Catalogo Articoli (Spogli Riviste)

OPAC HELP

Titolo:
Drug use and adverse event monitoring in German children
Autore:
Lewis, MA; Kuhl-Habich, D; von Rosen, J;
Indirizzi:
EPES Epidemiol Pharmacoepidemiol & Syst Res, D-12165 Berlin, Germany EPES Epidemiol Pharmacoepidemiol & Syst Res Berlin Germany D-12165 rmany Univ Kansas, Dept Prevent Med, Kansas City, KS USA Univ Kansas Kansas City KS USA as, Dept Prevent Med, Kansas City, KS USA Univ Surrey, Dept Hlth & Primary Care, Surrey, England Univ Surrey Surrey England y, Dept Hlth & Primary Care, Surrey, England
Titolo Testata:
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
fascicolo: 11, volume: 39, anno: 2001,
pagine: 507 - 512
SICI:
0946-1965(200111)39:11<507:DUAAEM>2.0.ZU;2-5
Fonte:
ISI
Lingua:
ENG
Keywords:
drug utilization; children; drug safety; adverse event monitoring;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
7
Recensione:
Indirizzi per estratti:
Indirizzo: Lewis, MA EPES Epidemiol Pharmacoepidemiol & Syst Res, Wulffstr 8, D-12165Berlin, Germany EPES Epidemiol Pharmacoepidemiol & Syst Res Wulffstr 8 Berlin Germany D-12165
Citazione:
M.A. Lewis et al., "Drug use and adverse event monitoring in German children", INT J CL PH, 39(11), 2001, pp. 507-512

Abstract

Objective: To assess drug use and the incidence of mild to moderate adverse drug effects (A-E) in children aged 0-16 years, with 2 different approaches. Methods: kll 185 pediatric practices in the State of Brandenburg, Germany, were surveyed (95% positive response). A random sample of 50 practices servicing 36,000 children participated in the study as sentinel physicians reporting any AE among their patients. Twenty practices servicing 14,000 children were included in a drug utilization component (DUC) which documenteddiagnoses, prescribing and AE in all children seen in a 3-month period. Results: The results on the DUC are based on 12,628 children with 26,168 physician contacts, 34,465 diagnoses and 33,140 drug prescriptions given to 85%of the children seen (average age: 6.7 years). Practice size ranged from 94 to 1473 children seen in a 3-month period. The average number of physician contacts per child was 2.1, with 10% seeing a physician 5 times and more. The diagnoses were respiratory ailments (30%), skin- (12%), injection- (11%) and trauma- (10%) related diagnoses. Major drug uses were respiratory (34% of prescriptions), anti-infective (22%), dermatological (13%), gastrointestinal (9%) and psychotropic agents (8%). One hundred and fifty-two AE affecting 150 children were documented in the DUC, 60% of these occurring within 3 days after treatment initiation. 83% of AE were mild (up to 4 on a scale from 1-6), and 85% were considered by physicians to be attributable. Only 4 reports of very severe events were received. 47% of reports were related to antibiotic uses, 31% to immunizations, 11% to respiratory, and 4% to gastrointestinal agents. While there are no differences in the occurrence ofA-E by gender, A-E decreases significantly by age, maintaining the same patterns of AE type and causative medication. Over a 3-month period, the incidence of mild to moderate ADR in children given medications is estimated as1,2100 per 100,000, or about 1%. Conclusions: Underreporting of AE remainsan issue even when a monitoring scheme suggests compliance. The results ofthis study show that while A-E in children are generally non-serious, 1% of treatments might elicit mild AE leading to a consultation. Direct practice recording produces more reports than a sentinel system.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 11/07/20 alle ore 14:34:20