It is a busy day at the pharmacy, the telephone rings, and on the telephone is an investigator from the Nebraska Department of Health and Human Services (“Department”). The investigator requests that the pharmacist answer a series of questions. The investigator also requests that the pharmacist produce documents. The pharmacist knows that failure to cooperate may itself be grounds for discipline.1 How should the pharmacist respond to the inquiry?
The Department is responsible for the investigation of pharmacists licensed to practice in the State of Nebraska. An investigation is generally initiated upon receipt of a complaint by the Department. Upon receipt of a complaint, the Department reviews the complaint internally as well as potentially with the Nebraska Board of Pharmacy or the Nebraska Attorney General’s Office. The complaint will either be dismissed or referred for investigation.
In many cases, a pharmacist does not consult with counsel during an investigation and contacts counsel for the first time when a petition for discipline has been or is about to be filed. Oftentimes, this puts the pharmacist at a significant disadvantage.
This article focuses on the period of time between the Department’s decision to initiate an investigation and the ultimate decision to institute disciplinary proceedings.2
Development of a Balanced Factual Record
The best result a pharmacist can obtain in an investigation is to persuade the Department, Board of Pharmacy and the Attorney General’s Office that no disciplinary action is appropriate. The next best result would be a negotiated settlement under disciplinary terms the pharmacist believes are fair given the conduct in question. The final option would be to contest the Department’s allegations at a formal hearing and convince the administrative law judge and the Department that either no, or a limited, disciplinary action is appropriate.
The key to obtaining a favorable result under any of the above scenarios is the development of a balanced factual record which puts the pharmacist’s alleged conduct in the best possible light. Unfortunately, at the point a petition for discipline is ready to be filed, the factual record is virtually complete from the Department’s perspective. Accordingly, any decision regarding the filing of a petition for discipline will likely be based on the Department’s version of the facts.
This can be problematic for a variety of reasons. First, the pharmacist has likely been formally and informally interviewed in person and by telephone by the Department investigator. The pharmacist may not have any notes or other accurate record of the interviews to clarify or question the Department’s version of the facts. The Department, on the other hand, often has detailed notes, and in some cases, transcribed recordings of the interviews.3
Second, during the course of the investigation, the pharmacist may have produced documents to the Department informally or in response to a subpoena without identifying4 or retaining copies of the produced documents. This leaves the pharmacist in the dark with respect to which documents the Department and the Attorney General’s Office may be relying upon in connection with any decision to institute disciplinary proceedings against the pharmacist.
Third, the pharmacist may have filled out a Prescription Error Report in connection with an incident under investigation. In doing so, the pharmacist may have given little or no consideration to the impact the responses in such a report may have on a subsequent investigation.
Finally, the pharmacist may not realize that in some cases a copy of the Department’s investigative report may be obtained, reviewed and discussed with the Attorney General’s Office prior to the filing of any petition for discipline against the pharmacist.
During the course of an investigation, a pharmacist should also keep in mind the following collateral considerations:
Professional Liability Insurance
Any applicable professional liability insurance policies should be reviewed for notification requirements.
The Pharmacist’s Relationship with the Department
As noted above, failure to cooperate with a Department investigation may itself be grounds for discipline. The pharmacist therefore needs to consider how to maintain full cooperation with the Department (the pharmacist’s day to day regulator), while at the same time defending any prior conduct that may be called into question by the Department’s investigators.
In the event there is, or may be, a criminal investigation regarding the conduct that is the subject of a Department investigation, the pharmacist must give careful consideration to any statements the pharmacist provides to the Department in the event they are subsequently provided to criminal authorities.
The pharmacist must also give careful consideration to any statements the pharmacist provides to the Department in the event such statements become discoverable in any related civil litigation.
Controlled Substance Registration Certificate
In any investigation regarding controlled substances, a pharmacist must consider the effect on the status of any Controlled Substance Registration Certificate, or any renewals thereof.5
Counsel: Pros and Cons
Given the above considerations, a pharmacist may want to weigh the following factors in any decision whether to consult with counsel once the Department initiates an investigation:
Can counsel assist the pharmacist in truthfully and completely responding to the Department’s requests in a fashion that: (1) puts any alleged conduct by the pharmacist in the best light, and (2) takes into account related collateral considerations.
Counsel as Advocate
Can counsel identify and raise good faith legal or factual issues on behalf of the pharmacist. Further, if such issues are identified and raised by counsel rather than the pharmacist, does this prevent the pharmacist from being viewed as uncooperative.
Joint Defense Arrangements
Can counsel for the pharmacist work with counsel for other parties targeted in an investigation to share information about the investigation without raising privilege waiver concerns.
Consulting with counsel will obviously increase the out of pocket costs to the pharmacist in an investigation. The pharmacist will therefore have to weigh the future benefit of these costs.6
All investigations are unique and may require different levels of counseling. The above considerations should assist the pharmacist in determining what role counsel should play in an investigation.
1 172 NAC 128-009.9.
2 The Department’s website provides an excellent overview of the entire disciplinary process, which is beyond the scope of this article. See http://dhhs.ne.gov/publichealth/Documents/discproc.pdf.
3 Under Nebraska Law, the investigator may record the investigator’s telephone interviews with the pharmacist, unbeknownst to the pharmacist. Neb.Rev.St. § 86-290(2)(b)&(c).
4 Any document produced in an investigation should be stamped with unique sequential numbers in order to identify the source of the document in the event it surfaces later in the investigation as a key document.
5 If a Controlled Substance Registration Certificate is suspended, revoked, or expires during the pendency of an investigation, an informal temporary extension may be obtained from the DEA under certain limited circumstances. DEA reporting requirements regarding missing controlled substances must also be considered.
6 Note, however, that in some cases, professional liability insurance may cover all or a portion of counsel fees.
“This article appeared in the January/February 2006 issue of The Nebraska Mortar & Pestle.”