Rhode Island Code of Regulations › Title 216 - Department of health › Chapter 40 - Professional licensing and facility regulation › Subchapter 15 - Pharmacy › Part 1 - Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors › Section 216-RICR-40-15-1.11 - Administration of Immunizations and Performance of Limited-Function Tests by Pharmacists

Current through June 14, 2024
1.11.1
Administration of Immunizations
A. An immunizing pharmacist shall follow a
				  written protocol from a prescriber or have obtained a valid prescription for
				  immunization administration to a patient.
B. Qualifications
1. A pharmacist may administer immunizations
				  to persons who are at least eighteen (18) years of age, as provided in §
												1.11   of this Part.
2. A pharmacist may administer influenza
				  vaccine to a person between the ages of nine (9) and eighteen (18) years old
				  inclusive.
3. A pharmacist may
				  administer any immunization, pursuant to §§
												1.11(B)(1) and
				  (2)   of this Part, available in accordance
				  with manufacturers' guidelines or established guidelines issued by the Centers
				  for Disease Control and Prevention's (CDC) Advisory Committee on Immunization
				  Practices (ACIP) or American Academy of Pediatrics (AAP) for administration to
				  patients.
4. A pharmacist who is
				  administering immunizations to a student eighteen (18) years of age or older
				  shall do so in accordance with the Regulations for Immunization and
				  Communicable Disease Testing in Preschool, School, Colleges or Universities
				  (Part 30-05-3 of this Title).
5. A pharmacist may administer immunizations
				  if the pharmacist has completed either:
a.
				  Immunization training within an accredited College of Pharmacy program and
				  possesses documentation of same; or
b. A twenty (20) hour course of training
				  recognized by the Board and in accordance with the following:
(1) The course of study for the training
				  program shall include current guidelines and recommendations of the Centers for
				  Disease Control and Prevention and the American Pharmacists
				  Association.
(2) The training
				  course of study shall include, at a minimum, the following components:
(AA) Mechanisms of action of immunizations,
				  contraindications, drug interactions, and monitoring after immunizations
				  administration;
(BB) Immunization
				  schedules;
(CC) Immunization
				  screening questions, informed consent, recordkeeping, registries and
				  State/Federal reporting mechanisms;
(DD) Vaccine storage and handling in
				  accordance with the guidelines of the U.S. Department of Health and Human
				  Services, Centers for Disease Control and Prevention, Advisory Committee on
				  Immunization Practices Recommendations and Guidelines;
(EE) Biohazard waste disposal;
(FF) Sterile techniques;
(GG) Establishing protocols and standing
				  orders;
(HH) Immunization
				  coalitions and other community resources available;
(II) Identifying, managing, and responding to
				  adverse events associated with immunization administration;
(JJ) Mechanism for reporting adverse events
				  to the Vaccine Adverse Event Reporting System (VAERS);
(KK) Reimbursement procedures and
				  immunization coverage by Federal, State, and local entities;
(LL) Administration techniques.
6. The
				  pharmacist shall possess evidence of current basic cardiopulmonary
				  resuscitation (CPR) training issued by the American Heart Association, the
				  American Red Cross, or other such similar training organization.
7. The pharmacist shall complete at least one
				  (1) hour of continuing education in the area of immunizations each
				  year.
8. A pharmacist shall not
				  delegate the administration of immunizations to another person, except;
a. A licensed pharmacy intern who has
				  completed a recognized immunization certificate training program and holds a
				  current basic cardiopulmonary resuscitation (CPR) training certificate, shall
				  carry out the same functions as an immunizing pharmacist pursuant to this Part
				  and shall do so under the direct supervision and with the authorization of an
				  immunizing pharmacist.
b. A
				  Technician II who has completed a recognized certificate training course on
				  appropriate immunization administration technique and holds a current basic
				  cardiopulmonary resuscitation (CPR) training certificate, shall be permitted to
				  administer vaccinations under the direct supervision and with the authorization
				  of an immunizing pharmacist when;
(1) The
				  immunizing pharmacist has completed all of the requirements pursuant to §
														1.11   of this Part prior to
				  administration of the vaccination.
(2) The immunizing pharmacist is on the
				  premises for post immunization monitoring of the patient.
C. Immunization
				  Administration Policies and Procedures: All immunizing pharmacists shall adhere
				  to written policies and procedures that include no less than the following:
1. A statement of the procedures, decision
				  criteria, or plan the pharmacist will follow when exercising the administration
				  authority, including when to refer the patient to the
				  physician/prescriber
2. A statement
				  of the procedures for emergency situations
3. A statement of record keeping and
				  documentation procedures
4. A
				  statement related to the handling and disposal of used or contaminated
				  equipment and supplies
5. A
				  statement requiring that the pharmacy give the appropriate Vaccine Information
				  Statement (VIS) to the patient or legal representative with each dose of
				  immunization covered by these forms
6. A statement that the pharmacy report
				  adverse events to the Vaccine Adverse Events Reporting System (VAERS) and to
				  the primary care provider, as identified by the patient
7. If a patient is immunized pursuant to a
				  valid prescription, a notation of such prescription shall be made in the
				  patient's pharmacy profile.
D. Prescriber Protocols
1. Prior to administering immunizations to
				  adults, pharmacists who have not obtained a valid prescription for immunization
				  administration shall follow written protocols established between either a
				  pharmacy or individually by a pharmacist and a protocol prescriber.
2. The protocol shall include, at a minimum:
a. A statement identifying the person
				  authorized to prescribe drugs who has delegated the activity;
b. A statement identifying either the
				  pharmacy or the individual pharmacist(s) authorized to administer immunizations
				  and a copy of said pharmacist's documentation of completion of the recognized
				  immunization training program;
c. A
				  statement identifying the routes and types of immunizations that a pharmacist
				  is authorized to administer (e.g., injectable and nasally
				  administered).
3. The
				  protocol shall be reviewed no less than every two (2) years by the prescriber
				  and an immunizing pharmacist.
4. An
				  immunizing pharmacist shall provide written notification of a patient's
				  immunization to the primary care provider, if known, within seven (7)
				  days.
E. Record-Keeping
				  and Reporting
1. The pharmacist who
				  administers any immunization shall maintain the following information in the
				  pharmacy records regarding each immunization administration:
a. Patient's name, address, and date of
				  birth;
b. Date of the
				  administration and site of injection of the immunization;
c. Name, dose, manufacturer, lot number, and
				  expiration date of the immunization;
d. Name and address of the patient's primary
				  healthcare provider, as identified by the patient, if known;
e. Name or identifiable initials of the
				  immunizing pharmacist, intern or Technician II if applicable;
f. Publication date of the Vaccine
				  Information Statement (VIS);
g.
				  Date that the VIS was provided to the patient.
2. The immunization records shall be
				  maintained for no less than two (2) years in accordance with all applicable
				  State and Federal statutes and Regulations pertaining to confidentiality.
3. Pharmacists authorized to
				  administer influenza immunizations to individuals between the ages of nine (9)
				  and eighteen (18) years, inclusive, shall be required to electronically report
				  to the Department all immunizations administered within seven (7) days of
				  administration in the format and for the populations required by the
				  Department.