Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This amendment updates and clarifies
requirements for pharmacists administering medication by prescription
order.
PURPOSE: This rule establishes procedures for
pharmacists to administer medication pursuant to a medical prescription
order.
(1) A pharmacist who
complies with the provisions of this rule may administer drugs and devices
pursuant to a medical prescription order, including vaccines.
(2) Except as otherwise provided by law, a
pharmacist may not delegate medication administration to another person, except
to an intern pharmacist who has met the qualifications under subsections
(3)(B)-(E) and is working under the direct supervision of a pharmacist who has
met the qualifications to administer drugs pursuant to a medical prescription
order. Proof of an intern's compliance with subsections (3)(B)-(E) must be
maintained by both the supervising pharmacist and the intern pharmacist for a
minimum of two (2) years.
(3)
Pharmacist Qualifications. A pharmacist who is administering drugs pursuant to
a medical prescription order must first file a Notification of Intent to
administer drugs by medical prescription order with the board. To file a
Notification of Intent, a pharmacist must-
(A) Hold a current Missouri pharmacist
license;
(B) Hold a current
healthcare provider level cardiopulmonary resuscitation (CPR) certification or
Basic Life Support certification issued by the American Heart Association , the
American Red Cross, or an equivalent organization. The certificate program must
have included an in-person skills assessment;
(C) Have successfully completed a certificate
program in medication administration and emergency procedures accredited by the
Accreditation Council for Pharmacy Education (ACPE), provided by an ACPE or
regionally accredited pharmacy or medical school/college or approved by Board
of Pharmacy. The required training program must provide instruction in-
1. Administration techniques, including
hands-on training in routes of administration;
2. Drug storage and handling;
3. Informed consent requirements;
4. Pre- and post- administration assessment
and counseling;
5. Biohazard waste
disposal; and
6. Identifying and
treating adverse reactions, including ana-phylactic reactions and needle
sticks;
(D) If a
pharmacist wishes to administer drugs by a route of administration not included
in the original certification 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 at the pharmacy and
available to the board on request; and
(E) Proof of compliance with this section
must be maintained for a minimum of two (2) years.
(4) General Requirements.
(A) Medication must be administered in
compliance with all applicable state and federal laws, including applicable
Vaccine Information Statements and informed consent requirements. Except as
otherwise authorized by law, vaccines must also be administered in accordance
with treatment guidelines established by the Centers for Disease Control and
Prevention (CDC) or in accordance with manufacturer's guidelines.
(B) Pharmacists must have a current and
accurate written policy and procedure manual covering all aspects of
administering drugs by medical prescription order, including:
1. Drug administration procedures;
2. Authorized routes of
administration;
3. Drug
storage;
4. Pre- and post-
administration assessment and counseling;
5. Biohazard waste disposal and disposal of
used/contaminated supplies;
6.
Identifying and handling acute adverse events or immunization reactions,
including anaphylactic reactions; and
7. Recordkeeping and notification procedures
and requirements.
(C)
Drugs must be stored within the manufacturer's labeled requirements, including
when administering outside of a pharmacy. Vaccines must be stored in accordance
with CDC guidelines at all times.
(D) Patients must be asked to remain in the
pharmacy a safe amount of time after administering a vaccine to observe any
adverse reactions, as required by section
338.010,
RSMo.
(5) Requirements
of Medical Prescription Order for Administration. At a minimum, the medical
prescription order from a licensed prescriber must include:
(A) The name of the licensed prescriber
issuing or authorizing the order;
(B) The name of the patient to receive the
drug;
(C) The name of the drug and
dose to be administered;
(D) The
route of administration;
(E) The
date of the original order; and
(F)
The date or schedule, if any, of each subsequent administration.
(6) Record Keeping.
(A) Pharmacists administering or supervising
administration of medication pursuant to this rule shall ensure the following
records are manually or electronically maintained separate from the
prescription files of a pharmacy for each administration:
1. The name, address, and date of birth of
the patient;
2. The date, route,
and anatomic site of the administration;
3. The medication name and dose. For vaccines
and biologics, the manufacturer, expiration date, and lot number must also be
documented and recorded;
4. For
vaccines, the name and address of the patient's primary health care provider,
as identified by the patient or an indication that a primary health care
provider was not provided;
5. The
identity of the administering pharmacist, or if applicable, the administering
intern pharmacist and his/her supervising pharmacist; and
6. If applicable, the nature of an adverse
reaction and who was notified.
(B) All records required by this regulation
must be kept by the pharmacist for two (2) years from the date of such record.
Except as otherwise required by section (3), records must be kept at the
pharmacy where the prescription order is maintained. If not administered on
behalf of a pharmacy, records not maintained at a pharmacy may be securely
stored at a location designated by the pharmacist. Records maintained at a
pharmacy must be produced immediately or within two (2) hours of a request from
the board or the board's authorized designee. Records not maintained at a
pharmacy must be produced within three (3) business days of a board
request.
(7)
Notification Requirements. Pharmacists administering or supervising
administration of medication under this rule, shall ensure:
(A) The patient's primary health care
provider is notified of the following within fourteen (14) days of
administering a vaccine:
1. The identity of
the patient;
2. The vaccine
administered;
3. The route of
administration;
4. The anatomic
site of the administration;
5. The
dose administered; and
6. The date
of administration;
(B)
The prescriber is notified within twenty-four (24) hours after learning of an
adverse event or reaction experienced by a patient following administration.
Notification is mandatory and cannot be waived;
(C) Any notifications required by state and
federal law are properly completed and documented; and
(D) Notifications required by this section
may be made electronically or in writing or via a common electronic medication
record that is accessible to and shared by both the physician and pharmacist.
Documentation of the required notifications, including the notification date,
must be maintained as required by subsection (6)(B) or electronically
retrievable at the request of the board or the board's authorized
designee.
(8)
Notification of Intent Refiling. To continue administration, a Notification of
Intent to administer drugs by medical prescription order must be refiled with
the board biennially along with the pharmacist's Missouri pharmacist license.
To refile, a pharmacist must meet the requirements of subsection (3)(B)
above.
*Original authority: 338.010, RSMo 1939, amended 1951,
1989, 1990, 2007; 338.140, RSMo 1939, amended 1981, 1989, 1997; and 338.280,
RSMo 1951, amended 1971, 1981 .