Featured Research

from universities, journals, and other organizations

More Stringent Evaluation On The Use Of Generic Medications In Thoracic Transplantation Recommended

Date:
June 2, 2009
Source:
Elsevier
Summary:
The current approval process for generic medication should be examined, suggests an educational advisory.

A closer look at regulatory and clinical concerns with generic immunosuppression medications in thoracic transplantation is required, according to an educational advisory by the International Society for Heart and Lung Transplantation (ISHLT) in the July 2009 issue of The Journal of Heart and Lung Transplantation.

Related Articles


Thoracic transplant patients require immunosuppressant medications that are classified by regulating agencies around the world as "critical dose drugs" due to an increase in risk of harm from comparatively small differences in dose or concentration. These “critical dose drugs”, however, do not receive any additional testing or evaluation in transplanted patients before being approved by worldwide regulating agencies.

Approval for brand names drugs is only given after careful testing by regulatory agencies. These drugs are studied in a stringently controlled format in patients who have the condition for which the drug is to be prescribed. The process for generic drug approval is different. Generic drugs are required to have the identical active ingredients as the brand product in the same strength and rate and extent of absorption. These products are then tested on a small number of healthy volunteers.

Evaluating healthy volunteers does not adequately represent the challenges faced in prescribing immunosuppressant medication in transplant recipients. Many times, transplant recipients are far from healthy and face the challenges of chronic disease, effects of drug therapy on non-translated organs, and interacting medications.  

“A presumably bioequivalent generic product when applied in the setting of transplantation often demonstrates a different and unanticipated pharmacokinetic profile.  This issue is of special concern in patients prone to graft rejection and especially in children”, said Dr. Patricia A. Uber, Assistant Professor of Medicine at University of Maryland School of Medicine and the lead author of this advisory.

The ISHLT Board of Directors assigned a group of transplant practitioners from various countries to develop this educational advisory to inform transplant practitioners about generic immunosuppression. 

Key recommendations in the educational advisory include:

  • Education of the patient to inform the health care professionals caring for them if their immunosuppressant medication has been changed
  • Education of other prescribers of the concerns regarding a switch to a generic immunosuppressant
  • Awareness that heightened surveillance following a change in critical medication to avoid adverse effects such as toxicity or rejection
  • Advocacy surrounding notification of an automatic generic substitution from the dispensing agencies to the prescriber

Story Source:

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


Cite This Page:

Elsevier. "More Stringent Evaluation On The Use Of Generic Medications In Thoracic Transplantation Recommended." ScienceDaily. ScienceDaily, 2 June 2009. <www.sciencedaily.com/releases/2009/06/090602083350.htm>.
Elsevier. (2009, June 2). More Stringent Evaluation On The Use Of Generic Medications In Thoracic Transplantation Recommended. ScienceDaily. Retrieved October 25, 2014 from www.sciencedaily.com/releases/2009/06/090602083350.htm
Elsevier. "More Stringent Evaluation On The Use Of Generic Medications In Thoracic Transplantation Recommended." ScienceDaily. www.sciencedaily.com/releases/2009/06/090602083350.htm (accessed October 25, 2014).

Share This



More Health & Medicine News

Saturday, October 25, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Texas Nurse Nina Pham Cured of Ebola

Texas Nurse Nina Pham Cured of Ebola

AFP (Oct. 25, 2014) — An American nurse who contracted Ebola while caring for a Liberian patient in Texas has been declared free of the virus and will leave the hospital. Duration: 01:01 Video provided by AFP
Powered by NewsLook.com
Toxin-Packed Stem Cells Used To Kill Cancer

Toxin-Packed Stem Cells Used To Kill Cancer

Newsy (Oct. 25, 2014) — A Harvard University Research Team created genetically engineered stem cells that are able to kill cancer cells, while leaving other cells unharmed. Video provided by Newsy
Powered by NewsLook.com
IKEA Desk Converts From Standing to Sitting With One Button

IKEA Desk Converts From Standing to Sitting With One Button

Buzz60 (Oct. 24, 2014) — IKEA is out with a new convertible desk that can convert from a sitting desk to a standing one with just the push of a button. Jen Markham explains. Video provided by Buzz60
Powered by NewsLook.com
Ebola Protective Suits Being Made in China

Ebola Protective Suits Being Made in China

AFP (Oct. 24, 2014) — A factory in China is busy making Ebola protective suits for healthcare workers and others fighting the spread of the virus. Duration: 00:38 Video provided by AFP
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:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

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