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The accomplishments of hospital pharmacy in 1990 are reviewed, and external and internal factors affecting the profession are described. Six issues were identified as having a major impact on hospital pharmacy in 1990: cost containment, productivity and leadership, patient safety, medical-legal and ethical considerations, human resource management, and computers and new technologies. Highlights of activity in each of these areas, as reported primarily in the American Journal of Hospital Pharmacy, are reviewed. Hospital pharmacy remains a vibrant and growing profession that is responding positively to external and internal challenges.
The wave of Good Clinical Practice (GCP) that swept Europe in the mid-eighties also hit Denmark. The influence from the USA was highly significant. However, the history of GCP in Denmark builds upon the ethical and scientific requirements for clinical trials of drugs which had developed over the preceding two decades. Furthermore, quality assurance of trials were already in progress. The Danish health authorities and the pharmaceutical industry were cooperating well in the evolution of GCP in Denmark. Parallelly, Denmark took an active part in the international harmonisation of the various GCP-guidelines within the Nordic countries, in the European Community, and world-wide through the development of the WHO- and the ICH-guidelines. In the work with these guidelines, several experts from a number of countries collaborated with Danish experts. Through this continuous interaction, Denmark profited from the tight connection with the circles and institutions where this development took place, both causing an increased awareness of GCP in Denmark, and an indisputable contribution from Danish participants to the international GCP-development. In 1987, an interdisciplinary Danish GCP Society was established. This has increased the understanding of GCP and, together with other activities, promoted the cooperation between the health authorities, the law-based ethics committee system, the sponsors, the investigators, and the Danish Data Protection Agency. The Society has arranged numerous courses and seminars, and held conferences and meetings in order to inform about GCP. The Danish GCP Society seems internationally to be rather unique in its scope and work. It is concluded that Denmark is well prepared for the coming regulations of trials on medicinal products proposed by the EU.
In this article we review the current initiatives by the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) on pharmacovigilance planning that are due for general release during 2004. These initiatives could form the basis for applying concepts of risk management to medicines throughout their life cycle, from preclinical and clinical development to marketed use. The CIOMS VI Working Group (with 28 senior scientists worldwide from drug regulatory authorities and pharmaceutical companies) is currently developing scientific guidance that relates to clinical trials for medicines during development. It recommends a developmental pharmacovigilance concept - a 'living' concept that would start early in drug development supporting the science and ethics of research leading up to licensing (marketing authorisation) and continuing to post-authorisation (postmarketing) pharmacovigilance. This approach is seen as complementary to current ICH initiatives called 'Pharmacovigilance Planning'. ICH will introduce two concepts in pharmacovigilance management of medicinal products: the 'Pharmacovigilance Specification' and the 'Pharmacovigilance Plan'. The 'Pharmacovigilance Specification' will summarise important knowns and unknowns about the medicine. It will include safety risks identified at the licensing stage, potential risks and any key missing information. These elements will be essential to the formulation of pharmacovigilance plans. Dialogue and common understanding between regulators and the pharmaceutical industry will be a key factor for developing pharmacovigilance plans during the life cycle of medicines. Appropriate interaction with health professionals and patients should also be planned for the future as regulatory systems become more transparent. Where no significant issues are apparent at the licensing (marketing authorisation) stage, routine pharmacovigilance practices will be followed during the marketing phase. Where issues do exist or the data are limited, further study, including epidemiological approaches can be planned. All types of medicines (new drugs, biological agents, orphan drugs) may be involved in these concepts, as would major extensions to existing medicines. Currently ongoing CIOMS and ICH initiatives are in line with emerging risk-management strategies in the US, the European Union and Japan aimed at early and proactive pharmacovigilance.
OBJECTIVE: Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research. DATA SOURCES: Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration. DATA SYNTHESIS: Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study. CONCLUSIONS: Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.
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Clinical trials are of paramount importance for the development and evaluation of new therapies for patients with human immunodeficiency virus (HIV) disease. The objective of an HIV clinical research unit is to conduct high quality clinical research with patients who have HIV disease. The conduct of these research studies requires accurate and complete data collection. Coordination of the patients' primary care must be complemented by a working knowledge of the relevant ethical issues. In addition, technical, managerial, and clinical expertise is needed for conducting the trials and collecting data. To accurately plan the research, personnel and resource allocation should be periodically assessed. Clinicians, particularly those who have not previously conducted clinical trials or who are considering the incorporation of a research program into a primary care setting, must be familiar with these issues in order to create and supervise this type of clinical research unit. A smoothly running clinic observing a defined cohort of patients is attractive to government agencies and pharmaceutical sponsors for funding of clinical trials and research projects.
OBJECTIVE: Drugs, as commercial products, are subject to diverse marketing methods including promotional activities. Although the legal/ethical aspects of promotional activities have been discussed in a limited manner, the patient has remained the neglected variable of this equation. The goal of our study, therefore, is to investigate the patients' opinion on the promotional activities of pharmaceutical companies. METHOD: A descriptive study was conducted at 44 primary health care centers in Turkey and 584 volunteers who applied to these centers were included. A questionnaire consisting of 42 questions was developed with demographic information in the first section, and drug ads and promotions included in the second section. Chi-square test and logistic regression analysis were used for statistical analysis. MAIN OUTCOME MEASURE: The awareness and ethical evaluation of patients of the promotional activities. RESULTS: Nearly 83% of the participants were aware of the promotion issue. Eighty percent found it unethical, 82% suggested that promotional activities should be forbidden, restricted or regulated. 1/3 of the participants believed that physicians made their drug choices based on the gifts and ads of pharmaceutical companies. Half of them had low confidence in the prescriptions of physicians who accepted gifts from the pharmaceutical companies. 54.5% of patients also considered promotional activities as a factor which increased drug prices. CONCLUSIONS: In our study, a considerable number of patients were aware of promotions and the effects of promotion on prescriptions. The findings of our study may contribute to the development of effective regulations on this issue. Very strict measures controlling drug companies' promotion activities must be formulated. Further, these regulations must incorporate and take into consideration the patients' opinion. Today, the basic need for the proper use of drugs does not rest in pharmaceutical promotion, but in providing adequate health services and effective education for both people and physicians.
Medical conduct relies on the efficacy and tolerability of a given pharmacotherapy. On the basis of an experimental comparison of different treatment options, a clinical trial provides the foundation for an evidence-based medicine that complies with state-of-the-art scientific practice. The quality of the data assessment determines the clinical relevance of the study results. Clinical trials are classified into Phases I-IV to ensure the development of an effective and safe pharmaceutical. The investigator is responsible for being experienced in the relevant area of expertise, for conducting the study according to the investigational plan, and for complying with ethical guidelines and drug safety.
STUDY OBJECTIVES: To determine the extent and diversity of involvement of pharmaceutical representatives in emergency medicine residency programs and to assess chief residents' beliefs and attitudes concerning this activity. DESIGN AND PARTICIPANTS: A multi-item survey with cover letter was mailed to the chief resident at each of the 87 Accreditation Council on Graduate Medical Education-approved emergency medicine residency programs in the United States at the time of study conception. MEASUREMENTS AND MAIN RESULTS: Eighty-three percent (72 of 87) of the questionnaires were returned. Ninety-three percent (66 of 71) of responders reported the involvement of pharmaceutical representatives in their emergency medicine residency. The most frequent activities (90%, 63 of 70) were to distribute small gifts (pens, notepads) and to provide meals during department functions such as journal clubs (80%, 56 of 70). Only 32 of 70 responding chief residents (46%) were aware of any established guidelines in their institution or residency program concerning relationships with pharmaceutical representatives, and 14 respondents (20%) believed that accepting gifts from pharmaceutical companies could affect their own prescribing habits. A few stated that pharmaceutical representative-sponsored educational functions were inappropriate. CONCLUSION: The interaction of pharmaceutical representatives with emergency medicine residents and residencies is widespread. More than 50% of the institutions supporting emergency medicine residency programs have no formal guidelines with regard to the interaction of their residents with pharmaceutical representatives or their guidelines are not known to the person most responsible for approval and arrangement of the pharmaceutical representative interaction--the emergency medicine chief resident. While most chief residents believed that accepting small gifts was reasonable, they also believed that accepting gifts valued at $100 or more and pharmaceutical representative sponsorship of trips was inappropriate.