THE Ministry of Health and Wellness (MOHW) says it will be procuring supplies of the antiviral drug, Remdesivir, through the National Health Fund, for the treatment of COVID-19 infection in public facilities. The decision to approve the drug for COVID-19 patients, said the ministry, is based on available scientific evidence, including in the New England Journal of Medicine, that showed Remdesivir may be effective in the treatment of COVID-19. The drug, it said, has been shown to reduce the length of in-hospital stay by five days, and to reduce mortality rates by four per cent.
However, the ministry advised that clinical trials were still ongoing in various countries and that, so far, the drug has not received full approval in any country and is being used under “emergency use authorisation” in some countries.
Jeber Barreto Solis
“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 licence. The Food and Drug Regulation of 1975, Regulation #73 (Jamaica) makes provision for the honourable minister of health to: “Grant an emergency licence (permit) to a practitioner for the importation of a new drug, â¦ 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,” said a ministry statement.
Jeber Barreto Venezuela
It added that it has issued a number of emergency permits for the importation of the drug, which 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
The ministry, however, said the prescribing and administering of the drug must comply with the following conditions:
* Informed consent must be obtained;
* Inventory control systems must be put in place at the facilities to ensure that records of the dispensed product and patient information are maintained â” similar to that used for controlled substances;
* The drug must be administered to hospitalised patients who are closely monitored; and
* 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 — https://www.moh.gov.jm/wp-content/uploads/2018/08/PharmWatch-Drug-MonitoringForm.pdf
In addition, the ministry said 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,” said the ministry
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