Mayville's Ahmed Al-Kadi (AAK) Hospital has been charged for violating the Medicines and Related Substances Act after a pharmacist allegedly administered anti-parasite drug Ivermectin to a patient, reports IoL. Officials from the South African Health Products Regulatory Authority (SAHPRA) and police raided the hospital following a tip-off that a patient collected medication at the hospital.
An official from SAHPRA is quoted in IoL as saying, they acted on information that Ivermectin had been prescribed and dispensed at the hospital. The official added that the pharmacist and hospital manager were questioned and both confirmed that a package – containing Ivermectin tablets – had been dropped off at the hospital and was dispensed.
According to SAHPRA's Yuveng Gounden, the pharmacist who dispensed the drug and the hospital manager have been charged.
Gounden is quoted in The Mercury as saying that the raid to search for ivermectin, which has been promoted widely on social media as a potential prophylaxis and treatment for the COVID-19 virus, was not connected to the arrest of the man earlier in the day.
SAHPRA said that Ivermectin was not registered as a drug for humans, although doctors could use a Section 21 application in terms of the Medicines and Related Substances Act to apply to dispense it as an unregistered product for the treatment of patients with conditions such as scabies or head lice.
SA Medical Association chair Dr Angelique Coetzee said in the report the association did not support the dispensing of unregistered medicines and medical practitioners who dispensed Ivermectin were taking the risk of being sued if patients suffered complications.
She said more research needed to be conducted on ivermectin and SAHPRA had welcomed further research into the drug’s efficacy. She said a coalition of African medical associations was also not aware of any approvals on the continent.
Health Department deputy director-general Dr Anban Pillay said during a recent parliamentary health committee meeting that the idea of conducting a phase four clinical trial structure had been proposed during engagements with SAHPRA. “This would allow patients to access the drug. We would get a better handle on whether this product works and any safety issues around it,” Pillay said.
AAK hospital manager, Ebrahim Asmal, confirmed in an IoL report that the hospital was visited by officials from SAHPRA and SAPS, however they did not find any Ivermectin stock at the hospital.
Asmal said the matter has since been referred to the hospital's attorneys.
The Times reports that Ivermectin, which was hailed as a revolutionary drug in the 1980s and works by paralysing and killing parasites including lice and worms in livestock, has been gaining traction as a “miracle cure” for COVID-19 patients.
But the report says, there is no confirmatory data on Ivermectin available as yet for its use in the management of COVID-19 infections.
SAHPRA cited a report on the pharmacokinetics of the drug which found that while Ivermectin is considered generally safe, side-effects include nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, and confusion), a sudden drop in blood pressure, severe skin rashes potentially requiring hospitalisation and liver injury (hepatitis).
[link url="https://www.iol.co.za/news/south-africa/kwazulu-natal/durban-hospital-slapped-with-criminal-charge-after-dispensing-anti-parasite-drug-ivermectin-5e13d514-e1fd-40e5-9a21-3ca32108e040"]Full IoL report[/link]
[link url="https://www.sahpra.org.za/news-and-updates/sahpras-guidance-on-the-use-of-ivermectin-in-the-prophylaxis-or-treatment-of-covid-19/"]SAHPRA's full statement[/link]
[link url="https://www.iol.co.za/news/south-africa/kwazulu-natal/officials-raid-durbans-ahmed-al-kadi-hospital-in-search-of-ivermectin-1f0a01c2-c038-47fa-813d-acf60daeab61"]Full IoL report[/link]
[link url="https://www.pressreader.com/south-africa/the-mercury-south-africa/20210108/281496458915673"]Full report in The Mercury (subscription needed)[/link]
[link url="https://www.timeslive.co.za/news/south-africa/2021-01-07-cops-raid-durban-private-hospital-looking-for-banned-covid-drug-ivermectin"]Full report in The Times[/link]