EDPS of Clinical Case Record and Scientific Document in the Industry Post-Marketing Surveillance of Drugs

1983 ◽  
Vol 22 (03) ◽  
pp. 135-148 ◽  
Author(s):  
T. Kitaguchi ◽  
T. Nojiri ◽  
S. Suzuki ◽  
T. Fukita ◽  
T. Kawana

In order to meet the multifarious needs for drug information and to cope with the post-marketing surveillance of drugs adequately, an on-line drug information network, which is composed of two data bases, clinical case record data base and literature data base, has been developed. Primary considerations in designing these systems were input of clean data, accurate input, insuring that no ADRs are overlooked, accumulation of the latest data, saving manpower required for processing, and processing large quantities of data. This system is also designed to input and to output in Japanese character.

1984 ◽  
Vol 18 (1) ◽  
pp. 62-64
Author(s):  
Ross H. Weaver

The AMA drug information base (AMA-DIB) is reviewed and the impact of computerized drug data bases on the practice of clinical pharmacy is discussed. The AMA-DIB is an on-line data base derived from the fifth edition of AMA Drug Evaluations. Thus, it represents consensus information. The data base consists of individual drug records, pharmacologic class records, and therapeutic class records. It is accessed via commands using keyword searches. Computerized on-line drug data bases will have an impact on the practice of clinical pharmacy. Information resource services will either discontinue or proliferate, depending on the quality of the service and the ability of the directors to adapt to future needs. Patient monitoring services will discover that these data bases allow easier access to more information, but the computer will not be able to transfer the data to direct patient care. Thus, their professional roles will remain intact. Clinical pharmacy researchers, in contrast, will notice little or no impact on their practice.


2007 ◽  
Vol 37 (4) ◽  
pp. 735-744 ◽  
Author(s):  
Agnes Vitry ◽  
Joel Lexchin ◽  
Peter R. Mansfield

Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy—in particular the drug approval process, the post-marketing surveillance system, the control of drug promotion, and the quality of independent drug information—require major reappraisal if we want to avoid similar disasters in the future.


1982 ◽  
Vol 21 (04) ◽  
pp. 181-186 ◽  
Author(s):  
M. A. A. Moussa

A drug information system (DARIS) has been created for handling reports on suspected drug reactions. The system is suitable for being run on desktop computers with a minimum of hardware requirements: 187 K read/write memory, flexible or hard disc drive and a thermal printer. The data base (DRUG) uses the QUERY and IMAGE programming capabilities for data entry and search. The data base to statistics link program (DBSTAT) enables data transfer from the data base into a file for statistical analysis and signalling suspected adverse drug reactions.The operational, medical and statistical aspects of the general population voluntary adverse drug reaction monitoring programme—recently initiated in the State of Kuwait—are described.


2007 ◽  
Vol 40 (05) ◽  
Author(s):  
M Kungel ◽  
A Engelhardt ◽  
T Spevakné-Göröcs ◽  
M Ebrecht ◽  
C Werner ◽  
...  

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