Mo. Code Regs. tit. 20 § 2150-5.025

Current through Register Vol. 49, No. 21, November 1, 2024.

Section 20 CSR 2150-5.025 - Administration of Vaccines

PURPOSE: This amendment implements 2023 legislative revisions to section 338.010, RSMo, and establishes pharmacist immunization procedures under revised section 338.010.1(4), RSMo.

PURPOSE: This rule establishes procedures for pharmacists administering vaccines as authorized by section 338.010.1, RSMo.

(1) A Missouri licensed pharmacist may order and administer vaccines as authorized by section 338.010.1, RSMo. Pharmacists must be competent to perform the services provided and maintain ongoing/ continued competency. Except as otherwise authorized by law, for purposes of section 338.010.1(4), RSMo, pharmacists may administer reformulated or updated versions of vaccines authorized by the U.S. Food and Drug Administration (FDA) after January 1, 2023, provided the initial vaccine was approved by the FDA prior to January 1, 2023.

(A) Vaccines must be administered in accordance with current treatment guidelines established by the Centers for Disease Control (CDC) and the manufacturer's guidelines, provided CDC guidelines shall control in the event of a conflict. Vaccines may not be administered to persons under seven (7) years of age unless otherwise authorized by law.

(B) Pharmacists shall ensure compliance with all state and federal laws and regulations pertaining to Vaccine Information Statements and informed consent requirements.

(C) Vaccines must be stored in accordance with CDC guidelines/recommendations and within the manufacturer's labeled requirements, including, when vaccinating outside of a pharmacy.

(D) A pharmacist may only delegate vaccine administration to an intern pharmacist or qualified pharmacy technician who has met the qualifications of subsections (3)(B) and (C) of this rule and is working under the direct supervision of a pharmacist qualified to administer vaccines. Proof of an intern's or qualified pharmacy technician's compliance with subsections (3)(B) and (C) must be maintained by both the supervising pharmacist and the intern pharmacist/qualifying pharmacy technician for a minimum of two (2) years.

(E) For purposes of this rule, a "qualified pharmacy technician" is defined as a currently registered Missouri pharmacy technician who-

1. Holds an active pharmacy technician certification issued by a certification entity accredited by the National Commission for Certifying Agencies;

2. Has an initial and, if applicable, annual documented assessment of competency in vaccine administration; and

3. Has assisted in the practice of pharmacy as a registered/licensed pharmacy technician in the state of Missouri or another U.S. state or territory for a minimum of one (1) year.

(2) For vaccines administered by protocol, the authorizing protocol physician is responsible for the oversight of, and accepts responsibility for, the vaccines administered by the pharmacist.

(3) Pharmacist Qualifications. Pharmacists administering vaccines as authorized by section 338.010.1, RSMo, must first file a Notification of Intent (NOI) to administer vaccines with the Missouri Board of Pharmacy via the Board of Pharmacy's website or on a form provided by the Board of Pharmacy. To file a NOI, a pharmacist must-

(A) Hold a current Missouri pharmacist license;

(B) Hold a current healthcare provider level cardiopulmonary resuscitation (CPR) or basic life support (BLS) certification issued by the American Heart Association, the American Red Cross, or an equivalent organization. The qualifying BLS or CPR certification program must have included a live in-person skills assessment; and

(C) Have successfully completed a certificate program in administering vaccines accredited by the Accreditation Council for Pharmacy Education (ACPE), provided by an ACPE, or regionally accredited pharmacy or medical school/college or approved by the Board of Pharmacy. The required certificate program must include a live/in-person training component and include instruction in:

1. Current CDC guidelines and recommendations for vaccines authorized by Chapter 338, RSMo, including, recommended immunization schedules;

2. Basic immunology and vaccine protection;

3. Physiology and techniques for vaccine administration, including, hands-on training in intramuscular, intradermal, subcutaneous and nasal administration routes, and other common routes of vaccine administration;

4. Pre- and post- vaccine screening or assessment; and

5. Identifying and treating adverse immunization reactions;

(D) Prior to administering vaccines by a route of administration not included in the original certificate program, the pharmacist must first be trained in the techniques of that route of administration by a licensed health care practitioner who is authorized to administer medication. Documentation of the required training and training date(s) must be maintained and available to the board on request.

(4) Pharmacist immunization activities must be safely and properly performed in accordance with the applicable standard of care.

(A) An adequate patient or medical history must be collected as deemed necessary or appropriate to allow the pharmacist to properly assess the patient.

(B) Prior to ordering or administering a vaccine authorized by Chapter 338, RSMo, the pharmacist shall use a screening procedure based on generally accepted clinical guidelines to identify appropriate patients for immunization. The pharmacist shall refer patients with a contraindication to the patient's primary care provider or an appropriate health care provider, as deemed necessary or appropriate.

(C) Pharmacists ordering or administering a vaccine as authorized by section 338.010, RSMo, may create a prescription in the pharmacist's name or, if applicable, the name of the authorizing protocol physician. The prescription may be dispensed by a licensed pharmacy and must be maintained in the prescription records of the dispensing pharmacy as provided by the Board of Pharmacy's rules. In addition to this rule, pharmacists shall comply with all applicable provisions of Chapter 338, RSMo, and the rules of the Board of Pharmacy governing prescribing and record-keeping, including but not limited to 20 CSR 2220-2.018.

(D) For vaccines ordered by a pharmacist, the pharmacist must maintain a patient record of each vaccine ordered that includes-

1. The patient's name, address, and date of birth;

2. The name and dosage of any vaccine ordered;

3. The name and address of the patient's primary health care provider, as provided by the patient;

4. The identity of the ordering pharmacist;

5. Documentation of any patient screening; and

6. Any other pertinent medical or medication information/history.

(5) Protocol Requirements.

(A) A Missouri licensed pharmacist may enter into a written protocol with a Missouri licensed physician to order and administer vaccines authorized by section 338.010.1(4), RSMo. The written protocol may be valid for a time period not to exceed one (1) year. The protocol must be renewed annually and include the following:

1. The identity of the participating pharmacist and physician;

2. Time period of the protocol;

3. Authorized vaccines;

4. The patient or groups of patients authorized for vaccination;

5. Allowed routes and anatomic sites of administration;

6. If applicable, authorization to create a prescription for each administration under the physician's name;

7. Patient assessment or referral requirements, if applicable;

8. Emergency response procedures, including, but not limited to, procedures for handling/addressing adverse reactions, anaphylactic reactions, and accidental needle sticks;

9. The length of time the pharmacist must observe an individual for adverse events following an injection;

10. Procedures for disposing of used and contaminated supplies;

11. Authorization to administer vaccines at a nonpharmacy location, if applicable;

12. Record-keeping requirements and any required notification procedures; and

13. A provision allowing termination of the protocol at any time at the request of any party.

(B) The protocol, and any subsequent amendments or alterations, must be reviewed and manually or electronically signed and dated by the pharmacist and authorizing protocol physician prior to its implementation, signifying that both are aware of its contents and agree to follow the terms of the protocol. A copy of the protocol must be maintained by both the pharmacist and the authorizing protocol physician for a minimum of eight (8) years after termination of the protocol.

(C) Additional pharmacists or immunization locations may be added to an existing protocol if the amendment is signed and dated by the authorizing protocol physician(s) and, if applicable, any newly added pharmacist(s). Existing pharmacists are not required to re-sign the protocol unless other protocol terms or provisions are changed.

(D) Within seventy-two (72) hours after a vaccine is administered, a prescription must be created in the ordering pharmacist's name for any vaccine dispensed. For vaccines provided pursuant to an immunization protocol with a Missouri licensed physician, the prescription must be obtained from the authorizing protocol physician for any vaccine dispensed or a prescription must be created in the protocol physician's name, documenting the dispensing within seventy-two (72) hours as authorized by protocol.

(6) Record Keeping.

(A) Within seventy-two (72) hours after a vaccine is administered, a prescription must be created in the ordering pharmacist's name for any vaccine dispensed. For vaccines provided pursuant to an immunization protocol with a Missouri licensed physician, the prescription must be obtained from the authorizing protocol physician for any vaccine dispensed or a prescription must be created in the authorizing protocol physician's name, documenting the dispensing within seventy-two (72) hours as authorized by protocol.

(B) For vaccines ordered by a pharmacist, the pharmacist must maintain a patient record of each vaccine ordered that includes-

1. The patient's name, address, and date of birth;

2. The date, route, and anatomic site of the administration;

3. The vaccine's name, dose, manufacturer, lot number, and expiration date;

4. The name and address of the patient's primary health care provider, as provided by the patient;

5. The identity of the administering pharmacist or, if applicable, the identity of the administering intern pharmacist or qualified pharmacy technician and supervising pharmacist;

6. Documentation of patient screening, if applicable;

7. The nature of any adverse reaction and who was notified, if applicable; and

8. Any other pertinent medical or medication information/history.

(C) The pharmacist shall ensure a record is maintained for each vaccine administered pursuant to section 338.010.1(4), RSMo, that includes-

1. The patient's name, address, and date of birth;

2. The date, route, and anatomic site of the administration;

3. The vaccine's name, dose, manufacturer, lot number, and expiration date;

4. The name and address of the patient's primary health care provider, as provided by the patient;

5. The identity of the administering pharmacist or, if applicable, the identity of the administering intern pharmacist or qualified pharmacy technician and supervising pharmacist;

6. Documentation of patient screening, if applicable;

7. The nature of any adverse reaction and who was notified, if applicable; and

8. Any other pertinent medical or medication information/ history.

(D) Notwithstanding any other provision of this rule, prescription records must be maintained as provided by Chapter 338, RSMo, and the rules of the board.

(E) The records required by this rule must be securely and confidentially maintained as follows:

1. If the vaccine is administered on behalf of a pharmacy, both the pharmacy and the pharmacist shall ensure the records required by subsections (6)(A)-(C) are promptly delivered to and maintained at the pharmacy separate from the pharmacy's prescription files;

2. If the vaccine is not being administered on behalf of a pharmacy, all records shall be maintained securely and confidentially by the pharmacist at an address identified in advance by the pharmacist or, if applicable, identified in the protocol;

3. Prescription records must be maintained as required by Chapter 338, RSMo, and the rules of the board; and

4. Records required by this rule must be maintained for two (2) years and made available for inspecting and copying by the State Board of Pharmacy or the State Board of Registration for the Healing Arts and/or their authorized representatives. Records maintained at a pharmacy must be produced during an inspection by the board and/or their authorized representatives. Records not maintained at a pharmacy must be produced within three (3) business days after a request from the State Board of Pharmacy, the Board of Registration for the Healing Arts, and/or their authorized representative. Failure to maintain or produce records as provided by this rule shall constitute grounds for discipline.

(7) Notification of Immunizations. Pharmacists immunizing pursuant to section 338.010.1(4), RSMo, must-

(A) Notify all persons or entities as required by state and federal law;

(B) Notify the protocol physician as required by the governing protocol, if applicable;

(C) Notify the patient's primary care provider as required by Chapter 338, RSMo; and

(D) Notify the patient's primary health care provider and, if different, the protocol physician, within twenty-four (24) hours after learning of any adverse event or reaction experienced by the patient. Adverse events or reactions must also be reported to the Vaccine Adverse Event Reporting System (VAERS) or its successor, within thirty (30) days.

(E) Unless otherwise provided by a governing protocol, notification may be made via a common electronic medication record that is accessible to and shared by both the physician and pharmacist. Proof of notification must be maintained in the pharmacist's records as provided in subsection (6)(B) of this rule.

(8) Notification of Intent Renewal. A Notification of Intent (NOI) to immunize as authorized by section 338.010.1(4), RSMo, must be renewed biennially with the immunizing pharmacist's Missouri pharmacist license. To renew a NOI, pharmacists must-

(A) Have a current healthcare provider cardiopulmonary resuscitation (CPR) or basic life support (BLS) certification that complies with subsection (3)(B) of this rule; and

(B) Have completed a minimum of two (2) hours of continuing education (0.2 CEU) related to administering vaccines or CDC immunization guidelines in a course approved by the Board of Pharmacy or provided by an ACPE accredited continuing education provider within the applicable pharmacist biennial renewal period (November 1 to October 31 of the immediately preceding even numbered years).

(C) The required continuing education (CE) shall be governed by 20 CSR 2220-7.080 and may be used to satisfy the pharmacist's biennial continuing education requirements. The initial training program required by section (3) of this rule may be used to satisfy the CE requirements of this subsection if the training program was completed within the applicable pharmacist biennial renewal cycle.

(9) A qualified pharmacy technician immunizing pursuant to this rule must be supervised by a Missouri-licensed pharmacist who is authorized to immunize pursuant to section 338.010, RSMo and who is physically present on-site when the vaccine is administered.

20 CSR 2150-5.025

AUTHORITY: section 334.125, RSMo 2000 and sections 338.010 and 338.220, RSMo Supp. 2009.* Emergency rule filed Oct. 24, 2007, effective Nov. 3, 2007, expired April 30, 2008. Original rule filed Oct. 24, 2007, effective May 30, 2008. Emergency amendment filed Oct. 22, 2009, effective Nov. 1, 2009, expired April 29, 2010. Amended: Filed Oct. 22, 2009, effective June 30, 2010

Amended by Missouri Register January 15, 2019/Volume 44, Number 2, effective 2/28/2019

Amended by Missouri Register June 1, 2021/Volume 46, Number 11, effective 7/31/2021

Amended by Missouri Register September 15, 2023/Volume 48, Number 18, effective 8/28/2023, exp. 2/23/2024 (Emergency)

Amended by Missouri Register December 15, 2023/volume 48, Number 24, effective 1/30/2024.

*Original authority: 334.125, RSMo 1959, amended 1993, 1995; 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009; and 338.220, RSMo 1951, amended 1969, 1981, 1989, 1997, 1999, 2001, 2004, 2007, 2009.