PAINKILLER LAW BLOG: Opioid Rx’ing Not Going Anywhere

A story just published by CNBC says Americans consume 80% of the world’s opioid prescriptions.  300 million prescriptions annually equals a $24 billion market for pharmaceutical companies, says the network.  The story also says that most other opioid consumption is in Canada and Western Europe.  This means that prescription painkillers, and the problems high prescribing rates have caused, are here to stay.

From the perspective of the person who needs these powerful medications to relieve chronic pain, the thriving prescription painkiller market is a welcome companion in daily life.  For pain patients, there sometimes is no reasonably or readily available alternative.  From the perspective of public health officials and policymakers, the size and resilience of the prescription painkiller market is a big and ongoing problem.

Caught in the middle, as they’ve been for years, are doctors who prescribe or are asked to prescribe opioid painkillers and similar narcotics.  How is a doctor supposed to know what to do for which patient, for how long, under what circumstances, for what reason, and with what qualifications and exceptions?  The answer lies in the law, more than it does in medicine.  That is to say, today law enforcement views medical judgment through the prism of legal tests.  A doctor’s medical judgment has to pass the legal test, for the doctor to remain out of criminal trouble, and remain safe from his or her Medical Board.  All the medical training, all the CME in the world won’t teach a physician about the law he or she must know.

There’s so much more to legal compliance in this area than reading and trying to follow a particular state’s prescribing guidelines.  The guidelines are just the beginning of the analysis, and many doctors haven’t even read the prescribing guidelines.  It is unfortunate that so many doctors are so overloaded with work, business affairs, trying to keep up with the data, and dealing with tons of bureaucratic paperwork and hassle just to get paid, that this critical area of physician training is going unattended.  It needn’t be this way.  There is a proven model for teaching doctors how to prescribe safely and legally.  This not only helps the physician, but it helps the patient, and it helps companies in the physician support business — malpractice insurance carriers, for example.

With the opioid market not about to pack up and leave town, doctors and those who support them need to know the law of narcotics prescribing, and be trained and assisted in achieving and maintaining full compliance.  The alternative, as we see from headlines every day, is the risk of physician criminal prosecution.

Meister Law Offices – founder of PAINKILLER LAW: Compliance and Defense for Healthcare Professionals.  213 293 3737.  steve@meisterlawoffices.com

 

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PAINKILLER LAW BLOG: Teaching Opioid Law to Doctors

I always say it in this blog:  To protect themselves and their patients, doctors have to know the law of controlled substance prescribing.  It is not enough to know some guidelines.  It’s not enough to go to medical school.  For a medical provider to make a dent in the prescription drug epidemic, and to be prepared to withstand a law enforcement investigation into their prescribing patterns, doctors must also know the law.

 

Two recent developments provide an opportunity for doctors to learn what they need to know.  First, approximately 60 medical schools around the U.S. have pledged to teach medical students about opioid and other narcotic prescribing.  While some critics see this as window dressing or lip service, I say good for the med schools for taking this on. The more med students learn about this phenomenon, which will invariably confront them in one way or another when they begin practice, the better.

 

Second, an important piece of the new federal effort, an authorization (as yet unfunded) for a $700 million opioid epidemic legislative response passed by Congress and signed by the President involves physician education. A recent article in The Atlantic magazine discusses this.  Specifically, physicians, says the legislation, need to be educated more broadly and in greater numbers about opioid and narcotic prescribing and how to help tackle the crisis.  If the education doctors will be receiving includes a close study of the legal landscape in this area, the course of study will hit all the points it needs to. If the legal curriculum is just recycled, vague gibberish from past D.E.A. trainings, it will be useless.  And if there’s no legal aspect at all to the training doctors will receive, my belief is that providers will be left unprotected, even as a new patient-protection demand is being placed on them.

The proof will be in the pudding, but at least there are steps which can potentially be taken in the right direction.

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PAINKILLER LAW BLOG: Keeping up with Marin

There are lots of things to like about Northern California’s beautiful Marin County.  First, my wife is from there.  Second, there’s great cycling, hiking on the county’s signature mountain, Tamalpais, or if you like swimming with baby great white sharks (no kidding), you can head to Stinson Beach.  Third, there’s San Quentin, the only state prison with a million dollar view of San Francisco.  Fourth, and the subject of today’s post, the county is home to RxSafe Marin, a local prescription drug task force which is educating doctors and saving lives.  It’s setting a standard other counties should follow.

In a time when statewide prescribing guidelines are not well or widely taught to physicians, and are used as more of a hammer than a teaching tool by the state’s Medical Board, and when the Centers for Disease Control delays releasing the closest thing to national opioid prescribing guidelines, because of lobbying pressure, Marin’s work at the county level is just what is needed.

A recent study shows that since Rx Safe Marin formed, opioid related deaths in the county have dropped significantly within a year.  The prescription drug problem still exists in the county, and in every county in California and the nation – Marin officials use the words “scourge,” “epidemic” and “crisis” to describe it – and the problem won’t ever be completely solved.  But a big drop in death rates means, well, it means fewer people receiving prescriptions from their genuinely well-intentioned doctors are dying.  Martha Stewart would call this “a good thing,” if Martha Stewart talked more about Oxycontin.

RxSafe Marin, comprised of health officials, electeds, law enforcement, public defenders, social workers and others, developed guidelines for opioid prescribers within the county.  The guidelines didn’t reinvent the wheel – at their core, they call for lower doses to be prescribed, and for doctors to check online databases to help ensure patients aren’t doctor shopping.  And according to recent statistics, it’s working.  What are the lessons we can learn from this?

The first lesson is that opioid prescribing guidelines only work when they’re widely taught to doctors, and just as widely followed.  RxSafe Marin puts something on paper, talks about it in the medical community, and has “action teams” to try and implement and spread the gospel of the medical-legal framework it has developed.  The second lesson is that local efforts can quickly get more done, and more effectively, than at the state or federal level.  The Medical Board of California is too bureaucratic, too unwieldy, and too afraid of assuming liability or having insufficient enforcement flexibility, to be clear with doctors about what should and should not be done.  In the absence of state leadership in responsible physician education, a county has taken the initiative and filled vacuum.  And third, local guidelines offer new protection for doctors who take the time to learn and implement them.  In practice, a doctor who takes advantage of a new educational opportunity, and who utilizes this new tool in her work, is declaring to all who’d ask that she knows the science, carefully decides whether to prescribe opioids for chronic pain, and voluntarily and consistently advances what the local medical community views as the safest and best way to treat patients in pain.

The flipside, of course, is that if you’re a doctor in a community such as Marin, who doesn’t know what RxSafe Marin is, or who otherwise doesn’t practice well within available prescribing guidelines, you’re running an added risk of being arrested and prosecuted for drug crimes.  With everybody else on notice that there’s a problem that the county is trying to address, what’s your excuse for not knowing about it and not doing anything about it?  I’ve heard DEA agents, detectives and prosecutors say that many, many times about the doctors they arrest and throw into criminal court.  From the patient safety and medical practice perspective, programs like RxSafe Marin are great, and they offer support for doctors to meet the legal test of medical judgment.  Doctors who don’t make the most of the opportunity are taking a huge risk, and running out of excuses.

 

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PAINKILLER LAW BLOG: FDA’s Best Bad Idea

The FDA recently announced a new “action plan” to deal with the nation’s public health crisis of opioid addiction, overdose and death.  Given that the FDA endorsed dubious science put forth by the pharmaceutical industry in initially blessing opioid prescribing for chronic pain, there are those who’d commend the FDA for its ongoing efforts to deal with the unexpected and deadly epidemic.  To others, however, the FDA’s latest attempt to do something recalls a great line from the Oscar-winning movie ARGO, where a lead CIA analyst tells his very skeptical boss that the plan to evacuate captive Americans from revolutionary Tehran by having them pose as a Canadian film crew is “the best bad idea we have, by far.”

According to its website, The FDA will (1) form new advisory committees to work alongside the committees already formed; (2) require new product warnings on opioid prescription labels; (3) mandate the generation of new data by drug manufacturers on the long term impact of extended release/long acting opioids; and, (4) train more prescribers on pain management and safe prescribing.  The first elements of the plan sound like more bureaucracy and over-reliance on opioid manufacturers to self-police and self-disclose.  The fourth element, however — educating more prescribers on pain management and safe prescribing — is well conceived and absolutely necessary.  Too many doctors, with the endorsement of the FDA, the Federation of State Medical Boards, and the gleeful good wishes of Big Pharma, got into pain management without knowing what they were doing.  Well intentioned physicians got way in over their heads, and still are.  Educating physicians in pain management and safe prescribing is the very least the FDA can now do.

To be what a prescriber really needs, physician education can’t just consist of seminars where everyone gets a copy of his or her state’s opioid prescribing guidelines, and a warning from the DEA speaker on the dais that from now on, things had better be right with one’s prescribing.  Instead, proper prescriber education starts with the guidelines, but doesn’t stop there.  Physicians must be educated that prescribing guidelines are a legal test of a doctor’s medical judgment, and that if law enforcement perceives guideline noncompliance, criminal liability can quickly follow.  Criminal liability, as in prosecution of a doctor for unsafe prescribing and more.

The FDA would do well to include this critical legal-medical component in its education program.  Physicians should demand nothing less.  That way, the FDA’s “best bad idea” would actually bring some good to patient safety and the profession.

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PAINKILLER LAW BLOG: “Meds Not Working? Good, Have Some More.”

A new study cited in the journal Pain Medicine shows that pain patients not prescribed opioids experience lower disability and higher physical function than those prescribed opioids, and that patients receiving opioids do not necessarily show improvement in physical function. In broad terms, the study is another in a growing series questioning the efficacy of opioids for chronic pain. Doctors who prescribe opioids and whose patients don’t show improved function are potentially violating state prescribing guidelines, and risking criminal prosecution for unsafe prescribing.

 

Of course, the study doesn’t find that every patient suffering pain but not prescribed opioids gets better, faster. We know that some pain patients don’t need opioids, for instance, and that those patients may show improvement more quickly because their underlying medical condition is less severe, or more amenable to non-narcotic medical treatment. Further, some patients receiving opioids do show improvement in physical function, which is great.   But with successive studies, or at least those not sponsored by the pharmaceutical industry, there is an accumulating body of evidence fundamentally questioning whether opioids are safe and effective. The answer so far, according to no less than the CDC in its proposed prescribing guidelines, is that opioids can be very easily addictive, and they often don’t work.

 

This doesn’t mean every doctor prescribing these controlled drugs should never write another chronic pain patient’s prescription, or turn patients to the street, or close a practice’s doors, or hang up the medical license and open a coin laundromat.   It means instead that when a state’s prescribing guidelines say something like, “Don’t keep prescribing if your patient shows insufficient improvement in physical function,” a doctor should not routinely and without one heck of a good written explanation write refill after refill, or increase a dose or summarily change to a more powerful painkiller. To blithely up a dose or switch to a bigger drug is to violate the prescribing guidelines in place in almost every state in the nation. And, to have medical records devoid of detailed evaluation and decision-making about each patient is to expose one’s self to criminal prosecution. I’ve seen it so many times in my criminal defense practice: Authorities from Medical Board investigators to sheriff’s detectives to DEA agents to prosecutors seize charts, run prescription monitoring reports, see no evidence of a doctor’s decisionmaking in the chart, and equate poor recordkeeping with pill-mill, assembly line moneymaking devoid of medical judgment and patient safety.

 

Of course, some doctors keeping poor records while prescribing to hundreds of pain patients ARE committing crimes. But in the majority of cases, doctors merely do not know their state’s guidelines well enough to realize that a patient’s improved physical function is a key LEGAL TEST of whether a certain medical treatment should continue. Read that again. A patient’s improved physical function is a key LEGAL TEST of whether a certain medical treatment should continue. Proper pain management practice today involves a careful combination of medical judgment and legal compliance.   Neglect just one, and you risk being prosecuted. Neglect both, and you virtually guarantee it.   Careful practice, good judgment, and thorough recordkeeping help build a viable defense if you are ever under criminal investigation or in the crosshairs of an eager prosecutor.   Get competent legal advice before trouble hits, and you’ll be better off.

 

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PAINKILLER LAW BLOG POST: A Medical Dilemma Like No Other

Happy new year!  I hope your holidays were great and that 2016 holds all good things in store for you and those you love.  The Painkiller Law Blog is back and ready for the new year.  Let’s dive right in with a story bizarre enough to push the envelope even in the already bizarre world of the prescription opioid epidemic.

A late 2015 issue of the highly regarded medical society publication, Annals of Internal Medicine, reports that most doctors continue to prescribe opioid painkillers to patients, even after a patient overdoses on the drugs.  Specifically, 91% of patients got a prescription from a doctor after an overdose, and 71% received a repeat prescription from the same doctor who’d seen the patient prior to the overdose.

Can you think of any other area of medical practice or treatment where this would happen?  Where the worst adverse outcome, as close to accidental patient death as you can get, would be met with a repeat of the treatment or prescription which caused the accident?  It brings to mind Mel Brooks’ line from Blazing Saddles, when has asks in Yiddish, “Hobn ir gezen aza a zakh in deyn lebn?”  English translation:  Have you seen such a thing in your life?

From where I sit, the answer is a resounding “no.”  But even more perplexing than the issue itself is why it is happening.  I posit the following four reasons:

 

1.  FDA Cluelessness.  The FDA doesn’t know what it’s doing about opioids.  The FDA is too busy telling pharmaceutical companies to develop abuse-resistant opioids and overdose antidotes.  These are good and needed, but they’re only needed because the FDA earlier approved mass prescribing, for chronic pain, of drugs which are now known to be highly addictive and generally not effective.  In a sense, the FDA’s response is to continually try and put Band-Aids on a cut the FDA keeps opening.

2.  Corporate Greed.  The pharmaceutical industry has made billions and billions of dollars off opioid sales, and continues to do so.  As long as the drugs are available for prescription for chronic pain – and with millions of patients addicted to painkillers, there’s no feasible way to simply stop allowing mass prescribing – Big Pharma has absolutely no incentive to do anything about the problem it helped create and from which it continues to profit.

3.  Patients’ Over-reliance on Painkillers.  Patients have to be their own best advocates and demand real solutions to their pain, not just drugs which mask symptoms until the medicine wears off, and whose dose has to be increased to bring even temporary relief.  Opioids don’t attack the source of pain; they don’t address an underlying medical problem.  There is no substitute for physical therapy, or surgery, or many other forms of treatment aimed at addressing the root cause of a medical problem.  Pain patients need compassion, support, understanding and help, and they need to participate in helping their doctors isolate and treat an underlying, root-cause medical condition.

4.  Doctors’ Ignorance and Poor Decision Making.  When 71% of patients are getting refills of an overdose-causing medication from the same doctor who originally prescribed, something is amiss in the medical profession.  Too many doctors went into pain management with insufficient training and knowledge.  Too few doctors undertake a real assessment of the efficacy and appropriateness of prescribing opioids, before they prescribe.  Too many doctors persist in their ignorance and get lazy when it comes to refilling a scrip, versus really helping a patient get better.  And, too few doctors know and follow their state’s guidelines for prescribing controlled drugs.  Doctors don’t bear all the responsibility, and they did not create this public health crisis, but they play a role in its perpetuation.  If a doctor is going to prescribe opioids, he or she has to know the criminal law, and follow it, or else the doctor will be placing herself and her patients at risk.

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PAINKILLER LAW BLOG: You Whine, You Win

Recently, the author Salman Rushdie remarked that today in the world, “so many people are upset about everything all of the time.”  Complaining does seem to be in great supply these days in all types of places and circumstances.  The idea of whining as a winning tactic comes to mind in light of last week’s decision by the New Hampshire Board of Medicine to hold off adopting emergency opioid-prescribing rules, after NH doctors voiced loud objections (read:  whined) about what an imposition the new emergency rules would be.  This story is significant for three reasons:   (1) The opioid crisis is becoming a presidential campaign issue in first-to-vote New Hampshire; (2) the doctors protesting the emergency rules won the day, when they should not have; and, (3) complying with opioid prescribing guidelines is not an option, it’s a legal requirement, it’s not that difficult, and if you don’t comply with legal requirements, you get busted and have no one to blame but yourself.

First, New Hampshire, like many other states, is experiencing a terrible problem with opioid prescribing, unintended addiction, accidental fatal overdoses, and legitimate pain patients’ turning to heroin as a pill-substitute just as pain sufferers are doing nationwide.  But what makes New Hampshire different is that all the presidential candidates really want to win there.  So, the prescription drug issue is being talked about by candidates Democratic and Republican.  Expect more attention to be paid to the issue in the coming weeks and months, and let’s hope the issue doesn’t get tossed out along with campaign posters when the politicians move on to the South Carolina and Nevada primaries.

Second, in this environment of urgency and political and media attention, you’d think the New Hampshire Board of Medicine would have an easier time adopting proposed emergency rules about opioid prescribing.  Its proposed rules, on which it held hearings last week, would have required prescribers to take a biannual (every two years) course in pain management and controlled substances; check the state’s automated prescription drug monitoring program before starting a patient on opioids; limited ER-written prescriptions to five days; and required annual or sometimes more frequent urine tests for patients taking opioid prescriptions.  Let’s face it:  Those aren’t onerous requirements; they’re reasonable, restrained, in line with other guidelines around the country, they’re limited in scope, and they’re not too tough, too time-consuming, or too expensive to comply with.

But they failed to pass.  The Board killed them after lobbying by doctors.  The doctors testifying before the Board in opposition to the proposed rules said ER docs would simply “ignore” requirements to collect information on substance abuse and mental health history before prescribing.  To understand how galling a statement this is, remember that opioid prescribing guidelines are the law; they are what DEA agents and other law enforcement officers look to in judging the legality/legitimacy of a prescriber’s work, and failure to follow guidelines is prima facie evidence of a criminal violation.  Against this backdrop, ponder the audacity of a licensed professional threatening to “ignore” a legal requirement, much less glibly declare in public his or her intention to flout the law.  That, my friends, is chutzpah.  Then there was the threat by NH docs that if the rules passed, doctors would simply stop treating patients who are prescribed opioids.  The refrain of “I’m going to take my marbles and go play somewhere else” is getting a little old, and if doctors don’t understand that prescribing guidelines are the law, not just a bunch of words to be ignored or attended to if one is in the mood, then the complaint and threat is going to soon be the medical profession’s equivalent of crying wolf.  Besides, if ignoring the guidelines will make more prescribing easier, then why would a doctor content to ignore the guidelines be worried about the burden of compliance, anyway?

Third and finally, the trick is to teach certain doctors to stop whining when their position lacks credibility, and instead show them that guideline compliance is much easier, takes much less time, and costs much less money than they think.  It’s not rocket science; it’s not even medicine.  It’s law, and if you don’t know the law and don’t follow it, you’re breaking it, and then you’ll need someone like me to help you, assuming you haven’t painted yourself into a corner with your public declarations about how little the law matters to you.

 

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PAINKILLER LAW BLOG: L.A. Doctor Convicted of Murder

Today’s post is a radio interview I did in Los Angeles a few days ago, following the guilty verdict in a murder trial of a Los Angeles-area pain management doctor named Lisa Tseng.  I was not the defense attorney in the case.  A jury found Dr. Tseng guilty of three counts of murder, in the deaths of three patients to whom she prescribed massive amounts of all kinds of narcotics.

The case’s highly unusual facts made it one the District Attorney wanted to try as a murder; in most cases, as I say in the radio interview, homicide charges are not brought against doctors, and murder charges in particular are most often declined by prosecutors, for a number of reasons.

While the Tseng verdict does not mean legitimate doctors should worry about being targeted for no reason, the problem is that many doctors who prescribe controlled substances don’t know the law, don’t know the current science, and don’t follow their state’s prescribing guidelines the way they should. What’s worse, many doctors think they know these things, and how to be and stay compliant – and it’s only when something goes disastrously wrong that they realize they should have been more circumspect in their prescribing, and much more careful in their charting.

I hope you enjoy the post and interview!

 

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