關於varenicline (Champix®)的安全性﹑risperidone (Risperdal®)和ropinirole (Requip®)的調配錯誤以及兒童服用paracetamol的劑量建議的最新資訊 Latest updates on safety of varenicline (Champix®), medication errors between risperidone (Risperdal®) and ropinirole (Requip®) and paracetamol d

Varenicline (Champix®)與心血管不良事件

        根據一項在700位患有心血管疾病的吸煙人士中使用varenicline (Champix®)或安慰劑的隨機﹑雙盲臨床試驗結果, 雖然兩者在整體上發生心血管不良事件的機率不高, 但相對服用安慰劑的病人, 使用Champix®治療的病人會出現較多的包括心臟病發在內的突發病症。由於該項試驗在設計上未能對安全性的臨床指標作出具有統計學差異的結論, 美國食物及藥物管理局(USFDA)將會繼續評估Champix®對心血管系統的風險。基於上述原因, 藥物監測暨管理處提醒醫生﹑藥劑師及其他衛生專業人士:

1.  吸煙是引起心血管疾病的一項獨立及主要的危險因子, 而Champix®有助於病人戒除煙癮。

2. 注意在患有心血管疾病並有使用Champix®的病人當中, 曾有少許心血管不良事件的個案報道, 當中包括心絞痛﹑非致死性的心肌梗塞以及外周血管疾病。

3. 對於患有心血管疾病的吸煙病人, 如需處方Champix®, 應衡量已知的效益及潛在的風險。

4. 對於獲處方Champix®的病人, 教導他們若出現心血管疾病的症狀, 如呼吸短促或困難﹑胸部疼痛﹑步行時腿部疼痛或這些症狀惡化時, 需向醫生求診

 

Risperidone (Risperdal®) ropinirole (Requip®):因名稱相近引起的調配錯誤

        Risperidone (Risperdal®)是治療精神分裂症﹑雙極症以及自閉症相關的激動症等精神疾病的抗精神病藥物, ropinirole (Requip®)是治療柏金遜病和腿不寧綜合症的多巴胺激動劑。美國食物及藥物管理局(USFDA)關注有病人錯誤地獲發Risperdal®或Requip®的藥物調配錯誤的報告, 某些服用了錯誤藥物的病人更需住院。兩藥混淆的原因是多方面的, 包括:

1. 商品名和通用名皆相似。

2. 外包裝和標籤相似。

3. 錯誤地書寫處方。

4. 藥物特性的各種類同, 如規格﹑劑型以及給藥間隔。

        基於上述原因, 藥物監測暨管理處建議醫生﹑藥劑師及其他衛生專業人士:

1. 確保處方上列印的藥物名稱是清楚的。

2. 詢問病人關於獲處方的藥物, 以確保病人知悉其用途, 處方上含有藥物的治療用途可有助確保病人服用正確的藥物。

3. 不管藥物儲存在藥架上或任何地方, 建議藥劑師將兩藥分開擺放

4. 如處方不合理, 或藥物名稱不清晰, 藥劑師應向醫生確認。

 

Paracetamol:兒童服用paracetamol 更確切的劑量建議

        英國藥物管理局(MHRA)近期建議更新兒童服用含有paracetamol液體製劑時的有關劑量, 該建議更仔細地劃分年齡層, 根據年齡層列出相應的劑量如下:

  

規格

現行

                          建議

年齡

劑量

年齡

劑量

120mg/5mL

3個月至1歲

2.5mL

3至6個月

2.5mL

1至6歲

5 至10 mL

6至24 個月

5mL

2至4歲

7.5mL

4至6歲

10mL

240或250 mg/5mL

6至12歲

5 至10 mL

6至8歲

5mL

8至10歲

7.5mL

10至12歲

10mL

 

       上述建議是為了確保兒童獲得與其年齡相應最合理的paracetamol劑量, 並不是因為現行採用的劑量存在安全性方面的問題。醫生仍可按照現行的劑量處方該藥, 但應按照說明書的建議, 不要超出每日建議服用的最大劑量。

 

Varenicline (Champix®) and cardiovascular adverse events

        A randomized, double-blind clinical trial of 700 smokers with cardiovascular disease who were treated with varenicline (Champix®) or placebo indicated while cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with Champix® than in patients treated with placebo. Owing to the trial was not designed to have statistical power to detect differences between the arms on the safety endpoints, the United States Food and Drug Administration (USFDA) is continuing to evaluate the cardiovascular safety of Champix®. In light of the above, Division of Pharmacovigilance and Pharmacoeconomics reminds physicians, pharmacists and other health professionals:

1. smoking is an independent and major risk factor for cardiovascular disease, and Champix® is effective in helping patients quit smoking.

2. be aware that a small of certain cardiovascular adverse events was reported in patients with cardiovascular disease receiving Champix®.  The events included angina pectoris, nonfatal myocardial infarction and peripheral vascular disease.

3. weigh the known benefits of Champix® against the potential risks deciding to use the drug in smokers with cardiovascular disease.

4. counsel patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking Champix® such as shortness of breath or trouble breathing, chest pain or pain in legs when walking.

 

Risperidone (Risperdal®) and ropinirole (Requip®): Medication errors due to name confusion

        Risperidone (Risperdal®) is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autistic disorder. Ropinirole (Requip®) is a dopamine agonist used in the treatment of Parkinson’s disease and Restless Legs Syndrome. The United States Food and Drug Administration (USFDA) is alerting the public to medication error reports in which patients were given Risperdal® instead of Requip® and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized. The causes of confusion between this two drugs are multi-factorial in nature including:

1. similarities of both the brand and generic names.

2. similarities of the container labels and carton packaging.

3. illegible handwriting on prescriptions.

4. overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.

        Therefore, Division of Pharmacovigilance and Pharmacoeconomics recommends physicians, pharmacists and other health professionals:

1.  be sure to clearly print the drug name on written prescriptions.

2.  counsel patients about their prescribed medication, making sure the patient understands its purpose. Including the medical reason for the medication on the prescription may help ensure the patient gets the correct medication.

3. pharmacists are advised to physically separate the stocks of these two drugs on the shelf or wherever they are stored.

4. pharmacists are advised to confirm the drug name with prescribers if the prescription is not legible or the drug name is not clearly stated.

 

Paracetamol: More exact paracetamol dosing for children to be introduced

        British’s Medicines and Healthcare products Regulatory Agency (MHRA) recently recommended an updated dosing for children’s liquid medicines containing paracetamol. The updated dosing will have a larger number of narrower age bands and will define a single dose per age band listed below:

strength

current

recommended

age

dose

age

dose

120mg/5mL

3 months to under 1year

2.5mL

3-6 months

2.5mL

1 year to under 6 years

5 to 10 mL

6-24 months

5mL

2-4 years

7.5mL

4-6 years

10mL

240 or 250 mg/5mL

6-12 years

5 to 10 mL

6-8 years

5mL

8-10 years

7.5mL

10-12 years

10mL

 

        The recommendation is to ensure children get the most optimal dose of paracetamol suitable for their age not because of safety concerns the dosage currently applied. Doctors can still prescribe paracetamol following the current dosing and should follow the advice on the packaging, making sure not to exceed the recommended daily maximum dose.

 

參考資料/References and websites:

https://www.fda.gov/Drugs/DrugSafety/ucm259161.htm

https://www.fda.gov/Drugs/DrugSafety/ucm258805.htm

https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON120251


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