Drug shortages have led to the use of unauthorized drugs in Ireland

Patients and doctors are grappling with continued shortages of key medicines leading to unlicensed medicines in Ireland having to be used as alternatives in some cases.

ver 160 drugs are in short supply, including paracetamol, EpiPens to treat life-threatening anaphylaxis, as well as forms of hormone replacement therapy (HRT).

In some cases, doctors have access to medicines that are authorized abroad but not here by the Health Products Regulatory Authority (HPRA) in order to fill the gaps.

Medicines referred to as ‘exempted medicines’ have not been assessed for authorization in Ireland.

A spokeswoman for the HPRA, which has not released an updated list since 2020, said the drugs can only be prescribed by doctors for patients under their direct care and that clinical care is not a matter. not within his jurisdiction.

Referring to the shortage of licensed medicines, she said: “In the case of medicines used most often in Ireland, there are usually several forms, strengths, brands and generic medicines from a variety of sources.

“In the event that some are in short supply of individual medications, alternative options such as alternative dosages, brand names and generic medications will generally be available to ensure continuity of treatment.”

Commenting on the ongoing shortages, Sandra Gannon, head of Azure Pharmaceuticals, which is involved here in supplying some of the old off-patent medicines, said she wanted more done by the Department of Health and the HSE to reduce the level of drug shortages. .

She said the price the HSE pays manufacturers for some older drugs needs to be looked at as it is too low compared to what they will get in other countries.

This means that Ireland is at a competitive disadvantage when there is a global shortage, with manufacturers more likely to supply the market where they get the best price.

“Take, for example, paracetamol. It was short in May, June and July. There are only two providers in the market. The price of a pack of 100 paracetamol at 500 mg, standard dosage, is reimbursed here at €1.60. The average in the rest of Europe is €3.51. In Finland it’s €3 and in the UK it’s €2.80.

“Where a drug is in short supply, companies will allocate available stock to markets that pay the most.

“Other examples are the cancer drug Tamoxifen and HRT. The price here is cheaper than anywhere else in Europe.

She said state deals with big pharma here are heavily focused on unlocking funding for new drugs — but there needs to be more balance.

Older drugs are “cheap drugs”. He would not need a major increase in the drug budget. If you don’t take care of them, they disappear.

Shortages are filled in some cases with exempt medicines, which are authorized in another country but not here.

“We are seeing products like paracetamol being introduced as part of exempt medicines to cover shortages in the market.”

She said if companies like hers were to be encouraged to invest in due diligence to convert these unlicensed drugs to nationally licensed products, there needed to be a greater element of price certainty.

The HPRA said Novartis, which markets the HRT Estradot range, has ordered more products to be manufactured. One force has returned and it expects to meet increased demand across all pack forces by mid-October.

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