Establishing Pharmacist Peer Review Committees in Texas: Improving Patient Care & Quality, Study notes of Pharmacy

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Guidelines for Establishing Pharmacist

Peer Review Committees

Texas State Board of Pharmacy

333 Guadalupe Street

Austin, TX 78701-

May 2001

Contents

• Introduction
  • Source
  • What is Peer Review?
• Basic Steps to Implement Peer Review
  • 1. Selecting Members for the Pharmacy Peer Review Committee
  • 2. Setting Quality Standards and Indicators
  • 3. Developing Reporting Procedures and Forms
  • 4. Evaluating Activities Against the Standard
  • 5. Making Recommendations / Maintaining Records
  • 6. Conducting Periodic Self-Audits
• Background Information and Illustrations for Basic Steps
  • Confidentiality
  • Definitions
  • Illustrations for Basic Steps - Suggestions
• Appendices
  • Appendix A - Texas Pharmacy Act, Peer Review
  • Appendix B - Resources
    • Organizations Advancing Quality of Pharmacy Services
    • Professional Associations
    • Accreditation Organizations
    • Information Sources for Quality Standards
    • Regulatory Oversight Organizations
  • Appendix C - Sample Forms
    • Initial Report - Community Pharmacy Dispensing Error
    • Initial Report - Hospital Pharmacy Medication Error

Basic Steps to Implement Peer Review

1. 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 adverse quality- related events, and the work environment. At a minimum, a peer review committee should consist of two or more people and be predominantly composed of peer pharmacists. Other members may include pharmacist-interns, pharmacy technicians, nurses, physicians, other health-care professionals, attorneys, consumers, and/or other personnel necessary for the proper functioning of the committee. Supervisors may participate in the committee but not for the purpose of performance evaluations. 2. Setting Quality Standards 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 to determine whether pharmacy services are improving or declining. 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. 3. Developing Reporting Procedures and Forms The pharmacy peer review committee should develop reporting procedures and forms for: - an ongoing assessment of the pharmacy’s activities against the quality standards; and - an assessment of adverse quality-related events.

Procedures and forms should be designed to provide the information necessary for the next step in the process, an evaluation against the standard. For an ongoing assessment, the data collected should permit an evaluation of quality performance over time.

For an adverse quality-related event, the data collected should permit an evaluation of how the system failed. To be effective, adverse quality-related events must first be detected and documented, then reported to the peer review committee. Procedures should be established concerning how to report an adverse quality-related event and to whom the initial report must be given. Information concerning the event should be documented as soon as possible after discovery of the adverse event, while recall is still fresh.

4. Evaluating Activities Against the Standard Information gathered during an ongoing assessment should be evaluated to determine whether the quality of pharmacy services is improving or declining. For an adverse quality-related event, the committee should direct an investigation and complete a root cause analysis to identify the basic or causal factors for the event.

The pharmacy peer review committee may decide not to review all assessment or incident reports, but rather, may wish to establish priorities and review only reports relating to those priorities. When determining priorities, the committee needs to consider activities that:

• occur frequently or affect a large number of patients (high-volume);
• place patients at risk (high-risk); or
• produce problems for patients or staff (problem-prone). 5. Making Recommendations / Maintaining Records When needed, based upon the evaluations, the pharmacy peer review committee should make written recommendations to appropriate entities with the authority to evaluate and implement the recommendations. 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 safely. 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 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. To maintain the confidentiality of peer review records, they must be kept separately from patient or drug order records.

6. Conducting Periodic Self-Audits 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 well peer review is working to improve quality. 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 audits should be conducted at least annually, the results evaluated, and appropriate adjustments made to the standards or process. Changes will inevitably be made to improve the system and provide a way to measure quality performance.

(2) a failure to identify and take appropriate action concerning: (a) over-utilization or under-utilization; (b) therapeutic duplication; (c) drug-disease contraindications; (d) drug-drug or food-drug interactions; (e) incorrect drug dosage or duration of drug treatment; (f) drug-allergy interactions; (g) clinical abuse/misuse; and/or (B) failure to provide counseling or providing inadequate or incorrect counseling to a patient or patient’s agent; and/or (C) providing inadequate or incorrect information to health-care professionals involved in a patient’s care. Continuous quality improvement - an ongoing process which improves the standards and procedures used to identify and evaluate quality-related events and to improve patient care. Indicator - an objective, measurable activity used to monitor and evaluate whether a process is performed within a set standard. Outcome-based - considers the result of the performance (or non-performance) of a function or process(es). 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 pharmacists 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 of 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. Pharmacy peer review process - part of an ongoing, outcome-based, continuous quality improvement process which goes beyond traditional personnel evaluations, risk management activities, or supervisory reviews of a pharmacy process and 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 continually improves the quality of care provided to patients. Quality standard - an expected level of performance measured by specific criteria or

indicators established by the pharmacy peer review committee. Peer - an individual who is of equal standing with another. Root cause analysis - A process of identifying the basic or causal factors that underlie the occurrence or possible occurrence of an adverse quality-related event. A root cause analysis focuses primarily on systems and processes, not individual performance.

Illustrations for Basic Steps - Suggestions

Peer review is one part of a continuous quality improvement program. Different practice settings will have different programs. The following charts list some of the considerations for each of the basic steps in the peer review process. This is not intended to be a complete discussion of the details of a peer review process. Any peer review process must be tailored to the individual practice setting. However, the following six steps are basic to the process and contain suggestions or examples to start the development process for a peer review program. Remember, to protect the confidentiality of peer review records, they must be kept separate from patient or drug order records.

1. Selecting Members for the Pharmacy Peer Review Committee

Composition Two or more people.

Predominantly peers of the those involved in the provision of pharmacy services.

To the extent possible, should be predominantly composed of people familiar with: (1) Pharmacy practice; (2) Continuous quality improvement; (3) Work environment; and (4) Causes and prevention of adverse quality-related events.

Examples of potential members

• Pharmacists
• Pharmacist-interns
• Pharmacy technicians
• Nurses
• Physicians
• Other health-care professionals
• Attorneys
• Representatives of Management (Not for purposes of performance evaluations)
• Others, as necessary for the proper functioning of the committee

Non-Employee Members of the Committee

Obtain signed statement that they will maintain the confidentiality of the Peer Review Committee.

7. Counseling will be conducted to improve patient compliance.

3. Developing Reporting Procedures and Forms

Develop procedures for reporting the indicators established

Need to determine:

• who is to make the report;
• to whom the report should be made;
• when the report should be made; and
• what should be reported. Ongoing Assessment
• The pharmacy peer review committee may focus on a small, manageable number of indicators. This focus group of indicators should change as needed to properly assess quality.
• Frequency of measurement.
• Size of the sample.

Adverse Quality-Related Events

• The person discovering an adverse quality-related event should be responsible for initiating the reporting process.
• Report all indicators relating to processes involved in the event.

Develop reporting forms

For the ongoing assessments.

For adverse quality-related events.

Documentation Documentation of an adverse quality-related event should be made as soon as possible after discovery, while recall of the event is fresh.

Community Pharmacy Example

Example of initial documentation for a dispensing error

Reporting form may contain:

• name, age, and gender of the patient;
• physician’s name;
• prescription number;
• new or refill prescription;
• if new prescription, how was it received by the pharmacy;
• names of the drugs involved;
• description of the error;
• date and time of the error;
• drug regimen review and counseling activities;
• date and time the physician was notified (and how notified);
• physician’s instructions;
• action taken;
• person(s) involved in the error; and
• person completing the report.

Hospital Pharmacy Example

4. Evaluating 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 activities that:

• occur frequently or affect a large number of patients (high-volume);
• place patients at risk (high-risk); and/or
• produce problems for patients or staff (problem prone).

Discussions Should be candid and non-punitive.

Intended to determine where quality performance failed.

Evaluation of data Ongoing Assessments

• Determine if the indicators show improvement or decline in the quality of services.

Adverse quality-related events

• Conduct an investigation based on priorities established by the committee.
• Complete a root cause analysis to identify the basic or causal factors that underlie the event.

Review and documentation of ongoing assessments and adverse quality- related events

A written record should be made which contains at least:

• the date, location, and participants in the pharmacy peer review process;
• a record of the facts relating to the event;
• the root cause analysis;
• the findings and determinations generated by the pharmacy peer review;
• recommendations to appropriate entities; and
• any actions or changes relating to individuals, systems, or processes that were made as a result of the recommendations, if any.

5. Making Recommendations / Maintaining Records

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.

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.

6. Conducting Periodic Self-Audits

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

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 quality performance.

Resources As entities develop a peer review process as part of a continuous quality improvement program, they may need to access resources on these topics. Appendix B contains a partial list of resources.

confidentiality provisions provided by this section. 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 pharmacy peer review committee’s final decision, including a statement of the basis for the decision. (f) 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 the privilege of confidentiality executed in writing by the committee. The evidentiary privilege created by this section may be invoked by any person or organization in any civil judicial or administrative proceeding unless the person or organization has secured a waiver of the privilege executed in writing by the chairman, vice chairman, or secretary of the affected pharmacy peer review committee. 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 Subsection (i) of this section, a plaintiff in such proceeding may disclose records or determinations of or communications to a peer review committee in rebuttal to information supplied by the defendant. Any person seeking access to privileged information must plead and prove waiver of the privilege. A member, employee, or agent of a pharmacy peer review committee who provides access to otherwise privileged communications or records in cooperation with law enforcement authorities in criminal investigations is not considered to have waived any privilege established under this section. (g) All persons, including governing bodies and medical staffs of health care entities, shall comply fully with a subpoena for documents or information issued by the board as otherwise authorized by law. The disclosure of documents or information under such subpoena does not constitute a waiver of the privilege associated with pharmacy peer review committee proceedings. Failure to comply with such subpoena constitutes grounds for disciplinary action against the facility or individual by the appropriate licensing board. (h) A cause of action does not accrue against the members, agents, or employees of a pharmacy peer review committee from any act, statement, determination, or recommendation made or act reported, without malice, in the course of peer review according to this section. (i) 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. Such use does not constitute a waiver of the confidential and privileged nature of pharmacy peer review committee proceedings. (j) Reports, information, or records received and maintained by the board pursuant to this section are considered investigative files and are confidential and may only be released as specified in Section 17(q) of this Act.

Appendix B

RESOURCES

Organizations Advancing Quality of Pharmacy Services

Institute of Medicine 2101 Constitution Ave., NW Washington, DC 20418 www.nationalacademies.org

Useful Publication The IOM Report - To Err is Human - Building a Safer Health System

Institute for Safe Medication Practices 1800 Byberry Rd., Suite 810 Huntingdon Valley, PA 19006 215/947- www.ismp.org

Useful Publications Medication Errors , edited by Michael R. Cohen, M.S., R.Ph. Medication Safety Self Assessment

National Patient Safety Foundation 515 North State Street Chicago, IL 60610 312/464- www.npsf.org

Pharmacy Quality Council c/o Academy of Managed Care Pharmacy 100 N. Pitt Street, Suite 400 Alexandria, VA 22314 703/683- www.amcp.org

Participating Organizations Academy of Managed Care Pharmacies American College of Apothecaries American College of Clinical Pharmacy American Pharmaceutical Association American Society of Consultant Pharmacists American Society of Health-System Pharmacists National Association of Chain Drug Stores National Community Pharmacists Association Pharmaceutical Care Management Association

Useful Publication Summary of National Pharmacy Quality Measures , February 1999

Texas Pharmacy Association P.O. Box 14709 Austin, TX 78761 512/836- www.txpharmacy.com

Texas Society of Health-System Pharmacists 1224 Centre West, Suite 200B Springfield, IL 62704 800/242- www.tshp.org

Accreditation Organizations

Joint Commission on the Accreditation of Healthcare Organizations One Renaissance Boulevard Oakbrook Terrace, IL 60181 630/792- www.jcaho.org

National Committee for Quality Assurance 2000 L Street NW, Suite 500 Washington, DC 20036 202/955- www.ncqa.org

American Accreditation Healthcare Commission (Formerly the Utilization Review Accreditation Commission) 1275 K Street NW, # Washington, DC 20005 202/216- www.urac.org

Information Sources for Quality Standards

Foundation for Accountability 202 SW Sixth Ave., Suite 700 Portland, OR 97204 503/223- www.facct.org

Agency for Health Care Policy and Research 2101 E. Jefferson Street, Suite 501 Rockville, MD 20852 301/594- www.ahcpr.gov

Regulatory Oversight Organizations

Health Care Financing Administration 7500 Security Boulevard Baltimore, MD 21244 410/786- www.hcfa.gov

Texas State Board of Pharmacy 333 Guadalupe Street Box 21 Austin, TX 78701- 512/305- www.tsbp.state.tx.us