PVmaps® is the data mining technology underlying ProSanos' Safety Products and
Services for Spontaneous Reporting System (SRS) Data. ProSanos clients have
access to PVmaps through our CLÆRITY®
software for signal investigation. PVmaps detects drug/event combinations occurring
at higher-than-expected frequencies in SRS data, and generates an intuitive,
two-dimensional presentation of the data. Each PVmap is supported by a table of
detailed statistical results for in-depth investigation. Available PVmaps include:
- Drug-focused PVmap Example
What
are the significant safety signals for a given drug?
- Trajectory PVmap Example
Has
a safety signal become more significant over time?
- Event-focused PVmap Example
What
drugs are most highly associated with a specific adverse event?
- Potential Interactions PVmap Example
What
other drugs are co-prescribed frequently when a drug / adverse event combination
of interest occurs?
- Comparative PVmap Example
How
do the safety profiles of two similar drugs compare?
- Potential Syndromes PVmap
What other events occur
frequently when a drug / adverse event combination of interest occurs?
- Related Events PVmap
What other events frequently
occur at the same time as an event of interest?
- Co-prescribed Drugs PVmap
What other drugs are highly
co-prescribed with a given drug?
About the PVmap of Interest Program
Through its MedWatch program the FDA receives spontaneous adverse drug event
reports from manufacturers as required by regulation, as well as voluntary reports
from health care professionals and consumers. These reports become part of a
large clinical database (the Adverse Event Reporting System or AERS Database)
which is publicly released quarterly. For more information or to obtain the AERS
data itself, please visit the FDA AERS website.
To illustrate the drug-safety investigative
capabilities of PVmaps, ProSanos has initiated a program to present a limited
set of PVmaps generated from the AERS database. On
a regular basis, we will post case studies focusing on current topics of discussion
within the industry. ProSanos is providing this information solely for illustrative
and discussion purposes. No reliance on this information for other purposes is
anticipated or authorized. For more information about PVmaps or the PVmap of the
Week program, .
Disclaimers
- Potential risks highlighted by drug safety analysis must be balanced against
the clinical benefit attained by the use of a pharmaceutical product in a given
clinical situation. Nothing in these analyses is intended to influence the
practice of medicine, nor to weigh the benefits of one product over another.
- Whether the reporting ratio of an adverse event is high enough to influence the
decision to use a given product or products can only be determined by a complete
analysis of the benefits, risks, and therapeutic alternatives.
- Use of the publicly available FDA AERS data does not imply endorsement or
agreement of the findings by the FDA Center for Drug Evaluation and Research.
- There are many factors that can influence how the adverse events are reported
in the AERS database and may impact the resulting safety signal. These include but
are not limited to: publicity and media attention, litigation, length of time drug
is on the market, whether the event in question has been previously attributed
to the drug, the source of the report, etc.
- AERS data must often be "cleaned" prior to analysis. This process may include
de-duplication, reconciliation of misspelled product names, mapping of adverse
events terms, and other manipulations which could introduce bias into the analysis.
- PVmaps has been evaluated as a safety signal investigation tool for over two years.
