Pharmacist ponders opening medical marijuana dispensary

Posted on August 22, 2017 by - DEA Prosecutions, Licensure

This might be a bad idea–for the pharmacist

In recent years, a number of states, including Oregon, have “legalized” marijuana for medical purposes (and in fewer states, for recreational use).  As reported in the Okeecheobee News, Florida voters recently approved legalization of medical marijuana and now Florida cities must decide whether to opt out.  If the Okeechobee City Council decides to allow medical marijuana dispensaries within city limits, one local pharmacist urges that he be considered to run the dispensary, but that might be a bad idea–for the pharmacist.

Florida pharmacist Steve Nelson acknowledges that “medicinal marijuana is not an easy issue,” but he is sympathetic, and he has seen the benefits of medical marijuana in treating seizures, terminal cancer, and chronic arthritis.  I don’t doubt him. Mr. Nelson is also quite experienced (40 years as a pharmacist) and appears cautious, urging the city council to be careful, to ensure adequate controls are in place.  One difficulty, according to the Okeecheobee News, is that the city would have “little power” to regulate medical marijuana because “regulation falls to [the] new state law.” It is not that simple, however.

Marijuana: a Schedule I banned substance under federal law

Despite Florida’s new state law, marijuana is still a Schedule I banned substance under the Controlled Substances Act (CSA), meaning that without a research permit or exception, marijuana cannot be possessed, prescribed, or dispensed for any purpose under federal law, and therein lies the rub.  Over the course of his 40 years experience, Mr. Nelson has practiced pharmacy with a state license as authorized in great part by a federal Registration administered by the DEA.  Now he wants to dispense marijuana contrary to the CSA’s drug schedules and DEA oversight?

Admittedly, for a number of reasons, federal law banning marijuana has been lightly enforced and, in those states where marijuana is “legal,” a lax attitude also prevails among the general public.  However, for those of us that possess a professional license, and especially healthcare providers also possessing a DEA Registration, we are held to higher standards.  In my experience, when there is a Board investigation, marijuana, medical or otherwise, is a complicating factor.  I know this to be true for Oregon physicians, whether recommending marijuana for medical use, or consuming marijuana for recreational use, and I fear my experience will prove true for Mr. Nelson should he choose to run a dispensary.  Yes, I know, Mr. Nelson’s state license and federal DEA Registration are not necessary to run a dispensary under Florida’s new law.  Still, Mr. Nelson is a state-licensed pharmacist, with two pharmacies dispensing controlled drugs as authorized by the CSA pursuant to separate DEA Registrations – does Mr. Nelson really want to run a third operation dispensing a Schedule I substance banned under the CSA?  As a lawyer, I recognize the legal distinctions and I can make the arguments to support Mr. Nelson’s goal of running a dispensary but, as a practical matter, I see the risks of unwanted scrutiny, and more.  Much more.  I earlier commented on physicians, marijuana, the new DEA, and the Oregon Medical Board and marijuana, the practice of medicine, and the Oregon Medical Board, cautioning Oregon physicians physicians not to become complacent when involved with marijuana.  I have also defended pharmacists and physicians for dispensing lawful drugs.  Given my experience, I cannot imagine recommending that a state-licensed, DEA-registered practitioner dispense a Schedule I banned substance, even if its “only” marijuana.

Narcotics: too many, too much, too long

Posted on July 9, 2017 by - DEA Prosecutions, Licensure

Oregon Medical Board investigations and narcotic prescribing

It is my recent experience that during medical board investigations, no matter what the nature of the initial complaint, a physician’s prescribing practices will be reviewed if there is any opportunity to do so. And why not? From the Oregon Medical Board’s perspective, there is a national opioid problem, and part of that problem resides in Oregon.  As recently as July 6, 2017, this was the “good news” in Oregon:

“Anne Schuchat, the CDC’s acting director, expressed tempered optimism about the first national decline in opioid prescriptions that the CDC has reported since the crisis began in the late 1990s.

“She said the prescription rate is still triple the level it was in 1999 and four times as much as it is in some European countries.  Even at the reduced prescribing rate, she said, enough opioids were ordered in 2015 to keep every American medicated round-the-clock for three weeks.

“‘It looks a little bit better, but you really have to put that in context,’ Schuchat told the Washington Post. ‘We’re still seeing too many people get too much for too long.'”

Study: Opioid prescriptions largely drop in Oregon counties, July 6, 2017.

The problem is worse in Oregon’s rural counties:

“In Oregon, Curry County prescribers gave out the most opioids per person in 2015, followed by Baker and Malheur counties.  At the bottom of the list — Grant County.”

Study: Opioid prescriptions largely drop in Oregon counties, July 6, 2017.

It is also my experience that rural practitioners will defend their prescribing practices by expressing sympathy for their patients, and explaining that a large percentage are uninsured and there isn’t a pain specialist for miles around. Unfortunately, it is my further experience that these explanations will not get you very far with the Oregon Medical Board.  From the Oregon Medical Board’s perspective, there may be a problem, but narcotics are not the long-term solution in most cases.  If you possess a state medical license and a federal DEA Registration, the Oregon Medical Board expects you to know this, and to do your part to correct the situation.

Sympathy, combined with skepticism and alternatives

The Oregon Medical Board makes its prescribing guidelines – Oregon Opioid Prescribing Guidelines: Recommendations for the Safe Use of Opioid Medications – available on the rotating banner of its website home page, or click here.

Using sarcasm to make a final point, if you truly want to invite trouble from the Drug Enforcement Administration (DEA) or the Oregon Medical Board, treat chronic pain with narcotics in excess of 90 days and 120 MED (morphine equivalent dose), with too much sympathy by the practitioner, in an under-served rural area, with a large percentage of uninsured patients and no pain specialist within miles, which is a recipe for trouble and an invitation for a DEA or Oregon Medical Board inquiry.

A perfect storm is brewing for physicians prescribing narcotics

Posted on May 18, 2017 by - DEA Prosecutions, Licensure

Defending physicians prescribing narcotics for chronic pain has never been easy and I have long criticized the the Drug enforcement Administration (DEA) for conflating the civil standard of care with the criminal conviction standard, thereby criminalizing the practice of medicine. Sixteen months ago I commented that the DEA unnecessarily extends its investigations to the detriment of physicians and patients (DEA investigations: How much is too much?), and 11 months ago I commented that a new standard of care has emerged for the treatment of chronic pain (The pendulum has swung: Treat chronic pain cautiously). Now Attorney General Jeff Sessions, who heads the DEA, has ordered his federal prosecutors to seek the maximum punishment for federal drug offenses. All tolled, a perfect storm is brewing for physicians prescribing narcotics to treat chronic pain.

Treating chronic pain > 90 days and 120 MED (morphine equivalent dose)

With a few exceptions (e.g., cancer pain or hospice care), if you treat chronic pain with narcotics in excess of 90 days and 120 MED (morphine equivalent dose) and your prescribing practices have not evolved over the past five to seven years consistent with the emerging standard of care, you have likely failed to “keep up” and you may be at risk of regulatory intervention. If you treat chronic pain with narcotics in excess of 90 days and 120 MED, and you are not a pain specialist, or you do not refer your patients to a pain specialist, and your patients are not on taper plans, your medical practice may be a ticking time bomb

Prescribing guidelines: The emerging standard of care

The following practice guidelines, offered by the Oregon Medical Board and Oregon Health & Science University (OHSU), reflect current standard of care expectations when prescribing narcotics to treat chronic pain:

If your practice is not in line with these recent guidelines, you may be risking sanctions by your state medical board or the DEA. If your practice comes to the attention of your state medical board, your medical license may be subject to quick restriction or threatened revocation. Similarly, if your practice comes to the attention of the DEA, your DEA Registration may be subject to restriction or revocation and, in a worst case scenario, you may be subject to a criminal investigation. This already serious problem has been exacerbated by a newly invigorated DEA that has been instructed United States Attorney General Jeff Sessions to pursue the maximum punishment available for federal drug law violations.

Physicians, marijuana, the new DEA, and the Oregon Medical Board

Posted on February 24, 2017 by - DEA Prosecutions, Licensure

Physicians beware: marijuana may complicate your professional life

I earlier wrote about marijuana, the practice of medicine, and the Oregon Medical Board, cautioning physicians that regardless of state law, marijuana is still a Schedule I banned substance under federal law, meaning that without a research permit or exception, it cannot be used or prescribed for any purpose under federal law.  Consequently, I cautioned physicians not to become complacent when recommending marijuana for medical use and not to confuse compliance with the Oregon Medical Marijuana Program (OMMP) with meeting the applicable standard of care.

Admittedly, under former Justice Department policy, federal law has been lightly enforced and in those states where marijuana is “legal,” a lax attitude prevails among the general public.  For those of us that possess professional licenses, however, we are often held to higher standards and this seems to be particularly true for Oregon physicians, whether they are recommending marijuana for medical use, or consuming marijuana in their off time.  This point was hammered home earlier this month when I represented two physicians during their Investigative Committee (IC) interviews at the Oregon Medical Board.  One physician had recommended marijuana for medical use.  Although he had strictly complied with the Oregon Medical Marijuana Program (OMMP), the Medical Board’s concern was the standard of care.  The other physician had never recommended marijuana for medical use, but he had admitted to personal use, and not always in a state where it was legal under state law.  Both physicians were honest and forthcoming, but marijuana had complicated their professional lives, something we all want to avoid.

Physicians, the times they are a changing: the new DEA

The times are not getting any easier for physicians recommending or using marijuana.  New Attorney General Jeff Sessions, who heads the Drug Enforcement Administration (DEA), has long opposed the legalization of recreational marijuana and yesterday, Sean Spicer, the President’s press secretary, explained during his daily press briefing that under the new administration we can expect “greater enforcement” of federal law banning the recreational use of marijuana even in those states where recreational use is “lawful” under state law.  I suspect the Oregon Medical Board was not surprised. During a side conversation earlier this month, a Medical Board investigator commented this might happen under the new administration and, a few weeks later, it did.  I think it is safe to assume that in this new era, the Oregon Medical Board will have still greater concerns about the recreational use of marijuana by physicians in any state, including Oregon, where it is “legal” under State law but still a Schedule I banned substance under Federal law.

Physician sentenced to a year and a day for seven drug felonies!

Posted on August 13, 2016 by - DEA Prosecutions, Uncategorized

Is there a new leniency in federal sentencing for prescription drug crimes?

In an effort to follow Drug Enforcement Administration (DEA) prosecutions, convictions, and sentencings around the country, I read Google alerts weekly, sometimes daily.  In recent months, I have been struck by relatively lenient sentences handed down by several different District Courts when sentencing physicians pleading to multiple counts of drug diversion (i.e., prescription drug crimes).  I have defended physicians and pharmacists facing prescription drug charges long enough to recognize trends.  Thus far, I haven’t commented, but today I am prompted to do so because I sense there may be a new trend, or new opportunities, for those that are paying attention.  Here is one recent example:

On August 9, 2016, it was reported that a West Virginia physician was sentenced in Federal District Court to a year and a day in jail after pleading guilty to seven felonies for illegal distribution of oxycodone.  The sentence included an $18,200 penalty, and required the physician surrender her medical license, but for those who are unaware of typical sentences for federal drug charges, this sentence is lenient!  According to news reports, this physician had both prior legal and disciplinary history, was charged with a 100-count indictment alleging that she and two coworkers wrote 157 illegal prescriptions for oxycodone, oxymorphone, methadone, and methylphenidate, and the physician authorized pre-signed, blank prescription forms, for use by her staff.  I am aware of much harsher sentences on what would appear to be much “cleaner” records.

A new trend or opportunity?

I haven’t done the research, and do not presently have the case to justify the time and expense, but for those physicians (and their lawyers) currently preparing to plead and be sentenced,a six-month review of recent federal District Court sentences involving drug diversion pleas around the country may be a worthy endeavor.  A little research may turn up other similar news reports of relatively lenient sentences, suggesting better results for physicians sentenced for prescription drug crimes than I have seen for a while.  There is perhaps something to be learned.

Ten year anniversary of U.S. Supreme Court opinion against DEA in favor of physicians and pharmacists

Posted on July 3, 2016 by - Appellate, DEA Prosecutions

This year marks ten years since the United States Supreme Court issued its opinion in the case of Gonzales v. Oregon (406 KB), decided January 17, 2006. In this case, the United States Supreme Court affirmed the Ninth Circuit Court of Appeals’ opinion (263 KB), which had earlier affirmed the federal District Court’s opinion (1.78 MB) enjoining former United States Attorney General John Ashcroft from prosecuting Oregon physicians and pharmacists.

Against the DEA, healthcare defense attorney seeks injunction

Normally, as a healthcare defense attorney, someone else, for example, a licensing Board or the Drug Enforcement Administration (DEA), initiates the litigation. In this case, however, in order to protect physicians and pharmacists throughout the State of Oregon, it was necessary that I become the plaintiffs’ attorney. I sued former Attorney General John Ashcroft and the DEA in federal District Court on behalf of a physician and a pharmacist who were threatened with federal criminal investigations, prosecutions, fines, and imprisonment. See Complaint (1.24 MB).

Important victory for physicians and pharmacists everywhere

The opinion by the United States Supreme Court is an important victory for physicians, pharmacists, and patients everywhere, because it establishes the precedent that the United States Attorney General may not define the scope of legitimate medical practice, and that the States, not the federal government, regulate the practice of medicine. Justice Kennedy, writing for the majority of the Court, concluded his 28 page opinion writing:

“The Government, in the end, maintains that the prescription requirement delegates to a single Executive officer the power to effect a radical shift of authority from the States to the Federal Government to define general standards of medical practice in every locality. The text and structure of the CSA show that Congress did not have this far-reaching intent to alter the federal-state balance and the congressional role in maintaining it. Gonzales v. Oregon (406 KB)(Kennedy, J.)”

This victory stands today – the injunction against the DEA is still in effect! This case is discussed in more detail on the appellate practice page of this website.

Pharmacist sentenced to 24 years in prison; convicted on “red flag” evidence

Posted on July 1, 2016 by - DEA Prosecutions

Pharmacist dispensed without a “legitimate medical purpose”

A Florida pharmacist was sentenced last week to 24 years in prison on multiple charges that include dispensing oxycodone without a “legitimate medical purpose.”  The evidence against the pharmacist was summarized as follows:  The pharmacist (1) accepted fake prescriptions from (2) customers who came in groups (3) from far distances to get (4) oxycodone.  The prescriptions were written by (5) known suspect prescribers and (6) the patients paid a premium, in cash, for the oxycodone.  In other words, the pharmacist failed to screen for the “red flags” of drug diversion.  Here is a link to the story: http://www.pharmacytimes.com/news/pharmacist-to-serve-24-years-in-prison-for-illegal-oxycodone-dispensing.

The Oregon Board of Pharmacy expects pharmacists to screen for “red flags”

I can assure you from my work as a healthcare defense attorney defending physicians, pharmacists, and prescribing nurses against prescription drug charges by the Drug Enforcement Administration (DEA) that screening for red flags is expected of all prescribing and dispensing practitioners.  Agreeable or not, screening for red flags is also important because whether a pharmacist screened for red flags will be considered by the Oregon Board of Pharmacy and DEA drug diversion investigators whenever there is suspected drug diversion.  The Oregon Board of Pharmacy addresses screening for red flags on its website at: http://www.oregon.gov/Pharmacy/pages/index.aspx), and further links to an YouTube educational video: https://www.youtube.com/watch?v=WY9BDgcdxaM&feature=youtu.be.  If you are an Oregon pharmacist, I encourage you to view this video.

Defending physicians who prescribe opioids

Posted on June 21, 2016 by - DEA Prosecutions, Licensure

Experiences of a healthcare defense attorney

I have defended physicians, pharmacists, and prescribing nurses from prescription drug charges by the Drug Enforcement Administration (DEA) long enough that I well remember the following events:

  • the short-lived FAQ’s briefly posted to the DEA’s website (the FAQs were removed from the DEA’s website because pain advocates and defense lawyers cited the favorable FAQ’s in the courtroom);
  • the “Quick Reference Card,” (the Quick Reference Card was a highly formatted legal crib sheet used by prosecuting attorneys in the courtroom, but it was discontinued due to its misstatements of the law of drug diversion);
  • the argument that opioid dosing is to be determined “titrating to full function” (finding the optimal dose to improve daily functioning – the best analgesia with the fewest side effects; but was this ever the standard?); and
  • the day in 2007 that Purdue Pharma pleaded guilty, and paid a $630 million settlement, against federal charges that it misled healthcare providers about the risks of OxyContin.

Overtime, I have accumulated the type of experience that causes me to offer cautious advice to prescribing physicians treating chronic pain with opioids. Cautious advice will sometimes disappoint a prescribing physician, and will certainly disappoint the physician’s patient seeking more aggressive treatment. I am, however, a healthcare defense attorney, and my experience includes keeping physicians out of prison, and winning their release from prison once they are there. In other words, my goal is to keep you out of trouble and cautious advice furthers that goal.

The pendulum has swung: Treat chronic pain cautiously

It is based on my experience that I can assure prescribing physicians and nurses that the treatment of chronic pain with opioids exposes you to scrutiny by the Oregon Medical Board, the Oregon State Board of Nursing, and the Drug Enforcement Administration. Based upon two recent experiences, I also detect that the pendulum has swung, and the emerging practice standards and protocols governing the treatment of chronic pain with opioids are more detailed than ever.

These Oregon Medical Board and OHSU publications may serve you well

I am a healthcare defense attorney, not a healthcare provider, so my opinion is informed by others, and at this point my opinion on this subject is not fully informed. Nonetheless, if you are a prescribing physician or nurse treating chronic pain with opioids, and you come under scrutiny by the Oregon Medical Board, the Oregon State Board of Nursing, and/or the Drug Enforcement Administration, you may be well served if you have followed these practice guidelines made available by the Oregon Medical Board and Oregon Health & Science University:

 

Purdue Pharma misleads physicians again?

Posted on June 18, 2016 by - DEA Prosecutions

I have been defending physicians, pharmacists, and prescribing nurses from prescription drug charges by the DEA long enough that I well remember the day in 2007 that Purdue Pharma pleaded guilty, and paid a $630 million settlement, against federal charges that it misled healthcare providers about the risks of OxyContin. Several of my physician clients during that period of time pointed to the misleading material they relied upon. Less than ten years later, here we go again. As reported by the Associated Press on June 10, 2016:

“The New Hampshire Attorney General’s office is targeting the maker of Oxycontin, a top selling prescription painkiller, with an investigation into whether it downplays the risks of addiction when marketing pain pills to doctors and other prescribers.”

And:

“. . . the company [Purdue Pharma] is no stranger to lawsuits: It pleaded guilty and paid a $630 million settlement in 2007 for federal charges that it misled doctors and patients about the risks of OxyContin. The OxyContin the company now produces uses a new formula that the company claims is less addictive.

“The new court filings allege Purdue is continuing to “engage in the type of deceptive marketing” that resulted in the 2007 settlement.”

Physicians, pharmacists, nurses caught in middle

Physicians, pharmacists, and prescribing nurses treating chronic pain are caught in the middle between the demands of patients and the scrutiny of the Drug Enforcement Administration (DEA), a difficult situation that is exacerbated by the ever-changing practice standards and, at times, misleading marketing by a prominent drug manufacture. The latest litigation is still its early stages, however, with the lawyers presently battling over discovery (the exchange of documents and other information), and alleged conflicts of interests. It will be interesting to see where this latest round of litigation against Purdue Pharma leads.

One way to evaluate an expert’s qualifications when defending against the DEA

Posted on April 3, 2016 by - DEA Prosecutions

Ask yourself: How many doctors has the expert’s testimony convicted?

I have the privilege of defending physicians, pharmacists and nurses before state licensing Boards and the Drug Enforcement Administration (DEA). In one such case defending against the DEA, there was much discussion about which expert physician had the better qualifications – our expert, or the the government’s expert? Each was capable of qualifying as an “expert witness,” but I feared my client, the defendant-physician, took too much comfort in the better qualifications of his expert. I feared this nuanced discussion of which expert witness had the better qualifications was creating a false sense well-being mere weeks before trial. For me, perhaps the more important question is how many doctors has the expert’s testimony convicted?

Do not dismiss the DEA’s expert witness

One thing is certain, if the DEA’s expert witness has led a jury to convict another physician, that’s a dangerous witness, despite any perceived lack of qualifications. In my experience, it is not the expert witness’ qualifications so much as it is what the expert is willing to say to a jury.

And do not become complacent

I can tell many stories where the physician believed the risk of conviction, or the risk of a lengthy prison sentence, was low. In my experience, physicians and their families often rationalize why they won’t be convicted, or, if they are convicted, why they will receive a lenient sentence, perhaps probation, or time served, or one year, only to be sentenced to 5 years or more, and in one case, to 15 years. While I have obtained good results, and have even obtained the release from prison of two physicians, most often, it doesn’t happen that way. If you want to see for yourself, search the internet using some of these search terms: “physician convicted,” “doctor convicted,” “physician sentenced,” “doctor sentenced,” “physician acquitted,” and “doctor acquitted.” You will soon discover that good results for defendant-physicians facing DEA prosecutions are few and far between. Prepare accordingly.