General Characteristics of the RADARS System
|
Rate calculations
|
Unique Recipients of Dispensed Drug (URDD) or population, per quarter or year, by Program
|
|
Reporting frequency to subscribers
|
Quarterly, more frequently by request
|
|
Publications
|
19 publications in peer reviewed journals and 45 abstracts presented at scientific conferences.
--View complete Publication list
|
|
Signal determination methodology
|
Rate thresholds of 2- or 5- cases per 100,000 population
Conditionally autoregressive (CAR) statistical model with Bayesian hierarchical model specification (under development)
|
|
Geographic specificity
|
3-digit ZIP code of patient or case
Coverage of 876 of 930 3-digit ZIP codes in the nation (94%)
|
|
Product Specificity
|
Drug class (e.g. buprenorphine, fentanyl, oxycodone, hydrocodone, methylphenidate, morphine) and specific product (e.g. Suboxone®, Concerta®, Kadian®)
|
|
Quality Assurance
|
· Document development and change control
· Implementation of Standard Operating Procedures (SOPs) for all Programs
· Quality control steps including data entry verification, data validation, data verification, and final report verification
· Database controls including validation, central database internal system data validation, database backup and disaster recovery processes, and audit trails
· Electronic systems controls including security and data transmission
· Corrective action processes
· Quality audits and monitoring including database quality audits, monitoring visits at Program sites, internal audits, and contractor audits
· Training program and documentation for all RADARS System staff
· Central database 21 CFR part 11 compliant
|
Characteristics of Individual Programs
|
|
Drug Diversion
|
Key Informant (KI incorporated into SKIP 4Q2008)
|
Poison Center
|
Opioid Treatment
|
Impaired Health Care Workers
|
Survey of Key Informants’ Patients
|
College Survey
|
|
Population
|
Cases of prescription drug diversion
|
Clinicians, epidemiologists, treatment counselors and other experts in substance abuse in a position to know about emerging drug abuse problems in their areas
|
Young children
Adolescents
Young Adults
Adults
Elderly
|
Opioid dependent treatment seekers entering methadone maintenance (public & private)
|
Early adopters to newly available pharmaceutical controlled substances
|
Patients of Key Informants who are seeking treatment
|
College students, recent initiates
|
|
Definition/
Type of Cases
|
Number of new instances of pharmaceutical diversion reported to or investigated by diversion units or regulatory boards
|
Use to get high or use as a substitute for other drugs of abuse as reported by health care professionals
|
Spontaneous reports of cases of acute medical events
|
Self-reported use to get high in last 30 days
|
Self-reported health care workers, cases investigated by regulatory agencies, or patients of impaired health care programs identified in any of the programs
|
Self-reported use to get high in last 30 days
|
Self-reported non-medical use in previous semester
|
|
Coverage
|
300 reporters from 50 states
|
196 reporters from 46 states |
44 states, 84% of US population covered
|
75 programs from 33 states and 28,239 questionnaire responders
|
As a subset of the other programs, coverage reflects that of the other programs
|
1557
questionnaire responders from 44 states
|
2,000 questionnaire responders from 50 states each semester
|
|
Reporting Timeframe
|
3 months
|
3 months
|
1 week
|
1 week
|
3 months
|
1 week
|
Semester/
Summer
|
|
Initiation of Data Collection for Trending Over Time
|
2002-Present
|
2002-2008
|
2003-Present
|
2005- Present
|
2007-Present
|
2008-Present
|
2008-Present
|