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Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
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Thrombotic risk minimization for Diane-35 and generics.
Irene D Bezemer1, Elisabeth Smits1, Fernie J A Penning-van Beest1
1PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands.
Pharmacoepidemiology and Drug Safety
|September 28, 2017
Summary
Risk minimization measures significantly reduced the use of cyproterone acetate/ethinylestradiol (CPA/EE) in the Netherlands. Despite similar user profiles for acne, overall CPA/EE prescriptions saw a substantial decrease.
Area of Science:
- Pharmacovigilance and Drug Utilization Studies
- Reproductive Health and Contraception
- Dermatology and Endocrinology
Background:
- Cyproterone acetate/ethinylestradiol (CPA/EE) is a hormonal contraceptive.
- Risk minimization measures were implemented in the Netherlands.
- The study evaluated the impact of these measures on CPA/EE prescribing patterns.
Purpose of the Study:
- To assess the effect of risk minimization strategies on CPA/EE utilization.
- To analyze indications for CPA/EE use and concurrent hormonal contraceptive (HC) dispensing.
- To examine trends in new CPA/EE users before and after risk mitigation.
Main Methods:
- Retrospective drug utilization study using pharmacy dispensing data (PHARMO Database Network).
- Identification of new CPA/EE users in 2011, 2012, and 2014.
- Linked general practitioner records to ascertain diagnoses (acne, hyperandrogenic conditions) and treatments.
Main Results:
- A significant decrease in new CPA/EE users was observed, from 3.7 per 1000 women in 2011/2012 to 0.7 in 2014.
- Proportions of users with acne or related treatments remained relatively stable (47-55%).
- Concomitant use of other hormonal contraceptives (HC) was low (2-3%), with potential concomitant use around 25%.
Conclusions:
- Risk minimization measures were associated with a substantial reduction in CPA/EE use in the Netherlands.
- User profiles regarding acne and hyperandrogenic conditions did not significantly change.
- The findings highlight the effectiveness of regulatory interventions in altering prescribing behavior for combined oral contraceptives.
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