Sunday, July 27, 2014

After Arizona, here’s a guide to the drugs used in lethal injections

Before the execution of Joseph R. Wood III in Arizona — an unusually drawn-out process that took nearly two hours, prompting an official review — Wood’s attorneys had argued that the lethal injection should be delayed until the state released more information about the drugs that would be used. After the Supreme Court lifted a stay of execution that was in place, Dale Baich, one of Wood’s attorneys, said that the looming execution came “with serious questions remaining about the drugs.”
Part of this stems from the fact that Arizona, which announced earlier this year that it would change the drugs used in lethal injection, was going to use a new drug combination that had not been used in the state before. But part of this also relates to an ongoing shortage of lethal injection drugs, one that has left states effectively experimenting with the drugs.This drug shortage is why Arizona used a different combination of drugs, and this drug shortage has resulted in a strange situation where different states are using different drugs for different executions, with the same states altering what they use from one execution to the next (and having the executions play out in different ways). So what drugs are being used and where? Why are they using different drugs? Here is a primer: A standard formula and a shortageFirst, some background. Until 2010, there was a fairly typical three-drug combination used for lethal injections, according to the Death Penalty Information Center. Inmates were killed utilized an anesthetic, a paralytic drug and a drug that stopped the heart. Most of the lethal injections carried out in 2009 and 2010, for example, used a three-drug combination that included the anesthetic sodium thiopental. (Ohio opted to just use sodium thiopental in an execution that year, but more on that in a moment.)
However, Lundbeck, the Danish company that had supplied the drug, protested its use in lethal injections. States began seeking out the drug from compounding pharmacies, but some lacked the necessary supplies of pentobarbital to keep using it. So some began using the sedative midazolam hydrochloride — and we want to emphasize the some states part. It has cropped up in less than half of the executions so far this year, while pentobarbital has been used in all of the others. (Here’s a longer look at the drug shortage and how states have responded.)
Here is a little more broken down by drug:
This anesthetic has been used in the most executions so far this year, cropping up on its own in more than half of the 26 lethal injections that have taken place. Oklahoma, Texas, Missouri and Georgia have all used it.
Oklahoma executed Michael Wilson in January using pentobarbital and two other drugs. In the first of several troubling episodes this year, Wilson’s final words, delivered seconds after the injections began, were: “I can feel my whole body burning.”
This drug has been used in 10 executions this year. Florida, Ohio, Oklahoma and, now, Arizona have all utilized it — and they have seen results that ranged from unusual to disturbing, according to eyewitnesses.
The Oklahoma execution, which used midazolam and two other drugs, was the most high-profile execution in the U.S. in recent memory. Clayton Lockett grimaced and clenched his teeth, witnesses said, causing the state’s Department of Corrections to halt the execution. He still died a short time later, and an initial autopsy pointed to a problem with the placement of the IV rather than the drugs.
But it wasn’t the first troubling execution involving midazolam to occur this year. In January, Ohio put Dennis McGuire to death using midazolam and hydromorphone — the same combination used in Arizona on Wednesday. This combination had not been used before in the U.S., but Ohio turned to it because of the drug shortage. It took McGuire nearly half an hour to die, and he spent part of that time gasping for air. Ohio state prison officials said in a review of the incident that McGuire did not suffer, but did say they will increase the dosage of the two drugs for future executions.
Florida wasn’t the first state to use midazolam in an execution. Last October, William Happ’s execution lasted 14 minutes; the Associated Press reported that it seemed Happ was conscious longer and moving more than other inmates killed using the earlier lethal injection formula.
Sodium thiopental 
Florida used this drug in the execution of Angel Diaz in 2006, which was so unusual — it lasted for 34 minutes and required a second dose of the chemicals — that then-Gov. Jeb Bush (R) suspended executions in the state and established a commission, which found that the execution team failed to ensure proper IV access during the execution and failed to follow the state’s execution protocols.
Before the drugs, problems with veins
There have also been problems related to just finding a way to deliver the drugs. While there are no indications that this was a problem in Arizona, difficulties placing an IV in a vein was a factor in at least two mishandled executions – Clayton Lockett in Oklahoma and Angel Diaz in Florida.
This also cropped up during a 2009 execution in Ohio, when the state tried to kill Romell Broom, only to eventually halt the execution because despite repeatedly sticking him with a needle, they were unable to find a suitable vein. (He remains on death row.) It also took about 30 minutes to properly place the IV in Kenneth Biros’s arm during his execution in 2009, when hebecame the first person executed with a single drug (sodium thiopental) rather than a three-drug combination.
Similarly, it took the execution team in Georgia about 30 minutes to find a vein to inject Brandon Rhode the following year. The same thing has happened several times in recent years.

Medicine shortage problem is far from solved, warns APPG

Shortages of branded medicines are now less visible than they were two years ago but the problem is still ongoing, according to the All-Party Pharmacy Group (APPG).
The APPG, who held an inquiry into drug shortages two years ago, believes the improvement can be explained by exchange rate fluctuations, with a strong pound leading to a decline in the parallel export of medicines intended for British patients, and that the underlying issues are still a concern.
“The problem is far from solved,” said Kevin Barron, Labour MP and the group’s chairman. “[Medicine] quotas imposed by manufacturers and some wholesalers remain in force. These are often opaque and inflexible, meaning that community pharmacists are still having to spend a large amount of their time negotiating to obtain the medicines their patients need.”
The group, who raise awareness of the pharmacy profession, claimed that pharmacists are having to ration medicines in order to manage drug shortages. It believes the government should be doing more to address the problem, suggesting the Department of Health (DoH) publish updated supply chain guidance addressing best practice in quota setting and management.
The APPG also noted the growing problem in the supply of generic medicines, which was not a concern when the inquiry was held. Some of the causes of generic shortages reflect the globalisation of the generics market, but that cannot be an excuse for “no action here in the UK”, says the APPG.
The statement follows an APPG meeting on drug shortages on 16 July 2014 with representatives from the pharmaceutical industry, wholesalers, the DoH and pharmacy bodies.

Drug shortage big issue for executions

The prolonged execution in Arizona looked troubling, but was it unconstitutional? The U.S. Supreme Court, which upheld the use of lethal injection six years ago, has held that “an isolated mishap” during an execution does not violate the Eighth Amendment. A question and answer look at the current state of executions.
Q: Why did Arizona use a two-drug combination that was also involved in a similar lengthy execution in Ohio?

A: After more than three decades of using the same three-drug combo to put hundreds of inmates to death with few problems, states have scrambled in recent years to find alternative drugs because of a shortage rooted in European opposition to capital punishment. Some states have obtained supplies of compounded pentobarbital, which doesn’t undergo the same type of federal regulations as regular pentobarbital, which is now unavailable. Other states, like Arizona, are turning to midazolam, a sedative, and hydromorphone, a painkiller.
Q: What caused the shortage?
A: Nine years ago, the European Union banned the export of products used for execution, citing its goal to be the “leading institutional actor and largest donor to the fight against the death penalty.” But beefed up rules in Europe have been felt most strongly in the United States, with shortages becoming chronic. In addition, U.S. manufacturers are now putting restrictions on the use of their drugs for executions.
Q: The Arizona execution lasted almost two hours. Doesn’t that constitute cruel and unusual punishment?
A: The answer depends on whether the inmate felt pain — the state says he didn’t — and whether any intentional actions to inflict pain can be proven. In addition, the U.S. Supreme Court has held that “an isolated mishap” during an execution does not violate the Eighth Amendment, “because such an event, while regrettable, does not suggest cruelty or a ‘substantial risk of serious harm,”’ according to a 1947 decision allowing Louisiana to return an inmate to the electric chair after a botched attempt a year earlier.
Q: Have death row inmates challenged any of the new drugs?
A: Defense attorneys have sued over compounded pentobarbital as posing a potential threat since its purity and effect can’t be guaranteed. Yet so far, executions with compounded pentobarbital in Missouri and Texas haven’t been problematic. Attorneys have also challenged the use of midazolam and hydromorphone, arguing that they could cause pain as inmates struggle to breathe.
Current legal challenges:
-- Oklahoma: Twenty-one death row inmates are seeking to halt any attempt to execute them using the state’s lethal injection protocols, which they allege present a risk of severe pain and suffering in violation of the U.S. Constitution. The inmates’ lawsuit followed the state’s botched April 29 execution of Clayton Lockett using a new three-drug method.
-- Missouri: Death row inmates claim the state’s refusal to name the drugmaker providing its execution drug, even privately to attorneys, makes it impossible to know whether the drug is suitable for an execution, or violates the constitutional guarantee against cruel and unusual punishment.
-- Ohio: Attorneys have unsuccessfully argued that the two-drug combo created an unconstitutional risk of suffering because of a phenomenon known as “air hunger” in which people experience terror as they strain to catch their breath.

Botched executions raise new questions

A botched execution in Arizona last week has sent many states scrambling to make sure their executions don't follow a similar grim scenario. 

It took Joseph Wood one hour and 57 minutes to die. He was administered a combination of midazolam and hydromorphone; it was the first time Arizona had used this combination of drugs to execute an inmate.  

Lethal injection has been the method of choice in the United States since 1976, and has be largely deemed the most humane way of executing prisoners without violating the Eighth Amendment, which forbids cruel and unusual punishment.  

Wood's execution in Arizona, in addition to the botched execution of Michael Lee Wilson in Oklahoma and Dennis McGuire in Ohio, has drawn attention to the method by which we execute are criminals.  

States with the death penalty previously obtained their execution drugs from Europe. The most commonly used drug is pentobarbital, which causes people to become unconscious to the point of death. This drug is often the primary ingredient, and is often mixed with pancuronium bromide, a paralytic, and potassium chloride, which stops the heart. However, in recent years European companies have refused to supply the United States with drugs for executions. States have instead had to turn to compounding pharmacies to get their drugs. 

In March of this year, Mississippi announced it would begin to receive its pentobarbital from a compounding pharmacy. Compounding pharmacies traditionally alter medications for specific users. They do not have to go through the same approval process that larger manufactures and traditional pharmacies do.  

"The MDOC uses pentobarbital, vecuronium bromide and potassium chloride in executions," said Grace Fisher, the communications director for the Department of Corrections.  

Mississippi has 50 inmates on death row. They will be the first in the state's history to be executed with drugs bought from compounding pharmacies.  

As of today, none of the 50 inmates on death row has a execution date set.  

There were six executions at Parchman in 2012. Two scheduled executions in 2013 were stayed, including that of Willie Manning of Starkville, whose execution was called off just hours before it was scheduled on May 6, 2013. Neither of the stays were attributed to the state's lethal injection methods.

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Illegal drugs threaten animals, too

Imagine waking up and finding your beloved pet on the floor convulsing, motionless or dead.
This was the real-life nightmare for horse trainers in both Lexington and Ocala, Fla. when they found their horses experiencing seizures and thrashing in their stalls. More than a dozen horses died or were severely injured, in some cases paralyzed, by illegally compounded medicines.
These horses were prescribed illegal drug concoctions that contained unsafe levels of pyrimethamine. By one account, 25 times the recommended amount, a deadly overdose.
There is legal and appropriate animal drug compounding. FDA-approved products may be modified (for example, adding flavorings, or turning tablets into a liquid) by a trained pharmacist on the order of a veterinarian to treat the medical needs of specific animals.
But some animal drug compounding pharmacies go far beyond those parameters, with deadly results. They mass produce and market drugs that mimic FDA-approved products, often using untested active ingredients, imported from countries that may not strictly control drug manufacturing.
These copies carry a cheaper price tag than approved drugs, but none of the consumer protection.
Why does this black market exist? It's both expensive and time-consuming to get FDA approval for a drug. For animal drugs, it can take up to 10 years and cost up to $100 million. But the process protects consumers and animals by ensuring that the approved drug is safe and effective.
FDA permits a limited amount of necessary compounding from bulk ingredients in order to make sure medical needs can be met when there is no approved drug. But these compounding pharmacies have taken the proverbial inch and run for murderous miles. Despite their attempts to muddy the waters with lawsuits and rhetoric, the law is clear: FDA and three federal appeals courts have ruled that compounding animal drugs from bulk substances is illegal.
The practice has caused harm to more than just horses. One university veterinary hospital has reported that dogs and cats are brought in, only to find they were being treated with illegally compounded drugs.
As a former FDA associate commissioner (and a current dog owner), I know the agency has rigorous enforcement authority. Pharmacies that engage in illegal manufacturing cannot be allowed to ignore the law and put animal health at risk in the name of selling a cheaper product.
For several approved animal drugs, FDA has sent warning letters to these pharmacies, but often they were ignored and the practices continued. Unfortunately there has been little to no follow-up by the agency. The FDA must have more strong and sustained enforcement to protect animal health.
What can you do? Talk to your veterinarian about treatment options for your pet. Ask if any drug being prescribed is FDA-approved. If not, and compounding is necessary, make sure the pharmacist preparing the compound has the credentials and license to do it safely and legally.
While that might sound obvious it is the only way to ensure the prescribed drug is what is best for your pet. If you have concerns about a pharmacy, check with your state board of pharmacy. At the same time, FDA must do its job of protecting our pets and animals by more regularly and aggressively enforcing the law and regulations.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest and a member of the Animal Health Institute's Board of Scientific Advisors.

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US FDA alerts healthcare professionals on recall of non-expired sterile drugs from Unique Pharma

The US Food and Drug Administration (FDA) is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.

The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products.

Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients, as these products may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

Unique Pharmaceuticals distributed these products nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.

Two recent inspections of the Unique Pharmaceuticals facility conducted by the FDA revealed insanitary conditions that result in a lack of sterility assurance of drug products produced at that facility. These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.

On July 11, 2014 the FDA issued a formal request to Unique Pharmaceuticals to conduct a recall of all non-expired, purportedly sterile drug products. The FDA also requested that the firm cease sterile compounding operations. As a result of the FDA requests, Unique Pharmaceuticals has agreed to the recall and is ceasing sterile compounding operations until sufficient corrections are made at its facility.

“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge health care professionals to follow recall instructions issued by the firm.”

To date, the FDA is not aware of reports of illness associated with the use of these products. Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their health care professional.

The FDA asks health care professionals and consumers to report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to the FDA’s MedWatch Adverse Event Reporting programme by:  completing and submitting the report online at MedWatch Online Voluntary Reporting Form; or downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178 Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to become an outsourcing facility. Outsourcing facilities:must comply with current good manufacturing practice requirements;will be subject to inspection by the FDA according to a risk-based schedule; and must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Zimbabwe: Govt admits failing to provide funds for vital drugs

HARARE - Paul Chimedza, deputy minister of Health and Child Care, has admitted that the country's hospitals are facing severe drug shortages which have compromised the treatment of patients.

He made the admission in the Senate on Thursday during ministers' question time.

MDC Senator Misheck Marava quizzed Chimedza on the stock levels of drugs in State hospitals.

"We are reading in the press about the drug shortages and also word is going round that the country's drugs or medical stocks are below the minimum levels. The citizens are in a sort of panic mood. Can you assure the country that we are safe?"

He spoke after the Daily News reported that State hospitals have run out of vital medicines, with the institutions prescribing even basic drugs for purchase at private pharmacies. The scarcity of drugs is creating grave problems for the poor.

Chimedza said the drug crisis was caused by government  under-funding the National Pharmaceutical Company (NatPharm), whose sole purpose is to procure drugs and distribute them to all State health institutions.

"The drug situation in the country is not up to the standard that we are satisfied with," Chimedza said.

"As government, we have failed to provide funds for our public entities. As a result, there is shortage of drugs in the central hospitals, provincial hospitals and district hospitals.

"The ministry of Health and Child Care has put a request to Treasury for $10 million which has to go to Nat Pharm but because of the shortage of funds, we were only allocated $3 million and  we have not received most of it at the moment." 

Chimedza said the country's health system was organised in a referral system where the lowest unit is called the rural health centre, followed by district hospital, provincial hospital, and the central hospitals which include Parirenyatwa, Mpilo and Harare hospitals.

He said the central and district hospitals were in a dire situation compared to the rural areas that were being funded by the donor community.

"Rural health centres, essentially drug level is at 80 percent  as most of them are supported by the multi-lateral partners," he said. "So there is a kit that is enough for the rural health centres so that they have their medicines that are used at that level that is adequate for the rural  communities." - See more at: