Fight Against Cancer Drug Shortages Goes Global

AMSTERDAM – Standard drugs commonly used to treat patients with hematologic and other malignancies are in worryingly short supply, not only in the United States, but also around the globe – a situation that has prompted three leading U.S. and European societies to issue an urgent call to action.

The American Society for Hematology (ASH), the European Hematology Association (EHA), and the European Cancer Patient Coalition (ECPC) issued joint statements June 16 to highlight the problem, which affects the care of patients with leukemia, lymphoma, myeloma, and other life-threatening blood disorders.

The international collaborative announced it would collect data on drug shortages and report the information to the respective authorities, as has been done in the United States. In addition, it "pledged to support legislation in the United States, Europe, and around the world that provides clear, effective interventions to alleviate drug shortages."

"Medicine should be available for any patient who needs it and there should be no barriers to access medicine."

Europe Takes Action

"In the United States, legislation is well under way that may curb drug shortages," Dr. Ulrich Jäger of the Medical University of Vienna, noted in the EHA press statement.

"In Europe, we do not even have a proper understanding of the problem," the EHA president added. "We must work together with our partners to raise awareness and protect the heath of patients with blood disorders worldwide."

In addition to issuing joint press statements, the societies used the joint ESH-ASH symposium at the annual congress of the European Hematology Association to highlight the issue. From the patient’s perspective, it is one of the most basic human rights to be given appropriate access to health care, said Viorica Cursaru, the president of Myeloma Euronet Romania, a member of the ECPC.

Ms. Cursaru noted that the EU health commissioner had stated that the ultimate objective of the EU is to have patients treated well in their own countries and that the time had come to implement Europewide strategies for health.

For this to happen, she argued, there needs to be not only a harmonized legal framework, but also appropriate infrastructure that is lacking in many, particularly eastern European, countries, the professional staff to implement changes, and the political will at both an EU and at a national level.

Big Pharma’s Perspective

Giving the European Federation of Pharmaceutical Industries and Associations (EFPIA), perspective, Brendan Barnes said that medicine shortages come down to more than just the price and availability; the issue is also about affordability and economic viability. EFPIA is a trade association representing the interests of the research-based pharmaceutical industry,

"We are private sector entities and we need to have a basis to do the business," Mr. Barnes maintained. While the industry wants to do all it can to ensure the adequate provision of drugs to everyone in need, via patient access schemes and reimbursement, accessibility, and affordability ultimately also comes down to local governments and their policies.

"We look to governments to support innovation through fair prices. We look to them for adequately resourced health systems, but health is a right we can only deliver if governments invest in health systems," Mr. Barnes said.

Changing the law is one thing, he said, but there also needs to be a health system in place to ensure that health interventions can successfully be delivered.

European Situation More Complex

"There are two issues at stake here as far as I can see, first is availability and second affordability," said hematologist Dr. Anton Hagenbeek of the Academic Medical Center at the University of Amsterdam in the Netherlands.

ASH is well ahead of the EU in keeping track of the drugs shortages problem, Dr. Hagenbeek observed. Indeed, ASH has collected data on hematologic drug shortages via its dedicated drug shortages portal for the past 18 months and regularly reports its findings to the Food & Drug Administration.

Drugs currently on the ASH/FDA shortage list include many generic, injectable drugs, including methotrexate, leucovorin, bleomycin, anthracyclines, and cisplatin, to name a few. According to the ASH press statement, more that 200 drugs were reported to be in short supply in the United States at one point last year, several dozen of which were critical to the care of patients with hematologic disorders.

The situation in Europe is undoubtedly more complex than in the United States, Dr. Hagenbeek observed. "We are not 1 country; we are 27 countries with our own rules and regulations."

Although it seems as if the EU has fewer drug shortages, compared with the United States, the number of incidents is increasing annually, he noted, citing a sudden shortage last year of cytosine arabinoside in the Netherlands.

The lack of an inventory to keep track of shortages needs addressing, Dr. Hagenbeek said. "Medicine should be available for any patient who needs it and there should be no barriers to access medicine," he said.

"Imagine AML induction without cytosine arabinoside, ALL induction without methotrexate and vincristine, and BEAM without the B, E, and A," Dr. Hagenbeek noted. This is a situation that is "simply unacceptable" for both hematologists as well as patients.

Following the U.S. Example

Speaking from the EHA’s perspective, Dr. Hagenbeek commented that European hematologists should follow the lead set by the United States by creating drug shortage databases in their respective countries and also by reporting drug shortages directly to the society.

Raising awareness is the start, Dr. Hagenbeek suggested. Notification of health authorities, and ultimately, hopefully changing European legislation will be the important next steps.

"EHA is in an excellent position to build on what we have already achieved as ASH in influencing legislation as a first step in dealing with the drug shortage issue," ASH president Armand Keating of the University of Toronto and the Princess Margaret Hospital in Toronto said in an interview.

"I think there are a number of potential solutions," Dr. Keating added, suggesting that an incentive-based rather than punitive-based system might be more successful in addressing drug shortages in the United States in particular.

"One of the things hematologists can do is inform patients about the issue," Dr. Keating suggested, as well as reporting drug shortages to their national health authorities and professional societies such as ASH and EHA.

Dr. Keating, Dr. Jäger, Ms. Cursaru, Mr. Barnes, and Dr. Hagenbeek had no relevant conflicts of interest other than representing their respective societies or professions.

AMSTERDAM – Standard drugs commonly used to treat patients with hematologic and other malignancies are in worryingly short supply, not only in the United States, but also around the globe – a situation that has prompted three leading U.S. and European societies to issue an urgent call to action.

The American Society for Hematology (ASH), the European Hematology Association (EHA), and the European Cancer Patient Coalition (ECPC) issued joint statements June 16 to highlight the problem, which affects the care of patients with leukemia, lymphoma, myeloma, and other life-threatening blood disorders.

The international collaborative announced it would collect data on drug shortages and report the information to the respective authorities, as has been done in the United States. In addition, it "pledged to support legislation in the United States, Europe, and around the world that provides clear, effective interventions to alleviate drug shortages."

"Medicine should be available for any patient who needs it and there should be no barriers to access medicine."

Europe Takes Action

"In the United States, legislation is well under way that may curb drug shortages," Dr. Ulrich Jäger of the Medical University of Vienna, noted in the EHA press statement.

"In Europe, we do not even have a proper understanding of the problem," the EHA president added. "We must work together with our partners to raise awareness and protect the heath of patients with blood disorders worldwide."

In addition to issuing joint press statements, the societies used the joint ESH-ASH symposium at the annual congress of the European Hematology Association to highlight the issue. From the patient’s perspective, it is one of the most basic human rights to be given appropriate access to health care, said Viorica Cursaru, the president of Myeloma Euronet Romania, a member of the ECPC.

Ms. Cursaru noted that the EU health commissioner had stated that the ultimate objective of the EU is to have patients treated well in their own countries and that the time had come to implement Europewide strategies for health.

For this to happen, she argued, there needs to be not only a harmonized legal framework, but also appropriate infrastructure that is lacking in many, particularly eastern European, countries, the professional staff to implement changes, and the political will at both an EU and at a national level.

Big Pharma’s Perspective

Giving the European Federation of Pharmaceutical Industries and Associations (EFPIA), perspective, Brendan Barnes said that medicine shortages come down to more than just the price and availability; the issue is also about affordability and economic viability. EFPIA is a trade association representing the interests of the research-based pharmaceutical industry,

"We are private sector entities and we need to have a basis to do the business," Mr. Barnes maintained. While the industry wants to do all it can to ensure the adequate provision of drugs to everyone in need, via patient access schemes and reimbursement, accessibility, and affordability ultimately also comes down to local governments and their policies.

"We look to governments to support innovation through fair prices. We look to them for adequately resourced health systems, but health is a right we can only deliver if governments invest in health systems," Mr. Barnes said.

Changing the law is one thing, he said, but there also needs to be a health system in place to ensure that health interventions can successfully be delivered.

European Situation More Complex

"There are two issues at stake here as far as I can see, first is availability and second affordability," said hematologist Dr. Anton Hagenbeek of the Academic Medical Center at the University of Amsterdam in the Netherlands.

ASH is well ahead of the EU in keeping track of the drugs shortages problem, Dr. Hagenbeek observed. Indeed, ASH has collected data on hematologic drug shortages via its dedicated drug shortages portal for the past 18 months and regularly reports its findings to the Food & Drug Administration.

Drugs currently on the ASH/FDA shortage list include many generic, injectable drugs, including methotrexate, leucovorin, bleomycin, anthracyclines, and cisplatin, to name a few. According to the ASH press statement, more that 200 drugs were reported to be in short supply in the United States at one point last year, several dozen of which were critical to the care of patients with hematologic disorders.

The situation in Europe is undoubtedly more complex than in the United States, Dr. Hagenbeek observed. "We are not 1 country; we are 27 countries with our own rules and regulations."

Although it seems as if the EU has fewer drug shortages, compared with the United States, the number of incidents is increasing annually, he noted, citing a sudden shortage last year of cytosine arabinoside in the Netherlands.

The lack of an inventory to keep track of shortages needs addressing, Dr. Hagenbeek said. "Medicine should be available for any patient who needs it and there should be no barriers to access medicine," he said.

"Imagine AML induction without cytosine arabinoside, ALL induction without methotrexate and vincristine, and BEAM without the B, E, and A," Dr. Hagenbeek noted. This is a situation that is "simply unacceptable" for both hematologists as well as patients.

Following the U.S. Example

Speaking from the EHA’s perspective, Dr. Hagenbeek commented that European hematologists should follow the lead set by the United States by creating drug shortage databases in their respective countries and also by reporting drug shortages directly to the society.

Raising awareness is the start, Dr. Hagenbeek suggested. Notification of health authorities, and ultimately, hopefully changing European legislation will be the important next steps.

"EHA is in an excellent position to build on what we have already achieved as ASH in influencing legislation as a first step in dealing with the drug shortage issue," ASH president Armand Keating of the University of Toronto and the Princess Margaret Hospital in Toronto said in an interview.

"I think there are a number of potential solutions," Dr. Keating added, suggesting that an incentive-based rather than punitive-based system might be more successful in addressing drug shortages in the United States in particular.

"One of the things hematologists can do is inform patients about the issue," Dr. Keating suggested, as well as reporting drug shortages to their national health authorities and professional societies such as ASH and EHA.

Dr. Keating, Dr. Jäger, Ms. Cursaru, Mr. Barnes, and Dr. Hagenbeek had no relevant conflicts of interest other than representing their respective societies or professions.

AMSTERDAM – Standard drugs commonly used to treat patients with hematologic and other malignancies are in worryingly short supply, not only in the United States, but also around the globe – a situation that has prompted three leading U.S. and European societies to issue an urgent call to action.

The American Society for Hematology (ASH), the European Hematology Association (EHA), and the European Cancer Patient Coalition (ECPC) issued joint statements June 16 to highlight the problem, which affects the care of patients with leukemia, lymphoma, myeloma, and other life-threatening blood disorders.

The international collaborative announced it would collect data on drug shortages and report the information to the respective authorities, as has been done in the United States. In addition, it "pledged to support legislation in the United States, Europe, and around the world that provides clear, effective interventions to alleviate drug shortages."

"Medicine should be available for any patient who needs it and there should be no barriers to access medicine."

Europe Takes Action

"In the United States, legislation is well under way that may curb drug shortages," Dr. Ulrich Jäger of the Medical University of Vienna, noted in the EHA press statement.

"In Europe, we do not even have a proper understanding of the problem," the EHA president added. "We must work together with our partners to raise awareness and protect the heath of patients with blood disorders worldwide."

In addition to issuing joint press statements, the societies used the joint ESH-ASH symposium at the annual congress of the European Hematology Association to highlight the issue. From the patient’s perspective, it is one of the most basic human rights to be given appropriate access to health care, said Viorica Cursaru, the president of Myeloma Euronet Romania, a member of the ECPC.

Ms. Cursaru noted that the EU health commissioner had stated that the ultimate objective of the EU is to have patients treated well in their own countries and that the time had come to implement Europewide strategies for health.

For this to happen, she argued, there needs to be not only a harmonized legal framework, but also appropriate infrastructure that is lacking in many, particularly eastern European, countries, the professional staff to implement changes, and the political will at both an EU and at a national level.

Big Pharma’s Perspective

Giving the European Federation of Pharmaceutical Industries and Associations (EFPIA), perspective, Brendan Barnes said that medicine shortages come down to more than just the price and availability; the issue is also about affordability and economic viability. EFPIA is a trade association representing the interests of the research-based pharmaceutical industry,

"We are private sector entities and we need to have a basis to do the business," Mr. Barnes maintained. While the industry wants to do all it can to ensure the adequate provision of drugs to everyone in need, via patient access schemes and reimbursement, accessibility, and affordability ultimately also comes down to local governments and their policies.

"We look to governments to support innovation through fair prices. We look to them for adequately resourced health systems, but health is a right we can only deliver if governments invest in health systems," Mr. Barnes said.

Changing the law is one thing, he said, but there also needs to be a health system in place to ensure that health interventions can successfully be delivered.

European Situation More Complex

"There are two issues at stake here as far as I can see, first is availability and second affordability," said hematologist Dr. Anton Hagenbeek of the Academic Medical Center at the University of Amsterdam in the Netherlands.

ASH is well ahead of the EU in keeping track of the drugs shortages problem, Dr. Hagenbeek observed. Indeed, ASH has collected data on hematologic drug shortages via its dedicated drug shortages portal for the past 18 months and regularly reports its findings to the Food & Drug Administration.

Drugs currently on the ASH/FDA shortage list include many generic, injectable drugs, including methotrexate, leucovorin, bleomycin, anthracyclines, and cisplatin, to name a few. According to the ASH press statement, more that 200 drugs were reported to be in short supply in the United States at one point last year, several dozen of which were critical to the care of patients with hematologic disorders.

The situation in Europe is undoubtedly more complex than in the United States, Dr. Hagenbeek observed. "We are not 1 country; we are 27 countries with our own rules and regulations."

Although it seems as if the EU has fewer drug shortages, compared with the United States, the number of incidents is increasing annually, he noted, citing a sudden shortage last year of cytosine arabinoside in the Netherlands.

The lack of an inventory to keep track of shortages needs addressing, Dr. Hagenbeek said. "Medicine should be available for any patient who needs it and there should be no barriers to access medicine," he said.

"Imagine AML induction without cytosine arabinoside, ALL induction without methotrexate and vincristine, and BEAM without the B, E, and A," Dr. Hagenbeek noted. This is a situation that is "simply unacceptable" for both hematologists as well as patients.

Following the U.S. Example

Speaking from the EHA’s perspective, Dr. Hagenbeek commented that European hematologists should follow the lead set by the United States by creating drug shortage databases in their respective countries and also by reporting drug shortages directly to the society.

Raising awareness is the start, Dr. Hagenbeek suggested. Notification of health authorities, and ultimately, hopefully changing European legislation will be the important next steps.

"EHA is in an excellent position to build on what we have already achieved as ASH in influencing legislation as a first step in dealing with the drug shortage issue," ASH president Armand Keating of the University of Toronto and the Princess Margaret Hospital in Toronto said in an interview.

"I think there are a number of potential solutions," Dr. Keating added, suggesting that an incentive-based rather than punitive-based system might be more successful in addressing drug shortages in the United States in particular.

"One of the things hematologists can do is inform patients about the issue," Dr. Keating suggested, as well as reporting drug shortages to their national health authorities and professional societies such as ASH and EHA.

Dr. Keating, Dr. Jäger, Ms. Cursaru, Mr. Barnes, and Dr. Hagenbeek had no relevant conflicts of interest other than representing their respective societies or professions.