THE IMMUNIZATION LAW AND POLICY PROGRAM MILKEN INSTITUTE, SCHOOL OF PUBLIC HEALTH AND HEALTH SERVICES GEORGE WASHINGTON UNIVERSIY.

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1 THE IMMUNIZATION LAW AND POLICY PROGRAM MILKEN INSTITUTE, SCHOOL OF PUBLIC HEALTH AND HEALTH SERVICES GEORGE WASHINGTON UNIVERSIY Standing Orders: Non-Physician Health Professionals & Immunization Practice Alexandra M. Stewart, JD Fall 2013 This study examines state laws in 2013 that govern the authority of medical assistants, midwives, different categories of nurses, pharmacists, and physician assistants to engage in immunization practice either under their own or delegated authority. Additionally, the settings where vaccines may be administered are identified. This project was funded by the National Center for Immunization & Respiratory Diseases Immunization Services Division (NCIRD) of the Centers for Disease Control and Prevention (CDC) under Contract Number CDC scientists collaborated with GW researchers to design the study and review project findings. Marisa A. Cox, M.A., MPH, Ricardo Lopez, M.A., MPH, Research Assistant, and Jacqueline E. Miller, Esq., MPH Immunization Law and Policy Program, Department of Health Policy, Milken Institute, School of Public Health and Health Services, George Washington University, provided research support.

2 TABLE OF CONTENTS SUMMARY OF FINDINGS... i METHODS... 2 ELEMENTS OF IMMUNIZATION PRACTICE... 2 TERMINOLOGY... 4 MEDICAL ASSISTANTS... 6 MIDWIVES NURSES PHARMACISTS PHYSICIAN ASSISTANTS... 49

3 SUMMARY OF FINDINGS This study examines state laws governing the authority of medical assistants, midwives, different categories of nurses, pharmacists, and physician assistants to: 1) assess a patient s immunization status, 2) prescribe one or more vaccines, and 3) administer vaccines either under their own or delegated authority. Additionally, the permissible patient populations and settings where vaccines may be administered are identified. All states have enacted laws permitting physicians to delegate certain medical tasks to nonphysician health professionals. Some states identify the providers who have legal authority to vaccinate patients. Laws that clearly outline the appropriate process and personnel authorized to administer vaccines under delegated authority protect providers from exposure to civil and/or criminal liability. Providers must ensure that the law authorizes patient assessment, prescription, or administration before proceeding. Most states have adopted vaccination-specific terminology when describing permissible practice. Other states reference a variation of drugs or legend drugs, or medications. Medical Assistants: Less than one-third of all states address the ability of medical assistants to assess or administer medications or vaccines and no state addresses prescription authority. Most states permitting medical assistants to administer vaccines require a physician, physician assistant, or a nurse in advanced practice to directly supervise the medical assistant, who typically must work within the physical boundaries of the provider s office. Midwives: In most states, certified midwives who are advanced practice nurses are subject to collaborative practice agreements and provide health care under the direction of a physician or protocols developed with a physician. The agreement may authorize a midwife to conduct patient assessments, write prescriptions, and administer medications in a variety of clinical and office settings. Several states have restricted the patients who may receive vaccination from midwives, because the practice of midwifery is limited to women and newborns. Nurses: This review includes various categories of nurses: 1) Nurses in Advanced Practice: a) Advanced Practice Nurse, b) Clinical Nurse Specialist, c) Nurse Practitioner; 2) Registered Nurse; 3) Practical Nurse; and 4) Vocational Nurse. Most states permit all categories of nurses to administer medications under their own or delegated authority. In addition to public and private clinical settings, nurses may practice in a broad range of community locations. Pharmacists: All states address how pharmacists may assess, prescribe, and/or administer vaccines under their own or delegated authority. Approximately half of states permit pharmacists to administer vaccines to children. Laws governing pharmacists most frequently reference vaccines, or adult or childhood immunizations. The most commonly identified vaccines are influenza, pneumococcal, and zoster vaccines. In addition to pharmacies, hospitals, and other health care facilities, a limited number of states authorize pharmacists to administer vaccines in other settings. Physician Assistants: All jurisdictions address the authorization of physician assistants to assess, prescribe, or administer vaccines and the level of required supervision. More than half of the states permit physician assistants to undertake immunization practice in a broad range of settings including a wide range of clinical and community locations. i

4 A decrease in the number of primary care physicians, coupled with an increase in the number of patients, requires a shift from physician-centered care to a model that includes sharing responsibility with non-physician health professionals. Delegating preventive services to nonphysician health professionals is a proven strategy to increase a physician s ability to provide high quality care to more patients. 1 Because the provision of vaccination services constitutes the conduct of medical practice, vaccine delivery is under the sole control of a physician and requires formal authorization in order for non-physicians to perform any procedure that constitutes medical practice. This study examines state laws governing the authority of medical assistants, midwives, different categories of nurses, pharmacists, and physician assistants to: 1) assess a patient s immunization status, 2) prescribe one or more vaccines, and 3) administer vaccines either under their own or delegated authority. Additionally, the settings where vaccines may be administered are identified. METHODS Using a standard legal research database, researchers identified medical and health professional practice acts and other relevant statutes and regulations, attorneys general opinions, judicial decisions, and professional licensing board decisions from fifty states and the District of Columbia (for purposes of this project the District of Columbia is considered a state). The data were analyzed to determine how the three elements of immunization practice were addressed: patient assessment, prescriptions for vaccines, and administration of vaccines. We also determined whether specific vaccines were identified, the permissible patient populations, and the permissible practice settings. ELEMENTS OF IMMUNIZATION PRACTICE The process of vaccinating an individual requires three separate activities: 1) Assessment of a patient s immunization status: Assessment may include screening, examining, diagnosing, or treating the patient. It does not include merely collecting or reporting data, taking a patient s history, or interviewing patients. 2) Prescription for one or more vaccines: Prescribing is oral, written, or electronic, and excludes simply transmitting a prescription issued by another provider. 3) Administration of one or more vaccines: Vaccines may be administered by injection, orally, or nasally. Administration does not include dispensing medication. Dispensing refers to the preparation, packaging, labeling, record keeping, and transfer of a prescription drug to a patient or an intermediary, who is responsible for administration of the drug. 2 1 Altschuler, J. et al. Estimating a Reasonable Patient Panel Size for Primary Care Physicians with Team-Based Task Delegation. Annals of Family Medicine. Vol. 10, No. 5. Oct Mosby's Medical Dictionary, 8th edition

5 THE ROLE OF STATE LAW IN REGULATING IMMUNIZATION PRACTICE All states have enacted laws permitting physicians to delegate certain medical tasks to non-physician health professionals. Some laws identify the providers who have legal authority to vaccinate patients, while in other cases, the law is silent. Laws that clearly outline the appropriate process and personnel who may assess a patient s vaccination status, prescribe vaccines, and administer vaccines will protect providers from exposure to civil and/or criminal liability. All providers who engage in any aspect of immunization practice must ensure that the law permits the activities before proceeding. The following excerpt from a 1997 case decided by the Appellate Court of Illinois, demonstrates the importance of establishing legal authorization before delegating medical care to non-physician personnel. A medical assistant (MA) had attended an educational program for MAs, taken additional relevant university classes, and further courses in a registered nurse program, all outside of Illinois. She had worked for multiple medical practices in Illinois for more than two decades, where a supervising physician instructed her to administer vaccines. She was convicted of practicing nursing without a license, in violation of the state s Nursing Act. She was sentenced to one year of supervision, was levied a $ fine, and was required to perform 60 hours of public service employment. While the court recognized that the MA had the ability and qualifications to perform the tasks, the court was unable to identify any provision in state law that outlined the functions of a medical assistant. The lack of explicit legal permission required the court to find the MA had acted outside the scope of her authority, even though the supervising physician had provided instruction, other supports, and remained on site: Dr. Kovacevic explained that, as a medical assistant, Stults performed... immunizations, during which he supervised her. In explaining what he meant by supervision, Dr. Kovacevic stated that supervision meant that he filled the needle, told Stults what to do, and then was somewhere in the office while Stults gave the immunization.... We find no Illinois statute that defines what a medical assistant is or designates what functions a medical assistant is able to perform.... [W]e find that the legislature carefully provided for assistants to medical personnel where it deemed assistants were warranted.... Therefore, because no statute provides that medical assistants may perform some of the same functions as nurses, Stults' performing the various nursing duties, even as a medical assistant, was in violation of the Nursing Act.... A person without a nursing license may not evaluate, treat, or counsel the ill, infirmed, or injured and may not administer medication to others. People v. Stults, 683 N.E.2d 521 (Ill. App. Ct. 1997) 3

6 TERMINOLOGY Delegation of Medical Care State laws delineating the authority of a medical provider to delegate identified medical tasks to a non-physician healthcare professional are described using different terminology and have been included in our research: 1) with collaboration, 2) collaborative practice, 3) collaborative practice agreement, 4) collaborative authority, 5) collaborating provider, 6) delegated authority, 7) delegation order, 8) delegation agreement, or 9) indicating acts that may be delegated from one provider to another. Additionally, a state s law may indicate that certain acts may only be performed with a prescription or with prescriptive authority or under a prescriptive agreement. Some states permit the delegation of health care through standardized procedures termed standing orders. Standing orders allow non-physician clinical personnel to assess patients and administer vaccines without a patient-specific order. Standing orders describe the specific type of medical practice that will be delegated, delineate the procedures that personnel must follow, identify the patient population that may be served, specify the level of physician supervision required, and govern the settings where services may occur. Adoption of Non Immunization-Specific Terms Several states use non-specific terms when addressing the authority of non-physicians to assess, prescribe, or administer vaccines. The following examples can describe vaccines and immunizations and have been included in our research: 1) diagnostic or therapeutic regimens, 2) drug or device by injection, 3) legend drug 3 /substances, 4) medications, 4 5) pharmacological agents, 6) prescription drugs or devices, 7) Schedule VI controlled substances, or 8) therapeutic measures. Adoption of Immunization-Specific Terms Forty-nine states have adopted immunization-specific terminology when describing permissible practice among the 10 categories of health professionals under review. See Table 1 below. 3 Legend drugs have been included because they are approved by the U.S. Food and Drug Administration (FDA) and are required by federal or state law to be dispensed to the public only when a licensed physician or other licensed provider prescribes them. A legend drug can be a controlled substance (narcotic), or a non-narcotic Legend Drug Law and Legal Definition. USLegal.com. Available at: 4 Medication is a general term that includes drugs and pharmaceuticals. Medications may be administered by injection or other methods. 4

7 Sixteen of 48 states apply immunization-specific language to only one category of health professional: fifteen of these states refer to pharmacists (Alabama, Arizona, Delaware, Florida, Idaho, Kansas, Louisiana, Nevada, North Carolina, North Dakota, Ohio, Rhode Island, South Carolina, West Virginia, and Wyoming). Michigan and Texas are the two states that use immunization-specific terms for all 11 categories of professionals. TABLE 1 STATES USING IMMUNIZATION-SPECIFIC LANGUAGE PROFESSIONAL STATE Medical Assistant Alaska, Georgia, Maryland, Michigan, Montana, Texas, Washington Midwife Massachusetts, Michigan, Mississippi, New York, Pennsylvania, Texas, Vermont, Washington Advanced Practice Nurse Connecticut, District of Columbia, Hawai i, Illinois, Iowa, Kentucky, Michigan, Texas Clinical Nurse Specialist Michigan, Mississippi, South Dakota, Texas Nurse Practitioner Alaska,, Massachusetts, Michigan, Mississippi, New York, Oregon, Pennsylvania, South Dakota, Texas, Washington Practical Nurse Connecticut, Georgia, Indiana, Maine, Massachusetts, Michigan, Mississippi, Pennsylvania, Tennessee, Texas, Virginia, Washington Alaska, Arkansas,, Colorado, Connecticut, Georgia, Illinois, Registered Nurse Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Texas, Virginia, Washington Vocational Nurse, Michigan, Texas Alabama, Arizona, Arkansas,, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawai i, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Pharmacist Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming Physician Assistant, Colorado, Hawai i, Illinois, Iowa, Massachusetts, Michigan, Oklahoma, Oregon, South Dakota, Texas, Wisconsin Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice Fall

8 MEDICAL ASSISTANTS Fifteen states address the ability of medical assistants (MAs) to assess patients or administer drugs, medications or vaccines either through statute or case law. These states are: Alaska, Arizona, Arkansas,, Florida, Georgia, Maryland, Michigan, Montana, New Jersey, South Dakota, Texas, and Washington. Illinois and Wyoming address MAs scope of practice only in case law, which showed that: Illinois prohibits MAs from practicing in the state and Wyoming permits MAs to routinely inject medications. See Table 2 and Figure 1 below. Authority to Assess Patient Status Five states address patient assessments (Arizona, Illinois, Maryland, South Dakota, and Texas). Arizona, South Dakota, and Texas allow MAs to conduct assessments under delegated authority, while Illinois and Maryland prohibit assessments. Excerpts from Texas and Maryland follow: [S]tanding delegation orders may include authority to undertake the following... (1) the taking of personal and medical history; (2) the performance of appropriate physical examination and the recording of physical findings Tex. Admin. Code (2012) Scope of Standing Delegation Orders * * * A. A physician may not delegate to an assistant technical acts which are exclusively limited to any individual required to be licensed, certified, registered, or otherwise recognized pursuant to any provision of the Health Occupations Article and the Education Article, Annotated Code of Maryland.... Code of Md. Regs (2012) Scope of Delegation; Code of Md (2013) Definitions; Code of Md. 19-3B-01 (2013) Definitions Authority to Prescribe Vaccines No state addresses whether MAs may prescribe any drugs, medication, or vaccine either under their own or delegated authority. Authority to Administer Vaccines Fourteen of the 15 states permit MAs to administer drugs, injections, medications, or vaccines, but only under delegated authority (Alaska, Arizona, Arkansas,, Florida, Georgia, Maryland, Michigan, Montana, New Jersey, South Dakota, Texas, Washington, and Wyoming). An example from Washington s statute is below: (4) A medical assistant-registered may perform the following duties delegated by, and under the supervision of, a health care practitioner... (f) Administering... vaccines, including combination or multidose vaccines.... Rev. Code of Wash , amended by 2013 Wash. Legis. Serv. Ch. 128 (S.H.B. 1515) (2013) Medical assistant-certified Authorized delegated duties Four state courts have addressed vaccine administration and MAs (Illinois, Georgia, Maryland, and Wyoming). Of the 4 decisions, Illinois is the only state that explicitly prohibits medical assistants from conducting any element of immunization practice. The court held that a 6

9 person without a nursing license may not evaluate, treat, or counsel the ill, infirmed, or injured and may not administer medication to others. 5 In cases in Georgia, 6 Maryland, 7 and Wyoming, 8 MAs routine administration of injectable medications or vaccines was determined to be within the scope of the MAs practice. Defining Patients who may Receive Vaccinations No state specifies the age range of patients who may receive vaccinations or other medications from MAs. Level of Supervision Required to Practice Thirteen states address the level of supervision MAs require (Alaska, Arizona, Arkansas,, Florida, Georgia, Maryland, Michigan, Montana, New Jersey, South Dakota, Texas, and Washington). In some states, MAs must be directly supervised. Other states include additional directives related to supervisor proximity to the MA while a vaccine is administered. Finally, states may specify only that MAs must be supervised. Arizona, Florida, and South Dakota require direct supervision. However, the obligations of the supervisor are not defined. Florida and South Dakota limit supervision authority to licensed physicians, while Arizona permits physician assistants or nurse practitioners to supervise MAs. An excerpt from Arizona is below: A. A medical assistant may perform the following medical procedures under the direct supervision of a doctor of medicine, physician assistant or nurse practitioner Administer injections. Ariz. Rev. Stat (2012) Medical assistants; use of title; violation; classification Four of the 13 states require the supervising physician, physician assistant, or advanced practice nurse to remain on-site during the administration of a vaccine (Alaska, Maryland, Montana, and New Jersey). Montana and New Jersey illustrate this policy: (2) Medical assistants shall work under the supervision of a Montana-licensed physician or podiatrist who is responsible for assigning administrative and clinical tasks to the medical assistant relating to the physician or podiatrist's practice of medicine. (3) Physician or podiatrist supervision shall be active and continuous but does not require the physical presence of the supervising physician or podiatrist at the time and place that services are rendered so long as the physician or podiatrist is available for consultation, except that physician or podiatrist supervision shall be onsite when a medical assistant performs: (a) invasive procedures; (b) administers medicine; or (c) performs allergy testing.... (7) The following tasks may not be assigned to a medical assistant: (a) any [invasive] procedures, including injections other than immunizations.... Admin. Rules of Mont (2012) Medical Assistant 5 People v. Stults, 683 N.E.2d 521 (Ill. App. Ct. 1997) 6 Kerr v. OB/GYN Associates of Savannah et al., 314 Ga.App. 40, 723 S.E.2d 302 (2012) 7 Community Clinic, Inc. et al. v. Department of Health and Mental Hygiene et al., 174 Md.App. 526, 922 A.2d 607. (2007) 8 Beavis v. Campbell County Memorial Hospital, 20 P.3d 508 (2001) 7

10 * * * 4. The physician shall remain on the premises at all times that treatment orders for injections are being carried out by the assistant and shall be within reasonable proximity to the treatment room and available to observe, assess and take any necessary action regarding effectiveness, adverse reaction or any emergency. 5. The certified medical assistant shall wear a clearly visible identification badge indicating his or her name and credentials.... N.J. Admin. Code 13: (2012) Delegation of administration of subcutaneous and intramuscular injections to certified medical assistants Arkansas is the only state that leaves the level of supervision to the discretion of the physician. An excerpt from the law is below: Section 2. Procedures for Delegating a Medical Practice A. Prior to delegating a medical practice or task, the physician shall determine the following:... 3) The appropriate level of supervision for the Physician to exercise while the medical practice or task is being performed.... Ark. Admin. Code (2012) Physician Delegation Regulation Five of the 13 states indicate only that MAs must be supervised (, Georgia, Michigan, Texas, and Washington). Quotes from Michigan and are below. In, specific authorization is required and Michigan requires only physician direction: (a)(1) Notwithstanding any other provision of law, a medical assistant may administer medication only by intradermal, subcutaneous, or intramuscular injections and perform skin tests and additional technical supportive services upon the specific authorization and supervision of a licensed physician and surgeon or a licensed podiatrist.... Cal. Business and Professions Code 2069 (2012) Medical assistants; authorized tasks under direction of certain medical professionals; delegation of supervision; definitions; inpatient care in general acute care hospitals prohibited; section not to be constructed to authorize medical assistants to perform certain tasks or nurse practitioner, nurse- midwife or physician assistant to be a laboratory director of a clinical laboratory * * * A health professional other than a physician may administer an immunizing agent as long as the agent is being administered under the direction of a physician. Mich. Comp. Laws (2013) Person who may administer immunizing agent Settings where Medical Assistants are Authorized to Vaccinate Six states identify the settings where the MA may perform (Alaska, Arkansas,, Georgia, Texas, and Washington). Alaska permits MAs to practice in any private or public ambulatory care setting: (b)... The certified medical assistant may only perform the delegated duty in a private or public ambulatory care setting Alaska Admin. Code (2012) Delegation of the administration of injectable medication 8

11 Arkansas, Georgia, Texas, and Washington allow MAs to provide services in the delegating physician s office. Arkansas requires the MA to work within the physical boundaries of the office as shown below: Section 3. Additional Requirements for Delegating the Administration of Drugs.... B. Administration of drugs, delegated pursuant to this Regulation, shall only be permissible within the physical boundaries of the delegating physician's offices... Ark. Admin. Code (2012) Physician Delegation Regulation permits MAs to work in licensed clinics: (a)(1) Notwithstanding any other provision of law, a medical assistant may administer medication only by intradermal, subcutaneous, or intramuscular injections and perform skin tests and additional technical supportive services upon the specific authorization and supervision of a licensed physician and surgeon or a licensed podiatrist. A medical assistant may also perform all these tasks and services in a [licensed] clinic... upon the specific authorization of a physician assistant, a nurse practitioner, or a nurse-midwife. Cal. Business and Professions Code 2069 (2012) Medical assistants; authorized tasks under direction of certain medical professionals; delegation of supervision; definitions; inpatient care in general acute care hospitals prohibited; section not to be constructed to authorize medical assistants to perform certain tasks or nurse practitioner, nurse-midwife or physician assistant to be a laboratory director of a clinical laboratory In Texas, MAs may provide services at facilities licensed by the State Board of Pharmacy: (c) A physician may also delegate to any qualified and properly trained person acting under the physician's supervision the act of administering or providing dangerous drugs through a facility licensed by the Texas State Board of Pharmacy, as ordered by the physician, that are used or required to meet the immediate needs of the physician's patients.... Tex. Stat. & Codes (2012) General Delegation of Administration and Provision of Dangerous Drugs; see also Tex. Stat. & Codes (2012) General Delegation of Administration and Provision of Dangerous Drugs Washington allows MAs to perform their duties at group practices, other health care facilities, and rural and small medical practices and clinics: The legislature finds that medical assistants are health professionals specifically trained to work in settings such as physicians' offices, clinics, group practices, and other health care facilities.... The legislature further finds that rural and small medical practices and clinics may have limited access to formally trained medical assistants.... Rev. Code of Wash , amended by 2013 Wash. Legis. Serv. Ch. 128 (S.H.B. 1515) (2013) Findings 9

12 Table 2: STANDING ORDERS: Medical Assistants & Immunization Practice Assessment Prescription Administration STATE Own Delegated Own Delegated Own Delegated Prohibited Prohibited Authority Authority Authority Authority Authority Authority Prohibited Alaska Arizona Arkansas Florida Georgia Illinois Maryland Michigan Montana N Jersey S Dakota Texas Washington Wyoming Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice Fall

13 Figure 1 Medical Assistants Medical Assistants are most frequently permitted to administer immunizations or injectable medications, followed by medications and drugs. No state identifies specific vaccines. Drugs or Legend Drugs/Substances Arkansas Maryland (oral) Texas Washington Medications Arizona Florida Illinois (prohibited) Montana South Dakota Washington Immunizations or Vaccines Alaska Georgia Illinois (prohibited) Maryland Michigan Montana Texas Washington Injectable Medication/Inoculation Alaska Arizona Georgia Maryland New Jersey Wyoming 11

14 MIDWIVES Midwives practice in all states under a variety of titles. Titles that appear in state laws include: certified nurse midwife, registered nurse midwife, nurse midwife, midwife, and traditional midwife. New Hampshire is the only state where physician assistants may be authorized to practice midwifery. See Table 3 and Figure 2 below. Forty-nine states address whether midwives may assess, prescribe, or administer drugs, medications, or vaccines. The laws in Oregon and Rhode Island do not address any of the elements of immunization practice for midwives. Authority to Assess Patient Status Forty-five states allow midwives to conduct patient assessments under their own authority. Twenty-eight of the 45 states also permit the practice under delegated authority. No state prohibits midwives from conducting patient assessments. Six states do not address this element of immunization practice (Kentucky, Michigan, New Jersey, Oregon, Pennsylvania, and Rhode Island). The excerpt from Utah shows that a collaborative agreement between a certified nurse midwife and a physician must be established in order for the midwife to conduct assessments: 9) Practice as a certified nurse midwife... (b)... includes: (i) having a safe mechanism for obtaining medical consultation, collaboration, and referral with one or more consulting physicians who have agreed to consult, collaborate, and receive referrals, but who are not required to sign a written document regarding the agreement... (iii) maintaining written documentation of the parameters of service for independent and collaborative midwifery management and transfer of care when needed... (c) the authority to: (i) elicit and record a patient's complete health information, including physical examination... (ii) assess findings and upon abnormal findings from the history, physical examination... collaborate with the consulting physician or another qualified physician, or refer the patient to the consulting physician or to another qualified physician as appropriate; (iii) diagnose, plan, and implement appropriate patient care, including the administration and prescribing of: (A) prescription drugs.... Utah Code 58-44a-102 (2012) Definitions Authority to Prescribe Vaccines Forty-four states address how midwives may prescribe drugs, medications, or vaccines under their own authority or through delegation. Seventeen states permit midwives to prescribe under their own license. Thirty states authorize midwives to prescribe under delegated authority. Montana, Tennessee, and Vermont are the three states that grant both independent and delegated prescription authority. Eight states do not address this element of immunization practice (Arizona, Arkansas, Connecticut, Michigan, Nebraska, Nevada, Oregon, and Rhode Island). Arizona and Minnesota have adopted different policies related to prescription authority for different categories of midwives. Arizona permits certified nurse midwives to prescribe legend drugs under their own authority. In contrast, Minnesota allows certified nurse midwives 12

15 to prescribe only under delegated authority. Traditional midwives in Minnesota shall not prescribe, [or] dispense... prescription drugs. The following provisions from Alabama and Pennsylvania illustrate how midwives may prescribe drugs and vaccines within a collaborative agreement. Examples from the District of Columbia and New Mexico authorize midwives to prescribe medications and dangerous drugs under their own authority: (a)... [C]ertified nurse midwives, engaged in collaborative practice with physicians practicing under protocols approved in the manner prescribed by this article may prescribe legend drugs to their patients.... Code of Ala (2012) Prescribing legend drugs; initiating call-in prescriptions; administering legend drugs * * * (5) A nurse-midwife may, in accordance with a collaborative agreement with a physician, and consistent with the nurse-midwife's academic educational preparation and National certification by the AMCB or its successor organizations, prescribe, dispense, order and administer... immunizing agents... and preventative measures. 49 Pa. Admin. Code 18.6 (2012) Practice of midwifery * * * [T]he nurse-midwife may perform any of the acts listed below, including:... (h) Prescribe appropriate medications... (j) Provide primary health care Dist. of Columbia Municipal Regs (2012) Scope of Practice * * * PRACTICE OF THE CERTIFIED NURSE-MIDWIFE: A. Scope of practice: midwifery practice as conducted by a CNM is the independent management of women's health care, focusing particularly on common primary care issues.... A CNM independently prescribes, distributes and administers dangerous drugs and devices appropriate to a client's condition..... B. Prescriptive authority. (1)... (a) A CNM may independently prescribe, distribute or administer dangerous drugs and devices appropriate to a client's condition.... N.M. Admin. Code (2012) Certified Nurse Midwives Authority to Administer Vaccines Forty-seven states address whether midwives may administer medications and/or vaccines. Eighteen of the 47 states permit midwives to administer under their own license and 44 allow administration under delegation. Fifteen states permit administration under both categories of authority. The four states that do not address administration duties are New Jersey, North Carolina, Oregon, and Rhode Island. Various levels of midwives in Arizona and Minnesota are granted different categories of authority related to administration of medications. As seen below, in Arizona, certified nurse midwives may administer legend drugs under independent authority, while midwives in the state are prohibited from doing so. Minnesota s rules are more restrictive for traditional midwives than those that apply to certified nurse midwives: CERTIFIED NURSE MIDWIFE A. The Board recognizes the following APRN roles: 1. Registered nurse practitioner (RNP) in a population focus including Certified Nurse Midwife as a population focus of RNP.... Ariz. 13

16 Admin. Code R , amended by 2013 AZ REG TEXT (2013) Roles and Population Foci of Advanced Practice Registered Nursing (APRN); Certification Programs 15. "Registered nurse practitioner" means a professional nurse who... (d) Has an expanded scope of practice within a specialty area that includes:... (v)... administering and dispensing therapeutic measures, including legend drugs... within the scope of registered nurse practitioner practice... Ariz. Rev. Stat (2012) Definitions A. An RNP... may: 1. Prescribe drugs and devices.... Ariz. Admin. Code R (2012) Prescribing Drugs and Devices MIDWIFE D. A midwife shall not administer drugs or medications except as provided in [referenced citations in other parts of the law that do not include any reference to vaccines or immunizations].... Ariz. Admin. Code R (2012) Prohibited Practice; Transfer of Care * * * Subdivision 1. Certified nurse-midwives. A certified nurse-midwife may prescribe and administer drugs and therapeutic devices within practice as a certified nurse-midwife.... Minn. Stat (2012) Prescribing drugs and therapeutic devices Subd. 9. Traditional midwifery services. Traditional midwifery services means the assessment and care of a woman and newborn during pregnancy, labor, birth, and the postpartum period outside a hospital.... Minn. Stat. 147D.01 (2012) Definitions (a) A licensed traditional midwife shall not prescribe, dispense, or administer prescription drugs, except as permitted under paragraph (b). (b) A licensed traditional midwife may administer vitamin K either orally or through intramuscular injection, postpartum antihemorrhagic drugs under emergency situations, local anesthetic, oxygen, and a prophylactic eye agent to the newborn infant.... Minn. Stat. 147D.09 (2012) Limitations of practice The provisions below from New Mexico and Washington show how midwives may administer drugs. Note that Washington limits administration authority to specific vaccines: The licensed midwife may provide care to women without general health or obstetrical complications.... Such care includes... (4) Well-woman care... (6) Administration of specific drugs and medications as outlined in the Mexico Midwives Association Policies and Procedures.... N.M. Admin. Code (2012) Licensed Midwives * * * A midwife licensed under this chapter may... administer such other drugs or medications as prescribed by a physician.... Rev. Code of Wash (2012) Administration of drugs and medications Rules (2)... [L]icensed midwives may obtain and administer the following medications... (e) Measles, Mumps, and Rubella (MMR) vaccine to nonimmune postpartum women, HBIG and HBV for neonates born to hepatitis B+ mothers.... Wash. Admin. Code (2012) Legend drugs and devices 14

17 Defining Patients who may Receive Vaccinations Eleven states have restricted the patients who may receive vaccinations from midwives (Arkansas, Massachusetts, Minnesota, Montana, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Washington, and Wisconsin). Because the practice of midwifery is necessarily limited to women and newborns, midwives have fewer opportunities to provide vaccines to a full range of patient populations. The following selections from Washington and Wisconsin outline a typical explanation of the scope of practice for midwives and the patients who may receive vaccines: (B)... (iv) Practice of nurse midwifery means the performance for compensation of nursing skills relevant to the management of women's health care, focusing on pregnancy, childbirth, the postpartum period, care of the newborn, family planning, and gynecological needs of women, within a health care system that provides for consultation, collaborative management, or referral as indicated by the health status of the client.... Ark. Code (2012) Definitions; see also Ark. Admin. Code II (2012) The Practice of Nursing * * * (2)... [L]icensed midwives may obtain and administer the following medications... (e) Measles, Mumps, and Rubella (MMR) vaccine to nonimmune postpartum women, HBIG and HBV for neonates born to hepatitis B+ mothers.... Wash. Admin. Code (2012) Legend drugs and devices * * * (1) The scope of practice is the overall management of women's health care, pregnancy, childbirth, postpartum care for newborns, family planning, and gynecological services consistent with the standards of practice of the American College of Nurse-Midwives and the education, training, and experience of the nurse-midwife. (2) The nurse-midwife shall collaborate with a physician with postgraduate training in obstetrics pursuant to a written agreement with that physician.... Wis. Admin. Code N 4.06 (2012) Scope of practice Level of Supervision Required to Practice In 38 states certified nurse midwives who are advanced practice nurses are subject to collaborative practice agreements and provide health care under the direction of a physician or protocols developed with a licensed physician. The agreement authorizes categories of care, treatment, or procedures to be performed by the midwife and the conditions for their performance (Alabama, Arkansas,, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, and Wisconsin). 15

18 The laws in Kansas and Massachusetts are examples of the performance expectations for both the physician and the midwife engaged in collaborative practice: Each [nurse midwife] shall be authorized to make independent decisions about advanced practice nursing needs of families, patients, and clients and medical decisions based on the authorization for collaborative practice with one or more physicians.... Kan. Admin. Regs (2012) Definition of expanded role; limitations; restrictions (a) Each written protocol that [a nurse midwife] is to follow when prescribing, administering, or supplying a prescription-only drug.... Kan. Admin. Regs a (2012) Protocol requirements; prescription orders Each advanced practice registered nurse in the role of nurse-mid-wife... shall be authorized to perform the following: (a) Provide independent nursing diagnosis... and treatment... (b) develop and manage the medical plan of care for patients or clients, based on the authorization for collaborative practice.... Kan. Admin. Regs (2012) Functions of the advanced practice registered nurse in the role of nurse-midwife (d) [a nurse midwife] may prescribe drugs pursuant to a written protocol as authorized by a responsible physician. Each written protocol shall contain a precise and detailed medical plan of care for each classification of disease or injury for which the advanced registered nurse practitioner is authorized to prescribe and shall specify all drugs which may be prescribed by the advanced registered nurse practitioner.... Kan. Stat (2012) Advanced practice nurse; standards and requirements for licensure; rules and regulations; roles, titles and abbreviations; prescription of drugs authorized; licensure of currently registered individuals * * * (4) Physician Supervision of [a Nurse Midwife] Engaged in Prescriptive Practice. (a) A supervising physician shall review and provide ongoing direction for the [nurse midwife s] prescriptive practice in accordance with written guidelines mutually developed and agreed upon with the [nurse midwife]... and the regulations of the Board of Registration in Nursing.... This supervision shall be provided as is necessary, taking into account the education, training and experience of the [nurse midwife], the nature of the [midwife s] practice, and the physician's availability to provide clinical backup to ensure that the [nurse midwife] is providing patient care in accordance with accepted standards of practice. (b) A supervising physician shall sign prescriptive practice guidelines only with those [midwives] for whom he or she is able to provide supervision... and (3), taking into account factors including, but not limited to geographical proximity, practice setting, volume and complexity of the patient population, and the experience, training and availability of the supervising physician and the [midwifes]. 243 Code of Mass. Regs (2012) Advanced Practice Nurse (APN) Eligible to Engage in Prescriptive Practice In Illinois, supervising physicians who have entered into a collaborative agreement with a midwife (who is considered an advanced practice nurse in the state), shall not be responsible for the acts or omissions of the midwife unless the physician has reason to believe the midwife is incompetent or commits willful and wanton misconduct : (e) A physician shall not be liable for the acts or omissions of a[n]... advanced practice nurse solely on the basis of having signed a supervision agreement or guidelines or a collaborative agreement, an order, a standing medical order, a standing delegation order, or other order or guideline authorizing a[n]... advanced practice nurse to perform acts, unless the physician has reason to believe the... advanced practice nurse lacked the competency to perform the act or acts or commits willful and wanton misconduct. (f) A collaborating physician may, but is not required to, delegate prescriptive authority to an 16

19 advanced practice nurse as part of a written collaborative agreement, and the delegation of prescriptive authority shall conform to the requirements of Section of the Nurse Practice Act Ill. Compiled Stat. 60/54.5 (2012) Physician delegation of authority to physician assistants and advanced practice nurses (a) A collaborating physician or podiatrist may, but is not required to, delegate prescriptive authority to an advanced practice nurse as part of a written collaborative agreement. This authority may, but is not required to, include prescription of, selection of, orders for, administration of, storage of, acceptance of samples of, and dispensing over the counter medications, legend drugs... and other preparations, including, but not limited to, botanical and herbal remedies Ill. Compiled Stat. 65/65-40 (2012) Written collaborative agreement; prescriptive authority Settings where Midwives are Authorized to Vaccinate Typically, state laws do not identify clinical and office settings where midwives are authorized to practice. However, 9 states have included provisions outlining the settings where midwives may practice (Illinois, Indiana, Iowa, Maryland, Massachusetts, Nebraska, North Dakota, Texas, and Wisconsin). Midwives may practice in settings including: hospitals, ambulatory surgical treatment centers, physicians offices, private practice, or any setting. Maryland permits midwives to practice in a nonprofit medical facility or clinic; health center operating on the campus of an institution of higher learning; public health facility; medical facility under contract with a state or local health department; or facility funded with public funds. Nebraska s law incorporates many of the typical settings where midwives may practice: (3) A certified nurse midwife may perform authorized medical functions only in the following settings: (a) In a licensed or certified health care facility as an employee or as a person granted privileges by the facility; (b) In the primary office of a licensed practitioner or in any setting authorized by the collaborating licensed practitioner, except that a certified nurse midwife shall not attend a home delivery; or (c) Within an organized public health agency.... Rev. Stat. of Neb (2012) Permitted practice described in practice agreement; supervision; settings; subject to review by board; rules and regulations 17

20 ` -Table 3: STANDING ORDERS: MIDWIVES & Immunization Practice ASSESSMENT PRESCRIPTION ADMINISTRATION STATE Own Delegated Own Delegated Own Delegated Prohibited Prohibited Authority Authority Authority Authority Authority Authority Prohibited Alabama Alaska Arizona Arkansas Colorado Connecticut Delaware DC Florida Georgia Hawai i Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Mass. Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada N Hamp. ` N Jersey N Mexico N York N Carolina N Dakota Ohio Oklahoma Oregon Penn. R Island S Carolina S Dakota Tennessee Texas Utah Vermont Virginia Washington W Virginia Wisconsin Wyoming Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice Fall

21 Figure 2 - Midwives Most frequently, states permit at least one category of midwife to administer medications, followed by immunizations or vaccines. Drugs or Legend Drugs/Substances Alabama Arizona Hawai i Illinois Kansas Maine Massachusetts Minnesota Missouri New Hampshire New Mexico North Dakota South Carolina Texas Utah Washington Wisconsin Medications Alabama Alaska Arizona Arkansas Colorado Delaware DC Florida Georgia Hawai i Idaho Illinois Iowa Kentucky Maine Maryland Minnesota Mississippi Missouri Montana Nevada New Hampshire New Mexico North Dakota Ohio Oklahoma Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia West Virginia Wyoming Immunizations or Vaccines Alaska Arkansas Colorado Hawai i Illinois Indiana Iowa Kentucky Maine Massachusetts Michigan Minnesota Mississippi Missouri New Hampshire New York Pennsylvania Tennessee Texas Virginia Washington Injectable Medication/Inoculation Alaska Maryland Virginia Pharmacological Agents Hawai i Idaho Therapeutic Measure/Regimen Hawai i Maryland HBIG Washington Hepatitis B Tennessee (case law) Washington Influenza Connecticut Georgia Massachusetts MMR Washington Pneumococcal Connecticut Rubella Vermont 19

22 NURSES This review included various categories of nurses including: 1) Nurses in Advanced Practice: a) Advanced Practice Nurse, b) Clinical Nurse Specialist, c) Nurse Practitioner, 2) Registered Nurse, 3) Practical Nurse, and 4) Vocational Nurse. All states address the ability of at least one category of nurse to assess, prescribe, or administer vaccines. See Tables 3, 4, 5 and Figures 3, 4, 5, 6, 7 below. Authority to Assess Patient Status Nurses in Advanced Practice Forty-nine states address assessment authority for nurses in advanced practice. Kentucky and Michigan are the two states that do not reference the practice. Forty-eight states (excluding Pennsylvania) permit advanced practice nurses to conduct patient assessments under their own license. Thirty-two states authorize patient assessments under delegated authority. No state prohibits assessments. The examples from Alabama describe how nurse practitioners may conduct assessments: (1) The certified registered nurse practitioner is responsible and accountable for the continuous and comprehensive management of a broad range of health services... with physician collaboration.... These services include but are not restricted to the following: (a) Evaluate current health status and risk factors of individuals based on comprehensive health history and comprehensive physical examinations and assessments. (b) Formulate a working diagnosis, develop and implement a treatment plan, evaluate and modify therapeutic regimens to promote positive patient outcomes.... Ala. Admin. Code r. 610-X (2012) Functions And Activities 2Of Certified Registered Nurse Practitioners... (3) ADVANCED PRACTICE NURSE.... A registered nurse.... Certified registered nurse practitioners (CRNP).... Certified registered nurse practitioners... are subject to collaborative practice agreements with an Alabama physician..... (5) COLLABORATION. A formal relationship between one or more certified registered nurse practitioners... and a physician or physicians under which these nurses may engage in advanced practice nursing as evidenced by written protocols approved in accordance with the requirements of this article or exempted in accordance with requirements of this article.... Code of Ala (2012) Definitions Registered Nurses Registered nurses (RNs) may assess patients in all states except Kentucky, Michigan, and Pennsylvania (48/51). These states permit RNs to assess under their own authority. Twentythree of the 48 states also permit RNs to assess under delegated authority (Alabama, Arizona, Delaware, DC, Florida, Hawai i, Idaho, Illinois, Indiana, Kansas, Montana, Nebraska, New Hampshire, New Mexico, North Dakota, Oklahoma, Oregon, South Carolina, Texas, Utah, Vermont, Washington, and Wyoming). No state prohibits RNs from conducting assessments. Provisions from Illinois are below: 20