Pharmaceutical product liability lawsuits are notoriously large and represent a major threat to the commercial success of new medications for years after they are introduced. There are new tools available to manage and reduce those risks.

Pre-approval research provides information to assure the Food and Drug Administration (FDA) that a new product is safe and effective. Based on the relatively small size of the test panel, the data argues for no more than relative safety, enough safety to justify approval for general use.

Post-approval research using conventional research methods is expensive and almost impossible to cost justify. The rapidly evolving availability of fully networked, cloud based Electronic Health Record (EHR) systems such as Practice Fusion is changing the economics.

As doctors are diagnosing and e-prescribing medication, both the diagnosis and the prescription are now captured in the doctor’s EHR. This is just a normal part of the doctor’s practice in lieu of historical paper notes and hand-written prescriptions. On subsequent visits, the doctor will review the patient’s medications and current conditions and will note progress effectiveness, or side-effects, real or potential risks. A change to a different medication can also signal concern about safety or relative effectiveness, any of these flags should be of interest to a manufacturer.

As use of the product continues to grow, the database will also grow. Analysts can now focus on specific groups of patients and still have statistically significant sample sizes. Are there characteristics about the patients whose doctors note side effects or change their prescription to another medication that suggest a need for new labeling or more detailed research? Is there a future lawsuit in the data?

Control groups composed of comparable patients can be developed based on the same set of EHR records—a form of virtual control group. This group can be much larger to assure statistical significance for almost all potential benchmarks for comparison with the test panel. Is the incidence of comparable medication emergencies higher, similar or perhaps even lower, among patients taking the target medication? Is there evidence of significant improvement or at least a slower rate of onset?

The data for both users and the control group is now being collected as part of the normal practice of thousands of physicians. The data is available with no additional cost for collection. There are of course costs for processing and analysis but those are small enough that pharmaceutical risk managers and their insurance companies should be assessing the cost for better health IT information data relative to the potential cost of future lawsuits.

Actual damages provide the basis for lawsuits but punitive damages are often a large part of the final settlement. Early indicators of potential damages offer opportunities to demonstrate concern for patient safety and thereby reduce or avoid punitive damages.

“We didn’t know about the risk,” is no longer a defense, if it ever was one.