Monday, March 31, 2014

U.S. FDA moves to offset shortage of common saline solution

Moving to offset shortages of a common saline used in hospitals and dialysis centers, the U.S. Food and Drug Administration said on Friday that it will temporarily allow Fresenius Kabi USA LLC to distribute normal saline from its manufacturing facility inNorway.
The FDA said the initial shipments would help but not resolve shortages of 0.9 percent sodium chloride injection, also known as normal saline. The drug is widely used to treat patients with dehydration and other medical conditions.

The FDA said it is continuing to work with Baxter Healthcare Corp, B.Braun Medical Inc. and Hospira Inc to restore their supplies to hospitals and health clinics. The agency is also working with Fresenius Medical Care which supplies the drug to dialysis centers.

Friday, March 28, 2014

Today's Shortages


Adenosine Injection

aspirin Tablets (Buffered)

Bupivacaine with epinephrine Injection

Mannitol Injection

Mesna Injection

Methylphenidate Hydrochloride

Neostigmine Methylsulfate Injection

Octreotide Injection

Oxytocin Injection

Phenylephrine Hydrochloride Injection

Phenytoin Injection

Promethazine Injection

Rocuronium Injection

Sumatriptan Succinate Injection

Technetium Tc99m Albumin Aggregated Injection

Testosterone Enanthate Injection

Thursday, March 27, 2014

Five new ways to die in Oklahoma during execution drug shortage

OKLAHOMA CITY – The Oklahoma Department of Corrections can now use five different methods to carry out lethal injections.
The new protocol comes after the state announced last week it could not get two of the three drugs it needs to kill Clayton Lockett, a convicted murderer.
Adopting the new methods allows the ODOC  to use wider array of drugs during a nationwide shortage of execution drugs.
Officials said the shortage is because many drug manufacturers are based in European countries and do not support capital punishment.
The new methods allow for a triple-dose of pentobarbital, a drug that concocted controversy when administered in the lethal injection of Oklahoma inmate Michael Wilson, who said “I can feel my whole body burning.”
Another method allows for the combination of midazolam and hydromorphon.
The combination was used in the first time this year in an Ohio execution that took an “unusually long” twenty minutes.
ODOC can also substitute vecuronium bromide, which stops the inmate’s breathing, with comparable agent.
Vercuronium bromide and pentobarbital, which causes unconsciousness, were two of the drugs the state was unable to get earlier this month.
Both drugs were used under the state’s previous lethal injection method.
The state provided the new methods to the attorneys of two inmates who are to be executed soon.
They are currently suing the state to learn more about the drugs that will be used to kill them.
Earlier this year, convicted murderers Clayton Lockett and Charles Warner filed a lawsuit against the ODOC.
The lawsuit alleges state law keeping the providers of execution drugs a secret could violate their Constitutional freedom from punishment in a cruel or unusual way.
Executions of both men were pushed back from March to April after the state announced it could not secure the drugs it needed to put them to death.
Lockett and Warners’ attorneys argue all direct manufacturers of execution drugs have stopped participating in lethal injections so the only option for the state to get the drugs is through compounding pharmacies.
Those pharmacies are scarcely regulated by the FDA.
However, because the state is not required to disclose the source of its drugs, the attorneys allege we cannot know whether the drugs are manufactured and stored in a safe way.
Staff for the U.C. Berkeley School of Law’s Death Penalty Clinic agreed in a press release.
“As many as four of the five drug combinations in the new protocol would require the use of compounded drugs made by compounding pharmacies,which operate outside of FDA oversight, making it impossible to know if the drugs have been properly prepared and tested in order to ensure the execution will be carried out in a manner that comports with the Constitution.”
The Oklahoma Attorney General’s Office maintains the secrecy law is necessary in order to procure the execution drugs at all.
“This amendment was spurred by a nation-wide shortage of execution drugs, brought on partially by threats of violence and political pressure exerted on suppliers of the drugs,” the Attorney General’s Office wrote in court documents. 
It cites a Missouri compounding pharmacy as an example after it received an emailed bomb threat when the media identified it as an execution drug manufacturer.
It also states The Apothecary Shoppe, a compounding pharmacy in Tulsa, was sued by a Missouri inmate because it was not authorized to distribute in Missouri, yet the Tulsa pharmacy was believed to be manufacturing its execution drugs.
Lockett was convicted of the 1999 killing of Stephanie Nieman in Kay County and raping her friend. He is scheduled for execution April 22.
Warner received the death penalty after the 1997 rape and murder an 11-month-old girl in Oklahoma County. His execution is slated for April 29.
Oklahoma County District Judge Patricia Parish will hear the merits of the drug lawsuit Wednesday.

Letter: GPOs are not responsible for generic drug shortages

Sen. Charles Schumer has been a consistent champion for patients and has worked vigorously to ensure that New Yorkers have access to the prescription drugs they need. (“Another Voice: Schumer defends system that creates shortages of critical prescription drugs,” March 16 News). Those who say otherwise have not watched him at work.
Schumer has used his powerful positions on the Senate Judiciary Committee and Senate Finance Committee to assure safe and reliable supplies for patients, physicians and hospitals. He has worked with health care group purchasing organizations (GPOs) and our supply chain partners who are taking innovative steps to mitigate the impact of generic drug shortages. GPOs are working to help solve the drug shortage problem through predictability and reliability provided by long-term contracts with manufacturers. All GPO contracts are voluntary and the product of competitive market negotiations. All hospitals can purchase “off contract” and often do. Contracts can be canceled and pricing regularly adjusted. Manufacturers consistently and quickly adjust pricing of GPO contracts when they experience shocks to production.
Hospitals use GPOs to aggregate their purchasing power and deliver cost savings. GPOs do not manufacture, compound, sell or take title to these drugs or any drugs in shortage. GPOs work with hospitals, manufacturers and distributors to help maintain a safe and reliable supply of products for health care providers.
As those who are intimately knowledgeable with the drug supply system know, GPOs have nothing to do with generic drug shortages. Even drug manufacturers and hospitals acknowledge this. The true causes of drug shortages are manufacturing problems, quality issues and barriers to getting new suppliers on line when supply is disrupted.

Baxter, FDA scramble to overcome shortage of nitroglycerin

A shortage of saline solution has already been hampering hospitals. Now emergency rooms are finding it difficult to get nitroglycerin, a drug they often turn to first when heart attack patients arrive.

According to The New York Times, Baxter International ($BAX) became the sole supplier of the drug last year when manufacturing problems sidelined supplies from Hospira ($HSP) and American Regent. Then in November, Baxter had to recall a lot of nitroglycerin in 5% dextrose when particulate was found in a vial. Unable to keep up with demand, Baxter has been rationing the drug to healthcare providers, the newspaper reported. It limited hospitals to 40% of their usual orders in January, then cut that to 20% this month, leaving doctors to figure out how to cope.
"It's one of those drugs that in certain circumstances, there really is no substitute for," Dr. Frederick Blum, an emergency room physician at Ruby Memorial Hospital in West Virginia, told the NYT. Supplies at his hospital are depleted to the point that if a couple of patients needed extended use, they would run out, he said.

A bulletin from the American Society of Health-System Pharmacists said American Regent has upgraded a plant and will be staging supplies as its production expands. Baxter spokeswoman Deborah Spak told the newspaper that it is ramping up production by the end of the week, allowing it to return to shipping at the same levels it had been in January. She noted that Baxter has been the one continuous supplier of nitroglycerin and was "hopeful that overall demand and supply will resume to a more predictable state within the next few months."

Meanwhile, the FDA has found an overseas supplier that can provide some product "in coming weeks," Capt. Valerie Jensen, associate director of the FDA's drug shortage program, told the NYT. "This is a critical drug. We will have something in place," she said.

The FDA is pursuing a similar solution for getting additional supplies of saline, another hospital staple that has been affected by supply constraints from the same three manufacturers. These tight spots in the supply chain illustrate one of the points in a recent Government Accountability Office report on drug shortages. Only a few manufacturers produce a majority of the low-margin sterile injectable drugs, and if they have issues, the supply chain suffers and frustration grows with the drug industry.

Dr. Ann Toran, chief of cardiac surgery at North Shore Medical Center in Salem, MA, told the NYT, "You want to feel that we're living in a land where if you come into the hospital with a heart attack, that you can get the best of care." She said her hospital's supply of nitroglycerin was running short. "To have that hanging over you as a doctor--a critical shortage of this essential medication--I just don't know what to say."

U.S. is running low on some basic medicines

The drip, drip of IV fluid at hospitals, the drug doctors give people having heart attacks and medicines for cancer patients are all in short supply.
“On any given day we’re tracking usually 300 drug products that are in shortage,” said Cynthia Reilly with the American Society of Health-System Pharmacists.
She says, right now, the shortage of IV fluid is at the top of everyone’s critical list.
“It’s almost, really like not having access to water,” Reilly says. 
 “When we run out of absolute basics, like we’re running out of now, that’s when things get really frustrating,” said Erin Fox, director of drug information at the University of Utah Hospitals and Clinics.
According to a report from the Government Accountability Office, the number of shortages tripled between 2007 and 2012. Sixty percent of the shortages are generic drugs, which are cheaper drugs.
“Drug manufacturing, in the U.S., is a business,” Fox says. “No company has an obligation to make any product, no matter how essential it is for patients.”
The FDA reports the number of new shortages has been falling since new rules went into place in 2012. But, says Capt. Valerie Jensen, associate director of the drug shortage program at the FDA, “some shortages are just not able to be avoided.”
Basic drug shortages are hard to fathom in a wealthy country like the U.S., but some of these drugs are produced by only one or two companies.
When a manufacturing line shuts down, or demand goes up, supplies run low.

Lookout List

Lookout List...things to keep your eye on..

Infuvite ADLT 

Infuvite Pediatric BULK 

Kinevac 10x1

Today's Shortages


Clindamycin Injection

Sodium Chloride Concentrated Solution for Injection

Wednesday, March 26, 2014

Department of Health and Human Services (HHS) and U.S. Government Accountability Office (GAO) Reports Highlight Need to Address Drug Shortages

Two recently released reports from the U.S. Department of Health and Human Services (HHS) and the U.S. Government Accountability Office, respectively, focus on the impact of prescription drug shortages, their potential causes and the role that HHS, particularly the Food and Drug Administration, plays in identifying, tracking and alleviating these problems.
In recent years, an increasing number of drug shortages have threatened public health by reducing—if not eliminating—patient access to critical pharmaceuticals.  As such, drug shortages have been the subject of considerable federal activity, including an October 2011 Executive Order that directed the U.S. Food and Drug Administration (FDA) to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines” (e.g., requiring broader reporting of manufacturing discontinuances and expediting regulatory reviews), and a December 2011 interim final rule issued by the FDA that amended the FDA’s early notification requirements. 

FDA Safety and Innovation Act

Perhaps most importantly, however, the FDA Safety and Innovation Act, Pub. L. No. 112-144, 126 Stat. 993 (2012) (FDASIA), significantly enhances the FDA’s ability to identify and mitigate the effects of drug shortages by:
  • Requiring all manufacturers of all covered prescription drugs (i.e., drugs that are life-supporting, life-sustaining or intended for use in the prevention or treatment of debilitating disease or condition, including any such drug used in emergency medical care or during surgery (except for radiopharmaceuticals and other products designated by the agency)) to notify the FDA of permanent discontinuation or temporary interruption in manufacturing (previously, the notification requirement applied only to sole product manufacturers
  • Authorizing the FDA to require (by regulation) that biological product manufacturers be included among those manufacturers required to provide notice of permanent discontinuation or temporary interruption
  • Requiring the FDA to send a non-compliance letter to firms that fail to provide the required notice of permanent discontinuation or temporary interruption
  • Expressly permitting the FDA to continue expediting reviews and inspections that may mitigate a shortage
  • Requiring the improvement of internal and external communications by the FDA regarding shortages
  • Mandating the development and implementation of a strategic plan for enhancing the FDA’s response to preventing and mitigating shortages
  • Triggering the initiation of a new rulemaking process (which will replace the December 2011 interim final rule) to incorporate the new requirements set forth in FDASIA

FDA Report

The FDASIA also requires the Department of Health and Human Services to submit an annual report on drug shortages to the U.S. Senate Committee on Health, Education, Labor & Pensions and the House Energy and Commerce Committee.  On February 5, 2014, the FDA submitted its first report, in which it discussed actions it has taken to identify and prevent or mitigate prescription drug shortages, and described the impact drug shortages have on the health care system, particularly on patients and health care providers.  With respect to the efficacy of the agency’s activities, the report states that the total number of actual drug shortages decreased from 250 in 2011 to 117 in 2012, with 280 other drug shortages prevented in 2012.  The FDA attributes these results to the above-described presidential, congressional and agency activity, which has resulted in manufacturers providing the FDA with earlier notice of potential shortages and the agency having additional time to work with sponsors and other groups to maintain patient access to critical medication. 
The report also highlights the mitigation efforts that the FDA can implement when faced with a potential shortage.  Mitigation efforts may include allowing other manufacturers to increase production to make up for the shortfall; expediting reviews and inspections relating to manufacturers attempting to restore production, competing manufacturers interested in starting new production and competing manufacturers interested in increasing existing production of products in shortage; and exercising temporary enforcement discretion for new sources of drugs.  The FDA also notes that is exercised its regulatory flexibility in order to prevent 140 drug shortages in the first nine months of 2013.

GAO Report

The FDASIA also requires the Government Accountability Office (GAO) to issue a report that examines the causes of drug shortages and formulates recommendations to prevent or minimize them.  On February 10, 2014, the GAO released this analysis.  To create this report, the GAO reviewed data, interviewed stakeholders and performed a meta-analysis of 20 different studies as well as FDA data.
The GAO found that, despite the efforts of the FDA, the number of drugs shortages remained high.  The GAO report notes that 44 percent of the shortages were sterile injectable generic drugs, 17 percent were sterile injectable brand name drugs and the remainder were oral drugs.  Even more disturbing, the GAO found that during the period from 2007 to 2012, nearly half of the reported shortages were for drugs that were in shortage multiple times.  According to the report four categories of drugs, anesthetics, anti-infectives, cardiovascular agents and nutritive drugs accounted for 53 percent of all drug shortages.
The GAO’s analysis indicates that the majority of drug shortages (70 percent) are related to manufacturing quality, delays or capacity issues.  While the report identified additional underlying factors, such as payer-related issues, particularly Medicare Part B pricing, and market-based price competition, the report does not present any of these factors as being significant causes of shortages.
Providers indicated to the GAO that drug shortages can affect patient care beyond just the inability to access drugs in short supply.  Provider groups highlighted the risks stemming from the inability to find suitable and effective alternative drugs, rationing care when drugs have limited availability and the increased cost of short supply drugs.  Provider groups also noted that their practices were required to devote additional staff and provider time and costs on managing drug inventory instead of providing direct patient care.
The GAO report lauds the FDA’s efforts to identify and mitigate drug shortages.  However, it notes that many contributing factors are beyond the FDA’s control.   The GAO recommends that the FDA streamline its existing processes by better and more consistently using the information it collects to further enhance its ability to identify, track and prevent drug shortages.


Patients, providers, manufacturers and payers alike will be encouraged by the FDA’s report of reductions in and the prevention of drug shortages.  Nevertheless, the GAO’s report and remaining shortage concerns suggest that significant progress remains to be made.  Therefore, where required to more fully address shortage-related issues, the FDA’s regulatory policy may evolve over time—at least to the extent required and permitted under the FDASIA.
For example, as mentioned above, the FDA intends to replace the 2011 interim final rule with regulations consistent with the FDASIA’s requirements.  The comment period for the proposed replacement rule closed in early January 2014, so the FDA could promulgate the final regulations as soon as later this year.  Therefore, interested entities—especially manufacturers—should carefully monitor communications regarding the final rule from the FDA, as well as other FDA activities under its drug shortage program.

Nitroglycerin, a Staple of Emergency Rooms, Is in Short Supply

The drug nitroglycerin has long been an emergency room staple, a front-line drug that is often the first thing doctors try when a patient shows up with a heart attack.
So when Baxter International, the country’s only manufacturer of injectable nitroglycerin, recently told hospitals that it was sharply cutting shipments of the drug, the news sent pharmacists and emergency room doctors into a panic. Hospitals have been struggling for years with intermittent shortages of the drug, but with the latest news, doctors worried they could actually run out.
Assurances by Baxter and the Food and Drug Administration on Tuesday that they were taking steps to ease the shortage offered small comfort.
“It’s one of those drugs that in certain circumstances, there really is no substitute for,” said Dr. Frederick Blum, an emergency doctor who treats patients at Ruby Memorial Hospital in West Virginia, which operates a regional trauma center. Supplies of nitroglycerin are so low, he said, that “if we had one or two patients that were really sick that needed extended drips, it could exhaust our supply pretty quickly.”
The nitroglycerin shortage is the latest example of how patchy the supply of some of the nation’s most critical drugs has become in recent years. Hundreds of drugs and hospital products have become scarce, partly because manufacturing and quality problems at aging factories have led to shutdowns of production lines and entire facilities.
A report by a federal watchdog agency last month found that the number of annual drug shortages tripled from 2007 to 2012. Like the nitroglycerin shortage, many of the shortfalls involve generic injectable drugs, which are often made by just a handful of manufacturers. The report, by the Government Accountability Office, cited a study that found just three manufacturers produced 71 percent of the country’s sterile injectable cancer drugs in 2008.
Shortfalls have ranged from critical cancer drugs to run-of-the-mill staples like the pain drug morphine. Many of the drugs sell at very low prices, raising questions about the financial incentives for companies to continue making them. A bottle of nitroglycerin from Baxter, for example, sells at a wholesale price of about $6. “These are old drugs that we’ve been using for many, many years,” Dr. Blum said. “They’re like mom and apple pie.”
Baxter, based in Deerfield, Ill., has been rationing supplies of injectable nitroglycerin since January because it has not been able to keep up with demand after the two other manufacturers of the drug, Hospira and American Regent, stopped selling their products because of manufacturing problems and delays. The drug is so common, and in such demand, that nearly every emergency department in the country could be expected to keep it in stock, experts said.
Baxter has been the sole supplier since last year, and in January, it limited hospitals to 40 percent of their usual orders. This month, hospital pharmacists and doctors said they were told that their allotment would be reduced even further, to 20 percent.
The University of Virginia Medical Center, in Charlottesville, Va., typically uses 48 to 50 infusions of nitroglycerin a month. Since the restrictions were imposed in January, the hospital is limited to no more than 24 a month, said Dr. Robert E. O’Connor, the chairman of the emergency medicine department at the University of Virginia School of Medicine. He said the hospital’s stock was currently down to just four infusions, each of which would treat a patient for 18 to 20 hours. “It really limits how we can take care of patients,” he said.
Baxter said on Tuesday that it was increasing production of nitroglycerin and would go back to shipping the drug at the January levels by the end of this week. The F.D.A., which has taken the emergency step of hunting for overseas sources of the drug, also said that it expected the shortage to ease soon.
Capt. Valerie Jensen, associate director of the agency’s drug shortage program, said that it had identified another supplier outside the United States, and that she expected fresh supplies “in the coming weeks.”
“This is a critical drug,” she said in an interview. “We will have something in place.”
Captain Jensen added that a similar arrangement was underway with intravenous saline solution, which also has been in shortage — at times critically — for months. Baxter also manufactures intravenous saline.
But some expressed skepticism that Baxter would follow through with its promises.
“I sincerely hope that is true, but I don’t have a lot of faith that it will be because there is such a demand for this product,” said Erin Fox, a drug shortage expert at the University of Utah. She warned that Baxter and other drug manufacturers had frequently failed to meet their own deadlines, and she said that hospitals were struggling to make do, even at the previous supply levels. “We’ve seen from their estimated release dates for their saline products that those have been pushed off as well.”
Deborah Spak, a spokeswoman for Baxter, said the company had been forced to ration its shipments of nitroglycerin as it raced to order more raw materials and redirect operations to ramp up manufacturing of the drug. She said that fluctuations in allocations to hospitals were typical when a drug was in shortage.
“Baxter has been the one continuous supplier of nitroglycerin in the U.S. and the company is making every effort to meet the needs of customers,” she wrote in an email message, adding that the company was “hopeful that overall demand and supply will resume to a more predictable state within the next few months.”
Nitroglycerin, which helps open the blood vessels, has been used for more than a century to treat patients with heart disease. In some situations, doctors can treat patients with a paste that is applied to the skin, or with tablets that are dissolved under the tongue. But for people experiencing serious heart attacks or congestive heart failure, only the intravenous form will work.
Several doctors said they found the unpredictability of the shortages frustrating. “You want to feel that we’re living in a land where if you come into the hospital with a heart attack, that you can get the best of care,” said Dr. Ann Toran, chief of cardiac surgery at North Shore Medical Center, a hospital in Salem, Mass., whose pharmacy is down to a small supply of nitroglycerin. “To have that hanging over you as a doctor — a critical shortage of this essential medication — I just don’t know what to say.”


MBABANE – SWAPOL has rolled out an initiative to track drug shortages in community health facilities through the use of mobile phones. 

The initiative is known as Tracking Access to Essential Medicines (Tendai) and has been achieved through the support of South African Regional Programme on Access of Medicines and Diagnostics (SARPAM). 

SWAPOL is an acronym for Swaziland Positive Living.  
This initiative uses mobile phones with special software to capture pictures, administer questionnaires and keep track of pharmaceutical availability in community clinics. 

Trained community monitors are able to track the quality of medicine and shortage of health workers, through monthly visits to the dispensaries in community clinics.  The project seeks to mobilise communities to push for access to affordable treatment particularly for those living with HIV.
Last week, about 20 community-based monitors, mobilised by SWAPOL, took part in the two-day training that was held at Lugogo Sun. 

Over the two days, they were taken through theory and practical sessions on how to use the specialised software on mobile phones to monitor drug shortages and capture stories on access to medicine. 

They were also assisted on how to download the latest version of the software online.
SWAPOL Project Coordinator Cebile Dlamini said the objective of the project is to promote access to essential medicines in community clinics.  
Asked why the project targets community clinics, Dlamini indicated that clinics are the first point of call for primary health care in rural communities. 

She said, as SWAPOL, they have noted with concern several challenges which include, but not limited to non-adherence to treatment, particularly for people on antiretroviral treatment (ART). 

“These clients sometimes do not get the regular three-month supply of drugs due to shortages or stock-outs.  
“As a result, we want to use this initiative to track availability of basic and popular medicines in clinics. We also want clients to share their multi-shaded clinic experience,” she explained.

Dlamini said they are using a local convenience shop model.  Communities generally readily find all the basic goods like bread, sugar and salt, for instance, in a local convenience shop.  Through this initiative, we will be able to flag some of the challenges faced by community clinics in terms of ensuring that they readily find ten basic medication for children and adults,’ she said.
On a monthly basis, the trained monitors will keep track of stock levels at the clinics and after a space of about six months; it would be possible to analyse the trends on what they find on a monthly basis.

Regional trainer Daniel Molokele of the Tracking Access to Essential Medicines (Tendai) said one of the basic requirements of this initiative was access to internet either through a mobile phone or Wi-Fi.  
Molokele is focusing on social mobilisation and advocacy as it relates to access to medicines.  
He said through this innovation, the community monitors will capture data on availability of drugs in health centres, and provide stories on key developments taking place within communities.

“Much as drug shortage impacts clients negatively, on the flipside, it presents a business opportunity for pharmacies in southern Africa.  
“We don’t want people on treatment to queue for hours to receive their medication so we need to mobilize for the production of generic drugs in southern Africa.  
“Some of these developing countries are still exempt from some of the restrictive laws on the production of generic drugs.  As such, they can produce drugs which can be supplied to other countries in southern Africa,” Molokele  said.
The Tracking Access to Essential Medicines (Tendai) initiative is inherently an advocacy tool. 

Civil society activists mobilised through this initiative are expected to operationalise findings from clinics by making proposals for policy changes.  
This is known as evidence-based advocacy to ensure that people readily have access to treatment.  
The activists will also facilitate linkages with tertiary institutions which carry out research on health issues.
NERCHA Director Khanya Mabuza said in an era where the country is moving towards embracing treatment of HIV as prevention, it has become increasingly critical to eliminate all kinds of barriers that hinders or compromises access to treatment. 

Pharmacists Urged Not To Assist US Executions

Several human rights and anti-death penalty groups have asked the American Pharmacists Association to prohibit members from participating in executions, a request that comes as states increasingly turn to pharmacists for lethal injection drugs.
The groups, which include Amnesty International, the NAACP and the American Civil Liberties Union, are targeting so-called compounded drugs. Such drugs, which are not federally regulated, are individually mixed versions of medications that prison systems are finding increasingly difficult to obtain.
Death penalty opponents say such drugs put inmates at risk of pain and suffering. Two years ago, an outbreak of meningitis that killed 64 and sickened hundreds was traced to a compounding facility in Massachusetts.
Pharmacists who provide compounded drugs are violating key provisions of the pharmacists' association code of ethics, including helping patients achieve "optimum benefit" from their medications, according to a letter the death penalty opponents presented to the association on Monday.
"Participation in executions undermines the position of trust that pharmacists enjoy in this nation," said the letter sent ahead of the association's annual meeting beginning Friday in Orlando, Fla. The letter is part of a lobbying effort spearheaded by the nonprofit group SumOfUs, which says it represents consumers and workers and seeks to "counterbalance the growing power of large corporations."
Numerous drug makers have put their products off limits for executions, drying up the supply available to prison systems. Missouri has used a compounded version of pentobarbital to execute four inmates with plans for a fifth at midnight Wednesday. Texas has used compounded pentobarbital to execute six inmates, with a seventh execution planned for Thursday.
Lawyers for death row inmates in Oklahoma have alleged the state used compounded pentobarbital to put an inmate to death in January. Michael Wilson's final words were, "I feel my whole body burning," and then he didn't move.
A plan by Georgia to use a similar specialty batch of pentobarbital has been put on hold by a lawsuit challenging the state prison agency's refusal to identify the compounding pharmacy that provided the drug. The lawsuit also questions the drug's safety and effectiveness.
In Ohio, the state's policy calls for the prison system to obtain compounded pentobarbital as a first choice, and then to use a backup method of a sedative and painkiller if the compounded drug can't be found. The state has chosen the backup method in the past two scheduled executions, although only one was carried out.
The American Medical Association prohibits members from taking action that could cause the death of a condemned inmate, although the association — like the pharmacists' group — is not a regulatory board with authority over licensing. The American Board of Anesthesiology, however, says anesthesiologists cannot participate in executions if they want board certification.
The pharmacists' association is unlikely to adopt any statement at this year's meeting because it has a long process for developing policies, spokeswoman Michelle Spinnler said in an email to The Associated Press Tuesday. She said the earliest the group's delegates could consider any proposal would be next year.
The association previously adopted policies opposing the use of the word "drug" for chemicals used in lethal injections, and opposing laws or regulations that require or prohibit pharmacists from participating in lethal injections.
Amnesty International believes the call to the pharmacists is another chance to express opposition to capital punishment, said Thenjiwe McHarris.
"Their profession is meant to preserve life, it's meant to do no harm, and the death penalty doesn't just challenge that, it's completely opposite to that mission," she said.
Any pharmacists' association policy would not affect members' ability to practice. But death penalty opponents hope that a policy change would filter down to state regulatory boards, which could require such a ban as part of licensing.

House committee passes bill regulating compounding pharmacies

Preventing a repeat of a 2012 fungal meningitis outbreak through a Massachusetts compounding pharmacy was the purpose of a bill approved unanimously by a House committee Monday.

Rep. Jimmy Patronis sponsored HB 7077, which would impose registration requirements and standards for “compounding pharmacies” which make medications tailored to the needs of individual patients.

Compounding pharmacies are located in other states but sell medicines in Florida. The House Health Care Appropriations Subcommittee approved the bill.

Lookout List

Hospital buyers...things to keep your eyes on...

Cyanoco 1000MCG 1ML 
Neostigmine 1:1000 
Vanco 1GM ADD

Today's Shortages

Cefazolin Injection
Copper Injection
Famotidine Injection
Granisetron Hydrochloride Injection
Lactated Ringer’s Injection Bags
Sodium Chloride 0.45% Injection Bags

A skewed view on drug shortages

I am writing in response to Peter Pitts' recent commentary "Another View: Drug shortage policies still come up short." It would be helpful if Mr. Pitts had identified his longstanding connections to the pharmaceutical industry, which funds his organization. His piece offers a distorted and wholly self-serving explanation of drug shortages, including misplaced blame on the critically important drug discount program called 340B.
Let's be upfront: I represent a non-profit organization of more than 1,000 hospitals that participate in the 340B program. The program was created in 1992 with bipartisan congressional support and signed into law by George H.W. Bush. It was expanded to rural hospitals in 2010 thanks to the hard work of Republicans and Democrats willing to take on Big Pharma.
340B allows hospitals and community health centers that serve high percentages of needy patients to buy medicines at discounted prices. Health providers, in turn, use their savings to supply medications for free or at reduced cost to uninsured or underinsured outpatients. In addition, healthcare providers use savings achieved through 340B to provide more services to their vulnerable patients, such as funding dialysis, cancer and diabetes clinics.
After a discussion of Food and Drug Administration oversight practices, Mr. Pitts partially blames "artificially low prices" for driving drug shortages and singles out the 340B program for special criticism. He's got his facts conveniently wrong. In the government report that he cites, forty percent of shortages studied by the FDA were due to product quality problems and plant maintenance. The remainder was driven by capacity limitations, product discontinuations or an increase in demand. Neither the FDA nor any other impartial source has ever blamed price discounting for drug shortages.
So the author resorts to making false assumptions without any supporting evidence. In the case of drugs purchased through the 340B program, there is no evidence that discounts have led to shortages. In an attempt to force this connection, Mr. Pitts cites to a 2011 Health and Human Services report and suggests scarcities are price driven. But the pricing data this report relies on do not include any 340B sales. What's more, the program only accounts for two percent of the $325 billion American drug market – hardly enough to cause artificial distortions.
Following the logic of his argument, there should be massive drug shortages every day due to discounts afforded to Medicaid, the Department of Defense, and the Veterans Administration which accounts for over $36 billion in U.S. pharmaceutical spending, a much larger share of the drug market than the 340B program's $7.2 billion in drug spending. Yet, the number of new shortages is on the decline.
How is this possible? Because Mr. Pitts' arguments grossly mischaracterize the facts.
Ted Slafsky is president and chief executive Officer of Safety Net Hospitals for Pharmaceutical Access.

Tuesday, March 25, 2014

Weekly FDA Enforcement Report For Drugs And Biologics

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for March 19, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action.
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
  • Biologics: No biologics recalled this week.
  • Drugs: CTV Best Group Inc., from Duluth, GA voluntarily recalled BEST Slim, a dietary supplement with 40 pills per bottle. The weight loss pill was marketed without FDA approval as an undeclared drug, sibutramine, was present. Specialty Medicine Compounding Pharmacy from Lafayette, South Lyon, MI recalled Dextrose Vial in Sterile Water due to non-sterility and mold in the product.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
  • Biologics: Blood Systems, Inc. from Scottsdale, AZ recalled several products including Red Blood Cells (Apheresis) Leukocytes Reduced, Platelets Pheresis Leukocytes Reduced, and Platelets Pheresis Leukocytes Reduced Irradiated due to inappropriate testing and donor unsuitability. OneBlood, Inc. recalled plasma, platelets, and red blood cells. Mid-America Transplant Services recalled human corneas due to an unsuitable donor. 
  • Drugs: Actavis Elizabeth LLC from Elizabeth, NJ recalled Alprazolam 1 mg Tablets due to consumer complaints of significant tablet erosion. The recall was voluntary and nationwide.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
  • Biologics: Blood Systems, Inc. and OneBlood, Inc. also had a few Class III biologics recalls. One Lamda Inc. recalled Terasaki HLA Tissue Typing Trays due to false positive results.
  • Drugs: E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York recalled Triamcinolone Acetonide Cream USP due to a labeling error, which read 01% rather than 0.1%. Qualitest Pharmaceuticals recalled Carisoprodol Tablets due to impurities. Pinnacle Biologics, Inc. recalled Photofrin (porfimer sodium) for Injection due to faulty expiration dates.
About FDA Enforcement Reports
Users have several options in viewing the report. The Product view is set as default. Users can select Event View, Print-Friendly View, Pending, and Download CSV.  For more information, view the Enforcement Report Navigation and Definitions page.