Thursday, March 17, 2016

Opioid Guidelines from CDC - FINALLY!

The Centers for Disease Control (CDC) have released its Opiod Guidelines. Opioids have been a regular source of discussion in workers' compensation. I have touched on the subject a few times in previous posts like More Powerful Opoids Approved, Curiouser and Curiouser, and We are on Notice. The Notice article references Michael Gavin; he and Mark Pew have written on this significantly, as has Joe Paduda. Coincidentally, a panel at the National Drug Abuse Summit later this month will address some of these issues again. Joe Paduda and Mark Pew will speak. 

The CDC is playing catch-up on Opioids at this stage. Drug deaths have been increasing. Drugs are the leading cause of accidental death in the United States. For 2014, the last year for which statistics are available, 47,055 lethal drug overdoses occurred here. 18,893 were prescription overdoses. As Dr. Seuss reminded with a favorite title, "The Time Has Come, The Time Is Now." And in that spirit the CDC Guidelines will perhaps provide some standards or guidance to address the two-prong problem: pain is troubling and even debilitating, but death is not an appropriate remedy. 

The Guidelines are long (over 50 pages, single spaced). They are intended to "provide recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care." That is an important distinction. If someone is in end-of-life, cancer, etc. perhaps there is less reason for restraint, due to the magnitude of the harm that is being treated.

The Guidelines provide guidance on (italics direct quoted): 
1) when to initiate or continue opioids for chronic pain; 
2) opioid selection, dosage, duration, follow-up, and discontinuation; and 
3) assessing risk and addressing harms of opioid use. 

The overarching point does not seem to preach positions or theories as it states its goal as improvement "communication between clinicians and patients about the risks and benefits of opioid therapy." That seems fairly even-handed. There are two sides to the story, and the issue is for people to understand both sides. This seems a balanced approach. 

The Guidelines note that "Opioids are commonly prescribed for pain." How often? "An estimated 20% of patients presenting to physician offices with noncancer pain symptoms or pain-related diagnoses  receive an opioid prescription." Twenty percent is fairly significant. The prevalence of Opioid prescription has increased significantly, as noted above. Notably, the rate has continued in recent years, even with significant discussion of deaths and addiction in the news. Thus, there is some suggestion that there has not yet been enough publicity or discussion. Some cynics have told me "not enough, or not the right, people have died yet." That seems harsh, particularly with the publicity brought by celebrity deaths. 

The Guidelines recognize that "chronic pain" exists. It further notes that patients "can be at risk for inadequate pain treatment." The goal is not to eliminate pain treatment, but to identify risks and deal with them. There are acknowledged complications including social and psychological issues that may bear consideration. 

From where does chronic pain come? the Guidelines note "predominantly musculoskeletal pain conditions" are involved. It points out that "clinicians should consider the full range of therapeutic options for the treatment of chronic pain," suggesting as a primary point that opioids are not the only solution. 

In fact, it says that "evidence supports short-term efficacy of opioids for reducing pain and improving function"  but laments that "few studies have been conducted to rigorously assess the long-term benefits of opioids for chronic pain." In other words, there is not sufficient evidence on the risk/benefit analysis of long-term use. Later in the report the CDC then concludes "no evidence shows a long-term benefit of opioids in pain and function versus no opioids for chronic pain with outcomes examined at least 1 year later." That is a long-winded statement, essentially cautioning against long-term use, based on the absence of proof of benefits from long-term use. 

Some of the risks are detailed in the Guidelines. "overdose and opioid use disorder" are two. The CDC cites that more than "420,000 emergency department visits were related to the misuse or abuse of narcotic pain relievers in 2011." That seems significant. There are issues with "tolerance" or essentially getting used to a dose, and therefore needing higher dose for relief. The CDC also discusses "addiction" and dependency.

Following significant study and research, the "guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function, and reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs."

The CDC has grouped the recommendation "into three areas for consideration:" (italics are direct quotes)
* Determining when to initiate or continue opioids for chronic pain.
* Opioid selection, dosage, duration, follow-up, and discontinuation.
* Assessing risk and addressing harms of opioid use.

In these categories, the CDC brings 12 essential recommendations, each of which comes with a "rationale for the recommendation, with considerations for implementation noted." A seemingly very thorough approach. 

The recommendations are to establish real communication, discuss risks, use immediate release, use lowest possible dose, follow-up with patients regularly, consider anti-overdose drugs, be conscious of interactions with other drugs, and utilize prescription drug databases and urine testing to check compliance. This in a nutshell may become the "best practices" check list for prescribing these pain medications. 

The 12 recommendations (italics are direct quotes):

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain.
2.  Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks.
3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.
4.  When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.
5.   When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to 90 MME/day or carefully justify a decision to titrate dosage to 90 MME/day.
6.   Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.
7.   Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation.
8.   Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use, are present.
9.  Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose.
10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.
11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
12. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

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