Chapter 2 Marilyn Winterton Edmunds and James Cawley Traditionally, prescriptive authority has been the domain of physicians and dentists. The impact of physician prescriptive authority and primary care practices on other types of providers is important. Research on the practices of nonphysician providers has demonstrated conclusively that they are qualified to provide primary care. Although physicians have a broader education than other types of health care providers such as nurse practitioners and physician assistants, the extent of education required to provide primary care services is not clear. It appears that many physicians may be overeducated to provide primary care and other clinicians might be just as competent in delivering primary care (Safreit, 1992), leaving physicians to care for patients with more complicated conditions that clearly require an extensive breadth of education. Some nonphysician providers, such as doctors of pharmacy (PharmDs), have added diagnostic and assessment skills to their pharmacology knowledge, making them valuable contributors to the health care team, while still not challenging the overall clinical role of physicians. Because of the importance of medications in treating primary care problems and in providing the full scope of health care services required by the typical primary care patient, all providers must be able to prescribe medications. This is especially true in rural areas, where only one provider may be available. However, it is just as true where many providers are competing with one another and trying to make a living. If meeting patients’ needs is the primary focus in the provision of primary care services, then providers should not be artificially restricted from meeting as many needs as possible (Safreit, 1992). For many years, the boundaries of nursing practice have been carefully constrained by state nurse practice acts that maintained that “nurses do not treat, diagnose, nor prescribe” (Kelly, 1974). However, the 1960s saw a critical mass of bored, talented nurse clinicians, whose substantial scientific education had been underused, and whose ideas about making changes in their role were spurred on by the consciousness raising of the feminist movement. This happened at a time when other health care personnel were being pulled into the Vietnam War and concern had arisen about how primary health care could continue to be delivered (Edmunds, 2000). This time was formative for the nurse practitioner (NP) movement. Although some educators decried the NP movement as a cause designed to encourage nurses to leave nursing to become handmaidens to physicians (Rogers, 1972), many nurses and some nursing leaders believed that this role would breathe new life into the profession of nursing (Ford, 1979). In contrast to NPs with their primary care focus, CNSs were educated for and practiced primarily in acute inpatient settings and specialty units. As such, although their practice was certainly advanced, they were not responsible for initiating the medical diagnosis and treatment of patients but were true experts in nursing care (Lewis, 1970). They provided advanced consultation and education and conducted research about specific patient problems. This group was frequently the most highly educated of the advanced practice nursing groups in that a master’s degree was almost mandatory for entry into the training. However, because they do not directly generate revenue, their role has been difficult to maintain. Initially, it was unclear whether there would be jobs for any of these nurses with advanced diagnostic and therapeutic training. It was also unclear if they could legally perform some of the tasks that they had been taught to perform. However, the educational programs that were eventually established were highly selective of their students and demanding in their requirements. Students were not allowed to graduate unless they could demonstrate a high degree of competence. Students were typically experienced nurses who were determined to practice nursing in a different way and wanted to make a difference. They were assertive and creative, and they were risk takers (Edmunds, 1978). Because of this combination of experience, competence, and assertiveness, these nurses earned support from patients and grudging acceptance from their physician colleagues. All expanded nursing roles enjoyed an uneasy relationship with medicine during the early phase of their professional development, and many physicians assisted in role development by teaching in educational programs and hiring the new types of providers. These physicians clearly came to respect and support the accomplishments of nurses in the advanced practice role. Early antagonism changed to tolerance or acceptance. Then, in the 1990s, new sources of hostility developed among physicians who had once been supportive. The American Medical Association (AMA) began urging physicians to consciously limit further “erosions of their turf” legislatively and professionally, and to view nurses with expanded roles who wanted direct reimbursement for their services as true competitors for patient loyalty and money (Safreit, 1992). Clearly, all advanced practice roles have survived for longer than 40 years because the clinicians who have practiced within them were competent (Brown & Grimes, 1995; OTA, 1986). Patients liked the blend of nursing with the expanded assessment and treatment skills of the new providers. The weight of evidence indicates that “within their areas of competence, NPs and CNMs provide care whose quality is equivalent to that of care provided by physicians. Moreover, NPs and CNMs are more adept than physicians at providing services that depend on communication with patients and preventive actions. . . . Patients are generally satisfied with the quality of care provided by NPs . . . and CNMs, particularly with the interpersonal aspects of care” (OTA, 1986). These new providers offered enhanced access to acceptable care, increased productivity, and cost-effective alternatives (OTA, 1986). These behaviors, combined with successful legislative efforts in each state to legally authorize the expanded practice of nurses, ensured survival and growth of the role. One component of role function with which each of these groups had to grapple, however, was prescriptive authority. Unlike CNMs or CRNAs, most NPs believed that they could not fully implement their role or provide services that patients required without being able to prescribe medications (Safreit, 1992). The need for CRNAs and CNMs to have prescriptive authority was less clear. Additionally, some aspects of CNS practice began to move away from hospital-based acute care services and to look increasingly like NP primary care practice. These nurses also desired prescriptive authority. So, these types of nurses were required to amend the nurse practice acts in all 50 states to obtain broader authority in their new roles and to gain specific authorization to “treat, diagnose, and prescribe.” Every state has since addressed this issue, with great variability in the legislation passed. Opening up a nurse practice act for revision was essential but often led to unwanted and unwarranted interpretation or regulation. Federal and state statutes and administrative law define control of drugs, including the act of prescribing. How these three elements work together to protect the public has evolved over time. Early regulatory precedents that gave primary prescriptive authority to physicians became a barrier to change for those new health care providers who sought prescriptive authority (Safreit, 1992; Sutliff, 1996). Before the turn of the century, no laws were in place to govern the use of drugs. A myriad of elixirs, tonics, and pills that contained any combination of drugs, including opium and cocaine, were sold freely to anyone who was willing to pay the price. It was not until 1906 that the federal government enacted the first law, the Food and Drug Act, that prohibited adulterated or misbranded food or drugs from interstate commerce (Nielsen, 1992). However, true drug safety was not effectively addressed until 1938, when the U.S. Congress passed the Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), which required drugs to be appropriately tested for safety and labeled with adequate directions for use. However, the explosion of new drug development in the 1940s made the labeling provision difficult to achieve. Thus, the Durham-Humphrey Amendment of 1951 was implemented, creating a separate category of drugs, known as legend drugs. Drugs were considered to be legend drugs if they bore the legend “Caution: Federal law prohibits dispensing without a prescription” (21 U.S.C. 353). These drugs did not require specific package labeling but instead required medical supervision for their sale and use. This act also instituted the process whereby the pharmacist dispensed legend drugs after first obtaining a written prescription from an authorized prescriber (Nielsen, 1992). The other major piece of federal legislation that affected drug regulation was the Comprehensive Drug Abuse Prevention and Control Act of 1970. This act limited prescribing, dispensing, manufacturing, and distribution to those individuals who were registered with the Drug Enforcement Administration (DEA), an agency of the Department of Justice. It also classified narcotics and other drugs such as depressants and stimulants by their abuse potential, with differing levels of control assigned to each class (Nielsen, 1992). Thus, some legend drugs were further categorized as controlled substances (see Chapter 10 for a classification of controlled substances) and were placed under additional restrictions. Although the federal government has taken broad control over drug regulation, it has no control over who may prescribe, dispense, or administer drugs (Buppert, 1999). This role belongs solely to the states and is generally addressed in the statutes, rules, and regulations that outline the licensure and scope of practice of specific health care providers. The state law that enables nurses to practice nursing is a legal statute titled the Nurse Practice Act. Nurses are individually licensed by the state in which they practice. In their efforts to protect a vulnerable and possibly ill-informed public in need of health care, every state has enacted licensing laws for health care providers. If people do not have the information or the ability to make safe judgments about the qualifications and abilities of providers, the state serves as a proxy to gather this information through licensing. Although the state establishes a list of minimum requirements that one must meet to be licensed within that state, meeting these requirements does not necessarily guarantee that the provider is competent. Thus, licensure as a mechanism to protect the public has not been conclusively demonstrated (Bullough, 1980). Boards of nursing have been somewhat perplexed about how to make certain they are protecting the public safety when the nursing role has changed so dramatically over time. In 1985, the National Council of State Boards of Nursing (NCSBN) adopted a position paper on advanced clinical practice that called for regulations to be adopted in each state that mandates a minimum of master’s preparation in a clinical nursing practice specialty, to serve as the basis for advanced clinical nursing practice. NCSBN also mandates recognition of national certification to identify nurses for advanced clinical nursing practice. However, it is clear that use of a national certification examination (established to provide professional recognition) to obtain a license to practice in an individual state is fraught with its own problems (Edmunds, 1992). Whether traditional registered nurse licensure adequately protects the public when a nurse moves into an expanded role, or whether a second license should be given, is a matter that is still being discussed (Klein, 2007). Nurses with advanced education want legislative parity with physicians, who are not required to obtain additional licenses if they are professionally credentialed in another specialty. In their seminal studies, Fink (1975) and, later, Trandel-Korenchuk and Trandel-Korenchuk (1978) attempted to categorize the variations in prescriptive authority allowed in different states as they related to NPs. Essentially, two types of prescriptive authority are afforded to NPs: delegable authority and authority legislated by nursing statutes or regulations. Delegable authority requires the nurse to perform under the direction of a physician, mandates the initial physician-patient relationship, and is legally based in medical practice acts. Delegable prescriptive authority can be further delineated into three subtypes: (1) physician determination of patient-specific medications and authorization of the nurse to prescribe accordingly for that patient, (2) standing order/protocols that serve as instructions for prescribing, and (3) renewal of prescriptions by the nurse, based on prescriptions initially ordered by the physician. Without delegated authority, the nurse cannot legally prescribe medications under any circumstances but can recommend nonprescription medications. Although these categories were defined in the 1970s, they are still relevant today, and these differences help to explain some of the barriers to prescriptive authority that have been faced by NPs. The clinical specialist in nursing practice is a nurse who, through study and supervised clinical practice at the graduate level (master’s or doctorate), has become expert in a defined area of knowledge and who practices in a selected clinical area of nursing (American Nurses Association, 1980). The role of the CNS embodies a unique combination of tasks. The specialist is prepared to serve as an expert in clinical practice, an educator, a consultant, a researcher, and, often, an administrator. “The boundaries of the specialty are defined by the phenomena of interest to the CNS. These phenomena may change, reflecting the needs of society, and may therefore cause the boundaries to expand” (Sparacino et al, 1990). In almost all states in which CNSs have obtained prescriptive authority, this has occurred because they formed coalitions with other APNs and were granted prescriptive authority through those coalitions. In many states, CRNAs, CNMs, NPs, and CNSs all are defined by legislative statute as APNs, and legislation has been written to grant prescriptive authority to APNs—not to individuals with different titles in that category. Because of this, many CNSs acknowledge that they have piggybacked on the efforts of other advanced practice nursing groups in the state to obtain prescriptive authority. In no states have CNSs obtained prescriptive authority while other nurses were denied those privileges (Pearson, 2007). This trend is likely to continue. Certified registered nurse anesthetists (CRNAs) are registered nurses who have become anesthesia specialists by taking a graduate curriculum that focuses on the development of clinical judgment and critical thinking. Their official website says, “They are qualified to make independent judgments concerning all aspects of anesthesia care based on their education, licensure, and certification. CRNAs are legally responsible for the anesthesia care they provide and are recognized in state law in all 50 states, the District of Columbia, Puerto Rico, and the Virgin Islands” (AANA, 2012). The CRNA provides preoperative, intraoperative, and postoperative care to patients and assists in the management and resuscitation of critical patients in intensive care, coronary care, and emergency situations. They develop their specialty in anesthesia by completing a graduate curriculum that emphasizes the development of critical judgment and critical thinking. “They are qualified to make independent judgments relative to all aspects of anesthesia care based on their education, licensure, and certification. As clinicians, they are legally responsible for the anesthesia care they provide” (AANA, 2012.) Nurse anesthetists have been providing anesthesia services in this country for longer than a century. Working in conjunction with anesthesiologists, surgeons, and, where authorized, podiatrists, dentists, and other health care providers, nurse anesthetists administer approximately 65% of all anesthetics given each year in the United States. They are found in every setting in which anesthesia is provided and work with every age group and every type of patient. They use the full gamut of anesthesia techniques, drugs, and technology and are the sole anesthesia providers in more than 70% of rural hospitals (AANA, 2012). The American Association of Nurse Anesthetists (2012) maintains that the CRNA scope of practice includes, among other things, the following: • Performing and documenting a preanesthetic assessment and evaluation of the patient, including requesting consultations and diagnostic studies; selecting, obtaining, ordering, and administering preanesthetic medications and fluids; and obtaining informed consent for anesthesia. • Developing and implementing an anesthetic plan. • Initiating the anesthetic technique, which may include general, regional, local, and sedation. • Selecting, obtaining, and administering the anesthetics, adjuvant and accessory drugs, and fluids necessary to manage the anesthetic. • Facilitating emergence and recovery from anesthesia by selecting, obtaining, ordering, and administering medications, fluids, and ventilatory support. • Implementing acute and chronic pain management modalities. • Responding to emergency situations by providing airway management, administration of emergency fluids and drugs, and using basic or advanced cardiac life support techniques. CRNAs provide anesthesia in collaboration with surgeons, anesthesiologists, dentists, podiatrists, and other qualified health care professionals. When anesthesia is administered by a nurse anesthetist, it is recognized as the practice of nursing; when administered by an anesthesiologist, it is recognized as the practice of medicine. Regardless of whether their educational background is in nursing or medicine, all anesthesia professionals give anesthesia the same way (AANA, 2012). • In 2001, the Centers for Medicare & Medicaid Services (CMS) changed the federal physician supervision rule for nurse anesthetists to allow state governors to opt out of this facility reimbursement requirement (which applies to hospitals and ambulatory surgical centers) by meeting certain criteria. To date, 16 states have opted out of the federal supervision requirement, most recently Colorado (September 2010). Additional states do not have supervision requirements in state law and are eligible to opt out should the governors elect to do so. Because of this definition, the traditional practice of nurse anesthetists, which involves ordering and directly administering controlled substances preoperatively, intraoperatively, and postoperatively, does not constitute “prescribing” under federal law. Therefore, CRNAs engaged in traditional practice do not need prescriptive authority or an individual DEA registration number to do so (Tobin, 2007). CRNAs engaged in traditional anesthesia practice have no need for a DEA number. However, if the state grants prescriptive authority to CRNAs, and they elect to use prescriptive authority in their practice, they then are subject to DEA registration requirements. The view of the AANA has been that, whether or not CRNAs need prescriptive authority, independent prescriptive authority enhances the role and so is desirable. It also may alleviate confusion about the exact nature of the authority of CRNAs. However, prescriptive authority is not viewed as an essential component without which they cannot practice (Tobin, 2007). State CRNA chapters vary in their perceived need for prescriptive authority and in terms of their evaluation of the political and professional environment that might bring success to those who seek such authority. Currently, five states grant independent prescriptive authority to CRNAs (Alaska, New Hampshire, Wyoming, Montana, and Washington). In 19 other states and the District of Columbia, some type of prescriptive authority has been linked to physician control (Tobin, 2007). Midwifery as practiced by certified nurse-midwives (CNMs) and certified midwives (CMs—who do not have a nursing background) encompasses a full range of primary health care services for women from adolescence to after menopause. These services include primary care, gynecologic and family planning services, preconception care, care during pregnancy, childbirth and the postpartum period, care of the normal newborn during the first 28 days of life, and treatment of male partners for sexually transmitted infections (ACNM, 2012). The CNM practices in a health care system that provides consultation, collaborative management, or referral as indicated by the health status of the client. Certification as a CNM requires education at the postgraduate level in nursing or an allied professional health care field (ACNM, 2012). The philosophy of the ACNM (ACNM, 2007; ACNM website, 2012) emphasizes a focus of the midwife on the needs of the individual and the family for care and physical, emotional, and social support, as well as involvement of significant others in this care according to cultural values and personal preferences. The practice of nurse-midwifery, which is delivered throughout the life span, advocates nonintervention in the normal processes of reproduction and development, as well as health education for women throughout the childbearing cycle. Midwifery has expanded to include gynecologic care of well women throughout the life cycle. Nurse-midwives provide this comprehensive health care, most frequently in collaboration with other members of the health care team. Women have always taken responsibility for the delivery of children. With the passage of the first medical practice acts in the 1920s, midwives suddenly found themselves directly opposed by obstetricians and legally outside the laws that physicians had crafted. This led to the expansion of formal academic midwifery programs and the requirement for midwives to obtain legal authorization for their services. The number of CNMs has consistently increased. Traditionally, CNMs find most of their clients among the indigent, who fear and cannot afford hospital-based obstetric care. Many of these clients have used lay midwives and view birthing as a natural process that should occur under the supervision of women. While continuing to provide care to underserved populations, CNMs now also provide care to women from all cross sections of the country (ACNM, 2012). The number of CNM-attended births has increased every year since 1975—the first year that the National Center for Health Statistics began to collect data—until 2009, when there was a slight decrease. Certified nurse-midwives (CNMs) and certified midwives (CMs) attended 313,516 births in 2009, according to the National Center for Health Statistics. (This is the most recent year for which final birth data are available from the National Center for Health Statistics.) This represents 11.3% of all vaginal births, or 7.6% of total U.S. births. In addition to more traditional health care settings, some CNMs choose to provide home birth services or work in birthing centers with other CNMs. A collaborative team of CNMs and physicians offer women a combination of primary and preventive care, along with specialized services as needed. The degree of collaboration with physicians depends on the medical needs of the individual woman and the practice setting. Of all visits to CNMs, 90% are made to obtain primary preventive care (70% for care during pregnancy and after birth, and 20% for care outside of the maternity cycle). Nurse-midwives on average devote about 10% of their time to direct care of birthing women and their newborns (ACNM, 2007; International Confederation Midwives, 2011). Certified nurse-midwives are legislatively authorized to practice in all 50 states and U.S. territories. In most states, the regulatory agency for the practice of nurse-midwifery is the state board of nursing. CNMs have been granted the authority to write prescriptions in all 50 United States and the District of Columbia, while CMs have been granted prescriptive authority only in the state of New York. Prescriptive authority for CNMs and CMs is regulated by individual state agencies and regulatory boards. Regulations regarding prescriptive authority for CNMs and CMs vary widely from state to state and are described, with a summary for each state presented. While CNMs are granted fully independent prescriptive authority in some states, the regulatory requirements relative to prescriptive authority for CNMs/CMs limit patients’ access to necessary services in most states (Osborne, 2011).
Historical Review of Prescriptive Authority
The Role of Nurses (NPs, CNMs, CRNAs, and CNSs) and Physician Assistants
Overview
The Prescriptive Authority of Nurses
Changes in Roles for Nurses: When and Why
Legal Foundation of Prescriptive Authority for Nurses in Advanced Practice Roles
Role of the Federal Government
State Control of Prescriptive Privileges
An Overview of the Prescribing of Advanced Practice Nurses
Clinical Nurse Specialists
Definition and Scope of Practice
Status of Prescriptive Authority
Certified Registered Nurse Anesthetists
Definition and Scope of Practice
Status of Prescriptive Authority for the CRNA
Certified Nurse-Midwives
Definition and Scope of Practice
Status of Prescriptive Authority for CNMs
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Historical Review of Prescriptive Authority: The Role of Nurses (NPs, CNMs, CRNAs, and CNSs) and Physician Assistants
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