New Trends in Pharmacovigilance

2018-12-19 Priyanka Saha Medical Writing and Pharmacovigilance


Pharmacovigilance is defined as the science and activities relating to detection, assessment, understanding and prevention of adverse effects or any other pharmaceutical-related problem. The rapid and consistent progress of medical and pharmaceutical sciences has resulted in the availability of modern medicines that can efficiently prevent, control and ameliorate disease states. Despite a plethora of benefits, adverse reactions to medicines are frequent and are mostly associated with novel drugs. The growth in worldwide diseases is directly proportional to consumption of pharmaceutical products and the consequent occurrence of adverse drug reactions (ADRs). ADRs are inevitable consequences of pharmacotherapy and have dramatically increased in prevalence over the years. It is thus imperative to have a well-organized strong system to systematically monitor, evaluate and assess the safety of medicines. Pharmacovigilance remains a dynamic clinical and scientific discipline and plays a vital role in healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. It illustrates a multi-modal supervisory role in promoting and improving public health.

In the past few decades, its scope has grown remarkably, encompassing not only ADR reporting but also drug–drug interactions, medication errors, lack of efficacy, counterfeit or substandard medicines. Many new trends have evolved shaping pharmacovigilance. Contract outsourcing is enhancing the operational efficiency of pharmacovigilance. With the enhanced demand for drug safety and monitoring, many multinational pharmaceutical companies are turning to Pharmacovigilance Outsourcing (PVO). Several third-party vendors provide pivotal benefits versus setting up an in-house pharmacovigilance structure, such as cost efficiencies. Cloud-based reporting technology has brought a robust global database of ADRs. A fully integrated system for physicians, healthcare providers, research institutions and user to store and access any registered pharmaceutical drug and its potential side effects has been developed.



Automation of PVO process has helped remove non-value-adding tasks such as administrative and clerical tasks thereby increasing labor efficiency. Several secondary data sources such as online journals, electronic medical records, social media, claims files, clinical data and electronic health records, regulatory reports and filings from different jurisdictions, online data submissions contribute to widespread reporting of ADRs. Today, ADRs can be reported by a click of a finger through online channels in real-time. Monitoring and reporting cycles can now be measured in days and weeks, rather than years and decades.

In pharmacovigilance processes, application of data analytics enhances the speed of signal detection. It essentially seeks information that point to causal relationships between pharmaceuticals and reported adverse or beneficial events. Artificial intelligence has the potential to turn PVO into a predictive science. It possesses the ability to assimilate huge amounts of cloud-based data, map patterns, and correlate with genetics and disease occurrences. This, in turn, leads to effective prediction of ADRs. The pharmacovigilance industry is trending to become extensively dependent on big data technology for end-to-end assimilation of huge amounts of information and ensures safety, integrity, quality and security of the data. 

Pharmacovigilance continues to grow, evolve and improve at a faster pace. With thousands of pharmaceutical drugs expected to hit the market in the next few years, there is an enhanced buzz for drug monitoring and regulation thereby driving the pharmacovigilance industry to grow at a projected cumulative annual growth rate of 14.2%. Pharmacovigilance is therefore one of the fastest growing industries and is a promising business process outsourcing venture.

Turacoz Skill Development Program (TSDP) aims to guide students and professionals and keep them updated about the new trends in pharmacovigilance and offers course in medical writing, pharmacovigilance, regulatory writing and scientific writing.

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