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.

Read More

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.

Read More

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

Read More

PAINKILLER LAW: ONDCP TO OFFER ONLINE TRAINING IN GUIDELINES FOR WRITING PAIN Rx’S

The National Office of Drug Control Policy has announced that it will offer online training to healthcare providers, medical students and interns, and medical schools about the guidelines providers should follow in deciding whether to prescribe or refill Schedule II painkillers.  This is good news.

To be effective and useful for providers, the guidelines must have a real-world orientation, not some high-minded but utterly unrealistic set of goals providers should strive to achieve.  I strongly urge providers to incorporate study of these guidelines into their practices immediately, as a proactive means of complying with federal and state criminal laws governing the prescription of Schedule II painkillers.  This is because, as the Painkillerlaw Blog has talked about before, there are both written and unwritten guidelines and criteria that the federal and state government law enforcement agencies investigating overdoses and healthcare providers follow.  The more the government has put in writing about what you as a provider should do or pay attention to in this area of your practice, the better prepared you will be not only to care for your patients, but to defend against government scrutiny in the event you find yourself the subject of an official probe, say if a patient of yours overdoses on painkillers you prescribed.  The more you can show a government investigator you are aware of the guidelines, and you follow them every day, the better the chances that you will not be unfairly blamed for a tragedy which might befall a patient but for which you should not bear legal or professional responsibility.

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 written, unwritten, clear, unclear, mandatory and discretionary enforcement guidelines and criteria in place nationwide and governing prescription of Schedule II painkillers.  Call us today for a free consultation at 213.293.3737, or email us at info@painkillerlaw.com.

 

Read More

PAINKILLER LAW: THE NEW “BLAME GAME” IN Rx ABUSE

Did you as a medical doctor, osteopath, physician’s assistant or pharmacist know that YOU are to blame for Rx abuse nationwide?  The White House Office of National Drug Control Policy is placing new emphasis on treatment and prevention of Rx abuse and urging a new, more “compassionate” model be adopted when it comes to how patients abusing prescription painkillers should be approached.  But blame for Rx abuse has to be placed somewhere.  And so it has been placed on healthcare providers who write painkiller prescriptions, and the pharmacists who fill them.

Look no further than an article in Wednesday’s Wall Street Journal for proof.  The article, “Making the Pharmacy Crawl,” explains that patients in many states have to travel to several pharmacies to fill legitimate prescriptions, as a result of new laws’ making “doctors criminally liable and revok[ing] their licenses for writing prescriptions for painkillers that lead to overdoses.”  This, in combination with pharmacies’ being subject to stricter limits on how many opioids they can dispense in a given period, has led, says the article, to a reduction in the number of doctors writing prescriptions, and in pharmacies’ not being able to fill what even a legitimate patient with a legitimate scrip might need. Is this really helping people? Or is it placing doctors’ judgment under a microscope, allowing if not requiring scrutiny of medical judgment, by government agents with no medical training or experience?  Is it substituting pharmacists’ judgment, discretion and ethics for hard and fast marching orders from the DEA?  Is it going to do anything to crack down on what the government calls the prescription painkiller epidemic, or will it just make people’s lives harder, subject them to more unwanted bureaucracy, and punish ethical practitioners and legitimate patients along with a few corrupt practitioners and drug addicts?

Ham-fisted governmental action that creates unintended consequences for good and law-abiding people abound, especially in an environment like this where the government is basically feeling its way as it goes.  When government treats a public health problem as a law enforcement problem, there is going to be a lot of collateral damage behind every press release or high profile arrest.  Don’t be the collateral damage.  Protect yourself and your practice from governmental heavyhanded behavior, by being in compliance now with all applicable criminal laws about prescribing painkillers.  Compliance goes a long way; it makes for ethical and sound patient care; it gives you peace of mind that if you’re ever investigated you will be ready; it helps persuade law enforcement that you are practicing appropriately and properly; and it acts as a foundation for a defense if you ever need.

Call Painkiller Law, a service of the Meister Law Offices, today for a free consultation on how to verify, achieve and maintain criminal law compliance in writing prescriptions for pain medication.  It’s good preventative medicine.  213.293.3737, or write us at info@painkillerlaw.com.

 

Read More

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.

Read More