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SAMA urges healthcare community to wait for convincing clinical evidence before using Ivermectin. SAHPRA is encouraged to facilitate limited registration for use strictly in trials
The South African Medical Association (SAMA) says the medical community must await guidance from the South African Health Products Regulatory Authority (SAHPRA) before making use of Ivermectin as a treatment for COVID-19. Until the use of Ivermectin in humans for COVID-19 is declared safe by SAHPRA we cannot advise doctors or other healthcare workers to use it, despite the growing body of evidence in support of its efficacy.
“We understand the desperation for an easy and effective treatment”, says Dr Angelique Coetzee, Chairperson of SAMA. However, she says, despite all the hype around Ivermectin for the prevention and treatment of COVID-19, convincing clinical evidence is yet to emerge from current trials.
Before any medicine can be manufactured, sold or used in South Africa, it must be approved for use by SAHPRA. Under extraordinary circumstances, SAHPRA can permit access to unregistered medicines, such as Ivermectin in terms of Section 21 of the Medicines and Related Substance Act, Act 101 of 1965. Ivermectin has not yet been approved for use in humans in South Africa. It’s efficacy in COVID-19 is still in question and more studies are required.
SAMA urges SAHPRA to facilitate registration of Ivermectin, allowing the importation and/or manufacture of the drug with its use limited strictly to approved clinical trials.
Doctors are urged NOT to buy and sell unregistered products claiming to contain Ivermectin, or promote these in any way. The composition of veterinary (and some imported) formulations is not done to the same stringent standards as medicines designed specifically for human use. This remains an unregistered medicine and is subject to Section 21 regulations. SAMA further notes that any medical practitioner who prescribes an unregistered drug can be held personally liable – and that medical insurance cover may be repudiated, should that drug cause any harm to the patient.
We therefore urge all doctors to only prescribe drugs which are registered with SAHPRA.
Those who wish to obtain Section 21 approval should consult SAPHRA’s guidance document on access to unregistered medicine. The document provides guidance on access to unregistered medicines for human use through the provisions of Section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and clarifies the mandate, intent and scope of this section and Regulation 29 of the General Regulations published in terms of the Act.
It also outlines the process to be followed when requesting a medicine through Section 21, as well as the information required to comply with the provisions of the Act and Regulations:
https://www.sahpra.org.za/wp-content/uploads/2020/12/2.52_Section_21_Access_to_Unregistered_Medicines_Sept20_v2-003.pdf
https://www.sahpra.org.za/unregistered-products/
SAMA salutes Doctors and their efforts to fight Covid-19. We encourages medical practitioners to continue to practice responsible, ethical medicine and to abide by the current legal regulations.
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SAMA mourns passing of Minister Jackson Mthembu
The South African Medical Association (SAMA) joins the rest of South Africa in mourning the passing of Minister in the Presidency Jackson Mthembu.
Minister Mthembu died of complications related to COVID-19. “Our thoughts and prayers are with Minister Mthembu’s family, friends, and colleagues, and all South Africans who were touched by his generosity of spirit, his leadership, and his humble approach to his duties. He was a man of the people and his death is a great loss for our country,” says Dr Angelique Coetzee, Chairperson of SAMA.
Dr Coetzee says Minister Mthembu will be remembered as a staunch campaigner for human rights, a leader with a clear vision, and a person who served his country with distinction.
“Jackson Mthembu exemplified servant leadership and a person who tackled each of his different positions with enthusiasm and professionalism. COVID-19 is a pernicious disease and it has again robbed our country of someone whose impact on our society is immeasurable,” concludes Dr Coetzee.
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The South African Medical Association (SAMA) extends its condolences to the families, friends and colleagues of the five people killed in the fatal helicopter crash in KwaZulu-Natal yesterday.
The South African Medical Association (SAMA) extends its condolences to the families, friends and colleagues of the five people killed in the fatal helicopter crash in KwaZulu-Natal yesterday.
Four healthcare workers and a pilot died in the crash. According to news reports, Dr Kgopotso Mononyane, Dr Curnick Mahlangu, nurse Mpho Xaba, paramedic Sinjin Farrance, and pilot Mark Stoxreiter were on their way to Hillcrest in the Natal Midlands to transport a critically ill patient to Netcare Milpark Hospital when they crashed.
Dr Mononyane had earlier delayed leaving for Hillcrest to be part of the team who tried to save Minister Jackson Mthembu, who also sadly died yesterday. Dr Mononyane eventually did leave with the rest of the team to KZN.
“This is so incredibly sad. Dedicated, hard-working and professional lives have been lost and families have been changed forever, Our thoughts and prayers go to every single person affected by this tragedy,” concludes Dr Coetzee.
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SAMA endorses caution by SATS on use of therapeutic bronchoscopy
The South African Medical Association (SAMA) says it supports the position of the South African Thoracic Society (SATS) discouraging the therapeutic bronchoscopy as part of routine management of severe COVID-19 pneumonia. SAMA cautions doctors against this practice saying it also agrees with the Ministerial Advisory Committee (MAC) that the procedure carries risks for patients and operators and can, therefore, not be recommended at present.
According to SATS, while it cannot exclude “… a potential short-term benefit from a therapeutic bronchoscopy in selected patients, there remains limited scientific or even other observational data to suggest that this procedure has an impact on outcome.”
SAMA says it concurs with SATS’ assessment that “… therapeutic bronchoscopy should not be seen as a ‘panacea’ for severe COVID-19 disease and certainly should not be offered as part of routine therapy.”
“The MAC also makes the point that the exact role of increased respiratory secretions in COVID-19 pneumonia remains unclear and, because of this, we advise that the use of therapeutic bronchoscopy be discouraged until further scientific evidence is available is provided,” says Dr Angelique Coetzee, Chairperson of SAMA.
Dr Coetzee says while there is a desire to provide the best care possible to patients, doctors should be careful not to perform procedures which are dangerous, and which may, ultimately, cause more damage than do good.
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Section 59 Investigation raises serious questions which must be dealt with - SAMA
The Interim Report on the Section 59 Inquiry into allegations of racial discrimination by medical schemes against Black healthcare providers raises serious questions about racism among medical schemes, and requires urgent, honest, and appropriate action by the medical schemes, and the authorities which govern them. The South African Medical Association (SAMA) says the findings must now spearhead remedies for harmful administration processes by the schemes and administrators, and the regulatory framework under which these practices are allowed to continue.
According to the Interim Report, the investigation focused particularly on the fraud, waste and abuse (FWA) systems “… by the three main administrators – Discovery, Medscheme and GEMS.” The Interim Report notes, “After considering all the evidence and responses, we find that between 2012 and 2019 Black practitioners were more likely to be found to have committed FWA than their Non-Black (White) counterparts, by Discovery, Medscheme and GEMS.
This means, for the reasons provided in this interim Report, there was unfair racial discrimination.” SAMA says the findings are unacceptable, shocking and disturbing, and require immediate attention by the implicated schemes. “Not only is it clear that Black doctors are discriminated against, but it is equally clear that the regulatory environment which allows this type of action to continue is still out of step with the realities of South Africa," says Dr Mvuyisi Mzukwa, Vice-Chairperson of SAMA.
Dr Mzukwa says SAMA’s view is that the unfair administrative processes followed by the medical schemes must now become the focus for investigation.
“We concur with the investigators that these findings are degrading, humiliating and distressing and there can be no justification whatsoever for these actions. It is now incumbent upon the authorities to take these findings further by investigating the regulatory framework which has allowed these practices to not only occur, but to flourish,” says Dr Mzukwa.
He says it is clear that the problems with this conduct by the medical schemes arises from an imbalance in the power structure between the big, well-financed administrators, and medical practitioners. This, he says, is evident where the report finds the interpretation of Section 59 (2) and (3) vague and confusing. These two sections are used by medical schemes to withhold payments and force providers to sign acknowledgement of debt in order to continue to be paid.
“The report refers to the above practice as blackmail which erases any doubt that the schemes must immediately review and rewrite their FWA processes; it goes without saying the current processes cannot continue. The Council for Medical Schemes and the Health Professions Council of South Africa have some serious introspection in respect of their own regulations which have allowed these schemes to operate within a legal framework they endorse.
These regulations lie at the heart of the problem the Section 59 Inquiry has identified,” he says. Critically, Dr Mzukwa, notes the report criticises the HPCSA and the CMSA for dereliction of their duty in handling complaints by providers. He says it indicates that both associations must reorganise their regulations to such a degree that they offer better clarity to avoid abuses of the regulations by people seeking to use them to their advantage – and the disadvantage of providers.
Dr Mzukwa says SAMA is appalled that Black doctors have been racially profiled in the way outlined in the report and says the Association will insist on not only a review but an overhaul of current scheme guidelines to ensure these are fair and equitable for all medical practitioners.
“We applaud the Section 59 inquiry for highlighting this most inhumane practice of racial profiling by the schemes and administrators. While the process of dealing with this is unfolding, we are duty bound to ensure a parallel process gets underway to clean up the harmful and often debilitating administrative processes of these schemes. Unfortunately, unless this root problem is addressed properly, this type of conduct will continue, and more and more Black doctors will face the same issues as their counterparts who testified at the inquiry’s hearings,” concludes Dr Mzukwa.
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