THE MISSISSIPPI LEGISLATURE

The PEER Committee conducted a review of the Mississippi Board of Pharmacy. PEER conducted the review pursuant to the authority granted by MISS. CODE ANN. Section 5-3-57 et seq. (1972). This review is a “cycle review,” which is not driven by specific complaints or allegations of misconduct.

In conducting this review, PEER first determined whether regulation of the pharmacy profession is necessary in order to reduce risks to the public. Once PEER established the public need for regulation of the pharmacy profession, PEER then evaluated how well the board carries out its two primary regulatory functions: (1) licensure of pharmacists and registration of pharmacy technicians, and (2) enforcement of state laws, rules and regulations governing the practice of pharmacy in Mississippi.

The Legislature created the Board of Pharmacy in 1916 to license pharmacists, regulate the practice of pharmacy, and enforce laws regarding the sale of morphine among practitioners.

Currently, the Board of Pharmacy regulates 1,422 pharmacies doing business in the state of Mississippi; 3,331 licensed pharmacists; 3,415 registered technicians; and 1,485 other providers and facilities. From FY 1999 to FY 2003, the number of regulated pharmacies and other related facilities grew by 7% and the number of licensed pharmacists grew by 10%.

The nature of pharmaceutical services requires adherence to written orders of individuals authorized by law to prescribe drugs. Because the practice of pharmacy includes dispensing, compounding, and administering prescribed substances, incompetent practices would negatively impact healthcare. Due to the fact that prescribed substances may contain narcotic agents, regulation of this profession becomes even more essential.

The Board of Pharmacy does not have formal, written criteria for accepting or rejecting applicants based on their criminal histories. State law requires pharmacists and pharmacy technicians to “be of good moral character,” but the board has no definition or criteria related to “moral character” to serve as a basis for acceptance or rejection of a candidate. Also, the board accepts self-reporting of criminal history rather than initially utilizing background check resources of the Department of Public Safety or Federal Bureau of Investigation. As a result, the board may have compromised the security of controlled substances and increased risk to the public.

The board provides assurance to the public of applicants’ competency to practice the profession of pharmacy by requiring passage of a validated national pharmacy examination. However, because the board’s examination of knowledge of state pharmacy laws and regulations has not been properly developed or administered, the board cannot assure the public that applicants have sufficient knowledge of state pharmacy laws and regulations, which constitute the environment in which they plan to practice. Since 1999, Mississippi has had a 5% failure rate on the first attempt of the state pharmacy exam; all candidates have passed upon re-examination. This relatively low failure rate illustrates that the examination may not have been properly developed and raises questions about the value that the state test provides.

As part of its enforcement responsibilities, the Board of Pharmacy conducts inspections of pharmacies and related facilities, conducts investigations of possible violations of pharmacy laws, and assesses penalties. PEER found problems with the number and frequency of the board’s inspections, the assignment of compliance agents to inspection regions, and compliance agents’ weapons certification.

Concerning the number and frequency of inspections, due in part to increasing demands on the Board of Pharmacy’s staff to conduct investigations, during the last five years the number of completed pharmacy and other provider inspections decreased by 24%, while the number of pharmacies and facilities subject to inspection grew by 7%. In FY 2003, the board’s compliance agents inspected 794 of 1,849 eligible pharmacies and facilities.

Concerning the assignment of compliance agents to inspection regions, the Board of Pharmacy has not established logical, written criteria for assigning compliance agents to inspection regions in a manner that makes the best use of agency resources. The board’s assignments do not minimize travel distance and resulting expenses to the state and do not take into account time management principles with which to maximize time available for conducting inspections.

Concerning compliance agents’ weapons certification, although their job description does not require the Board of Pharmacy’s compliance agents to perform law enforcement duties, state law confers upon these agents the authority of sworn law enforcement officers. The law allows these agents to carry a gun, but does not require them to complete minimum standards training for firearms. Thus the state has incurred the risk of agents with insufficient training carrying firearms without the demonstrated need to do so.

Without access to a source with current comprehensive policies and procedures, the staff must rely on other staff members, who may or may not provide correct information, thus risking errors in licensing, enforcement, and general administration.

1. The Board of Pharmacy should determine how it will enforce requirements of MISS. CODE ANN. Section 73-21-85 and 73-21-111 (1972) for pharmacists and pharmacy technicians to “[b]e of good moral character.” One option would be to develop a Code of Professional Ethics, Character and Reputation such as is employed by the Board of Registration for Professional Engineers and Land Surveyors (see Appendix B, page 28), and require that pharmacists observe such a code or face penalties.

   The Board of Pharmacy should then adopt formal, written criteria for accepting or rejecting pharmacist or pharmacy technician applicants on the basis of their criminal histories. In particular, these criteria should address applicants who have misdemeanor or felony convictions for violating federal or state laws governing alcohol, controlled substances, or theft.

2. The Legislature should amend MISS. CODE ANN. Section 73-21-85 and 73-21-111 (1972) to require the Board of Pharmacy to conduct background checks of applicants for a pharmacist’s license and pharmacy technician’s registration in order to ensure that they meet the statutory qualifications to “[b]e of good moral character” and further, to direct the Department of Public Safety to assist the board in conducting the background checks.

3. The Board of Pharmacy should ensure that its state pharmacy examination complies with professional testing standards, such as those promulgated by the Council on Licensure, Enforcement, and Regulation (CLEAR). The Board of Pharmacy should construct the examination so as to assure adequate coverage of the Pharmacy Practice Act, Uniform Controlled Substances Law, and most recent updates of pharmacy regulations.

4. The Board of Pharmacy should conduct a risk-based needs analysis to determine the best use of the two new positions authorized for FY 2005. The objective should be to use these positions in the most effective and efficient manner that will minimize risk to the public.

5. The Board of Pharmacy should conduct a risk-based needs analysis to determine the appropriate inspection cycle for pharmacies and regulated facilities. The board should adopt the results of the analysis into formal, written policy.

6. The Board of Pharmacy should adopt written criteria for making staff assignments to the pharmacy inspection regions. These criteria should seek to:

   • minimize state travel cost (gas, oil, and maintenance);

   • minimize travel distance for inspectors; and,

   • maximize available inspection time during each workday.

7. The Legislature should amend MISS. CODE ANN. Section 45-6-3 (1972) to remove any authority in law for compliance agents to function as law enforcement officers.

   Further, the Legislature should amend MISS. CODE ANN. Section 41-29-159 (1972) to provide that the only personnel of the Board of Pharmacy authorized to carry out law enforcement functions shall be those law enforcement officers within the meaning of MISS. CODE ANN. Section 45-6-3 (1972) and who are trained in accordance with MISS. CODE ANN. Section 45-6-1 et seq. (1972).

8. The Board of Pharmacy should adopt a policy that prohibits compliance agents from performing any sworn law enforcement officer duties, including carrying weapons, in conducting compliance inspections and assisting law enforcement officers in criminal investigations.

9. The Board of Pharmacy should develop policy and procedure manuals for its licensing and enforcement operations and ensure that its administrative and compliance manuals are comprehensive and current.

10. The Board of Pharmacy should establish a formal internal training program for its enforcement and licensing operations in order to minimize the possibility of administrative, communication, and operational errors.