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: HEALER BEWARE — MEDICAL BOARDS’ 2013 WISH LIST

2012 has seen the nation’s Medical Boards come under relentless scrutiny for allegedly dropping the ball on regulating healthcare providers who write prescriptions for opioids and other potentially addictive drugs.  2013 will see the Boards react in full.  We all know that when a Medical Board gets hit with criticism by Legislator A or Media Outlet B, the Board reflexively lashes out at Doctor C.   For you as a healthcare provider to know how to protect yourself from biased and careless official investigation, you need to know what your regulatory overseer is thinking, and how you could be at risk no matter how ethically and safely you do your job.  Here’s what is on Medical Boards’ “wish lists” nationwide for 2013:

1)  Criminal investigations, in addition to administrative inquiries, for any patient overdose death.  An excellent recent LA Times article roundly criticized the California Medical Board for what the paper viewed as lax oversight of doctors who lose patients to prescription drug overdoses.  The Medical Board’s first reaction will be to raise the stakes by initiating a more clearly criminal inquiry against a healthcare provider when any patient fatality is even partly attributable to prescription drugs.  The Board is out to vindicate itself.  Providers who underestimate the Board’s desire for vindication are operating at their own peril.

2)  Tightening up communication between coroners’ offices and Medical Boards.  It’s good policy for coroners to immediately notify Medical Boards whenever a death is attributed even partly to prescription drugs.  The danger, though, is what Medical Boards will do with the information as new reporting requirements become operative.  In the hands of Medical Boards desperate to rebuild their tarnished reputations, this could easily become a 1-800-WHO TO TARGET NEXT hotline.  That’s not what these new reporting laws intend, but I’m confident it will be their effect.

 

3)  Finding criminal and administrative liability when a provider gives prescription drugs to an addict.   Wait a minute:  Isn’t it permissible under federal and state law to prescribe controlled substances to an addicted person?  Yes.  In fact, doesn’t the law of many states expressly prohibit discipline against healthcare providers who do this?  Yes again.  But in the recent LA Times article cited above, a Medical Board investigator said that a patient’s death was “the inevitable result” of giving narcotics to an addict.  That sounds like a new theory of liability to me.  Take it from a defense lawyer:  An incorrect interpretation of the law does not always stop police from acting.  Healer beware.

I will have more to say on these particular topics, as well as what I think 2013 will bring for the broader issue of prescription drug abuse.  For now, take heed and make sure you’re in compliance with all the federal and state laws governing prescription painkillers and other drugs.  Remember that PAINKILLER LAW is here to help you.

info@painkillerlaw.com              213.293.3737               Meister Law Offices

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PAINKILLER LAW: SEIZING OPPORTUNITY, CALIFORNIA LAWMAKER BOLDLY JUMPS ON BANDWAGON

This past Sunday, the LA Times ran a searing and exhaustively researched article on prescription drug abuse, called “Dying for Relief.” This past Monday, as is the fashion among legislators nationwide, a California lawmaker loudly reacted to the article and grabbed a headline of his own.

Ordinarily, a legislator’s jumping on the bandwagon after a big article runs in the paper isn’t news. But here it is, because in response to the national public health problem of prescription drug abuse, California State Senator Curren Price, Jr. is introducing legislation that targets healthcare providers for law enforcement action. A law enforcement approach to a public health problem typically scores political points and funds new multiagency task forces, while doing nothing to actually address the problem. And innocent people – here, legitimate healthcare providers writing legal prescriptions for approved drugs – get steamrolled in the name of public safety.

Price’s idea isn’t so outrageous: He wants coroner’s offices in California to automatically report patient deaths to the California Medical Board whenever a coroner concludes that prescription drugs caused or contributed to someone’s death.

But the devil will be in the details, because the Medical Board is under tremendous pressure to “crack down” or “do something” about Rx abuse and suspected corrupt healthcare providers. All this while California law doesn’t even define “overprescribing,” for example.

PAINKILLER LAW will be watching very closely for the language and implications of the Price bill. I’m concerned that whereas a coroner’s findings may be circumspect and sober, the Medical Board will eagerly grab the autopsy report and form a posse to go after the “bad guy.” Senator Price needs to be alert to the pressure the Board will put on him and his committee to give the Board too much latitude in investigating, accusing or proceeding against healthcare providers who’ve written prescriptions for potentially addictive drugs. The offense itself is not clearly defined, yet law enforcement will want broad discretion to target it. That’s putting the cart before the horse.

Contact PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS, for a free consultation. We want to help you verify, achieve and maintain compliance with the criminal laws of prescribing for Schedule II through V drugs.

213.293.3737 info@painkillerlaw.com Meister Law Offices

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