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2000
Volume 32, Issue 40
  • ISSN: 0929-8673
  • E-ISSN: 1875-533X

Abstract

Background

Considering infants and young children, it is well established that their physiological and developmental peculiarities should not be confused with those of other patient categories, such as adults or vulnerable patients. Indeed, their anatomic-functional characteristics specifically influence the drug pharmacokinetic/pharmacodynamic profile. Therefore, the availability of specialists devoted to pediatric pharmacology within multidisciplinary teams is highly desirable to improve the care of these patients.

Objective

This work aims to describe the role of pediatric clinical pharmacologists in the context of pediatric clinical care in Italy, using a qualitative method based on the type of articles published.

Methods

A literature review was conducted according to the PRISMA guidelines, considering articles published on the PubMed database between January 2017 and March 2022 and using specific MeSH terms. The papers were attributed to two blind assessors and then processed for discussion. To support article screening, focusing on the words contained in article titles, the R package evidence synthesis tool was used.

Results

The search identified a total of 1544 articles, of which 93 were selected. The articles analyzed mainly concern therapeutic drug monitoring and pharmacovigilance with adverse drug reactions.

Conclusion

An insight into multidisciplinary work to prevent, diagnose, and treat pediatric diseases and to monitor treatments is provided in this study. However, this concept needs to be strengthened in the long term.

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2025-10-27

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References

  1. KearnsG.L. Abdel-RahmanS.M. AlanderS.W. BloweyD.L. LeederJ.S. KauffmanR.E. Developmental pharmacology-drug disposition, action, and therapy in infants and children.N. Engl. J. Med.2003349121157116710.1056/NEJMra03509213679531
     [Google Scholar]
  2. GuidiB. ParzialeA. NoccoL. MaieseA. RussaL.R. PaoloD.M. TurillazziE. Regulating pediatric off-label uses of medicines in the EU and USA: Challenges and potential solutions.Int. J. Clin. Pharm.202244126426910.1007/s11096‑021‑01303‑534495453
     [Google Scholar]
  3. van der ZandenT.M. SmeetsN.J.L. Hoop-SommenD.M. SchwerzelM.F.T. HuangH.J. BartenL.J.C. van der HeijdenJ.E.M. FreriksenJ.J.M. HorstinkA.A.L. HolsappelI.H.G. MooijM.G. HoogD.M. WildtD.S.N. Off-label, but on-evidence? a review of the level of evidence for pediatric pharmacotherapy.Clin. Pharmacol. Ther.202211261243125310.1002/cpt.273636069288
     [Google Scholar]
  4. RoseK. Grant-KelsJ.M. StrianoP. Therapeutic orphans, off-label, pediatric drug development: Towards reasonable pharmacotherapy for minors.Expert Opin. Pharmacother.202425182375238410.1080/14656566.2024.242667839526437
     [Google Scholar]
  5. TurnerM.A. HildebrandH. FernandesR.M. WildtD.S.N. MahlerF. HankardR. LearyR. BonifaziF. NobelsP. ChengK. AttarS. RossiP. RocchiF. ClaverolJ. NafriaB. GiaquintoC. The conect4children (c4c) consortium: Potential for improving european clinical research into medicines for children.Pharmaceut. Med.2021352717910.1007/s40290‑020‑00373‑633539007
     [Google Scholar]
  6. GouloozeSC VisPW KrekelsEHJ KnibbeCAJ. Advances in pharmacokinetic-pharmacodynamic modelling for pediatric drug development: Extrapolations and exposure-response analyses.Expert Rev. Clin. Pharmacol.202316121201120910.1080/17512433.2023.2288171
     [Google Scholar]
  7. DurairajC. BhattacharyaI. Challenges, approaches and enablers: Effectively triangulating towards dose selection in pediatric rare diseases.J. Pharmacokinet. Pharmacodyn.202350644545910.1007/s10928‑023‑09868‑637296230
     [Google Scholar]
  8. KuzmaN. KerstenH.B. ThompsonE.D. Evidence-based medicine in the clinical learning environment of pediatric hospital medicine.Pediatr. Clin. North Am.201966471372410.1016/j.pcl.2019.03.00131230618
     [Google Scholar]
  9. RandellR.L. Gelineau-MorelR. ThomasS. GonzalezD. LeederJ.S. HornikC.P. Training the next generation of pediatric clinical pharmacologists: Insights and trainee perspectives over 10 years.J. Clin. Pharmacol.202465338939510.1002/jcph.615539535328
     [Google Scholar]
  10. WalshJ. SchaufelbergerD. IurianS. KleinS. BatchelorH. TurnerR. GizurarsonS. BoltriL. AlessandriniE. TuleuC. Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect 4 children expert group white paper.Br. J. Clin. Pharmacol.202288125034505110.1111/bcp.1498934265091
     [Google Scholar]
  11. MoherD. LiberatiA. TetzlaffJ. AltmanD.G. PRISMA Group Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement.PLoS Med.200967e100009710.1371/journal.pmed.100009719621072
     [Google Scholar]
  12. WestgateM.J. revtools: An R package to support article screening for evidence synthesis.Res. Synth. Methods201910460661410.1002/jrsm.137431355546
     [Google Scholar]
  13. CarelloR. RicottiniL. MirandaV. PaneiP. RocchiL. ArcieriR. GalliE. Long-term treatment with low- dose medicine in chronic childhood eczema: A double-blind two-stage randomized control trial.Ital. J. Pediatr.20174317810.1186/s13052‑017‑0393‑528874171
     [Google Scholar]
  14. LerouxS. Jacqz-AigrainE. ElieV. LegrandF. Barin-Le GuellecC. AurichB. BiranV. DusangB. GoudjilS. CoopmanS. SanchezG.R. ZhaoW. ManzoniP. Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: A randomized, open-label clinical trial.Br. J. Clin. Pharmacol.20188491989199910.1111/bcp.1362829744900
     [Google Scholar]
  15. FilippiL. CavallaroG. BagnoliP. MonteD.M. FioriniP. BertiE. PadriniL. DonzelliG. AraimoG. CristoforiG. FumagalliM. MarcaL.G. BonaD.M.L. PasqualettiR. FortunatoP. OsnaghiS. TomasiniB. VanniM. CalvaniA.M. MilaniS. CortinovisI. PugiA. AgostiM. MoscaF. Propranolol 0.1% eye micro- drops in newborns with retinopathy of prematurity: A pilot clinical trial.Pediatr. Res.201781230731410.1038/pr.2016.23027814346
     [Google Scholar]
  16. FilippiL. CavallaroG. BertiE. PadriniL. AraimoG. RegiroliG. RaffaeliG. BozzettiV. TagliabueP. TomasiniB. MoriA. BuonocoreG. AgostiM. BossiA. ChiricoG. AversaS. FortunatoP. OsnaghiS. CavallottiB. SuzaniM. VanniM. BorsariG. DonatiS. NascimbeniG. NardoD. PiermarocchiS. MarcaL.G. ForniG. MilaniS. CortinovisI. CalvaniM. BagnoliP. MonteD.M. CalvaniA.M. PugiA. VillamorE. DonzelliG. MoscaF. Propranolol 0.2% eye micro-drops for retinopathy of prematurity: A prospective phase IIB study.Front Pediatr.2019718010.3389/fped.2019.0018031134171
     [Google Scholar]
  17. MancusoM.E. MahlanguJ. SidonioR.Jr TraskP. UguenM. ChangT. ShimaM. YoungG. OldenburgJ. MackensenV.S. Health-related quality of life and caregiver burden of emicizumab in children with haemophilia A and factor VIII inhibitors—Results from the HAVEN 2 study.Haemophilia20202661009101810.1111/hae.1418333084175
     [Google Scholar]
  18. NobiliV. AlisiA. MoscaA. CrudeleA. ZaffinaS. DenaroM. SmeriglioA. TrombettaD. The antioxidant effects of hydroxytyrosol and vitamin e on pediatric nonalcoholic fatty liver disease, in a clinical trial: A new treatment?Antioxid. Redox Signal.201931212713310.1089/ars.2018.770430588836
     [Google Scholar]
  19. EspositoC. ConteD.F. CeruloM. CoppolaV. EspositoG. RicciardiE. CrocettoF. CastagnettiM. CalignanoA. EscolinoM. Evaluation of efficacy of oxygen-enriched oil-based gel dressing in patients who underwent surgical repair of distal hypospadias: A prospective randomised clinical trial.World J. Urol.20213962205221510.1007/s00345‑020‑03419‑132852619
     [Google Scholar]
  20. CicciaM. ChakrokhR. MolinazziD. ZanniA. FarruggiaP. SandriF. Skin antisepsis with 0.05% sodium hypochlorite before central venous catheter insertion in neonates: A 2-year single-center experience.Am. J. Infect. Control201846216917210.1016/j.ajic.2017.08.01228967509
     [Google Scholar]
  21. PaneM. PalermoC. MessinaS. SansoneV.A. BrunoC. CatterucciaM. SframeliM. AlbamonteE. PedemonteM. D’AmicoA. BrigatiG. SanctisD.R. CorattiG. LucibelloS. BertiniE. VitaG. TizianoF.D. MercuriE. Nusinersen in type 1 SMA infants, children and young adults: Preliminary results on motor function.Neuromuscul. Disord.201828758258510.1016/j.nmd.2018.05.01029960818
     [Google Scholar]
  22. JóźwiakS. VeggiottiP. MoreiraJ. GamaH. RochaF. Soares-da-SilvaP. Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures.Epilepsy Behav.20188111110.1016/j.yebeh.2018.01.02929454255
     [Google Scholar]
  23. FalsaperlaR. MauceriL. PavoneP. BarbagalloM. VitalitiG. RuggieriM. PisaniF. CorselloG. Short-term neurodevelopmental outcome in term neonates treated with phenobarbital versus levetiracetam: A single-center experience.Behav. Neurol.201920191810.1155/2019/368354831281546
     [Google Scholar]
  24. GattiM. CojuttiP.G. CampoliC. CaramelliF. CorvagliaL.T. LanariM. PessionA. RamirezS. VialeP. PeaF. A proof of concept of the role of TDM-based clinical pharmacological advices in optimizing antimicrobial therapy on real-time in different paediatric settings.Front. Pharmacol.20211275507510.3389/fphar.2021.75507534646143
     [Google Scholar]
  25. GirmeniaC. AnninoL. BertainaA. MariottiB. CaselliD. FanciR. BarberiW. MarchesiF. CarottiA. FerrariA. CerchiaraE. CupelliL. ArcioniF. RibersaniM. ProiaA. CartoniC. GirardiK. VendittiA. CassettaM.I. FallaniS. NovelliA. Voriconazole treatment in adults and children with hematological diseases: Can it be used without measurement of plasma concentration?Med. Mycol.201856326327810.1093/mmy/myx05328992093
     [Google Scholar]
  26. CarloneG. SimeoneR. BaraldoM. MaestroA. ZanonD. BarbiE. MaximovaN. Area-under-the-curve-based mycophenolate mofetil dosage may contribute to decrease the incidence of graft-versus-host disease after allogeneic hematopoietic cell transplantation in pediatric patients.J. Clin. Med.202110340610.3390/jcm1003040633494356
     [Google Scholar]
  27. NicolòD.A. PinonM. PalermitiA. NonnatoA. MancaA. MulaJ. CatalanoS. TandoiF. RomagnoliR. D’AvolioA. CalvoP.L. Monitoring tacrolimus concentrations in whole blood and peripheral blood mononuclear cells: Inter- and intra-patient variability in a cohort of pediatric patients.Front. Pharmacol.20211275043310.3389/fphar.2021.75043334803692
     [Google Scholar]
  28. RizzariC. Lanvers-KaminskyC. ValsecchiM.G. BalleriniA. MatteoC. GerssJ. WuerthweinG. SilvestriD. ColombiniA. ConterV. BiondiA. SchrappeM. MoerickeA. ZimmermannM. StackelbergV.A. LinderkampC. FrühwaldM.C. LegienS. AttarbaschiA. ReismüllerB. KasperD. SmisekP. StaryJ. VintiL. BarisoneE. ParasoleR. MicalizziC. ZucchettiM. BoosJ. Asparagine levels in the cerebrospinal fluid of children with acute lymphoblastic leukemia treated with pegylated-asparaginase in the induction phase of the AIEOP-BFM ALL 2009 study.Haematologica201910491812182110.3324/haematol.2018.20643330705097
     [Google Scholar]
  29. NassoC. MecchioA. RotturaM. ValenziseM. Menniti-IppolitoF. CutroneoP.M. SquadritoV. SquadritoF. PallioG. IrreraN. ArcoraciV. AltavillaD. A 7-years active pharmacovigilance study of adverse drug reactions causing children admission to a pediatric emergency department in sicily.Front. Pharmacol.202011109010.3389/fphar.2020.0109032765282
     [Google Scholar]
  30. FrancoV. BarbieriM.A. CutroneoP.M. ArenaI. CicalaG. MarchioneP. SpinaE. PeruccaE. Pediatric adverse reactions to antiseizure medications – An analysis of data from the Italian spontaneous reporting system (2001–2019).Epilepsy Behav.202111910798910.1016/j.yebeh.2021.10798933946010
     [Google Scholar]
  31. PozziM. CarnovaleC. MazharF. PeetersG.G.A.M. GentiliM. NobileM. RadiceS. ClementiE. Adverse drug reactions related to mood and emotion in pediatric patients treated for attention deficit/hyperactivity disorder.J. Clin. Psychopharmacol.201939438639210.1097/JCP.000000000000105831205193
     [Google Scholar]
  32. PietroD.P. Della Casa AlberighiO. SilvestriM. ToscaM.A. RuoccoA. ConfortiG. RossiG.A. CastagnolaE. MerlanoM.C. ZappettiniS. RennaS. Monitoring adherence to guidelines of antibiotic use in pediatric pneumonia: The MAREA study.Ital. J. Pediatr.201743111310.1186/s13052‑017‑0432‑229273072
     [Google Scholar]
  33. LombardiN. CrescioliG. BettiolA. TuccoriM. RossiM. BonaiutiR. RavaldiC. LeviM. MugelliA. RicciS. LippiF. AzzariC. BonanniP. VannacciA. Vaccines safety in children and in general population: A pharmacovigilance study on adverse events following anti-infective vaccination in italy.Front. Pharmacol.20191094810.3389/fphar.2019.0094831543816
     [Google Scholar]
  34. CarnovaleC. MahzarF. ScibelliS. GentiliM. ArzentonE. MorettiU. LeoniO. PozziM. PeetersG.G.A.M. ClementiE. MedagliaM. RadiceS. Central nervous system-active drug abused and overdose in children: A worldwide exploratory study using the WHO pharmacovigilance database.Eur. J. Pediatr.2019178216117210.1007/s00431‑018‑3281‑030374752
     [Google Scholar]
  35. KaguelidouF. HolstiegeJ. SchinkT. BezemerI. PoluzziE. MazzagliaG. PedersenL. SturkenboomM. TrifiròG. ‘Use of antipsychotics in children and adolescents: A picture from the ARITMO population-based European cohort study’.Epidemiol. Psychiatr. Sci.202029e11710.1017/S204579602000029332308179
     [Google Scholar]
  36. Regulation (EC) No 1901/2006 of the european parliament and of the council.2006Available from: http://data.europa.eu/eli/reg/2006/1901/oj/eng
  37. Regulation (EC) No 1902/2006 of the european parliament and of the council.2006Available from: http://data.europa.eu/eli/reg/2006/1902/oj/eng
  38. COM_COM(2017)0626_EN.pdf.2017Available from: https://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2017/0626/COM_COM(2017)0626_EN.pdf [cited on March 17, 2024].
  39. JinG. WongS.T.C. Toward better drug repositioning: Prioritizing and integrating existing methods into efficient pipelines.Drug Discov. Today201419563764410.1016/j.drudis.2013.11.00524239728
     [Google Scholar]
  40. LazzeriniM. VillanacciV. PellegrinM.C. MartelossiS. MagazzùG. PellegrinoS. LucantoM.C. BarabinoA. CalviA. ArrigoS. LionettiP. FontanaM. ZuinG. MaggioreG. BramuzzoM. MaschioM. SalemmeM. ManentiS. LorenziL. DecortiG. MonticoM. VenturaA. Endoscopic and histologic healing in children with inflammatory bowel diseases treated with thalidomide.Clin. Gastroenterol. Hepatol.201715913821389.e110.1016/j.cgh.2017.02.02928286192
     [Google Scholar]
  41. AnJ WoodwardJJ SasakiT MinieM ElkonKB. Cutting edge: Antimalarial drugs inhibit IFN-β production through blockade of cyclic GMP-AMP synthase-DNA interaction.J. Immunol.19494089409310.4049/jimmunol.1402793
     [Google Scholar]
  42. ChenK. SchenoneA.L. BorgesN. MilitelloM. MenonV. Teaching an old dog new tricks: Colchicine in cardiovascular medicine.Am. J. Cardiovasc. Drugs201717534736010.1007/s40256‑017‑0226‑328353024
     [Google Scholar]
  43. BerkingA.C. FlaadtT. BehrensY.L. YoshimiA. LeipoldA. HolzerU. LangP. Quintanilla-MartinezL. SchlegelbergerB. ReiterA. NiemeyerC. StrahmB. GöhringG. Rare and potentially fatal - Cytogenetically cryptic TNIP1:PDGFRB and PCM1:FGFR1 fusion leading to myeloid/lymphoid neoplasms with eosinophilia in children.Cancer Genet.2023272-273293410.1016/j.cancergen.2023.01.00236657267
     [Google Scholar]
  44. NelsonR.M. ConklinL.S. KomocsarW.J. ChenF. WilliamsonF. CrandallW.V. The role of master protocols in pediatric drug development.Ther. Innov. Regul. Sci.202256689590210.1007/s43441‑022‑00448‑336045315
     [Google Scholar]
  45. MuensterS. ZarragoikoetxeaI. MoscatelliA. BalcellsJ. GaudardP. PouardP. MarczinN. JanssensS.P. Inhaled NO at a crossroads in cardiac surgery: Current need to improve mechanistic understanding, clinical trial design and scientific evidence.Front. Cardiovasc. Med.202411137463510.3389/fcvm.2024.137463538646153
     [Google Scholar]
  46. ServideiT. SgambatoA. LucchettiD. NavarraP. RuggieroA. Drug repurposing in pediatric brain tumors: Posterior fossa ependymoma and diffuse midline glioma under the looking glass.Front. Biosci.20232847710.31083/j.fbl280407737114548
     [Google Scholar]
  47. Miera-MaluendaM. Pérez-TorresM. MañasA. Rubio-San-SimónA. Butjosa-EspínM. Ruiz-DuranP. SeoaneJ.A. MorenoL. SeguraM.F. Advances in the approaches used to repurpose drugs for neuroblastoma.Expert Opin. Drug Discov.202419111309131910.1080/17460441.2024.240241339258785
     [Google Scholar]
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The Current and Potential Role of Pediatric Clinical Pharmacologists in Italy: A Review with Evidence Synthesis and Literature Analysis
Curr. Med. Chem. 32, 9066 (2025); https://doi.org/10.2174/0109298673291434250612050205
/content/journals/cmc/10.2174/0109298673291434250612050205
/content/journals/cmc/10.2174/0109298673291434250612050205
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  • Article Type:     Review Article
Keyword(s): clinical pharmacology; multidisciplinary team; Pediatric clinical pharmacologist; pediatrics; pharmacovigilance; therapeutic drug monitoring

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