Before the U.S. Senate approved new compounding legislation, senators made statements clarifying for the Food and Drug Administration (FDA) that the bill essentially preserves state board of pharmacy authority over the typical compounding work done by independent community pharmacies.
In particular, U.S. Senators Tom Coburn (R-Okla.) and John Boozman (R-Ark.) inserted extensive remarks on the subject into the Congressional Record history of the debate and approval of H.R. 3204, The Drug Quality and Security Act.
Their focus was on the compounding of medication for so-called “office use” by doctors and hospitals in their practice settings, sometimes in life-saving scenarios. For example, it is common for hospitals to stock IV fluid bags prepared by compounding pharmacies. In that case and that of compounded drugs on “crash carts” (used to treat cardiac arrest or other life-threatening conditions), it isn’t practical for physicians to write a prescription and only then have the pharmacy compound the drug.
“I want to make clear that this legislation does not change current state law or authority over the dispensing or distribution of medications by pharmacists, compounded or manufactured, for a prescriber’s administration to or treatment of a patient within their practice,” Sen. Coburn said. “The issue of office use, indeed all of pharmacy practice regulation, is best left to the states. So the omission of office use from 503(a) should not signal to the FDA that it has the authority to encroach upon State authority to regulate office use.”
H.R. 3204 “in no way” provides “some new expansive authority to the FDA to restrict interstate commerce or regulate intrastate commerce,” he continued.
“Finally, the legislation does not change the ability of ophthalmologists to administer drugs in their office to individual patients for the purposes of reducing macular degeneration. Under this legislation, physicians retain the ability to use compounding drugs in their office for their patients. This is a practice-of-medicine issue, so the art and science of medicine should not be impeded by the FDA. I will continue to monitor the implementation of section 503(A) in consultation with physicians, medical professionals, and pharmacy professionals. I also strongly encourage the FDA to ensure that these provisions are not used to restrict office use and restrict interstate sales of compounded pharmaceuticals within all applicable laws and regulations.”
“The practice of pharmacy, including pharmacy compounding, is a state issue,” Sen. Boozman said. “Nothing in this law changes that. Compounded drugs for office-use is a state issue. Nothing in this law changes that. Commonplace drug repackaging for drugs—like Avastin®—is a state issue.”
Sen. Boozman continued, “The omission of office-use from section 503(a) of the Food, Drug and Cosmetic Act should not signal to the FDA that it has the authority to encroach upon state authority to regulate office-use. This is not the intent of the law, and I will closely monitor FDA implementation as this process moves forward. If the state of Minnesota wants to prohibit drug repackaging and compounding—that’s its decision. But again, this law is by no means a green light for the FDA to usurp the rights of states. I want to make that crystal clear.”
Both lawmakers are doctors and presumably spoke from first-hand experience with compounded medications in an office setting. Indeed, Sen. Boozman noted that he relied on compounding pharmacies regularly when he practiced in a surgery center.
“Without compounders, doctors would not perform surgeries,” Sen. Boozman concluded. “Without compounders, oncologists would be forced to administer alternative chemotherapy drugs. Without compounders, patients would suffer from limited access. These are real issues and real problems, and we must take these realities into consideration.”
These are among the reasons NCPA endorsed H.R. 3204. NCPA staff will continue to work with policymakers to ensure the legislation is implemented properly.
http://ncpanet.wordpress.com/2013/11/26/community-pharmacy-compounding-preserved-under-newly-approved-legislation-senators-say/
Tuesday, November 26, 2013
Insurer Disputes Coverage For NECC-Linked Compounder
Law360, New York (November 25, 2013, 1:43 PM ET) -- Ironshore Specialty Insurance Co. sued to disavow covering a New England Compounding Center sister pharmacy against claims from alleged victims of the NECC-linked meningitis outbreak, saying Friday that attempts to paint the insured as an NECC alter ego don’t qualify for coverage.
Ironshore argued in Massachusetts federal court that Ameridose LLC — a compounding pharmacy owned and operated by many of the same people as NECC but legally distinct — cannot tap its $5 million excess policy for defense and indemnity against personal injury suits that...
http://www.law360.com/articles/491117/insurer-disputes-coverage-for-necc-linked-compounder
Ironshore argued in Massachusetts federal court that Ameridose LLC — a compounding pharmacy owned and operated by many of the same people as NECC but legally distinct — cannot tap its $5 million excess policy for defense and indemnity against personal injury suits that...
http://www.law360.com/articles/491117/insurer-disputes-coverage-for-necc-linked-compounder
New compounding pharmacy rules remain on hold in TN
Months after voting to implement strict new rules on compounding pharmacies on an emergency basis, a state regulatory board is still waiting for a vastly altered package to emerge and actually go into effect.
It was in June that the Tennessee Pharmacy Board voted to adopt emergency rules to make possible the quick shutdown of compounding pharmacies deemed to be a threat to public health and safety.
The action came as Tennessee found itself in the midst of a nationwide fungal meningitis outbreak caused by a Massachusetts compounding firm that shipped fungus-tainted steroids to health-care providers across the country. Only Michigan had more victims.
Sixteen deaths have been recorded among patients treated in Tennessee, while 154 were sickened from the methylprednisolone acetate shipped from the now-defunct New England Compounding Center.
In what he termed a major change, Reginald Dillard, executive director of the pharmacy board, said the board has been forced to remove provisions to issue an immediate cease-and-desist order to a compounder believed to be endangering the public health.
A companion measure giving the state health commissioner authority to issue such an order also has been eliminated.
Dillard said those provisions were stripped from the new rules after a review by the state attorney general concluded the cease-and-desist provisions would violate the state Administrative Procedures Act.
“The statutes do not allow us to do it,” Dillard said of the immediate cease-and-desist rules.
He said the licenses issued to pharmacists are considered a property right and can’t be revoked without due process, which would require prior formal notice and a hearing.
He said the attorney general also concluded that under current law the board cannot delegate its authority to revoke a license to the health commissioner.
Meeting minutes show pharmacy board members learned of the attorney general’s decision at their October meeting.
A board attorney, Stefan Cange, told members that not only would there have to be a hearing before a license suspension, but also the pharmacy board would bear the burden of proving that a suspension was justified.
Cange also told the board that while the health commissioner could recommend the suspension of a compounding pharmacy license, he could not implement a suspension on his own. “The commissioner has been removed from that process,” Cange said, according to the minutes.
Other technical changes were discussed at the October session, including the precise standards that compounding pharmacists will be required to follow when compounding sterile drugs. Dillard said the intent was to make it easier to keep the Tennessee standards in line with any changes in national norms.
As the state efforts to tighten regulations have inched along, Dillard acknowledged that a new federal law affecting compounding pharmacies has passed Congress and been sent to President Barack Obama, who is expected to sign it.
Under that law, Dillard said, compounders producing drugs in bulk can register with the U.S. Food and Drug Administration and become subject to federal scrutiny.
“It does kind of take the oversight from the state boards,” he said. “I hope they give the FDA the manpower to do it.”
He said it was too soon to determine whether the federal legislation would require changes in state laws or regulations.
As for the new state rules, Dillard said the revised package is undergoing a final review by the attorney general.
Baeteena Black, executive director of the Tennessee Pharmacists Association, said that while the exact form of the new rules won’t be known until the final legal review is completed, the association is generally in support of the board’s efforts.
http://www.tennessean.com/article/20131125/NEWS07/311250026?nclick_check=1
It was in June that the Tennessee Pharmacy Board voted to adopt emergency rules to make possible the quick shutdown of compounding pharmacies deemed to be a threat to public health and safety.
The action came as Tennessee found itself in the midst of a nationwide fungal meningitis outbreak caused by a Massachusetts compounding firm that shipped fungus-tainted steroids to health-care providers across the country. Only Michigan had more victims.
Sixteen deaths have been recorded among patients treated in Tennessee, while 154 were sickened from the methylprednisolone acetate shipped from the now-defunct New England Compounding Center.
In what he termed a major change, Reginald Dillard, executive director of the pharmacy board, said the board has been forced to remove provisions to issue an immediate cease-and-desist order to a compounder believed to be endangering the public health.
A companion measure giving the state health commissioner authority to issue such an order also has been eliminated.
Dillard said those provisions were stripped from the new rules after a review by the state attorney general concluded the cease-and-desist provisions would violate the state Administrative Procedures Act.
“The statutes do not allow us to do it,” Dillard said of the immediate cease-and-desist rules.
He said the licenses issued to pharmacists are considered a property right and can’t be revoked without due process, which would require prior formal notice and a hearing.
He said the attorney general also concluded that under current law the board cannot delegate its authority to revoke a license to the health commissioner.
Meeting minutes show pharmacy board members learned of the attorney general’s decision at their October meeting.
A board attorney, Stefan Cange, told members that not only would there have to be a hearing before a license suspension, but also the pharmacy board would bear the burden of proving that a suspension was justified.
Cange also told the board that while the health commissioner could recommend the suspension of a compounding pharmacy license, he could not implement a suspension on his own. “The commissioner has been removed from that process,” Cange said, according to the minutes.
Other technical changes were discussed at the October session, including the precise standards that compounding pharmacists will be required to follow when compounding sterile drugs. Dillard said the intent was to make it easier to keep the Tennessee standards in line with any changes in national norms.
As the state efforts to tighten regulations have inched along, Dillard acknowledged that a new federal law affecting compounding pharmacies has passed Congress and been sent to President Barack Obama, who is expected to sign it.
Under that law, Dillard said, compounders producing drugs in bulk can register with the U.S. Food and Drug Administration and become subject to federal scrutiny.
“It does kind of take the oversight from the state boards,” he said. “I hope they give the FDA the manpower to do it.”
He said it was too soon to determine whether the federal legislation would require changes in state laws or regulations.
As for the new state rules, Dillard said the revised package is undergoing a final review by the attorney general.
Baeteena Black, executive director of the Tennessee Pharmacists Association, said that while the exact form of the new rules won’t be known until the final legal review is completed, the association is generally in support of the board’s efforts.
http://www.tennessean.com/article/20131125/NEWS07/311250026?nclick_check=1
Victims in meningitis outbreak hope for criminal charges against compounding pharmacy
BOSTON -- Dirk Thompson III doesn't hold out much hope that he and the 750 other victims in a nationwide meningitis outbreak will ever see much, if any, compensation for the deaths and illnesses caused by tainted steroids.
He hopes to find justice another way if criminal charges are brought against the principals of a Massachusetts compounding pharmacy that made the steroid injections blamed for the fungal meningitis outbreak.
A federal grand jury in Boston has been investigating the New England Compounding Center for more than a year. A separate grand jury in Minnesota also has been conducting an investigation.
"They have to be prosecuted to the fullest extent of the law," said Thompson, 58, of Howell, Mich., who was hospitalized for 38 days with meningitis after receiving a steroid injection for back pain. "They were totally irresponsible."
Since the contaminated steroids were first discovered, 751 people in 20 states have developed fungal meningitis or other infections, including 64 who died. Michigan, Tennessee and Indiana were the hardest-hit states.
Federal prosecutors have declined to comment on the investigation, but the FBI recently asked anyone who received one of the tainted injections to fill out a questionnaire detailing their illnesses and saying whether they believe another medication distributed by NECC caused harm to them or their family.
Michigan Attorney General Bill Schuette said in a statement on Sunday that he and Boston U.S. Attorney Carmen Ortiz will hold a news conference Monday to discuss a development in the independent state and federal investigations into NECC.
The FBI, which has also sent agents to visit victims, set a Nov. 30 deadline for victims to submit the surveys online or to mail them to its health care fraud squad in Boston.
It is unclear whether the company or its executives will face criminal charges. Several lawyers who represent victims in lawsuits say health care companies charged with selling contaminated drugs often reach settlements with the federal government and agree to pay large fines. But the New England Compounding case is different because of the large number of deaths and serious illnesses caused by the tainted steroids.
"If there's enough evidence to show that these companies were operating and that the executives were operating in a way that was going to harm and hurt and eventually cause death, then we would presume that there would be some action, other than just a fine," said Boston attorney Kim Dougherty, whose firm represents more than 100 people who became ill or died in the outbreak.
Inspectors found a host of potential contaminants at the company's Framingham plant, including standing water, mold, water droplets and dirty equipment. Fungus was found in more than 50 vials from the pharmacy.
Regulators have also said the company did not perform enough tests before sending the drugs to hospitals and clinics and sent drugs in bulk quantities instead of prescriptions for individual patients.
The company gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits from victims. A bankruptcy court judge has set a Jan. 15 deadline for victims to file claims.
"I hope that the people involved are held accountable and that they are prosecuted to the full extent of the law," said George Cary, whose wife, Lilian, 67, developed fungal meningitis and died about a month later.
Cary, of Howell, Mich., received steroid shots at the same pain management clinic as his wife. He became ill with meningitis several weeks later and was hospitalized for three months.
"I think the victims all feel ... that none of the laws or regulations seem to have applied to (the people involved), and they've continued on with their lives while the victims have suffered immensely, deaths have occurred, people's whole families have been dramatically changed," Cary said. "This has really been a national disaster."
Attorneys for the company's principals, through a spokesman, declined to comment.
Christina DiIorio-Sterling, a spokesman for U.S. Attorney Carmen Ortiz, would say only that the investigation is continuing.
http://www.nbcnews.com/health/victims-meningitis-outbreak-hope-criminal-charges-against-compounding-pharmacy-2D11653410
He hopes to find justice another way if criminal charges are brought against the principals of a Massachusetts compounding pharmacy that made the steroid injections blamed for the fungal meningitis outbreak.
A federal grand jury in Boston has been investigating the New England Compounding Center for more than a year. A separate grand jury in Minnesota also has been conducting an investigation.
"They have to be prosecuted to the fullest extent of the law," said Thompson, 58, of Howell, Mich., who was hospitalized for 38 days with meningitis after receiving a steroid injection for back pain. "They were totally irresponsible."
Since the contaminated steroids were first discovered, 751 people in 20 states have developed fungal meningitis or other infections, including 64 who died. Michigan, Tennessee and Indiana were the hardest-hit states.
Federal prosecutors have declined to comment on the investigation, but the FBI recently asked anyone who received one of the tainted injections to fill out a questionnaire detailing their illnesses and saying whether they believe another medication distributed by NECC caused harm to them or their family.
Michigan Attorney General Bill Schuette said in a statement on Sunday that he and Boston U.S. Attorney Carmen Ortiz will hold a news conference Monday to discuss a development in the independent state and federal investigations into NECC.
The FBI, which has also sent agents to visit victims, set a Nov. 30 deadline for victims to submit the surveys online or to mail them to its health care fraud squad in Boston.
It is unclear whether the company or its executives will face criminal charges. Several lawyers who represent victims in lawsuits say health care companies charged with selling contaminated drugs often reach settlements with the federal government and agree to pay large fines. But the New England Compounding case is different because of the large number of deaths and serious illnesses caused by the tainted steroids.
"If there's enough evidence to show that these companies were operating and that the executives were operating in a way that was going to harm and hurt and eventually cause death, then we would presume that there would be some action, other than just a fine," said Boston attorney Kim Dougherty, whose firm represents more than 100 people who became ill or died in the outbreak.
Inspectors found a host of potential contaminants at the company's Framingham plant, including standing water, mold, water droplets and dirty equipment. Fungus was found in more than 50 vials from the pharmacy.
Regulators have also said the company did not perform enough tests before sending the drugs to hospitals and clinics and sent drugs in bulk quantities instead of prescriptions for individual patients.
The company gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits from victims. A bankruptcy court judge has set a Jan. 15 deadline for victims to file claims.
"I hope that the people involved are held accountable and that they are prosecuted to the full extent of the law," said George Cary, whose wife, Lilian, 67, developed fungal meningitis and died about a month later.
Cary, of Howell, Mich., received steroid shots at the same pain management clinic as his wife. He became ill with meningitis several weeks later and was hospitalized for three months.
"I think the victims all feel ... that none of the laws or regulations seem to have applied to (the people involved), and they've continued on with their lives while the victims have suffered immensely, deaths have occurred, people's whole families have been dramatically changed," Cary said. "This has really been a national disaster."
Attorneys for the company's principals, through a spokesman, declined to comment.
Christina DiIorio-Sterling, a spokesman for U.S. Attorney Carmen Ortiz, would say only that the investigation is continuing.
http://www.nbcnews.com/health/victims-meningitis-outbreak-hope-criminal-charges-against-compounding-pharmacy-2D11653410
Today's Shortages
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ASHP/FDA
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Amifostine Injection
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Amino Acid Products
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Ampicillin Sulbactam
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aspirin Tablets (Buffered)
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Cefpodoxime
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Ciprofloxacin Immediate-Release
Tablets
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Clindamycin Injection
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Estradiol Tablets
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Fluorouracil Injection
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Monday, November 25, 2013
A New Development in Compounding Pharmacy Case
Boston's U.S. attorney today will announce what authorities say is a new development in the probes into Framingham's New England Compounding Center linked to last year's fungal meningitis outbreak. The firm's steroid drugs have been linked to 751 meningitis and other infections across the country.
Surviving victims of last year's meningitis outbreak are waiting to see whether authorities announce criminal charges for anyone involved with New England Compounding Center. The FBI recently asked people who got one of the tainted shots from the center to fill out a questionnaire about the injections and their illnesses.
Surviving victims of last year's meningitis outbreak are waiting to see whether authorities announce criminal charges for anyone involved with New England Compounding Center. The FBI recently asked people who got one of the tainted shots from the center to fill out a questionnaire about the injections and their illnesses.
Pakistan: Shortage of cancer drugs flayed
SHORTAGE of basic cancer drugs in Pakistan for an extended period of time has taken toll on the poor patients which must be tackled urgently by the authorities concerned.
According to a press release on Sunday, Mian Aftab, president of an NGO working in health sector, said that the government permitted seven different companies for importing Cyclophosmamide and Doxorubaicin but these companies had stopped imports for various reasons, creating an acute shortage of the medicine in the country. He said that the hoarders and smugglers had found situation favourable, resulting in availability of medicine of questionable quality at some places in different trade names on unreasonably high rates which is out of the reach of majority of patients. He alleged the role of Drug Regulatory Authority of Pakistan (DRAP) was not laudable as they have not been taking action, paving the way for artificial shortage. Many private and public sector hospitals in the country were facing problems due to the shortage but nothing had been done to improve the situation. He said the government’s lethargy had been helping no one except greed-driven businessmen, therefore it should tackle the issue urgently.
http://www.thenews.com.pk/Todays-News-5-216141-Shortage-of-cancer-drugs-flayed
According to a press release on Sunday, Mian Aftab, president of an NGO working in health sector, said that the government permitted seven different companies for importing Cyclophosmamide and Doxorubaicin but these companies had stopped imports for various reasons, creating an acute shortage of the medicine in the country. He said that the hoarders and smugglers had found situation favourable, resulting in availability of medicine of questionable quality at some places in different trade names on unreasonably high rates which is out of the reach of majority of patients. He alleged the role of Drug Regulatory Authority of Pakistan (DRAP) was not laudable as they have not been taking action, paving the way for artificial shortage. Many private and public sector hospitals in the country were facing problems due to the shortage but nothing had been done to improve the situation. He said the government’s lethargy had been helping no one except greed-driven businessmen, therefore it should tackle the issue urgently.
http://www.thenews.com.pk/Todays-News-5-216141-Shortage-of-cancer-drugs-flayed
Today's Shortages
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ASHP/FDA
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Amifostine Injection
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Amino Acid Products
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Ampicillin Sulbactam
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aspirin Tablets (Buffered)
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Cefpodoxime
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Ciprofloxacin Immediate-Release
Tablets
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Clindamycin Injection
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Estradiol Tablets
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Fluorouracil Injection
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Friday, November 22, 2013
Today's Shortages
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ASHP/FDA
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Amifostine Injection
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Amino Acid Products
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Ampicillin Sulbactam
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aspirin Tablets (Buffered)
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Cefpodoxime
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Ciprofloxacin Immediate-Release
Tablets
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Clindamycin Injection
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Estradiol Tablets
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Fluorouracil Injection
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Thursday, November 21, 2013
Canada: New protocol and toolkit for managing drug shortages hinge on voluntary reporting by manufacturers
Health Canada recently announced the release of the Protocol for the Notification and Communication of Drug Shortages (PDF) (the "National Protocol") and the Multi-Stakeholder Toolkit(PDF) (the "Toolkit") developed by the Multi-Stakeholder Steering Committee on Drug Shortages.[1] The National Protocol and Toolkit were published amid increasing concern over the ongoing issue of drug shortages in Canada.
Both documents are available on the Drug Shortages website, which was launched and is maintained by Canada's Research-Based Pharmaceutical Companies (Rx&D), the Canadian Generic Pharmaceutical Association (CGPA), and the Canadian Pharmacists Association.
The National Protocol
Drug shortages occur when a manufacturer/importer anticipates that they cannot, or in fact cannot, supply a drug to meet projected demand. Shortages may be due to a number of possible causes, including surges in market demand, difficulties obtaining raw supplies, equipment malfunctions, plant shutdowns ordered by regulators, transport delays, or natural disasters.
The National Protocol establishes a "Tiered Notification and Communication Framework", which is a flexible case-by-case approach to reporting drug shortages and disseminating relevant information based on whether the shortage is anticipated (Tier 1), actual (Tier 2), or actual with the potential for significant impact on patient care (Tier 3). The document sets out clear expectations for when and how stakeholders across the drug supply chain (e.g., manufacturers, group purchasing organizations, wholesalers, distributors, healthcare professionals and regional/local health authorities) are expected to share information about shortages of human pharmaceutical and biological drugs (including vaccines) authorized for sale and marketed in Canada. This coordinated involvement of multiple stakeholders is intended to provide the healthcare system with an opportunity to react quickly to shortages and safeguard the health and safety of patients.
The National Protocol also establishes notification and communication expectations with respect to drug discontinuances. In particular, manufacturers are expected to provide six months advance notification of a drug's discontinuance on the Drug Shortages website.
Note that the National Protocol does not address distribution channel disruptions which may occur at the local, regional, or provincial/territorial levels that are unrelated to manufacturing issues, such that these types of supply chain disruptions may not be posted on the Drug Shortages website.
The Toolkit
Along with the National Protocol, the Toolkit aims to mitigate the impact of drug shortages in Canada by providing an overview of the Canadian drug supply chain, clarifying the roles and responsibilities of various stakeholders, and identifying steps that can be taken to prevent and reduce the impact of drug shortages.
The Toolkit sets out the most common reasons for shortages at each step in the supply chain (e.g., drug approvals, manufacturing, procurement and distribution, and front-line delivery) and suggests tools to avoid or manage the impact of shortages at that step. At the manufacturing stage, for example, suggestions include:
The National Protocol sets out a Tiered Notification and Communication Framework which defines the roles of stakeholders in the drug supply chain. The Toolkit canvases the causes of drug shortages at each level of the supply chain and provides recommendations to various stakeholders as how to prevent or manage drug shortages. Although the National Protocol adopts an industry approach through the inclusion of stakeholders throughout the supply chain, its success hinges on the timely and accurate disclosure of anticipated or actual shortages by manufacturers.
The recent focus on the drug shortage issue in Canada follows increased attention on this issue in the United States, where mandatory drug shortage reporting obligations for manufacturers were broadened significantly with the passing of the Food and Drug Administration Safety and Innovation Act (FDASIA) last year.[2]
The tools and processes set out in the National Protocol and Toolkit are not legally binding; rather, they are guidelines intended to mitigate negative patient outcomes by facilitating the effective communication of pertinent information throughout the drug supply chain in the event of anticipated or actual drug shortages.
http://www.lexology.com/library/detail.aspx?g=d8fbe860-313c-4636-b8e5-55882fec80e7
Both documents are available on the Drug Shortages website, which was launched and is maintained by Canada's Research-Based Pharmaceutical Companies (Rx&D), the Canadian Generic Pharmaceutical Association (CGPA), and the Canadian Pharmacists Association.
The National Protocol
Drug shortages occur when a manufacturer/importer anticipates that they cannot, or in fact cannot, supply a drug to meet projected demand. Shortages may be due to a number of possible causes, including surges in market demand, difficulties obtaining raw supplies, equipment malfunctions, plant shutdowns ordered by regulators, transport delays, or natural disasters.
The National Protocol establishes a "Tiered Notification and Communication Framework", which is a flexible case-by-case approach to reporting drug shortages and disseminating relevant information based on whether the shortage is anticipated (Tier 1), actual (Tier 2), or actual with the potential for significant impact on patient care (Tier 3). The document sets out clear expectations for when and how stakeholders across the drug supply chain (e.g., manufacturers, group purchasing organizations, wholesalers, distributors, healthcare professionals and regional/local health authorities) are expected to share information about shortages of human pharmaceutical and biological drugs (including vaccines) authorized for sale and marketed in Canada. This coordinated involvement of multiple stakeholders is intended to provide the healthcare system with an opportunity to react quickly to shortages and safeguard the health and safety of patients.
The National Protocol also establishes notification and communication expectations with respect to drug discontinuances. In particular, manufacturers are expected to provide six months advance notification of a drug's discontinuance on the Drug Shortages website.
Note that the National Protocol does not address distribution channel disruptions which may occur at the local, regional, or provincial/territorial levels that are unrelated to manufacturing issues, such that these types of supply chain disruptions may not be posted on the Drug Shortages website.
The Toolkit
Along with the National Protocol, the Toolkit aims to mitigate the impact of drug shortages in Canada by providing an overview of the Canadian drug supply chain, clarifying the roles and responsibilities of various stakeholders, and identifying steps that can be taken to prevent and reduce the impact of drug shortages.
The Toolkit sets out the most common reasons for shortages at each step in the supply chain (e.g., drug approvals, manufacturing, procurement and distribution, and front-line delivery) and suggests tools to avoid or manage the impact of shortages at that step. At the manufacturing stage, for example, suggestions include:
- identification and utilization of alternate sources of raw material supply;
- increased use of back-up manufacturing sites, packing and packaging components;
- maintenance of a reserve stock of products with a higher risk of shortage;
- increased coordination between sales and operation departments to better forecast sales and product volumes; and
- requiring that all manufacturing partners (e.g., vendors, distributors) have a Business Continuity Plan.
The National Protocol sets out a Tiered Notification and Communication Framework which defines the roles of stakeholders in the drug supply chain. The Toolkit canvases the causes of drug shortages at each level of the supply chain and provides recommendations to various stakeholders as how to prevent or manage drug shortages. Although the National Protocol adopts an industry approach through the inclusion of stakeholders throughout the supply chain, its success hinges on the timely and accurate disclosure of anticipated or actual shortages by manufacturers.
The recent focus on the drug shortage issue in Canada follows increased attention on this issue in the United States, where mandatory drug shortage reporting obligations for manufacturers were broadened significantly with the passing of the Food and Drug Administration Safety and Innovation Act (FDASIA) last year.[2]
The tools and processes set out in the National Protocol and Toolkit are not legally binding; rather, they are guidelines intended to mitigate negative patient outcomes by facilitating the effective communication of pertinent information throughout the drug supply chain in the event of anticipated or actual drug shortages.
http://www.lexology.com/library/detail.aspx?g=d8fbe860-313c-4636-b8e5-55882fec80e7
Zambia: Govt blames clinicians for drug shortages
HEALTH Minister Joseph Kasonde has blamed some clinicians for perceived drug shortages because they prescribe drugs without checking if they are available.
Dr Kasonde, however, said the introduction of new treatment guidelines would bring order and harmonise the dispensing of drugs.
He said the new guidelines, which were disease-oriented, reflected the consensus on the first choice for a range of medical conditions, and that they would guide clinicians and other health personnel on the rational use of medicines.
Dr Kasonde was speaking when he officiated at the launch of the revised standard treatment guidelines, Zambia formulary, Zambia essential medicines list and guidelines for medicines and therapeutic committee at Chilenje Health Centre in Lusaka yesterday.
”The first choice of each treatment for health problems is the basis for these documents we are launching today,” he said.
He said essential medicines were drugs that satisfied the health care needs of the majority of the population, adding that the rationale for selecting a limited number of essential medicines was to enhance supply, rational use and lower costs.
“This manual was developed from the essential medicines list. It includes medical information and other services that support good medicine management and the rational use of these v ital supplies,” Dr Kasonde.
He challenged health workers to utilise the manual, adding that this would result in increased monitoring and supervision of the functions of such medicines.
The Ministry of Health regularly updates medical guidelines to ensure that they remained relevant to health workers and the new trends of treating diseases.
Specialty pharmacies fill execution drug shortage, raising concerns
Death penalty states, suddenly faced with a shortage of drugs for executions, are increasingly turning to loosely regulated compounding pharmacies for the lethal dose — raising concerns about safety and secrecy.
Compounding pharmacies, which mix drugs under custom orders, drew national attention last year, after a meningitis outbreak killed 64 people and was traced to steroid injections brewed at a compounding pharmacy in Massachusetts.
The Food and Drug Administration does not regulate compounding pharmacies, although a bill awaiting President Barack Obama’s signature would give the FDA limited power to inspect and close the largest of them.
States are using compounding pharmacies to mix lethal injections because some major drug companies in recent years have stopped making drugs for executions or ordered that they not be used to put inmates to death.
On Wednesday, the state of Missouri used the product of a compounding pharmacy to execute a man convicted in a cross-country killing spree in the late 1970s. The convict, a white supremacist named Joseph Paul Franklin, is also the man who shot Larry Flynt in 1978, leaving him partly paralyzed.
The state put Franklin to death with an injection of pentobarbital, a barbiturate that it ordered from a compounding pharmacy. He stopped breathing three minutes after the injection and was declared dead seven minutes after that, according to witnesses.
For years, Missouri used a sequence of three drugs to execute inmates. In April 2012, as more drugmakers stopped selling them to prisons and corrections departments, the state switched to a single drug, the anesthetic propofol.
Then came an outcry from Europe, where most propofol is made. The European Union, strongly opposed to the death penalty, threatened to limit exports of the drug — which would have caused complications for countless hospitals.
Missouri Gov. Jay Nixon ordered a switch to pentobarbital. The state also designated the compounding pharmacy mixing it as a member of its official execution team, which under state law allows its identity to be kept secret.
A federal judge, Nanette Laughrey, granted Franklin a stay of execution on Tuesday and pointed out that the state had issued three different execution protocols in three months, one as recently as five days earlier.
“Franklin has been given no time to research the risk of pain associated with the department’s new protocol, the quality of the pentobarbital provided, and the record of the source of the pentobarbital,” she wrote.
A federal appeals court and the Supreme Court ruled against Franklin, however. He was put to death Wednesday minutes after the Supreme Court decision. The governor’s office did not return a request for comment.
'We don’t know quite what they’re getting'
Compounding pharmacies are at the center of a raft of recent legal challenges aimed at forestalling executions. Death penalty opponents say that the pharmacies cannot be trusted to produce safe drugs and that executions could be unusually cruel as a result.
“We don’t know quite what they’re getting,” said Deborah W. Denno, a professor at Fordham University law school who has written extensively about the death penalty. “It’s not being tested or approved in the way that it typically would be.”
Compounding pharmacies have to get a state license, and there is a national accrediting board, but accreditation is not required. The board’s executive director, Joe Cabaleiro, told NBC News that the board has no position on the use of compounded drugs for executions.
At least seven states have obtained or made plans to obtain execution drugs from compounding pharmacies, according to the Death Penalty Information Center, which opposes the death penalty.
That list includes Texas, which executes more inmates than any other state, and which turned to a compounding pharmacy last month to get its lethal drugs, according to documents obtained by The Associated Press under the Freedom of Information Act.
In Ohio, lawyers for a condemned child killer and rapist argued that he should not be put to death because the state planned to secure pentobarbital from a compounding pharmacy.
Because the compounding pharmacy supplying the state was mostly unregulated, and because the pentobarbital would be untested, the compounder — knowing he was mixing a deadly drug for a brutal killer — might be tempted to tamper, they wrote.
The lawyers wrote that the killer, Ronald Phillips, had a justified and extreme fear “that he will be chemically tortured if and when he is injected with compounded execution drugs.”
Days before Phillips was to die, the state abandoned the plan to use pentobarbital and said it would use an untested combination of the sedative midazolam and the painkiller hydromorphone.
Gov. John Kasich delayed the execution until July, but not for that reason. He said it was to give the state time to study Phillips’ last-minute request to donate his organs.
Denno said she was unaware of any “botched” lethal injections using drugs from compounding pharmacies. But just because an execution looks normal doesn’t mean something hasn’t gone wrong, such as inmates not getting enough sedative, she said.
The courts have struck back in some cases, she said. In Colorado and Georgia, judges have held this year that the state cannot withhold certain information about how it conducts lethal injection.
Denno said that executions are far from the basic purposes of compounding pharmacies, like mixing a special version of a prescription because a patient is allergic to a particular chemical.
“If I get a face cream and a compounding pharmacy leaves out an ingredient, maybe I can get a rash,” she said. “When we’re talking about somebody being executed, not sedated properly, the drug is creating more pain for them.”
http://usnews.nbcnews.com/_news/2013/11/20/21550920-specialty-pharmacies-fill-execution-drug-shortage-raising-concerns?lite
Compounding pharmacies, which mix drugs under custom orders, drew national attention last year, after a meningitis outbreak killed 64 people and was traced to steroid injections brewed at a compounding pharmacy in Massachusetts.
The Food and Drug Administration does not regulate compounding pharmacies, although a bill awaiting President Barack Obama’s signature would give the FDA limited power to inspect and close the largest of them.
States are using compounding pharmacies to mix lethal injections because some major drug companies in recent years have stopped making drugs for executions or ordered that they not be used to put inmates to death.
On Wednesday, the state of Missouri used the product of a compounding pharmacy to execute a man convicted in a cross-country killing spree in the late 1970s. The convict, a white supremacist named Joseph Paul Franklin, is also the man who shot Larry Flynt in 1978, leaving him partly paralyzed.
The state put Franklin to death with an injection of pentobarbital, a barbiturate that it ordered from a compounding pharmacy. He stopped breathing three minutes after the injection and was declared dead seven minutes after that, according to witnesses.
For years, Missouri used a sequence of three drugs to execute inmates. In April 2012, as more drugmakers stopped selling them to prisons and corrections departments, the state switched to a single drug, the anesthetic propofol.
Then came an outcry from Europe, where most propofol is made. The European Union, strongly opposed to the death penalty, threatened to limit exports of the drug — which would have caused complications for countless hospitals.
Missouri Gov. Jay Nixon ordered a switch to pentobarbital. The state also designated the compounding pharmacy mixing it as a member of its official execution team, which under state law allows its identity to be kept secret.
A federal judge, Nanette Laughrey, granted Franklin a stay of execution on Tuesday and pointed out that the state had issued three different execution protocols in three months, one as recently as five days earlier.
“Franklin has been given no time to research the risk of pain associated with the department’s new protocol, the quality of the pentobarbital provided, and the record of the source of the pentobarbital,” she wrote.
A federal appeals court and the Supreme Court ruled against Franklin, however. He was put to death Wednesday minutes after the Supreme Court decision. The governor’s office did not return a request for comment.
'We don’t know quite what they’re getting'
Compounding pharmacies are at the center of a raft of recent legal challenges aimed at forestalling executions. Death penalty opponents say that the pharmacies cannot be trusted to produce safe drugs and that executions could be unusually cruel as a result.
“We don’t know quite what they’re getting,” said Deborah W. Denno, a professor at Fordham University law school who has written extensively about the death penalty. “It’s not being tested or approved in the way that it typically would be.”
Compounding pharmacies have to get a state license, and there is a national accrediting board, but accreditation is not required. The board’s executive director, Joe Cabaleiro, told NBC News that the board has no position on the use of compounded drugs for executions.
At least seven states have obtained or made plans to obtain execution drugs from compounding pharmacies, according to the Death Penalty Information Center, which opposes the death penalty.
That list includes Texas, which executes more inmates than any other state, and which turned to a compounding pharmacy last month to get its lethal drugs, according to documents obtained by The Associated Press under the Freedom of Information Act.
In Ohio, lawyers for a condemned child killer and rapist argued that he should not be put to death because the state planned to secure pentobarbital from a compounding pharmacy.
Because the compounding pharmacy supplying the state was mostly unregulated, and because the pentobarbital would be untested, the compounder — knowing he was mixing a deadly drug for a brutal killer — might be tempted to tamper, they wrote.
The lawyers wrote that the killer, Ronald Phillips, had a justified and extreme fear “that he will be chemically tortured if and when he is injected with compounded execution drugs.”
Days before Phillips was to die, the state abandoned the plan to use pentobarbital and said it would use an untested combination of the sedative midazolam and the painkiller hydromorphone.
Gov. John Kasich delayed the execution until July, but not for that reason. He said it was to give the state time to study Phillips’ last-minute request to donate his organs.
Denno said she was unaware of any “botched” lethal injections using drugs from compounding pharmacies. But just because an execution looks normal doesn’t mean something hasn’t gone wrong, such as inmates not getting enough sedative, she said.
The courts have struck back in some cases, she said. In Colorado and Georgia, judges have held this year that the state cannot withhold certain information about how it conducts lethal injection.
Denno said that executions are far from the basic purposes of compounding pharmacies, like mixing a special version of a prescription because a patient is allergic to a particular chemical.
“If I get a face cream and a compounding pharmacy leaves out an ingredient, maybe I can get a rash,” she said. “When we’re talking about somebody being executed, not sedated properly, the drug is creating more pain for them.”
http://usnews.nbcnews.com/_news/2013/11/20/21550920-specialty-pharmacies-fill-execution-drug-shortage-raising-concerns?lite
Today's Shortages
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Atropine Sulfate Injection
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Dextrose (50%) Injection
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Lidocaine Injection
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Ondansetron Injection
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Sincalide Injection
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Wednesday, November 20, 2013
Canada: NDP calls for mandatory disclosure of drug shortages
Drug shortages have become a major problem in Canada – and costly headache for provinces – but an NDP MP is proposing a bill that will address this problem.
“This legislation can provide health professionals with the crucial notification they need to plan treatment for their patients during drug shortages,” said NDP MP Djaouida Sellah (Saint-Bruno—Saint-Hubert).
“We cannot afford to stop a given medication overnight because of an unexpected drug shortage. Whether it’s medication for epilepsy, cancer treatment, or pain management, health professionals need time to plan a safe transition.”
Many health experts support the NDP’s initiative, including the College of Physicians – who have been recommending the government require drug companies to inform Health Canada of drug shortages and, according to the College, “are heartened to see our recommendations to the federal government reflected in Bill C-523.”
“Too often the health and treatment of Canadians is jeopardized by sudden unforeseen drug shortages,” said Sellah. “Sadly, the federal government has been unwilling to require mandatory disclosure from industry. My bill will address this gap.”
http://www.northumberlandview.ca/index.php?module=news&type=user&func=display&sid=25440#.UozBEVko4eE
“This legislation can provide health professionals with the crucial notification they need to plan treatment for their patients during drug shortages,” said NDP MP Djaouida Sellah (Saint-Bruno—Saint-Hubert).
“We cannot afford to stop a given medication overnight because of an unexpected drug shortage. Whether it’s medication for epilepsy, cancer treatment, or pain management, health professionals need time to plan a safe transition.”
Many health experts support the NDP’s initiative, including the College of Physicians – who have been recommending the government require drug companies to inform Health Canada of drug shortages and, according to the College, “are heartened to see our recommendations to the federal government reflected in Bill C-523.”
“Too often the health and treatment of Canadians is jeopardized by sudden unforeseen drug shortages,” said Sellah. “Sadly, the federal government has been unwilling to require mandatory disclosure from industry. My bill will address this gap.”
http://www.northumberlandview.ca/index.php?module=news&type=user&func=display&sid=25440#.UozBEVko4eE
Drug compounding firm PharMEDium in $1 bln sale talks -sources
Nov 19 (Reuters) - PharMEDium Services LLC, a venture capital-backed provider of pharmacy compounding services to hospitals, is in discussions to sell itself for close to $1 billion, according to people familiar with the matter.
The Lake Forest, Illinois-based company is working with JPMorgan Chase & Co and is in talks with a small group of potential private equity buyers, including TPG Capital LP, about a possible deal, two of the people said on Tuesday.
The people asked not to be identified because the negotiations are private. Representatives of PharMEDium, JPMorgan and TPG did not immediately respond to requests for comment.
PharMEDium operates centers in four U.S. states where it compounds finished medicines from drug manufacturers and then dispatches them to thousands of hospitals across the country.
Traditionally, pharmacists who compound medications mix tailored doses for individual patients in response to a specific prescription.
The practice has mushroomed over the last decade, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
On Monday, the U.S. Senate approved a bill designed to prevent quality control issues that led last year to a deadly outbreak of fungal meningitis traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy.
PharMEDium was not associated with the scare and issued a statement on Monday welcoming passage of legislation.
A sale of PharMEDium would come more than six years after venture capital firm Oak Investment Partners bought a stake in the company from the private equity and venture capital arms of Robert W. Baird & Co, which together with PharMEDium founder and chief executive David Jonas retained equity stakes.
The $200 million recapitalization of the company in 2007 also involved $73.5 million in credit facilities by Allied Capital Corp, which has since been acquired by Ares Capital Corp .
PharMEDium was created in its current form in 2003 through the merger of newly formed PharMEDium Healthcare Corp with Baxter International Inc's Compass Services unit.
http://www.reuters.com/article/2013/11/19/pharmedium-sale-idUSL5N0J34GX20131119
The Lake Forest, Illinois-based company is working with JPMorgan Chase & Co and is in talks with a small group of potential private equity buyers, including TPG Capital LP, about a possible deal, two of the people said on Tuesday.
The people asked not to be identified because the negotiations are private. Representatives of PharMEDium, JPMorgan and TPG did not immediately respond to requests for comment.
PharMEDium operates centers in four U.S. states where it compounds finished medicines from drug manufacturers and then dispatches them to thousands of hospitals across the country.
Traditionally, pharmacists who compound medications mix tailored doses for individual patients in response to a specific prescription.
The practice has mushroomed over the last decade, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.
On Monday, the U.S. Senate approved a bill designed to prevent quality control issues that led last year to a deadly outbreak of fungal meningitis traced to a tainted pharmaceutical mixed by a Massachusetts pharmacy.
PharMEDium was not associated with the scare and issued a statement on Monday welcoming passage of legislation.
A sale of PharMEDium would come more than six years after venture capital firm Oak Investment Partners bought a stake in the company from the private equity and venture capital arms of Robert W. Baird & Co, which together with PharMEDium founder and chief executive David Jonas retained equity stakes.
The $200 million recapitalization of the company in 2007 also involved $73.5 million in credit facilities by Allied Capital Corp, which has since been acquired by Ares Capital Corp .
PharMEDium was created in its current form in 2003 through the merger of newly formed PharMEDium Healthcare Corp with Baxter International Inc's Compass Services unit.
http://www.reuters.com/article/2013/11/19/pharmedium-sale-idUSL5N0J34GX20131119
Tuesday, November 19, 2013
Drug shortage looms as Ariz. close to 4 executions
Four more Arizona death row inmates are close to execution dates, but the state may have to scramble to get the drugs it needs to carry out the sentences.
The U.S. Supreme Court recently turned away appeals in the four cases, putting the inmates near the end of the line.
A shortage of the single drug that Arizona uses may force officials with the Department of Corrections to find another drug or source because the sole manufacturer of the drug pentobarbital has blocked sales for executions.
That leaves the Arizona Department of Corrections with few available choices: A compounding pharmacy could mix up a batch of pentobarbital from its base ingredients, the state could buy it outside normal distribution channels, or it could switch to another drug or combinations of drugs, according to Dale Baich, who leads the unit of the federal public defender's office that represents inmates on death row.
Any of the choices could set off another round of legal challenges, based on what other state have seen, Baich said. The source of compounding ingredients and their efficacy could be challenged, for instance.
Corrections
spokesman Doug Nick told the Arizona Capitol Times ( http://bit.ly/1edBVwf) the state will follow the law. Stephanie Grisham, spokeswoman for the attorney general's office, said the state is weighing its options and considering the timing of the executions.
Arizona has seen similar legal challenges about the drugs it uses in its executions.
The state switched to pentobarbital in 2011 after a shortage of sodium thiopental threatened to sideline executions. Two inmates due for execution in October challenged the department's attempt to keep the name of the drug manufacturer secret.
U.S. District Judge Roslyn Silver ordered the department to reveal the drugmaker and provide the expiration date of the drug that would be used.
The batch of pentobarbital that was used to execute Edward Schad and Robert Jones last month expires this month, and additional factory-made pentobarbital likely isn't available because of the manufacturer's sales ban.
The state has yet to ask the Arizona Supreme Court for a warrant of execution for the four inmates whose appeals have been exhausted. The four are Pete Rogovich, Roger Scott, Joe Wood and Kevin Miles.
http://azdailysun.com/news/state-and-regional/drug-shortage-looms-as-ariz-close-to-executions/article_fa565fd8-0edd-53c9-85d8-614d3237de4c.html
The U.S. Supreme Court recently turned away appeals in the four cases, putting the inmates near the end of the line.
A shortage of the single drug that Arizona uses may force officials with the Department of Corrections to find another drug or source because the sole manufacturer of the drug pentobarbital has blocked sales for executions.
That leaves the Arizona Department of Corrections with few available choices: A compounding pharmacy could mix up a batch of pentobarbital from its base ingredients, the state could buy it outside normal distribution channels, or it could switch to another drug or combinations of drugs, according to Dale Baich, who leads the unit of the federal public defender's office that represents inmates on death row.
Any of the choices could set off another round of legal challenges, based on what other state have seen, Baich said. The source of compounding ingredients and their efficacy could be challenged, for instance.
Corrections
spokesman Doug Nick told the Arizona Capitol Times ( http://bit.ly/1edBVwf) the state will follow the law. Stephanie Grisham, spokeswoman for the attorney general's office, said the state is weighing its options and considering the timing of the executions.
Arizona has seen similar legal challenges about the drugs it uses in its executions.
The state switched to pentobarbital in 2011 after a shortage of sodium thiopental threatened to sideline executions. Two inmates due for execution in October challenged the department's attempt to keep the name of the drug manufacturer secret.
U.S. District Judge Roslyn Silver ordered the department to reveal the drugmaker and provide the expiration date of the drug that would be used.
The batch of pentobarbital that was used to execute Edward Schad and Robert Jones last month expires this month, and additional factory-made pentobarbital likely isn't available because of the manufacturer's sales ban.
The state has yet to ask the Arizona Supreme Court for a warrant of execution for the four inmates whose appeals have been exhausted. The four are Pete Rogovich, Roger Scott, Joe Wood and Kevin Miles.
http://azdailysun.com/news/state-and-regional/drug-shortage-looms-as-ariz-close-to-executions/article_fa565fd8-0edd-53c9-85d8-614d3237de4c.html
Senate passes drug-compounding, safety bill
A bill to bolster federal oversight of large-scale compounding pharmacies and establish a national prescription drug track-and-trace system is on the way to President Barack Obama’s desk.
The Senate approved the Drug Quality and Safety Act by voice vote Monday. It passed the House in September.
“Americans must have the confidence that their drugs — whether obtained at a hospital, at a doctor’s office or at the pharmacy counter — are safe, and that is exactly what this bill does,” Sen. Tom Harkin (D-Iowa), said in a statement. Harkin and Sen. Lamar Alexander (R-Tenn.) led the legislative effort in the Senate.
The bill encourages compounding pharmacies like the Massachusetts facility behind last year’s fungal meningitis outbreak to register for FDA regulation. The agency’s stamp of approval, while not mandatory, is expected to carry a significant advantage in the marketplace of hospitals and other providers that want assurances they are buying quality compounded drugs.
The legislation was spurred by a nationwide outbreak of fungal meningitis linked to contaminated steroid injections made by the New England Compounding Center. More than 750 people got sick and 64 died, according to the Centers for Disease Control and Prevention. NECC and a sister facility have been shut down and are now embroiled in lawsuits.
In the wake of the outbreak, state and federal authorities stepped up enforcement action on this niche industry, which produces bulk quantities of sterile injectable drugs and other products. Investigations in the House and Senate found the FDA’s oversight had been inadequate, in part due to conflicting court rulings on the agency’s authority. The bill is designed to address that.
The bill also will require a federal prescription drug track-and-trace system that will allow drugs to be followed from the manufacturer through the distribution system to the pharmacies that dispense them. It’s intended to prevent counterfeit or contaminated drugs from entering the market downstream in the supply chain and to allow faster recall of bad products.
Current “drug pedigree” requirements vary state by state. Rigorous provisions in California law were slated to start taking effect next year, and stakeholders in the pharmaceutical supply chain had put pressure on Congress to pass a law that would pre-empt the patchwork of state requirements.
The track-and-trace system gradually phases in over 10 years, at which point each package of drugs will be electronically traceable throughout the system. Compounding facilities are expected to begin the FDA registration process next year.
Both measures “are going to help ensure that the drugs Americans are taking are high quality and are safe,” said Gabrielle Cosel, manager of drug safety at The Pew Charitable Trusts.
Read more: http://www.politico.com/story/2013/11/senate-passes-drug-compounding-safety-bill-100011.html#ixzz2l6KxKU6d
The Senate approved the Drug Quality and Safety Act by voice vote Monday. It passed the House in September.
Advocates, including public health groups and most industry stakeholders, say it’s a significant step forward for the security of the country’s drug supply. The president is expected to sign the legislation.
“Americans must have the confidence that their drugs — whether obtained at a hospital, at a doctor’s office or at the pharmacy counter — are safe, and that is exactly what this bill does,” Sen. Tom Harkin (D-Iowa), said in a statement. Harkin and Sen. Lamar Alexander (R-Tenn.) led the legislative effort in the Senate.
The bill encourages compounding pharmacies like the Massachusetts facility behind last year’s fungal meningitis outbreak to register for FDA regulation. The agency’s stamp of approval, while not mandatory, is expected to carry a significant advantage in the marketplace of hospitals and other providers that want assurances they are buying quality compounded drugs.
The legislation was spurred by a nationwide outbreak of fungal meningitis linked to contaminated steroid injections made by the New England Compounding Center. More than 750 people got sick and 64 died, according to the Centers for Disease Control and Prevention. NECC and a sister facility have been shut down and are now embroiled in lawsuits.
In the wake of the outbreak, state and federal authorities stepped up enforcement action on this niche industry, which produces bulk quantities of sterile injectable drugs and other products. Investigations in the House and Senate found the FDA’s oversight had been inadequate, in part due to conflicting court rulings on the agency’s authority. The bill is designed to address that.
The bill also will require a federal prescription drug track-and-trace system that will allow drugs to be followed from the manufacturer through the distribution system to the pharmacies that dispense them. It’s intended to prevent counterfeit or contaminated drugs from entering the market downstream in the supply chain and to allow faster recall of bad products.
Current “drug pedigree” requirements vary state by state. Rigorous provisions in California law were slated to start taking effect next year, and stakeholders in the pharmaceutical supply chain had put pressure on Congress to pass a law that would pre-empt the patchwork of state requirements.
The track-and-trace system gradually phases in over 10 years, at which point each package of drugs will be electronically traceable throughout the system. Compounding facilities are expected to begin the FDA registration process next year.
Both measures “are going to help ensure that the drugs Americans are taking are high quality and are safe,” said Gabrielle Cosel, manager of drug safety at The Pew Charitable Trusts.
Read more: http://www.politico.com/story/2013/11/senate-passes-drug-compounding-safety-bill-100011.html#ixzz2l6KxKU6d
Bill on Drug Compounding Clears Congress a Year After a Meningitis Outbreak
A bill that would give the Food and Drug Administration more power to police compounding pharmacies passed its final hurdle in Congress on Monday, in what experts said was an important step to a safer drug supply in the United States.
The bill, which cleared the Senate without opposition, stops short of giving the F.D.A. complete authority over pharmacies that tailor-mix drugs for individual patients, a process known as compounding. But the bill still provides significant new safeguards, which have earned it the support of public health advocates around the country.
The bill, which cleared the Senate without opposition, stops short of giving the F.D.A. complete authority over pharmacies that tailor-mix drugs for individual patients, a process known as compounding. But the bill still provides significant new safeguards, which have earned it the support of public health advocates around the country.
“It has very sharp teeth,” said Sarah Sellers, a drug safety consultant who has tracked the issue for years.
Just over a year ago, tainted injectable drugs from a compounding pharmacy in Massachusetts caused a meningitis outbreak that killed 64 people across the country, according to the Centers for Disease Control and Prevention. The bill, which took shape in the months after the outbreak, was designed to prevent such events.
“This bill will improve oversight of high-risk drug compounding,” said Senator Tom Harkin, Democrat of Iowa, who was one of the authors. President Obama is expected to sign the bill into law.
The practice of compounding has expanded drastically in recent decades, driven partly by the economics of hospitals, which now outsource large parts of their drug mixing. Some pharmacies moved beyond the business of mixing medicines for individual patients to become mini-manufacturers.
But while compounders were subject to state law, the federal authorities had limited power over them. Unlike drug makers, they were not subject to federal requirements that they report problems to the F.D.A. or open their records to federal inspectors.
Those regulatory gaps burst into public view last fall when the New England Compounding Center, a compounding pharmacy outside Boston, shipped tainted steroid medication around the country, sickening 751 people, according to the C.D.C. The F.D.A. said it lacked the authority to properly police such companies, though some analysts argued that the agency had not been aggressive enough with the powers it had.
The bill, the Drug Quality and Security Act, is an effort to clarify that regulatory confusion. It would allow compounders that mass-produce drugs to register with the F.D.A. as “outsourcing facilities.” Under the law, they would be subject to rules on quality control and oversight, not unlike large drug makers.
Companies that did not wish to make the switch would continue producing under a narrower definition of compounding: mixing medicines for individual patients on the basis of a prescription, or making limited quantities ahead of a prescription. Those companies would not be subject to any new federal oversight.
The bill would not force companies to register with the F.D.A. While that might seem like a loophole, many analysts argued that market forces would press most of the larger compounders into registering.
Eighty percent of hospitals outsource some part of their sterile compounding, said Allan Coukell, senior director of drugs and medical devices at the Pew Charitable Trusts. He argued that having the option of buying from a facility with an F.D.A. seal of approval would probably come as a relief for many.
“Hospitals and doctors would have to seriously consider the implications of buying from a facility that does not meet those quality standards,” he said. “This doesn’t necessarily preclude the risky practices we’ve seen in recent years. But it’s a big improvement.”
Another market pressure, said Ms. Sellers, who once worked on the issue of compounding for the F.D.A., is product liability insurance, which manufacturers that are F.D.A.-approved generally carry. The insurance helps when something goes wrong with a drug. Ordinary pharmacies do not have to have such insurance, Ms. Sellers said.
The F.D.A. said the bill was a step forward, but expressed disappointment that it fell short of giving the agency fuller regulatory power. Compounders that did not opt for the stricter standards, for example, would still not be required to open their records to federal inspectors. The F.D.A. has said it has to resort to asking for subpoenas to gain access to compounding facilities’ records, and the agency had sought additional powers to avoid that.
The compounding industry’s trade group, the International Academy of Compounding Pharmacists, strongly opposed the bill in its final form. It said in a statement that if the goal was to avoid another outbreak like the one last fall, “the American public must know that this bill will not accomplish that goal.”
The group said in another statement that the bill “will without question result in patients’ inability to obtain access to needed medications,” and expressed concern that it would grant the F.D.A. “sweeping, unprecedented authority in determining what pharmacies can compound.”
The bill also would set up a system for tracking drugs. The system, which the authors of the bill said would help ensure that counterfeit and stolen drugs stayed out of the drug supply, includes nationwide serial numbers for drugs and an electronic drug-tracing mechanism.
Bill boosting FDA authority over compounding pharmacies heads to Obama
The U.S. Senate voted Monday to strengthen the Food and Drug Administration's authority over compounding pharmacies that produce large volumes of mixed drugs. The president is expected to sign the legislation, which will reach his desk about a year after drugs distributed by one such compounder led to a deadly multistate meningitis outbreak.
Lauded by supporters as a bicameral and bipartisan effort, the bill would allow the FDA to follow a national standard while regulating facilities making adulterated, misbranded or unapproved products as well as establish a list of drugs that may not be compounded for safety reasons.
Earlier versions of the bill would have required large-scale compounders to register with the federal agency rather than make the registration voluntary. But under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose whether to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy.
“Although it is a scaled-back version of earlier legislation, this bill is an important first step in assuring that compounded sterile products are prepared safely,” said Paul Abramowitz, CEO of the American Society of Health-System Pharmacists.
The FDA traditionally has oversight of drug manufacturing. As more large-scale compounders acted like manufacturers, it became unclear which regulatory bodies were expected to regulate them.
The American Hospital Association has said the bill is a “step in the right direction.”
“Counterfeit and contaminated drugs have taken hundreds of American lives and added hundreds of millions of dollars to our nation's healthcare costs,” said Allan Coukell, senior director of drugs and medical devices at the Pew Charitable Trusts. “This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality.”
Traditionally, compounding pharmacies mix and prepare drugs for individual patients, some of whom have allergies or other needs. However, during the past, some pharmacies have morphed into manufacturers that mix and ship batches of drugs across state lines to hundreds of providers.
The New England Compounding Center, a now-closed Framingham, Mass.-based compounder, was one of those pharmacies.
State health officials first identified the fungal meningitis outbreak in September 2012. Since then, 64 people have died and more than 700 people were sickened in 20 states after they received steroid injections mixed by NECC, according to the Centers for Disease Control and Prevention.
NECC eventually recalled all of its products and filed for bankruptcy protection. But that hasn't stopped hundreds of patients and their families from filing lawsuits against NECC and Ameridose, a sister company that has also since closed. In some cases, the patients have also sued the healthcare providers that distributed the injections.
The outbreak triggered changes across the entire healthcare supply chain. Some states such as California recently passed stricter laws regulating pharmacies that ship or dispense sterile drug products within state lines, while some providers such as Vanderbilt University Medical Center in Nashville were prompted by the outbreak to move forward with plans to develop their own centralized sterile compounding facilities.
Not all patient advocacy groups have supported the bill. Public Citizen has said the legislation “preserves the provisions that compounding pharmacies have abused under existing law and lax FDA oversight, and that they have used to produce unproven, unsafe drugs.” The organization argued that the FDA already had the authority it needed to regulate compounders such as the NECC. Some Republican lawmakers have said the same thing.
“Ultimately, the FDA knew NECC was breaking the law but chose to do nothing,” Rep. Tom Murphy (R-Pa.) said during a House Energy and Commerce subcommittee hearing in April.
Some experts say that the Drug Quality and Security Act will reduce legal liability for hospitals, which are expected to shift their purchasing practices to the companies that register with the FDA, said Blair Childs, senior vice president of public affairs for Premier. “They tried to make it more market-based,” he said.
In a Sept. 28 letter to Senate and House leaders, Childs said “strong oversight will still be needed by Congress to ensure that high-risk compound manufacturers are inspected by the Food and Drug Administration. In addition, Congress should ensure that drugs in shortage are allowed to be safely compounded to assist with our patient-care needs.”
Ongoing drug shortages are one reason hospitals have increasingly turned to compounders as an alternative source for drugs in short supply. HHS' inspector general's office this year reported that nearly all of the hospitals it surveyed use compounded sterile drugs and about 75% have purchased some compounded drugs from an external pharmacy.
http://www.modernhealthcare.com/article/20131118/NEWS/311189973/bill-boosting-fda-authority-over-compounding-pharmacies-heads-to?utm_source=frontpage&utm_medium=newsitem309&utm_campaign=carousel-traffic
Lauded by supporters as a bicameral and bipartisan effort, the bill would allow the FDA to follow a national standard while regulating facilities making adulterated, misbranded or unapproved products as well as establish a list of drugs that may not be compounded for safety reasons.
Earlier versions of the bill would have required large-scale compounders to register with the federal agency rather than make the registration voluntary. But under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose whether to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy.
“Although it is a scaled-back version of earlier legislation, this bill is an important first step in assuring that compounded sterile products are prepared safely,” said Paul Abramowitz, CEO of the American Society of Health-System Pharmacists.
The FDA traditionally has oversight of drug manufacturing. As more large-scale compounders acted like manufacturers, it became unclear which regulatory bodies were expected to regulate them.
The American Hospital Association has said the bill is a “step in the right direction.”
“Counterfeit and contaminated drugs have taken hundreds of American lives and added hundreds of millions of dollars to our nation's healthcare costs,” said Allan Coukell, senior director of drugs and medical devices at the Pew Charitable Trusts. “This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality.”
Traditionally, compounding pharmacies mix and prepare drugs for individual patients, some of whom have allergies or other needs. However, during the past, some pharmacies have morphed into manufacturers that mix and ship batches of drugs across state lines to hundreds of providers.
The New England Compounding Center, a now-closed Framingham, Mass.-based compounder, was one of those pharmacies.
State health officials first identified the fungal meningitis outbreak in September 2012. Since then, 64 people have died and more than 700 people were sickened in 20 states after they received steroid injections mixed by NECC, according to the Centers for Disease Control and Prevention.
NECC eventually recalled all of its products and filed for bankruptcy protection. But that hasn't stopped hundreds of patients and their families from filing lawsuits against NECC and Ameridose, a sister company that has also since closed. In some cases, the patients have also sued the healthcare providers that distributed the injections.
The outbreak triggered changes across the entire healthcare supply chain. Some states such as California recently passed stricter laws regulating pharmacies that ship or dispense sterile drug products within state lines, while some providers such as Vanderbilt University Medical Center in Nashville were prompted by the outbreak to move forward with plans to develop their own centralized sterile compounding facilities.
Not all patient advocacy groups have supported the bill. Public Citizen has said the legislation “preserves the provisions that compounding pharmacies have abused under existing law and lax FDA oversight, and that they have used to produce unproven, unsafe drugs.” The organization argued that the FDA already had the authority it needed to regulate compounders such as the NECC. Some Republican lawmakers have said the same thing.
“Ultimately, the FDA knew NECC was breaking the law but chose to do nothing,” Rep. Tom Murphy (R-Pa.) said during a House Energy and Commerce subcommittee hearing in April.
Some experts say that the Drug Quality and Security Act will reduce legal liability for hospitals, which are expected to shift their purchasing practices to the companies that register with the FDA, said Blair Childs, senior vice president of public affairs for Premier. “They tried to make it more market-based,” he said.
In a Sept. 28 letter to Senate and House leaders, Childs said “strong oversight will still be needed by Congress to ensure that high-risk compound manufacturers are inspected by the Food and Drug Administration. In addition, Congress should ensure that drugs in shortage are allowed to be safely compounded to assist with our patient-care needs.”
Ongoing drug shortages are one reason hospitals have increasingly turned to compounders as an alternative source for drugs in short supply. HHS' inspector general's office this year reported that nearly all of the hospitals it surveyed use compounded sterile drugs and about 75% have purchased some compounded drugs from an external pharmacy.
http://www.modernhealthcare.com/article/20131118/NEWS/311189973/bill-boosting-fda-authority-over-compounding-pharmacies-heads-to?utm_source=frontpage&utm_medium=newsitem309&utm_campaign=carousel-traffic
Drug Mixers Opened To FDA
WASHINGTON—A bill to regulate so-called compounding pharmacies is headed to the president for his expected signature, a little more than a year after tainted steroid injections from one such enterprise caused more than 750 cases of spinal meningitis.
Compounding pharmacies mix drugs for patients, but some mix drugs for thousands of patients and perform more like drug makers than corner drugstores.
Compounding pharmacies grabbed headlines last fall when it was learned that the New England Compounding Center of Framingham, Mass., sold thousands of doses of the steroid methylprednisolone acetate tainted by fungus, the Food and Drug Administration found. The steroid shots led to fungal meningitis that caused 64 deaths and sickened hundreds of people in 20 states. The center suspended operations in October 2012.
The legislation, which cleared the Senate on a voice vote on Monday and already passed in the House of Representatives, allows compounding pharmacies to declare themselves to be manufacturers, or, as the bill describes them, "outsourcers." By doing this, the pharmacies would voluntarily place themselves under full FDA regulation, meaning the agency will perform inspections and possibly find problems before they cause illness and death.
But the legislation doesn't draw a clear line delineating which, if any, compounders must be regulated by the FDA. Those not regulated by the FDA are supposed to be monitored by state pharmacy boards.
The FDA said it is pleased that the bill creates a new pathway in which a compounder can register as an "outsourcing facility" subject to federal quality standards and oversight. "While this bill does not provide FDA with all the additional authorities it sought related to compounding pharmacies, it provides a regulatory framework for certain compounders who register with FDA," a spokesman said.
Some government officials said the measure is too watered down to prevent future disease outbreaks like the one last year.
The Senate and House held extensive hearings earlier this year in which lawmakers struggled to find a way to distinguish between small compounders filling prescriptions and larger multistate ones selling large batches to customers across the country, sometimes without prescriptions.
Allan Coukell, who oversees medical programs at the Pew Charitable Trusts, said the bill "is not as far-reaching as earlier versions, but it is a significant proposal." He and others who support the bill said compounders may come to see FDA regulation as a kind of mark of quality, and that compounders that sell to major hospitals may seek to attain such a status if this bill becomes law.
Groups representing compounding pharmacists differed on their views about the bill.
The National Community Pharmacists Association, in a letter to House Republican and Democratic leaders recently, said the bill "provides a balanced and effective approach."
But David G. Miller, executive vice president of the International Academy of Compounding Pharmacists, said the legislation "will not further the safety of compounding medication, which was its only purpose."
Rep. Morgan Griffith (R., Va.) a member of the House Energy and Commerce Committee, which held hearings on the topic, called the bill "a first step at clarifying current law."
Sen. Edward Markey (D. Mass.) said, "For the first time, hospitals and health-care facilities will have access to safer compounded drugs that are subject to rigorous FDA standards and oversight. This bill will go a long way to ensure that public health is protected and compounded drugs are safe."
Congress brings specialty pharmacies under more federal scrutiny after meningitis outbreak
WASHINGTON — Congress took a half step Monday toward increasing federal oversight of so-called compounding pharmacies that custom mix medications in bulk, a year after a meningitis outbreak from contaminated steroid pain injections killed 64 people and sickened hundreds more.
The Senate approved the bill by voice vote, sending it to the White House, where President Barack Obama is expected to sign it into law. The legislation also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed it in September.
More than 750 people were sickened by last year’s outbreak of deadly fungal meningitis and many continue to suffer debilitating pain and nerve damage. The sickness was eventually traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states.
Jurisdiction over such large-volume compounders has been murky. Pharmacies that fill individual prescriptions from a doctor or other health professional are typically regulated by state boards, but the Food and Drug Administration regulates manufacturers of medicines. The compromise bill gives the FDA authority to inspect and close down large-volume compounders, but it doesn’t require the pharmacies to register with the FDA, as manufacturers of prescription drugs must do.
The bill attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar businesses to skirt both state and federal regulations. The measure clarifies the FDA’s authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors’ prescriptions.
Under the bill, pharmacies can voluntarily register with the FDA and submit to federal quality standards and inspections. FDA officials previously said requiring compounding pharmacies to register with the agency was crucial to preventing future outbreaks.
The bill’s supporters acknowledge that a voluntary approach will succeed only if doctors and hospitals choose to do business with FDA-registered pharmacies.
“Nobody will be required to register in this new category,” said Allan Coukell, drug safety expert with the Pew Charitable Trusts, which lobbied to pass the bill. “The success of the voluntary category will depend on hospitals, clinics and doctors choosing to buy from these FDA-registered facilities.”
Safety advocates say the bill leaves the door open for more rogue pharmacies like the one that caused last year’s outbreak.
“This voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA,” Rep. Rosa DeLauro, D-Conn., said after the House passed the bill.
FDA officials told Congress last year that regulating businesses like the NECC has been a struggle because of a “patchwork” of conflicting court decisions over the federal agency’s authority to deal with pharmacies.
Traditional compounding pharmacies, generally small operations that fill individual doctors’ prescriptions, will continue to be regulated by state pharmacy boards. Pharmacies that expand into shipping drugs without doctors’ prescriptions can voluntarily register with the FDA as “outsourcing facilities,” subject to quality standards and reporting requirements similar to manufacturers.
The FDA will retain the power to shut down any outsourcing pharmacy, registered or not, that does not meet quality standards or engages in illegal compounding, such as mass-producing copies of manufactured drugs.
Experts who helped craft the bill predict that nearly all large compounding pharmacies will register with the FDA as a cost of doing business.
But critics question how the FDA will be able to identify businesses that aren’t following regulations.
Even the compounding industry’s chief lobbying group said the bill will not stop pharmacies like the one that caused last year’s outbreak, and said it could lead to more confusion over pharmacy regulations.
“If the goal of this legislation is to prevent another NECC, which has been stated many times over, then the American public must know that this bill will not accomplish that goal. A voluntary category of outsourcing facilities is not the answer,” the International Academy of Compounding Pharmacists said in a statement.
The voluntary approach to regulation was a compromise forged by Republicans and Democrats in the GOP-controlled House. Earlier versions of the bill drafted in the Democratic-controlled Senate would have made registration mandatory.
Despite criticisms of the approach, the bill has garnered broad support, in part because it was bundled together with separate legislation designed to track prescription drugs throughout the U.S. supply chain.
The so-called track and trace system, long sought by doctors and patient groups, is designed to help authorities catch counterfeit or stolen drugs that increasingly have been making their way into the U.S. from overseas.
Drugmakers will be required to add serial numbers to all drug packages within four years. After 10 years the industry must upgrade to electronic codes that can be used to track medicines from the factory to the pharmacy. Drug distributors, packagers and wholesalers will be required to verify the distribution history of the products they ship.
http://www.washingtonpost.com/politics/congress/congress-putting-compounding-pharmacies-under-more-federal-scrutiny-after-meningitis-outbreak/2013/11/18/96e42d1e-5081-11e3-9ee6-2580086d8254_story_1.html
The Senate approved the bill by voice vote, sending it to the White House, where President Barack Obama is expected to sign it into law. The legislation also creates a national system for tracking prescription drugs from manufacturers to retail pharmacies, first through serial numbers on bottles and later through electronic codes. The House passed it in September.
More than 750 people were sickened by last year’s outbreak of deadly fungal meningitis and many continue to suffer debilitating pain and nerve damage. The sickness was eventually traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions. The company shipped more than 17,600 doses of the implicated steroid injection to 23 states.
Jurisdiction over such large-volume compounders has been murky. Pharmacies that fill individual prescriptions from a doctor or other health professional are typically regulated by state boards, but the Food and Drug Administration regulates manufacturers of medicines. The compromise bill gives the FDA authority to inspect and close down large-volume compounders, but it doesn’t require the pharmacies to register with the FDA, as manufacturers of prescription drugs must do.
The bill attempts to sort out the legal gray area that allowed the Massachusetts pharmacy and similar businesses to skirt both state and federal regulations. The measure clarifies the FDA’s authority over high-volume compounding pharmacies that mass-produce medications, rather than fill doctors’ prescriptions.
Under the bill, pharmacies can voluntarily register with the FDA and submit to federal quality standards and inspections. FDA officials previously said requiring compounding pharmacies to register with the agency was crucial to preventing future outbreaks.
The bill’s supporters acknowledge that a voluntary approach will succeed only if doctors and hospitals choose to do business with FDA-registered pharmacies.
“Nobody will be required to register in this new category,” said Allan Coukell, drug safety expert with the Pew Charitable Trusts, which lobbied to pass the bill. “The success of the voluntary category will depend on hospitals, clinics and doctors choosing to buy from these FDA-registered facilities.”
Safety advocates say the bill leaves the door open for more rogue pharmacies like the one that caused last year’s outbreak.
“This voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA,” Rep. Rosa DeLauro, D-Conn., said after the House passed the bill.
FDA officials told Congress last year that regulating businesses like the NECC has been a struggle because of a “patchwork” of conflicting court decisions over the federal agency’s authority to deal with pharmacies.
Traditional compounding pharmacies, generally small operations that fill individual doctors’ prescriptions, will continue to be regulated by state pharmacy boards. Pharmacies that expand into shipping drugs without doctors’ prescriptions can voluntarily register with the FDA as “outsourcing facilities,” subject to quality standards and reporting requirements similar to manufacturers.
The FDA will retain the power to shut down any outsourcing pharmacy, registered or not, that does not meet quality standards or engages in illegal compounding, such as mass-producing copies of manufactured drugs.
Experts who helped craft the bill predict that nearly all large compounding pharmacies will register with the FDA as a cost of doing business.
But critics question how the FDA will be able to identify businesses that aren’t following regulations.
Even the compounding industry’s chief lobbying group said the bill will not stop pharmacies like the one that caused last year’s outbreak, and said it could lead to more confusion over pharmacy regulations.
“If the goal of this legislation is to prevent another NECC, which has been stated many times over, then the American public must know that this bill will not accomplish that goal. A voluntary category of outsourcing facilities is not the answer,” the International Academy of Compounding Pharmacists said in a statement.
The voluntary approach to regulation was a compromise forged by Republicans and Democrats in the GOP-controlled House. Earlier versions of the bill drafted in the Democratic-controlled Senate would have made registration mandatory.
Despite criticisms of the approach, the bill has garnered broad support, in part because it was bundled together with separate legislation designed to track prescription drugs throughout the U.S. supply chain.
The so-called track and trace system, long sought by doctors and patient groups, is designed to help authorities catch counterfeit or stolen drugs that increasingly have been making their way into the U.S. from overseas.
Drugmakers will be required to add serial numbers to all drug packages within four years. After 10 years the industry must upgrade to electronic codes that can be used to track medicines from the factory to the pharmacy. Drug distributors, packagers and wholesalers will be required to verify the distribution history of the products they ship.
http://www.washingtonpost.com/politics/congress/congress-putting-compounding-pharmacies-under-more-federal-scrutiny-after-meningitis-outbreak/2013/11/18/96e42d1e-5081-11e3-9ee6-2580086d8254_story_1.html
Compounding Pharmacy Bill Might Not Make Drugs Safer
Most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed 64 people and sickened about 700 others in a fungal outbreak in 20 states.
Today, Congress passed legislation for stricter regulations on them to prevent repeat of what officials have called the "largest documented healthcare-related outbreak in the United States."
"Even in the midst of partisan stalemate, Congress can still come together to pass meaningful legislation to protect the public's health," said Allan Coukell, director of drugs and medical devices at Pew Charitable Trusts. "This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective and of the highest quality."
But not everyone is convinced the bill will make patients safer. In fact, some health policy experts say just the opposite.
"It makes what is now illegal legal," said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.
The Drug Quality and Security Act would give large-scale compounding pharmacies the option to register with the Food and Drug Administration and adhere to stricter guidelines for testing and maintaining quality and sterility. In early versions of the bill, these were called "compounding manufacturers," which compounding critics were quick to note suggests that they should be treated like other drug manufacturers and adhere to mandatory guidelines, which the bill does not require. In later versions of the bill, the language was toned down to "outsourcing facilities."
Supporters of the bill hope that compounding pharmacists will want to register with the FDA because doctors will prefer to use compounding pharmacists perceived as safer. Opponents fear compounders won't do it if it's not mandatory.
Carome said he opposes the bill because he said it legalizes a practice that was once illegal -- large scale compounding without individual prescriptions and without following the strictest quality and sterility guidelines that drug manufacturers must follow.
"It makes no sense to have two different tiers of drug manufacturers -- one that has to meet all the manufacturing guidelines and one that only has to meet some of them," Carome said. "We believe in a level playing field."
Traditional compounding pharmacies make drugs for one patient at a time because those patients can't swallow pills, are allergic to an ingredient or have some other special need that prevents them from taking the standard drug. But in recent decades, compounding pharmacists have increasingly made drugs on a scale similar to that of a drug manufacturer, meaning they don't always have prescriptions for individual patients.
"When you mass produce a large number of standard doses of a drug in a single batch, if quality fails, a potential to harm many more people exist," Carome said.
Pew Charitable Trusts supports the bill because it clarifies the existing law, which hasn't been able to keep up with the changing compounding pharmacy industry.
"Over many years, we've had repeated quality problems with compounded drugs," Coukell said. "It really suggests the status quo isn't working."
Shortly after patients began turning up with never-before-seen cases of fungal meningitis, NECC was accused of manufacturing the drugs rather than making them for individual patients. When FDA inspectors arrived at the lab in Framingham, Mass., they found that a quarter of the steroid injections in one of NECC's bins contained "greenish black foreign matter," according to the report. The FDA also identified several cleanrooms that had bacterial or mold overgrowths.
NECC owner Barry Cadden was subpoenaed to appear before Congress a year ago, but he declined to answer questions, invoking his Fifth Amendment right against self-incrimination.
The FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.
According to FDA records, there have been 22 compounding pharmacy recalls since last March. But there are no compounding pharmacy records in the database prior to that date going back five years -- though there may have been state recalls.
"I think the FDA realizes its own failure to act swiftly in the NECC case and that has elevated their scrutiny of compounding pharmacies to the point where [they] cannot -- [they] do not want to be put in the position of being accused of not taking swift action," said David Miller, president of the International Academy of Compounding Pharmacists, which had historically lobbied for looser oversight by the FDA in decades past, but last year blamed the FDA for not shutting down NECC.
Prior to the NECC outbreak, compounding pharmacies were regulated by state pharmacy boards, and the FDA said it didn't have the authority to properly regulate the industry. Its hope was that new legislation would change that.
Still, FDA officials said they are pleased with the new legislation.
"While this bill does not provide FDA with the additional authorities it sought, it provides a regulatory framework for certain compounders who register with the FDA," said FDA spokeswoman Erica Jefferson.
Compounding pharmacists who do not register with the FDA will be subject to the existing law, which is part of the Federal Food, Drug, and Cosmetic Act. This mandates that prescriptions be made for each patient individually, rather than in bulk, and has slightly less rigorous guidelines for quality and sterility testing.
Any compounding pharmacy that isn't compounding prescriptions for only individual patients would be acting illegally under the proposed law, but it doesn't provide a way for the FDA to figure out which pharmacies are misbehaving. That will still be up to state inspectors.
"The agency will continue enforcing the law to the full extent of its authority in order to protect public health," Jefferson said.
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