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Drug shortages create a crisis Act now or risk cancellations
Many ambulatory surgery programs are accustomed to using a specific size of vials for hydromorphone, but they have been forced by what is being described as the worst drug shortage ever to convert to vials twice the normal size due to a shortage of their customary vials.
"Once we start stocking in certain areas, people might be used to thinking that 2 mg is one vial," says John J. Lewin III, PharmD, MBA, BCPS, division director of critical care and surgery pharmacies and adjunct assistant professor for anesthesiology and critical care medicine, Division of Neurosciences Critical Care, at Johns Hopkins Medical Institutions, Baltimore, MD. Consequently, they have intended to give a 2 mg dose, but instead have administered the entire 4 mg vial, says Lewin, who says he is "intimately involved" with drug shortages.
With a different strength or vial size, and without "notifying staff that it is a different strength or different vial, without people paying attention, it's likely to lead to medication errors," Lewin says. Such incidents have been reported with morphine and hydromorphone, as well as epinephrine, he says.
Another error with alternatives has been include infusing Ativan at typical rate for propofol.1 Side effects, such as postoperative nausea and vomiting (PONV) also have been reported with some alternate drugs.1
In a 2010 survey of 1,800 healthcare providers, about one in five respondents reported adverse patient outcomes during the past year because of drug shortages, according to the Institute for Safe Medication Practices (ISMP)2 More than one-third (35%) said their facility had experienced a near miss during the past year due to a shortage, and about one in four reported actual errors.
Such incidents are more likely now that there have been recent shortages of several critical drugs including propofol, succinylcholine, and epinephrine. Other drugs that are also in shortage include certain neuromuscular blocking agents, regional anesthetics, and various opioids. Recently it has been announced that sodium thiopental (Pentothal) will no longer be available in the United States, due to its sole manufacturer ceasing production of the drug. The move has "extremely troubled" the American Society of Anesthesiologists (ASA), according to a statement released by the organization.3
"Although its use has decreased in recent years due to the introduction of newer medications, such as propofol, sodium thiopental is still considered a first-line anesthetic in many cases including those involving geriatric, neurologic, cardiovascular and obstetric patients, for whom the side effects of other medications could lead to serious complications," the ASA said.
The ASHP drug summit identified more than 200 shortages in 2010, Lewin says.
A large percentages of the drugs experiencing a shortage are generic injectable drugs, says Lewin. "That has implications for anyone who does surgery, hospitals and outpatient surgery centers alike," he says.
And the situation isn't expected to improve in the short-term, according to the American Society of Health-System Pharmacists (ASHP). Respondents to the 2010 survey said drug shortages in the year 2010 had been the worst ever. (To see the full results, go to www.ismp.org/Newsletters/acutecare/articles/20100923.asp.) The respondents were most concerned about: an increasing number of medications in short supply, alternative drugs that weren't always available and sometimes were unfamiliar and/or less desirable, errors and poor patient outcomes associated with the shortage or alternative drugs/dosages, no advance warning about impending shortages, and the time required to address the drug shortage. Surgeries have been cancelled due to drug shortages, experts share.
"Overall, survey respondents conveyed a real sense of crisis and are clearly looking for support to reduce the organizational burden and potential patient harm associated with drug shortages," according to ASHP, which co-sponsored a drug summit in 2010.4
Manufacturing difficulties and global outsourcing have created a "perfect storm" for medication shortages, says Erin R. Fox, PharmD, manager of the Drug Information Service at the University of Utah Hospitals & Clinics and adjunct associate professor in the Department of Pharmacotherapy at the University of Utah College of Pharmacy, both in Salt Lake City.5 Fox spoke at the Nov. 5, 2010, drug summit held by ASHP, ASA, ISMP, and the American Society of Clinical Oncology.
The causes include the need to meet good manufacturing practices established by the FDA, says Cynthia Reilly, BS Pharm, director of the Practice Development Division at ASHP. "Often to meet those practices, they are halting production or taking production lines down," Reilly says. Market withdrawals are another cause, as was the case with propofol, she says. Even if other manufacturers are making a product, they might not have anticipated that their competitor would be withdrawing the product, Reilly says. "It's difficult for them to get up to speed," she says.
Sometimes providers don't know there is a shortage until the product doesn't show up, Reilly says. "They order it the day before. They open the tote, and it's not available," Reilly says. "It presents a definitely level of challenge, staying on top of those things." When you place an order, ask for verification that it is available, sources advise.
Drug shortages can have a significant impact on patient safety and the quality of care for patients having surgery or a procedure involving sedation or anesthesia, says Arnold J. Berry, MD, vice president of scientific affairs at the ASA. "The shortages also have the potential to result in canceled or delayed medical treatments and procedures, as well as complications from having to use a substitute medication while the drug is in shortage," Berry says. The ASA has taken action with the Food and Drug Administration (FDA). "Last year, ASA was able to help alleviate the propofol shortage by working closely with the FDA to allow the importation of the European formulation of the drug, which resulted in greater availability for patients having outpatient surgery and diagnostic procedures such as colonoscopies," Berry says.
However, drug shortages can return at any time, sources say. The frustrations over the drug shortages have led to a "constant disaster mindset" with providers asking themselves, "How can I take care of my patients if I don't have the drugs I need?" Fox says.5 (For information on newly introduced legislation, see story, below. For what you should do and not do to prepare for future shortages, see stories below.)
Legislation may offer long-term solution
Potential solutions to ongoing drug shortages are being addressed. Recommendations to help address current shortages and prevent future ones were developed at a 2010 drug summit sponsored by the American Society of Health-System Pharmacists and other groups. (To view the report from the summit, go to http://www.ashp.org/drugshortages/summitreport.) And now, legislation has been introduced.
The "Preserving Access to Life-Saving Medications Act" (S. 296), introduced by Sens. Amy Klobuchar (D-MN) and Bob Casey (D-PA), would require prescription drug manufacturers to give early notification to the Food and Drug Administration (FDA) of any incident that would likely result in a drug shortage.
"The number of drugs in critically short supply is increasing at an alarming rate and threatens the quality of care in hospitals and clinics nationwide," said letters of support to Klobuchar and Casey sent by the AHA, ASA, ASHP, American Society of Clinical Oncology, and the Institute for Safe Medication Practices. "Many of these drugs play a critical role in life-saving treatments, including cancer therapies, widely used anesthetics, antimicrobials and pain medications. In many cases, therapeutic alternatives are not available or carry increased risk of severe side effects and drug-to-drug interactions. The potential harm to patient safety is of paramount concern."
Currently, manufacturers are not required except under very rare circumstances, to notify the FDA of when they'll stop making a product and when they'll be short, said John J. Lewin III, PharmD, MBA, BCPS, division director of critical care and surgery pharmacies and adjunct assistant professor for anesthesiology and critical care medicine, Division of Neurosciences Critical Care, at Johns Hopkins Medical Institutions, Baltimore, MD. Manufacturers often are reluctant to share such information, Lewin says. In fact, the no. 1 reason for drug shortages is "reason unknown," he says. Such a system makes it difficult for outpatient surgery managers to prepare in advance, Lewin says.
If the FDA administrators knew that a shortage was forthcoming, they could look in the files of the Office of Generic Drugs to see if other companies have a patent pending. "They could expedite that process," Lewin says.
Propofol in short supply? What you should not do
The shortage of drugs such as propofol, labeled as "single use only," might lead some providers to reuse the vials. Don't do it, experts warn.
"Serious patient outbreaks of infections have been linked to improper handling of propofol," says Arnold J. Berry, MD, vice president of scientific affairs at the American Society of Anesthesiologists (ASA).
The product is basically preservative-free, sources say. Each container should be used for only one patient, and use strict aseptic technique, advises Berry.
Under sterile conditions in a special room with air flow controlled with a hood, it would be acceptable for a pharmacist to split medications that come in multi-dose vials into several syringes for later use, Berry says. "The drugs would have to be used within a specified time to ensure the drug's potency and sterility," he says. "This information is often available from manufacturers or other sources." However, this practice would not be acceptable for propofol because of its unique characteristic that support bacterial growth, Berry says. The Food and Drug Administration (FDA) and ASA do not recommend dividing larger volumes of propofol into multiple syringes, he says.
Expect questions from your patients regarding propofol, says Cynthia Reilly, BS Pharm, director of the Practice Development Division at the American Society of Health-System Pharmacists. "We've encouraged, if you're having procedure, to ask, `Is this vial being used only on me?" Reilly says.
Take steps now to prepare for future drug shortages
One of the most important steps you can take to prepare your program for future drug shortages is to education. The Institute for Safe Medication Practices (ISMP) encourages you to identify a key person or team to stay up to date on shortages.1
Typically pharmacy purchasing agents are the first to know about a shortage, ISMP says. If the purchasing agent isn't a pharmacist, have the purchasing agent work closely with a pharmacist to evaluate the impact of the shortage and come up with solutions, the agency says.
Also, be on the alert for signs that a shortage is coming, such as orders that are not fully filled and specific drug strengths that are more difficult to purchase, ISMP advises. Additionally, you can learn about drug shortages through social media, professional groups, professional listserves and discussion groups, wholesalers, and purchasing groups, ISMP says.
Be proactive in finding equally good, therapeutic alternatives, says John J. Lewin III, PharmD, MBA, BCPS, division director of critical care and surgery pharmacies and adjunct assistant professor for anesthesiology and critical care medicine, Division of Neurosciences Critical Care, Johns Hopkins Medical Institutions, Baltimore. Consider these other suggestions:
Two web sites are available to educate yourself about drug shortages: the American Society of Health-System Pharmacists (www.ashp.org/shortages) and the Food and Drug Administration (www.fda.gov/Drugs/DrugSafety/DrugShortages).
Consider listing the seven or so drugs you use the most, and review the web sites to see if there are any shortages, says Cynthia Reilly, BS Pharm, director of the Practice Development Division at the American Society of Health-System Pharmacists.
Additionally, establish a drug shortage network with other local healthcare providers, ISMP advises.1 Such local collaborative networks can allow you to share information, share emergency supplies, and coordinate patients transfers when alternative drugs aren't suitable, the agency says.
Avoid a just-in-time inventory system for medications.
Inventory practices is a primary area that can mitigate the impact of drug shortages, Reilly says. Know what medications you have on hand, compared to your caseload and scheduling, she says.
"If you work a just-in-time inventory system, that leaves little cushion if there is no product available," Reilly cautions.
On the flip side, don't hoard products, she says. "Then you end up with some centers having large amounts, and in others patients have no access," Reilly says. Additionally, you run the risk of expiring the shelf life of your medication and being forced to waste it, which can be a significant expense, sources point out. (For more information on what to do during a shortage, see story, below.)
Don't panic Take action during shortage
The Institute for Safe Medication Practices (ISMP) makes the following suggestions:
When you find out there is an impending or actual shortage:
Ask the manufacturer for details, including how long the shortage will last and directions or ordering drugs on allocation or for emergencies.
Assess your inventory. Estimate how long the supply will last.
Research the drugs that are experiencing a shortage. What are the clinically appropriate uses, lowest optimal dose, and strategies to cut drug waste and inappropriate or unnecessary prescriptions?
Look at previous drug use evaluations (DUEs) or consider performing a DUE to determine how the drug is used in your facility.
Early, find potential alternatives. Create and use a standard, formal process for identifying and approving alternatives. You will need an expedited approval process when the standard process is not quick enough. Find alternatives from the literature, professional web sites, listserves, prescribers, and other local/regional providers (for consistency among prescribers who work at several sites).
Decisions about alternatives should be made with medical, nursing, and pharmacy staff.
Develop an education plan and, when appropriate, guidelines for use of alternative drugs.
Develop temporary therapeutic guidelines that reduce waste and tailor the drug's use to priority patients for whom the alternative drug might not be safe, effective, or desirable.
You might be able to obtain guidance from government agencies (e.g., Centers for Disease Control and Prevention, departments of health), medical/professional organizations (e.g., Anesthesia Patient Safety Foundation), and specialty groups.
Determine how long the drug will be available to priority patients.
Conduct a failure analysis.
Assess the potential hazard to patients and your facility. Conduct a mini failure mode and effects analysis (FMEA) to identify changes needed to processes and potential misuses of alternatives.
Determine how to manage the risk of serious errors and adverse reactions to alternative drugs, and take action. Consider how alternatives could affect prescribing practices, storage, final preparation (including directions for admixing), drug administration procedures, and technology (e.g., electronic prescribing, bar-coding systems, automated dispensing cabinets, and smart pump libraries).
Make changes to support safe use of alternatives.
When possible, have pharmacy prepare and dispense alternatives in the most ready-to-use form.
Address any sound and look-alike issues with an alternative drug's name and packaging. Determine if additional safety checks, alerts, and/or patient monitoring are required when prescribing, preparing, dispensing, and administering alternatives.
Have ongoing communication with staff.
Share information about the shortage, causes, and expected duration (if known); current drug availability; temporary therapeutic guidelines, including use limitations for the shortage drug; alternatives and how they will be supplied; dosing, preparation, and administration guidelines for alternates; error potential with alternatives and how to reduce risk; and additional patient monitoring and safety steps that might be required. Consider offering a report that includes this information and updating it daily. Use the staff meetings, newsletters, e-mail, web site, Intranet, posters/charts, and/or alerts in electronic systems to communicate.
Proactively monitor adverse events.
Use error and adverse event reporting systems as well as a hotline, chart review, focus group meetings, and/or discussions during pharmacy rounds to learn about hazardous conditions, near misses, and adverse events.
Source: Institute for Safe Medication Practices. "Weathering the Storm: managing the drug shortage crisis." ISMP Medication Safety Alert Acute Care edition. Oct. 7, 2010.