Transcript ECKERD PHARMACY RISK MANAGEMENT PROGRAM Pharmacy …

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 Harco’s knowledge of problems, and
Harco’s 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 day’s
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
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.
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.