216 R.I. Code R. 216-RICR-40-15-1.11

Current through December 26, 2024

Section 216-RICR-40-15-1.11 - Administration of Immunizations and Performance of Limited-Function Tests by Pharmacists

1.11.1Administration 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.

1.11.2Limited-Function Tests

A. Performing a Limited-Function Test. A pharmacist may perform a limited-function test, as defined in this Part, only in accordance with instructions provided in the kit manufacturer's package insert, and in accordance with guidance published by the Centers for Disease Control and Prevention, Division of Laboratory Programs, Standards, and Services.

B. Reporting Limited-Function Test Results

1. A report of a limited-function test shall contain, at a minimum, the following information:

a. Patient name;

b. Patient date of birth, sex and age;

c. Test performed;

d. Test results;

e. Interpretation, according to instructions in the product insert;

f. Reference range of lab results;

g. Comments or qualifying statement, if applicable;

h. Date completed or reported; and

i. Name of pharmacist performing the test.

2. Upon receiving consent from the patient, a pharmacist performing a limited-function test shall report test results to the patient's primary care practitioner, if known, within a reasonable timeframe.

3. In the event that a patient with an abnormal test result does not have an existing relationship with a primary care practitioner, the pharmacist shall make efforts to refer the patient to a primary care practitioner practice, health center, or clinic.

4. The pharmacist shall inform the patient that the limited-function test results are intended for informational amp; educational purposes, rather than diagnostic purposes.

5. The requirements of this section shall not apply to tests performed through a collaborative practice agreement, as defined in this Part.

C. Required Documents and Records. Each pharmacy where a pharmacist performs one or more limited-function tests shall maintain, at a minimum, the following:

1. Name of test;

2. Test procedures or site-specific work instructions;

3. Records of testing materials used, test system and equipment function checks, and maintenance;

4. Test results, including the results of any confirmatory or supplemental testing required by the kit manufacturer' s package insert;

5. Records of any test system failures, troubleshooting, and corrective action taken when problems are identified, including related communication with testing personnel;

6. Unless a different interval is specified by applicable statute or Regulation, records and documents required by this Part shall be maintained for three (3) years from the date of completion.

1.11.3Administration of Medications

A. In accordance with R.I. Gen. Laws § 5-19.1-1, a pharmacist can administer medications in the drug classes listed in §1.11.3(B) of this Part, to any age group, pursuant to a valid prescription or physician-approved protocol, including, but not limited to, a standing order, and under the following conditions:

1. The route(s) are FDA approved; and

2. The medication is administered privately.

a. The pharmacist must administer the medication in an area that provides for patient privacy, particularly for medications administered to sites that require removal of clothing (e.g., intramuscular injections into the gluteal muscles).

B. A pharmacist is authorized to administer medications in the following drug classes:

1. Anti-infectives

2. Anti-HIV

3. Purified Protein Derivative

4. Vaccines

5. Antipsychotics

6. Epinephrine

7. Buprenorphine

8. Vitamins

9. Hormones and Hormone Analogs

10. Fertility Agents

11. Contraceptives

12. Androgens

13. Biologics

14. Monoclonal Antibodies

15. Interferons

16. Calcium Regulating Agents

17. Immunologic Agents

18. Hematopoietic Agents

19. Dermatologic Agents

20. Colony Stimulating Factors

21. Antirheumatic Agents

22. Anticoagulants

23. Steroids

24. Opioid Antagonists

25. Topicals

C. Pharmacists shall not administer drugs in the following routes:

1. Intravenous Injections

2. Intravenous Infusions

a. Exception. If allowed at a code and per hospital policy, a pharmacist may administer intravenous infusions.

3. Intrathecal

4. Rectal

5. Intraocular

E. Pharmacists shall not administer the following drugs or drug classes:

1. Chemotherapy agents; and

2. Controlled Substances, except for those used for addiction treatment and hormones and hormone analogs.

F. A pharmacist who refuses to administer a medication based on professional judgment shall notify the prescriber of this decision within the earliest practicable time.

G. A pharmacist shall not administer medications to animals.

H. The pharmacist must document all medications administered in either the patient's paper or electronic prescription profile.

I. Training and Qualifications

1. Medication administration training within an accredited college of Pharmacy program or other organizations including but not limited to APhA, AMA, ASCP, ASHP or other accredited professional training organizations; or

2. Certification as an immunizing pharmacist.

J. The pharmacist must develop policies and procedures for medication administration services. Such policies must include no less than the following:

1. A statement of the procedures, decision criteria or plan that will be followed 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; and

5. A statement that the pharmacy report adverse events to the FDA and to the primary care provider, as identified by the patient

H. Record-Keeping and Reporting

1. The pharmacist who administers any medication shall keep a record either as a hard copy or electronic record (e.g., prescription profile of electronic health record) to maintain, at minimum, the following information regarding each medication administration:

a. Patient's name, address, and date of birth;

b. Medication name and dosage;

c. Date of the administration and route of administration;

d. Name and address of the patient's primary healthcare provider, as identified by the patient, if known; and

e. Name or identifiable initials of the administering pharmacist.

216 R.I. Code R. 216-RICR-40-15-1.11

Amended effective 5/17/2021
Amended effective 12/8/2022