Category Archives: Pharmaceutical Industry

How did we get here?

pillflagThe numbers are staggering: in the United States, the number of overdose deaths from prescription opioids has more than tripled in the past decade, resulting in nearly 15,000 fatalities in 2008 alone and now accounting for more than 40 deaths every single day – not to mention the fact that estimated annual health care costs from this epidemic are as high as $72.5 billion.

How did we get here?

In the latest issue of Emergency Medicine News, Dr. Leon Gussow, a physician and editor of The Poison Review blog, examines how opioid analgesics – once feared as dangerous medications with high risk for addiction and overdose – became the drug class most frequently prescribed in the U.S., with four million patients a year receiving scripts for these powerful medications.

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N.Y. imposes stricter controls on hydrocodone

purplepillsIn New York, Attorney General Eric Schneiderman has issued a letter to doctors, pharmacists and other medical professionals alerting them that the widely abused prescription painkiller hydrocodone is now a Schedule II controlled substance under new regulations recently passed by the state. In the letter, Schneiderman calls the drug “highly addictive,” noting that statewide prescriptions for hydrocodone filled increased from 3.8 million to 4.5 million from 2007 to 2009, an increase of 18.4%, while those for oxycodone have increased 82%. In many regions of the state, hydrocodone is the most commonly prescribed controlled substance, according to the letter.

The changes apply only to New York state, although the FDA is currently considering whether to reclassify hydrocodone-containing painkillers from Schedule III drugs to the more restrictive Schedule II on a federal level. In January, an expert panel voted 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

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CVS pays $650K to fund painkiller abuse education

pharmacyCVS-Caremark will shell out $650,000 to help New Jersey authorities establish an education and enforcement campaign on prescription drug safety and abuse, a payment that settles charges that the drug store chain co-mingled prescription pills in several of its pharmacies in the state.

The payment will help fund a public education campaign that will remind consumers to check their medication, learn about it through available resources and, whenever they have questions about the medication, to ask their pharmacist or physician. It will also address the dangers of prescription drug abuse, according to this report.

This isn’t the first tangle CVS has had with officials over prescription drugs. Last year, the DEA revoked the controlled substances licenses for two CVS pharmacies in Sanford, Fla. after accusing them of dispensing excessive amounts of oxycodone.

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Costco pharmacist claims he was fired for whistleblowing: ABC

pillsscatteredA former Costco pharmacy technician is suing the retail giant, claiming he was fired after raising concerns and contacting law enforcement about doctors he believed were over-prescribing powerful painkillers, ABC Los Angeles reports. Shad Thomas says he red-flagged seven local doctors over the years – including Dr. Lisa Tseng, the Rowland Heights former physician now awaiting trial on three counts of second-degree murder for the overdose deaths of three patients, and another who he claims prescribed 7,000 oxycodone to a single patient in one year. Costco has a bonus program for pharmacy managers that is partly based on sales, incentivizing managers to allow addicted patients to continue filling massive scripts, according to ABC News.

See more of ABC News’ reporting on painkiller abuse in southern California here.

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FDA mulls stronger controls on opioid prescribing

PillsLast week, the U.S. Food and Drug Administration held a two-day hearing to determine if more controls need to be placed on opioid prescribing. The hearing was the result of a citizen’s petition filed by the Physicians for Responsible Opioid Prescribing (PROP) and other advocates.

The petition asks the FDA to change the indication on opioid analgesics like OxyContin from “moderate to severe pain” to “severe pain” and to include a suggested duration of 90 days of continuous use. Current labels on opioid analgesics simply indicate that opioids are to be used for “moderate to severe pain,” without further qualification.

The FDA is still taking comments before it makes its decision regarding this issue, and you can let it know what your views are here.

To hear impact statements from those who testified at the meeting, go here.

Separately, the FDA is considering reclassifying hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II. In January, an expert panel advising the FDA voted 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

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Stricter doctor monitoring laws needed: consumer group

pills and pill bottlesConsumer Watchdog, a consumer advocacy group, is urging California lawmakers to hold hearings and investigate strong new laws in response to recent Los Angeles Times reports on widespread drug overdoses due to physician over-prescribing. In a letter sent to Gov. Jerry Brown on Wednesday, the group cited a disciplinary system that “caters to the interests of physicians and their political might, while refusing to answer to patients’ needs for greater transparency and accountability.”

The group also asked legislative leaders to consider random drug testing of physicians, citing a recent report about the medical board agreeing to restore the license of a West Hollywood psychiatrist who pleaded guilty to felony drug dealing and admitted to using methamphetamine.

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Doctors over-prescribing ADHD meds: NYT

bunchofpillsThe New York Times has a devastating story about a family who lost their 24-year-old son to suicide after he became addicted to the prescription drug Adderall. The story calls into question doctors who skip established diagnostic procedures, renew prescriptions reflexively and spend too little time with patients to accurately monitor side effects, noting that highly-addictive medications like Adderall provide a tunnel-like focus that has led growing numbers of teenagers and young adults to fake symptoms to obtain steady prescriptions.

Nearly 14 million monthly prescriptions for attention deficit hyperactivity disorder, or ADHD, were written for Americans ages 20 to 39 in 2011, two and a half times the 5.6 million just four years before, the article says.

Separately, a new study published in the Journal of the American Academy of Child and Adolescent Psychiatry revealed a significantly higher prevalence of substance abuse and cigarette use by adolescents with ADHD, according to this article.

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FDA panel backs stricter controls on Vicodin

The U.S. Food and Drug Administration may be set to reclassify hydrocodone-containing painkillers like Vicodin from Schedule III drugs to the more restrictive Schedule II, with an expert panel voting 19 to 10 in favor of the more stringent prescribing requirements. During a two-day hearing last week, the panel heard testimony from proponents who noted hydrocodone’s abuse potential (such products are currently the most-abused prescription medicine behind oxycodone), while critics argued that the move would hinder legitimate pain patients from obtaining treatment.

The FDA usually, but not always, follows the advice of its advisory panels.

The misuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the Centers for Disease Control and Prevention.

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FDA mulls hydrocodone reclassification

This week, the U.S. Food and Drug Administration is set to conduct a two-day hearing on whether hydrocodone products such as Vicodin should be more highly regulated like other narcotics like OxyContin and morphine, this article reports. FDA researchers said in recent briefing documents that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction, the article says. But critics say hydrocodone is potent and highly addictive, and that updating the drug’s classification could help bring the prescription drug addiction epidemic under control, according to the article.

Last year, pharmacy interest groups defeated an amendment to the FDA Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II.

Combination hydrocodone products such as Vicodin and Norco 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.

The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would have rescheduled hydrocodone 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.

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FDA panel says no to pumped-up Vicodin

A U.S. Food and Drug Administration panel has voted against the agency approving Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. In an 11-2 vote, the advisory panel said Zogenix had met FDA standards for safety and efficacy, but cited concerns about the danger of addiction posed by the opioid drug class, according to this article.

The FDA could still approve the drug for sale in the United States by imposing restrictions to protect public safety, though it usually follows the advice of its advisory panels when deciding whether to approve new medicines. Agency officials will consider the committee’s recommendation in deciding by March 1 whether to give Zohydro the green light, the article says.

San Diego-based Zogenix Inc.’s bid for FDA approval to begin marketing Zohydro has prompted some activists to appeal to the agency not to rubber-stamp more opioid drugs in the midst of an out-of-control epidemic. Proponents of extended-release versions of opioids – such as Purdue Pharma’s recently reformulated OxyContin, OP – claim the drugs are safer because they are “abuse-resistant,” but others point out that many opioid-addicted people simply swallow the pills whole. (Addicts are also already finding their way around allegedly tamper-proof versions.)

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