When Opioids Almost Kill You, Chances Are You'll Get More Opioids

I really wanted the first post of 2016 to be positive, uplifting, inspiring... but a study I read over the break was so unnerving, I had to go and ruin "return to work" day, already a day that lives in infamy, with even more depressing news.

Researchers at Boston Medical Center used a national database of prescription information to assess the likelihood of continued opioid prescriptions after a non-fatal overdose.  They looked at prescription information from 3,000 patients who experienced a non-fatal overdose between 2000 and 2012.  These patients were all prescribed opioids for chronic, non-cancer pain. 

Think about this: These 3,000 patients have already overdosed on prescription opioids. They are lucky to be alive. Surely, their healthcare providers will find another way, another mechanism, another approach to managing their pain. The risk here isn't illness or infection or a change in blood pressure... it's death.  

The bad news:

• Over 90% of these patients continued to receive opioids after their non-fatal overdose event
• 50% of these continued to receive the prescriptions from the same doctor
• 7% of the original group experienced a second overdose
• Two years after the first overdose, those with continuing opioid prescriptions were twice as likely to experience a second overdose event compared to those who were no longer receiving opioids. 

Why is this is happening?  

First, our fragmented healthcare system doesn't make it easy for prescribing physicians to discover the clinical events experienced by their patients outside of their immediate purview.  And patients may not want to disclose an overdose event for fear of having their medications discontinued.  I get that.  And it makes we wonder whether PDMPs should also include the ability for inpatient settings to report both fatal and non-fatal overdose events to the database so doctors can see this information whether its reported by the patient or not.  Linking electronic health records to PDMP systems would be a good start down this path.    

The second phenomenon driving these sorry statistics is that doctors are not comfortable weaning opioid (and other) medications.  No one, least of all me, would ever suggest immediate cessation of opioid therapy in light of a non-fatal overdose.  That's clinically irresponsible and potentially dangerous for the patient.  But the necessary steps forward are complicated: If the patient is on multiple medications that require weaning, which should we weaned first?  What titration steps should be used?  Is medication-assisted-therapy (MAT) an option?  Should I refer the patient or try to handle this myself?  These are hard questions and the primary care community, by far the most frequent prescribers of opioids, is currently ill-equipped to handle them.

Welcome to 2016.  Once more unto the breach, dear friends.  

Michael 

On Twitter @PRIUM1  

Why Aren't We Linking PDMPs and EHRs?

The development of prescription drug monitoring programs (PDMPs) nationwide is a necessary, albeit insufficient by itself, step in our fight against prescription drug misuse and abuse.  I've long advocated not just for mandatory reporting to PDMPs (which requires doctors and pharmacies to contribute data to the database) but also of mandatory use of the PDMP (by prescribing physicians prior to writing prescriptions for potentially dangerous medications).

Many physicians (and their associated lobbying groups) have pushed back on the notion of mandatory use of PDMPs based on three categories of objections:

First: "I don't get paid for this..."  Fair enough.  One could argue that a surgeon isn't explicitly paid to wash her hands prior to surgery and does so anyway because it's in the best interests of patient safety... though the reality is that our fee-for-service RVU-based system actually does pay the surgeon for that activity.  So I get this argument.  

Second: "The data isn't reliable... it's either not timely or not accurate..."  This is certainly an issue, though one that will resolve itself over time with proper funding and enforcement of reporting requirements.

Third: "The database access is inefficient, the technology isn't robust..."  Also an issue, but one that I think will resolve itself over time as critical mass develops around the need to exchange this data.

But what if we could fix all three issues in a single stroke of technological innovation?  

Ohio is doing just that.  Governor (and Republican presidential candidate) John Kasich is spending the necessary dollars (a whopping $1.5 million) to integrate Ohio's PDMP with the electronic health records systems of doctors, hospitals, and pharmacies.

This is genius.  

"The message to Ohioans, despite the fact that will still see a tsunami of drugs, is that we're not going to give up in this state until we win more and more battles, maybe ultimately the war," Kasich said at a news conference.

Why isn't every governor in the country working on this?  

Michael
On Twitter @PRIUM1

What Happens When Regulators Don't Trust Clinicians?

USA Today published an interesting point/counterpoint this week on the question of whether doctors should be forced to check a prescription drug monitoring database prior to writing a prescription for an opioid.  The advocates for such an approach (me included) argue that fundamental public health concerns trump the arguments against mandatory checks, primarily that this new step in the process of clinical delivery presents privacy and convenience hurdles.

But if one examines the true concerns of clinicians that have pushed back against mandatory PDMP checks, one would find a deeper, more meaningful, more consequential issue: when it comes to prescription drug misuse and abuse, government regulators are exhibiting ever higher levels of distrust of the medical community.   

Perhaps nowhere else has this been laid more plain than in Massachusetts.  Governor Charlie Baker, a former physician group and health plan CEO, has proposed an aggressive set of measures to stem the opioid epidemic in his state.  I'm not using the term "aggressive" lightly here...

Among several other potentially controversial provisions, the proposed bill would limit new prescriptions for opioids to 72 hours (with very limited exceptions for emergency situations).  A patient in Massachusetts might go to the doctor, complain of low back pain, and receive a script for pain management.  But the max a doctor would be able to write is a 3-day script.  After that, the patient would need to come back to the doctor for an additional script if the continuation of the medication is deemed necessary.

As expected, the reaction of Massachusetts doctors appears to range from supportive to skeptical to deeply concerned.

I haven't decided whether or not this is a good idea.  I'll be researching the approach and discussing it with others for a while before I come to any conclusions.

What strikes me is that regulatory bodies ranging from state work comp agencies (think "closed formularies") to state legislators (think "mandatory PDMP checks") to state governors (think "Charlie Baker's plan") are essentially saying: Enough of this.  It's gone on too long and too many people are dying.  The clinical community has had their chance.  It's time for us to step in and shut this down.

Will there be unintended consequences?  Yes.  Will it result in the mitigation of prescription drug misuse and abuse for which we all hope?  TBD.

Might the clinical community awake and recognize the necessity for them to self-correct this problem to avoid further unwelcome intrusion into clinical practice from the regulatory community?

I hope so.

Michael
On Twitter @PRIUM1

We Have to Do Better Than Statistically Significant

Researchers from the Bloomberg School of Public Health at Johns Hopkins have published a paper in the Journal of the American Medical Association looking at the impact of opioid prescribing in Florida after PDMP and pill mill reforms were put in place.  The results are "statistically significant." But statistical significance and public health impact are clearly two different things.

(You can read the abstract and purchase the study here.  You can read a synopsis here.)

The study compared opioid prescribing in Florida and Georgia, an attempt to measure one state's behavior vs. a "control" state that did not implement the reforms that Florida did (at least during the period of study from July 2010 to September 2012).  The results, in a nutshell:

• 1.4% decrease in opioid prescriptions
• 2.5% decrease in opioid volume
• 5.6% decrease in MED per transaction

While we should be celebrating any decrease in opioid use, these statistically significant reductions aren't altogether different than the data we're seeing from our industry's PBM drug trend reports measuring national changes in opioid use.  My reaction to both this study and the PBM drug trend reports is the same: We need to be doing much more to reduce medically unnecessary medications in the treatment of chronic pain.  

Leaving aside some of the shortcomings of this study (the data is from retail pharmacies only) and the frequent confusion among media and industry readers between correlation and causation (something the researchers address, but which is often ignored)... is this really the best we can do?  

It's possible the decreases will accelerate over time.  I'm hopeful that will be the case.  But the detailed results of the study show an interesting phenomena: the reduction in opioid prescriptions written by docs and the reduction in opioid use among patients is very much isolated to high prescribers (80th percentile and above) and high utilizers (80th percentile and above), respectively.  Docs and patients below the 80th percentile actually showed small increases in scripts and use.  

Maybe this shows we're striking the right balance.  Those with legitimate needs still have access while pill mills are being shut down?  Or maybe it shows we still have a lot of work to do... and that PDMPs and pill mill legislation, while absolutely necessary, will be nowhere near sufficient to fix the problem.  

Michael  

On Twitter @PRIUM1

A Legal Challenge to Prescription Drug Monitoring Databases?

Dr. Alwin Lewis was investigated by the Medical Board of California because of an odd diet he had apparently advised patients to undertake.  (The “five bite” diet… don’t eat breakfast, then eat five bites of food for the rest of the day.  I would have demanded an investigation, too.)  During the course of the investigation, the Medical Board uncovered inappropriate prescription patterns in California’s PDMP (the CURES database).  The Medical Board found that he had kept poor medical records and had over-prescribed medications to two patients.  He was placed on three years’ probation. 

And that’s when all heck broke loose…

Dr. Lewis took the case to court, arguing that the Board had gone too far in using information from the PDMP against him.  There’s a lot of confusion here, even by California standards.  Here are some key points to keep in mind:

First, the ACLU, civil rights attorneys, the California Medical Association (CMA), and several other groups are making a lot of noise about this case.  All of them are trying to push this issue far beyond the scope of the challenge that is actually being raised by the Dr. Lewis.  If Lewis prevails, the result will be a revision of the Medical Board’s investigation/disciplinary process, not an invalidation of the CURES statute.

Second, this case is not about protecting patients’ privacy; it’s about protecting patients’ privacy when doing so protects the doctor from a Board investigation.  Lewis has made it clear that this is not a facial challenge to the CURES statute; in fact, he concedes that in most instances, such as in an administrative audit of a pharmacist (but not a physician), pulling a patient’s prescription info is constitutional.  His position is that when a CURES audit is performed “for the express purpose of investigating physician practices,” the auditor should not be able to access patient records without a subpoena, warrant, or good cause.

Third, it’s also about protecting the doctor’s right to privacy.  Lewis is arguing that he has a direct, personal, right to privacy in regards to his prescribing patterns, and that the Board violated that right when they performed the CURES audit of his prescribing history without an administrative subpoena.  While that may sound like a terrible argument, this is California, and so there is actually appellate case law that supports him on that point.  This is actually a central theme in his petition.  He argues that when a pharmacy auditor looks at the medications dispensed to a patient by that pharmacist, neither the rights of the pharmacist nor the rights of the patient are violated; when a physician auditor views the medications prescribed to a patient by that physician, both the rights of the patient and the rights of the prescriber are violated.  Makes complete sense, right?  

The Board’s conduct – however excessive – was aimed at protecting patients.  The PDMP rules are aimed at protecting patients.  The only real danger to the patients’ interests came from the guy that is now trying to pose as their protector in order to get out of a disciplinary action. 

This case, regardless of what you might read elsewhere, shouldn't have a significant impact on PDMP use in California or any other state. 

Michael
Follow us on Twitter @PRIUM1 

Dangerous Databases? Security Risks and Public Health Benefits

Prop 46 was defeated in California on Tuesday by a 2-1 margin.  The proposition, among other things, required drug testing among doctors and lifted the caps for medical malpractice damages.  Prop 46 also would have required physicians to check the CURES database before prescribing or dispensing any schedule II-IV medication.

Predictably, the bill was unpopular among California physicians.  Disappointingly, the Prop 46 attack ads apparently devolved into scare tactics and silliness.  According to a WorkCompCentral article this morning, California voters heard things like the following, probably in the form of a voice over that made it sound dark and evil and conspiratorial:

"The vulnerable, government-run database is subject to being hacked, compromising the security of every Californian's personal prescription drug history" and "your personal prescription drug history could be made available for anyone to see."

Political ads are anathema to sound, rational policy debate.

Yes, there are risks associated with the existence of any public database (or private data, for that matter: see Home Depot, Target, etc.)  But no, those risks do not outweigh the obvious public health benefits of mandated PDMP use by prescribing physicians.

As I've written before, mandating that pharmacies report prescription drug data into the PDMP is a start.  Mandating that physicians register as users is a next step.  But mandating that doctors check the database before writing prescriptions that could be potentially dangerous to a patient or a community is the key to a successful PDMP program.  

Otherwise, it's just data sitting in a database.  

Apparently, plans are in the works to bring back this particular component of Prop 46 in front of the legislature.  Hopefully, this time around, the scare tactics will be drowned out by the voices of reason.

Michael
On Twitter @PRIUM1