Thursday 21 June, 2018

Health Ministry probes reported drug shortages at private pharmacies

The Ministry of Health is investigating reports of a shortage of drugs on the island and said it stands ready to meet with the Jamaica Association of Pharmacy Owners (JAPPO) on the matter.

In a news release on Friday, the ministry said it is in touch with a number of local distributors to find out from them any shortages or anticipated shortages they may have.

The ministry said in the past it has had scheduled meetings with the Pharmaceutical Society of Jamaica, in which matters of concern were amicably discussed.

"To date the ministry has not had a call from JAPPO or any other private sector drug-related organisation regarding the shortage of drug supplies in the private retail sector," the Health Ministry said, adding that "It must be noted that the local pharmaceutical manufacturing industry produces less than 10 per cent of the Jamaica’s pharmaceutical needs and, therefore, Jamaica depends largely on imported medicines."

The ministry added that drug shortages or stock-outs are caused by many factors, over which it often has no control. According to the ministry, these factors include:

- Business decisions by overseas manufacturers to voluntarily discontinue supplies.

- Global shortages affecting active pharmaceutical ingredients. In the absence of these raw materials, Finished Pharmaceutical Products cannot be supplied.

- In the presence of shortages, manufactures are likely to satisfy their country demands first, thus creating a shortage in other markets.

- Lack of early warning systems that could trigger impending drug shortages thus providing adequate opportunities to prepare for the shortage.  

"Manufacturers and distributors locally are required to notify the Standards and Regulation Division in the Ministry of Health regarding any problems that may arise regarding pharmaceuticals. However, the private industry is inconsistent in bringing these matters to the ministry’s attention, leaving the ministry unaware of these concerns," said the health ministry.

The ministry urged distributors to "take a proactive approach in notifying the ministry regarding drug shortages so that any intervention that is possible for the ministry to make, can be made before there is a total stock out or before it becomes impossible to source a drug."

The Food and Drugs Act and Regulations 1964 and 1965, which govern the regulation of drugs in Jamaica, require that all imported drugs be first registered by the Ministry of Health to ensure they satisfy the basic criteria for drug safety, drug quality and efficacy.

Following registration, permission to import must be given by the ministry via the Permit Approval System. The Pharmacy Council must licence any drug importer prior to importation. Dispensing (retail) pharmacies would, therefore, have to be reclassified and licensed as distributing pharmacies, the Health Ministry said.

The ministry also noted that the law requires that a product for which registration is sought in Jamaica, must first satisfy the laws in the country from which it is coming. Only five countries in the Caribbean have any systems for drug regulation "and Jamaica is by far the most advanced," the ministry said.

"There is a high possibility for counterfeit and/or substandard products in the unregulated markets. Importation under such circumstances could subject the local market to undesirable products. As these countries do not themselves assess or register the drugs they import, it would constitute a breach of Jamaica’s Laws to import from them," explained the ministry in the release.

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