War on drugs shifting gears: Cocaine deaths surge in South Florida

Posted on November 17, 2017 by Pharmaciststeve

Cocaine deaths surge with rise of drug smuggling into South Florida

http://www.sun-sentinel.com/local/palm-beach/fl-reg-cocaine-deaths-surge-20171116-story.html

Cocaine killed more people in Florida last year than any other drug, and authorities expect it will only get worse as traffickers push more of the narcotic through the Sunshine State.

Cocaine-related fatalities rose for the fourth year in a row in 2016, contributing to the deaths of 2,882 people, according to the latest data from the Florida Medical Examiner’s Commission.

The Drug Enforcement Administration says the deaths statewide coincide in part with an increase in Colombian cocaine moving through the Caribbean and entering South Florida. Much of the cocaine is being smuggled on planes and boats.

“What you’re seeing in the medical examiner data is a direct result of the increasing supply of cocaine,” said Justin Miller, intelligence chief for the DEA’s Miami field division. “Unfortunately, we are seeing the consequences of having that much cocaine coming into our region.”

Cocaine production in Colombia has hit a record high. That’s partly because the government ended the practice of aerial spraying of herbicides over coca fields, which curbed cultivation of the crop. The Colombian government ended the decadeslong program over health concerns.

Palm Beach, Broward and Miami-Dade counties last year saw some of the highest rates of cocaine-related deaths among Florida’s 67 counties, medical examiner data shows.

— Palm Beach County had more than 25 deaths per 100,000 people and was among the top four counties with the highest rates of cocaine-related deaths, at 405.

— Broward and Miami-Dade counties had 15 to 20 deaths per 100,000 people. Broward County had 328 cocaine-related deaths, while Miami-Dade had 439.

With the supply increasing, the price is going down. One kilo — about 2.2 pounds — of pure cocaine was worth between $28,000 and $35,000 two to three years ago, he said. Today, the same amount is worth $26,000 to $28,000.

On the streets of Miami, a gram sells for between $50 and $80 these days, Miller said.

Florida’s Customs and Border Protection says it seized 4,500 pounds of cocaine during its most recent budget year, a slight increase over the 4,200 pounds seized the year prior.

Trafficking organizations have begun dropping drugs into the ocean in waterproof packaging for retrieval using GPS coordinates, according to the DEA.

About 50 miles off the coast of Key West last year, recreational divers found more than 10 pounds of cocaine anchored to the ocean floor.

Colombian trafficking organizations ship cocaine and heroin directly to Florida, specifically Miami and Orlando, through private and commercial flights, air cargo, shipping containers and small boats, DEA records show.

An increased supply of cocaine isn’t the only reason for the rise in deaths.

Jim Hall, an epidemiologist for Nova Southeastern University, said many of the cocaine-related deaths are instances where people are using more than one drug at the same time, or one right after the other.

“Many of these people are dying because of cocaine with an opioid,” he said. “Or, they are taking contaminated cocaine.”

Miller, too, said much of today’s cocaine supply is “tainted” by other drugs. “In our lab submissions, we are seeing cocaine, heroin and fentanyl all being sold as the same substance,” Miller said.

With even more cocaine arriving on U.S. shores this year, the entire country — including Florida — can expect more deaths to come, DEA records show.

“Right now, from an enforcement standpoint, we are hitting them very hard. We have some tremendous operations going on right now,” Miller said. But still, “the outlook doesn’t look good right now.”

I wonder what/who the DEA is going to blame was the “gateway drug” for all of these people using/abusing Cocaine.  Since prescribers don’t issue prescriptions for COCAINE… AND  …Cocaine killed more people in Florida last year than any other drug…  cocaine related deaths INCREASING FOUR YEARS IN A ROW… and where are all the DEA/law enforcement seizures ?

 

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number of drug over dose deaths are JUST ESTIMATED ?

Posted on November 17, 2017 by Pharmaciststeve

Deaths Involving Fentanyl, Fentanyl Analogs, and U-47700 — 10 States, July–December 2016

https://www.cdc.gov/mmwr/volumes/66/wr/mm6643e1.htm

Preliminary estimates of U.S. drug overdose deaths exceeded 60,000 in 2016 and were partially driven by a fivefold increase in overdose deaths involving synthetic opioids (excluding methadone), from 3,105 in 2013 to approximately 20,000 in 2016 (1,2). Illicitly manufactured fentanyl, a synthetic opioid 50–100 times more potent than morphine, is primarily responsible for this rapid increase (3,4). In addition, fentanyl analogs such as acetylfentanyl, furanylfentanyl, and carfentanil are being detected increasingly in overdose deaths (5,6) and the illicit opioid drug supply (7). Carfentanil is estimated to be 10,000 times more potent than morphine (8). Estimates of the potency of acetylfentanyl and furanylfentanyl vary but suggest that they are less potent than fentanyl (9). Estimates of relative potency have some uncertainty because illicit fentanyl analog potency has not been evaluated in humans. This report describes opioid overdose deaths during July–December 2016 that tested positive for fentanyl, fentanyl analogs, or U-47700, an illicit synthetic opioid, in 10 states participating in CDC’s Enhanced State Opioid Overdose Surveillance (ESOOS) program.* Fentanyl analogs are similar in chemical structure to fentanyl but not routinely detected because specialized toxicology testing is required. Fentanyl was detected in at least half of opioid overdose deaths in seven of 10 states, and 57% of fentanyl-involved deaths also tested positive for other illicit drugs, such as heroin. Fentanyl analogs were present in >10% of opioid overdose deaths in four states, with carfentanil, furanylfentanyl, and acetylfentanyl identified most frequently. Expanded surveillance for opioid overdoses, including testing for fentanyl and fentanyl analogs, assists in tracking the rapidly changing illicit opioid market and informing innovative interventions designed to reduce opioid overdose deaths.

The 10 states† reporting data abstracted information from preliminary death certificates and medical examiner/coroner reports on unintentional and undetermined opioid overdose deaths using standard definitions for variables. Data were entered into the State Unintentional Drug Overdose Reporting System (SUDORS), the component of ESOOS designed for tracking fatal opioid overdoses.§ For each death, available data on demographic characteristics, circumstances of the overdose collected from death scene investigations (e.g., evidence of illicit drug use), and results of forensic toxicology testing were entered into SUDORS. Opioid overdose deaths occurring during July–December 2016 with positive test results for fentanyl, fentanyl analogs, and U-47700 in 10 states are described, and key demographic and overdose circumstance factors are stratified by substance. Full toxicology findings of decedents were reviewed, including the presence of heroin, cocaine, and methamphetamine. Because heroin involvement in overdose deaths is difficult to distinguish from prescription morphine, deaths in which heroin was confirmed by toxicologic findings were combined with deaths in which heroin was suspected because morphine was detected and death scene evidence suggested heroin use. The use of medical examiner/coroner reports, previously unavailable across states, provides unique insights into specific substances and circumstances associated with overdoses, which can inform interventions.

Fentanyl was detected in 56.3% of 5,152 opioid overdose deaths in the 10 states during July–December 2016 (Figure). Among these 2,903 fentanyl-positive deaths, fentanyl was determined to be a cause of death by the medical examiner or coroner in nearly all (97.1%) of the deaths. Northeastern states (Maine, Massachusetts, New Hampshire, and Rhode Island) and Missouri** reported the highest percentages of opioid overdose deaths involving fentanyl (approximately 60%–90%), followed by Midwestern and Southern states (Ohio, West Virginia, and Wisconsin), where approximately 30%–55% of decedents tested positive for fentanyl. New Mexico and Oklahoma reported the lowest percentage of fentanyl-involved deaths (approximately 15%–25%). In contrast, states detecting any fentanyl analogs in >10% of opioid overdose deaths were spread across the Northeast (Maine, 28.6%, New Hampshire, 12.2%), Midwest (Ohio, 26.0%), and South (West Virginia, 20.1%) (Figure) (Table 1).

Fentanyl analogs were present in 720 (14.0%) opioid overdose deaths, with the most common being carfentanil (389 deaths, 7.6%), furanylfentanyl (182, 3.5%), and acetylfentanyl (147, 2.9%) (Table 1). Fentanyl analogs contributed to death in 535 of the 573 (93.4%) decedents. Cause of death was not available for fentanyl analogs in 147 deaths.†† Five or more deaths involving carfentanil occurred in two states (Ohio and West Virginia), furanylfentanyl in five states (Maine, Massachusetts, Ohio, West Virginia, and Wisconsin), and acetylfentanyl in seven states (Maine, Massachusetts, New Hampshire, New Mexico, Ohio, West Virginia, and Wisconsin). U-47700 was present in 0.8% of deaths and found in five or more deaths only in Ohio, West Virginia, and Wisconsin (Table 1). Demographic characteristics of decedents were similar among overdose deaths involving fentanyl analogs and fentanyl (Table 2). Most were male (71.7% fentanyl and 72.2% fentanyl analogs), non-Hispanic white (81.3% fentanyl and 83.6% fentanyl analogs), and aged 25–44 years (58.4% fentanyl and 60.0% fentanyl analogs) (Table 2).

Other illicit drugs co-occurred in 57.0% and 51.3% of deaths involving fentanyl and fentanyl analogs, respectively, with cocaine and confirmed or suspected heroin detected in a substantial percentage of deaths (Table 2). Nearly half (45.8%) of deaths involving fentanyl analogs tested positive for two or more analogs or fentanyl, or both. Specifically, 30.9%, 51.1%, and 97.3% of deaths involving carfentanil, furanylfentanyl, and acetylfentanyl, respectively, tested positive for fentanyl or additional fentanyl analogs. Forensic investigations found evidence of injection drug use in 46.8% and 42.1% of overdose deaths involving fentanyl and fentanyl analogs, respectively. Approximately one in five deaths involving fentanyl and fentanyl analogs had no evidence of injection drug use but did have evidence of other routes of administration. Among these deaths, snorting (52.4% fentanyl and 68.8% fentanyl analogs) and ingestion (38.2% fentanyl and 29.7% fentanyl analogs) were most common. Although rare, transdermal administration was found among deaths involving fentanyl (1.2%), likely indicating pharmaceutical fentanyl (Table 2). More than one third of deaths had no evidence of route of administration.

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Discussion

This analysis of opioid overdose deaths in 10 states participating in the ESOOS program found that illicitly manufactured fentanyl is a key factor driving opioid overdose deaths and that fentanyl analogs are increasingly contributing to a complex illicit opioid market with significant public health implications. Previous reports have indicated that use of illicitly manufactured fentanyl mixed with heroin, with and without users’ knowledge, is driving many fentanyl overdoses, particularly east of the Mississippi River (3,4). Consistent with these findings, at least half of opioid overdose deaths in six of the seven participating states east of the Mississippi tested positive for fentanyl. Over half the overdose deaths involving fentanyl and fentanyl analogs tested positive for confirmed or suspected heroin (the most commonly detected illicit substance), cocaine, or methamphetamine. This supports findings from other reports indicating that fentanyl and fentanyl analogs are commonly used with or mixed with heroin or cocaine (3,4). Nearly half of overdose deaths involving fentanyl and fentanyl analogs, however, did not test positive for other illicit opioids, suggesting that fentanyl and fentanyl analogs might be emerging as unique illicit products.

Fentanyl and fentanyl analogs are highly potent and fast-acting synthetic compounds that can trigger rapid progression to loss of consciousness and death and thus might require immediate treatment and high doses of naloxone (5). Because of the potency of fentanyl and fentanyl analogs and the rapid onset of action, these drugs were determined by medical examiners and coroners to play a causal role in almost all fatal opioid overdoses in which they were detected. Injection, the most commonly reported route of administration in fatal overdoses, exacerbates these risks because of rapid absorption and high bioavailability. The high potency of fentanyl and fentanyl analogs, however, can result in overdose even when administered via other routes. Nearly one in five deaths involving fentanyl and fentanyl analogs had evidence of snorting, ingestion, or smoking, with no evidence of injection. Multiple overdose outbreaks and law enforcement drug product submissions across the country have reported counterfeit prescription pills laced with fentanyl and fentanyl analogs (10).

With few exceptions, fentanyl analogs are illicitly manufactured, because they do not have a legitimate medical use in humans.§§ The detection of fentanyl analogs in >10% of opioid overdoses in four states raises the concern that fentanyl analogs have become a part of illicit opioid markets in multiple states. The fentanyl analogs most commonly detected were carfentanil, furanylfentanyl, and acetylfentanyl. Carfentanil, which is intended for sedation of large animals, is much more potent than fentanyl, whereas furanylfentanyl and acetylfentanyl are less potent (9). Carfentanil contributed to approximately 350 overdose deaths in Ohio, but was detected in only one other state (West Virginia). Because of its extreme potency, even limited circulation of carfentanil could markedly increase the number of fatal overdoses. Recent data suggest that carfentanil deaths are occurring in multiple other states, including Kentucky, which reported 10 overdose deaths involving carfentanil in the second half of 2016 (Kentucky Department of Public Health, unpublished data, 2017) and New Hampshire, which reported 10 deaths in 2017.¶¶ Forty-six percent of SUDORS opioid overdose deaths involving fentanyl analogs tested positive for fentanyl or an additional fentanyl analog, ranging from 31% for carfentanil to 97% for acetylfentanyl. The increased mixing or co-use of fentanyl, heroin, cocaine, and varying fentanyl analogs might contribute to increased risk for overdose because persons misusing opioids and other drugs are exposed to drug products with substantially varied potency.

The findings in this report are subject to at least five limitations. First, results are limited to 10 states and therefore might not be generalizable. Second, the presence of fentanyl analogs is underestimated because commonly used toxicologic testing does not include fentanyl analogs, some fentanyl analogs are difficult to detect (9), and specialized testing for fentanyl analogs varied across states and over time. Third, the route of fentanyl and fentanyl analog administration must be interpreted cautiously because the data do not link specific drugs to routes of administration and thus the precise route of administration of fentanyl or fentanyl analogs cannot be determined in overdose deaths involving multiple substances (e.g., heroin and cocaine) and routes (e.g., injection and snorting). Fourth, the combination of deaths with toxicologic confirmation of heroin with those with detection of morphine and death scene evidence suggesting heroin use might have resulted in misclassification of some deaths. Finally, fentanyl source could not be definitively determined; however, only a small percentage of fentanyl deaths had evidence consistent with prescription fentanyl (e.g., transdermal use versus injection).

Illicitly manufactured fentanyl is now a major driver of opioid overdose deaths in multiple states, with a variety of fentanyl analogs increasingly involved, if not solely implicated, in these deaths. This finding raises concern that in the near future, fentanyl analog overdose deaths might mirror the rapidly rising trajectory of fentanyl overdose deaths that began in 2013 and become a major factor in opioid overdose deaths. In response to this concern, CDC expanded ESOOS to 32 states and the District of Columbia in 2017 and added funding for all 33 recipients to improve forensic toxicologic testing of opioid overdose deaths to include capacity to test for a wider range of fentanyl analogs.*** Increased implementation of evidence-based efforts targeting persons at high risk for illicit opioid use, including increased access to medication-assisted treatment, increased availability of naloxone in sufficient doses, and other innovative intervention programs targeting this group, is needed to address a large and growing percentage of opioid overdose deaths involving fentanyl and fentanyl analogs.

 

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Next Epidemic: Diabetes .. Family and emergency medicine Dr. Janette Nesheiwat discusses the rise of diabetes among Americans

Posted on November 17, 2017 by Pharmaciststeve

Diabetes rises to more than 100 million in the US, costing $850 billion per year globally

http://www.foxbusiness.com/features/2017/11/17/diabetes-rises-to-more-than-100-million-in-us-costing-850-billion-per-year-globally.html

The U.S. is dealing with a potential health epidemic as more than 114 million Americans are now living with diabetes or pre-diabetes, according to a report released by the Centers for Disease Control and Prevention (CDC).

Diabetes is the seventh-leading cause of death in the U.S. with nearly one in four adults living with diabetes, and 7.2 million Americans may not be aware they have the condition.

In an interview with FOX Business’ Trish Regan, Family & Emergency Medicine’s Dr. Janette Nesheiwat said sedentary lifestyles and unhealthy diets are contributing to the rapid increase in the number of people with diabetes in the U.S.

“Unhealthy foods is usually the contributing factor to diabetes and that’s because unhealthy living, unhealthy foods are cheap, fast and easy to get and it tastes good,” Dr. Nesheiwat said. “It tastes good because it’s loaded with chemicals and preservatives.”

The International Diabetes Federation reports that the number of people living with diabetes worldwide has tripled since 2000, costing $850 billion annually.

According to the CDC, Type 2 diabetes accounts for 90% to 95% of all diabetes cases and is linked to obesity and an inactive lifestyle.

“It is a little bit more difficult to eat healthier because you have to plan in advance, but that’s just a lifestyle change … that you have to make in order to live longer because our health habits now, our lifestyle now plays a role in how long we live,” Dr. Nesheiwat said.

November is National Diabetes Awareness Month.

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Former FDA Commissioner Testifies in Pennsylvania Xarelto Lawsuit, Says Safety Warnings Were Inadequate

Posted on November 17, 2017 by Pharmaciststeve

Former FDA Commissioner Testifies in Pennsylvania Xarelto Lawsuit, Says Safety Warnings Were Inadequate

https://www.rxinjuryhelp.com/news/2017/11/17/former-fda-commissioner-testifies-in-pennsylvania-xarelto-lawsuit-says-safety-warnings-were-inadequate/

A Indiana woman who allegedly suffered a serious gastrointestinal bleed due to Xarelto continued to present her case this week in the Philadelphia Court of Common Pleas, where Pennsylvania’s first trial involving the blooding thinner is currently underway.

On Tuesday, a former U.S. Food & Drug Administration (FDA) commissioner testifying on her behalf told the assembled jury that Xarelto’s warning labels were inadequate, asserting that they downplayed the potential for internal bleeding that had been observed in the drug’s clinical trials.

Dr. David Kessler: Xarelto Label Downplayed Bleeding Risk

Most of  Dr. David’s Kessler’s’ testimony focused on the ROCKET-AF study, which was key to Xarelto’s FDA approval in October 2011. Though the results from the trial showed a 3.6% rate of a bleeding event among Xarelto users globally, patients in the U.S. experienced bleeding side effects at a rate exceeding 8%.

Kessler, who served as FDA commissioner during both the George H.W. Bush and Bill Clinton administrations, criticized Bayer and Janssen Pharmaceuticals for failing to inform U.S. doctors of the findings.

“It’s important information to me,” he said. “I would want to know about it. It’s a clinically significant adverse event, it’s a demographic characteristic, and it should be in the label.”

Xarelto Lawsuit Plaintiff Underwent Transfusions for Gastrointestinal Bleed

More than 1,800 Xarelto lawsuits have been consolidated in a mass tort program now underway in the Philadelphia Court of Common Pleas. The case currently at trial was filed on behalf of an Indiana woman who took Xarelto for just over a year before she experienced a gastrointestinal hemorrhage. According to her complaint, the plaintiff spent four days in the hospital and underwent two blood transfusions while her doctors tried to find the source of her bleeding.

Nationwide, Bayer and Janssen are named defendants in more than 21,000 Xarelto lawsuits, all of which accuse the companies of downplaying the risk of internal bleeding and wrongly promoting it as a superior alternative to a much older blood thinner called warfarin.

While both warfarin and Xarelto can cause dangerous episodes of internal bleeding, warfarin-related hemorrhaging can be stopped via the administration of vitamin K. However, there currently exists no FDA- approved antidote to stop bleeding events linked to Xarelto.

The majority of U.S. Xarelto lawsuits are pending in the U.S. District Court, Eastern District of Louisiana, where all federally-filed product liability claims involving the blood thinner have been centralized for coordinated pretrial proceedings. So far, that litigation has convened three trials, all of which were decided for the defense.

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The Pain Pendulum

Posted on November 17, 2017 by Pharmaciststeve


The Pain Pendulum

http://abc7chicago.com/health/the-pain-pendulum/2654223/

CHICAGO (WLS) —

Imagine being in excruciating pain and not being able to get the relief you need, or any relief at all. Patients suffering from chronic pain say while the country is taking steps to battle the opioid epidemic, they are being victimized.

Sufferers of chronic pain told the I-Team the national crackdown on opioids is affecting their ability to get the narcotic medication they have been using effectively and responsibly for years, and they are scared.

Maria Pollock suffers from a connective tissue disorder called Ehlers-Danlos Syndrome. She said she’s been diagnosed with a genetic polymorphism, a condition that makes her resistant to many pain medications.

Pollock said the opioid drug that worked for her has been taken off the market due to abuse concerns. Now she’s having trouble finding a pain specialist willing to take her on as a patient.

Annette Delgado battles crippling pain attacks brought on by sickle cell disease. She sees a team of sickle cell experts at the University of Illinois Hospital in Chicago. Delgado said doctors there are doing their best to keep her pain in check, but said the long-acting morphine that keeps her functioning is now being denied by insurance.

Jenni Grover, an ambassador for the U.S. Pain Foundation and a chronic pain advocate, said the stories of desperation she hears are heartbreaking. She said patients tell her they’re being treated as if they are criminal drug addicts, and doctors are abandoning them because of new regulations and possible scrutiny by the medical community and federal regulators.

Grover, who also runs the website ChronicBabe.com, said many in the pain community are reporting their doctors are either refusing to prescribe opioids or notifying them that they will no longer be patients in their practice. She said this is a challenging and complicated issue for millions of people in the United States.

State and federal leaders, as well as medical practitioners and other providers, are using multiple strategies to address the opioid crisis; curtailing the opioid supply is one of them. Drug abuse experts say between 2001 and 2011 there was a huge increase in prescriptions for drugs such as morphine, codeine and hydrocodone. They say these pills flowed too freely to the wrong kind of patient, causing unnecessary and deadly addictions and helping fuel the drug epidemic.

Government data shows the number of prescriptions written for opioids has been falling since 2012.

The Centers for Disease Control and Prevention produced guidelines in 2016 recommending shorter durations for opioid prescriptions and the use of non-drug treatment for pain.

CLICK HERE for the CDC’s 2016 opioid guidelines

Some physicians insist opioids are not the best choice for chronic pain even if they seem to work. They said prescribing practices need to be re-balanced, but even as they try to address the problem they are also facing a troubling backlash.

Police said this past July in Mishawaka, Ind., Michael Jarvis became enraged when Dr. Todd Graham, a Northwestern Medicine graduate and physical medicine and rehabilitation specialist, refused to prescribe opioids to Jarvis’s wife for back pain relief. Police said Jarvis gunned down Dr. Graham before taking his own life.

Now federal agencies, lawmakers, even corner drug stores are putting opioid guidelines and restrictions in place.

New analysis from the National Conference of State Legislatures shows 24 state governments taking action.

CLICK HERE for the NCSL analysis

Most of the legislation limits first-time prescriptions to seven days. Some states are also setting dosage limits. As of right now, Illinois has no mandated restrictions.

The president of the Illinois State Medical Society said the group will continue to lobby against regulation.

But, Dr. Kern Singh, a spinal surgeon with Midwest Orthopaedics at Rush University Medical Center, said the reality is it’s very difficult to get insurance coverage for the non-narcotic, safer alternative treatments because they are so expensive.

Working with other pain specialists at Rush, he said they have created an effective approach to surgical pain that uses fewer opioids, but is frustrated because most insurance companies refuse to cover the safer, more expensive medication.

In the meantime desperate chronic pain patients can only wonder what they will have to resort to if they’re left with no options.

In a statement America’s Health Insurance Plans, an association representing the health insurance community, said, “Health insurance providers will continue to work with doctors, hospitals and state and local leaders to provide people with better pathways to healing – without putting their lives in danger because of opioids.”

Last week the Illinois Legislature passed a measure that would require medical providers to check the state’s Prescription Monitoring Program before writing an opioid prescription. Supporters said it’s designed to make it harder for patients to obtain prescriptions from multiple doctors, a practice known as doctor shopping.

FULL STATEMENT FROM THE AHIP

I think we can all agree that we’re dealing with a very serious, very pervasive epidemic in this country. Every 2.5 weeks we lose as many lives as we did during the attacks on September 11th as a result of the opioid crisis. America’s health insurance providers have been on the front lines of this emergency for some time and have seen firsthand the harm and disruption it has caused to their customers, their families and their communities.

No one should live with the consequences of opioid addiction. But no one should have to live with pain either. Health plans work closely with doctors and nurses on the safest, most proven, and most effective approaches to pain management. This includes practicing more cautious opioid prescribing, limiting overall dosages, and identifying alternative forms of pain management. Further, plans are encouraging the use of evidence-based care through medical management practices including non-narcotic medications, which research has shown can provide just as much relief as opioids. Many are also exploring and improving access to non-pharmacologic pain treatments that have been proven effective in reducing pain, depending on the individual (e.g., cognitive therapy, acupuncture, etc..). However, it’s important to note that treating pain is not a one-size fits-all – every patient is different and every situation is different.

AHIP and its member plans will also continue to support and promote the CDC Guidelines for Prescribing Opioids for Chronic Pain. These Guidelines articulate when and how to prescribe opioids – which include prescribing non-opioid treatments first, limiting both the dosage and the duration of prescription opioids, and reviewing a patient’s medical history to look for risks of addiction. AHIP also recently launched a new Safe, Transparent Opioid Prescribing (STOP) Initiative, — an industry-wide commitment to ensuring wide-spread adoption of these guidelines. The Initiative includes the introduction of the STOP Measure, which will enable health plans and providers to work together to more effectively improve adherence with the CDC Guidelines, significantly improving patient safety and reducing the risk of opioid misuse.

Health insurance providers will continue to work with doctors, hospitals, and state and local leaders to provide people with better pathways to healing – without putting their lives in danger because of opioids.

We have several resources on this issue, including our work with the President’s Commission on Combatting Drug Addiction and the Opioid Crisis: https://www.ahip.org/issues/opioids/

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Search Warrant for Dr Tennant’s office

Posted on November 16, 2017 by Pharmaciststeve

17-MJ-02867 (Application For SW) (1)

click on above link for all 78 pages

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44state AG’s: want cpp to SUFFER.. REPEAL Ensuring Patient Access and Effective Drug Enforcement Act ?

Posted on November 16, 2017 by Pharmaciststeve

44 state AGs ask Congress to repeal law favoring drug companies

http://www.jurist.org/paperchase/2017/11/44-state-ags-ask-congress-to-repeal-law-favoring-drug-companies.php

Attorneys general from 44 states on Tuesday signed a letter [text, PDF] asking Congress to repeal the Ensuring Patient Access and Effective Drug Enforcement Act [text, PDF], which they claim prevents the Drug Enforcement Agency (DEA) from using effective drug enforcement efforts.

The National Association of Attorneys General sent the letter to Republican and Democratic leaders in light of an investigation earlier this year that revealed the disabling effects of the Act on the DEA in preventing pharmaceutical companies from “spilling [WP report] prescription narcotics onto the nation’s streets.” The letter cites to federal laws affected by the Act and explains the Act’s affect on the DEA’s most important tool:

In the midst of this deepening public health crisis—at a time when our nation needs every available weapon at its disposal to combat the opioid epidemic—the Act effectively strips the Drug Enforcement Administration of a mission-critical tool, namely, the ability to issue an immediate suspension order against a drug manufacturer or distributor whose unlawful conduct poses an imminent danger to public health or safety.

Reports concerning the investigation were especially startling, considering Congress unanimously consented and “approved the law last year without a vote in either chamber” [WP report].

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AHA, ACC release new clinical guideline for managing hypertension in adults

Posted on November 16, 2017 by Pharmaciststeve

AHA, ACC release new clinical guideline for managing hypertension in adults

http://www.clinicaladvisor.com/cardiovascular-disease-information-center/almost-half-of-us-adult-population-now-hypertensive/article/707709/

The American Heart Association (AHA) and the American College of Cardiology (ACC) have released a new clinical practice guideline on managing high blood pressure in adults, redefining hypertension as 130 mm Hg/80 mm Hg from the previous 140 mm Hg/90 mm Hg.

With this new definition of hypertension, approximately 14% more US adults are categorized as hypertensive (from 32% to 46%).

 Paul Whelton, MD, writing committee chair, and his associates at AHA and ACC noted that one in five of the newly hypertensive patients will need medical treatment. The practice guideline focuses mainly on assisting healthcare professionals to help patients assess their risks and the preventive measures they can take against serious health issues.

The new guideline, published in the Journal of the American College of Cardiology and in Hypertension, divides systolic blood pressure (SBP) and diastolic blood pressure (DBP) into categories, giving patients a more specific definition of hypertension and the associated recommendations:

  • Normal BP is defined as <120 mm Hg/<80 mm Hg. According to the guideline, this group of patients practices healthy living styles and should have yearly checks to monitor their BP. 
  • Elevated BP is defined as 120 to 129 mm Hg/<80 mm Hg. This group is advised to make healthy changes in lifestyle and to reassess their BP in 3 to 6 months.
  • High BP is subcategorized into two stages:
    • Stage 1: BP ranging from 130 to 139 mm Hg/80 to 89 mm Hg. Clinicians must assess 10-year heart disease and stroke risk. If the risk is <10%, the patient is highly encouraged to make immediate lifestyle changes, including medication with follow-ups until the BP is well-controlled.
    • Stage 2: BP ≥140 mm Hg/≥90 mm Hg. Clinicians must stress lifestyle changes with 2 different classes of medications and monthly follow-ups until BP is well-controlled. Healthy life choices, according to the guideline, include quitting smoking, moderating alcohol consumption, increasing physical activity, and maintaining a healthy diet. Healthy life choices might also include medication and taking additional preventive risks for patients with higher, uncontrolled BP.

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DEA: alleges that Tennant prescribed such high doses of opioid pain medication that his patients could not possibly survive and that they must be selling them

Posted on November 16, 2017 by Pharmaciststeve

DEA Raids Dr. Forest Tennant’s Pain Clinic

https://www.painnewsnetwork.org/stories/2017/11/16/dea-raids-forest-tennants-pain-clinic

Agents with the Drug Enforcement Administration have raided the offices and home of Dr. Forest Tennant, a prominent California pain physician, confiscating all of his patient records, appointment books and financial documents.

In a 67-page search warrant, the DEA alleges that Tennant prescribed such high doses of opioid pain medication that his patients could not possibly survive and that they must be selling them.  It also alleges that Tennant took financial kickbacks from Insys Therapeutics, a controversial Arizona drug maker that is under federal investigation.

“It’s very lengthy and it goes into things in my past which are totally irrelevant but are obviously designed to smear me and make me look like a bad person. I see what they’re doing,” Tennant told PNN.

dr. forest tennant (courtesy montana public radio)

dr. forest tennant (courtesy montana public radio)

Tennant, who has not been charged with a crime, believes the raid is part of a broader effort to smear not only his reputation, but to discredit and intimidate other doctors who prescribe opioids to pain patients.  

“They’re not just going after me, they’re going after patients,” said Tennant. “I think the country better understand what they’re doing here. They’re saying that regulations don’t count, standards don’t count, and they’ll decide who can get drugs and how much.

“I’d be worried about every pain patient right now, not just mine.”

Tennant is a revered figure in the pain community because of his willingness to see patients with intractable chronic pain who are unable to find effective treatment elsewhere or have been abandoned by their doctors. At 76, Tennant could have retired years ago, but he regularly sees about 120 patients at his small pain clinic in West Covina, California. Many travel from out-of-state and some are in palliative care.  

Tennant, along with his wife and office manager, Miriam, jokingly refers to his clinic as a “mom and pop” operation, although in actuality he practices on the frontlines of pain management and has developed treatments for difficult and incurable conditions such as adhesive arachnoiditis, Ehlers-Danlos syndrome and Reflex Sympathetic Dystrophy (RSD).

Those treatments sometimes require high doses of opioid pain medication, but they also include hormone replacement, anti-inflammatory drugs and other therapies that help patients reduce their use of opioids. Tennant says he carefully screens all of his patients and follows all regulations.

“I understand what they’re after. They figure if they go after the big guy, then no one will prescribe,” he said. “If they’re going to hurt me, no doctor is going to be willing to prescribe or do anything. That’s what they’re attempting to do. They’re attempting to neutralize me if they can. And I think there needs to be an outcry.

“The time has come. Is this country going to treat pain patients or not? Are they going to let people die in pain or are they not?”

Ironically, the raid on Tennant’s clinic occurred on Monday, the same day he was testifying in Montana as a defense witness in the trial of another doctor accused of negligent homicide in the overdoses of two patients.

“It seems like a coincidence, doesn’t it?” Tennant said.

Insys Payments

Tennant acknowledges getting about $126,000 from Insys Therapeutics, payments that were primarily for speaking at events sponsored by the company.

Insys makes an oral spray called Subsys that contains fentanyl, a potent synthetic opioid. Subsys is only approved for the treatment of cancer pain, but Insys aggressively marketed Subsys to have doctors prescribe it “off label” to treat other pain conditions, allegedly resulting in hundreds of overdose deaths.

Several company officials, including Insys’ billionaire founder, have been indicted on federal charges that they bribed doctors with kickbacks and lucrative speaker fees in order to promote Subsys.  

Tennant says he stopped taking payments from Insys in 2015 and was dropped from the company’s speaker’s bureau last year.

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“What money we did make, we put in the clinic and used it to support the patients,” he said.

Tennant says he can still operate his clinic, but has been informed by the DEA that his charts and patient records will not be returned directly to him. Tennant is asking all of his patients to contact the DEA and request a copy of their medical records so that he can continue treating them. 

The DEA’s contention that Tennant’s patients are selling their opioid medication is preposterous, according to 64-year old Gary Snook, a Montana man who lives with adhesive arachnoiditis, a painful inflammation in his spinal nerves.

“The last thing I’m going to do is sell my medication,” says Snook, who was on an extremely high dose of opioid medication before he started seeing Tennant. “Dr. Tennant has me on such a low dose that I’m just barely getting through the month anyway. I don’t have any to sell.  

“He’s actually been able to lower my dose by about 80 percent, with his hormone therapy and stuff. I’m afraid these guys are sadly mistaken because he’s been moving patients in the opposite direction than they’re suggesting.”

Snook has a genetic condition that makes him a “high metabolizer” of opioids – meaning he has to take a high dose to get any kind of pain relief. His current daily dose is still about three times more than the highest amount recommended by the CDC.

 “I’m not selling mine. I’m just taking it to survive because it’s the only thing that works for my pain. I’ve tried all the modalities and unfortunately this is the only thing that works,” Snook said.

For the record, Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

 

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Mortality Rates for Overdose Patients Who Refuse Transport

Posted on November 14, 2017 by Pharmaciststeve

http://www.jems.com/articles/print/volume-42/issue-11/departments/street-science/mortality-rates-for-overdose-patients-who-refuse-transport.html

What’s the mortality rate for patients who receive naloxone and then refuse transport?

The Research

Levine M, Sanko S, Eckstein M. Assessing the risk of prehospital administration of naloxone with subsequent refusal of care. Prehosp Emerg Care. 2016;20(5):566-569.

The Science

The authors of this study reviewed a three-year period (July 1, 2011, to Dec. 31, 2013) for all patients who received naloxone (Narcan) by EMS providers with the Los Angeles Fire Department, and who subsequently refused additional medical care and were released at the scene.

They examined the coroner’s records to determine if any of these patients died within 24 hours, 30 days, or six months of their EMS encounter.

Of the 205 cases identified, the median age was 41 and 13% were female. Only one subject died within 24 hours of EMS care. The cause of death was coronary artery disease and heroin use. Two died within 30 days, one from coronary artery disease and cirrhosis and the other from unknown causes.

The authors conclude, “The practice of receiving prehospital naloxone by paramedics and subsequently refusing care is associated with an extremely low short- and intermediate- term mortality.”

Medic Wesley Comments

This study was published March 28, 2016. The data obtained was from 2011-2013. Oh, how quickly things change in the drug trade. The Centers for Disease Control (CDC) reported the number of opioid-related deaths in 2014 was a 9% increase from the previous year.1 The illegal drug trade changes every day. More potent forms of opioids are being manufactured, and with that, more deaths occur.

Releasing patients after administration of naloxone is a risk. The trend in this country is to blame someone else for our own bad choices and consequences-and to a certain degree, that liability rests with us, the healthcare professionals who had an opportunity to intervene and get these victims the help they need.

Once a patient is brought back to a functional respiratory status, or in some protocols, brought into consciousness, the patient is still at risk of relapse. Because the drug will outlast the antidote, the patient can’t be deemed competent or have the capacity to make a rational judgment.

The “treat and street” method works for some calls; however, there are just too many unknowns to say it’s a safe practice in today’s illicit drug use.

Don’t get me wrong. I understand that there aren’t enough resources to transport every drug overdose or to house those making reckless decisions. However, there are enough groups that think drug users are a vulnerable class, and therefore it’s public safety’s responsibility to rescue those individuals from the edge of death, at any cost. There are many in the legal profession willing to take this issue to court at the expense of your agency.

Rely on medical direction to see you through these cases, and make decisions in the best interest of the patient. The fact that a patient made a dangerous decision doesn’t relieve us from our professional and ethical duty to be a patient advocate.

Doc Wesley Comments

I agree with Medic Wesley that a “treat and street” approach may represent increased liability. Unfortunately, there’s no data to support that claim. I agree that this paper may not address the possible effects of significantly more powerful opiates such as carfentanyl, since it and other opiates didn’t become prevalent until after the study period reviewed by the authors.

It would be interesting to learn what percentage of known carfentanyl overdoses are returned to a clinically sober condition after naloxone administration. My experience has been that their respiratory status is improved, but they’re neither awake nor clear-headed enough to ambulate without assistance and competently refuse care.

Our EDs are sinking under the overwhelming amount of patients with drug, alcohol and mental illness. I understand the pressure that society places on us to protect them from themselves, but we have to stop trying to save everyone and concentrate on those that want help.

Those that want help will take it when offered. We live in a society that places the highest priority on patient autonomy; we’ve accepted standards to test the competency of a person who may be under the influence of drugs or alcohol. If this paper does anything, it should cause you to review your policies and determine if you’re meeting that standard when you release these patients from the scene.

 

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