Department of Clinical Research, Nizam’s institute of medical sciences, Hyderabad, India
Received date: 13/04/2015 Accepted date: 14/04/2015 Published date: 20/04/2015
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Pharmacovigilance (or drug safety surveillance) is a branch of science which deals with adverse reactions of pharmaceutical products enclosing collection, detection, monitoring, assessment and prevention of adverse reaction of pharmaceutical products. It is one of the crucial steps in drug development process, which ensures safety of newly developed pharmaceutical product. This study is conducted before post marketing surveillance, which helps in assessing the risk benefit ratio of new pharmaceutical product. Thus the formulation gets approval from FDA for further processing.
Pharmacovigilance; Safety; Efficacy; Adverse drug reaction; Signal detection; Post marketing surveillance
• early identification of unknown safety problems
• quantifying the probability of risk
• Measurement of effectiveness
Novel drug discovery is time consuming and expensive process, which also requires a strict vigilance to ensure safety and efficacy of the drug. Pharmacovigilance plays a crucial role in drug development process. The safety of pharmaceutical product may not be distinct, post effects of drug when used in combination of other drugs are generally unknown and safety concerned in different groups can be different as in young children, elderly patient, pregnant women.
Pharmacovigilance plays a pivotal role at different stages of drug discovery development process, which involves submission of reported adverse drug reactions observed during clinical trials to respective drug regulatory agencies [3,4].
Signals can be evolved from post marketing data or other sources, such as preclinical data and events associated with other produts of same pharmacologic class. After signal identification, it should be further subjected to assessment in order to identify potential safety risk [5-10].
Signals detected through four different methods: spontaneous reporting, published case reports, cohort studies and postmarketing clinical trials.
Identifying and reporting clinical findings of suspected adverse drug reactions with a marketed drug is termed as spontaneous or voluntary reporting.
Published case reports
Case reports with suspected ADRs which are published in medical journals is one way to alert others of possible drug hazards.
Companies may organize sponsor prospective or non-interventional cohort studies in order to resolve the queries rose after marketing the drugs.
Post-marketing clinical trials
Large randomized Clinical trials with wide entry criteria can be useful in detecting the safety and efficacy of marketed products.
Reporting of safety signals
With the detection of safety signals, sponsors would be responsible in submitting all the available safety information to regulatory authority, starting from preclinical findings to the current findings.
Regulatory authority will make the own assessment of available data considering the following: seriousness of event with respective to disease being treated, magnitude of the signal, biologic plausibility, consistency of findings with the available data sources, availability of other therapies and potential to mitigate the safety signal in the population through various risk management strategies.
Safety signals can be detected prior to product marketing approval or after the drug has been marketed. Scheme for pharmacovigilance depends on several factors (scientific and logistical) which includes: type of the signal, whether it occurs commonly or rarely, the nature of the population(s) at risk, whether the product is prescribed to a broad range of patients or in selected populations only and whether the product is dispensed at all pharmacies or via restricted distribution systems only.
The proposed pharmacovigilance scheme includes
It involves submitting adverse event reports in an expedited manner (i.e. as 15 day reports) or at more frequent, prespecified intervals (Eg. quarterly rather than annually).
It involves active surveillance to identify adverse events, which may not be observed or identified in passive surveillance.
Pharmacovigilance [11,12] is an important part of clinical research ranging from drug discovery to post marketing surveillance. With requirement to patient safety, prior identification of adverse drug reactions are utmost required. Pharmacovigilance [13-17] involves evaluating the information provided by health care providers , pharmaceutical companies and patients in order to diagnose the risk and benefits involved with respective to particular drug.
Pharmacovigilance is a very crucial part of drug discovery and development process, which requires careful monitoring of drug at every phase including pharmacovigilance inspection, reporting of ADR, periodic safety report, post-authorization safety studies [18-21]. Establishing good pharmacovigilance is foremost required in order to understand the drug safety issues during drug development process, thus patients can be provided with safe and effective innovative drugs.
With the developing trends in health care industry, information technology (IT) has transformed the world health care and clinical medicine, to meet their standards, thus improving the safety, efficacy of drugs, and reducing the costs. Booming of IT into clinical safety practice creates a strong platform, to establish pharmacovigilance  systems for safety signal detection. Thus, it bought a significant change in conducting clinical research practice of medicines and medical safety monitoring. For an fruitful pharmacovigilance system to be effective, all the stakeholders need to be keen enough throughout the lifecycle of a drug in the market. Thus pharmcovigilance is very critical step involved in drug development process, which ensures new innovative drug meets the regulatory compliance, thus enhancing the clinical trials safety and post marketing surveillance.