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Del. orders Zohydro prescribing restrictions

RXDelaware has put into place emergency prescribing regulations regarding Zohydro, a powerful new painkiller many critics fear may fuel the epidemic of painkiller abuse. Late last year, Zohydro gained FDA approval despite the fact that after its own advisory committee had voted 11-2 against allowing the drug on the market. Since then, 29 state attorneys general have urged the agency to reconsider its decision, and Massachusetts Gov. Deval Patrick even attempted to ban the drug (a federal judge later blocked that order). Delaware Secretary of State Jeffrey Bullock said the regulations were necessary “to address the imminent peril to the public health, safety and welfare of all Delawareans” caused by Zohydro. According to his statement:

The use of this new and dangerous narcotic painkiller known as Zohydro must be monitored closely because the abuse of it can be deadly. It carries even higher risks of abuse than other short-acting formulations.

Zogenix, the maker of Zohydro, recently reported that about 9,000 prescriptions were filled through June 13 since the drug hit the market in March. The company plans to target about 20,000 prescribers it describes as “high decile [extended-release/long-acting] opioid prescribers” who account for 60% of the market, and envisions Zohydro along the lines of the multibillion-dollar market for OxyContin, according to this article.

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Zohydro backlash intensifies despite FDA’s defense

No-pills-4-1-14Opposition to Zohydro, the powerful new opiate some critics are calling “heroin in a pill,” continues to build, but the U.S. Food and Drug Administration is strongly defending the agency’s approval of the drug, saying its benefits to pain patients outweigh the potential negative consequences.

Since its approval by the FDA last October, Zohydro has come under fire from members of Congress, state attorneys general, doctors and addiction specialists who have worked to block the pill from being sold in the U.S., according to this article. Critics want the agency to rescind its approval of Zohydro, citing the alleged danger of the drug as well as the growing abuse of prescription drugs nationwide, but the FDA says that instead of blocking the sale of Zohydro based on a fear of abuse and addiction, providers should screen patients before they prescribe the drug and while they are on it, the article says.

The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, citing concerns about the danger of addiction posed by the opioid drug class.

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Judge nixes Zohydro ban in Mass.

gavelA federal judge has struck down Massachusetts Gov. Deval Patrick’s ban on the controversial new form of hydrocodone, Zohydro, saying the state lacked the authority to override the FDA’s approval of the painkiller. U.S. District Court Judge Rya W. Zobel noted that the FDA approved Zohydro after a screening process, and said the federal regulatory agency has more power than the state in this case, according to this article. She also said Massachusetts lacked the authority to force Zohydro’s maker, Zogenix, to make an abuse-resistant form of the drug because that formulation has not been approved by the FDA, the article says.

Gov. Patrick issued the Zohydro ban last month, declaring a public health emergency in response to the state’s growing opioid addiction epidemic and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added.

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Pill and heroin deaths surge across the nation

pillsoverdoseDespite increased media coverage and efforts to crack down on abuse, overdose deaths due to prescription drugs and heroin continue to happen at alarming rates in many states.

In Massachusetts, Gov. Deval Patrick recently declared a public health emergency due to the sharp increase in heroin overdoses and opioid addiction, with many addicts shifting from more expensive and harder-to-get pills to heroin, which is cheaper and widely available. Massachusetts state police say 185 people died from suspected heroin overdoses between November and February, a figure that does not include overdose deaths in the state’s three largest cities; the number of all opioid-related deaths increased from 363 in 2000 to 642 in 2011.

In Oklahoma, unintentional prescription drug overdoses claimed the lives of 534 residents in 2012; state health authorities say about half of them had taken drugs prescribed by their own doctors, according to this article.

In Iowa, the number of heroin overdose deaths rose 700 percent from 2003 to 2012, from one death to eight, according to this article.

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Mass. Gov. bans Zohydro amid opioid epidemic

pills and pill bottlesMassachusetts Governor Deval Patrick has declared a public health emergency in response to the state’s growing opioid addiction epidemic, issuing an order banning the controversial new form of hydrocodone, Zohydro, and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added. The prescribing and dispensing of Zohydro, which was recently approved for sale by the FDA despite widespread protests, will be prohibited “until it is determined that adequate measures are in place to safeguard against the potential for diversion, overdose and misuse,” he said. The governor added:

The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large.

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Del. becomes 14th state to pass ‘Good Samaritan’ law

911 dial phone callThe governor of Delaware signed so-called “Good Samaritan” legislation on Tuesday offering protection to anyone seeking medical help in the event of a drug or alcohol overdose, making Delaware the 14th state to pass such a measure. The law gives immunity from prosecution to people reporting an overdose, even if he or she has been involved in drug-related activity.

The bill also grants immunity from prosecution for offenses related to underage drinking.

Lawmakers approved the bill only after exempting higher level drug felonies from its immunity protections, a change that worried some critics who claimed the exemptions weakened the bill and would discourage people from reporting overdoses.

In Delaware, overdose deaths nearly tripled from 50 in 1999 to 137 in 2009, with a majority in recent years involving at least one prescription drug, according to this article.

New Mexico was the first state to pass a Good Samaritan law in 2007, followed by California, Colorado, Connecticut, Florida, Illinois, Massachusetts, New York, Rhode Island, Washington, and the District of Columbia. According to TheFix.com, this year, nearly a dozen more states introduced bills: legislation in North Carolina and New Jersey succeeded, while other bills failed due to partisan bickering (Missouri, Mississippi and North Dakota), were killed in committee (New Hampshire and West Virginia), or ran out of time (Hawaii and Texas); Maine still has a live bill, but it isn’t likely to pass this year.

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Vt. becomes 13th state to pass ‘Good Samaritan’ law

911 dial phone callThe governor of Vermont signed so-called “Good Samaritan” legislation on Wednesday offering protection to anyone seeking medical help in the event of a drug or alcohol overdose, making Vermont the 13th state to pass such a measure. The law extends both to people seeking assistance for themselves and for others, and seeks to prevent overdose deaths by empowering witnesses to report such episodes quickly without fear of legal repercussions, according to this article.

Drug overdoses were responsible for killing 73 people in Vermont last year, and remain the leading cause of injury death to state residents between the ages of 25 and 64, the article says.

Separately on Wednesday, the governor also gave the stamp of approval to a measure that will increase access to naloxone, a medication used to reverse opiate overdose, the article says. Under that law, doctors who prescribe naloxone to opiate-using patients and bystanders who administer the drug to an overdose victim will no longer be to subject to civil liabilities resulting from rare adverse reactions to the drug, according to the article.

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Ky. drug dealers may face homicide charges for ODs

In Kentucky, where prescription drug and heroin addiction are rife, lawmakers plan to go after dealers with legislation that would allow homicide charges against those whose customers die of an overdose, according to this article. Senate Bill 6 would amend state statutes to make it clear that death from an overdose is a foreseeable event and allow prosecution for criminal homicide in such cases, the article says. Legislators are hoping the move will deter out-of-state dealers from coming to Kentucky to sell drugs.

Officials in other states have used similar laws to prosecute dealers. Though it is usually difficult to determine where a person obtained a drug after they die of an overdose, suspects are rarely charged with selling a drug that caused someone’s death. But in places like Massachusetts and Florida, authorities are becoming more willing to pursue such charges.

The number of heroin samples analyzed by the Kentucky State Police crime lab has increased 211% since 2010, according to this article. There were 433 samples analyzed in 2010, but that jumped to 1,349 samples last year, the article says.

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N.J. mulls legislation to encourage naloxone use

In New Jersey – where overdoses are the leading cause of accidental death, exceeding traffic fatalities and gun-related deaths – legislators are considering implementing a law that would grant immunity to those who dispense and administer naloxone, a medication that counters the effects of overdoses from opiates like OxyContin and heroin. The Opioid Antidote and Overdose Prevention Act would allow medical providers to prescribe naloxone and allow people to administer the drug to overdose victims without fear of being prosecuted. It would also require that prescription recipients get information on how to prevent and recognize overdoses, as well as how to administer the medication and care for the overdose victim. Eight other states have similar laws.

Last year, New Jersey legislators floated a separate bill that would have granted immunity to those who report overdoses, but Gov. Chris Christie nixed the measure, proposing that state officials study the issue instead. The governor claimed the legislation was too narrowly focused on encouraging more reporting of drug overdoses, rather than other aspects such as drug abuse deterrence, violence prevention and public safety.

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Must-see video wrap-up

About every 19 minutes, someone dies of an accidental prescription drug overdose. To learn more about this epidemic, here’s a compilation of some recent must-see video clips.

CNN’s Chief Medical Correspondent Dr. Sanjay Gupta shares his special report about accidental overdose and witnessing the epidemic first-hand in Washington State:

The Denver Post follows the lives of several young heroin addicts on the streets of Denver:

Los Angeles Times reporters Scott Glover and Lisa Girion discuss their investigation into prescription drug deaths. Their research revealed that in nearly half of the accidental deaths from prescription drugs in four Southern California counties, the deceased had a doctor’s prescription for at least one drug that caused or contributed to the death.

California Watch/The Center for Investigative Reporting reports that with the steady rise of prescription drug abuse in California, young pill addicts are succumbing in increasing numbers to heroin:

“Overtaken,” a short documentary about prescription drug and heroin addiction in Orange County, Calif.:

Current TV investigates painkiller and heroin addiction in Massachusetts:


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