PAINKILLER LAW BLOG: The FDA’s Original Blessing Isn’t a Pain Doc’s Original Sin

Doctors who prescribe opioid painkillers to chronic pain patients are, as we know, the subject of intense regulatory and law enforcement scrutiny today. Many of my doctor-clients are under investigation or being charged for supposed crimes arising out of their prescription writing. While every case is different, to me there is a universally applicable defense that should be raised on doctors’ behalf in court against a criminal charge.

That defense relates to lack of criminal intent, since opioids’ addictive power was not known or acknowledged until years after the drugs’ approval for mass use. Today, a criminal charge is at its essence a misguided and ill-considered way of blaming doctors for not having seen the future, for not having foreseen what would happen, even though government regulators and even the drug manufacturing companies didn’t see the abuse crisis coming, either.

The FDA originally blessed the prescribing of powerful and potentially addictive medication for chronic pain. We now know that the scientific evidence offered by Big Pharma about the safety of the medications for chronic pain was incomplete at best, wrong at worst. There are attempts being made today by counsel in various parts of the country to uncover any possible funny business or overly cozy relationships which may have existed between government regulators and private business (Pharma advocates) during the drugs’ approval process years ago. Is this the Erin Brockovich-like scandal waiting to break? Could be.

Whether or not a scandal exists or will be revealed, though, it still must be noted that doctors were the ones who were told by the FDA and the pharmaceutical companies that drugs like Oxycontin and other opioid-based painkillers were safe and effective for chronic pain. The addiction risk was significantly downplayed or underestimated by regulators and manufacturers. The drug companies unleashed a marketing and advertising juggernaut to persuade patients that the miracle pain drugs had at last arrived. That was then; this is now. And now that we know the drugs so frequently lead to addiction, we can change the advice and practice guidelines given to doctors, but we cannot hold them legally accountable for not knowing what the rest of us didn’t know, either – or what some people in the game may not have revealed – years ago.

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PAINKILLER LAW: Physician (and Physician’s Assistant), Heal Thyself

Recent Texas Medical Board actions bear mention just before the holidays, and are of particular interest to physicians’ assistants and their supervising MD’s or DO’s.  The TMB just handed down license revocation/suspension penalties against three PA’s and their supervisors, in cases of alleged “pill mills.”  Either the PA was accused of inappropriately prescribing, or the supervisor accused of inadequate supervision, or both.

Head into 2013 with the following tips in mind, if you work in a clinic or medical group that could, by virtue of its very existence, become a target of official inquiry:

For PA’s:

1)   Make sure your Delegated Services Agreement is up to snuff and up to date. Check with your state’s licensing authority as well as professional advocacy organizations or statewide trade groups to make sure the language of your DSA complies with the law of your state, and with federal law.

2)  DEA Number:  If you are authorized to write scrips, are you DEA-current?  Expiration dates can sneak up on you.  Whether you or the office staff keeps track of these matters, give it a year-end check just to be sure.

3)  Is your supervisor actually doing his or her job of reviewing your files at least as often as required by your state’s law?  In California, a supervising MD or DO is supposed to review all PA files every 7 days, especially when Schedule II – V prescriptions have been written.  If you don’t think your supervisor is in compliance, get on him or her to get with the program.  If they balk, weigh your options and always err on the side of staying in compliance with the law, whether it’s at that clinic/office, or another one.

For Supervising MD’s/DO’s:

1.   Don’t fall short in checking charts regularly and thoroughly.  If you are not in compliance with this basic requirement of PA supervision, achieve and maintain compliance immediately in order to (a) ensure patient safety, (b) be a helpful and responsible employer who invests in your employees, and (c) take an easy “find” away from investigators should you come under official scrutiny.

2.   Chart it, chart it, chart it.  Make sure charts are up to date with any advice/feedback/correction given to a PA by you upon chart review.  Again, patient safety will be enhanced, and regulators and investigators will see your diligent efforts to comply and properly supervise.

3.   Make sure your office’s and staff’s efforts and procedures for utilizing your state’s Prescription Drug Monitoring Program are current, understood and practiced every day.  You can’t catch every doctor shopper, and to be sure, PDMPs’ technology leave a lot to be desired, but you still need to do all you can.

4.    Create and nurture an environment of collaboration and communication with PA’s in your office, on all subjects of patient care but especially about Schedule II through V prescriptions.  A culture of candor and compliance is readily apparent to an inspector, investigator, regulator or law enforcement agent.  There are lots of ways to this, but it all starts with office culture, and that starts with you.

And with that, friends, Merry Christmas, happy holidays, happy new year to everyone, and PAINKILLER LAW will be back after January 1.

 

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PAINKILLER LAW: Fear and Self-Loathing in the Medical Academy

A recent article by Drs. Zachary Meisel and Jeanmarie Perrone, who teach at the University of Pennsylvania Medical School, asks whether “conscientious and well trained” doctors are to blame for prescription drug abuse. The authors say “yes.” That is, they say doctors are partially to blame, but the authors stay silent on why anyone else might be. That silence is damning, the good professors’ assessment is wrong, and their article is of great concern.

Not only is Rx abuse far too complex a problem to “blame” on any one constituency, but even more critically, it is always unsettling and even scary when one or two members of a profession presume to apologize on behalf of their colleagues nationwide for some perceived wrong. Today across the country we are seeing what the White House Drug Czar has called an “epidemic” of Rx abuse. We are also in response seeing a misplaced, hamfisted law enforcement approach to what is, in all but the most extreme cases, a public health problem. Federal and state law enforcement agencies will only be emboldened by an article whose glittering generalities
help legitimize the illegitimate and ill-advised belief that routinely going after doctors for alleged criminal conduct is the solution.

So are doctors to blame? In PAINKILLER LAW’s view, no, except in the most extreme cases. If a healthcare provider screens a patient carefully, does a thorough exam and makes an informed diagnosis, prescribes within the boundaries of established safety for an approved drug, counsels the patient on the possibility of addiction, monitors the patient conscientiously, verifies with any available prescription drug database, and uses his or her best judgment about how the patient is doing, what is the basis for a criminal charge against that doctor in the event of addiction or an overdose? Can the authors enlighten us, please, before asserting that good doctors are partly to blame?

Who else might be to “blame?” Patients themselves? That notion borders on blasphemy within the White House Drug Czar‘s Office; don’t be “blaming the victim,” the reasoning goes. What about Big Pharma? The drug companies marketed the pain-relieving powers of Oxy and its many opioid cousins back in the late 1980′s and early 1990′s. Were they wrong about the pain-relief qualities of the medications? Did they purposely understate the potentially addictive qualities of the drugs? What about medical schools and the philosophical and educational change that took place around the same time, so that med students would be trained to acknowledge and treat severe pain? Should we indict your school’s Academic Senate?

The point is, it’s too easy, suspiciously easy, to blame doctors, and that’s precisely what should make folks like Professors Meisel and Perrone think twice and choose their words carefully before they effectively if inadvertently bless today’s ill-conceived law enforcement priorities. Because if they’ve ever written a pain scrip themselves, they may have just made what an excitable cop or prosecutor might call a confession.

PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS. 213.293.3737 info@painkillerlaw.com

The Meister Law Offices

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PAINKILLER LAW: The Healthcare Provider’s Dilemma

Prescription for Addiction,” which ran in the Wall Street Journal this past weekend, is one of the most thorough, best researched and best written articles to date on the national issue of prescription painkiller abuse.  I urge you to read the article carefully.  Among its many astute observations, the article encapsulated what I call “The Healthcare Provider’s Dilemma,” when it wrote (in summary) that providers don’t always know when a patient is doctor-shopping for more pills, and pharmacies can’t “second guess” questionable prescriptions.  Let’s break this down in terms of what it means for a doctor, osteopath, physician’s assistant and pharmacist trying to practice ethically and comply with federal and state laws governing furnishing of Schedule II painkillers.

1.  MD’s, DO’s and PA’s:  The Journal got it right: Doctor-shopping doesn’t always jump out at even the most discerning practitioner.  A provider-client of mine was recently threatened by a patient who said she’d report him to the Medical Board if he refused to refill her scrip.  (Naturally, he refused.)  Short of such explicit behavior, though, are you supposed to know every time?  The law enforcement agencies whose marching orders are to “crack down” on so-called overprescribers think so.  This, even though everyone knows that state-run PDMP‘s (Prescription Drug Monitoring Programs) vary widely in their effectiveness, real-time availability of data, and pharmacy participation, so a database’s usefulness to a provider can be very limited.  Faced with a clever doctor-shopper who wants to play you, on the one hand, and a hungry federal agent who almost hopes you get duped into writing the scrip, on the other, how are you to handle this swirling turbine of danger?

2.  Pharmacists:  You as a pharmacist probably have more room than you know, when it comes to ensuring that you’re filling valid prescriptions from righteous providers for legitimate medical purposes.  Many states expressly tell pharmacists that “no” is an acceptable answer to a patient seeking what the pharmacist may think is an excessive dose, or overly frequent refills, or anything else the pharmacist thinks would compromise patient safety or professional ethics.  But there is a fine line between calling out a drug-seeking patient or a dirty doctor, and going hogwild turning away business in the name of a one-person crusade against prescription painkiller abuse.

How to handle The Provider’s Dilemma without losing your patience or your patients?  The Answer:  Be in compliance with the state and federal laws governing prescribing Schedule II painkillers.  There are some clear statements of law, and more often there are the more murky (and therefore more dangerous, in this environment) “guidelines” for writing scrips.  You need to know that law, or have it explained to you.  Then you need to incorporate a compliance program within your practice:  From patient intake and screening, to informed consent and periodic review, to regular exams, to diligent record keeping, to making use of whatever PDMP database is available – these and related steps, in much more detail, ensure your good and ethical practice of medicine, provision of legitimate healthcare, and they show objectively to an investigating agency that you are practicing appropriately and your patients are in safe hands.  Comply now, and be thankful later, for anyone can come under DEA or FDA or Medical Board scrutiny at any time.  You can’t help it if you’re placed under investigation, but there is a lot you can do to help guide the outcome, keep yourself out of trouble, and stay in business.

 

Call PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS today, at 213.293.3737, for a free consultation.  Or, write to us at info@painkillerlaw.com.  Remember:  An Apple A Day Keeps the Doctor Away, and Compliance Can Protect You From the D.E..A!

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PAINKILLER LAW: BEST PRACTICES FOR PRESCRIPTION DRUG MONITORING

The Pew Health Group has just released a report analyzing the features and effectiveness of individual states’ Prescription Drug Monitoring Programs, or PDMP‘s.  The report observes that while 45 out of 50 states in the U.S. have PDMP’s up and running, participation by healthcare providers and pharmacists in most states is optional, and funding and program effectiveness varies widely.  A good PDMP provides detailed information in as close to real-time as possible, to be utilized by providers, pharmacists, and others in spotting things like doctor-shopping, painkiller abuse, or drug-seeking behavior by patients.  It gives pharmacists and providers an accurate picture of a patient, and gives regulators a fuller picture of pharmacists and providers.  All healthcare providers and pharmacists should know what the recommended best practices are, in order to institute whatever they can at their own business.  That’s always a good way to (a) take good care of patients, and (b) demonstrate to law enforcement and regulators that you are doing everything you can to practice legally, safely and ethically.

Of note to MD’s, DO’s, PA’s and pharmacists should be that law enforcement, among others, can subscribe or be privy to information stored on a PDMP database.  Providers and pharmacists should maintain strict compliance with all applicable criminal and other laws governing prescribing and dispensing prescription painkillers.  Call Painkiller Law – the Meister Law Offices – at 213.293.3737 for a free consultation on complying with the law of prescription painkillers, and how to implement and maintain best practices in your business.  It’s good preventative medicine.

 

 

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