Two Congressmen introduced bipartisan legislation to address prescription drug shortages last week. The Drug Shortage Prevention Act would create a ‘Critical Drug List’ that would identify drugs that are susceptible to shortage, and require the FDA to develop a system to notify the public if a medicine is added to the list.
The bill would also require the FDA to inform distributors of an upcoming shortage so they can prevent secondary buyers from trying to collect drugs and sell them on the ‘grey market’ for higher prices. Distributors would also be able to reallocate supplies to delay and ease the effects of a shortage.
This bill marks the latest step in government efforts to respond to drug shortages, following an executive order that President Obama signed last October. Obama directed the FDA to speed up new manufacturing facilities’ reviews and encourage manufacturers to report shortages sooner so that limited drug supplies can be more effectively managed to prevent a drug shortage from becoming a crisis.
And while it is a positive sign that the issue of drug shortages are being taken seriously, these measures are only just a start. Drug shortages have become a growing and critical problem in America. In 2011, there were a record-high 267 new prescription drug shortages. This is 56 more than in 2010, when there were 211, and more than four times greater than the number of medication shortages in 2004, when just 58 drug shortages were reported.
The worsening drug shortage problem impacts patient care, especially in hospitals, as chemotherapy, surgery and care for patients with pain and infections are disrupted as a result of a lack of critical medicines. At least 15 deaths have been blamed on drug shortages in the past year.
The shortages have also delayed clinical trials that compare new, experimental drugs to older ones, and have led to extraordinary price extortion, causing many hospitals to have to pay extremely large markups for limited drugs.
The FDA says the shortages are primarily a result of manufacturing deficiencies that lead to production shutdowns. They are also caused by companies that end production of drugs that have small profit margins, consolidation in the generic drug industry, and not enough supplies of some ingredients.
While a lack of cancer drugs have been one of the most significant drug shortages, shortages have also been reported for drugs used to treat heart disease, central nervous system conditions, infection and pain. The IMS Institute, which provides information services for the health care industry, found that more than 80 percent of the products in short supply are generic, forcing patients looking for substitutes to get the brand-name drug and a higher co-payment.
Unfortunately, not many of the current shortages will be resolved soon, due to several key manufacturers that have had to shut down production because of contamination or other quality problems. Some medicines may only have one other manufacturer, which lacks the the capability to fill the gap immediately or entirely.
We must address the critical issue of drug shortages seriously and immediately in order to be most responsive to the well-being of patients generally and their ability to access life-saving medications as quickly as possible. It is important to address the complex set of manufacturing issues while continuing to encourage a market that promotes accessibility for these products. Health care providers and manufacturers can ascertain alternative treatment more effectively by tackling predicted drug shortage incidences early in the process.
Further, we must address and stop price gouging by secondary wholesalers. This jeopardizes patient safety, as it is impossible to guarantee that the medicines obtained by providers in this way have been handled in a way that maintains product integrity.
The pharmaceutical industry has worked hard to take proactive steps to address this problem thus far. The industry has worked closely with FDA and supply chain partners to address disruptions in availability of medicines as fast as possible. The industry is making continual investments in manufacturing processes to improve quality control, along with investments to constantly improvement technology to prevent future disruptions from happening.
Last month, the pharmaceutical industry introduced the Drug Shortages Resource Center. This site provides information about shortages, offers steps to take if affected by a shortage, provides links to FDA’s shortages page, and additional resources that provide guidance about this issue. This is the most recent example of the industry’s preemptive efforts to ensure the public is aware of any shortages, and offer steps they can take in case of unavailability.
The health care industry is deeply concerned with ensuring that patients have access to medicines. Pharmaceutical companies have demonstrated their commitment to maintaining good manufacturing practices and continuing to work closely and collaboratively with the FDA, providers and patients.
It is imperative that we seek a more thorough understanding of the many circumstances that can lead to a drug shortage as various industry stakeholders try to identify significant ways to help lessen, ease and address this serious problem. We must work together to protect availability and access to medicines.