Category Archives: Policy & Regulation

Minn. medical group wants MDs to take action

RXThe Minnesota Medical Association is considering requiring doctors to take continuing education courses on pain management and addiction and increasing use of the Minnesota Prescription Monitoring Program in order to deal with the state’s prescription drug abuse issue, according to this article. As of March 2013, only 40% of pharmacists and 30% of doctors in Minnesota were using the monitoring system, according to the article.

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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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FDA bans copycat versions of original Oxy amid abuse concerns

DRUG BANNEDThe U.S. Food and Drug Administration said Tuesday it will not approve 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.

According to the agency, “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.

The FDA’s decision came on the same day that Purdue’s patent on the original OxyContin expired, which normally opens the door for generic drug makers to launch their own cheaper versions of a product. Now, these generic companies will have to develop their own abuse-deterrent designs, preserving Purdue’s monopoly on the OxyContin market for the time being.

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Generic Oxy in N.Y. will enable abusers: Schumer

pillsscatteredNew York Sen. Charles Schumer is calling for added safety features to be imposed on generic forms of the prescription painkiller OxyContin that are set to hit the market in April. The lawmaker says he fears that these copycat versions, which do not include anti-abuse protections that cause them to turn into gels or chunks when crushed, could enable abusers, according to this article.

Many popularly abused prescription painkillers, including OxyContin, have been reformulated in recent years to allegedly make them abuse-resistant. But generic manufacturers are bringing their own versions of such drugs to market that don’t include tamper-proof properties.

The reformulation of OxyContin has prompted painkiller addicts across the country to switch to other opiates as well as heroin, recent research has shown.

Oxycodone prescriptions in Staten Island — which ranks third in oxycodone prescriptions per capita in the state — have remained relatively steady, with 141,022 written last year, compared to 142,059 in 2011, according to the article.

Overdose is now the leading cause of accidental death in New York, where almost 22.5 million prescriptions for all types of narcotic painkillers were written in in 2010, according to a recent report issued by the state’s attorney general.

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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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N.C. drug monitoring database underused: report

RXLike many states, North Carolina has implemented a prescription drug monitoring database to identify people who abuse and misuse powerful painkillers. Now, a new study at the University of North Carolina at Chapel Hill shows that the system – which is voluntary – is only used by about one-third of the 34,000 physicians who are registered with the Drug Enforcement Agency to prescribe controlled substances – and fewer than half of those registered actually used it in the last six months of 2011.

However, at the same time, the number of patients with the most severe drug-seeking behaviors – those who used 10 prescribers and 10 pharmacists within six months – decreased substantially from 217 in 2008 to 115 in 2012, the study found.

Prescription drug overdose kills an average of three people per day in North Carolina.

Nearly all states have operational prescription drug monitoring programs, with the exception of Montana, Nebraska, Arkansas, Wisconsin, Georgia, Maryland, New Hampshire, and the District of Columbia, according to the latest research from the Alliance of States with Prescription Monitoring Programs.

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