Joint Commission Resources Quality & Safety Network (JCRQSN) Resource Guide. A Focus on Medication Safety Issues: Storage and Security

Quality & Safety Network (JCRQSN) Resource Guide A Focus on Medication Safety Issues: Storage and Security May 28, 2015

About Joint Commission Resources Joint Commission Resources (JCR) is a client-focused, expert resource for healthcare organizations. It partners with these organizations, providing consulting services, educational services, and publications to assist in improving the quality, safety, and efficiency of healthcare services, and to assist in meeting the accreditation standards of The Joint Commission. JCR is a subsidiary of The Joint Commission, but provides services independently and confidentially, disclosing no information about its clients to The Joint Commission or others. Visit our web site at: www.jcrinc.com. Disclaimers Joint Commission Resources educational programs and publications support, but are separate from, the accreditation activities of The Joint Commission. Attendees at Joint Commission Resources educational programs and purchasers of Joint Commission Resources publications receive no special consideration or treatment in, or confidential information about, the accreditation process. The information in this Resource Guide has been compiled for educational purposes only and does not constitute any product, service, or process endorsement by The Joint Commission or organizations collaborating with The Joint Commission in the content of these programs. NOTE: Interactivation Health Networks is the distributor of the Joint Commission Resources Quality & Safety Network series and has no influence on the content of the series. 2015 Joint Commission Resources. The purchaser of this educational package is granted limited rights to photocopy this Resource Guide for internal educational use only. All other rights reserved. Requests for permission to make copies of this publication for any use not covered by these limited rights should be made in writing to: Department of Education Programs, Joint Commission Resources, One Renaissance Boulevard, Oakbrook Terrace, IL 60181. 2015 Joint Commission Resources 2 of 38

TABLE OF CONTENTS Program Summary...4 Program Outline...5 Continuing Education (CE) Credit...6 The Joint Commission Accreditation Standard and Elements of Performance: MM.03.01.01...7 Applicability of MM Standards to Sample Medications...9 A Checklist for Safe Use of Medication Samples...10 Time to Close the Door on Medication Storage Challenges...11 How to Comply with MM.03.01.01...11 Tracer Methodology 101: Medication Storage in Hospitals...14 Sentinel Event Alert: Preventing Infection from the Misuse of Vials...18 Road Map to Controlled Substance Diversion Prevention...25 Appendix A: Additional Resources...32 Appendix B: Faculty Biography...33 Appendix C: Continuing Education (CE) Accrediting Bodies...34 Appendix D: Discipline Codes Instructions...35 Appendix E: Post-Test...36 Appendix F: JCRQSN Contact Information...38 2015 Joint Commission Resources 3 of 38

Program Summary This page provides an overview of the program content and learning objectives. Please refer to the Table of Contents and Program Outline for a detailed list of the topics covered. The information included in this Resource Guide is intended to support but not duplicate the video presentation content. There may be additional information available online for this topic. Program Description Medication storage and security are distinct, yet they are interrelated processes that are keys to an effective medication management system. A growing number of medication errors in the United States have been caused by improper storage and security issues. This 60-minute activity focuses on the importance of maintaining safe storage and appropriate security of medications, and highlights the importance of developing a comprehensive organizational oversight of this issue. Program Objectives After completing this activity, the participant should be able to: 1. Identify standard MM.03.01.01 and its elements of performance (EP). 2. Define responsibility and accountability for medication storage and security. 3. Identify ways to foster an environment that can help decrease the chance of medication errors due to storage and security issues. Target Audience This activity is relevant to pharmacists, nurse leaders, physicians, organization leaders, managers and supervisors, and staff responsible for performance improvement (PI), patient safety, and risk management initiatives. 2015 Joint Commission Resources 4 of 38

Program Outline May 28, 2015 I. Introduction A. Program Content B. Objectives C. Faculty II. Review of Joint Commission Medication Safety Requirements III. Controlling Access to Medications IV. Preventing Diversion V. Conclusion VI. Post-Program Live Question and Answer Session A. Audio only telephone seminar with program faculty for 30 minutes following the program. B. Call 1-888-206-0090; enter conference code: 7925428. Or e-mail your questions or comments to: Questions@jcrqsn.com Program Broadcast Time Eastern: Central: Mountain: Pacific: 2:00 p.m. to 3:00 p.m. 1:00 p.m. to 2:00 p.m. 12:00 p.m. to 1:00 p.m. 11:00 a.m. to 12:00 p.m. Program Question and Answer Session During the live airing of this program on May 28, 2015, you may be able to talk directly with the faculty when prompted by the program s host. After this date, your message will be forwarded to the appropriate personnel. Immediately following the program, we invite you to join in a live discussion with the program presenters. Call 1-888-206-0090 and enter Conference Code: 7925428 to be included in the teleconference. To submit your question ahead of time or for additional details, please send an e-mail to questions@jcrqsn.com. If you submit your questions after this date, your message will be forwarded to the appropriate personnel. You can also receive answers to your questions by calling The Joint Commission s Standards Interpretation Hotline at 630-792-5900, option 6. 2015 Joint Commission Resources 5 of 38

Continuing Education (CE) Credit After viewing the JCR Quality & Safety Network presentation and reading this Resource Guide, please complete the required online CE/CME credit activities (test and feedback form). The test measures knowledge gained and/or provides a means of self-assessment on a specific topic. The feedback form provides us with valuable information regarding your thoughts on the activity s quality and effectiveness. NOTE: Effective April 1, 2012, the Learning Management System web site URL changed as noted below. Prior to the Program Presentation Day 1. Login to the JCRQSN Learning Management System web site at http://twnlms.com/ 2. Enroll yourself into the program Note: Your administrator may have already enrolled you in the program Select All Courses from the courses menu. Select the course category for the current year, 2015 Programs. Select the course for this program, When prompted, choose Yes to confirm that you would like to enroll yourself. 3. Display and print the desire documents (Resource Guide, etc.). Online Process for CE/CME Credit 1. Read the course materials and view the entire presentation. 2. Login to the JCRQSN Learning Management System web site at http://twnlms.com/ 3. Select from the courses menu block. Note: This assumes you have already been enrolled in the program as described above. 4. If you didn t view the broadcast video presentation, view it online. 5. Complete the online post test (see Appendix E). You have up to three attempts to successfully complete the test with a minimum passing score of 80%. Physicians must take the post test to obtain credit. 6. Complete the program feedback form. 7. On the top right corner of the main course page, you will see your completion status in the Status block. 8. Select Print Certificate from within the Status block to print your completion certificate. 2015 Joint Commission Resources 6 of 38

The Joint Commission Accreditation Standard and Elements of Performance: MM.03.01.01 Program: Hospital Chapter: Medication Management Standard: MM.03.01.01: The hospital safely stores medications. Rationale: Medication storage is designed to assist in maintaining medication integrity, promote the availability of medications when needed, minimize the risk of medication diversion, and reduce potential dispensing errors. Law and regulation and manufacturers' guidelines further define the hospital's approach to medication storage. EPs: 2 The hospital stores medications according to the manufacturers' recommendations or, in the absence of such recommendations, according to a pharmacist's instructions. Note: This element of performance is also applicable to sample medications. 3 The hospital stores all medications and biologicals, including controlled (scheduled) medications, in a secured area to prevent diversion, and locked when necessary, in accordance with law and regulation. Note 1: Scheduled medications include those listed in Schedules II-V of the Comprehensive Drug Abuse Prevention and Control Act of 1970. Note 2: This element of performance is also applicable to sample medications. 4 The hospital has a written policy addressing the control of medication between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage. Note: This element of performance is also applicable to sample medications. 5 The hospital implements its policy addressing the control of medication between receipt by an individual health care provider and its administration. Note: This element of performance is also applicable to sample medications. 6 The hospital prevents unauthorized individuals from obtaining medications in accordance with its policy and law and regulation. Note: This element of performance is also applicable to sample medications. 7 All stored medications and the components used in their preparation are labeled with the contents, expiration date, and any applicable warnings. Note: This element of performance is also applicable to sample medications. 8 The hospital removes all expired, damaged, and/or contaminated medications and stores them separately from medications available for administration. Note: This element of performance is also applicable to sample medications. 2015 Joint Commission Resources 7 of 38

9 The hospital keeps concentrated electrolytes present in patient care areas only when patient safety necessitates their immediate use, and precautions are used to prevent inadvertent administration. (See also MM.01.01.03, EP 2) 10 Medications in patient care areas are available in the most ready-to-administer forms commercially available or, if feasible, in unit doses that have been repackaged by the pharmacy or a licensed repackager. Note: This element of performance is also applicable to sample medications. 18 The hospital periodically inspects all medication storage areas. Note: This element of performance is also applicable to sample medications. 19 For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital has a pharmacy directed by a registered pharmacist or a supervised drug storage area, in accordance with law and regulation. Note: This element of performance is also applicable to sample medications. 24 For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital maintains records of the receipt and disposition of radiopharmaceuticals. 2015 Joint Commission Resources. All rights reserved. 2015 Joint Commission Resources 8 of 38

Applicability of MM Standards to Sample Medications Effective July 1, 2014, several Medication Management (MM) requirements will include applicability to the management of sample medications for the ambulatory care, behavioral health care, critical access hospital, home care, hospital, and office-based surgery programs. In response to increasing customer concerns regarding compliance and sample medications, The Joint Commission conducted an in-depth review of MM elements of performance (EPs) and selected several that were applicable to sample medications. After the selected MM EPs were evaluated with stakeholders, by professional and technical advisory Committees, and through a field review, The Joint Commission determined that the EPs listed in the box at right are applicable to sample medications. Each of the EPs selected as applicable to sample medications will be clarified with the following Note: Note: This element of performance is also applicable to sample medications. This Note will appear the MM chapter in the spring 2014 Edition and the 2014 Update 1 to the Comprehensive Accreditation Manuals for the programs listed above. The requirements will also be available on The Joint Commission website at http://www.jointcommission.org/standards_ information/prepublication_standards.aspx. A Note on Applicability Please note that, in making this clarification, The Joint Commission is not endorsing the use of sample medications. The new Note is meant only to identify Medication Management (MM) Requirements Applicable to Sample Medications* MM.01.01.01 (EPs 1 2) MM.01.01.03 (EPs 1 3, 5) MM.01.02.01 (EPs 1 3) MM.02.01.01 (EPs 1 3, 7 8) MM.03.01.01 (EPs 2 8, 10, 18 19) MM.03.01.05 (EPs 1 3) MM.04.01.01 (EP 10) MM.05.01.09 (EPs 1 3) MM.05.01.11 (EPs 1 2) MM.05.01.17 (EPs 1 4) MM.05.01.19 (EPs 1 4) MM.07.01.01 (EPs 1 2) MM.07.01.03 (EPs 1 3, 5) MM.08.01.01 (EPs 1 3, 6) * Please note that not all of the EPs listed in this table are applicable to each accreditation program. Accreditationspecific requirements are available on The Joint Commission website at http://www.jointcommission. org/standards_ information/prepublication_standards.aspx and will be in the spring 2014 E-dition as well as the 2014 update to the Comprehensive Accreditation Manuals. which MM EPs are applicable to sample medications for organizations that permit their use. MM EPs that do not have this Note are not applicable to sample medications. In addition, The Joint Commission determined that in the rare event a sample medication is used in an inpatient setting, the sample medication is subject to the complete MM standards like any other inpatient medication. The accreditation manuals will address this with a clarification to the MM Chapter Overview. Questions about this clarification may be directed to Kelly Podgorny DNP, RN, project director, Department of Standards and Survey Methods, at kpodgorny@jointcommission.org. Commission Perspectives, January 2014, Volume 34, Issue 1 Copyright 2014 The Joint Commission 2015 Joint Commission Resources 9 of 38

A Checklist for Safe Use of Medication Samples Proactively identify your organization s approach to medication samples. If you decide to allow the use of medication samples, determine the following: ll For which types of patients? ll On a trial basis or for chronic use? ll Which medications? ll Will you accept controlled substance medication samples? Define control over medication samples. ll Identify a secure location, with authorized access only. ll Determine who will receive samples. ll Determine who will log in samples. ll Determine who will maintain the sample location, remove and properly dispose of expired medications, and oversee recalled medications. ll Review state laws to determine who is authorized to dispense sample medications to the patient. Review the list of allowed medication samples for compliance with the following: ll Look-alike, sound-alike medication process, if appropriate ll High-alert or hazardous medication process, if appropriate ll Applicability for weight-based dosing in pediatric patients Include the following in the decision to provide a patient with a sample medication: ll Document in the patient s medical record. ll Properly label the sample. ll Take steps to ensure no contraindications, interactions, duplications, or patient-specific variables that might affect prescribing (check with the pharmacist). ll Log dispensing in sample medication log book. ll Provide information to the patient about the medication and its proper use. ll Consider providing the patient with a prescription for subsequent refills, with instructions. Consider formalizing medication sample decisions for your practice site with a policy. ll Educate staff and pharmaceutical representatives on these policy decisions. Joint Commission Resources 2014.

Time to Close the Door on Medication Storage Challenges How to Comply with MM.03.01.01 Refrigerated medications, controlled substances, sample medications, and emergency medications all these types of medications, along with any others dispensed in your health care organization, must be properly stored to maintain medication integrity, keep medications available, minimize the risk of medication diversion, and reduce potential dispensing errors. Despite the importance of safe medication storage, many organizations still struggle with this concept. Joint Commission data from the first six months of 2010 show that 31% of hospitals, 27% of critical access hospitals, 25% of ambulatory care organizations, 19% of office-based surgery practices, 14% of long term care organizations, and 12% of behavioral health care organizations were not compliant with Medication Management (MM) Standard MM.03.01.01, which requires organizations to safely store medications. Why does safe medication storage continue to be a challenge for many health care organizations? There are 18 elements of performance (EPs) for MM.03.01.01 across the multiple accreditation programs, and noncompliance with one EP means an organization can be scored not compliant with the standard. Sometimes staff members responsible for medication storage and security are unfamiliar with or are unclear about all of the standard s requirements. Those EPs cover the following areas: Ensuring appropriate conditions for medication storage Securing controlled substances Requiring policies that pertain to handling, storage, security, and return of medications from provision/ dispensing by the pharmacy until administration to the patient Labeling stored medications Inspecting medication areas Handling expired medications Here are some suggestions from Joint Commission experts on how various types of health care organizations can improve their compliance with safe medication storage: TIP Do a comprehensive assessment of current practice. Your organization needs to determine its specific policies and procedures related to medication storage as well as your actual practice and where there are holes. Often, organizations think they are performing this function well when they actually aren t, says Donna Tiberi Blaszczyk, R.N., associate director, Standards Interpretation Group, The Joint Commission. Closely examining the medications an organization stores, how it stores them, and whether practices reflect Joint Commission requirements is critical to determine areas of success and areas that need improvement. For example, The Joint Commission requires organizations to follow manufacturers recommendations when storing medications, in effect turning those recommendations into requirements. Ensuring that storage procedures follow manufacturers recommendations should be part of any assessment. TIP Review law and regulation. Every state has specific laws and regulations that relate to medication storage. Your organization should review current laws and regulations and have a process for receiving any updates to these laws and regulations. If an organization, such as a long term care organization, has many facilities across several states, the organization may want to consider using the strictest state s laws and regulations to govern the medication storage at all its facilities, says Lynette Foster, R.N., associate director, Standards Interpretation Group, The Joint Commission. This ensures that every facility complies with law and regulation. TIP Consult with the or a pharmacist. Pharmacists can be a key resource when designing effective medication storage programs. In a hospital, pharmacists are most likely on site and can easily participate in improvement projects targeting medication storage. In long term care and ambulatory care organizations, this is a little more challenging; 2015 Joint Commission Resources 11 of 38

however, consulting pharmacies, nearby hospital pharmacies, and even commercial pharmacies can be valuable resources. Pharmacists can help not only with determining the best ways to store medications but also with identifying any special storage needs and ensure that any recalled medications are removed from your organization, says Foster. TIP Address controlled substances. One key component of medication storage is the safety and security of controlled substances. This may involve locking sometimes even double locking medications in a secure area and closely monitoring the use of those medications. Monitoring efforts may include the use of a log or other documentation that records when a particular substance is removed from storage, who removes it, how much is used, how much is wasted, and what is done with that waste. Your organization should consider monitoring these logs at least daily, and staff should be trained to recognize inappropriate use of controlled substances and possible drug diversion. Because controlled substances can be considered a security risk, your organization may want to conduct a specific risk assessment on this aspect of medication storage to identify current procedures, possible risk points including risks for diversion and effective strategies for reducing risk. One strategy is to use a number lock instead of a keyed lock to prevent access to controlled medication. Only those individuals who should have access to the controlled substance are given the number, thus preventing individuals who should not have access from overcoming the lock. TIP Ensure proper temperature. Many medications must be stored at a specific temperature. When that temperature can be reached only through refrigeration, you must have a valid and reliable way to measure temperature to ensure its consistency. Some medications such as vaccines must be maintained at a constant temperature or they will break down, says Foster. It is critical in cases such as these that the organization has a temperature monitoring system and that the system is regularly checked. Staff should know how to check the monitoring system and what to do when a constant temperature is not maintained. There are a variety of ways to monitor temperature, and The Joint Commission does not require a specific method. For example, some organizations use an automated temperature monitoring system that has an alarm that sounds if the temperature drops below the required value. Other organizations use a thermometer that can show the temperature over the past 72 hours. With this type of system, staff can examine the temperature logs every morning to see if the temperature has remained constant throughout the past 24 hours. Pharmacists can help not only with determining the best ways to store medications but also with identifying any special storage needs and ensure that any recalled medications are removed from your organization, Lynette Foster, R.N., associate director, Standards Interpretation Group, The Joint Commission. For home care or hospice organizations, maintaining the proper temperature of medications can be particularly difficult. For example, if a nurse is visiting several patients in a day and brings their medications with him or her in the car, the nurse must ensure that he or she does not leave any medications requiring a controlled temperature in the car for too long. Leaving a controlled-temperature medication in the car during extreme weather can destabilize the medication, says Foster. Ideally, the nurse should deliver any refrigerated medications to patients early in the day, or, if that is not possible, have the medications delivered directly to the patient to avoid fluctuations in temperature. TIP Have a contingency plan for temperature system failure. Even if your organization has state-of-the-art refrigeration equipment, that equipment may fail, or the power may be disrupted, thereby disabling the system. Your organization therefore needs a backup plan. The plan should be clearly defined, and staff should be familiar with it. For example, if the refrigeration unit fails, staff should know whom to call typically the supervisor and the facility maintenance department and how to ensure the safety of the medication. If the refrigerator is connected to emergency backup power, leaving 2015 Joint Commission Resources 12 of 38

the medication in place may be appropriate. In other cases, disposing of the medication or putting it on dry ice and delivering it to another unit, department, or facility may be the best course. Enlisting pharmacists assistance in these situations is critical in determining the continued usability of the medication. TIP Store medications by use. One frequent problem with medication storage involves look-alike, sound-alike medications. To avoid inadvertent mix-ups, organizations should refrain from storing medications alphabetically, says Blaszczyk. Instead, they should consider storing them by use, for example, putting all the asthma medications together and all the diabetes medications together. Your organizations should also examine the packaging of medications to ensure that those with similar packaging are not stored next to each other. TIP Label high-alert medications. Identify any high-alert medications, such as heparin and epinephrine, through the use of stickers or special labels. Such careful identification shows staff that the medication is high alert and must be handled with care. TIP Don t forget sample medications. The storage of sample medications, just like that of any other medications, is governed by law and regulation and manufacturers instructions. Organizations that store a large amount of sample medications such as ambulatory care organizations should include them in their overall assessment of medication storage and address any risk points. Copyright 2011 Joint Commission on Accreditation of Health Care Organizations The Joint Commission: The Source, October 2010, Volume 8, Issue 10 2015 Joint Commission Resources 13 of 38

Tracer Methodology 101: Medication Storage in Hospitals The Joint Commission surveys medication storage under Medication Management (MM) Standard MM.03.01.01: The hospital safely stores medications. (See Related Requirements on page 15 for the complete standard.) In 2013, 34.7% of all hospitals surveyed were found noncompliant with this standard. By ensuring that medications are both appropriately and securely stored, hospitals can reduce any potential problems or medication errors. While the subject of medication storage covers everything from its location and security to its availability and control, the most important factor for hospitals to consider is how well the designed procedures support the provision of medication management and prevent any unanticipated events or errors. As part of the overall medication management process, the appropriate storage of medication is important not only for ensuring accessibility to the medication when needed, but also that the integrity (temperature and dating) of the medication has been maintained and that there are prompts for the safe use of high-risk or look-alike medications, notes Jane Schetter, RN, MSN, CNS, CJCP, senior CSR consultant at Joint Commission Resources. An important consideration, she adds, is that a hospital s approach to medication storage should be balanced. Not having a balanced approach can negatively impact the overall provision of medication management, explains Schetter. For example, while hospitals need to appropriately secure medications, it should be done in a way that does not impair patient care, she adds. Schetter warns against having too totalistic an approach toward how stored medications are secured. It s clear that hospitals will need to store controlled medications in a secured area in accordance with relevant local, state, and federal laws and regulations, she explains. But that does not mean that all medications need to be handled in exactly the same way. If a hospital has a policy that basically states all medications are locked, notes Schetter, this is an outdated approach to securing medications and can make delivering medications problematic. The key is to ensure that medications are safely stored, as the standard states, and that only authorized individuals have access to these medications, she adds. Improper storage of medications can adversely impact a medication s effectiveness, which could contribute to patient harm. Determining who is authorized to have access to where medications are stored should not be limited to those who may be authorized to administer or prepare medications, such as clinical or pharmacy staff alone. Determining who has access to medication storage areas should be dictated by who might need to be in that location, explains Jeannell Mansur, RPh, PharmD, FASHP, Practice Leader in Medication Safety at Joint Commission Resources. She points to cleaning or facilities staff who may not be authorized to handle the medication but may still need access to the area. Identification of who has access should be put in writing, whether it s in the job description or policy, Mansur adds. The key is to ensure that the correct levels of access are given in an appropriate manner. Mansur also stresses that there should be a timely process in place to remove authorized access for those staff who are no longer on staff at the hospital. Following set manufacturer guidelines is another important aspect of effective medication storage, notes Mansur. Hospitals should always safely store medications in a way that is secure and appropriate to the stability and recommended guidelines set forward by the manufacturer, she explains. It s critical to follow the guidelines, as the expiration of medications may require re-dating if the medicine has been opened or stored out of set temperature parameters. Mansur also points out that if a medication has been warmed, its expiration may also require re-dating as per manufacturer s guidelines. One way to ensure both the viability and stability of refrigerated medications is to monitor the temperature of fridges used. Mansur credits hospitals with consistently completing temperature logs. But she also stresses the importance of using the data from these logs to inform any necessary improvement 2015 Joint Commission Resources 14 of 38

Related Requirements MM.03.01.01 for Hospitals The hospital safely stores medications. Elements of Performance for MM.03.01.01 2. The hospital stores medications according to the manufacturers recommendations or, in the absence of such recommendations, according to a pharmacist s instructions. Note: This element of performance is also applicable to sample medications. 3. The hospital stores all medications and biologicals, including controlled (scheduled) medications, in a secured area to prevent diversion, and locked when necessary, in accordance with law and regulation. Note 1: Scheduled medications include those listed in Schedules II V of the Comprehensive Drug Abuse Prevention and Control Act of 1970. Note 2: This element of performance is also applicable to sample medications. 4. The hospital has a written policy addressing the control of medication between receipt by an individual health care provider and administration of the medication, including safe storage, handling, security, disposition, and return to storage. Note: This element of performance is also applicable to sample medications. 5. The hospital implements its policy addressing the control of medication between receipt by an individual health care provider and its administration. Note: This element of performance is also applicable to sample medications. 6. The hospital prevents unauthorized individuals from obtaining medications in accordance with its policy and law and regulation. Note: This element of performance is also applicable to sample medications. 7. All stored medications and the components used in their preparation are labeled with the contents, expiration date, and any applicable warnings. Note: This element of performance is also applicable to sample medications. 8. The hospital removes all expired, damaged, and/or contaminated medications and stores them separately from medications available for administration. Note: This element of performance is also applicable to sample medications. 9. The hospital keeps concentrated electrolytes present in patient care areas only when patient safety necessitates their immediate use, and precautions are used to prevent inadvertent administration. (See also MM.01.01.03, EP 2) 10. Medications in patient care areas are available in the most ready-to-administer forms commercially available or, if feasible, in unit-doses that have been repackaged by the pharmacy or a licensed repackager. Note: This element of performance is also applicable to sample medications. 18. The hospital periodically inspects all medication storage areas. Note: This element of performance is also applicable to sample medications. 19. For hospitals that use Joint Commission accreditation for deemed status purposes: The hospital has a pharmacy directed by a registered pharmacist or a supervised drug storage area, in accordance with law and regulation. Note: This element of performance is also applicable to sample medications. activities. There needs to be a mechanism in place to better inform and respond to any inconsistencies in temperatures, Mansur explains. If, for example, a log identifies a variation in fridge temperatures on a regular basis, there needs to be a responsive process in place to identify whether this may be due to staff competency (such as leaving a door open) or a mechanical problem with the fridge. Schetter and Mansur offer the following tips for hospitals to consider when effectively managing medication storage. Be aware of any federal, state, and local laws that might apply to medication storage and ensure that these are built into the hospital s policies. Ensure that there are standard operating procedures or policies related to security during all steps of the medication management process. Ensure that the organization has clearly defined, documented, and communicated who has access to medications. Consider implementing a centralized process to monitor and track medication management processes, including any issues relating to storage. This can help identify if there is an isolated issue to respond to or a more systemwide problem that requires improving. Balance medication security policies between guaranteeing no unauthorized access to medications and appropriate access by authorized staff for administration. 2015 Joint Commission Resources 15 of 38

Ensure that emergency medications and their supplies are immediately available while maintaining appropriate security. Frequent rounding should be conducted not only by pharmacy staff but by patient safety staff on a regular basis to ensure appropriate storage. The Scenario This tracer took place in a large urban teaching hospital located in a Southeastern state. During the course of the tracer, the surveyor met with pharmacy staff, nursing staff, and the hospital s patient safety staff. During the tracer, the surveyor focused some discussion around the issue of medication security and storage, exploring standards MM.01.01.03, MM.03.01.01, and MM.05.01.01 in particular. He examined data relating to medication storage and security, temperature monitoring, and relevant policies and procedures for storage across the whole hospital. Determining who is authorized to have access to where medications are stored should not be limited to those who may be authorized to administer or prepare medications, such as clinical or pharmacy staff alone. Exploring medication storage process. He first asked the staff to describe what their policies are for medication storage and who is involved in designing and implementing them. He asked the staff to describe how and where medications are stored and secured. [1,2] The pharmacy director explained that in addition to the pharmacy itself, there were medications stored in key areas of the hospital such as the radiology department and outpatient procedure rooms. [3] The surveyor asked what the process was to determine who had access to medication storage and how this was documented. [4] He then asked the staff to explain who reviews if these policies are being followed and how changes are made, if necessary. [5] The patient safety manager explained that her staff conducted regular rounds during which they checked compliance with their set policy and that the medication management team oversaw any changes to procedure. The surveyor then reviewed the hospital s policies and noted that recent changes had been updated and documented within the policy. Tracing temperatures and refrigeration. The surveyor then asked the group to describe what their process was to monitor and track any refrigerated medications. [6] The pharmacy director explained that the refrigerators were in secured, strategic locations and that pharmacy staff were responsible for checking logs. The surveyor asked if the hospital had undertaken any performance improvement activity lately in relation to medication storage. [7] The patient safety director reported that the organization had recently performed a proactive risk assessment of high-alert medication storage in a procedure room in the emergency department where they identified an issue with refrigerators being left unlocked or not being locked consistently this deviated from their set policy of keeping refrigerators locked. The team had determined that staff who needed medications in a hurry sometimes forgot to relock the fridge after use. The hospital was currently designing a performance improvement project to respond to this disparity. Moving forward. The surveyor and team discussed how to best address the issue of medication security in the emergency department by reviewing both the hospital s policy and whether or not there was an optimal way to effectively secure medications that was suited to the emergency medical environment and patient care. 2015 Joint Commission Resources 16 of 38

Sample Questions The following represent some questions that could be asked during a tracer. Use them as a starting point to plan your own tracers. 1. What is your process for safely and securely storing medications? 2. Who is involved in this process? 3. Where are your medications stored? 4. How do you determine who should have access to places where medications are stored? How is this communicated and monitored? What happens when an authorized staff member leaves the hospital? 5. How often do you review your medication storage policies? Who is involved in this process and how do you update or modify any policy? 6. What is your process to monitor temperatures for those medications that require refrigeration? 7. What kind of proactive risk assessments have you performed in relation to medication storage? What was your response to this assessment? If there are any changes you made, how did you implement these changes and track any improvements made? Mock Tracer Tracking Worksheet: Medication Storage in Hospitals Use this worksheet to record notes and areas of concern that you identify while conducting your organization s mock tracers. This information can be used to highlight a good practice or to determine issues that may require further follow-up. Checking yes or no indicates whether the staff member interviewed during the tracer answered the question correctly. An incorrect answer should always receive comments or recommendations for follow-up. Tracer Team Member: Staff Interviewed: Unit or Department Where Tracer Was Conducted: Tracer Patient or Medical Record: Tracer Questions Correct Answer Incorrect Answer Follow-Up Needed Comments or Notes 1. What is your process for safely and securely storing medications? 2. Who is involved in this process? 3. Where are your medications stored? 4. How do you determine who should have access to places where medications are stored? How is this communicated and monitored? What happens when an authorized staff member leaves the hospital? 5. How often do you review your medication storage policies? Who is involved in this process and how do you update or modify any policy? 6. What is your process to monitor temperatures for those medications that require refrigeration? 7. What kind of proactive risk assessments have you performed in relation to medication storage? What was your response to this assessment? If there are any changes you made, how did you implement these changes and track any improvements made? Copyright 2014 The Joint Commission The Source, July 2014, Volume 12, Issue 7 2015 Joint Commission Resources 17 of 38

Sentinel Event Alert: Preventing Infection from the Misuse of Vials Published for Joint Commission accredited organizations and interested health care professionals, Sentinel Event Alert identifies specific types of sentinel and adverse events and high risk conditions, describes their common underlying causes, and recommends steps to reduce risk and prevent future occurrences. Accredited organizations should consider information in a Sentinel Event Alert when designing or redesigning processes and consider implementing relevant suggestions contained in the alert or reasonable alternatives. Please route this issue to appropriate staff within your organization. Sentinel Event Alert may only be reproduced in its entirety and credited to The Joint Commission. To receive by email, or to view past issues, visit www.jointcommission.org. A complimentary publication of The Joint Commission, Issue 52, June 16, 2014 Thousands of patients have been adversely affected by the misuse of single-dose/single-use and multiple-dose vials. The misuse of these vials has caused harm to individual patients through occurrences and outbreaks of bloodborne pathogens and associated infections, including hepatitis B and C virus, 1,2 meningitis, and epidural abscesses. 3 Adverse events caused by this misuse have occurred in both inpatient and outpatient settings, according to the Centers for Disease Control and Prevention (CDC). The misuse of vials primarily involves the reuse of single-dose vials,3 which are intended to be used once for a single patient. Single-dose vials typically lack preservatives; therefore, using these vials more than once carries substantial risks for bacterial contamination, growth and infection. Since 2001, at least 49 outbreaks have occurred due to the mishandling of injectable medical products, according to the CDC. Twenty-one of these outbreaks involved transmission of hepatitis B or C; the other 28 were outbreaks of bacterial infections, primarily invasive bloodstream infections. While many of these outbreaks occurred in inpatient settings, a high percentage occurred in pain management clinics, where injections often are administered into the spine and other sterile spaces using preservative-free medications, and in cancer clinics, which typically provide chemotherapy or other infusion services to patients who may be immuno-compromised. In addition, more than 150,000 patients required notification during this time frame to undergo bloodborne pathogen testing after their potential exposure to unsafe injections. 4 Since 2001, at least 49 outbreaks have occurred due to the mishandling of injectable medical products, according to the CDC more than 150,000 patients required notification during this time frame to undergo bloodborne pathogen testing after their potential exposure to unsafe injections. 4 The CDC is aware of at least 19 bloodborne or bacterial infection outbreaks since 2007 associated with the misuse of single-dose/single-use vials. Seven involved bloodborne pathogen infections, and 12 were bacterial infections. All of these outbreaks occurred in the outpatient setting, with eight occurring in pain remediation clinics. 3 According to CDC officials, these examples likely underestimate the harm resulting from the misuse of single-dose/single-use vials. Due to the difficulty of tracing the misuse of vials to infections, the adverse impact of misusing a vial is typically not seen immediately. 5 Adverse events related to unsafe injection practices and lapses in infection control practices are underreported, and it remains a challenge to measure the true frequency of such occurrences. 2015 Joint Commission Resources 18 of 38

While the misuse of disposable parenteral syringes and pen injectors also contribute to adverse events and outbreaks, this Alert will focus on the safe use of vials. Causes and documentation of misuse A significant contributing factor to the misuse of vials is the lack of adherence to safe infection control practices and to aseptic techniques within health care organizations. For example, a survey of 5,446 health care practitioners found lapses in basic infection control practices relating to vial use. The results included: For single-dose/single-use vials, 6 percent admitted to sometimes or always using vials for multiple patients. For multiple-dose vials, 15 percent reported using the same syringe to re-enter a vial numerous times for the same patient; of that 15 percent, 6.5 percent reported saving vials for use on another patient. Of the 51 professionals who reported reusing a syringe to obtain an additional dose from a multiple-dose vial and then leaving it for use on another patient, about half (52.0%) were from the hospital setting. 6 A study by the CDC and the Centers for Medicare & Medicaid Services (CMS) published in the Journal of the American Medical Association (JAMA) found that two-thirds of inspected CMS-certified ambulatory surgical centers had lapses in basic infection control practices. Twenty-eight percent of these facilities used medications in single-dose vials for multiple patients. 7 In addition, some providers compromise safe infection control practices in attempts to prevent waste. 5,6,8 The compulsion to prevent waste is sometimes exacerbated by medication shortages or costs. 3,5,9 However, any cost savings achieved by preventing waste can quickly be offset by one or more adverse clinical outcomes. The medical literature contains many examples of individuals who acquired preventable bloodborne and bacterial infections. 10-20 Some patients died from these infections, and many others required prolonged, sometimes life-long, treatment and follow-up care as a result. In other instances, underlying health conditions may have been exacerbated. In addition, there can be tremendous financial costs associated with treating infected patients or containing an outbreak, and providers causing harm face significant legal ramifications or disciplinary action. 3 Recommendations and potential strategies for improvement While organizations are required by Joint Commission standards to safely dispense and administer medications (see next section for all related Joint Commission requirements), the accomplishment of these goals depends on preventative action taken by clinical staff who administer injections. Staff should always follow safe injection and infection control practices V including correct aseptic technique, hand hygiene and the one-time-only use of needles and syringes V along with the specific recommendations for single-dose/single-use vials and multiple-dose vials in this alert. Safe infection control practices always apply when transporting, storing, preparing and administering medications, solutions and related supplies. See the CDC s comprehensive injection safety resource: http://www.cdc.gov/injectionsafety. The following recommendations and potential strategies can be used to help prevent the misuse of vials, thereby preventing the spread of infection. 2015 Joint Commission Resources 19 of 38

Effective processes and procedures 1. Develop and implement effective evidence-based organization-wide standardized policy and procedures for the prevention of the misuse of vials. The policy should apply to all staff who administer injections to patients, and should address the following: Single-dose/single-use vials Use a single-dose/single-use vial for a single patient during the course of a single procedure. Discard the vial after this single use; used vials should never be returned to stock on clinical units, drug carts, anesthesia carts, etc. The One & Only Campaign from the CDC and Safe Injection Practices Coalition emphasizes ONE needle, ONE syringe, ONLY ONE time. Medications in single-dose/single-use vials lack antimicrobial preservatives and are therefore at greater risk to become contaminated and serve as a source of infection when used inappropriately. See campaign resources, including video. If a single-dose/single-use vial must be entered more than once during a single procedure for a single patient to achieve safe and accurate titration of dosage, use a new needle and new syringe for each entry. 21 Note: USP 797 states that single-dose/single-use vials opened in less than ISO Class 5 air quality be used within one hour, with any remaining contents discarded. Single-dose/single-use vials opened in ISO Class 5 air quality can be used up to six hours. 22 Do not combine or pool leftover contents of single-dose/single-use vials. Do not store used single-dose/single-use vials for later use, no matter what the size of the vial. 3 Unopened single-dose/single-use vials may be repackaged into multiple single-dose/single-use containers (e.g. syringes), which should be properly labeled, including the expiration date and a beyond-use date (which is different from the manufacturer assigned expiration date). This repackaging should be performed only by qualified personnel in ISO Class 5 air conditions in accordance with standards in the United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding - Sterile Preparations. Also, follow the manufacturer s recommendations pertaining to safe storage of that medication outside of its original container. 3,22 Multiple-dose vials Only vials clearly labeled by the manufacturer for multiple dose use can be used more than once. h Limit the use of a multiple-dose vial to only a single patient, whenever possible, to reduce the risk of contamination. 23,24,25 When multiple-dose vials are used more than once, use a new needle and new syringe for each entry. 23 Do not leave needles or other objects in vial entry diaphragms between uses, as this may contaminate the vial s contents. 23 Disinfect the vial s rubber septum before piercing by wiping (and using friction) with a sterile 70 percent isopropyl alcohol, 22 ethyl/ethanol alcohol, iodophor,26 or other approved antiseptic swab. Allow the septum to dry before inserting a needle or other device into the vial. 24 Once a multiple-dose vial is punctured, it should be assigned a beyond-use date. The beyond-use date for an opened or entered (e.g., needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days, unless otherwise specified by the manufacturer. Store multiple-dose vials outside the immediate patient treatment area; observe the manufacturer's storage recommendations. 24 All vials (single-dose/single-use and multiple-dose) Discard any vial if its sterility has been compromised or is questionable, including those having been placed on a used procedure tray or used during an emergency procedure even if the vial is unopened/unused. 24 Select the smallest vial necessary when making purchasing and treatment decisions to reduce waste. 3 Urge manufacturers to produce vials in appropriate sizes to reduce waste. 27 2015 Joint Commission Resources 20 of 38

2. Conduct regular quality checks on clinical units to look for open vials. Training and education 3. Provide annual education on injection safety and on preventing the misuse of vials for all staff who administer injections, including new or temporary staff. Education should include how to recognize and report known breaches of safe injection and infection control practices with vials, such as the use of a single-dose/single-use vial on more than one patient either accidentally (human error) or due to a mistaken belief that the breach was not significant or was justified (at-risk behavior). Staff education should aim to reduce gaps in knowledge regarding safe injection and infection control practices, and to reduce staff tolerance of behavioral choices that may place patients or others at risk of harm, such as using a single-dose vial of medication for multiple patients. 4. Before discharge, provide injection safety education to patients and caregivers who will use injectable medical products as part of a home health regimen. Use teach-back methods to assure understanding. Safety culture 5. Emphasize that all staff are responsible for reporting risks, errors (including near misses), and adverse events. Create a culture within which the reporting of unsafe injection and infection control practices or near misses is viewed as a necessary step to improve safety. 6. Report clusters of infections or other adverse events to the appropriate local and state public health authorities. While reporting of adverse events is usually voluntary, outbreak reporting is typically required by state public health departments. Failure to report illness clusters to public health authorities can result in delays in recognition of disease outbreaks and in implementation of control measures. Incidents of adverse events associated with the misuse of vials can be reported to: The Joint Commission, in accordance with its Sentinel Event policy FDA Adverse Event Reporting System (FAERS) Appropriate state agencies (reporting may be mandatory in some states). See reportable conditions by state State health departments, if multiple patients are involved. Appropriate patient safety organizations (PSOs), such as ECRI Institutes for the Institute for Safe Medication Practices (ISMP) National Medication Errors Reporting Program 7. When unsafe injection and infection control practices are identified, assess potential harm to patients and, if warranted, notify patients and test for bloodborne pathogens. Actions for notifying patients should be discussed with local and state public health authorities. Related Joint Commission requirements Reference the Standards FAQ for MM.03.01.01, Element of Performance (EP) 7, which requires organizations to re-label multiple-dose vials with a revised expiration date (that is, a beyond-use date) once staff opens or punctures a multiple-dose vial. Therefore, The Joint Commission requires a 28-day expiration date for multiple-dose vials the NEW syringe the NEW needle Scrub the rubber septum with an approved antiseptic swab. Allow to dry. Insert a new needle attached to a new syringe for each entry. from the date of opening or puncture, unless the manufacturer specifies otherwise (shorter or longer). In any case, the original expiration date printed on the vial cannot be extended. If the manufacturer s original expiration 2015 Joint Commission Resources 21 of 38