Today's problems in pharmaceutical ethics.
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The author has presented the state of Polish pharmacy directly before the Second World War. He underlined the dissonance between the owners and pharmaceutical employees. Parliamentary acts concerning pharmaceutical chamber and profession were to counteract the commercial tendencies. Unfortunately these acts had not been tested as they were directly followed by the outbreak of war.
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Efforts to limit pharmacy costs raise both ethical and economic considerations. Six values should inform pharmacy benefit management: (1) accepting resource constraints; (2) helping the sick; (3) protecting the worst off; (4) respecting autonomy; (5) sustaining trust; and (6) promoting inclusive decision making. Direct controls, such as formularies, step therapy, and prior authorization, can focus limited resources on the sick and worst off. However, direct controls limit autonomy and are administratively burdensome. Indirect controls, such as physician capitation, tiered copayments, and drug benefit caps, align physicians' and patients' interests with resource constraints, respect autonomy, and are administratively efficient. Unfortunately, they deter use based on cost, not medical need; they do not focus cuts on unnecessary or marginal drug use or focus resources on the sick. Budget caps are the least defensible, while tiered copays and physician capitation can be justified if implemented with safeguards. Formularies and step therapy are ethically justifiable if they can be efficiently instituted.
The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring is a continuous process in industry trials due to the regulatory requirements and the need to more thoroughly evaluate safety of new compounds. As part of this process, interim analyses are employed to make decisions about treatment effects. In some cases, such analyses may require the use of an external data monitoring committee to assist in the data review, analysis and decision making. A number of examples of interim analyses, with and without data monitoring committees, are discussed. Issues surrounding the need for external data monitoring committees and recommendations are presented. In particular the issues of sponsor participation in the data monitoring committee and controls of the decision making process are considered.
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Pharmaceutical manufacturing is one of the most financially lucrative industries in America due, in part, to massive marketing and advertising. The content of many symposia and medical journals as well as physician prescribing decisions seems to be influenced by the promotional efforts of pharmaceutical companies. In an effort to increase sales, the industry now advertises directly to the public. The role of the Food and Drug Administration and ethical standards established by medical organizations are discussed.
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