IMPROVING MEDICATION  
         SAFETY IN COMMUNITY  
         PHARMACY: 
         ASSESSING RISK  
         AND OPPORTUNITIES  
         FOR CHANGE 
             
            ISMP  
            Improving Medication Safety in Community Pharmacy: Assessing Risk and Opportunities for Change 
            Table of Contents 
             
            Table of Contents.........................................................................................i 
            Introduction................................................................................................1 
            Illustrating the Application of Key Elements of the Medication Use System™ 
            to Assess Risk.............................................................................................3 
              Key Element I:  Patient Information................................................................... 5 
              Key Element II:  Drug Information..................................................................... 9 
              Key Element III:  Communication of Drug Orders and Other Drug Information 13 
              Key Element IV:  Drug Labeling, Packaging, and Nomenclature........................ 21 
              Key Element V:  Drug Standardization, Storage, and Distribution..................... 30 
              Key Element VI:  Medication Device Acquisition, Use, and Monitoring.............. 38 
              Key Element VII:  Environmental Factors, Workflow, and Staffing Patterns..... 42 
              Key Element VIII:  Staff Competency and Education ........................................ 47 
              Key Element IX:  Patient Education................................................................... 53 
              Key Element X:  Quality Processes and Risk Management................................. 61 
            Final Quick Check Question.......................................................................68 
            Using the Assess-ERR™ Tool in Community Pharmacy..............................69 
            Illustrating the Application of the Key Elements through the Medication 
            Flow Process.............................................................................................71 
            Utilizing the Assess-ERR™ (Case Study) ...................................................78 
            Conclusion ................................................................................................96 
            Acknowledgements...................................................................................97 
            References................................................................................................99 
            Glossary..................................................................................................101 
            Appendix 1:  ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose 
            Designations...........................................................................................104 
            Appendix 2:  FDA and ISMP Lists of Look-Alike Drug Name Sets with 
            Recommended Tall Man Letters..............................................................107 
            Appendix 3:  Assess-ERR™ (Community Pharmacy Version)...................109 
            Appendix 4:  Strategies to be used with the  Assess-ERR™ (Community 
            Pharmacy Version)..................................................................................113 
            Appendix 5:  Selected Data from ISMP Medication Safety Self Assessment™ 
            for Community/Ambulatory Pharmacy....................................................115 
               
              ISMP  
              Improving Medication Safety in Community Pharmacy: Assessing Risk and Opportunities for Change 
              Introduction 
               
              The Importance of Systematic Analysis of Errors in Pharmacy Practice 
               
              The 2006 Institute of Medicine (IOM) report Preventing Medication Errors estimated 
              that, based on studies and referenced research, 51.5 million errors occur per 
                                              1
              3 billion prescriptions per year.  This amounts to four errors per 250 prescriptions 
              per pharmacy per day. The IOM further estimated that 6.5% of these errors were 
              clinically significant.  By extension, this translates to one clinically significant error 
              per 962 prescriptions.   
               
              Using these estimates, a typical community pharmacy that fills about 
              2,000 prescriptions per week may generate up to two clinically significant 
              prescription errors every week. 
               
              Surely there is room for improvement.  This manual has been designed to assist 
              community pharmacy practitioners and operators to assess their current practices 
              and enhance their procedures for improving safety in their practice settings.   
               
              The goal of every community pharmacy should be to continually improve their 
              medication-use system in order to help ensure the safest, highest quality of care 
              possible. To accomplish this, community pharmacies must assess their risks 
              associated with the medication-use process by monitoring actual and potential 
              medication errors and adverse events that occur within their organization. Analysis 
              and investigation of root causes of these events must then occur so that strategies 
              to improve the medication-use process and prevent future events may be identified 
              and implemented. Key to success is the quality of the information collected in the 
              reports, the analysis of the information, and the subsequent actions taken to 
              improve the system and prevent harm to patients.  
               
              The ISMP Medication Safety Self Assessment™ for Community/ Ambulatory 
              Pharmacy was developed in 2001 and made available to community and 
              ambulatory pharmacies for the purpose of encouraging individual pharmacies to self 
              evaluate their processes. Data collected from the more than 5000 pharmacies that 
              completed the self assessment indicates a lack of implementation of patient safety 
              initiatives in current practice. (To view examples of data that was collected from the 
              ISMP Medication Safety Self Assessment™ for Community/Ambulatory Pharmacy in 
              each of the key elements, see Appendix 5.) Therefore this “Improving Medication 
              Safety in Community Pharmacy:  Assessing Risk and Opportunities for Change” 
              manual was developed to educate community pharmacists on the key elements of 
              the medication-use system in order to self analyze errors and prioritize safety 
              changes that should be employed.  
                                                                                                       
                                                                                                       
               
              © ISMP 2009                                                                            1 
               
              ISMP  
              Improving Medication Safety in Community Pharmacy: Assessing Risk and Opportunities for Change 
              Goals 
              The goals of this manual are to: 
               
                 •  Raise awareness of error-prone processes in the medication delivery system.  
                 •  Build awareness of risk-identification opportunities in the community 
                    pharmacy setting. 
                 •  Maximize the appropriate application of system strategies to reduce 
                    organizational risk. 
               
              Outcomes 
              After utilizing this manual, community pharmacy personnel will be able to:  
               
                 •  Initiate a risk assessment process to identify medication safety 
                    improvements in the community pharmacy setting. 
                 •  Use ISMP’s Key Elements of the Medication Use System™ to help identify and 
                    prevent risk in daily practice. 
                 •  Examine flow diagrams or flow charts of the medication process to identify 
                    variability in current medication-use processes. 
                 •  Select effective error reduction strategies that can prevent patient harm. 
                 •  Review case scenario(s) of medication error or near miss events and apply 
                    knowledge of ISMP’s Key Elements to identify breakdowns in the system that 
                    have contributed to the error. 
                 •  Utilize the Assess-ERR™ for a medication error or near miss that has 
                    occurred in your practice 
               
              This manual is designed to help community pharmacy personnel identify potential 
              medication safety risks and prevent error. Pharmacists can use the materials and 
              tools in this manual to pinpoint specific areas of weakness in their medication 
              delivery systems and to provide a starting point for successful organizational 
              improvements. 
                                                                                                     
                                                                                                     
               
              © ISMP 2009                                                                          2