Voluntary Adverse Drug Reaction Research Articles

Information System for Post-marketing Drug Surveillance Scheme on Small Computers

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.

The lincomycins and the colitis issue: A perspective

The general problem of estimating the incidence of any adverse drug reaction is briefly discussed. Data from controlled clinical studies and from a voluntary adverse drug reaction reporting system are reported for colitis associated with clindamycin and lincomycin. It is postulated that the appearance of colitis with antibiotic therapy is a manifestation of the ability of the antibiotic to alter the autochthonous anaerobic microflora of the colon and thus provide a favourable environment for an opportunistic invader. Recommendations are given for the treatment of this type of colitis.