New opioid guidelines (or directives)???

The American Dental Assn just released a “new policy to combat opioid epidemic” (see https://www.ada.org/en/press-room/news-releases/2018-archives/march/american-dental-association-announces-new-policy-to-combat-opioid-epidemic ). 

Details (they support the following):

--mandatory continuing education in prescribing opioids

--statutory limits on opioid dosage and duration of no more than 7 days

--using the Prescription Drug Monitoring Program

Commentary (all of these studies are referenced in the press release, with links to the original documents):

--on looking at data from 2010-15 for 1.1 million privately insured dental patients, those who were given opioids had them a median of 3 days. But there were increases in opioid scripts for those 11-18 yo, and the highest median dose​ was in those 11-25 yo

--a Medicare claims study of >890,000 patients with a dental diagnosis found that 23% received an opioid within 14 days of diagnosis.

--they note that dentists do lots of opiate prescribing: they were the top specialty prescribing them in 1998 (15.5% of all opiate scripts), but decreased to 6.4% in 2012

--though the number of opiate scripts has decreased since 2011, the rates of overdoses has increased (esp from heroin and fentanyl)

--and, perhaps most importantly, they noted that 5 systematic reviews found that ibuprofen 400 plus acetaminophen 1000mg was superior to any opioid-containing med. in 2016 their policy was that dentists "consider NSAIDs as the first-line therapy for acute pain management”

-----------------------------------------------------------------------------

 The NY Times published an article on 3/27 about the anticipated Medicare crack-down on opiate prescriptions (see https://www.nytimes.com/2018/03/27/health/opioids-medicare-limits.html​ ), or seehttps://www.beckershospitalreview.com/opioids/medicare-likely-to-approve-opioid-prescription-limits-in-april-5-things-to-know.html for a summary. These new rules are to go into effect 1/1/2019, and were set to be approved 4/2/18 (though not apparently done yet).

Details:

--“Enhancing the OMS [Overutilization Monitoring System] by adding additional flags for high risk beneficiaries who use “potentiator” drugs (such as gabapentin and pregabalin) in combination with prescription opioids. OMS already flags concurrent benzodiazepine use”

--“Expecting all sponsors to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at a dosage level of 90 MME per day, with a 7 days supply allowance” [ieMedicare would deny coverage for more than 7 days of prescriptions equivalent to 90 mg of morphine equivalents daily, except for patients with cancer or in hospice]

--“Implementing a days supply limit for initial fills of prescription opioids (e.g., 7 days) for the treatment of acute pain with or without a daily dose maximum (e.g., 50 MME per day).”

--“Expecting all sponsors to implement soft POS safety edits (which can be overridden by a pharmacist) based on duplicative therapy of multiple long-acting opioids, and request feedback on concurrent prescription opioid and benzodiazepine soft edits”

Commentary:

--opiate use in the elderly is a pretty huge issue: 14.4 million of the 43.6 Medicare beneficiaries enrolled in Medicare D (1 in 3 people) received opioids, 80% were Schedule II or III. Highest in Arkansas at 44%, lowest in Hawaii (21%) and New York (22%). Most common was tramadol (14.8 million scripts in 2016), then hydrocodone-acetaminophen (11.3 million 5mg, 11.2 million 10mg, 5.7 million 7.5mg) and oxycodone-acetaminophen (5.0 million of the 5mg)

--Medicare estimates that 1.6 million patients are at or above these 90 MME levels

--my guess is that most of us see patients who require high dose opiates for adequate pain control, perhaps due to m-receptor polymorphisms (eg, my patient who was a 35 yo divinity student who had never used any mind-altering drugs including caffeine, had extensive back surgery, and in the icu needed the highest doses of IV fentanyl seen by the nurses there to get moderate pain control, and subsequently had marginal control on fentanyl 400 mg q3days along with oxycodone). These m -receptor variants are not so uncommon, a specific one is present in 50% of Japanese and 1-2% of African-Americans: see http://gmodestmedblogs.blogspot.com/2015/03/feelgood-gene.html 

-- though the Medicare directive (these are not really guidelines) does excuse cancer pain, I really do not know the difference in the pain felt by one of my patients has who fell off a 2^nd story level ladder and had many broken bones and is basically unable to walk without higher-dose opiates

--and, even if we can decrease opiate dosages on those on higher MMEs (and I have been successful in several patients), for many eager to get off opiates it really requires a slow titration down in order for people to be able to function/work. And it may be hard to get below the arbitrary cutoff per Medicare. there was a recent article on tapering opiate dosages down, though it was a 4-month process and only in those volunteering to decrease their doses, and they still could only get down to 150 MMEs: seehttp://gmodestmedblogs.blogspot.com/2018/03/tapering-opioids-in-patients-with.html

--i would also add that we really do not have great alternatives for pain management.  many of my older patients cannot/should not take NSAIDs, acetaminophen is not strong enough for many, and i have been using tramadol in several patients in their 90s with good functional effect (ie, they can function without being miserable). i do try to do local steroid injections for musculskeletal pains, and this can be very effective with essentially no adverse effects, but often i find no alternative to the opiates.

--and, this Medicare measure in many ways is a “blame-the-patient” approach: many of us gave lots of opiates in the 1980s and 1990s because the Institute of Medicine declared that we were undertreating pain.  Their impetus, as well as the impetus to have pain as the fifth vital sign, came directly from lobbying by Purdue Pharmaceuticals (the proud maker of the subsequently remarkably profitable oxycontin; Purdue also did an extensive advertising campaign touting how safe oxycontin was).

    --as a result, many patients, mine included, were put on very high MMEs of opiates, and for whatever reason (eg, downgrading of receptors, rewiring of the brain, m receptor variants….) have great trouble decreasing their doses without either loss of functional benefit, psychological trauma (and many of the patients with chronic pain do have important baseline psych issues such as PTSD, anxiety disorders, depression…., which could be exacerbated by a mandatory reduction in opiates), or potential withdrawal if the opiates are cut back too severely.

  

so, these two new pronouncements above reflect pretty different approaches to each side of the problem (decreasing initiating opioids and dealing with patients already on opioids for chronic pain):

--the ADA is using some reasonable data to show that most patients do not need opiates after dental procedures, and then encourages dentists to avoid or minimize prescriptions for opiates.  This approach supports the concept that the really important way to avoid future addiction and the attendant personal, family, community effects is to avoid starting the opiates in the first place, or to do so in special cases and for a very short period of time. to me, this approach is measured, allows for individual assessment, is about as evidence-based as we get, and reasonable overall. I do have questions about the maximum 7-day opiate prescription for acute pain. Some patients may well need longer courses of therapy (perhaps because of the procedure done. Or perhaps, as with several of my patients, they have an allergy to or cannot take NSAIDs, or for one of my patients, a true allergy to both acetaminophen and NSAIDs). So, I personally would not have a problem with the patient on opiates being re-evaluated in 5-7 days to see what he/she needed for pain control, though i disagree with an automatic “statutory” 7-day max.

--Medicare, instead, is using a blunt and dangerous approach, which may leave many patients with chronic pain and on long-term opiates in the positions of either suffering inordinately, or feeling they need to get drugs illicitly, creating the real potential of personal harm for the patient, either by being forced into the position of securing the drugs illegally (potential personal harm by the process, cost of drugs leading to not having money for other necessities, etc), or by getting impure illicits (drugs cut with fentanyl or its derivatives, other potentially fatal concoctions, or even switching to the cheaper alternative of heroin, with its attendant risks/contaminants)

--so, as per several prior blogs, I think the primary focus on decreasing opiate prescriptions and the number of pills in the community is to avoid starting opiates in the first place, whenever possible (and the ADA and Medicare do support these initiatives, though too dogmatically). The hard part is trying to decrease/stop opiates in those already on them, especially those on very high doses. Though it certainly makes sense to encourage clinicians and patients to get down to the lowest dose that is effective (and many of us have occasionally been able to work with patients to get them off opiates completely), the reality is that many patients are unable to reduce their dose significantly without the above potential untoward effects. And this is a individual clinical decision, not one that should be enforced by insurers, the government, medical societies, pharmacists, etc.

see http://gmodestmedblogs.blogspot.com/2018/01/post-op-surgery-opiates-and-subsequent.html​ , which notes that longer prescriptions of opiates lead to more subsequent use than higher doses

-- http://gmodestmedblogs.blogspot.com/2017/07/decreasing-opiate-prescriptions.html  notes decreasing opiate prescriptions, but increasing opioid-related deaths

-- http://gmodestmedblogs.blogspot.com/2017/02/opiate-prescribing-in-elderly-and.html has an interesting/pretty powerful retrospective study in older patients and naive to opiates (mean age 69) finding that those seeing high-intensity opiate prescribing ED physicians vs low-intensity ones for similar clinical conditions had a 30% increased likelihood of long-term use of opiates

and http://gmodestmedblogs.blogspot.com/search/label/pain%2Fopiates for all blogs, including studies showing that NSAIDs seem as effective as opiates in pain relief in emergency room studies as well as those with chronic back/hip/knee pain.