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

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.

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

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).

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

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.

CQI Program
Significant
42%

Essential
12%

Useful
40%

Not
Necessary
6%

Not Necessary
Useful
Significant
Essential

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.

Consumer Surveys
Significant
30%

Essential
5%

Useful
51%

Not
Necessary
14%

Not Necessary
Useful
Significant
Essential

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.

Criteria and Standards

Essential
15%

Not
Necessary
8%

Significant
47%

Useful
30%

Not Necessary
Useful
Significant
Essential

Periodic Self Audit

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

Benchmark over time.

Periodic Self Audit

Essential
10%

Significant
38%

Useful
40%

Not
Necessary
12%

Not Necessary
Useful
Significant
Essential

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.

Centralized Performance Database

Significant
30%

Essential
5%

Useful
51%

Not
Necessary
14%

Not Necessary
Useful
Significant
Essential

Practice Accountability Audit

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

Practice Accountability Audit

Significant
30%

Useful
38%

Essential
12%
Not
Necessary
20%

Not Necessary
Useful
Significant
Essential

CQI as a Risk Management System

RPh. & P.T. dispense according to established
Procedures
Quality related event
occurs
Quality
Consult
held

Telephone Reports and

in-store documentation

Quality Supervisor
Reviews

Quality Supervisor
Reviews
Management Kept
Informed of Progress

Quality Inservice
Developed

Management Reviews Policies and

Adjusts PRN

CQI and the Florida BOP

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.
(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; or
5. 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; or
7. clinical abuse/misuse.

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)

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.