PURDUE PHARMA’S SUPER SECRET LIST OF RISKY PRESCRIBERS: YOU CAN’T SEE IT.

This past Sunday’s Los Angeles Times tells that Purdue Pharmaceuticals, manufacturer of Oxycontin, has for about a decade maintained a lengthy list of Oxy prescribers who in Purdue’s view potentially overprescribe or otherwise put patients at risk. Purdue won’t disclose the list, though, and doesn’t reveal the criteria for how it decides whether to share an occasional name with a medical board or the DEA. This is extremely troubling, and Purdue’s position raises several major legal and policy concerns:

1. Purdue’s being stingy about revealing names or the criteria for revealing names to law enforcement leaves the company’s motives suspect and prevents relevant government agencies from being alerted to possible overprescribing or patient risk.

2. The list has been maintained since 2002; Oxy has been on the market since 1996. The very existence of the list suggests that Purdue knows the addiction potential of the drug it for years has marketed as safe and generally non-addictive. Wouldn’t an overriding interest in competent medical practice, safe prescribing and patient safety compel the sharing of information between the manufacturer, doctors and regulators?

3. The company’s own partial list of “red flags” for signs of overprescribing or shady Rx practices — long patient lines, people nodding off in the waiting room (in the manner of heroin addicts’ being “on the nod”), cash transactions, and lots of young patients supposedly in excruciating and ceaseless pain — includes the same signs law enforcement looks for, too. Why not share this information?

4. If a doctor is on the list, and is prosecuted for prescribing-related criminal offenses, is the list now supposed to be relevant evidence of guilt?

5. If a doctor is not on the list, and is prosecuted for prescribing-related criminal offenses, is the absence of that doc’s name on the list now exculpatory evidence of innocence?

My guess is that the exposure of the list’s existence will prompt (a) prosecutors and investigators to start issuing subpoenas for the list; (b) defense attorneys like me to subpoena the list or otherwise make the list’s existence an issue in a medical provider’s defense; (c) legislation at the state or federal level, or the threat of legislation, to compel Purdue to share information with appropriate authorities; (d) Purdue’s worrying about civil liability for previously not disclosing the list.

I expect we’ll be hearing more about this issue in the future. In the meantime, medical providers and their insurers and malpractice defense lawyers should know what the signs of risky prescribing are, and know how to ameliorate patient risk and maximize the practice and the appearance of practice of competent, informed medicine.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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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: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS

For Medical Doctors, Doctors of Osteopathy, and Physician’s Assistants:

An Apple A Day Keeps the Doctor Away, and Compliance Can Protect You from the D.E.A.

If you are an MD, DO or PA, you worked very, very hard, for many, many years to earn your degree and license, and build your practice to success. You didn’t suffer through medical school or undertake grueling PA training in order to get indicted. So why let investigative priorities dictated by Washington politicians and bureaucrats, which translate into aggressive and sometimes reckless law enforcement activity, target you unfairly and threaten your life’s work?

It is a sad truth of healthcare practice today that providing patients with needed relief for severe, chronic or debilitating pain can be dangerous business. Dangerous because you have the D.E.A., the F.D.A., Medical Boards, state regulators and local law enforcement looking over your shoulder to see whether you are “prescribing without a legitimate medical purpose” or “practicing outside the accepted standards of medicine.” Who even knows what those vague statements mean in a given situation? Whose judgment should control – that of the healthcare professional, or of a federal agent without a day’s medical training?

As many questions as current law enforcement policy and practice beg, most healthcare practitioners are not prepared for the day when the D.E.A. shows up with a warrant, accusing them of being nothing more than highly educated drug dealers. Such heavy handed tactics – in use with alarming frequency across the country, and boasted of by law enforcement agencies – can rattle even the most ethical and seasoned practitioner.

Be ready. Be in compliance with the laws governing prescription of Schedule II painkillers and pain medication, and let the Meister Law Offices help. Do this before the door-knock, before the subpoena, before the administrative inspection, before the D.E.A. or its counterparts have made up their minds about you. You can’t necessarily stop the government from investigating you, but if you are in compliance with laws governing prescription of Schedule II painkillers and pain medication, you don’t need to stop anything. You need to prevail in the end, and the best chance you have is to be in compliance before the inquiry ever starts.

From patient intake to prescription practice, use of electronic databases to protect against doctor-shopping, from internal controls to ongoing government-sponsored training for you and your staff, we will tell you how you are in compliance, what areas might deserve additional attention, and how to maintain a compliant practice that serves your patients safely, ethically and properly within the meaning of the applicable criminal law.

Call the Meister Law Offices today at 213.293.3737 for a free consultation.

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PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS

From the Meister Law Offices:

Doubtless in the past several years the availability and prescription rates of pain medication such as Oxycontin and other opioid derivatives have increased dramatically. So-called “pill mills” do exist; there is likely diversion of Schedule II narcotics from manufacturers, and perhaps some pharmacies, to the black market and the street.
However, the link law enforcement is drawing between illegal activity, and the everyday legitimate professional activities of the nation’s healthcare providers, has not been established. Since the vast majority of our nation’s healthcare providers are legitimate, ethical, honest and upstanding, the link will not be established. But don’t expect that to stop the DEA or local multiagency task force from busting in on your waiting room and announcing a search warrant. There goes your practice, your reputation, and possibly your license and livelihood.

Don’t become the next sacrificial lamb in the government’s game of enforcement catch-up. Just because it’s trendy and easy to blame healthcare providers for the problem of prescription painkiller abuse, doesn’t mean you should let the government have its way in destroying everything you worked so hard to build.

The way to protect your patients, your employees, your practice and yourself is by finding out and knowing now, today, whether your practice is in compliance with applicable federal and state criminal laws governing prescription, dispensing, and distribution of Schedule II painkillers. If you are ever audited, or otherwise find yourself under investigative scrutiny, you’ll want to know that you’re ready, that your practice is in full compliance with the law, and that you’ve nothing to fear from governmental attention.

Contact the Meister Law Offices, 213.293.3737 for a free consultation, or email us at info@painkillerlaw.com.

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