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)

What would be the appropriate management for a patient with herpes zoster (shingles)?

Point-of-purchase magazines sold mainly at the checkout stands in supermarkets are considered corporate magazines.

The first truly national general interest magazine with a large circulation was

The journalistic concept of fairness is reflected in:

The News Media Alliance estimates that people keep a magazine issue an average of seventeen weeks and that each issue has at least four adult readers on average. What is the term for this magazine sharing?

Making decisions based on principles that you want to be universally applied is an example of:

During the first half of the 20th century, which reporters described Prohibition and its repeal, the stock market crash, the Depression, the election of President Franklin D. Roosevelt, the New Deal, the bombings of London and Pearl Harbor, the Normandy invasion, Roosevelt’s funeral, and the signing of the armistice that ended World War II?

Which firm brought mass-marketing techniques to the book industry, offering book buyers an environment that was less like the traditional cozy atmosphere of an independent bookstore and more like a department store that paved the way for online retailing?

Ted Turner founded Cable News Network (CNN) in 1980, leading to around-the-clock cable news.