Safety indicators possible patient

As a general observation, the author s interactions with companies have led to the impression that there is a great deal of mystique associated with regulatory authorities by some companies. Every possible issue and detail are hyper-analyzed by those companies and what can be quite minor issues are invested with a significance out of proportion to their actual importance. What is important to assessors is that the development program of a specific product is logical, scientifically robust, and appropriate to the indication and patient population in question. Submission documents should be explicit, concise, and to the point with all the important issues addressed. Any omissions or deficiencies should be addressed and a robust justification for any deviations from the relevant guidelines should be provided. If these very basic principles are followed, applicants should not encounter problems with their submissions, provided, of course, the product is fit for purpose and has been proven to be of acceptable quality, safety, and efficacy. 

Examples of possible patient safety indicators derived from the criteria and the control functions are presented in Tables 9.3 and 9.4. 

The decision to use these agents should be made with considerable caution, and only after possible underlying causes of the patient s symptoms have been explored and treated appropriately. Although surveys indicate that BZDs are frequently prescribed for elderly patients, the NIH Consensus Development Conference stated that the efficacy and safety of sedatives and hypnotics have not been established for older people, nor has the extent to which they contribute to or alleviate sleep problems (302, 305, 306). Saizman (307) has pointed out that relatively few research studies, most of which are seriously flawed, have examined the therapeutic effect of these agents in elderly patients. Thus, recommendations for the use of BZDs in elderly patients are derived almost exclusively from studies of young adult patients, studies of pharmacokinetics and toxicity in elderly patients, and clinical and anecdotal experience. 

Iron therapy is indicated only for the prevention or cure of iron deficiency. In general terms, making 25 mg of iron per day available to the bone marrow will allow an iron deficiency anaemia to respond with a rise of 1% of haemoglobin (0.15 g Hb/100 ml) per day a reticulocyte response occurs between 4 and 12 days. An increase in the haemoglobin of at least 2 g/dl after 3 weeks of therapy is a reasonable criterion of an adequate response. Oral preparations are the treatment of choice for almost all patients due to their effectiveness, safety and low cost. Parenteral preparations should be restricted to the few patients unable to absorb or tolerate oral preparations. Red cell transfusion is necessary only in patients with severe symptomatic rmaemia or where chronic blood loss exceeds the possible rate of oral or parenteral replacement. 

If there were a secret to safety, it would lie in a thorough knowledge and understanding of this type of treatment. For doctors to give patients a wide range of choice, they must know how to use at least the three main types of conventional peels correctly alpha-hydroxy acids (AHAs), trichloroacetic acid (TCA) and phenol (for phenol, the doctor should at least know how to apply it locally). For each type of peel, the doctor must be perfectly acquainted with its indications, results, limitations and complications to be able to choose the right product for a given patient and to be able to apply it correctly. The patient should be informed of alternative techniques, their possibilities, contraindications, side-effects and cost. 

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