Publicação
Measuring the effectiveness of risk minimisation measures in pregnancy : case studies
| Resumo: | (Chapter: Teratogenic Medicinal Products) According to risk minimisation measures (RMM) analysis, retinoids, valproates, thalidomide and their analogues are among the teratogenic medicines with the well-established risk and well-consolidated pregnancy prevention programmes (PPP). Their PPPs present routine and additional RMM targeting both healthcare professionals (HCPs) and patients. The subsequent research aimed to investigate the extent of adherence to PPPs in Portugal through three case studies: Cross-sectional studies using surveys and semi-structured interviews/focus group were conducted to assess adherence to the oral retinoids, valproates, and thalidomide and its analogues PPPs. (Chapter: Retinoids) Showed high awareness of teratogenic risk among patients (96%), pharmacists (96%), and prescribers (96%). Patients use mostly the Patient Information Leaflet (PIL) and the packaging warning. Among pharmacists, only 1/4 consulted their guide and provided the patient card, 3/4 provided contraception counselling, and 44% discussed pregnancy testing. Among prescribers, 10% or fewer read their guide, provided the guide to patients, or signed the Risk Acknowledgment Form (RAF), while 2/3 mentioned the need for contraception during consultations, and 50% ensured pregnancy testing before treatment. (Chapter: Valproates) Revealed that 79% of patients, 97% of pharmacists, and 99% of physicians were aware of the teratogenic risk. None of the surveyed or interviewed women reported receiving, discussing, or signing the RAF, and only one reported receiving the patient guide. 85% or more of the women did not undergo pregnancy tests. 14% of physicians consulted the Prescriber’s Guide, 8% provided the Patient Guide, and 11% reviewed the RAF. 63% of pharmacists provided the patient alert card and 67% used the packaging warning in counselling. (Chapter: Thalidomide and Analogues) Revealed high knowledge (86-96%) among pharmacists but less consistent risk awareness among patients. Of the pharmacists, 57% used educational materials (EMs) and verified pregnancy test results. However, 43% did not due to a lack of direct patient contact, as some hospital dispensing is managed by nursing teams. Among women of childbearing potential, 80 to 100% did not receive the patient guide. The results indicate the ineffectiveness of PPPs in Portugal, as risk awareness is the only aspect approaching the 100% threshold deemed necessary for effectiveness. It is therefore essential to explore more effective strategies to achieve this objective. |
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| Autores principais: | Ferreira, Paula |
| Assunto: | Medicamento teratogénico Medidas de minimização de risco Programa de prevenção da gravidez Conhecimento Efetividade Risk minimisation measures Teratogenic medicine Pregnancy Prevention Programme Effectiveness Awareness |
| Ano: | 2025 |
| País: | Portugal |
| Tipo de documento: | tese de doutoramento |
| Tipo de acesso: | acesso restrito |
| Instituição associada: | Universidade de Lisboa |
| Idioma: | inglês |
| Origem: | Repositório da Universidade de Lisboa |
| Resumo: | (Chapter: Teratogenic Medicinal Products) According to risk minimisation measures (RMM) analysis, retinoids, valproates, thalidomide and their analogues are among the teratogenic medicines with the well-established risk and well-consolidated pregnancy prevention programmes (PPP). Their PPPs present routine and additional RMM targeting both healthcare professionals (HCPs) and patients. The subsequent research aimed to investigate the extent of adherence to PPPs in Portugal through three case studies: Cross-sectional studies using surveys and semi-structured interviews/focus group were conducted to assess adherence to the oral retinoids, valproates, and thalidomide and its analogues PPPs. (Chapter: Retinoids) Showed high awareness of teratogenic risk among patients (96%), pharmacists (96%), and prescribers (96%). Patients use mostly the Patient Information Leaflet (PIL) and the packaging warning. Among pharmacists, only 1/4 consulted their guide and provided the patient card, 3/4 provided contraception counselling, and 44% discussed pregnancy testing. Among prescribers, 10% or fewer read their guide, provided the guide to patients, or signed the Risk Acknowledgment Form (RAF), while 2/3 mentioned the need for contraception during consultations, and 50% ensured pregnancy testing before treatment. (Chapter: Valproates) Revealed that 79% of patients, 97% of pharmacists, and 99% of physicians were aware of the teratogenic risk. None of the surveyed or interviewed women reported receiving, discussing, or signing the RAF, and only one reported receiving the patient guide. 85% or more of the women did not undergo pregnancy tests. 14% of physicians consulted the Prescriber’s Guide, 8% provided the Patient Guide, and 11% reviewed the RAF. 63% of pharmacists provided the patient alert card and 67% used the packaging warning in counselling. (Chapter: Thalidomide and Analogues) Revealed high knowledge (86-96%) among pharmacists but less consistent risk awareness among patients. Of the pharmacists, 57% used educational materials (EMs) and verified pregnancy test results. However, 43% did not due to a lack of direct patient contact, as some hospital dispensing is managed by nursing teams. Among women of childbearing potential, 80 to 100% did not receive the patient guide. The results indicate the ineffectiveness of PPPs in Portugal, as risk awareness is the only aspect approaching the 100% threshold deemed necessary for effectiveness. It is therefore essential to explore more effective strategies to achieve this objective. |
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