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Increasing Patient Safety in Community Pharmacies

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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

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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
what is safetynet rx
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.
  • 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.
who is involved with safetynet rx
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
why is safetynet rx important
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.
what is involved in participating
What is Involved in Participating
  • 1. The commitment of at least two pharmacy staff 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
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
background information the foundation of safetynet rx
Background Information: The foundation of SafetyNET-Rx

the problem of pharmacy error
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


the qre clarifying the use of language
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


facilitator the quality team leader
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.


role of facilitators
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.
what does cqi look like
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.
g athering the troops
Gathering The Troops
  • Everyone must participate: Pharmacists, techs, clerks.
  • There are no stupid questions or suggestions.
  • Blaming others is forbidden.
setting the tone
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
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
Reviewing Facts About Events
  • Was the prescription telephoned to the pharmacy, or 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
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
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
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?
classification of dispensing errors
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%)
issues communication
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?
handling a failure of quality
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
      • 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
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”
“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

mssa cap1
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)

survey tool
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)

mssa 10 key elements
Patient information

Drug information

Communication of drug information

Drug labeling, packaging, nomenclature

Drug storage, stock and standardization

Use of devices

Environmental factors

Staff competency and education

Patient Education

Quality processes and risk management

MSSA: 10 Key Elements
mssa process
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

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
mssa scoring
MSSA Scoring

Scoring system reflects RISK inherent in that aspect of the medication system

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.

From a patient’s perspective
The person approach

The systems approach

Reactions to medication errors

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

The Person Approach“Blame and Shame”
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.

The Person Approach: Flaws
the systems approach
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

the systems approach1
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.

The Systems Approach
need to move away from blame shame
Who did it?


Errors are rare

Add more layers

Need to move away from “blame & shame”

What allowed it?

Thank you for reporting!

Errors are everywhere


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)

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 de-identified 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

Data Sharing Agreement
login page
Login Page
  • To access CPhIR, go to:
  • 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
      • E.g. Microsoft Outlook will launch in a new window
  • To navigate CPhIR, there are five tabs at the top of the page
  • Open incidents are displayed on the home page
      • 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
Report an Incident
  • The “Print Blank Form” option allows you to print a blank copy and enter data manually

Mandatory fields are in red, optional fields are in gray

report an incident1
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


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
report an incident2
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:
  • Enter complete medication name and DIN freeform
  • 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 auto-finish 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
  • 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
report an incident3
Report an Incident
  • “Degree of Harm to Patient due to Incident”
      • Select ONE degree of harm
report an incident4
Report an Incident
  • “Incident Description/How Incident was Discovered”
      • 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 incident5
Report an Incident

Expanded View of “Other Incident Info” and “Contributing Factors”

report an incident6
Report an Incident
  • A checkbox at the end of the form gives the option of closing the report
      • If left unchecked (Open) Default:
        • 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
      • If checked (Closed):
        • Cannot be edited
        • Will not be displayed on home page
        • Will be displayed during a 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:
        • Printed
        • Exported to PDF for record keeping
        • Exported to Excel for customized analysis
  • Example:
  • Search all incidents between Jan. 1, 2009 to Dec. 31, 2009 that involved an incorrect drug
      • Select dates from calendar
          • 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
  • Export Data Options
  • To view export options, scroll down under the search results at the bottom of the page
      • 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)



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)
  • 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
  • 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:
        • 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

Individual dataandaggregate data can be viewed in a graph and in a frequency / percentage table

your account
Your Account
  • Changepassword
      • Must be 8 characters long
      • Include letters, numbers, and punctuation
      • Case-sensitive (check caps lock)
  • Displays number of incidents reported
      • 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

What can we do with the medication incidents?

Analysis of 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
dissemination of information
Dissemination of Information

Sample ISMP Medication Safety Alert! Newsletter

And ISMP Canada Safety Bulletin

13 community pharmacies

6 independent

3 grocery

2 chain

2 mass merchandising

August 2008 to January 2010

1532 medication incidents analysed

1544 medication incidents voluntarily reported

12 duplicate or test entries

main themes
Product Mix-Ups

Incorrect Instructions

Wrong Patient

Compliance Aids

Changes in Treatment

Drug Therapy Problem

Main Themes