Rate calculations

Unique Recipients of Dispensed Drug (URDD) or population, per quarter or year, by Signal Detection System

Reporting frequency to subscribers

Quarterly, more frequently by request

Publications

17 publications in peer reviewed journals and 39 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 Signal Detection Systems

·      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 Signal Detection System sites, internal audits, and contractor audits

·      Training program and documentation for all RADARS System staff

·      Central database 21 CFR part 11 compliant

Drug Diversion

Key Informant

Poison Center

Opioid  Treatment Programs

Impaired Health Care Workers

Survey of Key Informants’ Patients

College Survey

Population

Cases of prescription drug diversion

Cases of prescription drug abuse as reported by treatment facilities

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 substance abuse treatment providers

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 SDSs

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, 83% of US population covered

75 programs from 33 states and 25,646 questionnaire responders

As a subset of the other SDSs, coverage reflects that of the other SDSs

400 questionnaire responders from 25 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

Initiation of Data Collection for Trending Over Time

2002

2002

2003

2005

2007

2008

2007