How Drug Shortages Might Affect You on the Job
By Debra Wood, RN, contributor
December 13, 2011 - Drug shortages have increasingly become a problem for nurses, physicians, pharmacists and, most importantly, patients, as manufacturing difficulties, shipping delays and ingredient shortages result in threats to public health and safety.
AnnMarie Papa, DNP, RN, CEN, NE-BC, FAEN, reported that nurses find drug shortages frustrating and called for greater transparency about supplies.
“Everyone who touches medications is affected by it,” said AnnMarie Papa, DNP, RN, CEN, NE-BC, FAEN, president of the Emergency Nurses Association.
Papa reported that emergency nurses have seen patients suffer needlessly and experience adverse events when substitute medications were not as effective or because, in some cases, no substitutes exist.
Often shortages remain off the radar until a nurse goes to give the drug, and it is not available. The nurse may call the pharmacy to track it down and learn about the national shortage. The nurse then notifies the physician to try to obtain a different order. Meanwhile, the patient waits.
“Every day something different comes up, and it’s hard to predict [what won’t be available],” said Papa, adding that “the biggest thing for nurses is the frustration.”
Drug shortages lead to medication errors
The Institute for Safe Medication Practices (ISMP) in Harsham, Penn., found in a 2010 survey widespread frustration and outrage among health care practitioners. While drug shortages exasperate nurses and health care professionals, they can be deadly to patients.
“This is definitely a nursing issue,” said Judy Smetzer, RN, BSN, FISMP, vice president of ISMP. “Nurses are the people administering the medications, and when they don’t have the correct product or a different strength than they are used to, they are the ones closest to the patient and can make an error.”
Smetzer offered several examples of how medication errors occur with drug shortages, based on incidents reported to ISMP. When the morphine shortage began, the 2 mg. strength was not available and pharmacies stocked higher dosages. The nurse expecting a 2 mg vial might not recognize it really is 10 mg and could administer an overdose. Eventually, even higher strengths of morphine became unavailable and hospital pharmacies switched to hydromorphone, which is seven times stronger than morphine. Some physicians inadvertently ordered the same number of milligrams, and nurses administered it, resulting in patient deaths. Likewise, different strength epinephrine led to overdoses of that drug.
“It’s a set-up for nurses to make mistakes,” said Smetzer, adding that in ISMP’s most recent survey, 20 percent of the participants reported bad patient outcomes related to drug shortages and a lot of near misses. Other outcomes, such as those related to the use of different chemotherapy regimens due to shortages, are harder to quantify. She reported that while shortages have always existed, the situation has never been worse.
Lack of vitamins or other elements needed by patients receiving parental nutrition is another cause for concern. Most of those patients do not have alternatives to maintain their nutritional status, so malnutrition will occur and could result in harm to the patient, even death, said American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) President Jay Mirtallo, MS, RPh, BCNSP, FASHP, director of the master’s in health systems pharmacy program at Ohio State University in Columbus.
Jay Mirtallo, MS, RPh, BCNSP, FASHP, encourages nurses to check TPN bags to ensure the nutrients ordered are being administered and to monitor patients for signs of deficiencies when some nutrients or vitamins are not available.
Mirtallo recommended nurses carefully check to ensure the nutrition bag contains what was ordered and to assess patients for signs of nutritional deficiencies.
When critical shortages occur, A.S.P.E.N. pulls together an interdisciplinary team of experts, including nurses, to come up with suggestions for managing during the shortage and then publishes the information on its website (http://www.nutritioncare.org/).
The scope of the problem
The U.S. Food and Drug Administration (FDA) Drug Shortage Program reported an increase from 61 shortages in 2005 to 178 in 2010, stating that quality and manufacturing problems were a major reason for shortages in 2010. However, the agency also said that some firms decided to discontinue making products for business reasons and some had problems with raw material supplies.
Of the 127 shortages studied by the FDA in 2010-11, 80 percent involved drugs delivered to patients by sterile injection, including oncology drugs, antibiotics and electrolyte/nutrition drugs. Injectables present more complex manufacturing processes, and most have only one manufacturer that produces at least 90 percent of the drug, according to facts released by the White House.
Mark DeLegge, M.D., global medical director for clinical affairs at Baxter International, Charleston, S.C., said that alternate manufacturers often can ramp up production but not enough to fulfill demand. Also, increasing production takes time. Shortages may persist for a year or longer. DeLegge recommends the FDA alert alternative suppliers early and make plans to deal with an impending shortage, perhaps allowing importations of quality products or incentivizing production by another firm, before shutting down a plant or line.
Early notification by manufacturers allowed the FDA to successfully prevent 99 drug shortages in 2011, most commonly by asking other manufacturers to step up production, by identifying ways to mitigate quality issues and by expediting reviews, according to the White House.
A Premier healthcare alliance analysis in March 2011 found that more than 240 drugs were in short supply or unavailable in 2010, and more than 400 generic equivalents were backordered for more than five days. Many of those drugs short in 2010 remained unavailable at the start of 2011. Premier reported that 42 percent of the sterile injectable shortages were due to product quality situations, 9 percent due to raw materials and 5 percent attributable to plant shutdowns, but 18 percent were due to manufacturers discontinuing production.
Many of the drugs in short supply are generics with small margins. Mirtallo explained that if profits are not large enough or costs are too high to bring a production line into compliance with good manufacturing practices, the company may decide to pull out of that business, further consolidating suppliers. Mirtallo said the shortages are a U.S. problem, with clinicians in other countries reporting adequate availability of the drugs and nutrients they need.
In July 2011, the American Hospital Association reported that 99.5 percent of the hospitals it surveyed had experienced one or more drug shortages in the prior six months, and 44 percent said they had 21 or more drug shortages. Nearly half of the responding hospitals, 47 percent, reported daily shortages. Eighty-two percent of the hospitals delayed patient treatment as a result of the shortage, and 78 percent of the hospitals rationed or restricted use of drugs in short supply.
Potential solutions for mitigating the problem
Papa would like to see greater transparency and wishes the pharmaceutical companies or suppliers would disclose the reason for a shortage and the expected length of time it will last, so caregivers can plan appropriately. Papa suggested resolving the issue may require bringing all stakeholders together to discuss ways to keep drugs flowing to the patients who need them.
DeLegge agreed that better communication among hospitals, industry and regulatory officials is needed to come up with solutions and to keep each other aware of pending actions that might create shortages, so everyone understands the ramifications and takes steps to protect the supply available.
The Emergency Nurses Association strongly supports the Preserving Access to Life Saving Medications Act (S.296), introduced by Senators Amy Klobuchar and Robert Casey, which would require pharmaceutical companies to notify the FDA when a factor arises that may result in a shortage. The bill would increase the accountability of pharmaceutical companies to the public, help ensure that the supply chain is more consistent and allow the opportunity to plan for foreseeable shortages.
Citing the number of drug shortages, Pres. Obama issued an executive order at the end of October 2011, directing the FDA and the Department of Justice to take action to help further reduce and prevent drug shortages, protect consumers, and prevent price gouging. The order requires the FDA to broaden the reporting of potential shortages and to expand its efforts to review new manufacturing sites, drug suppliers and manufacturing changes, and it provides additional FDA staffing to address the issue.
“[The executive order] is not going to solve it right away, but it’s a step in the right direction,” Smetzer said. “We have to give the FDA greater authority.”
Taking steps to avoid price gauging
Shortages have created a “gray market” in which unofficial supply channels sell the drugs at high markups without chain of supply documentation. Premier reported that the average markup offered by gray market vendors was 650 percent but some have been as high as 3,000 percent to 4,000 percent.
The president’s executive order directs the FDA to work with the Department of Justice to examine illegal hoarding or raising of prices to gouge customers.
An ISMP survey in July and August 2011 of purchasing agents and pharmacists reported that 56 percent of respondents received daily phone, email or fax solicitations from up to 10 different gray market vendors, and 28 percent of respondents reported weekly solicitations. Fifty-two percent of respondents had purchased one or more pharmaceutical products from gray market vendors during the prior two years, despite concerns about authenticity, cost and ethical considerations. Many of the respondents felt pressured by administrators or physicians to purchase the gray market drugs.
“That’s concerning, because if you don’t know the source and there is an issue with a patient, it’s more difficult to track that lot number and source,” DeLegge said. “And you have to make sure that drug house is storing the materials at a right temperature and at a safe location so there is no damage to the drug product.”
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