Author: Eli Stutsman

Drug diversion? Why “medical necessity” is not the standard

Last month two physicians, doctor John Couch and doctor Xiulu Ruan of Mobile, Alabama, pleaded not guilty to multiple charges of drug diversion. I have no personal knowledge of either Dr. John Couch or Dr. Xiulu Ruan, or of their case, having only read about the doctors in the media. What caught my attention was that the news report included a discussion of “medical necessity,” i.e., whether there was a “medical necessity for dispensing the controlled substance.” Medical necessity is not, however, the legal standard by which the crime is measured. Nor is malpractice. This is an issue I have devoted some time to while defending physicians charged with prescription drug crimes. Rather, “drug diversion” is a specific intent crime. To convict a doctor of drug diversion, the government must prove more than malpractice, and more than the absence of medical necessity.

The elements of the crime of drug diversion

Doctors Couch and Ruan had authority to prescribe controlled drugs by virtue of their DEA Registrations. Under 21 U.S.C. § 841(a)(1), it is generally agreed that the government must prove (1) that both doctors prescribed or dispensed a controlled substance, (2) that they acted knowingly and intentionally, and (3) that they did so other than for a legitimate medical purpose and in the usual course of his or her professional practice. See, e.g., United States v. Norris, 780 F2d 1207, 1209 (5th Cir. 1986); citing, U.S. v. Rosen, 582 F2d 1032, 1033 (5th Cir. 1978).

It is important to know, however, that the Controlled Substances Act (CSA), which is the statutory scheme passed by Congress, includes only the first two elements above. The third element,”legitimate medical purpose,” is rooted in an agency Rule promulgated by the Drug Enforcement Administration (DEA). See 21 C.F.R. 1306.04(a). That Rule provides that a controlled substance can be dispensed by a prescription “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. 1306.04(a); Norris, 780 F2d 1207,1209. Thus, lawyers defending doctors need to be careful that the agency’s Rule does not swallow the federal statute, watering down the criminal conviction standard.

Did the doctors “knowingly and intentionally” divert drugs?

Keeping the federal statute front and center, the question is whether Dr. John Couch or Dr. Xiulu Ruan intended to divert drugs, a specific intent crime. The DEA’s attorneys might very well prove that Dr. John Couch or Dr. Xiulu Ruan prescribed without medical necessity, or that they committed malpractice while prescribing, but more is required to prove the specific intent crime of drug diversion. The DEA’s attorneys must prove that doctors John Couch and Xiulu Ruan “knowingly and intentionally” diverted drugs to an illicit purpose. This is the burden of proof imposed upon the government, by the Congress, pursuant to 21 U.S.C. § 841(a)(1).

Dr. Lawrence Wean, of Media, Pennsylvania, sentenced to prison

Yesterday it was reported that 61 year-old doctor Lawrence Wean, of Media, Pennsylvania, a suburb of Philadelphia, was sentenced to prison for 10 to 20 years, and that he had earlier rejected a plea agreement that would have required less prison time. Experienced lawyers will know that rejecting a plea agreement and proceeding to trial is something of a gamble, and if you lose that gamble, you can expect to serve more time than what might otherwise been ordered after a plea, so a longer sentence for doctor Lawrence Wean comes as no surprise.

I have no personal knowledge of Dr. Lawrence Wean, or of his case, having only read about Dr. Wean’s case in the media. As I understand it from news reports, Dr. Wean sold prescription drugs to undercover officers, was convicted in October of writing unlawful prescriptions and filing false insurance claims, has been ordered to pay over $40,000 in fines and $62,000 in restitution, and was just sentenced to 10 to 20 years.

Too much exposure for physicians?

One of the things I have learned as an appellate lawyer defending physicians on appeal is that the additional time imposed at sentencing, after losing at trial, is disproportionately more time than anyone expected when measured against earlier plea offers or negotiations. In other words, the gamble for physicians facing drug diversion charges for prescription drug crimes, may be a larger gamble than the typical defendant might face when rejecting a plea agreement. Physicians, family members, and lawyers defending physicians for the first time, are genuinely surprised, something I have witnessed first hand.

Is there a better approach for some physicians?

One of the opportunities I would like to explore when the right case presents itself, is the idea of negotiating a very early and favorable plea agreement, followed by an quick sentencing and an early self-report to serve time, before the typical two-or-more years have passed, and extensive financial resources have been depleted, which is common when taking drug diversion charges to trial. Some might recall that this type of efficient resolution was Martha Stewart’s solution to her legal woes a few years back. She quickly negotiated a plea agreement, was sentenced, surrendered, served her time, and then got on with her life.

A unique physician will be necessary

This approach will require the right type of individual, and I have no way of knowing whether doctor Lawrence Wean was such an individual. Most physicians, it seems, are willing to postpone the start of trial as often as will be permitted, and they appear further willing to spend all that they have to avoid serving time. These tendencies appear to be true even after conviction, if the case is on appeal (although “bond” is seldom allowed on appeal, I have helped physicians remain free pending appeal). Nonetheless, for the right physician, I find the idea of a quick resolution and sentence intriguing. In the right case, a physician could enter a plea and serve his or her time in three years, at little financial cost, relatively speaking. In sharp contrast, however, at the end of three years, all many physicians will have to show for their efforts is one of more convictions and financial ruin, with a sentencing hearing, a prison term, and an uncertain appeal, on the horizon.

When in doubt, protect your right to appeal

Sometimes the decision to appeal a verdict or judgment is an easy decision. In anticipation of an appeal, trial lawyers will often make a “record” in the trial court proceeding. Other times, when the legal issues are novel or complicated, both the parties and the trial court understand that the losing party will likely appeal the loss. In these cases, the decision to file an appeal – or correctly stated, the decision to file a “Notice of Appeal” – is a relatively easy decision. Other times, however, the decision to appeal is more complicated, and the time remaining to make such a decision can run quickly.

When time is short – file the Notice of Appeal to protect the right to appeal

As an appellate lawyer, I am occasionally contacted days before the appeal period will run. In these cases, there is not enough time to evaluate the merits of the appeal. In order to protect your right to appeal, it is sometimes necessary to file the Notice of Appeal and then sort out the legal issues in soon afterward. If the decision to file a Notice of Appeal turns out to have been the wrong decision, the appeal may then be dismissed. In these cases, where the legal issues are sorted out after the Notice of Appeal has been filed, it is necessary to act quickly, to ensure you have a basis to appeal.

When “appealability” is uncertain – file the Notice of Appeal to protect the right to appeal

As an appellate lawyer, I am occasionally contacted because it is unknown whether a particular document or ruling may be appealed. In close-call cases, when time is short, it is often necessary to file what I sometimes refer to as a “precautionary Notice of Appeal,” to protect the potential right to appeal. Immediately thereafter, it is necessary to resolve any legal issues regarding whether the document or ruling is appealable, as these same issues will no doubt be spotted and raised by staff lawyers at the Court of Appeals, or by the opposing appellate lawyer. In those cases where the doubt cannot be satisfactorily resolved, the next step may be to file a motion to determine jurisdiction, to obtain the court’s determination as to whether the particular document or ruling may be appealed.

When the merits of an appeal are unknown – file the Notice of Appeal to protect the right to appeal

As an appellate lawyer, I am occasionally asked to provide an independent assessment as to the likelihood of success on appeal, before the period to file a Notice of Appeal expires. This is doable in some cases, where the issues (claims of error on appeal) are known in advance. In other cases, if the trial court record is large and the basis for the appeal uncertain, it will again be necessary to file a Notice of Appeal to protect the right to appeal. The independent assessment will follow soon after, after transcripts, exhibits, etc., are gathered and reviewed. In one such case, I had to advise a family that had lost at the Oregon Court of Appeals that I had no idea what I could do to help them, other than file the Notice of Appeal, gather the record, and start work – if we had a basis for the appeal, we would go forward; if not, we would dismiss the appeal. Indeed, we had a basis to appeal. Sometime later, in a unanimous 7-0 opinion, we won a reversal from the Oregon Supreme Court. The point is that occasionally it is necessary to file a Notice of Appeal, to protect the right to appeal, and then sort the issues immediately thereafter.

Reinstatement after surrender or revocation of your DEA Registration

In a prior post (November 26, 2015) I wrote about reinstatement of medical licenses for physicians, pharmacists, and nurses after revocation by (or surrender to) the Oregon State Board of Nursing, the Oregon Board of Pharmacy, or the Oregon Medical Board. Today I want to add that in the right circumstances, reinstatement of your DEA Registration by the Drug Enforcement Administration (DEA), is also possible.

Key considerations that a DEA Registration lawyer can help you with

I have guided one physician through reinstatement of her DEA Registration after it was revoked and that experience was like most other reinstatement applications. There are numerous issues to consider before reapplying and a licensure lawyer with DEA Registration experience can guide you through the analysis. For example, reinstatement of a DEA Registration is more likely if the DEA Registration was surrendered or revoked through an administrative proceeding (which is a civil proceeding), as opposed to a criminal proceeding. This should come as no surprise.

Also, if your DEA Registration was revoked, it will be necessary to wait-out the proscribed period of time before reapplying, and if your DEA Registration was surrendered, it will be necessary to wait-out the agreed upon period of time (if such an agreement was reached) before applying for reinstatement, and whatever the circumstances that led to the surrender or revocation of your DEA Registration should be addressed too. If you are smart and plan ahead, the wait period can be used to address or correct whatever it was that led to the surrender or revocation of your DEA Registration in the first place.

Be aware that the online application to reinstate your DEA Registration is designed to solicit full disclosure, and you will be required to disclose the history that led to the surrender or revocation of your DEA registration. Explanations will be required too. Explanations should be carefully constructed, well in advance; the moment of your online application is no time for experimenting with answers, phrasings, etc.

Know that because you will have answered “yes” to the disclosure questions, a larger review will be triggered. Your answers and explanations will need to be complete and accurate (but without saying more) to withstand the heightened level of scrutiny that will be imposed. Finally, you should expect to be interviewed by drug diversion agents before your application to reinstate your DEA Registration will be granted or denied. Such interviews are in-person and recorded. These interviews require thoughtful and detailed preparations; this is not a time to casually “show up and see what the questions are.” An experienced DEA attorney will know what concerns the DEA and can help you anticipate the questions and provide complete, accurate, and helpful answers.

A second chance for a DEA Registration is rare – don’t waste it

A second chance to possess a DEA Registration is rare and the process is complex. You will be dealing with administrative law, DEA lawyers, and drug diversion investigators. Do not waste your opportunity for reinstatement. Plan ahead, obtain competent legal advice, and do not delay seeking competent legal advice until you know things are going badly. By then, the common mistakes will have been made and you will have lessened your odds of success.


What happened to the doctor “let go” by Dr. Sylvia Hofstetter?

The story of doctor Sylvia Hofstetter, in what has been characterized as “the largest drug network unearthed so far in East Tennessee,” is unfolding publicly this year, although the investigation certainly traces back several years. I have no personal knowledge of this case, or of Dr. Sylvia Hofstetter, having only read about Dr. Hofstsetter’s case in the media. As I understand it from news reports, Dr. Hofstetter was indicted earlier this year and is facing trial next year for prescription drug charges arising out of a large “pill mill operation” in Knowxville and Lenoir City. The facts as alleged certainly look bad for doctor Sylvia Hofstetter and her colleagues, but they always do, even in the cases that turn out better in the end.

At least one doctor was viewed favorably

What caught my eye was the testimony of an FBI Special Agent, who reportedly testified that Dr. Sylvia Hofstetter let one doctor “go” because that doctor spent more time with patients and wouldn’t always write a prescription for a narcotic. One implication from the Special Agent’s testimony is that this doctor was exercising clinical judgment, which suggests he was practicing medicine, and not intentionally dealing (i.e., diverting) drugs. Even if you assume the factual allegations are true with respect to Dr. Hofstetter and the others, this doctor is situated differently, even in the eyes of the FBI Special Agent. The doctor is not identified by name and I wonder what happened to him. Most often, every physician in the clinic is indicted, but was this doctor spared from indictment?

A “legitimate medical purpose,” or intentionally dealing drugs?

If this doctor was indicted, the issue for him will likely be whether he was practicing medicine or intentionally dealing drugs, and it is further likely his case will become entangled in the quarrel between what constitutes “prescribing without a legitimate medical purpose” (in my opinion, this agency rule is often misused by the DEA), and what constitutes the “knowing or intentional distribution of a controlled substance outside the course of professional practice,” which is the statutory crime legislated by Congress in the Controlled Substances Act, a quarrel I have discussed elsewhere on this website, and will not repeat again here today.


Against the DEA, lawyers mount vastly different defenses

Part of my work requires that I review trial court records in order to prepare and file briefs on appeal. Consequently, I see the complete record, from beginning to end, prepared by different lawyers. One practice area that keeps me on my toes is defending physicians, pharmacists, and prescribing nurses from prescription drug charges by the DEA. Lawyers defending such cases can take vastly different approaches to their work. Some do a great deal of work to prepare, and do that work well in advance of trial. Others, not so much, saving preparations until close to trial, which can be unnerving to physicians, pharmacists and prescribing nurses, demanding professionals in their own right.

DEA lawyers present uniform prosecutions across the country

My experience includes directly defending or assisting physicians, pharmacists, and prescribing nurses in cases arising out of the Third, Fourth, Seventh, and Ninth Circuits and 13 states, including Indiana, South Carolina, Arizona, Oregon, Virginia, Georgia, Pennsylvania, Florida, Hawaii, Texas, Connecticut, California and Michigan. With this broad experience, I have seen first hand that the DEA lawyers take a similar if not uniform approach across the country when investigating and prosecuting physicians, pharmacists, and prescribing nurses, which should come as no surprise, since the DEA’s work is driven from the top down. I have also seen first hand that defense attorneys are far less uniform in their approach to their work, and the quality of each defense is dependent upon the individual firm and lawyer(s) responsible for preparing and delivering defense.

Working against the DEA, lawyer’s experience reveals common mistake

As a part of the work summarized above, I represented the physician and pharmacist before the United States Supreme Court in the case of Gonzales v. Oregon, 546 U.S. 243, 126 S. Ct. 904, 163 L. Ed. 2d 748 (2006). I am also the lawyer that obtained the release from prison of doctors David and Randall Chube, on appeal to Seventh Circuit Court of Appeals, in the case of US v. Chube II, 538 F3d 693 (7th Cir. 2008). Both these cases are discussed in detail elsewhere on this website, and that effort will not be repeated here, except one point bears repeating: If a case is not well-defended, the DEA will criminalize some aspects of the practice of medicine by confusing the civil standard of care with the criminal conviction standard. Don’t let this happen to you.

An adequate defense can be complicated and expensive

Drug diversion cases (i.e., prescribing or dispensing “without a legitimate medical purpose”) are complicated cases to defend, with each case presenting the intersection between law, medicine and, sometimes, politics, with the occasional involvement of the media. When mounting an adequate defense against the DEA, lawyers face divergent tasks, and it is difficult for one lawyer to do it all. This is not an uncommon problem in litigation generally. When I was a younger attorney, recruiting lawyers to help defend physicians in a small southern medical clinic, one senior attorney commented to me that “if we had four lawyers and $100,000 we could do something with this case,” and his comment is often spot on. The point I would stress to any physician, pharmacist, or prescribing nurse defending against prescription drug charges, is to ensure that your defense team is complete, and that your defense is prepared well in advance of trial.

Settling a dispute with your licensing Board

Is settlement possible?

The answer to this question is emphatically “yes.” In fact, most cases that proceed beyond an investigation, to the issuance of a Notice of Proposed Disciplinary Action, are settled. This is true whether you are a nurse, pharmacist, or physician licensed by the Oregon State Board of Nursing, the Oregon Board of Pharmacy, or the Oregon Medical Board. Such settlements are known by a different name – a “consent order,” or a “stipulated order,” to name two examples – but these are settlements nonetheless.

How to settle your case

Unlike most settlements,you don’t pay money to settle a disciplinary matter. Instead, you agree to accept “discipline” by your licensing Board. In a case involving a “minor” violation or discrepancy, the settlement may be an agreement to accept a “reprimand.” A reprimand is on the low end of the disciplinary continuum, typically the starting place for discipline, although a reprimand should not be dismissed lightly, a point I stressed in a prior post on September 25, 2015. If a reprimand is not enough, perhaps a fine or short suspension will be necessary to reach settlement. In a more difficult case, you may need to negotiate probation, and perhaps the imposition of practice mentors and monitors. In the worst case, you are left to negotiate surrender of your licensure, and, hopefully a fw key terms of future reinstatement

A smart settlement requires an experienced lawyer and an experienced investigator (the investigator with your licensing Board is most likely experienced, but if not, rest assured, someone else with experience will negotiate on behalf of the Board). The trick to a smart settlement is that both negotiators must be experienced in order to recognize the most likely outcome, whether your case is litigated or settled. The goal of a smart settlement is to get to the “bottom line” quickly sparing cost and grief. Unreasonable expectations on either side with thwart a smart settlement.

Is settlement necessary?

A settlement is never necessary, because a licensee always has a right to a hearing to defend his or her license, unless or until you waive that right, usually as part of your settlement. Even if settlement is not necessary, settlement should always be considered. I had two cases this year in which settlement was earnestly discussed, but ultimately rejected. The investigator proposed settling offering to stipulate to a reprimand in each case. In the end, however, I recommended against a reprimand-settlement after determining that neither of my clients violated any law or practice standard. My clients accepted my recommendation and, in the end, the Board closed both cases without discipline. The two examples show why experience is helpful, if not necessary.

In a more serious case, especially one where you are exposed to revocation of your license, settlement may be your best option, and perhaps the only way to manage risks and control expenses. In the worst of cases, where your licensing Board is pursuing nothing short of revocation, settlement may be your only option if you want to manage risks and ensure that you keep your license.

How to proceed

An experienced licensure lawyer will be necessary, otherwise your decision to settle, to stand firm, or to proceed to hearing, will be more akin to a gamble that an informed decision. An experienced lawyer will be able to evaluate your specific circumstances and make reasoned recommendations. In some cases, an experienced lawyer can strongly recommend when to stand firm, or when to settle. In other cases – the close-call cases – an experienced lawyer can make recommendations in the alternative, enumerating the pros and cons for each recommendation, enabling you to make the best decision in your unique circumstance. In the worst of cases, where your hearing will certainly result in a loss, an experienced lawyer will recognize that inevitability and tell you as much, i.e., that anything gained through settlement will be more than will be gained by taking that case to hearing. An experienced lawyer will guide you through this process.

Reinstatement after surrender or revocation of your state medical license

There is a second chance

This week have I worked with a pharmacist and a nurse, both of whom are taking steps toward reinstatement of their licenses to practice pharmacy and nursing. In the nurse’s case, she surrendered her license just over a year ago. At that time, we negotiated a few key terms of reinstatement as part of a larger settlement.Today her application for reinstatement is pending. In the pharmacist’s case, his revocation was the recent result of taking his case to hearing, and losing. He retained me afterward. Despite his recent revocation, there was an extenuating fact or two and, only months after his revocation, he is taking the first steps necessary toward reinstatement.

Reinstatement after revocation or surrender is possible

Both the nurse and the pharmacist have reason to be hopeful about reinstatement. These are not pie-in-the-sky dreams in either case. In both cases, reinstatement is a very real possibility. On behalf of the nurse, I am working directly with the investigator at the Oregon State Board of nursing that accepted the nurse’s surrender of licensure just over one year ago. Similarly, on behalf of the pharmacist, I am working directly with the individual at the Oregon Board of Pharmacy most closely connected to the pharmacist’s revocation of licensure. These are very real and genuine discussions, with the representatives of each licensing Board being helpful and encouraging.

What you need to know

If you have surrendered your license, or lost your license to revocation, and you want to practice again, there is hope. In the two cases I mention above, the path to reinstatement will require approximately 18 months of earnest work. There are no tricks, and there is no magic, and whatever the circumstances that led to the surrender or revocation of your licensure, those circumstances will need to be fully addressed. Trust with your licensing Board will need to be fully reestablished.

How to get started

After surrender or revocation, your position is too weak and you are too emotionally involved to do this on your own. In the right circumstances, I can approach the licensing Board on your behalf, negotiate a potential reinstatement process, and then guide and represent you throughout that process. Nothing is guaranteed, however, and honest hard work will be required. If either one of us falters in this regard, your chances of reinstatement will be reduced.

Settling your case on appeal

Is it possible to settle a case on appeal, after losing at trial?

Yes, it is sometimes possible to settle a civil case on appeal, even after losing the case at trial. If you have a one or more meritorious issues to claim as error on appeal, and there is still time to file your Notice of Appeal, your case may have significant settlement value. If you are uncertain about appealing, have an experienced appellate lawyer evaluate your potential appeal, both for its merit and its settlement value. And do not delay – the time allowed to file a Notice of Appeal is often short.

Do the legal issues matter?

Yes, the legal issues do matter. Some cases, for example, are simply not capable of settlement, take for example cases involving larger legal or political issues that reach beyond the parties, or child custody disputes, or any case where the parties are too closely or too emotionally involved. These cases can be very difficult, if not impossible, to settle. On the other hand, many business or transactional disputes are quite capable settlement, particularly if the parties are business-minded or pragmatic. The best chance of settling an appeal occurs when there is one or more meritorious issues on appeals, both parties are pragmatic, and both parties want out of the litigation.

How best to proceed – a few practice tips:

The initial assessment is important. An experienced appellate lawyer, one that is also experienced with settlements, will be necessary to evaluate both your chances of success on appeal and the likelihood of an appellate settlement. In some cases, an experienced appellate lawyer can recommend when to stand firm, or when to settle. In other cases – the close-call cases – an experienced appellate lawyer can make recommendations in the alternative, enumerating the pros and cons for each recommendation, enabling you to make the best decision in your unique circumstance. In the worst of cases, an experienced appellate lawyer will know when you have little chance of success on appeal, and will tell you as much, i.e., that anything gained through settlement will be more than will be gained by taking up the appeal. An experienced appellate lawyer can guide you through this process.

Avoid spending too much time on the merits of an appeal. A discussion with the other side about the merits of an appeal can be helpful at the start, but these discussions can quickly become counter-productive. When settlements occur it usually because the parties were able to temporarily set aside the legal fight and focus on the pragmatic benefits of a settlement for both sides. A experienced appellate lawyer, one skilled at both appeals and settlements, can guide you through the analysis and the negotiations.

Avoid trying to settle your own case. The parties to litigation can rarely settle an appeal on their own, usually because the parties are too closely involved. Experienced trial lawyers that remain objective throughout the litigation can be well suited to negotiate settlement, but sometime they are also too closely involved. In almost all cases, the addition of an appellate lawyer to the team, an appellate lawyer that is also experienced with settlements, is most helpful. In a future post, I will write about the appellate settlement program.


Pharmacists: Protect yourself by spreading responsibility

The responsibilities of an Oregon pharmacist are extensive

A pharmacist licensed to practice pharmacy by the Oregon Board of Pharmacy has the duty to use that degree of care, skill, diligence and professional judgment that is exercised by an ordinarily careful pharmacist in the same or similar circumstances. See OAR 855-019-0200. The general responsibilities of a pharmacist are extensive, and there are many opportunities to make a mistake. See, e.g., OAR 855-019-0200(1)-(7) (listing some responsibilities). Moreover, a retail or institutional pharmacy may only only be operated when a pharmacist is physically present in the pharmacy to supervise the pharmacy. See OAR 855-041-1015(1). It should come as no surprise then, that most mistakes or problems will be assigned to the pharmacist on duty when the mistake is made or the problem arises in some damaging way.

Be wary, share the problem, and implement corrections

Although a practicing pharmacist will always be responsible for meeting professional standards, be wary of accepting responsibility for institutional problems, or the problems of others. If workload is too high to avoid medication or dispensing errors, or if technicians or cashiers are exceeding the lawful scope of their respective roles, or whatever the problem may be, expose and share the problem. Be proactive. Find and implement solutions. Otherwise, you may be assuming sole responsibility for problems and mistakes that will no doubt occur under your supervision.

Do not become isolated; report upstream; seek help

If problems are not easily corrected, do not sit of the problem. Do not become isolated with the problem. Instead, report the problem upstream. A friendly email spotting a potential problem and asking for help is a good place to start. Proposing a solution is even better. The worst thing you can do, however, is to become isolated and do nothing, all the while being responsible for an unsafe practice that will eventually result in a problem that is reported to the Oregon Board of Pharmacy. When that happens, blaming the pace of workplace, or the staff, or the corporate management, will not get you very far if you failed to address the problem you spotted on your watch, while you were supervising the pharmacy.

Report the problem to others licensed by Oregon Board of Pharmacy

Each pharmacy must have one pharmacist-in-charge employed on a regular basis at each location who shall be responsible for the daily operation of the pharmacy. See OAR 855-041-1010(1). Share the problem with your pharmacist-in-charge. If you are the pharmacist-in-charge, report up to management and ownership. Remember, the pharmacy is also licensed by the Oregon Board of Pharmacy, and the pharmacy must ensure that it is in compliance with all state and federal laws and rules governing the practice of pharmacy and that all controlled substance records and inventories are maintained in conformance with the keeping and inventory requirements of federal law and board rules. See OAR 855-041-1010(2). If you instead choose to “sit” on a problem until it results in a complaint to the Oregon Board of Pharmacy – because your believe you lack the authority to correct the problem, or your believe that management “won’t do anything” – then the problem will be your problem alone, when the Oregon Board of Pharmacy becomes involved. Don’t let this happen to you.

When all else fails

If you genuinely believe you have no one to report to that will help you, then the problem is truly yours to resolve. At this point, you will be best served to consult a pharmacy inspector, or an experienced attorney, for guidance. An experienced licensure attorney can contact the Board of Pharmacy looking for solutions, without disclosing your name. In the rare event that you are left with no other alternative than to report your pharmacy to the Oregon Board of Pharmacy, an experienced licensure attorney can make the report for you, in the most constructive fashion. The alternative is to sit on a ticking time bomb. Don’t do it.