Pediatric News

JPPT Now In PubMed Central

The Journal of Pediatric Pharmacology and Therapeutics (JPPT) is now included in PubMed Central (PMC), which is a free digital archive of biomedical journal literature at the United States National Institutes of Health (NIH). PMC was developed and is managed by NIH's National Center for Biotechnology Information in the National Library of Medicine and is searchable through the National Library of Medicine website.

The Pediatric Pharmacy Advocacy Group has contracted with Allen Press, who is in the process of loading content from back issues of JPPT into PMC via the Back Issue Digitization project. As papers are entered they are viewable in PMC and are available free of charge. Once all back issues are loaded into PMC, citations and links for these articles will automatically be added to PubMed one issue at a time.

Inclusion in PubMed will broaden the readership of articles published in JPPT and subsequently impact the care of pediatric patients. Inclusion also means that information published in JPPT will be searchable, which should increase the citation of papers that have appeared in JPPT. Ultimately, our impact should rise and a greater stream of extremely high-quality manuscripts will be submitted and published in JPPT.

2011 PPAG FELLOWS ANNOUNCED

The Selection Committee is pleased to announce the 2011 Fellows in the Pediatric Pharmacy Advocacy Group. The new fellows were recognized on Friday, March 18, 2011 during the 20th Annual PPAG Annual Meeting and Pediatric Pharmacy Conference.

Peter Gal, PharmD

Peter Gal received a Bachelor of Science in Pharmacy degree at St John's University in 1975 and a Doctor of Pharmacy degree from SUNY at Buffalo in 1977. He became faculty at Mercer University 1977–1979, then at University North Carolina, Eshellman School of Pharmacy from 1979 to present.

Since 1977 Dr. Gal has focused in clinical practice in the neonatal intensive care unit. Currently, is is the Director of the Neonatal Pharmacotherapy Fellowship program and the Neonatal Pharmacology Research Laboratory at the Women's Hospital in Greensboro. Dr. Gal also serves as Director of Graduate Pharmacy Education Division of Greensboro Area Health Education Center. Dr. Gal has had numerous publications in textbooks and pharmacy and medical journals, including several in JPPT. He has also presented lectures throughout the US, including several at PPAG meetings.

Dr. Gal has been honored by PPAG, receiving the Helms Award in 2008. He has also received the Clinical Practice Award from ACCP and Howard Q Ferguson Award from UNC School of Pharmacy. Dr. Gal served on the inaugural committee for BCPS.

Kathy Gura, PharmD

Kathleen M. Gura, Pharm.D, BCNSP, FASHP, is the Team Leader with the Surgical Program and a clinical pharmacist with the Clinical Nutrition Service in the Division of Gastroenterology and Nutrition at Children's Hospital Boston. She is also an Associate Professor of Pharmacy Practice at the Massachusetts College of Pharmacy in Boston and an adjunct member of the faculty at Northeastern University, the University of Connecticut and the University of North Carolina at Chapel Hill.

Her professional focus is on academic clinical pharmacy and research, and her topics of expertise include nutritional support for the critically ill pediatric patient, nutritional support in intestinal failure, sterile products preparation, aluminum toxicity, and drug-nutrient interactions. She obtained both her BS in Pharmacy and her Doctor of Pharmacy from the Massachusetts College of Pharmacy in Boston. Certified as a Nutritional Support Pharmacist, Dr. Gura is a Fellow of the American Society of Health-System Pharmacists. She is also a member of several pharmaceutical societies, including the Pediatric Pharmacy Advocacy Group (PPAG), the American Society for Parenteral and Enteral Nutrition and the European Society for Parenteral and Enteral Nutrition. She has assumed leadership roles in a many of these organizations, serving as the Vice President of Finance for PPAG and President of the Massachusetts Society of Health Systems Pharmacists.

She was the recipient of the 2007 MPhA Innovative Practice Award and the 2008 ASPEN Serlick Award for safe practice in the field of parenteral nutrition and was recently awarded the 2009 Drug Therapy Research Award of the American Society of Health Systems Pharmacists and the 2010 Outstanding Service Award from the Massachusetts Society of Health System Pharmacists.

Dr. Gura is the author of several book chapters on pediatric nutrition and has written articles for many peer-reviewed journals on topics such as the parenteral nutrition associated cholestasis, clinical practice guidelines for parenteral nutrition, and the use of parenteral nutrition in the neonate. Her research in the area of PN associate liver injury is currently funded by the March of Dimes with additional funding coming from the FDA's orphan drug development program. Recently, Dr. Gura has begun collaborating with the staff at Bach Mai Medical Center in Hanoi, where she is helping to establish programs in both clinical nutrition and clinical pharmacy at the premier medical center in Vietnam.

Elizabeth Farrington, PharmD

Elizabeth Farrington, Pharm.D., BCPS, is a Pharmacist III in Pediatrics at the New Hanover Regional Medical Center in Wilmington, North Carolina and a Clinical Assistant Professor at the University of North Carolina (UNC) Eshellman School of Pharmacy, Chapel Hill, North Carolina.

For the past twenty years, Dr. Farrington's primary area of practice has been the Pediatric Intensive Care Unit (PICU). Dr. Farrington earned her Bachelor of Science in Pharmacy at the University of North Carolina in 1983 and her Doctor of Pharmacy degree from the University of Kentucky in 1985. She completed a two-year clinical pharmacy residency which included one year in pediatrics at the University of Kentucky A. B. Chandler Medical Center. She also completed a Pediatric Research Fellowship under Dr. Rich Leff at the University of Iowa in 1989. Dr. Farrington previously directed a Pediatric Pharmacotherapy Residency and has trained fourteen residents.

Donna Kraus, PharmD

Donna Kraus received her B.S. in Pharmacy and her Pharm.D.from the University of Illinois at Chicago (UIC). She completed her pediatric specialty residency at the University of Texas Health Science Center in San Antonio.

Dr. Kraus served as a pediatric clinical pharmacist in the PICU for 15 years and has been an ambulatory care pediatric pharmacist specializing in HIV for the past 12 years. She is currently an Associate Professor of Pharmacy Practice in the departments of Pharmacy Practice and Pediatrics at UIC. Dr. Kraus has been the director of the UIC Pediatric Residency Program for 23 years. She is an active educator and has been a guest lecturer in China, Thailand, and Hong Kong.

Dr. Kraus is an active member of numerous professional organizations and has served as a member of the Board of Directors of PPAG, Chairperson of the ASHP Commission on Therapeutics, Member-at-Large of the Academy of Pharmaceutical Research and Science (APhA), and member of the Alliance for Pediatric Quality, Improve First Measures Task Force (AAP). She has served as an Editorial Board member of AJHP and JPPT. She has authored original research articles, review articles, book chapters and is co-author of the Pediatric Dosage Handbook (now in its 17th edition).

Anne Lesko, PharmD

Anne Lesko, Pharm.D. is currently the Sr. Clinical Director of Pharmacy and the PGY1 Residency Program Director at Cincinnati Children's Hospital Medical Center. She is also Adjunct Associate Professor of Clinical Pharmacy at the University of Cincinnati, James L. Winkle College of Pharmacy. Prior to joining the Division of Pharmacy at Cincinnati Children's Hospital Medical Center, Dr. Lesko was Assistant Professor of Clinical Pharmacy at the St. Louis College of Pharmacy.

Dr. Lesko received her B.S. in Pharmacy degree from the St. Louis College of Pharmacy and her Pharm.D. degree from Northeastern University. She completed her residency at Tufts Medical Center and Boston Floating Children's Hospital. Dr. Lesko has served as President of the Pediatric Pharmacy Advocacy Group (PPAG), as well as, a member of the PPAG Board of Directors. She has also served as a member of the Commission on Credentialing for the American Society of Health-System Pharmacists. While at Cincinnati Children's Hospital Medical Center, Dr. Lesko has developed and expanded the clinical services of the Division of Pharmacy and established the pharmacy's ASHP accredited residency program. She serves as the Vice Chair of the Pharmacy and Therapeautics Committee and co-leads the hospital's adverse drug event reduction initiative. She has led a pediatric medication safety initiative for a national healthcare system and is currently participating in a state-wide children's hospital safety collaborative.

Sherry Luedtke, PharmD

Sherry Luedtke, PharmD is one of the founding faculty members of the School of Pharmacy at Texas Tech University, and is an Associate Professor of Pharmacy Practice. She also serves as the Director of the Pediatric Specialty Residency program.

Dr. Luedtke received her Bachelor of Science and Doctor of Pharmacy degrees from the University of Wisconsin. She completed her practice residency at Meriter Hospital and pediatric specialty residency at the University of Kentucky. Dr. Luedtke has given numerous presentations nationally and written several book chapters on pediatric pharmacotherapy. She provides clinical pharmacy services in neonatology and general pediatrics at Northwest Texas Children's Hospital. Dr. Luedtke has received numerous teaching and practice awards at both the University and State level. Most notably, she has been the recipient of the TTUHSC President's Distinguished Clinician Award, PPAG Best Practice Award, and twice received recognition for her practice in the Texans Caring for Texans Award.

She has been dedicated to the education of future pediatric practitioners having developed the Pediatric Specialty Residency (PGY2) at Texas Tech University Health Sciences Center School of Pharmacy. One of her proudest accomplishments is to have mentored outstanding practitioners who have become young leaders in the area of pediatric pharmacy. Dr. Luedtke has been a committed member to PPAG since 1995. She began her service to PPAG with her work on the Education Committee and subsequently has been involved at all levels including the Advocacy Committee, Board of Directors, and service as a Past President. She currently serves as the Associate Editor for the Journal of Pediatric Pharmacology and Therapeutics.

BPS Practice Analysis Task Force

The Board of Pharmacy Specialties (BPS) has appointed the following individuals to the practice analysis task force for pediatric pharmacy:

Sabrina Boehme, Pediatric Clinical Pharmacist/Transplant Pharmacist, Primary Children's Medical Center, and Professor of Pharmacy Practice, University of Southern Nevada, Salt Lake City, UT

Michelle Caruso, Clinical Specialist, Emergency Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Elizabeth Farrington, Pharmacist III Pediatrics, New Hanover Regional Medical Center, Betty A. Cameron Women's and Children's Hospital and Clinical Assistant Professor of Pharmacotherapy, UNC Eshelman School of Pharmacy, Wilmington, NC

Cyrine-Eliana Haidar, Outpatient Solid Tumor/Neuro-oncology Clinical Pharmacist, St Jude Children's Research Hospital, and Assistant Professor, The University of Tennessee Health Science Center College of Pharmacy, Memphis, TN

Jennifer Hamner, Manager for Clinical Pharmacy Services and Program Director PGY1 Residency, The Children's Hospital, Denver, CO

Kristin Klein, Clinical Pharmacist Pediatric Infectious Disease, University of Michigan Health System/C.S. Mott Children's Hospital and Clinical Assistant Professor, University of Michigan, Ann Arbor, MI

Robert Kuhn, Pediatric Clinical Pharmacist and Associate Director of Pharmacy Services, Kentucky Children's Hospital; Professor of Pharmacy Practice and Science and Pediatrics, University of Kentucky College of Pharmacy, Lexington, KY

Sean O'Neill, Medication Safety Officer / Pediatric Critical Care Specialist, The Children's Hospital of Philadelphia, and Course Coordinator, Jefferson School of Pharmacy, Philadelphia, PA

Kathy Pham, NICU Clinical Specialist & Director, Pharmacy Residency Programs, Children's National Medical Center, Washington, DC

Stephanie J. Phelps, Associate Dean Academic Affairs and Professor, Clinical Pharmacy and Pediatric, The University of Tennessee Health Science Center College of Pharmacy, Memphis, TN

Michael D. Reed, Associate Chairman, Department of Pediatrics, Children's Hospital Medical Center, Akron, OH and Professor of Pediatrics, Northeast Ohio Medical University, Rootstown, OH

Pediatric Acetaminophen Product Labels to Include Weight-Based Dosing

The FDA Advisory Panel voted unanimously to recommend enhancing dosing labels of single-ingredient pediatric acetaminophen products during the May 17–18, 2011 Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee to reduce the risk of potential medication errors.¹ The revised labels would include weight-based dosages for children ages 6 months to 2 years of age (label addition) for antipyresis and weight-based dosages (in addition to current age-related dosages) for children between 2 to 12 years of age for antipyresis and analgesia.² The CHPA supports all decisions made by the Advisory Panel except the exclusion of analgesia as an indication on the label for children 6 months to 2 years of age.² Although it was discussed that health care professionals may continue to recommend acetaminophen as an analgesic in the younger age group.^2,3

In addition to the above recommendations, the CHPA member companies have already announced several voluntary plans to further ensure the safe use of acetaminophen products.² There is a plan to convert all single-ingredient liquid acetaminophen products to a single concentration of 160-mg/5-mL beginning this year. Labels will continue to be distinguished between infants' and children's acetaminophen products. Flow restrictors will be added to minimize the amount of acetaminophen children will be exposed to during accidental, unsupervised ingestions. Oral syringes will be provided with all infants' products and oral dosing cups with all children's products. The industry is also looking to standardize the dosing devices with consistent and clearly visible measurement markings and to standardize the unit of measurement with “mL” on dosing charts and delivery devices.²

FDA Warns of Cognitive Delay In Offspring With Valproate

The US Food and Drug Administration has issued a safety announcement to underline the increased risk for lower cognitive test scores among children born to mothers taking valproate sodium or the related products valproic acid and divalproex sodium during pregnancy, relative to other antiepileptic medications.

The primary study supporting the conclusion is based on the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study.¹ This study showed that children exposed to valproate in utero throughout pregnancy had lower Differential Ability Scale (DAS) scores at age 3 years (92; 95% confidence interval [CI], 88-97) than those with prenatal exposure to other evaluated monotherapies, including lamotrigine (101; 95% CI, 98-104), carbamazepine (98; 95% CI, 95-102), and phenytoin (99; 95% CI, 94-104).

At the American Academy of Neurology's recent annual meeting, further data from follow-up to 4.5 years of age in the NEAD study found essentially the same conclusions. The FDA warning also cites several additional supportive studies, where cognitive tests were performed at ages 5 to 16 years.

“Although all of the available studies have methodological limitations, the weight of the evidence supports the conclusion that valproate exposure in utero causes subsequent adverse effects on cognitive development in offspring,” the FDA announcement concludes.

Guidelines on pregnancy in epilepsy developed by the American Academy of Neurology and the American Epilepsy Society released in 2009 already suggest that valproate should be avoided during pregnancy if possible. Women of childbearing age receiving valproate should be told of the increased risk for adverse effects on cognitive development with prenatal valproate exposure. When possible, alternative medications that have a lower risk for adverse birth outcomes should be considered.