Thursday, October 31, 2013

Pharmagen Announces Shift In Growth Strategy

SILVER SPRING, Md., Oct. 31, 2013 Pharmagen, Inc. (OTCBB: PHRX) (the "Company" or "Pharmagen") announces that it will shift its near-term focus to developing and deploying a  business plan to build a solid foundation for revenue and EBITDA growth.  Pharmagen's multi-solution driven model and access to public markets are an attractive platform to build a significant national competitor in the fight against drug shortages.
"We have been listening to our advisors and the street.  Before we can implement on our bigger vision, we have to get back to the basics," says Mackie Barch, Pharmagen's CEO.  "The plan is already underway and we expect to start implementing on it by the end of the year.  The plan has two parts:  One, to build organically off the foundation and platform we already have; and Two, to use that platform to support a comprehensive acquisition strategy.  We have already identified a list of target acquisitions and are currently seeking advice from investment banks, healthcare advisory/investment firms and/or family offices," Mackie continued. 
Pharmagen's goal is to engage the support needed to implement the plan, which includes financial partners and/or consultants that have experience and a proven track record in roll-up and consolidation plans.  Pharmagen has set a goal of acquiring three to four potential targets in the coming year.
About Pharmagen
Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. offers innovative solutions to the nations sterile pharmaceutical crisis.  With a multi-solution approach, Pharmagen is helping to meet the demand of the health provider market through independent wholesale, compounding, and IT solutions.  Nationally focused, Pharmagen is a distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins.  Pharmagen currently functions as a just-in-time source of supply for hospitals for those products that are hard-to-find due to drug manufacturers' production shortages.
Contact:  888-264-4597 or 
Follow Us on Twitter: @pharmagenrx or
The Drug Shortage Report
Safe Harbor StatementInformation in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements.  These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pharmagen actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements.  The risks, uncertainties and other factors are more fully discussed in Pharmagen's filings with the U.S. Securities and Exchange Commission.  All forward-looking statements attributable to Pharmagen herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pharmagen disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.

WSJ - FDA Sets New Rules to Better Address Drug Shortages

The Food and Drug Administration has forged plans to deal with the thorny medical issue of drug shortages, especially for sterile injectable drugs like those used in emergency medicine, cancer and intravenous nutrition.

Under a new rule, the FDA will require companies to notify the agency of any plans to stop making drugs that are in short supply, or of any temporary manufacturing stoppages that would threaten supply. For the first time, the FDA will also apply these requirements to complex "biologic" drugs that are manufactured in microorganisms, plant cells and animal cells.

The FDA will take these actions through a new federal rule, and a strategic plan on drug shortages, both of which will be disclosed on Thursday. They put new teeth into a law passed by Congress in 2012 and an order signed by President Barack Obama in 2011.

Many drugs are in chronic short supply, and production snafus can create other shortages.

"Drug shortages are complex, and this isn't something that will be resolved overnight," said Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. "But we can find workarounds when there are other manufacturers" to make a drug in short supply.

The federal agency has already made some progress on the drug-shortage front, with more companies alerting it to coming shortages so that it can proactively find substitute manufacturers. Following the 2011 presidential order, the number of notifications by companies alerting the FDA of impending production stoppages has increased six fold. The agency said, too, that it has helped prevent 195 drug shortages in 2011 and 282 in 2012.
But this accomplishment falls far short of resolving the problem, according to doctors and researchers.
"The number of new drug shortages is declining, and that's good news," said Erin R. Fox, manager of the Drug Information Service at the University of Utah. "But the ones we have already are not going away. The current status is we're really stuck, and it's almost getting worse."

Among those drugs in shortest supply, she said, are electrolytes, vitamins and fluids used in resuscitation and in treatment of premature infants. "Patients are going without therapy," said Dr. Fox, describing the situation as "incredibly critical." She said the problem stems from the fact that there are only a handful of companies making mostly generic versions of the products in question. From time to time, these companies have closed down some of their production because of impurities such as glass or metal found in injectable products.

Intravenous drugs for cancer, including liquid nutrition for patients unable to eat and drink by mouth, also are in short supply.

Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology, said there have been shortages of mostly generic cancer drugs such as leucovorin, daunorubicin and cytarabine.
"None of this has really gotten better," said Dr. Schilsky. "It's hard to say what the FDA can do except use discretion in their regulatory oversight, and work with suppliers to assure adequate raw material supply."

Mold in tainted medicine identified

Henry Ford Hospital identified Wednesday the types of mold it found in two vials of medicine supplied by a South Lyon compounding pharmacy.

One of the vials was contaminated with penicillium, a fungus that rarely causes illness, and the other contained aspergillus, which has been known to cause illnesses, especially among those with weakened immune systems, the hospital stated in a press release issued Wednesday.

The vials contained D50 — or dextrose 50 percent — which is sugar water, used to treat those with extremely low blood-sugar levels.

The contamination was discovered Oct. 16 by Henry Ford pharmacy technician Marilynn Hymon-Williams. The hospital immediately pulled all vials of the medication off its shelves and notified the manufacturer, Specialty Medicine Compounding Pharmacy.

Henry Ford officials analyzed the D50 vials that were removed from use, the press release stated. Most of them were free of contamination. However, one vial contained the penicillium fungus, and another vial contained aspergillus.

The South Lyon facility issued a voluntary statewide recall Oct. 18.

Officials at Specialty Medicine Compounding Pharmacy could not be reached for comment Wednesday.

The vials were sealed, hospital officials said, and showed no signs of tampering. The medicine was used at Henry Ford Hospital in Detroit but no other system facility.

There is no evidence anyone received a contaminated D50 shot, hospital officials said.

But the hospital is notifying 226 patients who were treated with D50 during their hospitalization at Henry Ford Hospital in Detroit between July 25 and Oct. 16 to contact the hospital if they have any signs of fever, cough, shortness of breath or pain from taking a deep breath.

Aspergillus infections are treatable, officials said.

Henry Ford has established a call line, 313-874-7733 for those with questions about their health or about the recall

South Lyon Pharmacy Closes Doors After Contamination Discovered

10/31/13 - Specialty Medicine Compounding Pharmacy in South Lyon has closed its doors following the discovery of mold in some of its sterile medications. On October 16th, Henry Ford Hospital in Detroit identified vials of dextrose solution, known as D50, produced by the pharmacy that had strange particles in the fluid. The hospital analyzed numerous vials from the pharmacy and, while most were free of contamination, two of them were found to contain mold. One contained penicillium, a relatively harmless fungus, while the other contained aspergillus (pictured), which can cause illness in humans, especially those with a weakened immune system. A voluntary recall of the pharmacy’s medications took place on October 18th, and yesterday Specialty Medicine Compounding announced that it would be temporarily closing its doors. A statement from the pharmacy’s PR firm indicates that the staff is currently working to transfer patients’ prescriptions to other pharmacies. So far no illnesses have resulted from the contaminated vials, but Henry Ford Detroit is urging those who were hospitalized there between July 25th and October 16th to be on the lookout for symptoms associated with infection. Anyone experiencing fever, cough, shortness of breath, or pain during deep breaths should contact the hospital at (313) 874-7733 for treatment, or they can email Patients will not be billed for the cost of treating an infection resulting from this incident. (TD)

Mass. Senate OKs compounding pharmacy regulation bill

The Senate today unanimously approved legislation regulating compounding pharmacies, nearly a year after a deadly national meningitis outbreak that originated at a Framingham pharmacy.

The House approved its version of the bill earlier this month.

Sen. John Keenan (D-Quincy), who co-chairs the Committee on Public Health, said the legislation brings compounding pharmacies "out of the shadows" and regulates them to ensure there are no more tragedies.

Thousands of people were sickened by a tainted steroid originating from the New England Compounding Center in Framingham, and 64 people died.

Differences in the two bills now have to be reconciled. The Senate bill (H 1899) exempts hospital pharmacies from aspects of the regulations, a difference Sen. Mark Montigny (D-New Bedford) criticized. Montigny said he wondered why hospitals would be exempt when they do a significant amount of compounding, and pointed out that hospitals make medical errors too that result in injury and death.

The bill establishes sterile compounding and complex non-sterile compounding specialty licenses to be issued by the Board of Registration of Pharmacy and requires inspectors to conduct both planned and unplanned inspections of licensed pharmacies. It also reconstitutes the Board of Registration of Pharmacy, and requires continuing education hours for pharmacists in sterile and complex non-sterile compounding.

Stores and pharmacies would also be required to report any improper dispensing of prescription drugs that result in serious injury or death to the Department of Public Health, as well as report any adverse drug events.

Tuesday, October 29, 2013

H.R. 3204: Drug Quality and Security Act - 42% of Passage

This bill passed in the House on September 28, 2013 and goes to the Senate next for consideration.
IntroducedSep 27, 2013
Referred to CommitteeSep 27, 2013
Passed HouseSep 28, 2013
Passed Senate...
Signed by the President...
42% chance of being enacted.
Only about 23% of bills that made it past committee in 2011–2013 were enacted. [show factors | methodology]

The committee chair determines whether a bill will move past the committee stage.

US lethal injection drug shortage

Texas has 317 inmates on death row, but only enough of a key lethal injection drug to execute two of them. Ohio has just one dose of the drug left.  
A nationwide shortage of sodium thiopental, an anesthetic that is part of the three-drug cocktail used in lethal injections, has thrown capital punishment in the United States into disarray, delaying executions and forcing the change of execution protocols in several states.
Last month, Hospira—the sole U.S. company approved to manufacture the drug—announced it will no longer produce sodium thiopental. This move followed a global campaign by death penalty opponents and pressure by Italian government officials after the company sought to shift production of the drug to an Italian plant.
The shortage of sodium thiopental has forced the 35 states using lethal injection to scramble for any remaining stock and to explore alternatives. 
“Many states will have to change their method of execution, which means regulatory changes that have to be approved and lengthy court challenges,” says Richard Dieter, executive director of the Death Penalty Information Center. “In many states, this could take months, if not years, delaying executions.”
Some states—including California, Arizona and Nebraska—were able to obtain the drug from suppliers in England and India. The British government has since banned such shipments. A class-action lawsuit against the Food and Drug Administration’s decision to allow the importation of the drug into the country without adequate inspection or quality checks is pending. Death penalty opponents have raised questions about the quality of the drugs, arguing that if the drugs were expired or otherwise failed to work effectively, inmates could suffer significant pain, violating the ban on cruel and unusual punishment. 
Whether executions will have to be delayed depends largely on the ability of states to make changes to their lethal injection protocols without legislative or regulatory changes.
In some states, switching to a new drug protocol is easily done. For an execution in December, Oklahoma replaced sodium thiopental with pentobarbital, a drug commonly used to euthanize animals. It is believed to be the first time the drug was used in a lethal injection. Ohio plans to do away the three-drug cocktail altogether..Beginning in March, the state will use a single dose of pentobarbital, becoming the first state to use the drug alone. This protocol is untested and many states are watching Ohio before changing their own protocols.
Tennessee is considering such a drug switch, which would not take long for the state to implement. Dorinda Carter, spokeswoman for the Tennessee Department of Correction, said such a change does not require new legislation and could be done after a departmental review. 
However, other states have long regulatory and review processes. In Maryland, for instance, the current protocol under review has been withdrawn because changes will be so substantial that the rules will have to be completely revised.
“Our current proposed regulations have been withdrawn, so the process for writing new proposed regulations starts again. There is no set timetable for that process," said Rick Binetti, a spokesman for the state Department of Public Safety and Correctional Services,
Dieter explained that many other states face a lengthy regulatory process, including California and Kentucky. In addition, any change in the drug or its supplier will likely lead to lawsuits from inmates facing execution. Dieter said he expects there will be legal challenges in almost every state currently using sodium thiopental. 
“Lawyers will challenge the use of new drug protocols or drugs that are imported from overseas,” he said  “Either way, there is enough of a change to warrant a challenge.” 
In the meantime, states continue to seek additional sources of sodium thiopental. On Jan. 25, 13 states asked the U.S. Department of Justice for help in identifying sources for the scarce drug or by making federal supplies available to states.

Today's Shortages


Ohio: Child Killer to Get Untried 2-Drug Injection

Ohio will use a dose of two drugs never tried before in a U.S. execution to put to death a condemned inmate who raped and killed his girlfriend's 3-year-old daughter, the state prisons agency said Monday.

Lawyers for death row inmate Ronald Phillips immediately sued to put off his Nov. 14 execution, saying Ohio delayed the announcement so long it didn't leave enough time to fully investigate the new method.
The agency made the decision because it couldn't obtain a supply of its former execution drug, pentobarbital, from a specialty pharmacy that mixes individual doses for patients, prisons spokeswoman JoEllen Smith said. The agency had considered using a compounding pharmacy after its supply of federally regulated pentobarbital expired last month.
Instead, the state will use an intravenous combination of midazolam, a sedative, and hydromorphone, a painkiller, in the Nov. 14 execution of Ronald Phillips of Akron.
Those drugs already are included in Ohio's never-tried backup execution method, which requires them to be injected directly into an inmate's muscle. No state has put a prisoner to death with that combination of drugs.
Florida uses midazolam as the first of three drugs, while Kentucky includes the two in its untested backup method.
Phillips, 40, was sentenced to death for killing Sheila Marie Evans in 1993 after a long period of abusing her.
Gov. John Kasich is weighing clemency for Phillips following the state Parole Board's unanimous recommendation against mercy last week.
Attorneys for Phillips filed documents in federal court Friday asking a judge to let them expand a current lawsuit to challenge the use of compounded pentobarbital. They filed an updated complaint Monday just hours after the state's announcement that it was selecting the two other drugs instead.
The state said it's reviewing the filing. Judge Gregory Frost scheduled a hearing for Friday.
Phillips' lawyers also are challenging the Department of Rehabilitation and Correction's decision to allow its director to delegate responsibilities for some execution duties. Phillips' lawyers say that breaks an agreement the agency made previously with Frost's approval.
Ohio's execution policy calls for it to try to buy specialty batches of pentobarbital from compounding pharmacies, which mix individual doses of drugs for specific patients. If that fails, the policy calls for the use of the two-drug approach.
A plan by Georgia to use a similar specialty batch of pentobarbital has been put on hold by a federal 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.
Compounding pharmacies are under increased scrutiny following last year's meningitis outbreak that killed more than 60 people and sickened hundreds and was linked to contaminated ingredients at the New England Compounding Center in Massachusetts.
Phillips' lawyers have pushed for mercy, arguing he was raped and beaten by his late father as a child and grew up in a chaotic, filthy environment.
The state says Phillips long denied suffering such abuse and raised it only as his execution became imminent.

FDA: 7 Infections Tied To Steroid Injections From Tenn. Compounding Pharmacy

Federal health officials are investigating reports of complications caused by possibly contaminated medications made by a Tennessee specialty pharmacy.

The Food and Drug Administration said Friday that the investigation involves seven reports from patients who received steroid injections from Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

The injections contain methylprednisolone acetate, the same drug at the center of last year's deadly outbreak of fungal meningitis. More than 55 people have died and over 740 others have been sickened after receiving contaminated injections from a Massachusetts compounding pharmacy, the New England Compounding Center. The steroids are usually used to treat pain and reduce inflammation.

The FDA said in a statement at least one of the seven cases appears to be a fungal infection. The government recommends doctors stop using any sterile drugs distributed by the pharmacy and quarantine them until further notice.

To date, there have been no reports of meningitis or life-threatening infections, the State of Tennessee Department of Health said in a press release.

The department added the patients were in Illinois and North Carolina, and received the injections after Dec. 6, 2012.

Health care facilities in at least 13 states received the products including: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, South Carolina, Tennessee and Texas.

"The pharmacy staff and management have been cooperative," state regulators added in the press release.

The Dyersburg State Gazette reported in April that Main Street Family Pharmacy had been placed on probation for two years by the Tennessee State Board of Pharmacy beginning in March. Last November, the Board had inspected the facility and found violations related to drug compounding, expired medications, and outdated prescription orders, the Tenn. paper reported.

CBS News requested comment from the pharmacy but phone calls were not returned.
Main Street Family Pharmacy is a compounding pharmacy, which means it mixes custom formulations of drugs based on doctors' specifications.

Compounding pharmacies have long operated in a legal gray area between state and federal regulations. Since last year's outbreak, the FDA has stepped up inspections of compounding pharmacies across the country, triggering several national recalls of potentially contaminated medications.

Drug compounders have been overseen by state pharmacy boards, with regulations varying widely depending on the state. Over the last 20 years some compounding pharmacies have grown into larger business, operating more like manufacturers by shipping thousands of doses of drugs across state lines. The FDA has occasionally tried to assert its authority over these operations, though it has repeatedly been challenged in court by pharmacy owners.

Legislation moving through Congress would give the FDA direct oversight over these so-called compounding manufacturers, with the aim of preventing future national outbreaks tied to compounded medications. While Republicans and Democrats in the Senate have coalesced around a bill, the House has not reached any such agreement.

Monday, October 28, 2013

Lacking Lethal Injection Drugs, States Find Untested Backups

The U.S. is facing a shortage of a drug widely used for lethal injections. With few options, states are turning to new drugs and compounding pharmacies, rather than overseas companies.

The move is raising safety concerns, and in some cases delaying executions. Other executions are proceeding, however, and advocates are asking whether the use of new drugs violates the inmates' Eighth Amendment protection from cruel and unusual punishment.

A Witness To Lethal Injection

In 1989, William Happ was sentenced to death for the murder and rape of 21-year-old Angie Crowley. For decades, Happ appealed and lost.

His death sentence remained, but the method of execution had changed since his conviction. Since 1924, Florida had used the electric chair to execute prisoners, but in 2000, facing pressure from the Supreme Court, the state switched to lethal injection.

More than a quarter century after Crowley's murder, Happ's execution date was finally set for Oct. 15, 2013. But the state had a problem: Supplies of pentobarbital, a drug commonly used for executions, were running low. As the execution date approached, the state ran out of the drug altogether.

So the Florida Department of Corrections decided to use a new drug a sedative called midazolam that had never been tested for execution. Nobody knew exactly how it would work.

Associated Press reporter Brendan Farrington was in the viewing room. "It's a very solemn, serious, quiet atmosphere. There's no talking," he tells All Things Considered host Arun Rath.

"They bring the witnesses in, and there's a screen across a long, rectangular window. And when they're ready to begin, the screen slowly rises," Farrington says. "The person conducting the execution will announce that the sentence is about to be carried out, tells this to the condemned, and asks if he has any last words."

Happ chose to speak, admitting to the crime and expressing shame for it. "[He said] he hopes God forgives him, and he realizes the family probably could not," Farrington says. "From there, the execution proceeds."

At 6 p.m. sharp, the execution began. Farrington had seen three other executions, none of which used midazolam. In those cases, he says, the prisoners' eyes closed "fairly quickly, and once their eyes closed, they usually stay closed."

"While it wasn't dramatically different than previous executions, it did seem like it took him longer to lose consciousness," Farrington says. "In Happ's case, his eyes were still opening two, three, four minutes into the process. Once they closed, about 10 minutes in, his head started moving kinda just around, and there was some motion."

There's no way to know if Happ was in pain during his last moments. Some anesthesia experts have expressed concern that midazolam and other untested sedatives could fail to work properly during an execution. If that happened, condemned prisoners could die slowly or painfully, a violation of legal guidelines for executions.

Megan McCracken studies lethal injection drugs for the Death Penalty Clinic at the University of California, Berkeley, School of Law.

"If the first drug does not in fact deeply anesthetize the prisoner," she says, "then he or she could be conscious and aware of being both paralyzed and able to experience pain and the experience of cardiac arrest."

In Search Of Drugs

NPR's Kathy Lohr has been covering the shortage of lethal injection drugs for years. She says the issue started when the drug company Hospira stopped making one of the most common drugs used in lethal injections, sodium thiopental. The anesthetic was used as part of a three-drug protocol.

"The company was the only maker of the drug in the United States," Lohr says. "But by 2011, the company stopped manufacturing it. In part, it really wanted to distance itself from executions."

The move caused a shortage, she says, "which basically led states to search for the drug wherever they could find it."

Some states began trading between themselves. Once the supply either runs out or expires, states are forced to come up with new protocols, find new drugs, or simply postpone the execution.

Missouri recently canceled an execution because it had planned to use propofol, a widely used anesthetic in U.S. hospitals. The drug is manufactured in Europe by the German company Fresenius Kabi. That potentially could have caused larger problems.

"The European Union has a statute that does not allow the export of any product that might be used in capital punishment," says company spokesman Matt Kuhn.

So when Fresenius Kabi got word of Missouri's plan to use the drug for capital punishment, it began limiting how the propofol would be distributed in the U.S. Kuhn says it supplies about 90 percent of the U.S. market for the drug.

"If propofol was used in an execution, then the likelihood of sanctions or a ban exporting it from the European Union would become a reality," he says. "And in turn, that would lead to a shortage of the product that's used 50 million times a year in the U.S."

Missouri announced Tuesday it would not use propofol; it's going to use pentobarbital instead.

Richard Dieter, who opposes the death penalty and directs the Death Penalty Information Center, says Missouri made the right decision in switching drugs.

"I think Missouri wisely got out of that whole crisis area and now finds a local pharmacy that will make a different drug, and joins Texas and some other states like Ohio and Georgia in this process," he says.

Compounding The Issue

But now there's another issue: Missouri and a number of states are now getting their drugs from compounding pharmacies. That bypasses the big European drug manufacturers altogether. The U.S. Food and Drug Administration doesn't regulate them, either.

"The drugs they're producing, including this pentobarbital, are not made specifically for executions and ... no court has actually reviewed this process," Lohr says. "So if the drugs cannot be validated as effective, this could be a violation of an inmate's Eighth Amendment right against cruel and unusual punishment."

Texas, Ohio and Missouri all have announced plans to use compounding pharmacies just this month.

"I think we should be using the best practice not what's available," Dieter says. "And that's what we've come down to: What can the states get a hold of from the backroom of local pharmacies, rather than what's recommended by medical experts."

In addition, states are withholding details about the compounding pharmacies. Georgia inmate Warren Lee Hill is challenging the state's claim that the information should be kept secret.

"His attorneys say they need this information about where the drug is coming from and how it's manufactured even to know if they can mount a legal challenge," Lohr says.

The states argue that the pharmacies may not want to sell the drugs if it's made public that they're contributing to capital punishment. A lack of sellers and therefore drugs could get in the way of carrying out executions.

"So that issue is now making its way through the courts in Georgia, and the execution of an inmate here, Warren Lee Hill, is on hold," Lohr says. "Also, more legal challenges are expected on this issue across the country."

CDC issues update on multistate outbreak of fungal meningitis, other infections

A year ago this month, the Centers for Disease Control and Prevention activated its Emergency Operations Center as part of the response to the tragic outbreak of fungal meningitis linked to three contaminated lots of preservative-free methylprednisolone acetate produced by the New England Compounding Center. As of October 23, 2013, there have been 751 cases of fungal meningitis and other infections associated with this outbreak; 64 of these patients have died. Since July 2013, one new case has been diagnosed. 

This week, CDC has two papers in the New England Journal of Medicine, one describing the clinical aspects of the infections associated with this outbreak and the other summarizing the epidemiologic investigation. The clinical paperExternal Web Site Icon, focusing on the early stages of the outbreak, describes patients who experienced a wide variety of illnesses, including meningitis, stroke, arachnoiditis -- inflammation of one of the membranes around the brain and spinal cord -- and epidural or paraspinal infections which ranged in severity from very mild to life-threatening. The epidemiology paperExternal Web Site Icon finalizes the original preliminary report published by the New England Journal of Medicine and details the efforts undertaken by public health agencies to identify and stop the outbreak.

This outbreak affected hundreds of people and their loved ones across the nation. Many patients continue to struggle with complications from fungal infections, including side effects of the antifungal drugs used to fight the infections, and continuing problems related to their infections. Many other people who received MPA or other NECC products, but who may not meet the CDC case definition, have faced anxiety surrounding their risk of infection.

To learn more about the long-term impacts of this outbreak, CDC awarded a contract to the University of Alabama at Birmingham to follow as many as 500 people with infections identified as a part of this outbreak. The study, which will run through at least August 2015, is designed to help answer questions about the longer-term health impacts on patients, which treatments were most effective and what their side effects are, how long treatment is needed, and whether and how often patients relapse after stopping therapy. Patients are being enrolled in the study by their infectious disease physicians. This information will be used to improve the care of current patients and any future patients linked to this outbreak, and potentially can inform treatment decisions in future cases of meningitis caused by similar types of fungal organisms.

This has been the largest outbreak of healthcare-associated infections ever reported in the United States. Since the outbreak began, additional outbreaks have been identified and linked to contaminated products from other compounding pharmacies. These outbreaks show the urgent need to address shortfalls in the oversight and safety of compounded drugs to reduce the inherent risks associated with these products, which have not undergone review and approval by the Food and Drug Administration. CDC supports efforts by FDA and state Boards of Pharmacy to provide appropriate and effective oversight of compounding pharmacies.

Saturday, October 26, 2013

Novo Nordisk recalls diabetes drugs in Europe

Novo Nordisk is recalling 3 million insulin products used for diabetes treatment in 13 European countries due to a production problem that can affect the strength of the drug.

The Danish drug maker says Friday's recall affects certain batches of the prefilled insulin pen NovoMix30 FlexPen in Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Luxemburg, Netherlands, Norway and Slovakia.

It also affects three batches of NovoMix30 Penfill cartridges in Britain and Ireland.
Novo Nordisk says a quality control showed 0.14 percent of the products don't meet the specifications for insulin strength, which could lead to high or low blood sugar levels.

Company spokesman Mike Rulis said there had been no reports of health problems from patients using the affected products, which were first shipped in March.

Repost: Cancer drug shortages create greater risk, costs

Cancer drug shortages are forcing treatment changes and delays that for some patients have led to worse outcomes, more therapy-related complications and higher costs, according to a national survey of health professionals published Thursday.

According to the survey results, of the 243 individuals who completed the survey, 98 percent reported having dealt with a shortage of at least one chemotherapy agent or other essential cancer-related drug in the previous 12 months.

“Drug supplies remain unpredictable, and serious problems persist,” said James Hoffman, PharmD, senior author of the results study and an associate member of St. Jude Children’s Research Hospital Department of Pharmaceutical Sciences and the hospital's medication outcomes and safety officer, in a press release.

The survey was conducted by the Hematology/Oncology Pharmacy Association and focuses specifically on the impact of cancer-related drug shortages. Survey results will be published in the April 1 edition of the American Journal of Health-System Pharmacy. The study was funded in part by a grant from the National Institutes of Health and ALSAC, the fund-raising arm of St. Jude Children’s Research Hospital.

The survey also found that 93 percent of participants reported that shortages forced delays in chemotherapy administration or other changes in cancer drug therapy.

Overall, 16 percent of respondents tied shortages to adverse patient outcomes, including disease progression or more treatment-related complications. One institution linked a patient's death to a shortage-related medication mistake.

The survey found shortages increase healthcare costs as scarcity drives up the price and requires staff time to manage the problem. About one-third of institutions in the survey reported pharmacy staff spent at least 20 hours each week working on issues related to the drug shortage. That included time spent trying to find scarce medications to purchase or identify alternatives. Eighty-five percent of respondents reported shortages led to higher medical costs.

Drug shortages also disrupted the clinical trials that are essential for developing new cancer treatments. The survey found that shortages forced 44 percent of institutions to either halt or delay enrollment in clinical trials. The problem also led some providers to change or omit medications.

The drugs most frequently reported in the survey as being in short supply were fluorouracil, leucovorin, liposomal doxorubicin and paclitaxel. Such shortages hit patients battling ovarian, breast and colorectal cancers particularly hard. For some patients, the survey found shortages meant traveling to other institutions for treatment or receiving alternative medications. For other patients, it meant treatment was delayed or continued with either lower doses of the missing drugs or without the drugs at all.

“To cure cancer patients we must often use complex treatment regimens, and shortages add unnecessary complexity. Unlike medications for other diseases, there are few, if any, therapeutically equivalent alternatives available for many oncology drugs in short supply,” Hoffman said in the press release.

In February, the University of Utah Drug Information Service, which monitors drug shortages and advises how to manage them, tracked national and regional shortages of more than 320 drugs, the highest number since 2010.

In 2012, legislation gave the U.S. Food and Drug Administration (FDA) additional tools to prevent and ease drug shortages, including requiring manufacturers to report anticipated supply problems of key medications. Despite the legislation, Hoffman said in the press release, “Drug supplies remain unpredictable and serious problems persist.”

Tackling America's greatest drug problem

America has a major drug problem, but it’s not the one that probably comes immediately to mind. It is a continual and rotating shortage of important drugs needed to treat a variety of legitimate medical conditions impacting patients and the healthcare supply chain.

The drug shortage issue has been an ongoing problem in recent years, even with a concerted effort to reduce shortages through earlier manufacturer notifications and better government enforcement. In October, the numbers of drugs in short supply ran between 100 and 250, depending on which organization is referenced.

There are a lot of different factors for the continued shortages, said Curtis Rooney, president of the Healthcare Supply Chain Association. “There are issues with production, with oversight and enforcement by the FDA, and with reimbursements. Right now it is creating a perfect storm.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) agrees. “The factors that contribute to drug shortages are complex and multidimensional,” the organization says. Among the reasons it cites for the shortages are:

shifts in clinical practices
wholesaler and pharmacy inventory practices
raw material shortages
changes in hospital and pharmacy contractual relationships with suppliers and wholesalers
adherence to distribution protocols mandated by the FDA
individual company decisions to discontinue specific medicines
natural disasters
manufacturing challenges
Rooney said drug shortages in recent years have been aided by the insufficient oversight by the Food and Drug Administration, but much of that was due to lack of authority on that agency’s part. Rooney expects new enforcement powers given to the FDA will soon pay off.

In the meantime, however, drug shortages continue to impact the healthcare supply chain, contribute to a “gray market” of alternative drugs, in some cases encourage price gouging, and in all cases, impact patient care.

The consequences of drug shortages are felt quickly in the supply chain, said Brent Petty, system vice president of supply chain at the Wellmont Health System in Kingsport, Tenn.

“When we have shortages it forces us to do a number of things,” Petty said. For one, “it forces us to reach out to non-contracted distributors. This may create a little bit of risk, because we may not know who is really behind that drug.”

Supply chain managers may have to execute a lot of electronic work-arounds as well, since these distributors are not a part of the hospital’s normal supply chain and distribution systems would otherwise reject the orders.

And having to work outside the normal supply chain means that a hospital may not get the pricing it desires, Petty noted.

According to PhRMA, when gray markets spring up, the potential for price gouging is high and the safety of products is not assured because there is no oversight to ensure that the products have been properly handled.

Another consequence of shortages that impacts the supply chain is panic. When drug distributors or healthcare clients learn of a pending shortage on one drug, said Roslyn Schulman, director of policy at the American Hospital Association, they create unanticipated demand for alternative drugs, which in turn leads to a shortage of those.

Friday, October 25, 2013

The unspoken contributor to drug shortages, strategic overstock

The other day I discovered a new term being thrown around in pharmacy circles, and that term is “strategic overstock”. The best way to describe strategic overstock is to call it what it is, i.e. hoarding. Of course healthcare systems don’t want you to call it hoarding because that would be considered inappropriate so they created a term that makes people think they’re doing something positive; marketing spin, if you will.

Regardless of the term being used, strategic overstock is clearly a contributing factor to the drug shortage problem that has plagued hospitals for the past couple of years. Don’t believe me? Consider this. Most hospital pharmacies keep pretty tight control of their inventories for obvious reasons, i.e. cost. Hospital pharmacies, like all entities that deal with high value items, try to turn their inventories as often as possible. No one wants to be sitting on millions of dollars of inventory at any given time.
I’ve visited with pharmacies that shoot for a 3-5 day supply of medication in the pharmacy, but that’s not common. It takes a great team with good data to run a pharmacy that tightly. More often I’ve seen inventory levels kept between 7 and 14 days. Sometimes more, but you get the gist.

Recently I came across a hospital pharmacy that keeps a 3 month supply of medications identified as “short” or on backorder; strategic overstock. This particular hospital has gone as far as to build a separate storage area away from the main pharmacy to manage their overstock, as well as dedicate an entire FTE to procuring and managing this strategic overstock.

This hospital has approximately 580 acute care beds. Assuming that most hospitals were to sit on a 14-day supply, it’s easy to see how much resources this facility is literally keeping out of the global system for patient care. Some simple math tells me that they’re eating up certain drug resources for at least five other hospitals of similar size; more if you consider smaller hospitals.

I’ve seen outrage over drug shortages. ASHP has gotten involved. Political entities have screamed at the top of their lungs, and gone as far as to enact legislation to prevent drug shortages. People have hammered drug companies for being irresponsible in how they’ve handled the drug shortages. But no one is looking to facilities to discourage what I’ve described above.

Strategic overstock is certainly a contributing factor to the drug shortage problem. I’d go as far as to say that it’s made the problem not only worse, but prolonged it. Why aren’t regulatory agencies looking at the problem and attempting to curtail it? Shouldn’t facilities that hoard medications in short supply be held accountable? I certainly think so.

Pharmacist told raw ingredient shortage cause of rising prescription prices

ATLANTA — You may notice an increase in your prescriptions.

Tanisha Clark certainly has noticed. She has to take a daily medication, but has now stopped taking them on a daily basis.
"I used to take a 90-day supply. I no longer get it filled because I can't afford it," Clark told Channel 2's Dave Huddleston.

Pharmacist Ira Katz has noticed the same thing.

"I'm just absolutely astounded by the proliferation of price increases in the generic drug industry," Katz said.

Katz says medication that used to cost $10 is now several hundred dollars.

"That's significant. Absolutely amazing," He said.

Katz told Huddleston the reason he got for the increase was because of a shortage of raw ingredients.

Katz said he is skeptical, and so is patient advocate Dorothy Leone-Glasser.

"I think there is another reason behind that," Leone-Glasser said.

Katz agrees. He suspects drug or insurance companies are increasing prices now, before the Affordable Care Act starts in March 2014 and they aren't able to increase prices.

Katz doesn't recommend you stop taking your medication as prescribed. Talk to your doctor first about switching the medication first.

"A lot of doctors are unaware of these increases, so we're having to call a doctor and say, 'Look this patient can't afford the cost of this medication, could we switch to something similar in the same class that hopefully could do the job?'" Katz said.

Today's Shortages

Mannitol Inj.

Thursday, October 24, 2013

Australia - Patients warned over shortage of hyperthyroidism drug

Australian pharmacies are running out of the medication for hyperthyroidism, a potentially life-threatening condition that affects about one in 50 people.
The Therapeutic Goods Administration (TGA) says patients should work out how much of the drug Carbimazole they have left and contact the their doctor to apply for more.

The TGA says the application process could take up to 10 working days, but the drug will be available sooner for patients who are seriously ill.

There is a global shortage of the drug, also known as Neo-Mercazole, which is often prescribed for people who have an overactive thyroid.

An alternative supply of the drug will not be available in pharmacies until mid-November.

Patients have been advised to work out how much of the drug they have left and then to contact their doctor to get more.

The company licensed to provide the drug, Link HealthCare, has apologised for the disruption in supply and has sourced a generic product based in Germany.

Today's Shortages

Butorphanol Tartrate Nasal Spray
Citric Acid, Gluconolactone, Magnesium Carbonate Irrigation Solution
Methotrexate Tablets
Phenobarbital Tablets
Prednisone Tablets
Sufentanil Injection
Sulfacetamide and Prednisolone Ophthalmic Ointment

Soloman Islands - Hospital reportedly faces drug shortage

BASIC medical drugs at the National Referral Hospital are reportedly running low.

That’s according to a well-placed source at the hospital.
“You’ve only heard of shortage of beds and lines at the hospital. But there’s also an acute shortage of basic drugs,” the source said.
“This is not new, it’s a problem we had here for a while,” the source added.

Permanent Secretary Dr Lester Ross and the Minister Charles Sigoto are not available for comments as they are abroad.
Attempts to talk to the undersecretary health care, Dr Cendric Alepandava also failed.

The health minister Charles Sigoto earlier said the ministry is seriously dealing with bed and doctor shortages at the hospital
But he never said anything about the shortage of medicine.

“We are dealing with the issues of bed and shortage doctors so I request everyone to be patient,” Mr Sigoto said.
This latest revelation of medicine shortage has sparked intense debate in the popular social media network, Forum Solomon Islands International.

Infections From Tainted Steroids Ranged in Severity: Update

WEDNESDAY, Oct. 23 (HealthDay News) -- The tainted steroid injections that caused a deadly meningitis outbreak last year seem to have triggered a broad range of symptoms in patients, according to a new study by the U.S. Centers for Disease Control and Prevention.

Since it began in September 2012, the outbreak of fungal meningitis has sickened 750 people in 20 states, resulting in 64 deaths, based on the latest CDC figures from last month.

The illnesses have all been traced to fungus-contaminated steroid medications that were given in injections to treat back and joint pain. A single company, the Massachusetts-based New England Compounding Center, distributed the drugs.

In the Oct. 24 issue of the New England Journal of Medicine, CDC researchers give a fuller account of the illnesses in six U.S. states that were hardest hit by the outbreak.

"This is the first detailed look at the early clinical course of patients involved in this outbreak," said study author Dr. John Jernigan, of the CDC's division of healthcare quality promotion.

Of 328 people who fell ill after having steroid injections near the spine, 81 percent had an infection affecting the central nervous system (CNS) -- the brain or spinal cord. That usually meant meningitis, which is an inflammation of the membranes around the spinal cord and brain.

Some people had other types of infections of the central nervous system, either in combination with meningitis or not. Thirty-five people suffered a stroke -- believed to be caused by the meningitis, Jernigan said -- and strokes were to blame for most of the 26 deaths in these states.

The rest of the patients (19 percent) had infections that stayed localized to the injection site and did not get into the central nervous system -- such as infections of the discs between the vertebrae.
Overall, the severity of patients' symptoms ranged from "very mild" to "life-threatening," the CDC team reported.

According to Jernigan, it's not clear why some people's infections did not invade the central nervous system. But nearly all of those non-CNS infections were seen in one state, Michigan. "We don't have an explanation for that," Jernigan said.

Whatever the details of the infections, the bottom line remains the same, according to Dr. Michael Carome of the Washington, D.C.-based watchdog group Public Citizen.

"This was a public health disaster," said Carome, who heads Public Citizen's health research group. "We think the great tragedy is, this was wholly preventable."

The tainted steroids behind the outbreak were made in a process called compounding, where a pharmacist mixes or alters drug ingredients to create a medication that meets particular patients' needs.

According to the U.S. Food and Drug Administration, compounding fills a vital role for people who have special medication needs. If they are allergic to a dye used in an FDA-approved drug, for instance, compounding pharmacies can remove that dye.

The problem, according to Public Citizen and other groups, is that some compounding pharmacies have moved into widespread drug distribution that goes beyond their traditional scope. Compounded drugs are not approved by the FDA, Carome pointed out, and the pharmacies themselves have escaped the FDA scrutiny that drug manufacturers face.

But that's not because the federal agency lacks the authority, Carome said. Oversight of the specialty pharmacies has traditionally fallen to states, but when the companies take on large-scale manufacturing, the FDA should, and needs to, step in, according to Public Citizen and other critics.
"We believe they already have the authority to intervene," Carome said. "Moving forward, we think the FDA needs to be more aggressive in its enforcement."

Since the outbreak, the agency has stepped up its inspections of compounding pharmacies, and there have been a number of injection-product recalls from various pharmacies due to concerns about contamination.

For its part, the New England Compounding Center ceased operations after the start of the fungal meningitis outbreak last fall.

The CDC and state officials estimate that around 14,000 Americans may have gotten steroid injections from the pharmacy. One particular steroid, methylprednisolone acetate, has been linked to the disease outbreak.

As for what the public can do, Carome advised asking questions. If your doctor recommends an injection medication, he said, ask whether it's a compounded product. "If it is," Carome said, "ask why you're getting it, and whether there's an FDA-approved alternative."

At this point, study author Jernigan said, it's "very unlikely" that anyone exposed to steroids from the New England Compounding Center will fall ill. "But we can't say there's no risk," he added.
Jernigan agreed that the outbreak highlights the dire consequences of medication contamination. "Very bad things can happen when people are exposed to contaminated drugs," he said. "We need to take steps to make sure the medication supply is safe."

Pharmagen Announces Clotamin(R) Now Available at

SILVER SPRING, Md., Oct. 23, 2013 /PRNewswire/ -- Pharmagen, Inc. (OTCBB: PHRX) (the "Company" or "Pharmagen") today announced that Clotamin(R) is now available at Clotamin(R) is a unique and complete multivitamin formulated without vitamin k to meet the special nutritional needs of people taking blood thinning medications (anticoagulants) such as Warfarin. Because it does not contain vitamin k, Clotamin(R) can be taken with Warfarin. Warfarin is the most prescribed blood thinning medication in North America and is also known under the brand names of Coumadin(R) , Jantoven(R) , Marevan(R) , and Waran(R) . Warfarin therapy reduces the formation of blood clots, which is important in the prevention of heart attacks, strokes, and blockage of major veins and arteries.

Vitamin k is a common ingredient in most multivitamins on the market and can thicken blood and interfere with Warfarin therapy. People who are prescribed blood thinners are required to follow strict nutritional guidelines in order to maintain healthy International Normalized Ratio (INR) levels. The most significant of these guidelines is the consumption of a consistent amount of vitamin k in their diet. Clotamin includes Biotin to prevent hair loss associated with Warfarin as well as a full b complex to boost energy.

To find Clotamin(R) at, follow this link

About Pharmagen

Pharmagen, Inc. ("Pharmagen"), and wholly owned subsidiaries and operating divisions Pharmagen Laboratories, Inc., Pharmagen Distribution, LLC and Pharmagen Nutraceuticals, Inc. is the leader in innovative solutions to the nations sterile pharmaceutical crisis. With a multifaceted approach, Pharmagen is meeting the demand of health provider market through dynamic, independent wholesale, compounding, and innovative IT solutions. Nationally focused, Pharmagen is a dynamic distributor of specialty drugs, compounding and admix pharmacy and producer of over-the-counter ("OTC") branded multivitamins to the healthcare provider market. Pharmagen currently functions as a just-in-time source of supply for hospitals for those products that are hard-to-find due to drug manufacturers' production shortages.

Contact: 888-264-4597 begin_of_the_skype_highlighting 888-264-4597 FREE  end_of_the_skype_highlighting or
Follow Us on Twitter: @pharmagenrx or
The Drug Shortage Report

Safe Harbor Statement
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words "forecast", "anticipate", "estimate", "project", "intend", "expect", "should", "believe", and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Pharmagen actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Pharmagen' filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Pharmagen herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Pharmagen disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.

Wednesday, October 23, 2013

Sun Pharma soars on buzz of higher Doxil sales in US

Sun Pharmaceutical Industries touched an all-time intraday high of Rs 587 a share on Thursday on hopes of higher sales of its key cancer drug, Doxil, after innovator Janssen Pharmaceuticals Inc, a unit of Johnson & Johnson (J&J), said on Wednesday that the drug will likely be in short supply in the coming weeks.

The expected shortage in supply is due to an interruption from the company’s own supplier, Ben Venue Laboratories Inc, J&J said. The company said it is unable to provide an estimate of when the cancer drug would be available again and advised healthcare providers to contact Sun Pharma.

Analysts tracking the sector pointed out that Sun Pharma already has 50% market share in this drug, and the development means it will be the only supplier in the US until J&J resumes supply.

Credit Suisse initiated coverage on the company’s unit Taro Pharmaceutical Industries with an “outperform” rating and a target of $85, saying improving growth visibility, was seen helping the shares.

Barclays reiterated its overweight rating on the stock saying “we see renewed opportunity to drive Doxorubicin growth”.

“Given the current Doxorubicin landscape, we reiterate our OW on Sun Pharma with a 12-month price target of Rs 600. We believe that Sun could likely repeat last year’s success (CY2012 revenues of $120 million vs CY13 revenues of $63 million year to date) as a result of the current situation,” the report added

FDA announces voluntary recall of certain sterile products from Specialty Medicine Compounding Pharmacy

The U.S. Food and Drug Administration is alerting hospitals, health care providers, veterinarians, and patients of a voluntary recall of certain human and veterinary products produced and distributed for sterile use by Specialty Medicine Compounding Pharmacy of South Lyon, Mich. 


According to information provided by Specialty Medicine Compounding Pharmacy, the recalled products were distributed directly to hospitals and patients located in the state of Michigan between July 1, 2013 and Oct. 19, 2013. No products were distributed outside of the state, according to the firm.


The recall is being initiated by Specialty Medicine Compounding Pharmacy after unidentified particulate matter was found floating in a sterile product from the same lot as products that may have been administered to patients at a Michigan hospital.


At this time the FDA recommends that any sterile product produced by Specialty Medicine Compounding Pharmacy should not be used or administered to patients or animals. Hospitals, health care providers, veterinarians, and patients who have received any sterile product produced by Specialty Medicine Compounding Pharmacy should immediately discontinue use, quarantine all sterile products, and return the recalled1 products to Specialty Medicine Compounding Pharmacy.


For additional details about the recall, please contact Specialty Medicine Compounding Pharmacy at 248-446-2643.


At this time the FDA is not aware of any adverse events associated with Specialty Medicine Compounding’s products. The FDA is working closely with the Centers for Disease Control and Prevention and Michigan state officials to determine the scope of the contamination. The agency’s investigation is ongoing.


“Patient safety is a top priority for the agency, and giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Out of an abundance of caution, we are recommending that patients discontinue use of any sterile product produced by this firm.”

Missouri joins U.S. states getting execution drugs from new suppliers

KANSAS CITY, Missouri (Reuters) - A "compounding pharmacy" will supply lethal injection drugs for future executions in Missouri, the latest U.S. state to turn to the lightly regulated sector after major pharmaceutical companies refused to sell drugs for executions, the state said on Tuesday.

The Missouri Department of Corrections said in a brief statement that it would switch to using a single drug for executions, pentobarbital. Missouri had used a three drug protocol until recently.

"The department also announced that it has added a compounding pharmacy to its execution team," the statement said. Asked the name of the pharmacy, department spokesman David Owen said that information could not be disclosed.

Missouri is the latest of a half dozen U.S. states turning for lethal injection drugs to compounding pharmacies - which typically mix drugs for individual prescriptions and are subject to light federal government regulation.

The practice has drawn protests from opponents of the death penalty and advocates for death row inmates, who say the lack of regulation risks a botched execution.

A Massachusetts compounding pharmacy was the source of tainted pain injections which caused an outbreak of a rare type of meningitis last year that killed at least 50 people and sickened hundreds in 20 states.

Compounding pharmacies must register with state authorities but their products are not regulated by the Food and Drug Administration.

Texas this month executed its first prisoner using a drug from a compounding pharmacy. Other states which have turned to such suppliers or have said they may do so soon include Georgia, South Dakota, Colorado and Ohio.

A judge in Georgia this year granted a temporary stay of execution for a prisoner in part because of concerns about the quality of the compounded drug.

Missouri announced earlier this month that it would search for a new drug for executions after it came under pressure from drug makers, especially in Europe, not to use the drug propofol in executions.

A German maker of the drug, Fresenius Kabi, had suspended shipments to a U.S. distributor after some of the drug was provided to Missouri for executions.

The American Civil Liberties Union (ACLU) had published on its website embarrassing details of emails from the drug supplier pleading for Missouri not use the drug propofol in executions because of pressure from Europe.

The ACLU issued a statement on Tuesday after the announcement, protesting Missouri's decision to keep the identity of its new supplier of lethal injection drugs secret.

"The state has retaliated by now making it illegal to name anyone who supplies the drugs. This is not the open and transparent government that Missourians deserve," the ACLU said.

Joseph Paul Franklin is the next Missouri inmate scheduled for execution on November 20.,0,495696.story

Saginaw Township compounding pharmacy meets with state lawmaker on pending legislation

SAGINAW, MI — The topic of compounding pharmacies have been a touchy subject for government policy makers since a deadly outbreak of fungal meningitis in 2012 that was attributed unsanitary conditions at New England Compounding Center in Massachusetts.

In Michigan, Attorney General Bill Schuette and State Sen. Joe Hune, R-Hamburg, have proposed a new state law that will regulate compounding pharmacies in the state. Federal lawmakers are proposing federal oversight of compounding pharmacies.

Michael Collins is a prescription compounding specialist running Healthway Compounding in Saginaw Township. During a visit on Monday, Oct. 21, by State Sen. Roger Kahn, R-Saginaw Township, Collins explained that regulation is sorely lacking under the current system.

"All I had to do is fill out an application form and a self-inspection," he said.

Currently, Collins said there is no federal oversight of Michigan businesses like his, which produce custom medications for individual patients by combining medications or converting pill or tablet medicines to liquid or other preparations. State oversight is provided directly by the state attorney general's office, he said.

Collins said he and other pharmacists believe some oversight is a good thing, though he cautions people not to lump all compounding pharmacies into the same group as places like the now-defunct New England Compounding Center.

He explained that the Massachusetts facility had a variety of sanitation problems that contributed to the outbreak, which in Michigan reached 260 patients and caused 19 deaths.

"There was jut a recipe for disaster there," Collins said.

As proof that not all compounding pharmacies are created equal, he pointed to Healthway's certification through the Pharmacy Compounding Accreditation Board and his requirement for all his pharmacy technicians to be trained and accredited, despite the fact that it is not required by law.

After briefly discussing the issue with the state senator, Collins handed Kahn a sterile scrubs to wear and turned him over to his staff, who gave the state lawmaker a tour of their three compounding laboratories.

"I just want to show you what we do and let you make up your own mind," Collins said.
After the tour, Kahn said he understood the importance of following the procedures put in place to ensure the drugs are being handled in a safe and sterile way.

"It appears that is what you do," he said.

Collins explained that though there are fewer than 10 full-scale compounding pharmacies like his in Michigan, there are about 3,500 pharmacists in the state who say they are compounding drugs at some level.

Kahn pointed out that regulating so many individual pharmacists could be difficult for the state government.

Collins said that, though he supports what he believes is being proposed in the state legislation, he is much more concerned about the potential federal oversight of his business.

"I believe it's going to be much more restrictive," he said of the pending federal legislation. "We think the state should be the one regulating us, not the federal government.

"The fight at the federal level has always been with the FDA (Food and Drug Administration). It's a turf war. They want control over compound drugs."

Collins said compounding pharmacies often face opposition from large drug manufacturers because they take customers from them.

"There has been just this constant battle," he said.

Collins has been running Healthway since he bought it in 1985. The business was originally located in St. Charles.

Today's Shortages

Allopurinol Injection
Cefazolin Injection
Cephalexin Oral Suspension
Chorionic Gonadotropin (Human) Injection
Dopamine Injection
Doxapram Injection
Haemophilus B Conjugate Vaccine
Nimodipine Capsules
Nitroglycerin Injection
Pegvisomant Injection
Torsemide Injection

Tuesday, October 22, 2013