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: When Crime’s All You Look For, You See Too Many Criminals

If you wake up every morning, strap on a badge and gun and go fight the War on Drugs, you come to view the world in a certain way. If your goal for each workday is to go in peace and not come back in pieces, your perspective on society, people, crime and your role in combating evil are invariably shaped by your experience. That’s why it’s a mistake for the DEA to bring its ordinary approach against drug crime to the issue of prescription drug abuse. But that is just what the agency is doing. It is basically treating like a criminal any healthcare professional who shows up on its radar.

At the recent joint conference sponsored by the California Medical Board and Board of Pharmacy, I heard the DEA speak about rampant drug diversion, pharmacists’ widespread complicity in prescription drug abuse, doctors wantonly prescribing outside the standard of care, drug dealers in white coats, and the DEA’s determination to crack down. The problem is, no one can quantify the degree of “complicity” by the nation’s pharmacists, or durably judge when a provider is prescribing outside the standard of care. The DEA says it’s happening, and its agents are the ones with the guns, and so, well, it must be happening.

The sense of things that I had coming into the conference was unfortunately not at all changed by what I heard there. The DEA’s talk was dominated by war stories of pharmaceutical distributors selling Oxy out the back door, of pharmacists ordering more than they need and keeping lousy records of where it all went, of doctors making megabucks writing scrips for no reason, and patients visiting websites devoted to the celebration of hallucinogens. Seriously, that’s what the speaker talked about. That’s clearly not the entire scope of the issue, and those characterizations don’t fairly define all medical providers or pharmacists or patients. None the less, the DEA is bringing its habitual mindset to a new class of cases and investigations – and a new “target” population – and that’s the wrong approach.

Clearly, the DEA is in reaction mode, just as Medical Boards nationwide are, and it’s being blamed for missing the early signs of what became a prescription drug abuse crisis. In reaction to the blame, the DEA is redirecting the pressure onto doctors, pharmacists and others who the DEA thinks are responsible for whatever the agency is supposed to be trying to stop. And what exactly is to be stopped? Who should decide whether a patient needs the drugs he or she is given: The prescriber, or the federal agent? If a doctor prescribes a lot of pills to a lot of patients, does it mean he or she is operating a pill mill? If a pharmacist fills prescriptions, is the pharmacist automatically part of the problem? And if the meaning of “outside the standard of care” can’t even be succinctly articulated in the law, how are law enforcement agents to know where the line is, BEFORE they decide a practitioner or pharmacist is dirty?

These are the questions all of us must vigilantly continue asking, persistently and if need be peskily, in this latest iteration of the War on Drugs. There is no easy answer, no matter what the DEA might think.

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PAINKILLER LAW: FDA and I Call For Abuse-Deterrent Drug Agents

The FDA today called upon pharmaceutical researchers to develop formulations of opioids that would bring pain relief while reducing the possibility of addiction. The FDA refers to “abuse-deterrent” drug agents in the chemical sense. I join the FDA in calling for abuse-deterrent drug agents, only the kind of agents I’m talking about wear badges, drive fast in unmarked cars, and show up heavily armed.

The FDA should be commended for its balanced approach, in which it seeks both the development of less addictive drugs, and the need to get real pain relief to patients. What concerns me is that in investigating healthcare providers who write Schedule II-V prescriptions, typically law enforcement agents including the DEA and state Medical Boards emphasize “case clearing” over balance, hard and fast over nuance, and black and white over shades of gray. Whereas the FDA’s January 9 statement expresses its extreme concern “about the inappropriate use of prescription opioids,” the FDA doesn’t define “inappropriate.” Left to the determination of the DEA, which has been accused of being late to the party on addressing prescription drug abuse, and left to state Medical Boards, which have been accused of bailing on the party altogether, the definition of “inappropriate” could be bent, twisted, contorted, and most dangerously, broadened to encompass practices and procedures which a better informed or more detached observer would never contemplate. But when the warrant is signed or the cuffs slapped on, it’s too late for a healthcare provider to say, “Let’s slow down, back up, look at this from the beginning, and then discuss.”

That is why every healthcare provider, risk manager, medical group manager and professional needs to know the black-letter federal and state law of Schedule II-V prescriptions, and the nuances and subtleties of how the law is interpreted, what influences and impacts the agencies charged with “cracking down” on supposedly corrupt providers, and what you can do now, today, to ensure patient safety and the protection of your practice. This is why PAINKILLER LAW exists. Don’t let yourself fall victim to the subjective and loosey-goosey way law enforcement agencies and Medical Boards are defining “inappropriate,” “overprescribing,” “gross negligence,” or other concepts whose interpretation could be fraught with peril for even the most honest and ethical MD, osteopath, or physician’s assistant. Let us help you verify, achieve and maintain full compliance with the laws that well-intentioned but hopelessly biased drug agents are ever more aggressively attempting to enforce.

PAINKILLER LAW – It’s good preventative medicine.

info@painkillerlaw.com 213.293.3737 MEISTER LAW OFFICES

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PAINKILLER LAW: The Provider’s Dilemma, Part Two

Healthcare providers writing legitimate prescriptions for pain medication today swim in shark-infested waters.  Every provider needs to protect herself or  himself from the crusading law enforcement agencies that presently are happy to shoot first and ask questions later in the new effort to “crack down on” or “do something about” prescription opioid abuse.  In previous posts I have coined the phrase, “The Provider’s Dilemma,” to describe the conflict faced by physicians, osteopaths and physician’s assistants in prescribing Schedule II through V medication for patients with severe, chronic or debilitating pain, on the one hand, and providers’ being subjected to unwarranted or impulsive administrative or criminal scrutiny for prescribing pain medication, on the other.  Today I elaborate on The Provider’s Dilemma, with special attention to two news releases which, ironically, came out within hours of one another.

The first release was from Virginia Commonwealth University’s Spine Center, which in a recent study found that long-term intrathecal opioid treatment can be beneficial for pain management and reduction.  The study cited concerns about tolerance, absence of relief, or development of dependency which can occur with patients taking oral opioids, but the study did nothing to undermine or debunk the notion that these drugs can bring much needed relief to patients suffering from real pain.  The science continues to be in line with patient-care policy in states like California, and with the instructional and philosophical approach taught in the nation’s medical schools for the past few decades:  That good medicine includes treating pain patients in need.

But then, in the second news release, the White House Office of National Drug Control Policy (“ONDCP”) boasted of the recent summit it had with a dozen or so other federal agencies, including the Justice Department, on the Office’s #1 priority:  Fighting what it once again called the “Prescription Drug Abuse Epidemic.”  Just the issuance of this release by the ONDCP should be enough to give pause even to the most scrupulous and conservative healthcare practitioner, mid-signature on the prescription pad.  This is because the awesome power of the White House, the D.E.A, and the rest of the federal government is today arrayed and ready for what the government considers the latest iteration of the War on Drugs.  Only this time, they’re pursuing healthcare providers instead of cartel kingpins, and the scourge they’re deploying against is for legitimate and lawful prescriptions, not street drugs.

What should you do?  On the one hand, the people who tell you it’s still OK to use your best medical judgment in writing painkiller prescriptions carry the wise words of Hippocrates.  But the people on the other side of the issue carry badges and guns, and the blessing of federal, state and local government to come after you if in the “considered” opinion of a prosecutor or cop with not one day’s medical training, you’ve crossed the line in prescribing opioids for pain.

What are your options?  You can stop writing prescriptions for any opioid painkiller and hope for the best, not only for yourself but for your patients whose medical needs you may end up neglecting.  Or, you can carefully and thoroughly incorporate best practices into how you assess, diagnose, treat and monitor anyone who needs pain relief, and be in compliance with federal and state criminal laws about writing for these medications.

That is where Painkiller Law: Criminal Law Compliance for Healthcare Providers comes in.  Painkiller Law is a comprehensive legal service offered by the Meister Law Offices.  We provide a top-to-bottom review of your practice to enable you to verify, achieve and maintain compliance with applicable laws, incorporate best practices into all you and your staff do, know where the red flags might be, and stand with you if you ever find yourself under investigation.  In the current enforcement environment, you cannot control whether the D.E.A. or F.D.A., or your state’s Medical Board, start looking at you.  You do not, however, need to be at their mercy.  Be in compliance, be ready, and thereby be best positioned to prevail.

Call Painkiller Law today for a free consultation, at 213.293.3737, or email info@painkillerlaw.com

 

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PAINKILLER LAW: DRUG CZAR SAYS SCRIP ABUSE STILL AN EPIDEMIC

The White House Drug Czar today released a report lauding what the WH a decrease in prescription painkiller abuse.  But he quickly added that in the view of the federal government, prescription painkiller abuse is still at “epidemic” levels and that enforcement against it will continue.

What does this mean for you as a healthcare provider?  It means everything the Feds and state and local authorities are doing now will continue.  From document requests, to prescription rate monitoring via database and by anecdotal and other evidence, to sting operations of suspected corrupt practitioners, current efforts will not abate.  What if you are, like most practitioners, ethical and not corrupt?  You need to be vigilant in your efforts to comply with the federal and state criminal laws regulating the prescription of Schedule II painkillers.  From patient intake to prescription monitoring to informed consent to treatment review, to knowing that “FDA” recommendations morph into “requirements” if they find you out of compliance, you need to protect yourself and your practice.  Remember:  While the world’s greatest neurosurgeon can get inside a DEA agent’s brain to operate, the doctor still won’t know what the agent is thinking, or how certain things in an office or on a prescription monitoring list look from the standpoint of law enforcement.  Be careful; be prepared; be in compliance.

Painkiller Law: Criminal Law Compliance for Healthcare Providers, is a service of the Meister Law Offices and can help you verify, achieve and maintain compliance with the criminal law of prescribing Schedule II pain medication.  Call us at 213.293.3737 for a free consultation, or email us at info@painkillerlaw.com.  Don’t become the Drug Czar’s next poster child.

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