Increasing Patient Safety in Community Pharmacies
Introduction to SafetyNET-Rx
•
•
•
•
•
What is SafetyNET-Rx?
Who is Involved?
Why is SafetyNET-Rx important to me?
Medication Safety Self Assessment-CAP
Community Pharmacy Incident Reporting
(CPhIR) tool
• How to implement SafetyNET-Rx in your
Pharmacy
2
What is SafetyNET-Rx?
 Continuous Quality Improvement (CQI) Program
designed to enhance patient safety through a
community pharmacy-based quality management
program.
 Purpose is to identify, report, analyze and learn from
medication errors and near misses, collectively known
as Quality Related events or QREs.
3
Objectives
 To provide an open dialogue between retail pharmacies, regulatory
bodies, and academic researchers on quality related events;
 To disseminate the knowledge needed to enable retail pharmacies to
assess and benchmark their own QRE reporting and learning
practices in a systematic and validated way;
 To provide a standardized, and packaged process that pharmacies
can adopt to identify, report, and manage QREs that meets the
NSCP standard for an effective continuing, documented quality
assurance program;
 To identify the major organizational culture and change management
issues that may promote or hamper the use of QRE reporting.
4
Who is involved with SafetyNET-Rx?
 Dalhousie University College of Pharmacy
 Dr. Neil MacKinnon
 St. Francis Xavier University
 Dr. Todd Boyle & Dr. Tom Mahaffey
 Institute for Safe Medication Practices (ISMP) Canada
 Certina Ho
 Nova Scotia College of Pharmacists (NSCP)
 Bev Zwicker
 Funded by:
 Nova Scotia Health Research Foundation (NSHRF)
 Social Sciences & Humanities Research Council
5
Why is SafetyNET-Rx Important?
 The Standard of Practice for Quality Assurance Programs in
Community Pharmacies was approved and adopted by the Council
of the Nova Scotia College of Pharmacists (NSCP) on March 30w.fth
2010.
 All pharmacies in Nova Scotia will be assessed against this standard
as part of their routine inspection beginning in October, 2010.
 Pharmacies participating in the SafetyNET–Rx project will have the
advantage of the support of the project team and resources to
establish the necessary policies and processes to achieve the
standard.
6
What is Involved in Participating
 1. The commitment of at least two pharmacy staff




7
members (ideally one pharmacist and one pharmacy
technician) to facilitate implementation of the process at
the store level.
2. Completion of Medication Safety Self-Assessment
(MSSA ) survey at the beginning and end of the project.
3. Utilization of the Canadian Pharmacy Incident
Reporting program (CPhIR).
4. Quarterly staff meetings.
5. Completion of SafetyNET-Rx project evaluation
surveys at various points throughout the project.
Advantages of Participation
 Free access to the MSSA tool for one year, a savings of
$325
 Free access to the online CPhIR reporting tool for one
year, a savings of $325
 Access to the SafetyNET-Rx website
 Ongoing support from the SafetyNET-Rx research team
to address quality-related problems or issues in your
pharmacy
8
Background Information:
The foundation of SafetyNET-Rx
http://media.cop.ufl.edu/camtasia/ms/error/video.html
http://media.cop.ufl.edu/videos/pha6277/abc.html
9
The Problem Of Pharmacy Error
 Mechanical Error
 Wrong Drug
 Lack of Knowledge
 Wrong Strength
 Lack of Skill
 Wrong Directions
 Lack of Care
 Wrong Patient
 Personal Distractions
 Judgmental Error
10
 Individual Causes
 System Causes
 Inaccurate Counseling
 Workflow
 Inaccurate DUR
 Communication
 Failure to Counsel
 Staffing
 Failure to Conduct DUR
 Patient Expectations
The QRE: Clarifying The Use of Language





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
11
Facilitator: 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.
12
Role of Facilitators
 As part of SafetyNET-Rx, each store will select at
least two in-store facilitators, ideally one pharmacist
and one pharmacy technician.
 To assist in tailoring the training to the needs of the
participants, and to achieve awareness of potential
issues impacting QREs prior to the training session,
each pharmacy is expected to complete and submit
the MSSA one week prior to their training session.
13
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.
14
Gathering The Troops
 Everyone must
participate:
Pharmacists, techs,
clerks.
 There are no stupid
questions or
suggestions.
 Blaming others is
forbidden.
15
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.
16
Promoting an Orderly Discussion
 Reviewing The Facts
 Facts about events
 Problem identification
 Facts about
 Problem resolution
environment
 Addressing The
Issues
 Staffing issues
 Workflow issues
 Communication Issues
 Reviewing Policies
17
 Problem Solving
 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




18
was 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 relief 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?
19
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?
20
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?
21
Classification of dispensing errors
 Types of error:
 Selection of wrong medicine (60.3%)
 Incorrect labelling of the medicine (33.0%)

Causes attributed to:
 misreading the prescription (24.5%)
 similarity of drug names (16.8%)
 selecting the previous drug or dose from the patient's
medication record on the pharmacy computer (11.4%)
 similar medicine packaging (7.6%)
 Circumstances associated with errors:
 Staffing issues (25.9%)
 Excessive workload and distractions (34.5%)
22
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?
23
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


24
Just the facts.
No scapegoating.
 The First Response
 Whom to Involve

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.
Why the reluctance to report?
 Fear of blame:
 “I would feel more comfortable if the information went to
someone other than my line manager”
 “I would be far more likely to use an anonymous system
because we have still got a residual blame culture”
 “Some managers don’t like errors being reported…because of
that particular manager you tend to keep things to yourself”

Pressure of work:
 “We are very busy and we don’t have the time to start writing
all this stuff down”
 Loyalty to colleagues:
 “I told them and we talked about it, but I didn’t report it to Head
Office”
25
“In seeking to improve safety, one of
the most frustrating aspects for
patients and professionals alike is the
apparent failure of health-care
systems to learn from their mistakes.”
Reference: WHO Draft Guidelines For Adverse Event Reporting And Learning
Systems http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf
26
MSSA – CAP
27
MSSA-CAP
 Proactive approach for risk assessment and quality improvement
 MSSA is simple to complete and results can identify areas of improvement to
becoming a safer medication system
 Increased practitioner and staff awareness of safety issues and practices
 Assesses safety of current medication practices
 Identifies improvement opportunities
 Supports monitoring of progress in changes
 Can compare your scores with maximum achievable AND aggregate scores
of similar pharmacies
 Addresses the Standard of Practice for Quality Assurance Programs in
Community Pharmacies (Nova Scotia College of Pharmacists)
28
Survey Tool
Key Elements: 10 key elements that most significantly
influence safe medication use
Core Characteristics: Further broken down into 20 core
distinguishing characteristics
Self-Assessment Item: Criteria that help to evaluate the
degree to which each key element or core characteristic
is met by the facility (89 in MSSA-CAP)
29
MSSA: 10 Key Elements
1.
Patient information
2.
Drug information
3.
Communication of drug information
4.
Drug labeling, packaging, nomenclature
5.
Drug storage, stock and standardization
6.
Use of devices
7.
Environmental factors
8.
Staff competency and education
9.
Patient Education
10. Quality processes and risk management
30
Self-Assessment Items Per Key Element
Key
Element
31
Description
Items
I
Patient Information
1-6
II
Drug Information
7-15
III
Communication of Drug Orders and Other Drug
Information
16-19
IV
Drug Labeling, Packaging, and Nomenclature
20-24
V
Drug Standardization, Storage, and Distribution
25-31
VI
Use of Devices
32-34
VII
Environmental Factors
35-49
VIII
Staff Competence and Education
50-55
IX
Patient Education
56-65
X
Quality Processes and Risk Management
66-89
MSSA Process
Engage a team from the pharmacy
Discuss each self assessment item with the team 
consensus
Enter data into password protected secure online site
Use online site to review results – numeric, graphs
1)
2)
3)
4)


5)
32
Scores compared to maximum achievable (items are assigned
a weighted score based on impact on patient safety and
sustained improvement)
Scores compared to aggregate scores of similar pharmacies
Repeat (every 1-3 years) to document progress with
improvement efforts
MSSA-CAP Team
 The medication system is complex, and involves
the actions of many people - no one person knows
everything about how the system is working
 Minimally team members should include a
pharmacist, pharmacy technician, manager
 Plan 3 x 1 hour meetings of the team if possible
33
MSSA Scoring
Scoring system reflects RISK inherent in that aspect of the
medication system
Response
34
Description
Score
(weighted)
A
Applicable but No Activity to implement
1
B
Discussed but not implemented
2
C
Partially implemented in some areas
3
D
Fully implemented in some areas
4
E
Fully implemented in all areas
5
Results - Example
35
Results - Example
36
Results - Example
37
Results - Example
38
Monitor Improvements – Example
39
From a patient’s perspective
 Medication errors may lead to profound suffering
and grief to the patients / family affected:
 A patient with advanced nasopharyngeal cancer had
inadvertently received an infusion of fluorouracil over 4
hours that was intended to be administered over 4
days.
 Profound mouth sores and reductions in red blood
cells, white blood cells and platelets developed.
 The patient died 22 days after the medication incident
occurred.
40
Preventable medical mistakes cause more deaths
per year than car accidents, breast cancer or
AIDS
Deaths per Year
98,000
43,458
42,297
16,516
Preventable
Medical
Mistakes
41
Car Accidents
Breast Cancer
AIDS
Reactions to medication errors
 The person approach
 The systems approach
42
The Person Approach
“Blame and Shame”
 “The person approach focuses on the errors of
individuals, blaming them for forgetfulness,
inattention, or moral weakness.”
• J. Reason, March 18, 2000, BMJ
 Focus is on blame & shame
 Focus on individual performances and not system
issues
43
The Person Approach: Flaws
 All staff, even the most experienced and
dedicated professionals can be involved in
preventable adverse events.
 Accidents result from a sequence of events and
tend to fall in recurrent patterns regardless of the
personnel involved.
 Fear of reprisals drives important information
underground.
44
The Systems Approach
“The systems approach is not about
changing the human condition but
rather the conditions under which
humans work.”
J.T. Reason, 2001
45
The Systems Approach
 Recognizes that:
 Humans are incapable of perfect performance.
 Accidents are caused by flaws in the working
environment (system) and that human errors
are an expected part of any working
environment.
 Accidents can be prevented by building a
system that is resilient to expected human
errors.
46
Need to move away from “blame & shame”
 Who did it?
 Punishment
 Errors are rare
 Add more layers
47
What allowed it?
Thank you for reporting!
Errors are everywhere
Simplify/standardize
CPhIR
• The Community Pharmacy Incident Reporting (CPhIR) program was designed
by ISMP Canada specifically for incident reporting in the community pharmacy
setting
• CPhIR contributes to the Canadian Medication Incident Reporting and
Prevention System (CMIRPS)
• Benefits of CPhIR:
•
Encourages assessment of contributing factors in medication incidents
•
Promotes development of system-based strategies for quality improvement and prevent
potential errors from occurring again in the future
•
Pharmacies can view aggregate data from CPhIR’s incident database to determine if other
pharmacies have had similar incidents
• Subscription to CPhIR includes ISMP Canada Safety Bulletins and ISMP US
Medication Safety Alert Bulletin (Community/Ambulatory Care Edition)
48
Data Sharing Agreement
• The user must sign a Data Sharing Agreement before gaining access to CPhIR
• ISMP Canada is committed to privacy and confidentiality
•
•
•
ISMP Canada complies with privacy legislation and best practices: Personal
Health Information Protection Act (PHIRA), Ontario 2004 and Personal Information
Protection and Electronic documents Act (PIPEDA), Canada 2000 – only deidentified and non-identifying information is collected
Data is used only for the purposes of analysis, shared learning, and incident
prevention strategy formulation
Access to CPhIR allows the user to view individual and aggregate data from the
incident database, this information is confidential and cannot be published without
written permission from ISMP Canada
• Upon receiving the signed Data Sharing Agreement, ISMP Canada will assign a
username and password
49
Login Page
• To access CPhIR, go to:

www.cphir.ca
• ISMP Canada will
provide each individual
pharmacy with a unique
username and password
• If you forget your
password or have any
other questions, click
“Contact ISMP Canada”
to send an e-mail
•
50
E.g. Microsoft Outlook
will launch in a new
window
Home
•
To navigate CPhIR, there are five tabs at the top of the page
•
Open incidents are displayed on the home page
•
•
51
An open incident is an incident that has been entered into the system and can still be edited within 90
days of the initial entry date
Open incidents are sorted by the date first entered (also numerically by incident number)
Report an Incident

Mandatory fields
are in red, optional
fields are in gray
52
The “Print
Blank Form” option
allows you to print a
blank copy and enter
data manually
Report an Incident

53
The following fields are listed in the incident reporting form:
•
Date Incident Occurred
•
Time Incident Occurred
•
Type of Incident
•
Incident Discovered By
•
Medication System Stages Involved in this Incident
•
Medications
•
Patient’s Gender
•
Patient’s Age
•
Degree of Harm to Patient due to Incident
•
Incident Description/How Incident was Discovered
•
Other Incident Information
•
Contributing Factors of this Incident
•
Actions at Store Level
•
Shared Learning for ISMP to Disseminate
•
Submit Report to ISMP Canada
Report an Incident
 “Medications”
•
By default, the incident is checked as a medication-related
incident
•
If unchecked, the medication fields will disappear
• Medication name(s) may be entered in 3 ways:
1. Enter complete medication name and DIN freeform
2. Enter the first few letters of the medication name and a
black auto-finish box will appear for a few seconds
•
To view options, roll the cursor anywhere within the
box and it will remain open until a selection is
chosen

Select the most appropriate option from the autofinish list (Health Canada’s Drug Product Database)
•
Brand Names (i.e. Lopressor, Apo-Metoprolol, etc.)
•
Generic Name (i.e. Metoprolol)

The DIN field will automatically be populated
3. Enter the DIN and choose from the auto-finish box, the
medication will automatically be entered
•
Multiple medications can be entered, as more medications
are entered, more fields will appear
54
Report an Incident
 “Degree of Harm to Patient due to Incident”
•
55
Select ONE degree of harm
Report an Incident
 “Incident Description/How Incident was Discovered”
56
•
Please do not supply identifying information (e.g., patient name or date
of birth, pharmacy name, or healthcare provider names).
•
Freeform textbox – enter description of incident
Report an Incident
Expanded View of “Other Incident Info” and “Contributing Factors”
57
Report an Incident
 A checkbox at the end of the form
gives the option of closing the report
•
If left unchecked (Open) Default:
–
–
–
•
If checked (Closed):
–
–
–
58
Can be edited for up to 90 days (after
which it automatically closes)
Will be displayed on the home page
Will not be displayed during a search
Cannot be edited
Will not be displayed on home page
Will be displayed during a search
Search
 The search function allows you to
find an individual or a series of
medication incidents based on
certain criteria
•
Search criteria are based on the
mandatory fields and contributing
factors
•
Open incidents will not be displayed
during the search
•
Search results can be:
–
–
–
59
Printed
Exported to PDF for record keeping
Exported to Excel for customized
analysis
Search
 Example:
 Search all incidents between Jan. 1, 2009 to Dec. 31, 2009 that involved an incorrect
drug
• Select dates from calendar

•
•
•
•
60
End Date cannot be before Start Date
Select Incorrect Drug from Type of Incident
Leave all other fields blank
Scroll to the bottom of the form and click Submit Search
To clear the form, click Reset
Search
 Export Data Options
•
To view export options, scroll down under the search results at the bottom of the page
61
•
PDF
– Exports all search results into a PDF file in a new window
– All results are exported, 1 incident per page

(unless it is a very detailed incident, may be more pages)
– Presents all entered data from each incident in a table format
– Check options to be included in PDF
•
Excel
– Exports all search results into Excel file in a new window
– Allows for customized analysis based on Excel functions (ex. Charts)
Search
PDF
Excel
62
Search
• Although ISMP Canada does not collect identifying
information, we recognize certain pharmacies would like
to have this information
• The search function allows the user to print each
medication incident with the following additional fields:
(ISMP Canada will not have access to this information)
•Date of Dispensing
•Prescription Number
•Transaction Number
•Dispensing Pharmacist of Prescription
•Signature of Dispensing Pharmacist
•Dispensing Pharmacy Technician of
Prescription
•Signature of Dispensing Technician
•Pharmacy Staff Member (who discovered
this incident)
•Signature of Pharmacy Staff Member (who
discovered this incident)
63
•Patient Name
•Patient Age
•Patient Address
•Patient Telephone
•Patient contacted by
•Patient contacted at [date/time]
•Prescriber Name
•Prescriber Telephone
•Prescriber contacted by
•Prescriber contacted at [date/time]
•Prescriber’s Comments
•Date Submitted to Central Office
Search
64
Stats
 The Stats function allows you to view the
number of medication incidents for your
pharmacy and all other pharmacies who
use CPhIR (aggregate data)
•
Medication incidents can be sorted by:
–
–
–
–
–
–
–
–
–
–
•
65
No. of Incidents by Day (i.e. Mon, Tue, Wed,
Thu, Fri, Sat, Sun)
No. of Incidents by Month
No. of Incidents by Year
No. of Incidents by Type
No. of Incidents by Discoverer
No. of Incidents by Medication System Stages
Involved
No. of Incidents by Degree of Harm to Patient
No. of Incidents by Contributing Factors
Top 10 DINs
Top 10 Active Ingredients
Stats are presented in data tables and
graphs
Stats
Individual data and
aggregate data can be
viewed in a graph and
in a frequency /
percentage table
66
Your Account
 Change password
•
•
•
Must be 8 characters long
Include letters, numbers, and punctuation
Case-sensitive (check caps lock)
 Displays number of incidents reported
•
•
67
Open incidents highlighted in blue
Clicking on the open incidents will bring you back to the home page
What can we do with the
medication incidents?
Analysis of Medication Incidents
Analysis of Medication Incidents
 “Ultimately, it is the action we take in response to
reporting – not reporting itself – that leads to
change.”
 Reference: WHO Draft Guidelines For Adverse Event Reporting And Learning
Systems http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf
69
Dissemination of Information
70
Results:
SafetyNET Phase I Data
Results
• 13 community pharmacies
•
•
•
•
6 independent
3 grocery
2 chain
2 mass merchandising
• August 2008 to January 2010
• 1532 medication incidents analysed
•
•
72
1544 medication incidents voluntarily reported
12 duplicate or test entries
Reported Medication Incidents Classified by Outcome
Reported Medication Incidents Classified by
Outcome
5.87% 0.07%
10.44%
A No Error
B No Harm (Patient received the
medication but did not ingest it)
C No Harm (Patient received and
ingested the medication, but did not
cause patient harm)
E Harm
83.62%
73
Reported Medication Incidents Classified by
Stages
Reported Medication Incidents Classified by Stages
1200
1000
Frequency
800
600
400
200
0
Prescribing
74
Order
Entry/Transcription
Dispensing/Delivery
Administration
Stages Involved
Monitoring
Not Applicable
Top 10 Reported Medications
Rank
75
Medication
Reported
Frequency
Reported Frequency
(%)
1
Metoprolol
31
1.72
2
Hydrochlorothiazide
29
1.61
3
Lorazepam
28
1.56
4
Amoxicillin
27
1.50
4
Rosuvastatin
27
1.50
6
Salbutamol
24
1.33
6
Venlafaxine
24
1.33
8
Levothyroxine
23
1.28
8
Metformin
23
1.28
10
Hydromorphone
21
1.17
10
Ranitidine
21
1.17
Main Themes
• Product Mix-Ups
• Incorrect Instructions
• Wrong Patient
• Compliance Aids
• Changes in Treatment
• Drug Therapy Problem
76
Questions?
77