Is Knowledge Power Developing An Infrastructure That Enhances Patient Safety Pharmacy CQI In Florida

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Is Knowledge Power?Developing An Infrastructure
ThatEnhances Patient SafetyPharmacy CQI In
Florida

• David B. Brushwood, R.Ph., J.D.
• Professor of Pharmacy Health Care Administration
• The University of Florida
• College of Pharmacy

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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.

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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.

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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).

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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

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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.

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CQI Program
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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.

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Consumer Surveys
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Criteria and Standards

• Criterion 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.

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Criteria and Standards
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Periodic Self Audit

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

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Periodic Self Audit
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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.

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Centralized Performance Database
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Practice Accountability Audit

• Evaluates Performance Database
• Triggered by violation of criteria/standards
• Request explanation of violation.
• Done by board or by profession.

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

• (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.

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CQI Components

• PP 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)

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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.