Featured Research

from universities, journals, and other organizations

Substandard, non-approved drugs put patients at risk: Physicians urged to think twice before they prescribe compounded drugs

Date:
October 15, 2012
Source:
Springer
Summary:
The recent outbreak of meningitis in the US -- and the subsequent deaths of 15 individuals -- has renewed scrutiny on the contemporary practice of pharmacy compounding. The risks to patients, and associated liability risk to prescribing physicians, largely outweigh the benefits when the practice goes beyond the traditional, extemporaneous role, according to experts.

The recent outbreak of meningitis in the US -- and the subsequent deaths of 15 individuals -- has renewed scrutiny on the contemporary practice of pharmacy compounding. The risks to patients, and associated liability risk to prescribing physicians, largely outweigh the benefits when the practice goes beyond the traditional, extemporaneous role, according to Sarah Sellers from q-Vigilance LLC and Wulf Utian from Case Western Reserve University in the US. Sellers and Utian's opinion piece is published online in the journal Drugs, published by Adis.

There is a place for traditional pharmacy compounding to fulfill medical needs of individuals that cannot be met with commercially available products. For example, a child who is unable to swallow tablets may be offered the liquid form of a drug, or a patient with a known allergy to an ingredient might be given alternatives. But formulations that are produced outside national regulatory frameworks lack studies to support their quality, safety and efficacy.

The authors explain, "FDA-approved products produced under federal Good Manufacturing Practice represent an essential standard of pharmaceutical care relied on by US citizens. Deviations from this standard of care should be made only under rare circumstances of medical necessity. Physicians should be cautious in their judgments regarding what circumstances would justify setting aside a federal standard for a professional one.

"Under the traditional model of pharmacy compounding, non-FDA approved drugs are formulated to meet individual patient needs under the order of a physician. In contrast to this traditional role, compounding practices have emerged throughout the US and other countries, with direct marketing of formulations to both patients and prescribers. As a result, non-FDA approved, compounded drugs may be driven by largely unregulated pharmacy advertisements to physicians and patients, and they place prescribers in the backseat for decision making.

Sellers and Utian's paper outlines the essential differences between FDA-approved drugs and compounded drugs and reasserts the primary medical role of physicians when deciding what medical circumstances may necessitate treatment with non-FDA approved products. They also review the consequences of prescribing substandard drugs, including serious adverse events, and discuss the liability issues physicians need to consider when prescribing non-FDA approved drugs.

The authors conclude that it is in the interests of prescribers to remember that:

  • Compounded drugs lack an FDA finding of safety, efficacy and manufacturing quality.
  • Compounded drugs are not interchangeable with FDA-approved branded or generic medication.
  • If an FDA-approved drug is available, then it should be prescribed and used.
  • Liability concerns may arise due to the prescribers' role as a 'learned' intermediary, if patient harm arises as a result of being prescribed a compounded drug.

Story Source:

The above story is based on materials provided by Springer. Note: Materials may be edited for content and length.


Journal Reference:

  1. Sarah Sellers, Wulf H. Utian. Pharmacy Compounding Primer for Physicians. Drugs, 2012; DOI: 10.2165/11640850-000000000-00000

Cite This Page:

Springer. "Substandard, non-approved drugs put patients at risk: Physicians urged to think twice before they prescribe compounded drugs." ScienceDaily. ScienceDaily, 15 October 2012. <www.sciencedaily.com/releases/2012/10/121015152538.htm>.
Springer. (2012, October 15). Substandard, non-approved drugs put patients at risk: Physicians urged to think twice before they prescribe compounded drugs. ScienceDaily. Retrieved April 19, 2014 from www.sciencedaily.com/releases/2012/10/121015152538.htm
Springer. "Substandard, non-approved drugs put patients at risk: Physicians urged to think twice before they prescribe compounded drugs." ScienceDaily. www.sciencedaily.com/releases/2012/10/121015152538.htm (accessed April 19, 2014).

Share This



More Health & Medicine News

Saturday, April 19, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

'Holy Grail' Of Weight Loss? New Find Could Be It

'Holy Grail' Of Weight Loss? New Find Could Be It

Newsy (Apr. 18, 2014) In a potential breakthrough for future obesity treatments, scientists have used MRI scans to pinpoint brown fat in a living adult for the first time. Video provided by Newsy
Powered by NewsLook.com
Little Progress Made In Fighting Food Poisoning, CDC Says

Little Progress Made In Fighting Food Poisoning, CDC Says

Newsy (Apr. 18, 2014) A new report shows rates of two foodborne infections increased in the U.S. in recent years, while salmonella actually dropped 9 percent. Video provided by Newsy
Powered by NewsLook.com
Scientists Create Stem Cells From Adult Skin Cells

Scientists Create Stem Cells From Adult Skin Cells

Newsy (Apr. 17, 2014) The breakthrough could mean a cure for some serious diseases and even the possibility of human cloning, but it's all still a way off. Video provided by Newsy
Powered by NewsLook.com
Obama: 8 Million Healthcare Signups

Obama: 8 Million Healthcare Signups

AP (Apr. 17, 2014) President Barack Obama gave a briefing Thursday announcing 8 million people have signed up under the Affordable Care Act. He blasted continued Republican efforts to repeal the law. (April 17) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins