怀孕期间处方用药很常见 而这可能太频繁了


  【24drs.com】研究者在一篇大型的人口基础研究中发现,虽然大部分医师知道为孕妇开药的复杂性,但仍是经常为她们开药。超过8成(82.5%)孕妇有被至少处方一个药品,42.0%被处方的某一项药品对于发育中的胎儿可能有危害。
  
  根据加州大学圣地牙哥分校Kristin Palmsten博士等人指出,这篇研究详列Medicaid保险之孕妇被处方的药品类型与时间,提出了一个令人不安的模式,这篇世代研究的结果在线发表于7月31日,将登载于9月版的妇产科期刊。
  
  Palmsten博士等人发现,最常被处方的药品是被用来治疗感染,他们也报告指出,较年轻的孕妇与白人孕妇比较常被处方。
  
  研究者检视了在怀孕前即纳入Medicaid保险之妇女(n = 1,106,757人)的资料,使用2000-2007年的Medicaid Analytic eXtract资料进行前瞻性的药物信息搜集,分析时也包括了由药师调剂的指示药,但是未纳入研究对象直接购买的成药或住院期间用药。
  
  最常被处方的药物是nitrofurantoin (21.6%)、metronidazole (19.4%)、amoxicillin (18.0%)、azithromycin (19.9%%)、以及promethazine (13.5%);其它比较常被处方的药品包括promethazine cephalexin以及codeine与acetaminophen。
  
  与35岁以上妇女相比,年轻妇女(<20岁)更可能被开立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,根据致畸胎信息系统,最常被处方的20种药物中,有9种被分类为「对人类之致畸胎风险的资料质量相当有限。
  
  Palmsten博士等人也发现,42.0%孕妇的处方中有属于美国食品药物管理局(FDA)的「怀孕用药等级D或X」药品;等级D的药品表示,根据不良反应数据,有与人类胎儿风险相关的证据,最常见处方的5种等级D药品为:codeine (11.9%%)、hydrocodone (10.2%%)、ibuprofen (4.9%%)、sulfamethoxazole (4.0%%)、以及hydrocortisone (4.0%)。作者们指出,根据使用情况,这些药品有时候可被视为等级B或C。
  
  等级X的药品,则是在动物或人类试验中发现会引起胎儿畸形。最常见处方的5种等级X药品为:荷尔蒙避孕药(4.9%)、temazepam (0.11%)、atorvastatin (0.07%)、simvastatin (0.04%)、以及warfarin (0.04%)。
  
  此外,研究者指出,最常被处方的药品中,有许多的怀孕安全资料相当有限或者是资料的证据等级低。他们写道,缺乏明确的安全信息会导致使用药物时有可能引起不良的怀孕结果,而有帮助的药品则可避免此风险。
  
  有许多鸦片类药物属于等级N,表示FDA没有将该药品分类。俄亥俄州克里夫兰凯斯西储大学Mallory E. Kremer医师和Kavita Shah Arora医师在发表的相关评论中,提出治疗鸦片成瘾孕妇有关的临床、法律与伦理考量。
  
  他们结论指出,产科医师必须清楚,成瘾是一种慢性疾病,而不是道德上的失败。针对有慢性疾病的孕妇追究刑事责任,在医学上与伦理上都是不适当的,且会加重社会对她们的污名化。对这些妇女之自主权的法律侵犯,更突显出她们在社会中的弱势角色。
  
  虽然孕妇复杂之用药问题的解决方案还不明确,但FDA做出了一项改变,旨在更佳地告知医疗服务提供者和病人有关的药物风险。截至2015年6月30日,FDA已改变了用于孕妇与哺乳妇之人类处方药品与生物制剂的标示方法,新版标示将会包括该药品在怀孕期间的风险摘要。
  
  妇产科期刊主编Nancy C. Chescheir医师在编辑评论中写道,有关此议题的一些文献加上联邦当局的警觉,影响了我们对孕妇的处方习惯,这将可改善患者需要接受药品时的照护质量。
  
  资料来源: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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