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.

DEA LIES about MJ/MMJ and NO ONE challenges them ?

DEA admits that weed has never killed anyone

http://www.mauinews.com/opinion/letters-to-the-editor/2017/07/dea-admits-that-weed-has-never-killed-anyone/

The Drug Enforcement Agency-Department of Justice released its latest 94-page report, “Drugs of Abuse,” on June 28.

No deaths from cannabis, ever, Page 75; 88,000 deaths from alcohol (National Institute of Health). Got that?

The DEA notes that “no deaths from overdose of marijuana have been reported.” See Page 74, “Marijuana/Cannabis.”

On Page 74, the DEA admits that the THC travels to “specific cannabinoid receptor (sites) on human nerve cells.”

Human brains are already prewired for cannabis — maybe because the human body can generate its own THC. Not for alcohol, which kills brain cells.

The DEA acknowledged that cannabis use can cause “merriment, happiness, and even exhilaration at high doses,” as well as “disinhibition, relaxation, increased sociability, and talkativeness.” This illegal substance even causes “enhanced sensory perception, giving rise to increased appreciation of music, art, and touch.”

The government itself (NIH) says alcohol is responsible for 88,000 deaths per year in the United States, and 15.1 million Americans suffer from “Alcohol Use Disorder.” And, alcohol remains legal.

Interestingly, the alcohol industry remains one of the largest anti-marijuana legalization lobbies.

See: www.niaaa.nih.gov/alcohol-health/ overview-alcohol-consumption/alcohol-facts-and-statistics.

Your alcoholic readers are going to say, “He got it right again. Let’s drink to his knowledge and wisdom. Pour me another one.”

Hot Spots for the Opioid Crisis

Hot Spots for the Opioid Crisis

Problematic pockets in every state, CDC reports

https://www.medpagetoday.com/PainManagement/PainManagement/66477

New county-level data from the CDC highlight the extreme geographic variation in opioid prescription rates, with some areas showing average morphine equivalents per capita 10 times greater than those of less-impacted counties. As seen in the map below, Appalachia appeared to be one giant hot spot. But every state had at least one county with a high per-capita rate of prescribed opioid use.

Overall prescribing has fallen in the past few years, but the amount of opioids per person was still three times higher in 2015 than it was in 1999.

Those were the major findings in a Vital Signs release from the CDC, which focused on opioid prescribing. The data looked at trends through 2015, which notably does not include the agency’s 2016 opioid guidelines. The numbers will serve as a baseline to measure the impact of those guidelines going forward, said acting CDC Director Anne Schuchat, MD.

“The bottom line remains, we still have too many people getting these opioid prescriptions for too many days at too high a dose,” she said.

In a statement, Patrice A. Harris, head of the American Medical Association’s opioid task force, said she was pleased to see the report confirm that physicians have been making “more judicious” prescribing decisions. She also called for increased prescribing of naloxone and pointed to the AMA’s own task force recommendations.

Enough opioids were prescribed in 2015 to medicate every American for three weeks straight. To combat overprescribing, she said physicians should do so only when benefits outweigh risks. Behavioral and physical therapy and NSAIDs should be first choices.

The average days’ supply has increased annually for the past decade, from 13.3 in 2006 to 17.7 in 2015. If opioids are prescribed, the CDC recommends the duration of the prescription should be short — three days or less — and dose amounts should be as low as possible to achieve adequate pain relief.

In that way, the trendline is encouraging. The average daily morphine-equivalent dose per prescription has declined each year since 2006. Schuchat said she expects to see further reductions as the 2016 recommendations are implemented.

“We won’t be able to solve it overnight, but changes … hold promise that prescribing practices can improve,” she said.

PROPaganda “alive and well”

July 7, 2017

Scott Gottlieb, MD

Commissioner of Food and Drugs,

U.S. Food and Drug Administration

10923 New Hampshire Avenue

Silver Spring, MD 20993

RE: Docket No. FDA-2017-D-2497

Dear Dr. Gottlieb,

Physicians for Responsible Opioid Prescribing (PROP) is pleased that FDA intends to revise the Blueprint

for Prescriber Education for Extended-Release and Long-Acting (ER/LA) Opioids Risk Evaluation and

Mitigation Strategies (REMS). When the original Blueprint curriculum was released as a draft in 2011,

PROP urged FDA to make changes (see attached). Our 2011 letter was signed by some of the nation’s leading experts in the fields of Pain, Addiction, Public Health, Primary Care and Internal Medicine.

Unfortunately, FDA disregarded our requested changes.

PROP has serious concerns about the revised Blueprint curriculum. We believe that serious flaws in the original Blueprint remain unaddressed. Furthermore, the Blueprint curriculum contradicts key

recommendations found in the 2016 Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, which recommended “nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain” and the more recent Department of Veterans

Affairs (VA) and Department of Defense (DoD) Clinical Practice Guideline for Opioid Therapy for Chronic Pain which recommended “against initiation of long-term opioid therapy for chronic pain.” We believe

the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline.

Specific example of inconsistencies between the Blueprint and the CDC and VA/DOD guidelines include the following:

1) The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically

recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.

2) The CDC and VA/DOD guideline highlight the lack of evidence supporting long-term use of opioids for chronic pain. The Blueprint omits this critical topic.

3) The VA/DOD guideline rejected the recommendation for opioid rotation as a strategy for managing tolerance, and the CDC guideline notes that the practice is not supported by evidence.

The Blueprint encourages opioid rotation.

4) The VA/DOD guideline describes the practice of prescribing immediate release (IR) opioids to patients on ER/LA opioids for “breakthrough pain” as controversial and the CDC guideline notes that the practice is not supported by evidence. The Blueprint calls for teaching this practice.

5) The CDC guideline states that when opioids are prescribed for acute pain “three days or less will often be sufficient; more than seven days will rarely be needed.” The Blueprint omits this critical prevention recommendation.

Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS.

We believe the Blueprint should be revised to include the following educational messages for prescribers:

1) Opioids are rarely needed for chronic pain. Given the poor safety profile for long-term opioid therapy, indications should be restricted to those where evidence suggests that benefit predictably exceeds risk. There are many common pain conditions, particularly chronic pain conditions where a central component is dominant, for which no such evidence exists, and for which alternatives to opioids have demonstrated superior long-term efficacy, in addition to greater safety. This includes fibromyalgia, pelvic pain syndromes, irritable bowel disease, chronic non-structural back pain, other non-specific musculoskeletal disorders and headache.

Recent evidence-based guidelines for these conditions emphasize avoiding opioids.

2) ER/LA versus IR opioids. Evidence increasingly suggests that when opioids are required A) intermittent IR opioid therapy at low doses is often sufficient, B) tolerance, dependence and dose escalation are more likely to arise with continuous (round-the-clock) opioid therapy than with intermittent therapy. Tolerance and dependence reduce efficacy and increase risk. Many clinicians are under the false impression that physiological dependence is benign and that opioids can be easily tapered. REMS education should help correct this serious misunderstanding. It is well established that daily long-term use and higher dose therapy are associated with greater risk, including greater risk for addiction and death.

3) Evidence suggest that children and adolescents are at greater risk of developing future misuse and addiction when exposed to addictive drugs, even when the exposure is brief and for acute pain, such as after dental extraction. Young people have a greater range of options for treating pain without the need to resort to opioids.

4) While close monitoring of patients using opioids is essential, due to inherent risks of overdose, physiological dependence and prescription opioid use disorder, there is no evidence that recommended monitoring practices, including risk screening, treatment agreements, urine drug screening and regular follow-up visits, are effective in reducing risks of overdose or prescription opioid use disorder. There is evidence that reducing opioid prescribing and lowering opioid doses can reduce risks of prescription opioid use disorder and opioid overdose.

In summary, we believe a prescriber education effort to improve outcomes for patients with pain will be ineffective unless past misinformation on risks and benefits are explicitly and forcefully corrected.

Prescribers are in need of education that will allow them to properly weigh risks versus benefits before prescribing opioids. An educational effort that fails to do this and instead continues to equate treatment of pain with a prescription for opioids is likely to worsen rather than improve the opioid crisis.

Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control. In 2011, FDA disregarded concerns of experts about its REMS Blueprint and an opportunity to promote more cautious prescribing was lost. Over the past 6 years, opioid overprescribing has led to many lost lives and many new cases of addiction. We hope FDA gets it right this time.

Sincerely,

Jane C. Ballantyne, MD, FRCA

President, PROP;

Professor, Anesthesiology and Pain Medicine

University of Washington

Andrew Kolodny, MD

Executive Director, PROP;

Co-director, Opioid Policy Research Collaborative

Heller School for Social Policy and Management

Brandeis University

Gary M. Franklin, MD, MPH

Vice President, State Affairs, PROP;

Research Professor, Departments of Environmental Health, Neurology, and Health

Services

University of Washington;

Medical Director, Washington State Department of Labor and Industries

Michael Von Korff, ScD

Vice President, Scientific Affairs, PROP;

Senior Investigator,

Kaiser Permanente Washington Health Research Institute

Chris Johnson, MD

Board of Directors, PROP;

Chair, MN Dept. of Human Services Opioid Prescribing Work Group;

Board of Trustees, Minnesota Medical Association

Anna Lembke, MD

Board of Directors, PROP;

Chief of Addiction Medicine

Stanford University School of Medicine

Rosemary Orr, MD

Board of Directors, PROP;

Professor of Anesthesiology and Pain Medicine,

University of Washington and Seattle Children’s Hospital

Danesh Mazloomdoost, MD

Board of Directors, PROP;

Medical Director

Wellward Regenerative Medicine

Jon Streltzer, M.D.

Board of Directors, PROP;

Professor Emeritus of Psychiatry,

University of Hawaii School of Medicine

Sheriff won’t let officers use Narcan, says life-saving drug not helping heroin epidemic

Sheriff won’t let officers use Narcan, says life-saving drug not helping heroin epidemic

http://www.foxnews.com/health/2017/07/07/sheriff-wont-let-officers-use-narcan-says-life-saving-drug-not-helping-heroin-epidemic.html

An Ohio sheriff is taking a stand in the war on heroin addiction that he said will get at the root of the epidemic, and that seems to fly in the face of standard police practices.

Sheriff Richard K. Jones of Butler County, Ohio, told the Cincinnati Enquirer that he believes the drug naloxone, a substance used to revive overdose victims that is known by its brand name Narcan, is more trouble than its worth.

“I don’t do Narcan,” Jones told the Enquirer, noting that his deputies “never carried it… nor will they.”

Jones’ position raises eyebrows for a number of reasons. In his state alone, health care costs related to the epidemic totaled some $1.1 billion in 2015, with Ohio tallying more prescription opioid overdose deaths that same year than any other state in the nation.

And it’s not as if his county has been immune, either. According to the Ohio Department of Health, there were less than two dozen unintentional drug overdose deaths in Butler county in 2003. By 2015, that number had skyrocketed to 195.

In June, Middletown city council member Dan Picard proposed a three-strike style policy for repeat-overdose victims. He said his proposal wasn’t meant to address the heroin issue, but to help the city budget cope with the high uptick in overdose calls. 

“My proposal is in regard to the financial survivability of our city,” Picard told The Washington Post. “If we’re spending $2 million this year and $4 million next year and $6 million after that, we’re in trouble. We’re going to have to start laying off. We’re going to have to raise taxes.” 

In Dayton, Ohio, the drug has been used to reverse overdoses more than 160 times since December 2015.

While there are no laws mandating the use of naloxone by law enforcement, data from the North Carolina Harm Reduction Coalition (NCHRC), a group committed to getting the drug into the hands of community members and law enforcement, suggests that 1,214 law enforcement agencies nationwide are using it as of December 2016.

For Jones, these numbers mean little when weighed against the safety of his deputies. Jones said that users can often become violent, or start vomiting once the drug is administered, and that for his officers “to get on the ground and spray it in their nose is simply dangerous.”

Jones told Fox News that another point he thinks is being missed in the debate over Narcan is that the drug has “helped revive and save some lives but not bring down the usage of heroin.”

Jones said the heroin problem is so bad in his county that “heroin parties” are being held with designated Narcan providers who can buy it at a health department. 

He said there have been at least three babies born in his county jail in the last 18 months that were addicted to heroin.

“I’ve held these little kids and their legs quiver,” Jones said. ” It’s sad.”

Jones isn’t alone in his reluctance to have officers carry the drug.

Chief Craig Bucheit of Hamilton, Ohio, won’t have his officers carry Narcan because the paramedics do.

“It would duplicate efforts,” Bucheit told Fox News.

The idea that using Narcan borders on a medical procedure, and thus should be left to people like EMT’s, is a philosophy embraced by some officers, as well. According to a man identified as a senior officer serving with a North Carolina municipal police department, the issue of whether officers should be carrying Narcan presents something of a Pandora’s Box.

“Officers have years of training and experience in enforcing the law and making arrests,” the officer wrote in Calibre Press. “It takes a unique mindset and specialized skills. It’s not realistic to ask an officer to switch all of that off in an instant and become a medical professional. Where do we draw the line? Do officers carry EpiPens? Anti-seizure medication? Nitroglycerin pills? These are things that can all save lives, too.”