Baxter Healthcare Corporation has two separate and important functions to monitor the Safety and Quality of the BioScience Products:
These groups work together in order to:
If a patient experiences an adverse event (a “side effect”), this will be reported to GPV where a team of physicians, nurses, pharmacists, and scientists are continuously monitoring the safety of all BioScience products. While “side effects” may be expected when any drug is given, GPV is always looking to ensure that there is no significant change in the safety of the product or whether new populations might be at particular risk, for example children or the elderly. Each adverse event report is processed by a GPV safety professional who works to make sure that the information is as complete as possible. This information is then forwarded to a safety physician for evaluation; immediate action is taken when required. These cases are also reported to regulatory agencies worldwide. In addition, once a month the GPV safety physicians review all reports as a team to determine if any further safety issues need to be addressed. GPV works closely with the Post Market Surveillance group to ensure that adverse events were not due to a problem with the quality of the product. Finally, GPV interacts with other Baxter teams, as well as external partners, to ensure that the products are being used correctly by the healthcare community.
The figure below outlines the process that GPV uses in reviewing reports of adverse events:
The Baxter quality organization is actively involved in the quality assessment of all medical adverse events as well as non-medical complaints. Using established procedures, adverse events are investigated by Global Quality Safety Assessment (GQSA) and non-medical complaints by the Global Product Distribution Surveillance (GPDS) teams.
The GQSA team collaborates closely with the Global Pharmacovigilance group in investigating adverse events. The following illustration describes the workflow for the investigation of adverse events:
