The U.S. Food and Drug Administration identified a record number of drug shortages in 2010, and this trend continues to worsen in 2011, particularly with older sterile injectable medications.
According to the FDA, unanticipated manufacturing problems are the major culprit behind these shortages. The agency also cites a dearth of raw materials, reformulations, disease outbreaks, unanticipated demand and updated therapeutic guidelines as factors that contribute to drug shortfalls.1
Consider injectable propofol, which reduces anxiety and produces a state of conscious sedation in settings from emergency departments to procedure rooms, ICUs and the OR.
Teva Pharmaceuticals identified possible microbial contamination in their propofol product in late 2009 before discontinuing production in May 2010, and Hospira, Inc. reported a shortage because of an unanticipated increase in demand. Meanwhile, APP increased production in response to reported shortages and directed providers to place orders through wholesalers and distributors.2
The shortage of certain chemotherapy drugs, including cytarabine, daunorubicin and leucovorin, is arguably the most heartbreaking scenario.
Cancer centers are dealing with an unprecedented shortage of Taxol, an important drug in the treatment of ovarian, breast and non-small cell lung cancer. Two drug companies that market the drug attribute the problem to manufacturing delays, another points to a raw material shortage while the other company cites increased demand.
Jeffrey W. Cronk, MD, a medical oncologist in northern California, is understandably concerned about the shortage of numerous chemotherapy agents, antibiotics and other drugs.
"Cancer patients are very vulnerable people who need these medications for their palliative and curative effects, and it's very difficult to explain what we're up against," he explained. "In many cases, there is no prudent substitute."
What's in Store?
As a member of a large physician practice, Cronk can often obtain drugs in limited supply from alternative suppliers or borrow from a local hospital.
"Sometimes, however, we have to substitute another drug that doesn't have as long a track record, or that may have greater toxicity," he noted. "When we can't get enough Taxol, for example, we may substitute Taxotere, which causes more myelosuppression and alopecia at higher doses. One of my patients recently ended up in the hospital with neutropenic fever related to Taxotere."
Each drug has its own supply and demand picture, making it difficult to ensure that patients will have access to the medication throughout the course of their treatment. While there will be some releases of Taxol in September 2011, several pharmaceutical companies say they cannot even estimate when their product will be available.3
The problem becomes even dicier when one firm has the market cornered.
For example, Janssen Products, LP is the sole manufacturer of doxorubicin liposomal injection, or Doxil, an injectable drug for the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma. Manufacturing issues have created a shortage of the drug world-wide and access will be intermittent, with a partial release sometime in the 4th quarter of 2011.4
In light of uncertainty about drug supplies, some pharmaceutical companies have taken the bull by the horns.
Janssen has established a physician allocation process so providers can ensure Doxil goes first to patients currently undergoing therapy with this drug. The company urges providers to avoid prescribing Doxil for new patients until there is an adequate supply.4
Nurses can serve as patient advocates by establishing strategies and policies to support these recommendations within their institution.
Judy Smetzer, BSN, RN, vice president at the Institute for Safe Medication Practices (ISMP), described how the dearth of critical medications has spurred the growth of gray market drugs.
"The past 2 years have been the worse we've ever seen, and these shortages involve critical drugs like chemotherapy agents, anesthetics and antibiotics," she noted.
"When physicians are trying to treat patients, they don't want to hear, 'We can't get that drug,' so the pharmacist may resort to drugs that can be marked up as much as 4,000 percent. Some [vendors] have been known to sell expired medications, counterfeit medications or stolen drugs."
Findings from a recent IMSP survey of pharmacists and purchasing agents at 549 hospitals show the depth of the problem.
More than half of the respondents said they are solicited daily by up to 10 different gray market vendors, one of every two respondents have purchased one or more of the products over the past 2 years, and 80 percent said they are buying more gray market products because of escalating drug shortages.5
Some hospitals refuse to purchase gray market drugs, citing concerns about authenticity, ethics, cost and storage conditions before purchase. Twelve percent of those who answered the ISMP survey said they were aware of medication errors, adverse drug reactions or product authenticity issues with the gray market drugs.5
Tackling the Issue
ISMP recommends hospitals work together in local coalitions to identify drug shortages, set limits on appropriate use and borrow from one facility to another to avoid gray market use. It's also a good idea, IMSP says, to learn best ordering practices, including back and direct ordering from the drug company.5
The American Society of Health-System Pharmacists recommends physicians evaluate the health system's supply of chemotherapy drugs before beginning a regimen and select alternative regimens if the supply is inadequate. They also suggest consulting an oncologist or hematologist for patient and neoplasm-specific drugs. Oncology nurses can and should be a part of the decision-making process when chemotherapy regimens are revised.
FDA encourages healthcare providers to identify other treatments that may take the place of unavailable drugs, and urges hospital pharmacists to develop processes for informing physicians of shortages and ensuring appropriate use of therapeutic alternatives.1
For example, there will be intermittent supplies of various formulations of propofol in the foreseeable future, but there are alternative hypnotic sedatives, such as lorazepam and midazolam. Clinicians can collaborate within health systems to identify priority uses of propofol and to identify therapeutic equivalents for lower priority applications.1
However, these substitutions may significantly increase the risk of medications errors.
"Nurses may be asked to use different strengths or formulations of a drug, or even an unfamiliar medication," Smetzer noted. "When there's a shortage of a drug that comes in a single-dose vial, providers may be tempted to get multiple doses from the vial. That practice increases the risk of contamination and creates an infection control problem."
Sandy Keefe is a frequent contributor to ADVANCE.
References for this article can be accessed here.