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Jan.15.2021View related content

Medication Administration: COVID-19 Vaccine (Ambulatory) - CE

ALERT

Take steps to eliminate interruptions and distractions during medication preparation.

OVERVIEW

The coronavirus disease 2019 (COVID-19) vaccine is an investigational vaccine for the prevention of COVID-19. The COVID-19 vaccine is not a U.S. Food and Drug Administration (FDA)-approved vaccine; however, the vaccine has been authorized for use under an Emergency Use Authorization (EUA) for active immunization for the prevention of COVID-19 in patients 16 years old and older by the Pfizer®-BioNTech COVID-19 vaccine3 and 18 years old and older by the Moderna® COVID-19 vaccine.2 Vaccination does not ensure immunity.2,3

Both vaccines contain lipid nanoparticle-formulated, nucleoside-modified messenger ribonucleic acid (mRNA) encoding the spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

The Pfizer-BioNTech COVID-19 vaccine is administered intramuscularly as a series of two doses (0.3 ml each), 3 weeks apart.3 The Moderna COVID-19 vaccine is administered intramuscularly as a series of two doses (0.5 ml each), 1 month apart.2

The COVID-19 vaccine is contraindicated in patients with a history of a severe allergic reaction to any component of the vaccine, including polyethylene glycol (PEG) or polysorbate.1 As with any biologic product, procedures should be in place to manage allergic reactions. Epinephrine (1 mg/ml) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine should be readily available.3

There are no data available on the interchangeability of the COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine should receive a second dose of the same vaccine to complete the vaccination series.2,3

If the patient expresses concern regarding the accuracy of a medication, the medication should not be given. The concern should be explored, the practitioner notified, and the order verified.

SUPPLIES

Click here for a list of supplies.

EDUCATION

  • Provide developmentally and culturally appropriate education based on the desire for knowledge, readiness to learn, and overall neurologic and psychosocial state.
  • Instruct the patient regarding the potential side effects and adverse reactions to the medication.
  • Explain the risks related to the procedure, including hematoma formation, nerve injury, and allergic reaction to the vaccine.
  • Under the EUA, provide the patient with information that is consistent with the Fact Sheet for Recipients and Caregivers before he or she receives the vaccine. This information includes:
    • The FDA’s authorized emergency use of this vaccine, which is not an FDA-approved vaccine
    • The patient’s option to accept or refuse the COVID-19 vaccine
    • The significant known and potential risks and benefits of the COVID-19 vaccine and the extent to which such potential risks and benefits are unknown
    • Available alternative preventive vaccines in clinical trials or approved for use under another EUA
  • Instruct the patient to bring an up-to-date list of medications (over-the-counter [OTC], supplements, and prescriptions) to every practitioner visit.4
  • Explain the importance of keeping to the vaccine schedule as much as possible.
  • Encourage questions and answer them as they arise.

PROCEDURE

  1. Perform hand hygiene.
  2. Introduce yourself to the patient.
  3. Verify the correct patient using two identifiers.
  4. Explain the procedure to the patient and ensure that he or she agrees to treatment.
  5. Ensure that evaluation findings are communicated to the clinical team leader per the organization’s practice.
  6. Obtain the patient’s medication history.
  7. Evaluate the patient for specific contraindications or precautions (e.g., previous anaphylaxis with a vaccine) related to vaccine administration and advise the practitioner accordingly.
  8. Evaluate the patient’s history of allergies, including medication or food allergies and previous allergic reactions.
  9. Evaluate the patient’s knowledge regarding the vaccine to be received.
  10. Obtain the vaccine and verify the expiration date.
  11. Assemble the appropriate-size needles, syringes, and other administration supplies, as needed.
  12. Ensure the six rights of medication safety: right medication, right dose, right time, right route, right patient, and right documentation.

Pfizer-BioNTech COVID-19 Vaccine

  1. Thaw the vaccine vial before use using one of two methods:
    1. Method 1, thaw under refrigeration: Allow the vial to thaw in the refrigerator at 2°C to 8°C (36°F to 46°F).3 When ready to use, remove the vial from the refrigerator and allow it to come to room temperature. Plan to dilute the vial within 2 hours.3
      1. A carton of vials may take up to 3 hours to thaw.3
      2. Thawed vials can be stored in the refrigerator for up to five days (120 hours).3
        The vial must reach room temperature before dilution and must be diluted within 2 hours. 3 Do not refreeze a thawed vial.
    2. Method 2, thaw at room temperature: Allow the vial to sit at room temperature up to 25°C (77°F) for 30 minutes.3 Plan to dilute the vial within 2 hours.3
      The vial must reach room temperature before dilution and must be diluted within 2 hours. 3 Do not refreeze a thawed vial.
  2. Invert the vaccine vial gently 10 times before adding the diluent.3
    Do not shake the vial.
  3. Inspect the liquid in the vial before dilution. The liquid is a white to off white suspension and may contain white to off-white opaque amorphous particles.
    Do not use the vial if the liquid is discolored or if other particles are observed.
  4. Dilute the vaccine.
    1. Using aseptic technique, withdraw 1.8 ml of sterile 0.9% sodium chloride solution into a syringe with a 21-G or narrower needle or blunt cannula.3
      Use only sterile 0.9% sodium chloride solution as a diluent. 3 Do not use bacteriostatic 0.9% sodium chloride solution or any other diluent.
    2. Cleanse the vaccine vial stopper with a single-use antiseptic swab.
    3. Insert the syringe with diluent into the vaccine vial and add 1.8 ml of 0.9% sodium chloride solution into the vaccine vial.3
    4. Equalize the vial pressure before removing the needle from the vial by withdrawing 1.8 ml of air into the empty diluent syringe.3
    5. Gently invert the vial 10 times to mix.3
      Do not shake the vial.
    6. Inspect the vaccine in the vial. The vaccine will be an off-white suspension.
      Do not use the vaccine if it is discolored or contains particulate matter.
    7. Record the date and time of dilution on the vaccine vial label.
    8. Store the vaccine between 2°C to 25°C (36°F to 77°F).3
      Minimize exposure of the vaccine to room light and avoid exposure to direct sunlight and ultraviolet light.
    9. Discard any unused vaccine 6 hours after dilution.3
  5. Perform hand hygiene and don gloves.
  6. Assist the patient to the appropriate position. Have the patient remove clothing from the designated arm if needed.
  7. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab and withdraw 0.3 ml of the vaccine.3
  8. Cleanse the site with alcohol or an antiseptic swab, per the organization’s practice. Allow the skin to dry completely.
  9. Administer the vaccine to the patient per the manufacturer’s instructions for use.
  10. Apply gentle pressure to the site; do not massage. Evaluate the site for bleeding and apply a bandage if needed.
    Rationale: Massage damages underlying tissue.
  11. Assist the patient to a comfortable position and have him or her replace clothing as needed.
  12. Discard the uncapped needle (or needle enclosed in the safety shield) and attached syringe into a puncture-proof and leakproof receptacle.
    Rationale: Discarding the uncapped needle helps prevent injury to the patient and health care team members. Recapping needles increases the risk for a needlestick injury.
  13. Monitor the patient for adverse and allergic reactions to the medication. Recognize and immediately treat respiratory distress and circulatory collapse, which are signs of a severe anaphylactic reaction. Follow the organization’s practice for emergency response.
  14. Provide the patient with a vaccination card that documents the brand name of the vaccine administered and includes the date when he or she needs to return for the second dose of the same COVID-19 vaccine that was administered initially.
  15. Discard supplies, remove gloves, and perform hand hygiene.
  16. Document the procedure in the patient’s record.

Moderna COVID-19 Vaccine

  1. Thaw the vaccine vial before use using one of two methods:
    1. Method 1, thaw under refrigeration: Allow the vial to thaw in the refrigerator at 2°C to 8°C (36°F to 46°F) for 2 hours and 30 minutes.2 When ready to use, remove the vial from the refrigerator and allow it to stand at room temperature for 15 minutes.2
      Vials can be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days before the first use. 2
      Do not refreeze a thawed vial.
    2. Method 2, thaw at room temperature: Allow the vial to sit at room temperature between 15°C to 25°C (59°F to 77°F) for 1 hour.2
      Unpunctured vials may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours. 2
      Do not refreeze a thawed vial.
  2. Swirl the vial gently after thawing and between each withdrawal.2
    Do not shake the vial. Do not dilute the vaccine.
  3. Inspect the vaccine suspension before administration. It should appear as a white to off-white suspension and may contain white or translucent product-related particles.
    Do not use the vial if the liquid is discolored or if other particles are observed.
  4. Store unpunctured vials between 8°C to 25°C (46°F to 77°F) for up to 12 hours.2
    Avoid exposure of the vial to light.
  5. Perform hand hygiene and don gloves.
  6. Assist the patient to an appropriate position. Have the patient remove clothing from the designated arm if needed.
  7. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab per the organization’s practice and withdraw 0.5 ml of the vaccine.2
  8. Cleanse the site with an antiseptic swab per the organization’s practice. Allow the skin to dry completely.
  9. Administer the vaccine to the patient per the manufacturer’s instructions for use.
  10. Apply gentle pressure to the site; do not massage. Evaluate the site for bleeding and apply a bandage if needed.
    Rationale: Massage damages underlying tissue.
  11. Assist the patient to a comfortable position and have him or her replace clothing as needed.
  12. Discard the uncapped needle (or needle enclosed in the safety shield) and attached syringe into a puncture-proof and leakproof receptacle.
    Rationale: Discarding the uncapped needle helps prevent injury to the patient and health care team members. Recapping needles increases the risk for a needlestick injury.
  13. Monitor the patient for adverse and allergic reactions to the medication. Recognize and immediately treat respiratory distress and circulatory collapse, which are signs of a severe anaphylactic reaction. Follow the organization’s practice for emergency response.
  14. Record the date and time of first use on the vaccine vial label.
  15. Store the punctured vial between 2°C to 25°C (36°F to 77°F).2 Discard the vial after 6 hours.2
  16. Provide the patient with a vaccination card that documents the brand name of the vaccine administered and includes the date when he or she needs to return for the second dose of the same COVID-19 vaccine that was administered initially.
  17. Discard supplies, remove gloves, and perform hand hygiene.
  18. Document the procedure in the patient’s record.

EXPECTED OUTCOMES

  • Medication administered per the six rights of medication safety
  • Patient able to explain purpose of vaccine
  • Desired effect of vaccine with no adverse reactions or signs of allergies

UNEXPECTED OUTCOMES

  • Medication not administered per the six rights of medication safety
  • Patient unable to explain the purpose of vaccine
  • Adverse reaction to the medication (local reactions are extremely common and resolve quickly)
    • Mild
      • Arthralgia
      • Chills
      • Fatigue
      • Fever
      • Headache
      • Injection site reaction
      • Malaise
      • Myalgia
      • Nausea
      • Vomiting
    • Moderate
      • Erythema
      • Lymphadenopathy
    • Severe
      • Serious hypersensitivity reactions
      • Anaphylaxis

DOCUMENTATION

  • Vaccine name, dose, route, site, and time and date of administration
  • Patient’s response to medication, including any adverse reactions
  • Unexpected outcomes and related interventions
  • Education
  • Evaluation findings communicated to the clinical team leader per the organization’s practice

REFERENCES

  1. Centers for Disease Control and Prevention (CDC). (2021). Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Retrieved January 12, 2021, from https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html (Level VII)
  2. Food and Drug Administration (FDA). (2020). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency use authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Retrieved January 12, 2021, from https://www.fda.gov/media/144637/download (Level VII)
  3. Food and Drug Administration (FDA). (2020). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Retrieved January 12, 2021, from https://www.fda.gov/media/144413/download (Level VII)
  4. Joint Commission, The. (2021). National patient safety goals for the ambulatory health care program. Retrieved January 12, 2021, from https://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2021/ahc_npsg_jan2021.pdf (Level VII)

Elsevier Skills Levels of Evidence

  • Level I - Systematic review of all relevant randomized controlled trials
  • Level II - At least one well-designed randomized controlled trial
  • Level III - Well-designed controlled trials without randomization
  • Level IV - Well-designed case-controlled or cohort studies
  • Level V - Descriptive or qualitative studies
  • Level VI - Single descriptive or qualitative study
  • Level VII - Authority opinion or expert committee reports