Automated data system CPK TDM chapter.pptx

Automated data system

1. AUTOMATED DATA SYSTEMS

2. There is a growing use of computerized databases containing medical care data , called ‘ Automated database’ Which are potential data sources for pharmacoepidemiological studies Automated data is a creation & implementation of technology that automatically process data. The technology includes computers & other electronic communications that gather, store, process, prepare & distribute data. The main purpose is, to quickly & efficiently process large amount of information with minimum human interaction.

3. IDEAL DATABASE Ideal database include records from: 1. Inpatient (IP) & Outpatient (OP) care. 2. Emergency care. 3. Mental health care. 4. All prescribed and OTC medications. 5. All laboratory and radiological tests, and 6. Alternative therapies.

4. The population covered by the database would be large enough to permit discovery of rare events of drugs. The drug(s) under investigation must be present in formulary and must be prescribed in sufficient quantity to provide adequate power of analysis Other requirements of an ideal database are that: 1. All parts are easily linked by means of a patient's unique identifier. 2. Records are updated on a regular basis. 3. Records should be verified and are reliable. Information on potential confounders such as smoking & alcohol consumption may only be available through chart review (or) more consistently through patient interviews.

5. CLAIMS DATABASES Claims data arises from a person's use of the health care system . When a patient goes to a pharmacy and gets a drug dispensed, the pharmacy bills the insurance carrier for the cost of that drug, and has to identify which medication was dispensed, the milligrams per tablet, number of tablets, etc . Analogously , if a patient goes to hospital (or) to a physician for medical care, the providers of care, bill the insurance carrier for the cost of medical care, and have to justify the bill with a diagnosis . If there is a common patient identification number for both the pharmacy and the medical care claims t hese elements could be linked & analysed as a longitudinal medical record

6. Provider : pharmacy Provider : Hospital Provider : Physicisn Payor DATA USER

7. Medical record databases: MRD (medical record databases) are more recent development arising out of the increasing use of computerization in medical care. The validity of the diagnosis data in these databases is better than that in claims databases. As these data are being used for medical care However there are also unique issue one needs to be concerned about especially the uncertain completeness of the data from the other , physicians and sites of care

8. Advantages: Potentially provides large sample size . Relatively inexpensive to use . Data can be complete . In addition these databases can be population based they can include outpatient drugs and disease and there is no opportunity for recall and interviewer bias, as they do rely on patient recall or interviewers to obtain their data

9. Disadvantages : Lack of information on some potential confounding variables, Ex: Smoking, alcohol etc . Administrative data bases are typically designed for billing and record keeping purposes and not for research. The validity of diagnostic details may not be certain in the case of administrative database, particularly for outpatient . Computerised database also do not typically include information on medication obtained outside particular insurance carriers plan Information on over the counter medication use (including dietary supplements) can be particularly important if it is a large component of the drug exposure of interest

10. Various automated data sources are used world-wide for conducting pharmacoepidemiological research. Some of them are: Group Health Cooperative . Health Maintenance Organization (HMO) research network . Medicaid Databases . Kaiser Permanente Medical Care Program . United Health Group. Etc

11. Database Location General practice research databases UK Group health cooperative Puget sound Settle US Kaiser permanente California , US Madicaid US Odense Denmark Ontario drug benefit Ontario, Canada Saskatchewan Canada

12. Group Health Cooperative: US Data from health maintenance organization (HIMO) has been used extensively to evaluate drug usage and the adverse and beneficial effects of marketed drugs and medical procedures GHC's is a automated & manual database serve as a major resource for many epidemiological studies, because individual records can be linked through time & across data sets by the unique consumer number assigned to each enrolee Strengths of GHC as a setting for epidemiological research include its identifiable and relatively stable population base, accessible and complete medical records each enrolee and computerised database

13. Kaiser permanente medical care program: US Patient records across multiple databases (Pharmacy records with hospitalization , outpatient laboratory results, claims received from non-KP providers etc.) and across time (for at least 10 years ) can be linked using, a unique medical record number assigned to each patient for all encounters with the program Cohort studies with considerable follow up are feasible in the KP database because of its size diversity, representativeness , relative stability and richness of its computerized clinical data.

14. HMO Research network: Research units in US HMO's are in a unique position to integrate research & practice for the improvement of health & health care among diverse population . It includes large sample size with a wide range of comorbid conditions and concomitant medications to evaluate the beneficial and adverse effects of drugs .

15. United Health Group: These databases have been used extensively to study drug safety and adverse drug reactions . United health group databases provide extensive data sources to study post marketing drug safety and to evaluate risk communication efforts.

16. UK General Practice Research database The general practice research database (GPRD) contains anonymised data on diagnoses , therapies and health relate behaviour recorded by GPs as part of the patients electronic medical record The GPRD has been validated and used to study a variety of medical conditions including cardiovascular , cancer , intestinal , dermatologic, pulmonary , and ophthalmologic outcomes