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The Association of Arkansas Counties have now joined in the lawsuit

By: Scott Carroll, Janelle Lilley (KATV Ch. 7 News) www.katv.com

LITTLE ROCK (KATV) — The Association of Arkansas Counties on Thursday afternoon became the second statewide group to file a federal lawsuit against opioid manufacturers and distributors over how the companies market and sell the drugs. 

The group joins the Arkansas Municipal League in suing the companies. Both organizations have accused the companies of downplaying the risks of opioids, particularly addiction, and exaggerating the benefits of the drugs.

They used false data and bad information to market to doctors that opioids were now safe for long-term treatment,” said AAC Executive Director Chris Villines.

The groups claim those practices have created a public health crisis in Arkansas and across the country that has led to physical harm and financial ruin for countless opioid users.

“For years, we’ve been paying local tax money to help handle overcrowded jails, overcrowded hospitals, put more deputies on the streets, so it’s really stretched the means of these counties to razor-thin layers,” Villines said.

Thirteen opioid manufacturers and distributors are listed as defendants in the lawsuits. Among the companies are Johnson & Johnson; Purdue Pharma; McKesson Corporation; Cardinal Health; Belgium-based Janssen Pharmaceuticals Ireland-based Activis Pharma.

In addition to the AAC’s lawsuit in federal court, Villines said Arkansas’ 75 counties will each file suit in their respective circuit court and will seek punitive damages specific to their county. He said AAC has hired a law firm from Alabama with experience in these cases to help the counties manage the lawsuits.

The suit says drug manufacturers “falsely and misleadingly” marketed opioids and persuaded doctors to over-prescribe the drugs through “front groups,” seemingly independent medical organizations that were actually paid by the drug-makers, and a small circle of influential and pro-opioid doctors known as “key opinion leaders.”

The Arkansas Municipal League compared the companies’ tactics to those of tobacco companies. The group, which represents more than 400 cities and towns in Arkansas, filed suit in U.S. District Court for the Eastern District of Arkansas earlier this week. It voluntarily dismissed, or withdrew, that lawsuit on Wednesday for a technical reason, but the municipal league plans to re-file the lawsuit in federal court.

The Healthcare Distribution Alliance, a national group that represents some of the distributors named as defendants, said in a statement Thursday that the companies are “deeply engaged in the issue and are taking our own steps to be part of the solution – but we aren’t willing to be scapegoats.”

“We don’t make medicines, market medicines, prescribe medicines, or dispense them to consumers,” John Parker, the group’s senior vice president, said in the statement. “Given our role, the idea that distributors are solely responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and how it is regulated.”

Drug-makers have denied wrongdoing in similar lawsuits.

Chicago, Seattle and Indianapolis are among the municipalities that have sued opioid manufacturers in recent years, according to reports.

Arkansas has the second-highest opioid prescription rate in the country, according to the U.S. Centers for Disease Control and Prevention. The agency reported the rate to be 114.6 opioid prescriptions per 100 people. The national average is 66.5 prescriptions per 100 people.

Villines said the drugs have been over-prescribed.

“They went way beyond what a normal opioid prescription had been prior to that and started marketing, I’ve heard from some of our coroners, up to 90-day supplies of opioids have been given out,” he said. “And the research that we’ve seen shows that you can be addicted to opioids in as little as five days.”

There were about 108 opioid-related deaths in Arkansas last year, according to the Arkansas Department of Health.

DEA wins national award for its website targeting college drug abuse

WASHINGTON – The U.S. Drug Enforcement Administration’s website for professionals working to prevent drug abuse among college students has received a Blue Pencil Award of Excellence by the National Association of Government Communicators.

In July 2017, DEA launched www.campusdrugprevention.gov to support drug abuse prevention programs on college campuses. The website was created as a one-stop resource for professionals working to prevent drug abuse among college students, including educators, student health centers, and student affairs personnel. In addition, it serves as a useful tool for college students, parents, and others involved in campus communities.

“Colleges and universities play an important role in preventing drug abuse among their students,” said Acting Administrator Robert W. Patterson. “DEA is honored to be recognized by the NAGC for its efforts to provide higher education professionals who focus on prevention with the information and tools they need to ensure the health and safety of their students.”

CampusDrugPrevention.gov offers valuable information, including data and research, news updates, publications, national and statewide conferences and events, prevention contacts and resources available from DEA and its federal partners. The website also includes a “Help a Friend” resource to educate and prepare for those who plan to talk to their friends or loved ones about drug use concerns.

The NAGC’s Blue Pencil and Gold Screen Awards is an annual international awards program that recognizes superior government communication products and those who produce them.

Arkansas Municipal League Honors State Drug Director

The Arkansas Municipal League at its 84th Convention, held June 13-15 in Little Rock, honored Arkansas Drug Director Kirk Lane with the John Woodruff “City Above Self” Award. The award is presented to a person who has provided lasting benefits to cities and towns of Arkansas, either collectively or individually, by being an outstanding example of dedication to their improvement.

As the state’s Drug Director, Lane stood in solidarity with the members of the Arkansas Municipal League on the steps of the State Capitol as we announced the historic opioid litigation earlier this year. The cities, counties, and the State of Arkansas are committed to fighting the opioid epidemic together.

The award is named in honor of Woodruff, the League’s communications coordinator and editor of City & Town from 1992 until his death in 2007. Before that John covered the North Little Rock beat for the Arkansas Gazette for 21 years. John worked tirelessly and unselfishly for the cities of Arkansas.

The Arkansas Municipal League is a service and advocacy organization for the municipalities of Arkansas. The League offers its programs and services to all 500 cities and towns in the state and was created in 1934 to assist cities with information and representation in the public affairs of our state and nation. To find out more, please visit www.arml.org.

(Photo: From left, Diane Woodruff, widow of John Woodruff, and Arkansas Drug Director Kirk Lane)

100+ lives saved by Arkansas Naloxone Project

More than 100 lives have been saved this year by the Arkansas Naloxone Project, which provides first responders naloxone toolkits to reverse an opioid overdose. Arkansas Drug Director Kirk Lane said that many of the 102 lives saved this year are attending substance abuse treatment facilities.

“This program receives some scrutiny at times from those that do not have an understanding of the issues at hand. Some feel that these people are unworthy of being saved,” Lane said. “It is important to understand that – If they are alive, there is a chance of recovery. We have met several of these saved individuals, and members of their family, and found that they are now in the process of going through recovery treatment because of these events.”

He added, “We hope that this project will reduce our fatality deaths during this epidemic, and help those with a substance abuse disorder a path towards recovery.”

To date 3,300 Narcan (naloxone) toolkits have been distributed to first responder agencies throughout the state, and each first responder must complete a naloxone training class. Among the items contained in a Narcan kit are two Naloxone nasal sprays, an opioid antagonist used to reverse the effects of an opioid induced overdose. The 3,300 Narcan kits were provided by the Criminal Justice Institute through a grant provided by the Blue & You Foundation for a Healthier Arkansas.

“Our goal is to get the life-saving naloxone kits in the hands of all first responders in the state, which includes them completing a training program,” Lane said. “In the near future, we also want to distribute naloxone kits to various people in society. When a life is saved with naloxone, there is hope for recovery.”

Though it should be used in an emergency situation (a suspected opioid overdose), Naloxone has no effect on non-opioid overdoses. Naloxone is available for purchase at some pharmacies in Arkansas.

To reduce the morbidity and mortality of opioid overdoses in Arkansas, Arkansas Governor Asa Hutchinson has a standing order [Arkansas Code § 17-92- 101(16)] allowing Arkansas-licensed pharmacists to initiate naloxone therapy including ordering, dispensing and/or administering naloxone, along with any necessary supplies for administration, to eligible persons who are at risk of experiencing an opioid-related overdose, or who are family members, friends, or others who are in a position to assist a person at risk of experiencing an opioid-related overdose.

Arkansas is 1 of 40 states exercising the Good Samaritan Overdose Immunity Laws, which encourages people to seek out medical attention for an overdose or for follow-up care after naloxone has been administered. These laws generally provide immunity from arrest, charge or prosecution for certain controlled substance possession and paraphernalia offenses when a person who is either experiencing an opiate-related overdose or observing one calls 911 for assistance or seeks medical attention. For more information: http://www.ncsl.org/research/civil-and-criminal-justice/drug-overdose-immunity-good-samaritan-laws.aspx.

FDA Cracks Down on Websites Marketing Unapproved Opioids (Targets Illegal Online Sales)

U.S. Food and Drug Administration warned nine (9) online networks – operating 53 websites – to stop illegally marketing “unapproved and misbranded” opioid medications, including tramadol and oxycodone, which are shipped through mailing services. The FDA outlined in warning letters that companies who fail to correct the violations will be subject to enforcement action, including product seizure or injunction.

FDA Commissioner Scott Gottlieb, M.D., said the warning letters were written to protect U.S. consumers from illicit opioids sold on the internet.

“The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales,” he said. “As part of that effort, we’re hosting a summit with internet stakeholders to find new ways to work collaboratively with them to address these issues. At the same time, we’ll be taking action against firms whose websites deliberately break the law.”

Gottlieb said the illegal sale of unapproved opioids online is contributing to the nation’s opioid epidemic.

“Today’s warning letters go right to the source of this illegal activity to let online network operators know that marketing illegal and unapproved opioids directly to U.S. consumers will not go unchallenged by the FDA,” he said. “Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives. The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids.”

In the following months, the FDA is taking additional steps to “Crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail.” Gottlieb said the warning letters noted that the websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol and oxycodone, in violation of the Federal Food, Drug, and Cosmetic Act.

“This is particularly concerning considering that FDA-approved tramadol and oxycodone carry boxed warnings, which is the FDA’s most prominent warning, indicating that the drugs carry a significant risk of serious or even life-threatening adverse effects,” Gottlieb said.

The FDA says the boxed warnings address risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems) and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, their use may result in coma or death.

 

The networks receiving warning letters include:

“The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder. We will continue to aggressively pursue these criminals and take swift action to protect the American public.”

The FDA requested responses from each of the companies within 10 working days. The companies are directed to inform the agency of the specific actions taken to address the agency’s concerns.

Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. One critical step to addressing this public health emergency is the adoption of a more proactive approach by internet stakeholders to crack down on internet traffic in illicit drugs. Illegal online pharmacies, drug dealers and others are increasingly using the internet to further their illicit distribution of opioids, where their risk of detection and repercussions is significantly reduced.

As part of this effort, Commissioner Gottlieb has invited internet stakeholders and thought-leaders, government entities, academic researchers and advocacy groups to an Online Opioid Summit on June 27 to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online. Topics to be addressed during the Summit include: research into the ease with which illicit opioids can be purchased online and industry approaches to addressing opioids marketed online, followed by a roundtable discussion to identify gaps and new solutions.

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft, and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation. The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

*Information provided by U.S. Food & Drug Administration press release.

AR Drug Director Encourages Coroners to Adopt New Death Investigation Reporting

(photo is courtesy of the Association of Arkansas Counties)
Arkansas Drug Director Kirk Lane encouraged state coroners to adopt a new death investigation reporting system called MDI (Medicolegal Death Investigation) Log program at the Arkansas Coroners’ Association 2018 Symposium. The system will help coroners more accurately report deaths, which will ultimately help the state collect better data to fight the opioid crisis.
Lane added that eight (8) counties are selected under the Prescription Drug Overdose grant to enable all first responders to receive Naloxone kits and Naloxone training. He said the primary benefit of the program is the standardization and consistency of investigation and reporting of all deaths in real time, resolving a problematic issue in the area of opioid overdose deaths.
“In the opioid crisis, we are currently addressing 2018 issues with 2016 data, which is often incomplete or inconsistent,” Lane said. “Having real time consistent, accurate data of overdose deaths in our state would provide documentary support for grant applications in a very competitive federal grant market – enabling us to obtain and more effectively allocate resources that will help all Arkansans.”
Other benefits of the MDI Log program include:
* Providing the Coroner a tool to collect information on mobile devices from the scene;
* Providing for the migration of data directly into ERAVE;
* Delivering case submission information for individuals sent to the ASCL for autopsy;
* Communicating death scene details, including photos, to the Medical Examiner staff;
* Sharing Medical records on deceased individuals electronically with Forensic Pathologists to assist in making determinations to submit or report out case (Medical Examiner Consult);
* Providing an opportunity to collect and share statewide death related data;
* Providing a mechanism to collect drug death toxicology results from all counties, which will dramatically improve the state’s overall data collection of the “Opioid Epidemic” sweeping the state.
“I encourage all Arkansas coroners to obtain and utilize this free program to improve their death investigation skills, as well as to assist our mission in dealing with the Opioid Crisis,” Lane said.
 
Members of the Arkansas Alcohol and Drug Abuse Coordinating Council voted unanimously during a meeting held on April 19, 2018, to endorse the MDI Log program and to encourage its use by all coroners and medical examiners within the state.

91 LIVES SAVED IN 2018 VIA 1ST RESPONDERS NALOXONE PROGRAM

From the distribution of 3,300 Narcan kits to first responder agencies throughout Arkansas, 91 lives have been saved since Jan. 1, 2018. Among the items contained in a Narcan kit are two Naloxone nasal sprays, an opioid antagonist used to reverse the effects of an opioid induced overdose.

“Our goal is to get the life-saving naloxone kits in the hands of all first responders in the state, which includes them completing a training program,” Arkansas Drug Director Kirk Lane said. “In the near future, we also want to distribute naloxone kits to various people in society. When a life is saved with naloxone, there is hope for recovery.”

The 1,300 Narcan kits were provided by the Criminal Justice Institute through a grant provided by the Blue & You Foundation for a Healthier Arkansas.

Though it should be used in an emergency situation (a suspected opioid overdose), Naloxone has no effect on non-opioid overdoses. Naloxone is available for purchase at some pharmacies in Arkansas.

To reduce the morbidity and mortality of opioid overdoses in Arkansas, Arkansas Governor Asa Hutchinson has a standing order [Arkansas Code § 17-92- 101(16)] allowing Arkansas-licensed pharmacists to initiate naloxone therapy including ordering, dispensing and/or administering naloxone, along with any necessary supplies for administration, to eligible persons who are at risk of experiencing an opioid-related overdose, or who are family members, friends, or others who are in a position to assist a person at risk of experiencing an opioid-related overdose.

Arkansas is 1 of 40 states exercising the Good Samaritan Overdose Immunity Laws, which encourages people to seek out medical attention for an overdose or for follow-up care after naloxone has been administered. These laws generally provide immunity from arrest, charge or prosecution for certain controlled substance possession and paraphernalia offenses when a person who is either experiencing an opiate-related overdose or observing one calls 911 for assistance or seeks medical attention. For more information: http://www.ncsl.org/research/civil-and-criminal-justice/drug-overdose-immunity-good-samaritan-laws.aspx.

Nearly 146 Tons of Medications Collected in Arkansas; 28K Collected on April 28

Nearly 146 tons of prescription medications have been collected in the state since the first Arkansas Prescription Drug Take Back Day in 2010! Starting off 2018 with a bang, Arkansans donated more than 28 thousand pounds of medications on April 28!

Justin King, Assistant Special Agent in Charge of the DEA-Little Rock District Office, said that, “Altogether, the 15 Prescription drug take back events have produced the return of almost 146 tons of unneeded medications, estimated at 406.2 million pills. Due to the commitment, dedication, and effort of the Arkansas Law Enforcement Community, its partners, and the multi-agency coalition, and due to excellent participation by Arkansans in all areas of the state, the take back events have been successful above and beyond all expectations.”

BACKGROUND:

The Office of National Drug Control Policy (ONDCP), as part of its National Drug Control Strategy, called for an increase of prescription drug return and disposal programs as a means to curbing prescription drug abuse. In early 2010, a coalition led by the State Drug Director, the Attorney General, both Arkansas Districts of the U.S. Attorney’s Office, and numerous federal, local, and state agencies, prevention professionals, and private organizations, launched an ongoing education program to encourage everyone to “Monitor, Secure, and Dispose” their prescription medications.

As part of the “Monitor, Secure, and Dispose” effort, the coalition organized Arkansas’s participation in the U.S. Drug Enforcement Administration’s National Prescription Take-Back Initiative, and take back events took place on September 25, 2010, April 30, 2011, October 29, 2011, April 28, 2012, September 29, 2012, April 27, 2013, October 26, 2013, April 26, 2014, and September 27, 2014. DEA announced the discontinuation of the national initiative in September 2014, but an Arkansas take back event under the leadership of partners within the state was held on April 25, 2015. DEA then reinstated the program nationally, and events since have been held on September 26, 2015, April 30, 2016, October 22, 2016, April 29, 2017, October 28, 2017, and April 28,2018. DISCLAIMER: **Collectively, there have been 16 total Arkansas prescription drug take back events: one local and 15 national events. Results from the State Take Back in Spring 2015 were rolled into the total results for National Take Back 10 held September 26, 2015.

STATISTICAL INFORMATION:

Including all 15 events:

* Arkansas ranks #3 nationally in pounds collected per capita with 0.097 pounds per person, just barely behind Wisconsin with 0.101 pounds per person and Maine with 0.244 pounds per person. (Determined using 2017 census estimates)

* Despite being just thirty-third in population among all states, Arkansas ranks #13 in total weight collected.

* Arkansas averaged 62 more law enforcement agencies per event than the national average.

* Also, per event, Arkansas averaged 182 collection sites – the national average per state was 116 per event.

* The four-state DEA region consisting of Alabama, Arkansas, Louisiana, and Mississippi pooled a total weight of 442,050 pounds for all 15 Take Backs. Arkansas, despite being the least populated of the four:

1. Accounts for 66% of the total weight, collecting 141,298 pounds more than the other three states combined;

2. Averages more participating law enforcement agencies than the other three states combined; and,

3. Accounts for 52% of the region’s total sites for Take Back 15.

For Take Back 15, only:

* Arkansas ranks #13 nationally in weight collected.

* Per capita, Arkansas continues to rank 5th in weight collected. Maine ranks #1, followed by New Hampshire,Wisconsin and Vermont, respectively.

* Arkansas ranks 10th in the number of registered collection sites and 9th in the number of participating law enforcement agencies.

* Per capita, Arkansas ranks 4th in registered collection sites and 3rd in participating law enforcement agencies.

DEA brings in record number of unused pills during 15th annual National Prescription Drug Take Back Day

***Official totals will not be available for a few days*****

WASHINGTON – Americans nationwide did their part to drop off a record number of unused, unwanted or expired prescription medications during the DEA’s 15th National Prescription Drug Take Back Day, at close to 6,000 sites across the country. Together with a record-setting amount of local, state and federal partners, DEA collected and destroyed close to one million pounds—nearly 475 tons—of potentially dangerous expired, unused, and unwanted prescription drugs, making it the most successful event in DEA history.

This brings the total amount of prescription drugs collected by DEA since the fall of 2010 to 9,964,714 pounds, or 4,982 tons.

“Today we are facing the worst drug crisis in American history, with one American dying of a drug overdose every nine minutes,” said Attorney General Jeff Sessions. “An unprecedented crisis like this one demands an unprecedented response–and that’s why President Trump has made this issue a priority for this administration. DEA’s National Drug Take Back Days are important opportunities for people to turn in unwanted and potentially addictive drugs with no questions asked. These Take Back Days continue to break records, with the latest taking nearly 1 million pounds of prescription drugs off of our streets. And so I want to thank DEA and especially every American who participated in this event. I have no doubt it will help keep drugs out of the wrong hands and stop the spread of addiction.”

“National Prescription Drug Take Back Day is a day for every American, in every community across the country, to come together and do his or her part to fight the opioid crisis – simply by disposing of unwanted prescription medications from their medicine cabinets,” said DEA Acting Administrator Robert W. Patterson. “This event – our 15th – brings us together with local, state and federal partners to fight the abuse of prescription drugs that is fueling the nation’s opioid epidemic.”

Now in its 9th year, National Prescription Drug Take Back Day events continue to remove ever-higher amounts of opioids and other medicines from the nation’s homes, where they could be stolen and abused by family members and visitors, including children and teens.

This initiative addresses a vital public safety and public health issue. Medicines that languish in home cabinets are highly susceptible to diversion, misuse and abuse. Rates of prescription drug abuse in the U.S. are alarmingly high, as are the number of accidental poisonings and overdoses due to these drugs. Studies show that a majority of abused prescription drugs are obtained from family and friends, including from the home medicine cabinet.

DEA launched its prescription drug take back program when both the Environmental Protection Agency and the Food and Drug Administration advised the public that their usual methods for disposing of unused medicines—flushing them down the toilet or throwing them in the trash—posed potential safety and health hazards.

Helping people to dispose of potentially harmful prescription drugs is just one way DEA is working to reduce the addiction and overdose deaths plaguing this country due to opioid medications.

Complete results for DEA’s fall Take Back Day are available at www.deatakeback.com. DEA’s next Prescription Drug Take Back Day is October 27, 2018.