Increasing Patient Safety in Community Pharmacies

2 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 Introduction to SafetyNET-Rx

What is SafetyNET-Rx? 3 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.

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.f th 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 SafetyNETRx 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 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. 7

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 9 http://media.cop.ufl.edu/camtasia/ms/error/video.html http://media.cop.ufl.edu/videos/pha6277/abc.html

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 10

The QRE: Clarifying The Use of Language Error (Backward Looking; Blame-Laying) Incident (Patient Received Medication) Near MissNear 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 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 17

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? 18

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 patients 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 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. 24

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 dont like errors being reportedbecause of that particular manager you tend to keep things to yourself Pressure of work: We are very busy and we dont have the time to start writing all this stuff down Loyalty to colleagues: I told them and we talked about it, but I didnt report it to Head Office 25

26 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.pdfhttp://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf

MSSA CAP 27

MSSA-CAP Pr oactive 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 DescriptionItems IPatient Information1-6 IIDrug Information7-15 IIICommunication of Drug Orders and Other Drug Information 16-19 IVDrug Labeling, Packaging, and Nomenclature20-24 VDrug Standardization, Storage, and Distribution25-31 VIUse of Devices32-34 VIIEnvironmental Factors35-49 VIIIStaff Competence and Education50-55 IXPatient Education56-65 XQuality Processes and Risk Management66-89 31

MSSA Process 1) Engage a team from the pharmacy 2) Discuss each self assessment item with the team consensus 3) Enter data into password protected secure online site 4) 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 5) Repeat (every 1-3 years) to document progress with improvement efforts 32

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 ResponseDescriptionScore (weighted) AApplicable but No Activity to implement1 BDiscussed but not implemented2 CPartially implemented in some areas3 DFully implemented in some areas4 EFully implemented in all areas5 34

Results - Example 35

Monitor Improvements Example 39

40 From a patients 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.

41 Preventable medical mistakes cause more deaths per year than car accidents, breast cancer or AIDS

42 The person approach The systems approach Reactions to medication errors

43 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

44 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.

45 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

46 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

47 Need to move away from blame & shame Who did it? Punishment Errors are rare Add more layers What allowed it? Thank you for reporting! Errors are everywhere Simplify/standardize

48 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 CPhIRs 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)

49 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

50 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 E.g. Microsoft Outlook will launch in a new window

51 Home 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)

52 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

53 Report an Incident 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 Patients Gender Patients 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

54 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 auto- finish list (Health Canadas 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

55 Report an Incident Degree of Harm to Patient due to Incident Select ONE degree of harm

56 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

57 Report an Incident Expanded View of Other Incident Info and Contributing Factors

58 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

59 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

60 Search 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

61 Search 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)

62 Search PDF Excel

63 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) 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] Prescribers Comments Date Submitted to Central Office 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)

64 Search

65 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: 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

66 Stats Individual data and aggregate data can be viewed in a graph and in a frequency / percentage table

67 Your Account Change password 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? Analysis of Medication Incidents

69 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.pdfhttp://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf

70 Dissemination of Information Sample ISMP Medication Safety Alert! Newsletter And ISMP Canada Safety Bulletin

Results: SafetyNET Phase I Data

72 Results 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

73 Reported Medication Incidents Classified by Outcome

74 Reported Medication Incidents Classified by Stages

75 Top 10 Reported Medications RankMedicationReported Frequency Reported Frequency (%) 1Metoprolol311.72 2Hydrochlorothiazide291.61 3Lorazepam281.56 4Amoxicillin271.50 4Rosuvastatin271.50 6Salbutamol241.33 6Venlafaxine241.33 8Levothyroxine231.28 8Metformin231.28 10Hydromorphone211.17 10Ranitidine211.17

76 Main Themes Product Mix-Ups Incorrect Instructions Wrong Patient Compliance Aids Changes in Treatment Drug Therapy Problem

Questions? 77

Documents

Increasing Patient Safety in Community Pharmacies