Science and Law
20th May 2013

5 Tips for Lawyers Using Adverse Event Reporting

When dealing with pharmaceutical litigation, it is critical for litigators to be familiar with the process of adverse event (AE) reporting as well as much of the terminology. As we discussed in a prior post, having a detailed understanding of the relevant terms and processes can be the difference between a good and bad outcome in the courtroom.

5 Tips for Lawyers Using Adverse Event Reporting

This article was authored by John Clark, MD,MSPH , who provides expertise to ISS in litigation involving pharmacovigilence and adverse event reporting. Dr. Clark has consulted with corporations and defense counsel on mass tort and complex litigation for the past three decades. He has worked with individual clients and industry groups on some of the country’s largest and most prominent pharmaceutical issues management. Dr. Clark is the President and Chief Medical Officer at PCSglobala pharmaceutical, biotechnology and medical device industries consulting company specializing in risk-reduction services.

 


When dealing with pharmaceutical litigation, it is critical for litigators to be familiar with the process of adverse event (AE) reporting as well as much of the terminology. As we discussed in a prior post, having a detailed understanding of the relevant terms and processes can be the difference between a good and bad outcome in the courtroom.

In this post, I provide an overview of the following relevant safety reporting concepts that can sometimes appear to present a safety problem that is not really there!

  • Adverse event report (AER)
  • Product quality report (PQR)
  • Individual case safety report (ICSR)
  • Health hazard evaluation (HHE)

Companies are required to submit two different kinds of reports that pertain to safety.  AERs are reports that are sent to pharmaceutical companies by providers or consumers.  They contain information about AEs that a patient or consumer experienced while taking a pharmaceutical product.  AERs that are sent on to health agencies are referred to as individual case safety reports (ICSRs).  Product quality reports (PQRs) are reports that are sent to pharmaceutical companies by manufacturing personnel, pharmacists, consumers and, occasionally, non-pharmacist providers.  They contain information about product abnormalities that can range from unacceptable appearance (e.g., product discoloration) to inappropriate product content (e.g., insufficient active ingredient).

Pharmaceutical companies screen both types of information for signals.  Signals that are located by examining AERs are called safety signals.  Signals that are located by examining PQRs are called health hazard evaluations (HHEs).

Some of the most difficult safety situations for pharmaceutical companies arise when a signal shows up in both AERs and PQRs.  That is, the signal appears to be a manufacturing problem that is also associated with medical consequences.  A good example of such a “double signal” involved Johnson and Johnson consumer products that had a musty-moldy smell.  According to many of the consumers who reported this PQR problem, the bad smell was also associated with severe gastrointestinal symptoms.

However, a careful trend analyses later showed that the musty-moldy smell was not temporally associated with the reported symptoms but rather with publicity surrounding product recalls.  In this instance the PQR signal was a true positive, but the AER signal turnedout to be a false positive.

PQR-AER “double signals” are becoming more common, and can be difficult to analyze.  I recommend the following 5 pointers to lawyers litigating cases that involve the evaluation of both PQRs and AERs:

  1. Carefully examine the reporting trends over time for both the PQRs and the AERs.  If the two signals are not clearly related to each other using time tests, it suggests that any proposed relationship is actually due to something else, such as adverse publicity.
  2. When benchmarking either an AER or a PQR signal make sure that the comparator reports used for the benchmarking have been selected in the same way that the AERs or PQRs have been selected. Many purported differences between signals and a background benchmark are actually apples to oranges comparisons (i.e., the background benchmark reports were selected in a different way than were the AERs and PQRs in the signal).
  3. Make sure that any medical conclusions regarding a PQR signal are made by a medically qualified analyst.
  4. Encourage the signal evaluator to use the AER and PQR dictionaries in ways that can demonstrate a robust relationship between PQRs and AERs.  For example, establishing such a relationship may require the evaluator to group and compare in a medially coherent way.
  5. Develop an assessment rating system with written criteria for the ratings that will meet the expectations of regulators, but will also allow medical personnel to provide a rating that accurately expresses their opinion.

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