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Category Archives: Policy & Regulation
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.
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.