Alicia Ault

HEART Bill Reintroduced

A bill that might address the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data reported to the federal government to be broken down by gender, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. The government's WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) program would be expanded from 20 states to the entire country.

Device Recalls Surge

Food and Drug Administration data indicate a 122% increase in recalls of high-risk medical devices from 2009 to 2010, from 23 to 51 class I devices, according to an analysis by the Gray Sheet. The products in the category defined by the risk of death or serious injury varied from infusion pumps to automated external defibrillators to saline syringes. The Gray Sheet found that class I device recalls in 2010 were the highest number ever and that in all categories, there were 717 recalls, up from 626 in 2009.

MRI-Pacemaker Pay Reconsidered

The Centers for Medicare and Medicaid Services is reopening the question of whether magnetic resonance imaging should be covered when done on a patient with an implanted cardiac pacemaker. The CMS said it was reconsidering its February decision never to cover MRI in that instance, in light of the FDA's approval during the same month of the Medtronic Revo MRI Sure Scan Pacing System, which allows for MRI scans. The approval of the pacemaker came days before the coverage decision but too late for the CMS to weigh the evidence for or against MRIs in patients receiving the new product. The CMS expects to propose a decision in September and make a final coverage decision in December.

Index to Measure Diabetes in U.S.

An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (

www.usdireport.com

What's in an Oath?

In a mailed survey, most physicians said an oath they took at medical school graduation influenced their practices “somewhat” or less. Researchers at the Mayo Clinic and the University of Chicago's ethics program asked 2,000 practicing physicians under age 65 whether they were given an oath and whether it influenced their professional lives. Just over 1,000 replied, and 80% said an oath, mostly a version of the Hippocratic Oath, was given at their schools. Only 26% said that it had influenced their practices “a lot,” with 37% saying “somewhat,” 24% “not much,” and 13% “not at all.” When asked to cite other sources of moral guidance, only 16% cited the AMA Code of Ethics. Ninety-two percent said their “personal sense of right and wrong” guided them. A third said great moral teachers mattered, and 28% said traditions mattered. Physicians who said they were religious were more likely to assign importance to the oaths and codes. But the authors, who published their findings in a letter in the March 14 issue of Archives of Internal Medicine, concluded that codes and oaths no longer inspire “binding moral identity” in most American physicians.

Court Passes on 'Pay for Delay'

The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.

HEART Bill Reintroduced

A bill that might address the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data reported to the federal government to be broken down by gender, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. The government's WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) program would be expanded from 20 states to the entire country.

Device Recalls Surge

Food and Drug Administration data indicate a 122% increase in recalls of high-risk medical devices from 2009 to 2010, from 23 to 51 class I devices, according to an analysis by the Gray Sheet. The products in the category defined by the risk of death or serious injury varied from infusion pumps to automated external defibrillators to saline syringes. The Gray Sheet found that class I device recalls in 2010 were the highest number ever and that in all categories, there were 717 recalls, up from 626 in 2009.

MRI-Pacemaker Pay Reconsidered

The Centers for Medicare and Medicaid Services is reopening the question of whether magnetic resonance imaging should be covered when done on a patient with an implanted cardiac pacemaker. The CMS said it was reconsidering its February decision never to cover MRI in that instance, in light of the FDA's approval during the same month of the Medtronic Revo MRI Sure Scan Pacing System, which allows for MRI scans. The approval of the pacemaker came days before the coverage decision but too late for the CMS to weigh the evidence for or against MRIs in patients receiving the new product. The CMS expects to propose a decision in September and make a final coverage decision in December.

Index to Measure Diabetes in U.S.

An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (

www.usdireport.com

What's in an Oath?

In a mailed survey, most physicians said an oath they took at medical school graduation influenced their practices “somewhat” or less. Researchers at the Mayo Clinic and the University of Chicago's ethics program asked 2,000 practicing physicians under age 65 whether they were given an oath and whether it influenced their professional lives. Just over 1,000 replied, and 80% said an oath, mostly a version of the Hippocratic Oath, was given at their schools. Only 26% said that it had influenced their practices “a lot,” with 37% saying “somewhat,” 24% “not much,” and 13% “not at all.” When asked to cite other sources of moral guidance, only 16% cited the AMA Code of Ethics. Ninety-two percent said their “personal sense of right and wrong” guided them. A third said great moral teachers mattered, and 28% said traditions mattered. Physicians who said they were religious were more likely to assign importance to the oaths and codes. But the authors, who published their findings in a letter in the March 14 issue of Archives of Internal Medicine, concluded that codes and oaths no longer inspire “binding moral identity” in most American physicians.

Court Passes on 'Pay for Delay'

The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.

HEART Bill Reintroduced

A bill that might address the shortage of women-specific data on cardiovascular conditions has been introduced again by Sen. Debbie Stabenow (D-Mich.) and Sen. Lisa Murkowski (R-Alaska). The Heart Disease Education, Research and Analysis, and Treatment (HEART) for Women Act would require health data reported to the federal government to be broken down by gender, race, and ethnicity. The bill (S. 438), which the senators have introduced in past congressional sessions without success, would also require the secretary of Health and Human Services to submit an annual report to Congress on women's access to quality care for cardiovascular disease. The government's WISEWOMAN (Well-Integrated Screening and Evaluation for Women Across the Nation) program would be expanded from 20 states to the entire country.

Device Recalls Surge

Food and Drug Administration data indicate a 122% increase in recalls of high-risk medical devices from 2009 to 2010, from 23 to 51 class I devices, according to an analysis by the Gray Sheet. The products in the category defined by the risk of death or serious injury varied from infusion pumps to automated external defibrillators to saline syringes. The Gray Sheet found that class I device recalls in 2010 were the highest number ever and that in all categories, there were 717 recalls, up from 626 in 2009.

MRI-Pacemaker Pay Reconsidered

The Centers for Medicare and Medicaid Services is reopening the question of whether magnetic resonance imaging should be covered when done on a patient with an implanted cardiac pacemaker. The CMS said it was reconsidering its February decision never to cover MRI in that instance, in light of the FDA's approval during the same month of the Medtronic Revo MRI Sure Scan Pacing System, which allows for MRI scans. The approval of the pacemaker came days before the coverage decision but too late for the CMS to weigh the evidence for or against MRIs in patients receiving the new product. The CMS expects to propose a decision in September and make a final coverage decision in December.

Index to Measure Diabetes in U.S.

An online database of 30,000 maps, charts and graphs will give users a new, comprehensive picture of the prevalence and cost of diabetes in the United States, said it sponsors. The U.S. Diabetes Index, available through the Web site USDI Report (

www.usdireport.com

What's in an Oath?

In a mailed survey, most physicians said an oath they took at medical school graduation influenced their practices “somewhat” or less. Researchers at the Mayo Clinic and the University of Chicago's ethics program asked 2,000 practicing physicians under age 65 whether they were given an oath and whether it influenced their professional lives. Just over 1,000 replied, and 80% said an oath, mostly a version of the Hippocratic Oath, was given at their schools. Only 26% said that it had influenced their practices “a lot,” with 37% saying “somewhat,” 24% “not much,” and 13% “not at all.” When asked to cite other sources of moral guidance, only 16% cited the AMA Code of Ethics. Ninety-two percent said their “personal sense of right and wrong” guided them. A third said great moral teachers mattered, and 28% said traditions mattered. Physicians who said they were religious were more likely to assign importance to the oaths and codes. But the authors, who published their findings in a letter in the March 14 issue of Archives of Internal Medicine, concluded that codes and oaths no longer inspire “binding moral identity” in most American physicians.

Court Passes on 'Pay for Delay'

The Supreme Court has refused to consider whether drug companies violate antitrust laws when they pay generic competitors to stay out of the marketplace. The high court's rejection of the case in March allowed companies to continue the practice, known as “pay for delay.” In this case, Bayer AG, which makes the antibiotic Cipro, paid generic competitor Barr Laboratories $398 million to not make a version of the drug. Leading up to the ruling, such deals have come under increased scrutiny. Last year, the Federal Trade Commission condemned the deals, and estimated that they will cost consumers about $35 billion over the next decade. There is also legislation pending in Congress (S. 27) to ban pay for delay.

GAITHERSBURG, MD. – The Food and Drug Administration should require that some genetic tests sold directly to consumers be ordered by a trained health care professional, and that such professionals should interpret results of most of these tests, an advisory committee to the agency has urged.

The panel did not take any formal votes during a meeting last month, but discussed a variety of issues related to tests that are currently sold, almost without any regulation, to consumers over the Internet. Last year, the FDA notified manufacturers of such tests that they must comply with agency rules, and the agency is working with companies now to help them win approval.

The tests run the gamut from diagnostics that determine carrier status for diseases like cystic fibrosis, to those that test for the presence of a specific mutation like BRCA or assess the risk of developing cardiovascular disease or certain cancers. A number of tests on the market have no scientific evidence to substantiate their claims for being able to predict outcomes such as whether a child will excel at sports.

In July 2010, the agency estimated that as many as 700 laboratories offer such direct-to-consumer (DTC) genetic tests.

During the course of the 2-day meeting, the 22 committee members struggled over whether the benefits of consumers' having access to such data outweigh the risks of their being unable to understand the results, or perhaps their becoming falsely reassured or upset by them. The panelists gave the agency some suggestions on how the risks of poor communication or bad test design could be mitigated.

But most of the debate centered on the role of physicians or trained health care professionals, and most panelists believed that professionals should be centrally involved at some point in the process. Test makers and the consumer member of the panel, for their part, said that Americans have the right to their own genetic data, and that in all likelihood, consumers would consult with a physician, especially if it were for a serious condition like Huntington's disease.

The FDA usually follows its panels' advice, but is not required to do so.

The FDA asked the panel to assess five test categories (carrier tests, “pre-symptomatic” tests, susceptibility tests, pharmacogenetic tests, and nutrigenic tests). The agency wanted to know whether some categories should be classified as lower or higher risk and thus be subject to more regulatory restrictions.

The panel did not feel comfortable with the selling of carrier tests (that is, those that identify cystic fibrosis, Tay-Sachs disease, and other conditions) directly to consumers. “Many of these disorders … can't be well communicated outside of clinical consultation,” said panelist Ira Lubin, Ph.D., a clinical molecular geneticist at the Centers for Disease Control and Prevention.

For tests that assess the risk of common conditions such as cancer, Alzheimer's, or cardiovascular disease, the panel was concerned that the results might be falsely reassuring or might discount environmental or lifestyle factors that might also contribute to risk.

“I don't think any of us are saying the patient or the consumer doesn't have a right to know,” said panelist Joann Boughman, Ph.D., CEO of the American Society of Human Genetics. “I would suggest we are not ready yet to put this directly into the consumers' hands.”

GAITHERSBURG, MD. – The Food and Drug Administration should require that some genetic tests sold directly to consumers be ordered by a trained health care professional, and that such professionals should interpret results of most of these tests, an advisory committee to the agency has urged.

The panel did not take any formal votes during a meeting last month, but discussed a variety of issues related to tests that are currently sold, almost without any regulation, to consumers over the Internet. Last year, the FDA notified manufacturers of such tests that they must comply with agency rules, and the agency is working with companies now to help them win approval.

The tests run the gamut from diagnostics that determine carrier status for diseases like cystic fibrosis, to those that test for the presence of a specific mutation like BRCA or assess the risk of developing cardiovascular disease or certain cancers. A number of tests on the market have no scientific evidence to substantiate their claims for being able to predict outcomes such as whether a child will excel at sports.

In July 2010, the agency estimated that as many as 700 laboratories offer such direct-to-consumer (DTC) genetic tests.

During the course of the 2-day meeting, the 22 committee members struggled over whether the benefits of consumers' having access to such data outweigh the risks of their being unable to understand the results, or perhaps their becoming falsely reassured or upset by them. The panelists gave the agency some suggestions on how the risks of poor communication or bad test design could be mitigated.

But most of the debate centered on the role of physicians or trained health care professionals, and most panelists believed that professionals should be centrally involved at some point in the process. Test makers and the consumer member of the panel, for their part, said that Americans have the right to their own genetic data, and that in all likelihood, consumers would consult with a physician, especially if it were for a serious condition like Huntington's disease.

The FDA usually follows its panels' advice, but is not required to do so.

The FDA asked the panel to assess five test categories (carrier tests, “pre-symptomatic” tests, susceptibility tests, pharmacogenetic tests, and nutrigenic tests). The agency wanted to know whether some categories should be classified as lower or higher risk and thus be subject to more regulatory restrictions.

The panel did not feel comfortable with the selling of carrier tests (that is, those that identify cystic fibrosis, Tay-Sachs disease, and other conditions) directly to consumers. “Many of these disorders … can't be well communicated outside of clinical consultation,” said panelist Ira Lubin, Ph.D., a clinical molecular geneticist at the Centers for Disease Control and Prevention.

For tests that assess the risk of common conditions such as cancer, Alzheimer's, or cardiovascular disease, the panel was concerned that the results might be falsely reassuring or might discount environmental or lifestyle factors that might also contribute to risk.

“I don't think any of us are saying the patient or the consumer doesn't have a right to know,” said panelist Joann Boughman, Ph.D., CEO of the American Society of Human Genetics. “I would suggest we are not ready yet to put this directly into the consumers' hands.”

GAITHERSBURG, MD. – The Food and Drug Administration should require that some genetic tests sold directly to consumers be ordered by a trained health care professional, and that such professionals should interpret results of most of these tests, an advisory committee to the agency has urged.

The panel did not take any formal votes during a meeting last month, but discussed a variety of issues related to tests that are currently sold, almost without any regulation, to consumers over the Internet. Last year, the FDA notified manufacturers of such tests that they must comply with agency rules, and the agency is working with companies now to help them win approval.

The tests run the gamut from diagnostics that determine carrier status for diseases like cystic fibrosis, to those that test for the presence of a specific mutation like BRCA or assess the risk of developing cardiovascular disease or certain cancers. A number of tests on the market have no scientific evidence to substantiate their claims for being able to predict outcomes such as whether a child will excel at sports.

In July 2010, the agency estimated that as many as 700 laboratories offer such direct-to-consumer (DTC) genetic tests.

During the course of the 2-day meeting, the 22 committee members struggled over whether the benefits of consumers' having access to such data outweigh the risks of their being unable to understand the results, or perhaps their becoming falsely reassured or upset by them. The panelists gave the agency some suggestions on how the risks of poor communication or bad test design could be mitigated.

But most of the debate centered on the role of physicians or trained health care professionals, and most panelists believed that professionals should be centrally involved at some point in the process. Test makers and the consumer member of the panel, for their part, said that Americans have the right to their own genetic data, and that in all likelihood, consumers would consult with a physician, especially if it were for a serious condition like Huntington's disease.

The FDA usually follows its panels' advice, but is not required to do so.

The FDA asked the panel to assess five test categories (carrier tests, “pre-symptomatic” tests, susceptibility tests, pharmacogenetic tests, and nutrigenic tests). The agency wanted to know whether some categories should be classified as lower or higher risk and thus be subject to more regulatory restrictions.

The panel did not feel comfortable with the selling of carrier tests (that is, those that identify cystic fibrosis, Tay-Sachs disease, and other conditions) directly to consumers. “Many of these disorders … can't be well communicated outside of clinical consultation,” said panelist Ira Lubin, Ph.D., a clinical molecular geneticist at the Centers for Disease Control and Prevention.

For tests that assess the risk of common conditions such as cancer, Alzheimer's, or cardiovascular disease, the panel was concerned that the results might be falsely reassuring or might discount environmental or lifestyle factors that might also contribute to risk.

“I don't think any of us are saying the patient or the consumer doesn't have a right to know,” said panelist Joann Boughman, Ph.D., CEO of the American Society of Human Genetics. “I would suggest we are not ready yet to put this directly into the consumers' hands.”

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier's analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier's analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It's very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn't affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier's National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier's findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient's treatment. That's just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier's analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier's analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It's very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn't affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier's National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier's findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient's treatment. That's just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier's analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier's analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It's very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn't affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier's National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier's findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient's treatment. That's just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

Ninety percent of hospitals experienced a drug shortage in the last half of 2010, and 80% said that the shortages had resulted in a delay or cancellation of a patient intervention as a result, according to a survey conducted by Premier Inc., a voluntary hospital and health care alliance and group purchasing organization.

Premier surveyed 311 pharmacy experts from hospitals; infusion centers; oncology and surgery centers; outpatient and retail pharmacies; and long-term care facilities about their experience with drug shortages during the period of July-Dec. 2010.

Not only did the vast majority report trouble accessing critical drugs, but at least a third reported experiencing access problem more than six times. According to Premier, shortages are at an all-time high. The Food and Drug Administration, the American Society of Health System Pharmacists, the American Society of Clinical Oncology, and other groups have been closely tracking the shortage problem over the last year and have been meeting to discuss potential solutions. The shortages have hit oncology particularly hard.

Over the second half of 2010, more than 240 drugs were in short supply or unavailable and more than 400 generic drugs were back ordered for 5 days or longer, according to Premier’s analysis. Many of those drugs still are not available. The major categories of drugs in short supply are anesthetic agents, other drugs used in emergency departments, and chemotherapy drugs.

The shortages are costing American hospitals at least $200 million a year, largely because the facilities have to buy more expensive alternatives or therapeutic equivalents. Hospitals are paying an average 11% more for these products, but sometimes more. The $200 million figure does not include additional labor for new dispensing systems and compounding, and the added expense for delays and disruptions in patient care, said Blair Childs, senior vice president of public affairs at Premier. These costs cannot be passed on to physicians, payers, or patients because of the nature of the hospitals’ purchasing contracts, so the facilities are absorbing the costs, he added.

There are multiple reasons for the shortages, according to Premier’s analysis, but one major problem is market consolidation. When the single supplier of a particular product has materials or manufacturing problems, no other manufacturers can take up the slack, Mr. Childs said.

Compounding the situation is the fact that many manufacturers, particularly of generic drugs, have ceased making products that are deemed no longer profitable. And, some distributors are buying up available supplies and instituting huge price increases, said Mike Alkire, president of Premier Purchasing Partners. He noted, for instance, that the diuretic furosemide previously sold for $1.21 a vial and is now being offered at $195 a vial.

Mr. Alkire said that the shortages were threatening patient safety. "It’s very, very important to understand that hospitals and other providers are doing unusual and unnatural activities to ensure the care of patients isn’t affected," he said. For instance, hospitals and pharmacists are purchasing drugs from distributors that may not have gone through the traditional vetting process used by Premier for vendors.

Martin Caponi, R.Ph., pharmacy director for Sacred Heart Medical Center in Eugene, Ore., said during the briefing that pharmacists and physicians are often the last to know of a shortage, leading to last-minute changes in dispensing and prescribing. Hospitals and providers are going to great lengths to ensure quality care, and yet, "Every step is being undermined by the drug shortages," said Mr. Caponi, chairman of Premier’s National Pharmacy Committee.

Premier and many other stakeholders are supporting legislation introduced by Sen. Amy Klobuchar (D-Minn.), the Preserving Access to Life-Saving Medications Act (S. 296).

During the briefing, Sen. Klobuchar characterized Premier’s findings as "disturbing." Among other things, her legislation would require a type of early-warning system from both manufacturers and the FDA. Drug makers would need to warn FDA at least 6 months in advance of discontinuing a product or give immediate notification if there was an unanticipated event that could lead to a potential shortage.

The FDA would be required to give the public and health providers faster notice too, Sen. Klobuchar said.

"Right now, pharmacists and physicians are about the last to know that a shortage is coming – sometimes they find out right before a patient’s treatment. That’s just not right," she said.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA's Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.

The Food and Drug Administration on March 24 expanded the approval of the shingles vaccine Zostavax for use in individuals aged 50-59 years.

The vaccine, manufactured by Merck & Co., was initially approved in 2006 for individuals aged 60 and older.

Photo credit: Wikimedia Commons user Timepants

Approval of use of the live, attenuated virus vaccine in the younger age group was based on a multicenter, placebo-controlled study that involved more than 22,000 adults who had a history of varicella but were herpes zoster–negative. They were followed for a year after a single Zostavax dose. There were 30 confirmed cases of herpes zoster among the 11,211 Zostavax recipients, compared with 99 among the 11,228 who got placebo, for an efficacy rate of about 70%.

The most common side effects were redness, pain and swelling at injection site, and headache.

The FDA said that about 200,000 healthy Americans aged 50-59 years experience shingles each year and that the incidence increases with age.

"The availability of Zostavax to a younger age group provides an additional opportunity to prevent this often painful and debilitating disease," Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research said in a statement.

The vaccine is contraindicated in people with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any other component of the vaccine and in the immunocompromised.