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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 200-201142010. 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. TABLE OF CONTENTS SUMMARY OF FINDINGS ......................................................................................................... i METHODS .................................................................................................................................... 2 ELEMENTS OF IMMUNIZATION PRACTICE ..................................................................... 2 TERMINOLOGY ......................................................................................................................... 4 MEDICAL ASSISTANTS ............................................................................................................ 6 MIDWIVES ................................................................................................................................. 12 NURSES ....................................................................................................................................... 20 PHARMACISTS ......................................................................................................................... 37 PHYSICIAN ASSISTANTS....................................................................................................... 49 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 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. 2012. 2 Mosby's Medical Dictionary, 8th edition. © 2009 2 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 $250.00 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 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: http://definitions.uslegal.com/l/legenddrug/. 4 Medication is a general term that includes drugs and pharmaceuticals. Medications may be administered by injection or other methods. 4 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 PROFESSIONAL Medical Assistant STATES USING IMMUNIZATION-SPECIFIC LANGUAGE STATE Alaska, Georgia, Maryland, Michigan, Montana, Texas, Washington Massachusetts, Michigan, Mississippi, New York, Pennsylvania, Texas, Midwife Vermont, Washington Connecticut, District of Columbia, Hawai’i, Illinois, Iowa, Kentucky, Advanced Practice Nurse Michigan, Texas Michigan, Mississippi, South Dakota, Texas Clinical Nurse Specialist Alaska, California, Massachusetts, Michigan, Mississippi, New York, Nurse Practitioner Oregon, Pennsylvania, South Dakota, Texas, Washington Connecticut, Georgia, Indiana, Maine, Massachusetts, Michigan, Practical Nurse Mississippi, Pennsylvania, Tennessee, Texas, Virginia, Washington Alaska, Arkansas, California, Colorado, Connecticut, Georgia, Illinois, Indiana, Iowa, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Registered Nurse Missouri, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Texas, Virginia, Washington California, Michigan, Texas Vocational Nurse Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawai’i, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Pharmacist 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 California, Colorado, Hawai’i, Illinois, Iowa, Massachusetts, Michigan, Physician Assistant Oklahoma, Oregon, South Dakota, Texas, Wisconsin Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice – Fall 2013 5 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, California, 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 . . . 22 Tex. Admin. Code § 193.4 (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. 10.32.12.04 (2012) Scope of Delegation; Code of Md. § 19-114 (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, California, 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. 18.360.050, 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 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, California, 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 . . . 2. Administer injections. Ariz. Rev. Stat. § 32-1456 (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. 24.156.640 (2012) Medical Assistant 5 People v. Stults, 683 N.E.2d 521 (Ill. App. Ct. 1997) 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) 6 7 *** 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 13:35-6.4 (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 § 060.00.1-31 (2012) Physician Delegation Regulation Five of the 13 states indicate only that MAs must be supervised (California, Georgia, Michigan, Texas, and Washington). Quotes from Michigan and California are below. In California, 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 333.9204 (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, California, 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. . . . 12 Alaska Admin. Code § 44.966 (2012) Delegation of the administration of injectable medication 8 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 § 060.00.1-31 (2012) Physician Delegation Regulation California 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 § 157.002 (2012) General Delegation of Administration and Provision of Dangerous Drugs; see also Tex. Stat. & Codes § 563.051 (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. 18.360.005, amended by 2013 Wash. Legis. Serv. Ch. 128 (S.H.B. 1515) (2013) Findings 9 Table 2: STANDING ORDERS: Medical Assistants & Immunization Practice STATE Alaska Arizona Arkansas California Florida Georgia Illinois Maryland Michigan Montana N Jersey S Dakota Texas Washington Wyoming Own Authority Assessment Delegated Authority Prohibited Own Authority Prescription ● ● ● Delegated Authority Prohibited Own Authority Administration Delegated Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Prohibited Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 10 ● 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 California Georgia Maryland New Jersey Wyoming 11 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 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. § 34-21-86 (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 . . . 17 Dist. of Columbia Municipal Regs. § 5808 (2012) Scope of Practice *** 16.11.2.10 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 16.11.2 (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 Admin. Code R4-19-501, amended by 2013 AZ REG TEXT 311810 (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. § 32-1601 (2012) Definitions A. An RNP . . . may: 1. Prescribe drugs and devices. . . . Ariz. Admin. Code R4-19-512 (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 § R9-16-108 (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. § 148.235 (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 16.11.3 (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. 18.50.115 (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 246-834-250 (2012) Legend drugs and devices 14 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 § 17-87-102 (2012) Definitions; see also Ark. Admin. Code 067.00.1-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 246-834-250 (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, California, 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 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. 60-11-101 (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. 60-11-104a (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. 60-11-105 (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. 65-1130 (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. 2.10 (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 advanced practice nurse as part of a written collaborative agreement, and the delegation of prescriptive authority shall conform to the requirements of Section 65-40 of the Nurse Practice Act. . . . 225 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. . . . 225 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. § 38-613 (2012) Permitted practice described in practice agreement; supervision; settings; subject to review by board; rules and regulations 17 STATE Alabama Alaska Arizona Arkansas California 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 ` -Table 3: STANDING ORDERS: MIDWIVES & Immunization Practice ASSESSMENT PRESCRIPTION ADMINISTRATION Own Delegated Own Delegated Own Delegated Prohibited Prohibited Prohibited Authority Authority Authority Authority Authority Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ` ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 18 ● ● ● ● ● ● ● ● ● ● ● 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 California 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 California 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 California Colorado Hawai’i Illinois Indiana Iowa Kentucky Maine Massachusetts Michigan Minnesota Mississippi Missouri New Hampshire New York Pennsylvania Tennessee Texas 19 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 California Connecticut Georgia Massachusetts MMR Washington Pneumococcal California Connecticut Rubella Vermont 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-5-.10 (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. § 34-21-81 (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 A registered professional nurse provides . . . nursing care . . . that includes but is not limited to: (1) the assessment of healthcare needs, nursing diagnosis, planning, implementation, and nursing evaluation . . . 225 Ill. Compiled Stat. 65/50-10 (2012) Definitions (a) Practice as a registered professional nurse . . . includes, but is not limited to, all of the following: (1) The comprehensive nursing assessment of the health status of patients that addresses changes to patient conditions. . . 225 Ill. Compiled Stat. 65/60-35 (2012) RN scope of practice Practical and Vocational Nurses Twenty-six states address how practical nurses (PNs) may assess patient status. Massachusetts and North Carolina are the 2 states that permit PNs to assess independently. Twenty-two states permit the practice under delegated authority. Arkansas and Iowa prohibit PNs from conducting any assessments. Texas is the only state that permits vocational nurses (VNs) to conduct assessments, but only under delegated authority. The provision from Alabama defines delegated patient assessment duties for practical nurses: (1) Patient assessment shall be provided in accordance with the definitions of professional nursing and practical nursing. . . . (3) The licensed practical nurse shall conduct and document focused nursing assessments of the health status of patients by: (a) Collecting objective and subjective data from observations, nursing examinations, interviews and written records in an accurate and timely manner as appropriate to the patient's health care needs. (b) Distinguishing abnormal from normal data. (c) Recording, and reporting the data. (d) Anticipating and recognizing changes or potential changes in patient status; identifying signs and symptoms of deviation from current health status. (e) Reporting findings of the focused nursing assessment to the registered nurse, licensed physician, advanced practice nurse, or dentist. (f) Implementing the plan of care. Ala. Admin. Code r. 610-X-6-.09 (2012) Assessment Standards Authority to Prescribe Vaccines Nurses in Advanced Practice Every jurisdiction (except Arkansas, Michigan, and New Mexico), has authorized at least one category of nurse in advanced practice to prescribe medications, either under their own license or through delegated authority. Two states prohibit nurses in advanced practice from prescribing: Alabama bars clinical nurse specialists from prescribing drugs, while Minnesota disallows traditional midwives from prescription authority. The following excerpts from Alabama show that registered nurse practitioners who practice collaboratively are permitted prescriptive authority. However, clinical nurse specialists who do not engage in collaborative practice may not prescribe drugs of any type: (1) Certified registered nurse practitioners engaged in collaborative practice with physicians may be granted prescriptive authority . . . . (2) Certified registered nurse practitioners practicing under protocols . . . may prescribe legend drugs to their patients. . . . Ala. Admin. Code r. 610-X-5-.11 (2012) Prescriptions And Medication Orders By Certified Registered Nurse Practitioners 21 Certified registered nurse practitioners . . . 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. § 34-21-86 (2012) Prescribing legend drugs; initiating call-in prescriptions; administering legend drug (3) ADVANCED PRACTICE NURSE. A registered nurse. . . . [C]linical nurse specialists (CNS). . . . [C]linical nurse specialists are not subject to collaborative practice agreements with an Alabama physician . . . and are prohibited from engaging in any of the acts or functions of a certified registered nurse practitioner (CRNP) or a certified nurse midwife (CNM). . . . (4) . . . d. . . . [A] clinical nurse specialist may not. . . 3. Prescribe drugs of any type. . . . Code of Ala. § 34-2181 (2012) Definitions Registered Nurses Six states address how RNs may prescribe drugs, medications, or vaccines (Alaska, Florida, Minnesota, Missouri, Oregon, and Tennessee). Forty-five states do not address prescription authority. No state permits RNs to prescribe medications under their own license. Under delegated authority, RNs may prescribe in Florida, Minnesota, Oregon, and Texas. Alaska and Missouri prohibit RNs from prescribing medications. Minnesota’s law is below: Subd. 8. Prescription by protocol. A registered nurse may implement a protocol that does not reference a specific patient and results in a prescription of a legend drug that has been predetermined and delegated by a licensed practitioner . . . when caring for a patient whose condition falls within the protocol and when the protocol specifies the circumstances under which the drug is to be prescribed or administered. Subd. 9. Vaccine by protocol. A nurse may implement a protocol that does not reference a specific patient and results in the administration of a vaccine that has been predetermined and delegated by a licensed practitioner . . . when caring for a patient whose characteristics fall within the protocol and when the protocol specifies the contraindications for implementation, including patients or populations of patients for whom the vaccine must not be administered and the conditions under which the vaccine must not be administered. . . . Minn. Stat. § 148.235 (2012) Prescribing drugs and therapeutic devices Practical and Vocational Nurses Texas is the only state that addresses prescription authority for LPNs and VNs. No state permits either category of nurse to prescribe drugs under their own authority or delegated authority. Texas expressly indicates that VNs may not prescribe “therapeutic or corrective measures,” as shown below: . . . (5) “Vocational nursing” . . . does not include acts of medical diagnosis or the prescription of therapeutic or corrective measures. Vocational nursing involves: (A) collecting data and performing focused nursing assessments of the health status of an individual. . . . Tex. Stat. & Codes § 301.002 (2012) Definitions 22 Authority to Administer Vaccines Nurses in Advanced Practice All states except Rhode Island address whether nurses in advanced practice may administer medications. Twenty-two states permit at least one category of nurse in advanced practice to administer medications independently and 46 states allow administration through delegated authority. Minnesota is the only state that prohibits advanced practice nurses from administering prescription drugs. Examples of independent administration authority from Kentucky and New Hampshire are below: (8) “Advanced registered nursing practice” means . . . registered nurses for advanced practice registered nursing as a certified nurse practitioner . . . certified nurse midwife, or clinical nurse specialist . . . . . . acts shall . . . include but not be limited to prescribing treatment, drugs . . . . Advanced registered nurse practitioners . . . shall be authorized to issue prescriptions for and dispense nonscheduled legend drugs. . . . . Ky. Rev. Stat. § 314.011 (2012) Definitions for chapter (7) “Healthcare provider” means a person licensed . . . to engage in advanced practice registered nursing. . . . (8)(a) A healthcare provider [may] administer[] immunizations. . . . 902 Ky. Admin. Regs. 2:060 (2012) Immunization schedules for attending child day care centers, certified family child care homes, other licensed facilities which care for children, preschool programs, and public and private primary and secondary schools *** I. Advanced registered nursing practice by nurse practitioners . . . scope of practice . . . shall be limited to: (a) Performing acts of advanced assessment, diagnosing, prescribing, selecting, administering, and providing therapeutic measures and treatment regimes . . . III. An ARNP shall have plenary authority to . . . prescribe, administer, and dispense and distribute to clients . . . noncontrolled drugs within the scope of the APRN’s practice as defined by this chapter. . . . N.H. Rev. Stat. § 326-B:11 (2012) Scope of Practice and Authority; Advanced Practice Registered Nurse Registered Nurses Every state except North Carolina, Rhode Island, and Vermont governs how RNs may administer medications. Eight states authorize RNs to administer medications under their own authority (California, Connecticut, Iowa, Maryland, New Hampshire, New Jersey, Oregon, and South Dakota). Forty-three states permit RNs to administer medications under delegated authority. No state prohibits medication administration by RNs. The following selections illustrate different approaches to medication administration for RNs. New Jersey describes independent practice during periods of vaccine shortage. Oregon illustrates how RNs may practice independently as a matter of routine practice, and Illinois demonstrates administration under delegation: b. To protect the public health during a vaccine shortage, the commissioner shall issue an order to implement a New Jersey Vaccine Education and Prioritization Plan, which shall comprise . . . (2) procedures for the distribution and administration of vaccines that shall apply to . . . nurses, health care facilities, pharmacies and others that dispense vaccines. The procedures shall include, but not be limited to, a definition of high-risk groups for priority protection or treatment in the event a 23 vaccine shortage is imminent or existent . . . . N.J. Stat. 26:13-23 (2012) New Jersey Vaccine Education and Prioritization Plan; conditions for establishment; “vaccine” defined; penalties for violation *** (2) . . . the Registered Nurse shall . . . (d) Implement the plan of care by: (A) Implementing treatments and therapy, appropriate to the context of care . . . medication administration. . . . Or. Admin. Rules 851-045-0060 (2012) Scope of Practice Standards for Registered Nurses *** A registered professional nurse provides . . . nursing care . . . that includes but is not limited to: . . . (4) the administration of medications and treatments as prescribed by a physician licensed to practice medicine . . . a licensed dentist, a licensed podiatrist, or a licensed optometrist or as prescribed by a physician assistant . . . or by an advanced practice nurse. . . . 225 Ill. Compiled Stat. 65/50-10 (2012) Definitions (a) Practice as a registered professional nurse . . . includes, but is not limited to, all of the following: . . . (3) The administration of medication or delegation of medication administration to licensed practical nurses. . . . 225 Ill. Compiled Stat. 65/60-35 (2012) RN scope of practice . . . registered nurse . . . will be responsible for administration of the remaining required immunizations. . . . 105 Ill. Compiled Stat. 5/27-8.1 (2012) Health examinations and immunizations Practical and Vocational Nurses Thirty-four states indicate the circumstances under which PNs and VNs may administer medications. Of these 34 states, only California, Colorado, Michigan, and Texas address VNs. Connecticut is the only state that allows PNs to administer medications as part of independent practice, but only in limited situations. Twenty-eight states permit PNs to engage in administration activities under delegation, as demonstrated by the example from Alabama. Arkansas and Iowa are the 2 states that prohibit PNs from administering medications. Arkansas’ provision is related to providers who may administer vaccines to children enrolled in Medicaid, while Iowa’s law ensures that PNs do not engage in practices reserved for RNs. Provisions from Connecticut, Alabama, Arkansas, and Iowa are below: [A] nurse who is employed by an agency licensed by the Department of Public Health as a home health care agency or a homemaker-home health aide agency may administer influenza and pneumococcal polysaccharide vaccines to persons in their homes . . . without a physician's order . . . . For purposes of this section, “nurse” means [a] . . . practical nurse . . . . Conn. Gen. Stat. § 19a-492d (2012) Vaccinations and medication administered by nurses employed by home health care agencies or homemaker-home health aide agencies *** (a) . . . (c) . . . [L]icensed practical nurses are authorized to administer any legend drug that has been lawfully ordered or prescribed by an authorized practitioner including certified registered nurse practitioners, certified nurse midwives, and/or assistants to physicians. Code of Ala. § 3421-86 (2012) Prescribing legend drugs; initiating call-in prescriptions; administering legend drugs 24 (3) . . . b. Practice of Practical Nursing. The performance, for compensation, of acts designed to promote and maintain health, prevent illness and injury and provide care utilizing standardized procedures and the nursing process, including administering medications and treatments, under the direction of a licensed professional nurse or a licensed or otherwise legally authorized physician or dentist. . . . Code of Ala. § 34-21-1 (2012) Definitions *** All screenings and immunizations must be performed by personnel meeting, at a minimum, registered nurse status. Ark. Admin. Code § 016.06.18-201.000 (2012) Arkansas Medicaid Participation Requirements for Child Health Services (EPSDT) Providers Except School-Based Child Health Services Providers *** 6.3(3) The licensed practical nurse shall not perform any activity requiring the knowledge and skill ascribed to the registered nurse, including . . . d. The initiation or administration of medications requiring the knowledge or skill level currently ascribed to the registered nurse. . . . Iowa Admin. Code 655-6.3(152) (2012) Minimum standards of practice for licensed practical nurses Four states address medication administration authority for VNs (California, Colorado, Michigan, and Texas). All these states authorize VNs to administer medications under delegated authority. No state permits VNs to administer medications independently, while no state prohibits them from administering. California specifically allows a VN to vaccinate all patients, including students. (This provision is also presented under Physician Assistant) The excerpt from Colorado shows that the state incorporates medication administration in the scope of practice for both practical and vocational nurses: (a) A licensed vocational nurse, acting under the direction of a physician may perform . . . (2) immunization techniques, providing such administration is upon standing orders of a supervising physician, or pursuant to written guidelines adopted by a hospital or medical group with whom the supervising physician is associated. Cal. Business and Professions Code § 2860.7 (2012) Performance of skin tests and immunizations; supervision and guidelines; qualifications (a) . . . [T]he [governing board of a school district] may permit a licensed physician and surgeon, or a health care practitioner listed in subdivision (b) who is acting under the direction of a supervising physician and surgeon, to administer an immunizing agent to a pupil whose parent or guardian has consented in writing to the administration of the immunizing agent. (b)(1) The following health care practitioners, acting under the direction of a supervising physician and surgeon, may administer an immunizing agent within the course of a school immunization program . . . (D) A licensed vocational nurse. . . . (2) A health care practitioner's authority to administer an immunizing agent pursuant to this subdivision is subject to the following conditions: (A) The administration of an immunizing agent is upon the standing orders of a supervising physician and surgeon and in accordance with any written regulations that the State Department of Public Health may adopt. (B) The school nurse is notified and he or she maintains control, as necessary, as supervisor of health . . . . (C) The health care practitioner may only administer immunizations for the prevention and control of any of the following: (i) Annual seasonal influenza. (ii) Influenza pandemic episodes. (iii) 25 Other diseases that represent a current or potential outbreak as declared by a federal, state, or local public health officer. Cal. Education Code § 49403 (2012) Cooperation in control of communicable disease and immunization of pupils *** (8) “Practical nurse”, “trained practical nurse”, “licensed vocational nurse”, or “licensed practical nurse” means a person . . . with the right to use the title “licensed practical nurse” . . . . (9)(a) “Practice of practical nursing” means the performance, under the supervision of a dentist, physician, podiatrist, or professional nurse authorized to practice in this state, of those services requiring the education, training, and experience, as evidenced by knowledge, abilities, and skills required in this article for licensing as a practical nurse . . . in . . . (IV) Administering treatments and medications prescribed by: (A) A legally authorized dentist, podiatrist, or physician; or (B) Physician assistant implementing a medical plan pursuant to . . . this section. (b) “Practice of practical nursing” includes the performance of delegated medical functions. nel. Colo. Rev. Stat. § 12-38-103 (2012) Definitions Defining Patients who may Receive Vaccinations Georgia is the only state that identifies the age range of patients who may receive vaccinations from RNs. RNs may administer influenza vaccine to children under age 13 with an individual prescription from a physician. When the child is under age 18, only parental/guardian consent is required. Level of Supervision Required to Practice Nurses in Advanced Practice All states require nurses in advanced practice to collaborate with a licensed physician, dentist, podiatrist, or licensed state health care delivery system to cooperate, coordinate, and consult with each other as appropriate within a collaborative agreement. The examples from Illinois show how the state approaches collaboration and physician liability: For a physician and an APN to collaborate, both the Medical Practice Act and the Nurse Practice Act require a written collaborative agreement for all APNs engaged in clinical practice. The collaborative agreement must describe the working relationship of the APN with the collaborating physician and authorize categories of care, treatment, or procedures to be performed by the APN. An APN's scope of practice expressly includes (but is not limited to) “[prescriptive authority[.]” A collaborating physician may delegate this authority pursuant to a written collaborative agreement. This authority includes “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[.]” As with PAs, APNs may dispense or prescribe drugs or medical supplies within the scope of practice of the supervising physician. 2009 WL 596125 Off. of the Atty. Gen. State of Ill., File No. 09-002 (2012) Authority of Advanced Practice Clinicians to Dispense and Administer Mifepristone (internal citations omitted) (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 advanced practice nurse as part of a written collaborative 26 agreement, and the delegation of prescriptive authority shall conform to the requirements of Section 65-40 of the Nurse Practice Act. . . . 225 Ill. Compiled Stat. 60/54.5 (2012) Physician delegation of authority to physician assistants and advanced practice nurses Registered Nurses All RNs must practice in collaboration with licensed physicians, dentists, or podiatrists. The laws from Georgia show how RNs must work with physicians in order to provide comprehensive health services: (8) “Practice nursing as a registered professional nurse” means to practice nursing by performing for compensation any of the following . . . (G) Collaborating with other members of the health care team in the management of care . . . (I) Administering, ordering, and dispensing medications, diagnostic studies, and medical treatments authorized by protocol, when such acts are authorized by other general laws and such acts are in conformity with those laws; (J) Administering medications and treatments as prescribed by a physician . . . a dentist . . . or a podiatrist . . . (K) Performing any other nursing act in the care and counsel of the ill, injured, or infirm, and in the promotion and maintenance of health with individuals, groups, or both throughout the life span. Code of Ga. § 43-26-3 (2012) Definitions (a) . . . (7) “Nurse” means a registered professional nurse . . . . who is regularly employed by a physician who actively engaged in the private practice of medicine. . . . (c) A physician engaged in the active practice of medicine may prescribe influenza vaccine for a group of patients via an influenza vaccine order contained in an influenza vaccine protocol agreement to be administered by a nurse, provided the physician is registered with the vaccination registry . . . . (q) No influenza vaccine protocol agreement entered into pursuant to this Code section shall permit a . . . nurse to administer an influenza vaccine to any child under the age of 13 without an individual prescription from a physician, and consent of the child's parent or legal guardian shall be a condition precedent to the administration of an influenza vaccine to a child under the age of 18. Code of Ga. § 43-3426.1 (2012) Influenza vaccine protocol agreement; vaccination for groups of patients; rules and regulations; liability Practical Nurses A supervising physician, dentist, podiatrist, nurse in advanced practice, registered nurse, or physician assistant must provide practical nurses with direct, on-site supervision. The selection from Georgia indicates LPNs may administer influenza vaccines under an established protocol. In Illinois, LPNs may conduct patient assessments as directed by the supervising provider authorized to delegate the activity: (a) . . . (7) “Nurse” means . . . a licensed practical nurse . . . who is regularly employed by a physician who actively engaged in the private practice of medicine. . . . (f) . . . a registered professional nurse who is a party to an influenza protocol agreement pursuant to this Code section may delegate the administration of influenza vaccine to a licensed practical nurse under the direct on-site supervision of the registered professional nurse. . . . (q) No influenza vaccine protocol agreement entered into pursuant to this Code section shall permit a . . . nurse to administer an influenza vaccine to any child under the age of 13 without an individual prescription from a physician, and consent of the child's parent or legal guardian shall be a condition precedent to the administration of an influenza vaccine to a child under the age of 18. Code of Ga. § 43-34-26.1 (2012) Influenza vaccine protocol agreement; vaccination for groups of patients; rules and regulations; liability 27 *** (a) Practice as a licensed practical nurse means a scope of basic nursing practice . . . as delegated by a registered professional nurse or an advanced practice nurse or as directed by a physician assistant, physician, dentist, or podiatrist, and includes, but is not limited to, all of the following: (1) Collecting data and collaborating in the assessment of the health status of a patient. . . . 225 Ill. Compiled Stat. 65/55-30 (2012) LPN scope of practice Settings where Nurses are Authorized to Vaccinate In addition to public and private clinical settings, nurses may practice in a broad range of locations, including: any and all settings, a patient’s home, a hospice, home health agency, community health settings, school nursing, occupational nursing, correctional facilities, and community mental health facilities. 28 Table 4: STANDING ORDERS: Nurses with Advanced Practices & Immunization Practice STATE Alabama Alaska Arizona Arkansas California 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 Own Authority A, C,N C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N ASSESSMENT Delegated Authority A,C,N A,C,N A, N A, C, N A,C,N A,C,N A, C, N A,C,N A,C,N A,C,N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N C, N A, C, N A, N A, C, N A, C, N A, C, N A,C,N A, C, N A, C, N A, N C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N Prohibited PRESCRIPTION Independent Delegated Prohibited Authority Authority A, N A, C N N N A, C, N A, C, N A, C, N A A, C, N A, C, N C, N A,C,N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, N A A,N A, N A, C, N A, N A, C, N A, C, N A, N A A, C, N A, N A, C, N N A, N A, N A, C, N C, N N A,C,N N A, C, N A, C, N A,C,N A, N A N A, N A, C, N A, C, N A, C, N C, N N A, C C, N A,C,N A, C, N N A, N A,C,N A A, N N A,C,N A A, N A, C, N A, N A, C, N A, C, N A, C, N A, C, N A A ADMINISTRATION Own Delegated Prohibited Authority Authority A, C, N N C,N N A, C,N A, C, N A,C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A,C,N A,C, N A, C, N A,C,N A, C, N A, C, N A, C, N A, C, N A, C, N A,C,N A, C, N A, N A, C,N A, C, N A,C,N A, N A,C,N A,C,N A, C, N A A, C, N A, C, N A,C,N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, C, N A, N A, C, N A, C, N A, C, N A, C, N C, N A, C, N A, C, N A A A, N A, C, N A= Advanced Practice, C=Clinical Nurse Specialist, N=Nurse Practitioner Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 29 A, C, N A,C,N A, C, N A, C, N C, N A C, N A,C,N A, C, N A, C, N A, C, N Table 5: STANDING ORDERS: Practical and Vocational Nurses & Immunization Practice STATE Alabama Alaska Arizona Arkansas California 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 Own Authority ASSESSMENT Delegated Authority P P Prohibited Own Authority PRESCRIPTION Delegated Prohibited Authority P ADMINISTRATION Delegated Prohibited Authority P P P P P P P P P Own Authority V P,V P P P P P P P P P P P P P P,V P P P P P P P P P P P P P P P P P, V P P V P P P P,V P P P P P P P P = Practical Nurse V= Vocational Nurse Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 30 P P Table 6: STANDING ORDERS: Registered Nurses & Immunization Practice STATE Alabama Alaska Arizona Arkansas California 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 Own Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ASSESSMENT Delegated Authority ● Prohibited Own Authority PRESCRIPTION Delegated Prohibited Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ADMINISTRATION Own Delegated Prohibited Authority Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 31 ● ● ● ● ● ● ● ● ● ● ● ● ● ● Figure 3 – Vocational and Practical Nurses Vocational and Licensed Practical Nurses are most frequently permitted to administer medications followed by immunizations. Immunizations or Vaccines Arkansas (prohibited) California Illinois Massachusetts Michigan Mississippi Pennsylvania Tennessee Texas Virginia Drugs or Legend Drugs/Substances Alabama Kansas Texas Wisconsin Medications Alabama Colorado Delaware Florida Hawai’i Idaho Illinois Iowa (prohibited) Kentucky Maine Maryland Minnesota Mississippi Montana North Dakota Ohio Pennsylvania South Carolina South Dakota Utah Wyoming Injectable Medication/Inoculation Washington Influenza California Connecticut Georgia Hepatitis B Tennessee Pneumococcal Connecticut 32 Figure 4 – Registered Nurses Registered Nurses are most frequently permitted to administer medications followed by immunizations or vaccines. Drugs or Legend Drugs/Substances Alabama Kansas Kentucky Massachusetts Minnesota Missouri Texas Wisconsin Immunizations or Vaccines Alaska Arkansas California Illinois Indiana Iowa Maine Massachusetts Michigan Minnesota Mississippi Missouri New Hampshire New Jersey New Mexico New York Pennsylvania Tennessee Texas Virginia Medications Alabama Alaska Arizona Arkansas California Colorado Delaware DC Florida Georgia Hawai’i Idaho Illinois Iowa Kentucky Maine Maryland Minnesota Mississippi Montana Nevada New Mexico North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington West Virginia Injectable Medication/Inoculation Alaska Washington Prevention Florida Maryland Virginia Washington Influenza California Connecticut Georgia New Hampshire Hepatitis B Tennessee Pneumococcal California Connecticut Wyoming 33 Figure 5 – Advanced Practice Nurses Advanced Practice Nurses are most frequently permitted to administer medications followed by immunizations or vaccines. Influenza vaccine is most frequently identified. Drugs or Legend Drugs/Substances Alabama Connecticut Delaware Hawai’i Illinois Indiana Kansas Kentucky Louisiana Maine Massachusetts Minnesota Missouri Montana North Carolina North Dakota South Carolina Texas Utah Washington Wisconsin Medications Alabama Arizona Arkansas California Colorado Delaware DC Florida Georgia Hawai’i Idaho Illinois Iowa Kentucky Maine Maryland Minnesota Mississippi Montana Nevada New Mexico North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Washington West Virginia Wyoming New York Pennsylvania Tennessee Texas Washington Immunizations or Vaccines Arkansas California DC Hawai’i Illinois Indiana Iowa Kentucky Maine Massachusetts Michigan Minnesota Mississippi Missouri New Hampshire New Jersey New Mexico HBIG Washington 34 Injectable Medication/Inoculation Washington Pharmacological Agents Hawai’i Idaho Influenza California Connecticut Georgia Massachusetts New Hampshire Hepatitis B Tennessee Washington MMR Washington Pneumococcal California Connecticut Rubella Vermont Figure 6 – Certified Nurse Specialists Certified Nurse Specialists are most frequently permitted to administer medications followed by immunizations and vaccines. Influenza vaccine is most frequently identified. Drugs or Legend Drugs/Substances Alabama Connecticut Illinois Kansas Kentucky Louisiana Massachusetts Minnesota Missouri Montana North Dakota South Carolina Texas Wisconsin Medications Alabama Alaska Arizona Arkansas California Colorado Delaware DC Florida Hawai’i Idaho Illinois Iowa Kentucky Maine Maryland Minnesota Mississippi Montana Nevada New Mexico North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wyoming Immunizations or Vaccines Alaska Arkansas California Hawai’i Illinois Indiana Iowa Kentucky Maine Massachusetts Michigan 35 Minnesota Mississippi Missouri New Hampshire New Jersey New Mexico New York Pennsylvania South Dakota Tennessee Texas Virginia Injectable Medication/Inoculation Alaska Washington Pharmacological Agents Hawai’i Idaho Influenza California Connecticut New Hampshire Hepatitis B Tennessee Pneumococcal California Connecticut Figure 7 – Nurse Practitioners Nurse Practitioners are most frequently permitted to administer medications followed by immunizations and vaccines. Influenza vaccine is most frequently identified. . Drugs or Legend Drugs/Substances Alabama Alaska Arizona California Connecticut Hawai’i Illinois Kansas Kentucky Louisiana Maine Massachusetts Minnesota Missouri Montana New Hampshire New York North Carolina North Dakota Oregon Pennsylvania South Carolina Texas Wisconsin Hawai’i Idaho Illinois Iowa Kentucky Maine Maryland Minnesota Mississippi Montana Nevada New Mexico North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wyoming Medications Alabama Alaska Arizona Arkansas California Colorado Delaware DC Florida Georgia Immunizations or Vaccines Alaska Arkansas California Hawai’i Illinois Indiana Iowa Kentucky Maine Massachusetts 36 Michigan Minnesota Mississippi Missouri New Hampshire New Jersey New Mexico New York Pennsylvania South Dakota Tennessee Texas Virginia Washington Injectable Medication/Inoculation Alaska Washington Pharmacological Agent Hawai’i Idaho Influenza California Connecticut Georgia Massachusetts New Hampshire Hepatitis B Tennessee Pneumococcal California Connecticut PHARMACISTS All 51 states address whether pharmacists may assess patient status, prescribe drugs, medications, or vaccines, or administer vaccines. See Table 7 and Figures 8 and 9 below. Authority to Assess Patient Status Five states address a pharmacist’s ability to assess patient status. Missouri and North Carolina permit pharmacists to assess patients under the pharmacist’s own license. Maine, New Jersey, and North Carolina allow assessments pursuant to delegated authority. No state prohibits pharmacists from accessing patients. The following excerpts from Maine and Missouri show the different approaches to patient assessment. Missouri has developed an exception for influenza and pneumococcal vaccination, permitting pharmacists to assess for contraindications in hospitals: Prior to administering a[n] . . . immunization, a pharmacist who holds a certificate of administration shall assess the patient for contraindications that would preclude vaccination. . . . Code of Maine Rules 02-392 Ch. 4-A, § 2 (2012) Administration Requirements *** PURPOSE: This rule establishes the requirements for pharmacy services and medication management in a hospital. . . . 34) All medication orders shall be written in the medical record and signed by the ordering practitioner with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy/protocol after an assessment for contraindications. . . . 19 Mo. Code of State Regs. 3020.100 (2012) Pharmacy Services and Medication Management in Hospitals Authority to Prescribe Vaccines Nine state laws indicate whether pharmacists may prescribe medications. Idaho, Oregon, and Wyoming are the 3 states permitting prescription authority under the pharmacist’s own license. Six states allow pharmacists to prescribe medications under delegated authority (Massachusetts, Mississippi, Montana, New Mexico, North Dakota, and Wyoming). South Dakota is the only state that expressly prohibits pharmacists from prescribing drugs. Provisions from Idaho permitting independent prescription authority, Mississippi allowing prescribing in institutions, and South Dakota prohibiting prescription authority are below: Licensed pharmacists may also prescribe agents for active immunization when prescribed for susceptible persons twelve (12) years of age or older for the protection from communicable disease. Idaho Code § 54-1704 (2012) Practice of pharmacy *** (ll) “Written guideline or protocol” means an agreement in which any practitioner authorized to prescribe drugs delegates to a pharmacist authority to conduct specific prescribing functions in an institutional setting, or with individual patients, provided that a specific protocol agreement is signed on each patient and is filed as required by law or by rule or regulation of the board. . . . Miss. Code § 73-21-73 (2012) Definitions 37 *** The practice of pharmacy does not authorize a pharmacist to prescribe drugs as a practitioner. S.D. Codified Laws § 36-11-22 (2012) Practice of pharmacy defined Authority to Administer Vaccines All 51 states address how pharmacists may administer medications. Fourteen states have granted pharmacists the power to administer vaccines and/or drugs as part of their independent practice (Alabama, Arizona, Idaho, Maine, Mississippi, Nebraska, New Hampshire, Oregon, South Carolina, South Dakota, Tennessee, Washington, West Virginia, and Wyoming). Forty-two states permit pharmacists to administer vaccines under delegated authority (Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawai’i, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Vermont, Virginia, Wisconsin, and Wyoming). The excerpt from Maine is an example of pharmacists’ ability to administer vaccines without a prescription or standing order. The selections below from Wyoming show that pharmacists may administer vaccines “only by prescription” in certain circumstances, and under their own authority only to healthy adults: [NOTE: A prescription, treatment protocol or written standing order from an authorized practitioner is not required for administration of influenza vaccines.] . . . Code of Maine Rules 02-392 Ch. 4-A, § 1 (2012) Minimum Requirements for Treatment Protocol Issued Pursuant to 32 MRSA §13833 *** (a) A pharmacist licensed under this act may only prescribe and administer immunizations recommended for healthy adults as authorized by the board. (b) A pharmacist licensed under this act may administer immunizations to adults who are considered high risk only by prescription from a licensed physician. . . . Wyo. Stat. § 33-24-157 (2012) Immunization administration (a) A pharmacist licensed by the board may prescribe and administer immunizations to healthy adults or administer immunizations to High- Risk Adults authorized by a physician, provided the pharmacist has: (i) Registered with the board to prescribe and administer immunizations. . . . Wyo. Rules & Regs. Ch. 16, Sec. 3 (2012) Qualifications Defining Patients who may Receive Vaccinations Forty-one states identify the ages of patients who may receive vaccines from pharmacists. Ten states have not addressed patient age (Alabama, Alaska, Michigan, Mississippi, Nebraska, Nevada, Oklahoma, Tennessee, Utah, and Washington). See Figure A 38 Twenty-four states permit pharmacists to vaccinate children (Arizona, Arkansas, Colorado, Georgia, Hawai’i, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Minnesota, Missouri, Montana, New Hampshire, New Mexico, North Dakota, Ohio, Oregon, Rhode Island, Texas, and Wisconsin). Of these 24 states, Colorado and Georgia restrict administration only to children. Children are defined by several age ranges, including: Children, under 13, 9-13, 14 and older, 6-17, 14-17, or under 18. The quotes from Wisconsin appear be inconsistent regarding the appropriate patient age ranges: (2) . . . A pharmacist may not administer a vaccine under this subsection to a person who is under the age of 6. (2g) . . . . A person engaged in the practice of pharmacy . . . may not administer a vaccine under this subsection to a person who is under the age of 18. . . . Wis. Stat. 450.035 (2012) Administration of drug products and devices; vaccines Thirty-nine states permit pharmacists to vaccinate adults who are variously defined as 18 and over, adults, the general public, any age, 19 and over, or any person. The states are Arizona, Arkansas, California, Connecticut, Delaware, DC, Florida, Hawai’i, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Missouri, Montana, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming. Seventeen of these states restrict vaccination to adults (California, Connecticut, Delaware, DC, Florida, Iowa, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, South Dakota, Vermont, Virginia, West Virginia, and Wyoming). Level of Supervision Required to Practice Fourteen states allow pharmacists to administer vaccines as a component of their independent practice (Alabama, Arizona, Idaho, Maine, Mississippi, Nebraska, New Hampshire, Oregon, South Carolina, South Dakota, Tennessee, Washington, West Virginia, and Wyoming). The provisions below show that Arizona authorizes pharmacists to administer vaccines to adults without a prescription, or under delegated authority based on the patient’s age, during a public health emergency, or the specific vaccine to be administered. Idaho authorizes pharmacists to prescribe and administer vaccines to individuals ages 12 and older: A. . . . [A] pharmacist . . . may administer the following to adults without a prescription. . . 1. Immunizations or vaccines listed in the United States centers for disease control and prevention's recommended adult immunization schedule. 2. Immunizations or vaccines recommended by the United States centers for disease control and prevention's health information for international travel. B. A pharmacist . . . may administer the following to a person who is at least six years of age but under eighteen years of age without a prescription . . . 1. Immunizations or vaccines for influenza. 2. Immunizations or vaccines in response to a public health emergency declared by the governor. . 39 C. Pursuant to a prescription order, a pharmacist . . . may administer immunizations and vaccines to a person who is at least six years of age but under eighteen years of age. . . . Ariz. Rev. Stat. § 32-1974 (2012) Pharmacists; administration of immunizations, vaccines and emergency medications; certification; reporting requirements; advisory committee; definition; see also Ariz. Admin. Code § R4-23-411 (2012) Pharmacist-administered or Pharmacy or Graduate Intern-administered Immunizations (for similar language) A. . . . 1. “Certified pharmacist” means an individual . . . who is authorized . . . to administer immunizations or vaccines to adults. . . . B. The following immunizations or vaccines require a prescription order before the immunization or vaccine may be administered . . . by a certified pharmacist: 1. Japanese Encephalitis vaccine, 2. Rabies vaccine, 3. Typhoid vaccines, and 4. Yellow fever vaccine. Ariz. Admin. Code § R9-6-1301 (2012) Immunizations or Vaccines Requiring a Prescription Order for Pharmacist Administration *** “Practice of pharmacy” means . . . drug administration . . . . Licensed pharmacists may also prescribe agents for active immunization when prescribed for susceptible persons twelve (12) years of age or older for the protection from communicable disease. Idaho Code § 54-1704 (2012) Practice of pharmacy Forty-two states permit pharmacists to administer vaccines under delegated authority (Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawai’i, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Vermont, Virginia, Wisconsin, and Wyoming). Examples from Arkansas and Colorado are below. Arkansas has created an exception to their rule that prescriptions issued by an authorized practitioner are required before a pharmacist may administer drugs and medicines. Influenza vaccines may be administered under a general written protocol based on the age of the patient. Other vaccines require additional supervision. Colorado requires a physician to authorize any vaccination and to also provide a protocol outlining how to respond to adverse reactions, identifies the educational materials to be distributed to patients, and highlights reporting requirements: (16)(A) “Practice of pharmacy” means the learned profession of: (i)(a) Dispensing, selling, distributing, transferring possession of, vending, bartering, or, in accordance with regulations adopted by the Arkansas State Board of Pharmacy, administering drugs, medicines, poisons, or chemicals that under the laws of the United States or the State of Arkansas may be sold or dispensed only on the prescription and order of a practitioner authorized by law to prescribe drugs, medicines, poisons, or chemicals. (b) Except in accordance with regulations adopted by the Arkansas State Board of Pharmacy as recommended by the Medications Administration Advisory Committee, the administration of medications shall be limited to the following classifications of medications: immunizations, vaccines. . . . (c) Influenza vaccines and influenza immunizations may be administered to a person seven (7) years of age and older under a general written protocol. (d) Vaccines and immunizations other than influenza vaccines and influenza immunizations may 40 be administered to a person from seven (7) years of age to eighteen (18) years of age under a patient-specific order or prescription and subject to reporting of the administration to the prescribing physician together with any reporting required under § 20-15-1203. (e) Vaccines and immunizations other than influenza vaccines and influenza immunizations may be administered to a person eighteen (18) years of age or older under a general written protocol. . . . (g) A general written protocol . . . and patient-specific orders or prescriptions . . . shall be from a physician licensed by the Arkansas State Medical Board and practicing in Arkansas or within fifty (50) miles of the Arkansas border. . . . Ark. Code § 17-92-101 (2012) Definitions . . . (b) Authority to administer medications/immunizations: (1) An Authority to Administer is a written protocol . . . from a practitioner for administration by a pharmacist of an approved medication or immunization. (2) Pharmacists may provide pharmaceutical care to patients seven (7) years of age and older by administering medications or immunizations to an eligible patient upon receiving an Authority to Administer or a valid prescription order by a practitioner so authorized to prescribe such medications or immunizations. . . . After completing the course of study . . . licensed interns . . . may provide pharmaceutical care to patients seven (7) years of age and older by administering medications or immunizations to an eligible patient, under the supervision of an appropriately licensed pharmacist with an Authority to Administer. . . . (c) Seven classifications of approved medications for administration (1) Immunizations (2) Vaccines. . . . . Ark. Admin. Code § 070.00.9-09-00-0002 (2012) Prescription Orders to Administer Medication and/or Immunizations *** 19.01.10 Qualifications. a. A pharmacist, or pharmacy intern under the supervision of a pharmacist certified in immunization, may administer vaccines AND IMMUNIZATIONS per authorization of a physician. . . . Routine childhood immunizations, as defined by the Colorado State Board of Health, shall comply with CDC guidelines. . . 19.01.20 A trained pharmacist may delegate the administration of vaccines AND IMMUNIZATIONS only to a trained pharmacy intern. 19.01.30 Policies and Procedures . . . b. . . . The prescription drug outlet must obtain a physician protocol for addressing allergic reactions to immunizations. c. The prescription drug outlet must give the appropriate "Vaccine Information Statement" (VIS) to the patient or legal representative with each dose of vaccine covered by these forms. The pharmacist must ensure that the patient or legal representative has received and signed the informed consent form and has had their questions answered prior to the administration of the vaccine. d. The prescription drug outlet must report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient. . . 3 Colo. Code. Regs. 719-1:19.00.00 (2012) Administration 41 Settings where Pharmacists are Authorized to Vaccinate Fifteen states identify the settings where pharmacists may or may not practice (California, Colorado, District of Columbia, Indiana, Massachusetts, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Pennsylvania, Texas, and Utah). In addition to pharmacies, hospitals, and other health care facilities, Colorado permits pharmacists to “remove . . . vaccines from the prescription drug outlet . . . for off-site administration.” In the District of Columbia, “the locations . . . . shall not include where a patient resides, except for a licensed nursing home, residential care facility assisted living center, the District of Columbia jail or a hospital.” However, in Indiana, administration can occur in a hospice or a patient’s home and in a home health agency. Texas authorizes administration in “any other location specifically identified in the written protocol.” 42 Table 7: STANDING ORDERS: Pharmacists & Immunization Practice STATE Alabama Alaska Arizona Arkansas California 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 ASSESSMENT Own Delegated Authority Authority Prohibited Own Authority PRESCRIPTION Delegated Prohibited Authority Own Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ADMINISTRATION Delegated Prohibited Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 43 Figure 8 - Pharmacists Vaccines Pharmacists are Authorized to Administer Influenza vaccine is most frequently highlighted, followed by Pneumococcal and Zoster vaccines. Drugs Alabama Alaska Mississippi Nebraska Tennessee Utah Vaccines, Immunizations Arizona Arkansas Colorado Delaware Hawai’i Idaho Illinois Iowa Kansas Kentucky Louisiana Maryland Massachusetts Michigan Minnesota Montana Nevada New Jersey New Mexico North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island Texas Vermont Virginia Washington Wisconsin Diphtheria Ohio Hepatitis A Ohio West Virginia Wyoming Hepatitis B Ohio West Virginia Wyoming HPV Wyoming Influenza Arizona Arkansas California Connecticut DC Florida Georgia Hawai’i Indiana Iowa Kansas Kentucky Maine Maryland Massachusetts Minnesota Missouri Montana New Hampshire New York North Carolina North Dakota Ohio Rhode Island South Carolina South Dakota Texas West Virginia Wyoming Japanese Encephalitis Arizona Meningococcal Missouri Ohio Wyoming Missouri New Hampshire New York North Carolina Ohio West Virginia Wyoming Pertussis Ohio Rabies Arizona Tetanus Ohio West Virginia Tetanus-diphtheria Maine West Virginia Wyoming Tdap West Virginia Wyoming Booster Tetanus-diphtheria Maine Typhoid Arizona Varicella Wyoming Yellow Fever Arizona Zoster Connecticut Florida Indiana Maine Maryland Missouri New Hampshire North Carolina Ohio West Virginia Wyoming MMR Wyoming Pneumococcal California Connecticut DC Florida Iowa Maine Maryland 44 FIGURE 9: PERMISSIBLE POPULATIONS FOR PHARMACIST-ADMINISTERED IMMUNIZATIONS PATIENT STATE DEFINITION SPECIAL INSTRUCTIONS AGE Alabama Alaska N/A N/A N/A Drug Arizona Adults Recommended by CDC & for travel Japanese Encephalitis Rabies Typhoid Yellow fever Medicaid will reimburse for vaccine administration Written protocol must be approved by a practitioner authorized to prescribe drugs and approved by the board Without a prescription or Immunizations in response to a public health emergency declared by the governor 6-17 Influenza Pursuant to a prescription order 6-17 7+ Vaccines Influenza Pursuant to a prescription order General written protocol. 7-17 Other than influenza Patient-specific order or prescription and subject to reporting of the administration to the prescribing physician together with any other reporting requirements California 18+ 50+ Colorado Children A general written protocol Pursuant to standing orders in a skilled nursing facility and approval of facility medical director Pursuant to physician authorization Connecticut Adult Delaware DC Adult 18+ with valid ID Any Influenza Pneumococcal Routine childhood immunizations, as defined by the Colorado State Board of Health and the CDC Flu Pneumococcal Zoster Immunizations Pneumococcal Influenza Arkansas Pursuant to the order of a licensed health care provider Pursuant to a valid prescription or physician protocol Pursuant to a written protocol signed and dated by a licensed physician Other Permissible Patients Current patients or patients who have received care from the physician within the twelve months prior to the date of the written protocol; Current patients of a practice's care or patients who have received care within the practice within the twelve months prior to the date of the written protocol; Residents of a health care, residential services, or assisted living facility, when the facility’s medical director is making the delegation; DC residents identified by the Director of the Department of Health as part of a public health services program, when the Director is the physician making the delegation Florida Adult Influenza Pneumococcal Zoster DC jail inmates, when the medical director is making the delegation Established protocol 45 FIGURE 9: PERMISSIBLE POPULATIONS FOR PHARMACIST-ADMINISTERED IMMUNIZATIONS PATIENT STATE DEFINITION SPECIAL INSTRUCTIONS AGE Georgia Under 13 Influenza Individual prescription from a physician Hawai’i Under 18 14-17 Influenza Influenza Consent of parent or legal guardian Pursuant to a valid prescription Idaho 18+ 12+ N/A May prescribe Illinois Indiana 14+ 18+ Vaccines For protection from communicable disease Vaccinations Influenza Zoster 14-17 Iowa Adults Influenza Pneumococcal Pursuant to a valid prescription or standing order, by a licensed physician Pursuant to a drug order, prescription, or a protocol approved by a physician Pursuant to a protocol only if the pharmacist receives the consent of a parent or legal guardian, and the parent or legal guardian is present at the time of immunization Pursuant to a written protocol for one or more patients Kansas 6-17 Other adult vaccines Influenza Kentucky 18+ Child Other than influenza Immunizations Pursuant to a vaccination protocol Pursuant to protocols 9-13 Influenza Pursuant to prescriber-approved protocols with the consent of a parent or guardian 14-17 Immunizations Pursuant to prescriber-approved protocols with the consent of a parent or guardian; Louisiana Adults Under 14 Immunizations Vaccines Pursuant to prescriber-approved protocols Pursuant to a prescription and informing the practitioner within 24 hours of the administration if the patient is under 14 years old Maine 16+ 9+ Vaccines Influenza Collaborative drug therapy management agreement including a patient specific order Pursuant to a treatment protocol authorizing the administration of immunizations and a prescription, treatment protocol or standing order. Under age 18 Pneumococcal Zoster Tetanus-diphtheriapertussis Tetanus-diphtheria Booster tetanusdiphtheria Pursuant to a prescription 18+ Pneumococcal Zoster Tetanus-diphtheriapertussis Tetanus-diphtheria Booster tetanusdiphtheria Pursuant to a treatment protocol or standing written order, the pharmacist shall verify that the patient is 18 years of age or older. Pursuant to a physician prescription or medication order for an individual patient Pursuant to a vaccination protocol 46 FIGURE 9: PERMISSIBLE POPULATIONS FOR PHARMACIST-ADMINISTERED IMMUNIZATIONS PATIENT STATE DEFINITION SPECIAL INSTRUCTIONS AGE Maryland 9-18 Influenza In accordance with regulations adopted by the Board, in consultation with the Department. Report to state’s Immunization Registry Adult Pursuant to a prescription from a physician 18+ Influenza Pneumococcal Zoster Any other Influenza Michigan Minnesota N/A 10+ Other immunizations Immunizing Agent Influenza Pursuant to the order of a physician and if the pharmacist is authorized to administer a controlled substance Administration under the direction of a physician Pursuant to standing orders or a written protocol with a physician Mississippi Missouri 18+ N/A 12+ Pursuant to standing orders or a written protocol with a physician Pursuant to specific protocol agreement signed for each patient Pursuant to written protocol authorized by a physician Montana 12+ All other vaccines Drugs Influenza Pneumonia Zoster Meningitis Influenza 18+ N/A N/A General Public Vaccines Drug Immunizations Influenza Pursuant to collaborative practice agreement N/A Pursuant to a written protocol Pursuant to collaborative pharmacy practice agreement May also administer under individual pharmacist license 18+ Pursuant to collaborative pharmacy practice agreement May also administer under individual pharmacist license Pursuant to a standing order or prescription Pursuant to written protocol Mass Nebraska Nevada New Hampshire Pursuant to a collaborative practice agreement Pursuant to collaborative practice agreement During a Public Health Emergency: State medical officer directive New Jersey New Mexico 18+ Any age New York 18+ North Carolina 18+ North Dakota 5+ Pneumococcal Zoster Vaccines ACIP-recommended or New Mexico Department of Health Influenza Pneumococcal Influenza Pneumococcal Zoster Influenza Ohio 11+ 14+ Vaccinations Influenza Upon order of a provider authorized to prescribe or by written protocol Pursuant to a physician approved protocol Pneumonia Tetanus Hepatitis A Hepatitis B Meningitis Diphtheria Pertussis Zoster Any other approved Pursuant to a patient specific prescription 18+ Pursuant to patient specific and non-patient specific orders and protocols Pursuant to a written protocol Only in consultation with primary care provider (Pneumococcal, Zoster) Upon order of a provider authorized to prescribe or by written protocol 47 FIGURE 9: PERMISSIBLE POPULATIONS FOR PHARMACIST-ADMINISTERED IMMUNIZATIONS PATIENT STATE DEFINITION SPECIAL INSTRUCTIONS AGE Oklahoma Oregon N/A 11-18 Immunizations Vaccines Penn 19+ 18+ Immunizations Rhode Island 9 through18 Influenza The state will not reimburse providers the cost of privately purchased vaccination. Pursuant to an order or written protocol approved by a physician or institutional medical staff Pursuant to a valid prescription or prescriber approved protocol S Carolina S Dakota Tennessee Texas 18+ 18+ 18+ N/A 0-13 Immunizations Influenza Influenza Drugs Immunizations Pursuant to a valid prescription or physician approved protocol Pursuant to a written protocol Pursuant to authorization by the Board of Pharmacists or a prescription drug order. None Pursuant to physician supervision and referral 7+ Influenza Pursuant to standing delegation orders Utah Vermont Any age N/A 18+ Immunizations Prescription drug CDC-recommended Virginia Washington West Virginia Adult N/A 18+ Wisconsin 6+ or 18+ Inconsistent law Immunizations Vaccines Influenza Pneumonia Hepatitis A Hepatitis B Zoster Tetanus Td Tdap Vaccines Pursuant to prescription or written protocol Pursuant to a lawful order of a practitioner and in accordance with written protocols Pursuant to a written protocol based on a collaborative practice agreement or a patient-specific prescription from a licensed prescriber Pursuant to a protocol submitted to the board May administer under pharmacist authority May administer under pharmacist authority Wyoming 19+ without any contraindication Pursuant to an order of a prescribing practitioner Must participate in the Vaccines for Children Program and administer under protocols approved by the Oregon Health Authority Pursuant to a written physician-approved protocol Td Pursuant to Board authorization Tdap MMR Varicella 19+ with an Influenza absolute or Pneumococcal Pursuant to a prescription from a licensed physician relative Hepatitis A contraindication Hepatitis B Meningococcal HPV Zoster Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 48 PHYSICIAN ASSISTANTS All 51 jurisdictions address how physician assistants (PAs) are authorized to assess patients, issue prescriptions, or administer vaccines. See Table 8 and Figure 10 below. Authority to Assess Patient Status Twenty six states address how PAs may assess patient status (Alaska, Arizona, California, Colorado, Delaware, DC, Florida, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi Missouri, Montana, Nevada, New Jersey, Ohio, Oklahoma, South Dakota, Texas, Utah, Virginia, West Virginia, and Wisconsin). These states permit PAs to conduct assessments only under delegated authority. No state prohibits assessments and no state addresses whether a PA may assess patients under their own license. The excerpt from Arizona is common among the states: A. A supervising physician may delegate health care tasks to a physician assistant. . . . C. The physician assistant may perform those duties and responsibilities, including the ordering, prescribing, dispensing and administration of drugs and medical devices that are delegated by the supervising physician. D. The physician assistant may provide any medical service that is delegated by the supervising physician if the service is within the physician assistant's skills, is within the physician's scope of practice and is supervised by the physician. . . . G. The physician assistant may perform health care tasks in any setting authorized by the supervising physician . . . These tasks may include: 1. Obtaining patient histories. 2. Performing physical examinations. 3. Ordering and performing diagnostic and therapeutic procedures. 4. Formulating a diagnostic impression. 5. Developing and implementing a treatment plan. 6. Monitoring the effectiveness of therapeutic interventions. . . . 9. Making appropriate referrals. 10. Prescribing schedule . . . and prescription-only medications. . . . 13. Performing other nonsurgical health care tasks that are normally taught in courses of training approved by the board, that are consistent with the training and experience of the physician assistant and that have been properly delegated by the supervising physician. . . . Ariz. Rev. Stat. § 32-2531 (2012) Physician assistant scope of practice; health care tasks; supervising physician duties; civil penalty Authority to Prescribe Vaccines All states except Iowa allow PAs to prescribe medications or vaccines under delegated authority. No state grants prescriptive authority under a PA’s own license. No state prohibits PAs from issuing prescriptions. The provision from Arkansas illustrates the expansive powers that have been delegated to the PA: (a) Physician assistants provide health care services with physician supervision. The supervising physician shall be identified on all prescriptions and orders. Physician assistants may perform those duties and responsibilities, including the prescribing, ordering, and administering drugs and medical devices, that are delegated by their supervising physicians. (b) Physician assistants shall be considered the agents of their supervising physicians in the performance of all practice-related activities, including, but not limited to, the ordering of diagnostic, therapeutic, and other medical services. (c) Physician assistants may perform health care 49 services in any setting authorized by the supervising physician in accordance with any applicable facility policy. Ark. Code § 17-105-107 (2012) Scope of authority—Delegatory authority—Agent of supervising physician (a) Physicians supervising physician assistants may delegate prescriptive authority to physician assistants to include prescribing, ordering, and administering . . . all legend drugs, and all nonschedule prescription medications and medical devices. All prescriptions and orders issued by a physician assistant shall also identify his or her supervising physician. . . . Ark. Code § 17-105-108 (2012) Prescriptive authority (a) Patient care orders generated by a physician assistant shall be construed as having the same medical, health, and legal force and effect as if the orders were generated by their supervising physician, provided that the supervising physician's name is identified in the patient care order. (b) The orders shall be complied with and carried out as if the orders had been issued by the physician assistant's supervising physician. Ark. Code § 17-105-122 (2012) Physician assistant patient care orders Authority to Administer Vaccines Thirty-five states permit PAs to administer legend drugs, medications, injections, or vaccines under delegated authority. The states are Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, DC, Hawai’i, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Montana, Nevada, New Hampshire, New Jersey, New Mexico, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin, and Wyoming. No state permits PAs to administer medications under independent authority and no state prohibits PAs from administering medications. Examples from Delaware and South Dakota are below: (h) Prescription and nonprescription medications may be initiated by standing orders if these standing orders have been approved by the supervising physician. . . 24 Del. Code § 1771 (2012) Physician's duties in supervision of a physician assistant *** Except for . . . immunizations . . . provided by . . . a physician's assistant are reimbursed at 90 percent of the physician's fee. . . . Reimbursement for . . . immunizations . . . provided by . . . a physician's assistant are reimbursed according to [rules related to the rate of payment]. Admin. Rules of S.D. 67:16:02:15 (2012) Reimbursement for services provided by nurse practitioner, clinical nurse specialist, or physician’s assistant Defining Patients who May Receive Vaccinations California and Colorado are the two states that have specified the patient populations eligible to receive vaccines from PAs. The following quotes show that California permits PAs to vaccinate students against influenza under standing orders, after parental consent, and with notification of the school nurse. In Colorado, PAs may vaccinate patients up to age 13: (a) . . . [T]he [governing board of a school district] may permit a licensed physician and surgeon, or a health care practitioner listed in subdivision (b) who is acting under the direction of a supervising physician and surgeon, to administer an immunizing agent to a pupil whose parent or guardian has consented in writing to the administration of the immunizing agent. 50 (b)(1) The following health care practitioners, acting under the direction of a supervising physician and surgeon, may administer an immunizing agent within the course of a school immunization program: (A) A physician assistant. . . . (2) A health care practitioner's authority to administer an immunizing agent pursuant to this subdivision is subject to the following conditions: (A) The administration of an immunizing agent is upon the standing orders of a supervising physician and surgeon and in accordance with any written regulations that the State Department of Public Health may adopt. (B) The school nurse is notified and he or she maintains control, as necessary, as supervisor of health . . . . (C) The health care practitioner may only administer immunizations for the prevention and control of any of the following: (i) Annual seasonal influenza. (ii) Influenza pandemic episodes. (iii) Other diseases that represent a current or potential outbreak as declared by a federal, state, or local public health officer. Cal. Education Code § 49403 (2012) Cooperation in control of communicable disease and immunization of pupils *** . . . (11) Child health supervision services. (a) For purposes of this subsection (11), unless the context otherwise requires, “child health supervision services” means those preventive services and immunizations required to be provided in basic and standard health benefit plans . . . to dependent children up to age thirteen. Such services shall be provided by a physician or pursuant to a physician's supervision or by a primary health care provider who is a physician's assistant . . . who has additional training in child health assessment and who is working in collaboration with a physician. Colo. Rev. Stat. § 10-16-104 (2012) Mandatory coverage provisions—definitions Level of Supervision Required to Practice All 51 states indicate how PAs are to be supervised. The excerpts from Georgia, Missouri and Wisconsin provide examples of how the scope of PA practice is limited by the supervising physician: (7) “Physician assistant” [may] provide patients' services not necessarily within the physical presence but under the personal direction or supervision of the supervising physician. Code of Ga. § 43-34-102 (2012) Definitions (e.1)(1) . . . [A] physician may delegate to a physician assistant . . . the authority to issue a prescription drug order or orders for any device . . . or to issue any dangerous drug . . . on a prescription drug order or prescription device order form . . . . Delegation of such authority shall be contained in the job description required by this Code section. The delegating physician shall remain responsible for the medical acts of the physician assistant performing such delegated acts and shall adequately supervise the physician assistant. If an existing job description for a physician assistant does not contain such authority to order a prescription drug or device order as provided by this subsection, that physician assistant may not issue any such prescription drug or device order until a new job description delegating such authority is submitted to and approved by the board. . . . . 51 *** 1. [T]he following terms mean . . . (8) “Supervision”, control exercised over a physician assistant working within the same facility as the supervising physician sixty-six percent of the time a physician assistant provides patient care, except a physician assistant may make follow-up patient examinations in hospitals, nursing homes, patient homes, and correctional facilities, each such examination being reviewed, approved and signed by the supervising physician . . . . Mo. Stat. 334.735 (2012) Definitions--rules--scope of practice--prohibited activities--board of healing arts to administer licensing program--supervision agreements--duties and liability of physicians . . . (5) The on-site supervision . . . shall not apply when a physician assistant is making follow-up patient examinations in hospitals, patient homes, nursing homes and correctional facilities without a supervising physician's presence. . . . 20 Mo. Code of State Regs. 2150-7.135 (2012) Physician Assistant Supervision Agreements *** (1) Scope and limitations. In providing medical care, the entire practice of any physician assistant shall be under the supervision of a licensed physician. The scope of practice is limited to providing medical care specified in sub. (2). A physician assistant's practice may not exceed his or her educational training or experience and may not exceed the scope of practice of the supervising physician. . . . (2) Medical care. Medical care a physician assistant may provide include: (a) Attending initially a patient of any age in any setting to obtain a personal medical history, perform an appropriate physical examination, and record and present pertinent data concerning the patient in a manner meaningful to the supervising physician. (b) Performing, or assisting in performing, routine diagnostic studies as appropriate for a specific practice settin[g]. (c) Performing routine therapeutic procedures, including, but not limited to, injections, immunizations . . . (i) Issuing written prescription orders for drugs under the supervision of a licensed physician. . . . Wis. Admin. Code Med 8.07 (2012) Practice Settings where Physician Assistants are Authorized to Vaccinate Thirty-eight states permit PAs to practice in a broad range of settings. The states are: Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawai’i, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. Permissible settings include a wide range of clinical and community locations: any setting in which the supervising physician agrees to provide supervision, acute care hospitals and other health care facilities, designated health manpower shortage areas, rural health clinics, Federally Qualified Health Centers, county health departments, patient’s homes, ambulances, school health fairs, industrial sites, wellness clinics, and correctional facilities. Excerpts from Texas provide an example of the array of permissible settings: (a) . . . “primary practice site” means: (1) the practice location . . . at which the physician spends the majority of the physician’s time; (2) a licensed hospital, a licensed long-term care facility, or a licensed adult care center . . . (3) a clinic operated by or for the benefit of a public school district . . . (4) the residence of an established patient; (5) another location at which the physician is physically present with the physician assistant . . . or (6) a location where a physician assistant . . . who practices on-site with the physician more than 50 percent of the time . . . (A) health care 52 services for established patients; (B) . . . voluntary charity health care services at a clinic run or sponsored by a nonprofit organization; or (C) . . . voluntary health care services during a declared emergency or disaster at a temporary facility operated or sponsored by a governmental entity or nonprofit organization and established to serve persons in this state. (b) At a physician's primary practice site. . . . Tex. Stat. & Codes § 157.053 (2012) Prescribing at Physician Primary Practice Sites; see also Tex. Stat. & Codes § 157.054 (2012) Prescribing at Facility-Based Practice Sites . . . (c) The activities . . . may be performed in any place authorized by a supervising physician, including a clinic, hospital, ambulatory surgical center, patient home, nursing home, or other institutional setting. . . . Tex. Stat. & Codes § 204.202 (2012) Scope of Practice (a) . . . (4) “Site serving a medically underserved population” means: (A) a site located in a medically underserved area; (B) a site located in a health manpower shortage area; (C) a clinic designated as a rural health . . . (D) a public health clinic or a family planning clinic under contract with the Texas Department of Human Services or the Texas Department of Health; (E) a site located in an area in which the Texas Department of Health determines there is an insufficient number of physicians providing services to eligible clients of federal, state, or locally funded health care programs; or (F) a site that the Texas Department of Health determines serves a disproportionate number of clients eligible to participate in federal, state, or locally funded health care programs. . . . Tex. Stat. & Codes § 157.052 (2012) Prescribing at Sites Serving Certain Medically Underserved Populations . . . (b) A physician may delegate to any qualified and properly trained person acting under the physician's supervision the act of administering or providing dangerous drugs in the physician's office. . . . (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 § 157.002 (2012) General Delegation of Administration and Provision of Dangerous Drugs 53 Table 8: STANDING ORDERS: Physician Assistants & Immunization Practice STATE Alabama Alaska Arizona Arkansas California 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 Own Authority ASSESSMENT Delegated Authority ● ● ● ● ● ● ● ● Prohibited Own Authority PRESCRIPTION Delegated Prohibited Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Own Authority ADMINISTRATION Delegated Prohibited Authority ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● Source: GWU/SPHHS STANDING ORDERS: Health Professionals & Immunization Practice—Fall 2013 54 Figure 10 – Physician Assistants Physician Assistants are most frequently permitted to administer legend drugs followed by medications. . Wisconsin Influenza California Massachusetts (seasonal, H1N1) Drugs or Legend Drugs/Substances Alabama Arizona Arkansas California Connecticut DC Hawai’i Indiana Kansas Kentucky Maryland Minnesota Mississippi Montana Nevada New Hampshire New Mexico Oklahoma Pennsylvania Texas Injectable Medication/Inoculation New Jersey Oklahoma Virginia Wisconsin Pharmacological Agents Mississippi Schedule VI Controlled Substances (includes any substance requiring a prescription) Virginia Medications Alabama Arkansas California Delaware Hawai’i Louisiana Mississippi New Jersey Oregon Wyoming Immunizations or Vaccines California Hawai’i Illinois Iowa Michigan Oklahoma South Dakota Texas 55