8 min readAn Ode to Pharmacovigilance Solutions

The pharmaceutical companies are accountable to track adverse side effects and reactions; hence drug safety and reporting is an ever increasing and daunting task faced by all pharmaceutical companies. The regulators such as FDA and EMEA are maintaining a stricter vigil so as to ensure that the pharmaceutical companies adhere to specified guidelines and regulations pertaining to drug safety requirements. In the event where the pharmaceutical company fails to adhere to regulations, they are fined millions of dollars or banned from the marketplace.

With the ever-mounting pressure from the regulators on the pharma companies, they are being forced to streamline the various reporting procedures and ensure that safety reports are processed in an accurate and timely manner. This would require the synchronization of Adverse Event Reporting and various other verticals such as electronic submissions, document management tools etc. Pharmaceutical companies are already seeing the need to modify their existing process structures and systems to adhere to the set protocols and standards. Several regulators like the EMEA have already implemented various structures and models for the pharmaceutical companies and regulators to submit adverse event reports electronically in specific formats such as E2B.

This decade also has seen a flurry of acquisitions and mergers in the pharmaceutical arena. The increasing pressure to come out successfully from the intense competition has resulted in the industry witnessing a large number of mergers and acquisitions among small and medium sized companies. But these mergers and acquisitions in the pharmaceutical domain have left companies with the issue of integration of disparate systems and a host of independent applications for overlapping tasks. There are several drawbacks when there are no integrated and centralized systems.

Firstly there would be large amount of data loss and inconsistencies in the data on adverse events across the systems besides the fact that there would be no amalgamated interface for getting adverse event reports from partners, regulators, local sites, call centres etc. There is also the need to integrate the paper based processing procedures with the automated systems, as manual processing would lead to higher operating costs. The maintenance of a centralized data bank to maintain and track drugs as they are released is highly imperative.

The pharmaceutical company that develops and manufactures drugs around the world has to define, document and publish the various procedures that enable the reporting and tracking of side effects that might occur once the drug has been released in the market. These side effects are termed as Adverse Events. It is required that each and every pharmaceutical company record and tag these Adverse Events. Once categorized, these events need to be reported back to the FDA and other regulatory agencies like the EMEA and other statuary bodies.

Depending on the severity of the events, the regulatory bodies then set the timeframe and future events needs to be continuously reported to them. Delays in reporting these adverse events can lead to the company being fined heavily or even having to pull the drug from the market. However most of the pharmaceutical companies are plagued with systems, which do not envelop all the processes end-to-end. This has resulted in severe inefficiencies and the requirement of regular audits to maintain a high degree of quality. In order to adhere to the strict regulatory guidelines set forth by the various agencies, the pharmaceutical companies are required to streamline and automate their adverse event management systems.

With a host of factors that accentuate the various problems being faced in the safety arena, pharmaceutical companies need to create a lot of awareness as well as assure the regulators and public alike that drug safety should not be a concern and that considerable steps are being taken to ensure that the drugs are totally safe. It is also required that critical safety data be easily and readily accessible to regulators through efficient reporting mechanisms. With the pharma industry at a vibrant stage with a large number of mergers and with a lot of research being outsourced, the creation of a reliable safety data model that complies with the regulatory nomenclature has become expensive.

In order to achieve their envisioned goals, large number of IT frameworks need to be developed to receive, process, report and analyze adverse event data in a integrated manner that adheres to standards and regulations laid down by the regulators. Within the IT frame work of pharmacovigilance applications the requirements of efficient operating models and intermittent regulatory audits have increased the need for continued support and maintenance overheads.


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