Few areas in pharma can benefit more from a top ten list than that of pharmacovigilance (PV). Ongoing developments in areas like E2B formats, potential FDA tome requirements, data-mining, DSM Boards needs, Eudravigilance, and EDI gateways have made the world a complex and challenging place for PV professionals today. In that context, a top 10 list devoted to pharmacovigilance can be of great service, either as a planning tool – for those wondering how to respond to these challenges – or as an internal check-up – for those looking to make a mid-course correction. So here’s my top 10 tips related to pharmacovigilance. It is my way of organizing the PV world into an action list.

1.THINK PAPERLESS

Yes, ‘paperless’ can be a cliché, but within clinical development, it is more and more of a reality. EDC systems collect data at sites without paper case report forms. Field monitors produce trip reports ‘online’ within their company’s clinical trial management system. The same reports are reviewed and signed electronically by management. On the back-end of the clinical process, data managers and even medical monitors are reviewing the data with online tools that provide sorting, graphing and searching capabilities. Yet in the PV world, case processing still consists of piles of folders, passed physically from one desk to another. Red folders for ‘hurry’; blue folders for ‘no hurry’; the whole scene could come from an office in the 1950s. Searching the files of vacationing colleagues for needed documents is a typical story that only magnifies the sense of deja vu. It is ironic that today’s adverse events systems allow electronic routing of cases, scanning and storage of external documents and other capabilities that make the folders obsolete. Yes, you can still print a document or a listing as a working copy, but the official record remains within the validated, secure system. The technology supporting this is mature and ready to be used.

2. START MEASURING

Let’s face it, measuring takes time that many of us are not prepared to spare. How many cases do you process in a year? How many people do you need to do this? What is your average number of follow-ups to get a case closed? Is this number good or bad? How do you know? Before you go to your boss to ask for that new system or those additional headcounts, it would be good to know how well you are doing with what you have now. Metrics by one PV organization claim to handle over 1,000 cases per year per FTE, while 250 cases per year per FTE is given as the ‘industry benchmark’. If 1,000 is the upper bound and 250 is the mean, we know there has to be a lower bound out there somewhere. Can you imagine a company where only 100 cases per year per FTE are done? Can you then imagine the differing workflows and data flows that produce a four-fold, or even a 10-fold, difference in efficiency? Where do you fit into this scheme? Your boss should ask you these questions before she signs up for more money or headcount.

3. BROADEN YOUR VIEW OF E2B

In today’s pharma landscape, marketing rights for a product can be divided across multiple companies, countries, indications and even categories of healthcare providers. One marketing partner may end up with the general practitioner market segment for a single indication across the Nordic countries and the UK, while five other companies will divide up the rest of the market across the EU, the US and Japan. Such marketing agreements, while presumably advantageous from a sales perspective, produce multiple, overlapping ICSR reporting responsibilities for the PV professionals at each company. How can a PV professional meet the interlocking demands for receiving and sending ICSR’s across so many partners for a single product?

One answer lies in looking beyond E2B as a means of reporting to health authorities, and to consider the use of both the common format and the gateway functionality to communicate with marketing partners. System vendors have promoted this for years, but several years later the typical sponsor is still struggling just to use the gateway to communicate with authorities. Many of you will know that the so-called E2B or ESTRI gateway is built on an electronic data interchange (EDI) format that is used by thousands of companies (including pharma companies) to process millions of transactions each year with their customers and supply partners. Yet, even in 2007, the number of ICSRs transmitted via a gateway is still measured in mere thousands, and the vast majority of these are between sponsors and agencies. Inter-partner exchange is still dominated by PDF attachments and retyped data. E2B and the gateway offer a new and better way forward.

4. STOP CHECKING THE CHECKERS

Many PV processes are still marked by the idea that ‘checking and rechecking’ equals quality. One process I encountered produced the following workflow:

• ICSRs are printed out by clerical staff for medical monitors to review

• Medical monitors redline the ICSRs and send them back for data entry

• Clerical staff make the changes, reprint the ICSRs, and send both copies back to the medical monitor

• The medical monitor then checks to make sure the corrections have been ‘correctly’ made.

Such ideas of ‘quality’ ignore the fundamental advances made in this area by people like Edward Deming and movements like TQM. Quality is now understood to be a good process followed by trained professionals. Gone are the days when we start searching for problems at the end of the assembly line. The same needs to happen within your organization’s processes.

5. LOOK BEYOND REPORTING

In many PV organizations, the main focus of departmental work, and even departmental goals, remains satisfying regulatory deadlines for reporting. Did we meet the expedited targets? Are all the annual updates filed on time? Such a view minimizes the potential value of pharmacovigilance to the larger organization, and contributes to the view that PV professionals mainly push paper around for a living.

What do your data tell you about the profile of your company’s products? What ideas do your data generate about potential new studies? How can they inform on-going protocols? Getting things filed on time remains essential, but it is no longer sufficient. There are more ways to add value, and forward-looking PV departments are finding ways to move beyond it.

6. KEEP A DUAL FOCUS

While most of your staff are immersed in the specifics of each case, making sure to respond to PV work on time, it means that someone in your group needs to be looking at the bigger picture. Where are the cases coming from? Are these numbers in balance with market share data? Are incident frequencies giving us clues we should pay attention to? Is this bigger picture review a stated part of your process? If so, which role is doing this? My repeated impression when visiting PV operations is that they are very busy, they focus on detail, and are under pressure to get cases and reports done and ‘out the door’. Without planned, allocated time to review, consider and contemplate the big picture, an important part of the PV function is being missed.

7. MAXIMIZE THE BENEFITS OF YOUR SYSTEM

How much of your adverse event system are you actually using? It is amazing to find duplicate functionally being maintained by PV departments outside of the AE system. The most common example of this is tracking spreadsheets. Even though most adverse event systems have tracking and timing mechanisms that can display the status and timelines of cases, these features go unused in favor of a spreadsheet. Another common culprit is reporting systems. Some departments have built complete, parallel databases in MS Access to run reports. Data get double loaded, or even double entered, so that summary reports on the data can be used. The AE system’s own reporting capabilitiesare ignored, or simply not trusted. If this sounds like your situation, fixing this may become the number one idea on this list. Ignored functionality means more cost, more training, more risk and a lousy thing to admit when your boss is quizzing you on your budget increase requests.

8. UPDATE YOUR STANDARDS

The words ‘SAE reconciliation’ generate a universal response across the industry and the response is not necessarily a good one. Reconciliation is an ongoing job that creates burdens for both clinical data managers and PV professionals. The better news is that both sides now have a dominant standard: SDTM 3.x for the data managers and DTD 2.x for PV departments. The use of these standards can facilitate reconciliation by providing consistent, predictable relationships between the two domains. Automated reconciliation can become better than ever by capitalizing on this consistency across all clinical trials.

9. GOOGLE YOUR DATA

The buzzword is data-mining and it refers to sophisticated single detection capabilities run against large amounts of data. Drug interactions and event interactions are some of the key outcomes being produced. Data-mining, however, is heavy duty, technical stuff compared to case processing, with a very different tool set and a demand for

expertise that may go beyond the capabilities of your current staff and your IT support. It is, however, a big part of the future of pharmacovigilance and the sooner you get started the better.

10. START COMPARING

No, I don’t mean just comparing your operations with other companies; I mean comparing yourself against yourself. Contrary to widely held views, there is more value in knowing how much better (or worse!) you are getting over time, as compared to merely knowing whether you are keeping up with your neighbors. PV departments across the industry are organized and staffed quite differently, with big differences in their technology infrastructures as well. Some companies have large, centralized operations, while others, often due to mergers and other corporate history, are dispersed and decentralized, even using different legacy AE systems. So comparing yourself with the guy over the fence may be unhelpful and even misleading.

Much more valuable is both knowing and measuring the impact of your own improvement efforts. You bought that tool and rebuilt that process last year. Has it made a difference? Was the difference worth the cost? These are the real signals of process improvement. You can still trade stories with your PV colleagues at the DIA conference. Just don’t confuse that with measuring progress.