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Pushing the boundaries of pharmacovigilance

by: Charles Arnold, Managing Director, Management Consulting Vicki Phelan, Director, Management Consulting

Underfunded and underloved. Tasked to accomplish more than ever before, but with fewer resources and, all too often, unclear direction from senior management. This is the life of the pharmacovigilance (PV) professional today.
Almost daily, the pressure mounts on PV groups to report more, accomplish more, and take greater responsibility for the long-term sustainability of pharmaceutical companies besieged with looming patent cliffs, shrinking profit margins and intensifying competition. And while they struggle to keep their tools and staff up to the many challenges they face, PV professionals are frequently viewed by senior management as just another cost center, rather than a strategic resource whose high standards for safety and quality are vital to safeguarding a companys global reputation. Yet PV professionals are not throwing up their hands in despair. Quite the contrary: Theyre working hard to find innovative solutions for dealing with wildly diverging regulatory requirements, stretched-to-the-limit budgets, and outdated information systems. The PV professionals interviewed for this white paper are developing innovative tools and techniques for handling outsourcing, for opening new territory in data collection and analysis, and, perhaps most importantly, for gaining credibility and resources, often by partnering with other departments in their own companies to achieve the critical mass needed to attract more serious attention from senior management. In the process, PV professionals are turning their function into a life insurance policy for protecting patents, products and reputations. PV at its most advanced is increasingly being viewed at many pharmaceutical companies as an invaluable bulwark against a fast-changing and unpredictable business environment.

This white paper will describe what is top of mind among several highly engaged professionals in PV. Despite the undeniable progress they have made, they readily admit they will need all the ingenuity they can muster. New challenges and requirements to rock the foundations of PV will undoubtedly surface over the coming months and years, and according to several experts, such challenges will not be long in coming.

Diverging requirements, growing concerns

Around the world, regulatory requirements are not only increasing exponentially, they are diverging so rapidly that often, there seems to be little, if any, similarity among different countries expectations and mandates. In the past, PV could generally meet multiple regulatory requirements with standard technologies and processes. In contrast, health authorities today seem to be competing against each other to see who can be the most rigorous in their mandates. As regulatory requirements diverge, the systems and databases used by PV organizations to track, analyze and report data cannot keep pace with the need to serve so many different masters simultaneously. The continual retooling and manual workarounds that result from such rapid divergence consume precious resources and lead to human errors and inaccuracies which result in challenges from regulatory agencies. As a first step, many PV professionals are identifying new technical standards and are working to enforce these standards with their affiliates and primary contractors around the world. As an example, one major pharmaceutical company was hearing from regulatory agencies that its case processing was far too inconsistent, resulting in gaps and errors in reports submitted to regulatory agencies. Apparently, the agencies were reacting to the companys widely varying processes for translating and routing data at case-handling centers around the world. Therefore, over

several months the company painstakingly constructed a master-tracking system with one set of uniform global standards for capturing, translating and routing data on adverse events. With the companys new master-tracking system, data on adverse events can now be keyed directly into the database at the point of entry anywhere the company operates, replacing paper forms that often had to be photocopied and mailed to regional offices for data entry, which only increased the risk of human error. The company expects to handle almost 200,000 adverse event reports every year with its new master-tracking system, which went live in September 2011. The system incorporates several work-saving features. For example, it can determine automatically if an adverse event involving one of the companys 15 best-selling products has already been described on the products label and package inserts, or if this event is unexpected. Such automated case reporting should increase data accuracy and consistency, according to system developers. Many decisions about adverse events cannot occur automatically but must be made by physicians and other experts within a company. Here, too, the companys new master-tracking system represents progress because easierto-read computer screens will help experts review and assess data. Other improvements include a work-routing feature to allow everyone who needs to know about an adverse event to see relevant data in the proper time frame and sequence. Like many other master-tracking systems now being installed by pharmaceutical companies interviewed for this white paper, this one companys system will ultimately deliver better service and higher satisfaction to regulatory agencies and customers.

Most of the experts cited in this paper believe that the use of third-party providers will increase over the next several years. This comes as no surprise considering that the global pharmaceutical industry was one of the earliest adopters of outsourcing for information technology and back-office processing. Much of the outsourcing currently taking place falls into the transactional bucket: data entry, intake, imaging, coding, case processing for non-serious cases, periodic reporting on older products, literature searches, and report and submission publishing. Processes that are higher up in the value chain, such as narrative writing and call center activities, are currently being outsourced by some pharmaceutical companies; however, they insist that these activities be handled by service providers whose staff have the same cultural background and native language skills as the service recipients. Some PV professionals believe that other, less transactional processes, such as the technical aspects of signal detection, may be outsourced in the near future. Other experts believe that certain tasks currently being outsourced will soon be brought back in-house or transferred to domestic service providers. These tasks include assembling aggregate safety reports or conducting higher-level scientific tests required for the medical assessment of critical cases. Undoubtedly, PV professionals will continue to change their mix of outsourced and in-house processes to meet changing needs.

Social media: Whats next?

Social media sites such as Facebook, PatientsLikeMe and Web MD may provide PV groups with a wealth of information that has previously been unavailable or impossible to obtain. This information, if accessed and analyzed appropriately, may complement traditional sources of information for PV groups. On the other hand, many PV professionals fear that the booming popularity of social media sites may prompt regulatory agencies to require that PV groups increase their surveillance of online activity related to on-market drugs, which will further drain the groups resources and increase their reporting obligations.

Outsourcing: Challenges old and new

The outsourcing of services continues to challenge PV professionals. Certain companies interviewed for this white paper still will not outsource any of their processes. Other companies, particularly smaller firms with narrow product portfolios and limited budgets, outsource practically every PVrelated task to third-party providers and retain only a handful of top-level physician reviewers in-house.

To anticipate future requirements from government agencies, groups like the Pharmacovigilance Expert Network, a subgroup within the Association of the British Pharmaceutical Industry (APBI), has been advocating that companies not wait for legislative or regulatory mandates on social media but instead develop procedures for analyzing data from noncompany-sponsored websites. These procedures can be recorded in documents that will become part of a companys PV risk management plan and can be produced during a pharmacovigilance inspection.

to enhance signal detection procedures in large databases include predictive modeling, clustering, link analysis and deviation detection, among others. At the same time, PV groups intent on using data mining have found themselves locked in a slow dance with government agencies just as intent on moving cautiously. In a 2005 set of guidelines, for example, the U.S. Department of Health and Human Services emphasized that the use of data mining techniques is not a required part of signal identification or evaluation. If data mining results are submitted to the U.S. FDA, they should be presented in the larger appropriate clinical content, which would include descriptions of the database and data mining tool being used, along with a careful assessment of individual case reports and other relevant safety information related to the particular drug-event combination of interest. As yet another example, one major company plans to lead its industry in the area of pharmacogenetics, which is the study of the genetic variations between individuals that may pre-dispose people to respond differently to medicines. Accordingly, this company is talking regularly with the FDA and EMA about how this and other monitoring mechanisms might be applied during the development, registration and pharmacovigilance of medicines. As the quest for improvement continues, new sources of data and new techniques for analysis will surely be identified and exploited by those PV professionals seeking to lead their companies and the entire industry into the future.

Uncovering new sources of data and methods for analysis

In their belief that PV must continually evolve, many leaders in the field are pushing the boundaries of their profession to develop new sources of data. One company is actively developing novel technologies for the purpose of accessing anonymised data obtained from the use of medicines in clinical practice. Information captured systematically in electronic patient records, says the company, could help identify a potential association between a side effect and a particular medicine or combination of medicines, by making it easier to compare side effects between patients who have and have not taken the medicines. As another example, several PV groups have been exploring the use of data mining and signal detection. These groups are seeking more sophisticated statistical approaches for automating the data analysis process, primarily because they can no longer afford to take days or weeks to analyze data if they wish to aggressively identify and manage emerging safety risks. The use of data mining and signal detection is well established during post-market surveillance. Its a relatively new concept to use advanced statistical methods to see and understand potential signals at earlier stages in the drug development process, such as during clinical trials. Data mining shows great promise to many PV professionals because it uses computerized algorithms to identify hidden patterns of unexpected occurrences in large databases. Such methods may assist PV groups with the task of screening huge numbers of drug-event combinations in databases for potential signals. The data mining tools now being developed

Gaining new allies and power for PV

For years, PV professionals have generally shouldered their burdens alone. But in many companies, the growing importance and even prestige of PV is starting to be noticed. Professionals in the areas of manufacturing and supply chain, for example, have long understood that many of the issues which ultimately become adverse events have their origins in the raw materials and the processes used in manufacturing, and during packaging, storage and transport. To prevent these and other risks, say many manufacturing and supply chain experts, shouldnt they have a permanent place on the risk management teams traditionally populated by PV, Development and Regulatory Affairs? While some PV professionals may object to the prospect of increased

interference from outsiders, other PV experts say the potential benefits of such cooperation may be well worthwhile if PV gains new and useful allies. Allies within a company have already been a vital support to many PV professionals interviewed for this white paper. One major pharmaceutical company recently wanted to set up an offshore delivery center for PV, but quickly realized that such a center would require too much overhead for the PV group to build and manage on its own. Outsourcing loomed as a likely solution. Yet by itself, the PV group was too small and underfunded to attract the attention of outsourcing providers with the full range of services that was needed for the project. This PV group turned to a consulting firm, which suggested a unique solution: Join with other groups within your company who want to improve their processes and save money through outsourcing. Guided by the consulting firm, the head of PV embarked on some intense politicking and soon found two interested allies: Global Discovery and the IT group that supported both PV and Global Discovery. With this approach, the PV head was able to gain the trust of these allies because his solution was viewed as having no hidden agenda and little, if any, bias toward PV. The three allies had very different objectives and operational strategies. Nonetheless, they agreed to join together to search for an outsourcing provider who could offer a full range of services they all needed. Because they brought so much business to the table they attracted several competitors. Once they chose one, the consulting firm originally hired by PV was able to structure a deal that benefited all three groups without unduly limiting their flexibility. In the future, for example, any one of the three groups can terminate its participation with the outsourcing provider without affecting the arrangements for the other two.

Cross-company forums and requirements

Many of the PV professionals consulted for this white paper are showing increasing interest in touching base with their peers at what one expert calls brainstorming think-tank type forums, despite the risk of revealing sensitive or confidential information. In response to this growing interest, many thirdparty consulting firms are establishing independent forums, either online or face-to-face, where professionals can share their experiences and address the mutual challenges required to develop and deploy drug-safety strategies within their companies. Such brainstorming between one competitor and another may become as necessary to all as it is now desirable to some. Currently, for example, information systems available to pharmaceutical or biotech companies employ a wide range of different data sources, each with their own data structure and mode of presentation. PV professionals worry that such diversity among the data sources hinders their integration, and may hamper the complete understanding of the information they contain. If the whole point of PV is signal detection, opines one expert, what is to prevent regulatory agencies from someday requiring that pharmaceutical companies submit their data in ways that will enable a regulatory agency to quickly and easily connect the dots between adverse events occurring with the products of one company and those of another companys products? For this reason, among many others, cooperation among PV groups that reaches across company lines like think-tank forums for cross-company brainstorming may become inescapable. With all the solutions they are uncovering and exploring, PV professionals are making huge progress in addressing the one issue they openly cite as the single most common PVrelated mistake made by organizations today: Not investing as much as they should in their pharmacovigilance programs. Organizations clearly gain a strategic advantage when they are the first to be aware of any safety problems with their products. A pharmacovigilance department is like an alarm system, says one expert. You can do without one, or you can have a cut-rate system. But what are the consequences if you are not warned?

About the authors

As Director for Management Consulting, Vicki Phelan understands the pain points of pharmaceutical and life sciences organizations as they are driven by continued healthcare reform and regulatory pressures. She has been instrumental in leveraging shared services and outsourcing to help organizations meet stringent cost reduction demands, access talent and best practices, take technological leaps, and face the new economic realities of drug development. Vicki has been influential in the expansion and maturing of outsourcing to include such areas as R&D, pharmacovigilance, regulatory affairs, real estate and clinical data management. Vicki joined KPMG with the acquisition of EquaTerra in February 2011. For more information on these topics presented, please contact Vicki at +1 609 304 1030 or A Managing Director for Management Consulting, Charles Arnold has spent nearly 20 years studying the management of information technology and business processes as both a service provider and as an advisor. He is a respected consultant to senior executives on service delivery methodologies, the ever-changing service provider landscape, and managing client engagements to improve the business value of SG&A support functions. Charles played a key role in an industry-first agreement between a pharmaceutical firm and a service provider to move never-before-outsourced functions into a new leveraged delivery model. Previously, Charles was Managing Director at EquaTerra, which KPMG acquired in February 2011. Prior to EquaTerra, Charles was the co-founder and COO of InSource Partners, which was acquired by EquaTerra in 2005. He also worked at Fourth Floor Consulting, EDS, and Northern Trust Company. Charles holds a bachelors degree from Harvard University. For additional discussion, Charles can be reached at: +1 773 960 8991 or

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