Opioid prescribing red flags. How to document, what to document, patient impact on obtaining opioid prescriptions!

Documenting ‘Red Flags’ on Opioids: Another Step in the Pharmacy Crawl

Ohio is back in the PainDr blogosphere again! Unsurprisingly, the state is making headlines around potentially painful opioid laws. In a recent ruling by a federal judge in Ohio overseeing the National Prescription Opiate Litigation (NPOL), pharmacists are now required to document refusal of opioid prescriptions based on ‘red flags’. Where did this come from? Why on Earth are we continuing to focus our efforts in fighting the overdose epidemic on monitoring prescription opioids? How is this going to impact patients?

Well, let’s dance once again to yet another step in the pharmacy crawl.


What is the NPOL and how did this ruling come about?

The NPOL is a combination of lawsuits filed against opioid manufactures, drug wholesalers, pharmacies, and other parties that have allegedly contributed to the opioid crisis. It has been brought on by states, counties, tribes, and other government entities and split into three tracks; pharmacies are included in track 3.

In the most recent ruling from this litigation, a federal judge found that pharmacists failed to identify and resolve ‘red flags’ that may have signaled opioid prescription invalidity, and that pharmacies did not implement policies and procedures that would have prevented the creation of a “public nuisance” by their pharmacists. The rationale used by the NPOL in this ruling was that pharmacists “abdicated their responsibility for screening opioid prescriptions which resulted in harm to the public”. Further, the federal judge who delivered the ruling noted that evidence presented during the trial showed that “pharmacists who refuse to fill a prescription often fail to document their refusal, and the pharmacy defendant fails to notify other pharmacists and stores of the refusal”.

Aside from abatement monies owed by pharmacies, the injunction order also requires that pharmacy defendants “institute policies and procedures requiring pharmacists to document any refusals to fill, and to consider prior refusals during their prescription validation process”.

What the heck does this all mean?


What are “Red Flags” regarding opioids prescriptions?

The first aspect that must be addressed around this ruling is actually defining what ‘red flags’ are as they relate to opioid prescriptions. If we were to ask the DEA or DOJ? Well, they may not provide a definitive answer!

To date, neither the DEA nor the DOJ have issued a comprehensive or thorough list of red flags that pharmacies or other healthcare clinicians must be aware of. In previous filings (the December Order in 2021 in Florida), ‘red flags’ have been described as “circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm”. Additionally, the DEA has listed examples of “common red flags” in the past including cocktail medications (meds/substances taken together that significantly increase patient’s risk of death or overdose), improper dosing for pain management (WHAT?), patients traveling long distances to fill controlled substances (patients routinely filling prescriptions traveling over 40 miles to pharmacy), cash payments, and price gauging (pharmacies charging patients higher than market value for controlled substances and/or opioids).

Let’s break some of these ‘red flags’ down a bit further.

Most of the ‘red flags’ listed by the DEA are actually, and should always be, part of the pharmacists duty when assessing ANY and ALL medications! We are always supposed to assess for drug-drug interactions, dosing (almost most importantly), drug-disease state interactions, and pharmacokinetic adjustments, amongst others. Thus, most of the ‘red flags’ should be done on an everyday basis anyway. As far as documentation goes? That is addressed below.

Things like price gauging and cash payments are a bit trickier. Certainly, most of us should agree that price gauging for ANY medication should be illegal. Patients have a hard enough time affording covered meds, why should we encourage individuals to drive up prices to optimize profits (WE’RE LOOKING AT YOU PBMs)? In regards to cash payments, that is a whole different ballgame. To be brief, occasionally, it is cheaper to purchase medications with cash versus using insurance. Finally, we would agree that patients consistently traveling long distances for prescriptions should make anyone a bit suspicious. Though, if we are truly that worried, just check the PDMP, call the prescriber, or help the patient find a closer pharmacy to them (most patients don’t want to travel miles and miles to fill a medication every month).

As we can already see, ‘red flags’ seems to be an incredibly subjective and poorly defined term. How can we absolutely prove that someone is “diverting opioids”, or taking greater amounts than prescribed, or, the term that is the bane of our existence, “drug-seeking”? Are there other ‘red flags’ associated with opioids that we should be evaluating for (respiratory problems, endocrine effects)? It’s hard enough to do this from a usual doctor’s office, let alone a pharmacy!


Are there even mechanisms for pharmacies to document ‘red flags’?

Even if we get past the actual problem of establishing what ‘red flags’ are, the next question I would offer to those making these rulings is what types of mechanisms were in place for pharmacists to successfully resolve ‘red flag’ issues in the first place? What about currently?

Most pharmacies I know have outdated technology sources that disallow easy documentation for just that pharmacy; let alone to be used on a global scale. American healthcare, including most pharmacies, is messy, divided, siloed, none of it being on the same page about anything. Thus, how do we expect such global access to patient records and communication without any current technologies in place to do so?

Don’t get me wrong, I fully support a more global approach to our healthcare system, especially at the pharmacy level. Pharmacists having access to renal function, liver function, certain metabolic panels, blood pressure readings, updated past medical histories, etc, etc, would be instrumentally helpful in allowing pharmacists to practice at the height of their licenses. It would help ensure all medications dispensed are therapeutically appropriate and safe for the patients pharmacists are treating! But, currently, our healthcare system doesn’t allow for this (at least cleanly). It’s one of the many problems with this system as a whole, and one that continues disallowing pharmacists from being able to optimize overall healthcare outcomes and help potentially reduce backlogging communication issues with prescribers.

Maybe, the NPOL shouldn’t be as hung up on the ‘red flag’ part of this ruling at all. Maybe, what we really should be advocating for is more thorough means of communication and evaluation between all sections of healthcare in general! Regardless of whether someone is on opioids, controlled substances, or your run-of-the-mill blood pressure medication!


The Bottom Line: ‘Red flags’ on opioids and the patient impact

It is difficult to tell what the overall impact will be from this most recent ruling regarding responsibility of pharmacists documenting ‘red flags’ relating to opioid prescriptions. Certainly, from a global documentation and care perspective, increasing pharmacist level of access is ultimately a good thing. This is mainly because it allows them to help make the best therapeutic decisions for patients and allows a more collaborative relationship with prescribers. Additionally, most ‘red flags’ are aspects of medications pharmacists should be assessing for anyway (as they should with ANY medication class).

However, this ruling doesn’t necessarily enhance pharmacist access in a global sense. The greatest fear is that this ruling is going to be abused at the corporate pharmacy and third party insurer levels because of the emphasis it has around opioids in particular. Opioid use disorder is already commonly misdiagnosed, and that is a diagnosis with highly selective and specific criteria… Now we’re expecting some arbitrary use of ‘red flags’ (that is poorly defined and subjective) to be assessed for and documented in a way to control dispensing of opioids?

This is a real issue!

There is no doubt more chronic pain sufferers are going to be turned away because of this; something that will result in potentially more overdose and death. There is even a high likelihood of this adding to the hindrances that patients with cancer-related pains are facing obtaining opioid prescriptions, as well as those with substance use disorders who may require certain prescriptions for acute situations.

If you want to legislate pharmacist’s responsibility around documentation, absolutely do it! Just don’t base it solely around the dispensing of controlled substances and assessing for ‘red flags’!! At the end of the day, patients are ultimately the ones who will suffer as a result.

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