0 items USD 0.00Preventing Drug Shortages: The Role of the FDA and Market Research
Table of Contents
- What is drug shortage?
- What is the current state of drug shortages in the United States?
- Since when the U.S. government started the drug shortages documentation process?
- What are the causes of drug shortage?
- What are the adverse effects of drug shortage?
- Who can report a drug shortage? Can an individual authorize to do so?
- Who are the Stakeholders?
- From where drug shortage information can be downloaded?
- How does the FDA deal with drug shortages?
- How can a market research company help?
- Example Case: Amifostine Injection
Drug shortages have been a concern for many years and have been addressed by various governments and regulatory agencies around the world.
The United States has a complex system for managing and addressing drug shortages, which can be caused by various factors, including manufacturing and quality issues, raw material shortages, and unexpected increases in demand. The Food and Drug Administration (FDA) works closely with drug manufacturers to prevent shortages and mitigate their impact when they do occur. We will see further in this article how FDA, along with Market Research agencies, can prevent unwanted circumstances.
1 . What is drug shortage?
A drug shortage is a situation in which the supply of a certain medication is insufficient to meet its demand. The Drug Shortages Report, a list of drugs that are in short supply or have been discontinued, is maintained by the U.S. Food and Drug Administration (FDA) and is updated regularly. The report is intended to help healthcare providers, pharmacists, and other stakeholders stay informed about shortages of drugs that may affect patient care. It includes information about the reason for the shortage, the expected duration, and any available alternatives. It is important to note that the report only includes shortages that have been reported to the FDA. There may be additional shortages that are not included in the report.
2 . What is the current state of drug shortages in the United States?
In the United States, drug shortages have been a particular concern in recent years. According to the U.S. Food and Drug Administration (FDA), over 189 new drug shortages were reported until 3rd January 2023. However, it is lower than in 2020. According to the American Society of Health-System Pharmacists (ASHP), there were 246 new drug shortages in the United States in 2020, with a total of 432 active shortages at the end of the year. These shortages affected a wide range of critical medications such as cancer, antibiotics, and electrolytes. The COVID-19 pandemic has also impacted drug shortages, with supply chain disruptions and increased demand for certain medications contributing to the problem.
3 . Since when the U.S. government started the drug shortages documentation process?
The U.S. Food and Drug Administration (FDA) began tracking and reporting on drug shortages in the United States in the early 1990s. In 2011, the FDA established the Drug Shortage Staff within the Center for Drug Evaluation and Research (CDER) to coordinate its efforts to address drug shortages.
The FDA's drug shortages report is published online and is updated regularly. It includes information about drugs that are currently in shortage or have been discontinued, the expected duration of the shortage, and any available alternatives. The report is intended to help healthcare providers, pharmacists, and other stakeholders stay informed about shortages that may affect patient care.
In addition to tracking and reporting on drug shortages, the FDA also works with manufacturers to identify and resolve any issues causing shortages. It allows temporary importation of drugs from other countries when necessary to help meet demand. The FDA also provides financial incentives to manufacturers to increase production and address shortages.
4 . What are the causes of drug shortage?
There may be several causes of drug shortages, including:
- Manufacturing issues: Manufacturing problems such as equipment failures, facility renovations, or production delays can contribute to drug shortages.
- Raw material shortages: Some drugs require specific raw materials that may be in short supply, leading to shortages of those medications.
- Quality control problems: If a drug fails quality control testing, production may be halted until the issue is resolved, leading to a shortage of that medication.
- Intellectual property issues: Patent disputes or other intellectual property issues can lead to a lack of access to certain medications.
- Economic factors: Economic factors such as low-profit margins or high production costs can make it difficult for manufacturers to produce certain medications.
- Limited production capacity: If a medication is only produced by a small number of manufacturers, a production issue at any one of those facilities can lead to a shortage of that drug.
5 . What are the adverse effects of drug shortage?
- Shortage of necessary medications for patients: Drug shortages can lead to a lack of access to necessary medications, which can be particularly problematic for patients with chronic conditions or serious illnesses.
- Increased costs for hospitals and pharmacies: Drug shortages can lead to higher prices for certain medications as demand outstrips supply. This can increase costs for hospitals and pharmacies and potentially be passed on to patients.
- Difficulty in finding alternative medications: In some cases, alternative medications may not be available or may not be suitable for all patients, making it difficult to manage their treatment.
- Negative impact on patient outcomes: Drug shortages can lead to delays in treatment or suboptimal treatment, which can have negative impacts on patient outcomes. Sometimes, this can result in longer hospital stays, increased healthcare costs, or even death.
6 . Who can report a drug shortage? Can an individual authorize to do so?
Anyone can report a drug shortage to the U.S. Food and Drug Administration (FDA). This includes stakeholders such as individuals, healthcare providers, pharmacies, and pharmaceutical manufacturers.
If you are aware of a drug shortage or discontinuation, you can report it to the FDA by contacting the Drug Shortage Staff at the FDA's Center for Drug Evaluation and Research (CDER). You can reach the Drug Shortage Staff by phone at (240) 402-7770 or by email at drugshortages@fda.hhs.gov.
It is important to note that the FDA relies on reports from different sources to identify and track drug shortages. The more information they have, the better equipped they are to address the issue and work to prevent shortages from occurring.
7 . Who are the Stakeholders?
There are several stakeholders in the issue of drug shortages. These include:
- Patients: Drug shortages can directly impact patients, as they may be unable to access the medications they need.
- Healthcare providers: Doctors, nurses, and other healthcare professionals rely on a reliable supply of drugs to treat their patients. Drug shortages can make it more difficult for them to provide effective care.
- Pharmaceutical companies: Manufacturers of drugs can be affected by shortages, as they may experience lost sales and revenue if their products are in short supply.
- Government agencies: The U.S. government, including the FDA and other agencies, addresses drug shortages and works to prevent them from occurring.
- Insurance companies: Drug shortages can increase healthcare costs, which may be passed on to insurance companies.
- Pharmacies: Pharmacies rely on a steady supply of drugs to fill prescriptions for their customers. Drug shortages can make it difficult for them to meet the needs of their patients.
8 . From where drug shortage information can be downloaded?
The U.S. Drug Shortages Report is published by the U.S. Food and Drug Administration (FDA) and is available on their website. You can view the report online or download it as a PDF file.
To view the report online, go to the FDA's drug shortages webpage (https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm). The report is updated regularly and includes information about drugs that are currently in shortage or have been discontinued.
To view the report online, go to the FDA's drug shortages webpage (https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm). The report is updated regularly and includes information about drugs that are currently in shortage or have been discontinued.
To download the report as a PDF, go to the FDA's drug shortages webpage and click on the "Print as PDF" button at the top. This will allow you to save the report to your computer or device.
You can also sign up to receive email updates about drug shortages by visiting the FDA's drug shortages webpage and clicking on the "Sign up for email alerts" button. This will allow you to receive notifications whenever the report is updated or a new shortage is identified.
9 . How does the FDA deal with drug shortages?
The FDA works to address drug shortages through a variety of strategies, including:
- Identifying and addressing the root cause of the shortage: The FDA works with manufacturers to identify the cause of the shortage and help them resolve the issue.
- Working with manufacturers to increase production: The FDA may work with manufacturers to increase the affected drug's production to meet demand.
- Approving temporary importation of drugs from other countries: If a drug is not available in the U.S., the FDA may allow temporary importation of the drug from other countries.
- Allowing the use of alternative therapies: In cases where a drug is in shortage, the FDA may allow the use of alternative therapies as a temporary solution.
- Providing updates and alerts to healthcare professionals and the public: The FDA maintains a database of drug shortages and alerts healthcare professionals and the public to any shortages that may affect them.
- Collaborating with other federal agencies: The FDA works with other federal agencies, such as the Department of Health and Human Services, to address drug shortages and ensure that the supply of drugs is maintained.
10 . How can a market research company help?
Market research companies can help drug manufacturers and other stakeholders understand and address drug shortages in several ways:
- Identifying the causes of shortages: Market research companies can conduct research to identify the root causes of drug shortages, such as production delays, manufacturing issues, raw material shortages, or unexpected demand.
- Assessing the impact of shortages: Market research companies can conduct surveys and other research to understand the impact of drug shortages on patients, healthcare providers, and other stakeholders.
- Identifying potential solutions: Market research companies can gather and analyze data to identify potential solutions to drug shortages, such as alternative treatments or therapies, temporary importation of drugs from other countries, or changes to regulations or production processes.
- Tracking the effectiveness of solutions: Market research companies can track the effectiveness of solutions implemented to address drug shortages and provide insights on their impact.
Market research companies can provide valuable insights and data to help manufacturers, healthcare providers, and stakeholders understand and address drug shortages more effectively.
11 . Example Case: Amifostine Injection
The FDA Drug Shortages portal shows that ETHYOL® (amifostine) for injection: 3 x 500 mg vials (NDC 76310-017-50), is currently running on shortage since June 2020, and the estimated shortage duration is still unknown.
About the drug
Amifostine injection is a prescription medication used to reduce the severity of side effects caused by certain cancer treatments. It is classified as a "radioprotective agent," meaning that it helps to protect healthy cells from the damaging effects of radiation therapy.
Shortage Background
Recently, there has been a shortage of amifostine injections in the United States. The drug shortage of Clinigen's Ethyol (amifostine) injection is ongoing. Ethyol has been unavailable for at least 90 days. Clinigen, Inc. is the sole supplier of amifostine injection, and the product supply has been depleted. Clinigen estimated supply would resume from late 2021 to early 2022, but the drug shortage portal still shows a shortage. This shortage has been caused by a number of factors, including manufacturing delays and increased demand for the drug due to the COVID-19 pandemic.
Impact
The shortage of amifostine injections has had a number of serious consequences for patients and healthcare providers. Many cancer patients have had to delay or alter their treatment plans due to the lack of availability of the drug, which can have serious consequences for their health and well-being. Additionally, the shortage has placed a burden on healthcare providers, who must find alternative treatments or work with limited supplies of the drug.
Solution
It is essential that steps be taken to address the shortage of amifostine injections as soon as possible. This may involve increased production of the drug, finding alternative treatments, or implementing other strategies to ensure that patients have access to the medication they need. Failure to address the shortage could have serious consequences for the health and well-being of cancer patients.
How does a custom or syndicated study on Amifostine Market can help?
A market research study can cover the following aspects of Amifostine.
- Amifostine market overview, market opportunities, market driving force, and market risks.
- Profile the top manufacturers of Amifostine, with price, sales, revenue, and global market share of Amifostine
- Amifostine competitive situation, sales, revenue, and global market share of top manufacturers
- Amifostine breakdown data are shown at the regional level to show the sales, revenue, and growth by region.
- Amifostine Sales by Type (400mg/Dose, 500mg/Dose)with sales market share and growth rate
- Sales data at the country level, with sales, revenue, and market share for key countries in the world, Amifostine market forecast by regions, type, and application, with sales and revenue
- Key raw materials and key suppliers, and industry chain of Amifostine.
- Amifostine sales channel, distributors, customers, and research findings to assist stakeholders.
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