Current through Register Vol. 47, No. 17, September 10, 2024
The purpose of this Rule is to clarify the limited
administration of medications by a direct-entry midwife as authorized by
section 12-225-107, C.R.S.
A. A direct-entry midwife may obtain and
administer medications only as set forth in this Rule and as set forth in
section 12-225-107, C.R.S..
B. Except as provided in section
12-225-107(7),
C.R.S., a direct-entry midwife must receive prior approval from the Director to
obtain and administer medications. A direct-entry midwife who seeks such
approval must submit a Medication Authority application in a manner approved by
the Director and pay the applicable fee.
1. A
direct-entry midwife applying for medication authority must have satisfactorily
completed a course in pharmacology, within six months prior to submitting an
application, that:
a. Is offered by a
post-secondary educational institution accredited by an accrediting board
recognized by the Council for Higher Education Accreditation of the American
Council on Education, is a program or course approved by MEAC, or is a program
or course otherwise approved by the Director;
b. Is, at a minimum, eight clock hours in
length and includes basic pharmacotherapeutic principles and administration of
medications, including the drugs listed in paragraph (C) of this Rule; and
c. Includes the following
elements:
(1) Mechanism of Pharmacological
Action;
(2) Indications;
(3) Therapeutic Effects;
(4) Side Effects/Adverse Reactions;
(5) Contraindications;
(6) Incompatibilities/Drug
Interactions;
(7) Drug
administration, including:
(a)
Dosage;
(b) Dosage Form and
Packaging;
(c) Routes of
Administration;
(d) Onset of
Action;
(e) Peak Effect;
and
(f) Duration of
Action;
(8)
Administration of medications through injection, which includes:
(a) Universal precautions including the use
and disposal of sharps;
(b) Safe
injection practices;
(c) Equipment,
including:
i. Needles;
ii. Filter Needles (for use with glass
ampules);
iii. Syringes;
iv. Skin surface disinfectants; and
v. Medication containers (ampules,
single-use vials);
(9) Appropriate injection sites;
(10) Procedures for drawing up and
administering drugs;
(11) Proper
disposal of hazardous and other contaminated materials; and
(12) Student demonstration of competence in
administering medications.
2. An applicant who does not meet the
requirements of subparagraph (1) above may request to demonstrate competency to
obtain and administer medications by other means. The Director shall consider
such a request on a case-specific basis. The decision to approve such a request
shall be at the sole discretion of the Director. In considering whether to
approve such a request, the Director shall consider public safety and such
other factors as the Director deems appropriate. If the Director grants
approval under this subparagraph (2) to obtain and administer medications, the
Director may subject such approval to lawful conditions the Director finds
necessary to protect the public.
C. The preferred drug list of medications a
direct-entry midwife may obtain and administer consists of:
1. Vitamin K1 (phylloquinone, phytonadione)
to a newborn, as prophylaxis for vitamin K deficiency bleeding. One 1 mg dose
of 2 mg / ml concentration vitamin K1 is authorized via intramuscular
injection.
2. Rho D immune globulin
to Rh-negative, antibody negative mothers, for the prevention of
isoimmunization in Rh (D) negative women. One 300 mcg dose (or as recommended
by the manufacturer) at 26- 28 weeks gestation is authorized via intramuscular
injection. In addition, one 300 mcg dose (or as recommended by the
manufacturer) administered via intramuscular injection to the mother is
authorized within 72 hours of delivery of an Rh-positive infant (or an infant
with unknown blood type) to an Rh-negative, antibody negative mother.
3. Antihemorrhagic drugs for control of
postpartum bleeding, limited to the following:
a. Oxytocin at 10 units/ml administered
intramuscularly.
b.
Methylergonovine at 0.2 mg/ml administered intramuscularly.
c. Misoprostol at 800 mcg administered
rectally or 400 to 600 mcg administered sublingually.
d. Postpartum hemorrhage may be prevented by
the administration of one dose of oxytocin following the birth of a baby and
before the delivery of the placenta. If bleeding remains normal and maternal
signs are stable, immediate transport is not necessary.
e. If a preventative dose of oxytocin has not
been given, postpartum hemorrhage may be controlled by administering one dose
of oxytocin followed by, if necessary, a second dose of oxytocin or one dose of
misoprostol or one dose of methylergonovine. Immediate transport must be
initiated if bleeding is not controlled or if the mother displays signs and
symptoms of shock.
f. If a
preventative dose of oxytocin has been given, postpartum hemorrhage may be
controlled by administering one additional dose of oxytocin, or one dose of
misoprostol or one dose of one dose of methylergonovine. Immediate transport
must be initiated if bleeding is not controlled or if the mother displays signs
and symptoms of shock.
4. Erythromycin Ophthalmic Ointment to a
newborn, for prophylaxis of neonatal ophthalmia, as provided by Section
25-4-303, C.R.S. A single topical
dose of Erythromycin Ophthalmic Ointment USP (0.5%) is to be administered
within one (1) hour after birth via topical application of a ribbon of ointment
approximately 1 cm in length into each eye.
5. Local anesthetics to perform sutures of
first-degree and second-degree perineal tears and limited to lidocaine 1% or 2%
for injection with or without epinephrine.
6. Group B Streptococcus (GBS) prophylaxis,
subject to the conditions set forth in section
12-225-107(7),
C.R.S.
D. Client
refusals of medication or treatment.
1.
Informed consent. If a client refuses the administration of either Vitamin K1
to her infant or Rho D immune globulin to herself, the direct-entry midwife
shall provide the client with an informed consent form containing a detailed
statement of the benefits of the medication and the risks of refusal, and shall
retain a copy of the form acknowledged and signed by the client.
2. Transport. If a client experiences
uncontrollable postpartum hemorrhage, the direct-entry midwife shall
immediately initiate the transportation of the client in accordance with the
emergency plan.
3. Eye prophylaxis.
If a client refuses the administration of eye prophylaxis to her infant, the
direct-entry midwife shall:
a. Provide the
client with a form setting forth the requirements of Section
25-4-303, C.R.S.; and
b. Retain a copy of the form acknowledged and
signed by the client.
E. Medication administration procedures must
meet safe and professional standards and must be performed in a manner
consistent with generally accepted parameters, including safe injection
practices and the standards of the Centers for Disease Control and Prevention
("CDC").
F. In order to best serve
the needs and ensure the safety of their clients, direct-entry midwives who
obtain and administer medications shall maintain competency regarding their use
through continuing education and other professional development
activities.
G. A direct-entry
midwife must be able to supply written documentation, upon request by the
Director, which substantiates appropriate training as required by this Rule.
Failure to provide written documentation is a violation of this Rule, and is
prima facie evidence that the direct-entry midwife is not competent and not
permitted to obtain or administer medications.
