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Category Archives: Policy & Regulation
Wisc. legislators tackle heroin abuse
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.
Posted in Informational, Policy & Regulation, Trends
Tagged addiction, Deaths, Good Samaritan laws, heroin, naloxone, Narcan, narcotics, overdose, overdoses, oxy, oxy-to-heroin, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, pills-to-heroin, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Teen deaths, Wisconsin
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Vt. heroin ODs doubled in past year
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.
Posted in Informational, Policy & Regulation, Trends
Tagged addiction, Deaths, heroin, narcotics, opiates, opioid, overdose, overdoses, oxy, oxy-to-heroin, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, pills-to-heroin, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Teen deaths, Vermont
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AGs ask FDA to require abuse-deterrent pills
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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, attorneys general, Deaths, narcotics, National Association of Attorneys General, opiates, opioid, overdose, overdoses, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, prescription drug abuse, prescriptions, Schedule II narcotics
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Doctors’ group backs stricter painkiller controls
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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, American College of Physicians, Big Pharma, doctor shopping, doctors, drug monitoring program, narcotics, opiates, oxy, OxyContin, painkillers, PDMP, pharmaceutical, pharmacy, prescription drug abuse, prescription drug monitoring database, prescriptions, Schedule II narcotics
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FDA OKs controversial form of Vicodin
The U.S. Food and Drug Administration panel 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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, FDA, hydrocodone, Lortab, narcotics, Norco, OP, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Purdue Pharma, Schedule II narcotics, Vicodin, Zogenix, Zohydro
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FDA moves for stricter hydrocodone controls
The 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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, Big Pharma, FDA, hydrocodone, morphine, narcotics, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, Percocet, pharmaceutical, prescription drug abuse, prescriptions, reclassification, reschedule, Schedule II narcotics, Schedule III narcotics, Vicodin, Xanax
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Calif. lawmakers OK painkiller legislation
The 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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, California, CURES, Deaths, doctor shopping, drug monitoring program, legislation, Los Angeles Times, narcotics, opiates, overdoses, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pharmacy, pill mills, pills, politics, prescription drug abuse, prescription drug monitoring program, prescriptions, Schedule II narcotics
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FDA unveils new labeling rules for opioids
Under 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.”
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, ARPO, Big Pharma, Deaths, FDA, hydrocodone, labeling, narcotics, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Vicodin
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Del. becomes 14th state to pass ‘Good Samaritan’ law
The governor of Delaware signed so-called “Good Samaritan” legislation on Tuesday offering protection to anyone seeking medical help in the event of a drug or alcohol overdose, making Delaware the 14th state to pass such a measure. The law gives immunity from prosecution to people reporting an overdose, even if he or she has been involved in drug-related activity.
The bill also grants immunity from prosecution for offenses related to underage drinking.
Lawmakers approved the bill only after exempting higher level drug felonies from its immunity protections, a change that worried some critics who claimed the exemptions weakened the bill and would discourage people from reporting overdoses.
In Delaware, overdose deaths nearly tripled from 50 in 1999 to 137 in 2009, with a majority in recent years involving at least one prescription drug, according to this article.
New Mexico was the first state to pass a Good Samaritan law in 2007, followed by California, Colorado, Connecticut, Florida, Illinois, Massachusetts, New York, Rhode Island, Washington, and the District of Columbia. According to TheFix.com, this year, nearly a dozen more states introduced bills: legislation in North Carolina and New Jersey succeeded, while other bills failed due to partisan bickering (Missouri, Mississippi and North Dakota), were killed in committee (New Hampshire and West Virginia), or ran out of time (Hawaii and Texas); Maine still has a live bill, but it isn’t likely to pass this year.
Posted in Crime, Informational, Policy & Regulation
Tagged addiction, Crime, Deaths, Delaware, Good Samarian, Good Samaritan laws, law, laws, narcotics, opiates, opioid, overdose, overdoses, oxycodone, OxyContin, pain medication, painkillers, pills, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Teen deaths
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FDA shutters rogue Internet pharmacies in massive crackdown
Federal regulators have launched a massive crackdown on Internet pharmacies that are selling unapproved and potentially dangerous prescription medicines that could pose significant public health risks. The U.S. Food and Drug Administration said it has shut down 1,677 websites for selling counterfeit or substandard medication, or for selling drugs without appropriate safeguards. Regulators have also seized more than $41 million worth of illegal medicines and arrested 58 people, while a number of additional websites have received regulatory warnings, according to the FDA.
Several sites had interfaces and names that could easily be confused with legitimate pharmacy retailers, such as Walgreens-Store.com, which imitated the well-known drugstore chain’s website, which is actually Walgreens.com, the agency said.
The crackdown marks the largest Internet-based action of its kind, the agency said, adding that prescription medicines, including those purchased online, should only be used with a valid prescription and under the supervision of a licensed health care provider.
Although regulators have long had their eye on the online market for prescription pills, it is still disturbingly easy to find a rogue Internet pharmacy that will sell painkillers like codeine and hydrocodone without a prescription, according to this article. Research shows that 97% of Internet pharmacies are not operating legitimately and most of those do not require a prescription at all, the article says. Many of these pharmacies are based overseas, and will provide the medication even if customers are underage, the article says.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, crackdown, Crime, doctor shopping, FDA, Internet, narcotics, online, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pharmacies, pharmacy, pill mills, pills, prescription drug abuse, prescriptions, Schedule II narcotics
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