Off-label use of drugs in Italy: A prospective, observational and multicentre study

Acta Paediatrica, International Journal of Paediatrics

Volumn 91, Issue 3, 2002, Pages 339-347

  Pandolfini, C ^a   Impicciatore, P ^a   Provasi, D ^a   Rocchi, F ^a   Campi, R ^a   Bonati, M ^a   Cattaneo, Maria Grazia ^a   Cornelli, Pieremilio ^a   Mirabile, Lorenzo ^a   Raffaelli, Maria Pia ^a   Sonzogni, Walter ^a   Taddei, Giancarlo ^a   Tellarini, Laura ^a   Bagarolo, Nuccia ^a   Cordiano, Luisella ^a   Pedrini, Antonella ^a   Rampazzo, Roberta ^a   Zorzi, Carlo ^a   Chiarelli, Francesco ^a   Mohn, Angelika ^a   De Donno, Valeria ^a   Favetta, Silvia ^a   Pietraru, Clara ^a   Poggio, Lorena ^a   Vivani, Paola ^a   Monina, Giovanna ^a   Primi, Ambrogina ^a   Coppini, Angela ^a   Di Pietro, Pasquale ^a   Gusmano, Rossana ^a   Mastrangioli, Alessandra ^a   Panetta, Eleonora ^a   Perfumo, Francesco ^a   Rossi, Rossella ^a   Amato, Cristina ^a   Giaretto, Giovanni ^a   Marone, Isabella ^a   Rocatti, Laura ^a   Serravalle, Paolo ^a   D'Andrea, Nicola ^a   Lardo, Giuseppina ^a   Marchetti, Federico ^a   Mencoboni, Maria Cristina ^a   Taccardi, Rosanna ^a   Ferrarese, Annalisa ^a   Joppi, Roberta ^a   Temporin, Gianfranco ^a   more..

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

Children; Drug labelling; Italy; Multicentre study; Off label drug use

Indexed keywords

ANALGESIC AGENT; ANESTHETIC AGENT; ANTACID AGENT; ANTIASTHMATIC AGENT; ANTICONVULSIVE AGENT; ANTIDIARRHEAL AGENT; ANTIHISTAMINIC AGENT; ANTIINFECTIVE AGENT; ANTITUSSIVE AGENT; BECLOMETASONE; CARDIOVASCULAR AGENT; CHOLINERGIC RECEPTOR BLOCKING AGENT; CORTICOSTEROID; NEUROLEPTIC AGENT; PARACETAMOL; VITAMIN;

ANALGESIA; ANTIBACTERIAL ACTIVITY; ARTICLE; ASTHMA; BRONCHOSPASM; CHILD; CLINICAL OBSERVATION; CLINICAL TRIAL; DOSE RESPONSE; DRUG FORMULATION; DRUG INDICATION; DRUG LABELING; DRUG QUALITY; DRUG USE; EVIDENCE BASED MEDICINE; FEMALE; FEVER; HUMAN; INFANT; ITALY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRESCRIPTION; PRIORITY JOURNAL; RESPIRATORY TRACT DISEASE; RESPIRATORY TRACT INFECTION; TREATMENT INDICATION;

CHILD; CHILD, PRESCHOOL; DRUG APPROVAL; DRUG LABELING; DRUG UTILIZATION; DRUGS, NON-PRESCRIPTION; FEMALE; HOSPITALIZATION; HUMANS; INFANT; ITALY; MALE; PRESCRIPTIONS, DRUG; PREVALENCE; PROSPECTIVE STUDIES; QUALITY OF HEALTH CARE; RISK ASSESSMENT; RISK FACTORS;

EID: 0142199047     PISSN: 08035253     EISSN: None     Source Type: Journal    
DOI: 10.1080/08035250252834030     Document Type: Article

References (33)

1. Licensing of medicines
2. Normativa e linee guida internazionali sulla sperimentazione clinica in ambito pediatrico
3. Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use
4. Frequency and appropriateness of drug prescribing for unlabeled uses in pediatric patients
5. Use of "off-label" and unlicensed drugs in paediatric intensive care unit
6. Pediatric drug therapy in the emergency department: Does it meet FDA-approved prescribing guidelines?
7. Unlicensed and off-label drug use in paediatric wards: Prospective study
8. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: A prospective study
9. Unapproved and off-label use of drugs in a children's hospital
10. Unlicensed and off-label drug use in paediatric wards in different European countries
11. Unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel
12. Unregistered and off-label drug use in Australian paediatric inpatients
13. Therapeutic orphans
14. Pharmacogenetics and development: Are infants and children at increased risk for adverse outcomes?
15. The incidence of prescriptions without marketing product license in a neonatal intensive care unit
16. Unlicensed and off label drug use in neonates
17. The role of inhaled corticosteroids in children with asthma
18. Effect of inhaled corticosteroids on episodes of wheezing associated with viral infection in school age children: Randomised double blind placebo controlled trial
19. Inhaled corticosteroids in childhood asthma: Growing concerns
20. Use of unlicensed drugs may be recommended in guidelines
21. International Agranulocytosis and Aplastic Anemia study. Risk of agranulocytosis and aplastic anemia. A first report of their relation to drug use with special reference to analgesics
22. Paediatric prescribing: Using unlicensed drugs and medicines outside their licensed indications
23. Intellectual property, drug licensing, freedom of information and public health
24. Pediatric drug formulations: Challenges and potential solutions
25. Cloralio idrato sciroppo: Valutazione della stabilità per l'attribuzione della data di scadenza
26. Register of clinical trials in children must be set up
27. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients
28. Closing the gap in drug therapy