Tag Archives: prescriptions

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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Drug-dependent newborn rate on the rise in Tenn.

babybottleDriven by the prescription drug addiction epidemic, Tennessee is seeing a dramatic rise in the number of newborns born dependent on drugs. In just slightly more than nine months this year, more babies in the state have been born dependent on drugs their mothers took during pregnancy than in all of 2011, according to this article. By the first week of October, 643 babies were born dependent, compared with 629 for all of 2011, and officials are projecting more than 800 drug dependent babies by the end of this year, the article says. The majority of these births involved a mother taking medicine prescribed by a health care provider, according to the article.

Newborns being born addicted to painkillers is yet another disturbing trend stemming from the rampant abuse of prescription drugs. Nationwide, the number of pregnant women who were dependent on or using opiates when they delivered increased from 4,839 in 2000 to 23,009 in 2009.

As a result, the incidence of babies being born with neonatal abstinence syndrome, a group of problems caused by maternal opiate use during pregnancy, has nearly tripled in the past decade. In 2009, the syndrome was diagnosed in newborns at a rate of 3.4 per 1,000 hospital births per year, up from 1.2 diagnoses per 1,000 births per year in 2000.

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VA over-prescribing narcotics to vets: report

soldier drugsEasy access to powerful prescription opiates has led to a rise in overdose deaths among war veterans, a new report has found. According to the Center for Investigative Reporting, the Department of Veterans Affairs has issued more than one opiate prescription per patient, on average, for the past two years. Prescriptions for four opiates – hydrocodone, oxycodone, methadone and morphine – have surged by 270% in the past 12 years, CIR found in an analysis of data obtained through a Freedom of Information Act request.

According to CIR:

The agency charged with helping veterans recover from war instead masks their pain with potent drugs, feeding addictions and contributing to a fatal overdose rate among VA patients that is nearly double the national average.

CIR notes that this spike in opiate prescriptions has occurred despite new VA regulations laid out in 2009 requiring clinicians to follow an “integrated approach” to helping veterans in pain, including a stronger focus on treating the root causes of pain rather than using powerful narcotics to reduce symptoms.

Many areas of the nation with military bases and large VA hospitals have seen prescription drug abuse skyrocket among American soldiers in recent years.

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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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Suburban pill addicts increasingly trying heroin

pills and syringeThe number of first-time heroin users in the U.S. is on the rise, as painkiller addicts turn to the street drug because it’s cheaper and more potent. This trend is particularly affecting suburban areas: in one Ohio county, 93 residents died during the first half of 2013 away after shooting, snorting or smoking heroin; another four fatally overdosed inside county limits, but resided elsewhere. In Tennessee, statewide data show that the number of heroin-incidents has more than doubled since 2010. And in West Virginia, data reported earlier this year showed a 44% increase in fatal heroin overdoses, a trend also noticed in increasing heroin seizures, ambulance runs and hospital admissions tied to the drug.

A study recently released by the Substance Abuse and Mental Health Services Administration found that people who used pain pills non-medically were 19 times more likely to start using heroin.

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Taking action on International Overdose Awareness Day

Today is International Overdose Awareness Day. Drug overdose death rates worldwide are skyrocketing: of the estimated 78,000 deaths in 2010 because of illegal drug use, more than half were due to painkillers, according to a recent study published in the medical journal The Lancet. And in the U.S., drug overdose is now the number one cause of accidental death of Americans between the ages of 35 and 54, killing over 38,000 people in 2010; many of these deaths were caused by prescription opiates.

The painkiller addiction epidemic has also led to a rise in heroin abuse. A new report by the Substance Abuse and Mental Health Services Administration also found that found that four out of five recent heroin initiates — about 79% — previously used prescription pain relievers non-medically. According to SAMHSA, the number of people reporting that they have used heroin in the past 12 months rose from 373,000 people in 2007 to 620,000 people in 2011. Similarly, the number of people dependent on heroin in the past 12 months climbed from 179,000 people in 2007 to 369,000 people in 2011.

As this editorial notes, despite the widespread nature of painkiller and heroin abuse, those who are addicted continue to be stigmatized.

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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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