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How serious is Danish recall of antibiotic medicine?

The Danish Medicines Agency, Lægemiddelstyrelsen, recently recalled antibiotic medicine Dicillin.

Published: 8 February 2023 13:58 CET

How serious is Danish recall of antibiotic medicine?

Illustration photo. Denmark's medicines authority has recalled an antibiotic product. Photo: Signe Goldmann/Ritzau Scanpix

The medicines authority said on Monday that persons using the antibiotic medicine Dicillin, produced by Sandoz, should return it to pharmacies to be replaced.

That came after multi-resistant bacteria known as CPO were detected in nine cases in patients who have taken the antibiotic.

The nine cases were detected over a four-month period.

The researcher who detected the issue with the antibiotic said in an interview with news wire Ritzau that he was very surprised when it first became apparent.

“We couldn’t believe it. What we had feared was actually the case,” senior physician and professor Ulrik Stenz Justesen of Odense University Hospital’s clinical microbiology department told Ritzau.

“I’ve been in this game for quite a few years now and I’ve never experienced anything like this before,” he said.

Around 35,000 people in Denmark were prescribed the antibiotic between September and December last year, according to the Danish Patient Data Authority (Sundhedsdatastyrelsen).

The actual number of people who are using the medicine could be larger than this because it may have been sold after that period, Ritzau writes.

Multi-resistant bacteria are resistant to treatment with several types of antibiotic.

CPO or carbapenemase-producing organisms are a group of bacteria that are resistant to several different types of antibiotics. They can be difficult to treat, according to information from the Danish Health Authority.

The risk of becoming seriously ill due to CPO is low for a healthy person, but people who are already ill or vulnerable can be at increased risk.

Infection with multiresistant bacteria can also mean all future hospital treatments for the affected person must be given in isolated rooms, so the bacteria are not passed on to other patients.

That could have serious consequences at Danish hospitals where capacity is already under strain, according to Justesen.

“That would increase the strain on a health system that is already severely strained,” he said.

Medicines of this type are produced under highly controlled conditions, which makes the discovery even more extraordinary, he explained.

“We don’t study medicines daily to see whether there are bacteria in them. But this is a bacteria that behaves so strangely that we immediately notice it,” he said.

Although the detection of the bacteria is concerning, the professor in microbiology said finding it was also reassuring in some way.

“We were also relieved that we could do something about it and get it stopped so we didn’t have to look around for many months for a source and know it was spreading in the community,” he said.

Manufacturer Sandoz has recalled all Dicillin packets and patients have been advised to return it to pharmacies to be replaced. Patients do not need to obtain a new prescription from their doctor.

“It’s important that you don’t stop your treatment if you are taking antibiotics. So patients to take 500mg Dicillin from Sandoz should go to their pharmacy to get a different, equivalent preparation,” the Danish Medicines Agency said in Monday’s statement.

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What exactly is wrong with the Danish health system?

What’s going on with the Danish health system?

The government in Denmark is trying to tackle a health system under pressure. Nurses are leaving the profession, waiting times for operations have increased by 50 percent over the last three years and there’s concern that soon patients’ health will be compromised.

“Perhaps we are actually seeing the end of the welfare society as we know it”, warned Kristian Antonsen, hospital director of Bispebjerg and Frederiksberg Hospital, earlier this year in the doctors’ journal Ugeskrift for Læger.

Jes Søgaard, professor of health economics at the University of Southern Denmark told The Local he believes there are four factors why the Danish health system is under pressure.

“Over the last ten years, there’s been increased patient pressure. The population is getting older and the budget hasn’t increased accordingly since 2016. Nurses are the ones who have especially felt the burden, with fewer nurses and an increasing number of patients.

“The second reason is the Covid-19 crisis. With additional patients, nurses felt they took a lot of the extra pressure. They often felt working conditions were unsafe, they didn’t have the necessary protection but also felt they were transferred to wards, for example intensive care, where they weren’t qualified and that created additional frustration among nurses. They feel underpaid.

“Thirdly, the nurses’ strike during the summer of 2021 created more tension,” Søgaard explained.

Nurses began a strike over pay and working conditions in June 2021. A collective bargaining deal rejected by the nurses’ trade union DSR was eventually enforced by government intervention and a pay agreement was imposed. This then caused more nurses to leave the profession and there’s since been an increase in hospital waiting lists.

“A fourth factor could be the increasing number of patient referrals, especially among the elderly, that are complicated because the patient has more diseases than the one they’ve been referred for. This is time consuming, so over the last twelve months, the hospitals haven’t been able to cope with that demand and that creates tension in the population,” Søgaard said.

How bad is the situation?

“It’s bad. Not as bad as the NHS in the UK, but quite bad. This is not the time to have a stroke,” Søgaard said, referring to the number of therapy treatments that would be delayed.

Kjeld Møller Pedersen, professor of health economics and health policy at the University of Southern Denmark, told The Local he’s never seen the healthcare system so pressurised.

“Increased waiting lists, recruitment problems and in general the whole health system is very much stressed, from what I can recall, more than it’s ever been,” he said.

But Pedersen added that patients should not be concerned about the quality of care they receive.

“The pressure is reflected in waiting times and lists but once you’re in hospital, you get sufficient care,” he said.

The Danish public health system guarantees patients an appointment within 30 days of referral. If this is not possible, the patient can be referred for private treatment. The guarantee was suspended during the coronavirus crisis but since it resumed, there has been a backlog, increased by the nurses’ strike.

In 2021, there were more than 180,000 patient referrals to private hospitals from the regional public health services. In 2020, the number was almost 148,000.

The 30-day treatment guarantee comes at an extra cost for hospitals and has also led to more staff moving to private care, Pedersen warned.

“I think the government is hoping the increased use of private hospitals to carry out procedures is what will save them and is what may reduce the waiting lists,” he added.

Healthcare system Denmark

Ditte Hammer works at Bispebjerg and Frederiksberg Hospital. Nurses say they are increasingly pressured and also have to spend time on non-professional tasks such as emptying the dishwasher and cleaning. Photo: Asger Ladefoged/Ritzau Scanpix

What can be done?

According to both Søgaard and Pedersen, a solution to the staff shortage is essential to addressing the health system’s problems.

“In my mind, the real bottle neck is manpower. There’s a shortage of nurses and in particular specialised nurses in intensive care and anaesthesia and it’s this that is causing a waiting list for operations,” Pedersen explained to The Local.

There is currently a shortage of around 5,000 nurses, according to the Danish Nursing Council (DSR), the trade union for nurses in Denmark.

“We have seen a drop in productivity between six and seven percent in 2022 compared to 2019, on top of staff shortage. This is because experienced nurses have left and been replaced by young nurses or nursing assistants.

“The only way to solve this in the short-run, is to get the experienced nurses back and the only motivation for this, is raising salaries by 5,000 kroner, including pension. Nurses want to get to 43,000 kroner a month,” Søgaard explained.

Pedersen agrees that increased salaries will help recruit more nurses but said the solution is not simple.

“The government has used the term ’emergency plan’ to rectify what is happening at the moment, such as increasing recruitment, promising economic gain if nurses come back to the profession and increasing the capacity for training nurses to become specialised in anaesthesia and intensive care.

“Some nurses have moved into the private health sector with better conditions, others have left the health profession entirely and they are very difficult to get back. The stumbling block is salary and it’s difficult to increase nurses’ wages and not do the same for midwives, physiotherapists, nurse assistants.

“However, the number of nurses in [care] homes and those assisting GPs in the municipalities is increasing. This is because they are not plagued by the 24-hour requirement to be on rota. Working conditions are also just as important as pay,” Pedersen said.

There were 18 percent fewer applicants entering nursing training programmes last year compared to 2019, according to Ministry of Education admission figures. The national organisation for municipalities, KL, estimates that by 2030, there will be a shortage of almost 16,000 social and healthcare assistants (Social og sundhedsassistent – SOSUs) across the country.

Recruitment is also affecting mental health services, with a national shortage of psychiatrists. An average of one in four patients had their referrals to mental health services rejected in several of Denmark’s regions, according to reports last summer.

What’s the long-term solution?

The government has formed a ten-year plan costing four billion kroner a year to overhaul the mental health sector.

A wider review of the whole healthcare system is planned for this year. During government coalition negotiations last December, the three parties – the Social Democrats, Liberals (Venstre) and Moderates – were unable to form a proposal for health service reforms so instead appointed a commission of experts to make recommendations by spring 2024.

The Moderates, led by Lars Løkke Rasmussen, previously said they wanted the the Danish Regions, the elected bodies which operate hospitals in Denmark’s five regions, to be scrapped in favour of a new system.

“At the moment we have five regions and in a sense they run healthcare, including the hospitals, doctor’s surgeries, office-based specialists. Then the municipalities provide home nursing, nursing homes and extra services,” Pedersen explained.

“The regions get funding from central government and block grants and they are controlled at an economic level very tightly. They have to stick to the budgets and it’s very difficult to get extra funding during a fiscal year,” Pedersen added.

Søgaard believes the regional system is effective because it takes local geographical needs into account and the fact that regional representatives are elected means the public interest is more likely to be voiced on their boards.

“The decentralised structure has been in Denmark for almost forever. We would never have a state-run system,” he said.

Whether a restructure of the heath system solves the current pressures, remains to be seen. In the meantime, the government will hope its short-term strategies are enough to avert a healthcare crisis.

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