國內BZD類鎮靜安眠藥處方情形評估

The assessment of Benzodiazepines hypnotics and sedatives prescription in Taiwan

潘建宇(Jian-Yu Pan)

指導教授 ： 譚秀芬

長榮大學/健康科學學院/醫務管理學研究所/碩士(2008年)

https://doi.org/10.6833/CJCU.2008.00162

摘要

研究動機：國內目前治療睡眠障礙之主要鎮靜安眠藥物為苯二氮平類藥物(BZD，Benzodiazepines)，相較於早期使用的巴比妥類藥物(Barbiturates)，BZD類鎮靜安眠藥具有較低的副作用及成癮性，但因使用上較為安全，產生處方劑量失當或藥物濫用之可能性則相對的提高。
研究目的：1.了解BZD類鎮靜安眠藥於我國門診之處方用藥型態，評估處方合理性。2.探討BZD類鎮靜安眠藥於我國門診處方疾患類型與醫院型態，分析並預測違反藥物使用規範之因素。
方法：研究資料為「全民健康保險研究資料庫」2004至2006年系統抽樣檔中之西醫門診處方治療明細檔及門診處方醫令明細檔，並與醫事機構檔、藥品主檔連結成整體資料庫，以SAS 9.1及SPSS 12.0版統計軟體進行資料處理與統計分析。除進行整體描述統計外，亦定義違反BZD類藥物使用規範之處方型態，與病患性別、年齡、就醫科別、診斷型態、醫院層級進行ANOVA、X2等推論性統計以探討之間差異，並以邏輯斯迴歸分析預測違反藥物使用規範之高風險族群。
研究結果：
處方型態部分，BZD類鎮靜安眠藥物於門診之使用率約2.94％，用藥金額平均為1,138元，給藥天數平均為20.13天，處方開立以短效藥居多，約占總處方BZD類鎮靜安眠藥門診人次之65.4％。以WHO ATC定義之標準日劑量(defined daily dose , DDD)為基數進行計算，BZD類鎮靜安眠藥物年平均耗用劑量約為370.82每千人日DDD。
處方合理性部分，本研究以二種違反規範指標評估，指標一、劑量為每日處方劑量與標準日劑量比值大於1 (PDD/DDD ratio＞1)：占總開立BZD類鎮靜安眠藥處方的20%，其中長效藥違規情形較為顯著，更以Flunitrazepam藥物之PDD/DDD ratio達2.7為最高。指標二、單次門診處方給藥天數超過28天：16.9％BZD處方給藥天數過長。
邏輯斯迴歸分析發現，控制其他影響變項後，門診處方長效BZD類鎮靜安眠藥時其劑量違規機率顯著高於短效及中效藥物(OR=1.95；95%CI: 1.74, 2.18)；FLUNITRAZEPAM成分藥物劑量違規機率顯著高於其他藥物(OR=16.35；95%CI: 14.19, 18.84)；女性患者處方BZD類鎮靜安眠藥產生劑量違規機率顯著低於男性，(OR=0.87；95%CI :0.826, 0.918)；治療項目為精神疾病時產生劑量違規機率顯著高於非精神疾病(OR=1.27；95%CI: 1.19, 1.362)；相較於基層院所，地區醫院(OR=1.32)、區域醫院(OR=1.11)及醫學中心(OR=1.19)其產生劑量違規機率均顯著的增加。
在違反建議給藥天數部分，控制其他變項後，治療項目為精神疾病產生違規給藥天數的機率顯著較非精神疾病高(OR=1.45; 95%CI: 1.35, 1.56)；年齡每增加一歲，產生違規給藥天數的機率顯著增加(OR=1.01; 95%CI: 1.00, 1.01)。
結論：經研究結果發現，西醫門診處方開立BZD類鎮靜安眠藥之情形，平均處方日劑量略高於標準日劑量，平均給藥天數未超過BZD類藥物使用規範之建議天數；儘管精神科仍為此類藥物最常開立之科別，但產生處方違規情形卻同時出現於家醫科及內科，且處方該藥之病患疾病型態除了精神類疾病，同時也包括高血壓、糖尿病等一般常見疾病。此外，俗稱FM2之“Flunitrazepam”藥物，其劑量違規情形遠高於其他BZD類鎮靜安眠藥物，將近16倍之多，故需更加關注該藥於門診之處方開立情況。故本研究建議醫師於門診開立BZD類鎮靜安眠藥時應減少非必要之處方開立且需加強BZD類藥物依賴及濫用案件的通報，並了解不合理藥物使用之原因；此外，建立鎮靜安眠藥物安全資訊系統，針對易處方違規藥物及其他風險因素進行監測與管理。

關鍵字

BZD鎮靜安眠藥物 ； 處方違規 ； 標準日劑量

並列摘要

Background: At present , BZD（Benzodiazepines）hypnotics and sedatives is the main treatment for sleep disorder in Taiwan, BZD also has less side effect and addiction than Barbiturates. Therefore, because of BZD’s safety for use, the possibility of dosage violation and drug abuse might be increased.
Objective:1.To know outpatients’ prescription patterns of BZD hypnotics and sedatives in Taiwan and to assess the rationality of prescription. 2.To probe into patients and hospitals’ patterns related to prescribed BZD hypnotics and sedatives and to analyzed and indicate risk factors that violated BZD’s using guideline.
Method: Data source is “National Health Insurance Research database” from years 2004 to 2006, sampling database of CD and OO dataset. Besides, In order to figure the entire analysis database, this study also connects with HOSB and DRUG dataset. This study use SAS 9.1 and SPSS 12.0 statistics software as tool to data programming and statistics analysis. In addition to the overall description, this study also defines patterns of BZD’s prescription which violates drug using guideline. And we use ANOVA、χ2 test to probe different prescription between various patient types(gender、age and diagnosis..) And hospital types (level and area...). Besides, this study uses Logistic Regression to predict and analyze high risk factors that violate BZD’s using guideline.
Result:In the part of prescription patterns, BZD’s prescribed prevalence in outpatient is about 2.94%, Drug average amount were 1,138 dollars, drug prescribed days average were 20.13. Short-term drugs were most frequent prescribed; it’s about 65.4% of all the outpatients that prescribed BZD hypnotics and sedatives. If we use“WHO ATC-Defined daily dose”as the measured base between all kinds of BZDs, the year-average numbers of DDDs per 1000 inhabitants per day was estimated to be 370.82.
In the part of rationality of prescription, this study defines two violated indexs. Index 1 as PDD/DDD ratio>1, estimated to be 20% of all the BZD’s outpatients prescription, and long-term BZDs’ violation were more significant; Flunitrazepam’s PDD/DDD about 2.7 was the highest. Index 2 as prescribed days over 28 days, prescribed-days violation was estimated to be 16.9%.
After control other effected variable, in the part of dosage-violate,long-term BZDs’ violated probility was significant higher than short-term and mid-term BZDs（OR=1.95;95%CI:1.74, 2.18）; Flunitrazepam’s violated probility was higher than other BZDs（OR=16.35 ;95%CI:14.19, 18.84）; Female’s violated probility was lesser than male（OR=0.87;95%CI:0.826,0.918）; treatment of mental disorder’s violated probility was higher than non-mental disorder（OR=1.27;95%CI:1.19,1.362）;Local hospital（OR=1.32）、Regional hospital（OR=1.11）、Medical center（OR=1.19）were higher than Primary care unit.
After control other effeted variable, treatment of mental disorder’s prescription -days violated probility was higher than non-mental disorde（OR=1.45;95%CI: 1.35,
1.56）; Increase by one years old each time, violation probability doubles apparently（OR=1.01;95%CI:1.00,1.01）.
Conclusions: As the results of study, outpatients prescribed BZD hypnotics and sedatives in Taiwan, prescribed daily dose was slightly higher than WHO define daily dose. Average prescribed day has not exceeded suggestion days of the BZD medicine use guidelines. Though psychiatric department still prescribed BZDs most frequently, violate prescription occurred in family's medicine and internal medicine at the same time.Etiher mental disorder or general common diseases as high blood pressure, diabetes were observerd to prescribe BZDs. In addition, the Flunitrazepam’s dosage violation is higher than other BZDs, nearly 16 times. So we need to pay more attention to BZDs’ prescription in clinical. This study advise doctor should reduce unessential prescription and strengthen report of BZDs dependent and abuse, understand the reason of BZDs’ misuse ; Furthermore, establish information system of hypnotics and sedatives to monitor and manage risk factors that easily violated.

Keywords: BZD hypnotics and sedatives, violated prescription, defined daily dose

並列關鍵字

BZD hypnotics and sedatives ； violated prescription ； defined daily dose

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