Medicines shortage forcing pharmacies to sell unlicenced products to patients

The medicines shortage is forcing pharmacies to sell unlicenced products to patients.

A new survey commissioned by Azure Pharmaceuticals has found that 43% of pharmacies are now dispensing up to five unlicenced medications every day.

Just short of 30% said they are dispensing between six and 10 every day, while 18% said they do so 11 to 20 times per day.

Some 8% said they do it more than 20 times a day.

The pharmacies are dispensing the products under the Exempt Medicinal Product (EMP) regulation, which allows a medication which is not authorised or registered in Ireland to be legally supplied to fulfil the special needs of patients.

The EMP was initially introduced for unique circumstances; however, Azure Pharmaceuticals has warned that it is now being used by pharmacies who can’t access products due to the medicines shortage.

On The Pat Kenny Show this morning, Azure Pharmaceuticals spokesperson Sandra Gannon said pharmacists are concerned about the increase.

“You’ve got unlicensed medicines that are supposed to be used by exception – so not for use generally,” she said.

“They’re coming from a variety of countries, increasingly with leaflets that are not in English, so that makes it incredibly difficult for patients when they’re taking their medicine, if they get, you know, a patient information leaflet that they don’t understand.

“They should be used by exception but what we’re seeing here is that, as the number of medicine shortages grow, pharmacists are being forced to use medicines from outside of Ireland – often outside of the EU – and more increasingly, with patient information leaflets that are not in English.

“Obviously this is leading to a high degree of concern for pharmacists and we’re now seeing 72% of pharmacists are dispensing between one and ten unlicensed medicines every day.

“It’s costing the State a lot of money and It’s costing patients money because quite often they have to pay out of pocket for the difference between the reimbursed licenced medicine and what is being charged for the unlicensed medicine.”

Digital Products Medicines shortage

According to the Health Products Regulatory Authority (HPRA), there are now more than 270 medium to high level shortages of medicines in Ireland.

Ms Gannon said there are several reasons for the shortage.

“What we’re seeing is obviously, globally, as people age, the demand for medicines is growing,” she said.

“We’re also seeing prices fall as products come off-patent and you get a number of reductions of price.

“We’re seeing then constraints in the manufacturing of the active pharmaceutical ingredients, so as prices fall, you’re seeing the movement of manufacturing to the Far East and decreasing numbers of suppliers there.

“So obviously supply is not matching demand and it’s global demand – so Ireland is competing with other jurisdictions for access to the same product and the manufacturers have choices where they decide to supply.

“So it’s a combined number of factors and it’s a growing problem globally.

“Obviously, with Ireland being a very small country, being the only English-speaking jurisdiction now in Europe and being an island, we’re seeing, probably, really, the thin end of the wedge when it comes to medicine shortages.”

She said it is important to note the medicines being sold are “licenced somewhere” – but the lack of clear instructions in English is causing problems for patients.

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