What does this scene sound like? Thousands of pages being faxed from country to country. Papers being printed on multi-part forms and signed in ink by the boss. Pleading with programmers to prepare a basic report from your database. Dozens of people doing what a handful of people could do. Key information about where things are stored only in someone’s head. Everyone checking and re-checking each other’s work.

Does it sound like banking in the 1960’s? Does it sound like your typical office of the 1970’s? Does it sound like clinical data management in the 1980’s? Are you old enough to have experienced a workplace like this? Unfortunately, these examples are from the 21st century, and culled from a range of biopharmaceutical companies. Call it the last frontier: drug safety operations.

Let’s be clear up front, so the lawyers can all sit back down: we are not talking about a public safety issue in any way. What we are talking about is a question of internal business efficiency only: drug safety operations optimization. With all of the appropriate focus on operational cost reduction in pharma these days, one of the areas which too often remains untouched is drug safety – not because it doesn’t need to be more efficient, but because executives are afraid to go near it, for obvious reasons. And unless the safety executive is innovative enough to volunteer for process analysis and improvement, it will likely never be forced on them.

Scenes from the Wilderness

When we have looked at drug safety operations at different biopharmas, we are struck by the huge range in case load (i.e., number of adverse event cases processed per drug safety staff) – varying literally by an order of magnitude from one company to the next — ten times the personnel to handle a similar case load. These variations have not been found to be explained by the variables one might guess – therapeutic area complexity, geographic diversity, staff preparedness, stage of development, or any other obvious explanation. Instead, it is a direct result of inefficient case load processing and other process wastefulness.

You can still find this kind of over-staffing in some other pharma departments , like CDM (clinical data management) and even monitoring, where the company culture dictates that a surfeit of human effort will protect against error. But this is a concept most industries have long since rejected, mostly because they could not afford to hold on to it.

Some safety managers will still cry that they need more staff, not less. But except in the most unusual circumstances (perhaps a budding biotech), this is the time to examine process efficiencies before signing those personnel requisitions.

Why does this happen? Inefficient processes, lots of paper, lots of checking each other’s work, and, frankly, a lack of pressure or will to work differently. Just one example: a reported adverse event consists of 3-5 pages of source documents. At one company, processing this information causes the 5 pages to balloon to 250 pages, since every change to any piece of data requires a new printout of the whole case for the archive, no matter how trivial the modification. Moving, reviewing and storing this kind of paper load is obviously inefficient, especially when thousands of cases are processed each year.

Second-Guessing

Often we will see an atmosphere of “quality control” that borders on mistrust or job security: checking and re-checking each other’s work ’til the cows come home. This is also a direct tie to a dependency on paper, but it also speaks to culture. Several companies have developed “quality” into a punishing, mistrustful exercise, where I tell you what to check and then I check later if you checked it! Quality (and the concomitant protection of public health) is achievable without these multiple layers of cross-checking. This is something CDM has been addressing for years – all CDM departments have to some extent (or to a great extent) streamlined their quality control (i.e., discrepancy management) processes to reduce time, effort and resources. Thus they avoid what safety departments still experience: a physician who will only review a case off-line (on paper), who will mark up the paper copy with corrections to be made by clerical staff in the system requiring that the case be printed out again so the originating physician can see if the system change corresponds with the original mark-up!

We see lots of paper in places in drug safety where you would think paper is long gone – even though nearly every company has already bought safety software tools precisely to eliminate that paper! For instance, we see companies admirably learning how to do ICSR submissions via E2B (paperless, by definition) to regulatory authorities, but still find those exact same companies faxing thousands of the same cases from one country affiliate to another. Why are the advantages of E2B ignored, just because the recipient is not an agency? And what happens to those faxes? The data is entered again by hand into the receiving office’s (separate) software system, introducing new errors and starting a whole new cycle of quality control.

Finally, we also see safety-specific technology all around but we do not see the safety departments taking responsibility for using it well, the way data managers, for example, do in a CDM department using a CDMS or EDC. In safety, instead, we see departments that remain beholden to their IT departments, like all of us were in days of yore, waiting for simple reports to be programmed by programmers, even when the technology is simple enough to be used by safety staff themselves. Who is complicit in this arrangement? Is IT holding on to the feeling of being useful? Does drug safety simply not have the time and/or technical understanding to use the tools they bought? In the memorable words of one country safety officer, “I simply don’t trust my computer.” Charming, but intolerable in modern times.

What this all most resembles is CDM in the 1980’s. It is remarkable that drug safety can sometimes still exhibit these qualities. The fix for CDM was executive intolerance for the cost and delay which such behavior caused in clinical trials, and the increasing automation and professionalization of CDM itself. It brings to mind that perhaps the answer for drug safety optimization is similarly two-fold: an executive spotlight on the issue, and the creation of a “DSDM,” or Drug Safety Data Manager, role which, like the clinical data manager, services as the interface between the user and the technology (between clinical operations and IT, in CDM’s case). As overstaffed as some drug safety departments are, moving some selected staff into a DSDM role could help eliminate the extra unnecessary staff through process streamlining.

Meanwhile, don’t look to the safety application vendors as the answer to process optimization. Historically they have not offered enough help, proactively, at reasonable cost, with the big picture in mind. These are, after all, cultural problems first, process problems second, and ultimately a matter of will. The tools the vendor sell are fine and have been for years; safety departments need to use them fully, and as enablers of process efficiency. This is the sponsor’s responsibility, not the software vendor’s.

And so, it comes back to a willingness to change. No sponsor wants to face a situation where external pressure forces a function to become more efficient. The best solution is always to anticipate areas for improvement and pursue them proactively. Assuming a sponsor can examine itself objectively, then basic process analysis skills, combined with safety domain expertise, should enable sponsors to eliminate these safety operations inefficiencies.

In the story of human progress, frontiers are reached, breached and conquered. We may lament the passing of some frontiers (the Amazon, the Arctic, restrooms without cellphone conversations), but drug safety inefficiency is not one to be mourned. Saddle up and tame this frontier so biopharma’s dollars can be used to the greatest good.