醫師特質對於開立FDA D與X級妊娠藥品之相關性分析

The association between physician characteristics and the prescription of FDA category D and X drugs

陳耀宗(Yao-Tsung Chen)

指導教授 ： 林恆慶

臺北醫學大學/公共衛生暨營養學院/醫務管理學研究所/碩士(2012年)

https://doi.org/10.6831/TMU.2012.00130

摘要

目的：美國藥物及食品管理局FDA為確保孕婦有安全的用藥環境，曾將藥品對胎兒所受之風險程度做分級管理。其中，尤其是D與X級這類妊娠藥品，更是需要受到監控與管制。依據國外研究顯示，婦女在懷孕期間仍無法完全避免妊娠處方藥品所帶來的危害，致使孕婦藥物使用情形，持續備受關注。該類妊娠藥品的使用情形，很有可能會因為不同的治療醫師，而產生不一致的用藥結果。所以，本研究主要目的是欲探討醫師特質與懷孕婦女使用D與X級處方藥品的關聯性。
方法：本研究以國家衛生研究院2004~2008年全民健康保險資料庫承保抽樣歸人檔，作次級資料分析。我們首先篩選出懷孕日期小於270天的14,430位孕婦，並藉由其就診期間之19,8420筆處方用藥紀錄，加以分級後，再進行分析。之後，在比對9,929位醫師對於上述處方的開立情形，以瞭解醫師特質對於開立FDA D與X級妊娠藥品之相關性。
結果：本研究在控制孕婦年齡及慢性病特徵後，分析醫師特質對於D與X級妊娠藥品的關聯性。首先，以醫師年齡結果顯示，若以30-39歲為參考族群，40-49歲的族群勝算比為1.23倍（95％CI＝1.16-1.31）、50-59歲的族群勝算比為1.53倍（95％CI＝1.43-1.64）；以醫師性別而言，男性醫師勝算比為女性醫師的0.68倍（95％CI＝0.63-0.73）；醫師科別，其他科別勝算比為婦產科的1.47倍（95％CI＝1.41-1.54）；最後，醫師執業區域，中區勝算比為北區的0.85倍（95％CI＝0.80-0.89）。如再進一步深入分析懷孕第一期醫師特質對於D與X級妊娠藥品的關聯性，則發現與懷孕全期的結果略為產生不同的現象。以醫師年齡來而言，40-49歲、50-59歲與大於59歲之族群，其勝算比分別為30-39歲族群的1.26倍（95％CI＝1.14-1.39）、1.50倍（95％CI＝1.34-1.68）與1.35倍（95％CI＝1.11-1.65）；醫師性別，男性醫師勝算比為女性醫師的0.63倍（95％CI＝0.56-0.71）；醫師科別，其他科別勝算比為婦產科的1.23倍（95％CI＝1.14-1.33），其結果，大致與懷孕全期相符。醫師執業區域，南區與東區勝算比為北區的1.12倍（95％CI＝1.03-1.22）及1.60倍（95％CI＝1.27-2.01）。
結論：本研究結果推論，醫師部份特質對於所開立之D與X級妊娠藥品確實會有相關。醫師年齡較大者（懷孕第一期結果亦同）、女性醫師（懷孕第一期結果亦同）、非婦產科醫師（懷孕第一期結果亦同）與不同區域之醫師，其D與X級藥品的開立行為具相關性。建議衛生主管機關應加強宣導妊娠藥物相關的使用規範，特別是針對懷孕第一期的孕婦，醫師在D與X級處方藥品的使用上應更為謹慎開立，以避免胎兒曝露在該類藥物的環境之中。

關鍵字：醫師特質、妊娠、藥物及食品管理局、D與X級處方藥品

關鍵字

醫師特質,妊娠,藥物及食品管理局,D與X級處方藥品

並列摘要

Abstract
Title of Thesis：The association between physician characteristics and the prescription of
FDA category D and X drugs
Author：Yao-Tsung Chen
Thesis advised by：Herng-Ching Lin, Ph. D.
Purpose：To ensure a safe medication for pregnant women, The Food and Drug Administration (FDA) in the United States categories prescription medications for use in pregnancy according to fetal risk. It needs to be monitoring and control for the drugs falling into FDA pregnancy category C and X. Studies have shown that pregnant women using either prescribed or medications during pregnancy results in harmful effects for mother and fetus. The effects of prescription medications used during pregnancy are required to be attention continually. The use of different drugs prescriptions for pregnant women from different physicians has different results. The main purpose of this study is to investigate the correlation between the characteristic of physician and pregnant patients’ prescriptions falling into FDA pregnancy category D and X.
Methods：This was a retrospective cohort study in which data from Large Health Insurance Dataset in National Institutes of Health from 2004 to 2008 was secondary data analyzed. The study comprised 14430 pregnant women whose pregnant day was less than 270 days and 198420 medicine prescriptions. These prescriptions were analyzed after classification. Next, we tried to understand physicians characteristics influences of prescriptions falling into FDA pregnancy category D and X by comparing 9929 physicians’ prescriptions
Results： The aim of study is to analyze the relation of physician characteristics for pregnancy D and X drug. First, the result of physician age expressed, if based on 30-39 age group, the odd ratio (OR) of 40-49 age group is 1.23 (95％CI＝1.16-1.31), 50-59 age group is 1.53 (95％CI＝1.43-1.64). Physician gender showed that OR is 0.68 (95％CI＝0.63-0.73) for male vs. woman and physician department showed that OR is 1.47 (95％CI＝1.41-1.54) for other department vs. Obstetrics and Gynecology. Finally, physician practice area showed that OR is 0.85 (95％CI＝0.80-0.89) for Central vs. North.
If further analysis to the relation of physician characteristics for pregnancy D and X drug on first trimester of pregnancy, it would find slight difference from full term pregnancy. For example, physician age expressed that if based on 30-39 age group, OR of the 40-49 age group is 1.26 (95％CI＝1.14-1.39)、the 50-59 age group is 1.26 (95％CI＝1.14-1.39) and more than 59 age group is 1.35 (95％CI＝1.11-1.65). Physician gender showed that OR is 0.63 (95％CI＝0.56-0.71) for male vs. woman and physician department showed that OR is 1.23 (95％CI＝1.14-1.33) for other department vs. Obstetrics and Gynecology. The result is similar between first trimester of pregnancy and full term pregnancy. Physician practice area showed that OR is 1.12 (95％CI＝1.03-1.22) for South vs. North and 1.60 (95％CI＝1.27-2.01) for Easter vs. North.
Conclusion：The results suggest that some of physician characteristics have an impact on prescribing drug for pregnancy category D and X. The characteristics are older physicians, female physicians, Non-gynecologists and different regions. (The result is consistent with the first trimester of pregnancy).
It is recommended that the health authorities take more importance and declaration about the medication guides of Gestation, especially for the first trimester of the women during pregnancy.
Physician should be noted that the use of category D and X medications for pregnancy women avoids fetus being exposed unnecessarily to these medications.

Keywords：physicians characteristics, pregnancy, Food and Drug Administration(FDA),
prescribing drug for pregnancy category D and X

並列關鍵字

physicians characteristics, pregnancy, Food and Drug Administration(FDA), prescribing drug for pregnancy category D and X

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