Program Director/Principal Investigator (Last, First, Middle): HANSEN, RICHARD, A. PROJECT SUMMARY / ABSTRACT Generic drugs play an important role in the U.S. healthcare system, but new post-marketing strategies are needed for evaluation of the safety and efficacy of generic drugs. This is particularly important for understanding how brand and generic drugs compare with authorized generics, which are a special kind of generic drug that contain the exact same active and inactive ingredients as the branded product, with the only difference being that they are labeled and marketed as generic drugs. A post-market surveillance system to compare usage and switching patterns among branded, authorized generic, and other generic products is necessary for effectively monitoring generic drugs. This proposal uses post-marketing data for selected example products to address three specific aims. Preliminary work uses novel approaches to characterize marketing intervals for relevant products, including creation of a reference list of National Drug Codes for use with claims data.
Aim 1 then assesses utilization and outcomes for brand, authorized generic, and other generic drugs, including an evaluation of product switching and switchback rates.
This aim i s conducted at the person-level using one of the Nations most comprehensive and enduring electronic health records integrated with longitudinal patient and claims data.
Aim 2 assesses market-level safety associated with entry of authorized generics and independent generics using the U.S. Food and Drug Administration adverse event reporting system database. Novel approaches to the evaluation of adverse event reporting rates for brand, authorized generic, and other generic drugs are tested.
Aim 3 creates a pilot system for safety surveillance of generic drugs, again using longitudinal person-level data from a regional electronic health record linked with administrative claims. The pilot safety surveillance system assesses known examples of adverse events for the test set of authorized generic drugs, and also tests a set of adverse events that are known to be drug- related but not necessarily labeled events for the drugs being studied. Algorithms generated for Aim 1 and Aim 3 will be run against 5 additional data sources that represent significantly larger (approximately 75 million people) and more diverse populations. This will provide replication data for further study. Data generated from this post-market generic drug evaluation is important to (1) identify signals indicative of possible differences in efficacy or adverse event rates between specific branded and generic products, (2) provide empirical evidence for patient and provider education when no differences are detected between branded and generic products, and (3) explore whether authorized generics provide a useful control group in the post-market surveillance evaluation for comparing differences in safety and efficacy outcomes (or lack thereof) for specific products. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page
HANSEN, RICHARD, A. PROJECT NARRATIVE Generic pharmaceuticals, including a special kind of generic known as an authorized generic, help to control healthcare costs. Little post-market research has compared the benefits, harms, usage, and substitution patterns of authorized generics, other generics, and brand drugs. This study uses novel post-market data sources and innovative methods to develop a pilot surveillance system that evaluates how utilization and outcomes compare for authorized generics, other generics, and brand drugs. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015) Page Continuation Format Page
|Hansen, R A; Qian, J; Berg, R L et al. (2018) Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug. Clin Pharmacol Ther 103:310-317|
|Cheng, Ning; Rahman, Md Motiur; Alatawi, Yasser et al. (2018) Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs. Drug Saf 41:363-376|
|Alatawi, Y; Rahman, Md M; Cheng, N et al. (2018) Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications. J Clin Pharm Ther 43:327-335|
|Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning et al. (2017) Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). Epilepsy Res 135:71-78|
|Hansen, Richard A; Qian, Jingjing; Berg, Richard et al. (2017) Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs. Pharmacotherapy 37:429-437|
|Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning et al. (2017) Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS). Clin Drug Investig 37:1143-1152|