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14 Articles in Volume 19, Issue #1
Analgesics of the Future: NKTR-181
Antidote to CDC Guideline; Plantar Fasciitis; Patient Input
Assessing and Treating Migraine in Women and Men
Demystifying Opioid-Induced Hyperalgesia
Editorial: Have We Gone Too Far? Can We Get Back?
How to Compel Patients to Complete Home Exercises
Inflammation Targeted Nanomedicine
Intravenous Stem Cell Administration for Ileitis
Invasive Surgery: Effective in Relieving Chronic Pain?
Pain Catastrophizing: What Practitioners Need to Know
Pain Therapy Options for the Home
Regenerative Medicine
The Future of Pain Management: An Experts' Roundtable
Whole Body Vibration: Potential Benefits in the Management of Pain and Physical Function

Editorial: Have We Gone Too Far? Can We Get Back?

Beyond the opioid crisis, new challenges—and hopes—await the pain practice community.
Pages 9-11

Any loss of life is tragic. No reasonable healthcare practitioner desires to contribute to the morbidity or mortality of his or her patients. Unfortunately, and far too often, clinicians with the best intentions actually do contribute to harm by failing to recognize risks inherent in a patient, procedure, medication, or the patient’s environment/household. In the authors’ collective 60-plus years of experience, prescribing opioids without a risk-management strategy in place to a patient with a history of abuse or psychiatric disease, including but not limited to anxiety, depression, PTSD, and/or bipolar disorder, is a recipe for disaster. Prescribing opioids to this population may be done, but it takes considerable effort and knowledge.

At the same time, abruptly discontinuing opioids or forcing tapers without patient consent has no scientific basis in the literature, and without careful consideration to potential harm in opioid legacy patients, this practice may be more harmful than leaving the patient on their current long-term opioid regimen. Adverse outcomes could include agitation, withdrawal, suicidal ideation, depression, increased PTSD if predisposed, and more. In fact, according to a recent commentary by pain experts across the globe, “New and grave risks now exist because of forced opioid tapering: an alarming increase in reports of patient suffering and suicides within and outside of the Veterans Affairs Healthcare System in the United States.”1 Nevertheless, government and insurance payor policymakers continue to employ dangerous criteria without adequate safety nets in place.

“Other” Crises Peering Over Our Shoulders

We know that addiction is a disease that does not discriminate. People of all races, genders, religions, ethnic backgrounds, and social classes repeatedly behave in ways they know are harmful. In fact, the order of addiction potential to the most common substances of choice are: nicotine, alcohol, and opioids, respectively. Much attention has been given to deaths related to opioids, but the following stats are often overlooked:

  • Cigarette smoking is responsible for more than 480,000 deaths per year in the US, including more than 41,000 deaths resulting from secondhand smoke exposure. This is about 1 in 5 deaths annually, or 1,300 deaths daily.2
  • An estimated 88,000 people (approximately 62,000 men and 26,000 women8) die from alcohol-related causes annually, making alcohol the third leading preventable cause of death in the US.3
  • Poor diet and physical inactivity are estimated to contribute to 365,000 deaths in the US.4

But when was the last time we discussed the tobacco, alcohol, or food epidemic in the context of pain management? Two decades ago, in 1998, clinicians were still learning about the abuse potential of prescription opioids. In 2008, we were in the midst of the crisis and focused on educating practitioners about the safe use of opioids. Now, in 2019, if you mention a prescription opioid crisis to clinicians, they look at you sideways. A majority of primary care clinicians have “just said no” to opioid prescribing, and those clinicians that continue to prescribe have mostly educated themselves on appropriate risk management, but are nonetheless faced with regulatory, board, and payor restrictions on dosage and quantity. While healthcare providers at large are working to address the crisis head-on, it is a well-known fact that the current opioid abuse landscape has shifted to illicit agents, primarily heroin and fentanyl analogs.

Despite the fact that the medical community has stepped up to address the opioid crisis, CMS is implementing a three-pronged approach to combating the opioid epidemic. These efforts include:

  • prevention of new cases of opioid use disorder (OUD)
  • treatment of patients who have already become physically dependent on or addicted to opioids
  • utilization of data from across the country to better target prevention and treatment activities.

What Lies Ahead

The new CMS rule calls for 7-day prescription limits for opioid naïve patients, meaning a provider will need to proactively request a coverage determination on behalf of the patient attesting to the medical need for a supply greater than 7 days. If this occurs prior to discharge from a hospital, or if there is a transitional care team, we encourage that the physician, pharmacist, or another clinician preemptively make a request if longer therapy is anticipated. There will also be an alert if a patient’s cumulative morphine milligram equivalent (MME) per day across all of their opioid prescription(s) reaches or exceeds 90 MME. In reviewing the alert, the dispensing pharmacist will need to consult with the prescriber to confirm a medical need for the higher MME. Once a pharmacist consults with a prescriber on the patient’s prescription for a plan year, the pharmacist will not be required to consult with the prescriber on every opioid prescription written for the same patient afterward, unless the plan implements further restrictions.

If a provider prescribes opioids or benzodiazepines for a patient who is identified as a potential at-risk patient, the Part D plan will contact the provider to review the patient’s total utilization pattern of frequently abused drugs. There may also be a “lock-in” program for both prescriber and pharmacy, whereby patients will be restricted to obtain prescriptions from only a single designated prescriber and pharmacy. It is noteworthy that no extra time has been afforded to pharmacists to initiate these calls or for the prescribing clinician to answer them. If they do find the time to participate and comply, neither clinician has a mechanism for reimbursement for the time. And, while support staff such as a nurse or medical assistant on the medical end may be able to address the pharmacist’s inquiry, only a pharmacist or licensed pharmacy intern may initiate the call by regulation.

Forced tapering and the pseudoscience around daily morphine equivalents have contributed to patient harms since the commencement of the controversial CDC opioid prescribing guideline in 2016 and will likely be compounded with the new CMS guidelines. While we embrace patient safety in terms of proper opioid use and dose reduction when indicated, these collective guidelines may very well contribute to dire patient and professional outcomes in this new year and beyond. In a recent PPM patient online poll (see below), 97% of 428 voters said they were nervous about these changes. Moreover, rather than encouraging prescriber–pharmacist collaboration, we are likely to see a wedge forced between them due to time constraints, which will ultimately end in forced opioid reductions with careful attention to individualized therapy.5

For almost 25 years, various pain experts have talked about opiophobia, which, as a country, we began to overcome and now, the pendulum has swung back. But just as there are patients that should not be on opioids, there are patients who have no other option or in whom alternative medications are more dangerous. And some of these patients require doses that exceed some arbitrary limits, whether due to tolerance, drug interactions with other chronic therapies, pharmacogenetic variability, and/or severity of pain.

There is no shortage of heart-wrenching patients stories that seem too detailed to dismiss as untruthful. Most of us have heard these stories, and even threats, from our suffering patients. We are certainly not advocating opioids for patients when they are not appropriate, but it has become standard practice to reduce or discontinue opioids from stable, low-risk pain patients for no legitimate reason. Clinicians have been forced to tell patients that they have to suffer in the same way we tell our children they cannot have another toy or cookie: “You get what you get and you don’t get upset.”

Hope is On the Way

We, like many pain clinicians, have spent significant time investigating new drug therapies, with the ultimate quest for an effective analgesic remedy that has no risk of abuse, addiction, or respiratory depression. Rest assured that help is on the way. Novel centrally acting agents, new opioid-like molecules, reformulated topical analgesics, and even nonpharmacological (“brain-wave”) devices will change the way we treat pain. If you’re skeptical, take a look at this issue’s expert roundtable on the “Future of Pain Management," or our new “Analgesics of the Future” column. And in the short term, let’s work to better and more effectively utilize the tools in our toolbox, which do include opioids when used responsibly as part of a multimodal plan for refractory pain patients.

While new pipeline options are on the way, it’s time to crawl out of the purgatory of learned helplessness. We all face the daunting task of balancing political rhetoric, regulatory and insurance policies, and the fear of regulatory scrutiny. But more importantly, we need to encourage collaboration and support for each other and, ultimately, for the patient who suffers daily with intractable pain and hopelessness.

 

PPM Editors-at-Large Jeff Gudin, MD, and Jeffrey Fudin, PharmD.

Last updated on: April 12, 2019
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