COVID-19: Ivermectin efficacy in treating COVID-19: FOI release

Information requested

1) How much is known by the Scottish Government and health organisations with regards to ivermectin and when were they made aware of it?

2) If the Scottish governments are not aware of ivermectin and its beneficial efficacy in the prophylaxis and treatment of Covid-19, who is responsible for this oversight

3) Given the horrendous death counts and hospital figures, when can we expect to see the expeditious deployment of Ivermectin in all health areas for the prophylaxis of health workers (46,000 in UK off sick) and the multi stage treatment of Covid-19 in hospitals which, as demonstrated, will lead to faster viral clearance, faster time to hospital discharge, faster time to clinical recovery and a 75% reduction in mortality rates.

4) Can we expect ivermectin to be used on the grounds of compassionate authorisation to save lives given the results of randomised controlled trials that have already been carried out and given the fact that the World Health Organisation classify Ivermectin as an “Essential Drug”.

5) Please state any reason why the health authorities would not use Ivermectin to treat Covid-19, given the information already stated and the fact that it is safe and has been previously dosed over 3.7 billion times.

Response

1) The Scottish Government is aware of several on-going trials that are being conducted worldwide into the use of ivermectin for the treatment of COVID-19. However, it is important to note that the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency responsible for the approval of clinical trials and for the licensing of medicinal products in the UK. The Scottish Government work closely with the MHRA to ensure that people in Scotland can access the best possible medicines. 
For further information on clinical trials with ivermectin, please refer to the following website: https://www.clinicaltrials.gov/

2) As noted in response to question one above, the Scottish Government is aware of on-going clinical trials which are considering the clinical effectiveness of ivermectin in COVID-19 patients.

3) Ivermectin is licensed for use as a topical cream in the treatment of rosacea in adult patients in the UK. It is currently not licensed for use in the treatment of COVID-19 symptoms in the UK and it should not be used by patients to self-medicate for prevention of the virus. It is important to note that when a product is granted a licence, it is for a specific indication – that is to say, it is only licenced to be used for the treatment of the specified condition within that licence, and not for use more generally.

A licence (or marketing authorisation) defines a medicine’s terms of use: its summary of product characteristics outlines, among other things, the indication(s), recommended dose(s), contraindications, and special warnings and precautions for use on which the licence is based, and it is in line with such use that the benefits of the medicine have been judged to outweigh the potential risks. Furthermore, a licensed medicine: has been assessed for efficacy, safety, and quality; has been manufactured to appropriate quality standards; and when placed on the market is accompanied by appropriate product information and labelling. Any other use would be considered off-label and the responsibility that falls on healthcare professionals may be greater than when prescribing a licensed medicine within the terms of its licence. Prescribers should pay particular attention to the risks associated with using a licensed medicine off-label. These risks may include: adverse reactions; product quality; or discrepant product information or labelling (eg, absence of  information for some unlicensed medicines, information in a foreign language for unlicensed imports, and potential confusion for patients or carers when the Patient Information Leaflet is inconsistent with a medicine’s off-label use).

For ivermectin to be granted a licence for use in treatment of COVID-19 symptoms, an application must be submitted to the MHRA for review.
The MHRA have advised that, at this time, no application has been received for a licence (also known as a marketing authorisation) containing ivermectin for use in the treatment of COVID-19, in the UK. However, should an application for a marketing authorisation be made for an ivermectin-containing medicine for the treatment of COVID-19, then the MHRA has processes in place to expedite such an application, as required.

4) It is for a pharmaceutical company to determine whether they will offer a medicine though a compassionate use process which would allow a doctors to apply to use the medicine; this is normally for unlicensed medicines, as opposed to off-label medicines. The decision to grant an individual patient compassionate access is one that the pharmaceutical company makes. The initial request is made by the patient’s doctor who will have decided that the medicine is the best and the only available treatment option. The company normally has a set of medically driven criteria that need to be met, as well as a patient’s overall medical circumstances. The reason for this is that compassionate use schemes are designed for extreme medical cases and are for patients where there has been some clinical trial evidence of potential benefit for a patient. Making a decision about requests for compassionate use of an unlicensed medicine is always complex.

5) A recently published research article (The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro) in the Antiviral Research publication in June 2020 described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. Laboratory studies such as this are common at early stages of drug development.

However, additional testing is needed in humans to determine whether ivermectin might be appropriate to prevent or treat COVID-19. As noted above, ivermectin is currently only licensed for use as a topical cream in the treatment of rosacea in adult patients in the UK, and not as a treatment for COVID-19.

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