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Tag: opioid epidemic

  • Opioid Antidote Naloxone Recalled By Manufacturer

    Opioid Antidote Naloxone Recalled By Manufacturer

    A batch of units sold between February 2017 and February 2018 are being recalled by the manufacturer. 

    The life-saving opioid overdose antidote naloxone has been recalled by its manufacturer, the Food and Drug Administration (FDA) announced.

    Drug company Hospira and its parent company Pfizer issued the recall on Monday, CNN reported, after discovering “loose particulate matter on the syringe plunger.”

    While no one has yet reported problems with the drug, Pfizer isn’t taking any chances. “In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity,” the drug maker said in its recall.

    Known by its brand name Narcan, naloxone has made headlines in recent years for its role in the nation’s opioid crisis, as it rapidly reverses the effects of overdoses.

    The drug is widely carried by ER doctors, paramedics and specially trained first responders, as well as the family members of people addicted to prescription painkillers and opioid users. (Previously, the drug was only available through hospitals, CNN noted.)

    First developed in 1961, naloxone quickly proved itself to be as effective as it is fast-acting. The drug has virtually no side effects and only stays in a person’s system for up to 90 minutes.

    “The sooner the drug is given, the better the result, because the brain of a person who isn’t breathing is being deprived of oxygen,” the Cleveland Clinic’s Dr. Thomas Waters told Health. It doesn’t reverse alcohol or non-opioid drug overdoses, though.

    There are currently three FDA-approved forms of naloxone, including injectable vials, autoinjectable devices and a pre-packaged nasal spray.

    According to the National Institute on Drug Abuse, naloxone acts as an opioid antagonist, binding to opioid receptors in the brain: “[The drug] can very quickly restore normal respiration to a person whose breathing has slowed or stopped as a result of overdosing with heroin or prescription opioid pain medications.”

    The drug recall affects single-use sterile cartridge units “with lot numbers 72680LL and 76510LL in 0.4 mg/ml, 1 mL in, and 2.5 mL strengths,” CNN reports.

    CNN added that the units were sold to wholesalers, hospitals and distributors in the United States, Puerto Rico and Guam between February 2017 and February 2018. 

    Fortune noted that the naloxone recall is just “the latest black eye” for Hospira, citing manufacturing shortages, lawsuits, staff cuts and warning letters from the FDA as problems that have plagued the company in recent years. The company’s Puerto Rico facilities, where many generic injectable and IV drugs were made, were shuttered after the “bombshell of Hurricane Maria” last year.

    View the original article at thefix.com

  • Can Sewage Provide Clues On How To Combat Opioid Crisis?

    Can Sewage Provide Clues On How To Combat Opioid Crisis?

    Sewage studies could prove to be more beneficial than hospital data and surveys when it comes to getting a closer look at residents’ drug intake.

    As cities continue searching for ways to combat the opioid crisis, some are turning to sewage for answers. 

    In fact, about six cities have asked Arizona State University to study their sewage for “chemical signatures that may help save lives,” according to Scientific American. 

    Rolf Halden, who is the director of ASU’s Biodesign Center for Environmental Health Engineering, says sewage is “the information superhighway under your feet.” Since 2003, Halden’s Human Health Observatory has been studying sewage in more than 300 municipalities across the world. 

    In the past, Scientific American notes, the team has searched for anything that can tell them about a community’s health, such as stress hormones, dietary choices, nicotine presence and hazardous chemicals. 

    But now, cities have begun asking for help when it comes to the opioid crisis by searching for evidence of opioid use. Currently, Halden and his team provide about six municipalities with monthly data about residents’ intake of substances such as heroin, fentanyl, oxycodone and other opioids. 

    This could prove more beneficial than hospital data and surveys, as used in the past, since people can’t lie about use through sewage, and it doesn’t take as long to collect. 

    “History has taught us that when you ask people about drug use, you often don’t get a truthful answer,” Halden told Scientific American. But, he says, “sewage doesn’t lie.” 

    When it comes to testing the sewage, researchers put it through what is called liquid chromatography, Scientific American states. In other words, the compounds in the sewage got separated and sorted.

    Researchers then put a solution through a device that can recognize and measure which drugs are present and how much. Researchers take these numbers and establish an estimate of the number of doses per 1,000 people. 

    Because it only takes researchers one or two days to test sewage, the results reflect nearly current patterns of drug use. 

    “If a city shuts down a pill mill—a clandestine operation where medical workers inappropriately prescribe powerful narcotics—or arrests a ring of dealers, it can measure the immediate impact,” Scientific American reports. “If opioids start to disappear from the wastewater, it could be an early indication of success. But if the sewage is suddenly flush with fentanyl, it may indicate that legal users deprived of their prescriptions are seeking street drugs instead.”

    This can be beneficial for various reasons. For example, if a large increase in drugs like fentanyl is observed, it allows first responders to be prepared to give the opioid antidote naloxone, and to make sure they have enough on hand.  

    Another benefit to testing sewage is that it allows officials to determine the impact of drug education programs. 

    According to Scientific American, sewage testing costs about $10,000 per year for cities, but that number can change depending how often testing is done and what is measured for. 

    “Right now people are surprisingly skeptical of what one can measure in wastewater,” Halden told Scientific American. But, he added, “I think this will become a common way of thinking in the future.”

    View the original article at thefix.com

  • Medical Schools Focus On Addiction Medicine Training In Light Of Opioid Crisis

    Medical Schools Focus On Addiction Medicine Training In Light Of Opioid Crisis

    Medical students are seeking out addiction medicine training and schools are making adjustments to fulfill their needs. 

    The opioid crisis is changing the way some medical schools are approaching training, according to the San Francisco Chronicle. 

    At the University of California, San Francisco (UCSF) School of Medicine, this is being done by implementing a yearlong fellowship in addiction medicine, the Chronicle reports. 

    The fellowship program is funded by the city and county of San Francisco and works to incorporate addiction medicine into overall medical training, rather than just psychiatric medicine. 

    Dr. Hannah Snyder is one of the fellowship participants and is expected to complete the program this month. 

    “I started learning about treating addiction and realizing we had highly effective medications to treat addiction,” Snyder told the Chronicle. “I got really excited about that because there’s a way to prevent people from having those complications in the first place.”

    According to the Chronicle, Snyder works at Ward 93 as part of the fellowship. Ward 93 is a methadone clinic at San Francisco General Hospital. There, she meets with patients to discuss treatment. 

    Snyder is also assisting other U.S. hospitals with new protocols for treating those with opioid use disorders. The Chronicle states that this “primarily means getting patients started on buprenorphine or methadone—two long-term prescription medications for opioid-use disorder—when they come to the hospital after overdosing or having severe withdrawal symptoms.” 

    The fellowship at UCSF School of Medicine isn’t the only one of its kind. In fact, since 2011, 52 U.S. addiction medicine fellowships have been accredited by the Addiction Medicine Foundation. 

    Fellowships are typically completed by doctors who have already finished their three- to six-year residency in a specific area and wish to take part in more training in a subspecialty, the Chronicle notes. It wasn’t until 2016 that addiction medicine was recognized as a subspecialty. 

    Dr. Anna Lembke, a psychiatrist at Stanford School of Medicine, is working to add addiction medicine courses to Stanford’s curriculum. 

    “It’s the dawning awareness within the medical community that addiction in general is a growing problem in our patient population,” she told the Chronicle. “The opioid epidemic has put it front and center in a way that gives people permission to focus on it. Suddenly there are research dollars available to study it, and federal grants. It has momentum it never had before.”

    At Stanford specifically, students are the ones pushing for additional education in the area. The Chronicle states that Alexander Ball, a fifth-year medical student, partnered with Lembke to create lectures centered around pain and addiction for first and second-year students. Some were incorporated into courses this year, and more will be next year, the Chronicle notes. 

    The lectures concentrate on opioid prescribing, administering buprenorphine and other medications and motivational interviewing, which is a counseling technique. 

    At UCSF, buprenorphine training has been offered as optional for residents and faculty since 2011, the Chronicle reports. Buprenorphine is used to treat opioid dependence and is a Schedule III narcotic, meaning doctors have to complete eight hours of training and get a waiver in order to prescribe it. 

    According to Dr. Scott Steiger, associate professor of medicine and psychiatry at UCSF, the buprenorphine training is drawing more and more medical professionals. 

    “Last year, we had to turn people away because we had reached our capacity for the room, which was 77,” Steiger told the Chronicle. “The next one (this spring), we had it in an auditorium to fit all the people. It’s telling that people are trying to get as much training as they can.”

    View the original article at thefix.com

  • FDA Challenges Developers To Make Better Pain Treatment Devices

    FDA Challenges Developers To Make Better Pain Treatment Devices

    For an innovation challenge, the FDA is looking for devices that provide more benefits than opioids, with fewer risks. 

    The Food and Drug Administration wants better options available for treating pain—and it is turning to developers for help. 

    The FDA announced this week that it is running a new innovation challenge for medical devices that provide solutions to detecting, treating and preventing addiction, addressing drug diversion and treating pain.

    Applications will be accepted through September, and the developers of devices that are chosen will be able to work closely with the FDA to bring their product to market. 

    “Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in tackling the opioid crisis. We must advance new ways to find tools to help address the human and financial toll of opioid addiction,” said FDA Commissioner Scott Gottlieb, M.D. 

    Gottlieb hopes that by encouraging the development of medical devices, fewer patients will need to rely on opioid pain relief, which has a high risk of addiction. 

    “For example, better medical devices that can effectively address local pain syndromes can, in some cases, supplant the use of systemic opioids. This can help reduce overall use of opioids,” he said. 

    Finding replacements for opioids is an important piece of confronting the opioid epidemic, he added. 

    “This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted to opioids and preventing new cases of addiction,” he said. “We’re hopeful that in collaborating with public health-minded innovators, we can identify and accelerate the development of new technologies, whether a device, diagnostic test, mobile medical app, or even new clinical decision support software, that can contribute in novel and effective ways to help reduce the scope of this crisis.”

    Developers can submit devices that are in any stage of development, including the concept phase. The FDA will be looking for devices that provide more benefits than opioids, with fewer risks. 

    In 2012, the FDA ran a similar innovation challenge that helped develop and bring to market new ways of treating renal disease, said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. He hopes this challenge will have similar results. 

    “The FDA stands ready to provide significant assistance and expedite premarket review of applications to help bring innovative devices that, if properly instituted, could help those at risk for addiction or treat those who might develop opioid use disorder,” he said. “We also hope that in turn these novel products may also help pave the way for the development of future products that build on the latest technologies.”

    View the original article at thefix.com

  • Older Americans Among "The Unseen" In The Opioid Epidemic

    Older Americans Among "The Unseen" In The Opioid Epidemic

    Opioid misuse nearly doubled for Americans older than 50 over a 12-year span. 

    The focus of the opioid crisis tends to be on younger generations. But this could be problematic, as, according to the Washington Post, older generations are increasingly at risk to develop opioid use disorders. 

    This is backed up by information from the Substance Abuse and Mental Health Services Administration (SAMHSA), which states that from 2002 to 2014, opioid misuse decreased in younger age groups, especially in those age 18-25.

    However, in Americans older than 50, use just about doubled. 

    On Wednesday, May 23, the Senate Special Committee on Aging held a session to discuss opioid use by the elderly population. 

    “Older Americans are among those unseen in this epidemic,” Sen. Robert P. Casey Jr. of Pennsylvania said, according to the Post. “In 2016, one in three people with a Medicare prescription drug plan received an opioid prescription. This puts baby boomers and our oldest generation at great risk.”

    Medicare can be problematic in situations such as this, because it funds opioids for patients, but it does not assist with care or medication that can be used to combat the opioid crisis, the Post notes. 

    William B. Stauffer, executive director of the Pennsylvania Recovery Organizations Alliance, in Harrisburg, Pennsylvania, spoke at the hearing and said one in three older Americans that have Medicare are prescribed opioids. 

    “However, while Medicare pays for opioid painkillers, Medicare does not pay for drug and alcohol treatment in most instances, nor does it pay for all of the medications that are used to help people in the treatment and recovery process,” he said, according to the Post. “Methadone, specifically, is a medication that is not covered by Medicare to treat opioid use conditions.”

    Gary Cantrell, a deputy inspector general at the Department of Health and Human Services, addressed Medicare Part D (prescription medication) beneficiaries, according to the Post.

    In 2016, Cantrell says, about 500,000 people “received high amounts of opioids” and nearly 20% of those are at “serious risk of opioid misuse or overdose.”

    For the elderly population, problematic use of opioids often starts with prescriptions rather than street drugs. 

    “Older adults are at high risk for medication misuse due to conditions like pain, sleep disorders/insomnia, and anxiety that commonly occur in this population,” Stauffer said, according to the Post. “They are more likely to receive prescriptions for psychoactive medications with misuse potential, such as opioid analgesics for pain and central nervous system depressants like benzodiazepines for sleep disorders and anxiety.”

    Apart from abuse, there are other risks associated with opioid use in older populations, too. The Post states that Sen. Susan Collins (R-Maine) pointed out at the hearing that, “Older adults taking opioids are also four to five times more likely to fall than those taking nonsteroidal, anti-inflammatory drugs.”

    Opioid misuse in seniors becomes even more dangerous because doctors can have a harder time recognizing the signs, Collins says. 

    “Regrettably,” Collins said, according to the Post, “health-care providers sometimes miss substance abuse among older adults, as the symptoms can be similar to depression or dementia.”

    View the original article at thefix.com

  • Police Seize Enough Fentanyl To Kill 26 Million People

    The record-breaking seizure was one of the biggest fentanyl busts in US history.

    Nebraska State Patrol managed to seize 118 pounds of fentanyl during a routine traffic stop.

    According to estimates by the U.S. Drug Enforcement Administration, this was enough fentanyl to kill 26 million people. This estimate is based on the fact, according to the DEA, that just two milligrams of the drug is enough to kill a person.

    On April 26, state troopers became aware of a suspicious semi-truck driving on the shoulder of Interstate 80. After pulling the truck over, troopers searched the vehicle and found the record-breaking stash in a hidden compartment. 

    At first glance, the troopers thought they had found a formidable mound of what was probably mostly cocaine. Testing of the drug was delayed because of the “dangerous nature of the substance,” as some drugs, including fentanyl, are dangerous if touched and absorbed into the skin or accidentally breathed in.

    It was fortunate they took such precautions, because testing revealed that all 118 pounds were fentanyl. This bust was the largest the state of Nebraska had ever seen, and is among the largest in the country, announced Nebraska Gov. Pete Ricketts.

    The driver and passenger of the truck, 46-year-old Felipe Genao-Minaya and 52-year-old Nelson Nunez, were arrested for possession of a controlled substance with intent to deliver. Authorities estimate the product they were hauling was worth more than $20 million.

    Fentanyl, a synthetic opioid, is anywhere between 50 and 100 times stronger than morphine and 30 to 50 times stronger than heroin.

    The drug has exacerbated the opioid crisis and has been involved in a few high-profile deaths, including Prince and Tom Petty. Petty was found unconscious in his home and was rushed to the hospital in full cardiac arrest. An autopsy revealed that among the drugs in his system, fentanyl featured prominently.

    In Prince’s case, neither he nor those close to him knew he was taking fentanyl. Everyone involved thought the pills were Vicodin, but they were actually fentanyl-laced counterfeits, according to an investigation.

    Kellyanne Conway, who was entrusted by the Trump administration with the task of tackling the opioid crisis, suggested that fentanyl addiction and deaths could be avoided if people opted for junk food as their vice instead.

    “I guess my short advice is, as somebody double your age, eat the ice cream, have the french fry, don’t buy the street drug,” Conway said. “Believe me, it all works out.”

    View the original article at thefix.com

  • Congress "Scared" To Take On American Medical Association Over Opioids

    Congress "Scared" To Take On American Medical Association Over Opioids

    A senator recently called out Congress for not standing up to the AMA for stalling progress on anti-opioid abuse regulations.

    A powerful physicians lobby is blocking efforts in Congress to regulate the way certain medications like opioid painkillers are prescribed, according to a new report.

    According to the Daily Beast, the American Medical Association has actively lobbied against certain measures that seek to limit the way that doctors give opioid prescriptions. And according to some members of Congress, fellow lawmakers are “too scared” to go up against the massive organization.

    This may have to do with the fact that in 2017, the AMA was the seventh highest lobbying spender ($21.5 million), and in 2016 gave nearly $2 million to members of Congress.

    The AMA has been forthright in its opposition to measures included in the Comprehensive Addiction & Recovery Act 2.0 (a proposed update to the 2016 law by the same name) that would limit opioid prescriptions to a three-day supply, according to Sen. Rob Portman of Ohio, a co-sponsor of the bill.

    The AMA also opposes mandatory opioid education for doctors, as well as the required use of prescription drug databases to check a patient’s history with certain drugs before prescribing a new medication.

    Members of Congress are “too scared to take on the AMA,” thus stalling progress on anti-opioid abuse regulation, said Sen. Joe Manchin of West Virginia.

    Many of the measures that the AMA is against appear on a list of guidelines issued by the Centers for Disease Control and Prevention (CDC) in 2016.

    The guidelines—which do not apply to palliative care, end-of-life care, or cancer treatment—encourage physicians to “start low and go slow” when prescribing opioid painkillers for chronic pain, and to “prescribe no more than needed.”

    The CDC also advises physicians to discuss the risk factors of using opioid medication with all patients, and to review each patient’s prescription drug history via the prescription drug monitoring database before prescribing.   

    But the AMA does not see a solution in mandating these reforms through legislation.

    “Limits and one-size-fits-all approaches will not end this epidemic,” the organization said in a statement. “The AMA has urged Congress, statehouses, and payers to cover evidence-based treatment that works. Most patients with opioid use disorder have trouble accessing care as payers and others put up obstacle.”

    View the original article at thefix.com

  • Philadelphia Grapples With Closing Heroin Camps

    Philadelphia Grapples With Closing Heroin Camps

    The city has promised to move people who are currently encamped in the area into drug treatment and permanent housing.

    City officials and charitable groups in Philadelphia are grappling with how best to help people as the city moves to dismantle tent cities that are overrun with opioid abuse.

    City officials hope to have four encampments closed by the end of May, and are giving camp residents priority access to housing and drug treatment. 

    “What I predict is going to happen? This bridge will be cleaned out, Tulip [encampment] will be cleaned out, they’ll go to the other bridges, they’ll go in abandoned buildings,” Nicole Bixler, a social worker, said earlier this month. “The community will be broken up, and they’ll die alone, and no one will know until we smell them in the summertime.”

    The camps are home to about 180 people, many of whom inject opioids. Last year, Philadelphia cleaned out its largest heroin encampment, which had become so well-known that it was featured on an episode of The Dr. Oz Show. The camp was home to people with addiction, many of whom moved on to other areas of the city when the camp was cleared out. 

    This time, the city has promised to move people who are currently encamped in the Kensington area of the city into drug treatment and permanent housing. Each day, city workers visit the camps to try to get people into area shelters or into treatment. In the past two weeks 39 people have entered treatment, more than in the past six months, according to the Philly Inquirer.  

    “Everybody wants it to work,” said City Councilwoman Maria Quinones-Sanchez, whose district has three of the encampments and two shelters that people are being relocated to. “This is the closest we’ve gotten to breaking down barriers on access to housing and treatment. It shouldn’t have taken this long, but we’re there.” 

    Still, some residents of the camp are frustrated that it took so long for the city to come up with a viable solution to the housing and drug crisis. 

    “Why wait until now to do this?” said Ryan Forrest, 28, who has lived in one of the camps for seven months. “Why did they let so many people get frostbite during the winter?”

    Forrest wasn’t sure what he was going to do when the camps were cleared, until he realized that he was on the city’s list of camp residents who were being prioritized for treatment and housing. 

    “I was going to stay until the end. I didn’t really have a plan,” he said. “But they were pushing me to the shelter, and they told me I was on the list, and I went up there.”

    People who work closely with the homeless population that lives in the camps are cautiously optimistic that reluctant residents like Forrest may get help with the new programming. 

    “I’m scared for what may happen,” said Tim Sheahan, an outreach worker with the city’s Department of Behavioral and Intellectual Disability Services. “We’ve gotten as close to treatment on demand as possible.”

    View the original article at thefix.com