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Among the myriad advances introduced to ensure that the global population is provided the best therapeutics and therapeutic approaches, pharmacovigilance has exhibited noteworthy contributions. Pharmacovigilance is a school of pharmacological science that encompasses every data gathering and scientific activity related to the prevention, understanding, detection, and assessment of adverse effects of pharmaceutical products and medical devices. It is an indispensable module of an efficacious drug regulation system that monitors and evaluates adverse drug reactions (ADRs).
Pharmacovigilance has become an important branch of clinical research and its demand is increasing at a substantial pace. Transparency Market Research, in its latest report, states that the global pharmacovigilance market, which stood at US$2.4 bn in 2013, will reach US$6.1 bn in 2020. If the figures hold true, the market will exhibit a promising 14.20% CAGR between 2014 and 2020.
Pharmacovigilance Ensures Better Patient Safety and Minimizes Costs
Recently, the ill effects of substandard pharmaceutical products, medication errors, and ADRs have been shown up in several studies. The incidence of such occurrences across the world has been so high that estimating the actual scale of these adverse impacts has become a herculean task. Whilst the majority of the documented evidence on ADR and medicine quality comes from industrialized nations, the situation in low- and middle-income countries is more urgent because of their poor healthcare infrastructure and unreliable quality and supply of medicines. Pharmacovigilance, broadly speaking, addresses three major discrepancies in the healthcare system, which include:
• Product quality
• Medication errors
• Adverse drug reactions
Product Quality:
Quality issues are common in pharmaceutical products that are deteriorated, adulterated, or defective due to primitive pharmaceutical practices, poor labeling, inadequate storage and distribution, and tampering. The availability of counterfeit products in the market also falls under this category.
Adverse Drug Reactions:
Adverse drug reactions or ADRs are harmful responses that occur in patients upon ingestion of prescribed medication. The most common ADRs include allergic reactions, reactions triggered by interaction with other medications, and adverse effects from withdrawal. The WHO identifies serious ADR as any reaction that could be life-threatening, fatal, or significantly disabling, thereby prolonging hospitalizations.
Medication Errors:
A medication error has been defined by the NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) as any event of inappropriate medical use while the medication is under the control of any healthcare professional, harming a patient in a way that could be prevented.
Pharmacovigilance has never been more important than it is in today’s zero-tolerance environment of drug safety. As the demand for ensuring patient safety at minimum cost increases, life sciences firms will seek ways to more aggressively identify and manage emerging safety risks. Presently, the worldwide network of pharmacovigilance centers is harmonized by Uppsala Monitoring Center for the effective functioning of drug safety monitoring around the world.
