1. Injection Safety Tennessee Department of Health, TCPS Regional Meetings August 2014

2. Acknowledgements Slides: Joe Perz, DrPH MA Division of Healthcare Quality Promotion Centers for Disease Control and Prevention

3. Injections and Infusions are Central to Healthcare Delivery Injections and infusions of parenteral medications likely represent the most common invasive procedure across all of healthcare  Chemotherapy  Intravenous antibiotics  Vaccination  Sedation/anesthesia for surgical procedures, endoscopy, and imaging/diagnostic studies  Joint injections  Cosmetic procedures  Alternative medicine

4. Injectable Medications  Safe healthcare delivery relies on supply of safe sterile injectable medications (free of intrinsic contamination)  Oversight required to assure injectable medications are supplied in a sterile form Majority are manufactured  FDA Standards  Extrinsic contamination can result from mishandling of medications during preparation and administration CDC addresses and promotes “Injection Safety” through guidelines and educational efforts

6. Risks of Injections Extends Beyond Recognized Outbreaks  Case-Control Study of Hepatitis B and Hepatitis C  48 reported cases of symptomatic acute hepatitis B or C  Persons aged 55 years and older – NY and OR  Excluded nursing home residents and cases identified as a result of outbreak investigations  In a multivariate model, behavioral risks (17% attributable risk), injections (37% attributable risk), and hemodialysis (8% attributable risk) were associated with case status  Conclusion: Healthcare exposures may represent an important source of new HBV and HCV infections among older adults Perz et al. Hepatology 2013

8. MSSA Cluster – Rheumatology Practice  Dec 2011: hospital IP notified health dept.  4 patients admitted (LOS 1-8 days) for surgical debridement of lab-confirmed MSSA infections  HD identified 5 th patient treated at different hospital ED  Cases all received joint injections at an independent outpatient rheumatology clinic on same afternoon  Site visit identified several infection control lapses  E.g., hand hygiene, not disinfecting vial septums, SDV reuse  Steroid (MPA) from a compounding pharmacy  labeled as “MDV” containing preservatives  Opened MDVs and SDVs kept on top of towel dispenser Drezner et al. Infect Control Hosp Epidemiol 2014;35(2):187-189

10. Main Street Family Pharmacy – Newbern, Tennessee Source: Tom Wilemon, The Tennessean

12. A total of 26 patients in 4 states developed a suspected infection associated with injection of a product, labeled as sterile, that was distributed by the Main Street Family Pharmacy (Newbern, TN) since December 1, 2012 Health departments determined 96 facilities in 17 states received recalled MPA. 81 facilities in 15 states administered MPA; these were provided instructions on product recall/testing, patient notification, case finding and reporting http://www.cdc.gov/hai/outbreaks/TN-pharmacy/

13. Not All Vials Are Created Equal “Patients and healthcare practitioners need to be aware that compounded drugs are not the same as generic drugs, which are approved by the FDA.” Drugs in R&D March 2013, Volume 13, Issue 1, pp 1-8 Jan. 8, 2014 FDA Letter to Hospital/Purchasers : “… you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities …”

14. Check the label – unless it is a manufactured vial with the term “multi-dose vial” printed on it, it is not a multi- dose vial

15. WJTV TV Outbreak of Bloodstream Infections at an Outpatient Chemotherapy Infusion Center, Mississippi, 2011 Dobbs et al, AJIC (2014) 731-4

16. Outbreak of Bloodstream Infections at an Outpatient Chemotherapy Infusion Center, Mississippi, 2011 Dobbs et al, AJIC (2014) 731-4  Mississippi State Dept of Health notified by local hospital of 4 inpatients with bacteremia / port infection  All had Pseudomonas aeruginosa with identical antimicrobial resistance patterns  2 had Klebsiella pneumoniae  All 4 were current receiving outpatient infusions at the same cancer center  Onsite investigation conducted by MSDH staff that afternoon

17. Initial Site Visit – Outpatient Chemotherapy Infusion Center, Mississippi, 2011 Dobbs et al, AJIC (2014) 731-4  Facility was converted merchant building housing clinic rooms, office space, medication mixing rooms (including vented hood for chemotherapy), and large infusion space  Single physician, 2 nurses, clerical staff  Staff and physician denied use of any common source medication or flush solutions  4 additional patients diagnosed later that day  Clinic closed by State Health Officer Order as an imminent public health threat  It was later determined that an administrator accessed ports and delivered infusions WJTV TV

18. Findings – Outpatient Chemotherapy Infusion Center, Mississippi, 2011 Dobbs et al, AJIC (2014) 731-4  Earlier that same month, reported cost-containment measures were instituted  Switched to common-source 1-L saline and 1-L heparin flush bags rather than single-dose vials for all port and line flushes These bags were used over several days for multiple patients A single syringe was dedicated to each patient to draw up the saline flush for the entire day; each syringe could be reused multiple times to access the common bag of saline solution before being discarded at the end of the day  Other syringes were dedicated to drawing up the heparin flush for all patients from the common-source heparin flush bag These heparin syringes were shared among multiple patients over an indeterminate period  In total, the investigation identified 14 confirmed cases and 1 probable case WJTV TV

20. Injection Practices Among Clinicians in United States Health Care Settings Survey of 5,500 U.S. healthcare professionals 1 percent “sometimes or always” reuse a syringe on a second patient 1 percent “sometimes or always” reuse a multidose vial for additional patients after accessing it with a used syringe 6 percent use single-dose/single use vials for more than one patient Pugliese G. et al. American Journal of Infection Control, 38 (10), 789-798.

21. Insulin Pen Reuse Incidents  Reuse of insulin pens for multiple patients, reportedly after changing needles has resulted in large notifications  NY hospital, 2008: 185 patients notified  TX hospital, 2009: 2,114 patients notified  WI hospital and outpatient clinic, 2011: 2,401 patients notified  2013: multiple incidents involving NY and NC, including 2 VA Medical Centers and a private hospital  March 2014: NY hospital, over 4,000 patients Schaefer et al. Diabetes Care. 2013 Nov;36(11):e188-9 www.newsday.com/news/health/south-nassau-hospital-alerting-4-247-patients- of-possible-blood-contamination-1.7359969

22. CDC Standard Precautions, 2007 Safe Injection Practices Key elements Use aseptic technique when preparing and administering medications Never administer medications from the same syringe to multiple patients Do not reuse a syringe to enter a medication vial or solution Do not administer medications from single-dose vials or intravenous solution bags to more than one patient Limit the use of multi-dose vials and dedicate them to a single patient whenever possible Wear a surgical mask when performing spinal injections www.cdc.gov/hicpac/pdf/isolation/isolation2007.pdf

23. Emerging Issue : Diversion & Tampering The National Association of Drug Diversion Investigators defines drug diversion as “any criminal act or deviation that removes a prescription drug from its intended path from the manufacturer to the patient.”

25. Mechanisms of Medication Theft (Diversion) by Healthcare Personnel  False documentation (e.g., medication dose not actually administered to the patient or “wasted” but instead saved for use by the provider)  Scavenging of wasted medication (e.g., removal of residual medication from used syringes)  Theft by tampering (e.g., removal of medication from a medication container or syringe and replacement with saline or other similarly appearing solution that may be administered to patients)  This type of diversion = tampering (federal offense)*  Not detectable by typical monitoring activities (e.g. dispensing cabinet records * http://www.fda.gov/RegulatoryInformation/Legislation/ucm148785.htm

26. Outbreaks of Hepatitis C associated with diversion: Recent U.S. Experience YearStateSettingCasesHealthcare Worker 2008FLHospital5Radiology technician 2009COHospital18Surgical technician 2012NH, KS, MDHospital45Traveling cardiac technician

27. Hepatitis C outbreak, Colorado 2009  CO Department of Public Health and Environment received 2 reports of acute HCV infection  Patients had undergone surgical procedures at same hospital  HCV-infected surgical technician stole fentanyl syringes that had been predrawn by anesthesia staff and left unlocked in the OR  Tech refilled contaminated syringes with saline to swap with additional fentanyl syringes  At least 18 patients infected; >8,000 patients notified  Notification included ASC that employed tech after she was fired from hospital and NY hospital where tech worked prior to the CO hospital  Tech sentenced to 30-year prison term

28. www.cdc.gov/injectionsafety/drugdiversion/

30. http://www.oneandonlycampaign.org/ Injection Safety Resources

31. http://www.oneandonlycampaign.org/content/audio-video

32. http://www.oneandonlycampaign.org/

35. http://www.oneandonlycampaign.org/content/bloodborne-pathogens-training

36. 1-800-CDC-INFO

37. Sterile Fluid Path What does this mean?

38. Sterile Fluid Path Description: “To identify the presence of a sterile fluid pathway within a medical device when other parts of the medical device are not necessarily supplied sterile” Check labeling of packaged products (prefilled saline syringes, etc…)

39. Some take-aways Protecting patients from infections and harm is a basic standard of care Patient safety must rest on a solid foundation Uniform standard of care Basic infection control and prevention of healthcare- associated infections is key At the end of the day, we are all patients

40. http://www.oneandonlycampaign.org/content/audio-video Video: Check your Steps!

41. http://www.oneandonlycampaign.org/content/audio-video Video: Managing Patient Safety, One Injection at a Time