Pharmacists dispensing unlicensed medications due to shortages

Exempt medicinal products can be legally supplied under prescription but are not assessed by the Health Products Regulatory Authority

There are more than 270 medium- to high-level medicine shortages, according to the most recent figures from the HPRA

More than 40 per cent of pharmacists are dispensing between one and five unlicensed medications a day due to shortages in the State, a new survey suggests.

An exempt medicinal product (EMP) is a medication that is not authorised or registered in Ireland but which can be legally supplied under prescription to fulfil special needs of patients.

The Health Products Regulatory Authority (HPRA) does not assess such products’ quality, safety or efficacy, as they are exempt from the requirement for marketing authorisation.

Sources working in the sector said the purpose of EMP was initially for unique circumstances, but it was increasingly being used to treat patients due to medication shortages. There are more than 270 medium- to high-level medicine shortages, according to the most recent figures from the HPRA.

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In the survey of 200 pharmacists by polling company Ireland Thinks, commissioned by Azure Pharmaceuticals, 43 per cent said they dispensed one-five EMPs a day, while 29 per cent said they dispensed six-10 daily.

A further 18 per cent of pharmacists said they dispensed EMPs 11-20 times a day, while 8 per cent said they did it in excess of 20 times a day.

Sandra Gannon, managing director of Azure Pharmaceuticals, said the increasing number of EMPs being used was “tangible proof of the consequences of not addressing medicine shortages”.

“Faced with continued shortages, their options are narrowing, leaving them with little choice but to increasingly dispense unlicensed medicines,” she said.

A spokeswoman for the Irish Pharmacy Union (IPU) said the trend on the number of EMPs being dispensed “continues to rise year on year”.

“The main reasons for this include medicine shortage of originator products to products not being licensed in Ireland, to products no longer marketed,” she said.

The spokeswoman said medicine shortages were an “ongoing concern for community pharmacists and the patients they serve”.

“Community pharmacists are under increasing pressure as they deal with the daily strain of trying to find ways of dealing with constant shortages, which is causing increasing anxiety for patients and taking significant time for pharmacist to resolve.”

A spokesman for the Department of Health said medicine shortages were a “feature of modern health service and a global problem”.

“The Department of Health is progressing a number of measures including primary legislative amendments to make regulations to enhance the security of medicines supply and for the better management of shortages,” the spokesman said. “For management of ongoing or anticipated high-impact shortages, the Department of Health convenes a multi-stakeholder group.”

Shauna Bowers

Shauna Bowers

Shauna Bowers is Health Correspondent of The Irish Times