The shortage of essential medications in patient care, once an episodic problem affecting the supply of one drug or another, has become for hospitals a serious chronic condition that saps resources and creates consequences for safety and clinical decision-making.
The number of scarce medications at 270-bed Kadlec Regional Medical Center routinely tallies in the double digits. From isolated shortages several years ago, the problem's steady growth has reached a point at which the usual printout of drugs in shortage on any given day runs three pages, says Dave Pearson, the Richland, Wash., hospital's pharmacy director. "The problem list [of drugs] from week to week is probably in the range of 40 products."
At 91-bed King's Daughters Medical Center in Brookhaven, Miss., the shortage "has been an ongoing battle for several years" as the pharmacy department tries to stay ahead of the problem using information from various supply chain partners and websites, says Clyde Sbravati, director of pharmacy services. Despite best efforts, "we still are surprised a third of the time" by a new shortage that presents itself "when we try to order a product and it's just not available."
The scarcities begin at the manufacturing level and then ripple through the supply chain. Hospitals typically do most of their buying through a few large medical product distributors, and they belong to a group purchasing organization that negotiates price and volume discounts.
Drug shortages "weren't on our radar" at Carolinas HealthCare System until about a year ago, says Kevin Isaacs, director of the new enterprise pharmacy for the Charlotte, N.C.-based system. But when the 39-hospital network analyzed the serious and uneven impact among facilities, the pharmacy function was centralized and individual hospitals were required to work together to keep scarce products on all their shelves, Isaacs says.
The scramble to stay ahead in the buying game is just the beginning of the challenge facing hospitals. The consequences reach deep into the daily operation, forcing significant changes in medical treatment and taking time away from patient care.
"When you look at pharmacists in hospitals, how their roles have expanded, many of them round with the physician, they evaluate patient medication regimens, they make recommendations based on their expertise in medication use," says Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists. "If they're bogged down trying to locate product, they've got less time to be out there helping patients and clinicians make the best use of these medications."
Fortunately for hospitals, "there is very often a competitor to the product that's in short supply," says Sbravati. Unfortunately, it may not be the one typically used, and the substitution "creates a cascade of problems" including "notifying providers and nurses, making sure all your safeguards you put in place for IV pumps are programmed" for the new drug, and altering orders and other parts of the regimen.
Changing workflow and pharmaceutical processes for every alternative drug introduced, often on short notice, is a nasty side effect of the drug shortage. It affects the way a pharmacy prepares a product and influences patient care by substituting often-unfamiliar products with different dosages and methods of administering them to patients, says Michael Butler, associate vice president of supply operations for the Purchasing Advantage unit of Quorum Health Resources.
Advance planning is essential. Policies and procedures that anticipate scenarios on choice and use of drugs have to be in place before the shortages hit. "You should actually give the same amount of detail to the plan as you would to a disaster-preparedness plan," Butler says.
The causes of shortages are complex and varied, ranging from not enough manufacturing capacity in the pharmaceutical industry to problems with raw materials, plant closures, shutdowns due to compromised quality, or a manufacturer's decision to discontinue a certain drug. A 2011 American Hospital Association survey of 820 hospitals disclosed that 99.5 percent reported a shortage, nearly half had more than 20 drugs in shortage and three in four rarely or never receive advance notification.
Products that become hard to get can be as basic as antacids like Zantac or sodium bicarbonate, but the heart of the shortage is the array of generic drugs sold primarily in vials and injected intravenously. The investment required to produce these drugs effectively and safely is substantial; profits are slim compared with those of brand names. "The margin on a lot of these sterile injectable drugs is so razor-thin that I really believe many companies are making a decision that it doesn't make sense to try and stay in this game anymore," Isaacs says. "So I don't see this problem going away any time, maybe even in my career."
Until such time as the supply-and-demand equation evens out, hospitals routinely are faced with either trying to find more of a scarce drug, making the existing inventory last longer or introducing a substitute into the clinical environment. Sometimes the mass move to an alternative drug can lead quickly to a shortage of that drug, requiring clinicians to go through several waves of substitution in short order.
Reacting to a shortage of Zantac, used to prevent stomach upset before surgery, King's Daughters elected to substitute Pepcid, which can be administered either with one syringe from a vial or infused over a 30-minute period in IV bags. Sbravati opted for the vials: Supply was plentiful, and it would not require two visits to a patient's room to administer. All went well for several days, but then hospital pharmacy directors everywhere figured out the same thing and available supply suddenly became spoken for. So the only alternative was to buy infusion bags of Pepcid, a second change for nurses in a week "because of a second shortage created by the first shortage," Sbravati says.
Locating products and making substitutions are just a few of the ways a pharmacy can be bogged down by the shortages. "The use of a second-line product also may involve additional research to determine what the major side effects are," Hill says. "Are there any documented drug-to-drug interactions that we need to be aware of as we administer it to the patient?"
Many individual shortages repeat over time, so "if I'm in governance, I'm going to want to make sure I've got all my i's dotted and t's crossed when it comes to knowing what the typical shorted drugs are," says Michael Alkire, chief operating officer of Premier Inc., which runs a large group purchasing organization. That includes working alternatives into the hospital formulary "so it doesn't have to be a topic of discussion on a fairly regular basis," and ensuring "the ability to move from one product to another in a very seamless way."
The labor involved in implementing changes in the use of drugs at health care institutions is on top of the higher costs of competing for scarce drugs or their substitutes. Labor costs to manage identification and implementation of alternatives were estimated at $200 million a year nationwide in a study by the AHA, the University of Michigan and the ASHP. The purchase of more expensive generic or therapeutic substitutes costs U.S. hospitals about $215 million annually, a Premier analysis concludes.
A well-developed relationship between pharmacists and key representatives of the medical staff must be fostered to get through the bumps in drug availability and reach agreement on how to conserve medications for the most essential clinical situations.
A drug normally used in a variety of situations when plentiful might have to be prioritized when short, leading to hard decisions on competing needs, says Sidney Phillips, director of pharmacy practice for the acute care division of Cardinal Health Pharmacy Distribution. "Boards and administrations should have plans ahead of time and not wait until you have the scenario of how to address those [competing needs]," he says. Committees can be authorized to make an objective decision on how to use a drug most effectively when there's not enough to go around.
At Carolinas HealthCare, the response process kicks in when a shortage looms — for example, a 10-day supply and no known resupply date. The clinicians and managers affected decide on an action plan, including usage restrictions and alternatives, Isaacs says.
When a recent shortage for the moderate-sedation drug Versed materialized, the chiefs of medicine met with reps from pharmacy, emergency department and endoscopy suites to restrict the drug's use to just endoscopy and one type of procedure in the ED. The health system faced shutting down four endoscopy suites if the supply ran out. After getting the word out across the system about the authorized limitations, usage was tracked daily and the drug moved around as needed. The central pharmacy system could locate where Versed or any other prioritized drug was being used outside stated priorities and correct it.
For a drug called Ativan, used to treat anxiety or insomnia, its IV formulation also has a critical emergency use — to stabilize seizures — and has no alternative, says Isaacs. Doctors were told to prescribe it in pill form for all other uses and save the IV doses for the single identified emergency situation. "A couple times I found where they were giving an elderly lady 2 milligrams of Ativan IV to help her go to sleep" even though she was taking her other meds by mouth, he says. "There are other ways to go to sleep."
Another drug that is "uniquely helpful" in emergency situations, a short-acting anesthetic called etomidate, was restricted at Kadlec Regional to only when doctors needed to rapidly insert a breathing tube into a patient and immediately begin a procedure, says Carrie Hofmeister, a senior pharmacy technician in charge of addressing shortages. By adhering to that policy in periods when the hospitals could not buy etomidate, "we've never completely run out," she says. "It's a combination of marshaling resources, communicating with the providers that are affected, and making sure that if it's a critically used drug that you sequester that inventory and position it in locations where it's really needed for emergencies."
In addition, the hospital's anesthesia director instructed colleagues to draw a dose of etomidate for patients at the moment they need it, not earlier in anticipation that the need for it might arise, Hofmeister adds. Purchased in vials rather than ready-to-use syringes, it has to be drawn out and either used during that case or discarded — but it only takes 10 to 15 seconds to load a syringe. "It's nice to be prepared, but you just can't do that until you know you're going to use it," she says.
At King's Daughters, a corps of hospitalists who see nearly all general medical patients was enlisted along with a contracted anesthesiology service to work with pharmacy to figure out where to cut down on a product, Sbravati says. One benefit has been greater diligence in moving patients from scarce intravenous drugs to more plentiful oral medication at the moment they recover sufficiently from a procedure.
Pharmacists and anesthesiologists even discussed how drugs are given before a procedure with an eye to cutting down on IV meds. At the height of the Zantac shortage, one idea was to dispense it to patients the day before surgery, to be taken orally instead of by IV the morning of the procedure. Concerns about patient compliance nixed the idea, but Sbravati says it was worth the consideration.
"Theoretically, it should work if you could rely on the patient to take it orally. Or if they're here at our hospital and we dictate what they take, maybe we can look at those patients."
'A full-time job'
All the extra effort to get essential drugs located, procured, continually monitored and safely used in a hospital increases the degree of difficulty in pharmacies and puts a strain on productivity. "It does take more time; you have more staff involvement in changing out your labels, redistributing [inventory], running down physicians and nurses, and trying to put all your safeguards in place," Sbravati says. "I'm probably spending an hour a day in personnel time, so that's five to six hours a week extra."
Carolinas HealthCare has a full-time certified technician and pharmaceutical buyer assigned to keep medications on shelves where and when needed. "If you're a large, integrated delivery network, you need to dedicate one or two resources to manage this," says Isaacs. "It's going to take that much time for that person. This is a full-time job in terms of managing drug shortages." And the pharmacy has reached out for reinforcements. The system already has an information technology physician champion for each medical discipline — infectious disease, internal medicine and others — and "they've agreed to be our go-to people for drug shortages as well," he says. "Peer-to-peer interaction between physicians helps you so much more in terms of any conservation strategy you employ."
Kadlec Regional's Hofmeister has 20 years' experience at the hospital, knows all the affected departments and the IT system, and "taking that knowledge base and … giving her training in purchasing was a very logical step for us and we got a huge payback on that investment," Pearson says.
"It's just getting too complicated to not have specialized skills at that," he says. Without a drug-shortage specialist, "you end up making all kinds of mistakes that way outweigh what you'd pay" for a dedicated staffer. Trying to handle the problem without extra staff "may make your productivity numbers [in the pharmacy] look better, but you'll hemorrhage money on drug expenditures."
John Morrissey is a freelance writer in Mount Prospect, Ill. His article originally was published in the September issue of Trustee.
FRAMING THE ISSUE:
- Medication shortages have become a chronic problem for hospitals. At a given time, dozens, if not hundreds, of needed drugs may be unavailable.
- There are several reasons for the shortage, ranging from manufacturers that stop production or ration output to pharmaceutical industry consolidation to voluntary and involuntary recalls.
- Hospitals must learn to track their drug supplies in real time and monitor the marketplace to anticipate shortages.
- Pharmacy departments must develop formularies that incorporate alternative medications, and understand and communicate how they differ from the original drug.
- Hospitals should do everything possible to avoid being victimized by "gray market" vendors.
Information in Short Supply, Too
The job of a pharmaceutical buyer should come down to what's needed in the next week or month, where it is being sold, and the negotiated terms of contracts with which to comply to ensure the best price. But today's state of uncertain supply prompts additional questions: What shortage is imminent? How long is it expected to last? In response, what changes in ordering are expected? How much more than usual should be bought in light of anticipated (or rumored) unavailability?
"Pharmacists are very alert to anything coming to them about shortages or medication availability," says Sidney Phillips, director of acute care pharmacy practice for Cardinal Health. In addition, there are "buyers in hospitals that are specifically trained for communication directly with distributors and group purchasing organizations as well as manufacturers about where drugs are in shortage."
A key information source is a website produced by the University of Utah and the American Society of Health-System Pharmacists (www.ashp.org/shortages). It posts a list of drugs in short supply as well as any other relevant information available, such as how long the shortage is expected to last and specifics on what caused it. "It's rare that we have the actual reason for the duration of the shortage, but to the extent we have that information, clinicians find it useful and we want to put it out there," says Joseph Hill, ASHP federal legislative affairs director. The site also lists therapeutic alternatives.
The cause and duration are as important to a shortage as the initial alert, because of the effect on buyer behavior, Hill says. "If it's a temporary shortage, or something that may not have that widespread of an impact, there's no need for people to get nervous … [and] start frantically contacting their suppliers and saying, 'Give me as much of this as possible.'"
The ASHP site and a more limited-scope list posted by the Food and Drug Administration communicate shortage information, but are "not as reactive as you hope they would be," says Clyde Sbravati, pharmacy director at King's Daughters Medical Center, Brookhaven, Miss. "It's just the Newsweek version of the news instead of the Daily Journal version."
To stay more up-to-date, buyers cultivate relationships with sales forces for drug companies and suppliers. "I'm fortunate in that I have some excellent people working with me representing a few of the companies [from which] we buy a majority of our product," Sbravati says. "I get email from these folks every other day or at a minimum weekly."
Hospitals also pump information from salespeople operating in the secondary drug market, which buys up drugs that will be or are already in short supply. Reps continually call around, seeking hospitals with no alternative but to purchase supplies at much higher prices. But some hospitals turn the tables on who's using whom, says Cheryl Schmiedel, pharmaceutical buyer for Carolinas HealthCare System.
No fewer than 35 of that type of supplier contact her weekly by phone or email. "They call for information, they want to know what's going on so they can buy it up and have it ready," Schmiedel says. "I don't offer any information, I just listen to what they have to say." If a rep says an item is going short, she takes notes and tries to validate the assertion.
One day last June, one such secondary distributor called King's Daughters trying to sell the anesthetic etomidate, which Sbravati knew was still in stock at his main distributor source, Cardinal Health. "If he's trying to sell it to me at $210 a box, when I normally buy it for $57 a box, then I know that somewhere in his territory … there's a shortage of this." — John Morrissey
To anticipate which drugs will be in short supply, hospitals must continually collect and analyze data on their own usage and monitor their supply chain partners and industry websites.
Know the alternative
Write alternative medications into the hospital formulary so that discussions don't have to be repeated every time certain drugs are unavailable.
Really know the alternative
Substitute drugs may have different side effects or may not interact with a patient's other medications the same way that the preferred, but unavailable drug might. Understanding what those differences is critical to patient safety.
Pharmacists, anesthesiologists and other medical staff must discuss drug shortages and alternatives on an ongoing and frequent basis. This might include formal electronic communications daily or weekly, as well as informal conversations as the need arises.
Centralize the pharmacy
Multiple-hospital systems may want to centralize the pharmacy function so that medications can be easily shared among facilities.
A drug shortage coordinator
Some hospitals designate a certified technician or pharmaceutical buyer to track medication availability full time and issue alerts about pending shortages.