There is an informational void about Pharmaceuticals in the training of most doctors, despite the importance of the prescription in medical care. The writing of the prescription is the final common pathway in therapeutic decision making, which involves such diverse forces and disciplines as anthropology, decision science, health economics, ethics, and politics, as well as pharmacology and clinical medicine. Programs to improve the precision and cost-effectiveness of doctors' prescribing must consider all of these factors if pharmacotherapeutics are to be used optimally.

A short description is given of the interplay between the pharmaceutical industry and its critics regarding the rational use of medicines since the 1960s. This was especially vigorous in the developing countries but also had ramifications in the industrialized world. The initiatives taken by the World Health Organization in starting a dialogue between the industry representatives in the International Federation of Pharmaceutical Manufacturers Associations and the critical voices of Health Action International are specially emphasized. The recent developments in the therapy of primary hypertension and peptic ulcer are discussed briefly as examples of the rapid changes in what should be rational in pharmacologic treatment of disease.

This paper describes the evolution of written patient information on prescription drugs, FDA's patient package insert proposal and its revocation before its implementation in the early 1980s, the status of voluntary and government efforts since that time, and a review of current trends in this area. The burgeoning practice of direct-to-consumer advertising of prescription drugs in the lay press is viewed within the context of these efforts. This paper also reviews the current developments in certain FDA regulated consumer products—over-the-counter drug labeling and nutrition labeling. The current state of patient information in the United States is reviewed in light of programs to improve prescription drug counseling, and current research in this area is discussed.

This article describes a project that looked at the availability of information on marketed pharmaceutical products to doctors and patients in six European countries. It examines the legal status of the drug compendia published in each country and reports on the Implementation of EC Directive 92/27/EEC on labeling and packaging. A small survey showed that it is hard to compare patient information because it is difficult to obtain copies of pack inserts available in each country. However, a limited analysis revealed some differences in the content and presentation of data for doctors and patients.

Pharmaceutical prescriptions are quite different in four European countries: Italy, France, Germany, and the United Kingdom. In particular, in 1992, among the 50 most sold products by value, only seven active principles are common to these four countries. In Italy, in 1994, there has been a substantial change in pharmaceutical prescriptions, since, for the first time, drugs have been reimbursed by the National Health System (NHS) on the basis of efficacy. As a result of this new policy, the 50 most-sold products by value have changed dramatically in the first five months of 1994. The pharmacologic and economic implications of this change are discussed.

There are marked geographical variations in rates of medical and surgical intervention at every level of aggregation and in every aspect of medical practice. These data raise a range of important theoretical, methodological, and policy issues. Much the same pattern of variation characterizes the prescription and consumption of therapeutic drugs. Data from a survey of general practice in New Zealand confirm the existence of extensive variability in prescribing. Multilevel techniques are deployed to isolate the specific interpractitioner element in this variability. Controlling for patient, diagnostic, and practitioner variables improves the predictive power of the model but does not reduce the extent of interpractitioner variability in prescribing rates. The existence of such variability raises questions about the role of clinical uncertainty and professional autonomy in the promotion of rational therapeutics in medical practice.

Medical noncompliance has been identified as a major public health problem that imposes a considerable financial burden upon modern health care systems. There is a large research record focusing on the understanding, measurement, and resolution of noncompliance, but it is consistently found that between one third and one half of patients fail to comply with medical advice and prescriptions. Critically absent from this research record has been the patient's role in medical decision making. For patients, particularly those with chronic illnesses, compliance is not an issue: they make their own reasoned decisions about treatments based on their own beliefs, personal circumstances, and the information available to them. The traditional concept of compliance is thus outmoded in modern health care systems, where chronic illness and questioning patients predominate.

Menorrhagia can be treated by drug therapy or surgery. General practitioners (GPs) can prescribe drugs to reduce menstrual blood loss as first-line treatment, referring patients for surgical treatment if drug therapy fails. This study examined the efficacy of drugs used to treat menorrhagia and surveyed British GPs to discover the extent to which they prescribed the most effective drugs for this condition. The results suggest that treatment of this condition in primary care falls short of desirable standards. A meta-analysis of randomized trials of drug therapy revealed wide differences in efficacy and side effects. The most effective drug (tranexamic acid) is little used by British GPs, whereas the least effective drug (norethisterone) is the most frequently prescribed.

Outcomes measurement will be key to the appropriate use of Pharmaceuticals as health care costs continue to rise. The generation of data showing the clinical, economic, and humanistic outcomes of pharmaceutical care will be essential to avoid decision making based solely on cost and to ensure that cost-effective, high-quality health care remains the health care system's top priority.

We analyze what is known and unknown about the contribution of the pharmacist as patient educator, physician consultant, and agent to affect patient outcomes in ambulatory settings. The need for pharmacist services is discussed, as are the theoretical underpinnings and quality of the scientific evidence to support their efficacy. The analysis is conducted in the context of a shift in pharmacists' roles from product to patient orientation as well as recent U.S. legislation mandating enhanced pharmacists' roles via drug utilization review for all Medicaid patients. We conclude with a research and action agenda, calling for stronger research designs in evaluating pharmacists' interventions. The shifting paradigm in the pharmacy profession, coupled with the implementation of the Omnibus Budget Reconciliation Act of 1990, provide unique opportunities for rigorous evaluations of pharmacists as agents of change for rational drug therapy.

The use of randomized control trials to assess the usefulness of therapeutic drugs over the last half century has brought significant benefits to patient care. The full potential benefits, however, have been only partially fulfilled because available data are frequently poorly used. Meta-analysis has emerged as an important tool for combining clinical evidence. Several examples are presented that compared the results of cumulative meta-analysis of randomized control trials with clinical expert recommendations. These comparisons demonstrated that clinical expert recommendations are often not synchronized with accumulating evidence, and this lack of recognition often resulted in delays in the acceptance of effective drugs and the slow abandonment of possibly harmful therapeutic practices. The problems of inappropriate therapeutic drug use will only intensify as new drugs are introduced and new uses for established drugs are proposed. The rational use of therapeutic drugs can be achieved only through the routine use of meta-analysis on high-quality clinical data. Some suggestions are made to improve the quality of the original research and the ways of assembling meta-analyses and disseminating their results.

There is growing demand for translations of health status questionnaires for use in multinational drug therapy studies and for population comparisons of health statistics. The International Quality of Life Assessment (IQOLA) Project is conducting a three-stage research program to determine the feasibility of translating the SF-36 Health Survey, widely used in English-speaking countries, into other languages. In stage 1, the conceptual equivalence and acceptability of translated questionnaires are evaluated and improved using qualitative and quantitative methods. In stage 2, assumptions underlying the construction and scoring of questionnaire scales are tested empirically. In stage 3, the equivalence of the interpretation of questionnaire scores across countries is tested using methods that closely approximate their intended use, and empirical results are compared. Data analyses from Sweden and the United Kingdom, as well as other research cited, support the feasibility of cross-cultural health measurement using the SF-36.

Five “big ticket” medical technologies (BTTs) in 1990 were compared in the 24 OECD countries in relation to population, the number of physicians, gross domestic product (GDP), and health care expenditures (HCE). Wide variations were observed between and within countries for all measures. Regression analysis revealed that HCE explains part of the variation in the distribution of computed tomography scanners (excluding Japan), magnetic resonance imaging units, and radiation therapy units (R2 between 0.40 and 0.69), but not extracorporeal shock wave lithotripters. To a lesser extent, GDP was also found to correlate with the distribution of these technologies, but no correlation was found with number of physicians. Other factors affecting the diffusion of these technologies are proposed for study.

The purpose of this study was to examine differences in the way Britain and the United States invest in and deploy a new medical technology. We used structured interviews to obtain information on the technical sophistication and approximate replacement value of all hospital-based obstetrical ultrasound machines in every maternity hospital in Washington state and Wales. The supply of hospital-based ultrasound machines—approximately two machines per 1,000 births—was similar in both countries. Wales had fewer advanced ultrasound machines than Washington state, and they were based exclusively in high-volume district general hospitals; there were no obstetric ultrasound machines in the private sector. In Washington state, the majority of advanced machines were in small and medium-sized hospitals, and many private offices had ultrasound machines. The approximate replacement value of hospital-based machines was three times as high per birth in Washington state as in Wales. In the case of obstetrical ultrasound, centralization of facilities, a relatively small private sector, and global budgeting lead to lower expenditures per patient within the National Health Service without compromising access to care.

A cross-sectional survey was used to compare the medical device education of 142 agency- and 443 hospital-employed Australian registered nurses. The two groups differed significantly on descriptive characteristics and on what they had learned about medical devices. Potential negative aspects of device use were nurse stress and patient harm, with a significantly larger proportion of hospital nurses indicating their use of any medical device had made them feel stress. Fear of harming the patient and being unsure of how to use the device caused stress in the majority of nurses. The incidence of patient harm was approximately 10% for each group.

A cost-effectiveness study compared visual laser ablation of the prostate (VLAP) with transurethral resection (TURP). Achieving equivalent outcomes, VLAP was more expensive than TURP. The result was sensitive to various assumptions, suggesting that VLAP might prove to be the preferred technology. Problems inherent in economic evaluation of emerging technologies are discussed.

This study analyzes opportunity costs for the treatment of end-stage renal disease. Kidney transplantation remains the most cost-effective treatment for uremia and is one of the most cost-effective technologies in health care. Improved survival of grafts and increased numbers of transplants have the potential to reduce costs for dialysis programs. To support organ donation activities, the public and concerned health professionals should be informed about the opportunity cost of “unnecessary” dialysis. These resources could be reallocated from dialysis to other programs. Among patients in dialysis, a more common use of chronic ambulatory peritoneal dialysis instead of institution-based hemodialysis would greatly increase cost-utility and further reduce the program costs of renal replacement therapy.