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The Swedish Medical Products Agency is seeking new authority to tackle drug shortages. Among other duties, it wants to be responsible for redistributing critical medicines to pharmacies and setting up a situational awareness system based on inventory and sales data.
In a recent interim report to the government, the Swedish Medical Products Agency (Läkemedelsverket) called on the government to give the agency a clearer, stronger national mandate and more powers to deal with future drug shortages.
Overall, Sweden’s medicines supply system works well, with 93% of marketed medicines available in Sweden. But the missing 7% creates major problems for patients and healthcare workers, said Veronica Arthurson, head of the agency’s department.
“There are currently concerns about the presence of residues of some cancer drugs, such as fluorouracil, some antibiotics, such as amoxicillin, and diabetes drugs called GLP-1 analogues, namely Ozempic,” she told Euractiv.
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Arthurson explains that the deficiencies were primarily due to manufacturing issues, but also to increased demand and more general just-in-time (JIT) inventory management, whereby the exact quantity of product required is delivered when a customer requests it.
“We need a national actor that can integrate the issues and has the capacity and authority to quickly decide on the necessary actions in the event of a drug shortage,” Arthurson said.
For example, the agency wants legal authority to make binding decisions on the redistribution and allocation of drugs by pharmaceutical players it regulates, such as pharmacies, wholesalers, and drug companies.
“Yes, we suggest that we should have the power to redistribute medicines between pharmacies and require wholesalers to supply medicines to specific pharmacies, or only to hospitals, for example, in cases of severe shortages,” added Veronica Arthurson.
Lessons learned during the pandemic
In reality, the measure was allocated to the agency on a temporary basis during the pandemic, when community and hospital pharmacies were asked to share critical medications, such as the much-needed anesthetic propofol.
“Such a reallocation is not currently possible due to Swedish law, but the pandemic has shown the need for a national player that can undertake such work,” Bengt Mattson, policy manager at LIF, the Swedish association of research-based pharmaceutical companies, explained to Euractiv.
Mattsson said he was pleased to see the Swedish Medical Products Agency was taking positive action.
“Sweden’s healthcare system is quite fragmented, so it’s good that the Medical Products Agency is now willing to take on this overall and greater responsibility as a national agency,” he said. “We have to make sure that medicines get to where they are needed.”
According to Bent Mattsen, HERA, Europe’s health emergency preparedness and response agency, is also discussing this issue.
Situational Awareness Report
In addition, the agency hopes to gain broad access to inventory and sales data from stakeholders to build system support to generate drug supply situational awareness reports, inspired by the Danish system’s working model.
The move is designed to allow the agency to better monitor when medicines run out. It will also improve Sweden’s procedures for reporting drug shortages to the European Medicines Agency (EMA), the report said.
Bengt Mattson said LIF has no problem with this approach: “However, we believe that for such a system to be truly valuable, it would be best to include not only the pharmaceutical industry, but also pharmacies and healthcare stocks.”
Learning from other countries
The agency also listed measures taken by Norway, Denmark, Finland, Iceland, Ireland, the United Kingdom, Germany and France to deal with drug shortages.
The survey shows that drug shortages have increased in all of these countries, but comprehensive solutions have yet to be found. However, Arthuson believes there are some practices that Sweden can learn from.
“Our analysis shows that in some of these countries, when regular medicines are out of stock, it appears to be easier to find alternatives.”
For example, in the UK, community pharmacists can use a ‘critical shortage protocol’ to dispense substitutes without the consent of the prescribing doctor.
The Swedish agency is interested and will continue to investigate. In the meantime, it is working with Sweden’s Centre of Excellence to help develop recommendations for clinical use when the drug is unavailable, Arthurson told Euractiv.
Lena Ring, CEO of the Swedish Pharmaceutical Society, is positive about the proposed new changes.
She told Euractiv: “During the COVID-19 pandemic, there are temporary provisions to reallocate medicines between pharmacies and we welcome suggestions on how existing stocks can be used in other contexts, as we have called for in the past.”
A balanced approach
Lena Lim said the new report includes recommendations for improving access to medicines at multiple levels.
Another TGA proposal is to introduce a legal obligation for individuals working on medicines shortages to provide the agency with information about shortages, but only if the agency has a need to know about the information.
“We agree on the importance of a balanced perspective when it comes to requirements for disclosure of data needed to address medicine shortages,” Lena Ring told Euractiv.
(Author: Monica Kleja; Editors: Vasiliki Angouridi, Brian Maguire | Euractiv Advocacy Lab)
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