Drug Shortages: FDA Report Identifies Root Causes and Potential Solutions
October 31st, 2019
A new report from the FDA identifies the root causes and possible solutions to better managing drug shortages in the U.S.
An FDA Drug Shortage Task Force recently published Drug Shortages: Root Causes and Potential Solutions. This report examines the root causes of and potential solutions for drug shortages. The report gathered information from stakeholders, research, and an economic analysis of the market conditions impacting the issue.
Root Causes Identified
The report concludes there are three root causes causing drug shortages:
Lack of incentives for manufacturers to produce less profitable drugs
When manufacturers have limited profitability opportunities, they are less likely to invest in older drugs and expanding capacity. Older generic drug manufacturers face intense price competition and smaller margins. If it’s not profitable, then pharmaceutical companies have no incentive to make more, even if there is demand.
Absence of recognition and reward for manufacturers for “mature quality systems,” which focus on continuous improvement and early detection of supply chain issues
Manufacturers must meet Current Good Manufacturing Practices (CGMPs). Mature quality management conforms to CGMPs while also including a performance and patient focus. Technology, process control, and planning support this focus. The problem here lies in the limitation of information. Purchasers have little information related to quality management.
Therefore, the market doesn’t reward manufacturers with price premiums for those that engage with modernization. Nor does it penalize those that do not. Again, there’s no incentive here for manufacturers to invest in manufacturing quality. This leads to quality problems, resulting in shortages.
Difficulty related to the recovery of the market due to disruptions caused by logistical and regulatory challenges
Drug supply chains are more complex than ever before. More production has gone abroad along with the use of contract manufacturers, adding to the intricacy. Most markets respond to shortages by increasing production. With logistical and regulatory red tape, it’s rather difficult to expand production to meet demand.
Drug Shortages Have Real-World Impacts
When drug shortages occur, patient health can worsen. It impacts the ability to treat a disease. Often substitutes don’t have the same effectiveness. A recent study found that 56% of hospitals reported having to change patient care due to shortages.
These shortages often impact the most vulnerable patients. One such example is children with T-cell acute lymphoblastic (ALL). This is a highly treatable cancer. However, the drugs used to treat them are older and more likely to be susceptible to shortage. As recent as 2019, nine of the 11 drugs used to treat ALL were hard to keep in stock.
Another example is the shortage of norepinephrine, a treatment for septic shock. In 2011, it was in shorty supply. Other drugs were used in its place, resulting in more deaths.
Information on current drug shortages can be found on the American Society of Health-System Pharmacists (ASHP) website.
Solving the Drug Shortage Problem
The report also identified possible solutions to the problem with three recommendations:
Create a shared understanding of the impact of drug shortages and the contracting practices that may contribute to them
Even though drug shortages are a well-known problem, little data has been collected and analyzed. The FDA cites three areas that need to be addressed:
- Quantification of the harm that drug shortages do to patients
- Characterization of shortages
- Transparency in private sector contracting practices
Develop a rating system to incentivize drug makers to invest in achieving quality management system maturity
Manufacturers still need to meet CGMP guidelines. But they need to be encouraged with incentives to do more. To accomplish this, a rating system is a good step. It could inform purchasers and even consumers about the quality of the product.
Promote sustainable private sector contracts
With more information about contracting practices and greater transparency could provide a new approach to contracting. With this, the supply of drugs could be more reliable. These contracts could address the root causes by providing financial incentives and rewarding manufacturers for mature quality management.
Additionally, there are currently legislative proposals and FDA initiatives that could help with the drug shortage problem. Those include:
- Better and improved guidance on data sharing
- Requirements of risk management plans and guidance on how to develop them
- Longer expiration dates
- Improved pharmaceutical product lifecycle management
There is no simple or sole solution to addressing the problem of drug shortages. Like much of healthcare, there are many stakeholders, each with their own agendas. However, this an issue that cannot be ignored, as it’s impacting patient care. It’s time for all parties to work together to find a clear path to managing what could turn into an epidemic.