Databases patient numbers

Wider range of patients than in NDA/PLA database Larger numbers of patients Active comparator study designs Supplemental efficacy studies Additional approvals in non-ICH countries Pharmacoepidemiology and pharmacoeconomics in particular healthcare environments Post-marketing commitments All of the above... 

An unexpected increase in cases of antibody-mediated PRCA associated with subcutaneous administration cfEprexfl for the period 2012-2013 was reported by the Singapore Government Health Sciences Authority (HSA). Between 2012 and June 2013, confirmed PRCA cases associated with Eprex accounted for 90% of such cases in the HSA Pharmacovigilance Database, a number considered disproportionately high by comparison to the baseline reporting trend. Subcutaneous injection was employed in all of the cases, each one a chronic kidney disease patient with an onset duration time of 7-19 months [20 ]. 

Brown et al. [18] documented statistics of isolated AVR in North America for 108,687 patients during the period from January 1, 1997 to December 31, 2006, compiled from the Society of Thoracic Surgeons National Database. The number of isolated AVR surgeries increased from about 10,000 to over 16,000 procedures per year. Although the specific percentage of mechanical versus bioprosthetic valves implanted is a topic of debate, almost 98% of all AVR procedures used one of these two alternatives. The STS Executive Summary Adult Cardiac Surgery Database provides statistics of valve replacement procedures up to December 2010 in North America [19], In 2010, over 25,000 isolated AVRs were performed, in addition to over 18,000 replacements along with coronary artery bypass (CAB). About 1500 patients underwent combined aortic (AV) and mitral valve (MV) replacement. 

Yazdanpanah et al. (2002) calculated the resource use and cost for different stages of HIV infection in France based on a clinical database of HIV-infected patients between 1994 and 1998. The total costs attributable to bed-day and day-care inpatient care included the mean cost of each inpatient day times the length of stay, as well as total number of laboratory tests, dosage and quantity of medications, and total number of procedures. The total cost attributable to outpatient care included the mean physician and nurse fees per visit, as well as total number of laboratory tests and total number of procedures. In the absence of an AIDS-deflning event, the average total cost of care ranged from US 797 per person-month in the highest CD4 stratum to US 1,261 per person-month in the lowest CD4 stratum. 

Time is a critical measure for clinical trial analysis. Time is captured in clinical trial databases in a study day variable. Study day can be defined as the number of days from therapeutic intervention to any given time point or event. By defining study day, you create a common metric for measuring time across a population of patients in a clinical trial. There can be a study day calculation for any time point of interest. Adverse event start, study termination, and clinical endpoint event date all make good choices for study day calculations. The study day calculation is performed with one of the two following approaches. 

Many of the major new products reaching the market in the last few years will have had total databases of 5000 or more patients, but when the subtractions are made for formulation, dose and indications that are no longer relevant, then, perhaps, no more than 2500-3500 remain. This is still far short of the number required to make an assessment of safety that would be appropriate for its expected performance when it reaches the market. 

Not only does the absolute total number of prescriptions differ among physician specialities, but also the likelihood that one will receive a prescription from a given specialty varies, once the patient is seen in the provider s office. From the 1996 NAMCS database, Hoagwood et al. (2000) found that prescription prevalence rates vary among different providers 94.9% of visits by children with ADHD to family practitioners entailed the prescription of stimulants, while only 74.2% of such visits to psychiatrists and 75.4% of visits to pediatricians resulted in a stimulant prescription. Furthermore, while 14.8% of the visits to psychiatrists resulted in a nonstimulant prescription, only 1.9% of visits to family practitioners involved nonstimulant medication prescriptions. When considering the likelihood of any medication being prescribed (stimulants or nonstimulants) for a child with presumed ADHD, 11% of psychiatrist visits resulted in no prescription at... 

The recurrence rate of intracranial tumors has been addressed in a number of large observational studies. Reports from the NCGS database (which includes 1262 children with brain tumors) and from England have shown no increase in intracranial tumor recurrence in patients treated with growth hormone (97,98). For patients with craniopharyngioma, postoperative irradiation reduced the recurrence rate, but growth hormone therapy did not increase the risk (99). 

Ronald et al. analyzed the direct costs of physician claims and the number of hospital admissions for OSAS patients in the Canadian Manitoba governmental health agency database. They found that 181 patients (145 men, 36 women) with untreated OSAS were shown to utilize health care at twice the rate of controls up to 10 years before diagnosis (48). The most significant increase in physician claims was noted up to 3 years before diagnosis. The total physician claims were 686,365 (Canadian) with a mean of 3792/patient, whereas controls generated 356,376 with a mean of 1969/patient. OSAS patients had almost a twofold increase in hospitalizations compared to controls over the 10-year period ... 

To calculate the total costs to provide a service, consider how much pharmacist and supportive personnel time will be involved in offering the service, as well as fixed costs and per-patient costs. One way to estimate how much time will be spent on providing direct patient care is to consider the time spent with each patient and how many patients will be targeted. The pharmacy s computerized database may be able to be supply the number of clients on a specific medication or with a specific health condition. This may help to estimate the number of potential patients for the service. This step is important because one of the first targets for a new value-added service can be the pharmacy s existing clientele. This will also ensure that there is an adequate population of patients to support such a service. Of course, one of the goals of offering a new service may be to increase the number of clients attracted to the pharmacy and therefore to increase prescription volume or prescription-related purchases. A... 

To estimate the costs of offering this service, Dr. Brouchard has made a worksheet of all the costs necessary to provide the service. He has reviewed the pharmacy database and has found that there are at least 800 patients who are taking at least one oral agent for diabetes or on insulin therapy and who have been seen in the last 12 months. He realizes that this is just an estimate of the total number of potential patients because some patients may be controlling their diabetes with diet and exercise, but he also knows that he wants to target patients who currently have uncontrolled blood glucose levels. 

Costs of goods and services seem intuitively simple to quantify. However, a number of potentially complicated issues must be considered. When identifying the goods or services, will the actual cost (wholesale cost) to the pharmacy or health care organization be measured, or will the charge to the patient or payer (retail cost) be measured Sometimes access to cost data may be limited, or the data may be entirely unavailable. For instance, if Cynthia Marshall was using a hospital database to collect hospitalization and emergency department information for the HMOs heart failure patients, it may be impossible to isolate the actual costs related to heart failure, particularly if a patient was admitted for multiple reasons. 

External fraud is an act committed by a third party that leads to data theft, data loss, and function disruption. People with technology skills can access (hack) the computer systems of pharmacies to steal or manipulate patient information for financial or nonfinancial reasons. For example, cell phone service provider T-Mobile experienced ongoing security problems that led to the publication of celebrity Paris Hiltons personal information and the telephone numbers of many Hollywood stars (Brian, 2005). One can only imagine the problems that could arise if patient data contained in a pharmacy s database were to be exposed, stolen, or manipulated. 

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