⑻ PZA

二、下列內文為美國 FDA 於今年六月十五日發布有關 pioglitazone 的安全訊息，請說 明遇有民眾詢問時，藥師應如何答覆？並討論我國藥品安全的機制應如何提昇？ （20 分） Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The Patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. This safety information is based on FDA's review of data from a five-year interim analysis of an ongoing, ten-year epidemiological study. The five-year results showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone. FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients. Additional Information for Patients, Information for Healthcare Professionals, and a Data Summary are provided in the Drug Safety Communication. FDA recommends that healthcare professionals should: ․ Not use pioglitazone in patients with active bladder cancer. ․ Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence. FDA will continue to evaluate data from the ongoing ten-year epidemiological study. The Agency will also conduct a comprehensive review of the results from the French study. FDA will update the public when more information becomes available.

三、何謂 Medication reconciliation？並就臺灣執行之現況予以討論。（8 分）

四、影響病人服藥順從性的因素十分多元，除了個人行為理論模式外，與藥品治療有關 的因素有那些？（8 分）

五、請討論於藥事作業中可應用那些電腦自動化技術，以提昇用藥安全，並舉實例說明 之。（20 分）

六、近來因食品添加物含有不法塑化劑事件而引起食品安全的風暴，並重創臺灣產品形 象。請說明藥品中是否可用塑化劑？其用途為何？如遇民眾詢問，藥師應如何回答？ （20 分）

⑴泊松比（Poisson Ratio）

⑵波線參數（ray parameter）

⑶規模（magnitude）及震度（intensity）

⑷ Gutenberg-Richter relationship（G-R law）

⑸Pn

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