Tag Archives: Big Pharma

Ky. to receive $32M for drug abuse treatment

money and pillsMore than $32 million recovered in settlements with two pharmaceutical companies will be used throughout Kentucky to expand substance abuse treatment, including opiate addictions. The state’s attorney general, Jack Conway, said the settlement funds will help create a new treatment center for adults, treatment scholarships, a grant program for new juvenile treatment beds and/or centers, and expanded services for juveniles.

Kentucky currently only has one-tenth of the substance abuse treatment beds it needs, according to data from the Substance Abuse and Mental Health Services Administration.

Conway’s suit against Merck Sharp & Dohme Corp., which accused the company of failing to disclose to doctors and patients that taking Vioxx significantly raised the risk of heart attack, recently settled for $25 million. His suit against GlaxoSmithKline for failing to disclose that patients taking its diabetes drug, Avandia, were at a higher risk for a cardiovascular event, settled for $15 million.

The illegal use of prescription drugs has dropped among young people in Kentucky over the past four years, according to state officials: in 2008, 15.2% of 12th-graders surveyed said they had used prescription drugs without a doctor’s permission, but that figure dropped to 9% in 2012.

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Doctors’ group backs stricter painkiller controls

Doctor with RX padA major doctors’ organization is urging its members to practice greater caution and restraint when prescribing prescription painkillers in light of the abuse epidemic. The American College of Physicians said in a policy letter published in the Annals of Internal Medicine that prescription drug abuse is a “serious public health problem” and that physicians and other health professionals with prescribing privileges play an important role in helping to ensure safe and effective use of drugs like OxyContin and Vicodin.

According to the group, evidence-based, nonbinding guidelines should be established regarding recommended maximum dosage and duration of therapy that a patient taking controlled substance medications may receive.

In addition, the ACP called for the establishment of a national prescription drug monitoring program to help doctors detect and prevent prescription drug abuse by identifying individuals who seek to obtain prescriptions for addictive medications from multiple physicians for themselves or to sell. Former President George W. Bush launched an initiative in 2005 authorizing federal grants for states to establish or enhance PDMPs, the group said, but funding was initially delayed and has been inconsistent.

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FDA OKs controversial form of Vicodin

pills and pill bottlesThe U.S. Food and Drug Administration has approved Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. The move comes amid criticism from those who say the FDA should not be approving any additional opioids given the current prescription drug addiction epidemic. An advisory panel last year voted against approving Zohydro, citing concerns about the danger of addiction posed by the opioid drug class.

Unlike other hydrocodone-containing drugs like Vicodin, Lortab and Norco, Zohydro is not buffered with acetaminophen or some other over-the-counter medication. The drug also lacks an abuse-deterrent feature such as the ones used in new formulations of drugs like OxyContin.

Hydrocodone is currently the second most-abused medicine in the U.S. behind oxycodone.

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FDA moves for stricter hydrocodone controls

bunchofpillsThe U.S. Food and Drug Administration has recommended reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, a move that would bring such medications in line with opioid painkillers such as oxycodone and morphine.

In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. Proponents of the reclassification have noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics have argued that the move would hinder legitimate pain patients from obtaining treatment.

The reclassification must be approved by the Department of Health and Human Services and the Drug Enforcement Administration, which will make a final scheduling decision.

Separately in September, the FDA announced new safety labeling changes for extended-release and long-acting opioid analgesics such as OxyContin. 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.

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Opioid prescriptions up, but pain treatment unimproved: study

PILLS.jpgPrescription opioid use has skyrocketed over the last decade, but the identification and treatment of pain has failed to improve – and the use of non-opioid analgesics has plateaued, or even declined, a new study has found.

The study by the Johns Hopkins Bloomberg School of Public Health, published Sept. 13 in the journal Medical Care, analyzed trends from 2000 to 2010 associated with patients seeking medical treatment for non-cancer pain, and found no significant change in the proportion of pain visits – approximately one-half – treated with pain relievers.

During that time period, opioid prescriptions nearly doubled, from 11% in 2000 to 19% in 2010, the study found. In addition, of approximately 164 million pain visits in 2010, roughly half were treated with some kind of pain relieving drug: 20% with an opioid and 27% with a non-opioid pain reliever, according to the study.

The information comes just after the U.S. Food and Drug Administration announced new labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics. 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.”

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Calif. lawmakers OK painkiller legislation

pills and pill bottlesThe California Senate has given the green light to two bills aimed at combatting prescription drug abuse and overdose deaths by helping authorities track painkiller prescriptions and enabling enhanced scrutiny of deaths involving such drugs.

The proposed legislation would require coroners to report prescription overdose deaths to the state’s medical board for review, according to the Los Angeles Times, which earlier reported on the nearly 4,000 accidental deaths involving prescription drugs in Southern California and found that in half the cases, drugs that caused or contributed to a death had been prescribed by that person’s physician.

The legislation would also enhance and provide sustained funding for California’s prescription drug monitoring system, known as CURES, which contains detailed data on prescriptions for painkillers, the LA Times said.

The two bills now head to the desk of Gov. Jerry Brown for approval.

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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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Pharmacy employees contributing to Maine painkiller thefts

pharmacyMore than one-third of the prescription drugs stolen from Maine pharmacies are taken by employees, a new report has found.

According to this article, an investigation by the Maine Center for Public Interest Reporting of state disciplinary records has revealed that from 2003 to 2013, 16 pharmacists and 41 pharmacy technicians lost their licenses for stealing drugs from pharmacy shelves or from the patients whose prescriptions they filled.

There are 1,866 pharmacists and 2,461 pharmacy technicians in Maine, so the percentage of pharmacy employees caught stealing drugs is small – although much of pharmacy drug theft likely goes undiscovered and unreported, the article notes.

The American Pharmacists Association has said that pharmacists’ easy access to powerful painkillers often encourages them to take the drugs.

While Maine is seeing some progress in terms of curbing prescription drug abuse, substance abuse specialists in the state say there has been a sharp uptick in heroin addiction as pill addicts make the switch to the illegal street drug.

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Nv. medical board eyes over-prescribing doctors

RXNearly two dozen doctors in Nevada are under investigation by the state’s medical board for allegedly over-prescribing the powerful painkiller OxyContin. The crackdown comes after Sen. Richard “Tick” Segerblom (D-Las Vegas) asked OxyContin maker Purdue Pharma to reveal the names of physicians contained in a database that includes some 1,800 doctors who showed signs of dangerous prescribing.

The Nevada medical board of examiners then met with Purdue and was provided with a list of doctors throughout the state who are suspected of criminal activity, according to this article.

Purdue claims it no longer promotes its product to the doctors at issue, the article says.

The company has taken the stance that the painkiller addiction epidemic was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets, but has admitted that a small number of physicians might account for a “substantial portion” of the nation’s black-market supply of prescription painkillers,

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Activists to hold rally for federal response to opioid epidemic

angry fistPrescription drug addiction activists across the nation are planning a rally to urge federal agencies to take action to prevent new cases of opioid addiction, prevent more overdose deaths and ensure access to effective treatment for millions who have become addicted.

The rally, called “Fed Up! Rally for a Federal Response to the Opioid Epidemic,” will be held Oct. 1 from noon to 2 p.m. at Capitol Hill (Upper Senate Park) in Washington, D.C., according to organizers.

Activists say addiction and overdose deaths due to narcotic painkillers and heroin
are one of the nation’s most urgent public health problems, and that the epidemic has placed a tremendous strain on the nation’s health care system, businesses, and local and state governments. Federal agencies, meanwhile, have been too slow and ineffective in responding to the problem, they say.

Click here to register for the event, and here to view a flyer for the rally.

You can learn more about the rally’s platform here, and view sponsorship opportunities here.

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