SYSTEM AND METHOD FOR SURVEILLANCE AND EVALUATION OF SAFETY RISKS ASSOCIATED WITH MEDICAL INTERVENTIONS
Certain embodiments described herein relate to systems and methods used to estimate safety-related risks associated with the use of medical products, treatments, and interventions (e.g., drugs, vaccines, medications, dietary supplements, and medical devices). More particularly, the present description relates to a method and system for estimating the risk (e.g., using a safety risk score, ranking, designation, estimate, or the like) associated with the use of an individual medical intervention.
1 . A system for estimating a safety profile for a medical intervention for a patient, the system comprising:
a memory configured to store multiple safety-related parameters derived from safety-related information for the given medical intervention; and
a processor coupled to the memory and operable to execute programmed instructions stored in the memory, wherein the programmed instructions are configured to:
assign an individual value for one or more of the safety-related parameters; and
output a safety related score for the medical intervention from the one or more individual values.
2 . The system according to claim 1 , wherein the medical intervention is a pharmacological intervention.
3 . The system according to claim 2 , wherein the safety related score is a single number.
4 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding Patient Outcome, or globally comparable term, from a safety or adverse event database.
5 . The system according to claim 1 , wherein the safety-related parameters comprises data regarding Adverse Event Seriousness, or globally comparable term, from a safety or adverse event database.
6 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding one or more disproportionality measures, or other related mathematical comparison, calculated from data in a safety or adverse event database.
7 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding a Condition Seriousness, or globally comparable, classification from a safety or adverse event database.
8 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding a Report Type, or globally comparable, classification from a safety or adverse event database.
9 . The system according to claim 1 , wherein the individual value comprises an Importance Weighting factor component.
10 - 11 . (canceled)
12 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding a drug Schedule, or globally comparable, classification.
13 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding a Medication Guide, or globally comparable, classification.
14 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding a Boxed Warning, or globally comparable, classification.
15 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding post-marketing safety information associated with the drug, medication, dietary supplement, or medical device.
16 . The system according to claim 1 , wherein the safety-related parameters comprise data regarding pre-marketing safety information associated with the drug, medication, dietary supplement, or medical device.
17 . The system according to claim 1 , wherein the safety related parameters comprise data from an adverse event, or related safety, database for drugs.
18 . The system according to claim 1 , wherein the safety-related parameters comprise data from one or more pharmacovigilance centers.
19 . (canceled)
20 . The system according to claim 18 , wherein the data has been subjected to a filtering protocol.
21 . The system according to claim 20 , wherein the filtering protocol is configured to perform one or more tasks selected from the group consisting of: automated name matching to correct for drug name misspellings and incorrect data; aggregation of generic and non-United States brand name drugs under a single brand name; separation of primary suspect and all suspect designations; removal of duplicate case reports; and identification of common adverse event and condition types.
22 . The system according to claim 1 , wherein the system is configured to output a safety related score for two or more medical interventions.
23 . The system according to claim 22 , wherein the two or more medical interventions are medical interventions that treat the same condition.
24 . (canceled)
25 . A method for estimating a safety profile for a medical intervention for a patient, the method comprising:
(a) inputting an identifier of the medical intervention into a safety profile estimating system comprising:
a memory configured to store multiple safety-related parameters derived from safety-related information for the given medical intervention; and
a processor coupled to the memory and operable to execute programmed instructions stored in the memory, wherein the programmed instructions are configured to:
assign an individual value for one or more of the safety-related parameters; and
output a safety related score for the medical intervention from the one or more individual values; and
(b) obtaining from the safety profile estimating system a safety related score for the medical intervention.
26 - 48 . (canceled)
49 . A system for filtering data from a pharmacovigilance center database, the system comprising:
a memory configured to store data from a pharmacovigilance center database; and
a processor coupled to the memory and operable to execute programmed instructions stored in the memory, wherein the programmed instructions are configured to:
filter the data according to a filtering protocol, wherein the filtering protocol is configured to perform one or more tasks selected from the group consisting of: automated name matching to correct for drug name misspellings and incorrect data; aggregation of generic and non-United States brand name drugs under a single brand name; separation of primary suspect and all suspect designations; removal of duplicate case reports; and identification of common adverse event and condition types; and
output a filtered dataset.
50 - 52 . (canceled)