Severe drug shortage in Sri Lanka hospitals affects treatment of patients

Colombo: A trade union affiliated to Sri Lanka's health sector, the All Ceylon Health Services Union (ACHSU) has said that the treatment of patients in hospitals island wide have been affected due to a shortage of medicinal drugs.

General Secretary of the Union, Gamini Kumarasinghe told the media that drugs to treat high blood pressure and heart diseases were not available in hospitals.

The union leader noted that although drug shortages are usually experienced during the end of the year, this time, the shortages are experienced at the beginning of the year.

He explained that the shortage of drugs was due to the lack of funds allocated by the government to the health sector for the purpose.

According to Kumarasinghe, although the government levies massive taxes on the people to use for development work and to maintain the health and education sectors, people depending on the state health sector has to purchase their medicines at high prices from the private sector.

Among the drugs that are in short supply in state sector hospitals according to the ACHSU are Ampicillin, Isoprenaline, Hydrocortisone, Dopamine, Calcium Gluconate, Tamiflu, Aldactone and Vitamin C, Aludrox, Losartan and many drugs for heart patients.

http://www.colombopage.com/archive_14A/Jan30_1391097412JV.php

Trial Delayed for South Lyon Pharmacy & Pharmacist

 A trial to determine whether or not to uphold the license suspension of a South Lyon pharmacy has been delayed. A trial had been set for this past Monday in Detroit concerning the license suspensions of Specialty Medicine Compounding Pharmacy and its owner, Kenny Walkup Jr. But officials say it’s now been reset for February 26th to allow for a key witness to attend. The identity of the witness was not disclosed. Attorney General Bill Schuette ordered the suspension in October after several of the pharmacy’s products at Henry Ford Hospital in Detroit were found to contain fungus. Previous testimony from inspectors for the state and the FDA indicated the pharmacy was not following proper procedures to ensure products were sterile. Walkup is alleged to have been acting as a drug manufacturer by distributing large amounts of medication to various hospitals and clinics even though the pharmacy is currently only licensed to fill individual prescriptions. He had applied for a license to manufacture drugs in October 2012, but that application was denied. Walkup’s attorney previously maintained that regulations allow pharmacists with that type of license to provide the service if it is less than 5% of the pharmacy’s business. A final decision will be made by the Michigan Pharmacy Disciplinary Subcommittee, but will largely be based on the judge’s recommendation. 

Pharmagen Now Listed on Registered Outsourcing Facilities at FDA

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm

Shortage of important heart medication causing concern

MONTREAL - Hundreds of Montreal heart patients are close to running out of a vital medication — and risk ending up in the emergency room — because of an unexpected shortage by the sole Canadian drug manufacturer that produces it.

The pill, a generic medication that is sold under the name of Flecainide, is used to prevent and treat cardiac arrhythmia, including attacks of atrial fibrillation, otherwise known as irregular heartbeat.

Although a Health Canada official said the drug should become available again by mid-February, some patients have already run out of the medication. The sudden scarcity of Flecainide is the latest in a series of drug shortages over the last few years, including antibiotics and chemotherapy agents, despite promises by the pharmaceutical industry to fix the problem.

“I have patients with absolutely no Flecainide left, and many, many others are going to run out within 10 to 15 days, with no medication to keep their hearts at a normal rhythm,” said Sami Magdi, a cardiologist at the Royal Victoria Hospital.

He estimated that hundreds of patients in Montreal, and possibly across the country, are affected by the shortage.

“This particular drug does not have an exact substitute and is not produced by another drug company in Canada,” Magdi added.

“If patients don’t get the medication, they can get an attack of atrial fibrillation and find themselves in the emergency (room). They’re not going to die, but they may have important sumptoms of an irregular heartbeat and some may pass out. They will probably flood the emergency rooms and doctors’ offices.”

Magdi has already contacted Health Canada and the Toronto drugmaker, AA Pharma Inc.

In an email to Magdi, Kelly Lehman, a program manager in the risk management unit of Health Canada, assured him that AA Pharma is working to resolve the shortage.

“I followed up with the company and was advised that the product is in backorder with an estimated re-supply date of mid-February,” Lehman said in the email. “I have asked the company to post the shortage on drugshortages.ca for better transparency and sharing of information.”

Norman Paul, president of AA Pharma, told The Gazette that his company has maintained a “sterling record” of keeping drugs in stock, “but unfortunately that doesn’t always happen ... and we apologize for the dilemma.

“It’s not like baking brownies,” he said of the “complex business of manufacturing drugs and all of the regulatory (rules) and testing before you release a product on an ongoing basis.”

Paul blamed the lack of Flecainide on a “worldwide shortage of API” or approved pharmaceutical ingredients, noting that a burgeoning pharmaceutical industry in India and other developing nations is using more and more of such raw ingredients for the manufacture of their drugs

Shortage of saline causes hospitals, dialysis centers to scramble to manage supply

A shortage of intravenous saline is causing hospitals and dialysis centers to scramble to manage their supplies of one of the most commonly used drugs.

Healthcare providers are asking doctors and staff to use smaller IV bags and find alternatives, if possible, to cope with the shortage, officials and executives said. Officials have not yet heard of any facilities running out of the solutions, “but we know that hospitals are still reporting that they may only have a few days supply,” said Valerie Jensen, associate director of the drug shortages program at the Food and Drug Administration.

Since mid-January, the FDA has received notices from “dozens of hospitals” each week about low supplies of IV saline, Jensen said Tuesday. High demand for IV saline has been prompted in part by a spike in flu cases in recent weeks. Many flu patients who are dehydrated need intravenous saline.

Frustration over the shortage prompted one hospital in the North to consider asking the government to release saline from its emergency stockpiles, according to Bona Benjamin, a senior executive at the American Society of Health-System Pharmacists. She cited privacy concerns in declining to identify the hospital.

“The flu spike is what suddenly escalated it and made it worse,” Benjamin said.

The FDA said it is working with the three manufacturers of intravenous saline solutions to address the shortage. The agency is also looking into alternative sources, including overseas suppliers. Baxter HealthCare Corp., Hospira Inc. and B. Braun Medical Inc. have stepped up production in response. Baxter spokeswoman Deborah Spak said the company has increased its production and is managing inventory to supply customers with the most critical needs. It has notified customers that normal production should be in place by the second quarter of the year.

“Baxter has been manufacturing solutions at maximum capacity in amounts exceeding those of prior years and is making investments to further increase supply in 2014,” she said in a statement.

Manufacturers first notified FDA late last year that they expected delays in filling orders, but they did not anticipate then that there would be shortages, officials said. A sharp increase in demand in mid-January turned the delay into a shortage.

At Olathe Medical Center outside Kansas City, Kan., pharmacy director Phil Schneider said he sent out a notice to medical staff of the 230-bed hospital two weeks ago asking them to take a number of steps to “spread out the supply that we had.”

The hospital typically uses 280 cases a month of IV saline, with each case containing 14 one-liter bags. The hospital had only about a five-day supply left. Schneider asked doctors to use 500-milliliter bags, among other steps, and as a result cut usage by about one-third.

By Monday, however, “we were again looking at shelves getting empty,” he said. He sent out another notice about conservation. And then on Tuesday, he received a shipment of 50 cases of saline, about a week’s supply.

A spokeswoman for MedStar Health, which operates MedStar Washington Hospital Center and MedStar Georgetown University Hospital in the District, said patient care has not been affected. But the health system is using smaller saline bags, looking for alternative IV solutions when possible, and reallocating saline across its system based on need.

Dialysis centers also rely on IV saline to cleanse their patients’ blood. Many centers were notified about a shortage in the fall, and some took action to stock up on saline.

“We’ve not heard of anyone on the edge,” said Rich Meade, a spokesman for the National Renal Administrators Association, which represents dialysis providers.

Capital Dialysis in Northeast Washington typically treats about 90 patients a day, with each treatment requiring one 1,000-milliliter bag of IV saline, medical director Jay Ocuin said. He has directed staff to use the saline more wisely. He also has enough to last another four to six weeks, he said.

http://www.washingtonpost.com/national/health-science/shortage-of-saline-causing-hospitals-dialsysis-centers-to-scramble-to-manage-supply/2014/01/28/9cfe2b8c-8862-11e3-833c-33098f9e5267_story.html

Today's Shortages

ASHP/FDA
Amikacin Injection
Ampicillin Sulbactam
aspirin Tablets (Buffered)
Benztropine Injection
Cefazolin Injection
Choline Magnesium Trisalicylate
Dihydroergotamine Mesylate Injection
Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP)
Dobutamine Injection
Doxazosin Tablets
Empty Evacuated Containers
Fluorometholone Ophthalmic Ointment
Fosphenytoin Injection
Haemophilus B Conjugate Vaccine

St. Louis region is hot spot of flu activity

The St. Louis region has experienced a sharp uptick in flu cases in recent weeks, according to Washington Universityphysicians at Barnes-Jewish Hospital who say they are dealing with a severe flu outbreak that includes deaths from the illness. The deaths primarily were of otherwise healthy young and middle-aged adults not vaccinated against influenza, according to the physicians. 

The H1N1 strain of the flu is causing the most problems, just as it did in 2009, disproportionately affecting younger patients, some of whom are so critically ill they are being treated in intensive care units. 

“We have seen a steep rise in flu cases, and we’re treating some very, very sick patients from the St. Louis area and others who have been transferred here from hospitals in the region,” said Steven Lawrence, MD, a Washington University infectious disease specialist at Barnes-Jewish. 

So far this season, 320 cases of influenza have been diagnosed at Barnes-Jewish, with an average of 10 to 12 new cases daily. While most patients have been treated and released, some young and middle-aged patients have developed severe cases of rapidly progressive influenza leading to serious illness. 

During the current flu outbreak, nine patients ranging in age from their mid-20s to mid-60s have died from flu-related illness at Barnes-Jewish Hospital. In all, about 35 patients with severe flu illness have been treated in the hospital’s intensive care units, with many of the sickest patients transferred from other hospitals in the region because of advanced treatments available at Barnes-Jewish. 

Some patients require dialysis because their kidneys have shut down, and others are receiving breathing assistance with heart-lung machines through a process called ECMO, which is short for extracorporeal membrane oxygenation. This specialized procedure has been shown to benefit patients with extremely severe cases of the flu. It involves running a patient’s blood through a machine that removes carbon dioxide and adds oxygen before blood is returned to the heart and pumped to the rest of the body. 

Barnes-Jewish has used ECMO to treat patients whose breathing problems have not improved on traditional ventilators. Only a few hospitals in the region offer ECMO, which requires expertise from cardiothoracic surgeons, critical care physicians, nurses and perfusionists to manage these cases. 

For patients with life-threatening infections who have not responded to traditional flu treatments like antiviral drugs Tamiflu and Relenza, Washington University physicians at Barnes-Jewish also are evaluating an investigational intravenous form of Relenza.

Washington University physicians at St. Louis Children’s Hospital have treated about 12 patients with influenza in the hospital’s intensive care unit, with two patients on ECMO. No flu-related deaths have been reported at Children’s. 

Because of the flu’s severity, physicians are strongly encouraging people to get the influenza vaccine if they have not already done so because the flu season has not yet peaked and the H1N1 influenza virus could be circulating for at least another month and possibly into the spring.

“It is not too late to get a flu shot,” Lawrence said. “Most of the influenza patients we’ve seen who are sick enough to be hospitalized did not get vaccinated. The vaccine is very effective against H1N1 flu, particularly in the younger and middle-aged patients hit hardest by this strain. Even though it does not prevent all cases, people who have been vaccinated and later get the flu often have less severe symptoms.” 

The Centers for Disease Control and Prevention recommends annual influenza vaccination for everyone 6 months and older. The seasonal flu vaccine protects against two strains of influenza A, including H1N1, as well as influenza B strains. The vaccine takes two weeks to be fully effective, but that should not discourage people from getting vaccinated, Lawrence added.

For patients sick with the flu, Tamiflu and Relenza are available by prescription. The drugs can help reduce the duration and severity of the illness, particularly if given within 48 hours of developing flu symptoms, such as sudden fever, body aches, chills and coughing. 

The risk of severe flu and flu complications generally is higher among children younger than 5, adults age 65 or older, pregnant women and people with chronic medical conditions like asthma, diabetes or heart disease. In most flu seasons, the majority of influenza-associated hospitalizations and deaths are among adults ages 65 or older. However, during the 2009 pandemic, just like this flu season, H1N1 flu caused more illness in children and young adults than in older adults. This is likely due to partial protection in older adults who were exposed to a similar flu virus decades ago. 

In addition to contacting medical providers for treatment advice, Lawrence also cautions that people with the flu should get plenty of rest and stay home for at least 24 hours after their temperature returns to normal, to avoid spreading flu to others.

http://news.wustl.edu/news/Pages/26344.aspx#.UulNymD5QTE.email

Lupin recalls hypertension treatment tablets from US market

Hyderabad: Pharma major Lupin has said its US subsidiary, Lupin Pharmaceuticals Inc, has initiated a voluntary recall of multiple lots of Quinapril Tablets USP from the US market after failing impurity specification test.

According to information available with the US Food and Drug Administration (FDA), the recall was initiated by the company last September and as many as 53,160 bottles (30,264 bottles of 5 mg and 22,896 bottles of 10 mg) of both the drugs (90-count bottles) are being recalled under Class-II classification.

In 2006, Lupin received final approval from the FDA for its abbreviated new drug application (ANDA) for Quinapril Tablets USP in 5 mg, 10 mg, 20 mg and 40 mg strengths. The drug is indicated to treat hypertension.

"During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval," the US health regulator said, citing the cause for the recall.

According to the US FDA, Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Both the drugs were manufactured by Lupin at its Goa facility.

When contacted, Lupin in a statement said, "This is an old event and a voluntary recall for a small batch of Quinapril Tablets 5 mg and 10 mg strengths; a precaution on our part, and of no business consequence."

http://profit.ndtv.com/news/corporates/article-lupin-recalls-hypertension-treatment-tablets-from-us-market-378993

U.S. hospitals hit with shortage of intravenous saline

(Reuters) - The U.S. Food and Drug Administration said on Tuesday it is working with the three manufacturers of intravenous saline solutions commonly used to hydrate hospital patients to address a shortage caused by a spike in demand.

Healthcare providers are reserving supplies of the fluids for their most seriously ill patients, and the product manufacturers - Baxter International Inc, Hospira Inc and B. Braun Medical Inc - have stepped up production in response, said Valerie Jensen, FDA's associate director for drug shortages.

"We have not heard of anyone running out of the IV solutions at this point, but we know the hospitals are not comfortable with the low supplies," Jensen said.

Manufacturers first notified FDA late last year that they expected delays in filling orders, but an increase in hospitalizations two weeks ago partly due to rising numbers of flu cases exacerbated the problem, she said.

"The increase in demand pushed this into a shortage," Jensen said.

To cope with the shortage, healthcare providers are using substitute products such as oral hydration fluids or smaller IV saline bags with slower drip rates when appropriate, said Bona Benjamin, director of medication use quality improvement for the American Society of Health System Pharmacists.

"We have heard from our members all over the country that the shortage is serious," Benjamin said. "People are able to cobble together enough of a supply to get by day to day."

Baxter spokeswoman Deborah Spak said the company has increased its production and is managing inventory to ensure supplies for customers with the most urgent needs.

"Baxter has been manufacturing solutions at maximum capacity in amounts exceeding those of prior years and is making investments to further increase supply in 2014," Spak said.

Hospira said it is expediting shipments to help mitigate local supply disruptions. "We are doing everything we can to meet the increase in demand," said company spokesman Dan Rosenberg.

Cathy Denning, a registered nurse with Novation, a supply chain company that works with hospitals and other healthcare providers, said it could be another two months before the shortage is resolved.

FDA's Jensen said the agency is also looking into alternative sources, including overseas suppliers, to help address the shortage.

http://www.chicagotribune.com/health/sns-rt-us-saline-shortage-20140128,0,6204172.story

Today's Shortages

ASHP/FDA
Bumetanide Tablets
Caffeine and Sodium Benzoate Injection
Diphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine (DTaP - IPV/Hib)
Indigo Carmine Injection
Methylene Blue Injection
Sodium Phosphate Injection
Sterile Empty Vials
Trace Elements Injection
Zinc Injection

Critical IV solution shortage affecting US hospitals

The country is experiencing a serious shortage of certain IV fluids, mainly involving sodium chloride injection 0.9% (IV saline) in 1,000 mL bags. Some hospitals have also been short of Lactated Ringer’s solution.  Smaller size bags are available right now but we’re hearing that those supplies are dwindling.

This latest drug shortage seems to have started back in November but has gotten progressively worse in the past couple of weeks and now hospitals are scrambling. The market in the US is served by Baxter (45%), Hospira (45%) and B. Braun (10%). Apparently the acute situation is related to increased demand (patients with influenza who are hospitalized) combined with a planned shutdown at Baxter for maintenance in December.  All of the manufacturers have communicated about supplies with their customers. The shortage is such that they’re allocating solutions to customers already under contract. It’s unclear how long this shortage situation will last but everything we’re hearing is that it’s going to be several weeks at least, and for some solutions it will be into March.  I’ve spoken to all three companies and they tell me they are working hard to get supplies back up to normal.

There are other IV solutions available such as 5% dextrose in water, 5% dextrose with smaller concentrations of sodium chloride than 0.9%, and many others, but they may not always be appropriate for a particular patient.  How long supplies of the various solutions will last is not known but we could very well see shortages with these too. Although it should be a last resort, it’s possible for hospital pharmacists to compound sodium chloride IV solutions using small volumes from very high concentration sodium chloride injection vials to bring solutions of lesser concentration up to 0.9%. But doing so can increase the potential for compounding errors so this should be a last resort. Compounding requires strict quality control checks to prevent accidentally adding too much or too little sodium chloride, either of which can be harmful.  Also, if compounding became routine it could lead to shortages of the high concentration sodium chloride vials, which happened last year due to production issues at one of the generic injectable companies.

Hospitals are being advised to use oral hydration as much as possible, or use smaller bags, at least while they last, along with more frequent bag changes. IV sodium chloride solutions are often used in surgical patients or patients with diabetes who must restrict dextrose intake since it is a sugar. So far we haven’t heard of delays in elective surgery but that is a possibility if things don’t turn around soon.

The sodium chloride shortage is the latest in a series of drug shortages that peaked in 2010. In October, FDA published a strategic plan to address drug shortages and legislation was passed in 2012 that requires manufacturers to notify FDA at least 6 months in advance when they are considering production shutdowns. FDA has also established a drug shortage section staffed by 11 individuals. My take is that there has been improvement overall but shortages remain of great concern, sometimes forcing less than adequate therapy and increasing the risk of medication errors when caregivers must break routines or use unfamiliar replacement products. 

FDA has sometimes worked with foreign manufacturers and allowed products to be imported to help alleviate the problem here. But that also presents problems because of differences in the way imported products are labeled, sometimes in a foreign language, and there can also be a variance in the exact ingredients and the strength per dosage unit. Although the option may exist to import IV solutions, it doesn’t seem likely because of the size and weight of the heavy cartons, the fact that millions of solutions are used every week in the US, and the likely enormous shipping costs.  

Read more at http://www.philly.com/philly/blogs/healthcare/Critical-IV-solution-shortage-affecting-US-hospitals.html#LdBWwqZKTUBOF8J6.99

Planning for drug shortages in LTC

Regional, national and local drug shortages are constantly changing. One month there may be a severe shortage of one item, while the next month healthcare providers have access to a steady supply. This issue causes gaps in care, and in a facility with a high-risk population to begin with, shortages could put patients' health in jeopardy.

Some drugs have limited options for a therapeutic equivalent In those instances, facilities may need to delay a treatment or use a different drug that may  change the drug interaction profile. Fifty-three percent of facilities that participated in a national survey noted that one to ten medication errors occurred in their facility as a result of a drug shortage.

In addition to being a threat to patient safety, drug shortages can become a very time- and labor-intensive situation for pharmacy managers and care givers to monitor for and manage. This is particularly true if patients have multiple co-morbidities and if the facility does not have the right processes in place to handle shortages. When there is a severe shortage, caregivers will need to identify all of the patients affected, evaluate impact of delay in therapy or therapeutic alternative, and write the appropriate change orders. Facilities must have a plan in place to turn to when they are faced with this drug shortage situation. 

Enacting a Plan 

Working alongside a pharmacy, long-term care facilities should be refining and reworking their plan for drug shortages on an ongoing basis to maintain high patient safety. Questions they should be able to answer include: Sourcing options? Stocking levels at the pharmacy until drug is unavailable? What are the clinical support resources to work with medical staff in order to develop an appropriate plan? What is the operational plan to execute response?

Long-term care pharmacies and facilities should also have a good understanding of their inventory on hand and be able to determine utilization rates for each medication.  In addition, caregivers should recognize which drugs will cause the most disruption when they suddenly are in short supply. The drug environment will change, so it is imperative that clinicians react quickly when there is no way to access the necessary drug.

Relationships Between Long-Term Care Facilities and the Pharmacy 

To ensure that the plan is secure, long-term care facilities must work closely with their pharmacies.. Long-term care providers must also ensure that their pharmacies have visibility across multiple locations so that medications can be mobilized across facilities when necessary. There should be good geographic balancing across multiple pharmacies when times of utilization are higher in one area than another. To optimize the ability to react, certain medications should be set aside into a safety stock to ensure that facilities have access even in shortage.  

Using Omnicell's Pandora Financials software, pharmacy managers have access to the constantly changing ASHP drug shortage database through a new ASHP Item Shortage widget to help reduce time spent managing shortage items.

Long-term care clinical staff can proactively check this online database and obtain visibility on drug shortages. This way, caregivers and pharmacy managers who are faced with a drug shortage can work together to execute a plan of action and keep their patients safe and healthy.

http://www.mcknights.com/planning-for-drug-shortages-in-ltc/article/331162/

Lethal Drugs Now Rare, States Eye Old-School Executions

With lethal-injection drugs in short supply and new questions looming about their effectiveness, lawmakers in some death penalty states are considering bringing back relics of a more gruesome past: firing squads, electrocutions, and gas chambers. Most states abandoned those execution methods more than a generation ago, but to some elected officials, the drug shortages and recent legal challenges are beginning to make lethal injection seem too vulnerable to complications.

"This isn't an attempt to time-warp back into the 1850s or the wild, wild West or anything like that," says Missouri state Rep. Rick Brattin, who this month proposed making firing squads an option for executions. "It's just that I foresee a problem, and I'm trying to come up with a solution that will be the most humane yet most economical for our state." A Wyoming lawmaker has also proposed a return to firing squads, while other officials in Missouri have raised the notion of rebuilding the state's gas chamber, and a Virginia lawmaker wants to make electrocution an option if lethal-injection drugs aren't available.

http://www.newser.com/story/181399/states-eye-return-to-old-fashioned-executions.html

Oklahoma pharmacy says it has not broken law in supplying lethal injection drugs

a Tulsa-based compounding pharmacy, publicly denied it has broken any federal or state laws in reportedly supplying lethal injection drugs to corrections officials in multiple states.

"In recent weeks, there have been erroneous allegations in the media about The Apothecary Shoppe’s supposed non-compliance with Federal and State laws and regulations regarding the preparation and dispensing of certain sterile injection compounds. The Apothecary Shoppe expressly denies these allegations," pharmacy employee Sarah Lees said in an email sent to NOLA.com | The Times-Picayune on Tuesday (Jan 28).

"The Apothecary Shoppe has, and continues to, comply with all Federal and State laws and regulations regarding the practice of pharmacy in the State of Oklahoma, and all States into which it dispenses medications."

Nowhere in the statement does Lees confirm to which states the Shoppe has supplied lethal injection drugs, nor does it note what drugs are produced there. Lees declined to comment further when contacted after the statement was released.

The Shoppe is the source for the pentobarbital that will be used to executive Missouri inmate Herbert Smulls, 56, according to a report by The Associated Press. A federal court denied Smull's request for a stay of execution Monday, according to the St. Louis Post-Dispatch. He is scheduled to be put to death at 12:01 a.m. Wednesday.

D.J. Lees, an employee at the pharmacy's flagship store in Tulsa, was also in touchwith Louisiana corrections officials in September 2013, and had asked the state to sign a non-disclosure agreement. Louisiana is slated to put to death convicted killer Christopher Sepulvado on Feb. 5, its first scheduled execution since 2010.

However, neither the business nor any of its listed pharmacists can be found on a list of the out-of-state pharmacies licensed in Louisiana; this is also true of Missouri, but officials there said the pharmacy has not broken state law because they traveled to Oklahoma to pick up the needed drugs.

"Missouri officials came to Oklahoma to pick up the drug, so the pharmacy did not need to be licensed in that state," Missouri Pharmacy Board Chief Compliance Officer Cindy Hamilton said, according to TulsaWorld.com.

Missouri is slated to use the barbiturate pentobarbital, a drug usually used to treat seizures and euthanize animals, to execute Smulls on Tuesday. But Louisiana officials confirmed Monday (Jan. 27) they were unable to secure that drug for Sepulvado's scheduled execution next week.

Instead, they moved to amend the state's execution protocol to allow for the use of a two-drug cocktail of midazolam and hydromorphone, the same used the Jan. 16 execution of Ohio inmate Dennis McGuire, who appeared to cough and writhe in pain for 25 minutes before he died. His family is now suing, stating the drug was illegally produced and supplied to the state by the drug manufacturer Hospira Inc.

Louisiana corrections officials declined to comment on from where they planned to procure the two-drug recipe. Calls Monday and Tuesday to the state Pharmacy Board were not returned, and Apothecary Shoppe representatives would not confirm if they would be the source of the drugs used to execute Sepulvado.

Louisiana's execution protocol repeatedly notes the need to procure the drug 30 days in advance of any scheduled execution. But, Louisiana DOC Spokeswoman Pam Laborde said Sepulvado's Feb. 5 execution is slated to go ahead as scheduled, unless a court orders a stay. Sepulvado has asked a Baton Rouge based federal judge to delay the execution on the grounds his due process rights are being violated.

He and fellow death row inmate Jessie Hoffman are also in the midst of a ongoing legal battle with the state, seeking to force corrections officials to release more information on the execution policy. On Tuesday, the two file a motion requested a federal judge sanction the state for not supplying them with all the documents ordered released by Jan. 24.

Sepulvado was convicted of the 1992 murder of his 6-year-old stepson Wesley Allen Mercer in Mansfield. Court records show he beat the boy and stabbed him with a screwdriver, before dunking him in a scalding hot bath. Hoffman was sentenced to death for the 1996 kidnapping, rape and killing of Mary "Molly" Elliott, an advertising executive in St. Tammany Parish.

While Hoffman and Sepulvado are the only currently named plaintiffs in the case, three other inmates filed a request to become interveners in the case on Jan. 8. The defendants in the case, listed as DOC Secretary James LeBlanc, Louisiana State Penitentiary at Angola Warden Burl Cain and Death Row Warden Angela Norwood, have requested an extension in filing their opposition to the motion due to inclement weather.

The three inmates are Bobby Hampton, Nathaniel Code and Kevan Brumfield. Hampton is on death row for the 1995 murder of liquor store employee Philip Russell Coleman Code in Shreveport. Brumfield was convicted of the 1993 slaying of Baton Rouge Police Corporal Betty Smothers. 

Code, one of the defendants in another case seeking to force Angola to regulate its death row temperatures, is awaiting execution for the murder of five people.

http://www.nola.com/crime/baton-rouge/index.ssf/2014/01/lethal_injection_execution_apothecary_shoppe.html

Tulsa pharmacy faces questions over lethal drug to be used in execution

Lawyers for Missouri death row inmate say secrecy surrounding source of pentobarbital undermines first amendment rights A pharmacy in Tulsa, Oklahoma, is under pressure to explain its potential role in an imminent execution 400 miles away in Missouri, where a death row prisoner is due to be administered a lethal injection drug, the source of which remains shrouded in secrecy.

With seven hours hours to go before the 12.01am CST scheduled execution of Herbert Smulls in the Eastern Reception, Diagnostic & Correctional Center in Bonne Terre, his lawyers are protesting that the secrecy surrounding Missouri's source of the 10mg of pentobarbital that will be used to kill him is hampering their efforts to defend him in his final moments.

At worst, the lawyers contend, Smulls could be subjected to cruel and unusual punishment by being executed with drugs that have been only lightly regulated and have not been subjected to public scrutiny.

State authorities have tried to obscure the identity of the compounding pharmacy that supplied the drug, going to such lengths as making the name of the business, like the execution team, protected from disclosure under Missouri law. But Cheryl Pilate, one of the defence lawyers fighting for Smulls's life, has named the Apothecary Shoppe, a compounding pharmacy in Tulsa, as the source of tonight's lethal injection drug.

“We have studied publicly available documents – information that any citizen can obtain – and concluded that the Apothecary Shoppe was the source,” Pilate told the Guardian.

Lawyers acting for Smulls, 56, who was sentenced to death for the 1991 murder of a jewelry store owner Stephen Honickman, have lodged a court motion protesting that the secrecy surrounding the source of the execution drugs is a violation of the prisoner's first amendment rights as well as his right to proper legal representation.

“We are being subjected to government secrecy at its most extreme. There is no greater manifestation of a state's power than to execute one of its citizens – and when that is done, it has to be done correctly,” Pilate said.

Maya Foa, a leading campaigner for greater public access to information about death penalty drugs, said “there can be no way of guaranteeing that the execution will not amount to torture. This begs the question of what states are really trying to hide.”

The contention of Smulls's attorneys that secrecy combined with the relatively light regulation of compounding pharmacies could subject prisoners to drawn-out and potentially painful deaths through the use of weak or ineffective lethal drugs was underlined earlier this month in Oklahoma’s execution of Michael Wilson. The prisoner's final words as he was put to death by a massive overdose of pentobarbital, obtained from an unnamed Oklahoma compounding pharmacy, were: “I feel my whole body burning.”

The Apothecary Shoppe makes up – or compounds – medication customised to individual customers under the jingle “the most important thing we did today was fill your prescription”. The Guardian contacted the owner of the Apothecary Shoppe, a pharmacist called DJ Lees, on Friday. He flatly denied any involvement with prison services in any state: “We do prepare compounded medication, but not in this case. You have got the wrong pharmacy,” he said.

But St Louis public radio, basing its deductions on documents released to the public under court order, has named the Apothecary Shoppe as the likely supplier of the pentobarbital in Missouri's possession. 

The Apothecary Shoppe has also been named by local media in Louisiana after state authorities released to lawyers acting on behalf of a death row inmate in that state a sequence of emails between DJ Lees and a senior official from the local prison service.

The emails, published by the New Orleans news outlet the Lens, show that Lees asked the state to sign a non-disclosure agreement keeping all aspects of their relationship secret. The non-disclosure form was made out in the name of the Georgia department of corrections, suggesting that a similar secret pact might also have been secured from that state.

The flirtation of a growing number of death penalty states with compounding pharmacies underlines the increasingly extreme measures they are taking to skirt a European-led boycott of medical drugs to US prison systems. States have attempted to protect their new, legally challenged supply lines by shrouding the identity of the compounding pharmacies they employ in secrecy.

Any transactions between the Apothecary Shoppe and the state authorities in Missouri, Louisiana or Georgia could be legally questionable because the pharmacy is unlicensed in those states to dispense or distribute controlled substances.

In Louisiana, out-of-state pharmacies doing business there are legally obliged to have a registered office inside state lines. Missouri pharmacy rules state: “Pharmacists shall not offer compounded drug products to other pharmacies, practitioners or commercial entities for subsequent resale or administration, except in the course of professional practice for a prescriber to administer to an individual patient by prescription.”

The Missouri authorities are attempting to overcome the inter-state legal hurdles by arguing that its officials travelled to Oklahoma to pick up the supply of pentobarbital, thus avoiding the need for the compounding pharmacy to ship the drug across state lines or to be licensed in Missouri.

On Tuesday, the Apothecary Shoppe issued a statement to the Guardian in which it insisted it has complied with all federal and state laws “regarding the practice of pharmacy in the state of Oklahoma, and all states into which it dispenses medications. We take compliance issues very seriously. Since our inception, we have adopted and implemented measures to ensure that we not only comply with federal and state laws, but also applicable regulations governing our pharmacy practice, including DEA regulations, FDA rules and requirements, and State Board of Pharmacy regulations in the various States into which we lawfully dispense medications.”

The Missouri department of corrections did not respond to Guardian requests for comment. The equivalent department in Louisiana declined to comment on grounds of ongoing litigation. It has however indicated that it continues look for a new supply of pentobarbital ahead of its next execution on 5 February and on Monday night rewrote its execution protocol to a new combination of two drugs that it clearly hopes will be more easily obtained.

Michael Rubenstein, the Louisiana lawyer who extracted from state authorities the Apothecary Shoppe emails under court order, said the lengths to which states were going to keep the supply of their drugs secret indicated something was wrong.

“Why are they insisting on such secrecy? It suggests they think that if the information comes out in clear light of day their actions won't withstand scrutiny,” he said.

Rubenstein said that though it was uncertain how far Louisiana had gone in its dealings with the Apothecary Shoppe, the rules against cross-state distribution of controlled substances without a license were clear. “Law enforcement officials appear to be violating state and federal laws so that they can go ahead an end a life. If they are going to execute human beings, the minimum we can expect is that they follow their own state laws.”

One of the criticisms leveled against compounding pharmacies is that they are not subject to federal regulation by the Food and Drug Administration. Inspections of compounded drugs in Missouri have found huge variations in standards. In 2008, a Missouri survey discovered that one in four samples failed to meet a test of potency.

Further alarm was raised ahead of the scheduled execution of Smulls after it was revealed in court documents that Missouri's batch of pentobarbital was tested for quality by the Analytical Research Laboratories (ARL) in Oklahoma City. ARL was among the labs that provided favourable test results for drugs compounded by the now-closed New England Compounding Center, which was implicated in the 2012 outbreak of fungal meningitis in which more than 60 people died.

Expert testimony filed into court by Smulls’s legal team records that the Food and Drug Administration found that ARL had failed to follow certain required procedures having inspected the lab in the wake of the outbreak, and numerous civil lawsuits are ongoing.

http://www.theguardian.com/world/2014/jan/28/tulsa-compounding-pharmacy-lethal-injection-execution

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