Pharmacists dispensing unlicensed medication due to shortage, union says

Pharmacists are having to increasingly dispense unlicensed medication due to shortages in the State, the representative union has said.

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 fulfill special needs of patients.

Sources working in the sector said the purpose of EMP was initially for unique circumstances, but it is growingly being used to treat patients due to medication shortages. There are more than 300 medicine shortages, according to the Health Product Regulatory Authority (HPRA).

One source working in the pharmaceutical industry warned about the use of EMPs, stating there were two recalls in the sector in recent months for potential harm to patients. Adding that the more often EMPs are used for this purpose, the “more likely for serious consequences”.

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A spokesman for the Irish Pharmacy Union (IPU), said pharmacists have seen an increase in the number of EMPs provided to patients this year.

[ Community pharmacy is a vital lifeline for our society – so why are pharmacists being cut loose? ]

“In our medicines shortages survey from earlier this year 95 per cent reported that there has been an increase in the number of unlicensed medicines they dispense with 82 per cent indicating it was because of a shortage of the originator product which is licensed in our country,” the spokesman said.

Jack Shanahan, a community pharmacist and editor of the IPU review, said the issues around unlicensed or unauthorised medication are becoming “starker and starker”.

“While none of us are privy to the commercial procurement secrets of the unlicensed medicine supplies, there is at least one obvious weakness – items originating within the EU, in unfamiliar language and characters, are ultra high-risk. What was once a quaint irregularity has become a millstone around our collective necks,” he said in a recent edition of the IPU review.

Earlier this year, the HPRA issued several recalls for EMPs in Ireland. Two were issued for an anti-psychotic drug - one in January and one in June.

Another recall was issued to patients for an antibiotic cream for treatment of skin and eye infections being issued as an eye-drop. The leaflet was in Polish, with no English translation.

Mr Shanahan said this recall was “potentially catastrophic”, stating the Falsified Medicines Directive (FMD), a patient safety initiative, “cannot protect the public when it needs to”.

A spokesman for the Department of Health said “there is no evidence that Ireland has been, or is, more impacted by medicines shortages than other EU Member States”.

[ Prescription medicine prices vary hugely across pharmacies, survey finds ]

“There is a mechanism in Ireland that allows for the supply of unauthorised medicines: the Exempt Medicinal Product (EMP) route. EMPs can be supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by their individual patients on their direct personal responsibility to fulfil the special needs of those patients,” the spokesman said.

“The HPRA does not assess such products’ quality, safety or efficacy, as they are exempt from the requirement for marketing authorisation. The HPRA has no role in the clinical decision regarding patient treatment.”

Meanwhile, Minister for Health Stephen Donnelly on Monday will announce plans to enable pharmacists to extend the validity of prescriptions from the current maximum period of six months to 12 months.

The new measure, which will take effect from March 1st, will also allow prescribers to write prescriptions with a maximum validity of 12 months, if they so wish.

The announcement follows the Minister’s acceptance of the first recommendation of the expert taskforce which is examining the possible expansion of the role of pharmacists.