May 15, 2007 (Vol. 27, No. 10)

Creating a Flexible and Proactive Approach to Patient Protection

A subtle conflict lives at the heart of the public’s faith in the pharmaceutical industry: Patients base their faith in medicines upon the idea that clinical trials and regulatory approval firmly establish drug safety. The fact is, however, that neither of these measures ensures security for all patients in all settings.

Pharmaceutical companies can employ a number of solutions, known collectively as pharmacovigilance, to detect, assess, and prevent adverse drug reactions. When properly designed and deployed, pharmacovigilance solutions mean more patient protection and fewer safety-related withdrawals.

In recent years, increases in the use of medicine and public awareness of safety issues have revealed challenges in four areas of operations—organizational alignment, operations management, data management, and risk management. We believe that companies can address these challenges and create a flexible and proactive approach to patient safety by aligning and connecting these four areas. Furthermore, our ideas on how companies can accomplish this fall into three discrete areas. A few of the specific actions companies can take within each of these sections are outlined in this article.

1. Align and clarify roles, responsibilities, and communications:

• Develop an objective, data-driven, team-based approach to risk monitoring and evaluation.

• Implement standard decision-making models, escalation processes, and communication channels.

• Align resources with the pharmacovigilance workload.

• Designate a pharmacovigilance operating model and business process owner.

• Ensure that process and organizational checks and balances limit bias and manage regulatory risk.

2. Standardize pharmacovigilance processes and data management:

• Align operational activities across departments and across sites.

• Deploy process-driven standard operating procedures, work instructions, and training materials.

• Establish data and system interoperability standards to accommodate safety data.

• Implement workflow management technology to ensure transparency of and access to safety information.

• Select a technology vendor based on established criteria.

3. Implement proactive risk minimization:

• Develop risk-management action plans based on standard risk-scoring methods.

• Implement data-mining techniques to bolster safety analytics, reporting, and investigation.

• Incorporate continuous improvement and standard risk communications plans.

• Create a dashboard that promotes awareness of safety risks across the portfolio and timely minimization of safety risks.

Many companies are well on their way to using pharmacovigilance solutions like these to improve the safety profile of their portfolios. As you can read in our full report, “Unlocking the Power of Pharmacovigilance: An Adaptive Approach to an Evolving Drug Safety Environment,” we suggest that firms can address challenges to better pharmacovigilance by integrating operations and utilizing data and risk-management techniques across the safety organization and related functions.

To develop our approach, we combined information gained from top drug safety and R&D executives with our experience in this area. The power of our integrated approach is that it aligns strategy with accountability and links diverse functional areas within an adaptable, integrated framework. In short, our approach allows companies to take sharp aim at the moving targets of regulator and patient expectations.

We believe that companies that look at their current operations within the context of our recommendations will greatly enhance the safety profile of their product portfolios. Such companies will find that they have greatly reduced both the costs and risks related to drug safety while achieving improved outcomes for all patients.

Mike Mentesana is a partner at PricewaterhouseCoopers.
E-mail: [email protected]. For additional information or to download the executive summary, please go to or contact [email protected] to submit a request for the full report.

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