Regulatory Perspectives on Pharmacy Error - SafetyNET-Rx

Report
David B. Brushwood, R.Ph., J.D.
Professor of Pharmaceutical Outcomes & Policy
The University of Florida
The Problem Of Pharmacy Error
 Mechanical Error
 Wrong Drug
 Wrong Strength
 Wrong Directions
 Wrong Patient
 Judgmental Error
 Inaccurate Counseling
 Inaccurate DUR
 Failure to Counsel
 Failure to Conduct
DUR
 Individual Causes
 Lack of Knowledge
 Lack of Skill
 Lack of Care
 Personal Distractions
 System Causes
 Workflow
 Communication
 Staffing
 Patient Expectations
Who Says There Is A Problem?
 Criminal Courts
 Licensing Agencies
 UK Pharmacist Elizabeth
 Shinn Case
Lee.
 http://media.cop.ufl.edu/
 US Pharmacist Eric Cropp.
videos/pha6277/abc.html
 http://media.cop.ufl.edu/camt
 Possible Solution
asia/ms/error/video.html
 Blame and Shame.
 Possible Solution:
 Blame and Train
 Decriminalize “one off”
Alternative: Mandatory
error.
Continuous Quality Improvement
 Forgive and Forget.
Studies Of Error In Medicine
 “Forgive and Remember”
 Charles Bosk
 “That humans make 0.1 percent errors on prescriptions may be
forgivable; that hospitals don’t take obvious actions to protect
themselves and patients, well within state-of-the-art, is not.”
 Michael Millenson
 “Almost all accidents result from human error, it is now
recognized that these errors are usually induced by faulty
systems that ‘set people up’ to fail. The great majority of effort
in improving safety should focus on safe systems, and the
health care organization itself should be held responsible for
safety.”
 The IOM Report
The QRE: Clarifying The Use of
Language
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Error (Backward Looking; Blame-Laying)
Incident (Patient Received Medication)
Near Miss—Near Hit (An Almost Error)
Sentinel Event (Screams Out Danger)
Quality-Related Event (QRE)
 Incidents
 Near Hits
 Sentinel Events
 Positive QREs
The Quality Team Leader
 Does not have all of the answers, but does know how
to ask the right questions.
 This person is responsible for
 Initial training,
 Implementation of the program,
 Continuation of the program, and
 Conduct of Quality Consults.
 Not a “spy” for management. This activity is separate
from performance evaluation.
Steps in Order Processing
 Receiving the Order
 Data Entry
 Utilization Review
 Prescription Assembly
 Pharmacist Final Check (The Red Line)
 Special Care
 Delivery to Patient
 Follow-up With Patient
Receiving The Order
 Identify person presenting Rx/Request.
 Relax and negotiate realistic pickup time.
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(Waiter/Later?) Sign re time expectation.
Confirm information in new Rx, refill.
Evaluate Rx/Request.
Confirming patient profile is up-to-date.
Update insurance information.
Original order notes.
Segregate one patient’s order from others.
Data Entry
 Interpretation of information in Rx/Refill.
 Confirming correct patient, prescriber, Rx info.
 Check inventory on drug prescribed.
 Confirm completeness of patient info—see receiving
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Rx.
Review previous Rx for changes/confirmation.
Check notes.
Calculate days supply; quantity.
Half minute review.
Utilization Review
 Check if patient is still using cancelled drugs.
 Notes on old/new Rxs with cross references; same or not
same. (SAB) (NEW)
 Ask patient if patient info can resolve.
 Hard edits; Pharmacist ONLY to proceed.
 Soft edits; Info for final check.
Prescription Assembly
 Review hard copy of Rx.
 Identify needed products.
 Retrieve needed products from stock.
 DIN check & note.
 Expiration date check & note.
 Appropriate vial.
 Storage.
 Place appropriate product and quantity in container. Note quantity.
 Affix label & auxiliary labels.
 Confirm patient-directed information, and special notes (1 of 3, 2 of
3, etc.)
 Place all prescriptions for one pt together.
 Document ID of preparer.
Pharmacist Final Check
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Reconcile stock bottle with printed information.
Visualize contents of container.
Hard copy Rx matches computer printed info.
Quantity & refills are correct.
Review DURs; review indication, dose, appropriateness, use
patient profile if necessary.
Identify checker.
Make sure documentation has been done.
Place in packaging for patient.
Note if patient needs counseling.
Half minute review.
Place across red line.
Special Care
 Insurance issues.
 Prescriber issues.
 Patient issues.
Delivery to the Patient
 Patient ID: Verify Address and/or Phone Number.
 Show and Tell: Name of drug, directions, refills, told to
patient.
 Maintain patient privacy.
 Inform of change in Rx; drug.
 If not delivered in person, confirm receipt.
Follow-up With Patient
 Check adherence and outcomes.
 If delivered other than through personal delivery,
provide necessary information.
What Does CQI Look Like?
 Define the process
through which
prescriptions are filled.
 Make a record of
quality related events.
 Discuss how systems
can be used to prevent
similar events in the
future.
The Pharmacy System and CQI
RPh. & P.T. dispense according to established
Procedures (Stations??)
Quality related event
occurs
CQI
Consult
held
Incident Reports and/or
in-store documentation
CQI Consultant
Reviews
CQI Consultant
Reviews
Management Kept
Informed of Progress
Report to Users
Data, Analysis
Report to Central Data Processing Agency
Gathering The Troops
 Everyone must
participate:
Pharmacists, techs,
clerks.
 There are no stupid
questions or
suggestions.
 Blaming others is
forbidden.
Setting The Tone
 This is a professional
meeting to improve
outcomes for
patients.
 The focus is on the
future, not the past.
 Everything said is
held in confidence.
 My job is to help you
not punish you.
Promoting an Orderly Discussion
 Reviewing The Facts
 Facts about events
 Facts about
environment
 Addressing The Issues
 Staffing issues
 Workflow issues
 Communication
Issues
 Reviewing Policies
 Problem Solving
 Problem identification
 Problem resolution
 Open time for any
comment
 Encouraging follow
through
 Follow policies
 Remember the team
Reviewing Facts About Events
 Was the prescription telephoned to the pharmacy, or was
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it transmitted in writing (paper, fax, or computer)?
Was the prescription a new prescription or a refill
prescription?
Was the prescription prepared for a person who chose to
wait for it, or was it prepared for the “will call” or delivery
area?
Was the prescription dispensed to the patient or to
another person acting for the patient?
Was the pharmacist a fill-in pharmacist?
Facts About Environment
 How many prescriptions were filled on the day the
incident occurred?
 How many pharmacists/techs/clerks were working on
that day?
 It is documented that DUR was done (if needed) with
the prescription?
 Is it documented that the patient was offered (or
received) counseling?
 Was there anything “special” about the day?
Issues: Staffing
 Are the supportive staff hours scheduled properly to
efficiently handle peaks in prescription volume?
 Do the pharmacists’ schedules provide for sufficient
overlap on peak volume days?
 Are all personnel properly trained, especially with
regard to prescription error prevention procedures?
Issues: Workflow
 Are look alike and sound alike drugs separated in their
physical location on shelves to reduce confusion?
 Is the primary work area/counter organized for
accuracy; is it neat and clean?
 Are baskets used to separate waiting and will call
prescriptions?
Issues: Communication
 Are personnel repeating the patient’s name and the
name of the physician to the person picking up the
prescription?
 Are pharmacists evaluating all DUR computer
prompts before a tech fills a prescription?
 Are procedures implemented to assure that all
medications going into a bag are for that patient?
Reviewing Policies
 Are drug code checks used in filling prescriptions and
automatic counting devices?
 Are telephone refill orders cross checked by obtaining
the patient’s name, Rx number, and the name of the
medication?
 Is partner check being used at the end of each day?
Toward Solutions
 How will we know that the problem has been solved?
 What are the possible solutions to the problem?
 Of the suggested solutions, which is the best and why?
Open Time For Any Comment
 Talk with me about
whether policies are
working.
 Talk with me about
whether policies are being
followed.
 Talk with me about the
CQI system.
 Talk with me about this
CQI consult meeting.
Pharmacist Only Questions
 Why does my medication
look different this time?
 Why are the directions
different from those my
doctor told me?
 You don’t seem to have
spelled my (or my doctor’s)
name correctly?
 If I’m allergic to aspirin can I
take this?
Handling a Failure of Quality
 First Duty--Practice
Good Pharmacy
Care for the
patient!!!!!!
 Attitude, Attitude,
Attitude!
 Investigate all
complaints in a caring
manner.
 Choose the right
language
 Write notes carefully
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Just the facts.
No scapegoating.
 The First Response
 Whom to Involve
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Pharmacist Responsibility
 Where to go
 Quiet Place-Confidentiality
 Careful Listening
 What to Say
 “I can see you are upset”
 “Thank you for bringing this to
our attention”
 NOT “We sure got sloppy, what a
terrible error.”
 The “Safe” Apology
 Objective Description
 We will learn from this.
Time for Questions/Comments

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