Guidelines for Establishing Pharmacy Peer Review Committees, Summaries of Pharmacy

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May 2019

Guidelines for Establishing

Pharmacy Peer Review Committees

Texas State Board of Pharmacy

333 Guadalupe Street, Suite 500

Austin, TX 78701

Table of Contents

Appendix D Example of Community Pharmacy Setting Quality Standards,

• Introduction
  • • Source
  • • What is Peer Review?
  • • Is Peer Review Confidential?
• Basic Steps Involved in Starting a Pharmacy Peer Review Process
  • • Selecting Members for the Pharmacy Peer Review Committee............
  • • Developing Reporting Procedures and Forms…………………………....
  • • Setting Quality Standards, Processes, and Indicators
  • • Evaluating Quality-Related Activities Against the Standard
    • Meetings • Conducting Periodic Self-Audits at the Peer Review Committee
  • • Making Recommendations and Maintaining Records
• Appendices
• Appendix A Definitions
• Appendix B Texas Pharmacy Act......................................................................................
• Appendix C Resources
  • Prescription.................................................................................................... Processes, and Indicators Involved in a Properly Dispensed
• Appendix E Community and Hospital Pharmacy Error Reporting Form Examples
  • • Community Pharmacy
  • • Hospital Pharmacy
• Appendix F Pharmacy Peer Review Committee Reporting Form Example

Is Peer Review Confidential?

The Texas Pharmacy Act, specifically Sections 564.103, 564.104, and 564.105, T EX.O CC .C ODE A NN. Title 3, highlights the following provisions regarding confidentiality of the peer review process (see Appendix B):

• Establishing Confidentiality

All proceedings and records of a pharmacy peer review committee are confidential, and all communications made to a pharmacy peer review committee are privileged, unless a court determines a proceeding, record, or communication is relevant to an anticompetitive action or a discrimination action under 42 U.S.C. §1983.

• Permissive Release of Peer Review Records

The final report and any other communications, records, or proceedings of a peer review committee may be released to another pharmacy peer review committee, appropriate state or federal agencies (including licensing entities) and national accreditation committees, or the state board of registration or licensure of this or any other state.

• No Waiver of Confidentiality

Disclosure to the affected pharmacist of any confidential information of the peer review committee does not constitute waiver of the confidentiality provision.

• Not Subject to Subpoena (Other than a Board Subpoena)

Unless disclosure is required or authorized by law, records or determinations of or communications to a pharmacy peer review committee are not subject to subpoena or discovery and are not admissible as evidence in any civil judicial or administrative proceeding without waiver of confidentiality in writing by the committee. However, all persons, including governing bodies and medical staffs of health care entities, shall fully comply with a subpoena issued by the Board for documents or information. Failure to comply with a subpoena issued by the Board may result in disciplinary action by the Board or other appropriate licensing agency against the facility or individual. Disclosure of documents or information to the Board in response to a Board subpoena does not constitute waiver of the privilege associated with a pharmacy peer review committee proceeding.

• May be Used in Civil and Criminal Actions

If a pharmacy peer review committee, a person participating in peer review or any organization named as a defendant in any civil action filed as a result of participation in peer review may use otherwise confidential information in the committee’s, person’s, or organization’s own defense or in a claim or suit under Section 564.106(b), a plaintiff in the proceeding may disclose records or determinations of, or communications to, a peer review committee in rebuttal to information supplied by the defendant.

Basic Steps Involved in Starting a Peer Review Process

Selecting Members for the Pharmacy Peer Review Committee

The composition of the committee is the responsibility of the entity which establishes the committee. The committee should include individuals familiar with pharmacy practice, continuous quality improvement, causes and prevention of quality related activities, and the work environment. At a minimum, a peer review committee should consist of two or more people and be predominantly composed of peers which may include pharmacists, pharmacist-interns, pharmacy technicians, nurses, physicians, other health-care professionals, attorneys, and/or other personnel necessary for the proper functioning of the committee. A signed statement should be obtained from each member agreeing to maintain the confidentiality of the pharmacy peer review committee.

Considerations in Selecting Members for the Pharmacy Peer Review Committee

Composition

Two or more people

Predominantly peers of those involved in the provision of pharmacy services

To the extent possible, should be predominantly composed of people familiar with the following:

• Pharmacy practice;
• Continuous quality improvement;
• Work environment; and
• Causes and prevention of quality-related activities.

Examples of Potential Members

• Pharmacists;
• Student Pharmacist-Interns;
• Pharmacy Technicians/Trainees;
• Nurses;
• Physicians;
• Other health-care related professionals;
• Attorneys;
• Representatives of management (not for the purpose of performance evaluations); and/or
• Others, as necessary for the proper functioning of the committee.

Confidentiality Requirements

A signed statement should be obtained from each member agreeing to maintain the confidentiality of the Peer Review Committee.

The following are examples of information that could be included in the pharmacy report

for quality related events or errors:

A Community Pharmacy Error Reporting Form could contain the following information:

• Age of the patient;
• Physician’s name;
• Prescription number;
• Notation if a new or refill prescription;
• If a new prescription, notation of how received;
• Name and strength of the drug involved in the quality-related activity;
• Description of the quality-related activity;
• How was the pharmacy notified of the error;
• Date and time the quality-related event occurred;
• Record drug regimen review and counseling activities;
• Date and time the physician was notified and how notified;
• Physician’s instructions;
• Action(s) taken by the pharmacy;
• Name and title of person completing the report.

A Hospital Pharmacy Error Reporting Form could contain the following information:

• Age and location of the patient;
• Date and time of the quality-related activity;
• Prescription number
• Physician’s Name
• Description of the quality-related activity;
• Prescribed route of administration and actual route of administration;
• How was the error discovered;
• Amount of time lapsed before discovery of the error;
• Physician’s orders as written;
• Additional intervention(s) needed (if required);
• Adverse patient outcome(s) or change in condition;
• To whom the quality-related event was reported to and when; and
• Name and title of person completing the report.

See Appendix E to view examples of Error Reporting Forms.

Setting Quality Standards, Processes, and Indicators

One of the initial duties of a pharmacy peer review committee is to establish standards for quality against which pharmacy services will be evaluated. Once a standard has been established, indicators should be identified to measure whether the standard is being met. As with any quality improvement process, standards and indicators will continually evolve.

Considerations in Setting Quality Standards, Processes, and Indicators

Establish Quality Standards and Processes

• Develop standards to evaluate quality-related activity.
• Develop standards sufficient to permit a self- assessment of the quality of pharmacy services provided to patients served.
• Develop standards sufficient to permit comparison of quality standards for one period of time to another.
• Describe the process or necessary steps required to meet a quality standard.

Establish Indicators

Each standard should have measurable indicators for specific actions which, when properly performed, result in a quality product.

See Appendix D to view a Community Pharmacy Example of Setting Quality Standards, Processes, and Indicators

Evaluating Quality-Related Activities Against the Standard

Information gathered during an ongoing assessment should be evaluated to determine the quality of pharmacy services. For a quality-related activity, the committee should review the pharmacy systems and/or processes for deficiencies to identify possible contributing factors. A process for evaluating all quality-related activities is recommended. The pharmacy peer review committee may wish to establish priorities and formally review reports relating to those priorities. The committee may consider priorities based on frequency, risk, or level of impact.

Considerations in Evaluating Quality-Related Activities Against the Standard

Determine What to Review

• Set priorities for what the peer review committee will review
• When establishing priorities, the committee needs to consider the frequency, risk, and level of impact.

Discussions

• Should be candid and non-punitive
• Intended to determine where quality performance failed

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Conducting Periodic Self-Audits at the Peer Review Committee Meetings

Peer review is a part of the facility's continuous quality improvement program. An essential component of any continuous quality improvement program is to periodically evaluate how the peer review is improving quality through the periodic self-assessment. Questions should be asked, such as:

• Are the quality standards being met?
• Are the quality standards adequate?
• Do the results, over time, show an improvement in quality for the pharmacy?

The self-audit provides feedback for the entire peer review system. These self-audits should be conducted at least annually unless directed to occur quarterly per Board Order, the results evaluated, and appropriate adjustments made to the standards or process.

Considerations in Conducting Periodic Self-Audits

Conducted

At least annually or more frequently as determined by the committee or the Board.

Periodically Evaluate How Well Peer Review is Working to Improve Quality

Questions like the following should be asked:

• Are the quality standards being met?
• Are the quality standards adequate?
• Do the results over time show an improvement in quality?

Adjustments to the Peer Review Process

Changes should be identified and made to any portion of the peer review process which does not facilitate improvement in the quality performance.

See Appendix C for a list of resources related to the peer review process as a part of a continuous quality improvement program.

Making Recommendations and Maintaining Records

When needed, based upon the evaluations, the pharmacy peer review committee should make written recommendations to appropriate entities. Although the pharmacy peer review process is intended to identify and make recommendations to improve performance through education, training, and changes to systems and processes, the committee may occasionally identify individuals who can no longer practice safety. In those situations, where the authority and actions within the facility may not be enough to protect the public, the committee should recommend to management, or other appropriate entity, that the individual be reported to the appropriate regulatory authority.

If a pharmacy peer review committee identifies a concern that could result in censure, license suspension, restriction, limitation, or revocation by the board or denial of membership or privileges in a health-care entity, the affected individual shall be provided a written copy of the recommendation of the pharmacy peer review committee and a copy of the committee's final decision, including a statement of the basis for the decision.

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Reporting

The committee shall make a record of the periodic self- audit to include at a minimum:

• Date and location
• Names of attendees and their title
• Any changes made as a result of a previous recommendation

If necessary due to additional quality-related events, the following should also.be recorded:

• Description
• Discussion
• Recommendations
• Changes Made

Reporting of Recommendations

Determine the appropriate entity within the organization with the authority to evaluate and implement the recommendations.

Protection of the Public

If the committee identifies an individual who can no longer practice safely, the peer review committee should recommend to management, or other appropriate entity, that the individual be reported to the appropriate regulatory authority.

Records

A complete written record of the pharmacy peer review committee’s review should be maintained by the committee for a minimum of two years.

To maintain the confidentiality of peer review records, they must be kept separate from patient or drug order records.

A copy of the record(s) must be submitted to the Board if requested.

Notification

If a pharmacy peer review committee takes action that could result in censure, license suspension, restriction, limitation, or revocation by the Board or denial of membership or privileges in a health care entity, the affected pharmacist shall be provided a written copy of the recommendation of the pharmacy peer review committee and a copy of the committee’s final decision, including a statement of the basis for the decision.

A complete, written record of the pharmacy peer review committee's review should be

maintained by the committee for a minimum of two years at the location and made

available for inspection by Board staff upon request.

Appendix A Definitions

Continuous Quality Improvement Process - an ongoing process which improves the standards and procedures used to identify and evaluate quality-related activities and to improve patient care.

Indicator - an objective, measurable activity used to monitor and evaluate whether a process is performed within a set standard.

Peer - an individual who is of equal standing with another.

Pharmacy Peer Review Committee -

(A) a pharmacy peer review, judicial, or grievance committee of a pharmacy society or association that is authorized to evaluate the quality of pharmacy services or the competence of pharmacy personnel and suggest improvements in pharmacy systems to enhance patient care; or

(B) a pharmacy peer review committee established by the owner of a pharmacy or an employer that is authorized to evaluate the quality of pharmacy services or the competence of pharmacy personnel and suggest improvements in pharmacy systems to enhance patient care.

Pharmacy Peer Review Process - part of an ongoing, continuous quality improvement process which involves:

(A) the setting and periodic re-evaluation of standards for quality by which a pharmacy operation will be evaluated;

(B) the collection of data necessary to identify when those standards are not being met and data necessary to evaluate the reason(s) the deficiency occurred;

(C) an objective review of the data by an appropriate peer review committee to make recommendations for quality improvement; and

(D) an appropriate feedback mechanism to ensure that the process is operating in a manner which seeks to continually improves the quality of care provided to patients.

Quality Related Activity - a known or suspected medication error that reached the patient and/or a medication error that is intercepted prior to dispensing (i.e., near misses) including, but not limited to:

(A) a variation from the prescriber's drug order, including:

(1) an incorrect drug;

(2) an incorrect strength:

(3) an incorrect dose;

(4) an incorrect dosage form;

(5) an incorrect quantity;

(6) the drug to the wrong patient;

(7) inadequate or incorrect directions;

(8) inadequate or incorrect packaging:

(9) inadequate or incorrect labeling: and/or

(B) failure to identify and take appropriate action concerning drug regimen review; and/or

(C) failure to provide counseling or providing inadequate or incorrect counseling to a patient or patient's agent; and/or

(D) providing inadequate or incorrect information to health-care professionals involved in a patient's care.

Sec. 564.003. Disclosure of Certain Information.

(a) The board may disclose information confidential under Section 564.002 only: (1) during a proceeding conducted by the State Office of Administrative Hearings, the board, or a panel of the board, or in a subsequent trial or appeal of a board action or order; (2) to a pharmacist licensing or disciplinary authority of another jurisdiction; (3) under a court order; (4) to a person providing a service to the board, including an expert witness, investigator, or employee of an entity that contracts with the board, related to a disciplinary proceeding against an applicant or license holder, if the information is necessary for preparation for, or a presentation in, the proceeding; or (5) as provided by Subsection (b). (a-1) Information that is disclosed under Subsection (a) remains confidential and is not subject to discovery or subpoena in a civil suit and may not be introduced as evidence in any action other than an appeal of a board action. (a-2) Information that is confidential under Section 564.002 and that is admitted under seal in a proceeding conducted by the State Office of Administrative Hearings is confidential information for the purpose of a subsequent trial or appeal. (b) The board may disclose that the license of a pharmacist who is the subject of an order of the board that is confidential under Section 564.002 is suspended, revoked, canceled, restricted, or retired or that the pharmacist is in any other manner limited in the practice of pharmacy. The board may not disclose the nature of the impairment or other information that resulted in the board’s action.

Sec. 564.004. Immunity.

(a) Any person, including a board employee or member, peer review committee member, pharmaceutical organization committee member, or pharmaceutical organization district or local intervenor, who provides information, reports, or records under Section 564.001 to aid an impaired pharmacist or pharmacy student is immune from civil liability if the person provides the information in good faith. (b) Subsection (a) shall be liberally construed to accomplish the purposes of this subchapter, and the immunity provided under that subsection is in addition to any other immunity provided by law. (c) A person who provides information or assistance to the board under this subchapter is presumed to have acted in good faith. A person who alleges a lack of good faith has the burden of proof on that issue.

Sec. 564.005. Record of Report.

On a determination by the board that a report submitted by a peer review committee or pharmaceutical organization committee under Section 564.001 (a) or (b) is without merit, the board shall expunge the report from the pharmacist’s or pharmacy student’s individual record in the board’s office.

Sec. 564.006. Examination of Report.

A pharmacist, a pharmacy student, or an authorized representative of the pharmacist or student is entitled on request to examine the peer review or the pharmaceutical organization committee report

submitted to the board and to place into the record a statement of reasonable length of the pharmacist’s or pharmacy student’s view concerning information in the report.

•••

SUBCHAPTER C. PHARMACY PEER REVIEW

Sec. 564.101. Definitions.

In this subchapter:

(1) “Pharmacy peer review committee” means: (A) a pharmacy peer review, judicial, or grievance committee of a pharmacy society or association that is authorized to evaluate the quality of pharmacy services or the competence of pharmacists and suggest improvements in pharmacy systems to enhance patient care; or (B) a pharmacy peer review committee established by a person who owns a pharmacy or employs pharmacists that is authorized to evaluate the quality of pharmacy services or the competence of pharmacists and suggest improvements in pharmacy systems to enhance patient care. (2) “Pharmacy society or association” means a membership organization of pharmacists that is incorporated under the Texas Non-Profit Corporation Act (Article 1396-1.01 et seq., Vernon’s Texas Civil Statutes) or that is exempt from the payment of federal income taxes under Section 501(c) of the Internal Revenue Code of 1986.

Sec. 564.102. Pharmacy Peer Review Committee.

(a) A pharmacy peer review committee may be established to evaluate the quality of pharmacy services or the competence of pharmacists and suggest improvements in pharmacy systems to enhance patient care. (b) The committee may review documentation of quality-related activities in a pharmacy, assess system failures and personnel deficiencies, determine facts, and make recommendations or issue decisions in a written report that can be used for continuous quality improvement purposes. (c) A pharmacy peer review committee includes the members, employees, and agents of the committee, including assistants, investigators, attorneys, and any other agent that serves the committee in any capacity.

Sec. 564.103. Confidentiality.

(a) Except as otherwise provided by this subchapter, all proceedings and records of a pharmacy peer review committee are confidential and all communications made to a pharmacy peer review committee are privileged. (b) If a court makes a preliminary finding that a proceeding, record, or communication described by Subsection (a) is relevant to an anticompetitive action or an action brought under federal civil rights provisions under 42 U.S.C. Section 1983, then the proceeding, record, or communication is not confidential to the extent it is considered to be relevant. (c) The final report of, and any written or oral communication made to, a pharmacy peer review committee and the records and proceedings of the committee may be disclosed to another pharmacy peer review committee, appropriate state or federal agencies, national accreditation bodies, or the state board of registration or licensure of this or any other state.

(b) A pharmacy peer review committee, a person participating in peer review, or a health care entity named as a defendant in any civil action filed as a result of participation in peer review may use otherwise confidential information obtained for legitimate internal business and professional purposes, including use in the committee’s, person’s, or entity’s own defense. The use of the information does not waive the confidential and privileged nature of pharmacy peer review committee proceedings.

Appendix C Resources

The list of resources listed below is not all inclusive but is provided to you as a reference for entities who may be developing a peer review process as part of a continuous quality improvement program.

Organizations Advancing Quality of Pharmacy Services:

Institute for Safe Medication Practices https://www.ismp.org

The National Academies of Sciences, Engineering, and Medicine http://nationalacademies.org

Pharmacy Quality Alliance https://www.pqaalliance.org

The Institute for Healthcare Improvement and the National Patient Safety Foundation (IHI/NPSF) https://www.npsf.org http://www.ihi.org

National Coordinating Council for Medication Error Reporting and Prevention https://www.nccmerp.org

Professional Associations

Academy of Managed Care Pharmacy http://amcp.org

American College of Clinical Pharmacy https://www.accp.com

American Pharmacists Association https://pharmacist.com

American Society of Consultant Pharmacists https://www.ascp.com

American Society of Health-System Pharmacists https://www.ashp.org

National Association of Chain Drug Stores https://www.nacds.org

National Community Pharmacists Association https://www.ncpanet.org

Pharmaceutical Care Management Association https://www.pcmanet.org