Archive for Opioid

POLL: Rural Americans “Profoundly Worried” about Opioid Crisis

POLL: Rural Americans “Profoundly Worried” about Opioid Crisis

BOSTON — According to a new NPR/Robert Wood Johnson Foundation/Harvard T.H. Chan School of Public Health poll, rural Americans cite drug/opioid abuse as the biggest problem facing their local community (25 percent), followed by economic concerns (21 percent).

The poll of 1,300 adults living in the rural United States found that a majority of rural Americans (57 percent) say opioid addiction is a serious problem in their community, and about half (49 percent) say they personally know someone who has struggled with opioid addiction. “What has been widely recognized is the serious economic problems facing rural communities today. What has not is that drug/opioid abuse in rural communities is now viewed with the same high level of concern as economic threats,” said Robert J. Blendon, co-director of the survey and the Richard L. Menschel Professor of Health Policy and Political Analysis at Harvard T.H. Chan School of Public Health.

On economic issues, rural Americans largely hold negative views of their local economy, but nearly one-third have seen economic progress in recent years. A majority of rural Americans (55 percent) rate their local economy as only fair or poor, while over the past five years, 31% say their local economy has gotten better, and 21 percent say it has gotten worse.

Rural Americans are divided over whether they expect the major problems facing their communities will be solved in the near future, and a majority believe outside help will be necessary to solve these problems. About half of rural Americans (51 percent) say they are confident that major problems facing their local community will be solved in the next five years, and 58 percent believe their community needs outside help to solve its major problems. Among those who say their community needs outside help, about six in ten rural Americans (61 percent) think the government will play the greatest role in solving major problems facing their local community.

In addition, many rural Americans are optimistic about the future. A majority of rural parents (55 percent) think their children will be better off financially than themselves when their children become their age. “There is no single vision of life in small-town America, just as there is no one-size-fits-all solution to improving health,” said Richard Besser, president and CEO of the Robert Wood Johnson Foundation. “But we see in this diversity a common thread — an understanding that health and wellbeing means many things: better access to health care, good job opportunities, and quality education for all.”

View the complete poll findings.

Key Findings

Many rural Americans are optimistic about future jobs

Many rural Americans are optimistic about future job opportunities, but they recognize new training and skills may be important for the future rural workforce. Looking ahead five years, 39 percent of rural Americans believe the number of good jobs in their local economy will increase, while 47% believe they will stay the same.

About one-third of rural Americans (34 percent) say it will be important for them to get training or develop new skills in order to keep their job or find a better job in their local community in the next five years, including 25 percent of all rural adults who say they will need computer and technical skills and 24% who say they will need a first or more advanced educational degree or certificate.

Education, job growth, and health care will improve rural economies

When it comes to improving their local economy, a majority of rural Americans think the following approaches would be very helpful: creating better long-term job opportunities (64 percent), improving the quality of local public schools (61 percent), improving access to health care (55 percent), and improving access to advanced job training or skills development (51 percent). (See table below.)

Rural Americans’ Views on Approaches to Improving the Local Rural Economy

 Q44. Recently, a number of leadership groups have recommended different approaches for improving the economy of communities like yours. For each of the following, please tell me how helpful you think this approach would be for improving the economy of your local community…[insert item]. Do you think this would be very helpful, somewhat helpful, not too helpful, or not at all helpful? 

Percent saying “very helpful”
1.     Creating better long-term job opportunities 64%
2.     Improving the quality of local public schools 61%
3.     Improving access to health care 55%
4.     Improving access to advanced job training or skills development 51%
5.     Improving local infrastructure like roads, bridges, and public buildings 48%
6.     Improving the use of advanced technology in local industry and farming 44%
7.     Improving access to small business loans and investments 44%
8.     Improving access to high-speed internet 43%

NPR/Robert Wood Johnson Foundation/Harvard T.H. Chan School of Public Health, Life in Rural America, 6/6/18 – 8/4/18. Q44. Questions asked among a half-sample of respondents: Half Sample A N=669, Half Sample B N=631 rural adults ages 18+.

There are sizable gaps between how minorities and non-minorities believe people are treated in rural communities

Despite low recognition of discrimination against minority groups in their local community by all rural Americans, rural adults belonging to several minority groups see much higher rates of discrimination against members of their group. For example, only 21 percent of all rural Americans say that generally speaking, they think Latinos are discriminated against in their local community, yet 44 percent of Latinos living in rural areas say they think Latinos are discriminated against in their local community. A majority of Latinos (56 percent) also say they think recent immigrants are discriminated against in their local community, compared to 29 percent of all rural Americans who share this view.

*Not enough cases for analysis. NPR/Robert Wood Johnson Foundation/Harvard T.H. Chan School of Public Health, Life in Rural America, 6/6/18 – 8/4/18. Q19. Total N=1,300 rural adults ages 18+.

Methodology

The poll in this study is part of an on-going series of surveys developed by researchers at the Harvard Opinion Research Program (HORP) at Harvard T.H. Chan School of Public Health in partnership with the Robert Wood Johnson Foundation and National Public Radio. The research team consists of the following members at each institution.

Harvard T.H. Chan School of Public Health:  Robert J. Blendon, Professor of Health Policy and Political Analysis and Executive Director of HORP; John M. Benson, Senior Research Scientist and Managing Director of HORP; Mary T. Gorski Findling, Research Associate; Logan S. Casey, Research Associate in Public Opinion; Justin M. Sayde, Administrative and Research Manager.

Robert Wood Johnson Foundation: Carolyn Miller, Senior Program Officer, Research and Evaluation; and Jordan Reese, Director of Media Relations.

NPR: Andrea Kissack, Senior Supervising Editor, Science Desk; Joe Neel, Deputy Senior Supervising Editor, Science Desk; Vickie Walton-James, Senior Supervising Editor, National Desk; Laura Smitherman, Deputy Senior Supervising Editor, National Desk; Luis Clemens, Supervising Editor, National Desk; Ken Barcus, Midwest Bureau Chief.

Interviews were conducted by SSRS of Glen Mills (PA) via telephone (including both landline and cell phone) using random-digit dialing, June 6 – August 4, 2018, among a nationally representative probability-based sample of 1,300 adults age 18 or older living in the rural United States. Interviews were conducted in English and Spanish. The margin of error for total respondents is ±3.6 percentage points at the 95% confidence level. The sample of Rural Americans is defined in this survey as adults living in areas that are not part of a Metropolitan Statistical Area (MSA). This is the definition used in the 2016 National Exit Poll.

Possible sources of non-sampling error include non-response bias, as well as question wording and ordering effects. Non-response in telephone surveys produces some known biases in survey-derived estimates because participation tends to vary for different subgroups of the population. To compensate for these known biases and for variations in probability of selection within and across households, sample data are weighted by cell phone/landline use and demographics (sex, age, education, and Census region) to reflect the true population. Other techniques, including random-digit dialing, replicate subsamples, and systematic respondent selection within households, are used to ensure that the sample is representative.

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New Interactive Map Shows How Alabama Measures Up in the National Opioid Crisis

New Interactive Map Shows How Alabama Measures Up in the National Opioid Crisis

WASHINGTON, Oct. 4, 2018 – A new interactive data tool launched by the United States Department of Agriculture and NORC at the University of Chicago shows for the first time an in-depth, county-by-county, look at the impact of the opioid epidemic across the entire country. The tool is intended to help leaders build grassroots strategies to better address the needs in their communities.

The opioid misuse Community Assessment Tool enables users to overlay substance misuse data against socioeconomic, census and other public information. This data will help leaders, researchers and policymakers assess what actions will be most effective in addressing the opioid crisis at the local level.

USDA’s launch of the Community Assessment Tool closely follows President Trump’s declaration of October as National Substance Abuse Prevention Month. Approximately 72,000 Americans died from drug overdoses in 2017; 49,000 of those deaths involved an opioid. Many of these deaths have been fueled by the misuse of prescription pain medications. The severity of the current opioid misuse crisis requires immediate action.

Rural Development partnered with the Walsh Center for Rural Health Analysis at NORC at the University of Chicago to create the Community Assessment Tool. NORC at the University of Chicago is a non-partisan research institution that delivers reliable data and rigorous analysis to guide critical programmatic, business and policy decisions. Today, government, corporate and nonprofit organizations around the world partner with NORC to transform increasingly complex information into useful knowledge. The Walsh Center focuses on a wide array of issues affecting rural providers and residents, including health care quality and public health systems.

In April 2017, President Trump established the Interagency Task Force on Agriculture and Rural Prosperity to identify legislative, regulatory and policy changes that could promote agriculture and prosperity in rural communities. In January 2018, Secretary Perdue presented the Task Force’s findings to President Trump. These findings included 31 recommendations to align the federal government with state, local and tribal governments to take advantage of opportunities that exist in rural America. Increasing investments in rural infrastructure is a key recommendation of the task force.

To view the report in its entirety, please view the Report to the President of the United States from the Task Force on Agriculture and Rural Prosperity (PDF, 5.4 MB). In addition, to view the categories of the recommendations, please view the Rural Prosperity infographic.

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ProAssurance and Sure Med Compliance Join to Fight Opioid Crisis

ProAssurance and Sure Med Compliance Join to Fight Opioid Crisis

BIRMINGHAM ─ ProAssurance Corporation has announced an exclusive affiliation with Sure Med Compliance® (SMC) to promote the use of SMC’s Care Continuity Program® (CCP) in an effort to help combat the opioid epidemic in the United States.

ProAssurance-insured physicians will be eligible for discounted access to Sure Med’s Care Continuity Program

The CCP helps physicians and other health care providers develop and maintain responsible prescribing practices for opioids and other scheduled medications by equipping them with tools to verify patients suitable for opioid therapy, identify with significant risk factors, and closely monitor the effects of treatment over time.

“As an industry leader, we are acutely aware of the devastating effects of the opioid epidemic in this country. We are concerned about the epidemic’s professional liability implications for physicians and other healthcare providers, as well as its broader effects on the healthcare system in general. We are proud to affiliate with Sure Med Compliance to offer our insureds exclusive discounted access to this cutting-edge approach to patient safety and effective treatment, ” said Howard H. Friedman, president of ProAssurance’s Healthcare Professional Liability Group.

John Bowman, Sure Med Compliance’s Chief Executive Officer, emphasized the importance of the newly formed affiliation.

“Our Care Continuity Program provides a proven path toward optimal outcomes for patients whose treatment requires the use of opioids and other potentially addictive drugs,” Bowman said. “In turn, CCP helps physicians avoid potential liability issues, which has always been a focus of ProAssurance and why we are so excited about this affiliation. We are confident their national footprint will help Sure Med Compliance reach more physicians and assist more patients than ever before.”

Through this affiliation, ProAssurance insureds who meet certain eligibility requirements will have access to an exclusive 30-day free trial of the CCP. ProAssurance insureds who elect to continue using the Care Continuity Program will receive exclusive discounted rates. ProAssurance insureds may contact Sure Med Compliance to determine eligibility and initiate a 30-day free trial by visiting www.suremedcompliance.com/proassurance or calling (866) 517-2771.

“As a practicing pain management specialist, I have experienced firsthand the challenges physicians face in deciding to prescribe controlled substances. Using the Sure Med Compliance CCP in my practice has helped me ensure proper documentation and address potential issues before they occur,” said Sure Med Compliance’s Medical Director David Herrick, M.D., of Montgomery. Dr. Herrick is a past president of the Medical Association of the State of Alabama and a former member of the Alabama Board of Medical Examiners.

ProAssurance’s Chief Medical Officer Hayes V. Whiteside, M.D., encouraged physicians with ProAssurance to learn more about the CCP.

“Our commitment to provide our insureds with exclusive discounted access to the Sure Med Compliance CCP underscores ProAssurance’s commitment to ensure physicians and other health care providers are equipped with the risk management tools and services necessary to deal with the ever-changing realities of their chosen profession,” Dr. Whiteside said. “All ProAssurance insureds who regularly prescribe opioids, especially those who prescribe for chronic pain, are encouraged to engage Sure Med Compliance to learn more about how their Care Continuity Program can help them develop and maintain safe and responsible prescribing practices, which should lead to better outcomes for their patients.”

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Study: Doctors Reduced Opioid Prescriptions after Learning a Patient Overdosed

Study: Doctors Reduced Opioid Prescriptions after Learning a Patient Overdosed

Will clinicians become more careful in prescribing opioids if they are made of aware of the risks of these drugs first-hand? That was one of the core questions researchers set out to explore in a new study published in the August 2018 issue of Science. In doing so, they found that many clinicians do not learn of the deaths of those patients who overdose as they just disappear from their practice, outcomes unknown.

This disconnect from the personal experience of losing a patient due to fatal overdose, related to a prescription for opioids to relieve pain, makes the problem of the nation’s opioid crisis seem remote – statistics happening elsewhere. While the epidemic continues to exert its outsized impact, opioid prescription-writing levels have not responded with adequate risk-benefit analysis by prescribers tasked with caring for patients with complaints around pain.

“Clinicians may never know a patient they prescribed opioids to suffered a fatal overdose,” explained lead author Jason Doctor. “What we wanted to evaluate is whether closing that information gap will make them more judicious prescribers.” Doctor is the Director of Health Informatics at the USC Schaeffer Center for Health Policy & Economics and Associate Professor at the Price School of Public Policy.

The study leverages behavioral insights and psychology to give prescribers personal experience with the risk associated with opioids and finds that when a clinician learns one of their patients had suffered a fatal overdose they reduced the number of opioids prescribed by almost 10 percent in the following three months.

Doctor and his colleagues conducted a randomized trial between July 2015 and June 2016 of 861 clinicians who had prescribed to 170 patients who subsequently suffered a fatal overdose involving prescription opioids. Half the clinicians, who all practiced in San Diego County, were randomly selected to receive a letter from the county medical examiner notifying them that a patient they had prescribed opioids to in the past twelve months had a fatal overdose. The letter, which was supportive in tone, also provided information from the Centers for Disease Control and Prevention on safe prescribing guidelines, nudging clinicians toward better prescribing habits.

In the three months after receiving the letter, prescribing decreased by 9.7 percent compared to the control group who didn’t receive a letter. Furthermore, clinicians who received the letter were 7 percent less likely to start a new patient on opioids and less likely to prescribe higher doses.

The results are particularly exciting given that numerous, more traditional state regulations which often involve mandated limits on opioids have not been shown to have much impact. The authors point to numerous reasons why this study showed more promising results including its simplicity, that the letters still allows clinicians to decide when they will prescribe opioid analgesics and that it provides an important missing piece of clinical information to them.

This intervention is easily scalable nationwide as existing state and national resources already track the information necessary around overdose deaths associated with prescription and illicit drugs.

“Interventions that use behavioral insights to nudge clinicians to correct course are powerful, low-cost tools because they maintain the autonomy of the physician to ultimately decide the best course of care for their patient,” said Doctor. “In this case, we know opioids, though beneficial to some patients with certain conditions, come with high risks that the doctor may not fully grasp when observing patients in the clinic. Providing information about the harm that would otherwise go unseen by them gives physicians a clearer picture.”

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Co-authors include Andy Nguyen, Roneet Lev, Jonathan Lucas, Tara Knight, Henu Zhao, and Michael Menchine. Funding for the study was provided by the California Health Care Foundation and the National Institute on Aging at the National Institutes of Health (R21-AG057395-01).

The Leonard D. Schaeffer Center for Health Policy & Economics, one of the nation’s leading health policy centers, aims to measurably improve value in health through evidence-based policy solutions, research and educational excellence, and private and public sector engagement. The Center is a unique collaboration between the USC School of Pharmacy and the Sol Price School of Public Policy at the University of Southern California (USC).

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Reducing Opioid Prescriptions for One Operation Can Have a Spillover Effect to Other Procedures

Reducing Opioid Prescriptions for One Operation Can Have a Spillover Effect to Other Procedures

Study results show revised recommendations resulted in about 17 fewer pills being dispensed per patient for four major operations.

CHICAGO – To curb the use of opioids after major elective operations and prevent these pain relievers from falling into the wrong hands, surgeons at the University of Michigan developed prescribing recommendations based on published medical evidence for one operation, gallbladder removal, and then discovered a spillover effect that led them to prescribe roughly 10,000 fewer pills for other major operations, according to study results appearing as an “article in press” on the website of the Journal of the American College of Surgeons ahead of print.

“We changed how many opioids we dispense or prescribe to patients after laparoscopic cholecystectomy, which is performed for gallbladder removal,” said lead study author Michael Englesbe, MD, FACS, a transplant surgeon in the department of surgery, University of Michigan Health System, Ann Arbor.  “As an unintended spillover consequence, the change had a significant impact on how we prescribe for other procedures.”

The study noted that surgeons have been known to overprescribe opioids after operations, resulting in leftover pills that can sometimes be diverted for illegal use. Dr. Englesbe and coauthors set out to determine if prescribing guidelines for one specific operation would have an impact on reducing opioids prescribed for other surgical procedures.

In a previous study, * Dr. Englesbe and coauthors described their recommendations for opioids after minimally invasive gallbladder removal: 15 tablets of hydrocodone/ acetaminophen 5/325 mg or 10 tablets of oxycodone 5 mg; along with encouraging the use of non-opioid pain medications such as acetaminophen or ibuprofen.  They found that after implementing the recommendation, opioid prescriptions also declined significantly for four other types of major operations—thyroidectomy or parathyroidectomy (removal of all or part of the thyroid gland), and laparoscopic, or minimally invasive, appendectomy (surgical removal of the appendix), inguinal hernia repair, and sleeve gastrectomy (a weight-loss operation in which a portion of the stomach is removed).

The study involved reviews of 1,158 patient charts, 558 who had operations before the opioid recommendations were implemented and 600 over 10 months afterward to compare surgeons’ prescribing behavior.  For sleeve gastrectomy, the most extensive operation, the average prescription after surgery went from around 89 pills before the recommendations to around 58 afterward, about a 35 percent reduction.  The reductions for the other operations were more significant: about 43 percent for hernia repair (37 pills before to 21 after); and 50 percent or more for appendectomy (35 to 17 pills) and thyroidectomy/parathyroidectomy (16 to 8 pills).  The prescriptions were measured in oral morphine equivalents, with 100 OMEs equal to about 20 pills of hydrocodone/acetaminophen 5/325 mg.

Dr. Englesbe explained why the researchers chose these four operations:  “These procedures are not usually performed to treat pain, so there is an expectation that patients will have the procedure and essentially recover relatively quickly; and they are relatively straightforward elective operations that are commonly done across Michigan and throughout the United States.”

Despite the reduction in prescribing, patients requested refills after only minimally invasive appendectomy.  Prescriptions for non-opioid analgesics also increased significantly for two procedures.  For the four procedures across the entire study population, the revised recommendations resulted in roughly 10,000 fewer pills entering the community.  On average, that equals about 17 fewer pills per patient.

“These findings are relevant to any surgeon,” Dr. Englesbe said.  “Every surgeon, no matter what specialty or procedure they do, dentists included, needs to be thoughtful about how they prescribe opioids and be realistic that overprescribing can really have some devastating complications.”

Since the original recommendations for opioids after gallbladder removal, the Michigan Surgical Quality Collaborative and Opioid Prescribing Engagement Network have developed recommendations for 17 other procedures, including three types of hysterectomy, breast biopsy, and mastectomy.  The recommendations are reviewed quarterly and updated as needed, Dr. Englesbe said, and will soon include some dental procedures.  The recommendations are available at https://opioidprescribing.info.

“Some patients do not do well with opioids, and we as providers need to be very thoughtful while we give the best pain care possible but at the same time also make sure it’s the safest pain care,” Dr. Englesbe said.

Dr. Englesbe’s coauthors are Ryan Howard, MD, and Jay Lee, MD, of the department of surgery, Michigan Medicine, Ann Arbor; Mitchell Alameddine, BS, and Michael Klueh, BS, of the University of Michigan Medical School, Ann Arbor; Chad Brummett, MD, of the department of anesthesia, University of Michigan Health System; and Jennifer Waljee, MD, MS, MPH, FACS, of the section of plastic surgery, department of surgery, University of Michigan Health System.

“FACS” designates that a surgeon is a Fellow of the American College of Surgeons.

Citation: Spillover Effect of Evidence-Based Opioid Prescribing after Surgery. Journal of the American College of Surgeons. Available at: https://www.journalacs.org/article/S1072-7515(18)30436-8/fulltext.
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* Howard R, Waljee J, Brummett C, Englesbe M, Lee J.  Reduction in opioid prescribing through evidence-based prescribing guidelines.  JAMA Surg.  2018;153:285-287.

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What’s at Stake for Medical Professionals in “Pill Mill” Investigations

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases.  In this article, I discuss the consequences physicians and other medical professionals potentially face as a result of a “pill mill” investigation.

CRIMINAL PROSECUTION

A litany of criminal charges can be heaped on medical professionals at the conclusion of a “pill mill” investigation. Exactly what charges the government pursues will obviously depend on the facts and circumstances of each particular case. One charge that will inevitably be included in every “pill mill” indictment is an alleged violation of the Controlled Substances Act (“CSA”). The CSA governs the distribution and dispensing of various listed drugs, including narcotics, that are prescribed by physicians and other licensed medical providers. To issue a controlled substance, a physician must be licensed to practice by a state authority and must have a DEA registration number.

Under the CSA, controlled substances are placed into one of five “schedules” based on whether they have a currently accepted medical use in the United States, their relative abuse potential, and their likelihood of causing dependence when abused. Most opioids are Schedule II drugs because they have acceptable medical uses and but a high potential for abuse.

To be convicted under the CSA, the government must prove that (1) the defendant physician knowingly and intentionally distributed or dispensed a controlled substance, and (2) did so “for no legitimate medical purpose and outside the usual course of professional practice.” Determining whether a physician has illegally prescribed drugs under this standard is never simple and will necessarily involve a “battle of the experts.”

A criminal conviction for violating the CSA may result in a vast array of prison sentences under the federal Sentencing Guidelines, a set of advisory sentencing rules that establish a uniform policy for individuals convicted of felony crimes in federal court. The exact range may vary significantly from case-to-case, depending primarily on the type and quantity of controlled substances involved. And these ranges can be staggeringly severe. In a recent “pill mill” case in Mobile, Ala., the physicians each faced a guidelines range of imprisonment of 30 to 240 years, although the court sentenced them well below that range (20 and 21 years, respectively) – as it had the discretion to do. In addition to applicable guidelines ranges in each case, the CSA provides for statutorily “enhanced” sentences in certain circumstances. For instance, if the government proves that a patient’s death resulted from the distribution of a Schedule II controlled substance, the convicted physician will face a sentence of no less than 20 years and up to life in prison.

SEIZURE AND FORFEITURE

In almost every “pill mill” case, the government will attempt to seize (take possession of) and forfeit (take ownership of) bank accounts, business assets, and personal assets of the targeted medical professional based on a theory that they are “proceeds” of the alleged “pill mill” operation or somehow “facilitated” the purported criminal enterprise. For example, following the physicians’ convictions in the case mentioned above, the government forfeited their bank accounts, investment and retirement accounts, college fund accounts, houses, beach-fount condominiums, and 20-plus luxury automobiles.

CIVIL LIABILITY

On top of criminal prosecution, a “pill mill” investigation could result in a civil lawsuit by the government against the targeted physician or medical professional, to the extent they have billed a federal health care program. For instance, the government might bring a direct suit under the False Claims Act (“FCA”), alleging that the physician made false diagnoses, prescribed drugs for non-covered indications, or prescribed excessive or “medically unnecessary” drugs for Medicare or Medicaid patients. Likewise, the government may join in a “qui tam” suit, which is initiated by a “whistleblower” – such as a current or former employee of the practice – claiming the targeted physician or practice has violated the FCA and other laws.

ADMINISTRATIVE PROCEEDINGS

In addition to facing criminal prosecution, the loss of asserts, and civil liability, physicians investigated or charged in a “pill mill” case can be subject to a number of administrative sanctions. The DEA, in particular, has a range of administrative actions it can take, such as: issuing a letter of admonition to the registrant providing notice of a violation of the applicable law/regulations; requiring the registrant to enter into a memorandum of understanding agreeing to take certain corrective steps to stave off revocation of the registration; or, for the most serious alleged violations, pursuing a show cause order to appear before an administrative law judge, during which the DEA will advocate for revocation of the registration.

Like the DEA, state professional boards (such as medical and pharmacy boards) have disciplinary authority and can sanction practitioners for professional violations, such prohibiting a physician from prescribing specific schedules of drugs, suspending a physician’s medical and/or dispensing license, or revoking the license.

Further, the Centers for Medicare & Medicaid Services (“CMS”) may limit, suspend, or revoke a provider’s Medicare billing privileges for, among other things, noncompliance with Medicare enrolment requirements, a felony conviction related to controlled substances, or a pattern of improper prescribing practices. Likewise, state Medicaid agencies can impose various administrative sanctions against providers, including outright exclusion from the program.

CONCLUSION

The consequences physicians and other medical professionals face as a result of a “pill mill” investigation are varied and potentially severe. Given that, pain management practitioners should be acutely aware of any signs that they are under investigation, including, among other things, receiving a government subpoena or civil investigative demand or learning that the practice’s employees or patients have been interviewed by investigating agents. Upon receiving the slightest hint of an investigation, practitioners should act quickly in obtaining legal counsel to conduct an internal investigation, determine the practice’s potential exposure, and intervene on the practice’s behalf in the hopes of warding off further government scrutiny.

For more information on these issues, please contact Burr & Forman’s Health Care team. Burr & Forman is an official partner with the Medical Association.

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AMA Rep Discusses Partnership with Medical Association during Opioid Council Meeting

AMA Rep Discusses Partnership with Medical Association during Opioid Council Meeting

MONTGOMERY ─ Earlier this week, the Governor’s Opioid Overdose and Addiction Council met to discuss reports from various stakeholders and committees, but there was also a special guest speaker. Daniel Blaney-Koen, senior legislative attorney from the American Medical Association, joined the task force to discuss what the AMA is doing nationally with policy interventions to try and reverse the opioid epidemic as well as its partnership with the Medical Association with the development and promotion of a toolkit to provide more educational material to Alabama’s physicians.

According to Blaney-Koen, opioid prescriptions are decreasing nationwide, and Alabama has beaten the national average in reducing the number of opioids prescribed.

“We want to emphasize solutions,” Blaney-Koen said. “I’d rather emphasize solutions that can change the course of this epidemic. We all want this epidemic to end, and there is hope for optimism that it will. The unmet needs for treatment are what will sustain this epidemic, so evidence-based care and treatment is where we need to put our focus.”

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Special Report: Physician Leadership is Boosting War on Opioids

Special Report: Physician Leadership is Boosting War on Opioids

MONTGOMERY – According to a new report by the American Medical Association, physicians have taken the lead in the nation’s battle on opioids by lowering the number of opioid prescriptions they write, making better use of state prescription drug monitoring programs, becoming better trained and certified in the use of opioid use disorders, and in access to naloxone.

“Everyone can agree there is no quick fix to the country’s opioid epidemic. In Alabama, our physicians took a leadership role many years ago by taking a hard look at where we were and where we needed to be,” said Mark Jackson, executive director of the Medical Association of the State of Alabama. “As an association, we created the first educational program to train our physicians, and we passed legislation to reduce prescription drug abuse and diversion. Our Smart & Safe Alabama Program continues to be the only prescription drug awareness program in Alabama created and maintained by physicians. Even though Alabama has come a long way in the fight against opioids, we have a long way yet to go.”

According to the progress report, although physician leadership is helping to reverse the opioid epidemic, more than 115 people in the United States die from an opioid-related overdose every day. Physicians and medical specialty groups are continuing in a concerted effort to expand access to quality care for pain and substance use disorders in an attempt to quell the epidemic.

The report also found:

  • Opioid prescribing decreased for the fifth year in a row. Physicians have decreased opioid prescriptions nationwide for the fifth year in a row. Between 2013 and 2017, the number of opioid prescriptions decreased by more than 55 million — a 22.2 percent decrease nationally. During that time, Alabama beat the national average by decreasing opioid prescriptions by 23.3 percent.
  • Physicians are enhancing their education. In 2017, nearly 550,000 physicians and other health care professionals took continuing medical education classes and other education and training in pain management, substance use disorders and related areas. Many of these resources are offered by the AMA, state, and specialty societies, and more than 350 of these resources can be found on the AMA opioid microsite, end-opioid-epidemic.org. The Medical Association was one of the first states to offer an opioid prescribing education course in the country in 2009. The main course is offered three times each year and has reached more than 5,000 prescribers to date.
  • Access to naloxone is on the rise. Naloxone prescriptions more than doubled in 2017, from about 3,500 to 8,000 naloxone prescriptions dispensed weekly. So far in 2018, that upward trend has continued; as of April, 11,600 naloxone prescriptions are dispensed weekly – the highest rate on record. In 2016, the Medical Association helped pass legislation in Alabama authorizing the State Health Officer to sign a standing order to allow Alabama’s pharmacists to dispense naloxone to people in a position to assist others at risk of an overdose as well as to an individual at risk of experiencing an opiate-related overdose.

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FDA Classifies Kratom as Opioid

FDA Classifies Kratom as Opioid

The U.S. Food and Drug Administration has officially classified the plant kratom, originally seen as an opioid alternative, as an opioid itself, stating that compounds in kratom act like prescription-strength opioids.

Found in Malaysia, the leaves of the kratom plant are traditionally crushed and made into a tea to treat pain as well as heroin or morphine dependence and possibly reduce withdrawal cravings. According to the American Kratom Association, there are 3 million to 5 million kratom users in the U.S. The supplement can be found in head shops and gas stations sold as powders, pills, capsules and energy drinks.

FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid compounds, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

The scientific data and event reports have “clearly revealed” compounds in kratom make it “not just a plant — it’s an opioid,” said FDA Commissioner Scott Gottlieb, M.D., “and it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold, and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

The FDA announced the voluntary destruction and recall of all kratom-based products manufactured nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution. The FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take their products off the market and submit any necessary evidence to the FDA.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said Dr. Gottlieb. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products.”

The FDA recommends consumers not use any kratom products and dispose of any products currently in their possession. “At this time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said Dr. Gottlieb.

The FDA has received 44 reports of deaths associated with the use of kratom. Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products.

Posted in: Opioid

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State of Alabama Files Lawsuit Against Purdue Pharma

State of Alabama Files Lawsuit Against Purdue Pharma

MONTGOMERY – The State of Alabama has joined other states in filing a complaint against opioid manufacturer Purdue Pharma, LP, one of the largest opioid manufacturers in the country. The complaint alleges Purdue’s marketing of these drugs contributed to the creation of the opioid epidemic in Alabama.

The lawsuit comes on the heels of a report by the Alabama Opioid Overdose and Addiction Council, appointed by Gov. Kay Ivey in mid-2017 to devise solutions to the state’s opioid crisis.

That report found at least 30,000 Alabama residents over the age of 17 are dependent on heroin or prescription painkillers. The council also found the drug overdose death rate in Alabama also increased 82 percent from 2006 to 2014. During that period, 5,128 people died from overdoses. In the U.S, more than 42,000 overdose deaths in 2016 involved opioids, according to the Centers for Disease Control and Prevention.

The lawsuit alleges that marketers persuaded physicians that prescription painkillers were not addictive, according to Alabama Attorney General Steve Marshall.

“The lies that they were told and trained in over the years whether it be that there was no dosage too high of an opioid … or even this concept of a pseudo-addiction that if somebody appeared in an office demonstrating signs of addiction that just meant that they needed more pain medication,” AG Marshall said.

Purdue denies the allegations, writing in a statement that its drugs are approved by the Food and Drug Administration and make up only 2 percent of all opioids prescribed.

Purdue Pharma manufactures, markets and sells prescription opioid pain medications, including the brand name drugs OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER and Targiniq ER, as well as generic opioids. OxyContin constitutes roughly 30 percent of the entire market for analgesic drugs (painkillers). Purdue’s drugs compose a majority of the extended release market, for use with chronic non-cancer pain patients, which is the most dangerous method of use. Prescription opioids constitute the largest component of the opioid epidemic, both in quantity and damage caused.

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