Drug-Related Data

Antiviral hERG CaCo-2 Flux HLM (min) ICgonM Inhibition Pappx1(r cni/s 

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For a number of developing countries, the only drug related data available on the demand side was treatment demand. In such cases, the approach taken was to look for other countries in the region with a similar socioeconomic structure, which reported annual prevalence data and treatment data. As a next step, the ratio of people treated per 1000 drug users was calculated for each country. The results from different countries were... 

Drug-related data from law-enforcement agencies reflect variations in national legislation as well as in resources and priorities. Although differences in recording procedures and definitions prevent accurate comparison, tendencies are described whenever possible. 

This module should contain reports of all the clinical studies and other related data that were conducted to demonstrate the safety and efficacy of the drug in human subjects. The standard headings used to present this information are shown in Figure 6.5. An example of headings for a tabulated listing of clinical studies is shown in Table 6.4. 

If the behavioral activity of PCP is related to its block of pre-synaptic K channels (Albuquerque et al. 1981 Albuquerque et al. 1983 Blaustein and Ickowicz 1983), PCP-like analogues should block these same K channels with a rank order of potency that parallels their relative in vi vo psychotomimetic activity. One of the most behavioral ly potent PCP-like agents is TCP (1 -[1 -(2 -thienyl)-cyclohexyl] piperidine) (Shannon 1983). Figure 4 illustrates the dose-response curves for the block of components S and T by this drug. The data indicate that TCP is a more potent blocker of Sv than is PCP (figure 2). TCP blocked component T only at high concentrations (>10 5M), and in this respect was approximately equivalent in potency to PCP (figure 2). 

Another external response to concerns about MCOs has been an increased interest in measuring the quality of care they deliver [35]. This interest has resulted in the development of numerous quality indicators. One example, HEDIS (Health Plan Employer Data and Information Set), is a standardized set of performance indicators used to compare health plans. Developed by the National Committee for Quality Assurance, HEDIS measures allow employers and employees to evaluate different plans. Only a small number of HEDIS indicators are related to medication use, but more drug-related indicators are likely to be added in the future. The use of quality indicators likely will increase as the measures become more refined and tested. 

Clinical phase I and II data reveal arzoxifene to be safe, well tolerated, and efficacious. Two multi-institutional phase II trials including 100 women with metastatic or recurrent endometrial cancer have demonstrated significant activity of arzoxifene at 20 mg/d in patients with metastatic or recurrent endometrial cancer. The observed clinical response rates were 25 and 31%, with a mean response duration of 19.3 and 13.9 months, respectively. Progression of the disease was stabilised in a substantial number of women. Toxicity was mild, except for two cases of pulmonary embolism that might have been drug related (Burke et al. 2003). 

Incomplete Information. Incomplete information is not unique to ADR evaluation but is common to all areas of medical practice. The lack of sufficiently detailed, time-related data on drug administration and disease markers may make it impossible to render a reasoned judgment on many ADR cases, leaving them in their original and unsatisfactory anecdotal status. 

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