Aligning Medical Information and PV

Pharmaceutical companies are in a period of significant change as they seek greater efficiencies and operational control through cross-disciplinary approaches across various departments and regions. As instant, digital communication from around the world has become more widespread over the past 20 years, the industry has widely acknowledged that there are opportunities to pivot toward more collaborative and interconnected processes.

Breaking down the historic barriers of entire organizations—especially those with hundreds or thousands of employees and decades of legacy processes—can seem daunting and take years of careful, long term planning. One area of early focus is the potential across medical information (MI) and pharmacovigilance (PV), especially at the local or affiliate level.

By removing the historical barriers between local affiliates and combining certain elements of MI and local PV, pharmaceutical companies can become more efficient, creating greater consistency and improving overall customer satisfaction. Rather than treating these as separate and siloed business units, life sciences leaders are noting that there could be emerging benefits from combining certain aspects of these two operations for heightened synergy, communications and, ultimately, patient safety.

The current status and inefficiencies

Many pharma manufacturers face the challenge of managing numerous local affiliates across a multitude of countries. For MI, each local or regional contact center serves as the critical information source for customer inquiries. Meanwhile, a separate local PV team is responsible for adverse event (AE) intake, regulatory reporting, literature review and a source of local qualified person for PV (QPPV). These provincial partners frequently act as independent entities, meaning there is little transparency between them and the larger pharmaceutical parent company. Their varying approaches can have a negative effect on oversight, efficiency and what is actually happening on a global basis. Moreover, these individual approaches can be challenging to overcome with success relying on detailed planning, education, management and oversight to implement new and more standardized, streamlined processes.

Those pharmaceutical firms seeking synergies from handling both MI and local PV intake in a joint, more unified approach will often require partners to assist with regional issues, such as language support and regulatory reporting. For instance, service providers can assist with MI inquiry management, translation and PV post-marketing safety activities. Staffs who understand local dialects reduce the reliance on translation vendors, increasing quality and reducing the cost of fielding, processing and transcribing these calls across the various countries. Often this can be done more efficiently from more centralized locations where staff can be shared. This also creates more knowledge about specific regional requirements, for example, deep cultural knowledge and experience with specific local tools and templates in local language.

Use of technology can also overcome inefficiencies when combining some aspects of MI and PV and working in above-country models. Bringing in a centralized system is key, allowing information entered at the local level to be translated into English and sent to the global processing department to more quickly and accurately identify trends or areas of concern, whether at a local, regional or global level.

The future of joint MI and PV strategy

Traditionally, PV operations are managed by biopharmaceutical organizations as part of their compliance requirements, while MI teams were either part of the PV or medical affairs group and focused more on customer service.

MI teams are usually responsible for staffing contact centers and answering medical and scientific inquiries about new medicines, especially when they first come to market. However, MI also increasingly represents an important source of information around AEs. MI experts triage these events, gathering some initial data from callers and then passing them off to the PV team to intake, process and report.

With their background, however, MI staff can be trained to perform PV activities along with their current MI remit, such as local AE intake and entry into the global safety database, resulting in heightened efficiency. A centralized management structure for overseeing these local affiliates enables streamlined service delivery and improved compliance and oversight. For example, a major pharma company may be distributing products in 100 countries with a partner affiliate in each that operates by its own rules and processes. As a result, this highly disparate structure reduces transparency and introduces inconsistencies in costs, volumes and quality. The first step in creating a more cohesive approach involves analyzing what is happening at the country level—including such factors as the volume of MI inquiries and PV intake events—and then performing a gap analysis. Armed with new insights, companies can create a new plan, streamline processes and add technology to optimize resource deployment, including for low-volume geographic regions and during volume surges.

Improved oversight can result in greater standardization. The benefit of a joint strategy is immediately apparent from the planning and start-up phases and continues as experience is gained working at the local country level. When implementing a more structured approach to working with the various affiliates, pharma organizations will need to influence these groups to adopt a new style of working to ensure that reporting of information is done consistently. Transition support will be needed to adopt a more centralized, compliant approach to gathering and reporting information to ensure compliance, transparency and standardized KPIs at a global level. Cross-training teams on information and processes, along with introducing better communication technologies, allows for some greater synergies. However, it is important to note that MI individuals can be cross trained to support the PV team as needed to provide additional depth and knowledge to the team. That is not the case for the PV team; many are not trained at the proper level to assist with MI objectives.

Next steps for leaders

The continued advancement and adoption of technology in the pharmaceutical space has reached a point where there are now tangible business benefits to creating more centralized management and interaction among departments such as MI and local PV. Artificial intelligence (AI), automation and the cloud are transforming how information is shared, communicated and captured at contact centers. Technology will aid in the industry shift to a more combined MI and local PV strategy, jointly with a human-based model.

Training, education and new process implementation will also be required to break down the traditional silos that exist between functional areas, local affiliates and corporate headquarters. As companies look to increase interoperability, partnering with technology and service providers who have life sciences knowledge and experience will be helpful in managing the transformation.

Thoughtful change management is also critical, incorporating cross-functional training and communication backed by deep industry expertise and process implementation that is unique to every organization based on its size and needs. Furthermore, drug manufacturers who succeed at bridging the gaps between local and global business units will be those that work collaboratively with industry experts with specific local-level knowledge to not just ideate a strategy that works for them but also to oversee its implementation.

The question is not whether there are benefits to combining MI and local PV, but rather how to go about it in a successful manner. Employing life sciences understanding, advanced technology and a careful roadmap for centralized management and local implementation, biopharma companies can more fully realize the financial and operational benefits of MI and local PV connectivity, while helping to mitigate risk.

About the authors

Alisa Hummings (left) is Senior Director, Medical Information and Clinical Event Validation and Adjudication (CEVA), IQVIA; Simon Johns (right) is Director, Medical Information and Marketed Product Safety, IQVIA.