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Perspicacity in Pharmacovigilance

Mounika Sathelli1*, Kiran Mayee K2

1Department of Pharmacy, St. Mary’s College of Pharmacy, JNTUH, Secunderabad, India

2Department of Pharmaceutical Analysis and Quality Assurance, Mallareddy College of Pharmacy, Osmania University.

*Corresponding Author:
Mounika Sathelli
Department of Pharmacy, St. Mary’s College of Pharmacy, JNTUH, Secunderabad, India
E-mail: [email protected]

Received Date: 30-10-2015; Accepted Date: 04-11-2015; Published Date: 19-11-2015

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Current day?s pharmacovigilance have been fast evolving sector in the fields of medicine and software technologies. Present insight focuses on major trends of pharmacovigilance in various countries, its importance, use in different drug strategies, future advances. Pharmacovigilance advancing into the major factor of drug safety portions of the drug introduction into market has gained huge response. It has generated into key fields in the Pharmacy profession providing well sophisticated opportunities to Pharmacy professionals around the globe.


Pharmacovigilance; Drug Safety; Adverse drug reactions; Statistical Analysis System; clinical trials


Pharmacovigilance (PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Pharmacovigilance includes safe drug clinical trials with various measures to obtain a efficacious quality product such as Clinical trials in artemether lumefantrine in pregnant women [1] etc.


Various examples are taken into account regarding the massive clinical trials administered for safe Drug analysis which covers the broad scope the recent laws of pharmacovigilance in European and US [2], Pharmacovigilance teaching strategies in the major countries [3,4], Biosimilars in Pharmacovigilance [5], Pharmacogenetics Therapies development [6], SAR Studies [7], ADR studies [8-10], Alcohol Medication Interactions [11,12].

Safety signal initiative by WHO regarding Pharmacovigilance has developed as a system [13,14]. Patient Safety have evolved at rate in all the Countries on the primary focus of drug safety in clinical perspectives [15,16], the trends, scope ,future initiatives, Modern developing technologies have wide scope for the enhancement of Pharmacovigilance career [17-21].

Pharmacovigilance Vs Adverse Drug Interactions

The safety of drug is peculiar when in the case of adverse drug interaction appears such as clinical pharmacists major role and the correct quality dosage, the various reports illustrated are [22-29], the adverse drug interactions being the main obstacle for the Pharmacovigilance, thus including several steps.

Recent Pharmacovigilance studies use the reliable software of SAS (Statistical Analysis System) for the early and fast retrieval of large clinical data in number of Individuals participating. Even the Pharmacovigilance have evolved in the economic field rapidly with global advancements and approaches

Adverse reactions effect lead to serious consequences which result in drug- drug interaction, drug to foreign substance interaction, etc.

Hence a clear study with safety measures in use with well developed and highly professional individual’s presence is required. Careful review on the adverse drug reactions must be clear as adverse drug reactions are undesirable impacts on the drug which badly affect the drug influence in treatment.

Special Technologies are used for drug safety with upcoming development in technology such as use of Apple’s Research Kit a recent innovation for medical research data collection, where retrieval of absolute details in less time is possible.

Several Excipients used in drug development are carefully scrutinized for its further non interaction with drug main active ingredients.

Physician’s views and concerns regarding several cases they handle may give us the idea regarding the adverse drug reactions and hence the knowledge of Pharmacovigilance at present can be noticed.

Recently Pharmacovigilance for Novel Oral Anticoagulants have been studied which show that physicians should be precise regarding the pharmacology of NOACs, dose adjustments, contra- indications, drug-drug interactions.

They should have a complete record of patients with the Anticoagulants treated with adverse reactions reported if any.

Safety and efficacy assessment is prime importance in Pharmacovigilance. Clinical trials are framed as such maintaining a set of regulations and procedures that determine the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.

Special regulations are followed in Pharmacovigilance which are mentioned by Food & Drug Administration organisation, where every clinical trial is followed with utmost care and importance towards studies of Adverse Drug Interactions are studied and well defined terms are illustrated for the improvement of clinical trials in each and every stage starting from Clinical Trial-I to Clinical Trial-III, and Clinical Trial IV after releasing into market with the effective and strong documented suggestions by persons excelled in Pharmacovigilance.

Pharmacovigilance hence developed into a major research interest today in pharmacy professional with more employment opportunities in Multinational organizations as the the field is related to scientific arena of science and technology requiring developing of knowledge in the fields of software development tools coupled with scientific knowledge.

Drug safety is hence a very crucial factor as the drug starting from its formulation, quality checks, approval by FDA in preliminary stages, Quality Assurance, clinical trials and then into the market all at last gives or based on result of Drug Safety.

If Safety province of Drug is not maintained it may lead to vain of all works done starting from formulation to release in market, which results in heavy money loss and financial crisis.


Recent trends in the development of Pharmacovigilance provide enormous employment opportunities for the vast pharmacy professionals especially and the fast growing era show a major path in the economics field, with careful studies absconding the Adverse drug reaction problems [34-41].

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