Data that are being cited about opioids, addiction, suicide and overdose may not tell the whole story. That’s the conclusion that a health rehabilitation expert and frequent commenter on chronic pain treatment believes.
Terri Lewis, PhD., who is a contributing editor to the National Pain Report, has been looking at data. She thinks the data tell a story different from the current conversation about addiction.
She prepared some data in a PowerPoint presentation that can be viewed at the end of the story. She distributed this information to media sources because, as she said, this week would have been her father’s birthday. Her father died at the age of 57 (and suffered from chronic pain). Her son also suffers from intractable chronic pain. As a daughter and a mother, she fights for the chronic pain patient.
As she said, “I put this (data) out to acknowledge their struggle, and everyone else who deals with this process of trying to live on this planet under the nanny state and also to suggest that we are not learning what we need to learn.
She also agreed to do an interview on what she has uncovered.
National Pain Report: You are indicating that more off label prescribing is occurring and not being followed for impact. What do you believe it would show if the data were being properly analyzed?
Terri Lewis, PhD. In the last few days I have intensively reviewed the CMS Medicare Part D data in their newly released opioid tracking tool; the mortality statistics in the WONDER system at CDC; a number of recent research articles in JAMA that decompose prescription data from direct sources; and after listening to consumers deal with the effects of prescribing protocols foisted upon them, I have to say that I am compelled to question the obvious. The top 50 drugs prescribed are loaded with the potential for adverse events and drug: drug interactions that our systems do not routinely detect. Off label prescribing is associated with greater rates for serious adverse events, than for FDA approved uses. Off label prescriptions are often dispensed to the most vulnerable people, including those with chronic pain – gabapentin and tramadol are prime examples. Bother are associated with increased rates of suicidal ideation and frequently they are prescribed together, particularly when the physician decides to step the patient off of opioids. In too many cases, there doesn’t seem to be a connection between the act of prescribing and the consequences of prescribing. And that may be something of great importance when one considers that 63% of those who deceased in CDC’s 2013 mortality statistics had prescribing practices associated with polypharmacy or the regular use of 5 or more prescriptions in the month prior to their death.
National Pain Report: “From a patient’s perspective–drug to drug interaction is a problem, one they don’t even recognize at times.. Shouldn’t the patient be talking more with doctors and pharmacists (and vice versa) on this issue?
Terri Lewis PhD. It’s hard to get a word in edgewise in a 15 minute office visit. And when your pharmacist leaves the conversation to a clerk who invites you to sign on the dotted line that you got a piece of paper (counseling), consumers may never make the connection between physical, mental or cognitive distress and their prescriptions. This is made even more difficult with mail order systems. Importantly, we are measuring the numbers of scripts written, but patients can tell you that they are almost never asked whether the scripts that are written for them produce the anticipated result. In many cases they don’t and that causes the working alliance between physician and patient to crack. If the physician is measuring adherence and conformance and asks that you pee in a cup, but can’t connect it to treatment outcomes, you’ve got a problem. And this is too often the case.
National Pain Report: You study the issue of and are a eloquent spokesperson for how our health care delivery system is injured if not downright broken. What do the data you provided indicate from that point of view and how would you remedy it.
Terri Lewis PhD. “The very first thing we need to do is open up the national conversation and move it away from the four camps that have emerged – addiction, chronic pain, and ‘them’ – physicians and policy makers. First, because we may be having entirely the wrong set of conversations and while we are talking around each other we aren’t talking to each other, so there is no productivity. Second, we have to come to the table and honestly examine the system in which we are working – revisit the questions and assumptions, and insist on an open dialogue with input from all of the stakeholders to this system. I am also a care partner to my son who has severe chronic pain and depression – and we are fighting the suicidal ideation battle- so I have current, fresh experience with how harmful repeated failure is. We cannot improve care unless we become much more skeptical and much more willing to bring all of the stakeholders to the table. Examine the collective experience, and reframe this conversation to one that is focused on the impact of our practices. We need to let the data talk to us, address the logical fallacies, and implement continuous improvement strategies – a Manhattan Project as others have described it. Most importantly, we need to ask patients how our decisions affect them. We have nothing without this.”
“What we have now is dangerous. And we are playing a dangerous ‘us against them game’ that will harm us. By 2030 – which is just around the corner – we will be a super-aged population – what that means is that half of the population will be aged 65+ in years and among this group, 2 or more chronic health conditions will be the reality of their daily lives. Our current lack of uniform access to health care and ‘drive by’ prescribing practices will hasten this process and increase the likelihood that this group will be even sicker than we might imagine. We haven’t even accounted for adapting our health care practices to address an increasingly aged population. This is of particular concern because we are creating large numbers of newly injured every year with our current health care design.”
“We are in trouble. And we don’t know it because we are so busy talking we aren’t listening. We need to use this opportunity to learn, improve our practices, and prevent and reduce new harms.”
The follow data was adapted from the PowerPoint presentation that Terri Lewis, PhD. sent to media outlets:
- We have new tools and new findings to explore this controversy.
- Between 1999 and 2012, the reported use of prescription drugs across 18 drug classes increased by 8% to 59% of all adults. If these, 11 drug classes were responsible for this increase and included antihyperlipidemic agents, antidepressants, prescription proton-pump inhibitors, and muscle relaxants. The off-label prescribing of FDA approved drugs for off label applications is associated with serious adverse events.
- In looking at the top 50 most commonly prescribed drugs in Medicare Part D’s program (681K prescribers in 50 states) there is plenty to be concerned about with regard to off label prescribing and drug-drug interactions.
- Should we be asking whether polypharmacy and drug-drug interactions are common among the top 50 prescribed drugs? Whether the likelihood of adverse events might include accidental poisoning and impaired judgment? Whether suicidal ideation might follow when risky medications are prescribed off label for illnesses or injuries that by themselves, promote the onset of chronic pain?
- 100,000,000 people live with chronic pain (IOM,1999). Why aren’t more affected persons with chronic pain negatively affected by opioid prescribing practices? What do we know about the impact of our prescribing practices for opioids alone, or opioids prescribed in combination with other drugs classes? What do we know about the impact of stepping off opioids onto other drug classes prescribed off label for chronic pain? What is the relationship of prescribing practices to consumer function? Are we confusing the act of prescribing with management of outcomes?
- We don’t know as much as we need to. I guarantee you this.
The drug combinations with the highest event prevalence (Prev. = a/(a+b)) in STRIDE, for each event.
- The drug combinations with the highest event prevalence (Prev. = a/(a+b)) in STRIDE, for each event. AMIA Jt Summits Transl Sci Proc. 2013; 2013: 83–87. Published online 2013 Mar 18, Medscape
- Eguale, T., Buckeridge, D.L. Verma, A., Winslade, N.E., Benedetti, A, Hanley, Ja.A. & Tamblyn, R. (2015, November 2). Association of Off-Label Drug Use and Adverse Drug Events in an Adult Population, JAMA ONLINE FIRST
- Kantor, E.D. Rehm, C.D, Haas, J.S., Chan, A.T., Giovannucci, E., (2015, November 3). Trends in Prescription Drug Use Among Adults in the United States From 1999-2012, JAMA
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