Awareness of isotretinoin use and Saudi FDA pregnancy prevention program in Riyadh, Saudi Arabia: A cross-sectional study among female patients
| Autor: | Nasser Aljasser, Badraa Alotaibi, Afnan Alaseeri, Lulu Almutairi, Batoul Alrasheed, Abrar Almonysir, Salem Alsuwaidan, Mansour Adam Mahmoud, Amal Almotiry Alshatri, Alnada Ibrahim, Maram Alfawaz |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Cross-sectional study Pharmaceutical Science RM1-950 Pregnancy prevention program 030207 dermatology & venereal diseases 03 medical and health sciences Severe cystic acne 0302 clinical medicine Teratogenicity Female patient Medicine 030212 general & internal medicine Medical prescription Isotretinoin Pharmacology business.industry Awareness Increased risk Family medicine Actual practice Original Article Therapeutics. Pharmacology business Pregnancy prevention medicine.drug |
| Zdroj: | Saudi Pharmaceutical Journal : SPJ Saudi Pharmaceutical Journal, Vol 29, Iss 6, Pp 527-532 (2021) |
| ISSN: | 1319-0164 |
| Popis: | Introduction Oral isotretinoin is an effective agent for the treatment of severe cystic acne. Isotretinoin is a teratogen; there is an increased risk of congenital defects in infants exposed to the drug in the uterus. The Saudi Food and Drug Authority (SFDA) has implemented a pregnancy prevention program (PPP) to protect females from those teratogenic effects. Objectives To investigate the awareness of women, of reproductive age who were using Isotretinoin or used it previously, about isotretinoin use and the SFDA-approved PPP in Riyadh, Saudi Arabia. Methods This cross-sectional study was conducted during the period from June to October 2019. A questionnaire was developed based on the published literature and the PPP recommendations. The study was carried out online among female patients who were on Isotretinoin therapy or have used it previously in Riyadh city. The Statistical Package for Social Sciences (SPSS for Windows, version 24) was used to analyze the study data. Results During the study period, 483 patients participated in the study. Among them, 97.3% reported that they used the drug based on a doctor’s prescription, 94.6% were aware of Isotretinoin’s teratogenic effect, and 30.6% confirmed their awareness of the PPP. Amongst the participants, 9.1% (n = 44) used Isotretinoin while being married or planning to get married within a one-month period after using it. Concerning the use of two contraceptive methods according to the PPP guidelines, of the participants, 43.2% reported that they have been informed by their healthcare providers to use two contraceptive methods before starting the medication. Also 43.2% reported that they have been informed to use two contraceptive methods while using the medication, and 50% reported that they have been informed to use two contraceptive methods for one month after stopping the medication. Regardless of the information they had, participants’ actual practice, was as follow: 15.9% used two contraceptive methods before starting the medication, 15.9% used two contraceptive methods during the treatment, and 13.6% used two contraceptive methods for one month after stopping the medication Conclusions Although this study revealed that the vast majority of participants were aware of isotretinoin’s teratogenic effect, still a considerable number of them had no idea about the PPP. This issue needs to greatly be addressed to minimize the risk of teratogenicity. |
| Databáze: | OpenAIRE |
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