Tag Archives: DEA

DEA clamps down on hydrocodone

HydrocodoneHydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.

Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.

Combination hydrocodone products are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.

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Walgreens to pay $80M over black-market Oxy sales

bunchofpillsThe U.S. Drug Enforcement Agency announced Tuesday that Walgreens has agreed to shell out $80 million to settle allegations that it allowed oxycodone and other controlled drugs to be diverted for black market sales from its Jupiter, Fla., distribution center.

The settlement, which is the largest in the DEA’s history, comes after the agency accused Walgreens last year of failing to maintain proper controls to ensure it didn’t dispense drugs to addicts and drug dealers.

According to the DEA, the Jupiter distribution center has been the single largest distributor of oxycodone products in Florida since 2009. In 2011, 16 of the top 25 largest oxycodone purchasers by Walgreens retail pharmacies, including the top six purchasers, were in Florida and supplied by the Jupiter center, the agency said.

Walgreens “committed an unprecedented number of record-keeping and dispensing violations” under the Controlled Substances Act, which is designed to prevent prescription painkillers from ending up on the streets, the DEA said.

In addition to the payout, Walgreens’ Jupiter center is banned from distributing and dispensing similar controlled substances until 2014. The deal also resolves similar investigations nationwide, including in Colorado, Michigan, and New York.

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DEA bans Walgreens from shipping Oxy in Fla.

The U.S. Drug Enforcement Agency has barred Walgreens from shipping oxycodone and other controlled drugs from its Jupiter, Fla., distribution center after finding that the company failed to maintain proper controls to ensure it didn’t dispense drugs to addicts and drug dealers.

According to the DEA, the distribution center has been the single largest distributor of oxycodone products in Florida since 2009. In 2011, 16 of the top 25 largest oxycodone purchasers by Walgreens retail pharmacies, including the top six purchasers, were in Florida and supplied by the Jupiter center, the agency said.

The strike against Walgreens comes just after the DEA revoked the controlled substances licenses for two CVS pharmacies in Sanford, Fla., after also accusing them of dispensing excessive amounts of oxycodone.

Separately in May, Cardinal Health reached a deal with the DEA that blocked its Lakeland, Fla. facility from distributing controlled substances for two years following similar accusations.

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Manchin to Oxy Watchdog: “I will not give up this fight”

Earlier this week, pharmacy interest groups defeated an amendment to the Food and Drug Administration Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone. The provision had been accepted as an amendment to the U.S. Senate’s version of the bill, but it was cut from the final bill that reconciled the Senate and House provisions after the Generic Pharmaceutical Association objected to it, claiming it would restrict access and increase prices to the painkillers.

Today, Oxy Watchdog caught up with the amendment’s author, U.S. Senator Joe Manchin (D-W.Va.), who said the bipartisan measure was defeated due to the efforts of high-powered and well-funded lobbyists representing groups that have a huge financial stake in keeping these pills as accessible as possible. But he vowed to continue the fight against prescription drug abuse, and said he planned to re-introduce the amendment in the future.


Watchdog: Tell us more about the reasons you decided to introduce this measure. What’s the landscape like in West Virginia regarding prescription drug abuse?

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Cardinal settles with DEA over painkiller distribution

Cardinal Health has reached a deal with the Drug Enforcement Administration that will block one of its Florida facilities from distributing controlled substances for two years. The company also said it will take steps to improve anti-diversion procedures designed to prevent prescription drugs from being abused.

Earlier this year, the DEA suspended Cardinal’s license after finding that the company – which is one of the nation’s largest distributors of pharmaceuticals – sold excessive amounts of oxycodone to four Florida pharmacies. (The suspension related only to the company’s license to distribute controlled substances from its Lakeland, Fla. facility, which the DEA claims shipped 50 times as much oxycodone to its top four customers than it has shipped to its other Florida retail customers.)

Cardinal challenged the suspension in federal court, and both the company and the DEA filed documents that gave an inside look into how prescription painkillers have flooded the black market.

Cardinal was initially granted a temporary restraining order blocking the suspension after convincing a judge that the move would disrupt drug shipments to more than 2,500 pharmacy customers in Florida, Georgia and South Carolina. The company said it has “robust controls and performs careful due diligence,” noting that in the past four years, it has stopped shipping controlled medicines to more than 350 pharmacies it determined posed an unreasonable risk of diversion, including 160 in Florida alone.

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Cardinal loses round in DEA painkiller distribution fight

A federal judge has ruled that the Drug Enforcement Administration can block Cardinal Health from distributing controlled substances from one of its Florida facilities. Earlier this month, the DEA suspended Cardinal’s license after finding that the company – which is one of the nation’s largest distributors of pharmaceuticals – sold excessive amounts of oxycodone to four Florida pharmacies. (The suspension relates only to the company’s license to distribute controlled substances from its Lakeland, Fla. facility, which the DEA claims shipped 50 times as much oxycodone to its top four customers than it has shipped to its other Florida retail customers.)

Cardinal challenged the suspension in federal court, and both the company and the DEA filed documents that give an inside look into how prescription painkillers have flooded the black market.

Cardinal was granted a temporary restraining order blocking the suspension after convincing a different judge that the move would disrupt drug shipments to more than 2,500 pharmacy customers in Florida, Georgia and South Carolina. The company said it has “robust controls and performs careful due diligence,” noting that in the past four years, it has stopped shipping controlled medicines to more than 350 pharmacies it determined posed an unreasonable risk of diversion, including 160 in Florida alone.

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DEA, Cardinal Health face off over painkiller sales

Earlier this month, the Drug Enforcement Administration suspended Cardinal Health’s license to distribute controlled substances, accusing the company – which is one of the nation’s largest distributors of pharmaceuticals – of selling excessive amounts of oxycodone to four Florida pharmacies. (The suspension relates only to the company’s license to distribute controlled substances from its Lakeland, Fla. facility, which the DEA claims shipped 50 times as much oxycodone to its top four customers than it has shipped to its other Florida retail customers.) Cardinal has challenged the suspension in federal court, and both the company and the DEA recently filed documents that give an inside look into how prescription painkillers have flooded the black market.

The DEA alleges that Cardinal knew or should have known that the pharmacies were inappropriately filling prescriptions issued by DEA-licensed physicians for non-medical reasons.

Meanwhile, Cardinal has been granted a temporary restraining order blocking the suspension after convincing a judge that the move would disrupt drug shipments to more than 2,500 pharmacy customers in Florida, Georgia and South Carolina. The company says it has “robust controls and performs careful due diligence,” noting that in the past four years, it has stopped shipping controlled medicines to more than 350 pharmacies it determined posed an unreasonable risk of diversion, including 160 in Florida alone.

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Mack resumes painkiller regulation efforts

Rep. Mary Bono Mack, R-Ca., is resuming a series of Congressional hearings on prescription drug abuse that began last year. While Mack says painkillers like oxycodone have become too available, some patient advocates and addiction experts contend that a congressional committee is not the appropriate forum for addressing the conditions under which such powerful drugs should be prescribed.

Among Mack’s proposals are the Stop Oxy Abuse Act, which would restrict the use of any pain-relief drug containing oxycodone to “the relief of severe-only instead of moderate-to-severe pain,” and the Ryan Creedon Act of 2011 would require anyone who prescribes controlled substances to be educated on the risks such drugs pose to patients before they can register with the U.S. Drug Enforcement Administration. DEA registration is already required by federal law. Unlike President Barack Obama’s recent plan to curb prescription drug abuse – which allows pharmaceutical companies themselves to “educate” doctors on the risks of their products – the bill specifies that this training should be provided by a medical society, a state medical licensing board, an accredited continuing education provider, or “another organization that the Secretary [of Health and Human Services] determines is appropriate for providing such training or certification.”

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Teen pill abuse spurs schools’ use of drug-sniffing dogs

Parental concerns over teens’ abuse of prescription drugs has prompted several California school districts to rely on drug-sniffing canines to detect the presence of pills. The police chief in one district that is considering using the dogs said OxyContin use has increased, leading more teens to turn to heroin as a cheaper replacement high.

In 2009, 7 million Americans aged 12 years and older abused prescription drugs for non-medical purposes within the past month, and every day, on average, 2,500 teens use prescription drugs to get high for the first time, according to the Substance Abuse and Mental Health Services Administration.

Read more about prescription drug addiction in teens here and here.

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In N.Y., Oxy prescriptions skyrocket: report

Prescriptions for oxycodone in New York rose by 82 percent from 2007 to 2010, according to a new report issued by the state’s attorney general. Almost 22.5 million prescriptions for all types of narcotic painkillers were written in the state in 2010, with an especially high quantity of prescriptions being written on Staten Island and in large areas of Suffolk County, the report says.

New York has suffered brutally at the hands of the prescription drug addiction epidemic. Earlier in January, Sen. Charles Schumer, D-N.Y., called on the DEA to share data collected on pharmaceutical and prescription drug theft with local law enforcement. That move came in the wake of the latest deadly pharmacy robbery on New Year’s Eve in Seaford, N.Y. and in the face of the quadruple homicide that occurred at a Medford, N.Y. pharmacy last year.

Read more about New York’s painkiller addiction troubles here and here.

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