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Improving IV Medication Safety: Identifying the Risk Points Presented as a Midday Symposium at the 44 ASHP Midyear Clinical Meeting and Exhibition th Tuesday, December 8, 2009 Las Vegas, Nevada Please be advised that this activity is being audio recorded for archival purposes and, in some cases, for repurposing of the content for enduring materials. 2 Improving IV Medication Safety: Identifying the Risk Points AGENDA 11:30 a.m. – 11:35 a.m. Welcome / Introductory Remarks Rita Shane, Pharm.D., FASHP, FCSHP Program Chair 11:35 a.m. – 12:10 p.m. Identifying the Risk Points: Back to the Basics Rita Shane, Pharm.D., FASHP, FCSHP 12:10 p.m. – 12:45 p.m. Managing the Risk Points to Improve Medication Safety Ginette A. Pepper, Ph.D., RN, FAAN 12:45 p.m. – 1:20 p.m. Case Scenario: Evaluating a Medication Management System and Implementing Safety Solutions Karen Fiumara, Pharm.D., BCPS 1:20 p.m. – 1:30 p.m. Faculty Discussion and Audience Questions All Faculty FACULTY Rita Shane, Pharm.D., FASHP, FCSHP Director of Pharmacy Services Cedars-Sinai Medical Center Los Angeles, California Assistant Dean, Clinical Pharmacy Services University of California, San Francisco, School of Pharmacy San Francisco, California Ginette A. Pepper, Ph.D., RN, FAAN Professor and Associate Dean for Research Helen Lowe Bamberger Colby Presidential Endowed Chair in Gerontological Nursing Director, Hartford Center of Geriatric Nursing University of Utah College of Nursing Salt Lake City, Utah Karen Fiumara, Pharm.D., BCPS Patient Safety Officer Brigham and Women’s Hospital Adjunct Assistant Professor of Pharmacy Practice Massachusetts College of Pharmacy and Allied Health Sciences Boston, Massachusetts 3 Improving IV Medication Safety: Identifying the Risk Points DISCLOSURE STATEMENT In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Guidelines for Standards for Commercial Support, ASHP Advantage requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g., employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on presentations. All faculty and planners for ASHP Advantage education activities are qualified and selected by ASHP Advantage and required to disclose any relevant financial relationships with commercial interests. ASHP Advantage identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity. The faculty and planners report the following relationships: Rita Shane, Pharm.D., FASHP, FCSHP, Program Chair Dr. Shane declares that she has served as a consultant for Abbott. Ginette A. Pepper, Ph.D., RN, FAAN Dr. Pepper declares that she has no relationships pertinent to this activity. Karen Fiumara, Pharm.D., BCPS Dr. Fiumara declares that she has no relationships pertinent to this activity. Ron DeChant, M.S., B.S.Pharm. Mr. DeChant declares that he has no relationships pertinent to this activity. 4 Improving IV Medication Safety: Identifying the Risk Points ACTIVITY OVERVIEW This symposium will provide pharmacists with practical methods for minimizing potential IV medication errors by identifying risk points in the medication management system. Strategies for managing these risk points will be discussed as well as the sharing of successful practices that have been demonstrated to enhance safety in various organizations around the country. Experts will provide guidance on how a pharmacy department can identify high-risk processes, identify errors before they reach a patient, and develop systems that quickly mitigate the effect of any harm to a patient with emphasis on IV medication use. An automated audience response system will be used to facilitate active learning and application of knowledge to practice. ACTIVITY OBJECTIVES At the conclusion of this knowledge-based educational activity, participants should be able to • Describe a process to identify medication management system risk points. • Identify at least one risk point within each of the six critical processes of medication management. • Explain a successful medication management strategy that has been demonstrated to enhance safety within an organization. • Evaluate the medication management system within an organization and implement a strategy to enhance safety. 5 Improving IV Medication Safety: Identifying the Risk Points CONTINUING EDUCATION ACCREDITATION The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 2.0 hours (0.2 CEUs) of continuing pharmacy education credit (ACPE activity #204000-09-436-L01P). Attendees must complete a Continuing Pharmacy Education Request online and may immediately print their official statements of continuing pharmacy education credit at the ASHP Learning Center at http://ce.ashp.org following the activity. Complete instructions for receiving your statement of continuing pharmacy education online are on the next page. Be sure to record the five-digit session code announced during the activity. Available soon at http://ashpmedia.org/symposia/IVsafety So that this educational activity can be shared with a wider audience, a Web-based version of it is being developed. Encourage your pharmacist colleagues who were unable to attend the Midyear to look for this free online continuing pharmacy education activity beginning in March 2010. Please note that individuals who claim CPE credit for the live symposium are ineligible to claim credit for the Web-based activity. 6 Improving IV Medication Safety: Identifying the Risk Points Instructions for Processing CPE online at http://ce.ashp.org The ASHP Learning Center allows participants to obtain statements of continuing pharmacy education (CPE) conveniently and immediately using any computer with an internet connection. To obtain your CPE statements for ASHP Advantage activities, please visit http://ce.ashp.org 1. Log in to the ASHP Learning Center using your e-mail address and password. If you have not logged in to the new ASHP Learning Center (launched August 2008) and are not a member of ASHP, you will need to set up an account by clicking on “Become a user” and following the instructions. 2. Once logged in to the site, click on “Process Meeting CE.” 3. If you are a registered attendee at the ASHP Midyear Clinical Meeting, click on the start button to the right of ASHP Midyear Clinical Meeting 2009. If you are not registered to attend the ASHP Midyear Clinical Meeting, click on the start link to the right of the activity title. If this activity title does not appear in your meeting list, enter the 5-digit activity code in the box above the list and click submit. The activity code for this activity is 09436. Click register again when prompted. When you receive the “thank you for registering” message, click continue. This step will bring you back to your meeting list. Click on the start link to the right of the activity title. 4. Click on the click here link to view sessions associated with the day of the activity. This activity was held on Tuesday, December 8, 2009. 5. Enter the session code, which was announced during the activity, and select the number of hours equal to your participation in the activity. Pharmacists should only claim credit for the amount of time they participate in an activity. 6. Click submit to receive the attestation page. 7. Confirm your participation and click submit. Your transcript page will appear. 8. Click on view/print statement of credit next to the meeting name to print your CPE statement. Session Code Date of Activity Activity Code Tuesday, December 8 09436 (announced during the live activity) CPE credit hours 2 NEED HELP? Contact ASHP Advantage at [email protected]. 7 Improving IV Medication Safety: Identifying the Risk Points 8 Improving IV Medication Safety: Identifying the Risk Points Rita Shane, Pharm.D., FASHP, FCSHP Director of Pharmacy Services Cedars-Sinai Medical Center Los Angeles, California Assistant Dean, Clinical Pharmacy Services University of California, San Francisco, School of Pharmacy San Francisco, California Rita Shane, Pharm.D., FASHP, FCSHP, is Director of Pharmacy Services at CedarsSinai Medical Center, a 950-bed acute- and tertiary-care, teaching institution in Los Angeles, CA, and Assistant Dean, Clinical Pharmacy Services at the University of California, San Francisco (UCSF), School of Pharmacy. She is responsible for more than 300 staff members. Dr. Shane’s goal is to ensure that wherever patients need care, there is a demand for pharmacists to ensure optimal management of medications. Over the years, Dr. Shane has been recognized for her passion for the profession. She is the recipient of the 2007 California Society of Health-System Pharmacists (CSHP) Pharmacist of the Year Award and the 2007 Distinguished Service Award from the ASHP Section of Pharmacy Practice Managers. Dr. Shane was the 2005 recipient of the ASHP Distinguished Leadership Award and the 1995 recipient of the John Webb Visiting Professorship in Hospital Pharmacy for management excellence. Dr. Shane is a co-investigator in two research studies in collaboration with the UCSF School of Pharmacy and approved by the California State Board of Pharmacy to demonstrate the safety and importance of allowing technicians to check technician-filled medication cassettes in hospitals. She also worked collaboratively with CSHP to author language in support of this regulatory change, which was approved by the State of California effective in January 2007. Dr. Shane was co-investigator of a 2000 National Patient Safety Foundation Research Award to study the impact of dedicated medication nurses on the rate of medication administration errors, a randomized, controlled trial the results of which were subsequently published in the Archives of Internal Medicine. Dr. Shane recently served as the U.S. facilitator at the Global Conference on the Future of Hospital Pharmacy held during the 68th Congress of the International Pharmaceutical Federation and was responsible for reviewing the international literature on the subject of medication administration. She also is one of the investigators in a multicenter study of medications errors recovered by emergency department pharmacists. Throughout her career, Dr. Shane has participated on committees and task forces at the state and national level; she recently was a member of the American Hospital Association Committee on Health Professions and The Joint Commission Professional Technical Advisory Committee. She has presented at local, state, national, and international meetings and has published a number of papers in the pharmacy literature. 9 Improving IV Medication Safety: Identifying the Risk Points Rita Shane, Pharm.D., FASHP, FCSHP, Program Chair PRESENTATION Identifying the Risk Points: Back to the Basics OVERVIEW Intravenous (i.v.) medication therapy is characterized by complexity and has been associated with significant morbidity and mortality. Sixty one percent of serious and life threatening errors are associated with i.v. medications, and one study demonstrated a 73% error rate with i.v. boluses given too fast. USP MEDMARX® received 129,436 parenteral-related error reports from the years 2000 through 2006. Of these, 78.9% of harmful errors were associated with the i.v. route of administration. Evidence demonstrates that high risk therapies such as chemotherapy and high alert medications, and high risk populations such as pediatrics and critical care patients, are of particular concern. Therefore, it is essential that each element of the medication-use process is examined to identify potential risks associated with intravenous medications. LEARNING OBJECTIVES At the conclusion of this knowledge-based educational activity, participants should be able to • Cite evidence supporting the risks associated with intravenous (i.v.) medications. • Conduct a risk assessment for i.v. medications based on the elements of the medication-use process. • Identify high-risk therapies and populations associated with i.v. errors. • Identify potential i.v. safety solutions. 10 Identifying the Risk Points: Back to the Basics Rita Shane, Pharm.D., FASHP, FCSHP Director, Pharmacy Services Cedars-Sinai Medical Center, Los Angeles, CA Assistant Dean, Clinical Pharmacy USCF School of Pharmacy, San Francisco, CA Objectives • Cite evidence supporting the risks associated with intravenous (i.v.) medications • Conduct a risk assessment for i.v. medications based on the elements of the medication-use process • Identify high-risk therapies and populations associated with i.v. errors • Identify potential i.v. safety solutions Medication-Use Process Selection & Procurement Storage Ordering & Transcribing Preparing & Dispensing Administering Monitoring The Joint Commission: MM. 8.10: Annually identify and evaluate risk points in the medication-use process 11 IV Errors and Harm: The Evidence • 61% of serious and life threatening errors are associated with i.v. medications • 73% error rate with i.v. boluses (i.v. push) given too fast • USP MEDMARX® 129,436 parenteralrelated errors reported 2000-2006 – 78.9% of harmful errors associated with i.v. route – 57.8% of these harmful errors occurred at administration step Harmful Parenteral Errors Reported to USP Route % N IV 3,056 78.9 Subcutaneous 697 18 Epidural 74 1.9 Intravascular 48 1.2 Intrathecal 19 <1 Based on 3,873 records Categories E-I during 2002-2006 Proceedings of a summit on preventing patient harm and death from i.v. medication errors. Am J Health-Syst Pharm. 2008; 65:2367-79. Which parenteral route is associated with the most harm? A. B. C. D. Subcutaneous Intrathecal Intramuscular Intravenous 12 Top 10 Drugs Most Frequently Involved in Harmful Parenteral Errors Drug N Morphine Heparin Hydromorphone Insulin 270 263 195 155 Vancomycin Fentanyl Furosemide Potassium Chloride Meperidine 125 120 73 70 67 Methylprednisolone 56 Based on 3,184 reports submitted to MEDMARX involving parenteral routes (Epidural, Intrathecal, Intravascular and Intravenous) for calendar years 2002-2006 Which parenteral medication is most frequently associated with harm? A. B. C. D. Diazepam Natalizumab Vincristine Morphine IV Errors and Harm: The Evidence • A study using observation methodology to evaluate the causes of errors in i.v. drug preparation and administration – One or more errors occurred in 49% of i.v. doses observed doses – Of these,1% were judged to be potentially severe – 29% potentially moderate errors Taxis K, Barber N. Qual Safe Health Care. 2003; 12(5): 343-7. 13 Use of Observation Methodology to Detect Medication Errors Medication Errors 300 300 200 100 17 1 0 Observation Chart Review Incident Reports Flynn et al. Am J Health-Syst Pharm. 2002; 59(5): 436-46. When comparing the number of errors detected by traditional medication error reporting to the number of errors that will be detected by observation, the ratio is: A. B. C. D. 300:17 17:1 300:1 400:1 IV Errors and Harm: The Evidence • In the UK, injectable medication error events reported to the National Reporting and Learning System are responsible for more deaths than any other category of events • Causes – – – – • Calculation errors including dilution errors Poor aseptic technique Wrong route, rate and patient Lack of information at the point of use National Patient Safety Agency recommendations – Conduct a risk assessment of injectable medication practices – Provide current protocols and procedures – Ensure the availability of information in clinical areas Matthew L. Nurs Stand. 2007; 21(31):45-8. 14 IV Risks: Pharmaceutical Calculations • More than 1 in 6 medication errors involves a calculation error • Study demonstrated that 81% of nurses were unable to correctly calculate medications 90% of time • 43.5% of test scores requiring calculations were below 70% accuracy • Pediatrics: 14.2% of orders from mg to ml converted incorrectly; maximum dose deviation of 400% Shane R. Am J Health-Syst Pharm. 2009; 66(Suppl):542-8. IV Risks: Wrong Route • USP MedMARX program reported tubing misconnections in over 300 reports – Epidural lines connected to i.v.’s – Oral cough syrup given i.v. push – Tube feedings administered through peripheral i.v.’s • Deaths reported internationally with intrathecally vincristine and i.v. bupivicaine • Pediatric errors associated with oral medications given i.v. due to lack of oral syringes Hicks R, Becker S. J Infus Nurs 2006; 29(1): 20-7. Harmful wrong route errors include all but the following: A. Oral liquid given i.v. B. i.v. given intrathecal C. Tube feedings given i.v. D. Tube feedings given po 15 IV Medication Complexity • USP <797> • High-risk therapies – – – – Chemotherapy High-alert medications PCA Epidural medications • High-risk populations – Pediatrics • Dose considerations • Volume considerations • Preservatives – Critical Care • TPNs • Infusion devices, implantable pumps, tubing, catheters • Quality assurance • Pharmaceutical calculations • Labeling • Compatibilities • Expiration dating • Rates of infusion • Outsourcing considerations High-Risk Populations Critical Care • Nearly 2/3 of medications in the ICU are given via i.v. route • 10.6% error rate in dosage calculation and administration reported in a surgical ICU – Implication: 1/10 i.v. infusions in an ICU are prepared or administered in error Pediatrics • USP MedMARX®-2.5% of medication errors led to harm • TJC Sentinel Alert re: pediatric safety – Oral syringes in patient care areas – Preparation of patient-specific doses – Dose calculation sheets for emergency use and common medications Kane-Gill S, Weber R. Crit Care Clin. 2006; 22(2): 273-90, vi. The Joint Commission. Preventing pediatric medication errors. online (accessed 2008 Apr 12). High-Risk Therapies • Chemotherapy – Double checks at each step of the medication-use process against the original order – Intrathecal therapy safeguards (vinca alkaloids, L-asparaginase) • PCA Tool Kit Order sets – Patient Selection – Opioids for breakthrough pain – Morphine/hydromorphone mix-ups ref. 1 IV Safety/PCA Tool Kit San Diego Project.pdf 16 Risks: Lack of IV Medication Training and Education • Pharmacists – IV medication therapy does not appear to be an area of focus in pharmacy training • Recent survey regarding the extent of instruction on sterile preparations in U.S. pharmacy schools revealed only 13% of schools felt that students had “adequate training in compounding sterile preparations” • Technicians – Minimal requirements in most technician training programs Technology to Prevent IV Errors: Smart Pumps • % adoption • Study demonstrated that alerts were bypassed 25% of the time (Rothschild J et al. Crit Care Med. 2005) • Lack of standardizations of drug names, rates, and concentrations – Study of 100 drug libraries used in smart pumps: substantial variability in drug names, concentrations and dose units within the same library • Magnesium sulfate: mg/hr, mg/kg/hr, gm/hr, mcg/kg/hr, meq/kg/hr and gm/hr (Bates D et al. TJC J Qual Patient Saf. 2005) 2007 ASHP Survey of U.S. Hospital and Health System Adoption & Implementation of Health Information Technology. IV Errors Make Headline News Chemotherapy Overdose – On December 3, 1994, 39-year-old Boston Globe health reporter Betsy Lehman died of complications of an overdose of cyclophosphamide at the Dana-Farber Cancer Institute. Media reported the event intensively, with 28 front-page headlines over the next 3 years. (ref 13. AHRQ. Perspectives on safety: organizational change in the face of highly public errors.) • Pharmacist sentenced to 6 months in jail – • Ohio hospital pharmacist failed to recognize that technician had made a chemotherapy solution with 23.4% NaCl leading to death of an infant. (ref. 14 ISMP.org) Plain D5W or hypotonic saline solutions post-op could result in acute hyponatremia and death in healthy children 17 IV Errors Make Headline News • Deaths from Intravenous Colchicine Resulting from a Compounding Pharmacy Error --- Oregon and Washington, 2007 (MMWR Weekly Oct 12, 2007; 56(40);1050-2.) • ‘Wrong' injection killed toddler (BBC News, 6 October, 2003) – Patient received neuromuscular blocker instead of a sedative • Fatal 1,000-fold overdose of zinc in TPN due to confusion between mcg and mg (ISMP.org) • 200 epidural blunders admitted after 3 women die. (Oakeshoff 2006) • Dennis Quaid's Babies Given Heparin Overdoses Medical Malpractice Attorney Source Types of IV Errors According to an i.v. medication errors study, almost half of all i.v. errors occurred in preparing or administering medication. Common i.v. errors include, but are not limited to: – – – – – – – Improper injection of drug Wrong time of administration Extra dosage or wrong dose of drug is administered Failure to give medication through an i.v. Faulty i.v. pumps and valves Incompatible combination of drugs administered Wrong drug or solution was used http://www.medical-malpractice-attorney-source.com/medical_malpractice/hospital-malpractice/iverrors.html, (accessed 2009 Oct 10). National Focus on IV Safety • The Joint Commission – – – – – – – Standardized solutions Pharmacy preparation Labeling Look-alikes Pediatric Sentinel Alert - patient specific doses Responsibility for performance of outsource vendors Anticoagulation safety - Sentinel Alert • USP Chapter <797> 18 National Focus on IV Safety 2008 ASHP IV Safety Summit • Goals – Achieve consensus on initial standard practices – Identify barriers and means to overcome – Prioritize recommended safe practices for immediate implementation and for long term strategic planning – Obtain stakeholder commitment to improve i.v. safety • #1 Short Term Action – Use drug information from authoritative sources to establish national standards for i.v. use: • Drug name • Recommended minimum and maximum dosages, upper and lower administration rate limits that may not be overridden, • Standardized concentrations and dosing units, and commercially available strengths and concentrations Medication-Use Process Selection & Procurement Storage Ordering & Transcribing Preparing & Dispensing Administering Monitoring The Joint Commission: MM. 8.10: Annually identify and evaluate risk points in the medication use process Selection and Procurement • “Purchasing for safety”: International focus • Does selection of new i.v. medications include an assessment of risks associated at each step of the medication-use process? – Storage? Prescribing preparation? Rate of infusion? Infusion related reactions? Monitoring? • How are risks associated with use of vials minimized? – Is heparin purchased in 10,000 unit/ml vials or 5,000 unit pre-filled syringes? – Are vial sizes of the same medication limited? • How are drug shortages managed to minimize potential for a medication error? 19 Storage • What methods are used to ensure safe storage of medications? • How are automated cabinets filled? • Are periodic audits conducted of medication storage areas in pharmacies? Patient care areas? Clinics? • Are chemotherapy medications stored separately from other medications? Ordering and Transcribing • Have guidelines/protocols been developed and implemented for ICU titrations? For PCA orders? • Do chemotherapy orders require an order form or order-set with fields to ensure dosing is displayed based on body surface area and per dose? Total # doses? Total dose/cycle? • (For hospitals without CPOE) Are orders on the MAR/eMAR checked against the original order by the nurse? CPOE = computerized prescriber order entry eMAR = electronic medication administration record Preparation/Dispensing • What methods are available to assess accuracy of compounded products – Is observation methodology used? – Is validation methodology using spectroscopy? – Is refractometry used for dextrose in TPNs? • Are premade i.v. products purchased if available? • What checking processes are used for chemotherapy? Epidurals? Pediatric/Neonatal i.v.’s? • Are any i.v. medications pre-checked by the pharmacist prior to preparation? 20 Preparation/Dispensing • Have standard concentrations been implemented? • How are high alert medications prepared and dispensed? • How is accuracy of i.v. labeling assessed? • What is the approach to ensuring the quality of outsourced i.v. preparations? • If a TPN compounder is used, what safeguards exist to prevent errors? Administering • Do nurses double check high-alert medications prior to administration? • Are there established maximum rates of administration for i.v. medications? • How are nurses trained in pharmaceutical calculations? • How are nurses trained in the use of infusion devices? – How are overrides of smart pump alerts managed? Monitoring • Are high-alert i.v. infusions checked to verify accuracy of infusion and rate? • Are observation studies conducted to evaluate compliance with safe medication practices? • “5Rs”? • Are Nursing and Pharmacy double checking processes? 21 IV Safety Solutions • Label lines to prevent wrong route due to tubing misconnections • Stock oral syringes on pediatric wards • When a large number of dosage units are ordered (e.g., more than two tablets, capsules, vials, or ampuls) for a single patient dose, the medication order should be questioned • Consider pharmaceutical calculations examinations for pharmacy and nursing staffs IV Safety Solutions • Standardize dosage units across all systems – Order Sets, Information System: CPOE/Pharmacy System/EMAR or paper MAR, Smart Pumps, Labels • When standard drug concentrations or dosage charts are not available, dosage calculations, flow rates, and other mathematical calculations should be checked by a second individual (e.g., another nurse or a pharmacist) • New technology should be prospectively evaluated for potential risks (FMEA = failure mode effectiveness analysis) • Observation methodology should be used to evaluate i.v. medication processes Thank You! 22 Improving IV Medication Safety: Identifying the Risk Points SELECTED REFERENCES AND RESOURCES 1. Agency for Healthcare Research and Quality. Perspectives on safety: organizational change in the face of highly public errors. http://www.webmm.ahrq.gov/perspective.aspx?perspectiveID=3 (accessed 2009 Oct 12) 2. Bates, DW, Vanderveen T, Seger D et al. Variability in intravenous medication practices: implications for medication safety. Jt Comm J Qual Patient Saf. 2005; 31(4): 203-10. 3. British Broadcasting Corporation, BBC News. 2003; Oct 6. 4. Flynn E, Barker K, Pepper G, Bates D et al. Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities. Am J Health-Syst Pharm. 2002; 59:436-46. 5. Hicks, RW, Becker SC. An overview of intravenous-related medication administration errors as reported to MEDMARX, a national medication errorreporting program. J Infus Nurs. 2006; 29(1): 20-7. 6. ISMP Medication Safety Alert. Criminal prosecution of human error will likely have dangerous long-term consequences. 2007; 12(5):1-2. http://www.ismp.org/Newsletters/acutecare/articles/20090423.asp (accessed 2009 Oct 12) 7. Joint Commission (2008) Preventing pediatric medication errors. http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_39.htm., (accessed 2008 April 12) 8. Kane-Gill S, Weber R. Principles and practices of medication safety in the ICU. Crit Care Clin. 2006; 22(2): 273-90. 9. Matthew, L. Injectable medication therapy: a patient safety challenge. Nurs Stand 2007: 21(31): 45-8. 10. Medical malpractice attorney source online. http://www.medical-malpracticeattorney-source.com/medical_malpractice/hospital-malpractice/iv-errors.html (accessed 2009 Oct 10). 11. Morbidity and Mortality Weekly Report. Oct 12, 2007; 56(40);1050-2. 12. Pedersen C, Gumpper K. 2007 ASHP Survey of U.S. Hospital and Health System Adoption & Implementation of Health Information Technology. Am J Health-Syst Pharm. 2008; 65:2244-64. 13. Proceedings of a summit on preventing patient harm and death from i.v. medication errors. Am J Health-Syst Pharm. 2008; 65:2367-79. 23 Improving IV Medication Safety: Identifying the Risk Points 14. Rothschild JM, Keohane CA, Cook EF et al. A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Crit Care Med. 2005; 33:533-40. 15. San Diego Patient Safety Task Force. Tool Kit: Patient Controlled Analgesia (PCA) Guidelines of Care for the Opioid Naïve Patient. 2008; http://www.ashp.org/DocLibrary/Policy/PatientSafety/IVSafety/PCAToolKitSanDieg oProject.pdf, accessed 10/11/09. 16. Shane R. Current status of administration of medications. Am J Health-Syst Pharm. 2009; 66(Suppl):542-8. 17. Taxis K, Barber N. Causes of intravenous medication errors: an ethnographic study. Qual Saf Health Care. 2003; 12:343-7. 24 Improving IV Medication Safety: Identifying the Risk Points SELF–ASSESSMENT QUESTIONS 1. Which parenteral route is associated with the most harm? a. b. c. d. Subcutaneous. Intrathecal. Intramuscular. Intravenous. 2. Which parenteral medication is most frequently associated with harm? a. b. c. d. Diazepam. Natalizumab. Vincristine. Morphine. 3. When comparing the number of errors detected by traditional medication error reporting to the number of errors that will be detected by observation, the ratio is: a. b. c. d. 300:17. 17:1. 300:1. 400:1. Answers 1. d 2. d 3. c 25 Improving IV Medication Safety: Identifying the Risk Points 26 Improving IV Medication Safety: Identifying the Risk Points Ginette A. Pepper, Ph.D., RN, FAAN Professor and Associate Dean for Research Helen Lowe Bamberger Colby Presidential Endowed Chair in Gerontological Nursing Director, Hartford Center of Geriatric Nursing University of Utah College of Nursing Salt Lake City, Utah Ginette A. Pepper, Ph.D., RN, FAAN completed her basic education in nursing at the University of Colorado. After serving a tour in the Army Nurse Corps, she earned her Master of Science in Medical-Surgical Nursing from the University of Utah. On graduation she assumed a position as the nation’s first geriatric nurse practitioner. Ginny received her Ph.D. in Psychobiological Nursing and Pharmacology from the University of Colorado Health Sciences Center and was a clinical nurse researcher at the Denver VA, Swedish Medical Center, and HealthONE. She was a member of the University of Colorado faculty beginning in 1974 through 2003. From 1990 through 2003 she held positions as the Director of Faculty Practice, Director of the Master’s Program, and Director of the Nursing Doctorate program. In 2007 she completed a fellowship at the National Institutes of Health (NIH) in human genetics. Dr. Pepper is a nationally recognized expert in medication safety, has published extensively on the topics of medication safety and geriatric care in nursing, medical, and pharmacy journals, and frequently speaks nationally and internationally. She has been a member of the Safe Medication Use and the Nomenclature Expert Committees of the United States Pharmacopeia and on the Editorial Boards of Nurse Advis-Err, the nursing newsletter for the Institute for Safe Medication Practices (ISMP), and the Joint Commission Journal on Quality and Safety. She has been principle investigator on two federally funded studies on medication safety, one on medication-related falls and imbalance in community-dwelling elderly and the other on the effects of nurses’ working conditions on medication administration safety in hospitals. She has been co-investigator and consultant on numerous other federally funded medication safety grants. Since 2003, Dr. Pepper has been Professor and the Helen Bamberger Colby Presidential Endowed Chair in Gerontological Nursing at the University of Utah College of Nursing. She is also the Associate Dean for Research and Ph.D. Program and Director, Hartford Center of Geriatric Nursing Excellence. 27 Improving IV Medication Safety: Identifying the Risk Points Ginette A. Pepper, Ph.D., RN, FAAN PRESENTATION Managing the Risk Points to Improve Medication Safety OVERVIEW This presentation expands on the discussion of identifying IV risk points and medicationuse patient safety. Strategies to reduce the risk of error and ameliorate harm in all phases of the medication-use process are discussed from the perspective of nursing. Three factors that can help to bridge the phases of the medication-use process include training, decision support, and work redesign. Additionally, proposed revisions to the USP General Chapter section on injectables to enhance patient safety are reviewed. Management of technology adoption and implications of recent research on factors associated with the risk of medication error, high risk procedures, and nursing best practices are presented. LEARNING OBJECTIVES At the conclusion of this knowledge-based educational activity, participants should be able to • Evaluate the role of training, decision support, and workflow redesign on medication administration safety. • List three strategies to overcome issues in use of technology to promote medication administration safety. • Critique new research on the risk factors and best practices for errors in medication administration. 28 Managing the Risk Points to Improve Medication Safety Bridging the Nursing Perspective Ginette A. Pepper, Ph.D., R.N., FAAN Professor and Endowed Chair Associate Dean for Research Director, Hartford Center of Geriatric Nursing Excellence University of Utah College of Nursing Salt Lake City, Utah Objectives • Evaluate the role of training, decision support, and workflow redesign on medication administration safety • List three strategies to overcome issues in use of technology to promote medication administration safety • Critique new research on the risk factors and best practices for errors in medication administration Medication-Use Process (Nursing Perspective) Ordering & Transcribing Selection & Preparing Procurement & Dispensing Storage Preparing & Administering Monitoring The Joint Commission: MM. 8.10: Annually identify and evaluate risk points in the medication-use process 29 Medication-Use Process (MUP) Tra i n in (System Perspective) g Selection & Preparing Procurement & Dispensing Storage Ordering & Transcribing Preparing & Administering Monitoring ow io kfl icat r o f W odi M n on isi ort c De upp S The Joint Commission: MM. 8.10: Annually identify and evaluate risk points in the medication use process “Bridges” Across MUP • Training – Clinical pharmacology and therapeutics – Rationale for changes and innovations • What they told me about unit dosing – Shared mental models – GAP analysis: • Effectiveness? – The Denver Nurses Case • Extra specialty practice – A NURSE IS A NURSE IS A NURSE – Novices • Orientee/Agency/Pool/Float Which of the following is accurate about using classroom training and testing of nurses as the central strategy in medication safety? A. Little evidence that it effectively changes behaviors B. Those at greatest risk for error are likely to attend C. The same curriculum is effective across specialties areas. D. It is low cost 30 “Bridges” Across MUP • Workflow Modification – Assess impact; adjust impact • Communicate rationale for changes to the sharp end • Include representatives from the sharp end on the planning team • Continuous process improvement – GAP analysis • Expertise in human factors engineering • Cost of nursing time • Reality: nurses are the safety net “Bridges” Across MUP • Decision Support – Nurses make decisions? – What’s wrong with the 5 Rights? • Right patient, time, drug, dose, route • Goals, not procedures • We don’t know which procedures achieve 5 Rs – GAP analysis • Informatics focus is not nursing • Nurse’s capacity to articulate decisions • Expectations paradox Ordering & Transcribing CPOE (computerized provider order entry) • • • • Handwriting and Legibility Completeness of information Omissions (not transcribed) Decrease slips and lapses Issues with CPOE • • • Error is not eliminated New types of error Complex orders 31 Ordering & Transcribing Issue #1: Error is not eliminated • Ambulatory chemotherapy errors: adult (4% CPOE vs. pediatric (1% handwritten) Gandhi et al. Cancer. 2005; 104 (11): 2477. • CPOE vs. handwritten orders for pediatric infusions increased speed and satisfaction, but not accuracy Sowan et al. AMIA Annual Symposium Proceedings. 2006; 1105. • CPOE system with standardized concentrations that generates infusion chart • 108 simulated infusions with 72 errors; 53% handwritten detected vs. 40% CPOE (p=.07) Ordering & Transcribing Issue #2: New types of errors • Case study: Vincristine injected subcutaneously (vs. IV “bolus”) because incorrect route entered during protocol creation. Garlantezec, et al. J Oncol Pharm Pract, Oct 15, 2009 (online) – Experienced nurse did not make the error but novice did – Recommendations: • Nurses training and testing • Pharmacists develop new ways to detect errors Ordering & Transcribing Issue #3: Complexity and ambiguity of orders • Ancillary pre-medications in chemotherapy • Therapeutic substitutions • Contingent orders: the medication administered is dependent upon some clinical parameter • What does “oral” mean when there is an enteral feeding tube in place? Gandhi et al. (2005). Cancer, 104 (11): 2477. 32 Dispensing & Preparing • Unit dose (a moment of silence) – 15-20% error (stock drugs); 5-8% unit dose Runciman et al (2003) Int J Qual Health Care, 15 (suppl), i49 • Procurement and USP revision • Automated Dispensing Cabinets (ADC) and other technology • Standardized medication dispensing – Standardized concentrations – Manufacturer Ready-to-Use USP General Chapter <1> INJECTIONS: Labeling On Ferrules and Cap Overseals USP 32, page 34 Published PF 36 (1) • Ferrules and overseals are reserved for critical safety messages – Intended to prevent imminent, life-threatening situations, e.g., “Warning---Paralyzing Agent – If no cautionary statement, the top surface must remain blank • Product that goes to the nursing unit should be interpretable by nurses According to the proposed revision of the section on ferrules and overseals of General Chapter 1 USP 34, what can be printed on the top surface of vials for injectables? A. Anti-counterfeiting logos B. Must be diluted C. 5 mg D. Must be refrigerated 33 Automated Dispensing Cabinets • 2007 ISMP (Institute for Safe Medication Practices) forum to establish guidelines for design and use. Comments published in Nurse Advise-Err (Apr 2009) – Location, access, interruptions, students, poor practices “Thank you for the opportunity to share my frustrations with a system that was “sold” to nursing. This is another example of departments making decisions about the use of technology without checking out the impact on nursing care. Most often it adds more time to our patient care, more distance to travel and thereby increasing our patients’ frustration with how long it takes to get their medications to them or their treatments. Our information technology department is commonly changing our IT/nursing world without considering the “work arounds” nursing will have to figure out to make the technology work in a practical way.” www.ismp.og/newsletter/nursing/articles/adcComments200906.asp Other Technologies • Barcode Medication Administration (BCMA) important technology for intercepting dispensing and administration errors – 73% dispensing; 28% administration Cochran et al. (2007) Jt Comiss J Qual & Patient Safety, 33, 293. • IV Pumps including Smart Pumps – Dosing errors (pump programming and bypassing safeguards) • After FMEA, double-check was required of all high-alert medications • Extensive training Adachi and Lodolce (2005). Am J Health Syst Pharm, 62, 917. Bullock et al. (2006). Crit Care Nurs Clin N Am, 18, 515. Which of the following approaches is most likely to be effective in decreasing work-arounds by nurses in use of technology? A. Mandatory in-service class/module annually B. Requiring double checks documented in chart C. Including nurses in implementation planning and CQI 34 IV Drug Delivery Systems Second Consensus Development Conference – Ranked delivery systems on applicability (to special populations), ease of use, regulatory compliance, cost, implementation, patient safety • • • • • Manufacturer ready to use Outsourced ready to use Point of care activated* Pharmacy compounding Non-pharmacy compounded (e.g., nursing unit) *If used, need pharmacy/nursing enforcing functions Sanborn et al. 2009. Am J Health-Syst Pharm 15:66, 185 Standardized Concentrations • Study of drug concentrations – Neuroscience unit in UK – Collected 151 syringes for insulin, midazolam, norepinephrine, dopamine, potassium, magnesium – Majority exceeded concentration by more than 10% – Labeling quality correlated with accuracy – Concluded: use pre-prepared syringes Wheeler et al. 2006 Intensive Care Med., 34, 1441 Preparation & Administration • Risk factors for errors • Best Practices • High risk areas – Bolus dosing – Tubing misconnections 35 Risk Factors for Medication Administration Error (MAE) • Multinational study – 113 ICUs in 27 countries; 1328 patients – 861 IV errors in 24 hr, 75% omission, 0.9% suffered permanent harm Patient factors Unit factors Practice factors Organ failure 1.19 Larger units 1.01 Basic monitoring # IV meds 1.06 Pt per nurse 1.30 Critical incident Sx 0.69 0.19 ICU interv. 1.50 Occupancy 1.03 Checks of shift change 0.68 Monday Unk Pt turnover 0.73 Valentin et al., BMJ, 2009 Risk Factors for MAE • Self-report of near-miss in Japan – 525 person days yields 94 errors from 88 nurses – Work load (delay due to heavy workload) and lack of experience increased risk for error Seki & Yamazaki. 2006. J Nurs Manage, 14, 128. • Errors in Pediatric units – 485 observation periods during weekdays by pharmacy students – Risks: • • • • • IV drugs (0.28) Non-IV (4.44) Prepared by pharmacists (1.66) Administered by float/temp/student (1.67) Complicated therapies (1.22) Prot et al. 2005. J Qual Heath Care. 17, 381. Best Practices Unpublished study in San Francisco area that focused on practices that improved accuracy from 85%-98% • Compare medication to MAR (medication administration record) • Keep medication labeled until administration • Check two [patient identifiers] • Immediately record administration in chart • Explain the medication to the patient • Minimize distractions and disruptions during the administration process Olson B. Error prevention strategies: it’s not Sophie’s choice folks. Available: http://florencedotcom.blogspot.com/2009/11/error-prevention-strategies-itsnot.html (Accessed 2009 Nov 9) 36 Which of the following is NOT one of the best practices of medication administration associated with accuracy in the UCSF study? A. Decrease distraction and interruption B. Take the MAR to the bedside C. Explain the medication to the patient D. Keep medications labeled until administration High Risk Practice Areas • Bolus Medications – – – – – Rate of administration Many are high alert medications Multi-step preparation Reference/decision support at point of care. Technology? Taxis and Barber 2003. BMJ, 326, 1-4. Paparella 2004. J Emerg Nurs, 30, 478. • Tubing “Misconnections” – Confusing enteral, parenteral, and epidural lines – Recent reports in labor and delivery setting Broussard B. 2009. Nursing for Women’s Health, 13, 155. – Label lines, put different pumps on opposite side of bed. (color coding?) Monitoring • The most disregarded phase of medication safety • Study to evaluate how many IV-ADEs (adverse drug events) were preventable by smart pump technology – Pre-post design; chart review – Of 100 preventable ADE, only 4 (2 pre; 2 post) were preventable – Majority were preventable by monitoring (37%) and intervening (45%) Nukols 2007. JGIM, 23 (Suppl 1), 41. 37 Best Bridges • More pharmacists • More nurses • More communication Thank You! 38 Improving IV Medication Safety: Identifying the Risk Points SELECTED REFERENCES 1. Adachi W, Lodolce A. Use of failure mode and effects analysis in improving the safety of i.v. drug administration. Am J Health-Syst Pharm. 2005; 62: 917-20. 2. ADC Comments June 2009. Available www.ismp.og/newsletter/nursing/articles/adcComments200906.asp (accessed 2009 Nov 2). 3. U.S. Pharmacopeia. Briefing. Labeling on Ferrules and Cap Overseals Section of Chapter <1> INJECTIONS. USP 32. http://www.usp.org/pdf/EN/aboutUSP/theStandard2008Summer.pdf (accessed 2009 Nov 1). 4. Broussard B. Preventing medication errors. Nursing for Women’s Health, 2009; 13: 155-8. 5. Bullock J, Jordan D, Gawlinski A et al. Standardizing i.v. infusion medication concentrations to reduce variability in medication errors. Crit Care Nurs Clin N Am. 2006; 18; 515-21. 6. Cochran G, Jones K, Brockman J et al. Errors prevented by and associated with bar-code medication administration. Jt Commission J on Quality & Pt Safety, 2007; 33: 293-301. 7. Follow ISMP guidelines to safeguard the design and use of automated dispensing cabinets. Nurse Advise-ERR, 2009; 7:1-4. 8. Gandhi T, Bartel S, Shulman L et al. Medication safety in the ambulatory chemotherapy setting. Cancer, 2003; 104: 2477-83. 9. Le Garlantezec P, Aupee O, Almeras D, Lefewure L et al. Drug administration error related to computerized prescribing. J. Oncol Pharm Practice, 2009; Oct 15:1-4. (pre-pub online). 10. Message in our mailbox: a nursing perspective on ADCs, Nurse Advise-ERR, 2009; 7 (6): 4. 11. Nuckols T, Bower A, Paddock S et al. Programmable infusion pumps in ICUs: an analysis of corresponding adverse drug events. JGIM, 2007; 23 (Suppl 1), 41-5. 12. Paparella S. Avoiding disastrous outcomes with rapid intravenous push medications. J Emerg Nurs. 2004; 30: 478-80. 13. Prot S, Fontan J, Alberti C et al. Drug administration errors and their determinants in pediatric in-patients. Int J Qual Health Care, 2005; 17; 381-9. 14. Runciman W, Roughhead E, Semple S et al. Adverse drug effects and medication errors in Australia. Int J Qual Health Care, 2003; 15 (suppl): 49-59. 39 Improving IV Medication Safety: Identifying the Risk Points 15. Sanborn M, Moody M, Harder K, Pepper G et al. Second consensus development conference on the safety of intravenous drug delivery systems—2008. Am J. Health Syst Pharm, 2009; 66: 185-92. 16. Seki Y, Yamazaki Y. Effects of working conditions on intravenous medication errors in a Japanese hospital. J Nurs Manage. 2006; 14: 128-39. 17. Sowan A, Gaffor M, Soeken K et al. A comparison of medication administration errors using CPOE vs handwritten orders for continuous drug infusions. AMIA Annual Symp Proceedings, 2006; 1105. 18. Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous drug errors. BMJ. 2003; 326: 1-4. 19. Valentin A, Capuzzo M, Guidet B et al. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009; 338:b814. http://www.bmj.com/cgi/content/full/338/mar12_1/b814 (accessed 2009 Nov 1). 20. Wheeler D, Degen B, Sehmi J et al. Variability in the concentrations of intravenous drug infusions prepared in a critical care unit. Intensive Care Med, 2008; 34: 14417. 40 Improving IV Medication Safety: Identifying the Risk Points SELF–ASSESSMENT QUESTIONS 1. Which substantial cause of medication administration error has been most successfully addressed by CPOE (computerized provider order entry)? a. b. c. d. Lack of decision support for nurses. Complexity of medication orders. Communication among providers. Illegible handwriting. 2. Proposed revision of the USP General Chapter <1> section on injectables limits printing on the top surface of vials of injectable liquids to a. b. c. d. Statements that promotes safety. Logos and words to prevent counterfeiting. Cautions on imminent life-threatening situations. Statements guiding administration technique. 3. The safety concepts underlying the proposed revision of USP General Chapter <1> section on injectables is a. b. c. d. Information overload and alert fatigue. Confirmation bias and LASA. Forcing functions and shared mental model. Systems thinking and near miss. Answers 1. d 2. c 3. a 41 Improving IV Medication Safety: Identifying the Risk Points 42 Improving IV Medication Safety: Identifying the Risk Points Karen Fiumara, Pharm.D., BCPS Patient Safety Officer Brigham and Women’s Hospital Adjunct Assistant Professor of Pharmacy Practice Massachusetts College of Pharmacy and Allied Health Sciences Boston, Massachusetts Karen Fiumara, Pharm.D., BCPS is the Patient Safety Manager of Brigham and Women’s Hospital (BWH), in Boston, Massachusetts. She is an Assistant Professor of Clinical Pharmacy Practice at both Northeastern University and Massachusetts College of Pharmacy. She received her Doctor of Pharmacy from Massachusetts College of Pharmacy in 2002 and completed her residency program at Brigham and Women’s Hospital in 2003. Dr. Fiumara is a member of various professional societies, including the American Society of Health System Pharmacists, the Massachusetts Society of Health Systems Pharmacists and the American Pharmaceutical Association. She serves on the Brigham and Women’s Hospital’s multidisciplinary Drug Safety Committee, which is charged with reviewing all medication safety related issues and adverse events. She works closely with information systems specialists as a liaison on numerous patient safety projects, and co-chairs the Brigham and Women’s Hospital Joint Commission Anticoagulation Task Force. She works as Clinical Pharmacy Consultant for the New England Journal of Medicine. Dr. Fiumara has authored papers in the fields of medication safety, adverse drug events, and anticoagulation. 43 Improving IV Medication Safety: Identifying the Risk Points Karen Fiumara, Pharm.D., BCPS PRESENTATION Case Scenario: Evaluating a Medication Management System and Implementing Safety Solutions OVERVIEW Many studies have been published on the risks and error rates associated with intravenous medications. The current literature continues to highlight the high risk nature of intravenous sterile preparations and their administration to patients. Unfortunately, there are limited tools available to critically assess potential gaps in intravenous medication administration and preparation. This presentation discusses common medication errors and reviews system-based strategies for error prevention. LEARNING OBJECTIVES At the conclusion of this knowledge-based educational activity, participants should be able to • Explain a successful medication management strategy that has been demonstrated to enhance safety within an organization. • Discuss the utility of barcode technology as a system-based safety solution in intravenous medication preparation. • Describe the benefits of intelligent infusion pump technology as a system-based safety solution for administration to patients. 44 Case Scenario: Evaluating a Medication Management System and Implementing Safety Solutions Karen Fiumara, Pharm.D., BCPS Patient Safety Manager Brigham and Women’s Hospital Boston, MA Complexity of Health Care 30 years ago Primary Care Practitioners (PCPs) Hospital-based Physicians Today Physician Practice Groups 1 hour of paperwork per Administrative work was >4 hours of paperwork day left to administrators per day Practiced from privately owned clinics Specialists focused on a particular system of the body Employed minimal support staff Most PCPs are part of practice groups Average ICU patients require 178 daily tasks How to manage the increasing complexity of patient care? Plsek. BMJ. 2001; 323: 625-628. Complexity of Other Industries • October 30, 1935 U.S. Army held flight competition for airplane manufacturers • Boeing developed long range bomber – 5 times as many bombs – Faster – 2 times farther • Premier flight pilot Major Ployer Hill 45 Checklists/Reminders • Investigation revealed nothing mechanical had gone wrong. Crash was due to “pilot error.” • Aircraft was substantially more complex – – – – Four engines Retractable landing gear New wing flaps Varying air speeds • Deemed “too much plane to fly” • Boeing nearly went bankrupt • Group of test pilots developed a checklist – Pilots flew a total of 1.8 million miles without a single accident 46 Medical Error Rates • Two errors per day = 99% proficiency level • If 99% was “good enough”: – Airline industry = 2 unsafe landings per day at Chicago O’Hare International airport – Banking industry = 22,000 checks deducted from the wrong account per hour – Postal industry = 18,322 pieces of mail will be mishandled in the next hour • How do we transform health care into a high reliability industry? Leape LL. JAMA. 1994;272:1851-7. How do we transform health care into a high reliability industry? A. Employ only medical professionals with background in banking, airline, or auto industries B. Critically evaluate systems issues that lead to error C. Implement and test strategies to reduce error D. Both B and C What Keeps Us Awake at Night? • Many medication and patient safety officers say…. “what keeps me awake at night is what goes on during the day in the IV room!” 47 Enlarged version on page 61 Do We Have Concerns About How We Are Preparing Sterile IV Admixtures in Hospitals? Nearly 50% of surveyed hospitals did not have a formal QI program for sterility and accuracy of IV Admixtures American Journal of Health System Pharmacists, 2005 National Survey of Pharmacy practice in hospital settings: Dispensing and Administration, Volume 63 Feb 16, 2006. Do We Have Concerns about How We Are Preparing Sterile IV Admixtures in Hospitals? Enlarged version on page 62 Parshuram C et al. The Annals of Pharmacotherapy. 2006;40(5):805. Anton C et al. Arch Intern Med. 2003;163(8):982. Parshuram C et al. Critical Care Med. 2003;31(10):2483. Hayes B et al. The Annals of Pharmacotherapy. 2008;42(6):766. Enlarged version on page 63 Do We Have Concerns About How We Are Preparing Sterile IV Admixtures in Hospitals? Ashram C et al. CMAJ: 2008;178(1):42. Cousins D et al. Qual Saf Health Care. 2005;14(3):190. Veronika W et al.. Pharmacy World & Science. 2003;25(3)104. 48 Which of the following can be considered a preparation error? A. B. C. Nurse administers dose of cefepime to a patient who is febrile and neutropenic 10 hours late Technician prepares a TPN using insulin 500 unit vs. insulin 100 unit vial Pharmacist approves an order for ampicillin 500mg with ampicillin 1000 mg Types of IV Errors • Improper injection of drug • Wrong volume of drug • Extra dosage or wrong dose of drug is administered • Failure to give medication through an i.v. • Faulty i.v. pumps and valves • Incompatible combination of drugs administered • Wrong drug or solution was used Flynn EA at al. Am J Hosp Pharm 1997:54;904-12. Patient Case Dilution Error • Baby LC # 1, 5 day old male • Prematurity, 32 weeks • Treated with beractant, TPN + UFH 0.5 units/mL • New PICC line inserted, flushed with heparin/ saline • New TPN bag at 4 PM • Baby began to hemorrhage from all access sites • 7 transfusions, 10-15 mL UFH = unfractionated heparin; TPN = total parenteral nutrition 49 Sept 17th, 2006 Enlarged version on page 64 Dec 7th, 2007 People Magazine Enlarged version on page 65 Patient Case – Dilution Error • Medication errors are common in the NICU – NICU patients are 8 times more likely to experience a medication error with the potential to cause harm than adults – 54% of errors involved intravenous medications Kaushal et al. JAMA. 2001;285:2114-20. 50 Bar-code Technology • An effective tool in many nonhealth care industries – Grocery stores are more automated than health care • Provides a fail safe automated identification and feedback system in real time • Performs the “five rights” checking in one easy efficient process Can bar-code technology be useful in the IV room? A. Yes, but only to verify the correct product; barcode can’t help with verifying concentrations, or expiration dates B. Yes, barcode technology can verify correct product, expiration dates and concentration C. No, barcode technology is not helpful in the IV room setting Steps to Make a Patient Specific Compounded Sterile Preparation (CSP) • Prescriber orders medication via computerized prescriber order entry (CPOE) • Pharmacist conducts clinical review and approves order • Label generated in the Sterile Products Room • Barcode scan set-up • Prep label generated • Compounding process under the laminar flow hood (LFH) • Pharmacist then checks and sends to the patient floor 51 The Sterile Products Room Neonatal IV Preparation • 50 bed – neonatal intensive care unit • Routinely requires extremely low dose medications that are NOT commercially available • Example: 24 week GA male weighing 3 grams, transferred to NICU, intubated for management of extreme prematurity, on pressors with inadequate repose started on hydrocortisone IV 0.5 mg/kg (1.5 mg) Q12H NICU – How many dilution steps are required to prepare a 1.5mg dose from a 100 mg/2mL solution? A. One dilution to a final concentration of 100mg/mL B. Two dilution steps to a final concentration of 50mg/mL C. Three dilution steps to a final concentration of 1mg/mL solution 52 NICU Pharmacy System • The commercially available product for hydrocortisone is a 100 mg vial. The vial is reconstituted with 2 mL sterile water for injection for a concentration of 50 mg/mL • Total dose of 1.5 mg cannot be accurately measured using a 50 mg/mL concentration • The BWH NICU system is able to take in consideration reconstitutions and multiple dilutions to ensure the correct dose is used to compound a final product Enlarged version on page 66 Wt: 3000 grams Pharmacist can select the 1 mg/mL concentration for the final product dilution which is need to accurately measure a dose of 1.5 mg Enlarged version on page 67 Wt: 3000 grams After the pharmacist selects the final dilution concentration, the total volume will fill in to match the final dilution chosen. 53 Enlarged version on page 68 Enlarged version on page 69 All NICU medications that need to be reconstituted prior to compounding are listed in a “reconstitution table.” Enlarged version on page 70 All medications that require further dilution are in this “Dilution Table”. 54 Reliance on Technology “To err is human, but to really mess things up… you need a computer” -Anonymous Sterile Products Room To prepare the Hydrocortisone: • The final dilution that will be used to make the final product (1.5 mg dose) is 1 mg/mL • Four labels will generate to make this CSP 1. 2. 3. 4. Patient specific label Reconstitution label Dilution label for 10mg/ml Dilution label for 1mg/ml Sterile Products Room • The system forces the user to proceed “in order” to make the final patient product • The system directs the user to: – Step 1: reconstitute the vial – Step 2: dilute the 50 mg/mL concentration to 10 mg/mL – Step 3: dilute the 10 mg/ mL concentration to 1 mg/mL – Step 4: manufacture CSP • Each step is set-up, prepared, and checked by the pharmacist 55 Enlarged version on page 71 Step 1: The system instructs the user to put 2 ml of sterile water into the vial, which will make it 50 mg/ml concentration; the product is manufactured and a bar-coded label for the 50 mg/mL solution is affixed to the reconstituted solution. Enlarged version on page 72 Step 2: Once the reconstitution is completed, the dilution label for the 10 mg/mL can be scanned. The system asks for the reconstituted 50 mg/mL barcode to be scanned. The system defaults the amount of medication and diluents needed to manufacture the 10 mg/mL product. The product is manufactured and a bar-coded label for the 10 mg/mL solution is affixed to the diluted solution. Enlarged version on page 73 Step 3: Once the product is diluted to a 10 mg/mL concentration, the 1 mg/mL prep label can be scanned. The system computes the volume of medication and diluent needed to manufacture the 1 mg/mL product. The product is manufactured and a bar-code label for the 1 mg/mL solution is affixed to the diluted solution. 56 Enlarged version on page 74 Step 4: Once the dilution of 1 mg/mL prepared; the system prompts the user to prepare the patient specific medication. The system requires the hydrocortisone 1 mg/mL dilution to be scanned and computes the amount of volume need to prepare the final CSP. Safety Features • The system will not allow the user to proceed if the wrong step/drug/diluent is scanned. If you tried to make the 1 mg/mL final patient dose with the 10 mg/mL dilution, the system issues a hard stop. • Bar-code labels are affixed to each product during the prep stage. The barcode is associated with the prepared dilution. • There are 3 steps to every dilution: Set-up, Preparation, and Check • Each step requires a pharmacist double-check Pharmacist Check • When the first pharmacist enters his/her key, the second pharmacist must key in right after. If one pharmacist signs and then backs out without the other pharmacist key, it will start the checking process over again. • The system cannot be bypassed. The user is not able to proceed to the next step until two pharmacists have entered their keys. 57 Barcodes • All reconstitution and dilution labels have barcodes with lot numbers and expiration dates assigned to them. • If the user tries to scan a dilution after the expiration date, the system alerts the user that the product is expired. Administration related IV Errors Lack of standardized dosing methods Case report from Institute for Safe Medication Practices (ISMP): • An 80-year-old male (80 kg) taken to an urgent care center for treatment of urosepsis and septic shock • Ordered dopamine in a mcg/kg/minute dose to treat persistent hypotension • Over the next hour, the infusion was titrated upward two times in 5 mcg/kg increments with no response • A critical care transport service was called to transport the patient to a nearby hospital for admission to a critical care unit • The transport team independently calculated the rate of infusion • Identified that the dopamine dose had been programmed in mcg/kg/HOUR, not mcg/kg/MINUTE Patient Case - Infusion Error Error Description • 57 YOM end stage CMP • EF = 10% • Heart transplant candidate with BIVAD • Receiving UFH 900 units per hour (9 ml/hr) • New order to reduce heparin 800 units per hour @ 10:22 PM • Infusion pump set for 800 ml per hour • • • • • • • • 8:45 pm aPTT = 75.1 1:13 am protamine 25mg 1:28 am aPTT = >150 3:13 am aPTT = >150 3:32 am protamine 26mg 2 units PRBC 4:08 am aPTT = >150 8:21 am aPTT = 44.4 58 UFH Error Analysis: BWH • 1 event per 1,000 patients – 52% - Administration related – 31% - Equipment failure, rate or dosing error – 23% - Infusion pump • 6% - Prolonged length of stay or significant harm *Patient Safety Initiative: Hospital invested $3 million in state of the art infusion pumps* Fanikos J et al. Medication errors associated with anticoagulation therapy in the hospital.Am J Cardiol 2004;94:532-5. Objectives Methods Evaluate impact of “smart” Programmed the drug library infusion technology on to alert for over-doses or anticoagulation administration under-doses To determine if infusion technology equipped with drug libraries may reduce medication errors Alerts where subsequently recorded in the device’s electronic memory along with the user’s next action Retrospectively reviewed all anticoagulant alerts and the user’s next action for all devices from 10/2003 through 1/2005 Dosing Errors and their Magnitude 25 10 X Underdose 1 15 100 X Underdose 8 > 100 X Overdose 21 21 2 40 100 X Overdose 2 31 10 X Overdose 0 5 10 15 UFH 4 20 ARG 25 Lep 30 5 35 40 45 Bival UFH = unfractionated heparin; ARG = argatroban; Lep = lepirudin; Bival = bivalirudin 59 Data Entry Errors Frequently Repeated with Unfractionated Heparin (UFH) 300 286 27.2 % entry errors User repeated the error Frequency 250 200 150 100 63 27 50 12 3 1 1 4 5 6 9 0 1 2 3 No. of Incorrect Device Entries Conclusions • Pharmacy departments should critically evaluate risk points • Practical use of medication-use safety strategies such as bar-code scanning, smart infusion devices, and standardization of medication administration can be valuable tools in reducing medication errors during compounding and administering sterile products • Error reduction strategies must include high reliability, system-based solutions Thank you! 60 Do We Have Concerns About How We Are Preparing Sterile IV Admixtures in Hospitals? Nearly 50% of surveyed hospitals did not have a formal QI program for sterility and accuracy of IV Admixtures American Journal of Health System Pharmacists, 2005 National Survey of Pharmacy practice in hospital settings: Dispensing and Administration, Volume 63 Feb 16, 2006. 61 Do We Have Concerns about How We Are Preparing Sterile IV Admixtures in Hospitals? Parshuram C et al. The Annals of Pharmacotherapy. 2006;40(5):805. Anton C et al. Arch Intern Med. 2003;163(8):982. Parshuram C et al. Critical Care Med. 2003;31(10):2483. Hayes B et al. The Annals of Pharmacotherapy. 2008;42(6):766. 62 Do We Have Concerns About How We Are Preparing Sterile IV Admixtures in Hospitals? Ashram C et al. CMAJ: 2008;178(1):42. Cousins D et al. Qual Saf Health Care. 2005;14(3):190. Veronika W et al.. Pharmacy World & Science. 2003;25(3)104. 63 Sept 17th, 2006 Dec 7th, 2007 People Magazine 64 65 Wt: 3000 grams Pharmacist can select the 1 mg/mL concentration for the final product dilution which is need to accurately measure a dose of 1.5 mg 66 Wt: 3000 grams After the pharmacist selects the final dilution concentration, the total volume will fill in to match the final dilution chosen. 67 68 All NICU medications that need to be reconstituted prior to compounding are listed in a “reconstitution table.” 69 All medications that require further dilution are in this “Dilution Table”. 70 Step 1: The system instructs the user to put 2 ml of sterile water into the vial, which will make it 50 mg/ml concentration; the product is manufactured and a bar-coded label for the 50 mg/mL solution is affixed to the reconstituted solution. 71 Step 2: Once the reconstitution is completed, the dilution label for the 10 mg/mL can be scanned. The system asks for the reconstituted 50 mg/mL barcode to be scanned. The system defaults the amount of medication and diluents needed to manufacture the 10 mg/mL product. The product is manufactured and a bar-coded label for the 10 mg/mL solution is affixed to the diluted solution. 72 Step 3: Once the product is diluted to a 10 mg/mL concentration, the 1 mg/mL prep label can be scanned. The system computes the volume of medication and diluent needed to manufacture the 1 mg/mL product. The product is manufactured and a bar-code label for the 1 mg/mL solution is affixed to the diluted solution. 73 Step 4: Once the dilution of 1 mg/mL prepared; the system prompts the user to prepare the patient specific medication. The system requires the hydrocortisone 1 mg/mL dilution to be scanned and computes the amount of volume need to prepare the final CSP. 74 Improving IV Medication Safety: Identifying the Risk Points SELECTED REFERENCES AND RESOURCES 1. Anton C, Ferner R. Medication errors detected in infusions. Arch Intern Med. 2003; 163:982. 2. Ashram C, et al. Systematic evaluation of errors occurring during the preparation of intravenous medication. CMAJ. 2008; 178(1):42. 3. Cousins D, Sabatier B, Begue D et al. Medication errors in intravenous drug preparation and administration: a multicentre audit in the UK, Germany and France. Qual Saf Health Care. 2005;14:190-5. 4. Fanikos J, Fiumara K, Baroletti S et al. Impact of smart infusion technology on administration of anticoagulations (unfractionated heparin, argatroban, lepirudin, and bivalirudin). Am J Cardiol. 2007; 99:1002-5. 5. Fanikos J, Stapinski C, Koo S et al. Medication errors associated with anticoagulation therapy in the hospital. Am J Cardiol. 2004; 94:532-535 6. Flynn E, Pearson R, Barker K. Observational study of accuracy in compounding IV admixtures at five hospitals. Am J Hosp Pharm. 1997; 54:904-12. 7. Hayes B, Klein-Schwartz W, Doyon S. Frequency of medication errors with intravenous acetylcysteine for acetaminophen overdose. Ann of Pharmacother: 2008; 42:766-70. Epub 2008 Apr 29. 8. Kaushal R, Bates D, Landrigan C et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001;285:2114-20. 9. Leape L. Error in medicine. JAMA. 1995; 272(23):1851-7. 10. Parshuram C, Ng G, Ho T. Discrepancies between ordered and delivered concentrations of opiate infusions in critical care. Crit Care Med. 2003; 31(10):2483-7. 11. Parshuram C, Dupuis L. To T et al. Occurrence and impact of unanticipated variation in intravenous methotrexate dosing. Ann Pharmacother. 2006; 40:805-11. Epub 2006 Apr 25. 12. Pedersen C, Schneider P, Scheckelhoff D. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration—2005. Am J HealthSyst Pharm. 2006; 63:327-45. 13. Veronika W et al. An observational study of intravenous medication errors in the United Kingdom and in Germany. Pharm World & Science. 2003; 25:104. 14. Plsek P, Greenhalgh T. Complexity science: the challenge of complexity in health care. BMJ; 2001; 323(7313):625-8. 75 Improving IV Medication Safety: Identifying the Risk Points SELF–ASSESSMENT QUESTIONS 1. In comparison to 30 years ago, modern health care is: a. More complex. b. Less complex. c. Associated with less administrative work. 2. Quality assurance/quality insurance programs in intravenous (i.v.) sterile product preparation suites are: a. Routinely used. b. Seldom used. c. Used in approximately 50% of hospitals. 3. Which of the following can be classified as an i.v. room preparation error? a. Technician manufactures an i.v. in the wrong base solution. b. A nurse administers and i.v. at the wrong time. c. A physician orders the wrong dose of methotrexate i.v. Answers 1. a 2. c 3. a 76