4 Colo. Code Regs. § 739-1.17

Current through Register Vol. 47, No. 22, November 25, 2024

Section 4 CCR 739-1.17 - ADMINISTRATION OF MEDICATIONS

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.

4 CCR 739-1.17

40 CR 12, June 25, 2017, effective 8/1/2017

41 CR 01, January 10, 2018, effective 1/30/2018

43 CR 03, February 10, 2020, effective 1/1/2020

43 CR 07, April 10, 2020, effective 4/30/2020

43 CR 22, November 25, 2020, effective 12/15/2020

44 CR 09, May 10, 2021, effective 5/30/2021

44 CR 20, October 25, 2021, effective 11/14/2021

45 CR 17, September 10, 2022, effective 8/15/2022

45 CR 21, November 10, 2022, effective 11/30/2022