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Published in: European Journal of Pediatrics 6/2007

Open Access 01-06-2007 | Original Paper

Drug related problems and off-label drug treatment in children as seen at a drug information centre

Authors: Elin Kimland, Ulf Bergman, Synnöve Lindemalm, Ylva Böttiger

Published in: European Journal of Pediatrics | Issue 6/2007

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Abstract

The aim of this work was to analyse the characteristics of Questions and Answers (Q&As) at a drug information centre (DIC) regarding drug related problems and off-label drug treatment in children. All questions concerning children 15 years or younger at a DIC in Stockholm, Sweden during the years 1995–2004 were analysed with respect to the main drug related problem, drug/s and drug group/s, whether the drugs were licensed or not, pediatric labelling of the drug/s and age and sex of the patient. Q&As were classified as whether or not they included evaluated literature information, adding to the labelling of the drugs. We identified 249 Q&As concerning pediatric drug treatment. Each question addressed an average of 1.5 drugs. More than two-thirds of the Q&As concerned adverse drug reactions and pediatric drug choice or dosing. Every second question was classified as off-label, psychotropic drugs being the most common. In half of all off-label Q&As, pediatric documentation on drug efficacy and safety outside the Swedish catalogue of medical products was found. Most Q&As concerned newborns and infants. However, the off-label proportion among questions was highest in adolescence as well as the evaluated literature information, adding to the labelling of the drugs. It was thus found that off-label drug treatment is common among pediatric questions at a DIC. This service can provide additional literature based information contributing to a safer use of drugs in children. There is still, however, a substantial need for clinical documentation of drug use in children.
Literature
1.
go back to reference Addis A, Impicciatore P, Miglio D, Colombo F, Bonati M (1995) Drug use in pregnancy and lactation: the work of a regional drug information centre. Ann Pharmacother 29:632–633PubMed Addis A, Impicciatore P, Miglio D, Colombo F, Bonati M (1995) Drug use in pregnancy and lactation: the work of a regional drug information centre. Ann Pharmacother 29:632–633PubMed
2.
go back to reference Alván G, Öhman B, Sjöqvist F (1983) Problem oriented drug information: a clinical pharmacological service. Lancet 2:1410–1412PubMedCrossRef Alván G, Öhman B, Sjöqvist F (1983) Problem oriented drug information: a clinical pharmacological service. Lancet 2:1410–1412PubMedCrossRef
3.
go back to reference Bramness GJ, Hausken AM, Sakshaug S, Skurtveit S, Rønning M (2005) Prescription of selective serotonin reuptake inhibitors 1990–2004. Tidsskr Nor Laegeforen 125:2470–2473 [in Norwegian]PubMed Bramness GJ, Hausken AM, Sakshaug S, Skurtveit S, Rønning M (2005) Prescription of selective serotonin reuptake inhibitors 1990–2004. Tidsskr Nor Laegeforen 125:2470–2473 [in Norwegian]PubMed
4.
go back to reference Clavenna A, Bonati M, Rossi E, De Rosa M (2004) Increase in non-evidence based use of antidepressants in children is cause for concern. BMJ 328:711–712PubMedCrossRef Clavenna A, Bonati M, Rossi E, De Rosa M (2004) Increase in non-evidence based use of antidepressants in children is cause for concern. BMJ 328:711–712PubMedCrossRef
5.
go back to reference Committee on Safety of Medicines (2006) Use of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents with major depressive disorder (MDD). Medicines and Healthcare products Regulatory Agency (MHRA), UK. Available at: http://www.mhra.gov.uk. Cited 01 March 2006 Committee on Safety of Medicines (2006) Use of selective serotonin reuptake inhibitors (SSRIs) in children and adolescents with major depressive disorder (MDD). Medicines and Healthcare products Regulatory Agency (MHRA), UK. Available at: http://​www.​mhra.​gov.​uk. Cited 01 March 2006
6.
go back to reference Conroy S (2002) Unlicensed and off-label drug use. Pediatr Drugs 4:353–359 Conroy S (2002) Unlicensed and off-label drug use. Pediatr Drugs 4:353–359
7.
go back to reference Easton LK, Colin BC, Brien JE (2004) Frequency and characteristics of hospital admissions associated with drug-related problems in paediatrics. Br J Clin Pharmacol 57:611–615PubMedCrossRef Easton LK, Colin BC, Brien JE (2004) Frequency and characteristics of hospital admissions associated with drug-related problems in paediatrics. Br J Clin Pharmacol 57:611–615PubMedCrossRef
8.
go back to reference Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS (2005) Off-label prescribing to children: attitude and experience of general practitioners. Br J Clin Pharmacol 60:145–149PubMedCrossRef Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS (2005) Off-label prescribing to children: attitude and experience of general practitioners. Br J Clin Pharmacol 60:145–149PubMedCrossRef
9.
go back to reference Elwin CE (1981) Trimethoprim- sulphamethoxazole during pregnancy. Experience of a follow-up of a register at a drug information centre. In: Nordbring F, Burman LG (eds) Urinary tract infections: current aspects of pathogenesis, prognosis and trimethoprim-sulphametoxazole therapy: proceeding of a Wellcome foundation symposium held in Stockholm, March 29–30,1979. Almqvist & Wiksell International, Stockholm, pp 109–115 Elwin CE (1981) Trimethoprim- sulphamethoxazole during pregnancy. Experience of a follow-up of a register at a drug information centre. In: Nordbring F, Burman LG (eds) Urinary tract infections: current aspects of pathogenesis, prognosis and trimethoprim-sulphametoxazole therapy: proceeding of a Wellcome foundation symposium held in Stockholm, March 29–30,1979. Almqvist & Wiksell International, Stockholm, pp 109–115
10.
go back to reference FASS (2004) The Swedish catalogue of medical products, 1995–2004. LIF, Stockholm, Sweden FASS (2004) The Swedish catalogue of medical products, 1995–2004. LIF, Stockholm, Sweden
11.
go back to reference Impicciatore P, Choonara I (1999) Status of new medicines approved by the European medicines evaluation agency regarding paediatric use. Br J Clin Pharmacol 48:15–18PubMedCrossRef Impicciatore P, Choonara I (1999) Status of new medicines approved by the European medicines evaluation agency regarding paediatric use. Br J Clin Pharmacol 48:15–18PubMedCrossRef
12.
go back to reference Impicciatore P, Choonara I, Clarkson A, Provasi A, Pandolfini C, Bonati M (2001) Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 52:77–83PubMedCrossRef Impicciatore P, Choonara I, Clarkson A, Provasi A, Pandolfini C, Bonati M (2001) Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 52:77–83PubMedCrossRef
13.
go back to reference Jonville-Béra AP, Béra F, Autret-Leca E (2005) Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study. Eur J Clin Pharmacol 61:231–236PubMedCrossRef Jonville-Béra AP, Béra F, Autret-Leca E (2005) Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study. Eur J Clin Pharmacol 61:231–236PubMedCrossRef
14.
go back to reference Kasilo O, Romero M, Bonati M, Tognoni G (1988) Information on drug use in pregnancy from the viewpoint regional drug information centre. Eur J Clin Pharmacol 35:447–453PubMedCrossRef Kasilo O, Romero M, Bonati M, Tognoni G (1988) Information on drug use in pregnancy from the viewpoint regional drug information centre. Eur J Clin Pharmacol 35:447–453PubMedCrossRef
15.
go back to reference Lyrvall H, Nordin C, Jonsson E, Alvan G, Ohman B (1993) Potential savings of consulting a drug information centre. Ann Pharmacother 27:1540PubMed Lyrvall H, Nordin C, Jonsson E, Alvan G, Ohman B (1993) Potential savings of consulting a drug information centre. Ann Pharmacother 27:1540PubMed
16.
go back to reference Madsen H, Andersen M, Hallas J (2001) Drug prescribing among Danish children: a population-based study. Eur J Clin Pharmacol 57:159–165PubMedCrossRef Madsen H, Andersen M, Hallas J (2001) Drug prescribing among Danish children: a population-based study. Eur J Clin Pharmacol 57:159–165PubMedCrossRef
17.
go back to reference Martin RM, Wilton LV, Mann RD, Steventon P, Hilton SR (1998) General practitioners prescribe SSRIs to children off-label. BMJ 317:204PubMed Martin RM, Wilton LV, Mann RD, Steventon P, Hilton SR (1998) General practitioners prescribe SSRIs to children off-label. BMJ 317:204PubMed
18.
go back to reference Öhman B, Lyrvall H, Törnqvist E, Alván G, Sjöqvist F (1992) Clinical pharmacology and the provision of drug information. Eur J Clin Pharmacol 42:563–568PubMedCrossRef Öhman B, Lyrvall H, Törnqvist E, Alván G, Sjöqvist F (1992) Clinical pharmacology and the provision of drug information. Eur J Clin Pharmacol 42:563–568PubMedCrossRef
19.
go back to reference Öhman B, Lyrvall H, Alván G (1993) Use of Drugline—a question and answer database. Ann Pharmacother 27:278–284PubMed Öhman B, Lyrvall H, Alván G (1993) Use of Drugline—a question and answer database. Ann Pharmacother 27:278–284PubMed
20.
go back to reference Pandolfini C, Bonati M (2005) A literature review on off-label drug use in children. Eur J Pediatrics 164:552–558CrossRef Pandolfini C, Bonati M (2005) A literature review on off-label drug use in children. Eur J Pediatrics 164:552–558CrossRef
21.
go back to reference Sanz EJ, Bergman U, Dahlstrom M (1989) Paediatric drug prescribing. A comparison of Tenerife (Canary Islands, Spain) and Sweden. Eur J Clin Pharmacol 37:65–68PubMed Sanz EJ, Bergman U, Dahlstrom M (1989) Paediatric drug prescribing. A comparison of Tenerife (Canary Islands, Spain) and Sweden. Eur J Clin Pharmacol 37:65–68PubMed
22.
go back to reference Schwartz S, Stoelben S, Ebert U, Siepmann M, Krappweis J, Kirch W (1999) Regional drug information service. Int J Clin Pharmacol Therap 37:263–268 Schwartz S, Stoelben S, Ebert U, Siepmann M, Krappweis J, Kirch W (1999) Regional drug information service. Int J Clin Pharmacol Therap 37:263–268
23.
go back to reference Serreau R, Le Heuzey MF, Gilbert A, Mouren MC, Jacqz-Aigain E (2004) Unlicensed and off-label use of psychotropics medications in French children: a prospective study. Paediatr Perinatal Drug Ther 6:14–19CrossRef Serreau R, Le Heuzey MF, Gilbert A, Mouren MC, Jacqz-Aigain E (2004) Unlicensed and off-label use of psychotropics medications in French children: a prospective study. Paediatr Perinatal Drug Ther 6:14–19CrossRef
24.
go back to reference Straand J, Rokstad K, Heggedal U (1998) Drug prescribing for children in general practice. A report from the More and Romsadal prescription study. Acta Paediatr 87:218–224PubMedCrossRef Straand J, Rokstad K, Heggedal U (1998) Drug prescribing for children in general practice. A report from the More and Romsadal prescription study. Acta Paediatr 87:218–224PubMedCrossRef
25.
go back to reference Temple ME, Robinson RF, Miller JC, Hayes JR, Nahata MC (2004) Frequency and preventability of adverse drug reactions in paediatric patients. Drug Saf 27:819–829PubMedCrossRef Temple ME, Robinson RF, Miller JC, Hayes JR, Nahata MC (2004) Frequency and preventability of adverse drug reactions in paediatric patients. Drug Saf 27:819–829PubMedCrossRef
26.
go back to reference ‘tJong G, van der Linden P, Bakker E, van der Lely N, Eland I, Stricker B, van den Anker J (2002) Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 58:293–297CrossRef ‘tJong G, van der Linden P, Bakker E, van der Lely N, Eland I, Stricker B, van den Anker J (2002) Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 58:293–297CrossRef
27.
go back to reference Ufer M, Rane A, Karlsson Å, Kimland E, Bergman U (2003) Widespread off-label prescribing of topical but not systemic drugs for 350,000 paediatric outpatients in Stockholm. Eur J Clin Pharmacol 58:779–783PubMed Ufer M, Rane A, Karlsson Å, Kimland E, Bergman U (2003) Widespread off-label prescribing of topical but not systemic drugs for 350,000 paediatric outpatients in Stockholm. Eur J Clin Pharmacol 58:779–783PubMed
28.
go back to reference Ufer M, Kimland E, Bergman U (2004) Adverse drug reactions and off-label prescribing for paediatric outpatients a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Saf 13:147–152PubMedCrossRef Ufer M, Kimland E, Bergman U (2004) Adverse drug reactions and off-label prescribing for paediatric outpatients a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Saf 13:147–152PubMedCrossRef
30.
go back to reference Yaffe SJ, Aranda JV (eds) (2005) Neonatal and pediatric pharmacology: therapeutic principles in practice, 3rd edn. WB Saunders, Philadelphia Yaffe SJ, Aranda JV (eds) (2005) Neonatal and pediatric pharmacology: therapeutic principles in practice, 3rd edn. WB Saunders, Philadelphia
Metadata
Title
Drug related problems and off-label drug treatment in children as seen at a drug information centre
Authors
Elin Kimland
Ulf Bergman
Synnöve Lindemalm
Ylva Böttiger
Publication date
01-06-2007
Publisher
Springer-Verlag
Published in
European Journal of Pediatrics / Issue 6/2007
Print ISSN: 0340-6199
Electronic ISSN: 1432-1076
DOI
https://doi.org/10.1007/s00431-006-0385-8

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