1. Preparing for Vaccine Administration: Warnings, Precautions and Contraindications Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases University of Louisville

2. Objectives Review preparation for vaccine immunization with a patient safety strategy Identify the differences between warnings, precautions and contraindications relative to vaccines Explore steps that may prevent inappropriate withholding of vaccines due to misunderstandings of warnings, precautions, and contraindications

3. Basics of assessment and triage prior to pharmaceutical agent administration Be aware of purpose of the pharmaceutical intervention Know the agent (action, the 5 Rs, contraindications, other safety issues) Know the type of vaccine (live or killed) Know the targeted patient population Special needs necessitate special interventions

4. Contraindications v. Warnings and Precautions Contraindications- Reasons to withhold the medication or treatment. May or may not be absolute. Warnings and Precautions- Reasons to consider the risk v. benefit of the agent in relation to existing medical conditions Know absolute contraindications before administering any agent Know the process for verifying proper action when there are questions of contraindications or precautions

5. Contraindications v. Warnings and Precautions May also need to consider adverse reactions and drug interactions Not included in the warnings/precautions lists, but should receive equal consideration

6. Special/Function Needs Populations Cultural context, age, literacy, health literacy Language or other communication needs May need medical care or other medical interventions Independence Supervision Transportation

7. http://www.immunize.org/packageinserts/ Package Inserts Primary document to obtain information relative to FDA approval of the vaccine Explicit information about contraindications, warnings and precautions Will prove information about what occurred during clinical trials, but not about populations that were not studied It is critical that this information be read prior to administering any vaccine FDA approval information may not mirror what is in APIC recommendations

9. Case Study A 25 year old healthcare worker wants FluMist instead of a flu shot. This healthcare worker has a history of exercise-induced asthma. Would this healthcare worker be able to receive FluMist?

11. Case Study A 25 year old healthcare worker wants FluMist instead of a flu shot. This healthcare worker has a history of exercise-induced asthma. Would this healthcare worker be able to receive FluMist? Contraindications: severe allergic reaction Warnings and Precautions: Hx of GBS; immunocompromised Special populations: pregnant women, nursing mothers, geriatrics

12. Case Study 65 year old healthcare worker working as the primary environmental services personnel in the neonatal ICU. Facility policy includes immunization for persons working in areas at high risk for pertussis. Can this healthcare worker receive this vaccine? Can he receive this at the same time as his flu vaccine?

14. Case Study 65 year old healthcare worker working as the primary environmental services personnel in the neonatal ICU. Facility policy includes immunization for persons working in areas at high risk for pertussis. Can this healthcare worker receive this vaccine? Can he receive this at the same time as his flu vaccine? Contraindications: severe allergic reaction, encephalopathy Warnings and Precautions: latex, GBS, Unstable neurologic conditions, arthus-type reaction within last 10 years

15. Case Study 21 year old female has not completed her human papillomavirus (HPV) vaccine series. She had the first one when she was 18, but fainted afterward. Now, she is afraid that it was a serious reaction and the next dose could cause her significant harm. How do we talk with this person about the HPV vaccine?

17. Case Study 21 year old female has not completed her human papillomavirus (HPV) vaccine series. She had the first one when she was 18, but fainted afterward. Now, she is afraid that it was a serious reaction and the next dose could cause her significant harm. How do we talk with this person about the HPV vaccine? Contraindications: Severe allergic reaction Warnings and Precautions: syncopal episodes

18. Summary Contraindications are the absolutes unless otherwise stipulated (usually by public health statement) Warnings and precautions should prompt a risk/benefit assessment Adverse reactions should prompt preparation and patient education A vaccine-supporting strategy employs an opt- out approach rather than an opt-in approach