Navigation Links
More stringent evaluation on the use of generic medications in thoracic transplantation
Date:6/2/2009

Philadelphia, 2 June 2009 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 (www.jhltonline.org/), published by Elsevier.

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:

  1. Education of the patient to inform the health care professionals caring for them if their immunosuppressant medication has been changed

  2. Education of other prescribers of the concerns regarding a switch to a generic immunosuppressant

  3. Awareness that heightened surveillance following a change in critical medication to avoid adverse effects such as toxicity or rejection

  4. Advocacy surrounding notification of an automatic generic substitution from the dispensing agencies to the prescriber


'/>"/>

Contact: Maureen Hunter
m.hunter@elsevier.com
215-239-3671
Elsevier
Source:Eurekalert

Related medicine news :

1. RecordGone.com Helps California Nurses Expunge Criminal Records to Meet More Stringent Licensing Standards
2. International Committee Recommends Stringent Guidelines for Translating Stem Cell Therapies From the Lab Bench to the Bedside
3. QLT announces positive results from the evaluation of Visudyne(R) combination therapy
4. Prospective Evaluation Finds High Levels of Satisfaction with ConvaTec Moldable Skin Barrier
5. Pennsylvania DEP Releases Evaluation of Air Quality Program
6. Bradmer provides clinical trial update and announces evaluation of strategic alternatives
7. Charleston Conducts Evaluation of an Opioid Symptoms Questionnaire
8. Womens cancer outcomes improved by surgical evaluation
9. CASA* Evaluation of Welfare Demonstration Program in New Jersey Finds Effective Approach to Addiction Recovery and Employment
10. New Williamsburg Health Evaluation Center, The Ultimate Investment In Future Health And Well-Being, Set To Open In March
11. Childrens cancer group recommends global evaluation system for neuroblastoma to improve treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... ... 2017 , ... Order Custom Tee Shirts Online , Welldonedesigns.com ... to be concerned about garment selection, expensive graphic designers, substandard printing, and shipping. ... and shipped within 5-10 days. And every garment we ship is shipped ...
(Date:9/25/2017)... ... September 25, 2017 , ... How many things are on your average ... phrase “more than any sane human could possibly complete,” then you’re all too familiar ... are desperately trying to be everything to everybody all the time. , Self-proclaimed overly ...
(Date:9/25/2017)... Grants Pass, OR (PRWEB) , ... September 25, ... ... good idea. Kleyne, host of the nationally syndicated The Sharon Kleyne Hour Power ... Tears® EyeMist®, would like us to shift our Olympic focus from a once-every-four-years ...
(Date:9/25/2017)... ... September 25, 2017 , ... ... services supporting clinical research, today announces that 30 of its domain experts ... drug development lifecycle at upcoming industry conferences and webinars. Drawing on broad ...
(Date:9/25/2017)... ... September 25, 2017 , ... ... to announce the next generation for LASIK in Manhattan with Contoura Vision, the ... technologically advanced laser systems available in the United States to correct nearsightedness and ...
Breaking Medicine News(10 mins):
(Date:9/12/2017)... 12, 2017   EcoVadis , the leading platform for environmental, social ... annual edition of its Global CSR Risk and Performance Index. The report ... based on Scorecard Ratings that analyzed nearly 800,000 data points across the ... ... ...
(Date:9/9/2017)... Lilly and Company (NYSE: LLY ) will ... an investigational, oral, first-in-class molecule for the acute treatment ... placebo in the Phase 3 SPARTAN study. Detailed results ... the International Headache Society (IHC) in Vancouver ... lasmiditan,s potential to reduce pain and provide freedom from ...
(Date:9/7/2017)... , Sept. 7, 2017  Zimmer Biomet Holdings, Inc. ... healthcare, today announced that it will be participating in ... Conference at the Grand Hyatt hotel in New York.  ... at 11:40 a.m. Eastern Time. A live ... Biomet,s Investor Relations website at http://investor.zimmerbiomet.com .   ...
Breaking Medicine Technology: