This is based on the available scientific evidence, including in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2007764) that shows Remdesivir may be effective in the treatment of COVID-19. The drug has been shown to reduce the length of in-hospital stay by five (5) days, and to reduce mortality rates by four per cent (4%).
However, the Ministry wishes to advise the public that clinical trials are still ongoing in various countries. So far, the drug has not received full approval in any country and is being used under “Emergency Use Authorisation” in some countries.
In Jamaica, while we await full registration approval in the country of origin, the drug can be used under the controls of a study or under an emergency license. The Food and Drug Regulation of 1975, Regulation #73 (Jamaica), makes provision for the Honourable Minister of Health to: “grant an emergency license (permit) to a practitioner for the importation of a new drug, … if that drug is required for the treatment of an urgent case, and the Minister is satisfied that it is in the best interest of the patient for whom the drug is intended, that the importation be effected without delay”.
The Ministry has issued a number of emergency permits for the importation of the drug. This requires a letter from the prescribing physician indicating the need for this drug and including recognition of the responsibility for prescribing an unapproved drug as well as the consent of the patient to take an unapproved drug.
Further, the Ministry has stipulated that the prescribing and administering of the drug comply with the following conditions:
- informed consent must be obtained;
- that inventory control systems be put in place at the facilities to ensure that records of the dispensed product and patient information are maintained – similar to that used for controlled substances;
- that the drug be administered to hospitalised patients who are closely monitored; and
- that serious adverse events must be tracked and reported to the Pharmacovigilance Unit of the Standards and Regulations Division of the MOHW, using the PharmWatch Drug Monitoring Form, located on the MOHW website at https://www.moh.gov.jm/wp-content/uploads/2018/08/PharmWatch-Drug-MonitoringForm.pdf.
Clinical outcome reports must also be submitted to the Health Services Planning and Integration Branch of the Ministry.
The public will be updated on the progress with the procurement of the drug.