Archive for Opioid

FDA Classifies Kratom as Opioid

FDA Classifies Kratom as Opioid

The U.S. Food and Drug Administration has officially classified the plant kratom, originally seen as an opioid alternative, as an opioid itself, stating that compounds in kratom act like prescription-strength opioids.

Found in Malaysia, the leaves of the kratom plant are traditionally crushed and made into a tea to treat pain as well as heroin or morphine dependence and possibly reduce withdrawal cravings. According to the American Kratom Association, there are 3 million to 5 million kratom users in the U.S. The supplement can be found in head shops and gas stations sold as powders, pills, capsules and energy drinks.

FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid compounds, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

The scientific data and event reports have “clearly revealed” compounds in kratom make it “not just a plant — it’s an opioid,” said FDA Commissioner Scott Gottlieb, M.D., “and it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold, and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

The FDA announced the voluntary destruction and recall of all kratom-based products manufactured nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution. The FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take their products off the market and submit any necessary evidence to the FDA.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said Dr. Gottlieb. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products.”

The FDA recommends consumers not use any kratom products and dispose of any products currently in their possession. “At this time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said Dr. Gottlieb.

The FDA has received 44 reports of deaths associated with the use of kratom. Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products.

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State of Alabama Files Lawsuit Against Purdue Pharma

State of Alabama Files Lawsuit Against Purdue Pharma

MONTGOMERY – The State of Alabama has joined other states in filing a complaint against opioid manufacturer Purdue Pharma, LP, one of the largest opioid manufacturers in the country. The complaint alleges Purdue’s marketing of these drugs contributed to the creation of the opioid epidemic in Alabama.

The lawsuit comes on the heels of a report by the Alabama Opioid Overdose and Addiction Council, appointed by Gov. Kay Ivey in mid-2017 to devise solutions to the state’s opioid crisis.

That report found at least 30,000 Alabama residents over the age of 17 are dependent on heroin or prescription painkillers. The council also found the drug overdose death rate in Alabama also increased 82 percent from 2006 to 2014. During that period, 5,128 people died from overdoses. In the U.S, more than 42,000 overdose deaths in 2016 involved opioids, according to the Centers for Disease Control and Prevention.

The lawsuit alleges that marketers persuaded physicians that prescription painkillers were not addictive, according to Alabama Attorney General Steve Marshall.

“The lies that they were told and trained in over the years whether it be that there was no dosage too high of an opioid … or even this concept of a pseudo-addiction that if somebody appeared in an office demonstrating signs of addiction that just meant that they needed more pain medication,” AG Marshall said.

Purdue denies the allegations, writing in a statement that its drugs are approved by the Food and Drug Administration and make up only 2 percent of all opioids prescribed.

Purdue Pharma manufactures, markets and sells prescription opioid pain medications, including the brand name drugs OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER and Targiniq ER, as well as generic opioids. OxyContin constitutes roughly 30 percent of the entire market for analgesic drugs (painkillers). Purdue’s drugs compose a majority of the extended release market, for use with chronic non-cancer pain patients, which is the most dangerous method of use. Prescription opioids constitute the largest component of the opioid epidemic, both in quantity and damage caused.

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Alabama Opioid Overdose and Addiction Council Issues Formal Report

Alabama Opioid Overdose and Addiction Council Issues Formal Report

MONTGOMERY — Co-chairs of the Alabama Opioid Overdose and Addiction Council, Attorney General Steve Marshall, Commissioner Lynn Beshear of the Alabama Department of Mental Health, and Acting State Health Officer Dr. Scott Harris, announced the issuance of the Council’s formal report of its findings.

The Council was created in August 2017 by an executive order of Gov. Kay Ivey, and tasked with developing a strategic plan “that establishes recommendations for policy, regulatory and legislative actions to address the overdose crisis in Alabama.” The Council and its subcommittees have met several times since then, and have submitted its formal plan to the Governor.

“Families, health care professionals and government officials at every level seek real solutions concerning the impact the opioid crisis has on Alabamians,” said Commissioner Beshear. “The next step in our effort will convene the Implementation Team of the Alabama Opioid Overdose and Addiction Council, as well as quarterly meetings of the full council to implement researched opportunities. We believe the work of the council offers preventive strategies, intervention and treatment options, and a community response that addresses this dire need. Working together, it will require organized sustained engagement of citizens and government with healthcare professionals.”

Dr. Harris said, “Opioid addiction and abuse is a tremendous problem that affects Alabama in many different ways. Our hospitals, schools, churches and prisons are all struggling to deal with the problems caused by addiction and by increasing numbers of opioid deaths. The comprehensive action plan the council has developed includes improvements to the Alabama Prescription Drug Monitoring Program that make it easier for prescribers to identify opioid abuse and to motivate abusers to find help for themselves, their families and communities. We are encouraged that the council has offered strategies that have the potential to reverse this crisis that affects so many Alabamians, and appreciate the input of so many individuals to find effective solutions.”

“After working with the dedicated people who have given so much of their time and concern to this council and its subcommittees, I am heartened that we can make progress to fight the terrible blight of opioid abuse in Alabama,” Attorney General Marshall said. “I want to thank Gov. Ivey for bringing us together in a commitment to search for solutions and work toward implementing them. I have been proud to serve with Commissioner Beshear and Dr. Harris in this vital endeavor, and I am grateful to all the members of this Council and its subcommittees for their outstanding achievement in bringing forth these valuable recommendations.”

The Council’s report presents a four-pronged action plan to address prevention of opioid misuse, intervention within the law enforcement and justice systems, treatment of those with opioid use disorders, and community response that engages the people of Alabama in finding solutions at a local level.

Some of the major findings are summarized below:

PREVENTION

  • Improve and modernize the Alabama Prescription Drug Monitoring Program so that it will be more user-friendly, and more prescribers will participate and be better informed; the Governor is requested to support a legislative appropriation of $1.1 million to the Alabama Department of Public Health for this;
  • Strengthen prescription data and research capabilities and create a unique identifier for each individual patient;
  • Promote efforts to educate current and future prescribers, better implement current guidelines, adopt guidelines specific to opioid prescribing and impose mandatory opioid prescribing education;
  • Create a website and messaging campaign to reduce the stigma of opioid addiction; and implement an outreach program to teach young people the dangers and to avoid opioids;
  • Create a website and social media campaign to motivate opioid abusers to seek help and to effectively connect them and family members with ways to get help; and
  • Create a partnership for the Alabama Department of Mental Health to provide training about addiction to law enforcement agencies and the judiciary.

INTERVENTION

  • Advocate legislation in the 2018 session to specifically prohibit trafficking in fentanyl and carfentanil, which is particularly important because vastly smaller amounts of these than other opioids can be deadly; for example, a lethal dose of fentanyl is 1,000 times less than that of heroin, and the threshold amounts for the crimes of trafficking in fentanyl and carfentanil would better be measured in micrograms; and
  • As overdoses are 50 times greater for those leaving incarceration or other enforced abstinence, establish a process for the Department of Mental Health to reduce the stigma of medication-assisted treatment, and begin a pilot program by the Department of Corrections in partnership with the Board of Pardons and Paroles to use naloxone, counseling and life skills to help released inmates remain drug free.

TREATMENT AND RECOVERY

  • Promote adequate funding for treatment services and recovery support;
  • Establish collaboration between the Department of Mental Health and recovery support providers to increase access;
  • Support creating two addiction medicine fellowships to train Alabama physicians to recognize and treat substance abuse;
  • Expand access and target effective treatment and prevention programs to areas where there is greater need; and
  • Improve education of professionals through continuing education for licensing and expand postsecondary and graduate curriculums.

COMMUNITY RESPONSE

  • Increase access to naloxone, and maintain a list of participating pharmacies;
  • Prioritize naloxone to law enforcement and for distribution in areas of greatest need;
  • Provide naloxone training for first-responders;
  • Encourage prescribing naloxone for high-risk patients;
  • Have a Community Anti-Drug Coalitions of America program in each judicial circuit and work toward having them at municipal levels;
  • Engage employers, businesses, higher education and private-sector in a network to get resources into communities;
  • Encourage having a Stepping Up Initiative in each county to work with the criminal justice system regarding incarceration of those with mental health problems; and
  • Develop ways to provide service to veterans regarding opioid issues.

A copy of the Council’s report is available for download here.

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New Research Shows Americans with Mental Illness use Opioids at Alarming Levels

New Research Shows Americans with Mental Illness use Opioids at Alarming Levels

More than half of all opioid medications distributed each year in the United States are prescribed to adults with mental illness — patients diagnosed with depression and anxiety — according to new research by Dartmouth-Hitchcock and the University of Michigan.

The study, published in the July issue of the Journal of the American Board of Family Medicine, is among the first to show the extent to which the population of Americans with mental illness use opioids.

In the setting of the U.S. opioid crisis, the authors warn this connection between mental illness and opioid prescribing is particularly concerning because mental illness is also a prominent risk factor for overdose and other adverse opioid-related outcomes.

“Adults with mental health disorders were more than twice as likely to receive an opioid prescription,” said Dr. Brian Sites, an anesthesiologist at Dartmouth-Hitchcock. This higher opioid use among those with mental illness persists across all key characteristics including cancer status and various levels of self-reported pain.

“Despite representing only 16 percent of the adult population, adults with mental health disorders receive more than half of all opioid prescriptions distributed each year in the United States,” said Matthew Davis of the University of Michigan, co-author of the study.

The study found among the 38.6 million Americans diagnosed with mental health disorders more than seven million (or 18 percent) are being prescribed opioids each year. In comparison, only 5 percent of adults without mental disorders are likely to use prescription opioids.

“Because of the vulnerable nature of patients with mental illness, such as their susceptibility for opioid dependency and abuse, this finding warrants urgent attention to determine if the risks associated with such prescribing are balanced with therapeutic benefits,” Sites warns. Sites noted because pain is a subjective phenomenon, “the presence of mental illness may influence the complex dynamic between patient, provider and health system that results in the decision to write an opioid prescription.”

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An Overlooked Epidemic: Older Americans Taking Too Many Unneeded Drugs

An Overlooked Epidemic: Older Americans Taking Too Many Unneeded Drugs

Consider it America’s other prescription drug epidemic.

For decades, experts have warned that older Americans are taking too many unnecessary drugs, often prescribed by multiple doctors, for dubious or unknown reasons. Researchers estimate that 25 percent of people ages 65 to 69 take at least five prescription drugs to treat chronic conditions, a figure that jumps to nearly 46 percent for those between 70 and 79. Doctors say it is not uncommon to encounter patients taking more than 20 drugs to treat acid reflux, heart disease, depression or insomnia or other disorders.

Unlike the overuse of opioid painkillers, the polypharmacy problem has attracted little attention, even though its hazards are well documented. But some doctors are working to reverse the trend.

At least 15 percent of seniors seeking care annually from doctors or hospitals have suffered a medication problem; in half of these cases, the problem is believed to be potentially preventable. Studies have linked polypharmacy to unnecessary death. Older patients, who have greater difficulty metabolizing medicines, are more likely to suffer dizziness, confusion and falls. And the side effects of drugs are frequently misinterpreted as a new problem, triggering more prescriptions, a process known as a prescribing cascade.

The glide path to overuse can be gradual: A patient taking a drug to lower blood pressure develops swollen ankles, so a doctor prescribes a diuretic. The diuretic causes a potassium deficiency, resulting in a medicine to treat low potassium. But that triggers nausea, which is treated with another drug, which causes confusion, which in turn is treated with more medication.

For many patients, problems arise when they are discharged from the hospital on a host of new medications, layered on top of old ones.

Alice Cave, who divides her time between Alexandria, Va., and Tucson, Ariz., discovered this when she traveled to Cheyenne, Wyo., after her 87-year-old aunt was sent home following treatment for a stroke in 2015.

Before her hospitalization, Cave said, her aunt, a retired telephone company employee whose vision is impaired by glaucoma, had been taking seven drugs per day. Five new ones were added in the hospital, Cave said.

“She came home and had a huge bag of pills, half of which she was already taking, plus pages and pages of instructions,” she said. Some were supposed to be taken with food, some on an empty stomach. Cave said she spent several hours sorting the medications into a giant blue pillbox. “It was crazy — and scary.”

Cave said she felt helpless to do much; her aunt’s doctors didn’t question the need for more drugs.

When Shannon Brownlee’s mother was taken to an emergency room recently to determine whether her arm pain might signal a heart attack (it didn’t) a cardiologist prescribed five new drugs — including an opioid — to the small dose of a diuretic she had been taking to control her blood pressure.

Brownlee, senior vice president of the Lown Institute, a Boston-based group that seeks to improve health care quality by reducing unnecessary treatment, said that when her brother questioned the necessity of so many new drugs for a woman in her late 80s, the specialist replied frostily, “I don’t see anything wrong with prescribing lots of medication to older people.”

Bring the Pill Bottles

“This problem has gotten worse because the average American is on a lot more medications than 15 years ago,” said cardiologist Rita Redberg, a professor of medicine at the University of California at San Francisco.

Studies bolster Redberg’s contention: A 2015 report found that the share of Americans of all ages who regularly took at least five prescription drugs nearly doubled between 2000 and 2012, from 8 percent to 15 percent. University of Michigan researchers recently reported that the percentage of people older than 65 taking at least three psychiatric drugs more than doubled in the nine years beginning in 2004. Nearly half of those taking the potent medications, which include antipsychotic drugs used to treat schizophrenia, had no mental health diagnosis.

Redberg and other doctors are trying to counter the blizzard of prescriptions through a grass-roots movement called “deprescribing” — systematically discontinuing medicines that are inappropriate, duplicative or unnecessary.

Interest in deprescribing, which was pioneered in Canada and Australia, is growing in the United States, bolstered by physician-led efforts, such as the five-year-old Choosing Wisely campaign. The Beers Criteria, a list of overused and potentially unsafe drugs for seniors first published in 1991, has been followed by other tools aimed at curbing unnecessary drug use.

“Lots of different medications get started for reasons that are never supported by evidence,” said Redberg, editor in chief of JAMA Internal Medicine. “In general, we like the idea of taking a pill” a lot better than non-drug measures, such as improved eating habits or exercise.

“That’s what we were taught as physicians: to prescribe drugs,” said Ranit Mishori, a professor of family medicine at Georgetown University and a proponent of deprescribing. “We are definitely not taught how to take people off meds.”

Kathryn McGrath, a Philadelphia geriatrician, said she tries to begin every appointment with a review of medications, which she asks patients to bring with them. “I think having the pill bottles” is much more powerful than a list, said McGrath, who has written about how to deprescribe safely.

Although support is growing, deprescribing faces formidable obstacles.

Among them, experts say, is a paucity of research about how best to do it, relentless advertising that encourages consumers to ask their doctors for new drugs, and a strong disinclination – baked into the culture of medicine — to countermand what another physician has ordered. Time constraints play a significant role. So do performance measures that are viewed as a mandate to prescribe drugs even when they make virtually no sense, such as giving statins to terminally ill patients.

A Reluctance to Overrule

“There’s a reluctance to tinker or change things too much,” said University of Michigan geriatric psychiatrist Donovan Maust, who labels the phenomenon “clinical inertia.” When inheriting a new patient, Maust said, doctors tend to assume that if a colleague prescribed a drug, there must be a good reason for it — even if they don’t know what it is. Maust said he tries to combat inertia by writing time-limited orders for medication.

He recently began treating a man in his 80s with dementia who was taking eight psychiatric drugs — each of which can cause significant side effects and most of which had been prescribed for undetermined reasons.

“It’s very typical to see a patient who has a few episodes of reflux and is then put on a [proton pump inhibitor, or PPI] and a few years later are still taking it,” said Georgetown’s Mishori. Many experts say the heartburn drugs are overprescribed, and studies have linked their long-term use to fractures, dementia and premature death.

“This is a cultural problem and an awareness problem exacerbated by the fragmentation of care,” said Brownlee, the author of “Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer.” Many doctors, she added, have never heard of deprescribing.

Before his death several years ago, doctors advised Brownlee’s father, a hospice patient, to continue taking a statin, along with several other medications. None would improve or extend his life, and all had potentially harmful side effects.

Rx: What For?

Older people taking lots of medication was what Canadian pharmacist Barbara Farrell encountered when she began working at a geriatric hospital in Ottawa nearly two decades ago. Her experience, she said, was a catalyst for the Canadian Deprescribing Network, a consortium of researchers, physicians, pharmacists and health advocates she co-founded. The group seeks to drastically reduce inappropriate medication use among Canadian seniors by 2020.

Farrell, a clinical scientist at the Bruyere Research Institute, has also helped write guidelines, used by doctors in the United States and other countries, to safely deprescribe certain classes of widely used drugs, including proton pump inhibitors and sedatives.

“I’ve found a lot of receptivity” to the guidelines among physicians, Farrell said. “We know there are pockets around Canada and the world where they’re being implemented.”

One of Farrell’s most memorable successes involved a woman in her late 70s who was using a wheelchair and was nearly comatose.

“She would literally slide out of her chair,” Farrell recalled. The woman was taking 27 drugs four times per day and had been diagnosed with dementia and a host of other ailments.

After reviewing her medications, Farrell and her colleagues were able to weed out duplicative and potentially harmful drugs and reduce the doses of others. A year later, the woman was “like a different person”: She was able to walk with a cane and live mostly independently, and she reported that her doctor said she did not have dementia after all.

When Farrell asked another patient why she was taking thyroid medication, the woman replied that her doctor had prescribed it for weight loss after her last pregnancy — in 1955.

“The patients I see are the tip of the iceberg,” Farrell said.

One way to facilitate deprescribing, Farrell said, is to require doctors to record why a drug is being prescribed, a proposal the deprescribing network has made to Canadian health officials. A recent study by a team from the Boston VA Healthcare System found strong support among doctors for this concept.

While some doctors are reluctant to discontinue medications, patients can be wary, too.

“They may say, ‘I tried stopping my sleeping pill and I couldn’t sleep the next night, so I figured I needed it,’” Farrell said. ” Nobody explained to them that rebound insomnia, which can occur after stopping sleeping pills, lasts three to five days.”

Mishori said that she deprescribes only one medication at a time so she can detect any problem that arises from that change. And, she adds, “I never take people off of a medication without doing something else.” In the case of heartburn drugs, she might first recommend taking the drug only when needed, not continuously. Or she might suggest a safer alternative, such as an over-the-counter antacid tablet.

Maust, the geriatric psychiatrist, recommends that doctors actively focus on “the big picture” and carefully weigh whether the benefits of a drug outweigh its risks.

“In geriatrics,” he said, “less is more.”

By Sandra G. BoodmanKHN’s coverage related to aging and improving the care of older adults is supported in part by The John A. Hartford Foundation.

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Study: Range of Opioid Prescribers Play Important Role in Epidemic

Study: Range of Opioid Prescribers Play Important Role in Epidemic

A cross-section of opioid prescribers that typically do not prescribe large volumes of opioids, including primary care physicians, surgeons and non-physician health care providers, frequently prescribe opioids to high-risk patients, according to a new study by researchers at the Johns Hopkins Bloomberg School of Public Health. The findings suggest high-volume prescribers, including “pill mill” doctors, should not be the sole focus of public health efforts to curb the opioid abuse epidemic. The study also found “opioid shoppers,” patients who obtain prescriptions from multiple doctors and pharmacies, are much less common than other high-risk patient groups, suggesting why policy solutions focused on these patients have not yielded larger reductions in opioid overdoses.

“This crisis has been misconstrued as one involving just a small subset of doctors and patients,” said senior author G. Caleb Alexander, M.D., associate professor in the Department of Epidemiology at the Bloomberg School and founding co-Director of the Johns Hopkins Center for Drug Safety and Effectiveness. “Our results underscore the need for targeted interventions aimed at all opioid prescribers, not just high-volume prescribers alone.”

The study, which published on Nov. 29 in Addiction, comes as America’s opioid crisis continues to worsen. Opioids include not only the recreational, poppy-derived drug heroin but also many newer and much more potent synthetic painkillers available by prescription, such as fentanyl and oxycodone. Opioids tend to be highly addictive and when overdosed can stop a user from breathing. Drug overdose deaths in the U.S., which now mostly involve opioids, surged from about 52,000 in 2015 to more than 64,000 in 2016.

Alexander and colleagues have found in previous, smaller-scale studies that a small minority of doctors can account for an inordinately high proportion of opioid prescriptions: just 4 percent of opioid prescribers in Florida, for example, accounted for 40 percent of all opioid prescriptions in that state in 2010.

For this study, he and his team, including first author Hsien-Yen Chang, PhD, an assistant scientist in the Bloomberg School’s Department of Health Policy and Management, examined the relationship between high-volume prescribers and high-risk patients more closely. “While we and others have demonstrated that opioid prescribing tends to be concentrated among a relatively small group of providers, in the current study, we wanted to examine how commonly high-risk patients are prescribed opioids by low-volume prescribers,” Chang said. “We were also interested in whether we could identify systematic differences in the doses and durations prescribed by different groups of doctors caring for the same patients.”

The study covered more than 24 million opioid prescriptions in 2015 by more than 4 million residents of California, Florida, Georgia, Maryland, or Washington, as recorded in a nationwide pharmacy database, QuintilesIMS’ LifeLink LRx.

A key finding was that the high-volume prescribers – those who stayed in the top 5 percent, in terms of total opioid volume, during every quarter of 2015 – were far from being the only prescribers for high-risk patients. Across the five states studied, the remaining, low-volume prescribers accounted for 18 to 56 percent of all opioid prescriptions to high-risk patients, depending on how such patients were defined.

“The point here is that ordinary, low-volume prescribers are routinely coming into contact with high-risk patients, which should be a wake-up call for these prescribers,” Alexander said. “We need to build systems to help prescribers better identify these patients, screen them for opioid use disorders, and improve the quality of their pain management.”

The analysis also revealed “opioid shoppers,” the patient group most commonly thought of as being at high-risk for non-medical use, represent only a small fraction of all opioid users. The researchers defined opioid-shoppers in the study as those receiving prescriptions from more than three prescribers and three pharmacies during any 90-day period. They found this group made up just 0.1 percent of the 4 million patients covered in the study.

“The public health impact of ‘opioid-shoppers’ pales in comparison to that of other high-risk groups we examined,” Alexander said.

The first of these groups, “concomitant users,” were defined as people filling prescriptions for more than 30 days of opioids plus benzodiazepines, a class of tranquilizing drugs that includes Valium and Xanax. Like opioids, benzodiazepines can suppress the nerve signals that sustain breathing. “These two classes of drug interact and enhance each other–they make a dangerous combination,” Alexander said. Nearly one in 10 (9.3 percent) of the opioid prescription users covered in the study were concomitant users.

Chronic high-dose opioid users, comprising 3.7 percent of the total, were another high-risk group that dwarfed the opioid-shopper group. Chronic high-dose users were defined as those filling prescriptions for three months or more for opioids with daily doses equivalent in potency to more than 100 mg of morphine.

The researchers also analyzed prescribers’ prescription patterns and found that, for a group of patients seeing both high- and low-volume prescribers, high-volume prescribers on average prescribed larger doses compared to low-volume prescribers (61 vs. 53 mg morphine equivalents per prescription). Prescriptions from high-volume prescribers also provided about 40 percent more days of supply (22.1 vs. 15.6 days). “Even when the same patients were receiving prescriptions from both low-volume and high-volume prescribers, there was a clear tendency for the high-volume prescribers to provide higher doses for more days of use,” Chang said.

“Our study suggests systematic differences among prescribers. How many opioids you are prescribed, and for how long, appears to depend not only on who you are, but who you see,” Alexander said.

In late October of this year, the Bloomberg School of Public Health and the Clinton Foundation released a comprehensive report, “The Opioid Epidemic: From Evidence to Impact,” that provides evidence-based recommendations to reverse the rising tide of injuries and deaths from prescription opioids. Among its recommendations, the report emphasizes the important role that prescribing guidelines play in improving the safe use of prescription opioids by reducing high-risk use. It also underscores the role of Prescription Drug Monitoring Programs in helping to improve the ability for clinicians to deliver high-quality care for those with pain while reducing the risks associated with unsafe opioid use.

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CMS Announces New Medicaid Policy to Combat Opioid Crisis

CMS Announces New Medicaid Policy to Combat Opioid Crisis

Just a week after President Trump declared the opioid epidemic a public health emergency, the Centers for Medicare & Medicaid Services (CMS) announced a new policy to allow states to design demonstration projects that increase access to treatment for opioid use disorder (OUD) and other substance use disorders (SUD). CMS’s new demonstration policy responds to the President’s directive and provides states with greater flexibility to design programs that improve access to high quality, clinically appropriate treatment.

Through this updated policy, states will be able to pay for a fuller continuum of care to treat SUD, including critical treatment in residential treatment facilities that Medicaid is unable to pay for without a waiver, according to a letter CMS sent to state Medicaid directors. Previously, states had been required to build out their entire delivery system for SUD treatment while also meeting rigid CMS standards before Medicaid demonstration approvals could be granted. The new policy will allow states to provide greater treatment options while improving their continuum of care over time.

According to a new study, nearly a quarter of patients on Medicaid filled a prescription for an opioid painkiller in 2015. Express Scripts, one of the largest pharmacy benefits manager of Medicaid drug benefits in the country, analyzed data on 1.8 million opioid prescriptions given to 3.1 million Medicaid enrollees in 14 states. It found that 6 percent of all Medicaid prescriptions were for opioids. Of those that acquired opioids, nearly one-third took the medications for more than 30 days.

Opioids also contributed notably to costs, accounting for 4.1 percent of plan costs overall. Medicaid enrollees are 10 times more likely to be drug addicts or substance abusers than the general population, according to the report.

In the letter, CMS said that state projects under its new program should aim to make notable improvements over the course of five years with goals to increase access, reduce overdose deaths, reduce use of the emergency department or inpatient care for drug addiction treatment and improve care coordination.

CMS also said that it will “ensure states take significant steps” to reduce opioid prescribing.

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Trump: Opioid Epidemic “Worst Drug Crisis” in U.S. History

Trump: Opioid Epidemic “Worst Drug Crisis” in U.S. History

President Trump called the opioid epidemic the “worst drug crisis” to strike the U.S. in its history while declaring a public health emergency – not a national emergency as promised earlier in the summer. According to the Centers for Disease Control and Prevention, more than 140 American die every day from an opioid overdose, which made President Trump’s announcement one of the most anticipated of the last few months yet not quite what health care advocates were expecting.

“Nobody has seen anything like this going on now. As Americans, we cannot allow this to continue,” Trump said at a White House ceremony. “It is time to liberate our communities from this scourge of drug addiction. … We can be the generation that ends the opioid epidemic. We can do it.”

There’s a legal distinction between a public health emergency, which the secretary of Health and Human Services can declare under the Public Health Services Act, and a presidential emergency under the Stafford Act or the National Emergencies Act. The President’s Opioid Commission recommended in July for a declaration of national emergency in order for the president to have more power to waive privacy laws and Medicaid regulations.

However, declaring a public health emergency, which can only last for 90 days and be renewed a number of times, demonstrates the complexity of an opioid crisis that continues to grow through an ever-evolving cycle of addiction, from prescription pain pills to illegal heroin to the lethality of fentanyl.

What the public health emergency won’t do is free up much federal funding. Acting Health and Human Services Secretary Eric Hargan will be given more room to loosen certain regulations that he otherwise would not be able to.

The declaration will expand access to telemedicine to better help those with an addiction in remote areas receive medications; allow for the shifting of resources within HIV/AIDS programs to help people eligible for those programs receive substance use disorder treatments; and more. It could spur a fight for funding in Congress, as Senate Democrats have introduced a bill to put $45 billion toward the epidemic. Many Republicans also back much more funding to combat the epidemic.

The opioid action is the first public health emergency with a nationwide scope since a year-long emergency to prepare for the H1N1 influenza virus in 2009 and 2010.

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CDC Reports Rising Rates of Drug Overdose Deaths in Rural Areas

CDC Reports Rising Rates of Drug Overdose Deaths in Rural Areas

Rates of drug overdose deaths are rising in nonmetropolitan (rural) areas, surpassing rates in metropolitan (urban) areas, according to a new report in the Morbidity and Mortality Weekly Report (MMWR) released this week by the Centers for Disease Control and Prevention (CDC).

Drug overdoses are the leading cause of injury death in the United States, resulting in approximately 52,000 deaths in 2015. This report analyzed trends in illicit drug use and disorders from 2003-2014 and drug overdose deaths from 1999-2015 in urban and rural areas. In 1999, drug overdose death rates for urban areas were higher than in rural areas (6.4 per 100,000 population versus 4.0 per 100,000). The rates converged in 2004, and in 2006 the rural rate began trending higher than the urban rate. In 2015, the most recent year in this analysis, the rural rate of 17.0 per 100,000 remains slightly higher than the urban rate of 16.2 per 100,000.

Urban and rural areas experienced significant increases in the percentage of people reporting past-month illicit drug use. However, there were also significant declines in the percentage of people with drug use disorders among those reporting illicit drug use in the past year. The new findings also show an increase in overdose deaths between 1999 and 2015 among urban and rural residents. This increase was consistent across sex, race, and intent (unintentional, suicide, homicide, or undetermined).

“The drug overdose death rate in rural areas is higher than in urban areas,” said CDC Director Brenda Fitzgerald, M.D. “We need to understand why this is happening so that our work with states and communities can help stop illicit drug use and overdose deaths in America.”

Although the percentage of people reporting illicit drug use is less common in rural areas, the effects of use appear to be greater. The percentage of people with drug use disorders among those reporting past-year illicit drug use were similar in rural and urban areas.

Additional findings from the CDC study:

  • In 1999, drug overdose death rates for urban areas were higher than in rural areas (6.4 per 100,000 population versus 4.0 per 100,000). The rates converged in 2004, and by 2006 the rural rate (11.7 per 100,000) was slightly higher than the urban rate (11.5 per 100,000).
  • The percentage of people reporting past-month use of illicit drugs declined for youth ages 12-17 over a 10-year period but increased substantially in other age groups.
  • The percentage of people reporting past-month use of illicit drugs was higher for urban areas during the study period.
  • Among people reporting illicit drug use in the past year, drug use disorders decreased during the study period.
  • In 2015, approximately six times as many drug overdose deaths occurred in urban areas than in rural areas (urban: 45,059; rural: 7,345).

Most overdose deaths occurred in homes, where rescue efforts may fall to relatives who have limited knowledge of or access to life-saving treatment and overdose follow-up care. Considering where people live and where they die from overdose could improve interventions to prevent overdose. Understanding differences in illicit drug use, illicit drug use disorders, and drug overdose deaths in urban and rural areas can help public health professionals to identify, monitor, and prioritize responses.

Visit HHS’s Opioids website for more information on their 5-point strategy to combat the opioid crisis.

Visit CDC’s Opioid Overdose website for data, tools, and resources on opioid overdose prevention.

Visit CDC’s Rural Health website for more information on rural health topics.

Posted in: Opioid

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CVS Pharmacy, Others to Limit Prescriptions for Opioids

CVS Pharmacy, Others to Limit Prescriptions for Opioids

Beginning in February 2018, CVS Pharmacy will limit the dose of opioid pain medication and restrict new prescriptions for acute pain to a 7-day supply, which adheres to the Centers for Disease Control and Prevention’s guidelines for prescribing opioids. This limit involves capping daily low-dosages and requires patients to receive versions of the medication that give pain-relief for a short period of time rather than a long duration. However, pharma companies seem to be following in the pharmacy’s footsteps as well.

According to the CVS plan, for a patient to receive an opioid prescription for longer than seven days, the patient would need to complete a pre-authorization for the medication — obtained after the pharmacy benefit manager consults with the prescribing doctor — and will have to pay for them out of pocket. The plan also includes in-store pharmacy training and awareness programs on opioid safety and addiction prevention, along with 750 in-store medical disposal units.

While the seven-day quantity limit on opioid prescriptions is intended for CVS Caremark’s PBM clients and applies only to prescriptions written for acute conditions, such as a minor surgery or dental procedure, CVS is not the first — and will not the be last — to place limitations on opioid prescriptions. Earlier this week during a meeting of President Trump’s opioid commission, the Pharmaceutical Research and Manufacturers of America announced support to limit the supply of opioids to seven days for acute pain management. PhRMA is a trade organization representing more than three dozen pharma companies, including AstraZeneca, Bayer, Allergan, Bristol-Myer Squibb, Eli Lilly, Johnson & Johnson, Merck, Pfizer, Teva, Novartis, GlaxoSmithKline, and Purdue Pharma.

In August, OptumRx announced the initial results of its Opioid Risk Management program, which is also reducing opioid use. The program places maximum fill limits on opioid therapy regardless of whether the patient is new to opioids or a chronic user. Results include:

  • 82 percent decrease in prescriptions above the CDC guideline recommended dose of 50 mg morphine equivalent dose (MED) per day for first-fill acute prescriptions;
  • 65 percent decrease in prescriptions for first-fill acute opioid treatment written above the maximum seven-day supply;
  • 68 percent decrease in prescriptions for current chronic opioid utilizers issues for >90 mg MED; and
  • 14 percent reduction in average dose across all opioid prescriptions.

Posted in: Opioid

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