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Category Archives: Policy & Regulation
Hydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.
Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.
Combination hydrocodone products 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.
Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.
Pennsylvania — which ranks 14th in the nation in prescription overdose deaths — has unveiled new emergency room opioid prescribing guidelines in an attempt to stem the tide of prescription drug abuse.
The new guidelines state that emergency room doctors should limit prescriptions for short-acting opioid painkillers to a week’s supply, and should not prescribe OxyContin, methadone or extended-release morphine without coordinating with the patient’s primary care physician.
According to the guidelines:
Opioid analgesics may be necessary for the relief of pain, but improper use of opioids poses a threat to the individual and to society. Providers have a responsibility to diagnose and treat pain using sound clinical judgment, and such treatment may include the prescribing of opioids. Providers also have a responsibility to minimize the potential for the abuse and diversion of opioids. Therefore, providers should use proper safeguards to minimize the potential for abuse and diversion of opioids.
Health care providers wrote 259 million prescriptions for painkillers in 2012, enough for every adult in the U.S. to have a bottle of pills, according to the U.S. Centers for Disease Control and Prevention.
U.S. Attorney General Eric Holder is urging federal law enforcement agencies to identify, train and equip personnel who may interact with a victim of a heroin overdose with the drug naloxone. The potentially life-saving drug — which effectively restores breathing to a victim in the midst of a heroin or opioid overdose — is already carried by officers in some state and local law enforcement groups while on patrol.
The U.S. Department of Justice wants federal law enforcement agencies, as well as their state and local partners, to review their policies and procedures to determine whether personnel should be equipped and trained to recognize and respond to opioid overdose by various methods, including the use of naloxone, otherwise known as Narcan. Seventeen states and the District of Columbia have amended their laws to increase access to naloxone, resulting in over 10,000 overdose reversals since 2001.
According to Holder:
The shocking increase in overdose deaths illustrates that addiction to heroin and other opioids, including some prescription painkillers, represents nothing less than a public health crisis. I am confident that expanding the availability of naloxone has the potential to save the lives, families and futures of countless people across the nation.
FedEx Corp. is facing charges that it delivered prescription painkillers and other controlled substances for illegal Internet pharmacies.
The charges include 15 counts of conspiracy to distribute controlled substances and misbranded drugs and drug trafficking. Prosecutors claim FedEx delivered drugs to Internet pharmacies that supplied pills to customers who filled out online questionnaires without undergoing doctors’ examinations, in violation of federal and state drug laws.
According to the indictment, FedEx knew as early as 2004 that it was delivering drugs to dealers and addicts:
FedEx’s couriers in Kentucky, Tennessee, and Virginia expressed safety concerns that were circulated to FedEx Senior management, including that FedEx trucks were stopped on the road by online pharmacy customers demanding packages of pills, that the delivery address was a parking lot, school, or vacant home where several car loads of people were waiting for the FedEx driver to arrive with their drugs, that customers were jumping on the FedEx trucks and demanding online pharmacy packages, and that FedEx drivers were threatened if they insisted on delivering packages to the addresses instead of giving the packages to customers who demanded them. In response to these concerns, FedEx adopted a procedure whereby Internet pharmacy packages from problematic shippers were held for pick up at specific stations, rather than delivered to the recipient’s address.
An older form of the powerful prescription painkiller OxyContin that has been banned in the United States is still showing up in some areas of the country, possibly making the journey from Canada, where it is still legal, according to this article. In 2013, the FDA banned generic versions of OxyContin, which could easily be crushed, in favor of a tamper-resistant version produced exclusively by Oxy maker Purdue Pharma under a new patent. The Canadian government has so far continued to approve generic, crushable forms of oxycodone that are highly prone to abuse — though it has recently indicated it may soon force all opioid manufacturers to render their products tamper-resistant.
The news came as a study into skyrocketing opioid deaths in Canada found that painkillers are responsible for one in eight deaths among young adults in Ontario, according to this article. Opioid overdoses killed nearly 6,000 people in Ontario between 1991 and 2010, half of them under the age of 42, the study found.
Canada is the world’s second largest per capita consumer of prescription opioids after the United States.
Delaware has put into place emergency prescribing regulations regarding Zohydro, a powerful new painkiller many critics fear may fuel the epidemic of painkiller abuse. Late last year, Zohydro gained FDA approval despite the fact that after its own advisory committee had voted 11-2 against allowing the drug on the market. Since then, 29 state attorneys general have urged the agency to reconsider its decision, and Massachusetts Gov. Deval Patrick even attempted to ban the drug (a federal judge later blocked that order). Delaware Secretary of State Jeffrey Bullock said the regulations were necessary “to address the imminent peril to the public health, safety and welfare of all Delawareans” caused by Zohydro. According to his statement:
The use of this new and dangerous narcotic painkiller known as Zohydro must be monitored closely because the abuse of it can be deadly. It carries even higher risks of abuse than other short-acting formulations.
Zogenix, the maker of Zohydro, recently reported that about 9,000 prescriptions were filled through June 13 since the drug hit the market in March. The company plans to target about 20,000 prescribers it describes as “high decile [extended-release/long-acting] opioid prescribers” who account for 60% of the market, and envisions Zohydro along the lines of the multibillion-dollar market for OxyContin, according to this article.
A federal judge has struck down Massachusetts Gov. Deval Patrick’s ban on the controversial new form of hydrocodone, Zohydro, saying the state lacked the authority to override the FDA’s approval of the painkiller. U.S. District Court Judge Rya W. Zobel noted that the FDA approved Zohydro after a screening process, and said the federal regulatory agency has more power than the state in this case, according to this article. She also said Massachusetts lacked the authority to force Zohydro’s maker, Zogenix, to make an abuse-resistant form of the drug because that formulation has not been approved by the FDA, the article says.
Gov. Patrick issued the Zohydro ban last month, declaring a public health emergency in response to the state’s growing opioid addiction epidemic 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.
Tennessee lawmakers have given the green light to a bill that would allow criminal assault charges to be filed against women whose infants suffer harm from their mothers’ prenatal drug abuse. The measure, which would allow prosecutors to press assault charges on women if an infant’s “addiction or harm is a result of her illegal use of a narcotic drug taken while pregnant,” has been sent to Gov. Bill Haslam for approval, according to this article.
Driven by the prescription drug addiction epidemic, Tennessee is seeing a dramatic rise in the number of newborns born with neonatal abstinence syndrome. In just slightly more than nine months last year, more babies in the state were born dependent on drugs their mothers took during pregnancy than in all of 2011, according to this article. By the first week of October 2013, 643 babies were born dependent, compared with 629 for all of 2011. The majority of these births involved a mother taking medicine prescribed by a health care provider.
Neonatal abstinence syndrome is a group of problems that occur in a newborn who was exposed to addictive illegal or prescription drugs while in the mother’s womb. Symptoms include excessive crying, seizures, vomiting, fever, and slow weight gain. Some NAS babies may need to receive fluids intravenously; others with more severe symptoms may require medicine to treat withdrawal.
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.