Drug Shortages Frustrate Health Care Providers
The University of Utahs Drug Information Service, which tracks the availability of pharmaceuticals for the American Society of Health-System Pharmacists (ASHP), has issued more than 30 bulletins since April 2001 alerting pharmacists about shortages and offering updates and advice on the situations.
Three months into 2002, FDA had identified 8 "medically necessary" drug products, not including vaccines, as being in short supply and 11 other products, including various strengths of methylprednisolone acetate injectable suspension, as having limited distribution.
Shortages stem from all sorts of circumstances, including a hurricane in the Caribbean that affects the raw-material supply, FDA shutting down a manufacturers processing plant for various reasons, and a firms decision to halt production.
Inadequate communication. Amy Buesing, president of the New Mexico Society of Health-System Pharmacists and pharmacy director for Memorial Medical Center in Las Cruces, the states second largest city, said she has dealt with periodic shortages of products in the past. But "nothing like what we have been experiencing lately," she said.
"These are unprecedented times," Buesing said. "Things have gotten so bad that we have made this a standing agenda item on our [pharmacy and therapeutics] committee."
Most pharmacists, Buesing said, do not learn about a drug shortage until they hear of it from their wholesalers representative. Drug manufacturers, in her view, ultimately are responsible for the lack of communication about product shortages.
"They have got to know what is coming down the pike," she said. "They know that when they have a problem getting raw materials or a problem with the FDA, that there is going to be a decrease in their products. But they dont let us know about it until pretty much after the fact."
Philip Payne, Memorials pharmacy operations supervisor, said that, when manufacturers do notify hospitals and pharmacists about a product shortage, the companies often do not provide a detailed explanation about what created the shortage or when the drug will be available.
One example, Payne noted, is the shortage of methylprednisolone acetate injectable suspension, best known by the brand name Depo-Medrol, by Pharmacia Corporation.
"They really didnt given us a lot of details about it," Payne said. "Our wholesaler doesnt know what happened either. Weve only been told that its manufacturing problems. I dont know what manufacturers are thinking. Maybe they dont want to tell us right away because they think that the issue is going to go away. But they need to let us know so we can prepare to use alternatives."
Proposals. Manufacturers, Buesing said, need to establish a standard way to report drug shortages to pharmacists, other health care providers, wholesalers, and the government and cooperate more when communicating about shortages.
"It should feel like a partnership where we are all working for improvements," she said. But this will take a "united and collective voice" from pharmacists, hospitals, buyers, wholesalers, and the government, she said, to pressure manufacturers to improve their notification process.
"I dont foresee legislative action, but I do think it would be worthy to notify our politicians," Buesing said. "Im not sure they are aware of the magnitude of the problem. Change is needed. And somethings got to give."
Kathleen M. Cantwell, ASHPs federal legislative affairs director and government affairs counsel, said the Society has met with the staffs of congressional offices to educate them about the problem. Cantwell noted that ASHP has established an ongoing relationship with those staff members as they consider legislative approaches to addressing the shortage problem.
Alan Goldhammer, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said his organization has had discussions with FDA and a distributors association about the problems that cause drug shortages. But, he said, the issue is "complex."
The practice of maintaining just-in-time inventories, Goldhammer noted, has fueled the supply problems. "Its just like an automobile assembly line when a part is on back order," he said. "The process stops until they can get the parts."
Goldhammer contended that vaccine manufacturers have made a "concerted effort" to notify the Centers for Disease Control and Prevention when "things are in short supply" and have provided information about when a product is "projected to come back."
Reality. But Memorials Payne disagreed.
The sudden shortage earlier this year of the measles, mumps, and rubella (MMR) virus vaccine live caught everyone off-guard, he said. Merck & Co. Inc. is the sole manufacturer of MMR vaccine.
Details about when the vaccine would be available have been "unclear," Payne said.
When health-system pharmacists, Payne noted, are not provided with dependable information about when an unavailable drug will be accessible again, often they resort to buying from what he calls "alternative suppliers."
"We rarely use them," he said. "First of all, their prices are outrageous. They are really thriving now because of the drug shortages. But if I got a call today, and they were reliable, I would probably access some of their supplies."
Brian D. Benson, pharmacy manager for Iowa Lutheran Hospital, a 300-bed facility in Des Moines, said he doesnt have to wait for those calls.
Telemarketers who work for secondary wholesalers, firms that Benson refers to as "drug brokers," contact him daily with offers for products that are in high demand and short supply.
"One of the things I have found ironic is that, when we have a shortage on some things, these . . . distributors and wholesalers have an ample supply," he said.
Benson said he receives faxed advertisements from wholesalers for products that are generally unavailable and have a 200% markup on the price. "Its just crazy," he said.
But Benson has resorted to paying those higher prices demanded by some vendors, he said, "to keep the peace with physicians" at his hospital.
Benson said he suspects some secondary wholesalers representatives of holding on to some products, or hoarding, to ensure they meet monthly sales quotas.
He suggested that state boards of pharmacy send their investigators to examine drug wholesalers inventories and sales records to see if hoarding is a regular practice for some companies. However, he noted, most states lack the personnel needed to conduct thorough investigations.
Benson said Iowa has about four investigators for the entire state. (The Iowa Board of Pharmacy Examiners said it employs three investigators, although it did employ four until recently.)
Wholesalers point of view. Sal Ricciardi, president of the Pharmaceutical Distributors Association, a group of secondary wholesalers, said he does not know of any wholesaler that hoards drug products.
"Unequivocally, we do not hoard," he said. "We are buying in an open-market system. We want to quickly sell our products in another market." Ricciardi added, "We sell products to pharmacies at prices that are less expensive or cheaper" than market prices.
But he hastened to add that he could speak only for his own wholesale company, Purity Wholesale Grocers Inc., based in Boca Raton, Florida, and not for other wholesalers.
He said most pharmacists "dont completely understand what we do and how we do it."
Mark Doyon, spokesman for the Healthcare Distribution Management Association (HDMA), responding by e-mail, said "it is important to understand that distributors are in the business of moving productnot hoarding it." HDMA is a trade group for wholesalers and distributors.
"While there can be unscrupulous companies in any business," he said, "HDMA does not defend hoarding or any practice that could hurt patients."
He added that health care distributors "exist to increase efficiencies in the system and to drive down costs for everyone in itbenefiting not only the supply system as a whole, but ultimately the patient."
Making the best of a bad situation. Thomas J. Johnson, an assistant professor at South Dakota State Universitys College of Pharmacy and a critical care pharmacist at Avera McKennan Hospital in Sioux Falls, said he believes that 95% of drug shortages are caused by legitimate circumstances. The other 5%, he said, could be associated with hoarding by secondary wholesalers who want to drive up prices.
"Its kind of like the airlines when they cancel a flight," Johnson said. "You cant really prove that the sudden mechanical problems are because a flight is not full, and they would prefer to have a full plane. Hoarding by wholesalers is one of those suspicions we all have, but it would be hard to prove."
Johnson said hospitals and pharmacists could help relieve some of the shortage issues by making the best use of their medications, "especially when it involves the more expensive products."
Pharmacists should view product shortages, he said, as an opportunity to educate physicians that "sometimes the preferred drug is not always the most appropriate."
Said Johnson: "Obviously every drug has its niche, but at the same time it might not be the best thing in every case. This is a good opportunity for pharmacists to recommend substitutions that a physician might discover works better. There will be those physicians who demand a specific drug, and that is fine. But if there is a shortage of that drug, we should reserve it and not use the best and the brightest for everything."
When drug shortages began to be prevalent, Johnson said, there were some physicians at his hospital who thought that "pounding their fists" would resolve the matter.
"But most of them have figured out now that if we cant get the drug, we cant get the drug," he said.
Johnson said his pharmacy posts a list of unavailable drug products in the physicians lounge. "That way, if their favorite drug is on the list, they know ahead of time," he said.
A place for FDA. FDA, Johnson said, needs to take a more proactive role in helping drug manufacturers resolve problems that lead to drug shortages.
Bill May, pharmacy operations coordinator for United Medical Center, a 155-bed hospital in Cheyenne, Wyoming, said FDA should consider alternatives to shutting down a production plant.
"We want FDA to make sure our drugs are safe," he said, "but when a manufacturer is the only company that makes a drug that is heavily used by the market, I think FDA needs to have a good reason before they go in and shut down a plant. If it is a recall or something is not right, thats one thing. But they need to evaluate the situation."
May said FDA forced Wyeth-Ayerst, now known as Wyeth Pharmaceuticals, to stop shipping pantoprazole sodium for injection, marketed under the brand name Protonix I.V., because of an insufficient supply of the products inline filters.
"There was nothing wrong with the drug," May said. "And they did find an alternative filter." But FDAs action caused a backlog at the company.
FDA and drug manufacturers, May said, must work together to make the stoppage of production a "smoother transaction" for groups further down the pharmaceutical supply chain when the government decides to halt output at a plant.
"Its all in the communication," he said. "There is no need for these sudden, massive shortages."
Bulletins Issued by University of Utaha
|Anesthetics, injectable||Measles, mumps, and rubella virus vaccine live|
|Antiemetics||Meperidine hydrochloride injection|
|Bacitracin for injection||Mivacurium injection|
|Betamethasone injections||Nalbuphine injection|
|Calcitriol capsules and oral solution||Naloxone hydrochloride injection|
|Caspofungin injection||Oxytocin injection|
|Corticosteroid suspensions, injectable||Pantoprazole injection|
|Crotalidae antivenins||Piperacillintazobactam and piperacillin injections|
|Danaparoid sodium injection||Pneumococcal seven-valent conjugate vaccine|
|Dexamethasone sodium phosphate injection||Secobarbital capsules|
|Diazepam injection||Sincalide injection|
|Diphenhydramine hydrochloride injection||Succinylcholine injection|
|Diuretics||Tetanus and diphtheria toxoids and tetanus toxoid|
|Ganciclovir sodium injection||Thiamine hydrochloride injection|
|Heparin sodium injection||Thioguanine|
|Hepatitis vaccines||Tubocurarine chloride injection|
|Hyaluronidase injection||Varicella virus vaccine live|
aDrug product shortage bulletins, available at www.ashp.org/shortage, are prepared by the University of Utah Drug Information Center and provided by ASHP through the support of Novation LLC.