CDC 90MG RESTRICTION DOES NOT APPLY TO CHRONIC PAIN PATIENTS

Transcripts of CDC press conference on day of release of Guideline, March 15, 2016 12:30am, and text from the Guideline Recommendation #5 with analysis in italics

note: {xxxx} bracketed references can be directly googled, and emphasis is the editor’s.

From the press release 3/15/2016

“I’ll let Dr. Deb Houry, who is the Director of The National Center for Injury Prevention and Control (the division of CDC responsible for Guideline) in which this work resides, comment further. Dr. Houry.”

DR. DEBORAH HOURY: “Thank you. There were comments on both sides. We have a lot of organizations who actually thought we should have lower dosages or shorter duration. So there was a balance of both shorter and longer. With regards to the actual dosage, we tried to apply more nuances. You’ll see that in the full document. At 50 MME we actually carefully reassess the patient’s benefits and risks. At 90 MME, we say there’s a clear cap but you should justify the decision. And then it talks about referring to a pain specialist. When you do look at a lot of the emerging evidence, though, there is evidence of increase overdose as the dose escalates. Providers did want a number in general to guide their practice. Again, these are guidelines, not regulatory, so this will help physicians in their daily practices to determine what safe dosages are. And this is about initiation of opioids for those dosesWe feel strongly that you do not initiate an opioid naive patient on a high level of opioid because of the substantial risk of overdose. As Dr. Frieden mentioned, we did provide a range and that was modification we did after the feedback for the acute pain recommendation. We think it’s important for physicians to always use the shortest course possible but did want to allow more flexibility in that number.”

ED: The 90mg cutoff is clearly for opiate naive people, new pain medicine startups, which is a reasonable idea. The 90mg cutoff is not for non-naive patients already on pain medicine, as they would not qualify as being naive for first time use. Addiction is triggered at first use by those with the genetic predisposition, estimated at 0.5% of the population. Asking if the person has never taken an opiate, and cautioning them, would be a way to provide early diagnosis and early intervention.

There are no further comments in this press briefing about prolonged use, or use in people who are not naive or who have been taking opiates, only first time use. CDC never intended the 90mg cutoff to be applied to anyone other than new opiate patients, say, in the ER or after surgery, at which time, if naive to opiates, it would be appropriate to go slowly. This press conference introduced the Guideline itself. Below are verbatim excerpts from Recommendation 5, in the “Guideline” of 3–15–16, also limiting the 90mg cutoff for first time pain treatment. Looking directly at the recommendation in the text of the”Guideline”:

Recommendation 5 from CDC “Guideline”, 2016.

“When opioids are started, clinicians should prescribe the lowest effective dose” CDC introduces for the first time in medical practice dosage cutoff numbers being misconstrued for long term pain treatment. The Guideline goes on to introduce for the first time “(one) should avoid increasing the dosage beyond 90 mg MME.” Again this is “when opiates are started”, not for chronic pain disease treatment. The FDA previously ruled these limits were not scientifically supportable {FDA 2012-P-0818} for any use. FDA is the only regulatory authority for all prescription drugs.

Clinicians should use caution when prescribing opioids at any dosage”(this has always been standard of practice) “and should carefully reassess evidence of individual benefits and risk when increasing dosage to 50mg or more morphine milligram equivalents or MME” — again in first time use.

(There are no references given to support this new number of 50mg, nor references to the validity and reliability of the MME metric.)

— ”and should avoid increasing dosage to 90mg or more MME per day”again — in first time use only. FDA previously disagreed with these limits {FDA2012-P-0818} or with any cut, and remarked problems can occur at lower MME as well. This is the infamously misquoted “first time use” 90mg cutoff adopted in the entire country, as applied to all those beyond a “first time use”. Doctors are being arrested for “prescribing too much” based on this scientifically discredited number, and even worse, never recommended by CDC — an agency without regulatory authority for prescription drugs.

Ed: These attempts to limit the dosage of a prescription drug are by “voluntary” compliance and are intrusions into the practice of medicine, reserved for state regulation — not for federal government. (See Supreme Court decision [268 US 5}, and statute [42 USC 1395].) Further, limitations of dosage for opiate medicines were already scientifically reviewed and discredited by the FDA {FDA 2012-P-0818}

Basically there is no cutoff, 90 mg or otherwise in the CDC “Guideline” which limits, or intends to limit, or suggests a limit to full FDA approved dose titration to effectiveness at any labeled milligram dose following the first opiate naive dose, as clinically determined to the be EMME (Effective Morphine Milligram Equivalent) for each patient.

Reference;https://medium.com/@ThomasKlineMD/cdc-90mg-restriction-does-not-apply-to-chronic-pain-patients-4e49e171ade6

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