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: 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: 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.

 

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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.

 

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PAINKILLER LAW: New Drug Control Policy; Caution Urged for Prescription Painkiller Providers

Prevention and treatment of drug abuse are the new watchwords of today’s newly released National Drug Control Strategy, published by the White House’s Office of National Drug Control Policy (ONDCP).  While the government wants to find a workable balance between what it calls the “enforcement-centric war on drugs and the extreme position of legalization,” the MD’s, DO’s and PA’s who write prescriptions for painkillers should only expect continued and increasing government scrutiny.

I say this because the ONDCP’s emphasis on prevention and treatment is directed at the user, not the person who provides the drug to the user.  And while the ONDCP discussion largely focuses on the market for illicit drugs such as cocaine and methamphetamine, the government continually talks of the perceived epidemic of prescription painkiller abuse.  The focus of government agencies like the FDA, DEA, state Medical Boards and local law enforcement is on doctors and physician’s assistants who write prescriptions for controlled substances.  Just today, in fact, the DEA raided (for the second time in several months) a Jupiter, FL Walgreens distribution center, on the theory that Walgreens may be diverting or at least failing to keep track of mass quantities of oxydocone and other opioid derivatives.  Walgreens maintains it is cooperating with federal authorities in the matter.

The lesson from these two stories is that while the end-user, in your case the patient, may benefit from the White House’s new policy imperatives, the healthcare provider writing the Schedule II painkiller prescription will continue to be under the government’s watchful eye.  Now more than at any time in memory, provider compliance with federal and state criminal laws governing the prescription and dispensing of prescription painkillers is critical to the survival of any medical practice.  The range and depth of laws to comply with is formidable, and obtaining competent and thorough legal advice on the matter is highly advisable.

Contact PAINKILLER LAW – the Meister Law Offices – at 213.293.3737 for a free consultation about Criminal Law Compliance for Healthcare Providers.  Or, email us at info@painkillerlaw.com

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