Knowledge, Awareness, and Attitudes of Healthcare Professionals and Patients Regarding Pregnancy Prevention Programmes: A Survey and Interview-Based Case Study on Valproates in Portugal
摘要
Valproate’s teratogenic potential has been recognised since 1980. Although its use in pregnancy is primarily associated with risks of neural tube defects and autism, it can also cause developmental delay. In 2018, a pregnancy prevention programme (PPP) was implemented after a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found that, despite the 2014 risk minimization measures (RMM), many patients were still unaware of these risks, high levels of exposure among female of childbearing potential persisted, and prescribing conditions were not consistently followed.
Research Design and MethodsWe conducted a study encompassing both quantitative and qualitative components. A cross-sectional, web-based survey was performed targeting physicians, pharmacists, and patients to gain understanding of the status of awareness, knowledge, and utilisation of the valproates PPP. Subsequently, semi-structured telephone interviews were conducted with patients undergoing valproates treatment to delve deeper into causes of survey results, as well as to explore barriers to PPP compliance and suggestions for improvement.
ResultsSurvey responses from 34 female patients, 82 prescribers, and 68 pharmacists were analysed, along with interviews with seven patients. Findings revealed that 79% of patients, 97% of pharmacists, and 99% of prescribers were aware of the teratogenic risk of these medicines. However, none of the surveyed or interviewed women reported receiving, discussing with their doctor, or signing the Risk Acknowledgement Form (RAF), and only one recalled receiving the Patient Guide. Additionally, at least 85% of women did not undergo pregnancy testing before, during, or after treatment, while 59% reported using contraception. Among prescribers, 14% had consulted the Prescriber’s Guide, 8% confirmed providing the Patient Guide, and 11% reported reviewing the RAF with patients. Among pharmacists, 63% had distributed the patient card, and 67% incorporated package warnings into their counselling. Only 26% of women recalled receiving contraception counselling, in contrast to 79% of prescribers and 42% of pharmacists who reported providing such guidance. The barriers to implementing the PPP included limited dissemination and training on the PPP, insufficient knowledge and access to educational materials, time constraints during patient interactions, and some patient resistance to information. Suggested opportunities for improvement included alerts in electronic prescribing and pharmacy dispensing systems.
ConclusionsOverall, despite high awareness of valproate’s teratogenic risk, particularly among healthcare professionals, adherence to the PPP remained limited. Strengthening communication, improving implementation strategies, and reinforcing compliance measures are essential to ensuring patient safety.