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pharmafile | June 10, 2008 | News story | Sales and Marketing |Â Â Â
Pharmacovigilance solutions: essential for the future of healthcare
Although many newer pharmacovigilance solutions are still in the nascent stages, and despite pharmaceutical companies' reluctance to adopt them, it is becoming increasingly obvious that these tools will play an essential role in protecting public health. As drug safety regulations increase, signal detection technologies will aid in the costly act of identifying and managing adverse drug events.
The business environment for the pharmaceutical industry has changed immensely over the past few years, with the current blockbuster business model no longer viable for companies to sustain growth. As the industry faces growing competition from generic drugs, declining product pipelines, and rising R&D costs, pharmaceutical executives are becoming increasingly anxious. A company can no longer afford to go through the entire drug development process, only for the drug to be rejected by the regulatory agencies, or worse, be removed post-market due to safety concerns. Drug safety issues not only affect a company's business portfolio, they can also lead to high lawsuit payouts.
It is therefore essential for a pharmaceutical company to implement a proactive pharmacovigilance and risk management strategy, which encompasses the use of technology to ensure production of a safe and effective drug. This will ensure it will be approved and maintain a favorable risk-benefit ratio post-approval.
The pharmaceutical industry is a highly regulated global market, and must adhere not only to federal and local rules, but also to international regulations. Companies must adapt to constantly changing government regulations to ensure compliance and eventual approval of their drug products, and the response to these new rules is driving the adoption of pharmacovigilance solutions.
Companies will need to ensure they report and communicate safety issues related to a drug in every country where the drug is marketed. The adoption of advanced pharmacovigilance tools, specifically signal detection and management technology solutions, data management tools, and adverse event reporting systems, will greatly help companies manage the large amounts of safety data, as well as generate and submit reports to specific countries or regions based on their regulations.
In order for pharmacovigilance to be effective, a radical change must take place in the signal detection and management process. The use of data mining and signal detection during post-market surveillance is not unheard of, but using these technologies in clinical trials is a relatively new concept. In the past, analysis of clinical data required a back-and-forth discussion between researchers and statisticians, and could take anywhere from a few days to a few weeks to complete the analysis. Using advanced signal detection technologies throughout the clinical trials process allows researchers to perform ad hoc, close to real-time analysis on the data, reducing time in the interchange between researchers and statisticians.
For a drug that is deemed 'safe', this time-saving could lead to a reduction in development costs and a faster time-to-market. On the other hand, early detection of safety issues could also lead to termination of future clinical trials, which protects patients from further suffering, and saves companies money that would be spent on clinical trials, litigation, and regulatory fines.
Detection of potential safety issues early will allow pharmaceutical companies to manage these safety signals throughout the product's lifecycle. Unfortunately, however, the industry is still skeptical of the benefits provided by advanced signal detection technologies.
IT vendors must therefore take an active role in educating companies about using pharmacovigilance solutions. They must position signal detection technologies as essential tools for developing comprehensive risk management strategies which will not only benefit the company, but ultimately the public.
Ultimately, it is crucial that drug companies and regulatory agencies develop comprehensive pharmacovigilance strategies. This will enable them to intelligently analyze the risks and benefits of each drug prior to introduction into the mass market, and monitor any adverse drug reaction post-market. Advanced computerized systems and IT solutions to help with drug safety monitoring will soon become essential tools for companies that want to survive in this predictive and proactive pharmacovigilance environment.
Related research:
Addressing Key Challenges in Drug Safety
Biosimilars Series: Regulatory and development issues – hurdles exist but are surmountable
Generics will play an increasingly important role in the pharma industry
