Balance, Pain, Palliative Care

Balancing the USA’s access to opioids: Thoughts on new CDC report.


“Overdoses involving prescription painkillers are at epidemic levels and now kill more Americans than heroin and cocaine combined. States, health insurers, health care providers and individuals have critical roles to play in the national effort to stop this epidemic of overdoses while we protect patients who need prescriptions to control pain. ”

Thomas Frieden, M.D., M.P.H., CDC Director 1/11/2011

I was going to use the term “rebalancing” to address the issue of opioid access in the USA, but I am not sure there has even been balance.  The CDC report, “Prescription Painkiller Overdoses in the US” released yesterday confirms the lack of balance in the US.  The CDC director states it well: Stop the deaths from opioids, while ensuring appropriate medical care.

The Cancer Pain Initiative here in Wisconsin grew out of the imbalance in opioid access for patients with cancer.  The Pain and Policy Studies Group was created to improve the legislation and regulations that were impeding accessing to opioids, to quote the CDC Director, for those “patients who need prescriptions to control pain.”  Restricting the number of pills a patient can get in a 30 day period, allowing only 10 days of tablets on a prescription, or saying that opioids are a treatment of last resort can have dramatic impacts on patients with cancer and other life limiting (or serious) illnesses.  And yes access to opioids has improved for patients with life limiting illnesses in the palliative care area, but still has a way to go.

But at the same time, there has been a large movement to make opioids available for non cancer pain. Some say pharma has been behind this. Yes in part, but also from groups like the Joint Commission that has said we need as a profession, to ensure pain relief as part of US Healthcare.  Medical groups have agreed that opioids are useful in “carefully selected” patients, but no one is defining who these carefully selected patients are.

To achieve balance, we can do the many things listed by the CDC “What can be done”, but just as the strength of the evidence for the use of opioids in chronic non-cancer pain is questioned, what is the strength of the evidence for these recommendations. Do opioid agreements make a difference and are they ethical? Does random urine testing reduce the risk of misuse, diversion or abuse?  If I mandate these into law. will cancer patients be required to sign a “contract” that may increase their perception that they should not be taking medications that may greatly relieve their suffering.

I am greatly concerned about the epidemic of opioid deaths. I am concerned for those who are dying and I am concerned for the potential ramification on the “balance” that may impede appropriate and necessary palliative care.  What happens in the US has a huge impact around the world, and the USA’s “War on Drugs” has contributed to poor opioid access for “patients who need prescriptions to control pain” in most other parts of the world.

What do we need?  A better understanding of the problem.  There is nothing in this week’s report that changes the statistics that Methadone is the leading drug associated with opioids deaths.  And these deaths are most common in white middle aged men living in rural communities.  And the report quotes from the 2010 National Survey on Drug Use and Health, a report that shows that there has been no increase in the percentage of people misusing opioids (Table 2.3).  Maybe is not an increase in the misuse and abuse? Do physicians lack the appropriate knowledge and skills to use these medications? This particularly applies to methadone, a leading cause of opioid deaths (see Fibs, Lies and Statistics: Do you understand the US prescription Opioid Crisis?)

An opportunity exists to establish balance through sensible dialogue with a number of key groups, the White House, DEA, CDC and Civil Society. Let’s seize that opportunity!

A footnote: nonmedical use of opioids in these reports is defined as use without a prescription of the individual’s own or simply for the experience or feeling the drugs caused. Using the vicodan that is in the bathroom cupboard from a family members tooth extraction for a sprain ankle is misuse. Offering a friend a vicodan for a severe headache is misuse. It does not necessarily represent “the start of chronic misuse.”

Source of Prescription Drugs

  • Past year nonmedical users of psychotherapeutic drugs are asked how they obtained the drugs they most recently used nonmedically. Rates averaged across 2009 and 2010 show that over one half of the nonmedical users of pain relievers, tranquilizers, stimulants, and sedatives aged 12 or older got the prescription drugs they most recently used “from a friend or relative for free.” In a follow-up question, three quarters or more of these respondents indicated that their friend or relative had obtained the drugs from one doctor.
  • Among persons aged 12 or older in 2009-2010 who used pain relievers nonmedically in the past 12 months, 55.0 percent got the pain relievers they most recently used from a friend or relative for free. Another 11.4 percent bought them from a friend or relative (which was significantly higher than the 8.9 percent from 2007-2008), and 4.8 percent took them from a friend or relative without asking. More than one in six (17.3 percent) indicated that they got the drugs they most recently used through a prescription from one doctor, while about 1 in 20 users (4.4 percent) got pain relievers from a drug dealer or other stranger, and 0.4 percent bought them on the Internet. These percentages were similar to those reported in 2007-2008.
  • Among persons aged 12 or older in 2009-2010 who used pain relievers nonmedically and indicated that they obtained the drugs from a friend or relative for free, the individuals reported that in 79.4 percent of the instances that the friend or relative obtained the drugs from just one doctor. Only 2.3 percent reported that the friend or relative had bought the drugs from a drug dealer or other stranger.

About Pain policy & palliative care

Improving global pain relief by achieving balanced access to opioids worldwide

Discussion

6 thoughts on “Balancing the USA’s access to opioids: Thoughts on new CDC report.

  1. From Time Magazine
    http://healthland.time.com/2011/11/02/are-doctors-really-to-blame-for-the-overdose-epidemic/
    Maia Szalavitz is a health writer at TIME.com.
    Find her on Twitter at @maiasz.
    You can also continue the discussion on TIME Healthland’s Facebook page and on Twitter at @TIMEHealthland.

    Read more: http://healthland.time.com/2011/11/02/are-doctors-really-to-blame-for-the-overdose-epidemic/#ixzz1ca4ThwcI

    Posted by Pain policy & palliative care | November 2, 2011, 3:12 PM
  2. Jim,

    Thank you very much for blogging about the CDC’s report.

    In your posting you raised a few points that I’d like to respond to.

    “To achieve balance, we can do the many things listed by the CDC, but just as the strength of the evidence for the use of opioids in chronic non-cancer pain is questioned, what is the strength of the evidence for these recommendations.”

    Please clarify- are you suggesting that the CDC’s proposed measures shouldn’t be followed because we don’t have evidence that they’ll work?

    “I am concerned for the potential ramification on the “balance” that may impede appropriate and necessary palliative care.”

    So am I… but I don’t believe that it’s the CDC or regulations to limit inappropriate access to opioids that are the problem. I truly believe that the real threat to opioid use in palliative care is coming from pharma-funded groups that advocate for aggressive treatment of chronic pain with opioids (including the Wisconsin PPSG). This advocacy played a role in bringing on the epidemic and it currently plays a role in preventing implementation of measures that could bring it under control.

    For example, when a patient in need of palliative care reads in the paper about overdose deaths and addiction to opioids, it’s no wonder that they are reluctant to take a medication that could ease their suffering.

    I also imagine that as international awareness of the opioid analgesic epidemic in the US increases, the good efforts of international palliative advocates will become harder.

    -Andrew

    Posted by andrewkolodny | November 6, 2011, 12:18 PM
    • Andrew,
      Re strength of evidence: I am just asking that we apply the same principle of “strength of evidence” evenly across medicine. A criticism of using opioids for chronic non-cancer pain, is in fact, the lack of evidence. There is not good scientific evidence to support “opioid contracts” or “agreements” or “urine drug testing” in reducing misuse, abuse or diversion in the management of chronic non-cancer pain, although they are very much part of clinical practice. What is good for the goose should be good for the gander!

      Can you please provide evidence of where the Pain and Policy Studies Group has advocated for “aggressive treatment of chronic pain with opioids.” As pointed out in various blogs, there is considerable confusion with PPSG and the Pain Initiatives. PPSG is very different and separate from the Pain Initiatives. PPSG has always advocated for appropriate laws to facilitate the use of controlled substances when they are medically appropriate. It is interesting to look at our State report card review for 2008. I can find no correlation with a state’s ranking on laws with either opioids consumed or opioid associated deaths. It seems that targeting the appropriate change in laws and regulations for responsible prescribing, as agreed by the Federation of State Medical Licensing Boards, may not be that fruitful in correcting the overdose epidemic. As I say, I don’t know. We need a much better understanding of the issue and data.

      PPSG will continue to do its work both nationally and gobally in achieving balance, or as the CDC Director says; “Stop this epidemic of overdoses while we protect patients who need prescriptions to control pain.”

      @jfclearywisc

      Posted by Pain policy & palliative care | November 6, 2011, 2:10 PM
  3. Jim,

    You’ve asked me to provide evidence of PPSG advocacy for treatment of chronic pain with opioids. Please correct me if I’m wrong, but I believe David Joranson was director of PPSG when he co-chaired (with David Haddox from Purdue Pharma) the 1996 APS/AAPM consensus statement “The Use of Opioids for the Treatment of Chronic Pain.” This consensus statement encouraged aggressive treatment of chronic pain with opioids by overstating benefits and dangerously minimizing risks. There are many people who believe that the consensus statement played an important role in ushering in the opioid epidemic.

    A critique of this consensus statement can be found in a recent article I wrote with Michael Von Korff and Roger Chou ( see http://www.annals.org/content/155/5/325.full ). BTW- The AAPM recently pulled this statement off their website.

    According to articles written by David Joranson, he used this statement in his advocacy with state medical boards and the FSMB to liberalize opioid prescribing.

    For a very recent example… I would point to PPSG’s involvement in a successful industry-funded campaign against FDA’s plan to regulate manufacturers of extended-release opioids. The REMS FDA first proposed in 2009 placed a burden on pharmaceutical companies to ensure that their products would be used more responsibly. PPSG joined forces with other industry-funded group to argue that the plan would impede access to opioids for “millions of American with chronic pain.”

    The effort was so successful that when the FDA presented a revised, industry-friendly plan to an expert panel, it was voted down by the panel for being “too soft.” (See: http://abcnews.go.com/Health/PainManagement/fda-advisors-reject-agency-plan-control-opioid-soft/story?id=11240232#.TrdACWC4Iq8 ).

    The original FDA plan proposed 2 years ago might have saved lives. But it was killed with the help of the PPSG. That’s 30,000 additional deaths, at least some of which might have been prevented.

    -Andrew

    Posted by andrewkolodny | November 6, 2011, 8:44 PM
    • Andrew,
      I think an opportunity is being missed for many to work collaboratively together to achieve balance with regards opioids in the USA to reduce the deaths from opioids while protecting those who need them for pain control.
      The examples you have given to my question “Can you please provide evidence of where the Pain and Policy Studies Group has advocated for Aggressive treatment of chronic pain with opioids” are a little soft.
      The APS/AAPM guidelines were published in 1996, with much of the work being done in 1994 and 1995. These guidelines were written for chronic pain in general, with no clear definition of chronic non-cancer pain.
      David Joranson was one of the American Pain Society representatives on that panel, chaired by Dr David Haddox, a pain physician in Academic Practice at the time (he went to work with Purdue some years later).
      These guidelines were endorsed by the boards of the American Pain Society and the American Academy of Pain Medicine and were used by many as a guide for clinical practice.
      I have not seen anything to indicate that AAPM has retracted these guidelines. I suspect their collaboration with APS on further guidelines in 2009 under the leadership of Dr Chou, with my colleague and PPSG member Aaron Gilson, PhD. contributing, has lead to them being pulled from their web site. PPSG was not formed until 1996 after much of the work of writing these guidelines was complete. To attribute the findings of a committee to one author is not accurate. This would be the equivalent of saying the Oregon Health and Science University promotes the Use of Chronic Opioids for carefully selected patients with non cancer pain because of Dr Chou’s chairmanship of the panel.

      PPSG was not involved in a campaign against the FDA Risk Evaluation and Mitigation Strategy. PPSG wrote a letter that stated:
      “The PPSG promotes a public health approach to the issue of the non-medical use of prescription opioids, which requires the comprehensive identification of vectors (or sources) so that effective interventions can be targeted successfully. To this end, before implementing a REMS, we recommend that the FDA consider the following issues:
      (1) Thoroughly understanding the non-medical use of prescription opioids,
      (2) Authority to regulate medical practice (does the FDA have the ability to regulate medical practice)
      (3) Possible unintended effects of the REMS,
      (4) Determining “success” of the REMS, and
      (5) Better utilizing already-existing drug control programs.

      As a co-signer of this letter (http://www.painpolicy.wisc.edu/domestic/REMS.pdf), I can assure you there was no industry input towards this letter. Responding to the FDA like this is part of the democratic process of the USA.

      There is an imbalance in opioid availability in the US. We need, as the CDC Director stated, to reduce the epidemic of opioid deaths, while protecting those who need opioids for medical purposes.
      We can come much closer to the achievement of balance with accurate data, which the White House has indicated is hard to obtain, and truthful and trusting collaboration.
      @jfclearywisc

      Posted by Pain policy & palliative care | November 6, 2011, 10:04 PM
  4. I think the “need for balance” i.e. restriction of opioids is simply a push by people who stand to make money off of criminalizing opioids(like government agencies and addiction medicine specialists, drug companies that market pseudo-opioids like tramadol or NSAIDS, or other alternative medicines like Gabapentin), not a reflection of any actual need to reduce or stop prescribing relatively harmless medicines for pain. Opioids are much easier on the body, esp. liver, kidneys, heart, digestive system than NSAIDS, work better at killing pain, and are inexpensive. The biggest dangers of prescription opioid use are in the apap added to them, and use in combination with other CNS depressants, usually polypharmacy and/or with alcohol. NSAIDS are dangerous and cannot be used long term, and in sham trials physical therapy has been shown to be equivalent to placebo at best, and is a huge waste of money and time for everyone except for those recuperating from surgery. So what is the alternative that doctors are supposed to prescribe to hurting patients? As has been seen already, stigmatizing and tightly restricting access to doctor prescribed opioids is leading more people to heroin use, which is much more dangerous. Prohibition of alcohol didnt work, prohibition of narcotics is not working, it’s time to try something else.

    Posted by Robert Gostfson | February 3, 2016, 5:03 PM

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