20 CSR 2220-6.040 - Administration by 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 or qualified pharmacy technician
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 order.
(A) 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 medication 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.
(B) Proof of an
intern's or qualified pharmacy technician's compliance with subsections
(3)(B)-(E) must be maintained by both the supervising pharmacist and the intern
pharmacist/ qualified pharmacy technician 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 the 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 anaphylactic 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 or qualified pharmacy technician 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)
For vaccines, a pharmacist shall inform the patient that the administration of
the vaccine will be entered into the ShowMeVax system, as administered by the
Department of Health and Senior Services. The patient shall attest to the
inclusion of such information in the system by signing a form provided by the
pharmacist. Entry into ShowMeVax must occur within fourteen (14) days. If the
patient indicates that he or she does not want such information entered into
the ShowMeVax system, the pharmacist must provide a written report within
fourteen (14) days of administration of a vaccine to the patient's primary
health care provider, if provided by the patient, containing-
1. The identity of the patient;
2. The identity of the vaccine or vaccines
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. Vaccine adverse events or
reactions must also be reported to the Vaccine Adverse Event Reporting System
(VAERS) or its successor, within thirty (30) days;
(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.
(9) A qualified pharmacy technician
administering medication pursuant to this rule must be supervised by a
Missouri-licensed pharmacist who is authorized to administer medication
pursuant to this rule and who is physically present on-site when the medication
is administered.
Notes
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