Baltimore, MD—According to Ernest Anderson, Jr, MS, RPh, System Vice President of Pharmacy, Steward Health Care System, Boston, MA, “If you’re not familiar with the drug shortage issue, you must be living under a rock.”
Just before Mr Anderson’s presentation at the 2012 annual meeting of the Association of Community Cancer Centers (ACCC) as part of a panel discussion on the topic, the US Food and Drug Administration (FDA) exercised its authority to allow the immediate importation of the liposomal formulation of doxorubicin (Doxil) from a previously unauthorized international supply chain.
This action and others recently taken by the FDA will not, Mr Anderson says, solve the drug shortage problem; in fact, the FDA’s reactive perspective is in itself part of the problem. “The FDA can’t just react after the problem has occurred,” he said. “That’s when it’s too late.” What we need are long-term solutions.
ACCC panel member Warren Dodge, Principal, Creekside Holdings, San Anselmo, CA, explained what his research has revealed. “When I first became aware of the problem, I thought…this is the result of the government mandating average wholesale pricing [AWP], and now companies can’t make any money,” Mr Dodge said. “But after I looked closer, I realized the problem is much more complex.”
He identified many ways the drug supply can be negatively impacted, but AWP is indeed part of the problem. “It prevents the normal laws of supply and demand from going into effect,” he said. “Normally, if there is a shortage, the prices go up and manufacturers are incented to increase production. But that’s not happening.”
There can also be problems when the FDA enforces safety regulations that, at first consideration, seem to be in the patient’s best interest. “If you shut down a manufacturer that wasn’t meeting safety requirements, the consequence may well be that there is not enough remaining capacity in the industry to fill the void,” Mr Dodge noted, “ergo, shortages occur.”
Mr Dodge listed other reasons for shortages:
Drug wholesalers negotiating single-source multiyear contracts with generic manufacturers. “As a result, if you didn’t win that competitive bid, you were not incented to continue to manufacture that product because you don’t have enough access to the market.”
Too much of the supply is coming from too few vendors. “If there’s a problem with one source, and you’ve only got 2 to begin with,” then it can lead to a shortage.
Drug hoarding. “There have been occasions where hospitals and providers have been hoarding drugs,” and on behalf of your patients, it’s very tempting to do so. But that means that someone, somewhere, instead of having a small supply of a drug, has none.
Buying/selling drugs on the gray market. “This is hospitals reselling drugs out of the back door, and the practice makes me a bit crazy. Everybody knows the gray market exists, but I can’t find anybody who will admit to buying or selling drugs this way.”
Pricing of generics. “I mean, come on—a bottle of 5-FU is $15. How much can you possibly be making on that transaction?”
New Drug Application (NDA) requirements for generics. “The FDA put these rules regarding safety and efficacy in effect fairly recently. If a drug was approved before these regulations went into effect, a generic of that drug still has to go through the new NDA process. Well, it makes no economic sense for a company to invest in clinical trials for a generic drug under current pricing arrangements.”
Inventories are too tight. “This is about not wasting drugs, and often that has to do with stability testing. Yet, most would agree that current benchmarks for stability bear no resemblance to reality for many drugs.” Perfectly good drugs are being discarded or, to avoid discard, are understocked.”
A change in treatment guidelines. “I’ve seen examples where the guideline switches from drug A to drug B, and overnight you have a drug shortage.”
“About 2 and a half years ago, a guy comes to me for a consult for his stage III colon cancer,” said ACCC panelist Michael A. Kolodziej, MD, New York Oncology Hematology, PC, Albany Cancer Center, an affiliate of US Oncology. “So, I tell him FOLFOX is my choice for treatment (FOL, folinic acid [leucovorin]; F, 5-FU; OX, oxaliplatin [Eloxatin].” The patient sought out a second opinion from an oncologist at Memorial Sloan-Kettering Cancer Center, NY.
“After having my recommendation confirmed at Sloan-Kettering, the patient returned, and we sent him to the infusion room to begin treatment.” But then came a surprise. “When the patient got to the infusion room, he was told there was no leucovorin, and that he would have to wait, and boy was he mad,” Dr Kolodziej said. So mad, in fact, that the patient went back to New York for treatment, “where, much to my surprise, they had leucovorin.”
“I called my contacts at Sloan-Kettering, and they said, ‘yes, we’ve got it. Then I went back to my executive team at US Oncology and said ‘there’s something up.’” There was at least 1 hospital that had figured out a way to get what it needed, and Dr Kolodziej needed to figure out how.
Dr Kolodziej and his team did a very thorough analysis of the purchasing and distribution of generics at US Oncology. “We subsequently set out to develop a new methodology whereby we violated every single principle we had preached about inventory management, about how, with carboplatin at $5 a vial, it was okay to have a little more on hand.”
Dr Kolodziej then had to go to US Oncology’s physicians and explain that their cooperation and input was critical to making the new inventory policies workable. “Our goals had to be both aggressive and transparent,” Dr Kolodziej insisted. “We asked them to consider what therapeutic alternatives could be used for drugs that may not be available.” For example, if there wasn’t any bleomycin, cisplatin might have to be used. “We got out information about potential shortages early and often.”
More is better. Manufacturers are engaging in de facto rationing so that most customers are at least getting some product. For those working in a network, reaching out to practices within the network may help find the needed drug. “Since US Oncology has 10 hospitals, we’re almost certain to get something, which can then be distributed to our networked centers,” Dr Kolodziej said. He encourages those not in a network to join forces with other providers within the geographic region.
Institute a priority plan. “Cure the disease first,” Dr Kolodziej advised. “With methotrexate, acute leukemia patients get first dibs. For cytarabine, acute leukemia first, then mantle-cell lymphoma….You can make up a prioritization schedule, but make sure that patients receiving curative therapy get first crack.”
Communicate with payers. “Let them know what’s going on,” Dr Kolodziej stressed. Even if you make a substitution for a drug, you are still going to want to get paid for it.
Updates. And finally, keep on top of the news. For updates, and related information on drug shortages, visit www.ashp.org/drugshortages.
