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Category Archives: Policy & Regulation
The U.S. Food and Drug Administration has approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The hand-held device, known as Evzio, rapidly delivers a single dose of the drug naloxone and can be carried in a pocket or stored in a medicine cabinet, according to the agency. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for such situations, but until now it has been available mostly in hospitals and other medical settings.
Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous), the FDA said. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication.
Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the U.S. Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.
Massachusetts Governor Deval Patrick has declared a public health emergency in response to the state’s growing opioid addiction epidemic, issuing an order banning the controversial new form of hydrocodone, Zohydro, and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added. The prescribing and dispensing of Zohydro, which was recently approved for sale by the FDA despite widespread protests, will be prohibited “until it is determined that adequate measures are in place to safeguard against the potential for diversion, overdose and misuse,” he said. The governor added:
The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large.
A controversial bill that would boost penalties for drug dealers — particularly when the sale of drugs like heroin results in an overdose death — is gaining traction in Kentucky, where the House Judiciary Committee narrowly approved the measure. The bill needed 12 votes to advance out of committee, and only secured enough support when one lawmaker agreed to change her vote, with eight members passing and no one voting in opposition, according to this article.
The legislation would allow the prosecution of homicide when the sale of heroin or some other Schedule I controlled substance results in an overdose death; classify the controversial new painkiller Zohydro as a Schedule I drug; require the state Medicaid program to cover several inpatient and outpatient treatment options for people addicted to opiates, including heroin and prescription painkillers; and divert state funds to expand treatment programs, according to this article.
Prescription painkillers are the primary cause of overdose deaths in Kentucky, while heroin contributed to 129 Kentucky resident drug overdose deaths in 2012 — a 207 percent increase from the 42 heroin-involved deaths recorded in 2011.
Rhode Island authorities are taking emergency steps to address an overdose crisis by making the overdose antidote naloxone more widely available, including to law enforcement agencies. According to this article, the state’s health department says Rhode Island is in the midst of “a severe prescription and street-drug overdose crisis” and that expanded access to naloxone — otherwise known as Narcan — has become “immediately necessary to save lives.”
The emergency regulations allow for naloxone to be prescribed not only to a person experiencing an overdose or at risk of one, but to family members and friends in a position to assist, while police departments would also be able to obtain and administer Narcan under a standing order from a prescriber, according to the article.
Rhode Island reported 55 accidental overdose deaths this year through March 4, about twice the normal number, the article says.
Fifteen states and Washington, D.C. currently have some type of Narcan distribution program, including some where family and friends of addicts receive kits in case of emergency.
If you live on the West Coast, take note that the second annual ENOUGH! Rally is set to be held on March 24, 2014 on the south steps of the California State Capitol building in Sacramento from 10 a.m. to 2 p.m. According to the rally’s website, the goal of the event is to educate the public and to advocate for legislation and other action that can make a difference in curbing the prescription drug epidemic.
More details, according to the National Coalition Against Prescription Drug Abuse, which is organizing the event:
Pick up free educational materials at information tables and learn about the prevention and substance abuse treatment efforts organizations and treatment centers from around the state are engaged in. Stop by our legislation table to learn about prescription drug-related legislation being introduced during this legislative session and how to voice your support for it.
Multiple organizations will be on hand to provide free prescription drug related educational materials and information about the work they’re doing to make a difference in the area of prevention. Guest speakers include state legislators and advocacy groups who are sponsoring key legislation, representatives from several prevention and substance abuse treatment facilities and parents and others who have been personally impacted by this epidemic. A special dedication ceremony will be held for those lost to or otherwise impacted by prescription drug abuse/misuse.
The U.S. Food and Drug Administration’s approval of Zogenix Inc.’s Zohydro painkiller has come under fire from critics who say the agency should not be approving any additional opioids given the current prescription drug epidemic. Forty-two public health groups are urging the FDA to withdraw its support of the painkiller, according to National Public Radio. Zogenix says it will introduce a non-crushable version of Zohydro in three years and plans to closely monitor prescription abuse, and claims that millions legitimately need the drug, NPR reports. But addiction experts say another high-potent, high-dose, long-acting opioid drug will simply add more fuel to the painkiller addiction epidemic, NPR says.
The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, 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.
In Wisconsin, where heroin killed nearly 200 people in 2012, legislators are considering legislation that would provide immunity to anyone who helps a person who has overdosed on drugs, and would also provide immunity for possessing and administering the overdose antidote Narcan, according to this article.
They are also considering a separate bill that would target the abuse of opiate painkillers like Vicodin and OxyContin by allowing more medicine collection sites to accept them for disposal. A third measure would create regional treatment centers, the article says.
Heroin overdose deaths surpassed cocaine deaths in Milwaukee County for the first time in 2012, and heroin was present in 32% of fatal overdoses from mixed drug cocktails, according to this article. Narcan is increasingly being used to address the problem: statewide, emergency medical services have seen an increase in naloxone in the last three years, from 2,915 uses in 2010 to 3,247 in 2011 and 3,730 in 2012, the article says.
Overdose hospitalizations accounted for approximately two of every 10,000 hospital visits in 2012, and opiate-related deaths have grown from 2.19 per 100,000 deaths in 2000 to 8.08 in 2011, a report by the State Council on Alcohol and Other Drug Abuse found.
What started as an OxyContin and prescription drug addiction problem in Vermont has now grown into a full-blown heroin crisis, with heroin overdose deaths doubling last year from the year before, according to Gov. Peter Shumlin. There has been more than a 250% increase in people receiving heroin treatment in Vermont since 2000, with the greatest percentage increase, nearly 40%, in just the past year, the governor said in his state of the state address. Since 2000, treatment for all opiates increased by more than 770% increase; in 2013, there were twice as many federal indictments against heroin dealers than in the prior two years, and over five times as many as had been obtained in 2010, Shumlin added.
In addition, more than $2 million of heroin and other opiates are being trafficked into Vermont every week, the governor said. Due to the state’s proximity to Boston, New York, Philadelphia, and other cities where heroin is cheap, dealers can make a lot of money from addicts in Vermont: a $6 bag of heroin in New York City can go for up to $30, Shumlin said.
The National Association of Attorneys General has asked the U.S. Food and Drug Administration to require tamper-resistant versions of generic prescription painkillers in a bid to deter abuse. In a letter to the agency, 42 state and territorial attorneys general said the agency should ensure that generic opioids, like their branded counterparts, have abuse-deterrent properties.
The U.S. Centers for Disease Control and Prevention recently found that drug overdose deaths increased for the eleventh consecutive year in 2010. According to the agency, 38,329 people died from a drug overdose in the U.S. that year, up from 37,004 deaths in 2009.
Overdose deaths involving opioid analgesics have shown a similar increase, the CDC found: starting with 4,030 deaths in 1999, the number of deaths increased to 15,597 in 2009 and 16,651 in 2010.
In 2010, nearly 60% of the drug overdose deaths (22,134) involved pharmaceutical drugs. Opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in about 3 of every 4 pharmaceutical overdose deaths (16,651), according to the CDC.
A 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.