The Cure For Overprescribing

I  felt compelled to get this down because the continued wheel spinning on this subject is really starting to annoy me.  People are wringing their hands like they either don't know what to do or they angrily invoke some model that suggests a solution but not really.  The two common models invoked are the "medicalization" of society and the other is some sort of conspiracy (Big Pharma, psychiatry) to invent diagnoses and indications for prescribing medications in order for Big Pharma to make more money.  The recipients of all of the overprescribing are seen as hapless victims who never stood a chance in the face of the medicalization-conspiracy juggernaut.  All we have to do is stop the Big Pharma-monolithic psychiatry steamroller.

Some of the "solutions" to this dilemma are equally far fetched.  First of all lets say that any physicians affiliated with Big Pharma in any way need to report all of those connections.  There was recent evidence posted that this was not slowing down physician interest in these jobs - temporary or otherwise.  It is after all a free country and one where you have to make money to survive.  Physician compensation is dropping as the workload goes through the roof.  The reimbursement and hassle in psychiatry is so onerous that psychiatrists are the least likely speciality group to accept insurance.  Many physicians would like nothing better than to work for a pharmaceutical company.  So the lack of slowing down is certainly no surprise to me.  Those who are naive to the way transparency works probably thought that physicians would be too ashamed of their appearance of conflict of interest.  That is after all what we are talking about - an appearance of conflict of interest.  The prototype for transparency is the US Congress whose members blatantly take money from and provide easy access to the same industries that they regulate.  If transparency doesn't slow down Congress, why would it slow down physicians who are often in positions where they are actually being paid for rendering a service to the company and there is no evidence of  quid pro quo.

Another solution is to isolate physicians and trainees from pharmaceutical company representatives and  promotional materials.  Probably some of the weakest research in the history of the world is the research that shows that pharmaceutical promotions and advertising influences physicians to prescribe drugs.  The only weaker research is that Maintenance of Certification measures are worth the time and effort.  Not only that but by now it should be pretty clear that throwing pharmaceutical reps to the curb has not diminished the overprescribing of just about anything.  Practically all of the over prescribed antibiotics right now are generics.  The same thing is true of the overprescribed benzodiazepines and antidepressants.  As far as I can tell most of the overprescribed opioids are the usual hydrocodone/oxycodone and acetaminophen preparations and 30 mg generic oxycodone tablets.  Pharmaceutical company detailing has nothing to do with why all of these drugs are overprescribed.  Every hospital and clinic has a Pharmacy and Therapeutics Committee responsible for a formulary and they often have specific strategies to reduce costs associated with the most expensive drugs on that formulary.   I spent over a decade on two different P & T Committees.  I have never seen any member try to push through a drug - past about 20 physicians and PharmDs, based on a piece of pizza or a donut that a pharmaceutical rep gave them.  Even thinking that could happen is absurd.

What about the DSM-5 conspiracy?  What about the bereavement exclusion?  Won't that open up tens of millions of mourners to the hazards of antidepressant medications?  Only if their primary care physician is fairly clueless.  As I have previously posted psychiatrists have studied the problem and the solutions that Paula Clayton found 40 years ago are no different than today than they were then. It certainly is possible that treating rating scale results can increase antidepressant prescribing.  But that is currently considered state-of-the-art measurement based care by managed care organizations and some governments.  That is a clear force that facilitates overprescribing.

What about cognitive errors?  Do physicians really overprescribe because they lack the technical knowledge on how to prescribe?  I really doubt that is the problem.  I would cite the case of overprescribed antibiotics.  During my training and for many years after the Sanford Guide to Antimicrobial Therapy was considered definitive guidance for antibiotic therapy.  As HIV therapy increased in success and complexity an accompanying manual The Sanford Guide to HIV/AIDS Therapy came out.  Every medicine and surgery house officer and many staff counted on the microscopic type on these pages for definitive guidance on prescribing antibiotic and antiviral therapies.  It was just a question of identifying the pathogen, determining if the patient could tolerate the medication, and prescribing the drug as recommended.  So how is it possible that antibiotics are overprescribed?

So what are the real reasons for overprescribing?  The overprescribing literature extends back well over 20 years at this point.  Solutions are not readily found.  That literature generally comes down to particular class of drugs and the progress in that area.  I recently reviewed the REMS strategy to the current opioid problem and why I did not think that would work.  It really comes down to two things and neither of them has to do with a diagnosis or medicalization.  The first is that health care systems are currently set up to offer some type of test or pill as a solution to most problems.  At least when they are not claiming that they are responsible for your cradle-to-grave health and giving you a gym membership discount.  All of that goes out the window when you enter the clinic and have 5 or 10 minutes with a doctor.  In the case of mental health care, many of the conditions that present in primary care are better treated with psychotherapy than with medications, but most primary care physicians are not trained in psychotherapy.  Some are trained in motivational interviewing, but to suggest that will be successful in many of their patients is really an insult to the problems facing them.  Primary care physicians see patients with very difficult refractory problems.  These patients will see a specialist once or twice and then go back to their primary care physician for care with the same difficult problems.  Not overprescribing in many of these situations is really a question of limit setting rather than motivational interviewing.  That is especially true if the prescription is a drug that is addicting or can cause an altered state of consciousness.

The other issue is that systems of care these days, are set to run on the concept of customer satisfaction rather than excellent medical care.  The idea that a customer may not get what he or she wants is anathema to the MBAs that are currently in charge of the system.  The trickle down effect is that the physician who is setting limits on benzodiazepine, sedative hypnotics, stimulants, or opioid prescriptions will not get good customer satisfaction ratings and their compensation and role in the organization may be diminished as a result.  Health care systems that allow patients to rate their doctors on satisfaction ratings without considering that patients might be dissatisfied with reality should be held to task.

The second factor is the physician himself.  How many physicians have thought about all of the unconscious factors that lead to their overprescribing?  My guess is not many.  The problem of overprescribing is viewed as an informational deficit.  It is believed for example that teaching physicians all about chronic pain and the pharmacology of opioids will somehow reduce opioid overprescribing.  I don't see how anyone can come to that conclusion.  All physicians are taught pharmacology and most have experience prescribing opioids.  That approach seems as naive to me as the Joint Commission pain initiative in the year 2000.  Physicians need to determine for themselves why they are uncomfortable not giving a patient a prescription for whatever they are asking for.   I have heard a wide variety of reasons in my career and most of them have nothing to do with the indications for the drug.  The majority had to do with the physician believing that they could do something to alleviate the patient's distress and that wish was independent of what the diagnosis or indication for the drug was at the time.   The new variation on that theme is that physicians are somehow capable of overcoming the effects of a chronically impoverished environment, severe ongoing adversity, and either an inability or a resistance to change by prescribing a drug.  That is basically the same rationale that people use when they are addicted to drugs and alcohol.  They hope to use something to block out reality for a few hours.  Overprescribing will not change that.  The other interesting consideration is that the diagnosis is irrelevant.  It is tacked on afterwards for a prescription that is written for no real medical reason.

There needs to be better standards for determining what constitutes overprescribing and what does not.  I recently corresponded with the lead author of a paper looking at the issue overuse of health care services in the US (see reference 2).  The authors conclude that while there is ample evidence of overuse, the scope of research is limited.  Some of this is due to difficulties with definition and that would apply to the issue of overprescribing psychiatric medications.  The studies that frequently make the headlines have significant methodological problems.  A study I recently posted used two different data sources to conclude that antidepressants were being overprescribed.  The studies need to be more than prescription, survey and administrative data.  Those studies will necessarily be labor intensive and expensive.

In the end, I always come back to the informed consent model.  If the patient is competent to consent in most cases the physician and patient can have detailed conversation about the prescription including the risks and benefits and what it would like to go without it.  These are usually lengthy conversations.  These are tough decisions based on the fact that nobody wants to take medications regularly or see doctors for the purpose of continuing medications.  My own personal experience is consistent with what my patients have told me over the years - some change is desperately needed and that is often how the medication is viewed.  In that context people will often try medications with significant toxicity.  The medicines advertised on TV with death as a stated side effect are cases in point.  But no matter how much information passes, the physician needs to be the ultimate judge of whether the medication is a good idea.

It can never be a decision that is taken lightly.          

George Dawson, MD, DFAPA

1: Gordon M, Catchpole K, Baker P. Human factors perspective on the prescribing behavior of recent medical graduates: implications for educators. Adv Med Educ Pract. 2013 Jan 10;4:1-9. doi: 10.2147/AMEP.S40487. Print 2013. PubMed PMID: 23745094

2: Korenstein D, Falk R, Howell EA, Bishop T, Keyhani S. Overuse of health care services in the United States: an understudied problem. Arch Intern Med. 2012 Jan 23;172(2):171-8. doi: 10.1001/archinternmed.2011.772. Review. PubMed PMID: 22271125


Supplementary 1:  I was going to add a detailed explanation of my bubble diagram to this post but it is too long.  Look for a separate post about the bubbles.

Supplementary 2:  An updated higher resolution bubble diagram is located at this link.

Why Has Suboxone Turned Into A Problem?

The short answer is that it is like very other drug and there was always the potential for a problem.  Any practicing physician realizes that when a drug is approved by the FDA for general release to the public there are all kinds of unintended consequences that are possible.  That is the basis of post marketing surveillance by the FDA.  There is invariably a lot of hype associated with the release of a drug, but as I have previously pointed out the FDAs approval process is not in place to guarantee a drug that is safe for everyone.  It is focused on a releasing a drug that is a potential tool for responsible practitioners.  That means any drug can potentially cause a small number of serious unexpected reactions (liver failure, cardiac arrhythmia)  that even the most experienced practitioners will not be able to predict.  There is also an implicit understanding that the practitioners prescribing the drug have a thorough understanding of its pharmacology, indications and contraindications.  Many practitioners advise against trying out a product that has just been released but that advice is tempered by the severity of individual circumstances and the hope of relief and also the general bias that new drugs are somehow better than the old ones.  That bias has been repeatedly disproven.

Suboxone prescribers have to take a special course in order to get a prescriber number in addition to their usual DEA number.  I took the Suboxone prescriber course about 7 years ago.  It was a total of 8 hours of lectures given in a convention center room in a hotel.  It was jointly sponsored by state medical association.  The morning sessions were largely a review of the pharmacology of the drug and the scope of the opioid addiction problem at the time.  The afternoon session focused on vignettes of patients with addictions of varying complexities and the exercise was to determine of Suboxone should be prescribed to that person and how the induction would be done.  That was the first suggestion that something was problematic.  There apparently were no contraindications to Suboxone.  The clear message was that it should be given to anyone with an opioid addiction no matter what their social circumstances or comorbid psychiatric diagnoses and addictions.  There was a definite implication that this was a drug that would revolutionize the treatment of opioid addiction.

 
Suboxone is a combination of buprenorphine and naloxone.  Buprenorphine is the active ingredient in terms of treating addiction.  In this post I will use Suboxone and buprenorphine interchangeably.  The pharmacological properties of buprenorphine that were interesting in terms of potential use for addiction included the fact that it was a opioid mu receptor partial agonist and antagonist at the kappa receptor.  The partial agonist effects relevant for addiction such as euphoria and sedation occur at the lower doses and the antagonist effects occur at higher doses.  The antagonist effects like preventing respiratory depression were thought to put a ceiling effect on this side effects and make it safer than pure mu receptor agonists that would produce dose related toxicities.  In the Suboxone course the mixed agonist/antagonist effects were described as producing less toxicity and less risk of abuse.  The naloxone component of Suboxone is a pure mu receptor antagonist.  In the course I took, the explanation for the combination of buprenorphine and naloxone was that it reduced the risk of intravenous drug use and that this had occurred in Europe and it resulted in several deaths.  The company also sold Subutex which was buprenorphine only and indicated for use in pregnant women.

The pharmacodynamics and pharmacokinetics in real life can differ quite a bit from the idealized cases that the initial marketing and advertising was based upon.  Like many medications it can be a life changing drug.  People can recover and break the cycle of addiction, recovery and relapse and go on to productive lives.  It is the outliers that physicians need to be most concerned about.  In real life there are always going to be people who get significant side effects even at low doses and cannot tolerate the drug.  There are also people who tolerate the drug at high doses and do not experience the ceiling effect of mu receptor antagonism.  The people are probably very low in number but they are significant because they are not protected by the ceiling effect that is supposed to be there from the drug.  Drug addiction always attracts or produces a significant number of people who become amateur pharmacologists and use the drug to facilitate their addiction.  The word gets out and suddenly buprenorphine has street value (about $1,000 for a 1 month prescription) and opioid addicts can use it when they run out of heroin or oxycodone.  In a few people it is their preferred opioid because it has a longer half life.

The politics of Suboxone are as complicated as you will find in the pharmaceutical industry.  There are plenty of conflicts of interest in terms of how the drug was initially marketed and plenty of crossover between regulators and the company who developed, marketed and sold it - Reckitt-Benckiser.  According to a New York Times article last fall, the company was granted a period of exclusive sales that ended in 2009.  After that they went on the offensive to suggest that their new product - a Suboxone film was superior to the generic tablets especially in the area of child safety.  They stopped selling the Suboxone tablets at that point.  Insurance companies can work any controversy to their advantage and people on buprenorphine maintenance have been cut off based solely on the amount of time they have been taking the drug.  There are no scientific guidelines for how long a person should take buprenorphine and like most drugs used for maintenance therapy there will never be a study that looks at that question due to the expense.  Most experts would agree that if you have a severe addiction and have recovered based on buprenorphine there is no reason why you would be cut off.  In fact discontinuing buprenorphine seems to present a more significant problem as dose is tapered to 2 mg and  lower.   We also have a familiar political theme in the issue of opioids with the government seeming to create the problems in the first place and now saying: "Trust us we have the solution."  That may have explained the desperation in the descriptions of how public health officials were trying to increase Suboxone prescribers to address a public health opioid epidemic that was a likely result of government initiatives to improve the treatment of pain.

Suboxone has become a problem for the same reason that every other drug becomes a problem - unrealistic expectations, conflicts of interest, and a knowledge deficit on the part of the practitioners.  The title of the New York Times article illustrates how the press can look at the dual nature of drugs and imply that there is a larger problem.  I don't know of two many drugs that do not have a "Dark Side".  The negative trends in buprenorphine use can be reversed but it will take more than the suggested strategy in the NY Times article.  Here are a few ideas:

1.  The CDC needs to get involved and look at Suboxone/buprenorphine related deaths and study it in the same manner that they studied methadone.  It would be very instructive to see exactly where Suboxone/buprenorphine falls on the spectrum of deaths/100 kg MME (milligram morphine equivalents).  The expectation of some in the article is that it is much safer, I would prefer to see the numbers.  Only the CDC has access to the detailed data to look at this issue.  I would take it a step farther and suggest that the CDC recalculate this table on an annual basis as a key metric in reversing the significant public health problem of accidental opioid overdose deaths.

2.  The physicians prescribing the buprenorphine need to be highly motivated and well versed in prescribing medications to individuals with addictions.  The NY Times article suggests that there are many who take an entrepreneurial approach to the prescription of buprenorphine with cash only practices that vary from $100 - $250 a visit.  I have no problem with cash only practices if there is a quality approach.  By definition that involves a lot more than handing someone a prescription in 5 minutes.  The problem is the rest of what happens during that time is poorly defined.  The original prescribing information said that the physician needed to refer the patient to counseling services.  In many presentations of research that I have seen there is a clear movement to illustrate that - counseling adds little to nothing to outcomes when buprenorphine is prescribed.  There are problems drawing that conclusion about this research given the modest outcomes of the buprenorphine treatment.

3.  At least part of the interview of any patient recovering from the severe addiction that occurs with opioids is assessing their functional capacity.  What are they doing on a day to day basis and is that routine consistent with both recovery and a lack of cognitive side effects from the buprenorphine?  Being able to corroborate that improvement with a third party makes it even more reliable.

4.  A big part of the unconscious aspects of addiction is the behaviors that are present to continue the addiction despite the best conscious efforts of the person affected.  Good examples include craving, lying, and hiding use from others.  That requires prescribing physicians to engage their patients at this level and not develop a law enforcement transference.  A lot of physicians don't know how to respond to an accusation of: "You don't trust me!" when there is a question of the need for a toxicology screen or a discussion of a positive toxicology.  The interpersonal aspect of treatment is very important and it received no attention in the standard Suboxone prescribing course.

5.  Continued work on a model of treatment looking at all of the potential positive factors is needed.  There is nothing worse in medicine than to treat a scientific topic like a political one and not have a rational approach to the person with the problem.  Like the original course I took, there are  people out there who say that buprenorphine prescribed out of a physicians office is all that is needed.  Is that the case when you have a person who takes two to three times the prescribed amount to get high?  Or the person who is crushing it and snorting or injecting it?  Or the person who is selling it on the street to get purchase heroin?  Or the person who can't function due to cognitive problems at 2 mg a day?  Or the person who is hospitalized for recurrent bowel obstructions due to severe constipation?  As the prescribing physician - are  you confident that you can accurately screen for these problems?  What about competing approaches like the long acting mu antagonist naltrexone injections?  Where does 12-step recovery like Narcotics Anonymous fit in?  Where do sober housing and residential treatment fit in?  And finally - where can a person get detoxified and should anyone be forced to go through acute opioid withdrawal when they are incarcerated?

All of these questions are currently unanswered.  But like most treatments in medicine, the solution is typically a lot more than a pill.  Drugs with addictive potential always add the complication of significant financial gain from a captive audience.        

George Dawson, MD, DFAPA

Deborah Sontag.  Addiction Treatment With A Dark Side.  New York Times. November 16, 2013.

SAMHSA.  Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction.  A Treatment Improvement Protocol.  TIP 40.

NICE.  Naltrexone for the management of opioid dependence. 2010.

NICE.  Methadone and buprenorphine for the management of opioid dependence.  2010.

The FDA and Opiate Regulation

Does the FDA have a clue about the safe prescribing of opioids?  Based on their September 10 press release we are about to find out.  If you go to the FDA web page this appears to be the most relevant document.  It contains the following warnings:

BOXED WARNING

In the boxed warning in Highlights, include the following text:

• Tradename exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1)

• Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Tradename (formulation) whole to avoid exposure to a potentially fatal dose of (active opioid). (5.2)

• Accidental consumption of Tradename, especially in children, can result in fatal overdose of (active opioid). (5.2)

• For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome. (5.3)

For products with an interaction with alcohol, also include the following:

• Instruct patients not to consume alcohol or any products containing alcohol while taking Tradename because co-ingestion can result in fatal plasma (active opioid) levels.  (5.4)

As I read through these warnings I have several associations.  First off, physicians were told 12 years ago in JAMA that they were undertreating pain, misunderstood pain, and that pain treatment needed to change.  That was a naive document that depended on an assumption that pain could be "quantitated" on a 10 point scale.   Over a decade and 100,000 opioid overdose deaths later we are not told that providing this information on drug labels will make a difference.  That leads me to my second association, there is nothing in the above warning that I didn't learn in medical school 30 years ago, including the risk of neonatal withdrawal.  The third association is that this definition and intervention is almost completely naive about addiction.  A person with an addiction does not care about dire warnings.  They don't care about their pain ratings.  They care about acquiring and using addictive drugs.  It is the nature of addiction.  Their entire conscious state has changed. The tendency toward opiate addiction or not is probably biologically determined and a doctor cannot predict who is at risk.  If you take an initial dose of opiate and experience intense euphoria, high energy and productivity, and intense sense of well being or feel like you finally have become the person you always wanted to be - you may be a person at high risk for opiate addiction. It doesn't really matter if they have a chronic pain disorder.

What needs to be done?  What should the FDA being doing immediately.  The four most important misconceptions driving both the epidemic of opioid dependence and the accidental overdose trend are:

1.  Opioids are a silver bullet and will eliminate chronic pain if the dose is high enough.

2.  Once a maintenance dose is achieved the level of pain relief should be constant.

3.  Opioids are only taken for primary gain - the analgesic effect or the elimination of pain.

4.  Opiates - prescribed by a doctor will not lead to reactivation of a previous addiction.

What do people need to know now?  Probably not the new package insert for opioids.  Most physicians don't read it.  Every person taking an opioid need to know that it can affect their subjective state in such a way that it will place them at risk for addiction.  They need to know at that time that they need to contact their physician and discuss it and the possibility of alternate or more closely monitored treatment.  They need to know that there is no medicine that will treat chronic pain into remission.  Physicians need to know a number of things including the fact that there is no medication that will eliminate chronic pain.  They also need to know that it takes time and detailed evaluations (calls to pharmacy, tox screens, limited prescriptions, assessment of functional capacity) to optimize treatment and prevent addiction.

The warning on a package insert from the FDA containing seriously dated information will not do it.  Dire warnings about an epidemic won't do it.

George Dawson, MD, DFAPA

Treatment of chronic pain with opioids - back to the future

I thought I would wade in on this issue largely because I am not hearing a lot of rational discussion about the problem.  You might ask: "What does a psychiatrist know about this issue?" and the answer like most questions about psychiatry is "plenty".  I worked on a busy inpatient unit for 22 years and saw plenty of people with with severe chronic pain and episodic pain crises.  In that same facility, I also covered consults on medical and surgical patients many having problems with chronic pain and addiction.  As an addiction psychiatrist, I have talked with countless people who ran into problems with pain medications or relapsed to using another drug after being exposed to opiates for treatment of acute or chronic pain.  There seems to be very little reality based information out there to inform people about the risks and benefits of pain treatment with opiate medication.  The argument like most in our society is politically polarized to those who believe it is unconscionable to not treat pain even if it means a long course of opioids to those who believe that opioids are dangerous medications that should be conservatively prescribed.  So where does the truth lie?

I can tell you how it was in Minnesota in the 1990's.  There were very few pain specialists.  The wide spread prescription of opiate medications for chronic noncancer pain by generalists was uncommon.  In many cases if it seemed indicated, the generalist would refer their patient to a pain specialist who would provide them with a letter of agreement on the use of chronic opioids.  That all changed with a Joint Commission initiative on pain in 2000.  At least some authors see it that way and that was my experience.  Since then opioid prescriptions have been taking off with an associated increase in the production of these compounds.  This graphic from the CDC is instructive (click to enlarge).  The rates of increase of sales, deaths, and treatment admissions are all increasing at an astronomical rate relative to population growth.

The issue that is debated in the media and some government web sites is why is this happening and what is the best way to deal with it.  The FDA has recently incentivized drug manufacturers to come up with better tamper proof opioids.  The enforcement arm of the government is rigorously prosecuting some doctors.  The FDA has also initiated a course for doctors who prescribe opioids.  None of these measures addresses the core problems that were successfully addressed in Minnesota in the 1990s.  I will take a look at the specific issues involved:

1.  The genetics of opioid preference:   People at risk for abuse and addiction to opioids have intensely positive subjective experiences from taking opioids.  People not at risk have intensely negative experiences or the opioids make them physically ill.  We currently know nothing about the genetics of this response, but it makes sense to let patients know that if they do have an intensely positive response in terms of feeling euphoric or energetic that is not a good sign in terms of addiction potential.  It might even be reasonable to come up with a plan about what to do if that happens.  Seeing people back in a month who have no knowledge of this risk is probably not the best plan.  It is critical that there is a good therapeutic alliance between the patient and physician and that they are both focused on the full spectrum of problems.  

2.  The genetics of opioid response:  Individuals studies and reviews of studies generally show that a subset of patients respond to opioids.  There may be additional factors that should factor into patient selection such as the specific type of neuropathic pain.  The current concern and reaction to the opioid epidemic is based on the concept that opioid prescribing is a potentially high risk intervention.  If that is the case we need a better options for patient selection than a subjective report of pain.

3.  The public perception that opioids are the silver bullet of pain relief must be dispelled: This is the driving force behind escalating doses of opioids and the addition of benzodiazepines (an equally bad idea).  Excellent double blind placebo controlled studies of self titrated opioids in chronic neuropathic pain have showed moderate pain relief that is on par with non-opioid medication.

4.  Tolerance to analgesia and opioid induced hyperalgesia:  Education about these phenomena is needed because both lead to escalating doses of opioids.  The dose escalation may be appropriate, but in many cases the dose is increased with the goal of eradicating pain and that is an unrealistic goal.  In people who have analgesic induced hyperalgesia, they are often shocked that their pain improves with discontinuation of the opioids.

5.  Assessment of functional capacity is critical:  Functional capacity is the ability to function in daily life.  It must be carefully assessed in anyone who is on chronic opioid therapy.  At moderate doses and in combination with other pain medications opioids can impair coordination, cause excessive sedation, and lead to significant impairment in daily functioning.  This is a sign that the dose of the opioid may be too high and reducing the dose is indicated.

6.  A hierarchical approach to pain treatment is still necessary and is the most rational approach to reducing the current epidemic of excessive opioid prescriptions:  If the degree of pain relief across a population is the same, why not use the drug with the lowest abuse and overdose potential?  That was the default model in the 1990s in Minnesota.  The National Health Service in the United Kingdom has operationalized that as their current pathway for treating neuropathic pain in the algorithm below (click to enlarge).  Note that the medications with no abuse potential are at the entry levels in this diagram and that pain specialists are the gatekeepers for opioids.

  
Like most political debates the current debate about how to stop the epidemic of opioid overdoses ignores that fact that the problem may have originated with a political initiative in the first place.  Using the NICE algorithm to get us back to the Minnesota practice model of the 1990s is a logical solution.

George Dawson, MD, DFAPA


Rowbotham MC, Twilling L, Davies PS, Reisner L, Taylor K, Mohr D. Oral opioid therapy for chronic peripheral and central neuropathic pain. N Engl J Med. 2003 Mar 27;348(13):1223-32. PubMed PMID: 12660386.

National Institute for Health and Clinical Excellence. Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings. NHS. March 2010.

Supplementary 1:

The Care Pathway Graphic is copyrighted © National Institute for Health and Care Excellence (2010) and is posted based on their allowance for reproduction for educational and not-for-profit purposes.  See their updated and revised guideline at: http://www.nice.org.uk/nicemedia/live/14301/65782/65782.pdf

PROP Petitions the FDA on Opiates

Physicians for Responsible Opioid Prescribing (PROP) has petitioned the FDA to modify the warnings about opioids.  They cite the well known dimensions of the current epidemic including a four fold increase in opioid prescribing and a four fold increase in opioid related overdose deaths.  They also cite  numerous references about the real risks of prescribing opioids for chronic non cancer pain with very little guidance.

PROP highlights a big problem in medical research and associated public policy and that is the biasing influence of the pharmaceutical industry and a few people at the top.  The Institute of Medicine was instrumental in highlighting the issue of chronic pain and framing it as a discrete disease.  Although not mentioned specifically by PROP, the Joint Commission (then known as JCAHO) promoted pain recognition and treatment in the year 2000.  As this excerpt shows that initiative did not go well.

"In 2001, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) introduced the concept that pain was the “fifth vital sign,” in an effort to increase the awareness of pain in the hospitalized patient, and by design, improve the treatment of that pain. Unfortunately, the current emphasis on pain assessment as the fifth vital sign has resulted in the potential overmedication of a group of patients (139)" (see ref 1).

Without going into detail at this time, I think that are recurrent patterns of federal and state governments, the managed care industry, and the pharmaceutical industry and their affiliated organisations driving practice patterns and treatment guidelines based on very little evidence.  That culminates in broad initiatives like the PPACA that are widely hyped as advances in medical treatment, but they are basically an experiment in medicine founded on business and financial rather than scientific principles.  There may be no better example than the practice of prescribing opioids for chronic non cancer pain.   

Another contrast for this essay is the comparison with what has been years of psychiatric criticism based on the same principles.  The basic argument from the media, antipsychiatrists, generic psychiatric critics, and grandstanding politicians has been that the pharmaceutical industry has been able to financially influence psychiatrists to prescribe drugs that are at the best worthless or at the worst downright dangerous (their characterizations).  That despite the fact that black box warnings on psychiatric medication may be held to a much higher standard than other medication even if they target the same level of morbidity and mortality.  After all, there is no known psychiatric medication that is mass prescribed and has resulted in overdose deaths at the rate that people are currently dying from prescribed opioids.

Just a few weeks ago, the FDA posted a number of initiatives on their web site focused on the prescription of extended release opioids.  My read through the most detailed document shows that it does not touch on the principles outlined by PROP.  The idea that this is strictly a matter of educating physicians is an oversimplification.  This is a matter of creating initiatives that governments and sanctioning bodies insist that physicians follow and then coming up with other rules when the original ideas fail.

George Dawson, MD, DFAPA

1.  Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, Patel S, Manchikanti L. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines. Pain Physician. 2008 Mar;11(2 Suppl):S5-S62. Review. PubMed PMID: 18443640.