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Drug Shortages Roiling Oncology Practices, Impinging on Patient Care

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

 

 

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

 

 

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

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An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

 

 

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

 

 

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

An ongoing shortage of some crucial chemotherapy drugs is driving up the cost of the products and forcing oncologists to scramble for supplies or to find therapeutically equivalent alternatives, if there are any.

In some cases, oncologists are creating a triage system whereby the patient who is most likely to be cured will receive the therapy that’s in short supply.

Periodic shortages of pharmaceuticals are not unusual, but a number of factors have converged to create a unique squeeze in oncology – one that clinicians see as a mounting public health threat.

Dr. Michael Neuss said that the shortage will become a crisis only "when the first high-profile patient dies." Despite active concern and action by the American Society of Clinical Oncology, the shortage hasn’t reached the crisis point yet, at least in the public’s eye, said Dr. Neuss, immediate past chair of ASCO’s Clinical Practice Committee and a physician in private practice with Oncology Hematology Care in Cincinnati.

"There is no smoking gun that makes this obvious to people," he said.

Dr. Neuss sees the invisible hand of the free market as a not-beneficial guiding force in the shortage. Once a shortage occurs, distributors buy up the supplies and essentially corner the market, he said, citing conversations with his purchasing agent. That results in inflated prices for purchasers who have no alternative.

And cancer patients who need the therapies ultimately suffer, said Dr. Neuss.

Many Drugs Affected

At press time, both the Food and Drug Administration and the American Society of Health-System Pharmacists were reporting shortages of many drugs, including cisplatin, doxorubicin (both lyophilized powder and solution for injection), etoposide solution for injection, leucovorin calcium lyophilized powder for injection, levoleucovorin (Fusilev) 50-mg single-use vials, and some sizes of vincristine.

Cytarabine injection (powder for reconstitution) was added to the list in mid-December, and there’s also an ongoing shortage of certain vial sizes of Procrit (epoetin alfa) because of a manufacturing-related recall that took place in September.

Recently, there have been shortages of cyclophosphamide, daunorubicin, epirubicin, fluorouracil, mitomycin, paclitaxel, and vinblastine, among other chemotherapeutics.

The FDA – which, according to its Web site, has a policy "to help prevent or alleviate shortages, primarily of medically necessary drug products, since these can have significant public health consequences" – is monitoring the shortages. The agency does "see an end to these shortages based on the plans reported by the manufacturers," said Capt. Valerie Jensen, associate director of the FDA’s Center for Drug Evaluation and Research Drug Shortage Program, in an e-mail.

But, she added, "many of these shortages involve older sterile injectable drugs, and we’ve continued to see a trend of increasing shortages developing over the past several years for this group of drugs."

Fewer companies are interested in making the low-profit injectables, and those firms that do go into the market have limited manufacturing capability, said Capt. Jensen. Many of the companies in the market have had issues with accessing raw materials, or problems meeting the FDA’s quality guidelines.

Then there’s the manufacturing itself. "Sterile injectables have a long manufacturing lead time and a complex process, and when one of the few firms making these products experiences a problem, a shortage almost always occurs, since it is extremely difficult for the remaining firms to keep up with demand," she said.

Leucovorin: Canary in the Coal Mine

One of the biggest players in injectables – and generics – is Teva Pharmaceuticals. In April, the company began a voluntary manufacturing hold at its Irvine, Calif., plant to update systems and processes. The plant was the primary manufacturing site for all its injectables. The stoppage has had a domino effect, shifting demand to other manufacturers. Some have managed, but the shortage continues – especially for leucovorin and etoposide.

Teva spokeswoman Denise Bradley said, "We continue to work towards resuming manufacturing at that facility," but gave no indication as to when that might occur.

Capt. Jensen said that Teva should be back online by April 2011. In the meantime, the FDA has looked for additional manufacturers for leucovorin, including those overseas, as it also had to do to manage a shortage of propofol, an anesthetic agent. The agency has not found a suitable overseas candidate, but is working with another generic manufacturer to "have their product ready for the U.S. market as soon as possible."

For now, though, clinicians are struggling to figure out how to make do. Dr. George Kovach, medical director at Iowa Cancer Specialists in Davenport, said that his practice has not been affected by other shortages, but that getting leucovorin has been a challenge. Financially managing the shortage has also been an issue, said Dr. Kovach in an interview.

 

 

The alternative, Fusilev, costs about ten times as much as leucovorin. And Medicare reimburses only $750 of the $1,200 cost for Fusilev, said Dr. Kovach, a member of the Association of Community Cancer Care Centers (ACCC) board of trustees. For many patients, the practice would "eat the loss." Other patients were sent to the hospital outpatient department for treatment. The shortage seems to have lessened for the time being, but reimbursement continues to be an issue, said Dr. Kovach.

The leucovorin shortage has "impacted many colorectal cancer regimens," at the Maine Center for Cancer Medicine in Scarborough, said Steven L. D’Amato, a clinical pharmacy specialist, in an interview. "Clinics like ours lose money with every dose administered, but we’ve done this to maintain patients’ treatment schedules," said Mr. D’Amato.

"With leucovorin, we literally decide how much we have every day," said Dr. Neuss. Patients are prioritized to receive the drug based on whether administration would be curative. His practice has managed to procure adequate supplies of Fusilev, but it is, as noted, much more expensive.

And oncologists "really don’t know" whether Fusilev is equivalent, Dr. Neuss said. The FDA also warns on its shortage page that "there is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev)."

Forced to Alternatives

Similarly, there is an alternative to IV etoposide – an oral version. But with oral administration, "myelosuppression can be more erratic," said Dr. Lawrence Einhorn, a past president of ASCO and a distinguished professor and Lance Armstrong Foundation Chair in Oncology at Indiana University, Indianapolis, in an interview on the ASCO Web site. "Oral etoposide is a substitute, but a poor substitute for IV etoposide," he said.

Dr. Neuss said that his practice had been doubling the dose of the oral version as a substitute. "Is that the exact right conversion? I’m not sure," he said.

There are four manufacturers of the injection form: Teva, Bedford, APP, and Bristol-Myers Squibb. Because Teva has halted production, the FDA has worked with the others to increase production, said Capt. Jensen.

Mr. D’Amato said that the Maine Center is no longer experiencing etoposide shortages, but that getting doxorubicin has been a challenge. The shortage is starting to alleviate, but the lack of the therapy has affected investigational protocols and "all of our anthracycline-containing regimens," he said.

The situation has been more dire in Cincinnati, said Dr. Neuss. His practice has been unable to find an adequate supply. "We hold it back for patients that are getting curative therapy," he said.

Mr. D’Amato also notes recent shortages of bleomycin, desmopressin, and heparin. "Heparin flush solutions are still not available to us, so we prepare our own from higher concentrations of heparin. This is time consuming and also costly," he said.

And, the Maine Center just began experiencing problems getting melphalan tablets (Alkeran), which were produced by GlaxoSmithKline but will now be manufactured by ApoPharma. "They have no release date for the product, which is very problematic for existing patients being treated for multiple myeloma," said Mr. D’Amato.

Pediatric oncology seems to be hit particularly hard, as the intent for most children is to cure them of their cancer. Thus, a shortage could mean the difference between life and death. "I think those children need to be protected," said Dr. Neuss.

In an interview with ASCO’s Web site, pediatric oncologist and ASCO President-Elect Michael Link said that there are few acceptable alternatives for many of the therapies used in children. "Almost all children are treated on clinical trial protocols, and have been for many years, so we have a very large evidence base for many of the common drugs that we use – but are lacking evidence for substitutions, particularly in complex multi-drug regimens," Dr. Link said.

Where Next?

In early November, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices convened a summit to talk about causes of the shortages and to discuss potential solutions. The FDA and many drug manufacturers – including APP, Bedford, Hospira, and Teva, which had the most shortages in 2010 – attended the meeting.

According to a statement, the FDA told attendees that it had managed to prevent 24 shortages in the past year by working with the industry.

The ASHP said that work groups had been formed and would continue to develop action plans to "carry out the summit’s recommendations."

In early December, Sen. Amy Klobuchar, a Minnesota Democrat whose district includes the Mayo Clinic, wrote to FDA Commissioner Margaret Hamburg, urging an "immediate solution to the shortage of chemotherapy drugs."

 

 

ASCO is encouraging members to report shortages to the FDA and the ASHP. Dr. Link said in the ASCO interview that he realized that reporting "does nothing to alleviate that burden for the patient who needs the drug today – but the FDA can act more effectively when it’s armed with current information."

Dr. Neuss, for his part, thinks that the free market is not the answer. He thinks there should be a government-run exchange of some type to manage the supply, so that patients aren’t faced with potentially-life-threatening shortages.

Dr. Neuss, Dr. Kovach, and Mr. D’Amato reported no conflicts.

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