Tiêu đề 4. METHODS OF POST MARKETING SURVEILLANCE.pdf ✅

PHARMD GURU Page 2  The delayed discovery of Practolol’s adverse effects spurred efforts to improve post marketing surveillance. SOURCES OF PMS INFORMATION: The following may be considered as sources of information, some sources are proactive and some are reactive.  Expert users group (focus groups)  Customer surveys  Literature reviews  Customer complaints and warranty claims  The media  User’s reactions during training programs, etc. NEED FOR POST MARKETING SURVEILLANCE:  The primary objective of post marketing studies is to develop information about drug effects under customary conditions of drug use.  Rare adverse events may not be detected in Pre-licensure studies because even large clinical trials have limitations. TYPES OF POST MARKETING SURVEILLANCE: (a) SPONTANEOUS/VOLUNTARY REPORTING OF CASES: Voluntary reporting by physicians and other health care providers, hospitals and customers may act to alert FDA and pharmaceutical firms to possible adverse effects of drugs. Voluntary reporting of cases done by:  WHO international system  National Pharmacovigilance system INDIA  local (or) regional (Joint Commission requirement)  Scientific literature publications In other countries:  US-FDA Medwatch.  UK yellow card system.  Australia blue card system.

PHARMD GURU Page 4 time at subsequent clinical events. The rate of events is then compared between the two groups.  Thus, they are particularly useful for studies of newly marketed drugs, looking for drug effects. In contrast to case control studies, cohort studies can measure incidence rates. These studies, however, require very large samples of patients in order to detect relatively uncommon drug effects. This results in expensive studies, which are logistically difficult to perform. 5) RANDOMIZED CONTROL TRIALS:  These are also called experimental studies, differ from cohort studies in that the investigator controls the drug exposure, one (or) more of these studies are nearly always performed prior to marketing, primarily to test the efficacy of drugs.  They're often performed on highly selected groups of patients who are free of drugs and diseases, other than those under study. Thus, the results are often not applicable to the typical patients who will be taking the drug. Although these studies are designed to include an adequate number of patients to determine the efficacy of a drug, they are usually too small to detect uncommon drug effects.  In post marketing surveillance, they are mainly used to evaluate the efficacy of drugs for new indications. They're often costly (or) impractical in specific situations. For example: when a drug`s effects are rare (or) appear only for long term use (or) a long latency period.