In special report, Eamonn Brady MPSI does a deep-dive into the ever-more-urgent problem of medicine shortages in Ireland
Shortages of prescription and over-the-counter (OTC) medicines can occur for a variety of reasons, such as regulatory issues, manufacturing delays, an unexpected increase in demand, product quality issues, and lack of commercial viability.
Recent global events, such as the Covid-19 pandemic, the war in Ukraine, and financial pressures — including inflation, the temporary blockage of the Suez canal, and, more recently, the Holyhead closure — have been blamed as ‘reasons’ for pharmaceutical industry shortages both in Ireland and internationally. However, the reality is that these factors may have had some influence at the time but no longer are the reasons for current shortages.
In Ireland, nearly 40 per cent of people in the last two years have been affected by medicine shortages. Medicines in short supply have included treatments for pain, blood pressure, respiratory illnesses, HRT, ADHD, digestive conditions, and arthritis.
The main reason Ireland has more medicine shortages than other EU countries is the low cost paid for generics.
The umbrella group Medicines for Ireland — which represents companies supplying generic medicines and companies that supply 60 per cent of all prescription medication dispensed and consumed in Ireland — stated last year that it has “delivered significant savings to the State in the last two decades. While cost savings have benefited the drugs budget, very low prices pose a risk to pharmaceutical companies’ viability to supply the Irish market due to drug acquisition costs.”
According to Medicines for Ireland, “Ireland has a market supported by generic companies that compete on small margins and typically do not carry large amounts of stock”.
The group explains that “unsustainably low pricing for many off-patent medications is one of the main factors creating vulnerability in the supply of medicines” and it feels that failure to look at the low prices the HSE pays for generics will lead to increased shortages as companies realise that many drugs are no longer viable to keep on the Irish market.
Some 82 per cent of all prescriptions are dispensed in Ireland on State schemes — ie, Medical Card (GMS), Drugs Payment Scheme (DPS), and Long-Term Illness (LTI) — so low prices paid by the State for generics is a major reason for shortages.
Bear in mind that there are less than 10 generic companies in Ireland, which are now all foreign-owned, so the number of available generics could potentially decrease over the next few years if these firms decide, as some have already, to take loss-making drugs off the Irish market or even exit the market completely. For example, generic medicine companies Pinewood and Clonmel were Irish- owned until recently and now most of their lines are manufactured abroad, as it is not economic to make cheap generics in Ireland.
Moreover, the World Health Organisation has stated it “recognises medicine shortages as a global problem, which has increasingly affected Ireland and other smaller European countries in recent years”.
Owen McKeon, head of generic company Mylan (now Viatris), said in 2018: “Ireland has now reached a tipping point whereby the price of some generic medicines has fallen to such an extent that often a month’s supply can cost less than a bar of chocolate. This is unsustainable over the longer term. These low-cost medicines continue to be used by tens of thousands of Irish patients, but are also often most vulnerable to shortages.”
In 2008, Ireland had one of the highest prescription drugs costs in the European Union (EU), but the
price that our health service pays for generics fell to below the EU average from a few years ago. As a country with a low population which is located at the edge of Europe (making it more expensive to supply), we consequently now have a bigger issue with out-of- stock medication due to fewer generic companies seeing Ireland as a viable country to do business in.
An EU-wide problem
Research from Teva Pharmaceuticals shows that Europe’s generics make up 67 per cent of all medicines. But over the last 10 years, the number of generic medicines withdrawn from the EU market increased by 12 per cent, while, on average, 3 per cent fewer generic products were launched — meaning that at the end of 2012, there were 40,280 separate generic products and 10 years later, only 29,836 generics, representing a 26 per cent decline.
Generic medicines are part of the critical list of medicines adopted by the EU in December 2023 and many treat critical illnesses in adults and children, including infectious diseases, cancer, and mental illness.
Antimicrobial resistance kills at least 35,000 people annually in the EU/EEA and “threatens to unravel modern medicine as we know it”. Despite this, Europe now has “31 per cent fewer antibiotic medicines than were on the market in 2012, and some 21 per cent of children’s antibiotic syrups have disappeared in the same period,” according to Teva’s research.
How generic medicines are disappearing – and why Teva’s research ‘The Critical Medicines Health Check’, published in March 2024, found that in the decade up to the end of 2023, the “disappearance of generic medicines is caused by an onerous regulatory environment and excessive race to the bottom on price. For example, an ovarian and small-cell lung cancer medicine saw a 49 per cent decline in the number of available products between 2015 and 2023, as inflation and production costs increased and prices collapsed, forcing 46 per cent of its providers out of the market.”
Moreover, 69 per cent of all generics marketed in 2022 are supplied by just one or two firms, leading to bottlenecks in supply.
Antimicrobial resistance kills at least 35,000 people annually in the EU/EEA
Ireland has more medication with only one supplier than any other EU country, which creates a higher risk of shortages.
Salbutamol shortage and its impact
The lack of suppliers in Ireland is exemplified by the shortage of salbutamol, a potentially life-saving drug. Despite the fact that salbutamol is the only nebulised version of a bronchodilator licenced in Ireland for severe cases of shortness of breath — such as in asthma, exacerbations of COPD (bronchitis), bacterial, and viral infections — salbutamol nebules have been out of stock for nearly a year.
The two salbutamol nebule brands available in Ireland, Salamol Sterinebs and Ipramol (a combination version), were out of stock for most of 2024. Ventolin Nebules, which was the only other version available, was withdrawn from the market in Ireland a few years ago, with most industry insiders citing the reason being the low price paid for it by the HSE.
Salamol 2.5mg nebules came back into stock on January 15, 2025 — but soon went out of stock again. However, despite shortages for over a year, the only explanation the manufacturer could give was the “unexpected demand experienced in many countries”.
I know that in many countries where the price of salbutamol nebules are a lot higher than Ireland, there has been ‘less’ supply issues compared to Ireland. Moreover, the companies stated there were “appropriate alternative medicines approved” — but I know from being a pharmacist for more than 20 years that this is not true. There was no licenced bronchodilator for a minimum of six months and the likes of ipratropium nebules are not a suitable alternative. Despite the fact that it opens airways through an ‘anti- cholinergic’ effect, it is not nearly as intense or as quick at opening airways as salbutamol. Moreover, at the time of writing, ipratropium nebules are also out of stock.
Even terbinafine (Bricanyl) nebules are available in most countries worldwide, but not in Ireland. In my opinion, as a pharmacist, there was rarely a drug shortage situation that endangered patients’ lives more than the shortage of salbutamol nebulisers.
My pharmacy — Whelehans Pharmacy Clonmore in Mullingar — caters for the nursing home sector, as well as being a regular pharmacy. Since Christmas 2024, as flu and other viruses and bacterial infections have circulated, we have received on average 30 prescriptions a week for nursing home patients who were struggling with their breathing.
While these patients would also be prescribed the likes of oral prednisolone to reduce inflammation in the lungs (which ultimately helps breathing), these drugs can take days to work. So, before their effects kick in, the patient often needs a quick- acting nebulised reliever (a salbutamol inhaler would not be sufficient) to get them over the initial phase.
It was such a challenge for my team and I, as even though we could order the unlicenced version, by law it can only be ordered after a prescription has been received, and there were days when we had no stock to give. We obviously consulted with the nursing teams in each nursing home to ‘triage’ the patients with the worst breathing issues, but it led to so much stress for families, patients, nurses, and our own staff.
For the GPs prescribing salbutamol nebules, most were aware of the shortage and so often prescribed it more in ‘hope’ than anything else. Many patients had to end up on oxygen temporarily due to delays in supply and while the ultimate aim is to keep patients out of hospital, some ended up there. Although I can’t say for sure the exact numbers, some would have been hospitalised due to salbutamol nebule shortage. There are no figures countrywide on whether the shortage of salbutamol led to deaths — this is something we may never know.
Whelehans Clonmore is only one pharmacy in Ireland, although we are in a slightly unique position in that we cater for many very vulnerable nursing home patients. Since Christmas, the higher-than-normal amount of flu cases — especially in nursing homes due to the contagious nature of flu — definitely put the shortage of salbutamol is sharp focus for my team and other health professionals like GPs and nurses who we work with. **At least it’s eventually back in stock.
Other reasons for shortages
Extra cost of packaging for medicines in Ireland due to Brexit
Another factor blamed in the past is Brexit, but Brexit has had very little impact on Irish drug supply, mainly because there was a ‘soft’ Brexit and the Northern Ireland Protocol. But Brexit does pose a problem to the Irish drug supply, in that Ireland and the UK are both English-speaking countries — but Ireland is now the only English- speaking country in the EU.
Up to Brexit, many drug companies had dual licences for the UK and Ireland, as the shared language made packaging for Irish products cheaper pre-Brexit. Bear in mind also, it is not only the different packaging; Ireland now must have its own specific assembly run on packaging assembly lines in factories which are highly automated. While this may seem simple to change, it adds further preparation time and cost.
I was lucky enough in September 2024 to visit Europe’s largest generic manufacturer Krka, located in Slovenia, and along with other Irish pharmacists, we were physically shown that the allocated time for the packaging cycle, depending on the product, may only be 5,000 packs for Ireland. But previously when the UK had the same packaging, this same run could have been for 50,000 packs. Moreover, there is downtime between each packaging changeover and this further increases costs for Irish products.
Of course, companies like Krka are used to this as they supply most countries in Europe, which will already require country-specific changes on packaging, such as a different language and other regulatory differences.
However, in Ireland’s case, the advantage of being bundled with Britain for packaging pre-Brexit made
a significant difference in a very low- margin business, so Brexit-enforced Irish packaging changes have further reduced Ireland’s attractiveness for both new generic medicines, as well as the generics we currently are supplied with.
Some 60 per cent of drugs consumed in Ireland are generics. Without these financial pressures, our generics market would be expected to grow, as several important classes of commonly prescribed branded drugs like NOACs such as Xarelto and Eliquis — new, safer versions of blood thinners — start to come off patent this year in Ireland.
Penetration of generics in Ireland should therefore exceed 70 per cent in the next five years, but a lot of this is dependent on price. Specific packaging for Ireland means the increased cost per pack of medication, despite being only a cent or two per pack, when coupled with such tight margins, can make a real difference regarding the viability of supplying a generic to Ireland.
FMD (Falsified Medicine Directive)
FMD means that all prescription drugs in the EU must have a special extra FMD barcode which pharmacists scan to make sure the medicine is not false. This is a good thing. However, again, it is an extra packaging cost for already low margin generic companies due to more packaging costs.
More inspections of Indian ingredient manufacturers
A lot of generic medicines and active ingredients are made in India and the number of inspections by the Food and Drug Administration (FDA), the regulator of medicines in America, has increased in the last few years. This has resulted in more factories closing, at least temporarily, leading to a shortage, at times, of more medicines, as this affects European supply as well. However, on a positive note, a higher percentage of Indian drug manufacturing sites have passed FDA inspections.
Less sites to produce active ingredients
Another problem in the last few years is that fewer and bigger factories worldwide are used to make active ingredients for multiple companies in, for example, India and China. So, if that initial site is closed due to a fire or failed inspection, many companies are short of the same active ingredient at the same time.
For example, nearly all brands of rosuvastatin (a popular statin used for cholesterol) went out of stock a few years ago. And while the reason for nearly every generic company going short at the same time was not explained, the consensus from many in the industry was that one of the main factories that made the active ingredient went down for a period of time, leading to a major worldwide supply shortage.
Larger and older population
Demand is higher as our population grows and ages, and drug companies take account of this. However, something that blindsided drug companies for a while in relation to predicting supply is that Ireland has welcomed the eighth-highest number of Ukrainian refugees per capita. While we all agree that this is a positive response, remember that this represents more than 100,000 extra people (over a short period), often either very young or old, who need more medicines in general, so the demand on certain drug increased at a rate that could not have been envisaged prior to the war.
US tariffs
The Donald Trump-led US tariffs on its trading partners is another potential future risk to pharmaceutical supply chains. **At the time of writing, the American administration has made no announcement regarding pharmaceuticals.
While most drugs supplied to the European and Irish market are not made in the US, tariffs risk disrupting global supply chains. They also potentially create the risk that pharmaceutical companies (especially American ones) who manufacture pharmaceuticals — as well as other active ingredients and key components — outside of the US will change where they manufacture and where they supply. As this is a medium- to longer-term risk factor, it is harder to predict right now if and how it will affect pharmaceutical supply chains.
Solutions from drug companies and pharmacists to ensure you get your right drug at the right time are outlined below.
The Donald Trump-led US tariffs on its trading partners is another potential future risk
Temporary international versions
If an essential drug like an epilepsy drug is out of stock here for a prolonged period of time, the pharmaceutical company will avail of special approval from the Health Products Regulatory Authority (HPRA) to temporarily licence the UK — or another EU country’s — version in Ireland to ensure sufficient stock. This option works well, and the pharmaceutical company does not charge the HSE or private patient extra.
This special approval is used relatively rarely but is important for essential-to-life or essential-to-quality- of-life drugs, and relates mainly to brand drugs that have no alternatives here, such as some epilepsy drugs. It is not used often by generic companies, as there is usually more than one generic for most drugs and it is likely the generic companies do not have the financial margins to provide this service. Bear in mind too that this process means a lot of communication to GPs, pharmacists, and patients. Extra labelling when required for the pack is an extra cost for the pharmaceutical company, meaning this option would not be viable financially for generic companies.
Alternative unlicenced versions of Irish products that cost the patient more Another tool a pharmacist has to source an out-of-stock drug (very often in recent years), though at an extra cost financially for the patient, is for the pharmacist to procure an imported unlicenced version of the drug either from an Irish wholesaler such as United Drug, Uniphar, Medisource, and so on, or from a Northern Ireland wholesaler such as McDowells, thanks to the exemptions given to Northern Ireland companies to import to the Republic of Ireland despite Brexit.
However, these unlicenced versions are often significantly more expensive than the licensed Irish version, and in over 99 per cent of cases the HSE will not pay for them. On very rare occasions, the HSE will temporarily pay extra for essential drugs such as salbutamol nebules (see above) under what is called the HSE’s Hardship Scheme. This option only occurs under very strict criteria and the pharmacy must submit a lot of paperwork to the HSE for approval, otherwise the patient must pay the extra price.
Generally, drugs sourced this way are a minimum of 50 per cent more expensive than the licenced version, despite being identical. It is worth pointing out that just because a drug is unlicenced in Ireland does not mean it is any less safe, it is just not licenced in Ireland, ie, it is licenced in another country.
When a drug is out of stock here and the pharmacy procures an unlicenced equivalent after permission from a patient and their GP, it usually only takes a day (or even the same day) for the patient to get it, as most suppliers like United Drug and Uniphar keep unlicenced meds in stock, so the patient is generally not inconvenienced time-wise, only cost-wise.
Anyone unlucky enough to have experienced scabies in the last year will know that permethrin cream (Lyclear is the brand) is the most effective treatment, but that it has been pretty much out of stock for over two years — apart from rare brief returns to stock, but it is usually sold out again within 24 hours.
**Lyclear Cream is currently out of stock at the time of writing (end of January 2025) and there are currently three suppliers that I can find for unlicenced permethrin cream. In the Republic of Ireland, one charges three times the normal Lyclear price, and one charges four times the normal price. And the supplier I found in Northern Ireland charges twice the normal Lyclear Irish price, and so was the cheapest unlicenced version of permethrin I could find.
Pharmacy-only medicines (that normally do not need a prescription) can only be sourced by pharmacy with a prescription if an unlicenced version is needed
By law, all unlicenced medicines, even OTC medicines that do not normally need a prescription in Ireland (such as Lyclear), can only be ordered by the pharmacy via a prescription from the patient’s GP. This requirement obviously adds on cost to the patient if they do not have a GMS card, and time (time to contact GP and then for the GP to get a prescription to the pharmacy). The prescription-only stipulation for unlicenced medicines which are normally pharmacy- only is governed by No. 540/2003
— Medicinal Products (Prescription and Control of Supply) Regulations 2003. This requirement adds another layer of stress and bureaucracy, as well as potentially more cost to the patient, and it should be reviewed.
How regulators can tackle the medicines shortage
Medicine Shortage Framework
Ireland has a Medicine Shortage Framework, introduced by the HPRA and HSE/Department of Health in 2018 in conjunction with another nine organisations representing GPs, pharmacists, patients, some pharmaceutical industry involvement (very little), and others.
It is now operated by the HPRA on behalf of the Department of Health. However, the powers given to them to deal with these issues at the frontline are very weak.
Ireland’s Medicine Shortage Framework is not working
As a pharmacist on the frontline, I have not seen any success with the Medicine Shortage Framework. In fact, the out-of-stock situation has become worse since it was introduced in 2018. This is not the HPRA’s fault, as these increased shortages are more down to international factors and also the Government policy of paying so little for generic drugs — less than the European average — in a country the size of Greater Manchester.
This policy means that generic drug companies are firstly not targeting Ireland, as the income is not viable. An essential and popular blood pressure drug like Telmisartan 80mg, which was out of stock in Ireland in recent months, has ‘only’ three generic brands available in Ireland — Accord, Rowa, and Clonmel brands. The UK, a much bigger country than Ireland, has more than 20 brands of Telmisartan 80mg on the market and other (mainly bigger) EU countries also have a lot more generic alternatives than Ireland. This reality is mainly down to economics; ie, a bigger country equals a bigger market equals more sales, and therefore makes it more economic for companies to sell drugs there.
Ireland should copy the UK’s Serious Shortage Protocol (SSP)
The UK’s Serious Shortage Protocol (SSP) is a regulatory framework that allows pharmacists to supply an alternative medicine when a prescribed drug is unavailable. Introduced in 2019 under the Human Medicines Regulations 2012, the SSP aims to prevent disruptions in patient care due to supply chain issues.
When a shortage occurs, the Government issues an SSP for a specific medicine, detailing permitted substitutions, such as a different strength, formulation, or therapeutic equivalent. Most importantly, the
UK SSP means pharmacists can dispense an alternative but therapeutic equivalent without consulting the prescriber (unlike Irish pharmacists), ensuring continued treatment while reducing GP and pharmacist workload.
This protocol in the UK means drug shortages have far less impact on patient supply and delay than in Ireland. Pharmacists in Ireland have been calling for a similar system here for years, including through
the Irish Pharmacy Union. There are EU proposals on reducing medicine shortages, but there have been no changes yet on an EU level to improve the situation.
HPRA: Not all medicines are reported short
While individual brands or strengths of a medication may be temporarily unavailable, for many medicines there are appropriate substitutions. These include different strengths (which pharmacists can change without notifying the prescriber but obviously ensuring the patient is happy once the reasons are explained), brands (which pharmacists can change without notifying the prescriber but ensuring the patient is happy once the reasons are explained), or similar classes of medicine.
Another way of tackling medicine shortages is for manufacturers and stakeholders to better communicate and co-ordinate their efforts for the benefit of patients in Ireland. Currently, there are more than 400 medicines classified as being short on the HPRA website. However, I know many other drugs that are in short supply but are not listed are such. Drug companies must do more to notify the HPRA more promptly, which I admit can be a challenge with so many medicines going in and out of stock.
Despite being essential, drugs are still only a commodity
Despite the pharmaceutical industry and the supply of medicines being essential to people’s health, the reality is that the pharmaceutical industry is no different to other industries. At the end of the day, in the pharmaceutical industry, money talks and companies will sell where they get the biggest return.
Plus, when a drug goes short here, due to strict licencing laws, other drug firms cannot simply launch a medicine in Ireland within a matter of weeks, as there are so many regulatory hoops the company must go through. However, such regulation is important, as the last thing we want to see is inferior
or falsified medicines on pharmacy shelves. Unfortunately, desperate
Currently, there are more than 400 medicines classified as being short on the HPRA website
customers will turn to the Internet to purchase out-of-stock or hard-to-avail- of medicines such as Ozempic from bogus pharmacies, or individuals not even pretending to be pharmacies.
Most shortages do not lead to life-threatening issues for patients
Despite my explanation of the dangers associated with the recent salbutamol nebules shortage, it is extremely
rare. And as pharmacists are health professionals and experts in this area, in 99.9 per cent of cases, pharmacists find a suitable alternative to the out- of-stock drug — either an unlicenced version or a different strength of the same drug.
Another option is to contact the GP to find out the closest equivalent for, say, an antibiotic that is out of stock. Antibiotics feature high on ‘out-of- stock lists’ but because there is nearly always an alternative, it does not become an issue.
Despite Ireland being one of the biggest drug exporters in the world, this does not affect our domestic drug shortage issue
Finally, as it’s something that is often asked, despite Ireland being one of the biggest manufacturers of medication in the world by dollar value (approximately the seventh biggest exporter of medicines of all countries by dollar value), it comes as a surprise to many that we have one of the biggest shortage problems for medicines in Europe. However, the reality is that most medicines manufactured in Ireland are of very high value (branded medicines) and include the likes of vaccines, immunotherapy, cancer drugs, and medical devices that are for export only, often to the US, so these products do not influence the actual supply of medication in Ireland.
I explained earlier that most medicines shortages are generic medicines, and very few of generics are actually made in Ireland. Most generics are made in lower-cost countries and so, for the reasons described above, medicine shortages are higher here than in many other European countries.
Note: This article was written in mid- April 2025, so some of the shortage issues may have changed since.
References: Upon request.
This article is based on pharmaceutical and medical references, but some of the statements made in this article are the opinion of Eamonn Brady due to his experience as a pharmacist and are not meant to be the opinion of the general pharmaceutical industry.
Written by Eamonn Brady (Pharmacist). Whelehans Pharmacies, 38 Pearse St and Clonmore, Mullingar. Tel 04493 34591 (Pearse St) or 04493 10266 (Clonmore), Mullingar. www.whelehans.ie
