Been a while since I did a pharmacy post, so let’s do one of those.
One of my Substack projects that I’ve teased at least once is an outsider-focused explainer on basic outpatient management of pain. By coincidence, my director of pharmacy asked me1 to review our institutions policy for pain assessment and management. I was handed a copy of two of the Joint Commission’s R3 reports and got less than a page into one before I realized ooh I need to write A Thing about it. This post is that.
The Joint Commission (TJC2) is an independent, non-profit organization that certifies most healthcare organizations in the US. Accreditation is, in theory, voluntary, but in practice it’s a requirement by most federal and state governments for participation in Medicare and Medicaid programs, effectively making it mandatory if you want to run a hospital3. Optimistically, TJC is responsible for assuring hospitals et al. are legit. Much less optimistically, TJC is a regulatory cartel. Between this paragraph and the post’s title you can probably guess I’m not impressed.
I’m going to go into more detail on the two R3 reports I was asked to comb through, but before we get there let’s thoroughly establish my primary beef with regulation of the style that will be amply demonstrated by TJC, and something I hinted at in the parts of my retail pharmacy explainer dealing with red flags for controlled substance diversion: regulators demanding high standards without specification.
The DEA advises us to watch for "red flags"—signs that a patient may not be obtaining a prescription for legitimate use—but doesn't bother to codify any of it and doesn't even provide an official list of red flags. The lines between poorly-written-but-legitimate and correctly-written-but-not-legitimate blur very badly. Some frequently cited red flags include:
Prescriptions for large quantities of drugs, especially in combinations, and double especially if that combination is opioids, benzodiazepines, and muscle relaxants
Frequent prescriptions from the same prescriber for multiple patients with similar details (directions, quantities, etc.)
Multiple identical prescriptions for people at the same address
Unusually long distances between addresses for the patient, prescriber, and pharmacy
Patients paying in cash or refusing to use insurance
All manner of suspicious incidental behavior
You might notice a frustrating pattern here: these all have plausible exceptions. It’s not actually that unusual for someone to have all of pain, anxiety, and muscle problems; someone might have unpredictable severe muscle spasms that cause severe pain and thus makes them incredibly anxious. Couples coming in with identical prescriptions strikes me less as automatic abuse and generally points to prescribers having stubbornly consistent/lazy prescribing habits. Sometimes someone needs a specialist and the nearest psychiatrist/pain specialist/specialty surgeon is 300 miles away. Sometimes people just flat don't have insurance.
I also go on to describe my baseline objection to what I guess I’ll refer to as nonspecific-feel-good-requirement-style-regulation when discussing new prescription counseling requirements:
My chief objection to prescription counseling mandates is how context insensitive it is, both to patients and to your average retail pharmacist who is being buried under increasingly impossible workloads. There are a lot of people who are going to be well- or best-served by the bog-standard, “Do you have any questions about your medication?” And the people’s whose lives are going to be most impacted by your input as a pharmacist are the ones who answer “yes” to that question: parents with sick children who want to be sure how to give their augmentin, new diabetics who have suddenly had their world turned upside-down and need to know how to use a glucometer, the patient who is lost after their doctor threw a bunch of new medications at them but didn’t have the time to explain why or what they are, etc. I’ve seen all of those, and multiple times each.
Everyone probably should be counseled on their medication (hint: maybe not by the person answering two phones and desperately trying to get some dude out of their drive-thru), but not everyone needs to be, and all I’m saying here is that I sort of feel like that’s not an unimportant distinction.
Emphasis added, the first key point here is context insensitivity. We’re going to require a high standard of care but we’re not going to care what it costs or what we’re actually asking—what incentives we’re creating or how we’re requiring people to behave (or not behave)—because the requirement qua requirement makes irresistible boilerplate. This transitions into the second problem because we’re not going to do the hard work of deciding what specifically constitutes a high standard of care because that means we’ll have to think about what accomplishing that might be required to look like and also lord knows we don’t want to do anything that looks like something we could be held accountable for4.
The other thing that’s frustrating to me about TJC compliance is that we’re far past the point of Goodharting this. Some of this is on us, but it’s incredible how many things we do in the hospital purely because they’re required for TJC compliance with no thought to whether any given requirement is good or bad or whether we should be doing that behavior whether we’re being looked at or not.
We’re also going to address the most obvious rebuttal to all of this, that TJC is all that stands between the vulnerable healthcare-needing public and rampant, greedy hospital slumlords trying to make an easy buck by murdering you with shoddy, low-quality care.
The answer, of course, is yes. No regulation isn’t really on the table here. But while we’re correctly not trusting local healthcare administration to have our best interests at heart even when they’re nominally about healthcare, why shouldn’t we reserve the same level of skeptical scrutiny for the next administrative level up? TJC is non-profit and, in theory, is mission-focused on consumer advocacy and protection, but uh so are quite a few of the hospitals they regulate5. We should expect it’s roughly the same level of effort to do the minimum amount of work necessary to pocket federal funding for minimal output in either case. What’s the equivalent of rampant, greedy hospital slumlords but just bumped up one more administrative level?
Here’s where I say, “so why don’t I ever see public discussion on whether the standards set by TJC good and reasonable?” But let’s not pretend this isn’t a huge political problem6. Again, “everyone deserves the best possible healthcare with no expenses spared at no cost to them” is too tempting of a boilerplate to launch an effective rhetorical or political counter against. The general public is just going to be too resistant to the level of nuance required to treat healthcare like the scarce resource that it is.
A little while back this tweet about younger doctors wanting work-life balance went quasi-viral. Discussion inevitably got around to “we need more doctors” which was where I commented with:
I think demand outstrips supply so much that “salaries will drop” is not a reasonable rebuttal to [“we need more doctors”]
However increasing supply of docs will require you to dilute the quality of med school admission and graduation requirements which may not strictly be something we’d like
Point being that there’s a lot of discussion that skips over: “we want more doctors” => we need more people to apply to med school + there needs to be more med schools + we need more med school applicants to successfully get into med school => in all likelihood admission standards and graduation requirements will need to be relaxed.
The same is broadly true for healthcare. If you want more of it, if you want better access and lower costs, there are only so many roads open to you before you need to start, shall we say, having more realistic expectations. Most people don’t want to hear this.
But this also applies for the resources needed to actually operate, say, a hospital. If every subspecialty comes with a TJC requirement like “you need to have a specialist available for all of these” you either have to hire one or externally contract with one, neither of which are cheap or even strictly available everywhere. Every “you need to have a policy for this” implies an increasingly not-insubstantial office of policy-making people skyrocketing your budgets. The stricter the arbitrary requirements around beyond use dating and automated dispensing machine maintenance, the more man hours and pharmacy budget disappears down an irretrievable black hole with no measurable increase in healthcare quality or outcomes.
So on to the meat here. Fortunately, you don’t have to take my word on their word, kind of; everything I’m looking at for the purposes of this post is available publicly at this link7, although, tellingly, TJC sells "manuals" for accreditation, certification, and compliance with their standards and only appears to sell access to the actual standards themselves.
Specifically here, I’m looking at Issue 11 and Issue 15 (the yellow button on each page links to the actual pdf), Pain Assessment and Management Standards for Hospitals and Critical Access Hospitals respectively. Issue 15 (the “critical access hospitals” one) is newer by around a year8 but I’m mostly going to pull from Issue 11 for discussion since it’s meant for general hospitals, also they’re basically identical. These “issues” appear to be area-practice summaries of pieces taken from the full standards manual, though I’m not prepared to drop the minimum $359 to be able to personally verify9.
I’m going to continue harping on this briefly10 because I want to highlight how dubious it is that organizations like TJC are getting public funding without the public being able to check their work. I have the same complaint for the stupid prices some organizations charge for continuing education et al.; it strikes me as quite backwards to require healthcare workers to be held to high standards without providing them those standards, plainly, for free11. Priesthoods be damned.
Anyways.
Starting in the “Leadership” section at the top, we immediately have our first “what are we doing here”:
EP12 1: The hospital has a leader or leadership team that is responsible for pain management and safe opioid prescribing and develops and monitors performance improvement activities.
Here’s our first encounter with two staples of hospital regulation: A) we’re going to require you to designate someone we can blame and B) we’re going to require you to have a written policy13. But surely we can agree leadership is important right, it’s right there in the rationale, which is even backed up by ironclad sources like—oh the first link is broken, and the second link contains some incredible gems like:
EP 2-7 are only slightly varying levels of sensible and unambiguously good, though I do think it’s slightly awkward to have all of these in the leadership section and not the provision of care section, though spoiler: much of it repeats. I guess, reading between the lines we can sort of infer it’s an implied threat to the hospital administration if everything here isn’t being taken care of.
EP 4 & 5 are our first “you will treat it or refer” rules. I should temper my instinct to mark this as kind-of-ridiculous by noting that we’re in the specific context of pain management in general & critical access hospitals, where it doesn’t make sense to give the hospital an out to just, say, not treat your physical discomfort.
The objection I would make here would make more sense in the context of, say, severe mental illness or a specialized disease like cancer where it’s very possible to have smaller local hospitals that aren’t equipped to field those problems14. In those cases, should we enforce systematic referrals? Yeah, probably, despite my implied objection several paragraphs back15. My actual objection here is with who is responsible for the systematic referrals—IMO this ought to be something provided to hospitals not required from them.
What I’m wondering is this: TJC is provided public funding, and accreditation is required for hospitals to receive public funding, why aren’t the referral networks publicly organized, either by a regulatory group like TJC or by the actual government16? There’s an alternative answer to this that nobody likes but would put a bow on it: your health insurance provider (who unfortunately might also be the government anyways) is going to already have a strict referral network, though your hospital won’t automatically have access to it without some facilitation.
The “Medical Staff” section has a single EP about involving staff in policy development and performance improvement (backed up by another broken HRSA.gov link) and the “Performance Improvement” section at the bottom has 3 bits on performance evaluation. I don’t really want to get to into an extensive digression whining about performance improvement as a concept except to say I feel this kind of thing should probably be a collaboration between an institution—which will be naturally busy doing its thing—and TJC—who will have a birds eye view and access to what works at other institutions—versus the latter just dinging you if you can’t prove you’re feverishly doing it on your own. It should be a natural internal part of any operating organization but this is another place where operation gets severely bogged down in the appearance of compliance versus any practical consideration for what quality assurance might truly look like.
The “Provision of Treatment, Care, and Services” has several more focused, on-the-ground variations on the themes from the leadership section. EP 1-3 are also prima facie sensible and seem to all be an “are you doing it” check box. 1 & 4 are questionable “use the best guidelines” stuff but again don’t care to offer guidance on what the best guidelines are. 3 is another “do it or refer”.
EP 5 is the first thing so far where it’s something you could reasonably expect to have to tell even competent institutions they are required to do; involving the patient in treatment is surprisingly/alarmingly unintuitive for hospitals. Everything so far has been “figure it out/write the policy” on the kinds of things where only the worst institutions would not be doing it (eg make sure you ask about pain in the emergency department!), but this is the first one that firmly suggests you do something even a competent institution might be very tempted not to do. In the spirit of legible control, even in something where you need the patient’s subjective input to pick a treatment there’s expected institutional inertia to doing anything other than “tell us your pain on this scale and then take this corresponding pill/etc.” EP 5 is also somewhat relatively specific on what it wants to see you do.
EP 6 takes us back off the rails though by asking us to make judgments about who we think might become an addict. Just kidding, it means we simply assume all patients will17.
EP 7 touches on another problem I haven’t gotten to complain about directly yet: nonspecific monitoring requirements. This goes beyond “you can’t do nothing”, they want you to have results, and plans for those results, but they don’t seem too preoccupied with which results beyond having a couple of token examples.
EP 8 is another one of those things that sounds great on paper but is reducible to a standardized handout everyone gets on discharge. I can’t rightly say removing this requirement would ensure patients get better info, but what would ensure patients get better info was by having some amount of specification for what info patients get.
In the middle of writing this I’ve read some alarmingly compelling stuff on banking regulation by Patrick McKenzie and it’s the kind of thing that does make me sort of wonder if my baseline assumptions around regulation are flawed, but I’d still need to be convinced out of them and so this will be my first signpost inviting people to correct me if they think I’m wrong (or boost my ego by agreeing with me).
To recap, I’m apparently frustrated that healthcare regulation is not strictly prescriptive at all. Because the problems we’re solving are not formulaic and their solutions are highly context dependent, it makes less sense to me that you’d also subjectively measure the minimum requirements and mandate information resource availability without providing for access. This feels counterintuitive when put this plainly but to explain: it makes sense to me that you’d have a “you figure it out” type of rule for something like banking where you’re mostly dealing with factual information (and the challenges lie mostly in how it’s sorted and filtered) and likewise in the inverse, it makes more sense to me when you’re mostly dealing with extremely probabilistic data that, accepting you need to have some sort of targets to hit, you’d have those targets be at least concretely described.
And the other staff pharmacists plus our one pharmacy student, so this didn’t land specifically on me.
Previously, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). I actually hadn’t known until writing this that they’d changed their name; everyone still calls them Jayco.
Lazily letting Claude finish the explanation:
In practice, TJC profoundly influences daily hospital operations through its detailed standards covering everything from patient safety and quality of care to facility maintenance and staff credentials. The organization conducts unannounced surveys every 18-36 months, during which surveyors evaluate compliance with hundreds of standards. These standards drive hospitals to maintain specific policies and procedures, implement safety protocols (like the "Universal Protocol" for preventing wrong-site surgery), follow standardized communication practices (such as bedside handoffs), and maintain detailed documentation of care.
This footnote might be a placeholder for my future argument but unlike a lot of the bullshit I write I actually have what I think is a reasonable solution here: there perhaps needs to be multiple competing independent regulatory agencies. Either break up TJC or use some of the same public funding to establish a second and third competitor and/or have some kind of accountable oversight on the regulators.
According to HHS, 49.2% of hospitals are non-profit.
Not helped by proposing we scrutinize regulation right around the time everyone’s collective eyes are rolling out of their skulls at the “Department of Government Efficiency”.
We’re not going to unpack lots of stuff there that is only arguably relevant to actual healthcare quality, eg R3 Report Issue 38: National Patient Safety Goal to Improve Health Care Equity.
But being from 2018 still makes it worryingly ancient.
I’m not even confident my institution has bothered to actually buy it given that I was just handed printed copies of the R3 reports.
I hadn’t even noticed until I got roughly here in the draft, I was motivated to start this partly because I could publicly point to what I was roasting. This will still basically apply but I’m going to continue to be salty for this entire section.
This is alarmingly common. USP regulations sorry standards (that every board of pharmacy just cites and requires by law) on compounding, which are notoriously strict and arcane, also are not available for free.
“Element of Performance”
I’m getting awfully snarky here but I do want to say I think point B) here is good and you want lots of this.
Though, long term pain management is a not-unimportant outpatient specialty where having a local referral option is a very pro-socially good thing to have, given that opiate addiction is no small problem.
If every subspecialty comes with a TJC requirement like “you need to have a specialist available for all of these” you either have to hire one or externally contract with one, neither of which are cheap or even strictly available everywhere.
Again I’m not going to pretend we don’t know the answer to this question, but we ought to be asking it much more loudly.
Again, my snarkiness is masking a pretty legitimate problem here wrt hospitals being very lax about controlled substances while someone is inpatient and not having to deal with the consequences once they’re discharged. EP 6 isn’t doing anything to address that, though.