Original Notice.

     Preproposal statement of inquiry was filed as WSR 02-17-053.

     Title of Rule and Other Identifying Information: WAC 246-834-250 Midwifery legend drugs and devices, RCW 18.50.115 lists drugs that a midwife may obtain and administer and also states that the secretary, after consultation with representatives of the Midwifery Advisory Committee (MAC), the Board of Pharmacy (BOP), and the Medical Quality Assurance Commission (MQAC), may adopt rules to authorize licensed midwives to purchase and use legend drugs and devices in addition to the drugs already authorized by law. These changes are recommended by MAC and BOP and MQAC have agreed that the proposal is satisfactory.

     Hearing Location(s): Department of Health, Point Plaza East, Room 139, 310 Israel Road S.E., Tumwater, WA, 98501 [98502], on January 4, 2005, at 1:30 p.m.

     Date of Intended Adoption: January 11, 2005.

     Submit Written Comments to: Leann Yount, 310 Israel Road S.E., P.O. Box 47860, Tumwater, WA, 98501 [98502], (360) 236-4997, e-mail leann.yount@doh.wa.gov, fax (360) 236-4626, by January 1, 2005.

     Assistance for Persons with Disabilities: Contact Leann Yount by January 1, 2005, TTY (800) 833-6388.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed changes to WAC 246-834-250 includes adding drugs which could be essential to the midwife in emergency situations, such as Terbutaline and antihemorrhagic drugs to control postpartum hemorrhage. The changes also require the midwife to transport the patient after using such drugs as magnesium sulphate and epinephrine, drugs currently allowed per this rule, and for some new drugs added to the list. The changes also require the midwife to have a procedure, policy or guideline for the use of each drug.

     Rules will ensure midwifery patients, in an emergent situation, can receive effective and immediate medical intervention in accordance with the expansion of drugs and devices a midwife can use in an emergent situation.

     Medicine has advanced since 1990 and changes to the rule will bring the rule up to date with the current practice of medicine, while making it safer for the patient.

     Statutory Authority for Adoption: RCW 18.50.115.

     Statute Being Implemented: RCW 18.50.115.

     Rule is not necessitated by federal law, federal or state court decision.

     Name of Proponent: Department of Health and the Midwifery Advisory Committee, governmental.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Kendra Pitzler, 310 Israel Road S.E., Tumwater, WA 98501 [98502], (360) 236-4723.

     A small business economic impact statement has been prepared under chapter 19.85 RCW.

     RCW 18.50.115 regulates the administration of drugs and medications by licensed midwives. The chapter explicitly states midwives licensed under this chapter may obtain and administer prophylactic ophthalmic medication, postpartum oxytocic, vitamin K, Rho immune globulin (human), and local anesthetic and may administer such other drugs or medications as prescribed by a physician. The chapter also allows the secretary, under consultation with representatives of MAC, BOP, and MQAC, may adopt rules that authorize licensed midwives to purchase and use legend drugs and devices in addition to the drugs authorized in the chapter.

     Midwives are independent practitioners who normally practice in a birth center or a home setting. Because they are independent practitioners, they need to be prepared for emergencies. The current rules were adopted in January 1991. These rules describe legend drugs and devices deemed integral to providing safe care to the public. However, medicine has made great strides in the past twelve years and it is time to review these rules to assure midwives are able to obtain and administer all legend drugs and devices that are now integral to providing safe care.

     In addition, MAC recommended that these rules be looked at as part of their "standards of practice" to assure that it is clear what drugs a midwife may obtain and administer and which devices they may use to assist in the birthing process. These changes may help protect the public by assuring licensed midwives have clear direction regarding the medications and procedures that may safely be administered by midwives in or outside the hospital setting.

     Furthermore, there have been questions regarding the legality of using devices not on the list. Some midwives have been using such devices. Therefore, DOH desires to clarify if use of a particular device is unsafe or make it clear that only devices listed are approved for use by licensed midwives.

     The DOH is considering amendments to WAC 246-834-250 to ensure all medications necessary to protect the patient can be obtained and administered by a licensed midwife.

     Rule-making Requirements of the Regulatory Fairness Act (chapter 19.85 RCW): The Regulatory Fairness Act, RCW 19.85.030 requires the department to conduct a small business economic impact statement (SBEIS) for proposed rules that have more than minor impact on small businesses. As defined in RCW 19.85.020 a small business is "any business entity, including a sole proprietorship, corporation, partnership, or other legal entity, that is owned and operated independently from all other businesses, that has the purpose of making a profit, and that has fifty or fewer employees."

     I. What do the new rules require? The proposed amendments to WAC 246-834-250 seek to ensure all licensed midwives can obtain and administer the necessary medications to protect the patient.

     Specifically, the amendments to the rule:

•     Add new legend drugs and devices a licensed midwife can purchase and administer that include airway suction devices, electronic fetal monitoring, toco monitoring, neonatal and adult resuscitation equipment, including oxygen, glucometer, centrifuge.

•     Prevent licensed midwives from purchasing and using heparin locks.

•     Allow pharmacies to issue breast pumps, compression stockings and belts, maternity belts, and cervical caps ordered by licensed midwives. Previously, the rule only allowed pharmacies to fill orders for diaphragms by licensed midwives.

•     Requires transport after the use of certain medications to assure safety.

•     Explicitly state the previously allowed medications in RCW 18.50.115 that a licensed midwife may administer.

•     Update the list of medications a licensed midwife may obtain and administer to include the:

     •     Removal of 5% dextrose with water.

     •     Addition of heparin and 0.9% sodium chloride for use in intravenous locks.

     •     Addition of sterile water for intradermal injections for pain relief.

     •     Addition of magnesium sulfate for prevention of maternal seizures pending transport. The current language asserts use shall be only for allergic reactions regulated by MAC established protocols. The new language removes such regulation.

     •     Clarification of epinephrine use. The new rule states epinephrine can be used for maternal anaphylaxis pending transport while the current language states epinephrine can be used for allergic reactions.

     •     Extend the purchase and use of Rubella to the Measles, Mumps, and Rubella (MMR) vaccine and extending the use of the MMR vaccine to HBIG and HBV for neonates born to Hepatitis B+ mothers.

     •     Addition of terbutaline for nonreassuring fetal heart tones and/or cord prolapse pending transport.      Addition of antibiotics for intrapartum prophylaxis of Group B Beta hemolytic Streptococcus (GBS) per current CDC guidelines.

     •     Addition of antihemorrhagic drugs to control postpartum hemorrhage, such as misoprostel per rectum (for use only in postpartum hemorrhage), methylergonovine maleate in the absence of hypertension, oral or intramuscular, prostaglandin F2 alpha (hemobate, intramuscular).

•     Eliminate the need of a midwife to submit a report, on approved forms, within thirty days of administering epinephrine or magnesium sulfate.

•     Assign the responsibility of procedure, policy or guideline for the use of each device and drug to the licensed midwife.

     II. Which industries are affected by this rule? In preparing this SBEIS, DOH used the following codes:

SIC Industry Code and Title	Minor Impact Threshold ($)
8049 Offices of health practitioners, ne	66.10

     Licensed midwives do not qualify for an individual SIC classification and are represented with other health facilities without an SIC code under the general title of "Offices of health practitioners, ne." To better identify the type of businesses that employ licensed midwives, DOH conducted a survey of all currently licensed midwives in Washington state. The survey found the following identified workplaces*:

	Private Practitioner**	Birth Center	Other
In what setting do you work?*	72	26	8

     *Those surveyed could give multiple answers.

     **Private practitioner working in clinic as the sole midwife or in partnership with other midwives and performing home births.

     The survey concluded that 68% of licensed midwives are private practitioners working in clinic as the sole midwife or in partnership with other midwives and performing home births. Also, 24.5% of licensed midwives are practicing in birth centers, 4.7% are working in hospitals, and 7.5% are working in unique health care settings (faculty member, midwives collective, and large private center).

     The DOH survey also found that a great proportion of those private practitioners were self-employed or worked in a business with only a few employees. The DOH survey found the following percentage breakdown for private practitioners:

	Self employed	2 employees	3 employees	4 employees	5-10 employees	10< employees
Employment of Private practitioners	54.4%	17.7%	10.1%	3.8%	6.3%	1.2%

     III. What are the costs of complying with this rule for small businesses (those with 50 or fewer employees) and for the largest 10% of businesses affected? Small and large businesses will incur a cost to find substitutes to the drugs and devices prohibited in the proposed rule changes. Substitutes for both heparin locks and 5% dextrose with water are considered to be of minimal cost. Removing heparin locks was necessary because heparin is not found in the current midwifery formulary. There are numerous other devices that substitute for heparin locks at similar cost.

     IV. Does the rule impose a disproportionate impact on small businesses? There is no disproportionate impact on small businesses. While businesses will incur costs to purchase and use substitutes to the prohibited drugs and devices, the cost per unit is assumed to be the same for both small and large businesses.

     V. How are small businesses involved in the development of this rule? The DOH held a meeting in September 2002 to obtain input from interested parties. The meeting was held at the DOH office in Olympia with teleconference with the department's North Seattle and Spokane locations. The department also sent notices to all licensed midwives, approved midwifery schools, the interested parties list for committee meetings, the interested parties list for standards of practice, and associations and state offices which have possible interest.

     A copy of the statement may be obtained by contacting Kendra Pitzler, Program Manager, Department of Health, Midwifery Program, 310 Israel Road S.E., Tumwater, WA 98501 [98502], phone (360) 236-4723, fax (360) 236-4738, e-mail Kendra.Pitzler@doh.wa.gov.

     A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Kendra Pitzler, Program Manager, Department of Health, 310 Israel Road S.W., P.O. Box 47864, Olympia, WA 98504-7864, phone (360) 236-4724, fax (360) 236-4738, e-mail Kendra.Pitzler@com.

M. C. Selecky

Secretary

OTS-6773.1

AMENDATORY SECTION(Amending Order 121, filed 12/27/90, effective 1/31/91)

WAC 246-834-250   Legend drugs and devices.   (1) Licensed midwives may purchase and use legend drugs and devices ((which are deemed integral to providing safe care to the public. Such devices include the following)) as follows:

     (a) Dopplers, syringes, needles, phlebotomy equipment, suture, urinary catheters, intravenous equipment, ((heparin locks,)) amnihooks, ((and "DeLee type" mucous traps;)) airway suction devices, electronic fetal monitoring, toco monitoring, neonatal and adult resuscitation equipment, including oxygen, glucometer, centrifuge; and

     (b) Pharmacies may ((fill orders for)) issue breast pumps, compression stockings and belts, maternity belts, diaphragms ((which have been issued)) and cervical caps, ordered by licensed midwives ((for postpartum women)).

     (2) In addition to ((medications)) prophylactic ophthalmic medication, postpartum oxytocic, vitamin K, Rho immune globulin (human), and local anesthetic medications as listed in RCW 18.50.115, licensed midwives may obtain and administer the following medications:

     (a) Intravenous fluids limited to Lactated Ringers, 5% Dextrose with Lactated Ringers((, and 5% Dextrose with water)) heparin and 0.9% sodium chloride for use in intravenous locks;

     (b) ((Heparin for use in heparin locks,)) Sterile water for intradermal injections for pain relief;

     (c) Magnesium sulphate for prevention of maternal seizures pending transport;

     (d) Epinephrine for use in ((allergic reactions, and Magnesium Sulphate shall be used according to midwifery advisory committee established protocols. Such protocols shall state the indications for use, the dosage and the administration of these medications.

     (c) Licensed midwives may obtain and administer Rubella)) maternal anaphylaxis pending transport;

     (e) Measles, Mumps, and Rubella (MMR) vaccine to nonimmune postpartum women, HBIG and HBV for neonates born to hepatitis B+ mothers;

     (f) Terbutaline for nonreassuring fetal heart tones and/or cord prolapse pending transport;

     (g) Antibiotics for intrapartum prophylaxis of Group B Beta hemolytic Streptococcus (GBS) per current CDC guidelines; and

     (h) Antihemorrhagic drugs to control postpartum hemorrhage, such as misoprostel per rectum (for use only in postpartum hemorrhage), methylergonovine maleate in the absence of hypertension, oral or intramuscular, prostaglandin F2 alpha (hemobate), intramuscular.

     (3) The client's records shall contain documentation of all medications administered.

     (4) ((Whenever Epinephrine or Magnesium Sulfate is administered, a report, on approved forms, shall be submitted within thirty days to the midwifery advisory committee.)) The midwife must have a procedure, policy or guideline for the use of each drug.

[Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-834-250, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 18.50.040(3) and 18.50.115. 88-12-040 (Order PM 732), § 308-115-250, filed 5/27/88.]

© Washington State Code Reviser's Office