High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.—Oct. 2014
Autoři:
Brechkerts Lieske Angruni Tukayo aff001; Bruce Sunderland aff001; Richard Parsons aff003; Petra Czarniak aff001
Působiště autorů:
School of Pharmacy and Biomedical Sciences, Curtin University, Bentley, Western Australia, Australia
aff001; Health Polytechnic Jayapura Indonesian Ministry of Health, Jakarta, Indonesia
aff002; School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Bentley, Western Australia, Australia
aff003
Vyšlo v časopise:
PLoS ONE 15(1)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0227687
Souhrn
Background
Data on off-label and unlicensed prescribing in children in Indonesia is limited. The aims of this study were to determine the prevalence of off-label and unlicensed prescribing for paediatric patients in a public hospital, Indonesia.
Method
A retrospective cross-sectional study of 200 randomly selected paediatric patients admitted to hospital between August and October 2014, collected patient details and all drugs prescribed. Licensed drugs were classified as off-label if there was a non-compliance with the Product Information for age, weight, indication, dose, frequency and route of administration, if there was a contraindication, special precautions or not recommended for children. Unlicensed drugs were those not approved for use in Indonesia. The main outcome was the prevalence of off-label or unlicensed prescribing to infants, children and adolescents and the impact of age group on off-label prescribing.
Results
A total of 200 patients received 1961 medicines of which 1807/1961 (92.1%) were licensed and 154/1961 (7.9%) were unlicensed. There were 1403/1961 (71.5%) drugs prescribed off-label. More than half of the total drugs (n = 1066; 54.4%) were administered parenterally. Every patient was prescribed at least one off-label drug. Indication (n = 810; 34.6%) was the most common reason for off-label prescribing. Ranitidine was the most frequent drug prescribed off label. Darplex® (dihydroartemisinin and piperaquine), although manufactured in Indonesia, was unlicensed. There was a significant difference between age group and off-label prescribing in that children were prescribed significantly less off-label drugs (p<0.0003).
Conclusion
This study revealed a high prevalence of off-label and unlicensed drug use in paediatric patients in this hospital, exposing them to drug treatments or regimens that had not been approved by regulatory authorities. The high incidence of invasive parenteral prescribing is of concern for paediatric patients. Incentives are needed to encourage specific drug evaluation in paediatric populations.
Klíčová slova:
Adolescents – Drug information – Drug licensing – Drug research and development – Drugs – Infants – Pediatrics – Routes of administration
Zdroje
1. Ivanovska V, Rademaker CM, van Dijk L, Mantel-Teeuwisse AK. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134(2):361–372. doi: 10.1542/peds.2013-3225 25022739
2. Yamashiro Y, Martin J, Gazarian M, Kling S, Nakamura H, Matsui A, et al. Drug development: the use of unlicensed/off-label medicines in pediatrics. Journal of pediatric gastroenterology and nutrition. 2012;55(5):506–510. doi: 10.1097/MPG.0b013e318272af1f 22983373
3. Magalhães J, Rodrigues AT, Roque F, Figueiras A, Falcão A, Herdeiro MT. Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review. European journal of clinical pharmacology. 2015;71(1):1–13. doi: 10.1007/s00228-014-1768-9 25318905
4. State of paediatric medicines in the EU– 10 years of the EU paediatric regulation Eurpean Union. 2017. https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf
5. Knellwolf A-L, Bauzon S, Alberighi ODC, Lutsar I, Bácsy E, Alfarez D, et al. Framework conditions facilitating paediatric clinical research. Italian journal of pediatrics. 2011;37(1):12.
6. Contopoulos-Ioannidis DG, Baltogianni MS, Ioannidis JP. Comparative effectiveness of medical interventions in adults versus children. The Journal of pediatrics. 2010;157(2):322–330. e17. doi: 10.1016/j.jpeds.2010.02.011 20434730
7. Lathyris D, Panagiotou OA, Baltogianni M, Ioannidis JP, Contopoulos-Ioannidis DG. Safety of medical interventions in children versus adults. Pediatrics. 2014;133(3):e666–e673. doi: 10.1542/peds.2013-3128 24567023
8. Allegaert K, Van De Velde M, van den Anker J. Neonatal clinical pharmacology. Pediatric Anesthesia. 2014;24(1):30–38. doi: 10.1111/pan.12176 23617305
9. Review of laws, regulations, and uses of off-label drugs in Indonesia—Final report. 2017. http://adphealth.org/upload/resource/Review_of_Laws_Regulations_and_Uses_of_Off-label_Drugs_in_Indonesia_2018_ADP.pdf
10. Corny J, Lebel D, Bailey B, Bussières J-F. Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. The Journal of Pediatric Pharmacology and Therapeutics. 2015;20(4):316–328. 26380572
11. Khdour MR, Hallak HO, Alayasa KS, AlShahed QN, Hawwa AF, McElnay JC. Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine. International journal of clinical pharmacy. 2011;33(4):650–655. doi: 10.1007/s11096-011-9520-3 21567279
12. Balan S, Hassali MAA, Mak VS. Two decades of off-label prescribing in children: a literature review. World Journal of Pediatrics. 2018;14(6):528–540. doi: 10.1007/s12519-018-0186-y 30218415
13. The Head of Drug and Food Controller Agency. Regulation of the head of drug and food controller agency (number HK.03.1.23.10.11.08481 of 2011) concerning criteria and procedure of drug registration 2011. http://www.flevin.com/id/lgso/translations/JICAMirror/english/4886_HK.03.1.23.10.11.08481_e.html
14. Clinical Investigation of Medicinal Products in the Pediatric Population (E11). EU: Adopted by CPMP, July 2000, issued as CPMP/ICH/2711/99. Published in the Federal Register: FDA; 2001. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf
15. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index 2015 2015. http://www.whocc.no/atc_ddd_index/
16. The National Agency of Drug and Food Control. Registration database. Indonesia. 2015. https://www.pom.go.id/new/
17. MIMS Indonesia 2015. Monthly Index of Medical Specialities (eMIMS). 2015 [cited In: Indonesia: MIMS. http://www.mimsonline.com/Indonesia/home/Index#
18. MIMS Indonesia: Petunjuk Konsultasi 14 2014/2015 ed. Jakarta (Indonesia): BIP (Buana Ilmu Populer). 2015. https://www.mims.com/indonesia
19. Indonesian National Medicine Information 2013. http://pionas.pom.go.id/book/ioni
20. Ramadaniati HU, Tambunan T, Khairani S, Adisty HS. Off-label and unlicensed prescribing in paediatric inpatients with nephrotic syndrome in a major teaching hospital: An Indonesian context. Asian J Pharm Clin Res. 2017;10(1):355–359.
21. Rahajeng B, Ikawati Z, Andayani TM, Dwiprahasto I. A retrospective study—the off-label use of anticonvulsants at a private hospital in Indonesia. 2018. IJPPS. 10(5): 119–122
22. Czarniak P, Bint L, Favié L, Parsons R, Hughes J, Sunderland B. Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital. PloS one. 2015;10(3):e0120630. doi: 10.1371/journal.pone.0120630 25756896
23. Delmas S, Bourdon O, Brion F, Prot-Labarthe S. Unlicensed and off-label medicines and prescriptions: A descriptive analysis of the medicines formulary and of the 56,800 prescriptions in a paediatric hospital.
24. Hsien L, Breddemann A, Frobel A-K, Heusch A, Schmidt KG, Läer S. Off-label drug use among hospitalised children: identifying areas with the highest need for research. Pharmacy world & science. 2008;30(5):497–502.
25. Lindell-Osuagwu L, Hakkarainen M, Sepponen K, Vainio K, Naaranlahti T, Kokki H. Prescribing for off-label use and unauthorized medicines in three paediatric wards in Finland, the status before and after the E uropean U nion P aediatric R egulation. Journal of clinical pharmacy and therapeutics. 2014;39(2):144–153. doi: 10.1111/jcpt.12119 24329556
26. Bavdekar S, Sadawarte PA, Gogtay NJ, Jain SS, Jadhav S. Off-label drug use in a Pediatric Intensive Care Unit. The Indian Journal of Pediatrics. 2009;76(11):1113–1118. doi: 10.1007/s12098-009-0238-3 20092023
27. Ferreira Ld A, Ibiapina Cd C, Machado MGP, Fagundes EDT. High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit. Revista da Associação Médica Brasileira. 2012;58(1):82–87. 22392321
28. Lee JL, Redzuan AM, Shah NM. Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia. International journal of clinical pharmacy. 2013;35(6):1025–1029. doi: 10.1007/s11096-013-9846-0 24022725
29. Li Y, Xu J, Wang F, Wang B, Liu L, Hou W, et al. Overprescribing in China, driven by financial incentives, results in very high use of antibiotics, injections, and corticosteroids. Health affairs. 2012;31(5):1075–1082. doi: 10.1377/hlthaff.2010.0965 22566449
30. World Health Organisation. Towards the safe and appropriate use of injections worldwide: progress report 2000–2001 [Internet]. 2002 https://apps.who.int/iris/handle/10665/67810
31. Slažneva J, Kovács L, Kuželová M. Off-label drug use among hospitalized children: identifying extent and nature. Acta Facultatis Pharmaceuticae Universitatis Comenianae. 2012;59(1):48–54.
32. Carnovale C, Conti V, Perrone V, Antoniazzi S, Pozzi M, Merlino L, et al. Paediatric drug use with focus on off-label prescriptions in Lombardy and implications for therapeutic approaches. European journal of pediatrics. 2013;172(12):1679–1685. doi: 10.1007/s00431-013-2111-7 23913312
33. Laforgia N, Nuccio MM, Schettini F, Dell'Aera M, Gasbarro AR, Dell'Erba A, et al. Off-label and unlicensed drug use among neonatal intensive care units in Southern Italy. Pediatrics International. 2014;56(1):57–59. doi: 10.1111/ped.12190 23937449
34. Ballard CD, Peterson GM, Thompson AJ, Beggs SA. Off-label use of medicines in paediatric inpatients at an A ustralian teaching hospital. Journal of paediatrics and child health. 2013;49(1):38–42. doi: 10.1111/jpc.12065 23279160
35. Landwehr C, Richardson J, Bint L, Parsons R, Sunderland B, Czarniak P. Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia. PloS one. 2019;14(1):e0210237. doi: 10.1371/journal.pone.0210237 30620749
36. Jonville-Bera A, Bera F, Autret-Leca E. Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study. European journal of clinical pharmacology. 2005;61(3):231–236. doi: 10.1007/s00228-004-0881-6 15824914
37. Wallerstedt SM, Brunlöf G, Sundström A. Rates of spontaneous reports of adverse drug reactions for drugs reported in children. Drug safety. 2011;34(8):669–682. doi: 10.2165/11591730-000000000-00000 21751827
38. Bonati M, Jacqz-Aigrain E, Choonara I. Licensed medicines, off-label use or evidence-based. Which is most important? Archives of diseases in childhood. 2017;102(1):53–54.
39. Hill P. Off licence and off label prescribing in children: litigation fears for physicians. Archives of disease in childhood. 2005;90(suppl 1):i17–i18.
40. Sabtu N, Enoch D, Brown N. Antibiotic resistance: what, why, where, when and how? British medical bulletin. 2015;116(1)
Článek vyšel v časopise
PLOS One
2020 Číslo 1
- S diagnostikou Parkinsonovy nemoci může nově pomoci AI nástroj pro hodnocení mrkacího reflexu
- Proč při poslechu některé muziky prostě musíme tančit?
- Je libo čepici místo mozkového implantátu?
- Chůze do schodů pomáhá prodloužit život a vyhnout se srdečním chorobám
- Pomůže v budoucnu s triáží na pohotovostech umělá inteligence?
Nejčtenější v tomto čísle
- Severity of misophonia symptoms is associated with worse cognitive control when exposed to misophonia trigger sounds
- Chemical analysis of snus products from the United States and northern Europe
- Calcium dobesilate reduces VEGF signaling by interfering with heparan sulfate binding site and protects from vascular complications in diabetic mice
- Effect of Lactobacillus acidophilus D2/CSL (CECT 4529) supplementation in drinking water on chicken crop and caeca microbiome
Zvyšte si kvalifikaci online z pohodlí domova
Všechny kurzy