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Minnesota Board
of Pharmacy |
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Minnesota Board
of Pharmacy |
OVERVIEW OF THE COMPLAINT REVIEW PROCESS
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, controlled
substance researchers, drug wholesalers and drug manufactures. The Board approves licenses
or registrations for these individuals or businesses, and also decides when to impose
disciplinary action.
B. Board Staff
The staff of the Board of Pharmacy are employees of the State of Minnesota who handle the day to day operations of the Board. Approximately five people are employed to gather licensing and complaint information for the Board's review and to handle administrative functions. Five Board Surveyors, all of whom are pharmacists, are employed to inspect all licensees located in the state and to investigate complaints.
II. PROTOCOL FOR COMPLAINT PROCESSING
A. Complaints and Reports:
Information regarding Pharmacists who may be in violation of the Minnesota Pharmacy Practice Act
(Minn. Stat. 151), comes to the attention of the Board through written
complaints/reports. Complaints/reports may be filed by anyone. Complaints and reports are
not public information and may not be discussed with anyone except the respondent (subject
of the investigation) and the complainant or reporter. The Board is mandated to
investigate all jurisdictional complaints against individuals it regulates. In other
words, if the complaint alleges a violation of the Pharmacy Practice Act, the complaint
will be investigated. An example of a non-jurisdictional complaint is one which alleges an
excessive fee for services performed. The Board does not have the authority to determine
how much a pharmacy charges for services.
B. File Set up and Assignment:
1. Set Up: When a jurisdictional complaint is received, a file is assigned to a
surveyor who will have responsibility for that file until no further action is required.
2. Beginning the Investigation: For most complaints, the surveyor will obtain a response from the respondent and all pertinent records. The completed investigation will be returned to the Board for appropriate follow up. Allegations of active chemical dependency or mental/physical illness presenting an imminent danger to the public are investigated on an individual basis.
1. Committee on Professional Standards (COPS)
a. The Committee on Professional Standards (COPS) is comprised of two Board members
who have agreed to serve on the Committee and are appointed for a one year term, the
Board's Executive Director, and the Board's Legal Counsel.
b. The COPS meets the day before each Board meeting to discuss and decide pending disciplinary matters and complaints, and to meet with respondents who have been asked to appear before the COPS.
a. Dismissal. The Committee may choose to dismiss the complaint and so inform the respondent.
b. Continue, pending further investigation or some other specified action.
c. Corrective Action. The Committee may recommend that the respondent enter into an Agreement for Corrective Action. This Agreement is a contract between the Committee and the respondent in which the respondent agrees to take certain remedial action, usually educational, to correct problems identified in the Complaint Review process.
Corrective action is not disciplinary action, but it is a public document. The Agreement is ratified by the Committee chair and does not require action by the full Board.
d. Disciplinary Action:
(1) The Committee may recommend that the respondent's license be conditioned or restricted.
(2) Should the Committee determine that the respondent's license should be restricted or suspended, or if it feels a written reprimand is warranted, it will request the Board's attorney to prepare a Notice of Conference and serve it on the licensee.
(3) The Committee may recommend that the respondent's license be immediately suspended. If the Board approves the summary suspension, based on a finding that the respondent has violated the Pharmacy Practice Act and the respondent's continued practice creates a serious risk of harm to the public, the respondent is entitled to a hearing within 30 days of the issuance of the suspension order.
III. THE CONFERENCE
A. Generally
1. A conference with a licensee is a non-public meeting between the Board's Complaint Review Committee (one Board member, the Board's executive director, and the Board's attorney), the licensee, and his or her attorney.
2. At the conference, the allegations are presented to the licensee, and the licensee is given an opportunity to respond to the allegations. An attempt is then made to find a way to resolve the matter through a stipulation and order.
IV. THE STIPULATION AND ORDER
A. Generally
1. The Stipulation is an agreement between the respondent and the Complaint Review Committee in which the respondent agrees that certain restrictions should be imposed on their pharmacy license as a result of the Committee having identified areas in which the respondent violated the Pharmacy Practice Act.
2. The Order is issued by the full Board when it has reviewed and ratified the Stipulation between the Complaint Review Committee and the respondent. The Order implements the terms of the Stipulation. The Stipulation and Order are incorporated into one written instrument.
3. When the Complaint Review Committee finds the respondent is in violation of the Pharmacy Practice Act, it will ask the respondent to voluntarily enter into a Stipulation and Order to place restrictions on their license.
4. Should the respondent refuse to agree to stipulate to the restrictions offered by the Complaint Review Committee, or, if the full Board rejects the proposed Stipulation and Order, the matter may proceed to a contested case hearing initiated under the Administrative Procedures Act. The 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.
V. HEALTH PROFESSIONALS SERVICE PROGRAM:
A. Description: In 1994, legislation for the Health Professionals Services Program (HPSP), Minn. Stat. ``214.31-214.37, was approved. HPSP serves several boards, including the Board of Pharmacy. HPSP is a non-disciplinary approach to monitoring Pharmacists who are unable to practice with reasonable skill and safety by reason of illness, use of alcohol, drugs, chemicals, or any other materials, or as a result of any mental, physical, or psychological condition.
B. Ineligible Licensees: Participation in HPSP is not permitted for certain licensees, including those accused of sexual misconduct or those who have been terminated from HPSP for non-compliance.
C. Location: The address for HPSP is
Energy Park Place
1380 Energy Park Lane
Suite 202
St. Paul, MN 55108
Telephone 651-643-2120
FAX 651-643-2163
Questions and Answers About the Complaint Review Process
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