Tag: licensure attorney

Common mistakes licensees make when communicating with their licensing Boards – Part I

Knowing that you are under investigation by your licensing Board will, in the best of cases, create a sense of unease, and, in the worst of cases, create a sense of panic. How you respond when you are under investigation is crucial. If you are represented by experienced licensure counsel, your lawyer will take control of the communications and the deadlines. In doing so, your licensure lawyer will create a “comfort zone,” sparing you much grief and anxiety, while serving the greater purpose of providing you with legal representation.

What you need to know

If you are under investigation, the record you are creating is a public record, and it will be the record that is litigated should your case proceed to hearing. This is why the communications you receive from your investigator are formal, cogent, and professional – your investigator knows what he or she is doing. Similarly, your licensure lawyer’s communications, sent on your behalf, will be coordinated, thoughtful, and legally strategic. In the most difficult of cases, this is absolutely necessary to succeed, and in the easiest cases, this is still necessary to help you prevent mistakes.

Where the trouble starts

All too often, however, licensees defend their cases on their own, usually until one or more common mistakes become apparent, compelling the licensee to retain licensure counsel. Such mistakes often fall into two broad categories. Licensees in the first category, not sure what to do, but feeling the need to do something, communicate too freely, too casually, and too often, with their licensing Boards. Conversely, licensees in the second category, feeling overwhelmed, if not threatened, are slow to respond, or fail to respond at all. Next week I will share a few examples of common mistakes.

For pharmacists: What you need to know about reporting a drug loss or theft

Once you discover a drug loss or theft, time is short. The applicable Oregon Administrative Rule (OAR) requires that you report a “significant” drug loss or violation related to theft to the Board of Pharmacy within “one business day.” OAR 855-041-1030(2) & (3) (Reporting Drug Loss) provides as follows:

(2) The outlet shall notify the Board in the event of a significant drug loss or violation related to drug theft within one (1) business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (D.E.A. Form 106) is sent to the Drug Enforcement Administration, a copy shall be sent to the Board.

To notify the Drug Enforcement Administration (DEA), go online and complete and submit a DEA Form 106. Print a copy and send it to the Oregon Board of Pharmacy, as required by OAR 855-041-1030(3), quoted immediately above. Never forget, however, that you are creating a public record. You are also reporting to the DEA and your licensing Board, both of which have significant enforcement powers. Consequently, you will be well served to have a competent attorney advise you throughout the reporting process. It is my preference to review, if not prepare, both reports.

A significant drug loss or theft will prompt an investigation by the Oregon Board of Pharmacy, and perhaps the DEA as well, depending upon the circumstances. The pharmacist(s), and especially the pharmacist in charge responsible for the pharmacy’s annual audits, perpetual inventories, and security of the pharmacy, will be exposed to additional scrutiny by the Oregon Board of Pharmacy and by the DEA. You will want competent legal counsel from the onset. If you proceed without competent legal counsel, you do so at your own peril.

What you should expect

If the cause of the drug loss or drug theft is not clear from the beginning, an investigation will certainly follow, and that investigation will continue until the cause of the drug loss or drug theft is fully known and understood by the Oregon Board of Pharmacy and, perhaps, the DEA as well. You will be interviewed. You should expect that one, or more, Board of Pharmacy inspectors will be involved until the case is resolved.

You should further expect that your pharmacy’s relevant annual audits and perpetual inventories will be requested and reviewed by pharmacy inspectors. Any shortcomings in your pharmacy’s inventory systems will prompt further review by the pharmacy inspectors. More will be required of the pharmacist in charge, as compared to a staff pharmacist, but all will need to be proactive in the investigation and resolution of any perceived lapse in pharmacy security. If the pharmacy’s inventory systems and procedures are legally inadequate, the responsible pharmacist(s), and especially the pharmacist in charge, will face additional scrutiny, and may face disciplinary proceedings.

If you are reporting a drug theft, and the theft was accomplished due to a security lapse, the Board of Pharmacy will pursue the security lapse until the cause of the security lapse is known. If the drug theft was accomplished after hours by someone other than a pharmacist, the pharmacy inspectors and the Board of Pharmacy will further want to know how, or why, a non-pharmacist had access to pharmacy keys and/or pass codes. OAR 855-041-1020 (Security of Prescription Area) requires the following:

(1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those drugs.

(2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs.

(3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041-2100.

(4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area.

(5) Any security system deviating from the requirements of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such security system, as approved by the Board, shall be maintained in the pharmacy.

Finally, you should expect that the Board of Pharmacy investigation will continue until all discrepancies in inventory and systems have been understood and corrected. To the extent you are pro-active and take charge (if you don’t lead the investigation, a pharmacy inspector will), you will improve your chances of a positive and quick resolution. I would be remiss not to add that you will need legal counsel to guide you through the process.

I just received a notice of proposed discipline – what does this mean?

If you have received a notice of proposed disciplinary action, it most likely means that your licensing board, whether it be the Oregon Medical Board, the Oregon Board of Pharmacy, or the Oregon State Board of Nursing (or any of the other state licensing boards in Oregon), has concluded its investigation, reached certain conclusions about your practice standards, and is now proposing to discipline you for one or more deficiencies, by imposing one or more sanctions upon you.

The range of sanctions

Sanctions include being reprimanded; having your license to practice medicine, pharmacy, or nursing temporarily suspended, indefinitely suspended, or permanently suspended; or having your license to practice medicine, pharmacy, or nursing permanently revoked. Sanctions further include monetary fines, continuing education, recurrent training, the imposition of a mentor and monitoring, and periods of probation (five years is not uncommon). One or more sanctions, in combination, may be imposed by your licensing board, as the board sees fit.

Illicit drug use; impairment; fitness to practice your profession

If illicit drug use or abuse is involved, then you should further expect to complete an assessment and the drug treatment necessary to restore your health. If you are impaired, or your fitness to practice as a physician, pharmacist, or nurse is at issue, these assessments may be extensive and expensive, and may require travel to an approved facility.

The board’s concerns

The general concern of all healthcare licensing boards is to ensure patient safety and the competency of the individual practitioner. If a pharmacy is involved, the board will further want to ensure the security of the drug inventory.

What are the next steps?

If you haven’t been represented by licensure counsel thus far, the next step is to retain legal counsel. Too many health care providers wait to obtain legal advice until shortly before or after being interviewed by field investigators or licensing boards, or worse, after receiving written findings and proposed sanctions, i.e., a notice of proposed disciplinary action. At this point, your licensing board has reached conclusions about your practice, and at this late date, your opportunity to participate and influence proposed findings and sanctions has been greatly diminished, but there is still important work to do. The next step is to negotiate a settlement, or to proceed to an administrative hearing. No matter what you do, you need legal counsel. You have waited too long if you have not retained legal counsel at this point.