Increasing Patient Safety in Community Pharmacies

1. Increasing Patient Safety in Community Pharmacies

2. 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

3. 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.

4. 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.

5. 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

6. 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.

7. 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.

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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.

14. 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.

15. Gathering The Troops • Everyone must participate: Pharmacists, techs, clerks. • There are no stupid questions or suggestions. • Blaming others is forbidden.

16. 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.

17. 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

18. 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?

19. 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?

20. 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?

21. 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?

22. 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%)

23. 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?

24. 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.

25. 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”

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.pdf

27. MSSA – CAP

28. 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) MSSA-CAP

29. 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)

30. 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

31. Self-Assessment Items Per Key Element

32. 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

33. 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

34. MSSA Scoring Scoring system reflects RISK inherent in that aspect of the medication system

35. Results - Example

36. Results - Example

37. Results - Example

38. Results - Example

39. Monitor Improvements – Example

40. 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

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 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”

44. 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

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

48. 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) CPhIR

49. 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

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