As the Obama Administration and federal agencies begin preparing for implementation of key provisions of the Affordable Care Act (ACA), one significant problem facing public health officials is concerning many: hospital drug shortages. In fact, a recent story from ABC News noted that “Many hospital patients are being turned away for potentially life-saving injection treatments in what may be the largest U.S. hospital drug shortage in over two decades.”
Those drugs facing shortages, according to the story, include “injectables and sedation medication such as propofol, the popular blood thinner heparin, and hard-hitting chemotherapy drugs like doxorubicin.” Dr. Michael Link, president-elect of the American Society of Clinical Oncology, noted that he had never “encountered shortages that may affect patient care” in his 30 years of practice.
According to an editorial published in the New England Journal of Medicine, “limited manufacturing, lagging production time, and lack of profits from these drugs are contributing to the shortage.” Since the production cost outweighs the profits for some companies, many firms are “producing cheaper generic drugs and are shunning some costly brands.”
Other causes for the shortages include manufacturing difficulties, natural disasters that affect production, reductions in the supply of raw materials (of which 80% come from outside the U.S.), unexpected increases in demand, voluntary recalls, manufacturer business decisions, FDA enforcement actions to ensure public safety and artificial shortages due to stockpiling.
Both the American Society of Health-System Pharmacists (ASHP) and FDA maintain drug-shortage lists. The FDA’s includes nearly 60 medically necessary products. The ASHP list is even more comprehensive, with over 140 drugs.
Because of these shortages, “Doctors at local hospitals are frustrated and many times they’re not even informed of the shortage, according to survey results of more than 1,800 health care practitioners (68% of them pharmacists) released in September by the Institute for Safe Medication Practices. Of those surveyed, 85 percent said they were given little to no information on how long the shortages would last.” Respondents were most alarmed by the use of less desirable, unfamiliar and often more expensive alternative drugs. They were concerned of potential for errors, poor patient outcomes or preventable adverse drug events.
The shortages have caused dozens of doctors nationwide to find alternative treatments for some of their patients. Dr. John Goldberg, pediatric oncologist at the University of Miami School of Medicine, explained to ABC News’ Medical Unit that the shortages have caused doctors to “spend a great deal of physician and pharmacy time developing priority trees to allocate available drug if necessary as well as to scour suppliers for drug shipments.”
Consequently, one of the significant problems facing physicians is that “since these medications are mainly housed in hospitals, most patients won’t know it might not be available until they really need it,” and when doctors finally find out about the shortages, “many are never told exactly when some of these medications will be available again.
While some “medications in short supply offer an equivalent substitute, in some cases insurance companies do not reimburse patients for the substituted therapies and patients who are unable to pay cannot get a drug that would be a good substitute.”
One potential cause for the miscommunication in drug shortages is the fact that the U.S. Food and Drug Administration (FDA) cannot regulate how much a manufacturing company can make. Additionally, manufacturers are not required to report shortages to the FDA. The amount of drugs made available within a hospital is an agreement between the hospital and specific manufacturers.
Cancer Drugs
When it comes to shortages of oncology drugs used to treat cancer “there isn’t really an alternative agent.” Dr. Link noted that unfortunately, “a multitude of key drugs used for multiple different cancers in adults and children, and that are key players in management have recently become unavailable.” Although some of them have possible workarounds or substitutions, Dr. Link noted that “in other cases there is not a good substitution.” For example, chemotherapy drugs such as doxorubicin, etoposide, vincristine and cisplatin that treat breast, gastric, ovarian, thyroid, small cell lung, lymphoma and other cancers, unfortunately have no recognized standard alternatives for the majority of clinical situations, Link said in a previous interview with ASCO, according to Daily Finance.
Discussion
Consequently, Valerie Jensen, associate director of the FDA’s drug-shortages program, noted that FDA is “doing everything the agency can within their current regulatory authority.” She further added that FDA is working to resolve every drug shortage on their list, but that “It’s a very long list right now, and it’s been long throughout this year.”
Ms. Jensen further explained that the FDA is trying to resolve these shortage as quickly as possible while ensuring public safety, and noted that “if a firm has expired inventory of a needed drug and it can give FDA data to support a longer expiration date, the agency will review it. “
Since FDA does not have the authority to require notifications of shortages from companies, groups such as ASHP and ASCO are calling on Congress and FDA to create requirements for early notifications so that doctors, pharmacists and nurses will have adequate time to find a potential substitute and learn about it so that dispensing errors can be minimized. Others suggested FDA authorizing importation of a drug that is in shortage.
Consequently, Senator, Amy Klobuchar (D-MN), sent a letter in December to FDA Commissioner Margaret Hamburg requesting “immediate action” to ensure adequate supplies of essential drugs. Klobuchar said she’ll also introduce legislation in January that would require pharmaceutical companies to notify the FDA when they decide to limit or discontinue production of drugs, and give the FDA the authority to expedite approval for substitute treatments or the importation of drugs.
Supporters of this kind of policy change and legislation have also proposed offering incentive payment for companies reporting early about possible shortage-causing problems. Others want policies that prohibit companies from taking advantage of shortages and charging exorbitant prices for drugs in short supply.
Conclusion
Ultimately, the drug shortage problem raises serious regulatory concerns for patients and health practitioners. As some doctors and hospitals are turning to a so-called “grey market” to get the supply they need by paying and charging a higher price for drugs in short supply, our health care system will slowly turn into treatment for the ‘haves’ and ‘have-nots.’
Legislation or policies addressing these shortages are crucial because doctors, hospitals, and pharmacists are spending more and more resources on managing the shortage problem instead of treating patients, leading to less efficient and effective care. To improve patient safety and to continue an adequate supply of drugs, Congress and FDA must tackle this issue accordingly.
How would you feel if the next time you went in for treatment, your doctor told you he was out of your medication because a company decided not to make it anymore, and they never informed anyone?