ASGE/SAGES Working Group on Natural Orifice Translumenal Endoscopic Surgery White Paper October 2005.
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National surveys reveal that the public has lost confidence in the safety of food. There is lack of co-ordination and failure to overcome institutional barriers at many levels throughout the food chain. The abolition of the post of medical officer of health and the public health departments of local government over which it presided, in view of many, including members of parliament, has been the most damaging of all changes to the public health and many have asked for the restoration of this post. Health departments have no overall statutory responsibility for food safety. The medical expertise of medical officers of health provided the executive authority with the necessary support in managing and controlling outbreaks of food poisoning, a point emphasised in the recommendations made by an inquiry set up by the government following the worst ever outbreak of food poisoning in Lanarkshire, Scotland, UK. Only such an appointment at local level will restore public confidence in food safety.
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The British government proposal to introduce drug budgets will compel general practitioners to consider the financial consequences of prescribing. In our country, the practitioner neither in the past nor now has an incentive to consider the cost of his prescription, and few efforts have been made to influence it, if we exclude the pharmacy industry. In the present article, the situation of both countries is analyzed and the answers of the general practitioners of Girona and Scotland to questions that examine their predisposition towards considering costs when prescribing are compared. The reduction of the prescription costs must be formulated as a part of a rational prescription and should employ a combination of approaches: education, feedback, administrative changes, and incentives. The procedures to encourage a more efficient use of medicines require an active participation of the practitioners in managing the resources of their practices.
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Specific safeguards to guide the approval process and substitution practices for generic immunosuppressive agents are necessary for the effective delivery of patient care. Currently, the Food and Drug Administration (FDA) requires the demonstration of bioequivalence of generic drugs to innovator drugs in normal healthy subjects, a criterion that may be insufficient for critical-dose drugs. For generic equivalents of critical-dose drugs and for innovator critical-dose drugs, there should be a requirement for replicate studies measuring intrasubject variability and subject-treatment interactions to establish that bioequivalence holds true. Extensive testing of generic drugs in all target patient types is impractical and should not be required. However, when evidence suggests that the bioavailability of a critical-dose drug may vary substantially in certain subgroups, the FDA should require a demonstration of bioequivalence of generic versions to innovator products in these representative target populations. Changes in the approval process for generics should be accompanied by more consistent substitution practices. Pharmacists should notify the prescribing physician and patient whenever a critical-dose drug (generic or brand name) is dispensed in a different formulation from the one the patient has been taking. Therapeutic substitution for such drugs should not be made unless the prescribing physician has granted approval. The health care provider should consider instituting appropriate monitoring whenever patients are switched between generic formulations or between innovator drugs and generic formulations. Patients should be well informed about generic substitutes so that they can participate in treatment choices.
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