Dunne J, Rodriguez WJ, Murphy MD, Beasley BN, Burckart GJ, Filie JD, et al. Extrapolation of adult data and other data in pediatric drug-development programs. Pediatrics. 2011;128(5):e1242-1249.

Article  PubMed  Google Scholar 

Samuels S, Park K, Bhatt-Mehta V, Sun H, Mulugeta Y, Yao L, et al. Pediatric efficacy extrapolation in drug development submitted to the US food and drug administration 2015–2020. J Clin Pharmacol. 2023;63(3):307–13.

Article  CAS  PubMed  Google Scholar 

US Food and Drug Administration. Pediatric Research Equity Act of 2003. Available at: https://www.congress.gov/108/plaws/publ155/PLAW-108publ155.pdf (Accessed April 4, 2024).

European Commission. Regulation (EC) No 1901/2006 of the European Parliament of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. (2006). Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006R1901&from=EN (Accessed April 4 2024).

Hoon D, Taylor MT, Kapadia P, Gerhard T, Strom BL, Horton DB. Trends in off-label drug use in ambulatory settings: 2006–2015. Pediatrics. 2019;144(4): e20190896.

Article  PubMed  Google Scholar 

Palmaro A, Bissuel R, Renaud N, Durrieu G, Escourrou B, Oustric S, et al. Off-label prescribing in pediatric outpatients. Pediatrics. 2015;135(1):49–58.

Article  PubMed  Google Scholar 

Olsson J, Kimland E, Pettersson S, Odlind V. Paediatric drug use with focus on off-label prescriptions in Swedish outpatient care–a nationwide study. Acta Paediatr. 2011;100(9):1272–5.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lasky T, Artaman A, Czaja AS, Maruti SS, Osokogu OU, Verhamme KMC, et al. Current needs in pediatric pharmacoepidemiology. Pharmacoepidemiol Drug Saf. 2016;25(6):738–42.

Article  PubMed  Google Scholar 

Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology–drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349(12):1157–67.

Article  CAS  PubMed  Google Scholar 

Taine M, Offredo L, Dray-Spira R, Weill A, Chalumeau M, Zureik M. Paediatric outpatient prescriptions in France between 2010 and 2019: a nationwide population-based study: paediatric outpatient prescriptions in France, 2010 to 2019. Lancet Reg Health Eur. 2021;7: 100129.

Article  PubMed  PubMed Central  Google Scholar 

Sturkenboom MCJM, Verhamme KMC, Nicolosi A, Murray ML, Neubert A, Caudri D, et al. Drug use in children: cohort study in three European countries. BMJ. 2008;24(337): a2245.

Article  Google Scholar 

Taine M, Offredo L, Weill A, Dray-Spira R, Zureik M, Chalumeau M. Pediatric outpatient prescriptions in countries with advanced economies in the 21st Century: a systematic review. JAMA Netw Open. 2022;5(4): e225964.

Article  PubMed  PubMed Central  Google Scholar 

Skajaa N, Gehrt L, Nieminen H, Laake I, Englund H, Sönksen UW, et al. Trends in antibiotic use in Danish, Finnish. Norwegian and Swedish Children Clin Epidemiol. 2022;14:937–47.

Article  PubMed  Google Scholar 

Reilev M, Thomsen RW, Aabenhus R, Sydenham RV, Hansen JG, Pottegård A. Switching between antibiotics among danish children 0–4 Years of age: a nationwide drug utilization study. Pediatr Infect Dis J. 2018;37(11):1112–7.

Article  PubMed  Google Scholar 

Finkelstein JA, Raebel MA, Nordin JD, Lakoma M, Young JG. Trends in outpatient antibiotic use in 3 health plans. Pediatrics. 2019;143(1): e20181259.

Article  PubMed  Google Scholar 

Pottegård A, Schmidt SAJ, Wallach-Kildemoes H, Sørensen HT, Hallas J, Schmidt M. Data resource profile: the danish national prescription registry. Int J Epidemiol. 2017;46(3):798–798f.

PubMed  Google Scholar 

WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment 2021. Oslo, Norway; 2020.

Rasmussen L, Valentin J, Gesser KM, Hallas J, Pottegård A. Validity of the prescriber information in the Danish national prescription registry. Basic Clin Pharmacol Toxicol. 2016;119(4):376–80.

Article  CAS  PubMed  Google Scholar 

Rasmussen L, Wettermark B, Steinke D, Pottegård A. Core concepts in pharmacoepidemiology: measures of drug utilization based on individual-level drug dispensing data. Pharmacoepidemiol Drug Saf. 2022;31(10):1015–26.

Article  PubMed  PubMed Central  Google Scholar 

Schmidt M, Hallas J, Laursen M, Friis S. Data resource profile: Danish online drug use statistics (MEDSTAT). Int J Epidemiol. 2016;45(5):1401–1402g.

Article  PubMed  Google Scholar 

Danish online drug use statistics (MEDSTAT). Available at https://medstat.dk/en (Accessed July 13, 2023).

Dahlén E, Kindblom JM, Kimland EE. Defined daily doses in pediatric dosing- a theoretical example. Pharmacol Res Perspect. 2023;11(2): e01061.

Article  PubMed  PubMed Central  Google Scholar 

Statistics Denmark. https://www.statbank.dk/20021.

Furu K, Wettermark B, Andersen M, Martikainen JE, Almarsdottir AB, Sørensen HT. The Nordic countries as a cohort for pharmacoepidemiological research. Basic Clin Pharmacol Toxicol. 2010;106(2):86–94.

Article  CAS  PubMed  Google Scholar 

Pottegård A, de Pont CR, Houji A, Christiansen CB, Paulsen MS, Thomsen JL, et al. Primary non-adherence in general practice: a Danish register study. Eur J Clin Pharmacol. 2014;70(6):757–63.

Article  PubMed  Google Scholar 

Norwegian Institute of Public Health. Norwegian prescription database. Available at https://www.norpd.no/ (Accessed Jul 13, 2023).

Socialstyrelsen. Statistical Database, Pharmaceuticals. Available at https://sdb.socialstyrelsen.se/if_lak/val_eng.aspx (Accessed Feb 13, 2024).

Zhang T, Smith MA, Camp PG, Shajari S, MacLeod SM, Carleton BC. Prescription drug dispensing profiles for one million children: a population-based analysis. Eur J Clin Pharmacol. 2013;69(3):581–8.

Article  PubMed  Google Scholar 

Tomlin AM, Woods DJ, Lloyd HS, Tilyard MW. Trends in Outpatient prescription medicine use in New Zealand children 2010–2015: a national population-based study. Paediatr Drugs. 2018;20(5):465–74.

Article  PubMed  Google Scholar 

Danish Ministry of Health. “National action plan on antibiotics in human healthcare”, 2017. Available at: https://sum.dk/Media/6/2/National-handlingsplan-for-antibiotika-til-mennesker-UK%20version.pdf (accessed Feb 12, 2024).

Wesselhoeft R, Rasmussen L, Jensen PB, Jennum PJ, Skurtveit S, Hartz I, et al. Use of hypnotic drugs among children, adolescents, and young adults in Scandinavia. Acta Psychiatr Scand. 2021;144(2):100–12.

Article  CAS  PubMed  Google Scholar 

Sørensen AMS, Wesselhöeft R, Andersen JH, Reutfors J, Cesta CE, Furu K, et al. Trends in use of attention deficit hyperactivity disorder medication among children and adolescents in Scandinavia in 2010–2020. Eur Child Adolesc Psychiatry. 2023;32(10):2049–56.

Article  PubMed  Google Scholar 

Bruno C, Havard A, Gillies MB, Coghill D, Brett J, Guastella AJ, et al. Patterns of attention deficit hyperactivity disorder medicine use in the era of new non-stimulant medicines: a population-based study among Australian children and adults (2013–2020). Aust N Z J Psychiatry. 2023;57(5):675–85.

Article  PubMed  Google Scholar 

Bliddal M, Rasmussen L, Andersen JH, Jensen PB, Pottegård A, Munk-Olsen T, et al. Psychotropic medication use and psychiatric disorders during the COVID-19 pandemic among danish children, adolescents, and young adults. JAMA Psychiat. 2023;80(2):176–80.

Article  Google Scholar 

Kuitunen I, Uimonen MM, Ponkilainen VT, Mattila VM. Primary care visits due to mental health problems and use of psychotropic medication during the COVID-19 pandemic in Finnish adolescents and young adults. Child Adolesc Psychiatry Ment Health. 2023;17(1):35.

Article  PubMed  PubMed Central  Google Scholar 

Antoniou T, Pajer K, Gardner W, Penner M, Lunsky Y, McCormack D, et al. Impact of COVID-19 pandemic on prescription stimulant use among children and youth: a population-based study. Eur Child Adolesc Psychiatry. 2024. https://doi.org/10.1007/s00787-023-02346-x.

Article  PubMed  PubMed Central  Google Scholar 

Pedersen E, Tripodi E, Aakjær M, Li H, Cantarutti A, Nyberg F, Andersen M, Lupattelli A, Nordeng H. Drug utilisation in children and adolescents before and after the start of the COVID‐19 pandemic: interrupted time‐series analyses in three European countries. Paediatric and Perinatal Epidemiol. 2024;38(6):450–60. https://doi.org/10.1111/ppe.13046.

Article  Google Scholar 

Thomas R, Mitchell GK, Batstra L. Attention-deficit/hyperactivity disorder: are we helping or harming? BMJ. 2013;5(347): f6172.

Article  Google Scholar 

The Danish Health Authority. National guideline on Diagnosis and Treatment of ADHD in Children and Adolescents. Available at: https://www.sst.dk/da/Udgivelser/2021/NKR-ADHD-hos-boern-og-unge (Accessed November 20, 2024).

Gimbach S, Vogel D, Fried R, Faraone SV, Banaschewski T, Buitelaar J, et al. ADHD medicine consumption in Europe after COVID-19: catch-up or trend change? BMC Psychiatry. 2024;24(1):112.