Dr Ray Walley had a problem. A patient had presented with an infection that was uncomfortable and also very contagious. He prescribed a medication for it only to find it was unavailable. He tried a second option; again the message back from the patient’s pharmacist was that it also was unavailable.
In frustration he took to social media: “A plea to chemists: if a medicine unavailable, can u please advise what is available as an alternative for all issues – I am on second option not available for ... – I am not a soothsayer.”
The incident highlighted two major issues affecting primary healthcare in Ireland this winter – supply problems and communications issues.
Supply is a now a significant ongoing issue for the health service. The most recent list published by the Health Products Regulatory Authority (HPRA), which regulates the supply of medicine in the Irish market, says that there are 189 medicines currently out of stock in the Republic.
The HPRA does have an alert system for doctors but, oddly, the agency does not use it to let GPs know when medicines are out of stock even though it can and does use the alert system to notify them of drug safety issues.
Instead doctors are writing prescriptions for medicines that may or may not be available. And where they are not, Dr Walley says, basic information is not made available.
“Pharmacists will tell you it is not in supply but that is it,” says Dr Walley, a Dublin GP and associate clinical professor of general practice at UCD school of medicine. “If it is not available they are the ones who can send us back, tell us that this antibiotic is available and can replace the other one.
“I do not have the time to scramble around to try to find an alternative to a particular drug because if I do there are other patients whom I have waiting that I will not get to see. Telling me it is not available; you might as well tell me nothing.”
Time is at a premium for all GPs, as patients looking for appointments amid the seasonal surge of winter bugs know only too well. Patients who cannot see a doctor may ultimately land in hospital, with conditions that would have been more easily treatable had they been seen earlier – and at far less cost to the State.
The pressure on primary care is more acute than ever as a return to normal after a couple of years of relative isolation means many young children are more vulnerable to a range of common infections because they have not had the chance to build up immunity over time.
Dr Walley says around 98 per cent of GPs have been computerised for over a decade in an effort to improve efficiency. A secure clinical email system – Healthmail – exists specifically to allow healthcare providers to send and receive clinical patient information quickly and in a secure manner. It came into its own during Covid-19 as the preferred method of sending prescriptions between GPs and a patient’s pharmacy.
For their part pharmacists say GPs should include acceptable alternatives on the original prescription. And they claim that often communications with surgeries, including on Healthmail, go unanswered or patients arrive at the pharmacy out of surgery hours. They want the Government to put in place a serious-shortage protocol that would allow pharmacist to dispense alternatives when the prescribed medicine is out of stock.
Clare Fitzell, head of professional services at the Irish Pharmacy Union (IPU), notes that the UK introduced a similar provision earlier this year. “It would allow pharmacists to use their own professional judgment to supply equivalent products to the patient without the need to go back to the GP.”
GPs are wary, warning that patients can suffer idiosyncratic reactions to particular medicines and that pharmacists do not have the full data on patients that GPs do, which might make them aware of such risks.
The Standing Committee of European Doctors (CPME) is a group representing national medical associations across Europe. It is charged with contributing the medical profession’s point of view in EU and European policymaking. Back in April 2020, in a report presented to EU officials, it said: “Communication is crucial in preventing shortages. Doctors must have access to up-to-date information to be able to adequately respond to arising and existing shortages.”
Dr Walley says that alongside notification of shortages, it should be obligatory on the pharmaceutical industry, the pharmaceutical suppliers and the pharmacies to introduce notification of demand spikes for particular medicines.
In 2022 it seems incredible that a system, in which all players are working under a high degree of stress, should be hobbled by basic and easily-addressed communications protocols. Particularly as supply shortages are not going away any time soon.
Shortages of key medicines have been a growing issue globally. In Europe the European Parliament in 2020 noted that there had been a 20-fold increase in shortages between 2000 and 2018 – even before Covid-19 disrupted supply chains.
And the problem is becoming more acute. In part it is due to ongoing issues in supply chains that have not returned to normal after the restrictions imposed during the Covid-19 pandemic – and also the transfer of capacity at that time to production of vaccine and antiviral medication.
Countries across the EU are increasingly dependent on India and China for the manufacture of active pharmaceutical ingredients, the raw material for medicines. China, in particular, has not yet fully reopened as it battles renewed Covid outbreaks.
“We have seen shortages across Europe and these are probably going to get worse rather than better, so we need to be agile,” said Irish Pharmacy Union president Dermot Twomey.
And Ireland’s peripheral status makes its position even more acute. “Pharma companies are waiting till they have full deliveries before moving them [because of rising energy and transport prices] and some [medicines] are being delisted as they can get better prices paid in other states,” Mr Twomey said in a recent interview.
He noted there was meant to be a 30-day stock of certain essential medicines in the State. “We understand that is down to 12 days at the moment.”
He said a serious-shortage protocol would address the 73 per cent of medicines where there is an alternative available but warned that supplies of the other 27 per cent “need to be available”.
The CPME report urged back in 2020 that member states “should adopt policies to increase diversification of supply sources and become more independent from production sites outside Europe, most importantly in case of essential medicines”. It said the overreliance on India and China was “a real threat to the secure and stable supply in the EU”, and pressed the EU to bring the production of essential medicines back into the EU.
That raises the issue of price. Many of the medicines affected by the current shortages are long-established products. The current HPRA list of medicines out of stock includes five forms of Amoxicillin, four brands of penicillin and of six brands of paracetamol – many of which will not be available for some months.
These are all generic drugs, long off patent. With continual downward pressure on price, producers of active pharmaceutical ingredient (API) have over time either exited the market on the basis it is no longer sustainable or relocated to the lowest manufacturing cost locations. Bringing production of this API back into Europe at current prices is simply unaffordable.
Azure Pharmaceuticals specialises in supplying older medicines that are either no longer available or suffering supply interruptions to the market. Founder Sandra Gannon says that part of the problem is the limited number of suppliers of certain vital medicines – noting that there are only two, and in one case three suppliers worldwide for those three common drugs on the Irish “out of stock” list.
“We need multiple sources of supply to keep those medicines in stock,” she says, “with backup suppliers filling in when others suffer manufacturing or supply chain glitches or quality issues. A number of products have been withdrawn fully from different markets, including Ireland, because no one is prepared to supply them.
“The issue with a company like ours is that the files that support some of these older medicines are really old. They need research and development to bring them up to standard for new licensing standards. And people will not do that for small markets. We are waiting 13 months for pricing approval for a particular medicine [in Ireland]. We have the licence. It’s a product with a troublesome past [in terms of supply] and it is on allocation.”
She notes that Ireland’s framework agreement on supply and pricing requires suppliers of generic products to bring this product in at a 60 per cent discount to the price of the original branded product. “For this product the reference price is €3.63. We could not even make it for 60 per cent less than that, never mind supply it. So we are sitting on a licence we cannot use. We invested €100,000 on that. And there are a lot of companies in the same boat. The current system puts people off bringing products to market.”
Dr Walley says it is a problem the European Union will have to grasp. “Europe needs to come together and ensure we have access to supplies. The reason we have a Common Agricultural Policy was for food security. Is it not the case that medicines are just as important as food?”
