換藥對慢性病照護結果的影響-以某區域教學醫院糖尿病病人為例

The Impact of Medication Switches on Care Outcome: A Case of Diabetes Patient at a Regional Teaching Hospital in Northern Taiwan

官玫秀(Mei-Hsiouh Guan)

指導教授 ： 鄭守夏

國立臺灣大學/公共衛生學院/健康政策與管理研究所/碩士(2021年)

https://doi.org/10.6342/NTU202100889

摘要

研究背景：
每兩年一次的藥品聯合招標，結果總是會造成換藥潮，雖然各醫院對藥品聯合招標訂有相關的藥品品質管控規範，但部分的醫師仍對此換藥潮充滿不安全感，認為聯合採購會造成藥品品質下降或是需頻繁更換廠牌而影響照護品質。某區域教學醫院自2014年起採用最有利標決標的方式進行藥品招標，其目的是為了在藥品價格的競爭中能同時兼顧藥品品質與藥品價格。該區域醫院於2019年進行兩年一度的藥品聯合招標，決標結果部分病患長期使用的原廠藥未得標，被學名藥取代，決標品項公告後，院內部分醫師、藥師，甚至病患開始擔憂原廠藥未得標會影響照護品質，顯示其對學名藥缺乏信心，也對最有利標的制度產生懷疑。

各國主管機關多以生體相等性（bioequivalence, BE）試驗或通過生體可用率（bioavailability, BA）的方式來證實學名藥的療效及安全性與原廠藥無異，但臨床上醫師或病人常反應改用學名藥之後，療效不佳，需調高劑量才能達到原有原廠藥的療效，不過這些抱怨總是雷聲大雨點小，在「藥品療效不等通報系統」通報的數字上並未能反應出這個問題。

研究目的：
兩年一次藥品招標換藥的政策及學名藥與原廠藥的療效是否相等一直受到質疑，本研究希望能藉由臨床研究加以探討，期望有助於釐清醫療人員及病患的疑慮，也可減輕兩年一次的藥品聯合招標政策造成的衝擊。

研究方法：
以糖尿病共同照護網的病人為例，利用院內醫療資訊系統資料庫為資料來源，分析醫院常用的兩個原廠藥（Actos®, Crestor®）未得標，醫師換藥之後造成的療效影響，比較換藥組與對照組換藥前後的檢驗值的差異，檢驗值分為別HbA1c及LDL，並以差異中的差異分析法做進一步探討。同時分析原廠藥用罄後醫師的處方行為及換藥三個月後醫令處方是否再有變動等情形。另外以問卷探討糖尿病照護網病患對於藥品聯合招標後，可能面臨以三同藥品替代原本藥品治療的感受與意見，問卷同時也分析病患用藥順從性的狀況。

研究結果：
高血糖照護結果，換藥組，換藥前及換藥後HbA1c平均分別為7.08 ± 1.09 %及7.04 ± 0.97 %；對照組，換藥前及換藥後HbA1c平均分別為6.93 ± 1.15 %及6.91 ± 1.07 %；換藥組p=0.063，對照組p=0.059，兩組內換藥前後的HbA1c並沒有統計上的差異。換藥組與對照組HbA1c前後差異分別為0.0424 %及0.0209 %，p值為0.243大於0.05，兩組間前後的差異沒有統計上的顯著差異。

高血脂照護結果，換藥組，換藥前及換藥後LDL平均分別為82.79 ± 30.02 mg/dl及83.35 ± 26.18 mg/dl；對照組，換藥前及換藥後LDL平均分別為83.80 ± 24.84 mg/dl及83.74 ± 24.66 mg/dl；換藥組p=0.319，對照組p=0.467，組內換藥前後的LDL並沒有統計上的差異。換藥組換藥後的LDL比換藥前高，差異為0.56 mg/dl；對照組換藥後的LDL較換藥前低，差異為0.06mg/dl；p值為0.326大於0.05，兩組間前後的差異沒有統計上的顯著差異。

問卷結果，有關降血糖藥物的療效，63.1 %表示效果差不多；19.8 %覺得效果好一點；17.1 %覺得效果差一點。降血脂藥物療效狀況依次為效果差不多佔63.1 %；效果差一點佔19.8 %，效果好一點有17.1 %。對於換藥後副作用的狀況，63.1 %表示沒有副作用；18 %表示副作用沒有什麼改變；其他依次11.7 %為副作用變多/嚴重；7.2%為副作用變少/輕微。

結論：
研究結果發現，換藥不會對慢性病照護的結果造成影響，即使是由原廠藥替換成同成分、同含量、同劑型的台廠藥，其照護結果還是相當。這也代表著使用最有利標的招標方式，可以找到品質良好的同等品，在節省藥品成本支出之虞，一樣可以兼顧照護品質，本研究同時也從臨床面證明學名藥的療效沒有比原廠藥差。

從病患角度來看，只有一成多的患者反應糖尿病或高血脂藥物療效變差，或表示換藥後藥物副作用增加，高達八成多的病患表示換藥後效果或副作用與換藥前差不多。

兩年一次藥品招標是可行的政策，沒有證據顯示會對慢性病患的照顧有比較差的結果，可有效的降低醫院藥品成本的支出，另外同時也可支持政府的「三同」政策推動，以節省健保藥品費用。

關鍵字

藥品聯合招標 ； 換藥 ； 療效相等 ； 原廠藥 ； 學名藥 ； 照護結果

並列摘要

Background:
The two-yearly pharmaceutical tender policy always results in a big change of hospital formulary. The result of pharmaceutical tender in 2019, two commonly used brand name drugs are replaced by generic drugs. Some doctors, pharmacists and even some patients start to worry about the result might lead to poor quality of care outcome.

Competent authorities in various countries mostly use bioequivalence (BE) or bioavailability (BA) to verify the efficacy and safety of generic drugs are no different from brand name drugs. But in clinical practice, doctors or patients frequently complain about the efficacy of generic drugs after medication switches, but the " Post-Marketing Drug Quality Management Reporting System" did not reflect this problem.

Objective:
This study aims to analyze the impact of medication switches on care outcome. The medication switches were the result of the pharmaceutical tender. This research is to understand whether the biennially pharmaceutical tender policy will influence the care outcome and to understand whether generic drug and brand name drug are therapeutic equivalents.

Methods:
Using Hospital/Medical Information System (HIS) database as a data source, this research will analyze care outcome when two band name drugs (Actos®, Crestor®) were replaced by generic drugs after pharmaceutical tender. We will compare difference of lab test result (HbA1c and LDL) between treatment group and control group to investigate the effect of medication switches. Study will also analyze doctor’s prescription behavior once the medications were no longer in the hospital formulary and 3 months after that. In addition, a questionnaire was used to explore the concern and opinions of pharmaceutical tender and related medication switches, as well as analyzing the medication adherence status among patients in the diabetes shared care network.

Result:
In hyperglycemia treatment, there was no statistical difference in HbA1c before and after medication switches in treatment and control groups. There was no statistical difference in difference of HbA1c before and after medication switches between treatment and control groups. The same result can be found in LDL in dyslipidemia treatment.

According to the results of the questionnaire, 63.1% said that the effect of hypoglycemic drugs was similar; 19.8% felt better; 17.1% felt a little worse. Regarding the effect of the lipid-lowering drugs, 63.1% felt similar; 17.1% felt better; 19.8% felt a little worse. Regarding the side effects, 63.1% said that there was no side effect; 18% felt no difference; 11.7% felt more/severe; 7.2% felt less/slight.

Conclusion:
The results of the study found that medication switches will not affect the care outcome of chronic disease, even if the brand name drug is replaced by a generic drug. This means that pharmaceutical tender policy can be used to find good-quality equivalent and cost-saving products. This study also proves clinically that the efficacy of the generic drug and the brand name drug are therapeutic equivalent.

Only about 10% of patients report that the effects of hypoglycemic/ lipid-lowering drugs have deteriorated, or side effects have increased. Up to 80% of the patients felt that the drug effects or side effects are similar or better to those before the medication switches.

Keyword：Medication Switches、Therapeutic Equivalents、Brand Name Drug、Generic Drug、Care Outcomes

並列關鍵字

Medication Switches ； Therapeutic Equivalents ； Brand Name Drug ； Generic Drug ； Care Outcomes

參考文獻

英文參考文獻

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