| アブストラクト | BACKGROUND: Carmustine, a nitrosourea alkylating medicine, is not registered for marketing in South Africa but is made available for clinical use through Section 21 of the Medicines and Related Substances Act 101 of 1965. This regulatory mechanism permits the importation and use of unregistered medicines when no suitable registered alternatives are available. Given the limited local utilisation and reliance on special authorisation, post-marketing safety monitoring is particularly important. This study aimed to characterise the global safety profile of carmustine in order to inform and contextualise pharmacovigilance practices and regulatory oversight in South Africa. METHODS: A retrospective descriptive analysis was conducted using Individual Case Safety Reports (ICSRs) submitted to VigiBase from its international birth date. Reports listing carmustine as a suspected or interacting medicine were included. Demographic characteristics, reporter type, seriousness, outcomes, and reported adverse events were summarised using descriptive statistics. RESULTS: Forty-two global ICSRs were identified and 39 ICSRs were further analysed. Most adverse events (AEs) occurred in adults, were classified as serious and were predominantly from the Americas and Europe. No reports originated from Africa. DISCUSSION: Carmustine remains accessible in South Africa only via Section 21, with limited public regulatory transparency. Neoplasms were the most frequently reported AEs (34.8%), many classified as serious, including secondary malignancies consistent with known myelosuppressive effects. Respiratory toxicities were also common and expected. However, most reported preferred terms were deemed unexpected when assessed against product information. Death was reported in 28.6% of cases. CONCLUSIONS: These findings highlight regional pharmacovigilance disparities, under-reporting in Africa, and gaps in safety monitoring. There is a need for strengthened monitoring, regulatory transparency, and updated safety communication for Section 21 medicines. |
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