懷孕期間處方用藥很常見 而這可能太頻繁了


  【24drs.com】研究者在一篇大型的人口基礎研究中發現,雖然大部分醫師知道為孕婦開藥的複雜性,但仍是經常為她們開藥。超過8成(82.5%)孕婦有被至少處方一個藥品,42.0%被處方的某一項藥品對於發育中的胎兒可能有危害。
  
  根據加州大學聖地牙哥分校Kristin Palmsten博士等人指出,這篇研究詳列Medicaid保險之孕婦被處方的藥品類型與時間,提出了一個令人不安的模式,這篇世代研究的結果線上發表於7月31日,將登載於9月版的婦產科期刊。
  
  Palmsten博士等人發現,最常被處方的藥品是被用來治療感染,他們也報告指出,較年輕的孕婦與白人孕婦比較常被處方。
  
  研究者檢視了在懷孕前即納入Medicaid保險之婦女(n = 1,106,757人)的資料,使用2000-2007年的Medicaid Analytic eXtract資料進行前瞻性的藥物資訊蒐集,分析時也包括了由藥師調劑的指示藥,但是未納入研究對象直接購買的成藥或住院期間用藥。
  
  最常被處方的藥物是nitrofurantoin (21.6%)、metronidazole (19.4%)、amoxicillin (18.0%)、azithromycin (19.9%%)、以及promethazine (13.5%);其他比較常被處方的藥品包括promethazine cephalexin以及codeine與acetaminophen。
  
  與35歲以上婦女相比,年輕婦女(<20歲)更可能被開立nitrofurantoin (23.9% vs 15.4%)、metronidazole (20.7% vs 12.0%)、以及azithromycin (21.1% vs 11%)。
  
  研究者也指出,根據致畸胎資訊系統,最常被處方的20種藥物中,有9種被分類為「對人類之致畸胎風險的資料質量相當有限。
  
  Palmsten博士等人也發現,42.0%孕婦的處方中有屬於美國食品藥物管理局(FDA)的「懷孕用藥等級D或X」藥品;等級D的藥品表示,根據不良反應數據,有與人類胎兒風險相關的證據,最常見處方的5種等級D藥品為:codeine (11.9%%)、hydrocodone (10.2%%)、ibuprofen (4.9%%)、sulfamethoxazole (4.0%%)、以及hydrocortisone (4.0%)。作者們指出,根據使用情況,這些藥品有時候可被視為等級B或C。
  
  等級X的藥品,則是在動物或人類試驗中發現會引起胎兒畸形。最常見處方的5種等級X藥品為:荷爾蒙避孕藥(4.9%)、temazepam (0.11%)、atorvastatin (0.07%)、simvastatin (0.04%)、以及warfarin (0.04%)。
  
  此外,研究者指出,最常被處方的藥品中,有許多的懷孕安全資料相當有限或者是資料的證據等級低。他們寫道,缺乏明確的安全資訊會導致使用藥物時有可能引起不良的懷孕結果,而有幫助的藥品則可避免此風險。
  
  有許多鴉片類藥物屬於等級N,表示FDA沒有將該藥品分類。俄亥俄州克里夫蘭凱斯西儲大學Mallory E. Kremer醫師和Kavita Shah Arora醫師在發表的相關評論中,提出治療鴉片成癮孕婦有關的臨床、法律與倫理考量。
  
  他們結論指出,產科醫師必須清楚,成癮是一種慢性疾病,而不是道德上的失敗。針對有慢性疾病的孕婦追究刑事責任,在醫學上與倫理上都是不適當的,且會加重社會對她們的汙名化。對這些婦女之自主權的法律侵犯,更突顯出她們在社會中的弱勢角色。
  
  雖然孕婦複雜之用藥問題的解決方案還不明確,但FDA做出了一項改變,旨在更佳地告知醫療服務提供者和病人有關的藥物風險。截至2015年6月30日,FDA已改變了用於孕婦與哺乳婦之人類處方藥品與生物製劑的標示方法,新版標示將會包括該藥品在懷孕期間的風險摘要。
  
  婦產科期刊主編Nancy C. Chescheir醫師在編輯評論中寫道,有關此議題的一些文獻加上聯邦當局的警覺,影響了我們對孕婦的處方習慣,這將可改善患者需要接受藥品時的照護品質。
  
  資料來源:http://www.24drs.com/
  
  Native link:Prescription Meds Common in Pregnancy; Maybe Too Common

Prescription Meds Common in Pregnancy; Maybe Too Common

By Lara C. Pullen, PhD
Medscape Medical News

Although most physicians acknowledge the complexity of prescribing drugs to pregnant women, they nonetheless prescribe them frequently. More than four of five (82.5%) pregnant women were prescribed at least one medication, and 42.0% were prescribed a drug that is potentially harmful to the developing fetus, researchers found in a large, population-based study.

The study, which details the type and timing of medications prescribed to pregnant Medicaid patients, presents a disturbing pattern, according to Kristin Palmsten, ScD, from the University of California, San Diego, in La Jolla, and colleagues. The authors published the results of their cohort study online July 31 and in the September issue of Obstetrics & Gynecology.

Landscape Now

Dr Palmsten and colleagues found that the most commonly dispensed medications are those used to treat infections. They also report that dispensing is more common for younger pregnant women and white women.

The researchers examined data for women enrolled in Medicaid before pregnancy (n = 1,106,757), using 2000 to 2007 Medicaid Analytic eXtract data for prospectively collected medication information. The analysis included over-the-counter medications dispensed by a pharmacist, but excluded medications purchased over the counter directly or prescribed during hospitalizations.

The most commonly dispensed medications were nitrofurantoin (21.6%), metronidazole (19.4%), amoxicillin (18.0%), azithromycin (19.9%), and promethazine (13.5%). Other frequently dispensed medications include promethazine cephalexin and codeine with acetaminophen.

Compared with women older than 35 years, younger women (<20 years) were more likely to receive nitrofurantoin (23.9% vs 15.4%), metronidazole (20.7% vs 12.0%), and azithromycin (21.1% vs 11%).

The investigators also note that nine of the 20 most commonly dispensed medications are rated as having limited to fair data quality and quantity to inform human teratogenic risk assessments by the Teratogen Information System.

Drugs That May Cause Harm

Dr Palmsten and colleagues also found that 42.0% of pregnant women filled a prescription for a former US Food and Drug Administration (FDA) category D or X drug during pregnancy. Category D medications are associated with evidence of human fetal risk based on adverse reaction data. The top five most commonly prescribed category D medications were codeine (11.9%), hydrocodone (10.2%), ibuprofen (4.9%), sulfamethoxazole (4.0%), and hydrocortisone (4.0%). The authors note that some of those agents are considered category B or C drugs, depending on the circumstances of use.

Class X medications have been tested in animals or humans and found to cause fetal abnormalities. The five most commonly prescribed category X drugs were hormonal contraceptives (4.9%), temazepam (0.11%), atorvastatin (0.07%), simvastatin (0.04%), and warfarin (0.04%).

Moreover, the researchers note that many of the most commonly dispensed medications have limited or low-quality data available regarding safety during pregnancy. “Lack of unambiguous safety information may lead to the use of medications with potential to cause adverse pregnancy outcomes, whereas beneficial medications may be avoided,” they write.

Many opioids are category N, meaning the FDA has not classified the drug. An accompanying commentary by Mallory E. Kremer, MD, and Kavita Shah Arora, MD, MBE, from Case Western Reserve University in Cleveland, Ohio, described the clinical, legal, and ethical considerations associated with treating pregnant women who are addicted to opioids.

They conclude that "obstetricians must be clear: addiction is a chronic disease and not a moral failing. Criminally targeting women for chronic health conditions in pregnancy is medically and ethically inappropriate and reinforces societal stigmas. Surreptitious legal encroachments on women's autonomy highlight their continued vulnerable role in society."

New Labeling From the FDA

Although the solution to the complex problem of drug use by pregnant women is not clear, the FDA has made a change that is designed to better inform healthcare providers and patients about the risks of drugs. As of June 30, 2015, the FDA has changed the way it labels human prescription medications and biologic preparations for use in pregnancy and lactation. The new labels will include a summary of the risks of the drug during pregnancy.

"The articles in this issue, coupled with awareness of recent federal changes that affect our prescribing habits in pregnancy, will improve the quality of care our patients receive when medications are needed or are misused," write Nancy C. Chescheir, MD, editor-in-chief of Obstetrics & Gynecology, in an accompanying editorial.

The Pharmacoepidemiology Program at the Harvard School of Public Health (with which several of Dr Palmsten's colleagues are affiliated) is partially supported by training grants from Pfizer, Takeda, Bayer, and Phrma. The other authors have disclosed no relevant financial relationships.

Obstet Gynecol. 2015;126:463-478.

    
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