Policy Statement

Policy Statement 2017-08: Joint policy - pharmacist administration of vaccines

Date: 06/20/2017
Organization: Department of Public Health
Board of Registration in Pharmacy
Drug Control Program
Referenced Sources: 105 CMR 700

Adopted April 3, 2012 as Joint Policy 2012-02
Revised June 30, 2015 as Joint Policy 2015-01
Revised June 20, 2017 as Joint Policy 2017-08

The Massachusetts Department of Public Health (MDPH or the Department), through the Drug Control Program, Immunization Program and Board of Registration in Pharmacy, is making vaccines more accessible by authorizing administration by pharmacists and pharmacy interns. Qualified pharmacists and pharmacy interns may administer certain vaccines to individuals 9 years of age and older as included in the Recommended Immunization Schedules approved by the U.S. Centers for Disease Control and Prevention (CDC).

MDPH Drug Control Program regulations (105 CMR 700.004 (B)(6)) permit pharmacists and pharmacy interns who have completed a duly accredited training course to administer vaccines designated by the Department.

Table of Contents

Vaccines Authorized by this Policy

Vaccines authorized under this policy are those included in the latest recommended immunizations as approved by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).

The recommended immunization schedule for adults is published here:

https://www.cdc.gov/vaccines/schedules/hcp/adult.html

The recommended immunization schedule for children 18 years of age or younger is published here:

https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

Vaccine Recipients Covered by this Policy

Under this policy, qualified pharmacists and pharmacy interns are authorized to administer vaccines included in the ACIP recommended immunization schedules to individuals 9 years of age and older.

Requirements for Vaccine Administration

  1. To administer vaccines, a prescription, prescriber directive or standing order is required.
  2. A standing order is required to administer single dose emergency epinephrine.
  3. Model standing orders for all vaccines included in the Recommended Schedule and emergency standing orders for the treatment of adverse events following vaccination are available at Immunization Action Coalitions website:  http://www.immunize.org/standing-orders/.

MDPH has standing orders for some vaccines:

http://www.mass.gov/eohhs/gov/departments/dph/programs/id/immunization/model-standing-orders.html.

In addition, MDPH has Clinic Operation guidelines available at:

http://www.mass.gov/eohhs/docs/dph/cdc/immunization/clinic-guidelines.pdf

Federal Law (http://www.immunize.org/catg.d/p2027.pdf) requires that a vaccine provider give the patient or legal representative the appropriate Vaccine Information Statement (VIS) whenever a vaccine is administered. More information about VIS can be found at https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html.

Communications

  1. A notification/record of immunization should be provided to the patient’s physician. See link for sample vaccine recording form: http://www.immunize.org/catg.d/p2023.pdf
  2. If an immunization is being administered to a person younger than 18 years old, information on primary care providers in the pharmacy’s geographic area should be provided.
  3. If the purpose of the visit is for a childhood immunization other than the influenza vaccine, counseling on the importance of establishing and maintaining a relationship with a pediatric or family practice for ongoing medical and well-child care must be provided.

Disclosure of Free Pediatric Vaccine Availability

  1. The MDPH Immunization Program provides all routinely recommended childhood vaccines free of charge to health care providers for administration to individuals through 18 years of age regardless of insurance status (see Childhood Availability Table (DOC) for additional information).
  2. In order to receive free state-supplied vaccines, health care providers must enroll in the Immunization Program utilizing the Massachusetts Immunization Information System (MIIS) and agree to comply with all of the program requirements outlined in the Agreement to Comply with Federal and State Vaccine Administration and the Guidelines for Compliance with Federal and State Vaccine Administration Requirements which include proper vaccine storage and handling, vaccine administration documentation, fulfilling annual training requirements, and both routine biannual as well as periodic unannounced site visits by MDPH staff. Under state law, all licensed health care professionals that administer vaccines must report such information to the immunization registry M.G.L. c.111 s24m.
  3. If your site is not enrolled in the MDPH Immunization Program, you must inform parents/guardians of patients under 19 years of age that there may be a significant out of pocket expense for the vaccine and they can obtain the vaccine at no cost through their primary care provider. Suggested language to inform patients/parents of this should read: “Please note: the cost of the vaccines your child will be receiving may not be covered by your health insurance, resulting in a significant out of pocket expense.  You can avoid this expense by having your child vaccinated at his or her primary care provider.”
  4. If you would like more information about enrolling in the Immunization Program please contact the Vaccine Management Unit at (617) 983-6828.

Vaccine Storage and Handling

Pharmacies must ensure all vaccines are stored and handled according to both the vaccine package inserts and the latest CDC guidelines and recommendation on vaccine storage and handling found at: https://www.cdc.gov/vaccines/hcp/admin/storage/index.html.

Reporting of Adverse Events

The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report to the Vaccine Adverse Event Reporting System (VAERS) (http://vaers.hhs.gov/index):

  1. Any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine; or
  2. Any adverse event occurring within the specified time period after vaccination that is listed in the VAERS Table of Reportable Events: https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf

Training

  1. Pharmacists and pharmacy interns administering vaccines must attend and pass an accredited training course that meets the requirements of 105 CMR 700.004(B)(6)(d)1.
  2. Minimum program requirements:
    1. 12 contact hours of  self-study modules with case studies and assessment exam
    2. Hands-on assessment of intramuscular and subcutaneous injection technique
    3. 8 contact hours of live seminar with final exam
  3. The goals of training programs are to:
    1. Provide comprehensive immunization education and training
    2. Teach pharmacists and pharmacy interns to administer immunizations in compliance with legal and regulatory standards
    3. Teach pharmacists and pharmacy interns to identify at-risk patient populations needing immunizations
    4. Provide pharmacists and pharmacy interns with the knowledge, skills, and resources necessary to establish and promote a successful immunization service
  4. All such courses must, at a minimum, be accredited by the U.S. Centers for Disease Control and Prevention; the Accreditation Council for Pharmacist Education (ACPE) (www.acpe-accredit.org); or similar health authority or professional body. The program must also include pre-administration education and screening, vaccine storage and handling, administration of medication, record-keeping and reporting of adverse events.
  5. Information on other accredited courses is available through professional organizations, colleges and other sources.
  6. Proof of training must be kept on file in the pharmacy.
  7. Unless mandated by the accrediting body, current CPR certification is recommended.

Resources

Downloads for 2017-08: Joint policy - pharmacist administration of vaccines

Referenced Sources:

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