Correspondence Address:
Upendra Nagaich
Editor, Journal of Advanced Pharmaceutical Technology and Research (JAPTR), Editor-in-Chief, SPER Times Secretary, Society of Pharmaceutical Education and Research, 22-C, Jawahar Colony, Gwalior - 474 001, M.P.
India

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Dear Friends,

Pharmacovigilance is gaining an utmost significance in the working of pharmacy discipline. It is exactly related to the term, known as drug safety which directly deals with the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effect with pharmaceutical products. Pharmacovigilance actually composed of two words namely Pharmakon (Greek word: Drug) and vigilare (Latin word: To observe). Generally, it is related to the hazards identification so as to minimize the risk that may cause harm to patient. As such, pharmacovigilance profoundly converges on adverse drug reactions (ADRs) which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors like overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of significance since they may result in an ADR. There are several specific terminologies associated with pharmacovigilance like ADR, adverse event (AE), causal relationship, clinical trial, control group, effectiveness, efficacy, harm, risk factor etc., which need to be focused to completely understand the concept of drug safety. World Health Organization, International Conference on Harmonization, The Council for International Organizations of Medical Science, and International Society of Pharmacovigilance are some key organizations which play significant role in the development of global oversight of pharmacovigilance. Two main activities closely associated with pharmacovigilance are AE reporting and risk management. AE reporting involves the receipt, triage, data entering, assessment, distribution, reporting and archiving of AE data and documentation. AE reports source includes impulsive reports from healthcare professionals or patients, requested reports from patient support programs, reports from clinical or post marketing studies and literature sources, reports from the media (including social media and websites), and reports reported to drug regulatory authorities themselves. Risk management is the subject matter within pharmacovigilance which is accountable for signal detection and the monitoring of the risk benefit profile of drugs. Other significant activities within the sphere of risk management are compilation of risk management plans and aggregate reports such as the Periodic Safety Update Report, Periodic Benefit Risk Evaluation Report, and the Development Safety Update Report.

Likewise, pharmacovigilance holds on medical devices and herbal medicines. Medical device reporting is the reporting of AEs with medical devices is similar to that of drug products but differences are there. Conclusively, pharmacovigilance still needs to be explored in other areas of pharmacy discipline so that a close observation could be done with the health of patients and their treatments.