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Party drug ketamine closer to approval for depression

From CNN:

The Food and Drug Administration put the experimental drug esketamine (also known as ketamine) on the fast track to official approval for use in treating major depression, Janssen Pharmaceutical announced Tuesday. This designated "breakthrough therapy" would offer psychiatrists a new method for treating patients with suicidal tendencies and would qualify as the first new treatment for major depressive disorder in about half a century.

In some quarters, though, this potentially effective medicine can't escape its reputation as "Special K," a street drug known for producing a high similar to an out-of-body experience -- and sometimes used as a date rape drug.

Ketamine was first synthesized in 1962 by Calvin Stevens at Parke Davis Laboratories, according to Encyclopedia Britannica. It received FDA approval for use in humans in 1970, and shortly after, Army doctors used the drug on American soldiers fighting in Vietnam as an analgesic and sedative. Yet its minor hallucinogenic side effects soon warned doctors off treating people. Today, ketamine's most common use is as a veterinary anesthetic.

A concern with using ketamine to treat depression is that it can reverse tolerance to opioids, Coffman said. Essentially, patients will get a higher dose of pain medicines, she explained, so any psychiatric uses would require "close oversight" by a multidisciplinary team of doctors.
Iosifescu said the short-term effects are known, but the long-term effects remain mysterious.
 
Another concern is the similarity between prescription ketamine and the street drug, a substance of abuse.

These are all reasons why Janssen's formulation will be provided and administered in doctors' offices or clinics, not distributed by pharmacies.
Posted: 8/22/2016 10:21:00 AM

Tags: , , , ,

New Webinar- “Flakka”: The Truth Behind the Latest Designer Drug Media Storm

From: NMS Labs

Donna Papsun, a forensic toxicologist at NMS Labs, will be hosting a free webinar on Flakka, the new dangerous designer drug that is taking the country by storm.  "Flakka” is the latest street name referring to alpha-pyrrolidinophenone (alpha PVP), a novel psychoactive substance that has been on the recreational drug market since 2012.  Former street names include “Gravel”, which was allegedly alpha PVP mixed with lorazepam, and “Bath Salts”, a catch-all term referring to a number of synthetic stimulants.  This webinar will focus on the toxicology of alpha PVP and highlight the prevalence of this drug by recreational users.  Although the abuse of alpha PVP is not new, it is certainly a designer drug trend that deserves the attention of public health authorities, law enforcement, medical examiners, and toxicology laboratories. 

Register today and learn more about Flakka, Alpha PVP, and other novel psychoative substances as well as how they are effecting the world of toxicology.  The webinar will be held Monday, June 1st at 1pm and will last roughly a half hour.  You can register for the free webinar here

 

Researchers document drug use among Ultra Music Festival attendees

From: Miami Herald

Fair or not, after 16 years Ultra Music Festival has developed a reputation not only as a cornucopia of lights and sounds, but also as a smorgasbord of psychotropic uppers and downers.  But according to a federally funded study, if you ask 100 audience members to pee in a cup in exchange for a $20 Dunkin’ Donuts gift card, 80 just might test positive for drugs.

At least, researchers from the Center for Forensic Science Research & Education said that was their experience last year when they set up camp outside Bayfront Park and sought to document drug use among the thousands of ticket holders who flock to downtown Miami each year for three days of electronic dance music. The event typically sells more than 160,000 tickets.

Out of 145 voluntary participants, 72 percent admitted to having consumed marijuana, cocaine, molly or ecstasy during the past week. And for the 100-plus brave souls who went a step further and agreed to have their blood taken, or give a urine sample, researchers said they found that 58 percent and 80 percent, respectively, had recently consumed designer drugs.

The goal of the study, according to a summary of the results, was not to find out how many at Ultra are on drugs, but to get a better grasp of “some of the newly emerging and potentially dangerous new drugs popular in the [electronic dance music] community.”

“We found the participants at the event were very open with us about their knowledge of the drug scene and drug use,” said Barry Logan, the Pennsylvania-based center’s executive director. “We found a lot of the time what they thought they were taking was not what they were taking.”

Of the 104 urine samples, more than 80 percent tested positive for a synthetic drug, most commonly molly, followed by Alpha-PVP, a synthetic bath salt known as gravel, which ultimately killed 21-year-old Adonis Peña Escoto last year.

However, Logan said the survey was conducted with far too small a sample size — less than one tenth of a percent of the tickets sold for the festival — to be taken as any kind of statistical representation of the drug use at Ultra.

“A lot of people who read this assume it’s an indicator of prevalence, which I don’t think it is,” said Logan.

Now in its 16th year, Ultra is returning to downtown Miami in late March as an 18-and-older festival.


Read more here: http://www.miamiherald.com/news/local/community/miami-dade/article9709724.html#storylink=cpy

Drugged Driving Increases While Drunk Driving Decreases

From: Insurance Journal

The nation’s decades-long campaign to combat drunk driving continues to make our roads safer, but use of marijuana and prescription drugs is increasingly prominent on the highways, creating new safety questions, according to two studies released by the Department of Transportation’s National Highway Traffic Safety Administration.

One study, the latest version of NHTSA’s Roadside Survey of Alcohol and Drug Use by Drivers, found that the number of drivers with alcohol in their system has declined by nearly one-third since 2007, and by more than three-quarters since 1973.

But the same survey found a large increase in the number of drivers using marijuana or other illegal drugs. In the 2014 survey, nearly one in four drivers tested positive for at least one drug that could affect safety.

A one-third reduction in alcohol use over just seven years “shows how a focused effort and cooperation among the federal government, states and communities, law enforcement, safety advocates and industry can make an enormous difference,” said NHTSA Administrator Mark Rosekind.

However, Rosekind said, the survey raises “significant questions about drug use and highway safety. The rising prevalence of marijuana and other drugs is a challenge to everyone who is dedicated to saving lives and reducing crashes,” said NHTSA Administr

The reports are consistent with another study released in June by Public Health Reports. This study found that since 1993, the profile of a drugged driver has changed substantially. More drivers are now testing positive for prescription drugs, cannabis, and multiple drugs, and they are more likely to be older than 50.

“While we’ve seen a decrease over the years in motor vehicle fatalities involving people under the influence, the nature of those crashes is changing,” said the Public Health Reports study author, Fernando Wilson, PhD, associate professor at the University of Nebraska Medical Center.

Wilson found that the percentage of drugged drivers with three or more drugs in their system nearly doubled from 1993 to 2010, increasing from 11.5 percent to 21.5 percent.

Learn more about drugged driving and state-by-state impared driving laws at StopDUID.org


NMS Labs Recognizes an Increase in Heroin and Fentanyl use

From:

In recent years there has been a sharp rise in heroin use and heroin overdoses. According to recent data from the National Institute on Drug Abuse (NIDA), a rise in heroin abuse in the United States has been associated with an increase in fatal overdoses. Furthermore, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued an alert about an increase in deaths related to the use of heroin laced with fentanyl.

Fentanyl is a powerful painkiller that is reported to be up to 100 times more potent than morphine, an active ingredient in heroin. Law enforcement from across the country have started to notice that some of the heroin they’ve seized has been laced with the painkiller, fentanyl. Heroin laced with fentanyl is a deadly mixture, especially since most users are unaware that the heroin has been tainted.

This is a significant public health concern. Many users unknowingly inject this potent drug combination and overdose as a result. For those lucky enough to make it to the hospital, treatment may come too little too late. Since most hospitals don’t screen for fentanyl, medical staff may believe that they are only treating a heroin overdose which is usually easier to reverse. More attention needs to be brought to the issue of fentanyl-laced heroin before it becomes a greater epidemic. Additionally, there is evidence that in some cases the heroin being sold is pure fentanyl without any heroin.

In reviewing our results for drug trends, we have found fentanyl to be more prevalent than ever before.

“After seeing the trend of increasing fentanyl use, we knew the best thing to do was to include fentanyl detection to all of our postmortem panels,” Said Dr. Barry Logan, Chief of Forensic Toxicology at NMS Labs.

In just 90 days we saw 88 cases positive for both fentanyl and 6-acetylmorphine (a unique metabolite of heroin) from across the country. You can view a chart of our findings along with a full report here.

Heroin Deaths Double in the Past Two Years

From: Bloomberg News

The number of Americans dying from heroin overdoses doubled across 28 states in 2012 from 2010, according to the Centers for Disease Control and Prevention, fueled by easy access and rising rates of opioid addiction.

The unusual analysis published today in the CDC’s weekly bulletin stemmed from the agency’s effort to determine if reports from some states about spikes in heroin use and related deaths since 2010 were part of a larger nationwide trend. They found a growing problem with fatal overdoses of heroin.

Health officials have focused in recent years on reducing abuse of prescription opioid painkillers, such as OxyContin. Overdoses of those medicines quadrupled from 1999 through 2010, while heroin, a cheaper and more available alternative, increased by less than 50 percent. The report confirms heroin has made a comeback in 28 states, as noted by Vermont Governor Peter Shumlin who said in January his state was in a “full-blown heroin crisis.”

Deaths from heroin overdoses rose across the board: in both genders, all ages, all racial and ethnic groups and all regions of the country, the CDC report found.

“The findings indicate a need for intensified prevention efforts aimed at reducing overdose deaths from all types of opioids,” the report found. “Efforts to prevent expansion of the number of opioid pain reliever users who might use heroin when it is available should continue.”

Death Toll

There were 3,635 heroin deaths in 2012, an increase from 1,779 two years earlier. While the crackdown on opioid abuse may have led users to heroin, painkillers are still more deadly. Opioid overdoses killed 9,869 Americans in 2012, down 5.4 percent from 2010.

Additional data suggests that prescription painkillers may be a gateway drug to heroin use, the report said. Three-quarters of patients in a rehabilitation program who started using heroin after 2000 said the first opioid they took was a prescription medication. More than 80 percent of people who began using heroin in the 1960s said they started with the drug.

“Reducing inappropriate opioid prescribing remains a crucial public health strategy to address both prescription opioid and heroin overdoses,” said CDC Director Thomas Frieden. “Addressing prescription opioid abuse by changing prescribing is likely to prevent heroin use in the long term.”
 

DEA Further Restricts Hydrocodone Combination Products

From: Medscape

The US Drug Enforcement Administration (DEA) voted today (Aug 21) to move forward with rescheduling hydrocodone combination products (HCPs) from schedule III to schedule II drugs. Schedule II medications are considered to be the most potentially harmful and open to abuse.

In addition to containing hydrocodone, HCPs also contain nonnarcotic substances such as aspirin or acetaminophen. Although hydrocodone by itself is classified as a schedule II drug, HCPs have been in the schedule III classification ever since the Controlled Substances Act (CSA) was first passed by Congress back in 1971.

"Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS,...the DEA finds that these facts and all other relevant data constitute evidence of potential for abuse of HCPs," write the DEA in their final rule.

"As such, the DEA is rescheduling HCPs as a schedule II controlled substance under the CSA," they add.

Substantial Feedback

HCPs are currently approved for marketing for the treatment of pain and for cough suppression.

The DEA published its formal proposal in February and asked for feedback, which could be given until April 28. The organization received 573 comments, of which 52% supported the recommended rescheduling, 41% opposed, and 7% did not voice a definitive opinion.

Patrick Morrisey, the attorney general from West Virginia, the state with the highest per capita rate of prescription drug overdoses in 2013, was among those who wrote in support of the rescheduling.

"This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers, it is necessary to combat the drug abuse epidemic that is destroying so many...communities," wrote Morrisey.

"Rescheduling hydrocodone is one way to help prevent this drug from falling into the wrong hands and will ensure that these drugs are handled with the same precautions as other pain medications, such as oxycodone, hydromorphone, and fentanyl," he added in a release.

Also falling under the schedule II classification are illegal substances, such as methamphetamine and heroin, and prescribed medications, such as dextroamphetamine sulphate (Adderal, Teva Pharmaceuticals).

Once the final rule goes into effect, anybody who handles HCPs will be subject to the CSA's schedule II regulatory controls. This will include "administrative, civil, and criminal sanctions applicable to the manufacture, distribution, dispensing, importing, exporting, engaging in research, conducting instructional activities, and conducting chemical analysis" of these substances.

In addition, any individual who handles or desires to hand HCPs will need to register with the DEA.

The final rule will be published in the Federal Register on August 22, 2014.