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Tag: opioid use disorder

  • New Dosage Strength Of Opioid Addiction Drug Approved By FDA

    New Dosage Strength Of Opioid Addiction Drug Approved By FDA

    The FDA commissioner noted that the approval will expand access for patients and reduce drug development costs.

    The U.S. Food and Drug Administration (FDA) approved a new dosage strength for a maintenance drug for the treatment of opioid addiction.

    Cassipa, which is a sublingual (applied under the tongue) film that combines the opioid treatment drug buprenorphine and the opioid overdose reversal drug naloxone, will now be available in a 16 milligrams/4 milligrams dosage, and according to FDA Commissioner Scott Gottlieb, should be used in conjunction with counseling and therapy.

    The new dosage strength is approved by the FDA in both brand name and generic versions, and in various strengths.

    The approval underscores the agency’s emphasis on greater development of and access to medication-assisted treatment (MAT) for substance use disorder. The full range of MAT is a key element of the U.S. Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis, and was the focus of guidelines issued to drug manufacturers for evaluating the effectiveness of new or existing MAT products. 

    In a statement issued in April 2018, Gottlieb described the FDA-approved MAT drugs—methadone, buprenorphine and naltrexone—as “safe and effective in combination with counseling and psychosocial support to stabilize brain chemistry [and] reduce or block the euphoric effects of opioids.”

    The FDA has also cited statistics from the Substance Abuse and Mental Health Services Administration (SAMHSA), which found that patients using MAT for opioid dependency have reduced their chance of overdose death by half.

    In addition to its suggested efficacy for opioid use disorder, Gottlieb noted that newer treatment options like the increased dosage strength for Cassipa will not only “broaden access for patients,” but may also “reduce drug development costs, so products may be offered at a lower price to patients” via the agency’s “streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine.”

    This approach is the abbreviated 505(b)(2) pathway under the Federal Food, Drug and Cosmetic Act, which allows manufacturers to use the FDA’s findings regarding the safety of their product to grant approval.

    The FDA is advising that Cassipa should be used in conjunction with a complete treatment plan that includes counseling and other support, and should only be used after the patient is introduced to the drug and stabilized up to a dose of 16 mg of buprenorphine using another marketed product. Additionally, Cassipa can only be prescribed by Drug Addiction Treatment Act-certified prescribers.

    View the original article at thefix.com

  • Doctors Gave No Reason For Writing Opioid Scripts In Nearly 30% Of Cases

    Doctors Gave No Reason For Writing Opioid Scripts In Nearly 30% Of Cases

    A new study uncovered that doctors were prescribing opioids for hypertension and high cholesterol when no pain diagnosis was recorded. 

    A team at Harvard Medical School and the Rand Corp. combed through medical records from 2006 to 2015 and found that physicians gave no explanation for writing an opioid prescription in 29% of the cases.

    According to NBC News, the Centers for Disease Control and Prevention (CDC) has been working to get doctors to pull back on opioid prescriptions, citing careless prescribing as one cause of the opioid crisis. In 2016, more than 42,000 people died of opioid overdose, according to the CDC.

    The new study was led by Nicole Maestas, professor of health care policy at Harvard. Maestas and study coauthors went through tens of thousands of medical records, and then honed in on more than 31,000 physician surveys that included an opioid prescription.

    In two-thirds of the prescriptions, some type of pain diagnosis was present.

    The report, published in the Annals of Internal Medicine, then concluded, “No pain diagnosis was recorded at the remaining 28.5%.”

    “At visits with no pain diagnosis recorded, the most common diagnoses were hypertension, hyperlipidemia (high cholesterol), opioid dependence and ‘other follow-up examination,’” the research revealed.

    This over-prescribing could be unfairly impacting people who do have serious pain conditions and are finding it difficult to access the opioids they need to manage their pain due to new restrictions and doctors who fear that they will be targeted for over-prescribing.

    Dr. Tisamarie Sherry, who worked on the study, was reported in NBC News as emphasizing, “Whatever the reasons, lack of robust documentation undermines our efforts to understand physician prescribing patterns and curtails our ability to stem overprescribing.”

    The study also showed that 24% of youth who appeared with an opioid use disorder did not have a prescription to a medication-assisted treatment (MAT) drug to control their cravings.

    Drugs like buprenorphine and methadone are approved by the Food and Drug Administration for the treatment of opioid use disorder.

    “In this multistate study of addiction treatment and retention in care, we found that three-quarters of youths diagnosed with opioid use disorder received treatment within three months,” researchers wrote in JAMA Pediatrics. “However, most treatment included behavioral health services only, and fewer than one of four youths received timely buprenorphine, naltrexone or methadone treatment.”

    View the original article at thefix.com

  • Former Purdue Pharma Exec May Profit From Opioid Addiction Drug

    Former Purdue Pharma Exec May Profit From Opioid Addiction Drug

    Richard Sackler’s involvement with a new formulation of buprenorphine has drawn a wave of criticism. 

    A new formulation of buprenorphine, a medication used to treat opioid addiction, is due to hit the market—but some have taken issue with one of the inventors’ ties to Purdue Pharma, the maker of OxyContin.

    Richard Sackler is listed as one of six inventors on a patent for a new formulation of buprenorphine issued in January, the Financial Times reported. Sackler is also the former chairman and president of Purdue Pharma, according to the Washington Post, and the son of Raymond Sackler, one of the company’s founders.

    Purdue Pharma is the target of more than 1,000 lawsuits from cities, states, counties and tribes across the United States. The pharmaceutical giant and maker of OxyContin is accused of exaggerating the benefits and downplaying the risk of the opioid painkiller, and fueling the national opioid addiction epidemic.

    “It’s reprehensible what Purdue Pharma has done to our public health,” says Luke Nasta, director of Camelot, a New York-based treatment center. The Sacklers “shouldn’t be allowed to peddle any more synthetic opiates—and that includes opioid substitutes.”

    According to the patent, unlike the tablet or film formulation that’s currently available, the new drug will come in a fast-dissolving wafer that is placed under the tongue.

    According to the inventors, the fast-dissolving formula will make it less likely for the drug to be abused and sold on the black market.

    Colorado recently added to the mounting lawsuits against Purdue Pharma—accusing the company of playing a “significant role in causing the opioid epidemic.”

    “Purdue’s habit-forming medications coupled with their reckless marketing have robbed children of their parents, families of their sons and daughters, and destroyed the lives of our friends, neighbors, and co-workers,” said state Attorney General Cynthia Coffman in a statement. “While no amount of money can bring back our loved ones, it can compensate for the enormous costs brought about by Purdue’s intentional misconduct.”

    Members of the otherwise little known Sackler family have come to light for their ties to Purdue Pharma.

    This past March, a group of about 50 people came together at the Metropolitan Museum of Art in New York City to protest members of the Sackler family’s alleged involvement in perpetuating opioid abuse. Led by artist Nan Goldin, the protestors threw pill bottles marked “OxyContin” into the reflecting pool in the Sackler Wing of the museum, named for the family’s contributions to the museum.

    The family has donated millions of dollars to arts institutions like the Met over the years.

    View the original article at thefix.com

  • Are Moms With Opioid Addiction At Heightened Risk For Overdose?

    Are Moms With Opioid Addiction At Heightened Risk For Overdose?

    A new study examined pregnant women and new moms with opioid use disorder.

    After finding out she was pregnant with her second child while in a Massachusetts prison, Katie Raftery entered treatment for heroin use. She stayed seven months, until her son was born. It wasn’t until he was about six weeks old that she began to feel the familiar urges to return to using.

    According to the Sarasota Herald Tribune, a new study shows that women who use opioids, like Raftery, are at greater risk of an overdose in the year following their child’s birth.

    Rather than return to using, Raftery was able to use her insurance coverage and reach out to her doctor to ask for buprenorphine, a medication that can treat opioid use disorder. But not all women in the country have the ability to take similar actions. 

    According to the Herald Tribune, in states that do not offer expanded Medicaid, low-income women lose their insurance coverage eight weeks after giving birth. Addiction experts say this is concerning, as it makes a relapse during postpartum depression and opioid cravings more likely. 

    “As a whole, women with substance use disorders do quite well during pregnancy, due in large extent to access to care, insurance coverage and attention from social services,” Mishka Terplan, an obstetrics and gynecology physician at Virginia Commonwealth University School of Medicine, told the newspaper. “Where things fall apart is postpartum. We actually abandon women after delivery.”

    Terplan served as the co-author of the study published last month. During the course of the study, researchers kept track of more than 4,000 women with opioid use disorder in Massachusetts, for the duration of the year before and after giving birth.

    The study’s results indicated that deaths from opioid overdoses decrease during pregnancy, but increase in the seven to 12 months following birth. Since all of the women involved in the study resided in Massachusetts, insurance coverage was not a factor.

    Davida Schiff, lead author of the study and a physician at Massachusetts General Hospital, tells the Herald Journal that sustaining care for women well after childbirth is vital.

    “Pregnancy seems to be a time for change. Women tend to make healthier decisions during pregnancy. So, for women with an opioid addiction, it can be a motivating moment,” she said. 

    “We should capitalize on the emotions women feel during pregnancy, and sustain their care or enhance it during the postpartum period, which is arguably the most challenging.”

    The Herald Journal states that while the opioid epidemic has hit the country hard as a whole, it has impacted subgroups, like pregnant women and new moms, especially hard.

    The Centers for Disease Control and Prevention (CDC) found that between 1999 and 2014, the number of pregnant women who used opioids more than quadrupled.

    View the original article at thefix.com

  • Are Construction Workers Hit Hardest By Opioid Addiction?

    Are Construction Workers Hit Hardest By Opioid Addiction?

    A new survey examined the occupations of those who died from opioid-related causes. 

    It’s been considered a problem for years, and a new study in Massachusetts has proven that the construction industry is the worst affected from opioid-related overdose deaths. Architecture and engineering are the only careers with higher death rates among women than men.

    “The primary workforce in construction is male, and they’re twice as common to abuse prescription drugs than females,” Eric Goplerud told Forbes. Goplerud is senior vice president of the Department of Substance Abuse Mental Health and Criminal Justice Studies at NORC at the University of Chicago.

    Dezeen magazine reported that the Massachusetts Department of Public Health published a report on the opioid epidemic in a state that had opioid overdose deaths more than double between 2011 and 2015. The Opioid-Related Overdose Deaths in Massachusetts by Industry and Occupation survey reviewed death certificates from those years to compile data about industry and occupation, gender, race, and age among the deaths.

    Between 2011 and 2015, 5,580 Massachusetts residents died from opioid-related overdoses. Some of these deaths were excluded from the study.

    Construction and extraction workers were found to make up over 24% of the total, the highest amount of any particular profession. The analysis of the study authors believe this is due to the high amount of injuries people in this field endure. The report quotes a statistic that four out of every 100 construction workers are injured on site.

    “Pain is a common feature among injured workers and previous research indicates that opioids are frequently prescribed for pain management following work-related injuries, which has the potential to lead to opioid use disorders,” according to Dezeen. The study was first reported by the Architect’s Newspaper.

    According to experts interviewed in the Forbes piece, changing the construction company owners’ approach to opioid abuse is not going to be easy. Many (if not most) construction companies have a zero tolerance policy regarding positive drug tests of workers. If a worker tests positive, it often means he or she loses the job.

    “You go on construction sites, and you see those signs saying ‘you’re out of there if you test positive,’” Boston Properties Life Safety and Security Assistant Director John Tello told Forbes. “It seems like there is a divide in what’s going on and what needs to be done to help these people.”

    “Helping wean workers off opioids as they prepare to return to work should be part of any rehabilitation treatment,” Goplerud told Forbes.

    View the original article at thefix.com

  • Opioid Use Quadrupled Among Pregnant Women

    Opioid Use Quadrupled Among Pregnant Women

    The prevalence of opioid use disorder present at a hospital delivery rose from 1.5 per 1,000 deliveries in 1999 to 6.5 per 1,000 in 2014.

    Opioid use among pregnant women quadrupled between 1999 and 2014, rising alongside the rate at which opioid use disorder has increased in the general population, according to a new report. 

    “When something is so broad and affects all populations, we also see it reflected in the pregnant population,” Dr. Elizabeth E. Krans, an assistant professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at the University of Pittsburgh, told CNN Health.

    The Centers for Disease Control and Prevention (CDC) published its report on Friday (August 10). The CDC analysis found that nationally, the prevalence of opioid use disorder present at a hospital delivery rose from 1.5 per 1,000 deliveries in 1999 to 6.5 per 1,000 in 2014.

    However, in some states the problem was much more prevalent. In Vermont, for example, opioids are a factor in 48.6 out of every 1,000 deliveries. 

    Data was only available in 28 states, but indicated that opioid use in pregnant populations varies widely. Washington, D.C. had the lowest prevalence in 2014 at just 0.7 deliveries per 1,000, while Vermont had the highest.

    The increase in the prevalence of opioids was also uneven: California and Hawaii saw relatively small increases, while Maine, New Mexico, Vermont and West Virginia saw large spikes in the reported use of opioids among pregnant women. 

    State policies on drug use during pregnancy can affect reporting, since in 23 states and Washington, D.C., using drugs while pregnant is considered child abuse. This might prevent some women from being honest about their drug use. 

    “Data on the impact of these policies are scarce,” the authors wrote. 

    “Pregnancy is a really important time. Women are often worried that invested in their own health and the health of their baby, but they’re also fearful of judgment,” Krans said. 

    Women who are using opioids when they become pregnant are often told to go on medication-assisted treatment throughout their pregnancies, as that is the safest option for mother and baby. “We have effective treatments that are available during pregnancy, and we want to encourage women to seek early care and engage in treatment as soon as possible,” Krans said. 

    Left untreated, opioid use can lead to a variety of pregnancy complications and negative health effects for the child. 

    “Opioid use by pregnant women represents a significant public health concern given the association of opioid exposure and adverse maternal and neonatal outcomes, including preterm labor, stillbirth, neonatal abstinence syndrome, and maternal mortality,” the authors wrote. 

    View the original article at thefix.com

  • Man Sues Prison For Addiction Medication Access

    Man Sues Prison For Addiction Medication Access

    The 30-year-old at the center of the suit started using painkillers as a teen and was prescribed Suboxone five years ago.

    Last week, the ACLU sued Maine’s prisons and one county jail over their continued refusal to give addiction medication to inmates.

    Zachary Smith, who is scheduled to go to prison in September, filed a federal lawsuit targeting the Aroostook County Sheriff’s Office and Maine Department of Corrections, claiming violations of the Eighth Amendment’s ban on cruel and unusual punishment and also of the Americans with Disabilities Act. 

    “Denying needed medication to people with opioid use disorders serves absolutely no good purpose, and actually undermines the important goal of keeping people off of opiates,” ACLU of Maine legal director Zachary Heiden said in a statement. “Going to prison shouldn’t be an automatic death sentence, but that is the chance we take when we cut prisoners off from adequate medical care.”

    Failure to provide medication can lead to painful forced withdrawal and increase the risk of overdose. 

    The 30-year-old at the center of the suit started using painkillers as a teen and was prescribed Suboxone five years ago. “If I did not get on buprenorphine I’d probably be dead,” he told the Bangor Daily News. 

    He was denied access to his medication last year during a short stint in the county jail. So, once he knew he had prison time in his future—a nine-month sentence for domestic assault—Smith and the ACLU wrote a letter to the state’s correctional system requesting that he continue to receive his medication behind bars.

    When they got no response, they filed suit.

    Although medication-assisted treatment (MAT) is considered the standard of care on the outside, many county jails and state prisons refuse to provide it. In Maine, according to the Bangor paper, only Knox County Jail provides Suboxone, though the Penobscot County Jail offers another alternative, the injectable treatment Vivitrol. 

    Prison officials declined to comment.

    “If we’re being sued, I can’t speak about that,” Maine Department of Corrections Commissioner Joseph Fitzpatrick told the Press Herald. “Once they’ve filed, I’m not able to comment.”

    Though the legal action could be ground-breaking for Maine prisoners, it’s not the first of its kind. In June, the ACLU of Washington launched a class-action suit against a jail there for denying inmates access to methadone and Suboxone as part of a policy the organization called “harmful, unwise and illegal.” 

    “The ADA prohibits singling out a group of people because of their disability and denying them access to medical services to which they would otherwise be entitled,” the organization wrote at the time. “The Whatcom County Jail has a policy of denying people with (opioid use disorder) the medication they need while providing necessary medication to everyone else, which is discrimination.” 

    Two months earlier, advocates in Massachusetts publicly pondered a lawsuit there, even as federal prosecutors announced an investigation into whether failure to provide addiction medications is a violation of the ADA. 

    View the original article at thefix.com

  • Overdose Risks During Pregnancy Examined In New Study

    Overdose Risks During Pregnancy Examined In New Study

    The study revealed the need for better addiction recovery support for pregnant women with substance use disorder. 

    A new study has found that the risk of overdose drops in pregnant women but increases after giving birth.

    The study, published in the journal Obstetrics & Gynecology, looked at women giving birth in Massachusetts. In doing so, researchers found a greater number of women with opioid use disorder than had been found in other states. 

    Researchers also discovered that during pregnancy, opioid overdose events went down, the third trimester resulting in the lowest amount. However, after birth, that number rose and became especially high from 6 to 12 months after delivery.

    “Our findings suggest we need to develop extended and long-term services to support women and families impacted by substance use disorder,” said Davida Schiff, a pediatrician at MassGeneral Hospital for Children and the lead author of the paper, according to Science Daily. “We need additional research to determine the best ways to improve retention in treatment and adherence to medication therapy after delivery, and we need to enhance our medical and public health infrastructure to provide support to women in achieving long-term recovery.”

    In many states, opioid overdoses have been “major contributors to pregnancy-associated deaths.” In pregnant women, estimates of opioid use disorder range from .4 to .8%, and up to 2% in all women that fall into the reproductive age category. 

    Pregnancy can drive a woman to seek treatment, Science Daily notes. Often, such treatment includes therapy and potentially medications like methadone or buprenorphine.

    Researchers chose to study a Department of Public Health dataset, which included nearly 178,000 deliveries of an infant 20 or more gestational weeks to Massachusetts women between Jan. 1, 2012 and Sept. 30, 2014. Of those, 4,154 women were found to have likelihood of opioid use disorder within a year before giving birth.

    Additionally, of the women in the dataset, 184 experienced what researchers refer to as an opioid overdose event in the year preceding or following delivery. Such an event means the woman faced admission to a heath care facility for an overdose or death as a result of an overdose.

    Those who experienced an overdose event were “more likely to be younger, single, unemployed, less educated and less likely to have received adequate prenatal care,” Science Daily reported. They were more likely “to have evidence of homelessness or a diagnosis of anxiety or depression.”

    Co-author and Massachusetts Commissioner of Public Health Monica Bhare says that this research is vital in gaining a bigger picture of who is most at risk.

    “These findings help expand the lens from which we view the epidemic and allow us to tailor our policies and programs in ways that will increase opportunities for treatment and recovery for these women and their children,” she said. 

    View the original article at thefix.com

  • Cory Monteith Took Pain Meds For Dental Work Before Fatal Overdose

    Cory Monteith Took Pain Meds For Dental Work Before Fatal Overdose

    “He had a lot of medication in his system, which was not good for his body coming out of rehab,” the actor’s mother recently revealed.

    The late actor Cory Monteith had been taking pain medication after a “massive” dental procedure he’d had not long before his fatal overdose on July 13, 2013, according to his mother Ann McGregor.

    The Canadian actor, known for his role as Finn Hudson on the TV series Glee, died in a Vancouver hotel room from a toxic drug mixture including heroin, alcohol, and traces of morphine and codeine, according to the coroner’s report. He was 31 at the time.

    Around the fifth anniversary of his tragic death, his mother discussed his use of pain medication post-dental work between May and July of 2013.

    “He had a lot of medication in his system, which was not good for his body coming out of rehab,” she said, according to Washington, D.C.’s WENN. “He didn’t have enough drugs in his system to kill him, but for some reason it did because of his intolerance.”

    Journalist and author Maia Szalavitz explained the effect that abstinence-based treatment programs like the one Monteith attended in the spring prior to his death will have on a person’s tolerance.

    “Monteith followed the pattern of the 90% of opioid addicts who are coerced into 12-step recovery and denied an adequate period of maintenance treatment: He relapsed,” she wrote in her commentary, published in The Fix.

    Szalavitz explained that the risk of overdose “is highest in the initial few months” after a period of abstinence, because a person’s tolerance to the drug will drop during that time.

    Not only was the actor “likely not informed” about this heightened risk of overdose from his treatment program, he was not given the option to use medications specifically to aid his recover such as methadone, buprenorphine, and naloxone, which Szalavitz says would have dramatically reduced the risk of overdose.

    When Glee co-creator Ryan Murphy discovered that Monteith was using again, he convinced the actor to enter a 30-day treatment program in April 2013, putting the show on hold.

    Prior to that, the actor publicly discussed his near-decade-long recovery in Parade magazine in 2011, saying that he was “lucky to be alive.”

    He first committed to sobriety at the age of 19. “I was done fighting myself,” he told Parade. “I had a serious problem.”

    In his memory, his mother McGregor works to empower youth in the fine arts, through the British Columbia-based Amber Academy in Canada.

    “Cory believed in prevention, rather than trying to fix people,” she said. “He wanted to give children opportunities to shine and feel good about themselves so they wouldn’t turn to drugs.”

    View the original article at thefix.com

  • FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

    FDA: Limiting Opioids Won't Curb Crisis, Responsible Prescribing Will

    The FDA commissioner issued a statement addressing the stigma aimed at pain patients and the need for providers to take a patient-centric approach.

    Strict opioid prescribing regulations are harming some chronic pain patients, according to U.S. Food and Drug Administration Commissioner Scott Gottlieb.

    On Monday, July 9, the FDA released a statement about its Patient-Focused Drug Development Meeting, during which Gottlieb brought up the struggles some patients face because of strict opioid prescribing laws. 

    According to PatientEngagementHIT, there are some instances in which patients, such as those those facing “metastatic cancer pain management and chronic migraine management,” are best fit for a long-term opioid prescription.

    “Tragically, we know that for some patients, loss of quality of life due to crushing pain has resulted in increased thoughts of or actual suicide,” Gottlieb said in the statement. “This is unacceptable. Reflecting this, even as we seek to curb overprescribing of opioids, we also must make sure that patients with a true medical need for these drugs can access these therapies.”

    While Gottlieb acknowledges that prescribing regulations are necessary in order to fight the opioid crisis, he also says those strategies are negatively affecting patients who rely on the medications for pain management.

    Gottlieb and his colleagues have learned through patient workgroups that patients in need of pain management say they feel stigmatized and have a difficult time building healthy relationships with care providers.

    According to Gottlieb, simply banning opioids or increasing the difficulty of obtaining a prescription is not the solution to the issue. He says instead, better education needs to be available to providers and opioid prescribing should take a “patient-centric” approach, taking patient “preferences, needs, and patient education approaches” into account.

    “Balancing the need to maintain access with the mandate to aggressively confront the addiction crisis starts with good medical management,” Gottlieb said in the statement. “All patients in pain should benefit from the skillful and appropriate care of their pain. It’s also critical that we take this same aggressive approach to changing the culture of medicine around treating pain… Patients in pain deserve thoughtful, careful and tailored approaches to the treatment of their medical conditions.”

    The statement also outlines steps the FDA has taken to push responsible prescribing methods. For example, the FDA released a blueprint for drug manufacturers focusing on how they can educate prescribers. Additionally, the FDA is working with medical professionals to develop resources for clinicians.

    “We need to be mindful of this history, learn from it and make sure that we act aggressively to confront new trends that may continue to fuel the current crisis or lead to a new epidemic of addiction,” Gottlieb explained.

    The FDA also stated that combating the opioid crisis should not involve limiting or banning opioids, but instead has to do with better education about practices.

    “Our goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids,” Gottlieb said in the statement. “In this way, we’ll help ensure that we’re not unnecessarily putting patients as risk of addiction by overprescribing opioids, while also maintaining appropriate access to care for patients with serious pain. In pursuing these goals, we must make sure that patients inform our work.”

    View the original article at thefix.com