Insight into Ivermectin
Durban - Rumoured to be effective in treating or managing Covid-19, the ivermectin drug has been in demand.
Ivermectin is listed on the World Health Organization (WHO) Model List of Essential Medicines, listed under anti-infective medicines.
According to Pfizer, a pharmaceutical company, anti-infectives are medicines that work to prevent or treat infections, they include antibacterials, antivirals, antifungals and antiparasitic medications.
However, on the list, WHO stated that the presence of an entry on the Essential Medicines List carries no assurance as to pharmaceutical quality. It is the responsibility of the relevant national or regional drug regulatory authority to ensure that each product is of appropriate pharmaceutical quality (including stability) and that, when relevant, different products are interchangeable.
Recent research by the national Health Department on the rapid review of ivermectin for Covid-19 revealed that the overall quality of the randomised trials involving ivermectin in Covid‐19 patients was extremely low; from the available randomised control trial evidence, ivermectin is not superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomised control trials for any reduction in mortality and; eligible patients with Covid‐19 in South Africa should be considered for enrolment in relevant therapeutic trials.
The department was researching whether ivermectin should be used for managing Covid-19 patients compared to no intervention or an alternative intervention.
The department concluded that there was limited evidence for the repurposing of ivermectin for the treatment of Covid‐19 – two small early phase RCTs (randomised controlled trials) of ivermectin vs placebo constitute the bulk of the available evidence. Each had significant methodological shortcomings but, despite this, no clear benefit to ivermectin was seen with respect to viral load reduction or improvement in clinical outcomes. The effective concentrations and the relevance of in-vitro concentrations against Sars-CoV‐2 needs to be determined, and if this concentration is likely achieved in-vivo with few adverse events.
The South African Health Products Authority (SAHPRA) said ivermectin was registered for use in animals and not human use, but allowed the use of topical ivermectin as an unregistered product for the treatment of individual patients, with conditions such as scabies or head lice.
“SAHPRA reiterates its commitment to expedite the review of such studies. Furthermore, as the South African regulatory authority, SAHPRA will continue to evaluate any emerging peer reviewed publications or data on the use of ivermectin for the treatment of Covid-19 and notes that, according to the global clinical trials register, additional data should become available in the course of the next few months,” the association said.
“SAHPRA will also consider enabling access to approved formulations of ivermectin intended for human use, including through Section 21 authorisation, provided such a request is supported by evidence for the indication requested and is justified based on a risk benefit assessment that includes safety and clinical efficacy data.”
National Council of SPCAs consulting veterinarian Dr Bryce Marock said the NSPCA has used ivermectin on farm and companion animals, under the guidance of a veterinarian. For example, to treat mange and worms in dogs, nasal bots in sheep and worms in pigs.
“Ivermectin has been used on animals for internal and external parasites (never for viruses),” said Marock.
He added that ivermectin was mainstay treatment, especially for the indigent communities to treat their animals.
Marock asked the public to act responsibly and not to cause ivermectin to become strictly regulated due to the irresponsible and criminal actions of people “playing doctor”.
Last week, a man was arrested at King Shaka International Airport and charged for being in possession of unregistered medicines and the importation of medicines without a valid permit. He had 2 646 tablets, estimated to be worth R100 000.
In another incident, no ivermectin drug was found when SAHPRA officials and the police raided Ahmed Al-Kadi Private Hospital.
The Daily News