Missouri Code of State Regulations
Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE
Division 2150 - State Board of Registration for the Healing Arts
Chapter 5 - General Rules
Section 20 CSR 2150-5.025 - Administration of Vaccines
Universal Citation: 20 MO Code of State Regs 2150-5.025
Current through Register Vol. 49, No. 18, September 16, 2024
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.
*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.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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