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RADARS System Presents to the FDA On August 4, 2008, Richard C. Dart, M.D., Ph.D., Executive Director of
the RADARS System traveled to Washington, DC, to present an overview of the
RADARS System to approximately 40 employees of the U.S. Food and Drug
Administration (FDA). Attendees included employees from the Office of
Surveillance and Epidemiology, the Division of Anesthesia, Analgesia and
Rheumatology, and Controlled Substances. The presentation provided regulatory
officials with a better understanding of the RADARS System and its signal
detection systems, with examples of research that can be performed using
RADARS System data, and with an overview of the quarterly RADARS System data
provided to pharmaceutical companies as part of their risk management
reporting obligations to the FDA. “This was an excellent
opportunity to present the RADARS System to the FDA. It was important to show
examples of RADARS System data and to show how pharmaceutical companies can,
and are, using these data to fulfill their regulatory obligations,” said Dr. Richard
C. Dart. “I look forward to working more closely with the FDA to understand
current regulations and ensure that the RADARS System adapts to the changing
regulatory environment.” As part of the presentation, Dr. Dart showed how RADARS System data are
useful for identifying trends during each stage of the drug dependence
pathway prior to remission, which includes five stages:
opportunity, use, abuse, and dependence. When monitoring a specific
medication, it is important for the manufacturer to track its product in a
variety of populations who may be at risk for drug dependence; this enables
the company to develop appropriate interventions. The graphic below demonstrates how the signal detection systems monitor
various populations along the drug dependence pathway.
Sources: Chilcoat HD,
Johanson CE. Vulnerability to Cocaine Abuse. Higgins ST,
Ed. Cocaine Abuse: Behavior,
Pharmacology, and Clinical Applications. San Diego, CA:
Academic Press; 1998: 313-341. Institute of Medicine – Committee on
Opportunities in Drug Abuse Research. Pathways
of Addiction. Washington, DC:
National Academy Press; 1996. |
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Effective
Interventions Needed to Prevent Nonmedical Pediatric Exposures to Opioid
Medications While
national surveys such as the 2006 Monitoring the Future continue to identify
prescription drug abuse as a major public health concern for adolescents, few
sources for information on prescription drug abuse and its effects on young
children exist. The RADARS System captures detailed data for
all age groups and recently conducted a study to understand the impact of
prescription opioid abuse on young children. The Under Recognized
Toll of Prescription Opioid Abuse on Young Children analyzed all
pediatric exposures, intentional and unintentional/other, as reported to the Poison
Center Signal Detection System. These exposure reasons capture data on
both the administration of a drug to a child by an adult, therapeutic errors,
and other events where a child came in contact with a medication while
exploring the home environment, among other reasons During the
study period (January 2003—June 2006), 9,240 exposure mentions to opioid
medications in children under the age of six were identified, with the median
age of exposure being two years. Nearly all of the exposures involved
unintentional ingestions occurring within the child’s home and eight
exposures resulted in death. “The volume of pediatric exposures involving prescription opioids is
alarming. In just three-and-a-half-years, more than nine thousand kids came
in contact with a prescription opioid medication, and most exposures occurred
in their own home,” commented Richard C. Dart, MD, PhD, Executive
Director of the RADARS System. “Understanding how children come in contact
with prescription medications is the first step in developing interventions
to safeguard children from medications found in households across the
nation.” This study was
conducted by the RADARS System in an ongoing effort to conduct research for
the benefit of the scientific community and the general public. The Under
Recognized Toll of Prescription Opioid Abuse on Young Children has been
accepted for publication in the Annals of Emergency Medicine. Prescription Opioid Exposures by Known
Outcome in Children Under the Age of Six: Data from RADARS System Poison Centers January 2003—June 2006
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RADARS
System Launches its Seventh Signal Detection System: A Survey of College Students The RADARS System has successfully launched the College
Survey Signal Detection System. The seventh signal detection system surveys
self-identified college students enrolled in two- or four- year programs nationwide.
The survey is conducted via an online
questionnaire completed at the end of fall and spring semesters/quarters and
at the end of the summer. The RADARS System began collecting data from this signal detection
system during the summer of 2008. |
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RADARS
System Summary of Characteristics The RADARS System has completed a table of characteristics which
summarizes the main data collection elements of the entire system and has
also created a table outlining the characteristics of each signal detection
system. This provides potential and current subscribers with an easy
reference about the RADARS System. Please visit the RADARS
System Characteristics page. General Characteristics of the RADARS System
Characteristics of Individual Signal Detection Systems (SDS)
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Recent
RADARS System Publications and Presentations · Bailey JE, Campagna E,
Dart RC, Reporting for the RADARS System Poison Center Group. The Under Recognized Toll of Prescription
Drug Abuse on Young Children. Annals of Emergency Medicine. In Press. · Hays BD, Klein-Schwartz
W, Doyon S. Toxicity of Buprenorphine
Overdoses in Children. Pediatrics. 2008; 121: 782-786. · Kirtland MN, Lemon S,
Bailey JE, Dart RC. Effectiveness of a Poison Center Intervention on Product
Coding. 2008 North American Congress of Clinical Toxicology. September, 2008. · Kirtland MN, Bailey JE,
Dart RC. Prescription Opioid Associated Death Rates Using RADARS System Data.
American Academy of Addiction Psychiatry Conference. December, 2008. · Montoya AM, Bailey
JE, Dart RC. Current Nonmedical Prescription Drug Use Among College Students:
Analysis of RADARS System Data. The American Academy of Addiction Psychiatry
Conference. December, 2008. |
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·
The National Association of State
Controlled Substances Authorities will host its annual meeting October
21-25 in Fort Lauderdale, Fla. Dr. Richard C. Dart of the RADARS System will
present, The Impact of Prescription Opioid Abuse on Young Children (<6 years
old): Report of Poison Center Data. ·
The International
Association for Pain and Chemical Dependency will host its annual meeting October 29 through November 1 in
Philadelphia, Pa. H. Westly Clark of the Center for Substance Abuse Treatment
will present, CSAT Report: A National
Assessment of Prescription Drug Abuse at the meeting. ·
The National Association of Drug Diversion
Investigators (NADDI) will hold its 19th annual conference on
November 11-14, 2008 in Nashville, Tenn. NADDI is a membership organization whose
members are responsible for investigating and prosecuting pharmaceutical drug
diversion. ·
The Food
and Drug Law Institute will host an Introduction to Drug Law
and Regulation: Understanding How the
FDA Regulates the Drug Industry November 20-21 in Washington, DC. · The American
Academy of Addiction Psychiatry will host its annual meeting December 4-7
in Boca Raton, Fla. Two RADARS System abstracts will be presented. |
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RADARS System
Mission Statement The RADARS System provides timely and
geographically-specific data to the pharmaceutical industry, regulatory
agencies, policymakers and medical/public health officials to aid in
understanding trends in the abuse, misuse, and diversion of prescription
drugs in the United States. |
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Rocky Mountain
Poison and Drug Center and Denver Health The RADARS System is a governmental nonprofit operation
of the Rocky Mountain Poison and Drug Center
(RMPDC), an agency of Denver Health
(DH). The RMPDC has been in operation for more than 50 years, making it one
of the oldest poison control centers in the nation. DH is the safety net
hospital for the City and County of Denver and is the Rocky Mountain region’s
academic Level I trauma center and includes Denver Public Health, Denver’s
911 emergency medical response system, nine family health centers, 12
school-based clinics, NurseLine, correctional care, Denver CARES, the Denver
Health Medical Plan, and the Rocky Mountain Center for Medical Response to
Terrorism, Mass Casualties and Epidemics.
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RADARS®
System § 777 Bannock Street § Mail Code 0180 § Denver, CO 80204 To
unsubscribe, please reply to this email with “unsubscribe” Questions or
comments? Email the RADARS System at radars@rmpdc.org |
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