Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States1. (3rd August 2013)

• Record Type: Journal Article
• Authors: Pinheiro, Simone P.; Kang, Elizabeth M.; Kim, Clara Y.; Governale, Laura A.; Zhou, Esther H.; Hammad, Tarek A.
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 22:Number 12(2013:Dec.)
• Page Start: 1251
• Page End: 1257
• Publication Date: 2013-08-03
• Subjects: Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.3481
• Languages: English
• ISSNs: 1053-8569

Abstract

<abstract abstract-type="main"> <title>ABSTRACT</title> <sec id="pds3481-sec-0001" sec-type="section"> <title>Purpose</title> <p>The major concern associated with isotretinoin treatment is its high teratogenic potential. Therefore, ensuring use of contraception while on therapy is an important strategy for at‐risk patients and has been emphasized in all risk management programs. iPledge, the latest and most rigorous isotretinoin program, requires, among other stipulations, monthly assessments of contraceptive use for patients undergoing isotretinoin treatment. The purpose of this study is to evaluate isotretinoin usage patterns and assess concomitant use of isotretinoin and contraceptives before and after iPledge.</p> </sec> <sec id="pds3481-sec-0002" sec-type="section"> <title>Methods</title> <p>Female patients aged 13–45 years with a new prescription for isotretinoin products during 2004–2008 were identified in the IMS Health longitudinal prescription claims database. Monthly concomitant use of isotretinoin and contraceptives was estimated. Segmented regression analysis of interrupted time series data was used to assess changes in monthly proportion of concomitant use in the 24 months preceding versus following iPledge implementation.</p> </sec> <sec id="pds3481-sec-0003" sec-type="section"> <title>Results</title> <p>The number of isotretinoin prescriptions decreased after iPledge implementation. A small but significant increase in monthly proportion of patients concomitantly using isotretinoin and contraceptive therapies was observed immediately after iPledge implementation (1.3%, <italic>p</italic>‐value = 0.02), particularly among younger patients (2.5%, <italic>p</italic>‐value < 0.01). No changes in the proportion of concomitancy over time (i.e. slope) between the periods before and after iPledge implementation were observed.</p> </sec> <sec id="pds3481-sec-0004" sec-type="section"> <title>Conclusion</title> <p>The findings of this pharmacy prescription claims‐based study suggest a small increase in concomitant use of isotretinoin and contraceptives coincident with the time of implementation of iPledge, particularly among younger women. Published 2013. This article is a U. S. Government work and is in the public domain in the USA.</p> </sec> </abstract>