Abstract
Signal detection and its assessment is the most important aspect in pharmacovigilance which plays a key role in ensuring that patients receive safe drugs. For detection of adverse drug reactions, clinical trials usually provide limited information as they are conducted under strictly controlled conditions. Some of the adverse drug reactions can be detected only after long term use in larger population and in specific patient groups due to specific concomitant medications or disease. The detection of unknown and unexpected safety signals as early as possible from post marketing data is one of the major challenge of pharmacovigilance. The current method of detecting a signal is predominantly based on spontaneous reporting, which is mainly helpful in detecting type B adverse effects and unusual type A adverse effects. Other sources of signals detection are prescription event monitoring, case control surveillance and follow up studies. Signal assessment is mainly performed by using Upsala Monitoring scale & Naranjo scale of probability to analyze the cause and effect analysis. Signal detection and their assessment is very vital and complex process. Thus, the main objective of this review is to provide a summary of the most common methods of signal detection and their assessment used in pharmacovigilance to confirm the safety of a drug. Recent developments, challenges, & future needs have also been discussed.
Highlights
All drugs are capable of producing adverse effects and whenever a drug is given a risk is taken
Patient information includes completeness of information with- patient initials, age, sex, date of birth (DOB), weight, diagnosis for which the medications were being taken, relevant history, adverse event description, adequate description of the event, when did the event occur? When did the event subside? How the event was managed? What was the outcome? Whether the event abated on stopping the drug or reducing the dose of the drug? Whether the event reappeared on reintroduction? Any supportive laboratory data? Drug information includes suspected medication with their brand name and/or generic name, labelled strength, manufacture, dose used, frequency of use, route used and therapy dates, concomitant medications including selfmedication and herbal remedies etc
Adverse events are regarded as serious if they were fatal, life-threatening, caused significant disability or incapacitation, caused or prolonged hospitalization, or required intervention to prevent any of these outcomes or led to congenital anomalies
Summary
All drugs are capable of producing adverse effects and whenever a drug is given a risk is taken. If any adverse drug reaction occurs during the trial, the principal investigator reports to the sponsor within 24hrs and to the Institutional review board (IRB) within 14 working days. The World Health Organisation (WHO) defines Pharmacovigilance as a science related to the detection, assessment, understanding and prevention of adverse reactions towards a medicinal product or any other medicine related problems in human beings [7]. The main objective of pharmacovigilance is to quantify previously recognized adverse drug reactions, to identify unrecognized adverse drug events, to evaluate the effectiveness of medicines in real-world situations, and to decrease mortality and morbidity associated with adverse events [8, 9]. A limited number of reports represent a signal [11]. In this review, we have tried to compile the qualitative methods of signal detection and its assessment used in pharmacovigilance
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