Price is the bottom line as Ireland struggles with supply of essential medicines – The Irish Times

Dr. Ray Wally had a problem. A patient presented with an infection that was uncomfortable and very contagious. He prescribed a medicine for it only to find it unavailable. He tried a second option; Again the message from the patient’s pharmacist was that it was also unavailable.

Frustrated, he took to social media: “A request to chemists: If any medicine is unavailable can you please suggest what is available as an alternative to all problems – I am on second option not available for this… – I am a Sathsyar No.”

The incident highlights two major issues affecting primary healthcare in Ireland this winter – supply issues and communication issues.

Supply is now a significant ongoing problem for health services. The most recent list published by the Health Products Regulatory Authority (HPRA), which regulates the supply of medicines to the Irish market, says that 189 medicines are currently out of stock in the Republic.

The HPRA has an alert system for doctors but, strangely, the agency does not use it to tell GPs when drugs are out of stock even though it does use alert systems and can notify them of drug safety issues.

Instead doctors are writing prescriptions for drugs that may or may not be available. And where they don’t, says Dr Walley, basic information is not made available.

“Pharmacists will tell you it’s not in supply but that’s it,” says Dr Walley, a GP in Dublin and associate clinical professor of general practice at the UCD School of Medicine. “If it’s not available they can send us back, tell us this antibiotic is available and substitute another one.

“I don’t have time to go around trying to find an alternative to a particular drug because if I do, there are other patients I’m waiting for that I won’t see. Telling me it’s not available; you might as well tell me nothing.” .”

Time is at a premium for all GPs, as patients seeking appointments amid the seasonal surge of winter bugs know all too well. Patients who cannot see a doctor may end up in the hospital, with conditions that could have been more easily treated if they had been seen earlier — and at a much lower cost to the state.

The return to normalcy after years of relative isolation puts more pressure on primary care than ever before, meaning many young children are more vulnerable to common infections because they haven’t had a chance to develop immunity over time.

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Dr Walley said about 98 per cent of GPs had been computerized for more than 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 in a fast and secure manner. It came into its own during Covid-19 as the preferred method of sending prescriptions between GPs and patient pharmacies.

Pharmacists, for their part, say the GP’s original prescription should include acceptable alternatives. And they claim that communications with the surgery, including Healthmail, often go unanswered or patients arrive at the pharmacy outside surgery hours. They want the government to put in place a severe-shortage protocol that allows pharmacists to provide alternatives when stocks of prescribed drugs run out.

Claire Fitzell, head of professional services at the Irish Pharmacy Union (IPU), noted that the UK introduced similar provisions earlier this year. “This will allow pharmacists to use their own professional judgment to provide the equivalent product to the patient without the need to go back to the GP.”

GPs remain cautious, warning that patients may suffer idiosyncratic reactions to certain drugs, and that pharmacists do not have the complete data on patients that GPs do, which could make them aware of such risks.

The Standing Committee of Doctors of Europe (CPME) is a group representing national medical associations across Europe. It is charged with contributing the perspective of the medical profession to EU and European policy-making. In April 2020, a report presented to EU officials said: “Communication is crucial to prevent deficits. Clinicians must have access to up-to-date information to be able to adequately respond to emerging and existing deficiencies.”

Dr. Wali said that along with shortage notifications, it should be mandatory for the pharmaceutical industry, drug suppliers and pharmacies to introduce demand surge notifications for certain drugs.

In 2022 it seems unbelievable that a system, where all players are operating under high levels of stress, should be hampered by basic and easily addressed communication protocols. Supply shortages in particular aren’t going away anytime soon.

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Shortages of essential medicines have been a growing problem worldwide. In Europe 2020, the European Parliament noted that the deficit had increased 20-fold between 2000 and 2018 – even before Covid-19 disrupted supply chains.

And the problem is getting worse. In part this is due to ongoing problems in supply chains that have not returned to normal following restrictions imposed during the Covid-19 pandemic – and the shift in capacity to produce vaccines and antiviral drugs during that time.

Countries across the EU are increasingly dependent on India and China for the production of active pharmaceutical ingredients, raw materials for medicines. China, in particular, has yet to fully reopen as it battles a renewed Covid outbreak.

“We’ve seen shortages across Europe and it’s probably going to get worse rather than better, so we have to be agile,” said Dermot Twomey, president of the Irish Pharmacy Union.

And Ireland’s peripheral status exacerbated its position. “Pharma companies are waiting until full delivery before moving them [because of rising energy and transport prices] and some [medicines] They are being listed because they can get better prices in other states,” Mr. Twomey said in a recent interview.

He pointed out that the state was supposed to have a 30-day stock of some essential medicines. “We understand that at this point it’s down to 12 days.”

He said a critical shortage protocol would address the 73 percent of drugs where alternatives were available but warned that supplies of the other 27 percent “need to be made available”.

In 2020 the CPME report again urged that member states “adopt policies to increase the diversity of sources of supply and, most importantly, be more independent from manufacturing sites outside Europe for essential medicines”. It said over-reliance on India and China was “a real threat to secure and stable supplies to the EU” and pressed the EU to bring production of essential medicines back to the EU.

That raises the issue of pricing. Many of the drugs affected by 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 six brands of paracetamol – many of which will not be available for months.

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These are all generic drugs, off-patent. With constant downward pressure on prices, active pharmaceutical ingredient (API) producers have over time exited the market on the grounds that it is no longer sustainable or shifted to the lowest production cost location. Bringing production of these APIs back to Europe at current prices is simply not feasible.

Azure Pharmaceuticals specializes in supplying older drugs that are either no longer available or face supply disruptions in the market. Founder Sandra Gannon says part of the problem is the limited number of suppliers of certain essential medicines – noting that there are only two and in one case three suppliers worldwide for those three common medicines on the Irish “out of stock” list.

“We need multiple sources of supply to keep those drugs in stock,” he says, “backup suppliers fill in when others suffer manufacturing or supply chain failures or quality issues. Several products have been completely recalled from various markets, including Ireland, because someone Not ready to deliver.

“The problem for a company like ours is that the files that support some of these old drugs are really old They require research and development to bring them up to standard for new licensing standards. And people won’t do that for small markets. We are waiting 13 months for price approval of a particular drug [in Ireland]. We have a license. It is a product of a troubled past [in terms of supply] And it’s on allocation.”

He noted that Ireland’s Framework Agreement on Supply and Pricing requires suppliers of generic products to offer the product at a 60 percent discount to the price of the original branded product. “The reference price for this product is €3.63. We couldn’t make it for 60 percent less than that, never mind delivering it. So we’re sitting with a license we can’t use. We invested €100,000 in it. And there are many companies in the same boat. The current system prevents people from bringing products to the market.”

Dr Wali says this is a problem the European Union needs to realise. “Europe needs to come together and ensure we have access to supplies. The reason we had a common agricultural policy was food security. Isn’t it that medicines are as important as food?

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