[22 marks]Racetam® is a newly registered anticonvulsant medi…
[22 marks]Racetam® is a newly registered anticonvulsant medicine, authorised in 2020 for the management of epilepsy in South Africa. In accordance with regulatory requirements, the holder of a certificate of registration (HCR) must provide updates at defined intervals to SAHPRA to ensure that the benefit–risk balance of Racetam® remains favourable during its life cycle. During the review of the most recent periodic safety update report (PSUR), severe respiratory depression was identified as an important identified risk. Populations considered to be at increased risk include individuals with compromised respiratory function, pre-existing neurological or respiratory disease, renal impairment, those on concomitant central nervous system (CNS) depressants, and the elderly. Additionally, Racetam® has been noted to have potential off-label use in the management of nerve pain, insomnia, and anxiety, raising concern over unsupervised use and possible adverse outcomes.5.1 Discuss the role of the PSUR in monitoring and analysing new or emerging information on the risks and benefits of Racetam®. Your response should explain the regulatory purpose of the PSUR in post-marketing surveillance and how it supports detection and assessment of new safety signals, such as severe respiratory depression. (8 marks)5.2 Propose routine and additional risk minimisation measures that could be applied for all patients and for specific high-risk groups to minimise the risk of severe respiratory depression associated with Racetam®. Your response should also explain how these measures are documented, monitored and updated. (14 marks)
Read Details[12 MARKS]A 10-year-old girl received a dose of new conjugat…
[12 MARKS]A 10-year-old girl received a dose of new conjugate vaccine. Within 12 hours, she developed a high-grade fever (39.5°C), malaise, and a generalised maculopapular rash. Her parents took her to the emergency department, where she was treated symptomatically and recovered fully within two days. The girl was not on any medication, and no underlying conditions were reported. Laboratory investigations showed no evidence of bacterial or viral infection. A few similar reports have been received nationally following administration of this vaccine. The national pharmacovigilance centre has been requested to assess the causal relationship between the vaccine and the reported adverse event.2.1 Using the key criteria and principles of causality assessment in vaccine safety surveillance, evaluate the likelihood that this vaccine caused the reported adverse event. (7 marks)2.2 Discuss why causality assessment is crucial for vaccine safety surveillance and regulatory decision-making. (5 marks)
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