Patients profiles

Figure 27.3 Once the data are transformed into CDISC standards and integrated with a drug safety analysis system, the data can be easily analyzed. In this figure we show a sample screen from WebSDM a drug safety analysis system being evaluated by the FDA. This screen allows the user to view different attributes of the variables in a user-specified data set. When a variable is selected, a graphical display of the data is produced on the right-hand side of the window. The user can then select to visualize a graphical display of the individual patient profiles under the variable in a different window.

Check the patient profile and talk with the patient to ensure that there are no significant drug interactions with other concurrent medications and therapies. 

It is important to develop a plan to educate patients and families about their drugs and doses. If modifications are necessary secondary to toxicity or inadequate response, establish a plan for treatment change. Remember that individual patients often do not fit the average patient profile, and dose modifications frequently are needed. The practitioner should be familiar with dosing ranges, WBC count, and other parameters that indicate appropriate treatment response. Based on response to prior phases of treatment, the clinician should recognize potential toxicides in subsequent phases of treatment with the same or different drugs at similar or different doses. 

Note It should be remembered that in many situations, the information given for dosage conversion from adult to children is not direct. The dose prescribed on a prescription or a medication order may be for an adult while the patient profile may reveal that the age of the patient is a few months or a few years and the patient is a child. 

Approximately 10% of new chemical entities (NCEs) show serious adverse drug reactions (ADRs) after market launch. Such events usually result in new black box warnings by the US Food and Drug Administration (FDA), label change or market withdrawal. The most common causes for these actions are hepatic toxicity, hematologic toxicity and cardiovascular toxicity [2], Reasons for such ADRs, which are identified only after NCEs are launched on the market, include the narrow spectrum of clinical disorders and participating patient profiles in clinical studies as well as the fact that serious ADRs are often rare and that the number of patient exposures required to identify such occurrences sometimes may range over a few millions [3],... 

The candidate secondary pharmacologic mechanisms for each of the five SSRIs are shown in Figures 6—41 to 6—45. These may lead to variations from one drug to another that could prove potentially more advantageous or less advantageous for different patient profiles. However, these are hypotheses that as yet are unconfirmed. Nevertheless, there are real differences among the five SSRIs for many individual patients, and sometimes only an empirical trial of different SSRIs will lead to the best match of a drug to an individual patient. 

For any value-added pharmacy service to be viable, there must be a sufficiently large number of consumers in the market who may be willing to purchase the service. Investing too many resources into a service that benefits a small number of consumers ultimately will lead to the demise of any business venture. Several sources can be used to determine the size of a market for a professional service. The easiest place for a business planner to start is to review a pharmacy s patient profiles, purchasing and financial records, and other internal data. Knowing how many prescriptions are filled for different classes of medications will help the planner to determine which conditions are the most prevalent among the pharmacy s patients. The only downfall of this method is that the information is limited to the pharmacy s current clientele. Many pharmacies would like to provide value-added pharmacy services that attract new patients. 

As pertinent variables are identified, it will become clear that some data will be easily obtainable, whereas information on other variables will be extremely difficult to acquire. Pharmacy-related data often are easily retrievable because much of the information can be obtained directly from the pharmacy s prescription computer program (and the patient profiles). Patient demographic information such as gender and age generally is also stored on the pharmacy computer. However, depending on the research question, data from other areas of the health care system may need to be collected as well. For instance, one hypothesis could be that a pharmacy service may result in a reduction in emergency department visits. Pharmacists often do not have access to data on emergency department visits in their own records. 

Additional potential benefits of genomics would be the identification of pharmacokinetic and pharmacodynamic patient profiles, which... 

Patient profiles should be current and contain adequate information. 

Atkinson AJ Jr, Ruo TI, Piergies AA, Breiter HC, Connelly TJ, Sedek GS, Juan D, Hubler GL, Hsieh A-M. Pharmacokinetics of N-acetylprocainamide in patients profiled with a stable isotope method. Clin Pharmacol Ther 1989 46 182-9. 

A data quality plan is a tool to aid in the implementation of data quality. The plan should be developed as soon as the protocol is finalized. Data quality is a shared responsibility across all functions. For example, the monitor assures quality by source document verification (SDV), and the clinician reviews listings of individual patient profiles and study outliers. ... 

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