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Institute for Pediatric Innovation Awarded Funding by University of Kansas to Analyze the Use of Extemporaneously Prepared Medicines in Children's Hospitals
| Source: Institute for Pediatric Innovation
CAMBRIDGE, MA--(Marketwire - June 30, 2008) - The Institute for Pediatric Innovation (IPI),
Inc., a nonprofit focused on catalyzing the commercialization of products
optimized for pediatric care, today announced that it has been awarded a
$50,000 grant to analyze the use of extemporaneously prepared liquid
formulations in children's hospitals. The study is being funded by the
University of Kansas.
Most children under the age of seven have difficulty taking tablets or
capsules, yet medicines often are not available in a liquid form with
provisions for age- and size-appropriate doses. As a result, pharmacists in
pediatric hospitals frequently must extemporaneously prepare liquid
formulations of drugs by making a suspension or solution from crushed
pills. This introduces the potential for errors and resultant risk to young
patients due to lack of efficacy and safety data.
"The pediatric community recognizes the problem of extemporaneous
preparations of medications for young patients," said Dr. Stephen P.
Spielberg, Principal Investigator for IPI's Pediatric Pharmaceutical
Reformulation Project. "In order to translate this awareness into an action
plan, we need to gather hard data from children's hospitals, so that we can
identify the medications that are most commonly reformulated, and set
priorities for future efforts. We are fortunate to have the support of some
of the leading pediatric institutions in the country in collaborating to
achieve the goals of this study."
"We are very pleased to work with the Institute for Pediatric Innovation on
this important market analysis project," said Scott Weir, PharmD, Ph.D.,
director of the Office of Therapeutics, Discovery and Development at the
University of Kansas. "We are currently developing a business plan to
establish a Kansas Bioscience Authority funded Center of Innovation in Drug
Delivery. The data generated by IPI will assist us in defining our drug
delivery core competencies as well as identifying pediatric drug products
the Center will help develop. Ultimately, our goal is to meet the
therapeutic needs of children."
Study Details
The study will involve collecting data from 25 children's hospitals in
North America on the production and use of extemporaneously compounded
liquid formulations. Each institution will collect data on the most
frequently reformulated products, stability information and financial data
related to the compounding of these medications. Each participating
hospital will agree to release the summarized data.
The study will be led by Ralph A. Lugo, PharmD, Professor and Chair,
Department of Pharmacy Practice, East Tennessee State University College of
Pharmacy; Dr. Robert M. Ward, M.D., Director of Pediatric Pharmacology,
University of Utah; and Dr. Stephen Spielberg, M.D., Ph.D. and Principal
Investigator for IPI. The study also will be supported by the Pediatric
Pharmacy Advocacy Group (PPAG) and founding members of IPI's Consortium of
Pediatric Hospitals: Children's Mercy Hospitals and Clinics, University
Hospitals Rainbow Babies and Children's Hospital and the Lucile Packard
Children's Hospital at Stanford.
Although pharmacists in pediatric hospitals have recognized concerns
regarding extemporaneous pediatric formulations for many years, there are
no current data on the scope of the problem on a national or international
scale. The last published information on this topic was a survey conducted
by the PPAG in 1997, highlighting the extent of the problem, including the
lack of data on validation of the formulations used, in terms of stability
and bioavailability, the potential for human error and the risk to
patients.
This study is part of IPI's Pediatric Pharmaceutical Reformulation Program,
which aims to define the most critical unmet clinical needs for better
formulated drugs for children. The program will set priorities for the
development of the identified pharmaceuticals according to potential for
clinical impact, formulation development requirements, clinical testing and
regulatory pathway, and commercialization considerations. The program team
is led by Dr. Stephen Spielberg.
About the Institute for Pediatric Innovation (IPI)
The Institute for Pediatric Innovation (www.pediatricinnovation.org) is a
nonprofit organization that was formed to improve the health of children by
increasing the availability of innovative medical products with the unique
attributes required for pediatric care. IPI seeks to transform pediatric
healthcare from a neglected orphaned market to a magnet for industry and
investor interest. IPI is led by an experienced team of experts in
licensing technology in pediatric medical care, commercializing medical
technology, and marketing medical devices and pharmaceutical products. To
date, IPI has received support from its consortium members along with the
Ewing Marion Kauffman Foundation, Children's Medical Ventures, Inc., AGA
Medical and Oxford Bioscience Partners.