ABSTRACT
Introduction ............................................................................................................ 332 Spontaneous Reporting Systems ............................................................................ 334
When to Report a Suspected ADR .................................................................... 336 Establishing Whether an Adverse Event Is an ADR ......................................... 336
ADRs ...................................................................................................................... 337 Type A (Augmented) ......................................................................................... 337 Type B (Bizarre) ................................................................................................ 338 Type C (Continuing).......................................................................................... 338 Type D (Delayed) .............................................................................................. 338 Type E (End of Use) .......................................................................................... 338
Pharmacoepidemiology .......................................................................................... 339 What Is the Drug Use in a Specic Population? ............................................... 339 What Are the Determinants of Drug Use? ........................................................ 339 What Are the Outcomes of Drug Use (Benecial and Adverse Effects)? ......... 339 Records of Drug Use, Determinants and Outcomes .........................................340 Measuring Disease Frequency .......................................................................... 341
Measuring Drug Use .............................................................................................. 343 Study Design .......................................................................................................... 345
Descriptive Studies ............................................................................................ 345 Case-Control Studies ........................................................................................346 Cohort Studies ................................................................................................... 347 Experimental Studies ........................................................................................ 347 Risk Estimates ................................................................................................... 347
Bias and Confounding ............................................................................................ 349 Conclusion ............................................................................................................. 351 Further Reading ..................................................................................................... 351 References .............................................................................................................. 352
Pharmacovigilance involves the detection of unexpected, and often undesirable, adverse effects of drugs. Pharmacoepidemiology, often considered a subdomain in pharmacovigilance, attempts to quantify the frequency of these adverse effects, and to identify subpopulations for which there are variations in the magnitudes of effects.
