Tag Archives: politics

FDA unveils new labeling rules for opioids

pill bottlesUnder pressure from activists and other critics, the U.S. Food and Drug Administration on Tuesday announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin.

According to the agency, the changes are aimed at combatting “the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities.”

The updated labels must state that such medications are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

In addition, because of the risk of addiction and abuse “even at recommended doses,” as well as the greater risks of overdose and death, the drugs must be labeled as “reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the agency said.

The FDA’s move was met with skepticism by some activists who were concerned the changes do not go far enough. Pete Jackson, the president of Advocates for the Reform of Prescription Opioids, said the development could be viewed as either a step in the right direction or as “another smokescreen put out by the FDA to make it look like they are doing something.”

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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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More residents using Ky. involuntary treatment law

head-in-hands-manAs the prescription drug and heroin epidemic in Kentucky has worsened, residents have been taking advantage of a law that allows parents or other concerned people to petition the court to order involuntary drug treatment for an adult, according to this article. The Matthew Casey Wethington Act for Substance Abuse Intervention, enacted in 2004, is named for Casey Wethington of Kenton County, who died of a heroin overdose in August 2002 at age 23, the article says. More than a dozen states have laws dealing with involuntary commitment for addiction treatment, including Florida and Ohio.

Fewer than 10 Casey’s Law petitions were filed in Boone, Campbell and Kenton counties each year from 2004 through 2008, the article notes, but cases for the three counties jumped to a total of 20 in 2009 and in 2010, then shot up to 66 in 2011 and 71 in 2012 as the opiate epidemic progressed.

Heroin use in Kentucky has exploded in the past decade, fed by sophisticated supply networks focused on mostly white suburban and rural users who have become hooked on prescription painkillers, according to an earlier article by the Cincinnati Enquirer.

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Generic Opana to remain on the market: FDA

PillsThe U.S. Food and Drug Administration said Friday it will continue to allow sales of the generic version of the painkiller Opana that does not include an abuse-resistant feature.

Opana’s manufacturer, Endo Pharmaceuticals, had submitted a petition to the agency asking it to ban generic forms of the painkiller, which Endo has reformulated as “Opana ER” to make it harder to abuse. That petition was denied by the FDA, which said Endo’s reformulation was not significantly safer than the original version:

While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.

Endo’s petition came after Purdue Pharma successfully asked the FDA to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make it more difficult to crush, break, or dissolve.

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Painkiller market to reach $8.4B by 2017: WSJ

pill money signPrescription painkiller sales are set to increase by 15% and hit $8.4 billion by 2017, due in part to the U.S. Food and Drug Administration’s recent decision to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse. Experts are predicting a race across the pharmaceutical industry to create a market where all opioids have abuse-deterrent properties, according to the Wall Street Journal.

According to the FDA, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”

OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.

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Awareness of ‘Good Samaritan’ laws still lacking

911 dial phone callAs of March 2013, drug overdose “Good Samaritan” laws were in effect in 10 states and the District of Columbia, and were being actively considered by at least a half-dozen state legislatures. But many people are unaware of these laws, or are still fearful of being arrested if they call for help for overdose victims, anecdotal evidence shows. For example, this article out of Chicago reports that in one county, 175 people have died of heroin overdoses since 2007. In many of those cases, the article says, the victims were surrounded by people when they overdosed, but no one called 911 for help – even though Illinois passed a Good Samaritan law last year.

Good Samaritan laws typically provide immunity from drug possession charges; immunity applies to a person who seeks medical aid during an overdose (for example, by calling 911 or taking someone to the ER), and to a person having an overdose.

Even though opiate overdoses are on the rise, many people don’t call 911 out of fear of arrest and prosecution, and instead rely on ineffective methods of reviving victims.

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Ga.’s prescription database in danger due to funding

computerpillsGeorgia’s new prescription drug monitoring database, which is set to become operational in June, may run out of the money it needs to operate soon after its implementation because lawmakers failed to appropriate any funding for the program when they passed legislation to create it in 2011, according to the Atlanta Journal-Constitution.

A two-year, $400,000 federal grant that pays startup costs for a new prescription monitoring program grant expires Sept. 30, the paper says.

In Georgia — which is among the last six states in the nation to put a prescription monitoring program in place, according to the National Alliance for Model State Drug Laws — prescription drug abuse causes or contributes to the overdose deaths of 11 people every week.

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Calif. lawmakers take action on painkiller abuse: LAT

bluepillsA California Senate committee has given the stamp of approval to a package of bills aimed at reducing prescription drug abuse and overdose deaths, including a measure that would require coroners to report deaths involving prescription drugs to the Medical Board of California. The Los Angeles Times reports that the committee also signed off on a bill that would upgrade the state’s prescription drug monitoring program, known as CURES. In addition, the committee approved a measure that would make it easier for the medical board to investigate physicians suspected of overprescribing and suspend their prescribing privileges, and a bill that would prohibit pharmacies from advertising commonly abused narcotic medications, such as OxyContin and Vicodin, according to the LA Times.

Before moving to the Senate floor, all four bills must clear additional committees, the Times said.

The Times recently issued a report finding that the California Medical Board has repeatedly failed to protect patients from reckless prescribing by doctors: it rarely tries to suspend the prescribing privileges of doctors under investigation, and even when it imposes sanctions, in most cases it allows doctors to continue practicing and prescribing. The Times’ examination of board records and county coroners’ files from 2005 through 2011 found that eight doctors disciplined for excessive prescribing later had patients die of overdoses or related causes; prescriptions those doctors wrote caused or contributed to 19 deaths.

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Iowa’s ‘lock-in’ program aims to curb doctor shoppers

computerpillsIowa has taken an interesting approach towards stopping the practice of seeking out multiple doctors for painkiller prescriptions with a program that “locks” Medicaid recipients into using one doctor, one pharmacy and one hospital. And according to this article, the program appears to be having some positive results: by locking in more patients, the state saved $14.8 million from July 2010 through September 2012 in the cost of drugs and doctors’ visits.

The number of “locked-in” Iowa Medicaid recipients has increased sevenfold from 200 in 2010 to 1,430 in January, the article says, a jump that came after Iowa Medicaid started screening patients not for just doctor-filled prescriptions, but for non-emergency visits to hospital emergency rooms.

The state’s prescription drug monitoring program was launched in March 2009, but only one-quarter of Iowa doctors and prescribers are registered to use the database, which includes more than 4.2 million prescriptions annually, the article says.

Prescription painkillers caused 62 deaths in Iowa in 2011, up from just four deaths in 2000, while prescription abuse treatment admissions more than quadrupled from 187 in 1999 to 878 in 2009, according to the Iowa Department of Public Health.

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