An Opioid Quality Metric Based on Dose Alone?

Posted on March 23, 2017 by Pharmaciststeve

An Opioid Quality Metric Based on Dose Alone?

80 Professionals Respond to NCQA

 
 https://medium.com/@StefanKertesz/an-opioid-quality-metric-based-on-dose-alone-80-professionals-respond-to-ncqa-6f9fbaa2338#.tyao6j7cx
 
I am a primary care doctor and researcher at University of Alabama at Birmingham who focuses on how to deliver high quality care for vulnerable populations.

Introduction: As the US comes to grips with a crisis of opioid overdose and addiction, many professionals have assessed that excessive opioid prescribing, based on weak data, helped us reach this point. Efforts to reduce prescribing while optimizing care for patients with pain, and expanding access to addiction treatment, are of cardinal importance. How we advance these objectives depends partly on changing our shared understandings of what it means to deliver good care. It also depends on policies, resources and formal methods to assess if we are doing a good job. The 2016 Guideline on Prescribing Opioids for Chronic Pain from the Centers for Disease Control and Prevention (CDC) represents one such effort.

In early 2017, a new and consequential proposal was made by the National Committee for Quality Assurance (NCQA), which seeks to advance health care quality through measurement and accreditation. NCQA’s highly influential performance measures help purchasers and consumers to assess whether health care quality is good or bad. When NCQA issued a draft set of standards related to opioids in 2017, they requested public comment. One of the measures counts the percentage of health plan members receiving opioid doses greater than the equivalent of 120 milligrams of morphine (MME), with a lower percentage counting as evidence of better care.

The premise, focused on dose, is similar to recent proposal from the Centers for Medicare and Medicaid Services. The concern about dose as an important risk factor for adverse opioid outcomes is well-justified. But well-justified concerns do not always translate into fault-free performance targets, particularly when doing so entails clinical practices not yet tested in scientific trials, and not endorsed by the CDC Guideline. Eighty doctoral level clinicians from across the country, mostly academic physicians, have endorsed the letter submitted to NCQA on March 22, 2017. They include four who had roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline, and five who edit scholarly journals in addiction medicine or pain. This document represents the opinion of signers, and not that of any agency for which they work. We welcome your feedback here or on Twitter, including two of the authors (@StefanKertesz @SubstanceAbuseJ) as well as NCQA itself (@NCQA).

Mary Barton, MD, MPP Vice President, Performance Measurement

National Commission for Quality Assurance

1100 13th Street, NW Suite 1000 Washington, DC, 20005

March 22, 2017

Dear Dr. Barton:

We write to register strong objection to the proposed “Opioid High Dosage” HEDIS measure, focused on minimizing the number patients receiving greater than 120 morphine milligram equivalents. As doctoral-level professionals in pain, in medicine and allied fields, we believe this measure will incentivize care that violates principles in the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. As a result, it will pose a serious risk to some patients currently receiving opioids. Many signatories to this letter have expertise in addiction medicine (signified “A” next to signature), or pain medicine (“P”). Persons among us who assisted the Centers for Disease Control and Prevention (CDC) in the 2016 Guideline are designated “C”. Many of us play professional roles in helping patients at high doses to taper, in mitigating opioid risk, in minimizing new opioid starts and in restraining dose escalation. Given these commitments, we understand that our strong objection to the proposed NCQA measure may come as a surprise.

To explain this objection, we must distinguish between the language of the CDC Guideline itself, and the perverse care decisions that the NCQA “Opioid High Dosage” binary measure will incentivize.

The CDC Guideline cites observational evidence associating higher opioid doses with increased adverse outcomes, including overdose. Such data justify restraint in opioid initiation (Recommendation 1) and dose escalation, with particularly careful reassessment of “evidence of individual benefits and risks” when considering increasing dosage to ≥50 mg/day and avoiding or carefully justifying decisions to titrate to ≥90 mg/day (Recommendation 5). However, the CDC Guideline did not prohibit dose escalation. Nor did it propose that any dose above a numeric threshold was “bad care”. Rather it insisted on “individual assessment of risk and benefit” as the primary basis for decision making related to both opioid dose titration and opioid dose reduction. For patients already receiving high opioid daily dosages, the CDC guideline states that “clinicians should discuss their safety concerns with the patient, consider tapering to a safer dosage (see Recommendations 5 and 7), and consider offering naloxone (see Recommendation 8).” High dose alone is not an indication for tapering or discontinuation.

On this basis, most of us wish to see an evolution toward fewer opioid starts and fewer patients at high doses. The proposed NCQA measure indulges no such subtleties. It will incentivize rapid efforts to minimize the number of patients whose current opioid dose exceeds 120 MME. The most efficient action to optimize measure performance would involve dose reduction for patients at >120 MME, regardless of patient acceptance, the mix of benefits and harms specific to the individual patient, or the potential harms of rapidly tapering patients prescribed high doses for many years. This is happening in many health systems today, despite the lack of any evidence to assess its impact on risk to patients, and the reality that the CDC Guideline did not endorse this approach.

Of particular concern, widespread unilateral dose reductions that would be incentivized by this HEDIS measure contradict Recommendations 5 and 7 of the CDC Guideline, both of which emphasize individualized assessment and decision making. Recommendation 5 applies only to new opioid starts. Recommendation 7 suggests working with patients on an individual basis to taper opioids when benefits are not sustained or when risks outweigh benefits. High dose is cited as simply one indicator of risk in the discussion of tapering. The proposed “Opioid High Dosage” measure eviscerates the CDC Guideline of these patient-centered considerations.

Put simply, the “Opioid High Dosage” measure will accelerate a reconfiguration of care that has never been tested in prospective trials and that could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death), protracted abstinence syndrome, and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain.

Finally we must underscore that institutional embrace of binary quality measures based on promising epidemiologic data has sometimes proven a mistake in retrospect. This has occurred with aggressive targets for glucose, blood pressure and lipid control. Even the widespread embrace of opioids itself (an effort to optimize pain scores) reflected extrapolation from limited data in ways that courted risk to patients.

We urge NCQA to recognize that binary metrics developed in the absence of compelling controlled trials are often treacherous. And there is little to justify a HEDIS measure that contradicts the language found in CDC Guideline Recommendations 5 and 7.

We recommend that NCQA abandon the Opioid High Dosage measure until trial data and expert review permit a more appropriate consideration of this issue. We are willing to assist you in identifying alternate measures that involve lower risk to patients.

This letter includes 80 signatories, with 4 who had formal roles assisting the Centers for Disease Control and Prevention in development of the 2016 CDC Guideline. Signers include 5 who edit scholarly journals in addiction medicine or pain, 60 with academic affiliations, 33 with special expertise in addictions, and 23 with special expertise in pain. Also, several signers have focused their careers on measuring and improving quality of care.

Disclaimer: Views expressed here are those of the signers alone, and do not represent formal positions of any employing or affiliated organization, university, or United States Federal Agency.

(A): Addiction Professional (P): Pain Professional (C ): Assisted the CDC in Opioid Guideline Development as Reviewer, Core Expert, or Author

Signatories

Stefan G. Kertesz, MD, MSc (A) University of Alabama at Birmingham School of Medicine

Adam J. Gordon, MD, MPH (A) University of Utah, Editor-in-Chief, Substance Abuse

Erin E. Krebs, MD, MPH (P, C) University of Minnesota Medical School

Joanna L. Starrels, MD, MS (A, P, C) Albert Einstein College of Medicine & Montefiore Medical Center

Chinazo Cunningham, MD, MS (A, C) Albert Einstein College of Medicine & Montefiore Medical Center

Matthew J. Bair, MD, MS Indiana University School of Medicine (P, C)

Richard Saitz MD MPH, DFASAM, FACP(A) Boston University School of Public Health, Senior Editor, Journal of Addiction Medicine

Jalie A. Tucker, PhD, MPH (A), University of Florida, Gainesville, Strategic Advisor, Addiction

Jeffrey H. Samet, MD, MPH (A) Boston University School of Medicine, Board, Addiction Medicine Foundation & Editor-in-Chief, Addiction Science & Clinical Practice

Michael E. Schatman, Ph.D (P)Tufts University School of Medicine, Editor-in-Chief, Journal of Pain Research

Peter D. Friedmann, MD, MPH, DFASAM, FACP (A) University of Massachusetts Medical School-Baystate, Deputy Editor, Journal of Substance Abuse Treatment

William M. Tierney, MD, MACP, Dell Medical School, University of Texas at Austin, Past President, Society of General Internal Medicine

Robert M Centor, MD, University of Alabama of Birmingham School of Medicine, Master, American College of Physicians, Past President, Society of General Internal Medicine

Nancy L. Keating, MD, MPH, Harvard Medical School and Brigham and Women’s Hospital

Max Michael, MD, Dean, University of Alabama at Birmingham School of Public Health

Ken Freedman, MD, MS, MBA (A) Tufts University School of Medicine, Boston, MA

Jane M. Liebschutz, MD MPH, (A,P) Boston University School of Medicine

Julia Lindenberg MD, Beth Israel Deaconess Medical Center

Terrence Shaneyfelt MD, MPh, University of Alabama at Birmingham School of Medicine

Name Redacted

Laurie Gordon, MD, New York, NY

David E. Pollio, PhD (A), Chair, Department of Social Work, University of Alabama at Birmingham

Daniel Pomerantz MD MPH FACP, Albert Einstein College of Medicine, New York

Toshiko Uchida, MD, FACP, Northwestern University Feinberg School of Medicine

John D. Goodson, MD, FACP. Harvard Medical School, Massachusetts General Hospital

Daniel P. Alford, MD, MPH, FACP, DFASAM (A, P) Boston University School of Medicine, Boston Medical Center

Carol K. Bates, MD, FACP, Harvard Medical School and Beth Israel Deaconess Medical Center

Lynn Webster, MD (P) Vice President, PRA Health Science and Past President, American Academy of Pain Medicine

Marcus A. Bachhuber, MD, MS, Montefiore Medical Center/Albert Einstein College of Medicine

James DeMicco, PharmD, Hackensack, New Jersey

Joseph W. Frank, MD, MPH (P) VA Eastern Colorado Health Care System and University of Colorado School of Medicine

Kimber P. Richter PhD, MPH (A) University of Kansas School of Medicine

Saul J. Weiner, MD, University of Illinois at Chicago School of Medicine

Michael Banks, MD, Orothwest

Michael Fingerhood MD FACP (A), Johns Hopkins University School of Medicine

Josiah D. “Jody” Rich, MD, MPH (A), Warren Alpert Medical School of Brown University

Signatory’s name redacted by request

Monika M. Safford, MD, Weill Cornell Medicine, New York, NY

Lauren Broyles, PhD, RN (A), Grant Writer’s Seminars and Workshops, VA Pittsburgh Healthcare System

Gerald Cochran, MSW, PhD (A), University of Pittsburgh, School of Social Work, School of Medicine

Ryan Kraemer, MD, University of Alabama at Birmingham School of Medicine

Thomas S. Huddle, MD, PhD, University of Alabama at Birmingham School of Medicine

Terri A, Lewis, PhD, NCoC, Southern Illinois University-Carbondale, Rehabilitation Institute

David Nagel, MD (P) private practice, author, “Needless Suffering; How Society Fails Those with Chronic Pain.”

Stephen J. Ziegler, PhD, JD, Indiana University-Purdue University, Dept of Public Policy

Janey C. Peterson EdD, MS, RN (P), Weill Cornell Medicine, New York, NY

Stephen A. Paget, MD (P) Hospital For Special Surgery, Weill Cornell Medicine, New York, NY

Diana Coffa, MD (P) (A), University of California, San Francisco, CA

Paula J. Lum, MD MPH FASAM (A), University of California, San Francisco, CA,

Tim Lahey, MD MMSc, Dartmouth’s Geisel School of Medicine

Diane S. Morse, MD (A), University of Rochester School of Medicine

Elvin Geng, MD MPH, University of California, San Francisco School of Medicine

Emma Stanton, MD MBA (A), Beacon Health Options

Thomas E. Reznik, MD, MPH (P), Providence VA Medical Center and Warren Alpert Medical School of Brown University

Barbara Herbert MD FASAM (A) Senior Medical Advisor, Column Health, Arlington Mass

Ingrid Binswanger, MD, MPH, MS (A) University of Colorado School of Medicine, Aurora, CO

Michael F. Bierer MD MPH (A) Harvard Medical School Boston MA

Howard Hoffberg, MD, (P) Rehabilitation and Pain Management Associates, Baltimore MD

Signatory’s name redacted by request

Thomas Sachy, MD, MSc, (P) (A) Georgia Pain and Behavioral Medicine, Gray, GA

Kevin R. Riggs, MD, MPH, University of Alabama at Birmingham School of Medicine

Calie Santana, MD, MHS, Internal Medicine, WESTMED Medical Group

Stephen Martin, MD, EdM (A) University of Massachusetts Medical School

Monica Gandhi MD, MPH, Professor of Medicine and Ward 86 Clinic Director, UCSF

Janet Grochowski, PharmD, Clinical Pharmacist, Positive Health Program (Ward 86), UCSF

Zackary Berger, MD, PhD, Johns Hopkins School of Medicine

Royce C. Lin MD, University of California, San Francisco School of Medicine

Sarah E. Wakeman, MD, FASAM (A), Massachusetts General Hospital, Harvard Medical School

Thomas Sachy, MD, MSc, (P) (A), Georgia Pain and Behavioral Medicine

Paul Arnstein, RN, PhD, FAAN (P)

David S. Craig, PharmD, Moffitt Cancer Center, Tampa FL

Michael J, Brennan, MD (P) The Pain Center of Fairfield, Fairfield CT

Sri Nalamachu, MD (P), Overland Park, KS

Jayne Pawasauskas, PharmD, BCPS (P) University of Rhode Island College of Pharmacy

Jeffrey Fudin, B.S., Pharm.D., DAAPM, FCCP, FASHP (P), President and Director, Scientific and Clinical Affairs, REMITIGATE, LLC

Debra F. Hobbins, DNP, APRN, LASUDC, CARN-AP, Anchorage, AK

Shelley Trazkovich, M.D (A) (P), Reisterstown, Maryland

James Patrick Murphy, MD, MMM, FASAM (A,P); Murphy Pain Center; Univ of Louisville Sch of Medicine; Past Pres, Greater Louisville Medical Soc

Anika Alvanzo, MD, MS, FASAM, FACP (A), Johns Hopkins University School of Medicine

Teresa Bryan, MD, University of Alabama at Birmingham School of Medicine

 
 
 
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    Stefan Kertesz, MD, MSc

    I am a primary care doctor and researcher at University of Alabama at Birmingham who focuses on how to deliver high quality care for vulnerable populations.

 
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80,000 EpiPen Devices Recalled Worldwide

Posted on March 22, 2017 by Pharmaciststeve

epipens

80,000 EpiPen Devices Recalled Worldwide

http://www.self.com/story/epipen-devices-recalled-worldwide

Mylan, the makers of the EpiPen, announced on Monday that more than 80,000 units of the EpiPen, the patented device used to dispense a life-saving dose of adrenaline (a.k.a. epinephrine) in cases of severe allergies, have been recalled in multiple countries. The recalled EpiPens could have a defective part that “may result in the device failing to activate,” said a statement issued by Mylan.

A spokesperson for Mylan tells Stat News that EpiPens have now been recalled in Australia, New Zealand, Japan, and several European countries, but the recall does not currently affect those in the United States.

The devices impacted by the recall are labeled with batch numbers 5FA665, 5FA6651, 5FA6652, and 5FA6653. Anyone with a recalled EpiPen can trade it in for a new device free, though Mylan is encouraging all those affected by the recall to keep their current EpiPen until a replacement arrives.

The recall is the latest controversy to besiege Mylan’s EpiPen product. A major price hike issued last year (capping years of increases) led to outcry from private citizens and lawmakers alike. Anger stemmed from both the choice by Mylan to seemingly turn an even greater profit from a life-saving drug, and the revelation that Mylan was engaged in a potentially illegal deal with schools to ensure that educational environments bought only the drug company’s branded product to keep in their facilities—a move that likely contributed to the increase in the EpiPen’s price. Many parents were quick to call out that the EpiPen is “a lifeline, not a luxury.” The price hike by Mylan put the price of the brand-name EpiPen two-pack at over $600. The company then released a generic version costing $300 for two injectors.

Pharmacy chain CVS reacted to the Mylan news last year by announcing the release of a new product, Adrenaclick, at its nationwide pharmacy locations. Adrenaclick retails for $109.99 for those with and without insurance, with CVS’s partner in developing the new product, Impax Laboratories, offering a coupon that would make the product only $9.99 for qualifying customers.

Major insurance company Cigna also reacted to the Mylan price hike by dropping the brand-name EpiPen from coverage by its health insurance plans, saying it would cover only the generic version of the drug.

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Irritable bowel syndrome medication linked to pancreatitis in certain patients

Posted on March 22, 2017 by Pharmaciststeve

Irritable bowel syndrome medication linked to pancreatitis in certain patients

http://www.clinicaladvisor.com/gastroenterology-information-center/fda-issues-warning-for-viberzi-irritable-bowel-syndrome-medication/article/645599/

The Food and Drug Administration (FDA) is warning patients and healthcare professionals that Viberzi (eluxadoline; Allergan) tablets should not be used in patients without a gallbladder due to an increased risk of developing serious pancreatitis that could lead to hospitalization or death. 

Viberzi, a mu-opioid receptor agonist, is approved to treat irritable bowel syndrome with diarrhea (IBS-D). Since its approval in May 2015 through February 2017, the FDA has received 120 reports of serious cases of pancreatitis or death. Of the 68 patients who provided gallbladder status, 56 did not have one and had received the recommended dose of Viberzi. There were also 76 patients who were hospitalized of which 2 patients died; these 2 patients were without a gallbladder. Other cases of serious pancreatitis or death also had 6 reports of sphincter of Oddi spasm and 16 reports of abdomen pain.

Healthcare professionals should consider alternative treatment options in patients without a gallbladder as hospitalizations and deaths due to pancreatitis have occurred with Viberzi use in these patients. Symptoms of pancreatitis have been reported after just 1 or 2 doses of Viberzi at the recommended dosage (75mg) in patients who do not have a gallbladder, and who do not drink alcohol. 

Viberzi should not be used in the following patients:

  • Who do not have a gallbladder
  • Have or may have had a blockage of the gallbladder or a sphincter of Oddi problem
  • Have had pancreatitis or other pancreas problems, including a blockage of the pancreas
  • History of serious liver problems
  • History of chronic or severe constipation
  • Have or may have had intestinal obstruction
  • History of alcohol abuse, alcohol addiction, or drinks more than three alcoholic beverages a day

Over-the-counter (OTC) or other FDA-approved medications can be considered to treat symptoms associated with IBS-D such as bismuth subsalicylate (Kaopectate and Pepto-Bismol), loperamide (Imodium), and diphenoxylate/atropine (Lomotil) for diarrhea, and simethicone (Gas-X and Mylicon) for gas relief. Alosetron HCl (Lotronex) and rifaximin (Xifaxan) are other approved prescription drugs for IBS-D. 

Viberzi, a CIV controlled substance, is available as 75mg and 100mg strength tablets in 60-count bottles.

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Compounding pharmacy president not guilty of 2nd degree murder

Posted on March 22, 2017 by Pharmaciststeve

Compounding pharmacy president guilty of racketeering, not guilty of 2nd degree murder

http://framingham.wickedlocal.com/news/20170322/compounding-pharmacy-president-guilty-of-racketeering-not-guilty-of-2nd-degree-murder

BOSTON — The former head of a Massachusetts pharmacy was acquitted Wednesday of murder allegations but convicted of racketeering and other crimes in a meningitis outbreak that was traced to fungus-contaminated drugs and killed 64 people across the country.

Prosecutors said Barry Cadden, 50, ran the business in an “extraordinarily dangerous” way by disregarding regulations on cleanliness to boost production and make more money.

 

Cadden, president and co-founder of the now-closed New England Compounding Center, was charged with 25 counts of second-degree murder, conspiracy and other offenses under federal racketeering law.

After five days of deliberations, the jury refused to hold Cadden responsible for the deaths and cleared him on the murder counts. He was found guilty of racketeering, conspiracy and fraud and could get a long prison term at sentencing June 21.

The 2012 outbreak of fungal meningitis and other infections in 20 states was traced by the Centers for Disease Control and Prevention to contaminated injections of medical steroids, given mostly to people with back pain. In addition to those who died, 700 people fell ill. Indiana, Michigan and Tennessee were hit hardest.

Joan Peay, 76, of Nashville, Tennessee, suffered two bouts of meningitis after receiving a shot for back pain. She wept upon learning the verdict.

“He killed people and he’s getting away with murder. I am furious,” she said. She said that she got so sick from meningitis “I didn’t care if I died,” and that she still suffers from hearing loss, memory problems, a stiff neck and low energy.

Alfred Rye, 77, of Maybee, Michigan, said: “I wish I could give him the same shot he gave me. I think they should pay for their crime.”

Rye fell ill after getting an injection in his lower back 4½ years ago. He said he continues to suffer from a loss of balance and other ill effects.

 “Life has been totally hell,” he said.

The racketeering charge and the 52 counts of fraud carry up to 20 years in prison each, but federal sentencing guidelines typically call for far less than the maximum.

The scandal threw a spotlight on compounding pharmacies, which differ from ordinary drugstores in that they custom-mix medications and supply them directly to hospitals and doctors. In 2013, in reaction to the outbreak, Congress increased federal oversight of such pharmacies.

 Federal prosecutor Amanda Strachan told the jury during the two-month trial that the deaths and illnesses happened because Cadden “decided to put profits before patients.”

NECC used expired ingredients and falsified logs to make it look as if the so-called clean rooms had been disinfected, prosecutors said. After the outbreak, regulators found multiple potential sources of contamination, including standing water and mold and bacteria in the air and on workers’ gloved fingertips.

Cadden’s lawyer, Bruce Singal, told the jury Cadden was not responsible for the deaths and pointed the finger at Glenn Chin, a supervisory pharmacist who ran the clean rooms where drugs were made. Chin has pleaded not guilty and is awaiting trial.

After the verdict, Singal said it was a “disgrace” that prosecutors brought murder allegations against Cadden.

 

“We’re very pleased that the jury acquitted Barry on all 25 of the murder charges and that he can now go home and tell his children that he’s not a murderer,” Singal said. “At the same time, it is Barry’s fervent wish … that people still remember the victims of this terrible public health outbreak.”

NECC filed for bankruptcy after getting hit with hundreds of lawsuits. NECC and several related companies reached a $200 million settlement with victims and their families.

Tom Carroll, a lawyer for the family of Kentucky Judge Eddie C. Lovelace, who died after receiving injections to treat neck and back pain, said the family was disappointed by the outcome of the trial.

“They very strongly felt that a murder conviction was in order,” Carroll said. “The family thinks he should get the maximum penalty.”

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99.1% of the filers were in support of kratom’s availability

Posted on March 22, 2017 by Pharmaciststeve

DEA kratom comment filing period findings

www.kratom-k.com/dea-kratom-comment-filing-period-findings/

ACFC releases kratom findings

DEA opened public comment in regards to a proposed ban of the kratom plant and it’s constituents late last year before a proposed ban. The response was quick, coordinated and overwhelming consisted of positive support. Thank to results from an early February study by the American Kratom Association and the American Coalition of Free Citizens. Over 23,000 total comment filers signed with a review of the results revealing that 99.1% of the filers were in support of kratom’s availability. Nearly a full 20% of the filers presented happened to be military veterans, just over 20% who commented with age were Senior citizens. DEA support for the ban dissolved due to the outpouring of support based on the efforts of the kratom community led by such organizations as American Kratom Association, Kratom United and Botanical Education Alliance.

The AKA/ACFC findings were surprising to many in the media who had previously slurred the plant product. Among those listing a profession, nearly half were involved in respected professions such as health care, research and science or law enforcement. For this particular group, 754 to 9 were pro-kratom/anti-ban (support of 98.7% among that particular group). 449 comment filers were self-identified as military veterans, 18% of the 2416 filers to specify a profession. Veteran support for kratom legality was an astounding margin of 448 to 1, or 99.8%. 576 health care professionals responding also supported kratom by a strong margin (569 to 7 or 99.8%). 3811 of the responders were 55 or older making up just over 20% of the total who replied regarding age. Once again the margin was overwhelming at 805 to 1, an astounding 99.9%.

Susan Ash

Susan Ash, director, American Kratom Association and Jason Jeffers, president, American Coalition of Free Citizens were quoted in a press release from AKA: “The face of kratom consumers is the face of America today. Our groups partnered-up to examine all of the public comments to DEA on the kratom ban because we were curious about who was responding and what they had to say. What we found is a kratom community of responsible consumers who look just like your family and the people who live next door. The results speak for themselves: 99 percent of those who comment, do not want the federal government to police the natural herb called kratom.”

Findings reveal overwhelming positive sentiment

Research and communications director, Katie Lair, of the American Coalition of Free Citizens, said: “The most curious thing about the public comments is that there were so few responses actually supporting the DEA. Only 113 people out of 23,116 commented in support of the DEA proposal to ban kratom. When you have so much anti-kratom propaganda circulating at the state level and misleading talk of a public health crisis, one would expect more public comments in support of what the DEA is trying to do. To have just 113 people nationwide support the DEA is remarkable for a campaign like this to determine whether something should be banned for the entire nation. The topline finding is obvious: There is no public appetite for banning kratom and continued fierce opposition can be expected by anyone who cares to do so.”

Medical professionals were defined as “medical doctors, registered nurses, psychiatrists, speech therapists and EMTs and trained first responders” in the context of the study. Recent research from Dr. Jack Henningfield, Ph.D., vice president of Research, Health Policy, and Abuse Liability at PinneyAssociates, suggests there is “insufficient evidence” for the DEA’s grounds in regard to a ban on the kratom plant (close botanical cousin to the coffee plant) or products derived from it’s leaf. The Henningfield report states that kratom has no greater (or possibly less) potential for abuse and dependence than “nutmeg, hops, St. John’s Wort, chamomile, guarana, and kola nut.”

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Follow the money trail : PBM’s demand 50% rebates from manufacturers

Posted on March 22, 2017 by Pharmaciststeve

Eli Lilly says it’s cutting an average of 50% off list prices—and its price hikes don’t work

http://www.fiercepharma.com/pharma/lilly-s-average-rebates-and-discounts-swell-to-50-off-list-prices

Heightened pressure from pharmacy benefit managers and increased competition among drugmakers are taking a big bite out of Eli Lilly’s list-price hikes—an 11-percentage-point bite, on average, the company said in a new report.

After raising list prices an average of 14% in 2016, and wheeling and dealing with payers, Eli Lilly netted an overall price increase of 2.4%, the company said in a new report. That’s a major comedown from 2015, when a 16.3% average increase yielded a net rise of 9.4%.

Lilly joined pharma peers Johnson & Johnson and Merck in unveiling its high-level pricing data, as part of a summary of its annual report. On average, the company says discounts have grown to 50% over the last 5 years, up from 28% in 2012.

What’s causing that increase? Lilly says more competition among drugmakers to win coverage, a change in its product portfolio, and hardball negotiations with PBMs. Mandatory government discounts that have grown “significantly” since the Affordable Care Act went into law in 2010 are also playing a role, according to the company.

RELATED: Single-digit price-hike pledge? J&J has that covered already, company report says

The Indianapolis drugmaker’s report comes on the heels of Merck’s and J&J’s similar disclosures. Each of those companies has felt the sting of payer pressure in recent years, the disclosures show. On average, J&J said it hasn’t raised prices above a single-digit percentage—a pledge Allergan CEO Brent Saunders famously made in September—dating back to 2012. J&J paid out $11 billion in rebates and discounts in 2016 and realized a 3.5% average net price increase, the company said.

Merck reported that its average rebates and discounts grew to 40% in 2016, up from 27% in 2010. The company realized a 5.5% price gain throughout its portfolio last year, negotiated down from a 9.6% average list price increase.

RELATED: Big Pharmas, top biotechs balk at investor group’s push for pricing transparency

However, each company pushed back on a recent request from the Interfaith Center on Corporate Responsibility for more detailed pricing information. That group wants to see drug-specific pricing data, a request stymied by many top drugmakers.

RELATED: In quick rebuttal, Express Scripts blasts Gilead exec’s pricing blame

The companies are reporting their pricing and rebate data as debate continues to intensify over the role PBMs play in U.S. drug costs. Shortly after a high-profile dust-up between Gilead Sciences and Express Scripts on the topic, Sen. Ron Wyden. D-Ore., unveiled legislation aimed at lifting “the veil of secrecy” behind drug rebates.

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Follow the money trail: Pharmacy Benefit Managers and Insulin Makers Face Price Scheme Lawsuit (CVS, ESRX)

Posted on March 22, 2017 by Pharmaciststeve

Pharmacy Benefit Managers and Insulin Makers Face Price Scheme Lawsuit (CVS, ESRX)

http://www.investopedia.com/news/pharmacy-benefit-managers-and-insulin-makers-face-price-scheme-lawsuit-cvs-esrx/

Three of the nation’s leading pharmacy benefit managers (PBM) have been named in a lawsuit charging that they participated with major insulin manufacturers in a price fixing scheme. CVS Health Corp. (CVS

) OptumRx unit were named in a federal court filing in New Jersey last week.

The PBMs are alleged to have been part of a collusion scheme along with Eli Lilly & Co. (LLY

 The three largest PBMs jointly account for 80% of the prescription drug industry in the U.S. and manage benefits for around 180 million individuals. (For more, see What Is the Pharmacy Benefit Management Industry?)

Second Case Against Insulin Makers

Four individual plaintiffs were joined by a nonprofit organization called the Type 1 Diabetes Defense Foundation is the suit.

In January, the three insulin makers were named as defendants in a separate federal court filing in Massachusetts, alleging that the companies significantly increased list prices of lifesaving insulin, raising them in lockstep and harming patients’ interests.

The cases come amid growing outcry over the nation’s opaque drug-pricing system which is seen as benefiting both drug manufacturers as well as intermediaries.

Along with the accusations that the drug makers colluded to increase the drug prices in a planned manner, which resulted in price increases of more than 150%, the plaintiffs also allege that the drug makers shared additional revenues with PBMs through rebates. (For more, see Supply Chain: The Big Leak Fueling High Drug Prices.)

Earlier in November, Senator Bernie Sanders requested the Justice department and the Federal Trade Commission investigate insulin drug makers for alleged price fixing. (For more, see Bernie Sanders Slams Drug Price Fixing.)

Responses from Drug Makers and PBMs

A CVS spokesperson claims that PBMs don’t have any role in determining drug prices, the allegations are built on a false premise and they are without merit. Novo Nordisk too disagrees with the allegations. Spokesmen for Express Scripts and Sanofi denied the allegations and said the companies would defend themselves vigorously, reports Bloomberg BNA.

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Pharma company linked to Ohio senator benefits from opioid addiction and treatment

Posted on March 22, 2017 by Pharmaciststeve

Pharma company linked to Ohio senator benefits from opioid addiction and treatment

http://www.newsnet5.com/news/local-news/oh-cuyahoga/pharma-company-linked-to-ohio-senator-benefits-from-opioid-addiction-and-treatment

CLEVELAND – We’ve seen the videos of countless Northeast Ohioans revived with Naloxone. The drug fighting an epidemic fueled in part by the billion dollar pharmaceutical industry.

But our News 5 investigation found at least one those big pharmaceutical companies is making money off the overdoses too.

Call after call throughout Northeast Ohio, reports of addicts on the brink of death given a second chance to live.

“Oh yes. It’s a black hole you can’t conceive of – unless you’ve been there,” Alison Allen recalled.

But where did this nightmare begin? “The way we got here frankly is prescription drugs and people getting addicted to opioids,” said Ohio Senator Rob Portman in a phone interview with News 5. To combat this epidemic, emergency crews have their own drug of choice, Naloxone. It’s what crews used to bring Alison Allen back to life after a near-fatal overdose. “My son found me, started CPR, called paramedics. I was dead for 5 minutes, they brought me around with Narcan,” said Allen.

A drug so effective, Senator Portman ensured every first responder in the U.S. Carried it, expanding access through the Comprehensive Addiction and Recovery Act (CARA) he co-authored. “Because they are saving lives every day,” said Portman.

An antidote to a deadly epidemic experts say was fueled by pharmaceutical companies, the same companies, that have donated heavily to Ohio lawmakers, including Senator Portman.

“I never vote or act based on contributions received and in this business you get contributions from lots of different groups,” said Portman. According to the Associated Press, Portman was a top recipient collecting over $200,000 in six years. One of those companies Pfizer Inc. Also contributed to his most recent campaign. “I don’t even know what drugs Pfizer makes I assume they make a lot of drugs including drugs that are very helpful for disease in Ohio.”

That is true because besides the opioid painkillers Pfizer is most notable for, it has also recently begun producing Naloxone by acquiring the leading seller of the reversal drug.

Portman tells News 5 he was not aware of that. “You are telling me new information, I am not aware of it, and again I make my decisions, including the CARA legislation, on what is best for my constituents,” said Portman.

Portman isn’t the only Ohio politician accepting pharmaceutical contributions. From 2006 to 2015 the Pain Care Forum, a coalition of pharmaceutical companies and their lobbyists, poured $3.5 million dollars into Ohio political coffers. According to the Associated Press,  a huge chunk,  $875,000 went to then House Speaker John Boehner, below him Representative Pat Tiberi received $300,000, while Congresswoman Marcia Fudge collected $78,000.

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All I want is to keep my pain from imprisoning me.

Posted on March 22, 2017 by Pharmaciststeve

All I want is to keep my pain from imprisoning me.

healthadvice.press/how-long-have-you-been-fighting-the-chronic-pain-system/

How long have you been in the system?

 

The medical system, I mean. I’m talking about the chronic pain and illness patients ― like me ― who make a pilgrimage to the doctor’s office month after month, year after year, until the pain stops (or we die).

 

Image result for How Long Have You Been Fighting The Chronic Pain System?

You know someone like this, since one in three people suffers from chronic pain in the United States. That’s right – between you, Mom, and Dad, statistically one of you is dealing with a physical or mental ailment that ranges from mild to debilitating, and has lasted longer than three months.

That’s pretty loose criteria. I sailed by that marker about 12 years ago.

When I was 17 our car was rear-ended by a man driving 65 miles per hour while we were stopped because of traffic. My aunt was the front passenger and my mother was in the driver’s seat. I could see my mom’s eyes widening in the rear-view mirror. I had enough time to think, “Oh, no,” and then I felt a force hit us that shook my entire world. Everything in the trunk ― luggage, golf clubs, my cousin’s saxophone ― slid forward and slammed against the back of my seat. The impact broke my spine in four places. Only three of the fractures were found after two weeks of staggering around on painkillers and taking the SATs for college; the fourth healed incorrectly, calcifying over a cluster of nerves.

Nine years later, my car was rear-ended again. It was a rainy day, and I’d left work late. Since that day, I’ve said to myself repeatedly, “If I’d been on time, maybe I wouldn’t have gotten hit.” A young woman in a rusty sky-blue sedan was driving at 35 miles per hour and skidded into my Elantra ― almost half the speed of my first accident, but it still required two cervical fusions.

Chronic pain patients have a moment when they realize they might be in this system for a long time ― an overwhelming system of insurance referrals and co-pays and specialists and medications.

On October 1, 2016, I’ll have been in the system for 12 years.

I realize now that, comparatively, it was tolerable at first. I saw pain management specialists, physical therapists, aqua therapists, chiropractors, manual therapists, acupuncturists, and yoga therapists – anyone who took a co-pay.

Then the system starting making decisions for me.

When Insurance Chooses Your Care

“We apologize, but we cannot accept you as a patient at this pain management facility because you have a relationship with another clinic.” This, paraphrased, is a letter I received when trying to change health centers. They said I couldn’t be seen unless they had a procedure that my current doctor did not offer. How would I know what procedure I needed until I met with them? How could I order from the menu without reading it? I tried to explain this to their staff. No luck.

I fled my pain management center when they substituted deep breathing for medication. (Side note: I was brought up by alternative medicine and have nothing but respect for it. My father started in athletic training before becoming a physical therapist and then a bio-integrative therapist.) I found a different hospital that still believed in medication… until the system cracked down.

You Cost Too Much Money

I received a chilling letter from my insurance company that said I was seeing too many “out of network providers” and included a list of my network’s physicians. Changing doctors when you are on a drug regimen is challenging; everyone surveys you with suspicion, especially in this climate with chronic pain patients being characterized as pill-seeking deviants. When it takes upward of 12 years to find the right medical professionals, nobody will stop me, much less an insurance company.

But what did the letter mean? That letter arrived on a Friday afternoon, too late to call their office. I spent the weekend thinking I’d have to find new doctors or pay obscene amounts of money to feel halfway decent. It was only at 9 a.m. the following Monday that I was informed, “Oh, you can still see your specialist! They just won’t be billed as Tier I.”

That was when I felt the walls closing in. If I hadn’t asked, I would’ve assumed that my doctors were no longer covered. I’d never felt hindered by the system before. Small attempts had been made to rein in my care, but nothing like this. I was nothing but a patient code number in a vast insurance network. Nobody cared about fixing or treating me.

It’s not entirely about insurance coverage. Other pain sufferers have reported how difficult it is even for established patients to get medication under the new CDC guidelines. In the end, coverage doesn’t matter if you can’t get prescriptions.

“I won’t have trouble,” I thought. “I’ve been in two car accidents. There are more than 1,000 pages of medical records.”

But the system doesn’t care how much proof you can produce.

You Can’t Have Meds

I had an appointment with my pain management doctor the day after the CDC’s opioid conference here in Boston. That was perfect timing. Before the appointment, it hadn’t been hard to receive medication. I’ve needed opioids for more than a decade, but now every prescription is questioned or, in Walgreens’ case, denied. My doctor admitted how terrifying the conference had been. And these are guidelines, remember. They’re not laws.

Blocking access to Vicodin or Percocet, I can understand. But Tramadol? It’s a synthetic opioid with a low risk of addiction when used long-term. Explaining that Tramadol barely covered the damage from my first accident, much less the second one, led nowhere productive. It doesn’t matter how much pain I have or how I do everything “right,” as in therapy, yoga, over-the-counter medications, topicals, wearables like the Quell pain relief device, and far more. Every appointment is now a fight. I spend days worrying about whether I’ll find myself without medication. I try to prepare for what I cannot prepare for.

The System Has Abandoned Us

Chronic pain patients are held captive and abandoned by this broken medical system. The message we hear is that doctors are too afraid to worry about our suffering. How can a doctor effectively treat patients when he’s waiting for the state licensing board to come knocking, saying he’s being investigated for overprescribing? As an attorney, I can understand. Professionals work hard for licenses. However, I’m not telling my clients, “Sorry, I can’t talk to the IRS on your behalf. There are too many people in debt. I know we’ve been helping you, but we can’t do that anymore. Have you looked into financial literacy classes?”

Studies say that opioids are not useful in the long run and can actually harm patients, causing opioid-induced hyperalgesia (a heightened sensitivity to pain). That’s not a good outcome. But some of us have no other options. That is the crux of our argument. You cannot remove our sole option and leave us with nothing, especially if we are using the medications as prescribed.

In the meantime, what are we supposed to do? I’m preparing for my medication to be taken away at any moment ― which has already caused a patient to die from a stroke caused by abrupt medication cessation, as I learned in an online advocacy group.

This situation is not our fault. We did not create the opioid epidemic. Most of us are responsible and should not be collectively penalized when someone isn’t. We are already held hostage by this system. All we want is to keep our pain from imprisoning us.

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ADA: the evidence for opioid therapy is weak in treating Diabetic Neuropathy ?

Posted on March 21, 2017 by Pharmaciststeve

Diabetic Neuropathy: New ADA Position Statement for Primary Care

http://www.medscape.com/viewarticle/876973

Diabetic Neuropathy: New Recommendations for Primary Care

Diabetic neuropathies are the most prevalent chronic complications of diabetes—and they are often devastating for the patient. Estimates of the incidence and prevalence of diabetic neuropathies vary greatly, but several large observational cohorts and other studies suggest that they occur in at least 20% of people with type 1 diabetes after 20 years of disease. Distal symmetrical polyneuropathy (DSPN) may affect at least 10%-15% of patients with newly diagnosed type 2 diabetes, with rates increasing to 50% after 10 years of disease.[1-4]

The American Diabetes Association recently released a new position statement on diabetic neuropathy. Medscape spoke with the lead author, Rodica Pop-Busui, MD, PhD, about how these recommendations can assist primary care providers (PCPs) in the prevention, early recognition, and appropriate management of neuropathies in patients with diabetes.

Medscape: What types of diabetic neuropathy should PCPs be aware of, and how common are they?
Rodica Pop-Busui, MD, PhD

Dr Pop-Busui: DSPN is the most prevalent form, and the best studied. DSPN is associated with several known severe complications, such as ulcers and infections, which can lead to lower-limb amputations. But even before that, the progressive damage of the various populations of nerve fibers may cause pain and/or lead to progressive loss of sensation, which decreases sense of balance and thermal discrimination; these factors increase the risk for falls or burns and affect patients’ daily function.

In addition to DSPN, the autonomic neuropathies, such as cardiovascular autonomic neuropathy, are relevant to clinical practice. More evidence has been unveiled in the past decade to further underline the seriousness of the consequences of diabetic neuropathies.

Medscape: The position statement emphasizes that the key to treatment of diabetic neuropathy is to prevent it in the first place. Are there any new strategies—beyond the recognized importance of adequate glucose control—that PCPs should be instituting in patients with diabetes or prediabetes?

Dr Busui: Evidence is emerging about the role of lifestyle interventions in the prevention of DSPN, which is quite exciting. A couple of studies show that, especially for patients with prediabetes and neuropathy, exercise and some types of diets seem to have a beneficial effect in prevention and possibly even reversal.[5-7] However, we don’t have the same strength of evidence that we have for the benefit of glucose control in type 1 diabetes. These data have to be confirmed, but lifestyle interventions are cited in the statement as promising therapeutic options.

Medscape: What type of exercise? How much exercise is required?

Dr Busui: We cited studies that tested the types of exercise used in the Diabetes Prevention Program: typically 30 minutes daily of moderate to intense exercise.[6,7] Other studies have looked at more intense exercise, but most studied the level of exercise used in the Diabetes Prevention Program.

Is Prevention Possible?

Medscape: According to the statement, enhanced glucose control is very effective in preventing diabetic peripheral neuropathy in patients with type 1 diabetes, but is less successful in those with type 2. Why is that?

Dr Busui: Patients with type 2 diabetes are typically very different from patients with type 1 diabetes. They also have other risk factors. Most are overweight or obese. Many have hypertension, metabolic syndrome, and the dyslipidemia associated with metabolic syndrome. All of these factors have been shown to be important in inducing nerve fiber damage, and may explain in part why glucose control alone has not been as effective in preventing diabetic neuropathy in patients with type 2 diabetes. Following an adequate diet can help you to prevent diabetes, check bioharmony advanced review on StreetInsider.

Patients with type 2 diabetes may also live with the disease for years without it being clearly diagnosed. It is thus likely that most of the patients included in interventional studies that looked specifically at glucose control, and captured some measures of neuropathy, may have been already in a more advanced stage of the disease.

In contrast, the Diabetes Control and Complications Trial (DCCT)[1,4] included patients with type 1 diabetes early in their course of disease, with no neuropathy at baseline, hypertension, or other complications, except very minimal retinopathy in a subgroup by study design. In addition, a most comprehensive assessment of neuropathy was conducted in the DCCT cohort at baseline and over time in a standardized fashion. Other trials that included patients with type 2 diabetes, such as ACCORD,[8] UK Prospective Diabetes Study (UKPDS),[9] the Veterans Affairs Diabetes Trial (VADT),[10] or BARI 2D,[11] involved patients with more advanced disease.

Another possibility is that neuropathy has been defined differently in many of these trials, or some very insensitive measures were used. For instance, in the VADT, neuropathy was defined only on the basis of patient-reported symptoms, which have a high degree of subjectivity.

DSPN in patients with type 2 diabetes typically presents at a more advanced stage because these patients have a constellation of risk factors that can induce nerve damage.

DSPN in patients with type 2 diabetes typically presents at a more advanced stage because these patients have a constellation of risk factors that can induce nerve damage. That is probably the main reason that we see less protective benefit from enhanced glucose control in these patients.

Medscape: So, is it correct that the factors that make prevention less successful in patients with type 2 diabetes are essentially the same factors that lead to a larger proportion of these patients progressing to DSPN?

Dr Busui: Yes. And, as I noted, it’s also possible that the true duration of disease in those patients may be much longer than years since diagnosis.

Symptomatic and Asymptomatic Neuropathy

Medscape: The statement also notes that up to one half of cases of DSPN may be asymptomatic. Why is that important?

Dr Busui: Some patients may experience pain, and some may experience numbness, although many have neither. DSPN is associated with a progressive lack of sensation, which is a risk factor for foot injuries or burns. It may result in patients using inappropriate footwear that can predispose them to more severe complications. In addition, a progressive loss of sensation may cause impaired balance, and may prevent patients from doing even usual activities that are important in their daily function.

Understanding the degree of dysfunction is important, because then the physician can advise the patient specifically about the type of activities that they may want to pay particular attention to, or the things that they need to avoid to prevent these complications. The position statement analyzed the evidence about the key parts of the examination that are easily done in the office, and the degree of deficits that are easy to identify. This will help providers avoid spending an enormous amount of time examining these patients or ordering unnecessary and expensive evaluations (such as nerve conduction studies) when the findings of the clinical examination, with or without symptoms, are very typical.
Image from Science Source

Medscape: The high proportion of asymptomatic patients points to the importance of screening. What are best practices for screening for DSPN? Should patients with prediabetes, or those who have other components of the metabolic syndrome, be screened?

Dr Busui: We emphasized in the statement the features that have been found to be consistent with a diagnosis of neuropathy. They can be assessed with simple instruments that can be carried in the coat pocket, such as a tuning fork, a monofilament, reflex hammer, or pushpins for a pinprick sensation test. We grade the evidence for these screening tests. Combining two of these evaluations increases the sensitivity and specificity of uncovering deficits associated with neuropathy, especially if some symptoms are present and the findings are symmetrical.

Sometimes just asking a patient, ‘Do your feet feel numb?’ is enough to make them aware that they have that sensation.

Sometimes just asking a patient, “Do your feet feel numb?” is enough to make them aware that they have that sensation. “Do you have some numbness in your hands when you wake up in the morning?” screens for another type of symptom.

We said that physicians should consider screening patients with metabolic syndrome or prediabetes, especially if they have some symptoms. A large body of evidence now demonstrates that when all three factors associated with metabolic syndrome are present, the likelihood of neuropathy is much higher. The fact that peripheral neuropathy can be present in patients with metabolic syndrome has been reported by several groups of independent investigators.

Pharmacotherapy of Diabetic Neuropathy

Medscape: Let’s turn our attention to treatment. The statement notes that glycemic control is not effective in management of pain. There are three US Food and Drug Administration (FDA)-approved therapies to treat the pain that is so common with DSPN: pregabalin, duloxetine, and tapentadol. However, the evidence for opioid therapy is weak, which leaves clinicians with pregabalin and duloxetine. What do you recommend in terms of pharmacotherapy? Is either agent preferred for a specific population?

Dr Busui: The position statement offers a much more comprehensive approach. We do indeed note which agents are FDA-approved, but after saying that, we provide the evidence for all therapies supported by available randomized clinical trials, published and unpublished. That’s how we came up with Table 4 in the statement, in which we critically considered dose titration, adverse effects, and number needed to treat from randomized clinical trials, and graded the level of evidence.

As our main outcome measure in judging the efficacy of pain reduction, we used either a 50% reduction in pain from baseline, or a 30% improvement in pain, which was shown in a very large study to be what is meaningful for the patient. The position statement also is trying to be patient-centered. Most patients feel that if they can reach that 50% reduction in pain, that’s great, and 30% is acceptable.

The table also lists, besides the FDA-approved drugs duloxetine and pregabalin, other drugs (such as gabapentin) that may not have the FDA stamp of approval but are at least as effective as those that do, and may offer the advantage of a substantial cost difference.

In addition, we provide an algorithm for how to combine two or even three agents at lower doses, to help clinicians have a more flexible approach and mitigate the side effects that are associated with the highest dose of each agent alone. That is also different from what was included in the previous position statement.

We make a strong case against prescribing narcotics for treating the pain associated with diabetic neuropathy, given the large spectrum of serious side effects and addiction risks compared with their effectiveness in this case

Autonomic Neuropathies

Medscape: Cardiovascular autonomic neuropathies are quite common in patients with longer-duration type 2 diabetes. In your experience, are most clinicians aware of the incidence of these types of neuropathies?

Dr Busui: The level of awareness seems to be increasing. A lot of the literature now confirms that cardiovascular autonomic neuropathy in particular clearly increases the risk for both major cardiovascular events and cardiovascular death.[13] That has been now confirmed, both in type 1 and type 2 diabetes, in large cohorts, where investigators adjusted for multiple cardiovascular risk factors. Physicians are becoming aware that having cardiovascular autonomic neuropathy places an additional risk on these patients.

Unfortunately, until the very late stages, this complication may be completely asymptomatic. Thus, a certain level of suspicion has to exist. Cardiovascular autonomic neuropathy may affect those with longer duration of disease or poor glucose control, but also young women, or patients with, impaired glucose tolerance or metabolic syndrome.

The presence of cardiovascular autonomic neuropathy can be also used as a tool to guide a patient’s adherence to certain therapeutic strategies, and to increase the awareness of physicians about how to titrate some of the medications that are used to treat hyperglycemia, especially in patients with type 2 diabetes, and to avoid hypoglycemia in patients who take insulin, whether they are type 1 or type 2. Rapid changes in blood glucose levels may trigger important arrhythmic events.

Medscape: Are the strategies recommended for prevention of DSPN the same strategies that may be effective in preventing autonomic neuropathy?

Dr Busui: In type 1 diabetes, glucose control instituted as early as possible is very effective in preventing cardiovascular autonomic neuropathy as demonstrated by the DCCT/Epidemiology of Diabetes Interventions and Complications study.[14,15] In type 2 diabetes, we have somewhat stronger evidence that a multifactorial intervention addressing several risk factors (blood glucose, blood pressure, lipids, lifestyle) does seem to prevent progression of cardiovascular autonomic neuropathy, as shown by the Steno-2 trial, a randomized trial conducted by the Steno Diabetes Center in Copenhagen that compared conventional vs intensive therapy.[16,17]

Medscape: Can you tell us about heart rate variability in these patients—is that a screening mechanism appropriate for primary care? Or should that be left to the cardiologist and the diabetologist?

Dr Busui: We have not recommended that all patients with diabetes should be screened for heart rate variability at this stage. It may not be necessary in all patients. But screening is recommended in patients who have a more complicated course; when we contemplate a certain medication change in patients who are already at high risk for hypoglycemia; or in those undergoing surgery, because that is a very high-risk state.

Medscape: For the PCP, the most critical thing is to be aware of these autonomic neuropathies, and to expect them in patients who exhibit cardiovascular symptoms or symptoms indicative of gastroparesis, such as early satiety, nausea, and bloating. Is that the main message—that clinicians should be aware of these complications and avoid indiscriminate testing to search for other pathologies?

Dr Busui: As far as gastroparesis is concerned, we do want clinicians to be aware that several classes of medications used to treat diabetes, including glucagon-like peptide-1 receptor agonists or pramlintide, can delay gastric emptying as one of their mechanisms of action. If a patient treated with one of these agents is experiencing nausea and vomiting, you may want to advise the patient to reduce portion sizes and slowly titrate the medication—because that would effectively mitigate the symptoms without the need to perform gastric emptying studies and/or prescribe prokinetic agents, which will defeat the purpose of the antidiabetic agents.

And, of course, this same effect—delayed gastric emptying—occurs in patients who are taking opioids, which are unfortunately prescribed too easily for treating pain in general or pain associated with neuropathy.

Obviously, gastric emptying studies are completely unnecessary in these patients. In some cases, delayed gastric emptying has serious consequences that can affect the patient’s glucose control. Patients on insulin may experience early hypoglycemic events if, as a result of delayed gastric emptying, their food is not absorbed, and then they can have late hyperglycemia. They can develop a vicious cycle between hypoglycemia and hyperglycemia. The physician should consider changing the pain medication regimen in this case, and use an algorithm that would be effective for the pain, but without such an adverse effect.

Medscape: Do you have any final words for our readers?

Dr Busui: I would like to stress that this document was the result of a very productive collaboration between endocrinologists and neurologists with known expertise in diabetic neuropathy and thus represents current consensus from both perspectives. Although the statement presents the currently available evidence for diabetic neuropathy, we have also included a section that summarizes still-unmet needs, especially with respect to early diagnosis and reversal of disease, that we hope will guide future research in a more unified fashion.

 

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