Email steve@steveariens.com 502-938-2414
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Filling so many prescriptions so fast that a pharmacist’s biggest concern is the ability to use the bathroom. Our study showed compliance with dispensing laws to be around 20%…so any wonder as to how the apetite for drug use amongst our citizens grew? Look to the insurance contracts and the chains that willingly signed them.
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PHILADELPHIA — Doctors need no special training to prescribe the opioid pain pills widely blamed for fueling a national addiction crisis.
But prescribing the medicine considered the gold standard for addiction treatment is another story entirely.
Opioid-based medications that help curb cravings, prevent overdoses, and allow drug users to get through the day without the fear of painful withdrawal have been proven to help people achieve lasting recovery far more reliably than quitting without medical help.
But, doctors say, federal regulations surrounding these treatment medications — and the special physician training and monitoring required to dispense them — have deterred many of their colleagues from obtaining the license needed to prescribe the drug.
Just 3 percent of doctors in Pennsylvania and 4 percent of those in Philadelphia have the waiver needed to prescribe the treatment medicine buprenorphine, according to the U.S. Drug Enforcement Administration. And the problem is worse in rural areas: Nearly 30 percent of rural Americans live in a county without a buprenorphine provider, according to new research from the Pew Charitable Trusts.
Methadone, the most heavily regulated opioid-based treatment drug, can only be dispensed at specially licensed clinics, and often requires users to visit daily for the drug and for counseling. Buprenorphine can be taken in one’s own home, and is available in pill form, as a longer-acting shot, and as the brand-name drug Suboxone, which combines buprenorphine with the overdose-reversal drug naloxone.
There are differences between the two opioid-based medicines, but both are longer-acting and don’t produce the peaks and troughs associated with short-term opioids, like heroin, making them useful for people in treatment.
Physicians who want to prescribe buprenorphine need a license commonly known as an x-waiver from the DEA and the U.S. Substance Abuse and Mental Health Services Administration, after taking an eight-hour training course.
The American Society of Addiction Medicine’s eight-hour training course, one of several on offer on the Substance Abuse and Mental Health Services Administration’s website, identifies its “learning objectives” as teaching doctors how to apply for the waiver, to identify patients who’d benefit from buprenorphine and to recognize other illnesses associated with opioid addiction.
From there, a doctor can treat up to 30 patients in their first year with the license, 100 in their second year, and are capped at 275 in their third.
Another irony: These restrictions apply only to doctors prescribing these medications for a substance use disorder. There’s no special license required to prescribe methadone for pain. And though buprenorphine is not FDA-approved for pain, some providers are prescribing it off-label without an x-waiver.
The DEA’s local spokesman, Pat Trainor, said the x-waiver “allows doctors to help people to get medication-assisted treatment in their communities — and not have to go to a narcotic treatment program, so as to avoid the stigma of that,” he said, and added that primary care doctors not accustomed to treating addiction need training to do so.
But doctors who treat people with addiction say the regulations themselves create stigma, and discourage more doctors from seeing substance use disorder as a disease that they can treat.
“Doctors have basically been taught and raised and are functioning in a system where addiction is always someone else’s job,” said Priya Mammen, an emergency physician and public health advocate from South Philadelphia. “The regulations treat these medications as qualitatively different from any other medication we prescribe. It gives off the impression that addiction is a specific kind of illness — but from all the literature, all the data we know, it’s a chronic disease. But it’s not treated like that in the system.”
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Jeanmarie Perrone, the director of the division of medical toxicology in the University of Pennsylvania’s emergency department, has worked to expand her system’s buprenorphine program.
She believes doctors should still get some kind of training before beginning to prescribe buprenorphine, and has helped implement classic behavioral incentives to get more doctors into training.
The university paid for x-waiver training courses for its physicians, and allowed them to take the course online. They sent emails telling stories of Penn patients’ success on Suboxone. “Each week they got an email sort of nudging them along in the process, saying, ‘It’s not too late to sign up, you still have time to finish this — and look what your colleagues are doing (with buprenorphine),” Perrone said.
About 75 percent of Penn’s full-time emergency department staff now have x-waivers. Perrone said her goal is to create “a culture of buprenorphine in the whole city.” She is pinning her hopes largely on newer doctors and medical students whose training increasingly includes addiction medicine.
Most physicians who obtain an x-waiver will likely not hit their prescribing cap. Many doctors who get the x-waiver don’t even use it, said Leo Beletsky, an associate professor of law and health sciences at Northeastern University’s law school.
“It’s not enough to get people waivered,” he said. “You still have these issues around stigma. People don’t want to submit themselves to periodic DEA audits. They just don’t want to deal with this element of their practice.”
Where the caps can present challenges, Beletsky said, is in larger clinical settings. In Philadelphia’s men’s prisons, a just-launched Suboxone program has been paused because the prisons’ doctors have already hit their prescribing caps, WHYY reported last month.
Bruce Herdman, the prisons’ chief of medical operations, said his doctors will be able to expand their prescribing caps to 275 patients each by midsummer. Until then, new inmates with substance use disorder are being directed to an abstinence-only treatment program that includes cognitive behavioral therapy.
The prison is also looking to hire doctors with higher buprenorphine caps in the meantime.
“We have a great treatment to provide, and I don’t understand the logic behind this federal regulation,” he said.
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https://wvrecord.com/stories/511741378-woman-s-estate-blames-medical-care-providers-for-her-death
HUNTINGTON — An administrator is suing a medical providers, citing alleged negligence and vicarious liability.
Kateland McCreery filed a complaint in Cabell Circuit Court against the defendants alleging that they deviated from acceptable standards of medical care.
According to the complaint, McCreery alleges that on Aug. 15, 2016, Teresa Ann Watts was presented to St. Mary’s emergency room and was misdiagnosed with heroin abuse. The misdiagnosis remained in her record and likely caused the negative effects on the medical care she received on subsequent visits, including after a motor vehicle accident on Sept. 6, 2016, when they failed to indicate that she was suffering from pulmonary hypertension and again on Oct. 28, 2016, which revealed yet again a severe pulmonary hypertension that led to her collapsed and death on Oct. 31, 2016, just seven minutes after being discharged despite the significant abnormal vital signs. Thus, the decedent’s family has and will suffer from sorrow, mental anguish, loss of solace, companionship, comfort, guidance, care and assistance because of her death.
The plaintiff holds Dr. Tarun Popli, St. Mary’s Hospitalist Services LLC, et al. responsible because they allegedly denied Watts adequate treatment, failed to re-intubate after her endotracheal tube had become dislodged during the ambulance ride and denied her the opportunity to be resuscitated.
The plaintiff requests a trial by jury and seeks judgment against the defendants for general and special damages, punitive damages, interest, attorney’s fees, costs and other relief that the court may deem just. She is represented by David H. Carriger and L. Dante diTrapano of The Calwell Practice LC in Charleston.
Cabell County Circuit Court Case number 18-C-638
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The CMS opioid overutilization criteria may not accurately identify patients at risk for opioid use disorder or overdose, according to a research letter published in JAMA.
“Based on the CMS opioid overutilization criteria, the majority of the Medicare Part D patients diagnosed with opioid use disorder or overdose were not identified as ‘opioid overutilizers,’ and more than half of ‘opioid overutilizers’ did not develop opioid use disorder or overdose during the study period,” Yu-Jung Jenny Wei, PhD, Msc, assistant professor of pharmaceutical outcomes and policy at the College of Pharmacy, University of Florida, told Healio Primary Care Today. “The CMS criteria seem not to be a good clinical marker for identifying patients at risk for opioid-related adverse events.”
To estimate the predictive value of the CMS opioid overutilization criteria in correctly identifying prescription opioid users at risk for opioid use disorder or overdose, researchers used the 5% Medicare sample from 2011 through 2014 from which they identified between 142,036 and 190,320 beneficiaries who had at least one opioid prescription filled every 6 months, were continuously enrolled in Parts A, B and D and who met the CMS criteria as opioid overutilizers. Opioid utilization was defined as receiving prescription opioids with a mean daily morphine equivalent dose 90 mg from more than three prescribers and pharmacists or receiving a mean daily morphine equivalent dose of 90 mg by more than four prescribers.
Breaking the study period into three 6-month cycles, researchers examined the performance measures over time to assess if accuracy changed with increasing efforts to combat the opioid crisis.
During any 6-month cycle, the proportion of beneficiaries who met CMS overutilization criteria ranged from 0.37% to 0.58%.
Throughout the entire 18-month follow-up, researchers found that the proportion of patients who had a diagnosis of opioid use disorder or overdose increased from 3.91% in the first cycle to 7.55% in the last.
In addition, researchers observed low sensitivity of the criteria which ranged from 4.96% (95% CI, 4.42-5.58) at the beginning of the study period to 2.52% (95% CI, 2.26-2.81) at the end (P < .001).
Positive predictive values ranged from 35.2% (95% CI, 32.14-38.38) to 50.95% (95% CI, 47-54.86) and specificity was greater than 99% in all cycles.
“CMS has required their Medicare Part D plans to implement the criteria,” Wei said. “It’s unclear the effectiveness of such criteria in stopping our national opioid epidemic and whether there are unintended consequences of such implementation. As we are developing solutions to the opioid crisis, it’s important for policymakers, health care providers, hospitals and health insurance companies to be aware that solely relying on opioid prescription data is likely to be ineffective in identifying the high-risk populations for interventions.” – by Melissa J. Webb
For more information: Yu-Jung Jenny Wei, PhD, MSc, can be reached at jenny.wei@cop.ufl.edu.
Disclosures: The authors report no relevant financial disclosures.
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One day after a customer opened fire inside a Garner Walgreens, wounding two people before he was shot by a Wake County deputy at a nearby restaurant, some pharmacists are saying threats are a daily occurrence on the job.
Pharmacist Gina Tandarich felt scared when she learned her former co-worker was one of the victims of the drug store shooting.
“It’s just sheer terror of what those people are going through,” she said.
Tandarich used to work with Sarah Wright, the 31-year-old pharmacy manager who remains in critical condition following Thursday’s shooting. She said she knew what Wright and her coworkers must have been going through.
“I’ve been spit on multiple times, I’ve had people throw their prescription bottles, their prescriptions, pocket books, cellphones, bottles of stuff that was over the counter at me,” Tandarich said.
Authorities said the shooting at the Walgreens at 1116 U.S. Highway 70 stemmed from an issue customer Stephen Denning experienced with his medication.
Tandarich said the verbal and sometimes physical attacks and threats are all part of the safety concerns she’s had about being a pharmacist for years.
Rachel Factor shares those same concerns. She’s been a pharmacist for two years and, in that time, she said she’s experienced her share of customers who were angry about their prescriptions.
“I’ve had people scream, scream and holler and yell. Sometimes they threaten to call the police,” Factor said. “It can be difficult.”
Factor and others said telling someone their prescription can’t be filled or is delayed can be a difficult conversation at times. Ultimately, though, they said they’re just trying to do their job and follow the law.
“With the opioid crisis, the laws are getting stricter and the more strict they get, the worse it is on us, because people want that medicine and they want it now,” Tandarich said.
“Anytime you’re dealing with the public, you never know how people are going to react. You just have to hope for the best and try to provide the best service that you can,” Factor said.
Wright, according to friends, is alert and continues to recover at WakeMed. Her co-worker, Brandon Gordon, remains in critical condition.
Denning also remained at WakeMed on Friday night. When he is released, he will be taken into custody and charged with one count of attempted murder and one count of assault with a deadly weapon.
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Halena Gazelka, M.D., a practicing Mayo Clinic pain specialist, was chosen to give testimony to the Senate HELP Committee Hearing on ‘Managing Pain During the Opioid Crisis’ on February 12, 2019. She also served on the HHS Pain Management Inter-Agency Task Force along with another hearing witness, Cindy Sternberg.
Dr. Gazelka did nothing to help the chronic pain patient or the doctors providing care, but instead reinforced government overreach into medicine and showed support of government attacks on pain management physicians. With witnesses like this, who needs enemies?
Dr. Gazelka’s primary testimony was in giving accolades to Mayo Clinic’s work, the “Mayo Clinic Guidelines for Acute and Chronic Opioid Prescribing”. She touts their work on reducing reliance on opioid medications while supposedly ensuring that patient needs for pain management are reasonably met, claiming improved pain management for their patients while at the same time, having a drastic reduction in excess opioid availability. For example, opioid prescriptions were reduced 50% in surgical practice, while supposedly maintaining patient satisfaction.
She mentions their non-opioid therapy treatments such as physical therapy, occupational therapy, biofeedback and nursing, along with cognitive behavioral therapy and mental health programs emphasizing the management of chronic pain without the use of opioids.
Her recommendations to the hearing (first mistake was in referring to the “opioid epidemic”) were in condoning federal government’s unconstitutional overreach into medicine by recommending that the government
The only pro-pain patient comment was that the physician should have the flexibility to manage and monitor patients individually. But at the same time, reading between the lines, she gives credence to the government attacks on physicians when she recommends “proactively addressing high-risk prescribing practices”. As long as physicians are being attacked for doing their job, pain patients will NOT get the treatment they might need.
“…we believe that the most appropriate policies will encourage responsible behavior, promote the use of effective non-opioid treatments where possible and proactively address high-risk prescribing practices. This approach is the most effective means of addressing the crisis before us without compromising legitimate patient care needs.”
She recommends the development of guidelines for opioid and non-opioid prescribing and therapies and then using these guidelines for measuring clinician practice and performance as part of value-based payment for services, such as the Quality Payment Program. She also recommends that Medicare and Medicaid should develop additional coverage of and reimbursement for non-opioid treatment regimens.
Then she spouts government propaganda, stating
“There is little medical evidence in support of long-term use of opioids in treating chronic pain.”
How could any practicing pain management physician make such a statement unless she knows where her bread is being buttered?
And then, to add insult to injury, she supports the illegal government watchdog activity against doctors stating
“optimizing existing prescription drug monitoring programs (PDMP) at the national level should also be strongly pursued.”
The PDMP programs are being used by the federal government to identify and target doctors who are prescribing opioids. A doctor in her position should be asking that the PDMP programs only be accessed by the medical professionals and pharmacists, as the programs were originally intended—not for law enforcement.
And although this hearing was focused on pain treatment, she further enforces the fake opioid addiction crisis calling for Medicare and Medicaid programs to embrace integrated, multi-faceted approaches to addiction treatment, increased treatment programs for opioid addiction including pushing medicine assisted therapy (MAT).
So basically, through Benedict Arnold physicians like Dr. Gazelka, the Senate committee heard what they wanted to hear.
Below you will find the full testimony printed, as well as my summary. The actual hearing can be heard HERE.
Gazelka testimony to HELP Hearing 2-12-19
Halena Gazelka, M.D Testimony Summary 2-12-19
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