A dose of doxycycline, a widely used generic antibiotic, cost less than $5 a year ago. Today it costs more than $100.
Shortages of the drug have benefited Hikma Pharmaceuticals, one of three suppliers that control more than 90 per cent of the market. Hikma raised sales guidance three times last year after halting production of the medicine, then starting again once supply had been squeezed and prices had soared.
Hopes of another sales boost lifted Hikma shares to a record high yesterday, up 6.3 per cent to £12.77, with UBS analysts adding the stock to its “buy” list.
Hikma management has cautioned to expect another generic drugmaker to enter the market this year, UBS said. But a new entrant would not want to disrupt things too much, suggesting pricing will fall by a maximum of 40 per cent this year, the broker forecast.
At that price, doxycycline can still generate earnings of at least $50m for Hikma this year, which would put group profit to 12 per cent above the consensus, UBS said. It had a £13.50 price target on Hikma stock.
http://www.ft.com/intl/cms/s/0/c6d64eda-73d6-11e3-a0c0-00144feabdc0.html#axzz2pOHjIx4p
Friday, January 3, 2014
Editorial: Compounding the problem
If chemical weapons killed 64 people on U.S. soil, the nation would be in a frenzy trying to determine what measures could be taken to prevent it from happening again.
Yet Americans largely reacted with a shrug when 64 people died, including four here in Ocala, and thousands more were sickened last year due to tainted steroid injections.
Sure, the incident led to national media coverage of problems at the Massachusetts compounding pharmacy where the steroid was produced and others like it. But the state and federal response has been mostly voluntary regulations that inspire little confidence that compounding pharmacies are receiving adequate oversight and that the public's safety is being protected.
For the past nine months, Star-Banner staff writer Fred Hiers has investigated the thousands of compounding pharmacies in Florida and beyond that are becoming significant players in the nation's drug market. His eye-opening series published last week, “Compound Fractures,” shows that the public remains at risk from unsafe drugs made at those pharmacies.
Last year's 64 deaths made for the most deadly compounding calamity in U.S. history. But they weren't the first deaths connected to compounding pharmacies. Drugs made in compounding pharmacies in Alabama, Maryland, South Carolina and Texas were previously linked to deaths due to problems such as drug contamination, improper sterilization practices and potency levels far higher than drug labels indicated.
Compounding pharmacies have taken advantage of outdated laws letting them make risky drugs in ever-increasing quantities and complexities while only drawing the same kind of regulation as a neighborhood pharmacy. They are making sterile compounds on a larger scale than ever intended, yet lack the equipment, testing and quality control of major drug manufacturers.
And our state and federal lawmakers refusal to impose real regulations on these operations is merely compounding the problem.
Congress did recently pass a law that encourages compounders to adopt stringent industry guidelines, but the legislation doesn't make them do so. Florida and other states are also operating under largely voluntary rules and lack the regulatory infrastructure, manpower and experience to regulate compounding pharmacies.
The U.S. Food and Drug Administration, which has consistently pressed for more regulatory authority over the compounding labs to no avail, this year inspected three Florida pharmacies and found each failed to ensure their compounded drugs met sterility and potency tests. One was an Ocala pharmacy, formerly known as Franck's Compounding Lab, which made drugs that killed 21 polo horses and damaged 31 people's eyesight.
Despite such incidents, experts such as University of Florida College of Pharmacy professor emeritus Paul Doering warn that regulations for compounding pharmacies remain inadequate.
It's hard to understand why scores of deaths and injuries haven't been enough to force real regulation.
Let's hope that Hiers' series opens the eyes of lawmakers and regulators to the serious problems remaining at compounding pharmacies before another tragedy happens.
http://www.ocala.com/article/20140102/OPINION01/131239929?p=1&tc=pg#gsc.tab=0
Yet Americans largely reacted with a shrug when 64 people died, including four here in Ocala, and thousands more were sickened last year due to tainted steroid injections.
Sure, the incident led to national media coverage of problems at the Massachusetts compounding pharmacy where the steroid was produced and others like it. But the state and federal response has been mostly voluntary regulations that inspire little confidence that compounding pharmacies are receiving adequate oversight and that the public's safety is being protected.
For the past nine months, Star-Banner staff writer Fred Hiers has investigated the thousands of compounding pharmacies in Florida and beyond that are becoming significant players in the nation's drug market. His eye-opening series published last week, “Compound Fractures,” shows that the public remains at risk from unsafe drugs made at those pharmacies.
Last year's 64 deaths made for the most deadly compounding calamity in U.S. history. But they weren't the first deaths connected to compounding pharmacies. Drugs made in compounding pharmacies in Alabama, Maryland, South Carolina and Texas were previously linked to deaths due to problems such as drug contamination, improper sterilization practices and potency levels far higher than drug labels indicated.
Compounding pharmacies have taken advantage of outdated laws letting them make risky drugs in ever-increasing quantities and complexities while only drawing the same kind of regulation as a neighborhood pharmacy. They are making sterile compounds on a larger scale than ever intended, yet lack the equipment, testing and quality control of major drug manufacturers.
And our state and federal lawmakers refusal to impose real regulations on these operations is merely compounding the problem.
Congress did recently pass a law that encourages compounders to adopt stringent industry guidelines, but the legislation doesn't make them do so. Florida and other states are also operating under largely voluntary rules and lack the regulatory infrastructure, manpower and experience to regulate compounding pharmacies.
The U.S. Food and Drug Administration, which has consistently pressed for more regulatory authority over the compounding labs to no avail, this year inspected three Florida pharmacies and found each failed to ensure their compounded drugs met sterility and potency tests. One was an Ocala pharmacy, formerly known as Franck's Compounding Lab, which made drugs that killed 21 polo horses and damaged 31 people's eyesight.
Despite such incidents, experts such as University of Florida College of Pharmacy professor emeritus Paul Doering warn that regulations for compounding pharmacies remain inadequate.
It's hard to understand why scores of deaths and injuries haven't been enough to force real regulation.
Let's hope that Hiers' series opens the eyes of lawmakers and regulators to the serious problems remaining at compounding pharmacies before another tragedy happens.
http://www.ocala.com/article/20140102/OPINION01/131239929?p=1&tc=pg#gsc.tab=0
State inspections found lacking for pharmacies
The deaths of 64 people injected with contaminated drugs created by New England Compounding Center last year drew wide public attention because of the scale of the tragedy and the mistakes uncovered after the fact.
But the incident was by no means isolated.
• In 2007, three died after being injected with a compounded drug made in a Texas pharmacy. Inspectors discovered that drugs were six times as potent as the labels indicated. Tougher state oversight would have prevented the deaths, critics say.
• In 2005, a contaminated compounded medicine produced by a Maryland pharmacy for use in open-heart surgery caused severe infections and three deaths.
• In 2002, two people died after being injected with tainted steroids produced by a South Carolina pharmacy. After the fact, South Carolina inspectors found the pharmacy unsanitary and its sterilization practices falling abysmally short.
• A year before the NECC deaths, nine people died when they received contaminated intravenous solutions from an Alabama pharmacy. The contaminating bacteria were typically found in water and sometimes bathrooms. Investigators after the fact found the same kind of bacteria at the pharmacy, including at a faucet that dispensed tap water.
• In 2012, Franck's Compounding Lab in Ocala made sterile compounds it shipped to doctors in seven states for use during eye surgeries. The drugs were contaminated with mold. Thirty-three people lost some of their sight or needed surgeries to try and fix what the infections destroyed.
The common theme among these episodes was that, while investigations of the deadly mishaps revealed unsanitary or unsterile conditions, each compounding pharmacy had passed inspection by its state pharmacy board.
http://www.heraldtribune.com/article/20131231/ARTICLE/312319993/-1/news08?Title=State-inspections-found-lacking-for-pharmacies#gsc.tab=0
But the incident was by no means isolated.
• In 2007, three died after being injected with a compounded drug made in a Texas pharmacy. Inspectors discovered that drugs were six times as potent as the labels indicated. Tougher state oversight would have prevented the deaths, critics say.
• In 2005, a contaminated compounded medicine produced by a Maryland pharmacy for use in open-heart surgery caused severe infections and three deaths.
• In 2002, two people died after being injected with tainted steroids produced by a South Carolina pharmacy. After the fact, South Carolina inspectors found the pharmacy unsanitary and its sterilization practices falling abysmally short.
• A year before the NECC deaths, nine people died when they received contaminated intravenous solutions from an Alabama pharmacy. The contaminating bacteria were typically found in water and sometimes bathrooms. Investigators after the fact found the same kind of bacteria at the pharmacy, including at a faucet that dispensed tap water.
• In 2012, Franck's Compounding Lab in Ocala made sterile compounds it shipped to doctors in seven states for use during eye surgeries. The drugs were contaminated with mold. Thirty-three people lost some of their sight or needed surgeries to try and fix what the infections destroyed.
The common theme among these episodes was that, while investigations of the deadly mishaps revealed unsanitary or unsterile conditions, each compounding pharmacy had passed inspection by its state pharmacy board.
http://www.heraldtribune.com/article/20131231/ARTICLE/312319993/-1/news08?Title=State-inspections-found-lacking-for-pharmacies#gsc.tab=0
Law regulating compounding pharmacies falls short
Additional steps are needed for regulating compounding pharmacies beyond those outlined in the Drug Quality and Security Act of 2013, some are warning.
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
The FDA has clearer authority, but needs support from other stakeholders, including adequate funding from Congress, Outterson noted. Furthermore, providers and health plans can play a role by insisting compounded drugs are exclusively sourced from FDA-regulated facilities.
"The Drug Quality and Security Act may have been a good first step, but patients will not be protected unless states, the FDA, and healthcare providers and plans act quickly to fill in the gaps left by Congress," Outterson concluded.
http://www.clinicaladvisor.com/law-regulating-compounding-pharmacies-falls-short/article/327389/
Kevin Outterson, JD, LLM, from the Boston University School of Law, discusses limitations of the Act, passed after a 2012 fungal meningitis outbreak originated at a New England compounding pharmacy.
His insights were recently published online in the New England Journal of Medicine.
Although the new Act goes some way to improve regulation, including reenactment of Section 503A, additional legislation is needed at the state level to avoid similar tragedies as the one that originated at the New England Compounding Center (NECC) in Framingham, Mass.
Many states do not mandate compliance with the sterile-compounding requirements, and most do not carefully regulate out-of-state compounding pharmacies, according to Outterson. Federal government has ceded much of the regulatory authority to states and they must ensure minimum quality standards are met, without triggering drug shortages.
The FDA has clearer authority, but needs support from other stakeholders, including adequate funding from Congress, Outterson noted. Furthermore, providers and health plans can play a role by insisting compounded drugs are exclusively sourced from FDA-regulated facilities.
"The Drug Quality and Security Act may have been a good first step, but patients will not be protected unless states, the FDA, and healthcare providers and plans act quickly to fill in the gaps left by Congress," Outterson concluded.
http://www.clinicaladvisor.com/law-regulating-compounding-pharmacies-falls-short/article/327389/
Investigation: Missouri's Execution Drug Source Raises Legal, Ethical Questions
In an investigation spanning the past few months, St. Louis Public Radio and the Beacon has discovered the state of Missouri may be ignoring its own laws in carrying out the death penalty by buying execution drugs from a pharmacy not licensed to do business in Missouri.As we’ve reported in previous months, a shortage of willing drug suppliers led Missouri Gov. Jay Nixon to direct the state to adopt a controversial new execution method.
Now the state is using a sedative, pentobarbital, a drug that’s also commonly used by veterinarians to euthanize animals. That was the drug used to execute two inmates in November and December.
The drug isn’t made by a drug manufacturer, but instead by a compounding pharmacy, which mixes the drug based on a specific request.
Compounding pharmacies, like Missouri’s execution drug supplier, aren’t regulated by the Food and Drug Administration. These types of pharmacies are supposed to be regulated by the states. The drugs they make have a significantly higher failure rate than FDA-approved drugs (1).
The execution drug’s potency is critical. If the drug is too weak, or even not what it’s supposed to be, it could result in a painful or slow death, a violation of the U.S. Constitution's ban on cruel and unusual punishment.
The state has fought hard to keep the identity of the supplier a secret, restricting public oversight, and making it difficult to know if the execution method is both legal and ethical.
The situation led a federal judge to declare that the state was getting its execution drug using a “shadow pharmacy hidden by the hangman’s hood.” (2)
But by piecing together documents from dozens of public records requests, St. Louis Public Radio and the Beacon has figured out that this "shadow pharmacy" is located in Oklahoma.
And it isn’t licensed in Missouri (3).
Under normal circumstances, selling a drug without a license could be a felony punishable by up to seven years in prison (4).
A picture of the compounding pharmacy's license in Oklahoma. We've redacted the date, but the other redactions were made by the Department of Corrections.
“When you violate Missouri law to carry out Missouri law, that seems contradictory,” said Tony Rothert of the American Civil Liberties Union of Missouri, which has challenged Missouri executions.
George Lombardi, the director of the Department of Corrections, is responsible for selecting the pharmacy as well as making its identity a secret. Calls to his office were not returned. But in an email, a spokesperson said, "The Department of Corrections complies with all laws relating to the acquisition of drugs used in executions."
The spokesperson declined to answer further questions.
A receipt issued by the Missouri Department of Corrections to the compounding pharmacy for "execution services" -- the pentobarbital.
The ACLU has sued the state for keeping the supplier a secret.
'When you violate Missouri law to carry out Missouri law, that seems contradictory.' -- Tony Rothert of the ACLU
“It’s not surprising," Rothert said when we told him that the pharmacy isn’t licensed. "The state has gone to great lengths to hide what it’s doing and to be secretive about what it’s doing. So it’s not surprising that there’s something there that the state was trying to cover up.”
This pharmacy is licensed to do business in Oklahoma (3). But getting licensed in Missouri isn’t just an administrative issue, it’s the way the state maintains quality.
Ned Milenkovich, a pharmacist and attorney who serves on the Illinois Board of Pharmacy, said the whole point of boards of pharmacy is to make sure that drugs are safe and effective.
“The purpose of the board is not to protect the pharmacy and the pharmacist but to protect the public of the state and the citizens of Missouri in this case,” Milenkovich said.
He said out-of-state pharmacies are legally required to be registered in the state to which they are shipping drugs. Another expert -- a former member of the Missouri Board of Pharmacy -- agreed (5).
A Gray Area
But when we got into specifics on the legality of the Department of Corrections buying the drug for an execution, both the experts said they were unsure and that it was a gray area. Under these circumstances, the state might get to play by different rules.
A prescription for 5 grams of pentobarbital compounded by the Oklahoma pharmacy and used by the Missouri Department of Corrections to put Joseph Paul Franklin to death.
We’ve asked the current members of the Missouri Board of Pharmacy to comment on whether they will be investigating the pharmacy for possibly breaking the law. They did not respond to our request for comment.
The legality of this specific situation is murky. But using a supplier not licensed by the Missouri Board of Pharmacy removes yet another layer of scrutiny in an already secretive process.
As noted above, the FDA does not oversee the execution drug this Oklahoma pharmacy makes. And if the Missouri Board of Pharmacy isn’t making sure the drug is what it claims to be, who is providing oversight?
Missouri is relying on another state to regulate the pharmacy and make sure its practices meet standards.
So why would the Department of Corrections use a pharmacy that's not regulated in Missouri to supply drugs for executions?
“It could be the case that they can’t find a pharmacy in Missouri to participate in this type of activity," Milenkovich said. "Because when you take your oath of pharmacist practice or your oath of medicine, a lot of people are, for whatever reason, put off by the fact that they are preparing a medication that is not going to be helpful for a person, is not going to treat them, but is rather going to put them to death.”
A Game Of Chess
Inmates are supposed to have the right to challenge the constitutionality of the state’s method of execution, and the courts are supposed to serve as a check on the state’s power.
But in practice, Missouri has executed inmates before the courts have ruled on whether doing so violated their rights (6).
A federal judge has criticized the state for treating executions “like a game of chess": making changes to their methods and moving to carry out lethal injections while the lawyers and the courts try to keep up (7).
In court, Missouri Attorney General Chris Koster's office has repeatedly defended the state's execution process. His office asserts that the supplier should be kept secret, although it declined to comment for this story.
The governor's office declined to comment as well. But Nixon has previously defended the department's new secrecy.
The label from the pentobarbital used to execute Joseph Paul Franklin in November.
“I feel like the Department of Corrections has come up with an appropriate protocol,” Nixon said in November. "I think we’ll stick with the protocol as designed."
The ACLU's Rothert said the state is basically saying, "trust us."
“Even though everything that they've done with respect to the procuring of drugs and carrying out the death penalty in recent months has shown that we can't trust them," Rothert said. "Instead what they’ve shown is that they will go to great lengths breaking Missouri law, disobeying court orders, in order to make sure executions are carried out.”
Missouri is scheduled to carry out its next execution in late January. That could be before the courts have time to decide if the state’s new execution method is constitutional.
Follow Chris McDaniel on Twitter: @csmcdaniel
Follow Veronique LaCapra on Twitter: @KWMUScience
Sources And Additional Information
1. It's worth pointing out that a recently passed law improves oversight of compounding pharmacies. It allows compounding pharmacies that mass-produce drugs to register with the FDA, if they choose.
As we've reported before, in inspections spanning the last decade, the Missouri Board of Pharmacy found that about one out of every five drugs made by compounding pharmacies failed to meet standards. Compare that to a failure rate of fewer than one in 50 for commercially manufactured products.
2. From Judge Kermit Bye, who serves on the 8th Circuit Court of Appeals:
"Its current practice of using shadow pharmacies hidden behind the hangman's hood, copycat pharmaceuticals, numerous last-minute changes to its execution protocol, and finally, its act of proceeding with an execution before the federal courts had completed their review of an active request for a stay, has committed this judge to subjecting the state's future implementation of the penalty of death to intense judicial scrutiny, for the sake of the death row inmates involved as well as adversaries and advocates of capital punishment alike."
3. This page contains registration with three different agencies.
The bottom third is a federal Drug Enforcement Agency license with all identifying information redacted.
The middle third is a registration with a state narcotics department. What tipped us off that it was Oklahoma was the name of the state department. It says “registered with the (redacted) State Bureau of Narcotics and Dangerous Drugs Control.” That's the name of Oklahoma’s narcotics department.
The top third is a registration with a state board of pharmacy. We compared the heavily redacted document to what a blank Oklahoma Board of Pharmacy license looks like, and it was a match. The nomenclature of the permits also matches, as well as the amount charged. We asked the Oklahoma Board of Pharmacy for all of its receipts for the date on the license (which we have redacted), and came up with three possible pharmacies – none of which are licensed in Missouri. An official with the Oklahoma Board of Pharmacy confirmed that the redacted license was for one of those three pharmacies.
A blank Oklahoma Board of Pharmacy License.
4. According to Mo. Revised Statute 338.195: “Any person, who is not licensed under this chapter, who violates any provision of sections 338.010 to 338.315 shall, upon conviction, be adjudged guilty of a class C felony.”
5. We also spoke to George Oestreich, who served on the Missouri Board of Pharmacy for five years.
6. Nicklasson was executed while his lawyers were asking for the full 8th Circuit Court of Appeals to decide whether his execution would be constitutional. Since the full court didn’t have time to decide until after Nicklasson was dead, the petition was dismissed as moot. In his dissent, Judge Kermit Bye wrote:
“Missouri executed Allen Nicklasson before this court had completed its review of Nicklasson's request for a stay of his execution, a request he brought in a pending action challenging the constitutionality of Missouri's execution protocol. That bears repeating. Missouri put Nicklasson to death before the federal courts had a final say on whether doing so violated the federal constitution…I am alarmed that Missouri proceeded with its execution of Allen Nicklasson before this court had even finished voting on Nicklasson's request for a stay. In my near fourteen years on the bench, this is the first time I can recall this happening.”
Note: Emphasis added by us.
But that’s not the only time federal judges have voiced their displeasure with how the state has conducted itself in carrying out executions.
Judge Nanette Laughrey ordered the state to reveal the identity of the compounding pharmacist to two members of the inmates’ legal team by Dec. 16. The state’s legal team, led by Attorney General Chris Koster, did not comply with the order.
A day after the judge's deadline, the state instead delivered a sealed envelope with the identities to the court, but not the members of the inmates' legal team.
7. Judge Laughrey has repeatedly criticized the state for changing its protocol numerous times, calling it a “frustratingly moving target.”
“Finally, litigation is not a game of chess…It would be a substantial departure from the way in which law suits are generally handled by this Court, to allow Defendants to succeed with this strategy. Rather, the pending dispute between the parties should be resolved on the merits after a reasonable opportunity for both sides to be heard, followed by a prompt, final order resolving the dispute. That is how it is normally done in America and it is a system that has worked quite well.”
Now the state is using a sedative, pentobarbital, a drug that’s also commonly used by veterinarians to euthanize animals. That was the drug used to execute two inmates in November and December.
The drug isn’t made by a drug manufacturer, but instead by a compounding pharmacy, which mixes the drug based on a specific request.
Compounding pharmacies, like Missouri’s execution drug supplier, aren’t regulated by the Food and Drug Administration. These types of pharmacies are supposed to be regulated by the states. The drugs they make have a significantly higher failure rate than FDA-approved drugs (1).
The execution drug’s potency is critical. If the drug is too weak, or even not what it’s supposed to be, it could result in a painful or slow death, a violation of the U.S. Constitution's ban on cruel and unusual punishment.
The state has fought hard to keep the identity of the supplier a secret, restricting public oversight, and making it difficult to know if the execution method is both legal and ethical.
The situation led a federal judge to declare that the state was getting its execution drug using a “shadow pharmacy hidden by the hangman’s hood.” (2)
But by piecing together documents from dozens of public records requests, St. Louis Public Radio and the Beacon has figured out that this "shadow pharmacy" is located in Oklahoma.
And it isn’t licensed in Missouri (3).
Under normal circumstances, selling a drug without a license could be a felony punishable by up to seven years in prison (4).
A picture of the compounding pharmacy's license in Oklahoma. We've redacted the date, but the other redactions were made by the Department of Corrections.
“When you violate Missouri law to carry out Missouri law, that seems contradictory,” said Tony Rothert of the American Civil Liberties Union of Missouri, which has challenged Missouri executions.
George Lombardi, the director of the Department of Corrections, is responsible for selecting the pharmacy as well as making its identity a secret. Calls to his office were not returned. But in an email, a spokesperson said, "The Department of Corrections complies with all laws relating to the acquisition of drugs used in executions."
The spokesperson declined to answer further questions.
A receipt issued by the Missouri Department of Corrections to the compounding pharmacy for "execution services" -- the pentobarbital.
The ACLU has sued the state for keeping the supplier a secret.
'When you violate Missouri law to carry out Missouri law, that seems contradictory.' -- Tony Rothert of the ACLU
“It’s not surprising," Rothert said when we told him that the pharmacy isn’t licensed. "The state has gone to great lengths to hide what it’s doing and to be secretive about what it’s doing. So it’s not surprising that there’s something there that the state was trying to cover up.”
This pharmacy is licensed to do business in Oklahoma (3). But getting licensed in Missouri isn’t just an administrative issue, it’s the way the state maintains quality.
Ned Milenkovich, a pharmacist and attorney who serves on the Illinois Board of Pharmacy, said the whole point of boards of pharmacy is to make sure that drugs are safe and effective.
“The purpose of the board is not to protect the pharmacy and the pharmacist but to protect the public of the state and the citizens of Missouri in this case,” Milenkovich said.
He said out-of-state pharmacies are legally required to be registered in the state to which they are shipping drugs. Another expert -- a former member of the Missouri Board of Pharmacy -- agreed (5).
A Gray Area
But when we got into specifics on the legality of the Department of Corrections buying the drug for an execution, both the experts said they were unsure and that it was a gray area. Under these circumstances, the state might get to play by different rules.
A prescription for 5 grams of pentobarbital compounded by the Oklahoma pharmacy and used by the Missouri Department of Corrections to put Joseph Paul Franklin to death.
We’ve asked the current members of the Missouri Board of Pharmacy to comment on whether they will be investigating the pharmacy for possibly breaking the law. They did not respond to our request for comment.
The legality of this specific situation is murky. But using a supplier not licensed by the Missouri Board of Pharmacy removes yet another layer of scrutiny in an already secretive process.
As noted above, the FDA does not oversee the execution drug this Oklahoma pharmacy makes. And if the Missouri Board of Pharmacy isn’t making sure the drug is what it claims to be, who is providing oversight?
Missouri is relying on another state to regulate the pharmacy and make sure its practices meet standards.
So why would the Department of Corrections use a pharmacy that's not regulated in Missouri to supply drugs for executions?
“It could be the case that they can’t find a pharmacy in Missouri to participate in this type of activity," Milenkovich said. "Because when you take your oath of pharmacist practice or your oath of medicine, a lot of people are, for whatever reason, put off by the fact that they are preparing a medication that is not going to be helpful for a person, is not going to treat them, but is rather going to put them to death.”
A Game Of Chess
Inmates are supposed to have the right to challenge the constitutionality of the state’s method of execution, and the courts are supposed to serve as a check on the state’s power.
But in practice, Missouri has executed inmates before the courts have ruled on whether doing so violated their rights (6).
A federal judge has criticized the state for treating executions “like a game of chess": making changes to their methods and moving to carry out lethal injections while the lawyers and the courts try to keep up (7).
In court, Missouri Attorney General Chris Koster's office has repeatedly defended the state's execution process. His office asserts that the supplier should be kept secret, although it declined to comment for this story.
The governor's office declined to comment as well. But Nixon has previously defended the department's new secrecy.
The label from the pentobarbital used to execute Joseph Paul Franklin in November.
“I feel like the Department of Corrections has come up with an appropriate protocol,” Nixon said in November. "I think we’ll stick with the protocol as designed."
The ACLU's Rothert said the state is basically saying, "trust us."
“Even though everything that they've done with respect to the procuring of drugs and carrying out the death penalty in recent months has shown that we can't trust them," Rothert said. "Instead what they’ve shown is that they will go to great lengths breaking Missouri law, disobeying court orders, in order to make sure executions are carried out.”
Missouri is scheduled to carry out its next execution in late January. That could be before the courts have time to decide if the state’s new execution method is constitutional.
Follow Chris McDaniel on Twitter: @csmcdaniel
Follow Veronique LaCapra on Twitter: @KWMUScience
Sources And Additional Information
1. It's worth pointing out that a recently passed law improves oversight of compounding pharmacies. It allows compounding pharmacies that mass-produce drugs to register with the FDA, if they choose.
As we've reported before, in inspections spanning the last decade, the Missouri Board of Pharmacy found that about one out of every five drugs made by compounding pharmacies failed to meet standards. Compare that to a failure rate of fewer than one in 50 for commercially manufactured products.
2. From Judge Kermit Bye, who serves on the 8th Circuit Court of Appeals:
"Its current practice of using shadow pharmacies hidden behind the hangman's hood, copycat pharmaceuticals, numerous last-minute changes to its execution protocol, and finally, its act of proceeding with an execution before the federal courts had completed their review of an active request for a stay, has committed this judge to subjecting the state's future implementation of the penalty of death to intense judicial scrutiny, for the sake of the death row inmates involved as well as adversaries and advocates of capital punishment alike."
3. This page contains registration with three different agencies.
The bottom third is a federal Drug Enforcement Agency license with all identifying information redacted.
The middle third is a registration with a state narcotics department. What tipped us off that it was Oklahoma was the name of the state department. It says “registered with the (redacted) State Bureau of Narcotics and Dangerous Drugs Control.” That's the name of Oklahoma’s narcotics department.
The top third is a registration with a state board of pharmacy. We compared the heavily redacted document to what a blank Oklahoma Board of Pharmacy license looks like, and it was a match. The nomenclature of the permits also matches, as well as the amount charged. We asked the Oklahoma Board of Pharmacy for all of its receipts for the date on the license (which we have redacted), and came up with three possible pharmacies – none of which are licensed in Missouri. An official with the Oklahoma Board of Pharmacy confirmed that the redacted license was for one of those three pharmacies.
A blank Oklahoma Board of Pharmacy License.
4. According to Mo. Revised Statute 338.195: “Any person, who is not licensed under this chapter, who violates any provision of sections 338.010 to 338.315 shall, upon conviction, be adjudged guilty of a class C felony.”
5. We also spoke to George Oestreich, who served on the Missouri Board of Pharmacy for five years.
6. Nicklasson was executed while his lawyers were asking for the full 8th Circuit Court of Appeals to decide whether his execution would be constitutional. Since the full court didn’t have time to decide until after Nicklasson was dead, the petition was dismissed as moot. In his dissent, Judge Kermit Bye wrote:
“Missouri executed Allen Nicklasson before this court had completed its review of Nicklasson's request for a stay of his execution, a request he brought in a pending action challenging the constitutionality of Missouri's execution protocol. That bears repeating. Missouri put Nicklasson to death before the federal courts had a final say on whether doing so violated the federal constitution…I am alarmed that Missouri proceeded with its execution of Allen Nicklasson before this court had even finished voting on Nicklasson's request for a stay. In my near fourteen years on the bench, this is the first time I can recall this happening.”
Note: Emphasis added by us.
But that’s not the only time federal judges have voiced their displeasure with how the state has conducted itself in carrying out executions.
Judge Nanette Laughrey ordered the state to reveal the identity of the compounding pharmacist to two members of the inmates’ legal team by Dec. 16. The state’s legal team, led by Attorney General Chris Koster, did not comply with the order.
A day after the judge's deadline, the state instead delivered a sealed envelope with the identities to the court, but not the members of the inmates' legal team.
7. Judge Laughrey has repeatedly criticized the state for changing its protocol numerous times, calling it a “frustratingly moving target.”
“Finally, litigation is not a game of chess…It would be a substantial departure from the way in which law suits are generally handled by this Court, to allow Defendants to succeed with this strategy. Rather, the pending dispute between the parties should be resolved on the merits after a reasonable opportunity for both sides to be heard, followed by a prompt, final order resolving the dispute. That is how it is normally done in America and it is a system that has worked quite well.”
Baxter Initiates Nationwide Voluntary Recall of Select Lots of Premix Parenteral Nutrition
FOR IMMEDIATE RELEASE - January 3, 2014 - Baxter International Inc. announced today it has initiated a voluntary recall in the United States of two lots of CLINIMIX and one lot of CLINIMIX E Injection parenteral nutrition products to the user level due to complaints of particulate matter found in the products. If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation, and inflammation in tissues and organs. There have been no reported adverse events associated with this issue to date, and the root cause of this voluntary recall has been identified and resolved.
CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are premixed sterile intravenous (IV) parenteral nutrition products that come in multi-chambered containers and are used as a caloric component and as a protein source in a parenteral nutrition program. The affected product codes are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot P285122, exp 05/14). Affected products were distributed to healthcare centers and distributors in the United Sates.
Baxter has notified customers, who are being directed not to use product from the recalled lots. Customers should locate and remove all affected product from their facility. The affected lots were distributed to customers between May 2012 and October 2013. Unaffected lot numbers can continue to be used according to the instructions for use. Affected product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online:www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
According to the CLINIMIX and CLINIMIX E product labeling, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. The use of a final filter is recommended during administration of all parenteral solutions where possible.
About Baxter
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
http://www.fda.gov/Safety/Recalls/ucm380387.htm
CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are premixed sterile intravenous (IV) parenteral nutrition products that come in multi-chambered containers and are used as a caloric component and as a protein source in a parenteral nutrition program. The affected product codes are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13) and 2B7709 (lot P285122, exp 05/14). Affected products were distributed to healthcare centers and distributors in the United Sates.
Baxter has notified customers, who are being directed not to use product from the recalled lots. Customers should locate and remove all affected product from their facility. The affected lots were distributed to customers between May 2012 and October 2013. Unaffected lot numbers can continue to be used according to the instructions for use. Affected product should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, between the hours of 7:00 a.m. and 6:00 p.m., Central Time. Unaffected lots of product are available for replacement.
Consumers with questions regarding this recall can call Baxter at 1-800-422-9837, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time, or e-mail Baxter at onebaxter@baxter.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Online:www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
According to the CLINIMIX and CLINIMIX E product labeling, parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit. The use of a final filter is recommended during administration of all parenteral solutions where possible.
About Baxter
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
http://www.fda.gov/Safety/Recalls/ucm380387.htm
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