THE NUMBER OF medicines facing shortages in Ireland has risen yet again, prompting the Minister for Health to meet with the health products regulator to try to fix the problem.
Around 350 medicines are currently out of stock or in short supply in Ireland, according to the Health Products Regulatory Authority (HPRA), up from 250 at the start of the year.
The shortages cause complications for patients who rely on certain medications. In many cases, alternatives are available – though it can require time-intensive coordination between GPs and pharmacists to find the most appropriate option.
One medicine subject to shortages is Ozempic, which is prescribed for patients with diabetes but has also been used off-label for weight management, causing increased demand.
Solutions used to inject the medicine in pre-filled pens are expected to be in short supply from the middle of this month for the 1mg strength dose and from early October for the 0.5mg strength.
Both products are expected to be back in stock from the week of 11 October, but Novo Nordisk, the pharmaceutical company that produces the drug, has warned that increased demand for Ozempic has created supply challenges over the last year and that it expects these to continue throughout 2023.
The company has recommended that no new patients should be put on to Ozempic during the shortage period.
Experts in Ireland and the EU have been warning for months that medicine shortages would worsen without political action. Earlier this year, the number of medicines on the Medicine Shortages Index hit a record high of nearly 250 – and it has continued to grow in the months since.
Minister for Health Stephen Donnelly has met with the HPRA to discuss potential solutions.
“One of the challenges we’re in the middle of overcoming is Brexit. As part of the Windsor Agreement, we lost the dual country packaging, which creates a challenge for us as Ireland is a very small market in global pharma terms, so we’re working on that,” the minister said.
Speaking to reporters, Donnelly said that the HPRA believes this is a “global trend and something Ireland needs to be very much on top of”.
“They’re working up various proposals in terms of that and really a large part of the answer for Ireland is going to be part of a single market within the EU and an EU-level approach to this to make sure we have security of supply,” he said.
The State needs to “make sure that we have sufficient line of sight of what’s coming in”.
“For example, the IT systems that are not currently satisfactory. The HPRA doesn’t know right now exactly what’s in the warehouses, what’s on the way to the warehouses and what’s in the pharmacies.
There are practical systems-based things we need to do.
“I asked them is this part of the global trend, are supply lines tightening up to an extent, and they said they are. We have solutions to those but we certainly will not be complacent and we will take whatever action is required.”
Pharmacists are no strangers to medicine shortages and are accustomed to finding alternatives for their patients, according to Clare Fitzell, the head of strategic policy at the Irish Pharmacy Union.
However, the shortages come with complications that can cause delays and additional pressures on pharmacies.
“The difficulty for pharmacists is sometimes to supply that product, they need to go back to the GP or they need to get the patient to get the prescription changed and then there’s a bit of delay in terms of patients receiving the new or equivalent medicine,” she explained, speaking to The Journal.
She said that pharmacists and GPs can usually coordinate well to find an appropriate alternative for patients, but there is “an issue with the GPs being incredibly busy – as are pharmacists – and then those delays in waiting to speak to the prescriber to get it changed can slow down the process of getting a product for a patient”.
Similarly, pharmacist Laura Dowling described how that process means pharmacists need to spend more time in the back on the phone instead of having one-to-ones with their patients.
“A pharmacist’s job is to go out and talk to their patients about their health and about their drugs and about interactions or side effects. When our time has been taken up by having to phone doctors to discuss things and try different medicines, it takes up so much more time. It certainly makes our job more laborious and takes us away from patient-facing time,” Dowling said.
Another challenge for pharmacists, according to Dowling, is a lag in information about which medicines are facing shortages.
“Sometimes the first time we notice something is short is when we can’t get it in stock, rather than us being informed beforehand, so it’s all very tricky.”
To help alleviate the pressure caused by shortages, Dowling called for the HPRA to provide live updates on its website and for the government to create a role for a Chief Pharmacist who could take responsibility for monitoring and managing shortages.
On the patient side, Fitzell encouraged people not to panic or try to stockpile a certain drug: “The majority of the medicines would have a product that could be supplied in its place.”
She advised members of the public, particularly with repeat prescriptions, to give their pharmacy advance notice where possible to allow time to resolve any issues that may arise.
“If you’re in your pharmacy and they give you an exempt medicinal product – that’s a product that we would source from a different European country to meet the patient demand in Ireland when we can’t get the product that’s licensed in Ireland – don’t worry, that product is safe,” Fitzell added.
“It’s licensed in another country and the pharmacist has done their best to try to get a product to meet their need at a time when potentially a medicine is short in Ireland.”
Diabetes medication
The shortage of Ozempic has gained particular attention due to the rapid increase in demand internationally over the last year and the potentially serious consequences for diabetes patients.
“The out-of-stock situation could result in patients missing required doses, which may have clinical consequences such as hyperglycaemia,” Novo Nordisk, the company behind Ozempic, detailed in a letter issued on Friday.
The company attributed the shortage to productions delays and demand.
“Healthcare professionals are urged to ensure that patients using Ozempic are made aware of this shortage and that patients at risk of running out of Ozempic are safely switched to another GLP-1 RA or other suitable alternative, based on your clinical judgement and market availability.”
It said that patients should not try to use pens with a different dose strength to try to achieve their prescribed dose as the pens are “single dose pens which deliver the specified dose”.
In a statement to The Journal, Diabetes Ireland said it is aware of a shortage of Ozempic, also known as semaglutide, since late last year due to global demand for the medicine and its increased use as an off-label drug for weight-management purposes.
The medicine can reduce serious diabetes-associated complications in adults with type 2 diabetes.
Diabetes Ireland said that while it recognises that the medicine is “licensed for the treatment of obesity and sympathise[s] with anyone with a clinical need for the medication who is unable to access it, we ask prescribers to prescribe Ozempic in line with its license as specified by the regulatory bodies in Ireland to help to maintain the continuity of care of people with type 2 diabetes”.
The organisation is advising that if people with type 2 diabetes have difficulty accessing the medication, they should contact their diabetes teams or general practice to discuss suitable options for an alternative medication that is appropriate for them.
In Northern Ireland, where around 180,000 people are diagnosed with diabetes and pre-diabetes illnesses, an MLA has also expressed concern about the availability of diabetes medication.
SDLP health spokesperson Colin McGrath said that “given the current pressures on our health service, it’s key that clinicians are openly communicating with patients currently receiving this medication about how their treatment will be managed going forward and if any changes are needed as a result of these shortages”.
He said it must be established what the impacts may be “on existing patients and how are we treating people newly diagnosed with Type 2 diabetes”.
“At the current rate we are prescribing these medicines and the number of people in the North living with diabetes I believe that we must do more to educate people and develop a strategy around Type 2 diabetes, alongside supporting those already living with the condition to prevent a real health emergency unfolding in the coming years.”
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