8 min readAn Ode to Pharmacovigilance Solutions

The pharmaceutical industry is in an era in which it has reached the crossroads, facing multiple challenges. The industry needs to overcome herculean challenges like the need to reduce timescales for new drug discovery, shrinking profit margins, supply chain pressures and changing regulatory requirements. The industry is in an extremely turbulent phase, besieged by intense competition, tighter margins and lack of new drug offerings being typical characteristics of this sector.

Over the coming years a lot of drugs will be going off-patent and as a result competition from generic manufacturers is growing at a fast pace. It is estimated that by 2012 approximately $ 31.0 billion1 worth of drugs are projected to go off-patent. Research and development costs are rising, while complying with drug regulations and safety protocols is becoming more complicated and expensive. In order to sustain valuable growth and succeed amidst the intense competition, pharma companies have geared themselves to implement some imperatives like cost reduction, increasing the market share of existing products, bringing newer products to the market in a shorter time span and avoiding unnecessary risk. However, the significant increase in time to market the drugs, drug development costs shooting up to more than a billion dollars2, and diligence in compliance issues are some challenges that straightjacket the implementation of the above mentioned imperatives.

Despite all these constraints the pharma companies continuously come out with new products. Surveillance of the safety of the product over its life on the market is very important in the first five years of a new drug as the long term side effects are often unknown. Even though clinical studies have verified the efficacy and the safety of the product there are some potential limitations. These limitations are due to confined sample sizes, stringent exclusion criteria, and rare adverse events as well as other unpredictable conditions after marketing such as off-label use, use in previously untested populations and so forth. Thus, the complete safety profile of a drug will not usually be available until a product is exposed to a sufficiently large population in the post-marketing phase.

The famous thalidomide disaster in the early 1960’s forced pharmaceutical companies to start monitoring and reporting spontaneous adverse reactions to their products to a number of regulatory authorities like Food & Drug Authority (FDA) and European Medicine Agency (EMEA). The pharma companies are required to collect data on adverse events, assess the seriousness of the events and report the various cases on a regular basis to the regulators. As a result of these established reporting practices some significant adverse reactions to currently marketed products were observed which were not seen during clinical testing which eventually resulted in those products being withdrawn from the market. The withdrawal of a product from the market would prove to be extremely costly in terms of litigation expenses, lost revenue, falling share price, and tarnished company image. There has been an instance when a company was recently asked by the courts to pay $1.0 billion for a single product-related death.

Major product withdrawals from the market have resulted in litigation settlements worth up to $5.0 billion. Following a major product withdrawal a company’s market capitalization can fall by a couple of billion dollars in a few months. Most recently the withdrawal of Vioxx resulted in a reduction in the company’s market capitalization of $27 billion3 overnight, the loss of $2.5 billion in annual sales, and potential legal liabilities of up to $10 billion4. In short, a product withdrawal can result in a major damage to the company’s goodwill and loss of tremendous value to its shareholders.

These challenges have resulted in pharmacovigilance emerging as a thrust area in which Information Technology can play a major role. It can help in reducing the probability of drug recalls and increased safety to patients.
Now what is pharmacovigilance? Pharmacovigilance could be defined as the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problems. This could particularly include long-term and short-term side effects of medicines. There have been quite a few areas of concern which have been brought under the umbrella of pharmacovigilance such as herbal medicines, traditional and complimentary medicines, blood products, biological, medical devices and vaccines.
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