Skip to main content
SpringerLink
Log in

Postmarketing Surveillance

  • Chapter
  • First Online:
Pediatric Clinical Pharmacology

Part of the book series: Handbook of Experimental Pharmacology ((HEP,volume 205))

Abstract

Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with a drug. The majority of postmarketing surveillance concern adverse drug reactions (ADRs) monitoring and evaluation. Other important postmarketing surveillance components include unapproved or off-label drug use, problems with orphan drugs, and lack of paediatric formulations, as well as issues concerning international clinical trials in paediatric population. The process of evaluating and improving the safety of medicines used in paediatric practice is referred to as paediatric pharmacovigilance. It requires special attention. Childhood diseases and disorders may be qualitatively and quantitatively different from their adult equivalents. This may affect either benefit or risk of therapies (or both), with a resulting impact on the risk/benefit balance. In addition, chronic conditions may require chronic treatment and susceptibility to ADRs may change throughout the patient’s lifetime according to age and stage of growth and development. Therefore, paediatric pharmacovigillance aspects need to be tailored to a number of variables based on heterogeneity of paediatric population. This chapter will summarize and discuss the key issues.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 389.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 499.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 499.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • Bate A, Lindquist M, Edwards IR (1998) A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 54:315–321

    Article  PubMed  CAS  Google Scholar 

  • Bücheler R, Schwab M, Mörike K et al (2002) Off label prescribing to children in primary care in Germany: retrospective cohort study. BMJ 324:1311–1312

    Article  PubMed  Google Scholar 

  • Chalumeau M, Treluyer J, Salanave B et al (2000) Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child 83:502–505

    Article  PubMed  CAS  Google Scholar 

  • Choonara I (2006) Paediatric pharmacovigilance. Paed Perinat Drug Ther 7:50–53

    Article  Google Scholar 

  • Cirko-Begovic A, Vrhovac B, Bakran I (1989) Intense monitoring of adverse drug reactions in infants and preschool children. Eur J Clin Pharmacol 36:63–65

    Article  PubMed  CAS  Google Scholar 

  • Clark RH, Bloom BT, Spitzer AR et al (2006) Reported medication use in the neonatal intensive care unit: data from a large national data set. Paediatrics 117(6):1979–1987

    Article  Google Scholar 

  • Conroy S, Choonara I, Impicciatore P et al (2000) Survey on unlicensed and off label drug use in paediatric wards in European countries. BMJ 320:79–82

    Article  PubMed  CAS  Google Scholar 

  • European Medicines Agency. Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indication (EMEA/CHMP/SWP/169215/2005), published 24.01.2008

    Google Scholar 

  • European Medicines Agency. Medicines for children. http://www.ema.europa.eu/pdfs/human/comp/29007207en.pdf. Accessed 27 Jan 27 2010

  • Evans SJW (2008) Stratification for spontaneous report databases. Drug Saf 31(11):1049–1053

    Article  PubMed  Google Scholar 

  • Evans SJW, Waller PC, Davis S (2001) Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 10(6):483–486

    Article  PubMed  CAS  Google Scholar 

  • Fortescue EB, Kaushal R, Landrigan CP et al (2003) Prioritizing strategies for preventing medication errors and adverse drug events in paediatric inpatients. Paediatrics 111:722–729

    Article  Google Scholar 

  • Garcia Rodriguez LA, Perez Gutthann S (1998) Use of the UK general practice research database for pharmacoepidemiology. Br J Clin Pharmacol 45:419–425

    Article  PubMed  CAS  Google Scholar 

  • Gijsen R, Jochemsen H, vanDijk L et al (2009) Frequency of ill-founded off-label prescribing in Dutch general practice. Pharmacoepidemiol Drug Saf 18:84–91

    Article  PubMed  Google Scholar 

  • Grégoire MC, Finley A (2007) Why were we abandoned? Orphan drugs in paediatric pain. Paediatr Child Health 12(2):95–96

    PubMed  Google Scholar 

  • Haffner ME (2006) Adopting orphan drugs – two dozen years of treating rare diseases. N Engl J Med 354:445–447

    Article  PubMed  CAS  Google Scholar 

  • Haffner S, von Laue N, Wirth S et al (2005) Detecting adverse drug reactions on paediatric wards: intensified surveillance versus computerised screening of laboratory values. Drug Saf 28(5):453–464

    Article  PubMed  Google Scholar 

  • Hartford CG, Petchel KS, Mickail H et al (2006) Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines. Drug Saf 29(8):657–673

    Article  PubMed  Google Scholar 

  • Horen B, Montastruc JL, Lapeyre-Mestre M (2002) Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 54:665–670

    Article  PubMed  Google Scholar 

  • Impicciatore P, Choonara I, Clarkson A et al (2001) Incidence of adverse drug reactions in paediatric in/out-patients: a systemic review and meta-analysis of prospective studies. Br J Clin Pharmacol 52:77–83

    Article  PubMed  CAS  Google Scholar 

  • International Conference on Harmonisation (ICH) (2000) Topic E 11: clinical investigation of medicinal products in the paediatric population. http://www.europa.emea.eu./pdfs/human/ich/271199EN.pdf

  • Johann-Liang R, Wyeth J, Chen M et al (2009) Paediatric drug surveillance and the food and drug administration’s adverse event reporting system: an overview of reports, 2003–2007. Pharmacoepidemiol Drug Saf 18:24–27

    Article  PubMed  Google Scholar 

  • Kaushal R, Bates DW, Landrigan C et al (2001) Medication errors and adverse drug events in paediatric inpatients. JAMA 285:2114–2120

    Article  PubMed  CAS  Google Scholar 

  • Kearns GL, Abdel-Rahman SM, Alander SW et al (2003) Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med 349(12):1157–1167

    Article  PubMed  CAS  Google Scholar 

  • Kimland E, Rane A, Ufer M et al (2005) Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharmacoepidemiol Drug Saf 14:493–499

    Article  PubMed  Google Scholar 

  • Kimland E, Bergman U, Lindemalm S et al (2007) Drug related problems and off-label drug treatment in children a seen at a drug information centre. Eur J Pediatr 166:527–532

    Article  PubMed  Google Scholar 

  • McIntyre J, Conroy S, Avery A et al (2000) Unlicensed and off-label prescribing of drugs in general practice. Arch Dis Child 83:498–501

    Article  PubMed  CAS  Google Scholar 

  • Meyboom RH, Egberts AC, Edwards IR et al (1997) Principles of signal detection in pharmacovigilance. Drug Saf 16(6):355–365

    Article  PubMed  CAS  Google Scholar 

  • Mühlbauer B, Janhsen K, Pichler J et al (2009) Off-label use of prescription drugs in childhood and adolescence. Dtsch Arztebl Int 106(3):25–31

    PubMed  Google Scholar 

  • Neubert A, Dormann H, Weiss J et al (2006) Are computerised monitoring systems of value to improve pharmacovigilance in paediatric patients? Eur J Clin Pharmacol 62(11):959–965

    Article  PubMed  Google Scholar 

  • Nunn T, Williams J (2005) Formulation of medicines for children. Br J Clin Pharmacol 59(6):674–676

    Article  PubMed  Google Scholar 

  • O’Donnell CP, Stone RJ, Morley CJ (2002) Unlicensed and off-label drug use in an Australian intensive care unit. Paediatrics 110:e52

    Article  Google Scholar 

  • Pandolfini C, Binati M (2005) A literature review on off-label drug use in children. Eur J Pediatr 164:552–558

    Article  PubMed  Google Scholar 

  • Roberts R, Rodriguez W, Murphy D et al (2003) Paediatric drug labeling. Improving the safety and efficacy of pediatrc therapies. JAMA 290(7):905–911

    Article  PubMed  Google Scholar 

  • Sanz E, Boada J (1987) Adverse drug reactions in paediatric outpatients. Int J Clin Pharmacol Res 7:169–172

    PubMed  CAS  Google Scholar 

  • ‘tJong GW, Eland IA, Strukenboom MC et al (2002) Unlicenced and off-label prescription of drugs to children: population based cohort study. BMJ 324:1313–1314

    Article  Google Scholar 

  • Turner S, Nunn AJ, Fielding K et al (1999) Adverse drug reactions to unlicensed and off label drugs on paediatric wards: a prospective study. Acta Paediatr 88(9):965–968

    Article  PubMed  CAS  Google Scholar 

  • 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 13:47–152

    Article  Google Scholar 

  • Wong I, Murray ML (2005) The potential of UK clinical databases in enhancing paediatric medication research. Br J Clin Pharmacol 59(6):750–755

    Article  PubMed  Google Scholar 

  • World Health Organization Guideline (2007) Promoting safety of medicines for children. www.who.int/medicines/publications/essentialmedicines/Promotion_safe_med_childrens.pdf

Download references

Author information

Authors and Affiliations

  1. Department for Clinical Pharmacology, University of Rijeka Medical School, University Hospital Center Rijeka, Krešimirova 42, 51000, Rijeka, Croatia

    Vera Vlahović-Palčevski

  2. Paul-Ehrlich-Institut, Referate Arzneimittelsicherheit, Paul-Ehrlich-Str. 51-59, 63225, Langen, Germany

    Dirk Mentzer

Authors
  1. Vera Vlahović-Palčevski
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Dirk Mentzer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vera Vlahović-Palčevski .

Editor information

Editors and Affiliations

  1. Klinik für Kinder- und Jugendmedizin, Univ.Klinikum Marburg, Baldingerstr. 12, Marburg, 35043, Germany

    Hannsjörg W. Seyberth

  2. Karolinska Institutet, Dept. Laboratory Medicine, Karolinska University Hostpital, Stockholm, 141 86, Sweden

    Anders Rane

  3. für Klinische Pharmakologie (IKP), Dr. Margarete Fischer-Bosch Institut, Auerbachstr. 112, Stuttgart, 70376, Germany

    Matthias Schwab

Rights and permissions

Reprints and permissions

Copyright information

© 2011 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Vlahović-Palčevski, V., Mentzer, D. (2011). Postmarketing Surveillance. In: Seyberth, H., Rane, A., Schwab, M. (eds) Pediatric Clinical Pharmacology. Handbook of Experimental Pharmacology, vol 205. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-20195-0_17

Download citation

Publish with us

Policies and ethics

Search

Navigation