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Cover -- Copyright -- Contents -- Section IV. Technical, Legal, and Analytic Considerations for Combining Registry Data With Other Data Sources -- Chapter 15. Interfacing Registries With Electronic Health Records -- 1. Introduction -- 2. EHRs and Patient Registries -- 3. EHRs and Evidence Development -- 4. Current Challenges in a Preinteroperable Environment -- 5. The Vision of EHR-Registry Interoperability -- 6. Interoperability Challenges -- 7. Partial and Potential Solutions -- 8. Momentum Toward a Functional Interoperability Solution -- 9. The Next Increment -- 10. What Has Been Done -- 11. Distributed Networks -- 12. Summary -- Case Examples for Chapter 15 -- Case Example 32. Using System Integration Software To Capture Registry Data From Electronic Health Records -- Case Example 33. Creating a Registry Interface To Incorporate Data From Multiple Electronic Health Records -- Case Example 34. Technical and Security Issues in Creating a Health Information Exchange -- Case Example 35. Developing a New Model for Gathering and Reporting Adverse Drug Events -- References for Chapter 15 -- Chapter 16. Linking Registry Data With Other Data Sources To Support New Studies -- 1. Introduction -- 2. Technical Aspects of Data Linkage Projects -- 3. Legal Aspects of Data Linkage Projects -- 4. Risk Mitigation for Data Linkage Projects -- 5. Legal and Technical Planning Questions -- 6. Summary -- Case Examples for Chapter 16 -- Case Example 36. Linking Registries at the International Level -- Case Example 37. Linking a Procedure-Based Registry With Claims Data To Study Long-Term Outcomes -- Case Example 38. Linking Registry Data To Examine Long-Term Survival -- Case Example 39. Linking Longitudinal Registry Data to Medicaid Analytical Extract Files -- References for Chapter 16 -- Chapter 17. Managing Patient Identity Across Data Sources -- 1. Introduction

Aims: To describe and characterize the first cohort of Post-Authorization Safety Study (PASS) protocols reviewed under the recent European pharmacovigilance legislation. Methods: A systematic approach was used to compile all publicly available information on PASS protocols and assessments submitted from July 2012 to July 2015 from Pharmacovigilance Risk Assessment Committee (PRAC) minutes, European Medicines Agency (EMA) and European Network of Pharmacovigilance and Pharmacoepidemiology (ENCePP) webpages. Results: During the study period, 189 different PASS protocols were submitted to the PRAC, half of which were entered in the ENCePP electronic register of post-authorization studies (EU-PAS) by July 2015. Those protocols were assessed during 353 PRAC reviews. The EMA published only 31% of the PRAC feedback, of which the main concerns were study design (37%) and feasibility (30%). Among the 189 PASS, slightly more involved primary data capture (58%). PASS assessing drug utilization mainly leveraged secondary data sources (58%). The majority of the PASS did not include a comparator (65%) and 35% of PASS also evaluated clinical effectiveness endpoints. Conclusions: To the best of our knowledge this is the first comprehensive review of three years of PASS protocols submitted under the new pharmacovigilance legislation. Our results show that both EMA and PASS sponsors could respectively increase the availability of protocol assessments and documents in the EU-PAS. Protocol content review and the high number of PRAC comments related to methodological issues and feasibility concerns should raise awareness among PASS stakeholders to design more thoughtful studies according to pharmacoepidemiological principles and existing guidelines.