Is Knowledge Power?Developing An Infrastructure ThatEnhances Patient Safety

Pharmacy CQI In FloridaDavid B. Brushwood, R.Ph., J.D.Professor of Pharmacy Health Care AdministrationThe University of FloridaCollege of Pharmacy

Who says the system is broken?The mediaTelevision programsMagazinesNewspapersState regulatorsThe courtsThe IOM ReportButNo pharmacist wants to make a mistakeNo pharmacy manager wants pharmacists to make a mistakeMaybe the system just needs to be organized better.

Harco Drugs v. Holloway669 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 Harcos knowledge of problems, and Harcos having failed to initiate sufficient institutional controls over the manner in which prescriptions were filled.

Alternative ResponsesDo Nothing.Punishment.AdvantagesPractical Appeal.Political Appeal.Emotional Appeal.DisadvantagesIneffectiveToo littleToo muchUnreliableUnfair

Centralized Data Reporting and FeedbackCentralized QA Program Error Prevention ClinicMandatory or Recommended CQIRegulating for Outcomes (Responsive Regulation) Brennan and Berwick, New Rules (1996).

Ten (Possible) ApproachesContinuous Quality Improvement ProgramProfessional Performance EvaluationConsumer SurveysCriteria and StandardsLocalized Minimum Data SetPeriodic Self AuditCentralized Performance DatabasePractice Accountability AuditInitial Licensure by PortfolioRelicensure by Portfolio

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

CQI Program

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

Consumer Surveys

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

Criteria and Standards

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

Periodic Self Audit

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

Centralized Performance Database

Practice Accountability AuditEvaluates Performance DatabaseTriggered by violation of criteria/standardsRequest explanation of violation.Done by board or by profession.

Practice Accountability Audit

CQI as a Risk Management SystemRPh. & P.T. dispense according to established ProceduresQuality related event occursQuality Supervisor ReviewsTelephone Reports and in-store documentationQuality Supervisor ReviewsQuality Inservice DevelopedManagement Kept Informed of ProgressManagement Reviews Policies and Adjusts PRNQuality Consult held

CQI and the Florida BOP(2) "QualityRelated 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; or5. providing inadequate or incorrect packaging, labeling, or directions.(b) a failure to identify and manage:1. overutilization or underutilization;2. therapeutic duplication;3. drugdisease contraindications;4. drugdrug interactions;5. incorrect drug dosage or duration of drug treatment;6. drugallergy interactions; or7. clinical abuse/misuse.

64B1627.300 Standards of Practice Continuous Quality Improvement Program.(1) "Continuous Quality Improvement Program" means a system of standards and procedures to identify and evaluate qualityrelated events and improve patient care.

CQI ComponentsP&P ManualCQI CommitteeRecord QREsReview Record at least once every 3 monthsstaffing levelsworkflowtechnological supportSummarization Document (no identifiers)Protection from Discovery (766.101 FS)

RESULTSInspector 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.