DANGER ZONE
INSULIN PENS: SINGLE PATIENT USE IS MANDATORY FOR SAFETY Author: Susan F. Paparella, MSN, RN, Horsham, PA Section Editor: Susan F. Paparella, MSN, RN
Earn Up to 8.0 CE Hours. See page 367. ata from the National Diabetes Statistics Report released in 2014 indicated that 9.3% of the United States population (29.1 million Americans) had diabetes; 1.25 million adults and children have type 1 diabetes, and 1.7 million new cases of diabetes are diagnosed each year. Stratified by race and ethnicity, American Indians/Alaskan natives have the highest prevalence of diabetes, followed closely by non-Hispanic blacks. Diabetes remains the seventh leading cause of death in the US, and in 2011, diabetic adults aged 18 years and older had more than 282,000 ED visits for hypoglycemia. 1 During the past several years, commercially available, prefilled insulin pens have been adopted for use in many US hospitals for the treatment of patients with diabetes. These pen-shaped injection devices contain insulin in a reservoir or cartridge and are designed to be used multiple times for a single patient by applying a new disposable needle each time the pen is used. Primarily intended to facilitate easy and accurate self-administration in the community setting, insulin pens quickly gained popularity in the hospital setting because the insulin is in a ready-to-use form and is prelabeled by the manufacturer with the product name and strength, as well as a bar code. When dispensed, each insulin pen can be easily labeled with the patient’s name, and use of these pens is ideal in
D
Susan Paparella, Member, Bux-Mont Chapter, is Vice President at the Institute for Safe Medication Practices (ISMP), Horsham, PA. *ISMP is a nonprofit organization that works closely with health care practitioners, consumers, hospitals, regulatory agencies, and professional organizations to educate caregivers about preventing medication errors. ISMP is the premier international resource on safe medication practices in health care institutions. If you would like to report medication errors to help others, E-mail us at: [email protected] or call (800)FAIL-SAF(e). This Medication Error Reporting Program keeps information confidential and secure. We will include only the level of detail that the reporter wishes in our publications. For correspondence, write: Susan Paparella, MSN, RN, Vice President, ISMP; E-mail: [email protected]. J Emerg Nurs 2015;41:340-2. 0099-1767 Available online 18 April 2015 Copyright © 2015 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jen.2015.03.009
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that it requires less time for the nurse or other practitioner to prepare a dose. 2 Because the pens were introduced at a time when safe injection practices with multi-dose vials were in question, practitioners also believed that this new device could improve safety by eliminating the risk of cross-contamination between patients. Although the pen has been widely accepted by patients for its ease of use, a number of event reports sent to the Institute for Safe Medication Practices (ISMP) and observed in the media suggest that all of the risks associated with the use of this type of device are not widely known. 2–10 One of the biggest concerns that may not be fully understood by all health care providers is the risk of blood-borne pathogen exposure when a pen device is reused on more than one patient. ISMP first reported on this practice in 2008. 3 Studies noted that squamous, epithelial, and red blood cells, hemoglobin, and macrophages were found in almost 58% of the pen cartridges after they were used. 10,11 Although newer refined pen devices have since been adopted, a 2013 study found contaminated cartridges in 5.6% of used insulin pens. 12 Unfortunately, this risk is not new. In January 2012, the Centers for Disease Control and Prevention published a clinical reminder to warn practitioners about the dangers of pen reuse. Quickly thereafter, in May 2012, the Centers for Medicare and Medicaid Services determined that hospitals will be issued a citation when they identify pen reuse in facilities. 6,13–15 As noted by the Food and Drug Administration and by repeated reports in the media, significant numbers of patients are potentially being exposed to blood-borne illness such as hepatitis B and C and HIV through the reuse of insulin pens. 16 These reported patient exposures include 2114 patients at a Texas Army medical center in 2009; 2345 patients in a Wisconsin clinic in 2011; and, in New York in 2013, 700 patients in a Veterans Affairs facility and more than 1900 patients in a general hospital. 2–8 Continued reports suggest that there may be a widespread misunderstanding about the safe use of insulin pens— namely, that sterility can be maintained between patients just by changing the needle. Withdrawing insulin from the cartridge of a used insulin pen into a clean syringe also risks
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Paparella/DANGER ZONE
potential contamination and is not considered safe practice. 4–8 In some cases, it appears that nurses and other practitioners do not recognize the dangers of reusing a syringe even with a new needle. In fact, in 2 recent reports, nurses knowingly used the same insulin pen for multiple patients. Both nurses believed that their practice was safe because they changed needles before using the device on another patient. In one case, the original patient had the HIV virus. The nurse also reported that sharing insulin pens was routine practice in another facility where she also worked. In the second reported case, even though each pen device had a patient-specific label, 2 insulin pens were reused to administer insulin to 3 patients. The nurse decided to reuse the pen instead of waiting for pharmacy to dispense insulin for a newly admitted patient. 4 Organizations that use insulin pens have begun to undertake numerous steps to eliminate this risk. Some organizations have chosen to remove insulin pens from their formulary and instead continue to use multiple-use vials, whereas others have decided to use pen devices in limited situations. One organization that utilizes bedside bar code scanning for medication administration decided to limit their exposure to pen device reuse by placing a patient-specific bar code on each insulin pen and providing around-the-clock education to all staff, reminding them specifically about the dangers associated with pen reuse. Middle managers assisted in coaching staff regarding at-risk behaviors and in monitoring practice. Even though their compliance with bar code scanning of insulin pens was considered excellent (established to be as high as 99% for almost 80,000 insulin doses), the 1% of doses “not scanned” represented more than 800 patient encounters when the patient was administered insulin via a nonscanned pen device. During the first 3 months of monitoring practice, several instances occurred in which insulin pen devices were reused on patients, despite all efforts to prevent reuse of the devices. Contributing factors to these events were not knowledge deficits but included system issues, at-risk behaviors, and human error. Typically, these events involved using the wrong patient’s pen obtained from a patient-specific storage drawer, mixing up pens that were carried in a pocket, untimely removal of pens from storage after a patient’s discharge, putting a pen back into a wrong patient’s drawer, and overriding a bar code scan. 8 Although insulin pens have been in use for several years, ED practitioners may not have had much direct exposure to these devices. Organizations that have adopted pen devices for insulin administration may still
July 2015
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may dispense multi-dose insulin vials to the emergency department. As more concentrated insulin products become available, such as U-200, U-300, and U-500 insulin, it is anticipated that several of these newer concentrations may only be available in a pen device. 17 Therefore, it is important for staff in any setting to understand the serious infection control risks and safety challenges associated with the reuse of pen devices. Insulin pens are intended for one person only, and changing the needle does not protect patients against exposure to blood-borne pathogens if the device has been used on another patient. Before insulin pens appear in your emergency department, or more importantly, if they have already arrived, take the time during a safety huddle or staff meeting to discuss the safe use of insulin pen devices. Risk avoidance is the best medicine. REFERENCES 1. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetesreport-web.pdf. Published 2014. Accessed April 3, 2015. 2. Institute for Safe Medication Practices. Considering insulin pens for routine hospital use? ISMP Med Saf Alert. 2008;13(9):1-3. 3. Institute for Safe Medication Practices. Safety briefs: cross contamination with insulin pens. ISMP Med Saf Alert. 2008;13(6):1-2. 4. Institute for Safe Medication Practices. Hazard alert: do not use an insulin pen for multiple patients! ISMP Med Saf Alert. 2012;17(1):1-4. 5. Institute for Safe Medication Practices. Safety briefs: 4,200 need testing after pen misuse. ISMP Med Saf Alert. 2014;19(6):1-2. 6. Institute for Safe Medication Practices. CMS citing reuse of insulin pens. ISMP Med Saf Alert. 2012;17(11):2. 7. Institute for Safe Medication Practices. Insulin pens again used on multiple patients. ISMP Med Saf Alert. 2013;18(2):2-3. 8. Institute for Safe Medication Practices. A crack in our best armor: “wrong patient” insulin pen injections alarmingly frequent even with barcode scanning. ISMP Med Saf Alert. 2014;19(21):1-5. 9. Institute for Safe Medication Practices. Safety briefs: insulin pen error. ISMP Med Saf Alert. 2014;19(21):3-4. 10. Le Floch JP, Herbreteau C, Lange F, Perlemuter L. Biologic material in needles and cartridges after insulin injection with a pen in diabetic patients. Diabetes Care. 1990;21(9):1502-1504. 11. Sonoki K, Yoshinari M, Iwase M, et al. Regurgitation of blood into insulin cartridges in the pen-like injectors. Diabetes Care. 2001;24(3):603-604. 12. Herdman ML, Larck C, Schliesser Sh, Jelic TM. Biologic contamination of insulin pens in a hospital setting. Am J Health Syst Pharm. 2013;70(14):1244-1248. 13. CDC Insulin pen safety. One insulin pen-one patient. Online at: http:// oneandonlycampaign.org/content/insulin-pen-safety. Accessed March 13, 2015.
WWW.JENONLINE.ORG
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14. Centers for Disease Control and Prevention. CDC clinical reminder: insulin pens should never be used for more than one patient. http:// www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html. Updated January 5, 2012. Accessed April 3, 2015.
shared use of insulin pens. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm133352.htm. Updated August 15, 2013. Accessed April 3, 2015.
15. Centers for Medicare and Medicaid Services. Use of insulin pens in health care facilities. https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationGenInfo/Downloads/Survey-and-CertLetter-12-30.pdf. Published May 18, 2012. Accessed April 3, 2015.
17. Institute for Safe Medication Practices. Future devise for U-500. ISMP Med Saf Alert. 2014;19(6):1.
16. US Food and Drug Administration. Information for healthcare professionals: risk of transmission of blood-borne pathogens from
342
JOURNAL OF EMERGENCY NURSING
Submissions to this column are encouraged and may be sent to Susan F. Paparella, MSN, RN [email protected]
VOLUME 41 • ISSUE 4
July 2015
INSULIN PENS: SINGLE PATIENT USE IS MANDATORY FOR SAFETY Author: Susan F. Paparella, MSN, RN, Horsham, PA Section Editor: Susan F. Paparella, MSN, RN
Earn Up to 8.0 CE Hours. See page 367. ata from the National Diabetes Statistics Report released in 2014 indicated that 9.3% of the United States population (29.1 million Americans) had diabetes; 1.25 million adults and children have type 1 diabetes, and 1.7 million new cases of diabetes are diagnosed each year. Stratified by race and ethnicity, American Indians/Alaskan natives have the highest prevalence of diabetes, followed closely by non-Hispanic blacks. Diabetes remains the seventh leading cause of death in the US, and in 2011, diabetic adults aged 18 years and older had more than 282,000 ED visits for hypoglycemia. 1 During the past several years, commercially available, prefilled insulin pens have been adopted for use in many US hospitals for the treatment of patients with diabetes. These pen-shaped injection devices contain insulin in a reservoir or cartridge and are designed to be used multiple times for a single patient by applying a new disposable needle each time the pen is used. Primarily intended to facilitate easy and accurate self-administration in the community setting, insulin pens quickly gained popularity in the hospital setting because the insulin is in a ready-to-use form and is prelabeled by the manufacturer with the product name and strength, as well as a bar code. When dispensed, each insulin pen can be easily labeled with the patient’s name, and use of these pens is ideal in
D
Susan Paparella, Member, Bux-Mont Chapter, is Vice President at the Institute for Safe Medication Practices (ISMP), Horsham, PA. *ISMP is a nonprofit organization that works closely with health care practitioners, consumers, hospitals, regulatory agencies, and professional organizations to educate caregivers about preventing medication errors. ISMP is the premier international resource on safe medication practices in health care institutions. If you would like to report medication errors to help others, E-mail us at: [email protected] or call (800)FAIL-SAF(e). This Medication Error Reporting Program keeps information confidential and secure. We will include only the level of detail that the reporter wishes in our publications. For correspondence, write: Susan Paparella, MSN, RN, Vice President, ISMP; E-mail: [email protected]. J Emerg Nurs 2015;41:340-2. 0099-1767 Available online 18 April 2015 Copyright © 2015 Emergency Nurses Association. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jen.2015.03.009
340
JOURNAL OF EMERGENCY NURSING
that it requires less time for the nurse or other practitioner to prepare a dose. 2 Because the pens were introduced at a time when safe injection practices with multi-dose vials were in question, practitioners also believed that this new device could improve safety by eliminating the risk of cross-contamination between patients. Although the pen has been widely accepted by patients for its ease of use, a number of event reports sent to the Institute for Safe Medication Practices (ISMP) and observed in the media suggest that all of the risks associated with the use of this type of device are not widely known. 2–10 One of the biggest concerns that may not be fully understood by all health care providers is the risk of blood-borne pathogen exposure when a pen device is reused on more than one patient. ISMP first reported on this practice in 2008. 3 Studies noted that squamous, epithelial, and red blood cells, hemoglobin, and macrophages were found in almost 58% of the pen cartridges after they were used. 10,11 Although newer refined pen devices have since been adopted, a 2013 study found contaminated cartridges in 5.6% of used insulin pens. 12 Unfortunately, this risk is not new. In January 2012, the Centers for Disease Control and Prevention published a clinical reminder to warn practitioners about the dangers of pen reuse. Quickly thereafter, in May 2012, the Centers for Medicare and Medicaid Services determined that hospitals will be issued a citation when they identify pen reuse in facilities. 6,13–15 As noted by the Food and Drug Administration and by repeated reports in the media, significant numbers of patients are potentially being exposed to blood-borne illness such as hepatitis B and C and HIV through the reuse of insulin pens. 16 These reported patient exposures include 2114 patients at a Texas Army medical center in 2009; 2345 patients in a Wisconsin clinic in 2011; and, in New York in 2013, 700 patients in a Veterans Affairs facility and more than 1900 patients in a general hospital. 2–8 Continued reports suggest that there may be a widespread misunderstanding about the safe use of insulin pens— namely, that sterility can be maintained between patients just by changing the needle. Withdrawing insulin from the cartridge of a used insulin pen into a clean syringe also risks
VOLUME 41 • ISSUE 4
July 2015
Paparella/DANGER ZONE
potential contamination and is not considered safe practice. 4–8 In some cases, it appears that nurses and other practitioners do not recognize the dangers of reusing a syringe even with a new needle. In fact, in 2 recent reports, nurses knowingly used the same insulin pen for multiple patients. Both nurses believed that their practice was safe because they changed needles before using the device on another patient. In one case, the original patient had the HIV virus. The nurse also reported that sharing insulin pens was routine practice in another facility where she also worked. In the second reported case, even though each pen device had a patient-specific label, 2 insulin pens were reused to administer insulin to 3 patients. The nurse decided to reuse the pen instead of waiting for pharmacy to dispense insulin for a newly admitted patient. 4 Organizations that use insulin pens have begun to undertake numerous steps to eliminate this risk. Some organizations have chosen to remove insulin pens from their formulary and instead continue to use multiple-use vials, whereas others have decided to use pen devices in limited situations. One organization that utilizes bedside bar code scanning for medication administration decided to limit their exposure to pen device reuse by placing a patient-specific bar code on each insulin pen and providing around-the-clock education to all staff, reminding them specifically about the dangers associated with pen reuse. Middle managers assisted in coaching staff regarding at-risk behaviors and in monitoring practice. Even though their compliance with bar code scanning of insulin pens was considered excellent (established to be as high as 99% for almost 80,000 insulin doses), the 1% of doses “not scanned” represented more than 800 patient encounters when the patient was administered insulin via a nonscanned pen device. During the first 3 months of monitoring practice, several instances occurred in which insulin pen devices were reused on patients, despite all efforts to prevent reuse of the devices. Contributing factors to these events were not knowledge deficits but included system issues, at-risk behaviors, and human error. Typically, these events involved using the wrong patient’s pen obtained from a patient-specific storage drawer, mixing up pens that were carried in a pocket, untimely removal of pens from storage after a patient’s discharge, putting a pen back into a wrong patient’s drawer, and overriding a bar code scan. 8 Although insulin pens have been in use for several years, ED practitioners may not have had much direct exposure to these devices. Organizations that have adopted pen devices for insulin administration may still
July 2015
VOLUME 41 • ISSUE 4
may dispense multi-dose insulin vials to the emergency department. As more concentrated insulin products become available, such as U-200, U-300, and U-500 insulin, it is anticipated that several of these newer concentrations may only be available in a pen device. 17 Therefore, it is important for staff in any setting to understand the serious infection control risks and safety challenges associated with the reuse of pen devices. Insulin pens are intended for one person only, and changing the needle does not protect patients against exposure to blood-borne pathogens if the device has been used on another patient. Before insulin pens appear in your emergency department, or more importantly, if they have already arrived, take the time during a safety huddle or staff meeting to discuss the safe use of insulin pen devices. Risk avoidance is the best medicine. REFERENCES 1. Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetesreport-web.pdf. Published 2014. Accessed April 3, 2015. 2. Institute for Safe Medication Practices. Considering insulin pens for routine hospital use? ISMP Med Saf Alert. 2008;13(9):1-3. 3. Institute for Safe Medication Practices. Safety briefs: cross contamination with insulin pens. ISMP Med Saf Alert. 2008;13(6):1-2. 4. Institute for Safe Medication Practices. Hazard alert: do not use an insulin pen for multiple patients! ISMP Med Saf Alert. 2012;17(1):1-4. 5. Institute for Safe Medication Practices. Safety briefs: 4,200 need testing after pen misuse. ISMP Med Saf Alert. 2014;19(6):1-2. 6. Institute for Safe Medication Practices. CMS citing reuse of insulin pens. ISMP Med Saf Alert. 2012;17(11):2. 7. Institute for Safe Medication Practices. Insulin pens again used on multiple patients. ISMP Med Saf Alert. 2013;18(2):2-3. 8. Institute for Safe Medication Practices. A crack in our best armor: “wrong patient” insulin pen injections alarmingly frequent even with barcode scanning. ISMP Med Saf Alert. 2014;19(21):1-5. 9. Institute for Safe Medication Practices. Safety briefs: insulin pen error. ISMP Med Saf Alert. 2014;19(21):3-4. 10. Le Floch JP, Herbreteau C, Lange F, Perlemuter L. Biologic material in needles and cartridges after insulin injection with a pen in diabetic patients. Diabetes Care. 1990;21(9):1502-1504. 11. Sonoki K, Yoshinari M, Iwase M, et al. Regurgitation of blood into insulin cartridges in the pen-like injectors. Diabetes Care. 2001;24(3):603-604. 12. Herdman ML, Larck C, Schliesser Sh, Jelic TM. Biologic contamination of insulin pens in a hospital setting. Am J Health Syst Pharm. 2013;70(14):1244-1248. 13. CDC Insulin pen safety. One insulin pen-one patient. Online at: http:// oneandonlycampaign.org/content/insulin-pen-safety. Accessed March 13, 2015.
WWW.JENONLINE.ORG
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DANGER ZONE/Paparella
14. Centers for Disease Control and Prevention. CDC clinical reminder: insulin pens should never be used for more than one patient. http:// www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html. Updated January 5, 2012. Accessed April 3, 2015.
shared use of insulin pens. http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm133352.htm. Updated August 15, 2013. Accessed April 3, 2015.
15. Centers for Medicare and Medicaid Services. Use of insulin pens in health care facilities. https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationGenInfo/Downloads/Survey-and-CertLetter-12-30.pdf. Published May 18, 2012. Accessed April 3, 2015.
17. Institute for Safe Medication Practices. Future devise for U-500. ISMP Med Saf Alert. 2014;19(6):1.
16. US Food and Drug Administration. Information for healthcare professionals: risk of transmission of blood-borne pathogens from
342
JOURNAL OF EMERGENCY NURSING
Submissions to this column are encouraged and may be sent to Susan F. Paparella, MSN, RN [email protected]
VOLUME 41 • ISSUE 4
July 2015
