Medicines are a vital component of healthcare. However, their shortages significantly challenge patients and the healthcare system. Drug shortages may affect any country, regardless of its economic level. All sorts of life-saving drugs are susceptible to shortages, but among these, sterile injectable drugs are known to have a higher risk of developing a shortage. While there are various reasons for such scarcity, the fact remains that shortages of medicinal products make it difficult to meet the therapeutic needs of patients.
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The financial implications of medicine shortages also cannot be overlooked. It has been observed that drug scarcity leads to an increase in the prices of therapies. Substitute drugs also become expensive, and they may not optimize clinical therapy.
Understanding the Causes of Drug Shortages
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Manufacturing Issues:
Manufacturing issues related to quality problems are primarily identified during routine checks, inspections and post-distribution. Issues such as microbial contamination, endotoxin presence, particulate matter in vials, and unexpected reactions between products and containers lead to voluntary recalls of medicinal products. Also, violations of Good Manufacturing Practice (GMP) result in defects in products’ quality and their subsequent shortages.
According to a recent report, the prevalence of cancer drug shortages in the US was due to longstanding manufacturing issues within specific plants. These disruptions in production have ripple effects throughout the healthcare industry.
Essentially, drug shortages, including those affecting chemotherapy agents, are driven by manufacturing challenges within certain plants. These disruptions have broader implications, impacting the availability of crucial medications across healthcare systems.
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Competing Priorities:
Competing priorities are another reason that leads to disparities in investment and production. Medicines with higher profitability receive greater attention than generics or injectable products, which require a rigorous manufacturing environment.
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Unavailability of raw materials:
The unavailability of raw materials such as active pharmaceutical ingredients (APIs), excipients, and packaging materials can also lead to drug scarcity. According to a study, 30% of shortages occur due to scarcity of raw materials needed to produce drugs.
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Business decisions:
Once a drug is manufactured, it is supplied to wholesalers or distributors, major vendors, Group Purchasing Organizations (GPOs), health care systems, etc. Business decisions made by these firms regarding drugs can have a direct consequence on the supply chain and may contribute to over-the-counter or prescription drug shortages.
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Shutdown of the Manufacturing Facility:
Closure of drug manufacturing sites has also contributed to drug shortages. Around 2% of drugs that were in shortage were actually due to their discontinuation by manufacturers.
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Pandemics:
Amidst the COVID-19 pandemic, the closure of borders and restrictions on drug exports by various countries posed a potential threat to global access to essential medicines.
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Geopolitical instability and trade disruptions:
These factors pose significant threats to the pharmaceutical supply chain. Political tensions and trade disputes can potentially disrupt the flow of pharmaceutical ingredients and finished products, resulting in shortages and increased prices. Also, some countries strategically prioritize pharmaceutical manufacturing to maintain control over essential medicines during crises.
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Other factors:
Poor ordering practices, delivery delays, and stockpiling leads to an increase in drug prices. Also, healthcare systems in a specific geographical area relying on the same supplier can lead to scarcity. This delay is mostly due to supplier contracts and is referred to as wholesaler-dependent drug shortages.
Strategies to mitigate drug shortages
Drug shortages can pose challenges, especially depending on the type of drug and the medical condition it treats. Pharmacists may communicate with prescribers to find alternative medications or treatments. Transparency in the drug manufacturing process, such as providing information on where drugs are made and their quality, is essential. Implementing new manufacturing technologies can also improve reliability and quality control.
Also, maintaining a national stockpile of essential medications could help manage shortages effectively. This stockpile would contain a supply of critical medications maintained by the private sector. This will help prepare in advance for any scarcity of drugs arising due to high demand or manufacturing issues.
Conclusion
The pharmaceutical industry basically operates at the crossroads of science, economics, and geopolitics. These factors influence decisions on intellectual property, access to medicines, regulatory harmonization, and supply chain security. As global health challenges persist, navigating the complexities of drug shortages will need to be addressed to ensure affordable and accessible healthcare worldwide.
FAQs
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What are drug shortages, and why do they occur?
Drug shortages refer to situations where there is an inadequate supply of medications to meet patients’ demands. They can occur due to manufacturing issues, unavailability of raw materials, business decisions, and geopolitical factors.
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Which medications are most susceptible to shortages?
While all types of medications can face shortages, sterile injectable drugs, and critical life-saving drugs, including those used in cancer treatment, are most susceptible to shortages.
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How do drug shortages impact patients and healthcare providers?
Drug shortages can impact patient care by causing delays in treatment and increasing financial burden. Healthcare providers may need to opt for substitute medicines, which may or may not prove to be effective in treating the conditions.
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What measures can be taken to address and mitigate drug shortages?
Addressing drug shortages requires a multi-faceted approach involving collaboration between pharmaceutical companies, healthcare providers, regulatory agencies, and policymakers. Strategies may include improving manufacturing practices, diversifying supply chains, implementing effective inventory management systems, and enhancing transparency and communication.
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What role does geopolitics play in exacerbating drug shortages?
Geopolitical factors such as trade disputes, war, border closures, and strategic manufacturing decisions can disrupt the pharmaceutical supply chain and lead to drug shortages.
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What is the Stop Drug Shortages Act?
The Stop Drug Shortages Act is a proposed legislation aimed at preventing drug shortages in the United States. It seeks to improve transparency in the pharmaceutical supply chain and require drug manufacturers to report potential shortages in advance. It also aims to encourage the FDA to expedite the review of new drug applications to increase market competition and mitigate shortages.
