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標題: | 台灣兒童族群門診中口服兒童製劑使用情形 Availability of Commercial Pediatric Oral Formulations and Their Utilization in Outpatient Prescriptions for Children in Taiwan |
作者: | Chia-Chi Chen 陳佳其 |
指導教授: | 林慧玲(Fe-Lin Lin Wu) |
關鍵字: | 兒童,兒童製劑,全民健康保險,門診病人,處方型態,台灣, children,pediatric formulation,National Health Insurance Research Database,outpatient,prescription pattern,Taiwan, |
出版年 : | 2009 |
學位: | 碩士 |
摘要: | 研究背景:
目前在台灣兒童藥物治療常面臨的問題,除了許多藥品缺乏兒童之適應症及建議劑量外,許多口服藥品缺乏兒童製劑,給藥前常必須進行劑型調整。台灣許多醫療院所對兒童開立處方時,將錠劑磨粉或將膠囊內容物取出分包,在這些操作過程中有許多潛在問題,而這樣的情形究竟是因為兒童製劑的缺乏還是其未被充分利用,值得探討。 研究目的: 本研究欲調查台灣目前有哪些口服兒童製劑,以及這些製劑在兒童族群門診實際被開方情況,以了解兒童用藥情形及可能面臨的問題。 研究材料與方法: 主要研究材料為中央健康保險局2009年7月公布之全民健康保險用藥品項資料,與國家衛生研究院提供全民健康保險研究資料庫之百萬人抽樣歸人檔中2005至2007年資料。 首先篩選適合年齡未滿12歲兒童族群使用之口服兒童製劑,需同時考量該製劑之藥品是否有兒童適應症、主成份是否有兒童劑量資訊、主成份含量是否適合兒童使用、劑型是否方便兒童使用、及製劑為單方或複方組成等條件,再由健保用藥品項所有健保給付之口服劑型製劑中,依上述條件逐一進行篩選,依兒童適用年齡切割為未滿6歲及6歲至未滿12歲兒童之兒童製劑,討論兒童製劑的組成及足夠性。 後續由健保資料庫之百萬人抽樣歸人檔,分析兒童族群門診就醫資料及處方中口服藥品的開方情形,包括兒童製劑在不同年齡兒童及不同特約別醫療院所使用情況、現有兒童製劑利用率、開方藥品與就醫診斷的相關性、固體劑型開立未滿1顆劑量之比例等,以了解目前兒童門診就醫及處方情形。 研究結果: 在9,268筆口服製劑的825種主成份及46種劑型中,經篩選共有3,077筆(33.20%)為適合未滿12歲兒童族群使用的兒童製劑,包括280種主成份(33.94%)及34種劑型(73.91%),其中適合未滿6歲兒童使用的則有1,620筆(17.48%),包括192種主成份(23.27%)及21種劑型(45.65%)。而這些兒童製劑依藥理分類以呼吸系統(如咳嗽及感冒、抗組織胺、阻塞性呼吸道疾病)、腸胃道及代謝(如胃酸相關疾病、功能性腸胃道疾病)、感染、神經系統、肌肉骨骼系統(如抗發炎及風濕)等類別之用藥品項為最多。 兒童門診處方部份,兒童就醫常見主診斷類別依序為呼吸系統疾病、消化系統疾病、徵候症狀及診斷欠明之各種病態,而最常見開方藥品類別也主要為呼吸系統與腸胃道及代謝等疾病之用藥。兒童製劑開方佔所有開方藥品的比例在未滿6歲兒童平均為21.18%(醫學中心、區域醫院、地區醫院、基層院所分別為63.02%、51.56%、45.46%、16.64%)、在6歲至未滿12歲兒童則為29.31%(醫學中心、區域醫院、地區醫院、基層院所分別為54.24%、50.15%、42.62%、27.30%),此比例明顯以基層院所最低;另外適當的兒童製劑品項中實際被開方利用者,僅佔所有品項的六成左右。醫師常開立的非兒童製劑藥品,其主成份大多皆有適當的兒童製劑可選擇。錠劑及膠囊的開方劑量未滿1顆者,在未滿6歲兒童平均比例為92.13%,而在6歲至未滿12歲兒童則為58.51%,其中非1/4或1/2顆之零散不易精確分割及量取劑量者即佔了一半以上,尤以基層院所最多。 結論: 台灣現有健保給付適合未滿12歲兒童的口服兒童製劑,其品項及主成份分別佔全部口服製劑的33.20%及33.94%,且這些製劑在各藥理分類所佔比例與兒童疾病診斷之分佈相當一致,表示兒童製劑符合兒童之用藥需求。但實際上兒童製劑佔門診的開方比例卻不到三成,尤其在基層院所最低,這代表許多兒童在用藥時是使用不適當的成份或者劑型含量。另外這些兒童製劑在兒童的利用率也不高,可知兒童製劑並未被充分利用。 Background: There are usually some problems of the pharmacotherapy in children in Taiwan. Many medicines lack pediatric indications and dosing information for children, and many oral formulations are not easy for children to take, so the dosage forms need to be modified before administration. In Taiwan, we usually pulverize the tablets or open the capsules to make powder packages for children, and there might be errors during each steps of the extemporaneous compounding. We need to know whether it is due to deficiency or low utilization of pediatric formulations. Objective: The availability and utilization of pediatric oral formulations in Taiwan were unknown. We wanted to investigate how many oral formulations are appropriate for children, and what the prescription patterns of these products are in Taiwan. Materials and Methods: The materials we used were the formula issued by the Bureau of National Health Insurance in July, 2009, as well as the claim data of the longitudinal database and registration datasets from the National Health Insurance Research Database between 2005 and 2007. The criteria of pediatric formulations appropriate for children younger than 12 years of age we used included whether there’re label indications and dosing information for children, as well as appropriate unit doses and dosage forms for them. We then screened oral pediatric formulations from the products with health insurance reimbursement based on these criteria. We devided them into formulations for children younger than 6 y/o and those for children 6-12 y/o, and then discussed the composition and sufficiency of these pediatric formulations. Then a retrospective study was performed. We analyzed the prescription patterns of outpatient children, including the prescribing rate and utilization of pediatric formulations, the correlation between the medications prescribed and the diagnoses of children, the rate of prescribed dosage less than 1 tablets/capsules, etc.. Results: 825 components and 46 dosage forms constituted all 9,268 oral formulations included in this study. There're 3,077 (33.20%) pediatric formulations for children younger than 12 y/o that contained 280 (33.94%) components and 34 (73.91%) dosage forms. 1620 of them (17.48%) were suitable for children younger than 6 y/o and these contained 192 (23.27%) components and 21 (45.65%) dosage forms. The most common pharmacological groups of these formulations were agents for respiratory system, alimentary tract and metabolism, antiinfectives, nervous system, and muscle-skeletal system. The main diagnoses of children were diseases of respiratory system, digestive system, and signs, symptoms and ill-defined conditions. And the most often prescribed agents were those used for respiratory system, and alimentary tract and metabolism. The prescribing rates of pediatric formulations were 21.18% in children younger than 6 y/o, and 29.31% in children between 6 and 12 y/o. The rate was significantly lower in local clinics than in other health institutes. Besides, only about 66% of all pediatric formulations were ever prescribed in children. There’re actually appropriate pediatric formulations for most main ingredients of the non-pediatric formulations prescribed. Many solid dosage forms were prescribed less than 1 tablet/capsule, and more than half of them were dosages other than 1/4 or 1/2 that made the accurate devision difficult. Conclusions: There're 33.20% oral formulations and 33.94% generic components suitable for children younger than 12 y/o. The distribution of the pharmacological groups of pediatric formulations and the diagnoses of children were pretty similar, which meant these met the usual needs of children. But the average prescribing rate of pediatric formulations was only about 20-30%, so many children got their medications with inappropriate components, doses, or dosage forms, especially in local clinics. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/45377 |
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顯示於系所單位: | 臨床藥學研究所 |
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