Protocol (Summary)

Pharmacist and Pharmacist Intern Requirements under the New South Carolina Single Statewide Vaccine Protocol – SUMMARY ONLY!

THIS IS NOT A SUBSITUTE FOR THE FULL OFFICIAL VERSION OF THE VACCINE PROTOCOL!

Click HERE for the revised vaccine protocol (updated 1/25/21)

1.)    Qualifications: (Section III)

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  1. Licensed in Good Standing in South Carolina;
  2. Have Basic Life Support (BLS) or Cardiopulmonary Resuscitation (CPR) Certification;
  3. Completed an approved pharmacy-based immunization training program accredited by ACPE or similar health authority or professional body approved by the SC Board of Pharmacy and the SC Board of medical Examiners;
  4. Complete at least one hour of ACPE-sponsored continuing education related to the administration of vaccines as part of his/her annual licensure requirements;
  5. Must maintain liability insurance that covers the administration of vaccines.

2.)    Limitations on Pharmacy-based Vaccinations: (Section IV)

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  1. Age: Non-influenza vaccines without a written order or prescription under this protocol must be at least 18 years. Flu vaccines from age 3 and up;
  2. Delegation: A pharmacist cannot delegate the administration of a vaccine to a pharmacy technician;
  3. Patient Specific Factors: Patients with contraindications, complex medical issues, including immunosuppression or history of Gullian-Barré syndrome should be referred to their primary care practitioner.

3.)    Protocol Facility and Equipment: (Section V & Appendix B)

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  1. Pharmacists administering under this protocol MUST maintain a copy of the protocol at each location at which a pharmacist administers vaccines; (Appendix B)
  2. Have an appropriate area for administering vaccines with supplies and equipment:

   i.      Current copy of this protocol;

  ii.      Supply of the most current federal VIS for vaccines being administered, or electronic access to these statements;

  iii.      Aqueous epinephrine USP (1:1000), in ampules, vials of solution, or prefilled devices (i.e., EpiPen). If EpiPens used, at least three (3) adult, single dose of 0.3 mg/0.3 ml) available;

  iv.      Diphenhydramine (Benadryl) injectable solution (50 mg per mL) and oral 25 – or 50-mg tablets;

  v.      Syringes 1-mL and 3-mL, 22g and 25g, 1-inch, and 1 ½ -inch needles for epinephrine and diphenhydramine;

  vi.      Alcohol swabs and bandages;

  vii.      Blood pressure monitoring device or stethoscope and sphygmomanometer (with pediatric, adult and extra-large cuffs);

  viii.      Adult and pediatric size pocket masks with one way valve;

  ix.      Flashlight with extra batteries (for examination of mouth and throat;

  x.      Time keeping device with ability to count seconds;

  xi.      Telephone access;

  xii.      Equipment to enable the vaccinee to sit or lie down if he/she experiences an adverse reaction to the vaccine, such as a yoga mat or reclining chair.

4.)    Informed Consent: (Section VI)

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  1. Before receiving the vaccine, the vaccinee (or his/her legal representative) MUST be given information about the risks and benefit associated with the vaccine
  2. Informed consent MUST be documented in Writing prior to administering vaccine;
  3. Either the pharmacist, pharmacist intern or supervising pharmacist MUST be identified on the consent form;
  4. At a minimum, you MUST use the Consent Form content found in Appendix E of this protocol (can be cut and pasted onto letterhead, etc.). You may use additional requirements for internal use;
  5. Each vaccinee and/or their legal representative MUST be provided with a Vaccine Information statement (VIS) for the vaccine provided;
  6. The vaccinee or legal representative must be given an opportunity to read the VIS ‘prior’ to the vaccine being administered;
  7. Non-English speaking persons must be given the VIS in their native language if available.

5.)    Post –Administration Records and Requirements: (Sections VII and VIII)

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  1. Record Keeping: Must create a record of vaccine(s) administered and maintain these records for:

  i.      10 years for those vaccinees 18 years and older;

  ii.      13 years for those vaccinees at least 13 years old but less than 18 years old.

  1. Records MUST include all the data required under Section VII, (a-h) of this protocol;
  2. Reporting Requirements:

  i.      Personal Immunization Record (PIR): Pharmacists/Interns MUST encourage all vaccinees to carry a personal immunization record card provided by the pharmacist. Pharmacist/Intern MUST record the date of the vaccination on the PIR.

  ii.      Medical Home Notification: Pharmacists/Interns MUST inform the vaccinee of the importance of having a medical home and receiving other preventive medical services. All vaccines shall be reported to the vaccinee’s designated primary care provider using the reporting form located in Appendix F of this protocol;

  iii.      Immunization Registry: All vaccines administered under protocol SHALL BE REPORTED starting immediately to the South Carolina Immunization Registry in compliance with the regulations established by Department of Health and Environmental Control (DHEC) regardless of the phase-in schedule provided in Regulation 61-120.

  iv.      Adverse Event Reporting: Pharmacists SHALL report all ‘clinically significant’ adverse events (death, hypersensitivity reactions, and contraindications as reported in manufacturer’s package inserts), regardless even if it is not certain that the vaccine caused the event, to the Vaccine Adverse Event Reporting System (VAERS).

6.)    Vaccination Safety: (Section IX)

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  1. a.       Infection Control and Sterile Technique:

  i.      Pharmacists/Interns MUST follow all appropriate precautions to minimize risk for spread of disease;

  1. b.      Prevention of Needle-stick Injuries:

  i.      Pharmacists/Interns MUST dispose of needles immediately after use in a labeled, puncture-proof container located in the same room where vaccine is administered;

  ii.      DO NOT recap needles prior to placing in container;

  iii.      Safety needles or needle-free injection devise should be used to reduce the risk of injuries.

  1. c.       Hepatitis B Vaccine:

  i.      ALL Pharmacists/Interns administering vaccines SHALL be vaccinated for Hepatitis B unless;

  1. Pharmacist/Intern previously received Hepatitis B vaccine;
  2. Antibody test reveals them to be immune;
  3. Contraindicated for medical reasons or,
  4. Pharmacist/Intern signs a Hepatitis-B Vaccine Declination Statement

7.)    Management of Adverse Events: (See Section X)

8.)    Supply Considerations: (See Section XI)

9.)    Vaccines (Section XII)

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  1. Pharmacists may administer FDA approved formulations of the following vaccines listed below under this protocol for those 18 years and older:

  i.      Haemophilus Influenzae

  ii.      Hepatitis A

  iii.      Hepatitis B

  iv.      Human Papillomavirus

  v.      Influenza (12 and older)

  vi.      Measles, Mumps, Rubella

  vii.      Meningococcal (MCV4 and MenB)

  viii.      Pneumococcal (PPSV23 and PCV13)

  ix.      Tetanus and diphtheria/Tetanus, diphtheria, and pertussis (Td/Tdap)

  x.      Varicella

  xi.      Zoster

  1. Pharmacists/Interns MUST assess patient eligibility according to indications, precautions, and contraindications recommended in the CURRENT guidelines from the AICP.

PLEASE REFER TO THE ENTIRE PROTOCOL AND ITS APPENDICES FOR FULL GUIDANCE UNDER SOUTH CAROLINA’S NEW PHARMACIST/INTERN VACCINE ADMINISTRATION PROTOCOL