Information Resources In PharmacoVigilance


Individual Reporting 

Doctors are the major source of reports. Those whose practice is primarily outside hospitals tend to care for patients for prolonged periods of time and may therefore also see the occurrence of slowly developing or delayed reactions. Since most severe reactions are seen in hospitals, physicians who are hospital-based are often able to ascertain previous drug administration, link it to the reaction, and submit a report. The physician, during an outpatient or inpatient examination, may decide that the patient has a recognizable syndrome of signs, symptoms, and/or laboratory findings and that this syndrome may be associated with a previously administered drug. He / She then reports this information to the centre.


Comprehensive Monitoring 

Comprehensive monitoring is typically performed in a hospital setting and the input consists of abstracts of patient identification, drug administration, and patient reactions. Specialized Methods are used to ensure that this information is complete, and case reports or summary data can be supplied to the national centre.


Population Monitoring 

In population monitoring the records of hospital or clinic patients, or of the entire population of a district, may be employed. Such monitoring could be effective when a large stable population is surveyed in an organized medical care system. As rapid advances are being made in the electronic processing of patient documentation and records, there may be unusual opportunities to incorporate a drug monitoring element in these systems. Population monitoring appears to have much to offer in that actual rates of reactions being obtained and truly unexpected reactions may be identified. It is complex and expensive, however, and the patient population may not be large enough for the detection of rare (1 in 10000-50 000) reactions. This system would automatically record drug use and patient syndromes or events, permitting searches for associations between the two. The results of such searches may be reported to the national centre.


Other Sources 

All potential sources of information should be considered. Each national centre must seize opportunities to exploit old and develop new sources of information. For example, useful information can come from poison control centres, social security records, inquest reports, and from clinical and basic pharmacology, toxicology, and pathology units.