Dru rug Util ilisation Studies and Access to Health Care Databases: : Societal and Legal Challenges Aurore Bergamasco, Caroline Tremblay, Alia Yousif, Yola Moride Pharmacoepidemiology & Risk Management .
Disclaimer • YOLARX is a privately held company specialized in consulting and study conduct in pharmacoepidemiology, pharmacovigilance and therapeutic risk management • Our current global customer base includes pharmaceutical companies as well as regulatory agencies from across the world • No funding was received for the present study 7 th PEP Colloquium 11 june 2015 2
Context • Drug utilisation studies (DUS) are increasingly requested by health authorities whether these are regulatory agencies (EMA) or third-party payers (HAS) • Optimizing the quality of the use of medicines • According to the EMA, DUS belong to post-authorization safety studies (PASS) contributing to the evaluation of risk management plans − Evaluation of the proper use of medicines in real life Patient profile, indication, dosages, treatment duration, concomitant medication, … − Evaluation of the effectiveness of risk minimisation measures Implementation Clinical outcomes DUS = Drug Utilization Study; HAS = Haute Autorité de Santé; EMA = European Medicines Agency; PASS = Post-Authorisation Safety Study 7 th PEP Colloquium 11 june 2015 3
Objectives Determine the interest of health care databases for the ❶ conduct of DUS. Identify the legislative and ethical frameworks relative to the ❷ conduct of DUS and, more particularly to the use of health care databaseses in different European countries. 7 th PEP Colloquium 11 june 2015 4
Methodology • Literature Review − January – April 2015 • Two stages − Systematic review of the ENCePP electronic register of studies Extraction of information regarding DUS (objectives, outcomes, data sources, regulatory requirement , …) − Review of existing legislative sources in the European countries Identification of the legal and ethical requirements applicable for the conduct of DUS and use of health care databases ENcEPP = European Network of Centers for Pharmacoepidemiology and Pharmacovigilance 7 th PEP Colloquium 11 june 2015 5
Results – Phase I (ENCePP Register) 173 DUS (planned, ongoing or finalized) 95 (54,9%) initiated upon request from a regulatory body (EMA, national health authority, … ) 74 (42,8%) 99 (57,2%) conducted using existing health care using other data sources databases (prospective studies, ad hoc data collection) (secondary data sources) Evaluation of drug utilisation modalities in real Specific objectives: life clinical practice setting: - Disease characteristics - Off-label use (biomarker, radiological examination , …) - Patient profiles - Patients characteristics (BMI, lifestyle factors , …) - Specific characteristics of the indication EMA = European Medicines Agency; BMI= Body Mass Index 7 th PEP Colloquium 11 june 2015 6
Results – Phase II (Legal Sources) DUS Regulatory Framework Databases Accessibility • Observational studies, also called Non- • Different modalities according to the interventional studies (NIS) countries and databases considered • Important discrepancies across local - Authorization from data protection agencies legislations - Restricted access to certain institutions • Heterogeneous legal and ethical requirements from different institutions - Access fees regarding observational studies - Ethics board approval - Protocol format (national requirements) NIS = Non-Interventional Studies 7 th PEP Colloquium 11 june 2015 7
Legal and Ethical Requirements – Examples Competent ANSM MHRA DHMA BfArM AIFA AEMPS Authority Agence nationale Medicines and Danish Federal Institute for Drugs Agenzia Agencia Española de sécurité du Healthcare Health and and Medical Devices Italiana del de Medicamentos médicament et des products Medicines farmaco y Productos produits de santé Regulatory Agency Authority Sanitarios Paul-Ehrlich-Institute Vaccines, Biomedicines Notification No No No At the national- Yes Yes to the level: competent EXCEPT for studies No authority requested by the At the regional- authorities level: Yes Approval by Yes Yes Yes Yes a research No No ethic board Study No No No No Yes Yes registration VFA local register or AIFA and clinicaltrials.gov Data Protection Agency 7 th PEP Colloquium 11 june 2015 8
Databases and Accessibility – Examples Databases SNIIRAM-PMSI EGB CPRD National registers GePaRD Accessibility Authorization List of Protocol approved Authorization from Project approval by from the CNIL authorized by a research ethic the Data the health insurance institutions board Protection providers and local established by authorities Danish institutions ministerial authorised by Persons employed by decree Statistics Denmark the BIPS Leibniz Benefits Exhaustiveness ₋ Representa- - Representativeness - Single identifier - Représentativeness tiveness - Sample size (linkage) - Sample size ₋ Depth (> 52 millions) - Data access (17 millions) (20 years) - Follow-up duration through the - Depth (> 10 ans) - Data linkage internet Disadvan- No clinical or Sample Size - Cost - Claims database (1/97 th ) tages environmental - Time for access information (lifestyle , …) 7 th PEP Colloquium 11 june 2015 9
Conclusion • Health care databases= Opportunity for the conduct of DUS in a timely mannner − Existing data − Interesting for public health Early identification of misuse situations Implementation of appropriate corrective measures Optimization of risk minimization measures • Databases ’ interest depends on study objectives and available data • Utility of the database mapping to identify fit-for-purposes databases for the conduct of DUS − Systematic and pragmatic literature review based on required data − Matrix of identified databases including their characteristics − Usefulness assessment to determine the most appropriate datasources for the DUS 7 th PEP Colloquium 11 june 2015 10
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