1. Is Knowledge Power? Developing An Infrastructure That Enhances Patient Safety Pharmacy CQI In Florida David B. Brushwood, R.Ph., J.D. Professor of Pharmacy Health Care Administration The University of Florida College of Pharmacy

2. Who says the system is broken? The media –Television programs –Magazines –Newspapers State regulators The courts The IOM Report But… –No pharmacist wants to make a mistake –No pharmacy manager wants pharmacists to make a mistake Maybe the system just needs to be organized better.

3. Harco Drugs v. Holloway 669 So.2d 878 (Ala. 1995). “We note that the jury was also informed of 233 incident reports that had been prepared by Harco employees during the three years preceding the incident. This evidence, in addition to evidence of complaints filed with the State Board of Pharmacy and the evidence of lawsuits filed alleging misfilled prescriptions, was relevant to show Harco’s knowledge of problems, and Harco’s having failed to initiate sufficient institutional controls over the manner in which prescriptions were filled.”

4. Alternative Responses Do Nothing. Punishment. –Advantages Practical Appeal. Political Appeal. Emotional Appeal. –Disadvantages Ineffective –Too little –Too much Unreliable Unfair Centralized Data Reporting and Feedback Centralized QA Program Error Prevention Clinic Mandatory or Recommended CQI Regulating for Outcomes (Responsive Regulation) Brennan and Berwick, New Rules (1996).

5. Ten (Possible) Approaches Continuous Quality Improvement Program Professional Performance Evaluation Consumer Surveys Criteria and Standards Localized Minimum Data Set Periodic Self Audit Centralized Performance Database Practice Accountability Audit Initial Licensure by Portfolio Relicensure by Portfolio

6. Continuous Quality Improvement Identify and record failures of quality. Take a systems view. Involve all personnel. Learn from past and plan for improved future. Records available for inspection.

7. CQI Program

8. Consumer Surveys Conducted at least once per year. Pertinent Questions –Is the pharmacist accessible? –Can you read your prescription label? –Is your drug therapy helping you get better? Evidence of completion available for inspection.

9. Consumer Surveys

10. Criteria and Standards Criterion: Predetermined elements with which comparison can be made. –Example: No refills more frequently than day’s supply indicates. Standard: Acceptable variation from criterion. –Example: Within 20% (6 days for 30 day period) ok.

11. Criteria and Standards

12. Periodic Self Audit Have criteria and standards been met? –Drug-drug interaction overrides. –Duplicative drug therapy. –Absence of documented patient education. Benchmark over time.

13. Periodic Self Audit

14. Centralized Performance Database Aggregate data from a large number of practice sites. –Uploaded to board. –Purchased from payer. Picture of quality throughout state. Compare practice sites.

15. Centralized Performance Database

16. Practice Accountability Audit Evaluates Performance Database Triggered by violation of criteria/standards Request explanation of violation. Done by board or by profession.

17. Practice Accountability Audit

18. CQI as a Risk Management System RPh. & P.T. dispense according to established Procedures Quality related event occurs Quality Supervisor Reviews Telephone Reports and in-store documentation Quality Supervisor Reviews Quality Inservice Developed Management Kept Informed of Progress Management Reviews Policies and Adjusts PRN Quality Consult held

19. CQI and the Florida BOP –(2) "Quality ‑ Related Event" means the inappropriate dispensing of a prescribed medication including: –(a) a variation from the prescriber's prescription order, including, but not limited to: –1. dispensing an incorrect drug; –2. dispensing an incorrect drug strength; –3. dispensing an incorrect dosage form; –4. dispensing the drug to the wrong patient; or –5. providing inadequate or incorrect packaging, labeling, or directions. –(b) a failure to identify and manage: –1. over ‑ utilization or under ‑ utilization; –2. therapeutic duplication; –3. drug ‑ disease contraindications; –4. drug ‑ drug interactions; –5. incorrect drug dosage or duration of drug treatment; –6. drug ‑ allergy interactions; or –7. clinical abuse/misuse. 64B16 ‑ 27.300 Standards of Practice ‑‑ Continuous Quality Improvement Program. (1) "Continuous Quality Improvement Program" means a system of standards and procedures to identify and evaluate quality ‑ related events and improve patient care.

20. CQI Components P&P Manual CQI Committee Record QREs Review Record at least once every 3 months –staffing levels –workflow –technological support Summarization Document (no identifiers) Protection from Discovery (766.101 FS)

21. RESULTS Inspector looks for evidence of CQI program and compliance. Inspector is educator and enabler, to prevent errors not react to them. Punishment for failure to conduct CQI, not for failure to be perfect. Commercial product available.