2. Speaker Background
Norman Tomaka
Pharmacist
Consultant Pharmacist
Licensed Health Care Risk ManagerLicensed Health Care Risk Manager
Affiliations
Consultant Pharmacy Services
Consultant Pharmacist
Health First, Inc. Melbourne, FL
Outpatient - Ambulatory Facilities
3. I do not have a vested interest or
an affiliation with any corporation or
organization offering financial
support or grant monies for this
seminar.
I do not have an affiliation with any
organization whose philosophy
could potentially bias this
presentation.
Speaker Disclosure
4. Describe characteristics of patient centered
medication education.
Review strategies to identify threats to outcomes-
focused pharmacy practice.
Describe effective risk reduction strategies for
managing controlled substances.
Discuss techniques to avoid “negligent” pharmacy
practice.
Objectives
5. Figure 1: Safe Access to Healthcare
Pharmacist
leadershipleadership
role
Pharmacist
Integrated
role
6. Characteristics of patient centered
Medication Education
Promote Safety
Robust Communication
Questions and Answers
Focus on Outcomes
8. Patient-Centered Medication Education
How do we do it? Patients
Environment
Education
Communication
http://www.medicare.gov/publications/pubs/pdf/11376.pdf
“Your Discharge Planning Checklist” by CMS
11. Patient-Centered Medication Education
How do we do it? Patients
Environment
Education
Communication
Identify patients correctly
Introduce yourself
Make eye contact
Repeat the patient’s question
Recognize the role of family members
Reference: Practical approaches for building a patient-centered culture. Web. Accessed January 3, 2011. <http://www.patient-centeredcare.org/chapters/chapter7a.pdf>.
12. Patient-Centered Medication Education
How do we do it? Patients
Environment
Education
Communication Explain the medication’s purpose
Encourage patients to ask questions
Explain non-pharmacological methods
Provide access to materials
Use technology to help improve education
Skylight™
(an example)
Reference: Practical approaches for building a patient-centered culture. Web. Accessed January 3, 2011. <http://www.patient-centeredcare.org/chapters/chapter7a.pdf>.
13. Skylight™
ACCESS
Interactive Television System
Reference: Skylight ACCESS Interactive Patient System. Web. Accessed January 3, 2012.
<http://www.aurorahealthcare.org/facilities/more/shared/skylight.asp?ID=0001>.
Figure 2: Interactive
14. Is Education an intervention?
Will education provided by the pharmacist prevent errors?
15. AHRQ* Project REDRED
(Re-Engineered Discharge) Training Program
*Figure 4:*Figure 4: US Department of Health & Human Services, Agency for Healthcare Research and Quality 2011
16. Patient-Centered Medication Education:
How do we do it? Patients
Environment
Education
Communication
Speak slowly and clearly
Ask the patient to repeat back major points
Ask the patient to perform a technique
that was taught
Ask open-ended questions
Improve communication between the staff
Reference: Practical approaches for building a patient-centered culture. Web. Accessed January 3, 2012.
http://www.patient-centeredcare.org/chapters/chapter7a.pdf.
18. Promote Accurate Drug Utilization
Documentation
Medication Reconciliation
Encourage documentation of:
Name of drug
Dosage
Route of administration
Time of last dose
Time usually taken
Use of assistance device
25. Clear documentation for patient visit
Nature and intensity of pain
Current and past treatments
Underlying or co-existing diseases
Effect of pain on physical and psychological function
Review of previous medical records
Previous diagnostic studies
History of alcohol and substance abuse
Receipt of controlled substance
Maintain a duplicate/copy of written/electronic prescription
Compliance FL Statute Chapter 893
26. Controlled Substances: FL Style
Know Your Patient!
Photo
identification
Verifiable
Information
“bonafide”
diagnosis
27. Discharge Prescriptions
Opportunity to improve
documentation in the patient chart
Integrate with medication list given at
discharge
Incorporate regulatory requirements
28. Discharge Prescriptions
Every written or computer generated prescription in
FL for a drug in DEA class 2, 3, 4 and 5 requires a
DOH approved tamper-resistant RX blank
Counterfeit resistant prescription blank or
printer paper must be produced by a FL DOH
approved printing vendor
Examples: Percocet®
, Lortab®
, Vicodin®
, Ambien®
Electronic prescriptions are exempt
Authenticated facsimile prescriptions are exempt
29. Secure Prescription (FL)
Script Size: 5-1/2" x 4-1/4"
1 part and 2 part forms
"VOID" Message Technology
BLUE colored background
Erasure protection
Watermark technology
Listed security features on reverse side
Counterfeit Proof Paper
30. Elements of a Valid Controlled
Substance Prescription in FL
FL DOH approved counterproof paper
Patient name
Patient date of birth
Date Rx is written
Name and strength of drug
Exact quantity in numeric and script format
Prescriber’s signature
Prescriber’s DEA permit #
Prescriber’s address and telephone #
32. http://ww2.doh.state.fl.us/ppv_search/default.aspx
September 6, 2011
09/16/1987
Dr MessyhandwritingDr Messyhandwriting
Lortab 7.5 mg/500 mg, # 24 (twenty-four)
Sig: one tablet po q 6 hours prn pain.
No refill
John Q. Public III
201 Primrose Lane, Melbourne, FL
FL DOH validation number isFL DOH validation number is
a unique alpha-numeric codea unique alpha-numeric code
assigned to the printer andassigned to the printer and
placed on the front of theplaced on the front of the
prescriptionprescription
36. Radiopharmaceuticals
Pharmacy is responsible for oversight and
accountability
Classified as “Drug” products
Track procurement and storage integrity
Outsource Vendors must document pedigree
Formulary?
FDA cGMP*
*Current good
manufacturing
practices
cgmp.com
37. Risk Reduction Strategies
Policy and procedure for storing,
disseminating, handling, administering and
disposing of drug products.
Areas that require attention include:
Storage temperatureStorage temperature
Clear identificationClear identification
SecuritySecurity
LabelingLabeling
Administration recordAdministration record
Pharmaceutical waste managementPharmaceutical waste management
42. FL EPA Guidelines: Published List
Reference: Florida Department of Environmental Protection. Web. Accessed January 3, 2011.
<http://www.dep.state.fl.us/waste/pharm/documents/Waste-Pharm-List_Dec07.pdf>.
48. CMSCMS requires surveyors and inspectors to check labelsrequires surveyors and inspectors to check labels
UnlabeledUnlabeled
SyringesSyringes
Unlabeled Syringes
DRUG
LABELING
ISSUES
PREOCCUPY
SURVEYORS
49. Single dose syringeSingle dose syringe
properly labeledproperly labeled
Opened Multi-dose
vial without
expiration date
Opened single-use vial dated
as multi-dose!
Confusion looks like……
50. Immediate use Dispensing Pin
If used, must withdraw
entire contents of vial
immediately if single
use vial
Designed for
preparation of several
pre-drawn labeled
syringes for ONE
ambulatory patient
51. Infection Control Standards- Compliance
Verify “preservative.” Look for “single dose.”
Confusion: single use vs. multi-dose (mdv)
52. Multi-dose Vials: A Challenge
The Problem at “Last Chance” Surgery Center:
Twice this month you have located large volume sterile
single use injectable vials that have been labeled
accurately as if they were multi-dose vials.
When reviewed with the staff, some become
confrontational saying, “You teach us to initial and labelYou teach us to initial and label
the vials with the 28 day expiration after puncturing!the vials with the 28 day expiration after puncturing!
But how are we supposed to reliably recognize a single
dose product versus a multi-use when the vials
are often the same size? This is too confusing!"
53. MDV: Root Cause Analysis
Why is this an issue? Brainstorming…..
MDV and single-dose vials have same appearance, size
No consistency in supply (i.e. varying single dose and MD vials)
Drug shortages contribute to varying inventory sizes
No consistent labeling procedure
Surgical staff is under more time constraint
Burden of assessing inventory falls on staff who do not
participate in drug ordering
Ishikawa Diagram
55. MDV: Solution
PLAN:
Pharmacy staff (or site inventory manager) will place
brightly colored label on all MDV upon arrival that
states, “Use by: ____”; date completed once opened
DO:
Construct labels to be placed on vials
Compile drug-specific reference list those MDV that
have a shelf-life less than the standard 28 days
CHECK:
With pharmacist oversight, staff and nursing are
responsible for implementing and monitoring program
ACT:
Hold in-service to inform staff of new program
56. Accountability of MDV Program
CQI* committee appoints a coordinating staff
member to monitor the routine tasks
associated with this program and report
quarterly
Adequate supply of labels provided
Labels placed in appropriate location on vial
Identify need for further in-services
*Continuous Quality Improvement
57. Program Assessment #1
CMS “Safe Access to Healthcare” initiatives
include all the following except:
a) Documented patient medication education
plan
b) Comprehensive plan for hospital patient
discharge that includes medication safety
c) Exclusion of family and friends during
patient education (HIPAA)
d) Review of a discharge “check-list” for each
patient
58. Program Assessment #1
“Safe Access to Healthcare” initiatives
include all the following except:
a) Documented patient medication education
plan
b) Comprehensive plan for hospital patient
discharge that includes medication safety
c) Exclusion of family and friends during
patient education (HIPAA)
d) Review of a discharge “check-list” for each
patient
59. Program Assessment #2
Medication ReconciliationMedication Reconciliation is a process thatis a process that
has demonstrated the potential to improvehas demonstrated the potential to improve
patient compliance with medication therapy.patient compliance with medication therapy.
All areAll are requiredrequired characteristics except:characteristics except:
a) Printed discharge medication list
b) Start/stop date for medication
c) Dose and frequency of a drug order
d) Physician's signature and date
60. Program Assessment #2
Medication ReconciliationMedication Reconciliation is a process thatis a process that
has demonstrated the potential to improvehas demonstrated the potential to improve
patient compliance with medication therapy.patient compliance with medication therapy.
All areAll are requiredrequired characteristics except:characteristics except:
a) Printed discharge medication list
b) Start/stop date for medication
c) Dose and frequency of a drug order
d)d) Physician's signature and datePhysician's signature and date
61. Program Assessment #3
““Best Practices” involved with drug product labelingBest Practices” involved with drug product labeling
within a healthcare facility include the followingwithin a healthcare facility include the following
except:except:
a) Cover the manufacturer’s expiration date, and assign a
“28 day” expiration date when puncturing a multi-dose
sterile product
b) Syringe label includes drug name, strength, and
expiration
c) Initials of the healthcare practitioner labeling the drug
62. Program Assessment #3
““Best Practices” involved with drug product labelingBest Practices” involved with drug product labeling
within a healthcare facility include the followingwithin a healthcare facility include the following
except:except:
a) Cover the manufacturer’s expiration date, and
assign a “28 day” expiration date when puncturing
a multi-dose sterile product
b) Syringe label includes drug name, strength, and
expiration
c) Initials of the healthcare practitioner labeling the drug
63. Program Assessment #4
True or FalseTrue or False
Drug product integrity is only the
responsibility of the healthcare
practitioner administering the drug to
the patient.
64. FALSE!FALSE! Everyone is responsible
Drug product integrity is theDrug product integrity is the
responsibility of the health-systemresponsibility of the health-system
All providers involved in procurement,All providers involved in procurement,
storage administration and disposal ofstorage administration and disposal of
the drug.the drug.
Patient-Centered CAREPatient-Centered CARE
Program Assessment #4
