Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States

• Published in: Pharmacoepidemiology and drug safety 2013-12, Vol.22 (12), p.1251-1257
• Main Authors: Pinheiro, Simone P., Kang, Elizabeth M., Kim, Clara Y., Governale, Laura A., Zhou, Esther H., Hammad, Tarek A.
• Format: Article
• Language: English
• Subjects: Abnormalities, Drug-Induced - prevention & control; Adolescent; Adult; Biological and medical sciences; Birth control; compliance; contraception; Contraceptive Agents - administration & dosage; Contraceptive Agents - therapeutic use; contraceptives; Dermatologic Agents - administration & dosage; Dermatologic Agents - adverse effects; Dermatologic Agents - therapeutic use; Drug Prescriptions - statistics & numerical data; Drug toxicity and drugs side effects treatment; Drug Utilization - trends; Female; Government Programs; Humans; iPledge; isotretinoin; Isotretinoin - administration & dosage; Isotretinoin - adverse effects; Isotretinoin - therapeutic use; Least-Squares Analysis; Medical sciences; Middle Aged; Miscellaneous (drug allergy, mutagens, teratogens...); pharmacoepidemiology; Pharmacology; Pharmacology. Drug treatments; Prescription drugs; Risk Management; Skin, nail, hair, dermoskeleton; United States; Young Adult
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.3481

ABSTRACT Purpose 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. Methods 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. Results 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%, p‐value = 0.02), particularly among younger patients (2.5%, p‐value