Rare is the pharmacist today who does not participate as a service provider in one or several third party prescription insurance programs. Latest figures indicate that 372.7 million prescriptions or 25.4 percent of all prescriptions dispensed in this country were paid for at least in part by some form of prescription drug insurance.’ The economic impact which these third party programs are having on the retail pharmacist has caused their prominence as one of the most serious and important issues in pharmacy today.

Most third party prescription programs (TPPPs) are similar in structure and include a program administrator or insurance company, a sponsor (often an employer or labor union), subscribers or beneficiaries. and the participating pharmacies. Typically, the insurer or program administrator (hereinafter. the administrator) offers a contract or a “pharmacy agreement” to each pharmacy in a particular area. Each pharmacy must then decide whether or not to accept the agreement and become a participating pharmacy.

The question of how and when a novel medical procedure becomes accepted as standard practice has important legal implications. It may in certain situations be determinative of whether third-party reimbursement is available for such procedures. It may also affect the standard used in determining a physician’s liability for negligence. This article discusses several innovative medical procedures and the process of their acceptance by the medical community. It will be seen that none of these examples effectively delineates the process by which an innovative procedure becomes the accepted standard of care. Finally, the article suggests a system based upon consensus among recognized medical experts, and recommends that this system supplant the traditional cost-benefit analysis which is currently used to determine the accepted standard of care.

No formal mechanism currently exists for the introduction of innovative medical technologies, in contrast to the complicated procedures developed for the orderly introduction of new drugs into the marketplace.

It has been seven years since the last major medical malpractice crisis, when the cost of liability insurance rose so astronomically that several important insurers withdrew from providing insurance coverage to physicians and health care institutions. Government and private policy groups at that time established committees to evaluate the medical malpractice crisis and to recommend changes that would bring about an amelioration of the adverse financial and health care features surrounding medical malpractice. The United States Department of Health, Education and Welfare published its Report of the Secretary's Commission on Medical Malpractice in 1973, documenting the extent of the crisis and recommending that alterations be made in the existing tort law to alleviate some of the financial burdens brought on by the increasing number of cases. In 1977, the Institute of Medicine of the National Academy of Sciences formed a Steering Committee on Medical injury Compensation that reviewed some of the special problems of the medical malpractice system and published its report.

Third party payment for health services in the United States has created an environment which offers little incentive to health care providers to be efficient. In response, health care policymakers have suggested that increased competition in the health care sector would encourage good managerial practices and improved cost efficiency. In recent years, health care providers that have the ability to provide services in a more cost-efficient manner have emerged; some, including health maintenance organizations and ambulatory surgical centers, have been encouraged by regulatory policy. In addition, a new alternative for the provision of emergency medical services has developed and has generated substantial controversy among physicians, hospitals, government officials, and the public. The entities that comprise this alternative are often collectively referred to as freestanding emergency care centers or “emergicenters.”

Much of the controversy surrounding emergicenters is caused by the lack of a definition which can be applied to the various emergicenter structures and operations.

The concept of allied health professionals practicing in hospitals arouses the opposition of many in the medical establishment. What is the nature of this conflict, and how can it be resolved? This article gives an overview of the reasons that allied health professionals are demanding hospital privileges, as well as the reasons that such privileges are opposed by physicians. In the author's opinion, the medical establishment should learn to accept practice in hospitals by non-physician providers, and can expect considerable legal opposition if it does not.

The first problem is to define what is meant by “allied health professional.” Generally, the term is applied to any health care provider who is not in the “MOD” group, which traditionally has included medicine (MD), osteopathy, and dentistry, although pursuant to certain federal regulations podiatry also falls within the MOD group. Thus, in a general sense, “allied health professionals” means everyone else who directly provides health care services.

The law of informed consent is in a state of flux. Originally a judicially-created doctrine, the doctrine varies from jurisdiction to jurisdiction in its theoretical basis for imposing liability (battery vs. negligence), the scope of the physician's duty to disclose (the “professional” vs. the. “prudent patient” standard), and, where negligence is the basis for the action, the requirement for finding proximate causation (subjective vs. objective basis). Many states have recently enacted statutes on informed consent which differ markedly in their provisions. Coexistent with this uncertainty about the precise form that the law should take, and perhaps underlying it, is a basic uncertainty about the purposes and rationale behind the informed consent doctrine, the feasibility of executing its dictates, and the effects of its application on the delivery of health care.

Consumer demand and federal support has caused the number of certified nurse-midwives to quadruple in the last decade, from 629 in 1970 to 2500 in 1982. Despite their record of reducing infant mortality and satisfying consumers, nurse-midwives are still an underutilized health resource. This article provides a brief history of nurse-midwifery. describes nurse-midwives’ education and current legal status, discusses obstacles to wider use of nurse-midwives, and examines the issues of safety and cost-effectiveness of nurse-midwifery practice.

The word “midwife” often evokes images of home births attended by “granny” or “lay” midwives who lack formal education in obstetrics. Yet, professionally educated nurse-midwives have practiced in this country since 1925, when an American nurse, educated in nurse-midwifery in England, came to the mountains of eastern Kentucky.

During the past few years, health care professions haw received strong criticism for seemingly ethically wrong or inhumane practices. The Tuskegee syphilis study, experimentation on mentally retarded persons at Willow-brook, forced sterilizations of retarded individuals, and alleged malpractice and Medicaid abuses are a few examples of those instances that have received publicity. Incidents such as these, coupled with the development of an aggressive consumerism and with escalating scientific technological advances, haw created an urgent and widespread concern about medical ethics or bioethics. The Hastings Institute, two presidentially appointed commissions on issues in medical ethics, and the introduction of ethics courses in the curricula of medical and nursing schools are responses to ethical concerns in health care.

Although numerous texts and articles on specific bioethical issues haw been published in recent years, troubling questions remain about the normative ethics that form the foundation of responses to these issues.

The Report of the National Commission on State Workers’ Compensation Laws heralded a new era for workers’compensation in the United States. Appointed by the President in 1970, the Commission issued its report in 1972, and pointed out the gross inadequacies of all the state systems. To compel the states to modernize their compensation laws, the Commission established 19 essential recommendations, and placed time limitations on the adoption of these standards by the states, with the threat that if these recommendations were not met by July 1975, the Commission would recommend to Congress that the non-complying state systems be taken over by the federal government and operated under the generally more liberal provisions of the Longshoremen's and Harbor Workers’ Compensation Act.

To be a nurse involves the assumption of ethical responsibility in all areas of practice. Infection control practice is a nursing specialty which exemplifies two ethical issues: the nurse's duty or moral obligation for patient advocacy and the right of patients to safe care. Individual moral responsibility is an important issue for the nurse epidemiologist because epidemiologic fact-finding provides information that may present ethical problems as well as suggest solutions. This paper discusses ethical dilemmas arising in infection control practice, as illustrated by three actual situations.

In the course of practice, questions may arise concerning the ethical responsibilities of a nurse epidemiologist to provide facts that may be used in cases of dispute. This discussion shall be limited to institutionally acquired or nosocomial infections.

Medical centers. with increasing frequency, are employing their own in-house attorneys. The express purpose for this is to avoid the cost of large corporate law firms, as well as to secure greater control over costs connected with medical malpractice litigation, such as loss control, risk management, and self-insurance programs. But are these offices appropriately and competently providing the full spectrum of legal services to the medical centers they serve?

This past spring, a conference in Chicago explored the role of in-house counsel in controlling corporate legal costs. The general consensus was that corporate clients, who consume from 65 to 85 percent of the legal services in the country, have allowed themselves to be “cowed by the demands of prestigious outside counsel.” According to press reports, ineffectual in-house counsel were criticized for their inability to curb excessive corporate legal fees and expenditures. The legal fees of outside firms were characterized as “just plain unnecessary.”

Most health professionals today would agree about the necessity of interdisciplinary health care for clients. The optimal division of labor, however, has been a source of concern if not outright disagreement.

Literature on “professional status” and on the interrelationships of health professionals abounds, possibly leading one to the impression that everything worth saying has already been said. However, developments in health care and in professional education are of a dynamic rather than of a static nature. For this reason alone a reconsideration of the roles and relationships of health care team members is justified from time to time.

Determining whether the health care system meets the needs of service recipients is only one important reason for studying role interactions.

In an article in the June, 1982 issue of this journal, Barry Furrow suggested that changing the name of the tort of “wrongful life” to “diminished life” would overcome the reluctance that many courts have shown to recognize its existence. Others have made similar suggestions, differing only in the names which they proposed as a replacement for “wrongful life.” It is my belief, however. that the problems that many courts and commentators have had with “wrongful life” are inherent in the nature of the action and will not be resolved by simply changing its name.

In the remainder of this article, 1 will employ the neutral term “X” to refer to any action brought by a child for having been born with some defect or handicap which could only have been prevented, given the current state of medical knowledge, by either aborting the child or preventing its conception. It is hoped that this device will avoid the danger of “semantic overload,” of which Professor Furrow wrote.

On July 1, 1982, the United States Supreme Court issued its opinion in Mississippi University for Women v. Hogan, ruling that the “female only” admission policy of a state-supported nursing school violated the equal protection clause of the fourteenth amendment. The case has political and legal implications not only for nursing education, but for the nursing profession as well.

Joe Hogan, a registered nurse, worked as a nursing supervisor in a medical center in Columbus, Mississippi. In 1979, he applied for admission to the baccalaureate program at Mississippi University for Women (MUW) School of Nursing, located in Columbus. Although he met all of the school’s substantive admission criteria, Hogan was denied admission solely because MUW has, since its inception, admitted only females. The school’s policies would, however, permit him to audit nursing courses and to attend continuing ed,ucation courses.

Generic drugs that have not been specifically approved by the Food and Drug Administration (FDA) are today being marketed, and considerable legal controversy surrounds the issue of whether the FDA can require premarketing approval of generic copy drugs (“me-toos”).

Prescribers and dispensers of drugs cannot blindly assume that every drug on the market has been approved by the FDA, and that it will be safe and effective, as can be seen from the following incident. In September 1981, in an unprecedented action, an Ohio grand jury indicted a pharmacist for manslaughter in the death of a woman to whom he sold a furosemide product unapproved by the Food and Drug Administration. The woman died of congestive heart failure and the grand jury found probable cause that the death was caused by the diuretic. The drug was dispensed despite a March 30,1979,news release from the Department of Health, Education and Welfare warning that unapproved furosemide tablets were being marketed and that these drugs might be ineffective and could possibly be harmful.

There is increasing societal concern about retention and retrieval of information about individuals; advances in technology have enlarged the means for storing and communicating personal information. Not surprisingly, some of this concern is directed toward medical records. Questions have arisen about ownership of and access to medical records, as well as their content. This column focuses solely on some basic issues pertaining to the content of medical records.

Information in a patient's medical record can be used as a basis for decisions concerning his insurance coverage or payments, employment, eligibility for educational or benefit programs, or the outcome of a lawsuit. Thus, the law generally recognizes the patient's right to control the access to his medical record by third parties.

Because of the permanence and potential importance of a patient's medical record, health professionals frequently raise questions about what to include in the record, who should write in a patient's chart, where and how to make corrections, and how to document specific problems such as patient injury or concerns about the quality of care the patient is receiving.

On March 31,1981, the New York Gurt of Appeals handed down its decision in the consolidated cases of Brother Joseph Fox and John Storar. The Eichner case was generally well known, having excited considerable national publicity both before and after the Appellate Division of the Supreme Court of New York handed down its opinion on March 17,1980. The Storar case,) conversely, was not as well known and was consolidated with the Eichner case, in the words of the Court of Appeals, because future similar cases would arise. As will be discussed more fully in this article, the consolidation of these two markedly dissimilar cases not only has created confusion, but also has served to obscure the position taken by the court of Appeals relative to other similar cases both in New York and other jurisdictions.

Brother Joseph Fox was an 83 year old member of a Catholic religious order who enjoyed good health until he suffered cardiac arrest during the performance of a hernia operation. As a result of the cardiac arrest, he became anoxic, suffered permanent brain damage, and became respirator-dependent.

Most health professionals today would agree about the necessity of interdisciplinary health care for clients. The optimal division of labor, however, has been a source of concern if not outright disagreement.

Literature on “professional status” and on the interrelationships of health professionals abounds, possibly leading one to the impression that everything worth saying has already been said. However, developments in health care and in professional education are of a dynamic rather than of a static nature. For this reason alone a reconsideration of the roles and relationships of health care team members is justified from time to time.

Determining whether the health care system meets the needs of service recipients is only one important reason for studying role interactions.

In a recent issue of the Hastings Center Report, Paul and Marilyn Bridge discuss the difficulties and frustrations they encountered with the physicians and hospital concerning a proposal to withhold treatment from their severely defective newborn son, Christopher. Born some three months prematurely, he had signs of viral encephalitis. His long-term outlook was quite dim: he had severe mental retardation, and would possibly suffer from uncontrollable convulsions, deafness, blindness, and quadraplegia. Brain damage was extensive, and was thought to extend to the cortex. While Christopher was not terminally ill nor in any immediate danger of dying, the pediatrician suggested that there would be situations in the future which perhaps ought not be treated, such as infection or the aspiration of food. The family rejected that option, and insisted on treatment until Christopher, on his 75th day of life, suffered cardiac arrest. After three days of ventilator support, the parents agreed to discontinue the heroic means supporting their son whom they now believed to be terminally ill and approaching brain death.