Niamh Cahill reports on Ireland’s medicine shortages and how they impact human health
The time spent by pharmacists dealing with medicine shortages has tripled in the last 10 years, according to the Pharmacy
Group of the European Union (PGEU). In 2023, the group estimated that every pharmacy in the EU, including Ireland, spent nearly 10 hours per week managing the impact of shortages.
The situation has become so onerous that some commentators believe the issue is a contributing factor in pharmacist burnout.
But the negative effects don’t stop there, unfortunately. PGEU has highlighted that not only can shortages cause stress among patients, they can lead to medication errors, patients ceasing treatment, increased costs, and raise the risk of adverse medical events.
Medicines shortages are now a common feature in healthcare globally, but many believe they have worsened significantly in recent years.
Some pharmacists in Ireland have argued that the situation is now at its worst. Indeed, drug shortages are commonly raised in political echelons. The matter of inadequate supplies of hormone replacement therapy (HRT) was raised in the Seanad in March by Senator Mary Fitzpatrick, for example.
Following the emergence of Covid-19 in 2020, medicines shortages were brought into sharp focus as demand for certain medicines soared and supply for other drugs became limited.
A spokesperson for the European Medicines Agency (EMA) told Irish Pharmacist that as a direct result of the pandemic, the EMA began several activities to better monitor and co-ordinate action on shortages within the EU.
The EMA spokesperson outlined that shortages have the potential to “seriously impact” human health. They added that medicine shortages can have “multiple causes”.
“For example, there can be manufacturing problems causing delays or interruptions in the production, shortages of raw materials, increased demand of medicines, distribution problems, labour disruptions and natural disasters,” explained the spokesperson.
“Generally, the availability of medicines is also susceptible to geopolitical instability, and events like the Ukraine war, the energy crisis, the increase in inflation and the Covid-19 pandemic in recent years have had an impact on shortages in Europe.”
Spokespersons for the HPRA and the Department of Health told the publication that the most commonly cited reasons for shortages are manufacturing and quality issues.
Impact
Rory O’Donnell, Donegal-based pharmacist, said that he deals with shortages on a daily basis.
“Every day I will have at least one difficult conversation where, very often, a life-saving medicine is not available and there is no alternative available. No matter how well practised you are at explaining to the public that this [drug shortages] is not just ourselves, they don’t always understand how their medicines cannot be available.
I’ve had some terribly difficult conversations with patients.
“We spend untold amount of time on the counter or on the phone having very difficult conversations because it’s not always possible to swap somebody to a different brand or molecule. Sometimes there are medicines that are unavailable full stop without any obvious therapeutic alternative. We get calls from patients from all over the country looking for certain types of medication.”
Dublin based pharmacist Tomás Conefrey said that in a recent four-hour period at the pharmacy, he encountered six instances of having to deal with a medicine shortage on a prescription.
“I had to explain this to the patient, contact the prescriber, look through different suppliers lists and check the HPRA shortages list online in each case,” he recalled.
“In my experience, it is the worst it has ever been. The reason is, the actual drug molecules are not available in many cases. This means that the generic brands of a particular medicine, for example Venlafaxine, are all not available.”
Jack Shanahan, a pharmacist based in Kerry, agreed that pharmacists are spending more and more time dealing with shortages.
He argued that due to market forces, the already relatively small Irish market had lost “quite a lot of medications over the last 10-to-15 years”.
“There are only two wholesalers in Ireland now but when I started out, there were five or six,” he said.
While many so-called high tech medicines used to treat long-term illnesses remain costly, he maintained:
“A lot of medicines — not all, but the vast majority — are cheaper here now than in Europe following various drug agreements” reached between the State, drug suppliers and healthcare authorities around pricing and supply in Ireland.
Mr Shanahan suggested the proposed medicine substitution protocol would help ease the time spent by pharmacists on managing shortages by allowing them to substitute medicines where appropriate.
He explained that “a lot of time is spent contacting GPs and prescribers about what they would like to prescribe when there is no alternative and some prescribers are very difficult to contact”.
“Some GPs write on prescriptions ‘or any suitable alternative’ but while the pharmacist knows exactly what they mean, we don’t have the legal power to change a prescription.”
But even if the protocol is introduced, drug shortages and the need to find suitable alternative medications will remain a very challenging process for patients, according to Mr Shanahan.
“Often, when we do find alternatives, this can sometimes cause confusion in patients. This is when another drug might mean a patient now has to take five tablets a day instead of one a day, for example,” he stated.
“There is a potential for problems here and issues do arise, but we try to avoid confusion so errors are avoided and patients keep taking their medication.”
Often, when we do find alternatives, this can sometimes cause confusion in patients
Changes
The Health (Miscellaneous Provisions) Act 2024 was signed into law in July 2024, giving a primary legislative basis for the introduction of Medicines Substitution Protocols (MSPs).
According to a spokesperson for the Department of Health, once in place, MSPs will “enable pharmacists to supply a specified alternative medicine for a specific shortage, in accordance with a protocol rather than a prescription, without needing to seek authorisation from the prescriber. The secondary legislation needed to provide a framework for MSPs, and the stakeholder discussions needed, are currently underway.”
The spokesperson did not provide a timeline on when MSPs would eventually be introduced, but said that there was no “evidence that shortages disproportionately impact patients in Ireland compared to other countries”.
“There are now more medicines available/ licensed, so this would be a contributing factor in the number of shortages. Most recent shortages stem from increased use/ prescriptions worldwide, as well as global supply chain issues which can impact upon the final supply of a medicine to Ireland.”
The WHO recognises medicine shortages as a global problem and says that they require increased focus from governments, given their potential public health impact.
A spokesperson for the IPU said that the union has consistently advocated for the Government to take a more proactive approach to the management of medicine shortages and to identify policy tools and actions to strengthen the continuity and security of the medicines supply chain.
The IPU has highlighted 10 key areas where action could be taken to alleviate problems, including enabling pharmacist- led therapeutic substitutions, improved reporting of shortages by marketing authorisation holders, and establishing a national critical medicine stockpile by building buffer stocks.
The Health Products Regulatory Authority (HPRA) is responsible for regulating and overseeing the safety, quality and efficacy of medicines in the market.
The Irish-specific definition of medicine shortages — from the HPRA, as not all countries define medicine shortages in the same way — describes them as being “when the supply of a medicinal product is inadequate to meet the needs of patients”.
Indeed, the definition itself, which is not uniform globally, points to perhaps the first area where improvements could be made.
PGEU has argued that a common definition of medicines shortages across the EU and the full supply chain could help “to better identify and evaluate medicine shortages and to accelerate a co-ordinated response”.
On 28 February 2025, the HPRA had been notified of 388 shortages affecting the market at this time, however, this figure changes regularly and is in constant flux as product shortages emerge and subsequently resolve.
A HPRA spokesperson said: “The causes of medicine shortages are multifactorial, including shortages of raw materials, manufacturing difficulties, product recalls due to potential quality defects, and increased demand.
“Medicine shortages can originate at any point in the supply chain and can involve and impact on many different stakeholders. Each shortage represents an individual set of circumstances.”
The HPRA outlined that each pharmaceutical company is responsible for supplying its product to the Irish market, monitoring its products’ supply to the Irish market, and notifying the HPRA and the HSE of potential shortages.
“The notification of possible shortages to the HPRA is the basis for triggering the medicines shortages framework (MSF) and the associated co-ordinated multi-stakeholder response as required, including preventative or mitigation strategies,” said the spokesperson.
The MSF is operated by the HPRA on behalf of the Department of Health and aims to prevent potential shortages from occurring and works to reduce the impact of shortages on patients by co-ordinating the management of potential or actual shortages as they arise.
Mr Conefrey maintained that there is significant room for improvement on communications to pharmacists around shortages.
“Certain products are not available at different times of the month. There is no continuity of supply,” he said.
“I am astounded in the era of email that more companies do not contact community pharmacy by email to advise of shortages. We are the last to know when a product is out of stock because we can’t obtain any stock. We are last to know when the stock is back, as it is usually when it appears in a dispensary order in the pharmacy that we find out.
Certain products are not available at different times of the month. There is no continuity of supply
“If we had more time on when a product is going out of stock and likewise when it is due to return, it would give us a little bit of breathing room to prepare. Some companies are very good at this, but I wish more companies would at least give us a heads-up if there is an impending shortage.”
A HPRA spokesperson said that it, along with the Department of Health and HSE, works together with manufacturers of medicines, wholesalers, and pharmacists to closely monitor the supply of medicines to Ireland, particularly where there are indications that supply may be disrupted.
“The HPRA continues to proactively engage with suppliers of medicines subject to persistent shortages, to understand the responses of the company to meet the increase in demand and/or introduction of necessary measures to prevent shortages from occurring. In certain cases, the HPRA has also engaged with relevant suppliers to explore opportunities for regulatory flexibilities, including supporting new authorisations, that can assist to better meet the current demand.”
Solutions
While the causes of medicine shortages, which are often complex, are well- documented, solutions on how best to comprehensively address the matter have been slow to materialise.
Mr O’Donnell maintained that the matter is not being taken seriously enough by Government.
A spokesperson for the HPRA, however, said that “through a combination of legislative action, regulatory expertise, and collaborative strategies, Ireland and relevant European institutions are taking affirmative measures in strengthening healthcare resilience and safeguarding continued access to medicines”.
The spokesperson highlighted the expansion of the mandate of the EMA to optimise the management and prevention of shortages at European level.
In the proposed revision of the EU Pharmaceutical legislation, which is currently under consideration, the European Commission has proposed further strengthening measures and specific initiatives, such as the introduction of the union list of critical medicines and the requirement for medicine suppliers to have in place shortage prevention plans.
“Such measures are anticipated to further improve supply chain resilience and promote continuity of supply… There is also ongoing work nationally, with the introduction of new legislation that will strengthen the capacity of the Medicines Shortage Framework to prevent and mitigate shortages. This includes the introduction of mandatory notifications of shortages to the HPRA, as well as facilitating the introduction of national stock monitoring systems. Such advancements should afford greater response capacity, with more forewarning of pending issues in supply, with actions that can then be taken in a timelier manner.”
