Ivermectin and Covid-19: SA drug regulator allows controlled, compassionate access

Grant

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This afternoon Boitumelo Semete-Makokotlela, CEO of the South African Health Products Regulatory Authority (SAHPRA) announced that it would “facilitate a controlled compassionate access programme” to the drug ivermectin for use for patients with Covid-19.

“Very detailed guidelines of this programme” will be announced “in coming days” that would build in the principles that are used to inform and grant s21 authorisations under the Medicines Act and would be “open to all patients”. A s21 authorisation is a mechanism used by SAHPRA for medicines that are not registered in South Africa, but which are known to be safe and efficacious and in use in other countries.


According to Semete-Makokotlela, applications would need to be made by health professionals so as to ensure they took responsibility for safety and monitor efficacy. “There’s a large responsibility we are placing on health professionals,” she said.
 

Grant

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SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the progamme would be open to all patients, with the healthcare professional being responsible for the application and monitoring of the patient
 

Gordon_R

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JohnStarr

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Another viewpoint criticising the premature obsession with Ivermectin:
I don't think they care...nor do some people on this forum care. Until some other drug becomes the next buzzword and they rail against the system for not doing enough to pass it as a COVID prevention.
Just like ginger...until some other food/root/herb becomes the next best thing.
 

netstrider

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I don't think they care...nor do some people on this forum care. Until some other drug becomes the next buzzword and they rail against the system for not doing enough to pass it as a COVID prevention.
Just like ginger...until some other food/root/herb becomes the next best thing.
In my case. I don't care either way. Ivermectin, no Ivermectin, Hydroxychloroquine, none of it. I really don't care.

****off with the politicians. That's what I care about.
 

Geoff.D

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Another viewpoint criticising the premature obsession with Ivermectin:
A terrible article published by Ground Up and Maverick, waaay below their normal quality standards!

Pandering to the establishment, trying to justify their reticence and bureaucratic slowness to move on a very serious situation.

The comments section is way better quality than the contents of the article.

As I stated previously, I tried to buy a pack of Colchicine on Friday when we were at Dischem. Well, suddenly it is under embargo! Why is that? Something that a few months ago would have been no problem at all to buy for Gout is now suddenly not available? Is this because the authorities are concerned that the public is now going to use it for self-medication?

The FACTS are SAHPRA has done absolutely nothing to explain why it has NOT seen to it that Ivermectin is listed as a medicine in SA already, based on its status as an "essential medicine" by the WHO, can't explain how its status has somehow been relegated to a medicine for "animal use only" when it is listed as an S3 medicine in the Act, and has been there's since the 80's.

SAHPRA does not even want to try and acknowledge the years and years of research into Ivermectin regarding its proven safety record.

SAHPRA is in fact encouraging the average Joe out there to become distrustful of its very important role in ensuring the safety of the SA people. We are about to be vaccinated against Covid 19 with various vaccines that have quite a pathetic actual efficacy even in the trials. Yet something that has been shown a few times as effective against alleviating suffering is summarily written off just because it has not been pushed through an RCT trial?

What all the Ivermectin groups are calling for is simply to place the medicine in the hands of doctors, make it easy to get it, and, then let the medical fraternity show it usefulness in treating Covid 19. And get it out of the clutches of the black market.

This very well written comment shows just how out of line the main article is:

Barry Davies
29 January 2021 at 21:59
I am impressed with the authors medical knowledge but his total lack of ability to do any form of critical thinking is outstanding. 250 million doses DONATED for river blindness, drug in use for 30+ years, some patient have been on the drug for 19 years with no side effects. Expensive rubbish, unsafe rubbish. One study indicates 75% reduction in mortality is “promising”. Mind boggling!! Some other drug that barely works & gives you diarrhoea but has been “scientifically tested & approved” is better!! Get a grip, you think your your “I’m like god because i know some medicine” will substitute for intellect?

Common sense should dictate that in an EMERGENCY without any other “promising” treatment you can give it to 1000 frontline covid-19 workers, without placebos, and see how many get covid. Actually been done in South America 1000 volunteers: 400 do not take anything = 58% contract Covid. 600 take Ivermectin = ZERO covid. Also promising?

The drug is safe and cheap if the 1000 person trial fails the worst case scenario is 600 people without worms.
Finally SAHPRA approved Ivermectin for human use some years ago!! (Scabies & head lice I think)
Why the panic to ban and confiscate a safe and approved drug?

The terms of the “compassionate use” are an insult more than a joke. Yes the courts have to decide because greed, incompetency and callous disregard for life by the ANC Cadres has to end now! The real virus in SA is the ANC.
Sure it is not going to stop the spread, BUT it is a huge advantage in keeping people out of hospital while we wait for the not so silver bullets to help us build up "herd Immunity".

And BTW, for those out there that had a go at me about the term "Compassionate Use" You realise who used it and where I got it from?
The term BTW is NOT used anywhere in ANY of the ACTs currently in force that have anything even remotely related to the control of medicines in SA.
 
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lumeer

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A terrible article published by Ground Up and Maverick, waaay below their normal quality standards!

Pandering to the establishment, trying to justify their reticence and bureaucratic slowness to move on a very serious situation.

The comments section is way better quality that the contents of the article.



The FACTS are SAHPRA has done absolutely nothing to explain why it has NOT seen to it that Ivermectin is listed as a medicine in SA already, based on its status as an "essential medicine" by the WHO, can't explain how its status has somehow been relegated to a medicine for "animal use only" when it is listed as an S3 medicine in the Act, and has been there's since the 80's.

SAHPRA does not even want to try and acknowledge the years and years of research into Ivermectin regarding its proven safety record.

SAHPRA is in fact encouraging the average Joe out there to become distrustful of its very important role in ensuring the safety of the SA people. We are about to be vaccinated against Covid 19 with various vaccines that have quite a pathetic actual efficacy even in the trials. Yet something that has been shown a few times as effective against alleviating suffering is summarily written off just because it has not been pushed through an RCT trial?

What all the Ivermectin groups are calling for is simply to place the medicine in the hands of doctors, make it easy to get it, and, then let the medical fraternity show it usefulness interesting Covid 19. And get it out of the clutches of the black market.

This very well written comment shows just how out of line the main article is:


Sure it is not going to stop the spread, BUT it is a huge advantage in keeping people out of hospital while we wait for the not so silver bullets to help us build up "herd Immunity".
Please link to the act in which ivermectin is listed as an S3 medicine.
 

Gerry

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A terrible article published by Ground Up and Maverick, waaay below their normal quality standards!

Pandering to the establishment, trying to justify their reticence and bureaucratic slowness to move on a very serious situation.

The comments section is way better quality than the contents of the article.



The FACTS are SAHPRA has done absolutely nothing to explain why it has NOT seen to it that Ivermectin is listed as a medicine in SA already, based on its status as an "essential medicine" by the WHO, can't explain how its status has somehow been relegated to a medicine for "animal use only" when it is listed as an S3 medicine in the Act, and has been there's since the 80's.

SAHPRA does not even want to try and acknowledge the years and years of research into Ivermectin regarding its proven safety record.

SAHPRA is in fact encouraging the average Joe out there to become distrustful of its very important role in ensuring the safety of the SA people. We are about to be vaccinated against Covid 19 with various vaccines that have quite a pathetic actual efficacy even in the trials. Yet something that has been shown a few times as effective against alleviating suffering is summarily written off just because it has not been pushed through an RCT trial?

What all the Ivermectin groups are calling for is simply to place the medicine in the hands of doctors, make it easy to get it, and, then let the medical fraternity show it usefulness in treating Covid 19. And get it out of the clutches of the black market.

This very well written comment shows just how out of line the main article is:








Sure it is not going to stop the spread, BUT it is a huge advantage in keeping people out of hospital while we wait for the not so silver bullets to help us build up "herd Immunity".

And BTW, for those out there that had a go at me about the term "Compassionate Use" You realise who used it and where I got it from?
The term BTW is NOT used anywhere in ANY of the ACTs currently in force that anything even remotely related to the control of medicines in SA.

Like I said, SAHPRA is a big pharma prostitute muppet .
gupta 'prof' karim is a celebrity drug dealer.

Every day that dribbles by I am just thankful as f_ck I have more
than enough Ivermectin.
 

lumeer

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Like I said, SAHPRA is a big pharma prostitute muppet .
gupta 'prof' karim is a celebrity drug dealer.

Every day that dribbles by I am just thankful as f_ck I have more
than enough Ivermectin.
If SAHPRA were a big pharma muppet, why haven't they approved ivermectin? Imagine the literally billions of rands market for ivermectin in South Africa if it were approved for human use.

Prof. Karim is a highly accomplished scientist with accolades from around the world.

Your comments are defamatory.
 

Gerry

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If SAHPRA were a big pharma muppet, why haven't they approved ivermectin? Imagine the literally billions of rands market for ivermectin in South Africa if it were approved for human use.

Prof. Karim is a highly accomplished scientist with accolades from around the world.

Your comments are defamatory.

are you pussified or something ?
 

Geoff.D

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Please link to the act in which ivermectin is listed as an S3 medicine.
Not at all difficult to find, start here: Acts and regulations - SAHPRA

What IS almost impossible to find anymore is an up to date list of all medicines "approved" for use in SA,
S0, S1, S2, S3, the main ones and then the others all the way through to S9. If such an online access is available then it is protected.

The list you kindly provided has not been updated since 2018.​
The MIMS is a publication that costs a fortune to purchase, and, therein lies the rub, there is NO updated current list of medicines registered in SA available to the general public. Presumably, the lot that publishes the MIMS are so firmly in control because they know that if such a public list is made available, their lucrative racket would come to an end.​
The legislative mandates of SAHPRA are derived from the Constitution; the National Health Act, 2003 (Act No. 61 of 2003); the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), as amended (hereinafter referred to as “the Medicines Act”); and other relevant legislation, regulations and policies.

Further, SAHPRA’s mandate has expanded to include the regulation and control of radiation emitting devices and radioactive nuclides under the Medicines Act and the Hazardous Substances Act, 1973 (Act No. 15 of 1973)

The Medicines Acts are:
  • Act No. 101 of 1965​
  • Act No. 72 of 2008​
  • Act No. 14 of 2015​

 

lumeer

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Not at all difficult to find, start here: Acts and regulations - SAHPRA

What IS almost impossible to find anymore is an up to date list of all medicines "approved" for use in SA,
S0, S1, S2, S3, the main ones and then the others all the way through to S9. If such an online access is available then it is protected.

The list you kindly provided has not been updated since 2018.​
The MIMS is a publication that costs a fortune to purchase, and, therein lies the rub, there is NO updated current list of medicines registered in SA available to the general public. Presumably, the lot that publishes the MIMS are so firmly in control because they know that if such a public list is made available, their lucrative racket would come to an end.​


The Medicines Acts are:
  • Act No. 101 of 1965​
  • Act No. 72 of 2008​
  • Act No. 14 of 2015​

You've not actually linked to the supposed "act" that lists ivermectin as an S3 medicine. There is no such act.

Geoff, stop with your lies, your conspiracy theories, and your defamatory statements about respected scientists.
 

Geoff.D

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You've not actually linked to the supposed "act" that lists ivermectin as an S3 medicine. There is no such act.

Geoff, stop with your lies, your conspiracy theories, and your defamatory statements about respected scientists.
Patience, and STOP accusing me of being defamatory. Leave that to others'.

I have given you the ACTs that apply. Next, I will post the EXTRACT out of the ACT as you appear to be too disinterested to do it yourself.
 
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Geoff.D

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Here it is:

MEDICINES AND RELATED SUBSTANCES ACT
NO. 101 OF 1965

[View Regulation]
[ASSENTED TO 19 JUNE, 1965]
[DATE OF COMMENCEMENT: 1 APRIL, 1966]
(Afrikaans text signed by the State President)
This Act was published in Government Gazette 40869 dated 26 May, 2017.

Please note that details of Government Notices published in Government Gazettes that amend the Schedules to the Act are annotated at the beginning of the Schedules

“medicine”— means any substance or mixture of substances used or purporting to be suitable for use or manufactured or sold for use in

(i) the diagnosis, treatment, mitigation, modification or prevention of disease, abnormal physical or mental state or the
symptoms thereof in humans; or
(ii) restoring, correcting or modifying any somatic or psychic or organic function in humans; and
includes any veterinary medicine;
Scheduled substance” means any medicine or other substance prescribed by the Minister under section 22A;
[S. 3 amended by s. 3 of Act No. 65 of 1974, by s. 1 of Act No. 36 of 1977, by s. 2 of Act No. 17 of 1979, by s. 46
of Act No. 97 of 1986 and by s. 3 of Act No. 94 of 1991, substituted by s. 3 of Act No. 90 of 1997 and by s. 3 of Act
No. 72 of 2008. Subs.
(9) substituted by s. 4 (c) of Act No. 14 of 2015.]
22A. Control of medicines, Scheduled substances, medical devices and IVDs.—

(1) Subject to this section, no person shall sell, have in his or her possession or manufacture any medicine, Scheduled substance, medical device or IVD, except in accordance with the prescribed conditions. [Subs. (1) substituted by s. 14 (b) of Act No. 14 of 2015.]
(2) The Minister may, on the recommendation of the Authority, prescribe the Scheduled substances referred to in this
section. [Subs. (2) substituted by s. 22 (a) of Act No. 72 of 2008.]
(3) Any Schedule 0 substance may be sold in an open shop.
(4) Any Schedule 1 substance shall not be sold— a long section
(5) Any Schedule 2, Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance shall not be sold by any person other
than—
(16) Notwithstanding anything to the contrary contained in this section—
any person may possess a Schedule 0, Schedule 1 or Schedule 2 substance for medicinal purposes;
any person may possess a Schedule 3, Schedule 4, Schedule 5 or Schedule 6 substance if he or she is in possession of a
prescription issued by an authorised prescriber;
[Para. (b) substituted by s. 5 (i) of Act No. 59 of 2002.]
SCHEDULE 0
[Schedule 0 inserted by Government Notice No. R.509 in Government Gazette 24727 of 10 April, 2003, substituted by
Government Notice No. 935 in Government Gazette 31387 of 5 September, 2008 and amended by Government
Notice No. R.1230 in Government Gazette 32838 of 31 December, 2009.]

.... to be continued in next post
 
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Geoff.D

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SCHEDULE 3 (many amendments)
Each of the amendments needs to be checked to find WHEN a change was made to this list. I am busy doing this to find out IF and why Ivermectin was removed from the list. The point is Ivermectin WAS listed as a Schedule 3 substance for use in treating humans. It is a bit of mission to find out WHY and when it was removed and in fact if that actually happened.

This should be the END of you continued attack on me to show you that in fact IV was approved for use in humans in SA. NOW PLEASE STOP with this nonsense. I will continue to work through ALL the amendments until I find the one that removed it if indeed it ever was removed from the list.

The list of substances under Schedule 3 is a very long one. so here are the two that under debate in this thread.

Colchicine, except when intended for the emergency treatment of acute gout, subject to a maximum total treatment course of 6 milligrams. (S2)
Ivermectin, except when intended and registered as an anthelmintic and/or ectoparasiticide in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
The above par. says that IV IS registered for use in Humans under S3, and IV is NOT S3 when used to treat animals.

Now put that in your pipe and smoke it!
I await your apology!
 
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lumeer

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Each of the amendments needs to be checked to find WHEN a change was made to this list. I am busy doing this to find out IF and why Ivermectin was removed from the list. The point is Ivermectin WAS listed as a Schedule 3 substance for use in treating humans. It is a bit of mission to find out WHY and when it was removed and in fact if that actually happened.

This should be the END of you continued attack on me to show you that in fact IV was approved for use in humans in SA. NOW PLEASE STOP with this nonsense. I will continue to work through ALL the amendments until I find the one that removed it if indeed it ever was removed from the list.

The list of substances under Schedule 3 is a very long one. so here are the two that under debate in this thread.



The above par. says that IV IS registered for use in Humans under S3, and IV is NOT S3 when used to treat animals.

Now put that in your pipe and smoke it!
I await your apology!
I apologise. It appears that ivermectin is indeed registered as an S3 medicine for human use. You were right. I don't understand what's going on then.
 

Gordon_R

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While the new ruling opens the door, actually prescribing Ivermectin is highly problematic for medical professionals:
The guidelines released last week were thin on details, but prescribing doctors will have to provide evidence of the drug’s registration and use in other countries and motivate for it as a treatment for their patients. They will need to provide package inserts and information on risks. They will also need to get patient consent. While these steps are required for any Section 21 or unregistered drug application, such as cannabis or cannabinoids, many medicines used off label usually have more robust efficacy and safety profiles in place to draw on.
The guidelines do not stipulate the dosages of ivermectin to be prescribed, as there is not enough data to support one dose over another. It also does not contain any warnings of what dosages might be considered toxic. This means that doctors will decide the dosage and for how long the treatment is required with no guidance from SAHPRA. While SAHPRA wants doctors to report on side-effects, it also did not provide any guidance on what doctors should be on the lookout for.
Ethical doctors who do decide to prescribe ivermectin will probably stick to low doses taken only a few times and will have to monitor patients carefully for any potential side-effects. Such doctors will need to have independently studied the available evidence of the use of ivermectin in Covid-19 and be satisfied that the evidence supports their decision to prescribe it. They will, after all, be going against the advice of most leading regulators and health bodies that advise that ivermectin should not be used to treat Covid-19, except in clinical trials.
 

Geoff.D

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While the new ruling opens the door, actually prescribing Ivermectin is highly problematic for medical professionals:
In other words, do the job they are trained for! And making assumptions about what doctors will most probably do is disingenuous.
The doctors that will apply are the ones who have been keeping themselves up to date on the progress of the trials taking place, not the sheep, pill pushers, who are waiting for an approved protocol to hide behind.
 
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