dr. schatman: disclosures
TRANSCRIPT
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Maintaining Balance Among Compassionate Prescribing, Ethical Clinical Strategies, and
Societal Obligations
Michael E. Schatman, Ph.D., CPEDirector of ResearchU.S. Pain Foundation
Bellevue, WA/Middletown, CT
Thursday, July 14, 2016
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Dr. Schatman: Disclosures
• Dr. Schatman has no conflicts of interest to disclose
The contents of this activity does include discussion of off-label or investigative drug uses.The faculty is aware that is their responsibility to disclose this information.
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Planning Committee, Disclosures
• Larry C. Driver, MDChair, AAPM Professional Education and CME Oversight Committee No relevant financial relationships
• Jennifer Westlund, MSWDirector of EducationAmerican Academy of Pain Medicine No relevant financial relationships
• Jessica Link, MDAssociate Medical WriterPharmaCom Group No relevant financial relationships
• Lynn R. Webster, MD
Medical Director
CRI Lifetree Salt Lake City, UT AstraZeneca (consultant)
Cara Therapeutics (consultant)
Charleston Labs (advisory board)
Egalet (advisory board)
Depomed (travel expenses)
Insys Therapeutics(consultant)
Jazz Pharmaceuticals (advisory board)
Kaleo Pharmaceuticals (advisory board)
Marathon Pharmaceuticals (consultant)
Merck (consultant)
Orexo Pharmaceuticals (advisory board)
Pfizer (advisory board)
Proove Biosciences(advisory board)
Trevena (advisory board)
Shionogi (advisory board)
Zogenix (consultant)
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Target Audience
• The overarching goal of PCSS-O is to offer evidence-based trainings on the safe and effective prescribing of opioid medications in the treatment of pain and/or opioid addiction.
• Our focus is to reach providers and/or providers-in-training from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators.
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Educational Objectives
• At the conclusion of this activity participants should be able to: Identify the stakeholders and recognize their influence on
prescribing chronic opioids in American pain management.
Recognize how lack of understanding of the importance of pain management throughout the healthcare system, restrictions of insurance coverage and payment policies, pharmaceutical and medical device industries, regulatory and law enforcement policies, clinical practice guidelines, and news and information media, may all abandon chronic pain patients without appropriate opioid therapy.
Examine and review the practice of risk mitigation strategies for all physicians prescribing these drugs including mandatory use of UDT, prescription drug monitoring programs (PDMPs) and physician education in opioid safety.
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AMA Code of Ethics (1847)
• “From the age of Hippocrates to the present time, the annals of every civilized people contain abundant evidences of the devotedness of medical men to the relief of their fellow-creatures from pain and disease…”
• American pain medicine has come a long way but there is concern that recent changes will reverse that progress.
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Attitudes Toward Opioid Analgesia
• American society has been labeled with many negative terms
• Among the least flattering are: Absolutist “Pendulumistic” Agenda-driven (as opposed to data driven) Disingenuous Financially-driven
• These descriptors can be used for attitudes and policies regarding opioid analgesia
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Problems with Chronic Opioid Therapy
• Lack of a long-term evidence of efficacy• Opioid-induced hyperalgesia• Possibility of: Abuse Addiction Overdose Diversion Death
• Opioid-induced endocrinopathy• Opioid-induced mood disorder
Von Korff M, et al. Ann Intern Med. 2011;155:325-328; Lee M, et al. Pain Physician 2011;14:145-161.; Ling W, et al. Drug Alcohol Rev. 2011;30:300-305.; Brennan MJ. Am J Med. 2013;126(3 Suppl 1):S12-18.; Leventhal AM, et al. Drug Alcohol Depend. 2011;116:163-169
9From NEJM, Volkow ND, et al, Medication-Assisted Therapies - Tackling the Opioid-Overdose Epidemic, 370(22), 2063. Copyright © 2014 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
Relationship of Opioids Prescribed to Opioid-Related Deaths
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Efficacy of Chronic Opioid Therapy
• “No evidence of benefit” is not the same as “evidence of no benefit”
• Current knowledge comes from: Surveys Case series Open-label follow-up studies Anecdotal evidence
• “Like any clinical therapy, some patients seem to do very well with chronic opioid therapy while others do not.”
• 2013 study: non-placebo-controlled, demonstrated sustained relief over 52 weeks
Ballantyne JC. Problems with chronic opioid therapy and the need for a multidisciplinary approach. In: Schatman ME, Campbell A (eds.). Chronic Pain Management: Guidelines for Multidisciplinary Program Development. New York: Informa Healthcare. 2007;49-64.; Richarz U, et al. Pain Pract.2013;13:30-40.;Katz MH. JAMA Intern Med. 2016[Epub ahead of print]; Hansen H, et al. The evolving role of opioid treatment in chronic pain management. In: Racz GB, Noe CB (eds.). Pain and Treatment. Intechopen. 2014;pp. 75-130. Available at: http://cdn.intechopen.com/pdfs-wm/47151.pdf
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Opioid Pendulum
Ballantyne JC, Sullivan MD. NEJM 2015;73:2098-2099.; Sullivan MD, Ballantyne JC. Pain 2016;157:65-69.; Schatman ME, Darnall BD. Pain Med. 2013;14:617-620.; Atkinson TJ, Schatman ME, Fudin J. J Pain Res. 2014;7:265-268.; Rauenzahn S, Del Fabbro E. Curr Opin Support Palliat Care 2014;8:273-278.; Morgan BD. Pain Manage Nurs. 2014;15:165-175.; Mann M, Chai E. Hosp Med Clin. 2014;3:567–581.; Pollack CV, Viscusi ER. Hosp Pract. 2015;43:36-45.
• The US went through a period of indiscriminate prescribing, causing misery on both individual and societal levels
• Opioids for chronic pain is becoming a thing of the past as arguments are being made that analgesia should not be the ends of pain medicine
• Now the pendulum has swung awry…to opiophobia• Opiophobia -> Oligoanalgesia
• Have patients lost their voice in this debate?• Has respect for patient autonomy been lost?
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We Must Find A Middle Ground
• In our current healthcare system finding “balance” will be difficult
• The opioid debate is complicated and many of us are directly involved
• There are many stakeholders in American pain medicine: Insurance companies Health systems Pharmaceutical industry Law enforcement (federal, state, local) Government health agencies Media
Schatman ME, Darnall BD. Pain Med. 2013;14:1627-1630.; Atkinson TJ, Schatman ME, Fudin J. J Pain Res. 2014;7:265-268.; Peppin JF, Schatman ME. J Pain Res. 2016;9:23-24.; Fudin J, Pratt Cleary J, Schatman ME. J Pain Res. 2016;9:153-156.
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Insurance Company Impact
• Profound impact on many levels• For years, most types of chronic
pain could be treated through interdisciplinary treatment programs
• Functional restoration was important; so was reducing reliance upon opioids
• Evidence-bases for cost-efficiency as well as for clinical efficacy were established
Hooten WM, et al. Pain Med. 2007;8:8–16; Turk DC, Swanson K. In: Schatman ME, Campbell A (eds.). Chronic Pain Management: Guidelines for Multidisciplinary Program Development. New York: Informa Healthcare;2007:15-38.
Medication
Psychology
Physical Therapy
Behavioral Therapy
Procedures
Support
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The Fall of Interdisciplinary Pain Clinics
• Over 1,000 programs in the 1990’s
• Decreased to fewer than 90 today
• ≥100 million Americans with chronic pain
• This leaves 1 program for every 1.1 million patients
Holzman AD, Turk DC. Pain Management: A Handbook of Psychological Treatment Approaches;1986.; Anooshian J, et al. Psychosomatics 1999;40:226-232; Schatman ME. Pain: Clin Updates 2012; 20(7):1-5.; Institute of Medicine. Relieving Pain in America 2011
Photo: “Closed” by Jasoon CC BY 2.0
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International Perspective
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Abuse-Deterrent Coverage
• Abuse-deterrent and tamper-resistant formulations are not perfect but do help reduce abuse
• Increase physician confidence in prescribing opioids .
• Not available as generics so are more expensive
• Due to cost, insurers often do not cover them
Peacock A, et al. Pharmacoepidemiol Drug Saf. 2015;24:1321-1333.; Hale ME, et al. J Opioid Manag. 2015;11:425-434.; Turk DC, et al. Pain Med. 2014;15:625-636; Keast SL, et al. J Manag Care Spec Pharm. 2016;22:347-356; Schatman ME, Webster LR. J Pain Res. 2015;8:153-158.
Photo: “Drug Costs” by Ano Lobb: CC BY 2.0
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Insurers: “Just Say No”
• Many for-profit insurers now limit opioid prescriptions due to fear of addiction and its associated costs
• Their focus is on cost-containment and profitability rather than obligation to the chronic pain patient
• Adds more complications and limits to effective pain care
Richmond DR. Trust me: insurers are not fiduciaries to their insured. ;Kentucky Law J. 1999-2000;88(1):1-32.; Schatman ME. Pain Med. 2011;12:415-426.; Franklin GM, et al. Am J Ind Med. 2012;55:325-331.;McCluskey PD. Boston Globe November 11, 2015.
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Health Systems Adopt No-Opioids Policy
• Began with anecdotal reports• Now beyond anecdotal: “Prescription drug crackdown making it hard for some to obtain
needed pain pills” “Tennova Healthcare to stop prescribing opiates for long-term
care.”• Research describes health system programs to reduce
opioid doses in patients on chronic opioid therapy: Demonstrated large decreases in mean daily doses Did not mention patient responses to dosage decreases
• It is distressing that researchers did not recommend alternative treatments that are evidence-based and accessible
Johnson S. Chattanooga Times Free Press, April 10, 2016. http://www.timesfreepress.com/news/local/story/2016/apr/10/prescriptidrug-crackdown-making-it-hard-some/359417/; Hardnett R. WBIR.COM, April 26, 2016. http://www.wbir.com/news/local/tennova-healthcare-to-stop-prescribing-opiates-for-long-term-care/154617362; Saunders KW, et al. Clin J Pain 2015;31:820-829.; von Korff M, et al. J Pain 2016;17:101-110.
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Health Systems Prescription Problems
The “chilling effect” is also having an adverse impact on primary care systems’ willingness to prescribe
• Physicians are abruptly discontinuing chronic opioid therapy in adherent patients
• Particularly problematic as many pain specialists have become less likely to prescribe opioids than PCPs
• Of great concern, state guidelines such as Washington’s require a referral to a “pain specialist” for high-dose opioid prescribing
Armstrong K, Berens MJ. New state law leaves patients in pain. Seattle Times, December 11, 2011; Kraus CN, et al. Curr Drug Saf. 2015;10:159-164.
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Pharma Influence on Prescribing
• Certain pharmaceutical companies played a role in the formation of the opioid crisis Misleading marketing statements created a sense of false
security in opioid prescribing
• Though marketing practices have changed, Pharma still influences prescribing: Paying the IMMPACT Group co-chairs up to $50,000 each to
facilitate drug approval meetings with the FDA Engaging in questionable “enriched enrollment randomized
withdrawal (EERW)” methods in clinical trials in order to fast-track opioid analgesics
Frederickson PD. Midwest Law J. 2008;22:115–147.; Whoriskey P. Pharmaceutical firms paid to attend meetings of panel that advises FDA, e-mails show. Washington Post, October 6, 2013; Campbell J, King NB. BioSocieties advance online publication, 4 April 2016
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Pharma Marketing Strategy
• Yet their greatest influence is probably through legal marketing Many non-CME presentations are infomercials Pharma-sponsored and -conducted opioid research is
published in the same issues of journals in which they advertise
• Some have called for prohibition of opioid marketing, particularly for chronic pain
• The AMA has proposed a ban on direct-to-consumer Pharma marketing
Ballantyne JC, Kolodny A. JAMA 2015;313:1059.; AMA. AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices. November 17, 2015. http://www.ama-assn.org/ama/pub/news/news/2015/2015-11-17-ban-consumer-prescription-drug-advertising.page; Schatman ME. Pain Med. Network 2012;27:10-11.
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Pharma’s Fight for Abuse-Deterrence
Burton TM. Wall Street Journal, April 1, 2015
• Developing improved tamper-resistant products Some groups oppose approval
because they are not yet completely “abuse-proof”.
• Yes, they are trying to make money and make opioid prescribing safer but are frustrated by insurers’ refusal to pay for these new formulations
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DEA and Government Crackdown
• DEA started the opioid war offensive Pill mills clearly had to be shut down Now shifted from focusing on preventing diversion, abuse,
overdoses, and deaths to investigating well-intentioned physicians for prescribing practices
• State governments also involved, at times with questionable legality 2010 – Florida state agencies and law enforcement
partnered with the federal government to shut down pill mills Massachusetts attempted to make Zohydro® illegal – which a
federal judge quickly overruled• State and local law enforcement have also been
involved with roles varying from town to town
Ray AL. Pain Med. 2001;2:178-179; Atkinson TJ, Schatman ME, Fudin J. J Pain Res. 2014;7:265-268.; Johnson J, et al. MMWR Morb Mortal Wkly Rep. 2014;63:569-574.; Jeffrey S. Medscape Multispecialty, April 16, 2014.
DEA: Drug Enforcement Agency
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Physicians Fear Prescribing Opioids
• Physicians’ primary fear seems to be regulatory scrutiny/sanction Almost half of primary care physicians
expressed such fear in a recent study Training on regulatory tracking
compliance did not reduce fear
Jamison RN, et al. 2015[Epub ahead of print].; Federation of State Medical Boards of the United States, Inc. Model policy on the use of opioid analgesics in the treatment of chronic pain. http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/pain_policy_july2013.pdf.
The 2013 Federation of State Medical Boards Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic
Pain addressed physician fears
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Federation of State Medical Boards Model Policy
• The policy states physicians should not fear prescribing under the following conditions: For a legitimate medical purpose In the usual course of professional practice Based on accepted scientific knowledge or sound clinical
grounds Based on clear documentation In compliance with applicable state or federal law
• Is this true today…is it becoming less so?
Federation of State Medical Boards of the United States, Inc. Model policy on the use of opioid analgesics in the treatment of chronic pain. http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/pain_policy_july2013.pdf.
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Restrictive Prescribing Regulations
• The public’s (and physicians’) confusion regarding “addiction” vs. “dependence” on opioids has had an impact on prescribing practices
• Restrictive prescribing regulations are unethical in two ways: Scare physicians into not prescribing
opioids Reinforces misconceptions, further
marginalizing already stigmatized patients
Fine RL. Proc (Bayl Univ Med Cent). 2007;20:5-12.; Frey-Revere S, Do EK. J Health Care Law Pol. 2013:16:193-213.
AUTHORIZED PAIN KILLERS ONLY
RESTRICTEDPRESCRIBING
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Federal Registrant Actions AgainstPhysicians
2003 - 34 2010 - 25
2004 - 74 2011 - 66
2005 - 40 2012 - 44
2006 - 32 2013 - 31
2007 - 42 2014 - 21
2008 - 24 2015 - 31
2009 – 26
US Department of Justice DEA Office of Diversion Control. Cases Against Doctors.http://www.deadiversion.usdoj.gov/crim_admin_actions/; Hoffmann D. New York Times, February 17, 2016.
Most Recent Numbers:• Actions taken against physicians are not the only story
• The number of investigations of physicians is not made public
• Erroneous prosecutions of physicians prescribing responsibly have a chilling effect on all prescribers
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Government Health Agency Guidelines
• It’s become all about the guidelines, quality and integrity of which are in contention
• 2009 Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain Not perfect….But relatively well-balanced and highly rated in a
systematic review• Tend to be arbitrary
• Disingenuous in suggesting that safer and more effective treatments are readily available Ex: Interagency Guideline on Prescribing Opioids for Pain
2015
Chou R, et al. J Pain 2009;10:113-130.; Nuckols TK, et al. Ann Intern Med. 2014;160:38-47.; Washington State Agency Medical Directors’ Group (AMDG) in collaboration with an Expert Advisory Panel, Actively Practicing Providers, Public Stakeholders, and Senior State Officials (Schatman ME – contributing author). Interagency Guideline on Prescribing Opioids for Pain 2015. Available at: http://www.agencymeddirectors.wa.gov/Files/2015AMDGOpioidGuideline.pdf.
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CDC Guideline
The recent CDC Guideline….practically and ethically problematic
• CDC claims the guideline is based on “scientific evidence” “CDC did not formally rate the quality of evidence“ Are they “consensus guidelines”?
• Drafted primarily by a “Core Expert Group” At least 5 Board Members of Physicians for Responsible Opioid Prescribing
(PROP) provided input as Core Expert Group, Stakeholder Review Group, or Peer Review Panel members
Many feel that PROP is very anti-opioid, representing a conflict of interest
Atkinson TJ, Schatman ME, Fudin J. J Pain Res. 2014;7:265-268.; Simon K. Can We Agree to Agree? Center for Lawful Access and Abuse Deterrence. August, 14, 2014. Available at: http://claad.org/can-we-agree-to-agree/. ; Polukhin E. Minn Physician 2015;28:16-17. https://issuu.com/mppub/docs/minnesota_physician_march_2015; Fudin J. Good, Bad, and Ugly of CDC Proposed Opioid Guidelines. October 23, 2015. http://paindr.com/good-bad-and-ugly-of-cdc-proposed-opioid-guidelines/.; Dowell D, et al. MMWR Morb Mortal Wkly Rep.2016;65:1-49.; http://www.supportprop.org/board-of-directors/
CDC: Centers for Disease Control and Prevention
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CDC Guideline: Recommendation or Law?
• To refer to the guideline as “voluntary” is disingenuous.
• Its potential to become de facto law is very real
• States are already passing more restrictive legislation consistent with the CDC guideline
• “Clearly the intent of CDC is that the guideline be distributed to and adopted by state public health entities and certifying organizations as if it had the legal authority of a regulation.”
Anson P. Pain News Network, October 8, 2015; Moulton C. Worcester Telegram and Gazette, March 25, 2016. http://www.telegram.com/article/20160324/NEWS/160329474.; Vestal C. Pew Charitable Trusts Stateline, March 3, 2016. http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/03/03/states-cdc-seek-limits-on-painkiller-prescribing.; Hansen CW. American Cancer Society Letter to Drs. Frieden and Houry (CDC), October 1, 2015.
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“The greatest deception men suffer is from their
own opinions.”
Leonardo da Vinci
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The Media Influence on Prescribing
• The opioid crisis is “bloody” and “if it bleeds, it leads.”
• The media has been a central player in the “war on opioids” against: Manufacturers Prescribers Patients
• PROP has become the “media darling” A search of Google News
indicates they’re cited almost daily
Pooley E. New York Magazine, October 9, 1989.; Whelan E, et al. Pain Res Manag. 2011;16:252–258.; Pitts PJ. J Commer Biotechnol. 2014;20(3):3.; Schweighardt AE, et al. Ann Pharmacother. 2014,48: 1362–1365.; Wilbers LE. Humanity Society. 2015;39:86–111.; Schatman ME. J Pain Res. 2015;8:885-887.; Krein SL, et al. J Rehabil Res Dev. 2016;53:107-116.; Kawai K, et al. Pain Pract. 2016[Epub ahead of print].; Hale ME, et al. Pain Pract. 2016[Epub ahead of print]
When did we last see a “feel good” story in the media about opioids helping a patient enjoy a better quality of life?
We’ve all seen it in our practices…and academic journals occasionally report benefits – including in empirical investigations
Graphic: “#202:Success Icon” by cristina012: CC BY-ND 3.0
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Where are the “feel-good” stories?
• May 27-28 (24-hour) Google News search for “opioid”
• 75 stories yielded
• Every story included some combination of the words “abuse”, “addiction”, “overdose” or “epidemic”
• Not a single “feel-good” story
• The closest found was entitled, “As Overdose Deaths Increase, So Do Life-Saving Organ Donations”
Nilsen E. Concord Monitor, May 7, 2016.
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Freedom of Press vs Patient Respect
• Many mentioned Prince…even though toxicology reports were not yet back
• Freedom of the press is important
• But is it right to stigmatize and marginalize patients for whom there is no other option other than opioid analgesia?
• Increased media coverage of opioids and their portrayal as a social problem was empirically determined to coincide with their decreased prescription
Borwein A, et al. J Pain 2013;14:1686-1693.
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Recent Article Seeking Balance
• “Unfortunately, the (opioid) situation has been blurred by some politicians, health professionals, and the media by their using inadequate concepts, misrepresenting and exaggerating facts, and demonizing pain patients.”.
• Does not sugar-coat the opioid crisis
• Yet urges balance
Scholten W. Henningfield JE. Negative outcomes of unbalanced opioid policy supported by clinicians, politicians, and the media. J Pain Palliat Care Pharmacother. 2016;30:4-12
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Saying “No”: The Easy Way Out?
• Years of indiscriminate prescribing cannot be “undone” by shifts in practice
• History should not be the cause of opiophobia, oligoanalgesia, and needless suffering
• The opioid crisis affects not only individuals, but society as a whole
• “Just saying no”: Not the answer, though it may seem an easy solution for many
physicians and policy-makers Not ethical practice; allows patients to needlessly suffer when
we have medication to relieve chronic pain May actually be construed as patient abandonment
Ziegler SJ. Pain Med. 2013;14:323-324.
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Risk Management
• Abuse and addiction will always be risks
• Physicians are morally obligated to be risk managers as an expression of nonmaleficence
• Are risk mitigation strategies a panacea? No, but the available data suggest that they help
• The data on the lack of use of these strategies is discouraging: Screening for psychosocial and behavioral risk
factors:
- Very recent data suggest that it is uncommon, less than 6% of physicians
Beauchamp TL, Childress J. Principles of Biomedical Ethics [5th ed]. New York: Oxford University Press, 2001.; Nuckols TK, et al. Ann Intern Med. 2014;160:38–47.; Butler SF, et al. Pain Med. 2016[Epub ahead of print].
Graphic: “Risk Down Arrow” by Jagbirlehl: CC-BY-SA-3.0
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Risk Management: UDT
Turner JA, et al. J Gen Intern Med. 2014;29:305-311.; Lasser KE, et al. J Subst Abuse Treat. 2016;60:101-109;Starrels JL, et al Ann Intern Med. 2010;152:712-720
• Hard to assess in “real world”, as most studies occur in academic medical centers – likely artificially inflated prevalence
• E.g., once a program encouraging use of UDT was initiated, half of all patients receiving COT received UDT, as opposed to only 7% 2 years prior
• Recent study involving community health service patients found that only 24% on opioids received even a single UDT
• The one American systematic review on UDT efficacy – while limited leans toward efficacy for misuse prevention
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Risk Management: PDMPs
• Great heterogeneity of programs from state to state Only 32% have an enrollment mandate
for physicians
• Percentage of prescribers who use PDMPs nationwide is extremely difficult to determine
• Outreach efforts to register more physician users not effective
• Efficacy of PDMPs: Empirically established for reducing overdose deaths and doctor-shopping
.
Manasco AT, et al. Pharmacoepidemiol Drug Saf. 2016[Epub ahead of print].; Deyo RA, et al. Clin J Pain 2015;31:782-787; Johnson H, et al. MMWR Morb Mortal Wkly Rep. 2014;63:569–574.; Delcher C, et al. Drug Alcohol Depend 2015;150:63-68
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Risk Management: Mandatory Education
• Mandatory education in opioid safety A touchy topic for some physicians Would such mandatory education allow physicians to make
better decisions in the face of outside influences?
• Undergraduate medical education in pain management is deficient Only 4 of 104 medical schools surveyed had a required pain
course- There are no full-term pain residency programs- Fellowships in pain medicine are available only for a few
types of specialists
Davis CS, Carr D. Drug Alcohol Depend. 2016[Epub ahead of print].; Mezei L, Murinson BB. J Pain 2011;12:1199-1208.; Johns Hopkins Bloomberg School of Public Health. The Prescription Opioid Epidemic: An Evidence-Based Approach; 2015.
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Ethical Prescribing
• Calls have been made for mandatory use of: UDT
PDMPs
Physician education in opioid safety• American physicians seem reluctant to accept these risk
management practices Ex: Half of all PCPs said they would discontinue opioid
prescribing if opioid education was required or they were compelled to provide patient education
• If physicians do not begin to universally mitigate risk associated with opioid prescribing, other stakeholders will “mitigate risk” by making opioids simply “go away”
• Tragically, this has already begun to happen…..Florida Senate Health Regulation Committee. Statement of estimated regulatory costs for the standards of practice for physicianspracticing in Pain Management Clinics Bill. 2010. (2010A Special Session):SB 1990.; Darnall BD, Schatman ME, Compton P, Goldberg DS, Rich BA. Pain Med. 2014;15:1999-2002.; Haffajee RL, et al. JAMA 2015;313:891–892.; Volkow ND, McLellan T. New Engl J Med. 2016;374:1253-1263; Schatman ME, Darnall BD, Cain J, Manworren RCB. Pain Med. 2013;14:1821-1825.; Anderson P. FDA panel: physician opioid training should be mandatory. Medscape Psychiatry and Mental Health, May 6, 2016. ; Alford DP, et al. Pain Med. 2016[Epub ahead of print].; Slevin KA, Ashburn MA. J Opioid Manag. 2011;7:109-115.; Watts C. Surg. Neurol. 2009;71:269-273.
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Summary and Conclusions
• Opioids are potentially dangerous As demonstrated by indiscriminate
prescribing fueled by illegal marketing in the beginning of this millennium
• Our current lack of options for access to safer and more effective chronic pain management necessitates opioids remain in physicians’ pain management armamentaria
• The influence of extraneous stakeholders in American pain medicine make prescribing onerous and frightening
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Summary and Conclusions
• Development of a single-payer system will go a long way toward allowing our system to catch up with those of the rest of the industrialized world
• Would any of you not feel safer prescribing if all opioids were abuse-deterrent formulations?
• Pharma isn’t perfect…but is responding to a wide range of pressures to clean up its act
• Are regulatory agencies a threat to physicians who prescribe opioids? Not if their risk mitigation practices are thorough, consistent,
and documented But other stakeholders may be a threat to physician and
patient autonomy
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Summary and Conclusions
• “Just saying no” to prescribing probably feels safe
• Yet doing so will cause needless suffering among tens of millions of Americans for whom there is presently no better option
• Practicing aggressive risk mitigation is the only ethical answer
• Sometimes, doing the right thing is not necessarily easy but it is still the right thing.
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THANK YOU
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References
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13. Board of Directors. 2016; http://www.supportprop.org/board-of-directors/.
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PCSS-O Colleague Support Program and Listserv
• PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications.
• PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management.
• Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties.
• The mentoring program is available at no cost to providers.
• Listserv: A resource that provides an “Expert of the Month” who will answer questions about educational content that has been presented through PCSS-O project. To join email: [email protected].
For more information on requesting or becoming a mentor visit:
www.pcss-o.org/colleague-support
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PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American
Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American
Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and
Southeast Consortium for Substance Abuse Training (SECSAT).
For more information visit: www.pcss-o.orgFor questions email: [email protected]
Twitter: @PCSSProjects
Funding for this initiative was made possible (in part) by Providers’ Clinical Support System for Opioid Therapies (grant no. 5H79TI025595) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department
of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.