Shortages and supply issues for important medications have long since reached critical levels and are affecting the provision of healthcare. According to the Federal Institute for Drugs and Medical Devices (the medical regulatory body in Germany), 493 medicinal products are currently unavailable. "These medicinal products are often also agents for which no equivalent alternative exists," said Germany's federal minister of health Karl Lauterbach, MPH, in the German Bundestag during the first discussion of the draft bill to tackle supply shortages.
The causes of the supply problems are complex: global, barely comprehensible supply chains, price dumping, regulatory challenges, and the effects of the COVID pandemic. Experts at a press briefing of the Science Media Center (SMC) Germany discussed how to improve supply.
David Francas, PhD, expert for data and supply chain analytics at Worms University in Worms, Germany, identified three main causes of supply issues. The first is production problems such as quality deficiencies, technical issues, and the availability of active substances. Next are market withdrawals. "This was one of the reasons with the fever syrup for children," Francas explained. "Because of this, Germany's second largest authorization holder at approximately 30% withdrew from the market, which meant we actually had a de facto monopoly situation." The third reason is an unexpected increase in demand. During the pandemic, for example, there was an increased therapeutic need because of an increased number of patients in intensive care.
Another example is the supply shortage with semaglutide (Ozempic, Wegovy). "Someone realized that you could use the drug to lose weight, it got a lot of hype, and suddenly you had an off-label use for the medication, which naturally also drives demand," said Francas.
Torsten Hoppe-Tichy, PhD, head of the Pharmacy Department at Heidelberg University Hospital in Germany, made it clear that hospital pharmacies are only partially able to offset supply shortages. It is clearly regulated in the legislation. "We are only able to produce something for our own patients occupying a bed in the hospital. What we [would have] potentially done to bridge the gap for transplant patients would have gone beyond this remit. But despite this situation, we would have absolutely done it to protect the patients," said Hoppe-Tichy.
Production and Stockpiles
Calls to bring production back to Germany are considered by Ulrike Holzgrabe, PhD, senior professor of pharmaceutical and medicinal chemistry at the Institute for Pharmacy and Food Chemistry, University of Würzburg, Germany, to be "a little naive." Especially since production is anything but simple. It is in fact rather complex. There are multiple companies that produce the intermediate products; to synthesize one active substance can involve multiple steps and interim stages.
"I am fully in support of taking multiple things into consideration and also moving things back to Germany. And it should be worth paying more for it, so that we become less dependent on China. But then again, we will never really become independent. This is because the Chinese have taken on a lot that we no longer wish to do. For example, halogen chemistry should not be performed in Germany again for environmental reasons," said Holzgrabe.
At best, larger stockpiles may help to relieve temporary shortfalls. "We have to think about how we make supply chains more resilient, how we achieve supply chain diversification, and we basically also have to say what this is worth to us."
Anti-Infectives and Oncology Drugs
There will not be any single, simple solution, said Hoppe-Tichy. "We have to see the whole thing as a political health problem." This means that both large democratic parties must take it on as a duty.
"We also have to take a long, hard look in the mirror," he added. It is not okay to prescribe an antidiabetic drug off-label to someone who wants to lose weight, but for whom no indication is present, he said, adding, "That is absurd."
With regard to hospital pharmacies, this means no more single sourcing for generics, but instead using multiple clinicians and purchasing from them if the prices differ slightly. "There are some measures directly available to us as players in the healthcare industry that we can use. We cannot forget this," said Hoppe-Tichy.
Holzgrabe added that shortages, supply, and production are complex events. "Above all, we should concentrate on having enough anti-infectives and oncology drugs. Mr. Lauterbach is right about that. How we manage to do this is not so simple. This is because, for example, drugs such as penicillin and cephalosporin, which we take in large quantities for infections, are relatively easy to produce, but many other antibiotics have a much more complex manufacturing process."
Mixture of Solutions?
Francas, the expert for data and supply chain analytics at Worms, reckons that the solution comprises multiple building blocks. First and foremost, a strategy is required. "For this strategy, we must first know where the biggest problems lie. And this should not dictate day-to-day business. Instead, we must actually know the facts of the supply chains, the demands of the physicians, the pharmacies who actually know what is relevant for the patients."
The second aspect is that "we require a multinational approach," said Francas. "Viewing the current woes as a national problem is fundamentally wrong, even if there may be exceptions to this."
Finally, there is no single solution. "It will potentially be a mixture of higher prices, or other prices in individual areas, of possible reshoring, but it certainly will not be a solo German effort. We may also need national reserves in certain fields, or even European reserves. However, we should not start renting this [warehouse] and that warehouse from the Bundeswehr and using them to store medicinal products like with Tamiflu, and then celebrate as they degrade bit by bit," Francas said.
This article was translated from the Medscape German Edition.
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Cite this: German Experts Suggest How to Avoid Future Drug Shortages - Medscape - Jun 09, 2023.