Work

Awareness of Risk Minimization Measures for Valproate and Pregnancy Prevention Program Compliance Among Pharmacists: A Cross-Sectional Survey in Romania

Year: 2025

Type: article

Abstract: Background/Objectives: Risk minimization measures, including a pregnancy prevention program (PPP), have been established by the European Medicine Agency to strengthen the restrictions on valproate (VPA) use in pregnant women/women with childbearing potential. We aimed to assess pharmacists’ awareness of the new measures and behavior in terms of compliance to PPP recommendations. Methods: We performed a cross-sectional, national, non-interventional survey among pharmacists between December 2024 and February 2025. No sample size calculations were performed. Inclusion criteria were pharmacists active in community pharmacies in Romania. Results: In total, 267 pharmacists were included, balanced in terms of age groups, with a slight predominance for 31–40 year olds (33.7%) and mostly female (93.3%). More than half (60.7%) did not recall receiving any type of PPP information (direct healthcare professional communication [DHPC] or educational materials [EMs]). Participants generally read the DHPC, fully (64.1%) or partially (21.4%); all reportedly read the EMs, generally fully (73.0%). Half (145, 54.2%) dispensed VPA at least once during the last 12 months. Among this subgroup, 15.2% used the EMs, 38.6% counseled the patient regarding the VPA teratogenic risk, and 32.4% counseled on the importance of effective contraceptive measures at every VPA dispensing. Neither awareness nor behavior met the pre-established success criteria; therefore, the overall PPP compliance was not demonstrated. Conclusions: Despite notable proportions of pharmacists offering counseling when dispensing, overall PPP compliance and EM use could be enhanced. More research is needed to identify why some measures are not properly adhered to, in order to increase the overall risk mitigation efficacy.

Source: Pharmaceuticals

DOI: 10.3390/ph18121861

Authors: Madalina Huruba, Daniel Leucuta, Andreea Farcas, Cristina Mogosan

Institution: Iuliu Hațieganu University of Medicine and Pharmacy

Language: English

Topic: Pharmacy and Medical Practices

Subfield: Pharmacology

Field: Pharmacology, Toxicology and Pharmaceutics

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,499