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: “That’s DOCTOR Po-Po to You!”

Doctor – a physician or surgeon.

Po-Po – slang for “police.”    

 

Generally speaking, law enforcement agents haven’t gone to medical school, and healthcare providers don’t raid your house.  But today across the country,  worlds are colliding.  With law enforcement agencies from the DEA to Medical Boards to local departments nationwide feeling the heat to “crack down” on practitioners who write painkiller prescriptions, we’re seeing medical judgment scrutinized and applied by agents and police officers with no medical training.  This is a very dangerous development.  The current investigative and enforcement environment should worry any healthcare provider who writes for Schedule II through V pain medication, no matter how ethical and scrupulous and appropriate the provider and the prescriptions may be.

In California, for example, you can be investigated for and accused of “overprescribing” opioids.  The thing is, there’s no definition – statutory, case law, regulatory, even clinical – of “overprescribing.”  How to determine what constitutes it, and whether it’s occurred?  That’s a work in progress, and in a “crack down” setting, you’d better hope that your practice and career aren’t the guinea pig on which Doctor Po-Po, the badge wielding agent who thinks he or she knows medicine as well as you, is experimenting.

The investigative, accusatory and discipline processes do not provide the slightest reassurance about fairness, due process, or lack of bias.  Who gets to decide whether to investigate?  The Medical Board.  Who decides whether to formally accuse?  The Medical Board.  Who initiates the disciplinary hearing?  The Medical Board.  Who presents evidence at the hearing, in other words, who’s effectively the prosecutor?  The Medical Board.  And who determines whether a practitioner suffers discipline, including licensing sanctions – in other words, who’s the judge?  You guessed it – the Medical Board.  If you’re not scared yet, then respectfully, it’s time for B-12 injection or at least a double espresso.

Were you a common [accused] criminal, you’d be constitutionally entitled to the separation of powers that comes with a criminal prosecution.  One person prosecutes, another defends, and a court or jury judges.  Not so with your medical license and career.  Your fate could be in the hands of the same people who’ve invested the time to go after you, who are under pressure to “do something,” who know they will look like idiots if they rule against themselves at a hearing, and who will be excoriated by a legislative budget or oversight committee for being too “soft” on disciplinary targets.

There are ways to help prevent yourself and your practice from becoming trapped in this swirling vortex of bureaucratic persecution.  First, make sure you are in compliance with the laws and standards, both written and unwritten, both objective and subjective, both mandatory and discretionary, of prescribing painkillers.  There are lots of ways to do this, but you need expert help to cover them all and incorporate them wisely into your practice, your office procedures, and your staff directives.

Second, if you ever find yourself under investigation, if a subpoena arrives, or if someone carrying a badge shows up at your office and asks to have a friendly conversation about how you supposedly screwed up, do the following four things, in order:

1)   Be smart.    2)   Be courteous.    3)   Be quiet.    4)   Call Painkiller Law right away, for guidance, reassurance, advice and help.

Painkiller Law:  Criminal Law Compliance for Healthcare Providers, is a service of the Meister Law Offices.  Call us today for a free consultation on verifying, achieving and maintaining compliance with the federal and state criminal laws which govern controlled substance pain medication.  It’s good preventative medicine.

213.293.3737     info@painkillerlaw.com

 

 

 

 

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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: DRUG CZAR SAYS SCRIP ABUSE STILL AN EPIDEMIC

The White House Drug Czar today released a report lauding what the WH a decrease in prescription painkiller abuse.  But he quickly added that in the view of the federal government, prescription painkiller abuse is still at “epidemic” levels and that enforcement against it will continue.

What does this mean for you as a healthcare provider?  It means everything the Feds and state and local authorities are doing now will continue.  From document requests, to prescription rate monitoring via database and by anecdotal and other evidence, to sting operations of suspected corrupt practitioners, current efforts will not abate.  What if you are, like most practitioners, ethical and not corrupt?  You need to be vigilant in your efforts to comply with the federal and state criminal laws regulating the prescription of Schedule II painkillers.  From patient intake to prescription monitoring to informed consent to treatment review, to knowing that “FDA” recommendations morph into “requirements” if they find you out of compliance, you need to protect yourself and your practice.  Remember:  While the world’s greatest neurosurgeon can get inside a DEA agent’s brain to operate, the doctor still won’t know what the agent is thinking, or how certain things in an office or on a prescription monitoring list look from the standpoint of law enforcement.  Be careful; be prepared; be in compliance.

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 criminal law of prescribing Schedule II pain medication.  Call us at 213.293.3737 for a free consultation, or email us at info@painkillerlaw.com.  Don’t become the Drug Czar’s next poster child.

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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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