PAINKILLER LAW BLOG: Fear, Dread and a Warm Welcome – Here Comes Zohydro

How can a drug about to hit the market be feared, dreaded, welcomed and deemed medically necessary, all at the same time? It’s complicated, so if the new “super painkiller” Zohydro had human feelings, it would definitely be in the midst of an identity crisis. In this post I’ll talk about the Zohydro kerfuffle, and why it’s more proof that in most cases, “blame” for prescription drug addiction lies with the drugs themselves, not the doctors who’ve prescribed them.

First, what is a “kerfuffle?” It’s a brouhaha. Commotion. Turmoil. Uproar. Hubbub. I learned the word from The Onion. Second, why the kerfuffle over Zohydro? Because Zohydro, a new opioid painkiller approved by the FDA and slated for market entry soon, is ten times more powerful than Oxycontin or Vicodin, and it contains no abuse-deterrent formulations. This has policymakers and even some medical societies worried that the drug will – well, how to say it gently? – kill or injure a lot of people who will be using it. Though the drug is slated to be used as a painkiller of last resort for patients who cannot get relief from other medication, its potency and its emergence on the market in an era of high rates of addiction, overdose and death from opioid painkillers are indeed cause for concern.

Last year, an FDA panel opposed approving Zohydro; the FDA itself then went against its panel’s recommendation and green-lighted the drug. The drug’s approval has been the subject of controversy ever since, and this week U.S. Senator Charles Schumer (D – N.Y.) asked the Dept. of Health and Human Services to reverse the FDA’s decision. Good luck, Chuck; the Congressmen from Big Pharma likely have a different view.

The controversy swirling around Zohydro got me thinking about doctors who prescribe opioid painkillers, and of law enforcement efforts to “do something” about the prescription drug crisis. To me, at the core of the Zohydro debate is the widespread belief that the drug’s mere availability will further aggravate an already serious public health problem. Is the worry that doctors, however cautiously, may be prescribing it? Or is it that Zohydro will exist at all? My answer is that people are worried about Zohydro’s very existence. To date, media reports haven’t much discussed the role doctors may play in prescribing the drug; reports instead have focused on how Zohydro’s very presence in the market will automatically impact the prescription drug crisis.

Isn’t this a powerful indicator that the problem could be the drug itself? After all, doctors would be directed to follow protocols, guidelines, safety measures and other steps in assessing patients’ eligibility and need for the drug, its effectiveness, and any problems that might arise in treatment. If that part of the discussion is so irrelevant in the minds of Zohydro critics, then doesn’t it stand to reason that doctors ordinarily aren’t the problem? Yes, it does, in case you’re on the fence about that one. I have long believed that in all but the extraordinary, outlier case, prescribers aren’t the problem so much as the drugs they’re prescribing are. The Zohydro kerfuffle is but one more piece of evidence that aggressively targeting legitimate doctors is the wrong way to go, especially when the same law enforcement agents who self-righteously kick in office doors and hold slanderous press conferences refuse to look past their own noses for the real roots of the problem.

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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: Yet More Evidence That the Drug is the Problem

Yet more evidence has emerged that long-acting extended release opioids for chronic pain should never have been marketed as safe, effective and generally non-addictive. To avoid criminal liability, malpractice suits or Medical Board actions, medical providers who prescribe opioids for their patients have to change with the changing science. To ignore the changing science – major developments emerge pretty much weekly now – is to risk imperiling patients with outdated information, and to consequently put your liberty and livelihood in great danger. If you’re out of the loop on information that could save your patients’ lives, when you had the chance to come up to speed and you ignored or passed on the opportunity, imagine how easy you’ll have made it for the DEA, or your licensing board, to nab you. I’ve said this before, and I say it again because there’s more important news to share about this.

Here’s what we know so far:

-The Centers for Disease Control believe that too many doctors are prescribing too many opioids to too many patients;

-The AMA concurs, to the great disappointment of pharmaceutical manufacturers;

-The FDA has ordered new labeling for long-acting extended release opioids to better warn providers and patients of the dangers of addiction and abuse;

-Johns Hopkins Medical School has concluded that even though opioid prescriptions have skyrocketed, fewer patients are actually experiencing pain relief.

And now, Exhibit 5: The National Pain Report on September 23, 2013 says that “a drug increasingly being used to treat opioid addiction may be fueling a new epidemic of diversion, overdose, addiction and death in the U.S.” The article talks about buprenorphine, known by its brand name, Suboxone, and how it is not only being prescribed by some doctors who don’t know what they’re doing, but that it’s also being sold on the street by heroin dealers because it reportedly softens any withdrawal symptoms between doses or highs.

And still, pharmaceutical manufacturers would have patients and physicians believe that the problem is not with the drugs themselves. Instead we see the same old acronyms like “the 5 R’s, or “S.A.F.E. N.A.R.C.” or other catchy phrases that do what they can, but which ultimately miss the point, in favor of the idea that the patient and the doctor can be in complete control in any prescribing or treatment scenario. Patients and doctors can’t be, because the drugs are too powerful. The nation’s prescription drug abuse epidemic and the weekly scientific bombshells prove this.

So what to do, if you are a medical provider? First, if you’re not in pain management, don’t get into it unless you are Board certified and fully trained by a body other than a self-interested, profit-motivated provider advocacy group. Such groups will sell you on taking the easy way, and that will ultimately disserve your patients and you. Second, if you already have a pain management practice, read and incorporate all the new scientific data into your practice without delay, so that you can show any law enforcement investigators that when the science changed, you changed with it. And third, even though the current assessment, treatment, monitoring and other compliance/patient safety tools are valid and should continue to be utilized, know that they’re increasingly being revealed as inadequate. They are no match for the immense power of the drugs they seek to keep in check. So relying on them alone will, as the science continues to advance, leave you high and dry when it comes to defending yourself against criminal, malpractice, or Medical Board scrutiny.

info@painkillerlaw.com MEISTER LAW OFFICES 213.293.3737

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PAINKILLER LAW: D.E.A. WINS TODAY; PATIENTS WILL LOSE TOMORROW

The FDA today concluded its highly watched two-day meeting on prescription drug abuse, notably – and erroneously, in PAINKILLER LAW’s opinion – endorsing a hardline proposal from the D.E.A. If the D.E.A. gets its way, and hydrocodone is reclassified as a Schedule II drug, patients will lose, and access to needed medication will be callously impeded.

The D.E.A has been pushing for this change, and the FDA panel by a close vote of 19 to 10 may be mistakenly coming around to the the D.E.A.’s position. Advocating similar change is a prominent doctors’ group, Physicians for Responsible Opioid Prescribing (PROP). But the coincidental joining of these two forces – cops and docs – doesn’t make the idea any more credible. This proposal if implemented could rigidly and with unreasonable orthodoxy deny thousands of legitimate pain patients access to the medicine they need. PROP and the D.E.A. in this instance seem to trust no one but themselves to decide for everyone else what medicine should be taken and for how long.

A direct and intended consequence of the D.E.A. proposal is that only MD’s could prescribe even Vicodin from now on. That means if you had dental surgery coming up, and your dentist told you it was going to be a tough recovery, he or she wouldn’t be able to give you even a few days’ worth of Vicodin for head-splitting midnight pain. You’d have to get that from your MD, after the pain was already knocking you over, or you’d have to get to the E.R. in the middle of the night to seek some relief. Why must the D.E.A. presume that ordinary citizens can’t be trusted to not become addicted to opioids even though they’re only given a three-day dose for acute pain?

This also means that if you see a physician’s assistant for your medical care, that person would no longer be able to write for certain pain medications, at all, ever. Is that reasonable? Is the D.E.A. making a competency judgment about licensed professionals? Is the agency dismissing the state legislatures and medical boards that have determined the legitimacy and licensing standards for PA’s in every state in the Union? Does the D.E.A. not care that frequently, PA’s serve patients in medically underserved communities? Did the D.E.A. not get the memo: That legislative support for PA practice often stems from the precise policy goal of getting qualified healthcare providers to those communities who need them most but have them least?

The best course is for the FDA to reject the D.E.A’s proposal. Expect the D.E.A., possibly PROP, and others to in good faith continue to pursue ultimately unsound idea. And remember that no amount of good intentions makes a bad idea better.

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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 Healthcare Provider’s Dilemma

Prescription for Addiction,” which ran in the Wall Street Journal this past weekend, is one of the most thorough, best researched and best written articles to date on the national issue of prescription painkiller abuse.  I urge you to read the article carefully.  Among its many astute observations, the article encapsulated what I call “The Healthcare Provider’s Dilemma,” when it wrote (in summary) that providers don’t always know when a patient is doctor-shopping for more pills, and pharmacies can’t “second guess” questionable prescriptions.  Let’s break this down in terms of what it means for a doctor, osteopath, physician’s assistant and pharmacist trying to practice ethically and comply with federal and state laws governing furnishing of Schedule II painkillers.

1.  MD’s, DO’s and PA’s:  The Journal got it right: Doctor-shopping doesn’t always jump out at even the most discerning practitioner.  A provider-client of mine was recently threatened by a patient who said she’d report him to the Medical Board if he refused to refill her scrip.  (Naturally, he refused.)  Short of such explicit behavior, though, are you supposed to know every time?  The law enforcement agencies whose marching orders are to “crack down” on so-called overprescribers think so.  This, even though everyone knows that state-run PDMP‘s (Prescription Drug Monitoring Programs) vary widely in their effectiveness, real-time availability of data, and pharmacy participation, so a database’s usefulness to a provider can be very limited.  Faced with a clever doctor-shopper who wants to play you, on the one hand, and a hungry federal agent who almost hopes you get duped into writing the scrip, on the other, how are you to handle this swirling turbine of danger?

2.  Pharmacists:  You as a pharmacist probably have more room than you know, when it comes to ensuring that you’re filling valid prescriptions from righteous providers for legitimate medical purposes.  Many states expressly tell pharmacists that “no” is an acceptable answer to a patient seeking what the pharmacist may think is an excessive dose, or overly frequent refills, or anything else the pharmacist thinks would compromise patient safety or professional ethics.  But there is a fine line between calling out a drug-seeking patient or a dirty doctor, and going hogwild turning away business in the name of a one-person crusade against prescription painkiller abuse.

How to handle The Provider’s Dilemma without losing your patience or your patients?  The Answer:  Be in compliance with the state and federal laws governing prescribing Schedule II painkillers.  There are some clear statements of law, and more often there are the more murky (and therefore more dangerous, in this environment) “guidelines” for writing scrips.  You need to know that law, or have it explained to you.  Then you need to incorporate a compliance program within your practice:  From patient intake and screening, to informed consent and periodic review, to regular exams, to diligent record keeping, to making use of whatever PDMP database is available – these and related steps, in much more detail, ensure your good and ethical practice of medicine, provision of legitimate healthcare, and they show objectively to an investigating agency that you are practicing appropriately and your patients are in safe hands.  Comply now, and be thankful later, for anyone can come under DEA or FDA or Medical Board scrutiny at any time.  You can’t help it if you’re placed under investigation, but there is a lot you can do to help guide the outcome, keep yourself out of trouble, and stay in business.

 

Call PAINKILLER LAW: CRIMINAL LAW COMPLIANCE FOR HEALTHCARE PROVIDERS today, at 213.293.3737, for a free consultation.  Or, write to us at info@painkillerlaw.com.  Remember:  An Apple A Day Keeps the Doctor Away, and Compliance Can Protect You From the D.E..A!

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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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