Pharmaceutical Executive Europe - November/December 2007 - (Page 33) Pharmaceutical Executive Europe Nov/Dec 2007 Risk management 33 companies against their most costly risks: the withdrawal of a product that has already reached the market, and the failure of a product in Phase III clinical trials. These events can put patients at risk and jeopardise substantial investments of time and money. The need for greater investment in pharmacovigilance is clear: ● A study recently published in the Archives of Internal Medicine showed that serious adverse events for prescription drugs reported to the FDA between 1998 and 2005 increased by nearly 260%. Fatal adverse drug events rose by 270% over the same period. These increases were four times greater than the growth in total out-patient prescriptions during that time.1 While these increased figures may be in part because of changes in reporting requirements, the prevalence of adverse events has undoubtedly increased. ● Approximately four of every 10 new drugs entering Phase III clinical studies fail to be submitted for regulatory approval.2 Of the drugs that are submitted to the FDA, approximately three of every 10 fail to receive approval within 36 months.3 Each of these failures represents an investment loss of hundreds of millions of dollars. Approximately 30% of clinical trial failures in 2000 were linked to safety.4 ● In 2003, a US-based Fortune 500 life sciences company agreed to pay $92.4 million to settle criminal and civil charges for failing to file over 2600 Medical Device Reports (MDRs), each representing an incident in which a medical device malfunctioned or its use was associated with death or serious injury. This did not account for litigation costs, goodwill lost and other expenses — costs that should be accounted for in the risk/benefit assessment. While risk and uncertainty cannot be completely removed from the drug development process — or from pharmaceutical products themselves — a proactive pharmacovigilance programme that Table 1 Safety risk mitigation actions and their benefits. Safety Preclinical Conduct preclinical toxicology and efficacy studies Compliance Develop RMPs and QP as part of product development plan Identify safety signals and warning levels as part of protocol development Asset Maximization Develop risk/benefit model of product compared to competitive products Develop KOL relationships Benefits to RM Actions Better leverage capital Better go/no-go decisions Assure payer/provider acceptance of product Gain investor confidence and funding Phase I-III Conduct additional studies on more patients to test proper dosage Execute high quality product information and labelling Educate physicians, pharmacists, and patients on correct product use Conduct GCP/GMP audits and assessments Put in place and maintain systems and processes to monitor safety signals and report adverse events Identify & measure key safety performance metrics Outsource to well-qualified vendors (CRO, CMO, CSO) Invest in counterfeit controls if high drug sales expected Gain KOL consensus on risk/benefit of product Minimize legal liability and insurance costs by having an effective, approved PV system in place Maximize good will with key stakeholders Improve predictability of costly later phase studies Diversify portfolio Avoid costly Phase III failures Postmarketing Conduct postmarketing studies Submit timely regulatory obligations (PMC annuals, safety update reports, etc.) Monitor patient compliance Maintain positive public image (company) and reputation (personal) Monitor market for competitive products, patent infringements and counterfeits Obtain higher sales Gain patient and physician advocacy
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