Prescription drug products that require patient package inserts; ampicillin and phenytoin--Food and Drug Administration. Final rule

The Food and Drug Administration (FDA) amends its patient package insert regulations to list ampicillin and phenytoin as drugs that must be dispensed with patient package inserts. The ampicillin patient package insert applies to drug products containing amoxicillin, ampicillin, or hetacillin. Elsewhere in this issue of the Federal Register, FDA announces the availability of final guideline patient package inserts for ampicillin and phenytoin and applies the agency's patient package insert regulations to them.     

Measuring the performance of research and technology programs: A balanced scorecard approach

Research programs, like other government programs, are now being requested to demonstrate relevance and value added to national social and economic needs. Complexity, unpredictability and other factors make it difficult to define specific performance measures for R&D programs. This paper describes the performance measurement efforts of one technology development program within the U.S. Department of Energy and proposes a strategy for applying this balanced scorecard approach to a fundamental research organization. Simple logical models of the inputs, activities, outcomes and long term results of R&D programs are proposed. A critical few measures of performance that answer questions from multiple audiences are then chosen across this performance spectrum. This paper describes work performed by Sandia National Laboratories Energy Policy and Planning Department, Albuquerque, New Mexico 87185, with the support of the U.S. Department of Energy under contract DE-AC0494AL85000. The continued support and enthusiams of Darrell Beschen in the DOE Office of Energy Efficiency and Renewable Energy and Iran Thomas in DOE Office of Energy Research, Basic Energy Sciences, is appreciated. The authors also acknowledge the contributions of John Reed and the training in the logic chart and performance spectrum provided by Ron Corbeil and Steve Montague. The opinions expressed are those of the authors and do not represent the opinions of the U.S. Department of Energy.     

The doctrine of informed consent: a tale of two cultures and two legal traditions

In this article, the author compares and contrasts the notion of informed consent in medical decision making in the Western legal system with the traditional Jewish biblical legal system. Walter critically examines the philosophical underpinnings of disease and medical healing in both legal systems, and describes the practical consequences that emanate from the different ideologies in terms of the individual's rights of choice of treatment. She explains that the Western system is predicated on notions of individual autonomy and self determination. Patients therefore have the autonomous ability to select and direct their own medical therapy. By contrast, the traditional biblical system of law is based on the concept that the body does not belong to the individual. Instead, the body is given to man by God as a trust to respect and preserve. Therefore, the individual patients "has no absolute right to control his body and ... he has no real decision making power as to medical treatment choices." In the Jewish biblical tradition, consent is not necessary for obviously beneficial or obviously non-beneficial procedures; consent is only necessary in decisions with uncertain outcomes or when making choices between equal options. Patients are encouraged to seek the counsel of religious authorities and to conform to rabbinical interpretations of the traditional Jewish law.     

Reallocating liability to medical staff review committee members: a response to the hospital corporate liability doctrine

Under the doctrine of hospital corporate liability, the hospital governing board bears the responsibility for detecting the incompetence of its staff physicians. Since hospital governing boards are generally composed of lay community members, they lack the expertise to evaluate the clinical competence of their staff. Therefore, they must delegate their screening responsibilities to medical staff review committees. After analyzing the development of hospital corporate liability doctrine, this Note examines the respective policing capabilities of review committees and the governing board. The Note contends that the board should not be held liable for aspects of the policing process which it is incapable of controlling. The Note concludes that, given their superior ability to evaluate clinical competency, staff review committees should shoulder the responsibility for the clinical aspects of staff evaluation, leaving remaining aspects to the hospital governing board. The Note proposes that courts should recognize a cause of action for negligence against medical staff review committee members in order to upgrade the effective policing of the medical profession.