Legal

Opioid Prescribing: Safe Practice

We currently face an unprecedented crisis involving opioids, as anyone paying attention to media reports knows. More people are dying of overdoses than die from vehicular crashes or from gun violence. Many of these overdose deaths, and most of the recently noted increases, involve opioids.

The reasons for the recent increase are multifactorial. One cause is the recent availability of low-cost, high-potency street opioids such as heroin and fentanyl. Another is an attitudinal shift, with many believing that prescription medications are, by their nature, safer than illicitly manufactured drugs.

There has also been a change in many prescribers’ practices in response to education regarding another crisis – the one of under-managed pain. Opioids continue to be the mainstay for the management of many types of pain, including severe acute pain, post-surgical pain, cancer-related pain, and pain associated with terminal conditions. However, as prescribers gain proficiency and become accustomed to utilizing opioids for these problems, many become relatively desensitized to the drawbacks associated with this class of medications.

Opioids are not first-line agents for the management of chronic, non-malignant pain. They have not been proven to be effective for such pain, though admittedly, very little in terms of alternatives has such proof either. Individuals have significant differences in sensitivity to various opioids, based on genomic variances in opioid receptors. Similarly, we have become increasingly aware that some individuals are biologically predisposed to the development of use disorders and addiction, with longer exposure to and higher doses of opioids raising such risk.

Policy-makers, after receiving input from multiple experts, developed a formal multi-pronged plan to address some of these issues presented by the opioid crisis. A balanced approach is the goal, emphasizing both the utility of opioids for severe pain and the risks of opioids when used improperly. One part of this balanced response was the development by the Food and Drug Administration (FDA) of an Opioid Risk Evaluation and Mitigation Strategies (REMS) plan. Originally covering only extended release and long-acting (ER/LA) opioids, it is being expanded to cover all opioid formulations. The REMS made available funds to create education for prescribers and the public, on the safe and balanced role of opioids in modern medical practice.

The American Academy of Hospice & Palliative Medicine (AAHPM) joined with a number of other professional societies to form the Collaborative for REMS Education. CO*RE represents a wide array of professionals, including primary care physicians, nurse practitioners and physician assistants, addiction specialists, oncologists, pain management specialists, as well as hospice & palliative medicine (HPM) physicians. The group has developed education addressing safe and effective opioid prescribing, appropriate use of opioid antagonists, opioid safe storage and disposal, abuse-deterrent formulations, addiction and use disorder screening, and prescribing in special populations. To date, CO*RE has provided more Opioids REMS education across the nation than any other group.

Now in its sixth edition, the CO*RE curriculum is called Opioid Prescribing: Safe Practice, and reinforces what all prescribers should understand about opioids in today’s regulatory and political climate. In September 2017, Dr. Ronald Crossno and Dr. Daniel Fischberg presented this information in a 2-hour webinar, providing an HPM slant to the material. This webinar was recorded and is now offered as a CME-accredited, REMS-compliant training on the AAHPM online store. This is provided free of charge, as required by the Opioid REMS blueprint. Participating in the webinar and finishing the associated post-test results in the clinician being designated a “Completer”, meaning the Completer can show proof of having taken the course, if such education is ever mandated.

Whether you are new to the field or an old pro at opioid prescribing, we encourage you to take the Opioids Prescribing: Safe Practice course and to complete the associated post-test. Virtually everyone who has taken it has admitted to learning something new, which they can incorporate into practice.

Submitted and written by Ronald J. Crossno, MD HMDC FAAHPM and Daniel Fischberg, MD PhD FAAHPM


Highlights of the November Issue of the Journal of Pain and Symptom Management (JPSM)

Listed below are a few articles from the most recent issue of the journal:

Breakthrough Cancer Pain: An Observational Study of 1000 European Oncology Patients
Andrew Davies, Alison Buchanan, Giovambattista Zeppetella, Josep Porta-Sales, Rudolf Likar, Wolfgang Weismayr, Ondrej Slama, Tarja Korhonen, Marilene Filbet, Philippe Poulain, Kyriaki Mystakidou, Alexandros Ardavanis, Tony O’Brien, Pauline Wilkinson, Augusto Caraceni, Furio Zucco, Wouter Zuurmond, Steen Andersen, Anette Damkier, Tove Vejlgaard, Friedemann Nauck, Lukas Radbruch, Karl-Fredrik Sjolund, and Mariann Stenberg

Targeted Investment Improves Access to Hospice and Palliative Care
Amy P. Abernethy, Janet Bull, Elizabeth Whitten, Rebecca Shelby, Jane L. Wheeler, and Donald H. Taylor, Jr.

The Cost-Effectiveness of the Decision to Hospitalize Nursing Home Residents With Advanced Dementia
Keith S. Goldfeld, Mary Beth Hamel, and Susan L. Mitchell

To access the articles, you must subscribe to JPSM or be a member of the American Academy of Hospice and Palliative Medicine (AAHPM). For further information on the Academy, call 847.375.4712 or visit aahpm.org.
Submitted by: David J. Casarett, MD, MA, Senior Associate Editor, JPSM

President Crossno’s Letter to American Medical News

Letter to American Medical News

January 6, 2012

Re: Handful of States Promise Physicians Online Access to Advance Directives, posted January 3, 2012 on amednews.com http://bit.ly/vFKMvx

When very sick patients are unable to express their wishes toward the end of life, nothing is more heartbreaking for doctors and loved ones than not knowing what those wishes are. It’s up to grieving and frightened family members to try to recall a past conversation, or remember whether there’s an advance directive, and if so, how to put their hands on it. Online registry programs for advance directives that give doctors access to this information would help ensure that we meet our patients’ wishes and that we don’t leave family members always questioning the decisions they were forced to make.

Patients need to hear from their doctors the importance of advance directives. They need to know that an advance directive can be changed, and that it can direct doctors to stop aggressive life-saving treatments, or continue them. Most important, an advance directive needs to be readily accessible when you need it. The American Academy of Hospice and Palliative Medicine has information on advance directives at www.aahpm.org and www.PalliativeDoctors.org

Ronald J. Crossno, MD CMD FAAFP FAAHPM

President, American Academy of Hospice and Palliative Medicine

REMS ARE COMING! – Comment before Dec 7!

It was a privilege to represent AAHPM at the fall meeting of the Council of Medical Specialty Societies in Washington D.C. on November 18 & 19, 2011. This was my first CMSS meeting and I was struck by the energy, collegiality, and nimble structure of this “society of medical societies.” There is no House of Delegates to debate everything like in the AMA – just a Board of Directors, Component Groups (CEO’s, Membership directors, clinical practice guideline developers, etc.) and occasional task forces. They have done a lot, but only taken a stand on 5 public topics – the most recent being support of comparative effectiveness research (in a letter the AAHPM signed).

I spent my time in a day-long seminar on the upcoming REMS – Risk Evaluation and Mitigation Strategy for long acting opioids. Regina Labelle, from the White House Office of National Drug Control Policy certainly got my attention when she explained that in 17 states, deaths from unintended drug overdoses now outnumber deaths from traffic accidents! Understandably Congress and the Administration want something done about this. Theresa Toigo, R.Ph., M.B.A., from the FDA explained that the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA the authority to require manufacturers to develop and implement a REMS when necessary to ensure the benefits of a drug or biological product outweigh its risks.

On April 19, 2011, in conjunction with the Office of National Drug Control Policy (ONDCP) release of the Obama Administration’s Epidemic: Responding to America’s Prescription Drug Abuse Crisis—a comprehensive action plan to address the national prescription drug abuse epidemic, FDA issued letters to application holders (makers and seller of opioids) directing them to submit a REMS within 120 days and describing the elements that needed to be included in the REMS (REMS notification letters).

So what is REMS and why should we care?

After notifying the makers and marketers of long-acting and extended-release (LA/ER) opioid drugs that they were required to submit a risk evaluation and mitigation strategy (REMS), FDA has been working with the sponsors that market these products on the required REMS. The central component of the Opioid REMS is an education program for prescribers (e.g., us) so that LA/ER opioid drugs can be prescribed and used safely. FDA expects the prescriber training to be conducted by accredited, independent continuing education (CE) providers (like AAHPM), without cost to the healthcare professionals, under unrestricted grants to accredited CE providers funded by the sponsors. Kate Regnier, M.A., M.B.A., from ACCME assured us that industry would not be dictating the curriculum so the CME can comply with ACCME standards.

What are they going to be teaching us?

On November 4, 2011, FDA announced the availability for public comment of a draft “Blueprint.” The Blueprint, developed by FDA with advice from other Federal agencies, is a basic outline and the core messages that FDA believes should be conveyed to prescribers in a basic two to three hour educational module. After it is completed and approved as part of the REMS, the Blueprint is posted on the FDA web site for use by CE providers in developing CE courses. The Blueprint for provider education can be found at

http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf

While, in general, I found these tenets reasonable, there isn’t a lot here about effective pain management for seriously ill patients. A few quotes will give you the flavor:

Health care professionals who prescribe extended-release (ER) and long-acting (LA) opioids are in a key position to balance the benefits of prescribing ER/LA opioids to treat pain against the risks of serious adverse outcomes including addiction, unintentional overdose, and death.

Prescribers should caution patients that ER/LA opioids can cause serious side effects that can lead to death.

Prescribers should explain that sharing ER/LA opioids with others may cause serious side effects including death, and that selling or giving away ER/LA opioids is against the law.

Prescribers should ensure that patients adhere to a treatment plan and monitor patients for misuse and abuse by

  • Recognizing aberrant behavior
  • Utilizing Prescription Drug Monitoring Programs to identify potential abuse where available
  • Understanding the role of drug testing and performing drug screens as indicated
  • Screening and referring for substance abuse treatment when indicated
  • Performing medication reconciliation at each visit

Whether this program will be required to maintain your DEA registration is being discussed. The REMS notification letters stated that although there is no mandatory requirement that prescribers take the course as a precondition to dispensing the medication to patients, application holders will be required to establish goals for the number of prescribers trained, collect the information about the number of prescribers who took the courses, and report the information to FDA as part of periodic required assessments. Although FDA recognizes that additional training modules could be helpful, FDA’s goal is to require basic education for all prescribers of long-acting and extended-release opioids, and at this time, FDA does not intend to develop or approve messages as part of the REMS beyond those approved in the basic core module.

Can we have any input into this?

We have until December 7 to submit comments on the draft Blueprint http://www.regulations.gov.

The AAHPM has been working with a group called CORE to develop a program that meets these criteria. Stay tuned for more about this.

Another indication that HPM is becoming more mainstream?

In the category of ‘what goes around comes around,’ a recent event reminded me of the ironies life can bring; but this is a cautionary tale for all. At this time last year, I was immersed in a trial. While there is a general impression that hospice and palliative medicine are relatively immune from issues of tort liability and malpractice, this is proving to be increasingly untrue. In some parts of the country, trial lawyers are exploring new theories of litigation with causes of action against hospice and palliative medicine providers, an untapped and fertile ground for potential malpractice awards. While this clearly isn’t “good news,” ironically it may be another milestone in HPM’s ongoing efforts to integrate into ‘mainstream medicine.’

The case involved a middle-aged man who presented with non-small cell lung cancer. At initial diagnosis, disease seemed to be limited. He underwent surgical resection to remove the mass; however, biopsies showed tumor present in the contralateral lung, as was confirmed by subsequent bronchoscopy. After completing radiation therapy, he had two more bronchoscopies, each confirming ongoing malignancy in both lungs. He was referred to hospice when he declined chemotherapy.

His course was complicated by pain, at least in part related to post-thoracotomy syndrome. This required high dose opioids for pain management, after failure of interventional techniques and other adjuvant therapies. While on hospice over the next couple of years, he underwent further diagnostic and prognostic evaluation, including imaging studies showing ongoing progression of disease.

Then something changed. Coincidentally at the time he moved out of our service area, reevaluation by his new treatment team indicated radiographic regression. His performance status began to improve. Believing his prognosis was extending, he was discharged from hospice and his new internist assumed duties as his primary care physician (PCP), including management of his ongoing pain.

Almost two years after his hospice discharge, a suit was filed. Five years after that, the suit finally went to trial. Discovery proceedings showed that his new PCP told this patient that there was an error, and that his cancer must have been misdiagnosed because if he really had cancer in the first place, he would have died. His PCP weaned the patient off opioids (despite ongoing pain) and told him that by giving him high dose opioids when he didn’t have cancer, the hospice and yours truly as the hospice doctor, (though I was eventually dropped as a named party in the suit) had turned him into an addict, which was malpractice.

This theory that we made him an addict then formed the basis for a suit, supported by one board-certified “expert” (a very part-time, hospice and palliative medicine physician from four states away), as well as a stack of articles indicating that opioids cause harm. These studies involved street heroin users, polydrug abusers, or patients with sleep apnea; not individuals being treated under careful medical supervision for severe pain. The defense included several HPM specialists and a renowned pain specialist, all of whom agreed that care was not only appropriate, but exemplary. In the end, this jury of our peers were evidently swayed by plaintiff attorneys theatrics like: referring to the commercial showing an egg frying in the pan with the statement, “here’s your brain; here’s your brain on drugs,”; or pouring out a 50-lb bag of beans over the floor in front of the jury to indicate (without having to prove up the numbers) how many pills the patient supposedly took during his hospice stay. Defense testimony that this represented a rare case of spontaneous remission was met with derision, the implication being that claiming “a miracle” as our defense is really no defense at all. The judge, clearly trying to champion the underdog, made several rulings favoring the plaintiff, which all later agreed would have been adequate basis for a successful appeal and eventual retrial.

When the jury, in its deliberations, began sending out questions indicating that an award was being contemplated, the suit was settled. Defense attorneys wanted to limit a potential high-dollar award, while plaintiff attorneys wanted to avoid the risk of an appeal sending the case back for re-trial. Post-trial juror debriefing revealed that no one really believed anyone had done anything wrong; but, “no one can have cancer like that just go away,” and “the poor man just deserved some sort of compensation for all he had been through.”

Regarding this being a cautionary tale: all medical practitioners should be aware that at trials, our legal system is much more about theatrics than scientific facts. To plaintiff lawyers, this is a business in which they will push all limits in order to win. To defense attorneys, this is about limiting financial risk. To judges, this is often about protecting the poor and unfortunate, even at the expense of those who did nothing wrong other than not being so unfortunate. Sadly, I used to believe what we’ve all been taught: that this is supposed to be about fairness and justice. During this almost three-week trial, I heard much more talk about winning the lottery than about achieving justice.

Ironically, what served as the trigger for blogging about this (if you can believe it), is that last week we received a referral to our hospice for a now slightly older man with terrible pain due to wide-spread, metastatic non-small cell lung cancer. His statement was that he’d had a “bad experience” with hospice once, but now he believed he needed that kind of care once again. Upon legal advice, it was decided to refer him on to a different agency; one that he had not previously sued. I have to admit feeling sad over that decision, since I still believe we treated him correctly the first time, and could again provide him appropriate relief of suffering, during these, his last days. But then again, life isn’t always fair.