Taming the Beast—Gabapentin. Ban It or Regulate It?

In my last post, I began with a question from Christy.  Her facility was considering banning gabapentin from their facility due to rampant abuse and diversion problems.  My last post dealt with gabapentin’s interesting history and the evidence base for off-label gabapentin prescribing.  This JailMedicine post will deal with the pros and cons of banning gabapentin versus creating rules to regulate gabapentin use and hopefully minimize diversion and abuse. Continue reading

What Makes a Good Medical Scoring System?

20050629My good friend Al Cichon wrote the following comments to me about my article on the 10 Point Pain Scale.

Use of a ‘scale’ to measure subjective factors is a true oxymoron (heavy on the moron part). The ‘fifth vital sign’ is a misdirected effort to solve a true quality care problem – in my opinion. Vital Signs are objective (as in measurable) indicators that have been demonstrated to provide consistently valid data for patient care.

JCAHO has imposed the ‘Pain Scale’ in an effort to assure that the assessment of pain will be factored into patient care. Unfortunately, it is a bureaucratic response to a clinical situation – if it can be made to be measurable (regardless of practical validity) it can be enforced. My apologies to proponents and defenders – but no matter how well intended; it is still dysfunctional.

Yet, we are obliged to employ some process of assessment to determine the impact of subjective symptoms in an efficient / effective manner. The many schemes (Pain 1-10; Cardiac pain 1-5; etc.) developed have achieved relative success / adoption / adaptation. It does seem that these processes have provided some benefit – yet they all suffer from the same susceptibility – subjectivity. Whether you are working in corrections (where any subjective report must be verified) or the community (where verification is not always considered) any of these schemes has the same risk – because there is no objective validation.

One possible option to stabilize the use of any such scale is some method of anchoring the initial or end point of the scale. That would then provide a somewhat stable reference for guiding care and transmitting information (about the patient) to other providers. Also, this mechanism can be employed in other subjective areas.

Begin with asking the patient – ‘What is the worst pain you have ever experienced?’ (the response is usually associated with fractures, renal calculi, child-birth, etc.) Now, lets’ label that as a 10 (or 5) and now –‘What is the discomfort you have now in comparison to that prior event?’ Then document the exchange in the record: Worst Pain: fractured wrist – 10); Current Pain: pulled muscle – 7. Now, no matter the number system you have an ‘anchor’ to both the scale and the present condition that can be related to the care process and others. It is important to document the ‘source’ of pain too – as this may be quite useful if you are explaining the case later (DOC, court, etc.)

One variant of this is: If you had a ‘bucket labeled depression and a stick marked off from 0 to 10 what is the worst you’ve ever felt and when”? The response will then provide an anchor (9 when I was admitted to the hospital after trying to kill myself). Additional questions are: How deep is that bucket now? Has it ever been at 0? If I could make it happen (wave magic wand) and get you released and home now – what would it be? (interestingly it can go up with release for many reasons)

When you ‘anchor’ the ‘pain scale’ it establishes the assessment in a relatable setting and can be quite helpful in guiding patient care. The ‘anchor’ can also be quite useful in discerning the ‘historical validity’ of the case as well – ‘Doc when I had that car accident with multiple fractures it was a 10; now my sprained (non-swollen, non-bruised) ankle is a 10 too!’

Clinical judgment is always the most important skill in any patient care situation. The data subjective & objective is helpful but must be understood / applied in the clinical context.

Also confounding the assessment is the different types of acute / chronic discomfort (myofascial, neuropathic, visceral). As important as assessing the level of pain is the type – physiologic source – since it is critical in guiding treatment.

As noted – ‘chronic pain’ is better measures by an assessment of the patients ADL (what daily activities are disrupted and is that new). If a patient can function (nutrition, hygiene, elimination) and participate in some activities then treatment of the physiologic cause is the most important clinical consideration.

Thanks, Al!  Excellent comments.  Let’s summarize:

  1. The 10-Point Pain Scale is not the only scoring system in medicine for subjective complaints. There is the Hamilton Rating Scale for Depression, for example.  Also, the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) for alcohol withdrawal.   There are scoring systems to rate abdominal pain and chest pain and the likelihood of pulmonary embolism.  I could go on and on.  All of these systems have the same limitations and liabilities, though some do a better job than others.
  2. Just because you assign a number to a complaint, that does not make it objective.  Because each of these scoring systems assigns a number to the complaint, there is a tendency to think of them as objective rather than subjective.  But as Al points out, this is not the case.  There is no real difference between someone who says his pain is “a six” and someone who says that he has “moderate pain.”
  3. In order for a subjective scoring system to work, it needs to be “anchored” in some way.  Al anchors the 10-Point Pain scale on the patient’s own worst experience.  Another commonly used clinical pain scale, the Visual Analogue Pain Scale, anchors the scale onto facial expressions.  The more “anchored” a system is, the better it is.  The less anchored it is, the less useful it will be.Unknown
  4. The more numbers in the scoring system, the less reliable it becomes.  Let’s say instead of a 10-Point Pain Score, we used a 1000-point pain score and were asking patients “would you say your pain is a 671 or a 672?”  Of course, a pain score of “672” gives us no more useful information than a “6.”  In fact, it gives us less useful information because it is more confusing.  In a scientific sense, the more numbers a subjective rating system has, the less “inter-rater reliability” that system has. The simplest subjective scale has only two scores, “None (zero)” and “Some (one),” as in “Do you have pain or not?”  The subjective scale perhaps used most often in daily life (Like when you go to a Thai restaurant and are asked how hot you want your food to be) is a four score scale:  None, Mild, Medium, Severe.  The Visual Analogue score is a 6 point scale.  CIWA-Ar uses 8 points.  And the 10-Point JCAHO Pain Scale uses 11 points (zero plus one through ten). Is the 10-Point JCAHO scale more accurate than a simple “mild-moderate-severe” system?  Probably not. In fact, no “probably” about it.  No.
  5. Subjective scoring systems work better at evaluating changes over time than the initial severity of a symptom.  If a patient says his pain is a “6,” I may not know exactly how that is different from a “7” or even a “4.”  But later, when the same patient now rates his pain as a “5,” I am pretty confident that his pain has decreased, at least by a little.
  6. Subjective scoring systems only work if the patient understands and is cooperative with the process.  Al helps the patient to understand the process with his excellent “anchoring” technique (which I will be adopting, by the way).  But the system still will not work if the patient always, no matter what, says “my pain is a 10.”   That is the main problem I run into in my jails; deciding when patients are exaggerating their symptoms.  For example, if a patient complains of “severe” constipation, what weight do I give to their use of the word “severe?”
  7. There are two types of subjectivity in scoring, the patient’s and ours.  The patient is subjective when rating her own pain or depression or whatever.  Then we clinicians make our own subjective assessments.  How sick does the patient look?  Often, the two assessments do not coincide, as when the patient rates his abdominal pain as a ten while munching on Cheetos and looking bored.  If I do not trust the patient’s own subjective assessment, sometimes I must substitute my own clinical judgment.
  8. Scoring systems for pain perform worse for chronic pain than for acute pain.  For chronic pain, a more useful assessment tool is to evaluate how the chronic pain affects Activities of Daily Living (ADLs).  Is the pain too debilitating to hold a job?  Play golf?  Go to the store?  Walk?  ADLs are usually much easier to assess in a correctional facility than in the outside world.  You can go down to housing and watch the patient.  How easily does the patient sit, stand, walk?  Does the patient go to recreation?  Sit for long periods of time playing cards or watching TV?  This sort of assessment is very useful for gauging the impact of chronic pain.

Any thoughts?  Please comment!

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What Do You Think of The 10 Point Pain Scale?

20050824I was asked via email what I thought of the 10 Point Pain Scale.  I have never been a big fan of the 10 Point Pain Scale, but I think that it is a particularly poor fit for Correctional Medicine and I don’t use it in my jails.

Hospitals have to use the 10 Point Pain Scale because it is mandated by JCAHO, the hospital accreditation body.  But JCAHO has no authority over jails and prisons. We don’t have to use it and I personally think we practitioners of Correctional Medicine are better off without it.

I used the 10 Point Pain Scale quite a lot when I worked in a busy Emergency Department, both because I had to (it was a JCAHO mandate) and because it can be useful in an ER setting.  The 10 Point Pain Scale is not bad at evaluating acute pain, like the pain from appendicitis or a broken leg.  However, it is not as useful when evaluating chronic pain like what we see in corrections.

Even in an ER setting, I noticed problems with the 10-Point Pain Scale.  First, it is entirely subjective.  In other words, patients say a number and there is no objective way to know if they are being honest or not.  In the ER, I suspected that many patients inflated their numbers.  For example:

My pain is 13-out-of-10.”

My abdominal pain is 10-out-of-10 (said while the patient was eating Cheetos).”

The 10 Point Pain Scale is more useful evaluating responses to therapy via changes in the pain scale.  So if a patient tells me that he has 10-out-of-10 pain, I may not be exactly sure what that means.  But if he later tells me that his pain now is 8-out-of-10, I know that he has improved.  But even that did not happen all of the time.

I had cases where I would treat patients with IV Dilaudid, say, until they were asleep.  Yet when the nurse woke them to ask about their pain, the patient would say (with slurred words) “itsh shtill a ten.”  Should I have given more Dilaudid based on that report of 10-out-of-10 pain?  Of course not!

Let me give an example from the other end of the spectrum.  Tough, stoic cowboy-types would come to the ER with long bone fractures and would rate their pain a “2-out-of-10.”  Do I then use Tylenol instead of IV narcotics to treat the pain from this femur fracture?  Again, of course not.

Finally, what do I do with a patient who rates her pain high–say 9 out of 10–but refuses narcotic pain medication?  Don’t laugh, that actually happens!  Some people are tough and can handle pain better than others.  Others would rather have pain than be gorked by pain meds.

In the end, even using the 10 Point Pain Scale, ER doctors still have to rely on their clinical judgment.  Yet that means there will be discrepancies between what the patient says his pain is and how it is treated.  Let’s say the nurse dutifully records in the medical record that the patient says his pain is 10-out-of-10, but, based on my clinical judgment, I do not give pain medication.  Later, when the medical record is reviewed by JCAHO, a hospital committee or a plaintiff’s attorney, I look like an uncaring sadist:  “My client was crying out that his pain was as bad as pain could possibly be and you did nothing, Doctor?”

And those are just the problems when the 10-Point Pain Scale is used to evaluate acute pain in ERs.  It is even worse when used to evaluate chronic pain in Correctional Medicine clinics.  Chronic pain patients tend more than acute pain patients to rate their pain 10 out of 10 and to admit to little change.  There is also more discrepancy between what chronic patients say (The pain is 10 out of 10) and what they do.  For example, consider the patient I actually had in one of my jails who told me in clinic that his chronic back pain was 10/10 in intensity.  Later in the day, I looked into the recreation area just in time to see this patient perform a perfect basketball reverse layup.  This did not mean that this patient did not have back pain at all—he probably really did–but it did mean that he probably did not have true “10 out of 10” pain.  It also meant that I could not trust this patient’s subjective pain scale scores.

It seems to me that I have to use even more clinical judgment in a jail than I did in the ER.  I have to weigh the potential adverse effects that narcotics have on the safety and security of the facility.  I have more patients with addiction problems and have to try to sort out true chronic pain from addiction.

Plus, in a jail, I have more true objective evidence to base my clinical decision on than I did in the ER since I can observe patients away from the medical clinic.  I can watch them at recreation.  I can watch them walk and talk and eat in their dorm.  I know the legal circumstances that landed them in jail, like illicit drug use, that an outside doctor may not ever know about.

The subjective 10 Point Pain Scale in such a setting is more hindrance than help, I believe.

I still ask the patients about their pain. I even use a pain scale, though a simpler one consisting of just four points: none, mild, medium and severe.  I also ask about changes in  pain:  “Is your pain improved since yesterday?”  But more importantly, I ask patients how their pain affects them in everyday life.  Can you sit?  Stand?  Watch TV?  Walk during recreation?  I record the answer and then compare that (if necessary) to observation of those activities.

The 10-Point Pain Scale does have its uses.  In my opinion, it works best for monitoring responses to therapy of acute pain.  For example, when I used to give IV Dilaudid in the ER to a patient with a femur fracture, her responses to the 10-Point Pain question would help me to know that I was getting somewhere with pain relief and when to stop.  Whether it worked better than asking “Is your pain improved?” or “Do you want any more pain medication?” is a debatable point.

But the 10 Point Pain Scale is not as useful for rating chronic pain.  In my opinion, it is the wrong tool for this task.

Feel free to disagree with me, though!  I could be wrong in my opinions!

What is your experience with the 10 Point Pain System used in hospitals?  Do you use it in your correctional facility?  Please comment!

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Evidence Based Use of NSAIDS—Less is More

When we want to do an evidence-based approach to the use of any drug, we have to consider three factors:

  1. What beneficial effects do we want the drug to have on our patients?
  2. What harm might the drug cause?  How can we maximize benefit while minimizing risk?
  3. How much does the drug cost?  Can we get a better risk/benefit profile from a less expensive drug?

A great place to start using these tools to evaluate appropriate drug use is with the Non-Steroidal Anti-Inflammatory Drugs (NSAIDS).  NSAIDS are commonly prescribed drugs, but, in general, we practitioners use them in inappropriate ways.  We overestimate the benefit they give.  We underestimate the risks they carry.  We completely ignore their costs; preferring, it seems, to prescribe expensive NSAIDS which offer no benefits over the cheap stuff.

In this article, I want to summarize the evidence about NSAIDS and suggest a protocol for their use based on that evidence.  I say summarize, because the body of research on NSAIDS is very large and I cannot include everything in this short paper.  NSAIDS are a very well understood class of medications.  Most of the information I include is not controversial.  It can be found in most textbooks and review articles.  I have included a couple of these at the end of the article.

Let’s start by going over the potential harm that NSAIDS can cause.  Most people know that NSAIDS can cause GI complications like ulcers and GI bleeding.  The question is—how big of a problem is this?  It turns out to be a very big problem, indeed:

  1. An estimated 16,500 patients die from GI bleeding caused by NSAIDS each year.  This is far more people than die of AIDS each year (13,500).  In fact, the CDC ranks deaths due to NSAID induced GI bleeding as the 14th leading cause of death in this country.
  2. Over 100,000 people are hospitalized each year with GI complications caused by NSAID use.  Total spending in theUSto treat NSAID complications is greater than 2 billion dollars annually.
  3. The iatrogenic cost factor of NSAID use is approximately 2.  In other words, for every dollar spent on NSAIDS, approximately one more dollar is spent treating NSAID induced complications.