivaroxaban prescription for atrial fibrillation in Catalonia, Spain: the need to manage the introduction of new drugs. Eur J Clin Pharmacol. 2014;70:249–250.
- Huiart L, Ferdynus C, Renoux C, et al. Trends in initiation of direct oral anticoagulant therapies for atrial fibrillation in a national population-based cross-sectional study in the French health insurance databases. BMJ Open. 2018;8:e018180.
- Selke KI, Selke GW, Eichler U, et al. Impact of EU risk assessment process and administrative regulations for manufacturers of combined hormonal contraceptive prescribing. An analysis of developments in Germany and the implications. Curr Med Res Opin. 2019;35:697–704.
- Artime E, Kahlon R, Qizilbash N, et al. A novel approach to correlate soft and hard outcomes: effectiveness of abatacept (Orencia®) patient alert cards in rheumatoid arthritis patients P-440. Pharmacoepidemiol Drug Saf. 2018;27(S2):519–520.
- Evaluation of the effectiveness of additional risk minimization measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell carcinoma (SCC) of the skin and hepatic toxicity in patients receiving voriconazole in the European Union (EU). [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=14677
- Assessment of physician behavior regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapinefumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the European Union (EU). [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=7518
- Post-authorisation study to evaluate the effectiveness of the risk minimization activities in the treatment of SPAF. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=12992
- Post Authorization Safety Study: knowledge about safety precautions among physicians in Denmark prescribingCPA/EE products. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=14684
- WEUKBRE5744: European survey of patient and prescriber understanding of risks associated with TROBALTTM. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=9225
- PRJ2250: survey of prescriber understanding of risks associated with TROBALT. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=12224
- Physician survey to assess effectiveness of strattera risk minimization activities in prescribers treating adult patients with ADHD. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=8936
- Physician survey to re-assess effectiveness of strattera risk minimization activities. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=8929
- EDURANT/EVIPLERA health care professional survey. Data on file from MAHs or Regulatory Agencies. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=9394 33
- Evaluation of the effectiveness of risk minimization measures: a survey among health care professionals to assess their knowledge and attitudes on prescribing conditions of Instanyl® in France and the Netherlands. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=9925
- Study to evaluate physician knowledge of safety and safe use information for Diane-35 and its generics in europe: an observational post-authorisation safety study. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=12800
- A cross-sectional study to evaluate the effectiveness of XALKORI patient information brochure among non-small cell lung cancer (NSCLC) patients receiving XALKORI treatment in Europe. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=14884
- A cross-sectional study to evaluate the effectiveness of XALKORI therapeutic management guide among physician prescribing XALKORI in Europe. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=14881
- A Post-Authorisation Safety Study (PASS) to assess the effectiveness of the risk minimization measures of domperidone – physician survey. [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=17698
- Healthcare professional and patient surveys to assess the effectiveness of risk minimization measures for concentrated insulin lispro (Humalog 200 units/ml KwikPen; Liprolog 200 units/ml KwikPen). [cited 2018 Sep 20]. Available from: http://www.encepp.eu/encepp/viewResource.htm?id=14615