Immunization Update

1. Immunization Update Deidra Van Gilder, Pharm.D.

2. Disclosure I have had no financial relationship over the past 12 months with any commercial sponsor with a vested interest in this presentation.

3. Objectives - Pharmacist • List steps to prevent exposure to blood borne pathogens during immunization delivery. • Describe recommended ways to help prevent vaccine administration errors. • Identify best practices for how to prevent and how to treat adverse reactions to vaccines.

4. Objectives - Technician • Determine proper storage and restocking recommendations for vaccines. • Describe the ways that technicians can assist during serious vaccine-related reactions.

5. Blood Borne Pathogens • As many as ⅓ of needle sticks occur during disposal • Estimated 600,000 - 800,000 needle sticks occur annually among healthcare workers • CDC estimates 62-88% of needle sticks can be prevented with safer medical devices Image and information: OSHA - Blood Borne Pathogens and Needlestick Prevention

6. Blood Borne Pathogens • Hepatitis B, Hepatitis C, HIV/AIDS • Exposure control plan • Update annually • Universal precautions • Treat all body fluid as infectious with blood borne pathogens • Provide personal protective equipment (PPE) • Gloves, gowns, eye protections, masks • Post-exposure evaluation plan • Provide information and training to workers OSHA - Blood Borne Pathogens and Needlestick Prevention

7. Sharps Safety • Organize administration area with sharps disposal within reach • Work in well-lit area with minimal distractions • ALWAYS keep exposed needle in view • Be comfortable with needle safety feature • Activate safety feature immediately after use • Do not overfill sharps container • Protect yourself with the Hepatitis B vaccine CDC - Sharps Safety for Healthcare Professionals

8. Needlestick Protocol • Immediately wash area with soap and water • Report injury and fill out exposure report sheet • Evaluate exposure source for HBV, HCV and HIV • Assess if patient is willing to consent for disease testing if unknown status • Immediately seek medical treatment if indicated • Assistance available from the Clinicians’ Post Exposure Prophylaxis Line (1-888-448-4911) CDC & NIOSH Emergency Sharps Information

9. Discussion • Discuss any incidents of needle sticks and how the facility you were at handled the situation. • Discuss changes made to prevent further needle sticks from occurring.

10. Vaccine Errors

11. ISMP 2017 Reported Immunization Errors Adapted from ISMP National Vaccine Errors Reporting Program 2017

12. Preventing Vaccine Errors Check vial label 3 times before administering Use careful labeling in vaccine storage unit Administering wrong vaccine-DTap/Tdap-PPSV23/PCV13 Using wrong diluent or administering diluent only Immunization Action Coalition Preventable Errors

13. Preventing Vaccine Errors Rotate stock, regular schedule for checking vaccine expirations Post reference materials for dose, site, and route for each vaccine Administering wrong dose, site, route, needle length or gauge Giving expired vaccine Immunization Action Coalition Preventable Errors

14. Shingrix Reconstitution - Example • Alcohol the tops of both vials • Remove all of diluent from vial 1 • The adjuvant solution may contain up to 0.75 ml • Transfer contents into vial 2 with powder • Gently shake until solution is completely mixed • Solution may vary from colorless to pale brown • Withdrawal 0.5 ml and administer to patient intramuscularly Image and Information: GSK Shingrix

15. Preventing Vaccine Errors Use reliable screening checklist to identify contraindications or identify opportunities to vaccinate Know the minimum ages and intervals Keep immunization schedules and recommendations available Giving a vaccine earlier than recommended age or dosing interval Screening checklist that fails to identify contraindications/ precautions Immunization Action Coalition Preventable Errors

16. Immunocompromised Patients • Immunocompromised patients should not receive live vaccines • MMR, varicella, nasal influenza • Patients should be up to date on all immunizations before starting biologics • Ex: Humira and Enbrel • Inactive vaccines can be administered to all patients regardless if they are immunocompromised Humira and Enbrel - Safety Information

17. Steroid Therapy and Live Vaccines • Concern with steroid dose equivalent to 2 mg/kg of actual body weight or 20 mg daily of prednisone for > 2 weeks • Providers should wait at least 1 month after discontinuing steroid therapy before administering a live vaccine • Steroid therapy less than 2 weeks, alternate-day, physiologic replacement, topical, aerosol, and intra-articular injections are NOT contraindications Immunization Action Coalition - Precautions and contraindications

18. Vaccine Errors • If a vaccination error has been made, be sure to report it as soon as possible • Institute for Safe Medication Practices (ISMP) • https://www.ismp.org/report-medication-error • Vaccine Adverse Event Reporting System (VAERS) • https://vaers.hhs.gov/reportevent.html Immunization Action Coalition Preventable Errors

19. Vaccine Storage and Handling

20. The Cold Chain • Proper handling and storage is vital to the efficacy of the vaccine • Improper handling and storage of vaccines can result in • decreased potency of the vaccines • limited protection • money lost in wasted vaccines • Effective cold chains require • well trained staff • dependable storage and temperature equipment • accurate vaccine inventory CDC Vaccine Storage and Handling Toolkit

21. Diagram from CDC Vaccine Storage and Handling Toolkit

22. Temperature Excursion • Notify supervisor • Document • Date, time, room temperature, storage unit temperature, inventory, description of event • Separate affected stock and label “Do not use” • Keep storing under correct conditions while evaluating how to proceed • Contact manufacturer for further guidance CDC Vaccine Storage and Handling Toolkit

23. DON’T Dolor nec DO Ipsum dolor amet dolor VACCINATION STORAGE • Maintain detailed and clear handling procedures that are kept up-to-date • Use units with combined refrigerator and freezer sections to save money and space • Plug in only one storage unit per outlet and alert others to not unplug units • Store food or beverage in the same unit as vaccines CDC Vaccine Storage and Handling Toolkit

24. DON’T Dolor nec DO Ipsum dolor amet dolor VACCINATION STORAGE • Use water bottles to stabilize refrigerator temperature between 2 - 8°C (36 - 46°F) • Use a thermometer that measures air temperatures • Place vaccines on the top shelf under cooling vent or in bottom drawers • Log temperatures at least twice daily CDC Vaccine Storage and Handling Toolkit

25. Anaphylaxis and Fainting

26. Anaphylaxis, False Allergy, or Syncope • Anaphylaxis • generalized itching, redness, hives, swelling, wheezing, cramps, tachycardia • False allergy • fever, upset stomach, red eyes, • Syncope • pale, sweating, cold hands and feet, nausea, lightheadedness, dizziness, weakness, visual disturbances, loss of consciousness, bradycardia APhA Pharmacy-Based Immunization Delivery 14th Edition

27. Treating Anaphylaxis • Lay patient on back with legs elevated • Give epinephrine IM in the lateral aspect of the thigh • Consider albuterol for bronchospasm • Administer glucagon if patient is on a beta-blocker and is not responding to epinephrine • Monitor vitals every 2-5 minutes • Assess Airway, Breathing, and Circulation • If severe, start CPR and call 911 CDC & ACIP Preventing and Managing Adverse Reactions

28. Epinephrine • 0.01 mg/kg/dose - maximum of 0.5 mg per dose • Repeat doses every 5 - 15 minutes for up to 3 doses • 1 mg/ml ampule or vial APhA Pharmacy-Based Immunization Delivery 14th Edition

29. Epinephrine Auto Injector Dosing • EpiPen: • 0.3 mg: > 30 kg • EpiPen Jr: • 0.15 mg : 15 - 30 kg • Auvi-Q: • 0.1 mg: 7.5 - 15 kg • 0.15 mg: 15 - 30 kg • 0.3 mg: > 30 kg EpiPen and Auvi-Q Prescribing Information

30. Anaphylactic Reactions • Be prepared! • Rare, potentially fatal, but usually reversible • Anaphylactic reactions occur in approximately 1.3 per 1 million doses of vaccines administered • Allow for fainting without patient hitting head or other injury • Access to hard surface if CPR is required • Ask patient/caregiver to monitor for adverse effects at home • Report event to Vaccine Adverse Event Reporting System (VAERS) APhA Pharmacy-Based Immunization Delivery 14th Edition

31. Fainting • Temporary loss of consciousness due to decreased blood flow to the brain • Usually triggered by pain or anxiety • Fainting can happen with any vaccine • Most common after combination of HPV, MCV4, and Tdap given to adolescents • Most likely do to process of vaccination and not vaccines themselves CDC Vaccine Safety Concerns - Fainting

32. Prevention of Fainting • Have patient sit or lay down • Give patient a snack or drink • Reassure patient • Have patient stay seated in view of the pharmacy for 15 minutes after receiving vaccine CDC Vaccine Safety Concerns - Fainting

33. Treatment of Fainting • Prevent fall or injury from fainting • Especially head injury • If patient does faint, observe patient until they regain consciousness • Determine if further treatment is needed • If fainting occurs outside medical facility and patient does not recover within a few minutes, contact emergency services CDC Vaccine Safety Concerns - Fainting

34. Discussion • Discuss any experiences with anaphylaxis or fainting after vaccines. • Discuss ways to successfully prevent or treat adverse reactions to vaccines.

35. Questions?

36. Active Learning Question - Pharmacist • What are diseases to worry about with needle sticks? • A. Hepatitis A • B. Hepatitis C • C. HIV • D. B & C • E. All of the above

37. Active Learning Question - Pharmacist • What are diseases to worry about with needle sticks? • D. B & C

38. Active Learning Question - Pharmacist • Patients on Enbrel or Humira may receive the nasal flu vaccine (FluMist). • True • False

39. Active Learning Question - Pharmacist • Patients on Enbrel or Humira may receive the nasal flu vaccine (FluMist). • False

40. Active Learning Question - Pharmacist • Anaphylaxis is low among vaccine recipients, but occur in approximately ____ events per 1 million doses administered.

41. Active Learning Question - Pharmacist • Anaphylaxis is low among vaccine recipients, but occur in approximately 1.3events per 1 million doses administered.

42. Active Learning Question - Technician • Identify significant measures that technicians can perform in helping to prevent vaccine errors? • A. Careful stocking of vaccines in storage unit • B. Checking regularly for expired vaccines • C. Rotate vaccine stock • D. All of the above

43. Active Learning Question - Technician • How can technicians help prevent vaccine errors? • D. All of the above

44. Active Learning Question - Technician • How can pharmacy technicians assist in an anaphylactic reaction to a vaccine? • A. Administer epinephrine to patient • B. Elevate the patient’s legs • C. Call 911 • D. B and C • E. All of the above

45. Active Learning Question - Technician • How can pharmacy technicians assist in an anaphylactic reaction to a vaccine? • D. B and C

46. References • Advisory Committee on Immunization Practices (ACIP) Adverse Reaction Guidelines for Immunization. [Updated 2017 Jul, cited 2019 Jul 6]. Available from: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/adverse-reactions.html • American Pharmacists Association (APhA) Pharmacy-Based Immunization Delivery - 14th Edition. 2018 Jul. • AUVI-Q (epinephrine injection, solution) Prescribing Information. Richmond, VA: Kaleo. 2017 Nov. • Centers for Disease Control and Prevention (CDC). Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program. 2008 Feb. Available from:https://www.cdc.gov/sharpssafety/pdf/sharpsworkbook_2008.pdf • CDC - Vaccine Safety: Common Concerns - Fainting (syncope) [Updated 2015 Oct, cited 2019 Jul 5]. Available from:https://www.cdc.gov/vaccinesafety/concerns/fainting.html • CDC - Vaccine Storage and Handling Toolkit. 2019 Jan. Available from:https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf • Enbrel (etanercept) Prescribing Information. Thousand Oaks, CA: Immunex Corporation. 2017 Oct. • Epinephrine injection. Prescribing Information. Rochester, MN: Par Sterile Products. 2014 Jul. • EPIPEN (epinephrine injection, solution). Prescribing Information. Canonsburg, PA: Mylan. 2016 May.

47. References • Humira(adalimumab) Prescribing Information. North Chicago, IL: AbbVie Inc, 2018 May. • Immunization Action Coalition (IAC). Vaccine Preventable Errors. [Updated 2019 Jan, cited 2019 Jul 6]. Available from: http://www.immunize.org/catg.d/p3033.pdf • IAC. Ask the Experts: Precautions and Contraindications [Updated 2019 Mar, cited 2019 Jul 6]. Available from:http://www.immunize.org/askexperts/precautions-contraindications.asp • Institute for Safe Medication Practices (ISMP) National Vaccine Errors Reporting Program 2017: Part I 2018 June 14, Part II 2018 June 28. Available from: https://www.ismp.org/resources/ismp-national- vaccine-errors-reporting-program-2017-analysis-part-i-vaccine-errors • McNeil, Michael M et al. “Risk of anaphylaxis after vaccination in children and adults.” The Journal of allergy and clinical immunology vol. 137,3 (2016): 868-78. doi:10.1016/j.jaci.2015.07.048 • National Institute for Occupational Safety & Health (NIOSH). Emergency Sharps Information. [Updated 2016 Oct, cited 2019 Jul 8]. Available from:https://www.cdc.gov/niosh/topics/bbp/emergnedl.html • Occupational Safety & Health Administration (OSHA). Bloodborne Pathogens Standard. [Updated 2001 May, cited 2019 Jul 8]. Available from:https://www.osha.gov/needlesticks/needlefact.html • Shingrix (zoster vaccine recombinant, adjuvanted) Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline Biologicals, 2017 October.