Swedish Paediatric Medicines - SwedPedMed
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1 Swedish Paediatric Medicines - SwedPedMed Anders Rane Senior Professor, MD PhD Past Chairman, Division of Clin Pharmacology at Karolinska Institutet, Past President, European Society of Developmental, Perinatal & Pediatric Pharmacology Karolinska Institutet, Division of Clin Pharmacology at Karolinska University Hospital, Stockholm, Sweden anders.rane@ki.se Namn Efternamn
2 The clinical reality 40 % of all kids under 18 år purchased a prescribed medicine from pharmacies in Most of the children were between 1 and 3 years, or in the upper teenage. mostly antiinfectives, and medicines for respiratory problems. Freely translated from the National Board of Health and Welfare (Socialstyrelsen) Namn Efternamn 16 juni
3 Prevalence, ADHD-medicines Development of current users of ADHD medicines in the Swedish population and percentage increase. No/ individuals. At lease one purchase (SocStyr) Boys/m en (age) N/ inhabita nts 2015 Increase since 2006 (%) Girls/women (ålder) N/ inhabita nts 2015 Increas e since 2006 % alla alla Namn Efternamn 16 juni
4 Antal patienter per 1000 invånare Prescribed medicines to children under 18 years, Psychoanaleptics ,0 50,0 40,0 30,0 20,0 10,0 0, N06 Psykoanaleptika Pojkar N06 Psykoanaleptika Flickor Namn Efternamn
5 400 Prescribed medicines to children under 18 years No of packages per 1000 inhabitants N06B Psykostimulantia, medel vid ADHD och nootropika Flickor Psychostimulants and nootropics N06B Psykostimulantia, medel vid ADHD och nootropika Pojkar N05C Sömnmedel och lugnande medel Flickor N05C Sömnmedel och lugnande medel Pojkar Hypnotics and sedatives Namn Efternamn
6 Off-label drug use in paediatrics A pan-european study Conclusions: British, German, Italian, Dutch, and Swedish data 46 percent of all drug prescriptions in hospital wards concerned unlicensed drugs (16/100) or off-label indications (84/100) Two of three (67%) patients received an unlicensed drug or an off-label drug prescription (e.g. Diuretics, opiates, anti-astmatics, NSAID s etc) (Conroy et al, Br Med J, 320: 79-82, 2000) Namn Efternamn
7 Off-label drug use in paediatrics A pan-european study Conclusions: British, German, Italian, Dutch, and Swedish data 46 percent of all drug prescriptions in hospital wards concerned unlicensed drugs (16/100) or off-label indications (84/100) Drugs without documentation to kids in Swedish hospitals All 48% 0-<1 m 61% 1 mån-<1 y 50% 1 år-<12 y 44% 12 år-18 y 33% >18 y? Two of three (67%) patients received an unlicensed drug or an off-label drug prescription (e.g. Diuretics, opiates, anti-astmatics, NSAID s etc) (Conroy et al, Br Med J, 320: 79-82, 2000) Namn Efternamn Conclusion: No change in 12 years time (Kimland et al Acta Paediatr Jul;101(7):772-8)
8 European Pediatric Regulation 2007 Fraction of clinical drug trials in the EU that includes children ( 1 participant > 18 y) Källa: EMA databases (SIAMED, DREAM). Name Surname 14/10/2015 8
9 European Paediatric Regulation 2007 Number of new paediatric medicines and indications och (approved by the central application with a new Marketing Authorisation) Källa: EMA databases (SIAMED, DREAM). Name Surname 14/10/2015 9
10 Name Surname 14/10/
11 Name Surname år år år år år år år år år år år år år år år år år år Swedish young population by age 14/10/ % 11
12 FACTS 10,000,000 inhabitants 20 % children (0-17 years) Umeå 100,000,000 customers visits to Swedish pharmacies annually Göteborg Uppsala Linköping Stockholm 85,000,000 prescriptions annually ( 3,000,000 to children 0-14 years) >2000 ADR reports annually (about 20 % for children 0-14 years) Swedish Adverse Drug Reaction Committee at MPA A Rane Sep 14 Lund Regional Departments of Clin Pharmacology Name Namn Surname Efternamn /10/2015 juni 12
13 Number of applications for clinical trials in Sweden Name Surname 14/10/
14 No. of ADRs / prescription X 1000 ADR reports in Sweden per age group All drugs excluding vaccines (normalised for no. of prescriptions) x ,500 0,400 0,300 0,200 0,100 0,000 Children aged 0-14 years Adults Ex
15 Number of ADR reports Number of ADR reports per age group in Sweden 3000 Vaccines other drugs Ex Age in years
16 How it started... Name Surname 14/10/
17 Medical Products Agency and FinPedMed s startup meeting at Arlanda August 2014 Inauguration of Intresseföreningen för Barn och Läkemedel* within *Current Board: Estelle Naumburg (Chair), Lisa Forsberg, Jenny Kindblom, Synnöve Lindemalm, Elisabeth Norman, Anders Rane Namn Efternamn
18 Consultation Support Trial units in PHC and hospitals Medical specialists Idea workshop and Networking in Sweden and Nordic countries Nordic MCT collaboration
19 Clinical platforms For clinical drug trials and other pediatric drug development Consultation Support Trial units in PHC and hospitals Medical specialists Idea workshop and Networking in Sweden and Nordic countries Nordic MCT collaboration
20 SwedPedMed in liasion with Swedish Clinical Research Nodes Norra sjukvårdsregionen: Forum Norr för klinisk forskning. Clinical platforms For clinical drug trials and other pediatric drug development Uppsala- Örebroregionen: En fristående enhet knuten till Uppsala Clinical Research Center (UCR). Västra sjukvårdsre gionen: Gothia Forum. Södra sjukvårdsregionen: FoUcentrum Skåne. Stockholms sjukvårdsre gion: Karolinska Trial Alliance (KTA). Sydöstra sjukvårdsregionen: Forum sydost
21 SwedPedMed in liasion with the other Nordic Countries Clinical platforms For clinical drug trials and other pediatric drug development
22 Name Surname 14/10/
23 Contact information Brief CV Specialty, experience, academic merits etc committed to respond (yes/no) to proposal within 72 hours Name Surname 14/10/
24 Regulation (EC) No 1901/2006 of the European 6 Parliament and of the Council of IcePedMed 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) 2 No 1768/92, Directive 2001/20/EC, Directive NorPedMed 2001/83/EC and Regulation (EC) No 726/ DanPedMed 4 NordicPedMed 5 SwedPedMed 1 FinPedMed 7 PedCRIN
25 Tack! Than k you! Namn Efternamn
26 FARMAKOVIGILANS Premarketing information Postmarketing surveillance Spontaneous reporting system (hypothesis generation, warning signals, alerts) Focused intensive ADR monitoring Cohort studies Case-control studies Namn Efternamn
27 Global Paediatric Pharmacovigilance Study Investigator Enrollment Coordinating Centre DNA/ tissue bank Namn Efternamn
28 Global Paediatric Pharmacovigilance Study Patient inclusion Effect monitoring Coordinating Centre DNA/ tissue bank Namn Efternamn
29 Global Paediatric Pharmacovigilance Study ADR reporting Analyses & genotyping of samples + controls Coordinating Centre DNA/ tissue bank Namn Efternamn
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