Jeffrey Fudin
Jeffrey Fudin
Dr. Jeff Fudin graduated from Albany College of Pharmacy & Health Sciences with a bachelor's degree and PharmD. He is a Diplomate to the American Academy of Pain Management, a Fellow to ACCP, a Fellow to ASHP, and a member of several other professional organizations. He is founder and CEO of Remitigate, LLC (remitigate.com), a software platform for interpreting urine drug screens (Urintel) and pharmacogenetics(Phenotel). Dr. Fudin is a section editor for Pain Medicine and serves on the editorial board for Practical Pain Management. He is founder/chairman of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT), an advocacy group in favor of safe opioid prescribing. He practices as a clinical pharmacy specialist (WOC) and director of PGY-2 pharmacy pain residency programs at the Stratton Veterans Administration Medical Center in Albany, New York. He is an adjunct associate professor of pharmacy practice at Western New England University College of Pharmacy and Albany C

The Conundrums of Chronic Opioid Therapy for Noncancer Pain Management

OCTOBER 06, 2014
In response to the recent article by Gary M. Franklin, MD, MPH, titled “Opioids for chronic non-cancer pain: A position paper of the American Academy of Neurology,” we wish to address a number of issues.1 

To start, Dr. Franklin states, “Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction.” We agree with a statement made by Bob Twillman, PhD, at the FDA hearings on February 8, 2013, that “the absence of evidence is not evidence of absence.” For example, there is no evidence to substantiate that jumping out of an airplane is dangerous but, nevertheless, it has not been studied. Interestingly, what the author fails to share here is that more deaths are caused each year by tobacco use than by all deaths from HIV, illegal drug use, alcohol use, motor vehicle injuries, suicides, and murders combined. Although there is no limit on the number of cigarettes that one can purchase or the nicotine intake from any consumers, we continue to see zealots serve up a “no opioid” meal.2-4

Inappropriate opioid prescribing is undertaken by a small percentage of prescribing physicians.5 It is both disheartening and difficult to comprehend that, with all of the national attention and various guidelines, providers remain comfortable with a knowledge deficit regarding the safety profile of opioids or the listed “best practices/universal precautions.” Pain management and monitoring for adverse events, misuse, and opioid use disorder are interdisciplinary duties. Mandating primary care physicians with limited time, training, and resources to complete the assessment, comprehensive medication management, and appropriate monitoring for aberrant behaviors is a disservice to the patients, providers, and the community at large, and it is an inherent public safety risk. We believe that here within lies the real problem, and it must be addressed if anyone expects to see an impactful paradigm shift.

A collaborative care model for the care of patients with chronic pain is a crucial element in the evolving health care reform environment.6  Any physician prescribing opioids—whether it is a primary care, mental health, emergency medicine, palliative care, infectious disease, or hospice—can benefit from having a pharmacist located in the same area or easily accessible through electronic consult services. Unfortunately, health care reimbursement policies do not provide payment for such pharmacy clinicians who could otherwise offer a uniquely needed expertise to provide best practice pain management. Prescription drugs are usually included with insurance, but pharmacist services are not required, despite the record of adverse drug and sentinel events. The prescriber and pharmacist both have a responsibility to ensure that the prescription is for a legitimate medical purpose.Insurers could face liability exposure for failure to detect and act (Duty to Warn, FL Supreme Court 2006).8

The Washington Opioid Dosing Guideline is just one resource, but the available tools alone will not optimize pain management and prevent harmful outcomes caused by health care’s culture. In fact, methadone overdoses have been on the rise in Washington, and one reason could be the inadequacy of their very own online opioid calculator: “Washington State Agency calculator does not convert from one opioid to another, but merely provides the morphine equivalents.”9 Furthermore, the suggested methadone conversion may be a particularly problematic contributor to that problem.

If a primary care provider has 15-20 minutes to review the history, complete the assessments for the problems presented, and devise appropriate risk modification plans, then poor pain management and substance abuse monitoring are expected. Having tools and educational in-services are a part of improving care for complex pain patients; however, a system redesign to support the implementation of best practices and incorporation of meaningful use into electronic health records is more likely to decrease opiate-related deaths and hospitalizations related to overdoses. 

The general consensus is that the strength of evidence for the effectiveness of long-term opioid use for long-term outcomes >1 year related to pain, function, and quality of life is insufficient. The evidence of opioid use and increasing the risk for opioid abuse, addiction, morbidity, and mortality is insufficient to low.10 Additionally, the available risk assessment tools lack sensitivity, specificity, and universal applicability.11,12 Moving forward, we know more research is needed, as most pain management articles end with a similar statement: “Ongoing research and data collection regarding opioid efficacy and management are needed.”1 

Where is leadership? Providers are busy with direct patient care duties, and there is a lack of career development awards and funding for pain research. Until well-designed studies are completed on the efficacy and safety of opioid use for chronic noncancer pain, blanket statements need to be avoided, as this can lead to misunderstandings, half-truths, provider scare tactics, and resultant suboptimal pain management. One example is the “US neurologists warn against long-term opioid use for non-cancer pain” article written by Ingrid Torjesen.13

Opioids are attractive to patients with chronic pain and to prescribers, as there is a lack of strong evidence with non-opioid treatment modalities. With an effective dose, the pain can diminish from a severe level to a moderate level, which can help the patient function on a daily basis. Opioid medications are only one part of a multifaceted approach to pain management and, when symptoms are not controlled, the treatment plan is reviewed and necessary changes can be made. Opioid use in combination with controlled comorbidities and healthy living habits can be the best treatment for some patients with chronic pain resulting in decreased pain and/or increased quality of life. Identifying these patients may be challenging, but we must not forget that there are patients who have legitimate chronic pain, compliant with opioid and non-opioid treatments, negative for aberrant behaviors, and whose leveling of functioning has improved as the result of their existing treatment approach.

The negative impacts of the current strategies used to decrease diversion of controlled substances are unknown. Our health care system could be causing patients to display behaviors similar to addiction by going to different providers, filling prescriptions at multiple pharmacies, having frequent emergency room visits to relieve chronic pain exacerbations, and driving up health care and societal costs. Underutilization of prescription drug monitoring programs in real time and interoperability across state lines is a barrier to discovering patients with aberrant behaviors. A patient can be obtaining controlled substances from bordering states, the Department of Defense, and the Veterans Healthcare Administration during the same time periods. This person may be selling the medications for profit, his pain may not be under control, and/or he may be abusing the medications. Patient-dealers are double threats to the system because they have a verifiable pain syndrome warranting legitimate opioid use.14

As clinicians, it is metaphorically difficult to resist the righting reflex; it is how the majority of us were trained! Our role is to offer a menu of options only when the patients are ready and the information necessary to make informed choices is available.15 People without chronic pain know that eating healthy, exercising, losing weight, and limiting the use of alcohol and tobacco is beneficial. If we can look beyond the symptoms of pain, we can connect the person with the necessary services. There is considerable evidence that provider and patient factors have a greater impact on outcome than the existing treatment procedures. Clinicians are experts, but patients are experts of themselves. Habits are hard to break and plans generally work better when they are developed and initiated with the patient. Our role as clinicians is to listen, evoke change in patients while making time to work with multiple disciplines to improve the quality of care, and mitigate the harms caused by the misuse of opioids. 

The damage done by the war on opioids has been an atrocity for legitimate opioid-requiring patients with persistent pain syndromes. Indeed, the pendulum has swung too far.16 Articles like Dr. Franklin’s1 serve to fuel this fire, rather than to offer intelligible options to mitigate the problem. With continued similar dialogue in various peer-reviewed journals, we are afraid that only substance abusers will win the war on opioids by doing what they do best: shifting the paradigm to alternative substances such as heroin. 

This article was collaboratively written with Kangwon “Christina” Song, PharmD. She is currently an Addiction Treatment Fellow at the South Texas Veterans Healthcare Administration. Her research interests include dissemination and implementation science for substance abuse and pain management, and prescription drug abuse and misuse monitoring. She completed her doctor of pharmacy degree at Philadelphia College of Pharmacy, PGY1 pharmacy practice residency at Memorial Health University Medical Center and PGY2 pain management and palliative care residency at the North Florida/South Georgia Veterans Healthcare Administration. Dr. Song holds academic appointments as Assistant Professor at the University of Texas Health Sciences Center and Assistant Professor at the University of Texas at Austin College of Pharmacy.

This article is the sole work of the authors and stated opinions/assertions do not reflect the opinion of employers, employee affiliates, and/or pharmaceutical companies listed.

References
  1. Franklin GM. Opioids for chronic noncancer pain: A position paper of the American Academy of Neurology. Neurology. 2014 Sep 30;83(14):1277-84.
  2. Centers for Disease Control and Prevention. Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses—United States, 2000–2004. Morbidity and Mortality Weekly Report. 2008;57(45):1226–8.
  3. McGinnis J, Foege WH. Actual Causes of Death in the United States. JAMA. 1993;270:2207–12.
  4. Centers for Disease Control and Prevention (CDC). Addressing Prescription Drug Abuse in the United States, Current Activities and Future Opportunities. CDC website. http://www.cdc.gov/homeand recreationalsafety/overdose/hhs_rx_abusehtml.2013. Accessed October 2, 2014.
  5. Cahana A, Dansie EJ, Theodore BR, et al. Redesigning delivery of opioids to optimize pain management, improve outcomes, and contain costs. Pain Med. 2013 Jan;14(1):36-42.
  6. Drug Enforcement Administration (DEA). Title 21 Code of Federal Regulations Part 1306-Prescriptions  DEA website. http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm.  Accessed October 2, 2014.
  7. Coalition Against Insurance Fraud(CAIF). Prescription for peril: how insurance fraud finances theft and abuse of addictive prescription drugs. CAIF website. http://www.insurancefraud.org/downloads/ drugDiversion.pdf. Accessed Oct 2, 2014.
  8. Shaw K and Fudin J. Evaluation and comparison of online equianalgesic opioid dose conversion calculators. Practical Pain Management. http://www.practicalpainmanagement.com/evaluation-comparison-online-equianalgesic-opioid-dose-conversion-calculators. Accessed Oct 4, 2014.
  9. National Institutes of Health (NIH). Pathways to prevention workshop: the role of opioids in the treatment of chronic pain. NIH website. https://prevention.nih.gov/docs/programs/p2p/ODPPain PanelStatementDraft_10-02-14.pdf. Accessed Oct 3, 2014.
  10. Martin D Cheatle and Cody Barker. Improving opioid prescription practices and reducing patient risk in the primary care setting. J Pain Res. 2014; 7: 301–311.
  11. Webster LR, Webster RM. Predicting aberrant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 2005 Nov-Dec;6(6):432-42.
  12. Ingrid Torjesen. US neurologist warn against long-term opioid use for non-cancer pain. The Pharmaceutical Journal. 2014 Sept 30. http://www.pharmaceutical-journal.com/news-and-analysis/news/us-neurologists-warn-against-long-term-opioid-use-for-non-cancer-pain/20066675.article. Accessed Oct 3, 2014.
  13. Fudin J, Levasseur DJ, Passik KL, et al. Chronic pain management with opioids in patients with past or current substance abuse problems. J Pharm Pract. 16 (2003), pp. 291–308.
  14. Miller WR, Forcehimes AA and Zweben A. Treating addiction: a guide for professionals. The Guilford Press; 2011.
  15. Atkinson TJ, Schatman ME, Fudin J. The damage done by the war on opioids: the pendulum has swung too far. J Pain Res. 2014 May 12;7:265-8.



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