Warum fehlen lebenswichtige Medikamente – und was können wir tun?
• Dr. med. univ. Daniel Pehböck, DESA / 0 Comments

Why are vital medicines missing - and what can we do?


Introduction to the problem

Drug shortages are a growing problem that affects patients, doctors and the healthcare system as a whole. They occur when the demand for a Drug availability, which can lead to serious consequences, especially in the case of vital Pharmaceuticals like Insulin or Antibiotics. This article looks at the causes of these shortages and offers practical solutions that individuals, governments and industry can implement.

Causes of drug shortages

The reasons for drug shortages are varied and complex. These include

  • Supply chain disruptions: Natural disasters, geopolitical conflicts or pandemics, such as the COVID-19 crisis, can disrupt the availability of raw materials, as in this report described.
  • Increased demand: Particularly during the pandemic, the demand for certain Medicationsuch as painkillers, which overstretched supplies.
  • Production problemsComplex manufacturing processes and the concentration of production on a small number of manufacturers, particularly in the case of Genericsincrease the risk of shortages.
  • Regulatory hurdlesQuality control problems or strict regulations can delay production.
  • Economic factors: Generics with low profit margins are less attractive for manufacturers, which can lead to production cutbacks, as in this article mentioned.

Effects on patients and the healthcare system

The effects of drug shortages are serious:

  • Patients cannot continue their treatment, which can lead to health deterioration or even death, especially with chemotherapeutic drugs.
  • Hospital staff often have to resort to alternative, possibly less effective treatments, which ties up time and resources and increases the risk of medication errors.
  • The public Health suffers when vaccines or Medication against infectious diseases are in short supply, which can encourage outbreaks.

Possible solutions and measures

Various approaches are conceivable to combat drug shortages:

  • Improved communicationBetter reporting of potential shortages can help coordinate responses, as the FDA noted in this FAQ emphasized.
  • Incentives for manufacturersFinancial Support or guaranteed offtake can affect the production of vital Medication promote.
  • Diversification of supply sourcesLess dependence on individual countries or manufacturers can increase security of supply.
  • Emergency supplies: The replenishment of stocks for critical Medication can help in crisis situations.
  • Regulatory adjustmentsSimplified approval procedures can speed up production.
  • Cooperations: Public-private partnerships, such as the Civica Rx initiative, can improve care, as in this report described.

At an individual level, patients can stay informed, talk to doctors about alternatives and Medication responsibly to avoid waste.

Detailed analysis and background information

Background and definition

Drug shortages occur when demand reaches a certain level. Drug exceeds what can happen at local, national or international level. This can lead to serious consequences, especially for vital Pharmaceuticals like Insulin, Antibiotics or chemotherapeutic agents. The definition includes both temporary and long-term supply problems caused by various factors, as in this FDA document described.

Causes in detail

The causes of drug shortages are multifactorial and include:

  • Supply chain disruptions: The production of Medication often depends on the availability of specific raw materials, which can be affected by natural disasters, geopolitical conflicts or pandemics. For example, the COVID-19 pandemic led to factory closures in China and India, which affected the supply of active ingredients, as in this WEF report shown.
  • Increased demand: During the pandemic, demand for painkillers and analgesics increased. Antibiotics which overstretched the available stocks, as shown in this article mentioned.
  • Production problems: Some Medicationespecially sterile Injectionshave complex manufacturing processes, and disruptions can quickly lead to shortages. Genericswhich are often produced by just a few manufacturers, are particularly susceptible, as shown in this AJMC article described.
  • Regulatory hurdlesQuality control problems or strict regulatory requirements can delay production, leading to supply bottlenecks.
  • Economic factors: Generics with low profit margins are less attractive for manufacturers, which can lead to production cutbacks or market exit. In 2023, product discontinuation increased by 40%, from 100 in 2022 to 140, as shown in this USP report indicated.

Effects on different levels

The effects of drug shortages are far-reaching and concern:

  • PatientsThey cannot continue their treatment, which leads to health deterioration, complications or even an increased risk of mortality. For example, the lack of chemotherapeutic drugs led to higher mortality rates, as in this PMC article described.
  • Hospital staffThey have to resort to alternative treatments, which ties up time and resources and increases the risk of medication errors, as in this WebMD article mentioned.
  • Public Health: Shortages of vaccines or Medication against infectious diseases can lead to outbreaks, which Health of the population is at risk.

Statistical overview

The following statistics illustrate the scale of the problem:

Year Number of active shortages (USA) Notes
2010 211 Highest figure to date, according to ASHP/UUHC
2022 295 Peak during the pandemic, according to the Senate Report
September 2024 277 50% of shortages last over 2 years, according to AJMC

These figures show that the problem is persistent and has not been sufficiently solved, as shown in this ASHP report documented.

Solutions and measures

Various strategies have been developed to combat drug shortages:

  • Improved transparency and communication: The FDA is working to notify manufacturers of potential shortages early, which prevented 38 shortages in 2010, as reported in this PMC article described.
  • Incentives for manufacturersFinancial Support or guaranteed offtake can affect the production of vital Medication promote, as in this Brookings article proposed.
  • Diversification of supply sources: Less dependence on individual countries, such as China or India, can increase security of supply, as shown in this NPR report emphasized.
  • Emergency supplies: The replenishment of stocks for critical Medication can help in crisis situations, such as in this EMA report recommended.
  • Regulatory adjustmentsSimplified approval procedures can speed up production, as in this FDA report described.
  • Public-private partnerships: Initiatives such as Civica Rx, a non-profit organization that supports vital Medication produced at cost prices, show success, as in this WEF report shown.

Individual measures

On an individual level, patients can do the following:

  • Stay informed: Regular review of sources such as Drugs.com for current scarcity information.
  • Talk to doctors: Discuss alternatives if a Drug is not available, as in this AMA report recommended.
  • Support advocacy: Organizations that advocate for policies against drug shortages support, as in this RPS report described.
  • Responsible handling: Medication Use only as directed and avoid waste to maintain availability.

Current examples and developments

Current examples of medication shortages include ADHD-Medication, Painkillerschemotherapeutic agents and Insulinas in this AJMC article described in detail. Of particular note is the shortage of intravenous fluids exacerbated by Hurricane Helene, which prompted the FDA to issue guidance on how to manage shortages.

Recent progress has also been made in combating shortages, such as Baxter's extension of expiration dates for some products, as in this AMA report documented. The FDA continues to work with manufacturers to identify and prevent potential shortages at an early stage, as described in this FDA report described.

Conclusion

The issue of drug shortages is complex and requires a multi-perspective approach. By understanding the causes and implementing comprehensive solutions, we can improve the supply of vital Medication and secure the Health protect the population. It is crucial that governments, industry and individuals work together to tackle this urgent problem.

Source: istockphoto bfk92


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