We can’t arrest our way out of this opiate crisis – Gov Scott – apparently didn’t get that memo

http://cbs12.com/news/local/palm-beach-county-looks-into-big-pharma-new-tools-utilized-to-fight-opioid-epidemic

Putting drug dealers behind bars with maximum penalties.

On Tuesday, Governor Rick Scott held a ceremonial bill signing at The Palm Beach County Jail.

 Now under Florida Law, people who sell drugs can be charged with murder.

The visit to the jail comes on the heels of Governor Scott declaring a statewide public health emergency.

And Florida is poised to get millions of federal grant dollars to fight the epidemic.

The new law also sets up a minimum three-year sentence for anyone caught with at least four grams of fentanyl. I also found out just how critical it is to have the right legal support when facing criminal charges. The legal team at https://www.newjerseycriminallawattorney.com/hudson-county/ was instrumental in helping me understand my options and build a strong defense. Their expertise and commitment were evident from start to finish.

Meanwhile, Palm Beach County is considering legal action that many small municipalities and states have already used in the war on drugs: Filing a lawsuit against prescription drug companies.

The Palm Beach County Commission ordered the county legal dept. to prepare a report– looking at the possibility of suing. Lawsuits are being filed nationwide — taking on certain pharmaceuticals — much in the way America took on big tobacco in the 90’s.

“We used legislation and litigation on big tobacco and look what it did,” said Marcel Fort.

Fort is a counselor and he has seen people from all walks of life become addicted to pain medication like oxycodone.

“I have been working in this field for 15 years and I saw the storm coming– I was there. When people were coming in, not your usual addicts, they had an injury, they went to a doctor, trusting the doctor would treat them right, and the doctors started pushing pain medications that were outrageous for what they had,” Fort said.

Fort is encouraged that the county’s commission is looking at legal action against drug-makers.

More than 20 governments– on state, county, and local levels– have filed civil cases against manufacturers, distributors and pharmacies which they claim are adding fuel to the fire in the opioid crisis.

Palm Beach County Commissioner Dave Kerner is a lawyer by trade and he says these are desperate times and he supports the county taking this measure. Kerner hopes when the legal department comes back with their report, commissioners will put this to a vote– and vote to sue.

“We intend to move on this quickly if the political willpower is there,” Kerner said.

In Palm Beach County, opioid overdose deaths almost quadrupled in the past five years, going from 143 in 2012 to 569 in 2016.

Marcel Fort says for some people it might be easy to dismiss these numbers, if they are personally not affected, but he says, there could be an addict in your immediate circle of friends or family, and you just don’t know it yet.

“It’s not based on socioeconomic status, it doesn’t care who you are, if addiction gets you, it gets you,” Fort said.

In Delray Beach, city leaders are considering a lawsuit of their own. Leaders say city resources like police and other first responders are being used to deal with this crisis and the city wants compensation.

Manufacturer fined for what wholesalers, doctors, pharmacies, pts do ?

Justice Department reaches first settlement with opioid manufacturer

https://www.washingtonpost.com/national/health-science/justice-department-reaches-first-settlement-with-opioid-manufacturer/2017/07/11/93e30328-666d-11e7-a1d7-9a32c91c6f40_story.html

The Justice Department and Mallinckrodt Pharmaceuticals reached a $35 million settlement Tuesday of charges that the company had failed to report signs that large quantities of its highly addictive oxycodone pills were diverted to the black market in Florida, where they helped stoke the opioid epidemic.

The agreement is the first with a major manufacturer of the opioids that have sparked a crisis of overdoses and addictions across the country. The Justice Department said the deal establishes “groundbreaking” new standards that require the company to track its drugs as they flow through the supply chain to consumers in an effort to control the epidemic.

The company had argued that once it passed the drugs to wholesale distributors, it was not responsible for illegal diversion of the painkillers as they were sent to retailers and then pain patients.

“The Department of Justice has the responsibility to ensure that our drug laws are being enforced and to protect the American people,” Attorney General Jeff Sessions said in a statement. “Part of that mission is holding drug manufacturers accountable for their actions. Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street.”

Chuck Rosenberg, the Drug Enforcement Administration’s acting administrator, said in the statement that “manufacturers and distributors have a crucial responsibility to ensure that controlled substances do not get into the wrong hands. When they violate their legal obligations, we will hold them accountable.”

 The Washington Post reported a tentative settlement between the two sides in April, highlighting the frustration of DEA investigators who had spent six years trying to hold Mallinckrodt responsible for its role in the epidemic. At one point, the government calculated that it could have assessed the company $2.3 billion in fines for nearly 44,000 violations of the federal Controlled Substances Act, according to confidential government documents obtained by The Post.

Between 2008 and 2012, Mallinckrodt pumped 500 million pills into Florida, 66 percent of all oxycodone sold in the state, The Post reported.

Nearly 180,000 people died of overdoses to prescription painkillers between 2000 and 2015, and the abuse of pharmaceutical opioids is widely blamed for a crisis that now involves many thousands of overdoses on heroin and fentanyl.

The settlement, which includes U.S. attorney’s offices in Michigan and New York, also holds Mallinckrodt responsible for record-keeping violations at its manufacturing plant in Hobart, N.Y. The agreement covers alleged violations during the years 2008 to 2011.

In a statement, Mallinckrodt, one of the largest manufacturers of generic oxycodone, denied wrongdoing and said that it had previously set aside enough money to cover the cost of the settlement. The company is based in Britain.

“While Mallinckrodt disagreed with the U.S. government’s allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,” Michael-Bryant Hicks, the company’s general counsel, said in the release.

Joseph T. Rannazzisi, who supervised DEA efforts to control diversion of opioids for a decade before he retired in 2015, said Tuesday that multimillion-dollar fines have not deterred large pharmaceutical corporations accused of failing to report suspicious orders of pain pills to the DEA.

“These fines mean nothing to Fortune 500 companies,” he said. “Large corporations see these fines as the cost of doing business. Unless there are meaningful sanctions brought against these companies, they will continue to violate the law.”

The government has reached nearly a dozen such settlements with wholesale distributors of opioids, including one that brought a record $150 million fine against McKesson Corp. Other large settlements have been reached with major retail drug chains.

Class Action Lawsuit – Blue Cross denial of mental health care

Suit alleges Blue Shield improperly denied mental health, drug treatment claims

http://www.fiercehealthcare.com/regulatory/suit-alleges-blue-shield-improperly-denied-mental-health-drug-treatment-claims

Blue Shield of California and its claims administrator wrongly restricted patients’ access to outpatient and residential mental health treatment, a class-action lawsuit says.

Initially filed in the U.S. District Court for the Northern District of California, the complaint comes from two parents who allege their teenage children were repeatedly denied coverage under their employer-based plans despite serious mental and substance abuse problems. In June, a federal district judge granted a request for class-action status, meaning that patients whose claims were rejected under similar circumstances may join as plaintiffs.

The suit contends that Blue Shield and Magellan Health Services of California, which handles the insurer’s mental health claims, developed criteria that violate accepted professional standards and the terms of the health plan itself. The suit also alleges violations of the Employee Retirement Income Security Act, a federal law that regulates employee benefit plans.

For instance, according to the suit, patients were authorized for residential care only if less intensive treatment in the previous three months was unsuccessful. Such a “fail-first” approach is inconsistent with standards established by professional psychologists and professional groups such as the American Psychiatric Association or the American Society of Addiction Medicine, the complaint says.

“They came up with internal guidelines which allowed them to justify denying coverage when it should have been provided,” said D. Brian Hufford, a New York-based partner at Zuckerman Spaeder LLP, one of the law firms representing the plaintiffs.

“It’s very difficult for patients to challenge those kinds of denials because … so much of the decision-making happens behind the scenes,” Hufford said.

In an email, Blue Shield said “we disagree with the allegations in the lawsuit,” adding that the insurer would continue to “defend the case vigorously.” In court documents, Magellan has denied wrongdoing, but it declined a request to comment for this story.

The plaintiffs seek to change Blue Shield’s and Magellan’s policies to be consistent with the law, generally accepted professional standards and the terms of its own plans, according to the lawsuit. Also, they seek to have the defendants reprocess thousands of mental health and substance-use benefit denials.

The lawsuit, Charles Des Roches, et al. v. California Physicians’ Service, et al., is part of a national strategy by the law firms involved to hold insurers accountable for their obligations to provide mental health treatment, Hufford said. In September 2016, the federal district court in Northern California certified a nationwide class action against United Behavioral Health, also contesting that insurer’s coverage criteria.

In the Blue Shield/Magellan lawsuit, plaintiff Charles Des Roches, of Salinas, Calif., said his 15-year-old son was admitted for urgent treatment to a drug rehab center in Southern California, suffering from major depression, abuse of multiple drugs and severe emotional disturbance. According to the lawsuit, the young man had a history of shoplifting, stealing money for drugs, severe anxiety and anger, for which he had already taken medication and received psychotherapy. He incurred a bill for tens of thousands of dollars, which Blue Shield refused to pay, the suit alleges.

Plaintiff Sylvia Meyer, of Los Angeles County, alleged Blue Shield rejected claims for her 18-year-old son, who received intensive outpatient psychiatric services following hospitalization for similar mental health and drug abuse problems. In both cases, the denials of coverage were based on Magellan’s benefit determination guidelines.

Magellan is among the nation’s largest managed-care companies for behavioral health. The suit is limited to Magellan’s Blue Shield employer-paid group members. However, if it succeeds, “it is hard to imagine that Magellan would be able to justify continued use of its proprietary guidelines in other markets,” according to Meiram Bendat, president of Psych-Appeal, a Los Angeles advocacy law firm that is co-counsel in the case.

Class-action lawsuits, potentially representing thousands of consumers, can “bring much broader and much more meaningful relief,” said Ira Burnim, legal director of the Bazelon Center for Mental Health Law in Washington, D.C., a legal advocacy organization. A win for the plaintiffscould have far-reaching effects in the managed-care industry, which commonly uses proprietary guidelines to adjudicate claims, he said. “Corporate authorizers are trying to figure out how to save health care dollars and address health needs cost effectively, and at the same time they have a profit motive. There can be a tension between those two goals,” said Burnim.

Generally accepted guidelines are neutral, transparent and based on thorough research, said Dr. Anita Everett, president of the American Psychiatric Association. In an email, she said that when insurance companies create their own standards, “[t]he process is often not transparent, conflicts are not disclosed, and the standard is generally more restrictive which suggests a focus on cost, rather than patient outcome.”

When insurance companies deny coverage based on restrictive guidelines, they shift the cost of appropriate care onto patients, said Everett. “A win in this case would mean that ‘medically necessary’ means just that, necessary as an objective medical matter not medically necessary only if not too expensive,” said Everett. Ideally, insurers would be required to disclose when their guidelines are more restrictive than generally accepted guidelines, so that employers and consumers evaluating insurance plans can make informed choices, she said.

The recent lawsuit challenges several other Blue Shield/Magellan “internal guidelines,” including requiring patients to prove they are a serious, imminent danger to themselves or others to qualify for residential mental health treatment.

“We dispute that the ‘imminent danger’ standard should apply for people who are seeking non-hospital levels of care,” said Bendat. “That’s a standard that generally applies to inpatient hospitalization, not residential treatment.”

Another Blue Shield/Magellan guideline, pertaining to outpatient treatment for substance use disorders, denies coverage unless a patient demonstrates “motivation to manage symptoms or make behavioral change,” the suit states. Yet “patients with substance use disorders are generally depressed and lack motivation, particularly in their early recovery,” Bendat said.

Under generally accepted standards, a lack of motivation, especially in adolescents, in itself warrants residential placement, Bendat said. Requiring patients to exhibit motivation in order to receive services “goes against the grain for why the treatment is necessary in the first place,” he said.

The guidelines also demand that intensive outpatient therapy be authorized only if the treatment plan is expected to bring about “significant improvement”—a requirement the suit alleges has “no basis in accepted medical standards.”

The medication categories most frequently associated with serious outcomes were cardiovascular drugs

Patient Medication Errors Doubled Over 13 Years

http://www.healthleadersmedia.com/quality/patient-medication-errors-doubled-over-13-years

The most common errors were taking or giving the wrong medication or incorrect dosage, and inadvertently taking or giving a medication twice, researchers have found. 

The frequency of serious medication errors by patients or their caregivers outside of a healthcare setting more than doubled from 2000 to 2012, according to a study in Clinical Toxicology.

Researchers from the Center for Injury Research and Policy and the Central Ohio Poison Center at Nationwide Children’s Hospital analyzed calls to poison control centers across the country over the 13-year period about medication errors that resulted in serious medical problems.

The rate of serious medication errors per 100,000 people more than doubled from 1.09 in 2000 to 2.28 in 2012. These errors occurred mostly in the home, affected people of all ages, and were associated with a wide variety of medications.

“Drug manufacturers and pharmacists have a role to play when it comes to reducing medication errors,” said Henry Spiller, a co-author of the study, and director of the Central Ohio Poison Center at Nationwide Children’s. “There is room for improvement in product packaging and labeling. Dosing instructions could be made clearer, especially for patients and caregivers with limited literacy or numeracy.”

The most common errors were taking or giving the wrong medication or incorrect dosage, and inadvertently taking or giving the medication twice. Among children, dosing errors and inadvertently taking or giving someone else’s medication were also common errors. One-third of medication errors resulted in hospital admission.

The medication categories most frequently associated with serious outcomes were cardiovascular drugs (21%), analgesics (12%), and hormones/hormone antagonists (11%). Most analgesic exposures were related to products containing acetaminophen (44%) or opioids (34%), and nearly two-thirds of hormone/hormone antagonist exposures were associated with insulin. Cardiovascular and analgesic medications combined accounted for 66% of all fatalities in this study.

Among children younger than six years, the rate of medication errors increased early in the study and then decreased after 2005, which was associated with a decrease in the use of cough and cold medicines attributable to the Food and Drug Administration’s 2007 warning against giving these drugs to children.

“Managing medications is an important skill for everyone, but parents and caregivers have the additional responsibility of managing others’ medications,” said study lead author Nichole Hodges, a researcher at the Center for Injury Research and Policy at Nationwide Children’s.

“When a child needs medication, one of the best things to do is keep a written log of the day and time each medication is given to ensure the child stays on schedule and does not get extra doses.”

Data for the study were obtained from the National Poison Data System, which is maintained by the American Association of Poison Control Centers.

NACDS Submits Comments to President’s Commission on Combating Drug Addiction and the Opioid Crisis

NACDS Submits Comments to President’s Commission on Combating Drug Addiction and the Opioid Crisis

https://www.benzinga.com/pressreleases/17/07/p9759366/nacds-submits-comments-to-presidents-commission-on-combating-drug-addic

National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson, IOM, CAE, submitted official comments to the President’s Commission on Combating Drug Addiction and the Opioid Crisis, which is chaired by New Jersey Governor Chris Christie. President Donald Trump signed an Executive Order on March 29, 2017, establishing the Commission. The comments reflect NACDS’ long-standing and ongoing commitment to help address prescription drug abuse, addiction and proper access.

Anderson described chain pharmacies’ “zero tolerance for prescription drug diversion” and extensive efforts to prevent it – including regulatory compliance, company-specific measures and collaboration with law enforcement and other authorities. He also noted challenges involved in pharmacists’ ethical duty to serve patients’ medical needs while meeting requirements of the Drug Enforcement Administration (DEA) to evaluate the legitimacy of the use of controlled substances.

Anderson wrote:

“The ongoing opioid abuse problem concerns both legal and illicit substances; that is, prescription opioids as well as heroin and illegal fentanyl analogs. NACDS and the chain pharmacy industry are committed to partnering with law enforcement agencies, policymakers, and others to work on viable strategies to prevent prescription drug diversion and abuse, including prescription opioids. One encouraging statistic is the decrease in the number of opioid prescriptions dispensed annually over the past few years. The number of opioid prescriptions dispensed at retail pharmacies declined almost 15% from 2013-2016 (Xponent, QuintilesIMS, 2017). Chain pharmacies engage daily in activities with the goal of preventing drug diversion and abuse. Since chain pharmacies operate in almost every community in the U.S., we support policies and initiatives to combat the prescription drug abuse problem nationwide. We believe that holistic approaches must be implemented at the federal level. We are pleased that we are helping to solve the opioid abuse problem.

“Pharmacists take their role in helping to ensure safe use of medications very seriously—but they cannot do it alone. We support a collaborative approach to curb prescription drug abuse and preserve patient access to their medically-necessary pain medications. We believe that there are a variety of ways to help curb prescription drug diversion, and chain pharmacies actively work on many initiatives to reduce this problem.”

Anderson also advised the Commission on opportunities to enhance existing strategies to curb opioid abuse, including in the following areas:

  • Patient and Provider Education: “NACDS supports prescriber education initiatives. NACDS also supports education efforts targeted at the general public…We have encouraged collaboration among FDA [the Food and Drug Administration]; the Institute of Medicine (IOM), and other agencies and stakeholders to identify further opportunities and develop prescriber education tools for other controlled substances. Additionally, we have encouraged collaboration among ONDCP [the Office of National Drug Control Policy] and state boards of medicine to ensure enhanced training for prescribers on the legitimate use of controlled substances…We have encouraged FDA to expedite implementation of the one-document solution, as doing so could help to ensure that patients who are prescribed controlled substances better understand appropriate use of these medications.”
  • Controlled Substance Prescription Drug Monitoring Programs (PDMP): “Unfortunately, there is great variability among state PDMPs…There exist no nationwide standards for the data that these programs collect, maintain, or provide; nor are there any nationwide standards for who may access the data among health care providers such as prescribers and pharmacists, health plans and Medicaid, or law enforcement officials; and there is no nationwide interconnectivity among the programs, which hinders regional surveillance of patients at risk and potential criminals. NACDS supports initiatives to establish a robust, national database with timely, reliable information and a standard set of requirements.”
  • Role of Electronic Prescribing: “NACDS is supporting draft federal legislation that would require prescriptions for controlled substances in the Medicare Part D program to be issued electronically. In addition, NACDS recently developed model state legislative language to pursue mandatory electronic prescribing for all prescriptions…We urge that the Administration finalize the DEA interim final rule (IFR) that allows for the electronic prescribing of controlled substances. The current limitations in the IFR serve as barriers to more widespread adoption of electronic prescribing technologies. Finally, we urge CMS to move to the latest version of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard so that prescribers and pharmacies may take full advantage of current electronic prescribing technologies.”
  • Limiting Initial Fills of Controlled Substance Prescriptions: “Several states have enacted laws or rules to establish limits on the maximum day supply that prescribers can authorize on initial prescriptions for certain controlled substances. A growing number of states are considering legislation that would enact similar limits… Notably, there is variation across states with respect to the scope of these policies, especially concerning the pending legislative proposals…NACDS advocates for standardized policies that ease implementation challenges so that patient care is not adversely impacted. We believe that the Commission could serve as a forum to assist states with implementing standardized policies.”
  • Promoting Access to Naloxone: “Pharmacists and pharmacies are primed to work in conjunction with other healthcare providers to increase access to naloxone for overdose prevention purposes…A number of states have employed various approaches to make it easier for pharmacists to provide naloxone to patients…Chain pharmacy supports state laws and policies…that eliminate administrative barriers to pharmacist-provided naloxone by authorizing pharmacists to provide naloxone without patient-specific prescriptions…Additionally, we support liability protections for all healthcare providers, including pharmacists, who prescribe and dispense naloxone in good faith.”
  • Take-back and Disposal of Consumers’ Unused Medications: “NACDS supports the safe and effective disposal of unwanted consumer medications, including controlled substances, to stem the abuse of such drugs and to better protect the environment…We believe that policymakers who have decided to tackle the drug disposal issue should ensure that pharmacies are able to create programs that best serve the needs of their patients, as well as workable solutions for their store locations. Overall, patients should have a wide variety of options for how they can dispose of their unused medications. With more options, we can expect to have higher patient participation in prescription drug disposal programs…When policymakers consider proposals for drug disposal, we ask that they consider retail pharmacies’ support for broad drug disposal programs that allow pharmacies to facilitate at least one of a variety of DEA authorized options for drug disposal…Retail pharmacies support consumer education programs on drug disposal developed and funded by the government and/or pharmaceutical manufacturers…Ideally, such materials would focus on the dangers of misuse and the potential for addiction to prescription controlled substances, treatment resources available, and the proper way to dispose of unused prescription controlled substances…Finally, any legislative package adopting the policy proposals outlined above should also include a preemption provision. NACDS encourages the Commission to work with DEA to promote continued periodic take-back events hosted by DEA. We also encourage the Commission to pursue patient education programs as outlined above.”
  • Collaborative Legislative Solutions: “NACDS and our members are focusing our energies on real, workable solutions that will address the problem of prescription drug abuse while also ensuring that legitimate patients are able to receive their prescription pain medications. In line with this goal, we supported the recently enacted ‘Ensuring Patient Access and Effective Drug Enforcement Act’ (P.L. 114-145). This legislation requires HHS [Department of Health and Human Services] to submit a report to Congress that identifies obstacles to legitimate patient access to controlled substances and outlines how collaboration among federal and state agencies and industry can benefit patients and prevent diversion and abuse of controlled substances…The report must be submitted to Congress no later than one year after the date of enactment. HHS has not met the one-year deadline for submitting this report to Congress.”
  • Target Illegitimate Internet Drug Sellers: “NACDS believes that an important strategy to stop drug diversion and abuse is addressing the problem of illegitimate internet drug sellers. These illicit online drug sellers have websites that target U.S. consumers with ads to sell drugs often without any prescription required. They operate in clear violation of U.S. state and federal laws and regulations that protect public health and safety. They sell drugs to consumers without the safety precautions of a legitimate prescriber-patient relationship, a valid prescription, or a licensed U.S. pharmacy. We support targeting illegal internet drug sellers by enabling entities, such as domain name registrars that issue websites, financial entities that handle payment transactions, internet service providers that show the illegitimate websites on the internet, and common carriers that provide the mailing services, to stop illicit transactions at their point of interaction with these bad actors. NACDS serves on the Board of Directors of the Alliance for Safe Online Pharmacies (ASOP) to support their work to shut down illegal internet drug sellers.”
  • Shutting Down Rogue Pain Clinics: “As the number of domestic-based rogue internet pharmacies has declined, there has been an increase in the number of rogue pain clinics. According to DEA, the practitioners in these clinics are responsible for the dispensing of millions of dosage units of oxycodone, a schedule II narcotic. NACDS supports the efforts of states that have enacted legislation to shut down these rogue clinics, such as the restriction of physicians’ ability to dispense oxycodone from pain clinics.”

Anderson’s complete comments include enhanced details related to each existing strategy and to each recommendation to the Commission.

For the original version on PRWeb visit: http://www.prweb.com/releases/2017/07/prweb14494359.htm

ANYONE NOTICE A PATTERN HERE ??? DEA REPEATEDLY VIOLATING LAWS ?

The DEA Are Violating Federal Law Over Recent CBD Claim

www.herb.co/2017/07/10/dea-cbd/

The DEA is trying to buckle down on medical cannabis components. However, the legality of CBD products, sourced from industrial hemp with 0.3% THC, became solid by the 2013 Farm Bill, signed into law by then President Obama. But that isn’t stopping them from violating federal law themselves to bully patients and businesses.

Hemp versus marijuana

Confused? That’s okay because it seems the DEA is also confused about what it can and cannot do. But while they tend to do it until punished, they expect the populace to wait until given their explicit blessing.

The 2013 Farm Bill specifically separated the classification of industrial hemp from cannabis. It allowed states to self-regulate hemp products, including setting up programs for the study and growth of the crop for “growth, cultivation, or marketing purposes”.

31 states have defined industrial hemp as distinct from marijuana and removed barriers to cultivation. Hemp-based products are legal in all 50 states.

So what is with the DEA?

In response to an ongoing report series about CBD versus the DEA, the agency sent a letter to The Cannabist on July 1st expounding their stance on the matter. Among their rhetoric were specific jabs at CW Hemp, a Colorado-based company growing industrial hemp to create Charlotte’s Web CBD oil.

In response, company CEO Joel Stanley shared a thorough breakdown of the DEA statement, along with specific links to legal references discounting their claims.

Because the Appropriations Act of 2017 prohibits the use of federal funds to hinder industrial hemp-based businesses, the DEA itself has violated federal law.

The language given by the continuing Appropriations Act of 2017, Sec. 773, explicitly states that federal funds may not be used to:

… prohibit the transportation, processing, sale, or use of industrial hemp that is grown or cultivated in accordance with section 7606 of the Agricultural Act of 2014, within or outside the State in which the industrial hemp is grown or cultivated.

Therefore, the DEA statement itself – because it was made by a federal agency – is not lawful; it constitutes an illegal use of federal funds to prohibit “industrial hemp” that is federally compliant. -Joel Stanely

The verdict?

The DEA enforces laws. Congress creates them. As much as the DEA would love to attack the safe, non-toxic, life-saving medicine, doing so renders their actions illegal. Therefore, any state or federal agency that goes after customers or businesses does so illegally. The case against the victims of their persecution could be thrown out of court.

For patients, this is a profound relief. For businesses, in order to remain safe, they must still comply with FDA regulations on labeling, product claims, and FDA-approved manufacturing facilities.

In essence, claiming CBD helps various conditions violates no law, as long as the branded product specifically does not make the claim.

Why is CBD such a priority?

While opiates and pharmaceutical abuses run rampant across the country, many are wondering why the DEA remains so adamant in attacking hemp products. Are they dangerous? No. Are they addictive? No. Are they easy targets? Absolutely.

Manipulating drug and forfeiture laws to fatten their budgets seems the DEA’s favorite pastime. It sure sounds a lot safer than going after the real problems. Medical patients don’t pose a danger to gun-toting agents like hardened gang members slinging heroin.

With that said, if ever faced with violent gun-toting aggressors at one’s door, don’t resist. Let the law handle them. Gangs are dangerous, and those with a license to steal and kill from the government even more so.

FDA says physicians will have to receive training to prescribe opioid painkillers

FDA says physicians will have to receive training to prescribe opioid painkillers

www.pulseheadlines.com/fda-physicians-receive-training-prescribe-opioid-painkillers/65025/

The Food and Drug Administration proposed on Monday new guidelines to fight the growing opioid epidemic that’s hitting the U.S., and pledged to make it its priority.

 FDA Commissioner Scott Gottlieb announced plans to require manufacturers of immediate-release painkillers to provide thorough education for physicians and health care professionals who prescribe these drugs.
Image Credit: Shutterstock
Image Credit: Shutterstock

The announcements were part of the opening statement of a two-day FDA meeting on painkiller abuse. Painkiller prescriptions account for 90 percent of the opioids prescribed in the United States, and some of the compounds include dangerous opioids like hydrocodone or combinations such as oxycodone with acetaminophen.

FDA will require training to prescribe extended-release opioid painkillers

Gottlieb noted that, for the time being, only makers of extended-release painkillers, which account for the remaining 10 percent of prescriptions, are required to provide training.

“America is simply awash in immediate-release opioid products,” said Gottlieb.

He noted that the new training requirements would aim at making sure that prescriptions are for patients who actually need them and under appropriate clinical circumstances.

The FDA will also survey doctors to ensure the term “abuse deterrent” isn’t giving a false sense of security that these drugs are less likely to lead to addiction than pills without that designation. Gottlieb noted that while abuse-deterrent versions of painkillers are manufactured to be harder to crush, snort or inject, the FDA doesn’t want to convey a perception that these versions are less prone to fueling addiction because they’re not.

Although the FDA does not require doctors to undergo the training currently, Gottlieb said he wants to pursue that possibility.

“Based on the feedback we’ve received from two public meetings over the past year, we’re actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition,” he said.

The commissioner that most people who become addicted to opioid painkillers will eventually move on to look higher dose formulations of these compounds or they’ll seek illicit street drugs that are “increasingly the low-cost alternatives.”

Endo International Plc halted sales of its addictive painkiller Opana ER

The agency has been taking measures against pharmaceutical companies, too, as the opioid epidemic continues to claim lives around the country. Last week, Endo International Plc complied with FDA’s request to halt U.S. sales of its powerful opioid painkiller Opana ER.

The FDA had said the abuse-deterrent version of the painkiller was linked to an outbreak of HIV and hepatitis C after users would inject it for a more potent high and share used needles. That marked the first time the FDA asked for the removal of an opioid from the market because of a public health consequence of abuse.

A court filing against Endo and Purdue Pharma, another pharmaceutical manufacturer, were also added last week to a lawsuit from 2014 by two counties in California. The lawsuits were filed as an effort to make the drug companies pay for the cost of addressing the opioid crisis.

Gottlieb also noted the agency would examine whether it should take action to reduce the number of 30-day prescriptions that are issued for pain related conditions that don’t need a whole month’s supply, such as dental procedures.

FDA Chief Says Agency Must Do More to Stop Abuse of Opioids

FDA Chief Says Agency Must Do More to Stop Abuse of Opioids

https://www.bloomberg.com/news/articles/2017-07-10/fda-chief-says-agency-must-do-more-to-stop-abuse-of-opioids

The U.S.’s top drug regulator said on Monday that more must be done to stem the country’s tide of opioid addiction, proposing new guidelines and restrictions on some of the most widely used pain pills.

Food and Drug Administration Commissioner Scott Gottlieb laid out plans to have drugmakers conduct doctor education programs on immediate-release opioids, which account for 90 percent of the 200 million opioid painkiller prescriptions written in the U.S. each year. The agency is also exploring whether pain-management training should be required for doctors as well as nurses, pharmacists or other health-care providers.

“America is simply awash in immediate-release opioid products,” Gottlieb said at a speech in Silver Spring, Maryland, as part of a two-day public FDA meeting on painkiller abuse.

“Many people who become addicted to opioids will eventually move on to seek higher dose formulations of these drugs or illicit street drugs, which are increasingly the low-cost alternatives,” Gottlieb said.

Gottlieb said the FDA also plans to survey doctors to make sure the term “abuse deterrent” isn’t giving a false sense of security that the painkillers are less likely to lead to addiction than pills without the designation. Abuse-deterrent versions of the pain pills are formulated to be harder to crush, snort or inject for a more potent high.

“We don’t want to improperly convey a perception that a product that’s resistant to manipulation and abuse is somehow also less prone to fueling addiction when that’s simply not true,” Gottlieb said.

Extended Release

The agency has already acted on related concerns under Gottlieb. Last week, Endo International Plc said it would halt U.S. sales of its powerful opioid painkiller Opana ER, after the FDA said the abuse-deterrent version of the drug had been tied to an outbreak of HIV and hepatitis C after users would inject it and share dirty needles.

Most of the opioids the FDA approves with abuse-deterrent features are extended-release versions. The regulator previously had criticized Endo’s abuse-deterrent technology and didn’t grant it the ability to claim abuse deterrence on the label.

The prescriber education the FDA intends to require for fast-acting opioids would help health-care providers better understand which patients are best suited for the drugs. The FDA recently proposed updating its “blueprint” for pain management education to include non-medication-based therapies including physical therapy, surgery and acupuncture. The FDA already requires prescriber education for extended-release opioids.

The FDA has said it will be examining whether it should take action to reduce the number of 30-day prescriptions that are written for pain related to conditions such as dental procedures that don’t require a whole month’s supply.

Medication mistakes are on the rise, leading to more serious health problems

Medication mistakes are on the rise, leading to more serious health problems

http://www.cbsnews.com/news/medication-mistakes-causing-more-health-problems-overdoses/

Every minute of every day, three Americans call a poison control center because they’ve made a major mistake with their medication.

Some have taken the wrong dose. Some have double-dosed, and others have taken the wrong medicine altogether.

The result: the rate of serious mix-ups has doubled since 2000, a new study reports.

Four out of 10 mistakes involve heart medications, painkillers or hormone therapy prescriptions, including insulin. And the errors often put patients in the hospital, the study found.

“Ever more drugs for ever more diagnoses in ever more people invites ever more error and adverse reactions,” said Dr. David Katz, director of the Yale University Prevention Research Center. He was not involved with the study.

The study researchers used U.S. National Poison Data System records to track errors involving prescription or over-the-counter medications taken outside a health care facility. Most of the drugs were taken at home, meaning patients, not health care professionals, made the mistakes.

The rate of serious medication errors rose from 1.09 for every 100,000 Americans in 2000 to 2.28 per 100,000 by 2012. One-third of the cases resulted in a hospital stay, the researchers said.

“Fortunately, most do not result in the serious outcomes found in this study,” said lead author Nichole Hodges. She is a research scientist with the Center for Injury Research and Policy at Nationwide Children’s Hospital in Columbus, Ohio.

But Hodges said the extent of the problem may be worse than the findings suggest.

“Because this study includes only medication errors reported to poison control centers, it is an underestimate of the true number of serious medication errors in the U.S.,” she said. “Unfortunately, we can’t tell from the data whether serious medication errors are occurring more frequently, or whether they are simply being reported more often.”

Nationwide, at least 1.5 million medication errors occur every year, with poison control centers logging them at a rate of one every 21 seconds.

The study found medication errors outside a medical facility shot up across all age ranges except one: children under age 6.

Among that young group, errors rose between 2000 and 2005, then started to fall. The study pointed to less use of pediatric cough and cold medicines after 2007, when the U.S. Food and Drug Administration advised parents to stop giving those drugs to children.

Most of the errors involved taking the wrong medicine, the wrong dosage or accidentally taking a medication twice.

Two-thirds of deaths in the study involved heart medicines and painkillers combined.

Heart medication mistakes accounted for more than a fifth of errors, while hormone therapy drugs such as insulin accounted for 11 percent.

Painkillers were involved in 12 percent of poisonings, and roughly 80 percent of painkiller mistakes involved products with acetaminophen (such as Tylenol) or an opioid drug.

Hodges said most medication mistakes can be prevented.

“Keeping a written log of when medications are administered can be a helpful strategy for parents and caregivers,” she said. “This is especially important if multiple individuals are administering medication to an individual.”

Hodges said patients should to talk to their doctor or pharmacist if they have questions about their medicines. Careful storage is also important.

“Individuals who use weekly pill planners should [also] ensure that they are child-resistant and stored up, away and out of sight of children,” Hodges added.

Drug makers could help, she noted, by improving drug packaging and labeling. In particular, she said, dosing instructions should be easier for people with limited reading and math skills.

The findings were published July 10 in the journal Clinical Toxicology.

DEA has created a litany of new duties on questionable statutory or regulatory basis.

A Call to Duty: DEA Practitioner Registrants Beware—DEA Wants You!

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2017/07/a-call-to-duty-dea-practitioner-registrants-bewaredea-wants-you.html

By John A. Gilbert, Jr. & Andrew J. Hull

Individual practitioners represent more than ninety percent of the approximately 1.6 million DEA registrants. We believe it fair to say that of all the types of DEA registrants (e.g., manufacturers, distributors, importers, etc.), individual practitioners have less opportunity to read the Federal Register for notices related to new duties and responsibilities.  Yet the DEA continually buries new duties and responsibilities related to prescribers in its administrative decisions rather than utilizing other methods such as guidance documents and notice-and-comment rulemaking to inform practitioners of the expanding duties.  Worse yet, as reflected in the recent case of Peter F. Kelly, D.P.M., 82 Fed. Reg. 28676 (June 23, 2017), DEA has created a litany of new duties on questionable statutory or regulatory basis. We also question whether the punishment fits the alleged misconduct of the registrant in this case. 

In Kelly, DEA alleged, inter alia, that one of the physician’s employees had misused the physician’s state registration by creating fraudulent prescriptions for state-controlled substances and then diverting those controlled substances into “illegitimate channels.”  Despite evidence that the physician cooperated with state officials when this activity was discovered and took steps to ensure it did not happened again, DEA appears to believe that physicians also need to become private investigators to fulfill their role as DEA registered physicians.  In the opinion, the DEA Acting Administrator addressed these allegations by identifying the following set of duties that apply: 

  • “[W]here a registrant is provided with credible information that his state prescribing authority is being used to divert a state-controlled (but not federally controlled) drug, such information triggers the duty to investigate whether his DEA registration is also being used to divert federally controlled substances.”
  • Additionally, in such a situation, and if the state prescription monitoring program (PMP) “permits a practitioner to obtain information as to his controlled substance prescribings,” the practitioner “has a duty to obtain that information and to determine whether unlawful prescriptions for federally controlled substances are also being dispensed under his registration.”
  • If state law does not authorize a practitioner to obtain a PMP report of “dispensings which have been attributed to him,” the practitioner “is obligated to obtain that information from a pharmacy that reports a fraudulent prescription to him.”
  • The practitioner “must report” to DEA and local enforcement authorities any information obtained from the practitioner’s investigation that shows a misuse of the registration.
  • The practitioner also “has a duty to conduct a reasonable investigation to determine whether his employees are involved in the misuse of his registration” upon receipt of “credible information” that the practitioner’s registration “may be the subject of misuse.”

Id. at 28686. 

Moreover, the Administrator basically implied that there is also a duty to terminate employees found to have engaged in wrong doing, and threatened “serious consequences” for failing to take such action. Id. at 28691. 

In support of establishing these new duties, the Administrator referenced the relatively obscure case of Rose Mary Jacinta Lewis, M.D., 72 Fed. Reg. 4035 (Jan. 29, 2007). That case involved a physician taken advantage of by a non-profit that allegedly supplied medical supplies for AIDS patients in Nigeria.  DEA alleged that individuals at the non-profit used the physician’s DEA registration to order mass quantities of controlled substances and diverted them into non-lawful channels.  Though the physician had some limited knowledge that her registration was being used unlawfully, DEA found that she “fail[ed] to take even the most rudimentary steps to investigate the misuse of her registration.” Id. at 4042.

The Administrator in that case held that the physician had a “duty” to perform an investigation:

Consistent with a registrant’s obligation to “provide effective controls and procedures to guard against theft and diversion of controlled substances,” 21 C.F.R. 1301.71(a), every registrant has a duty to conduct a reasonable investigation upon receiving credible information to suspect that a theft or diversion has occurred.

Id.

In the present Kelly decision, the Administrator again reiterated the alleged “duty” in Jacinta Lewis, and based the new obligations on this “duty.” Kelly, 82 Fed. Reg. at 28685-86.  Yet as outlined above, the breadth and scope of these new duties goes far beyond any reasonable interpretation of the existing law or regulations.

In Jacinta Lewis, DEA cited the first portion of 21 C.F.R. § 1301.71(a), which states that all registrants “shall provide effective controls and procedures to guard against theft and diversion of controlled substances.”  However, it neglected to cite the next sentence:

In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in [21 C.F.R. §§ 1301.72-1301.76] as standards for the physical security controls and operating procedures necessary to prevent diversion.

21 C.F.R. § 1301.71(a) (emphasis added). Sections 1301.75 and 1301.76 apply to practitioners and list out the duties placed on practitioners to ensure effective controls against diversion.  These duties include storage of controlled substances, employee screening, and reporting upon discovery of theft or loss of controlled substances.  These specific regulations contain the universe of duties placed on practitioners to fulfill their obligation under 21 C.F.R. § 1301.71(a) to “provide effective controls and procedures to guard against theft and diversion of controlled substances.”

The duty the Administrator raised in Jacinta Lewis, and now the expanded duties  in Kelly, do not reasonably flow from DEA’s regulations.  In fact, they effectively amend the existing finite list of obligations placed on practitioners in the regulations.  In our opinion, DEA is shirking its responsibilities as a federal agency to engage in proper rulemaking by creating new investigatory obligations for practitioners.  It also appears to be another example where DEA believes registrants are required, if not qualified, to be expert investigators capable of rooting out diversion schemes. 

To DEA’s credit, it did not enforce the new obligations announced in Kelly on the practitioner in that case (note, though, that the practitioner in Jacinta Lewis was not so fortunate).  The Administrator held that

as this is a new and additional duty beyond that which was announced in Jacinta Lewis, which applies only to a practitioner’s receipt of information that his DEA registration is being misused, I conclude that it cannot be retroactively imposed on Respondent.

Kelly, 82 Fed. Reg. at 28686. 

Finally, the Administrator imposed a one-year suspension on the prescriber. This punishment does not seem warranted particularly where there is no allegation that the physician was not otherwise inappropriately prescribing and dispensing controlled substances.  In our opinion, a suspension or probation would be more appropriate in cases where a practitioner is required to complete some type of treatment program.  In this case, while the registrant certainly needed to maintain better records and security, remedial training would be helpful if it does not warrant a one-year suspension from being able to practice medicine with controlled substances.*

Our advice, in short, is that DEA registered practitioners consider boning up on their investigative skills, or at minimum, binge watch episodes of NCIS.

*We note that the Administrator ordered that if the physician intended to “dispense” controlled substances after the suspension, the physician would need to show evidence of having completed a “prescribing” course.   We suspect this was in error and that the Administrator meant that the physician would have to complete a controlled substance dispensing course.