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Opioid Crisis Fast Facts | CNN

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CNN
—

Here’s a look at the opioid crisis.

Experts say the United States is in the throes of an opioid epidemic. An estimated 9.2 million Americans aged 12 and older misused opioids in 2021, including 8.7 million prescription pain reliever abusers and 1.1 million heroin users.

Opioids are drugs formulated to replicate the pain-reducing properties of opium. Prescription painkillers like morphine, oxycodone and hydrocodone are opioids. Illegal drugs like heroin and illicitly made fentanyl are also opioids. The word “opioid” is derived from the word “opium.”

Nearly 110,000 people died of drug overdoses in 2022, and more than two-thirds of those deaths involved a synthetic opioid.

Overdose deaths have been on the rise for years in the United States, but surged amid the Covid-19 pandemic: Annual deaths were nearly 50% higher in 2021 than in 2019, CDC data shows.

Prescription opioid volumes peaked in 2011, with the equivalent of 240 billion milligrams of morphine prescribed, according to the market research firm, IQVIA Institute for Human Data Science.

Alabama, Arkansas, Louisiana and Tennessee had the highest opioid dispensing rates in 2020.

Opioids such as morphine and codeine are naturally derived from opium poppy plants more commonly grown in Asia, Central America and South America. Heroin is an illegal drug synthesized from morphine.

Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients.

Fentanyl is a fully synthetic opioid, originally developed as a powerful anesthetic for surgery. It is also administered to alleviate severe pain associated with terminal illnesses like cancer. The drug is up to 100 times more powerful than morphine. Just a small dose can be deadly. Illicitly produced fentanyl has been a driving factor in the number of overdose deaths in recent years.

Methadone is another fully synthetic opioid. It is commonly dispensed to recovering heroin addicts to relieve the symptoms of withdrawal.

Opioids bind to receptors in the brain and spinal cord, disrupting pain signals. They also activate the reward areas of the brain by releasing the hormone dopamine, creating a feeling of euphoria or a “high.”

Opioid use disorder is the clinical term for opioid addiction or abuse.

People who become dependent on opioids may experience withdrawal symptoms when they stop using the medication. Dependence is often coupled with tolerance, meaning that users need to take increasingly larger doses for the same effect.

A drug called naloxone, available as an injection or a nasal spray, is used as a treatment for overdoses. It blocks or reverses the effects of opioids and is often carried by first responders.

More data on overdose deaths

The 21st Century Cures Act, passed in 2016, allocated $1 billion over two years in opioid crisis grants to states, providing funding for expanded treatment and prevention programs. In April 2017, Health and Human Services Secretary Tom Price announced the distribution of the first round of $485 million in grants to all 50 states and US territories.

In August 2017, Attorney General Jeff Sessions announced the launch of an Opioid Fraud and Abuse Detection Unit within the Department of Justice. The unit’s mission is to prosecute individuals who commit opioid-related health care fraud. The DOJ is also appointing US attorneys who will specialize in opioid health care fraud cases as part of a three-year pilot program in 12 jurisdictions nationwide.

On October 24, 2018, President Donald Trump signed opioid legislation into law. The SUPPORT for Patients and Communities Act includes provisions aimed at promoting research to find new drugs for pain management that will not be addictive. It also expands access to treatment for substance use disorders for Medicaid patients.

State legislatures have also introduced measures to regulate pain clinics and limit the quantity of opioids that doctors can dispense.

1861-1865 – During the Civil War, medics use morphine as a battlefield anesthetic. Many soldiers become dependent on the drug.

1898 – Heroin is first produced commercially by the Bayer Company. At the time, heroin is believed to be less habit-forming than morphine, so it is dispensed to individuals who are addicted to morphine.

1914 – Congress passes the Harrison Narcotics Act, which requires that doctors write prescriptions for narcotic drugs like opioids and cocaine. Importers, manufacturers and distributors of narcotics must register with the Treasury Department and pay taxes on products

1924 – The Anti-Heroin Act bans the production and sale of heroin in the United States.

1970 – The Controlled Substances Act becomes law. It creates groupings (or schedules) of drugs based on the potential for abuse. Heroin is a Schedule I drug while morphine, fentanyl, oxycodone (Percocet) and methadone are Schedule II. Hydrocodone (Vicodin) is originally a Schedule III medication. It is later recategorized as a Schedule II drug.

January 10, 1980 – A letter titled “Addiction Rare in Patients Treated with Narcotics” is published in the New England Journal of Medicine. It looks at incidences of painkiller addiction in a very specific population of hospitalized patients who were closely monitored. It becomes widely cited as proof that narcotics are a safe treatment for chronic pain.

1995 – OxyContin, a long-acting version of oxycodone that slowly releases the drug over 12 hours, is introduced and aggressively marketed as a safer pain pill by manufacturer, Purdue Pharma.

May 10, 2007 – Purdue Pharma pleads guilty for misleadingly advertising OxyContin as safer and less addictive than other opioids. The company and three executives are charged with “misleading and defrauding physicians and consumers.” Purdue and the executives agree to pay $634.5 million in criminal and civil fines.

2010 – FDA approves an “abuse-deterrent” formulation of OxyContin, to help curb abuse. However, people still find ways to abuse it.

May 20, 2015 – The DEA announces that it has arrested 280 people, including 22 doctors and pharmacists, after a 15-month sting operation centered on health care providers who dispense large amounts of opioids. The sting, dubbed Operation Pilluted, is the largest prescription drug bust in the history of the DEA.

March 18, 2016 – The CDC publishes guidelines for prescribing opioids for patients with chronic pain. Recommendations include prescribing over-the-counter pain relievers like acetaminophen and ibuprofen in lieu of opioids. Doctors are encouraged to promote exercise and behavioral treatments to help patients cope with pain.

March 29, 2017 – Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. New Jersey Governor Chris Christie is selected as the chairman of the group, with Trump’s son-in-law, Jared Kushner, as an adviser.

July 31, 2017 – After a delay, the White House panel examining the nation’s opioid epidemic releases its interim report, asking Trump to declare a national public health emergency to combat the ongoing crisis

September 22, 2017 – The pharmacy chain CVS announces that it will implement new restrictions on filling prescriptions for opioids, dispensing a limited seven-day supply to patients who are new to pain therapy.

November 1, 2017 – The opioid commission releases its final report. Its 56 recommendations include a proposal to establish nationwide drug courts that would place opioid addicts in treatment facilities rather than prison.

February 9, 2018 – A budget agreement signed by Trump authorizes $6 billion for opioid programs, with $3 billion allocated for 2018 and $3 billion allocated for 2019.

February 27, 2018 – Sessions announces a new opioid initiative: The Prescription Interdiction & Litigation (PIL) Task Force. The mission of the task force is to support local jurisdictions that have filed lawsuits against prescription drugmakers and distributors.

March 19, 2018 – The Trump administration outlines an initiative to stop opioid abuse. The three areas of concentration are law enforcement and interdiction; prevention and education via an ad campaign; and job-seeking assistance for individuals fighting addiction.

April 9, 2018 – The US surgeon general issues an advisory recommending that Americans carry the opioid overdose-reversing drug, naloxone. A surgeon general advisory is a rarely used tool to convey an urgent message. The last advisory issued by the surgeon general, more than a decade ago, focused on drinking during pregnancy.

May 1, 2018 – The Journal of the American Medical Association publishes a study that finds synthetic opioids like fentanyl caused about 46% of opioid deaths in 2016. That’s a three-fold increase compared with 2010, when synthetic opioids were involved in about 14% of opioid overdose deaths. It’s the first time that synthetic opioids surpassed prescription opioids and heroin as the primary cause of overdose fatalities.

May 30, 2018 – The journal Medical Care publishes a study that estimates the cost of medical care and substance abuse treatment for opioid addiction was $78.5 billion in 2013.

June 7, 2018 – The White House announces a new multimillion dollar public awareness advertising campaign to combat opioid addiction. The first four ads of the campaign are all based on true stories illustrating the extreme lengths young adults have gone to obtain the powerful drugs.

December 12, 2018 – According to the National Center for Health Statistics, fentanyl is now the most commonly used drug involved in drug overdoses. The rate of drug overdoses involving the synthetic opioid skyrocketed by about 113% each year from 2013 through 2016.

January 14, 2019 – The National Safety Council finds that, for the first time on record, the odds of dying from an opioid overdose in the United States are now greater than those of dying in a vehicle crash.

March 26, 2019 – Purdue Pharma agrees to pay a $270 million settlement to settle a historic lawsuit brought by the Oklahoma attorney general. The settlement will be used to fund addiction research and help cities and counties with the opioid crisis.

July 17, 2019 – The CDC releases preliminary data showing a 5.1% decline in drug overdoses during 2018. If the preliminary number is accurate, it would mark the first annual drop in overdose deaths in more than two decades.

August 26, 2019 – Oklahoma wins its case against Johnson & Johnson in the first major opioid lawsuit trial to be held in the United States. Cleveland County District Judge Thad Balkman orders Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis. The penalty is later reduced to $465 million, due to a mathematical error made when calculating the judgment. In November 2021, the Oklahoma Supreme Court reverses the decision.

September 15, 2019 – Purdue files for bankruptcy as part of a $10 billion agreement to settle opioid lawsuits. According to a statement from the chair of Purdue’s board of directors, the money will be allocated to communities nationwide struggling to address the crisis.

September 30, 2019 – The FDA and DEA announce that they sent warnings to four online networks, operating a total of 10 websites, which the agencies said are illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol.

February 25, 2020 – Mallinckrodt, a large opioid manufacturer, reaches a settlement agreement in principle worth $1.6 billion. Mallinckrodt says the proposed deal will resolve all opioid-related claims against the company and its subsidiaries if it moves forward. Plaintiffs would receive payments over an eight-year period to cover the costs of opioid-addition treatments and other needs.

October 21, 2020 – The Justice Department announces that Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to three federal criminal charges for its role in creating the nation’s opioid crisis. They agree to pay more than $8 billion and close down the company. The money will go to opioid treatment and abatement programs. The Justice Department also reached a separate $225 million civil settlement with the former owners of Purdue Pharma, the Sackler family. In November 2020, Purdue Pharma board chairman Steve Miller formally pleads guilty on behalf of the company.

March 15, 2021 – According to court documents, Purdue files a restructuring plan to dissolve itself and establish a new company dedicated to programs designed to combat the opioid crisis. As part of the proposed plan, the Sackler family agrees to pay an additional $4.2 billion over the next nine years to resolve various civil claims.

September 1, 2021 – In federal bankruptcy court, Judge Robert Drain rules that Purdue Pharma will be dissolved. The settlement agreement resolves all civil litigation against the Sackler family members, Purdue Pharma and other related parties and entities, and awards them broad legal protection against future civil litigation. The Sacklers will relinquish control of family foundations with over $175 million in assets to the trustees of a National Opioid Abatement Trust. On December 16, 2021, a federal judge overturns the settlement.

February 25, 2022 – Johnson & Johnson and the three largest US drug distributors – McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp – finalize a $26 billion nationwide opioid settlement.

March 3, 2022 – The Sackler families reaches a settlement with a group of states the first week of March, according to court filings. The settlement, ordered through court-ordered mediation that began in January, requires the Sacklers to pay out as much as $6 billion to states, individual claimants and opioid crisis abatement, if approved by a federal bankruptcy court judge.

November 2, 2022 – CVS and Walgreens agree to pay a combined $10 billion, over 10 and 15 years, to settle lawsuits brought by states and local governments alleging the retailers mishandled prescriptions of opioid painkillers.

November 15, 2022 – Walmart agrees to the framework of a $3.1 billion settlement, which resolves allegations from multiple states’ attorneys general that the company failed to regulate opioid prescriptions contributing to the nationwide opioid crisis.

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Covid-19 is no longer a public health emergency, but others remain | CNN

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CNN
—

The Covid-19 pandemic hit a major milestone this month as public health emergency declarations were ended by both the United States government and the World Health Organization. Emergency declarations for mpox also recently ended.

This doesn’t mean Covid-19 and mpox are no longer of concern, but it does mark the end of the availability of certain logistical capabilities to manage them.

Still, other critical health challenges were identified as health emergencies years before the start of the Covid-19 pandemic and continue to be so: the opioid crisis in the US and the global spread of poliovirus.

Some public health concerns can be serious health threats without a formal emergency declaration, said Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention.

It largely boils down to the logistics of government operations.

“When there’s an unusual situation that requires multiple parts of an agency or multiple parts of the government or multiple parts of society to come together and coordinate, collaborate and work efficiently, then an emergency declaration can be a useful tool,” said Frieden, president and CEO of Resolve to Save Lives, an organization focused on global epidemic prevention and cardiovascular health.

“Sometimes, an emergency is declared to make the point that it’s a big problem, to get people’s attention. Sometimes, an emergency is declared to get things done because that’s the only way you can bring certain governmental capacities to bear.”

According to WHO, a public health emergency of international concern is “an extraordinary event” that poses public health risk through the international spread of disease.

It creates an agreement between countries to abide by WHO’s recommendations for managing the emergency, often requiring a “coordinated international response.” Each country, in turn, declares its own public health emergency – declarations that carry legal weight. Countries use them to marshal resources and waive rules in order to ease a crisis.

In the US, the secretary of the Department of Health and Human Services can declare a public health emergency for diseases or disorders that pose a threat, including “significant outbreaks” of an infectious disease, bioterrorist attacks or otherwise.

This triggers the availability of a set of resources and actions for the federal government, such as additional funds and data and reporting requirements.

Emergency declarations typically last up to 90 days, with formal renewal required as necessary every three months after that.

The opioid crisis was determined to be a public health emergency in October 2017, during the Trump administration, driven by the rising rates of opioid-related deaths and opioid use disorder.

The declaration has been renewed for more than five years, most recently at the end of March.

According to the CDC, the opioid epidemic started in 1999 with a rise in prescription opioid overdose deaths. Deaths started to increase precipitously as synthetic opioids – particularly fentanyl – started to take over in 2013.

In 2021, overdose deaths reached record levels in the US, and about three-quarters – more than 80,000 deaths – involved opioids.

Within the first year of the opioid emergency declaration, HHS used expanded authorities to field a survey about treatment for opioid use disorder among providers and to expedite research on the topic.

Public health emergencies are also declared to help with recovery after natural disasters, most recently for severe storms that hit Mississippi in March.

However, the Government Accountability Office considers both federal management of the public health emergency system and efforts to combat drug misuse to be “high-risk” areas that are vulnerable or in need of broad reform.

In a recent report, the federal watchdog group said that it has found “persistent deficiencies in HHS’s leadership role preparing for and responding to public health emergencies” and no demonstrated progress in federal agencies’ actions to address drug misuse.

WHO has considered poliovirus a public health emergency of international concern since 2014.

A committee formed to address the emergency reviewed the most recent data on cases and spread this month and voted unanimously that ongoing risks merited an extension of the emergency declaration, which the director-general formalized Friday.

The committee was “encouraged by reported progress” but says that risks remain high for factors including weak vaccination rates that could have been affected by the Covid-19 pandemic.

WHO identified seven counties with potential risk for international spread. And the US is among a group of 37 countries with recently detected cases.

In July, a polio case identified in New York became the first in the US in nearly a decade. The identified case, along with several positive wastewater tests in nearby communities, met WHO criteria to consider the US a country with circulating poliovirus.

Experts warned that it could just be the “tip of the iceberg,” with hundreds of cases spreading silently.

Childhood vaccination rates in the US dropped during the Covid-19 pandemic. A CDC report found that about 93% of kindergarteners enrolled in the 2021-22 school year got the required vaccines, including measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); and polio. Coverage fell for the second year in a row amid the pandemic, from about 94% the previous year and below the federal target of 95%.

While no longer under a formal emergency declaration, Covid-19 continues to be part of the “landscape of health threats,” Frieden said.

But the efficiency and coordination that the formal declaration helps facilitate should always be the goal.

“I think there are really important lessons from Covid, including the need to have a much more resilient public health system so that we can find problems quickly and implement effective solutions quickly,” Frieden said.

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New approach gets newborns with opioid withdrawal out of the hospital sooner and with less medication | CNN

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CNN
—

Rates of neonatal abstinence syndrome surged in recent years, but a newer approach to caring for newborn babies exposed to opioids during pregnancy gets them out of the hospital sooner and with less medication, according to a study published on Sunday in the New England Journal of Medicine.

Newborns in opioid withdrawal may experience upset stomach, inconsolable crying, seizures and extreme discomfort. The study looked at the impacts of the Eat, Sleep, Console care approach on 1,300 infants at 26 US hospitals, and compared them with the current standard for caring for infants exposed to opioids.

Eat, Sleep, Console encourages involvement from parents, and prioritizes care that doesn’t involve medication, such as swaddling, skin-to-skin contact and breastfeeding. The usual approach involves a nurse measuring a baby’s withdrawal symptoms – such as their level of irritability, pitch of crying, fever or tremors – before providing treatment such as methadone or morphine.

“Compared to usual care, use of the Eat, Sleep, Console care approach substantially decreased time until infants with neonatal opioid withdrawal syndrome were medically ready for discharge, without increasing specified adverse outcomes,” the researchers wrote in the study.

The infants assessed with the Eat, Sleep, Console care method were discharged after eight days on average, compared with almost 15 days for the infants who were cared for by the standard approach, the researchers said. Additionally, infants in the Eat, Sleep, Console care group were 63% less likely to receive opioid medication – 19.5% received medication compared with 52% in the group receiving usual care.

The current approach to usual care “is a very comprehensive and nurse-led way of assessing the infant, whereas the Eat, Sleep, Console approach involves the mom in the way that you assess the infant, and allows the mom to take part in trying to soothe the infants and see if the infant is able to be soothed or is able to eat or is able to sleep,” according to Rebecca Baker, the director of the NIH HEAL Initiative, which provides grants to researchers studying ways to alleviate the country’s opioid health crisis.

“So, in that way, it’s a little bit more functional, like looking at the abilities of the infants versus how severely the infant is affected.”

Assessment results determine whether a baby should receive medication to control withdrawal symptoms, Baker said.

“So even with Eat, Sleep, Console, some infants that were exposed to a lot of opioids during a mother’s pregnancy, they’ll still need medication-based treatment for withdrawal. It’s just fewer of them need it and when they need it, they need less medication to manage the withdrawal symptoms,” she said.

The Eat, Sleep, Console method was developed about eight years ago, and some hospitals have already implemented it. But Baker said the study’s findings could change how more hospitals practice caring for infants with neonatal abstinence syndrome, which primarily occurs in infants who were exposed to opioids while in utero.

“The rise of really powerful fentanyl, the synthetic opioid, means that if a mother has used drugs during pregnancy, the baby will be exposed to more powerful drugs, which likely has an effect. We haven’t had a chance to study it in detail yet, but it will affect how they feel when they’re born and separated from the mom,” Baker said.

Findings from the study, which were presented at the PAS 2023 Meeting on Sunday, could have a big impact on hospitals by freeing up bed space in the neonatal intensive care unit and boosting morale among nurses at risk of burnout.

“We trained over 5,000 nurses as part of the study. They felt really empowered to help the mom care for the infant to help the infant recover, and so I think from a morale perspective, that’s incredibly important and valuable,” Baker said. “And as you know, nurses are facing really severe staffing shortages and morale challenges so having this tool available to them where they are kind of able to do something positive in the life of the infant and the connection with the mom is really important.”

The researchers are currently following up with a subgroup of the infants from the study for up to two years to see how they grow and develop.

“One of the things that we want to be really sure of is that there are no negative consequences associated with taking less medication, so we’ll be looking for that,” Baker said.

The United States has seen an explosion in the number of infants born with neonatal abstinence syndrome in recent years, swelling by about 82% between 2010 and 2017, according to the US Centers for Disease Control and Prevention. The number of maternal opioid-related diagnoses is also on the rise, increasing by 131% during that same time frame.

Nearly 60 infants are diagnosed with NAS each day, based on data from the U.S. Agency for Healthcare Research and Quality in 2020.

The United States’ opioid epidemic has been expanding in recent years and opioid deaths are the leading cause of accidental death in the US.

More than a million people have died of drug overdoses – mostly opioids – in the two decades since the US Centers for Disease Control and Prevention began collecting that data. Deaths from opioid overdoses rose more than 17% in just one year, from about 69,000 in 2020 to about 81,020 in 2021, the CDC found.

Most are among adults, but children are also dying, largely after ingesting synthetic opioids such as fentanyl. Between 1999 and 2016, nearly 9,000 children and adolescents died of opioid poisoning, with the highest annual rates among adolescents 15 to 19, the CDC found.

Opioid use during pregnancy has been linked to maternal mortality and risk of overdose for the mother, according to the CDC, while infants risk preterm birth, low birthweight, breathing problems and feeding problems.

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On ‘weed day,’ our medical analyst urges caution on recreational marijuana use | CNN

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CNN
—

As some people mark 4/20 as “weed day,” a day of celebration of marijuana use, I don’t want to bum you out — but I might.

Over the past decade, there has been a trend toward legalizing marijuana in the United States. Currently, at least 37 states, plus Washington, DC, have a comprehensive medical cannabis program. A growing number of states, currently at 21, have legalized recreational marijuana use.

I wanted to learn about the research around marijuana use, including the effects it has on the user and the medicinal uses for cannabis. I turned to CNN Medical Analyst Dr. Leana Wen, who has many concerns about recreational cannabis use, especially for certain populations such as young people and pregnant people.

Wen, who urged users and would-be users to be cautious, is an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She previously served as Baltimore’s health commissioner and as chair of Behavioral Health System Baltimore, where she oversaw policy and services around substances that can cause addiction, including marijuana.

CNN: What are the physiological effects of marijuana?

Dr. Leana Wen: Marijuana is a plant that has many active ingredients. One of the principal ones is a psychoactive compound called tetrahydrocannabinol. Often called THC, it’s similar to compounds that are naturally occurring in the body called cannabinoids and can mimic their function by attaching to cannabinoid receptors in the brain. In so doing, THC can disrupt normal mental and physical functions, including memory, concentration, movement and coordination.

Using marijuana can cause impaired thinking and interfere with someone’s ability to learn, according to the National Institute on Drug Abuse. Smoking cannabis can also impair the function of the parts of the brain that regulate balance, posture and reaction time. And THC stimulates the neurons involved in the reward system that release dopamine, or the “feel-good” brain chemical, which contributes to its addictive potential.

CNN: Marijuana is thought to have some positive and medicinal benefits. How can it be used for therapeutic purposes?

Wen: Short-term, many users report pleasant feelings, including happiness and relaxation. As a result, some people use marijuana to self-treat anxiety or depression. This is not a recommended use. What often ends up happening is that the person develops tolerance, requiring more and more of the drug to get the same effect.

There are some approved medicinal uses of marijuana for very specific indications. The US Food and Drug Administration has approved THC-based medications that are prescribed in pill form for treatment of nausea in patients with cancer undergoing chemotherapy and to stimulate appetite in patients with AIDS. There are several marijuana-based medications that are undergoing clinical trials for conditions like neuropathic pain, overactive bladder and muscle stiffness.

I think it’s really important for these and many more studies to continue. Researchers should continue to look not just at marijuana itself but its specific chemical components, since botanicals in their natural form can contain hundreds of active chemicals and obtaining the correct dosages may be challenging. In the meantime, users should use caution in evaluating supposed medicinal claims and clearly understand the risks of cannabis use.

CNN: What are the risks of marijuana use, and who may be particularly vulnerable to them?

Wen: The main concern about marijuana use is its impact on the developing brain. As the US Centers for Disease Control and Prevention states on its website, “Marijuana affects brain development. Developing brains, such as those in babies, children, and teenagers, are particularly susceptible to the harmful effects of marijuana and tetrahydrocannabinol.”

Numerous studies have linked marijuana use in women during pregnancy to a variety of cognitive and behavioral problems in their children. The CDC even warns against secondhand marijuana smoke exposure, and it also encourages breastfeeding individuals to avoid marijuana use.

Marijuana affects young people throughout adolescence and young adulthood. Much research has shown how marijuana use in childhood impacts memory, attention, learning and motivation. Regular cannabis use in adolescence is associated with higher likelihood of not completing high school and even lower IQ later in life. The negative impacts persist beyond the teen years. Some studies of university students have found that the regularity of marijuana use is correlated with lower grade point average in college.

I want to emphasize here that there is still a lot that we don’t know about the effects of marijuana, in particular long-term consequences. A recent study found that in adults, daily use of regular marijuana can increase the risk of coronary artery disease by as much as one-third. That’s the point, though; all the unknowns are exactly why I and many other clinicians and scientists urge caution.

To be clear, there are many reasons to support policy changes of decriminalizing marijuana, including to rectify the decades-long injustices of disproportionately incarcerating minority individuals for marijuana possession. However, supporting decriminalization should not be equated with believing that marijuana is totally safe. It’s not. Marijuana has the potential to cause real and lasting harm, especially to young people.

CNN: Could someone become addicted to marijuana?

Wen: Yes. There is a condition known as marijuana use disorder. Signs of this disorder include trying but failing to quit using marijuana;, continuing to use it even though it is causing problems at home, school or work;, and using marijuana in high-risk situations, including while driving. Some individuals, especially those who use large amounts, experience withdrawal symptoms when they try to stop.

As many as 3 in 10 people who use marijuana have marijuana use disorder, according to the CDC. The risk of developing marijuana use disorder is greater among those who use it more frequently and for those who started earlier in life.

CNN: Some people say that marijuana is no big deal, especially in comparison with other substances like alcohol and opioids. Would you agree that cannabis use is at least better than using those substances?

Wen: I wouldn’t frame it that way. It is true that marijuana doesn’t cause liver damage the way that high amounts of alcohol does, and it doesn’t have the lethality of opioids. If an adult is using marijuana once in a while, and not while driving, it’s probably not going to have lasting consequences.

However, there are harms associated with more frequent use of marijuana and in particular its use in children. In my opinion, the legalization movement has shifted the conversation so much towards acceptance of cannabis that we are neglecting the fact that it is a drug and, I believe, should be regulated just like alcohol, tobacco and opioids.

There should also be much more messaging and education so that people, including young people and their parents or guardians, can be aware of the harms of marijuana — just as they are aware of the harms of other drugs.

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Biden administration declares fentanyl laced with xylazine ‘an emerging threat’ in the US | CNN

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CNN
—

The White House has declared that the powerful synthetic opioid fentanyl combined with xylazine – an animal tranquilizer that’s increasingly being used in illicit drugs – is an “emerging threat” facing the United States due to its role in the ongoing opioid crisis.

Administration officials call the threat FAAX, for fentanyl-adulterated or -associated xylazine.

The move, announced Wednesday, marks the first time in history that any administration has declared a substance to be an emerging threat to the country, said Dr. Rahul Gupta, director of the Office of National Drug Control Policy. The SUPPORT Act of 2018 established that the office has authority to declare such “emerging threats,” and no administration has used it until now. Last year, Congress declared methamphetamine an emerging drug threat but none have been declared by an administration previously. Under other agencies or in separate circumstances, concerns such as bioterrorism, infectious diseases or climate change may be identified as “emerging threats.”

“This drug, which is an animal sedative, is being mixed with fentanyl and is being found in almost all 50 states now,” Gupta said Tuesday. “It’s become an important part for us to make sure that we’re declaring it an emerging threat.”

Now that the administration has declared fentanyl combined with xylazine an emerging threat, it has 90 days to coordinate a national response. “We are working quickly to develop and implement a whole of government nationwide plan, with real deliverable action, that will save lives and will be published within 90 days of this designation,” Gupta said.

Xylazine, also known as tranq or tranq dope, has been linked to an increasing number of overdose deaths in the United States due to its rising illicit use. Between 2020 and 2021, overdose deaths involving xylazine increased more than 1,000% in the South, 750% in the West and about 500% in the Midwest, according to an intelligence report released last year by the US Drug Enforcement Administration.

And in some cases, people might not even know that xylazine was in the drug they used.

Just last month, authorities at the DEA issued a public safety alert about the “widespread threat” of fentanyl mixed with xylazine, reporting that in 2022 approximately 23% of fentanyl powder and 7% of fentanyl pills seized by the DEA contained xylazine.

Fentanyl, which has been driving the opioid crisis, is a fast-acting opioid, and people who use it illicitly say that adding xylazine can extend the duration of the high the drug provides.

Xylazine is not an opioid. It is approved by the US Food and Drug Administration for use as a tranquilizer in veterinary medicine, typically in horses, but it is not approved for use in humans. And xylazine can do major damage to the human body, including leaving drug users with severe skin ulcers, soft-tissue wounds and necrosis – sometimes described as rotting skin – that can lead to amputation.

“Xylazine is one of the contaminants in fentanyl, but there could be others,” Gupta said. “So, I think with the declaration of an emerging threat, we’re sending a clear message to producers and traffickers of illicit xylazine and illicit fentanyl that we’re going to respond quicker, we’re going to match the challenge of evolution of these drugs supply, and that we’re going to protect lives first and foremost.”

Now that xylazine has been declared an emerging threat, some of President Biden’s $46 billion drug budget request to Congress can be used to respond.

This year, the Biden administration announced that the President has called on Congress to invest $46.1 billion for agencies overseen by the Office of National Drug Control Policy to tackle the nation’s illicit drug crisis.

If the budget request is not approved, there could be the option to reallocate money within the Office of National Drug Control Policy, but “we don’t want to be in a position where moneys that are being utilized for some other important aspect of saving lives has to be moved away for this purpose,” Gupta said Tuesday. “That is the reason we are asking Congress to act.”

Such funds could be used to test drugs on the street for xylazine, collect data on FAAX, invest in care for people exposed to FAAX and develop potential treatments for a xylazine-related overdose.

The medication naloxone, also known as Narcan, is an antidote for an opioid overdose, but people who have overdosed on a combination of opioids and xylazine may not immediately wake up after taking naloxone, as it may not reverse the effects of xylazine in the same way it does opioids.

“We need to recognize, first of all, that there is a shift that is occurring from organic compounds and substances like heroin and cocaine to more synthetics,” Gupta said of the state of the nation’s illicit drug crisis.

“Both the types of drugs have changed – from predominantly organic to predominantly synthetics – but the way drugs are bought and sold have also changed,” he said. “Now, all you need is a phone in the palm of your hand and a social media app to order and buy some of the most dangerous substances on planet Earth.”

Xylazine is just one of the many adulterants – or substances that are typically added to others – found in the nation’s illicit drug supply.

“All of a sudden, you can synthesize hundreds of compounds and kind of mix them together and see what does the best in the market,” Joseph Friedman, a researcher at the University of California, Los Angeles, told CNN in March. “People are synthesizing new benzodiazepines, new stimulants, new cannabinoids constantly and adding them into the drug supply. So people have no idea what they’re buying and what they’re consuming.”

Some of these adulterants may be as simple as sugar or artificial sweeteners added for taste or additives or fillers that bulk up the drug. Sometimes, they may be contaminants left over from the manufacturing process.

Addicted? How to get help

If you’re addicted to prescription drugs, help is available. You can call the Substance Abuse Mental Health Services Administration 24/7 hotline at 1-800-662-HELP(4357) or visit their website.

But all of these things can carry real-life health harms, says Naburan Dasgupta, an epidemiologist and senior scientist at the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.

Like an opioid, xylazine can depress the respiratory system, so the risk of overdose multiplies when it’s combined with heroin or fentanyl.

Also, “in the veterinary literature, we know that it causes a really bad severe form of anemia. And so when people are injecting heroin that’s contaminated with xylazine, they can end up with a near-fatal form of blood iron deficiency,” Dasgupta said in March. “We had one person here who ended up going to the hospital needing multiple blood transfusions. And it was all because of the xylazine.”

US lawmakers are moving to classify xylazine as a controlled substance.

In March, bipartisan legislation – the Combating Illicit Xylazine Act – was introduced in the House and Senate. It describes illicit xylazine as an “urgent threat to public health and safety” and calls for it to be a Schedule III drug under the Controlled Substances Act, a category on the five-level system for substances with moderate to low potential for physical or psychological dependence. Xylazine would be one level below opioids like fentanyl.

“Our bipartisan bill would take important steps to combat the abuse of xylazine by giving law enforcement more authority to crack down on the illicit distribution of this drug, including by putting stiffer penalties on criminals who are spreading this drug to our communities,” Sen. Maggie Hassan, D-N.H., said in a statement in March.

The bill would also require manufacturers to send reports on production and distribution to the DEA so the agency can ensure that the product is not being diverted to the black market.

“This bill recognizes the dangers posed by the increasing abuse of animal tranquilizers by drug traffickers, and provides new tools to combat this deadly trend,” Sen. Chuck Grassley, R-Iowa, said in the statement.

“It also ensures that folks like veterinarians, ranchers and cattlemen can continue to access these drugs for bona fide animal treatment.”

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FDA approves first over-the-counter version of opioid overdose antidote Narcan | CNN

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CNN
—

With drug overdose deaths continuing to hover near record levels, the US Food and Drug Administration on Wednesday approved for the first time an over-the-counter version of the opioid overdose antidote Narcan.

“The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” FDA Commissioner Dr. Robert Califf said in a statement.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Dr. Rahul Gupta, director of the White House’s Office of National Drug Control Policy, said accessibility is key to ensuring that the Narcan nasal spray saves lives.

“It’s really important that we continue to do everything possible in our power to make this life-saving drug available to anyone and everyone across the country,” Gupta said.

The White House drug czar said businesses, such as restaraunts and banks, and schools will be encouraged to purchase over-the-counter naloxone.

“We will encourage businesses, restaurants, banks, construction sites, schools, others to think about this – think about it as a smoke alarm or a defibrillator, to make it as easily accessible, because it’s not just you. It could be your neighbor, it could be your family, your friend, a person at work or school who might need it, ” Gupta said.

The nasal spray will come in a package of two 4-milligram doses, in case the person overdosing does not respond to the first dose. However, the drug’s maker, Emergent BioSolutions, says most overdoses can be reversed with a single dose. The product could be given to anyone, even children and babies.

The nasal spray is expected to be available for purchase in stores and online by late summer, Emergent said Wednesday.

More than a million people have died of drug overdoses in the two decades since the US Centers for Disease Control and Prevention began collecting that data. Many of those deaths were due to opioids. Deaths from opioid overdoses rose more than 17% in just one year, from about 69,000 in 2020 to about 81,020 in 2021, the CDC found.

Opioid deaths are the leading cause of accidental death in the US. Most are among adults, but children are also dying, largely after ingesting synthetic opioids such as fentanyl. Between 1999 and 2016, nearly 9,000 children and adolescents died of opioid poisoning, with the highest annual rates among adolescents 15 to 19, the CDC found.

Nearly every state in the US has standing orders that allow pharmacists or other qualified organizations to provide the medication without a personal prescription to people who are at risk of an overdose or are helping someone at risk, but making it available over the counter can make it easier for people to access the opioid antidote.

Research shows that wider availability could save lives as opioid overdoses have skyrocketed in recent years – much of it due to synthetic opioids like illicitly made fentanyl.

Emergent President and CEO Robert Kramer hailed the FDA’s decision as a “historic milestone.”

“We are dedicated to improving public health and assisting those working hard to end the opioid crisis – so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan Nasal Spray to help save a life,” Kramer said in a statement.

Narcan works by blocking the effects of opioids on the brain and restoring breathing. For the most effectiveness, it must be given as soon as signs of overdose appear.

The drug works on someone only if there are opioids in their system. It won’t work on any other type of drug overdose, but it won’t have adverse effects if given to someone who hasn’t taken opioids.

Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important to call 911 after giving the drug.

People given naloxone should be watched carefully until medical help arrives and monitored for another two hours.

About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

Emergent said it does not have information on how much OTC Narcan will cost.

Harm reduction experts say the price of naloxone has inhibited its accessibility to people who need it most. And although the cost will probably drop as it becomes available over the counter, they say it will probably still be out of reach for many.

“We’re not going to be able to ramp up naloxone distribution in a game-changing way until we get a better handle on the price,” said Nabarun Dasgupta, a scientist at the University of North Carolina’s Injury Prevention Research Center who studies drugs and infectious diseases. “There’s the promise on paper versus on the street, and it’s going to come down to the dollars and cents.”

Separate changes to grant funding by both the CDC and the Substance Abuse and Mental Health Services Administration will make it easier for states and local health departments to buy naloxone, he said.

Gupta said the Biden administration is asking the drugmakers to keep the price of the antidote low.

“That’s one of the things that the president has been very clear: that we’ve got to make sure that these life-saving medications, as well as treatment, is accessible across no matter where you live, rural or urban, rich or poor. We want to make sure this is accessible across broad swaths of people,” he said.

However, experts said the most meaningful work in the fight against the devastating outcomes of the drug overdose epidemic will come with ongoing emphasis on treatment for opioid use disorder and other harm-reduction strategies.

“While enabling people to access quality treatment for substance use disorders is critical, we must also acknowledge that people need to survive in order to have that choice,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, said in January.

Caleb Banta-Green, principal research scientist at the University of Washington’s Addictions, Drug & Alcohol Institute, has described naloxone as the “gateway drug” to a conversation about what substance use disorder is.

“It’s a conversation starter. It’s life-saving for the individual. It’s not a game-changer at the population level,” he said. “We need to do more. And we need to use treatment medications – methadone and buprenorphine – which are far higher overdose preventive approaches.”

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Chronic pain patients struggle to get opioid prescriptions filled, even as CDC eases guidelines | CNN

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KHN
—

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,” said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

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FDA-Mandated Tweak to Common Rx Painkillers May Have Saved Lives

Post By Health acetaminophen, combo drugs, opioids, painkillers

By Alan Mozes

HealthDay Reporter

WEDNESDAY, March 8, 2023 (HealthDay News) — Acetaminophen, a popular over-the-counter medication for millions struggling with pain and fever, can also be found in prescription painkillers that combine acetaminophen and an opioid into one pill.

The problem? The U.S. Food and Drug Administration has long known that high dosages of acetaminophen (Tylenol) can harm the liver. So, in 2011 the FDA set new safety limits on exactly how much acetaminophen could be packed into any prescription painkiller.

Now, a new study shows the move likely saved lives.

Ever since the FDA announced the regulatory change, which slashed the limits on acetaminophen from up to 750 milligrams (mg) to up to 325 mg, there has been an 11% to 16% annual drop in the number of hospitalizations and acute liver failure cases involving the combo painkiller. One such combo is Vicodin, which contains hydrocodone and acetaminophen.

“This suggests that the mandate was likely the largest driver in the decreases in acute liver failure cases and hospitalizations in combination acetaminophen-opioid products,” said study author Dr. Jayme Locke, director of the University of Alabama at Birmingham’s Comprehensive Transplant Institute.

The report was published in the March 7 issue of the Journal of the American Medical Association. Locke and her colleagues stressed that their investigation does not definitively prove that the FDA mandate directly caused acetaminophen-opioid drug complications to plummet.

“Certainly, other factors could have played a role,” Locke noted. “For example, the mandate may have brought the issue of acetaminophen toxicity to the forefront for both providers and patients,” presumably leading some to cut down on acetaminophen dosages on their own.

At the same time, she pointed out that the FDA mandate did not place any new limits on over-the-counter acetaminophen dosing. Not surprisingly, “similar [downward risk] trends were not observed in acetaminophen alone,” Locke said.

According to the study authors, the intended purpose of combining acetaminophen with an opioid was to enable doctors to expose patients to lower doses of each of the two drugs. Given the burgeoning opioid addiction crisis, that approach made sense.

But researchers started to warn that at such high doses acetaminophen was proving toxic to the liver.

In fact, the new report highlights one 2005 study that found more than 4 in 10 of all acute liver failure cases linked to acetaminophen use ended up being traced back to acetaminophen-opioid painkillers.

In 2009, such red flags prompted an FDA advisory panel to recommend an outright ban on such combo drugs. In the end, the FDA chose the dosage limit route.

To see if the new limit had a protective impact, Locke’s team analyzed figures compiled by the National Inpatient Sample (NIS) and the Acute Liver Failure Study Group (ALFSG).

NIS data provided details on roughly 473 million hospitalizations between 2007 and 2019. ALFSG data focused on adult patients who were treated for acute liver failure between 1998 and 2019.

The investigators then stacked pre-FDA mandate liver failure and hospitalization risk up against post-mandate risk. And what they saw was a dramatic drop in risk, coinciding with the FDA’s 2011 mandate.

For example, NIS data revealed that while roughly 12 out of 100,000 hospitalizations involved combo drug toxicity just before the FDA move, that figure dropped to just above 4 in 100,000 by 2019. And while the risk for being hospitalized with combo drug toxicity had been increasing 11% a year up to the time of the FDA’s new limit, that figure actually flipped to an 11% drop per year after the limit was announced.

ALFSG figures revealed a similar dynamic: 27% of acute liver failure cases were attributed to the drug combo at the time of the FDA move, but that figure dropped to 5% by 2019.

Locke said the study did not identify what percentage of combo drug users struggled with a substance use disorder before or after the FDA move. Nor did the team assess whether the new acetaminophen limit in any way reduced the potency of acetaminophen-opioid combinations.

But based on the evidence, Locke said her team is “pleased with the effectiveness of the mandate at decreasing acute liver failure cases.”

Dr. Marc Ghany, section chief of clinical hepatology research at the liver diseases branch at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, co-authored an editorial accompanying the study.

Ghany suggested that the FDA’s mandate can only go so far, given that combination acetaminophen-opioid formulations only account for about 20% of total acetaminophen use in the United States.

He pointed out that the study found “the rate of hospitalizations for individuals using non-prescription, over-the-counter acetaminophen-only products actually increased over the same period.”

The challenge now, said Ghany, is what to do about toxicity risk among the vast majority of patients who use over-the-counter acetaminophen.

“Efforts to improve consumer education on the risks of acetaminophen injury, and to provide simple and clear information of the risks of liver injury on the product label continue. But this alone may be insufficient, given the general belief among consumers that over-the-counter medications are safe,” he noted.

“The only way to protect against acetaminophen-related liver injury and death,” said Ghany, “would be to develop safer, more effective pain relievers.”

More information

There’s more on acetaminophen at the U.S. National Institutes of Health.

SOURCES: Jayme Locke, MD, MPH, director, UAB Comprehensive Transplant Institute, chief, division of transplantation, and professor of surgery, University of Alabama at Birmingham; Marc Ghany, MD, MHSc, section chief, clinical hepatology research section, liver diseases branch, U.S. National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md.; Journal of the American Medical Association, March 7, 2023

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Asthma, cancer, erectile drugs sent from abroad make up are most confiscations, despite opioid claims | CNN

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For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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Opioids Cause Half of All Poisonings in U.S. Kids Age 5 and Younger

Post By Health deaths from opioids, kids and opioids, opioids, opioids poison risk to kids

By Dennis Thompson

HealthDay Reporter

WEDNESDAY, March 8, 2023 (HealthDay News) — Opioids pose the greatest poison risk to children in the United States, accounting for more than half of poisoning deaths in infants and toddlers, a new study reports.

About 52% of poisoning deaths of children aged 5 and younger in 2018 involved the ingestion of an opioid, according to findings published online March 8 in the journal Pediatrics.

“In fact, it has doubled since 2005, when about 24% of all poisoning deaths were attributable to opioids,” said lead researcher Dr. Christopher Gaw, a pediatric emergency physician at Children’s Hospital of Philadelphia.

Experts chalk the rise in these child poisonings up to the United States’ continuing opioid epidemic.

“This confirms what we know, which is there are more opioids available in the household, and anytime something is more available, we see that mirrored in poisoning exposures,” said Dr. Diane Calello, a pediatric emergency physician and medical director of the New Jersey Poison Information and Education System, in Newark, N.J.

Gaw agreed.

“The opioid epidemic hasn’t spared our nation’s infants and young children,” he said. “They’re being affected, too.”

This week, news broke about a lawsuit filed against Airbnb by the family of a 19-month-old French girl who died after being exposed to fentanyl at a vacation rental in Florida.

The girl, Enora Lavenir, died in August 2021 after being put down for a nap during a family trip, NBC News reported. An autopsy found that she died of acute fentanyl toxicity, although it’s not clear how she ingested the powerful synthetic opioid.

The lawsuit alleges that the rental had a history of use as a party house, even though its Airbnb listing advertised it as a “peaceful place to stay.”

For this study, Gaw and his colleagues reviewed child death review data from the U.S. National Center for Fatality Review and Prevention.

In all, 731 poisoning deaths in children aged 5 and younger were reported to the center between 2005 and 2018. Overall, infants under age 1 accounted for 2 out of 5 poisoning deaths.

During the study period, opioids were involved in about47% of deaths, followed by over-the-counter pain, cold and allergy medications (15%).

Child deaths owing to opioids more than double

But year by year, child deaths related to opioid exposure increased — more than doubling between 2005 and 2018.

Even a small dose of prescription opioids can put an infant or toddler’s life at risk, given their tiny size, said Dr. Sam Wang, a pediatric toxicologist with Children’s Hospital Colorado in Aurora.

And the risk is even greater from synthetic opioids like fentanyl, which is 50 to 100 times stronger than morphine.

“The amount of fentanyl can vary in these small illicit pills, but it can be enough to kill an adult, let alone a child,” Wang said.

“We’ve had cases where young children, typically less than 2 or 3 years of age, come in after ingesting illicit fentanyl, and there have been deaths reported in our state from this,” he added. “We’ve had really sick children needing naloxone because of it.”

Nearly two-thirds of poisoning deaths occurred in the child’s home, the findings showed. Roughly one-third of the kids were being supervised by someone other than their parents when they were poisoned.

Most of these were accidental poisonings, data show.

“Kids are curious, kids are active, and we know from experience and from other studies that oftentimes kids are exposed accidentally,” Gaw said. “They are just exploring their environment and they find an opioid and they end up ingesting it. A lot of these are what we call exploratory ingestion.”

Illicit opioids bring particular risks, but Rx opioids are also a threat

Households in which people are taking illicit opioids like heroin or fentanyl pose a particular danger to children, Calello said.

“When a child lives in a home with illicit drugs, things like supervision and safety are usually also not as good as they would be under normal circumstances,” she said. “That’s called drug endangerment. Those children are at greater risk not only of poisoning but of [death] by poisoning.”

However, prescription opioids are also a poisoning threat to children, one that is often overlooked, Calello added.

“Sometimes when parents are taking a medication that they themselves are very familiar with, they don’t ascribe danger to that medication. It’s a familiar thing, so how can one pill possibly kill a child?” she said. “So educating parents or adults who are prescribed opioids that they are potentially very dangerous to young children in the home is important.”

Wang agreed.

“Even legitimate opioids that are not properly stored and kept out of reach of children can cause death, if the child would get into them,” he said.

Gaw urged parents to be proactive by storing opioids out of children’s reach, under lock and key.

“Children are active and curious. They move quickly. Supervising kids is great, but it’s not the end all, be all,” Gaw said. “We like to stress that instead of putting all your effort into supervision, that parents and families should really focus on preparedness and prevention.”

How to protect your kids if you are prescribed opioids

Anyone who’s being sent home with opioids should be fully educated on the threat the drugs pose to kids, both experts said.

For example, parents and caregivers should know that any opioids not kept in a child-proof prescription bottle pose an immediate threat, Calello said.

“Make sure that opioid pills are stored in that prescription bottle with a child-resistant closure. Not in a purse, in a tissue, in a wallet, in a pocket,” she said. “If they’re not locked up in a child-resistant bottle, it’s just that much more likely a child is going to get into it.”

Research has shown that even tougher unit-dose packaging can better protect kids, Wang said.

“When you have to open one small package to get a single dose out, it dramatically decreases unintentional exposures in young children because it’s not as easy to get into them,” he said.

Gaw suggested that people prescribed opioids be sent home with naloxone, the drug that can reverse a potentially fatal overdose.

“When we think of naloxone, I think a lot of people think about naloxone for older individuals or adults, but we really want to emphasize that naloxone is a life-saving antidote for anyone of any age, and that includes children,” he explained.

Children’s Hospital of Philadelphia has been pursuing a pilot program to distribute naloxone to interested families, Gaw said.

“We provide the training, they receive the (naloxone) kits, and they’re able to go home with that potentially lifesaving medicine,” he said.

How to tell if a child has ingested opioids

Finally, Calello emphasized that people should not intentionally administer opioids to a child, in a misguided attempt to soothe them.

“It’s important that people know that a crying infant is not going to be calmed by a small dose of an opioid,” Calello said.

A child exposed to opioids will have very small pupils, “what we call pinpoint pupil,” will act lethargic or difficult to rouse, or have slowed, shallow breathing, Gaw said.

These symptoms should prompt a call to 911, Gaw said.

People who want to know more or are unsure if their child has been poisoned can call the National Poison Control Center’s hotline at 800-222-1222, Gaw added.

More information

Children’s Hospital of Philadelphia has more about poison control and prevention.

SOURCES: Christopher Gaw, MD, pediatric emergency physician, Children’s Hospital of Philadelphia; Diane Calello, MD, pediatric emergency physician, medical director of the New Jersey Poison Information and Education System, Newark, N.J.; Sam Wang, MD, pediatric toxicologist, Children’s Hospital Colorado, Aurora; Pediatrics, March 8, 2023, online

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#Opioids #Poisonings #Kids #Age #Younger

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