MONITORING OF PRESCRIPTIONS FOR VOLUNTARY INTERRUPTION OF PREGNANCY AND SPONTANEOUS ABORTION WITHIN THE FIRST TRIMESTER OF PREGNANCY
European Statement
Clinical Pharmacy Services
Author(s)
V. Mureddu, G. Ledda, G. Adamu, M. Rivano, A. Cadeddu. Hospital Pharmacy Department, Azienda Ospedaliero Universitaria, Cagliari.
Why was it done?
Mifepristone and misoprostol are provided for Voluntary Pregnancy Interruption (VPI) and Spontaneous Miscarriage (SM) according to different reimbursement schemes, based on different gestational age. According to Summary of Product Characteristics (SPC), the use of mifepristone and misoprostol is approved only within the first 63 days of pregnancy. Recently, access to treatment for VPI and SM has been extended by the Italian Medicines Agency by the I trimester of pregnancy. VPI within the first 49 days of gestation, the use of mifepristone and misoprostol is authorized according to SPCs. From 50th to 63th days is guaranteed under the law 649/96, that allows and reimburses the use of medicines for off-label indications. From 63th to 90th is considered an off-label prescription. Regarding SM, mifepristone and misoprostol can be used within the I trimester under the law 648/96. All these different reimbursement schemes are used as part of the Italian pricing-reimbursement system.
What was done?
To ensure appropriateness, a specific prescription form has been drafted to support clinicians in prescribing according to the correct reimbursement scheme gestational age, therapeutic indication and dosage must be reported in the prescription form.
How was it done?
The development of the prescription form required a deep knowledge of both the law under which the right of abortion is guaranteed and Italian reimbursement schemes. The prescription form was introduced in October 2022.
Prescriptions of all pharmacological treatments are ordinarily made through electronic software; therefore the prescription form was uploaded. Prescriptions from 01/01/2024 to 30/06/2024 were collected and retrospectively analyzed.
What has been achieved?
Prescription forms analysis showed that a total of 83 women were treated. In 53 cases the treatment was used for VPI and in 30 for SM. In 27% of cases, prescriptions were considered as per in-label. In 66% cases, prescriptions were allowed according to Law 648/96. In 7% of cases, prescriptions were off-label.
What next?
According to the development of reimbursement schemes, the prescription form will be implemented. Italy provides universal coverage for all citizens and residents; keeping it sustainable is one of the hardest challenges of these day. The contribution of hospital pharmacists in monitoring prescriptions has a pivotal role in making equal access to these treatments.