Increased Focus on Primary Care

Primary care as a concept involves the provision of integrated, accessible health care services by clinicians who are accountable for addressing “personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community” (Vaneslow et al, 1995). It is generally agreed that providing health care includes one or more of the following functions: assessing health status, promoting healthy lifestyles, identifying/diagnosing normal and abnormal conditions, determining the causes of abnormal conditions, providing referral to health care specialists, selecting appropriate therapeutic measures, implementing treatment, and supervising or monitoring the patient on an ongoing basis. These tasks are commonly referred to as prevention, diagnosis, prescription, and treatment. They describe professional behaviors that involve deciding what is wrong with a patient and then choosing among available therapeutic options to prescribe and implement a course of treatment. Traditionally, these behaviors have been the exclusive domain of the physician and, to a lesser extent, the dentist, until 1965, when other nonphysician provider roles began to emerge.

Traditional Provision of Primary Care

Physicians clearly are the most numerous primary care providers, and their prescriptive practice has influenced all other clinicians who gain prescriptive authority. States first began to enact medical practice acts in the 1920s to protect the public safety. Before that time, the quality of medical education and the competency of physicians were variable. Medical practice acts granted title protection to those individuals who called themselves physicians and identified what requirements must be met for that title to be given. Although other categories of health care professionals were certainly in existence at that time, physicians were the first health care practitioners to gain legislative recognition of their practice (Starr, 1982). The statutory definitions initially created by physicians for the scope of their practice were extremely broad. In an exhaustive study of regulatory restrictions on new types of health care providers, Safreit (1992) provided an example (NC Gen. Stat No. 90-18 [1983]) of one state’s definition of physician or surgeon as follows:

Any person . . . who shall diagnose or attempt to diagnose, treat or attempt to treat, operate or attempt to operate on, or prescribe for or administer to, or profess to treat any human ailment, physical or mental, or any physical injury to or deformity of another person.

Because of the way in which the medical practice acts were written, physicians emerged with an exclusive right to practice that gave them a preeminent position in a hierarchy of healing occupations. Designating physicians as the only providers with diagnostic and treatment authority was intended to protect the public. However, the breadth of the medical practice acts, combined with provisions making it illegal for anyone not licensed as a physician to carry out any acts included in the definition, made it difficult for other health care workers to describe their contributions. All other health care providers, including groups such as nurses and nurse-midwives, had to redefine their tasks or functions as separate from the all-encompassing medical scope of practice. They then had to seek legislative recognition of their own professional roles, no matter how traditional or longstanding their activities might have been (Safreit, 1992).

Dominance of the physician in the health care hierarchy created a virtual monopoly in health care. The medical sociology and professionalization literature is filled with extensive analyses of the factors that led to the development of the cultural, economic, political, and social authority and dominance of the physician, especially the growth and power of organized medicine (Freidson, 1970, 1970b; Starr, 1982).

Having obtained the exclusive right to practice, however, physicians also recognized their need for the services of other practitioners of healing who were “useful to the physician and necessary to his practice” (Safreit, 1992), even if it required giving up some of their monopolistic control. A noted medical sociologist who has traced the professionalization of physicians notes that to solve this dilemma, physicians extended their right to practice to a right from the state to control the activities of other occupations “so as to limit what they could do and to supervise or direct their activities” (Freidson, 1970). In doing so, the profession was able to establish organizational structures that preserved a distinct sphere of professional dominance and autonomy (Safreit, 1992).

The role of the physician has changed dramatically during the past 50 years. Driven by new technology, new procedures, and new medications, physicians have been attracted into specialty practice in greater numbers, leaving primary care positions vacant. Medicare reimbursement has fueled the growth of tertiary care.

The emergence of nonphysicians who claimed preparation for and the desire to provide primary care services came at a time when there was a shortage of primary care services. The emergence of this new group challenged the professional control by physicians, the organizations that have consolidated their authority, and the legislation designed to protect and preserve that position.

Beginning in 1992, the Physician Payment Review Commission recommended radical changes in Medicare reimbursement methods. This shift directly increased financial reimbursement to clinicians who were providing primary care and thus indirectly created an incentive to attract more providers into primary care. The hope was that the numbers and types of providers would be more evenly aligned with the numbers and types of patients who require health care.

Medical schools began to place greater emphasis on preparing primary care clinicians. Teaching methods shifted from the acute care model to include a greater focus on primary care. The hospitalist emerged as a specialist, thus relieving the primary care physician of the need to provide in-hospital care. Reimbursement began to reward the general practitioner. All of these changes have resulted in qualified success, bringing increased credibility and recognition to primary care providers; however, the number of specialists remains disproportionate.

Notwithstanding the longstanding precedent for physicians to provide primary care, there remained a disparity in the ability of physicians to meet the primary care needs of the populace. Nonphysician providers began to fill that niche with increasing success. The nonphysician providers who emerged during the 1960s and 1970s were well accepted by their patients; delivered high-quality, cost-effective care; and generally increased the access of patients to health care (OTA, 1986). These providers continued to work cooperatively with physician providers, most often in joint practices.

Importance of Prescriptive Authority in Health Care Delivery

Medications are powerful weapons against disease. Pharmaceutical companies add many new drugs every year to the nation’s pharmacopoeia. Hundreds of new drugs, including many new drugs for children, are in the research and development pipeline and are providing a new armamentarium for clinicians to use in treating patients with chronic disease.

Research on Prescriptive Practice of Physicians

Physicians and dentists are the professionals who traditionally have been given the undisputed right to prescriptive authority. The prescriptive practice of physicians in primary care practice has been thoroughly documented by the pharmaceutical industry. What medications physicians order and how many prescriptions are written are closely monitored. Studies have not only evaluated basic prescribing practices but have analyzed the effects that multiple variables have on prescribing habits. While the prescriptive behavior of physicians may not be the gold standard of primary care practice, it has been the only standard, and their strengths and weaknesses bear exploration by other groups seeking prescriptive authority. Some of the key findings are briefly presented here.

The National Ambulatory Medical Care Survey (Cherry & Woodwell, 2002) collected data on drugs most frequently used in office-based practice and found that 64.21% of all office visits resulted in the generation of at least one prescription. The top five categories of prescriptions were antidepressants, nonsteroidal antiinflammatory agents, antihistamines or bronchodilators, antihypertensives, and antihyperlipidemics. During the past 20 years, these categories have remained relatively consistent, although antimicrobial drugs have now fallen from the top five. In the 2000 National Ambulatory Medical Care Survey (Cherry & Woodwell, 2002), researchers examined physician prescribing in both general and family practice. They found that for those patients who made an office visit, 33.9% did not receive any prescription; however, 28% received one prescription, 16.1% received two, 8.8% received three, 4.9% received four, 3.2% received five, and 5.3% received six. The percent of visits involving medications ranged from 78.8% for internists to 29.9% for general surgeons. General and family practice physicians deal with medications in 76.3% of visits.

Many more studies have examined the types of medications prescribed, and over the years, patterns have changed. Stolley and Lasagna (1969) found that 95% of all physicians prescribed one or more medications to a patient with a common cold, and more than 60% of these prescriptions were for antibiotics. In 1972, a computerized retrieval system examined 20,000 prescriptions and found that antibiotics topped the list of most frequently prescribed medications, followed by tranquilizers, nonnarcotic analgesics, oral contraceptives, and antitussives (Stolley et al, 1972b). In 1974, researchers found sedatives and hypnotics heading the list (21%), and antibiotics (15%), antihistamines (8%), dermatologic preparations (6.6%), and cardiovascular drugs (6.5%) accounted for the top five classifications (Rosenberg et al, 1974). As the years progressed, sedatives, tranquilizers, and hypnotics began to decline in popularity (DeNuzzo, 1981; Knoben & Wertheimer, 1976; Rossiter, 1983). The 2000 National Ambulatory Medical Care Survey, which was released by the Centers for Disease Control and Prevention (Cherry & Woodwell, 2002), shows that the top categories of drugs are very similar to those reported 20 years earlier. However, antibiotic categories have become antimicrobial, accounting for the change in prescribing due to AIDS. The most frequently prescribed drug in 2000 was Claritin, followed by Lipitor, Synthroid, Premarin, and amoxicillin. Acetaminophen was the generic substance most frequently prescribed. The survey documented a 21% increase over the past several years in the percent of office visits in cases in which cardiovascular-renal drugs, such as angiotensin-converting enzyme inhibitors, β-blockers, or antihypertensive medications, were prescribed. Between 1997 and 2000, a 25% increase in percentage of visits occurred in cases in which a hormone was prescribed, whereas the increase in the percent of metabolic/nutrient drug visits rose by 41%. The report suggested that these changes reflect the drug use patterns of the health-conscious baby boomers and the growing number of seniors whose chronic conditions can be treated by the wide variety of medications on the market today. Of note is that in the latest findings presented in the 2004 report, antidepressants are the most widely prescribed drugs. After 2006 statistics were collected in terms of “mentioned drugs,” and numbers of prescriptions for drug categories were not calculated. However, by 2008 analgesics were 10.7% of drugs mentioned, antihyperlipidemic agents followed with 5.8%, and antidepressants agents at 4.2%. Beta-adrenergic blocking agents and antidiabetic agents followed, with anxiolytics, sedatives, and hypnotics making up the next highly mentioned category of drugs. Analysis of the medication data reveals that the drug categories mentioned were dominated by five therapeutic classes: pain relievers, cardiovascular-renal drugs, respiratory tract drugs, CNS drugs, and antidiabetic drugs (USDHHS, 2008).

Less research has been conducted on the appropriateness of physician prescriptive practices, although the literature suggests that some physicians may write prescriptions for problems that might well respond to many nonpharmacologic treatments (Avorn et al, 1991). Considerable numbers of prescriptions are also written for off-label or non-FDA-approved drug use.

The pharmaceutical industry has expended considerable research dollars on determining how best to influence prescribers to adopt a particular drug. When a new drug product is developed, research suggests that the rate of adoption by prescribers may be divided into five profiles: innovators, early adopters, early majority, late majority, and laggards. Although the speed at which prescribers adopt the drug varies, the individuals within each profile all go through a four-step process—awareness of the new drug, interest, evaluation, and trial—that leads to adoption.

Denig and Haaijer-Ruskamp (1992) described an “evoked set” that includes a small number of possible treatments (typically containing all therapies, including nondrug therapies) that a physician might consider for a specific condition. Clearly, if a therapy is unfamiliar or unknown, it will not be included in the physician’s evoked set. The evoked set for all possible medical problems makes up the “total drug repertoire” or “therapeutic armamentarium” and, on average, includes 144 drug preparations per physician. Researchers have concluded that over a 12-month period, physicians write 5.4% of prescriptions for new drugs and that 42% of the time this product replaced a drug that was previously part of the repertoire. “Once a product is part of the evoked set, it has a propensity to be prescribed through habit rather than through active problem-solving” (Groves et al, 2002). So prescribers both adopt and relinquish drugs in their therapeutic armamentarium. This change in the product choice comes as innovation is diffused or communicated through certain channels over time among the members of a social system. Burban, Link, and Doucette (2001) suggested that the factors that influence new drug adoption are the perceived attributes of the innovations, communication channels used to discuss these attributes, the nature of the social system, and physician characteristics.

Other studies over the years have attempted to predict which variables most strongly affect prescribing habits. Younger physicians and specialists tend to prescribe more appropriately and to prescribe fewer medications (Miles & Roland, 1975; NCHS, 1983a;). Stolley et al (1972) also noted that generally the more appropriate prescriber was the one who was in a large group practice and who used physician consultants and journal articles to guide pharmacologic decision making. Miller (1973, 1974), Smith (1977), and Stolley and Lasagna (1972) identified multiple variables that may influence drug prescribing. Colleagues, pharmaceutical representatives, journal articles, the Physicians’ Desk Reference, medical meetings, sponsored office lunch discussions, and journal advertising were reportedly the primary sources of information about medications and therapeutic regimens.

In a summary of a growing body of literature, it has been suggested that financial ties to drug companies may influence physicians’ prescribing judgments. One study found that physicians who requested specific additions to a hospital pharmacy were substantially more likely to have met with drug company representatives or to have accepted money from drug companies. However, physicians may not recognize the potential influence of drug companies on their behavior. One study of primary care physicians said that they placed little weight on drug advertisements (68%), pharmaceutical representatives (54%), and patient preference (74%) and that they relied heavily on academic sources for drug information. Yet the study found that commercial rather than scientific sources of drug information dominated their drug information materials.

Guidelines issued by the U.S. Food and Drug Administration (FDA) in 2001 prompted the American Medical Association and the Pharmaceutical Manufacturers and Researchers of America (PhRMA) to issue ethical guidelines that clarify the appropriate relationship between pharmaceutical companies and drug prescribers. These guidelines forbid pharmaceutical companies from giving to prescribers nonpatient care–related items exceeding $100 in value; they also clarify the role that pharmaceutical companies can and cannot play in the continuing education of provider groups. Current gifts to health care providers from pharmaceutical companies are restricted so that even pens are forbidden.