Drug Shortages: The Health and National Security Risk

The shortage of these commonly used hospital products can have a significant impact on patients. Patients may be unable to get the care they need, or they may have to switch to different medications that may not be as effective or have different side effects. Hospitals may have to ration medications, or they may have to delay or cancel medical procedures.

There are a number of oncology products that are currently in drug shortage. Some of the most common include:

• Cisplatin: Cisplatin is a chemotherapy drug used to treat a variety of cancers, including bladder cancer, head and neck cancer, and lung cancer.
• Carboplatin: Carboplatin is another chemotherapy drug used to treat a variety of cancers, including ovarian cancer, lung cancer, and head and neck cancer.
• Methotrexate: Methotrexate is a chemotherapy drug used to treat a variety of cancers, including leukemia, lymphoma, and breast cancer.
• Fludarabine: Fludarabine is a chemotherapy drug used to treat chronic lymphocytic leukemia (CLL).
• G-CSF: Granulocyte colony-stimulating factor (G-CSF) is a medication used to boost the production of white blood cells.
• Neulasta: Neulasta is a brand-name version of G-CSF.
• Plerixafor: Plerixafor is a medication used to mobilize stem cells from the bone marrow into the bloodstream.
• Zevalin: Zevalin is a brand-name version of rituximab, a monoclonal antibody used to treat lymphoma.
• Vincristine drug shortage: Vincristine is a chemotherapy drug that is used to treat a variety of cancers. The drug has been in short supply in recent years due to a number of factors, including manufacturing problems and overreliance on foreign manufacture. The shortage has had a significant impact on patients, as it has made it difficult for them to get the treatment they need.
• Sodium chloride 0.9% drug shortage: Sodium chloride 0.9%, also known as normal saline, is a sterile solution of sodium chloride in water. It is used to flush intravenous lines, to administer medications, and to treat dehydration. The drug has been in short supply in recent years due to a number of factors, including increased demand, manufacturing problems, and overreliance on foreign manufacture. The shortage has had a significant impact on patients, as it has made it difficult for them to get the care they need.
• IV contrast media shortage: IV contrast media is a type of dye that is used in medical imaging procedures, such as X-rays, CT scans, and MRIs. It helps to make the structures inside the body visible on the images. The drug has been in short supply in recent years due to a number of factors, including increased demand, manufacturing problems, and overreliance on foreign manufacture. The shortage has had a significant impact on patients, as it has made it difficult for them to get the care they need.

Price erosion and shrinking profit margins are contributing to drug shortages in a number of ways. Some of the most common include:

• Lower prices discourage manufacturers from producing drugs. When the price of a drug falls, it becomes less profitable for manufacturers to produce that drug. This can lead to shortages, as manufacturers may choose to discontinue production of the drug or to focus on producing other, more profitable drugs.
• Lower prices make it difficult for manufacturers to recoup their research and development costs. The development of new drugs is a costly process, and manufacturers need to be able to recoup their research and development costs in order to stay in business. When prices for drugs are low, it can be difficult for manufacturers to do this. This can lead to shortages, as manufacturers may be less likely to invest in the development of new drugs.
• Lower prices make it difficult for manufacturers to maintain a reliable supply of drugs. Manufacturers need to be able to maintain a reliable supply of drugs in order to meet the needs of patients. However, when prices are low, it can be difficult for manufacturers to do this. This can lead to shortages, as manufacturers may not be able to afford to maintain a large enough inventory of drugs.

Middlemen in the drug supply chain can contribute to drug shortages in a number of ways. Some of the most common include: 

• They can add a layer of complexity to the supply chain. This can make it more difficult to track the movement of drugs and to identify potential problems.
• They can take a cut of the profits, which can reduce the amount of money that is available to manufacturers to invest in production. This can make it more difficult for manufacturers to maintain a reliable supply of drugs.
• They can engage in speculation, which can lead to hoarding and shortages. For example, if a middleman believes that the price of a drug is going to go up, they may buy up a large quantity of the drug and then sell it at a higher price. This can create a shortage of the drug for patients who need it.

Manufacturing facility quality issues can contribute to drug shortages in a number of ways. Some of the most common include: 

• Contamination: If a manufacturing facility is not properly clean or if there is a problem with the manufacturing process, it can lead to contamination of the drug product. This can make the drug unsafe for patients and can lead to a shortage of the drug.
• Recalls: If a manufacturing facility discovers that a drug product is contaminated or otherwise not safe, they may issue a recall. This means that the drug product is removed from the market and patients may have difficulty getting it.
• Production problems: If a manufacturing facility has production problems, it can lead to a shortage of the drug product. This can happen for a variety of reasons, such as equipment malfunctions, staffing shortages, or problems with the supply of raw materials.
• Compliance issues: If a manufacturing facility is not in compliance with regulations, it can lead to a shortage of the drug product. This can happen if the facility is not following good manufacturing practices (GMPs) or if they are not meeting the requirements of the U.S. Food and Drug Administration (FDA).

The FDA Drug Shortage Task Force is a group of federal officials from the FDA, the Department of Health and Human Services (HHS), and other agencies who work together to address drug shortages. The task force was established in 2018 in response to a request from Congress.

The task force’s goals are to:

• Identify the root causes of drug shortages.
• Develop and implement solutions to prevent and mitigate drug shortages.
• Increase communication and coordination between stakeholders.

The task force has made a number of recommendations to address drug shortages, including:

• Enhancing the FDA’s oversight of drug manufacturing
• Providing financial incentives to manufacturers to produce low-margin drugs
• Improving the supply chain for drugs
• Increasing transparency in the drug market

The task force’s work is ongoing, and it is hoped that their efforts will help to reduce the number of drug shortages in the future.

Here are some of the specific actions that the FDA Drug Shortage Task Force has taken to address drug shortages:

• Establishing a Drug Shortage Dashboard: The FDA Drug Shortage Dashboard is a website that provides information about drug shortages, including the names of the drugs, the reasons for the shortages, and the steps that the FDA is taking to address them.
• Providing financial assistance to manufacturers: The FDA has provided financial assistance to manufacturers of low-margin drugs to help them maintain a reliable supply of these drugs.
• Working with other countries to address drug shortages: The FDA is working with other countries to address drug shortages by sharing information and coordinating efforts.
• Providing guidance to manufacturers: The FDA has issued guidance to manufacturers on how to prevent and mitigate drug shortages.

Overreliance on foreign manufacture is a significant contributing factor to drug shortages in the United States. According to a 2018 report by the Government Accountability Office (GAO), 80% of active pharmaceutical ingredients (APIs) used in the US are manufactured overseas, primarily in China and India. This reliance on foreign suppliers has made the US drug supply chain more vulnerable to disruptions, such as natural disasters, trade wars, and manufacturing problems.

Here are some of the specific ways that overreliance on foreign manufacture can contribute to drug shortages:

• Natural disasters: Natural disasters, such as earthquakes and floods, can damage manufacturing facilities in foreign countries, leading to shortages of APIs and finished drugs. 
• Trade wars: Trade wars can disrupt the flow of APIs and finished drugs from foreign countries to the US. 
• Manufacturing problems: Manufacturing problems, such as contamination or recalls, can also lead to shortages of drugs.