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Overview of Complaints

MINNESOTA BOARD OF PHARMACY
Brief Overview of Complaint and Disciplinary Processes

I. INTRODUCTION

A. The Board of Pharmacy
1. The Board of Pharmacy consists of seven Board members appointed by the Governor; five Board members must be pharmacists, and two members must be public members.
2. The Board regulates pharmacists, pharmacies, pharmacy technicians, pharmacy interns, controlled substance researchers, medical gas distributors, drug wholesalers and drug manufacturers. The Board issues licenses or registrations for these individuals or businesses, investigates complaints against them and decides when to impose disciplinary action.
B. Board Staff. The staff of the Board of Pharmacy consists of employees of the State of Minnesota who handle the day to day operations of the Board. Nine people are employed to gather licensing and complaint information for the Board's review and to handle administrative functions. Seven Board Surveyors, all of whom are licensed pharmacists, are employed to inspect all licensed facilities located within the state and to investigate complaints.

II. PROTOCOL FOR COMPLAINT PROCESSING

A. Complaints and Reports
Information regarding licensees and registrants who may be in violation of the laws and rules administered by the Board, comes to the attention of the Board through inspections or written complaints. Complaints may be filed by anyone. Complaints are not public information and may not be discussed with anyone except the respondent (subject of the investigation) and the complainant (the individual who files the complaint). The Board is required to investigate all jurisdictional complaints against individuals and businesses that it regulates. In other words, if the complaint alleges a violation of a law or rule administered by the Board, the complaint will be investigated. An example of a non-jurisdictional complaint is one which alleges an excessive cost for prescriptions or for services performed by a pharmacy. The Board does not have the authority to regulate how much a pharmacy charges for prescriptions or services.
B. Complaint Assignment and Investigation
  1. When a jurisdictional complaint is received, office staff enters it into the Boards licensing and regulatory database system. The file is usually assigned to a surveyor, who will investigate the complaint. Some complaints are referred to the Office of the Attorney General for investigation.
  2. For most complaints, the surveyor will perform a number of tasks, including: visiting the pharmacy in question, interviewing its employees and reviewing its policies and procedures. The Surveyor will also look at and obtain copies of any relevant records and documents. The Surveyor will write a complaint investigation report and give it to the Boards Chief Surveyor for processing.
C. Complaint Review Panel (CRP)
  1. The CRP is comprised of two Board members and is staffed by the Boards Executive Director, Deputy Director and Chief Surveyor. The CRP receives legal counsel from an Assistant Attorney General.
  2. The CRP meets regularly to review complaints for which investigations have been completed. The CRP may take one of several actions:
  • A continuance occurs when the CRP wants additional information about the complaint. The Surveyor may be directed to gather the additional information or the Office of the Attorney General may be asked to conduct an investigation.
  • Dismissal of the complaint usually occurs when the investigation of the complaint does not substantiate the allegation that was made. (In other words, when the evidence gathered does not prove that the alleged violation of law or rule actually occurred). Dismissal may also occur when the allegations are substantiated, but when discipline is not warranted. (That is, the violation of law or rule that occurred is very minor).
  • The CRP may decide that disciplinary action is not warranted but that the licensee or registrant needs to take appropriate corrective action. In that case, the CRP will ask the respondent to enter into an Agreement for Corrective Action(ACA). This agreement is a contract between the CRP and the respondent in which the respondent agrees to take certain remedial action to correct problems identified in the complaint review process. The remedial action might consist of taking additional training, developing new policies and procedures, retaking the pharmacy law exam, etc. Even though an ACA is not a form of discipline, it is a public document. An ACA is signed by a member of the CRP and does not require action by the full Board.
  • The CRP may decide that disciplinary action is appropriate. If that is the case, the Boards Executive Director and Deputy Director will work with the Assistant Attorney General to schedule a conference between the licensee or registrant with the CRP. The licensee or registrant will receive a formal Notice of Conference that provides the date and time of the conference, lists the allegations and provides information about the possible outcomes of the conference.
  1. A conference between the CRP and a licensee or registrant is not open to the public. Only the members of the CRP, Board staff, the Assistant Attorney General and licensees/registrants and their attorneys are allowed to attend the conference. At the conference, the allegations are presented to the licensee/registrant, who is given an opportunity to respond to the allegations.
  2. At the conclusion of the conference, the CRP may decide that one or more of several disciplinary actions is appropriate: dismiss the complaint; place restrictions on the license or registration of the respondent; suspend or revoke the license or registration of the respondent; ask the licensee or respondent to voluntarily surrender the license or registration; issue a reprimand; or assess a civil penalty (i.e. fine).
D. Disciplinary Orders
  1. The most common order issued by the Board is called a Stipulation and Consent Order. The Stipulation is an agreement between the respondent and the CRP as to the facts and appropriate discipline for the case.
  2. The Order is issued by the full Board when it has reviewed and ratified the Stipulation between the CRP and the respondent. The Order implements the terms of the Stipulation. The Stipulation and Consent Order are incorporated into one written document.
  3. If the respondent refuses to agree to stipulate to the facts and discipline proposed by the CRP, the matter may proceed to a contested case hearing initiated under the Administrative Procedures Act. An Administrative Hearing is held before an Administrative Law Judge (ALJ) and involves the presentation of testimony and submission of exhibits in a manner similar to a civil trial. If the Board is successful at the contested case hearing, the ALJ will indicate that the Board's position is correct and make a recommendation which will be limited to discipline or no discipline. After reviewing the ALJ report, the Board may issue a Findings of Fact, Conclusions of Law and Order, which describes the disciplinary action taken against the respondent.
  4. Disciplinary orders are public documents and they are made available on the Boards Web site.
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