'A nightmare': Why hundreds of vital drugs are in short supply

Medication shortages in Ireland are increasingly impacting patient care, according to the Chair of the Irish Pharmacy Union's Contractors' Committee, Kathy Maher.

In two years there has been a 30% increase in drug shortages in Ireland, statistics from the Health Products Regulatory Authority (HPRA) show.

"Shortages are definitely getting worse," Ms Maher told Prime Time.

"I have to tell people month in, month out, 'I'm really sorry, but this brand has changed, or your medicine might be a different colour, a different shape, a different size.' That is not adequate patient care," she told Prime Time.

The problem is affecting a range of everyday medications relied on by patients, although high-profile drugs like Ozempic tend to grab headlines.

Breathing nebulisers, steroid creams, ADHD medications and blood pressure drugs are among 444 drugs currently on the HPRA’s Medicine Shortages List.

Among them is Daktarin, an anti-fungal medication used to treat fungal skin and mouth infections; the blood pressure medication Telmisartan; and Ipramol which is used to treat chronic breathing difficulties.

Global supply chain

So, what's causing the shortages?

The global market for medicines is under pressure, with many developed countries, not just Ireland, experiencing problems.

Manufacturing and supply chain issues have been exacerbated since the Covid-19 pandemic. These can occur unexpectedly, resulting in quality issues like batch failures, or stem from scheduled and planned activities like plant maintenance.

Where the drugs and their component parts are manufactured is another key element of the problem. The European Union has become increasingly dependent on non-EU countries for imported medicines.

On generic drugs specifically, there has been a reduction in the number of manufacturing sites operating globally, while the production of active pharmaceutical ingredients for such medicines has become predominantly located in India and China.

This consolidation, in combination with leaner, more disruption-prone, global supply chains has reduced the resilience of supply.

Increased demand

Demand-side issues are also a feature. Changes in clinical practise has led to some suppliers falling short, while there has also been a growth in 'patient-led demand' for certain products.

There has been a significant increase in demand for Attention Deficit Hyperactivity Disorder (ADHD) medications, for example.

Almost 20,000 patients have been prescribed medication for the condition between January and August this year, according to the HSE.

‘Please call back for the remainder of your prescription’ is regularly written on the boxes of Sarah Hayden’s ADHD medication, Tyvense. She says frequently pills are missing because there is not enough stock.

"Probably over the last six months, there's been a problem nearly every single time," she told Prime Time.

"It takes hours on the phone trying to get through, trying to call different pharmacies to see who has it in stock".

The midwifery student from Wexford Town was prescribed stimulant medication following a life-changing diagnosis of ADHD three years ago.

"I took the medication for the first time and there was no noise. My head was silent. It was the first time I was actually productive."

Having experienced the benefits, she’s now forced to take drastic measures to make sure she has enough medicine to complete upcoming, final-year assignment deadlines.

"I’m rationing my medication. I have two pills left and I'm holding on to those to make sure that I can do what I need to do and to meet my deadlines.

"That's not something you'd ever expect to have to do."

An additional complication for ADHD patients is that stimulant medications are controlled, 'Schedule Two' substances. They are drugs that have medical uses but are dangerous if misused. In such cases, pharmacists cannot deviate from specific prescriptions.

For example, if a dose of 80mg is not available but there are 40mg pills in stock the chemist cannot dispense a double dose. Instead, a new prescription is required.

The use-by date of stimulant prescriptions is also very short. Patients have just 14 days to get the medication having received the prescription, which can create problems if pills are out of stock.

Dr Sarah Carty opened a GP-led ADHD service in October 2022. Since then, ADHDdoc has developed a six-month waiting list for appointments. That might sound long, but it is still a lot shorter than the public system which has assessment lists that are years long.

"There’s been a huge increase in the number of people looking for a diagnosis of ADHD," Dr Carty told Prime Time.

Although medication is not required by everyone with ADHD, for many it is of huge benefit, Dr Carty explained.

"ADHD has a neurobiological basis to it, so these medications work on those parts of the brain which have been underperforming. They wake that part of the brain up."

The drugs have an effectiveness rate of between 70-80%, Dr Carty said, but clinicians must explain the shortages to patients when they issue prescriptions.

"I'm giving the prescription with one hand but I'm nearly taking back with the other, saying a patient may have to go to 15 or 20 different pharmacies to get it.

"It's heartbreaking for clinicians and for pharmacists, but most of all for patients," she said.

ADHD clinicians are bombarded with requests for prescriptions to be amended and updated because of the strict criteria of Schedule Two medications, Dr Carty explained.

The clinic has hired a full-time nurse whose job is largely taken up with such administration. Patients with ADHD are not well placed to manage a lengthy, complicated process to source medications, she added.

"We know that it is the reason why people give up their ADHD medications because it just all becomes too much."

For student Sarah Hayden, the shortages of her medication are a real worry.

"It's a nightmare," she told Prime Time. "Before I was medicated I didn't realise the difference it could make. I don't want to go back to how hard it was."

The HPRA told Prime Time the shortage of ADHD medications has been the subject of significant engagement across Health Service stakeholders.

"Where at all possible, all parties are focused on pre-empting and responding to any potential impacts on medicines supply," it said.

The authority said suppliers of some ADHD medicines have put in place allocations to ensure equitable supply to Irish patients.

"Where a shortage cannot be prevented, we aim to provide useful information to healthcare professionals and patients, in particular in cases where suitable alternatives available are limited."

Cost of production

While ADHD medications are still under patent, many of the other drugs experiencing shortages are off-patent, generic medications.

According to manufacturers, a significant factor in the shortages of such medications is the price paid to suppliers.In general, competitive procurement in developed economies has driven prices for generic medicines down to close to the marginal cost of production, according to a recent report by the UK's Royal Pharmaceutical Society. That may be at the expense of resilient manufacturing and supply chains, it suggested.

"Chasing lower prices may be a mixed blessing if it leads to portfolio pruning and disincentivises manufacturers from supplying," the report concluded.

The Irish State is due to renegotiate a new deal with suppliers in the coming months. There are calls for such procurement contracts to also emphasise supply chain resilience including quality measures, and ensure manufacturers have sufficient lead time to adjust production when needed.

Pharmacists have also been advocating for the appointment of a Chief Pharmaceutical Officer (CPO) arguing that the position would ensure that medicine supplies are consistently addressed at senior levels of the health system.

Another initiative regularly suggested to address shortages is the creation of a national stockpile of critical medicines to buffer against supply shocks.While the Department of Health said Ireland does not mandate holding of contingency stocks, "work on mitigating shortages of critical medicines is ongoing in various fora at a European level, such as via the Critical Medicines Alliance.

"European legislators are also pushing for laws to reduce dependency on chemical imports from China – which they believe will shore up the supply chain.In the meantime, pharmacies are increasing their use of unlicensed or 'Exempt Medicinal Products’.

"An unlicensed medicine is always safe. It's licensed for use in another country, it just does not have a licence for use in Ireland," Pharmacist Kathy Maher explained.

However, such drugs can cause confusion because the information leaflets are often in a foreign language and pharmacists must instead verbally outline instructions to customers.

Those instructions are added to the lengthy conversations with patients when the dose, brand name, or administration of a medication is changing.

"All of that takes away from the time that I want to spend going through the medical conditions.

"People are getting confused and there’s a risk they could take too many pills, or not take enough," Ms Maher said.

Unlicensed medications are not covered by reimbursement schemes so they can cost patients more than the original prescription. Pharmacists must also advise clinicians that the medication has changed.

While there is flexibility in the use of unlicensed medications, the Irish Pharmacy Union is calling for greater autonomy for pharmacists to swap and substitute other medications that are in short supply.

"I'm the clinician that knows what is safe and effective to use, and I would like to be empowered and enabled to therapeutically switch from one product to another," Kathy Maher explained.

The Department of Health told Prime Time legislation is in train to expand the autonomy of pharmacists.

"The secondary legislation needed to provide a framework for Medicines Substitution Protocols, and the stakeholder discussions needed, are currently underway."

The HPRA meanwhile told Prime Time medicine shortages are experienced by all countries regardless of size or economic status.

It said it was exploring opportunities for regulatory flexibilities including supporting new authorisations that can assist to better meet demand.

It added that the medicines which are experiencing shortages are a fraction of the total available and many drugs supplied in Ireland have more than one strength, form, pack size or brand, available from different suppliers.

"We would urge caution both in making any direct correlation between shortage reporting rates and potential impact on public health, and in representing such data as indicative of an increase or decrease in risk to patients," it said.

Reporter Louise Byrne and producer Lucinda Glynn's report will be on Prime Time on December 17 at 9.35pm on RTÉ One and RTÉ Player.