Transparency in Medical Records is Critical for Accurate Pharmacovigilance, a Case Study

Zvi Herschman , Founding Member, ISOP Israel, Jerusalem, Israel (
Consultant in Toxicology New York City Poison Control Center, NY, NY, USA
Forensic Consultant, Jerusalem, Israel

In the course of investigating an unexpected event leading to the death of a patient in a large medical center, the issue of whether a drug and series of drugs were administered became central.  The initial copy of the chart supplied by the hospital had a list of the medications dispensed in its pharmacy section of the electronic medical record. Upon review of the record it became apparent that the record was tampered with and the supplied chart was not only incomplete but forged. Clinical notes did not support all the drugs given, adverse effects were not noted, medical and nursing notes were missing for days or shifts of treatment, and the observations of witnesses did not support the clinical notes.  Further investigation revealed that the guiding hand for the tampering was the individual assigned to head the Risk Management department at the medical center.  The government agency responsible for regulating this sector has not enforced its mandate to compel the institution to supply the complete and truthful records, to present an action plan for its own investigation and evaluate how the entire discipline of Risk Management in the medical sector must be addressed for full compliance with established law. 

Worldwide, pharmacovigilance as a key element of Medical Risk Management has been ascendant. However, the entire enterprise is grounded in the idea that the source information for vigilance is transparent and true. When Risk Management is interpreted to mean that history is changed so as to make a sentinel event not have occurred, our mission is in danger of failing. The serious question we must face is how are we to bring the needed safety changes to the field of Medicine if our source information is less than reliable. If the management of risk is tainted by an ethic of subterfuge, then our job is much more complex than simple policy innovations for safety; we must dedicate efforts to enlist the active, useful, participation of government regulatory agencies and the legal system to insure that our stock in trade- transmission of true, reliable and evaluable medical information-is guaranteed and unimpeded.

Abstract Reference & Short Personal Biography of Presenting Author
Zvi Herschman, MD

is Founding Member, ISOP Israel; Jerusalem, Israel;   Consultant in Toxicology New York City Poison Control Center, NY, NY, USA; Forensic Consultant, Jerusalem, Israel

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