PPAG RSS Feed

Therapeutic Challenges of Treating Fungal Infections in Pediatric Oncology and Stem Cell Transplant Patients on 24-Jul-13 2:00 PM

Wed, 24 Jul 2013 19:00:00 GMT

Therapeutic Challenges of Treating Fungal Infections in Pediatric Oncology and Stem Cell Transplant Patients
Start Date: 24-Jul-13 2:00 PM
End Time: 24-Jul-13 3:00 PM
Location: PPAG GoToWebinar
Speaker: Shane Cross, PharmD and Jeff Scott PharmD

Event Details:

This is a one-hour knowledge-based continuing education program. Pharmacists who work in the pediatric setting (particularly PPAG members) are encouraged to participate in this program.

At the end of this session, participants will be able to:

Identify risk factors for fungal infections in pediatric oncology
Discuss antifungal therapy within the fever and neutropenia setting
Recognize challenges with antifungal therapies in the pediatric oncology population.
Describe indications and recommendations for antifungal drug therapy in pediatric oncology patients.

CEU Information
Program Number: 0180-0000-13-002-L01-P (one contact hour or 0.1 CEU)
Program Type: Knowedge-based

The Pediatric Pharmacy Advocacy Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

In order to receive credit, participants must register for the program, attend the program, and fill out a post-program survey.

This program is 100% supported through program registration fees and PPAG membership dues. PPAG has not received financial support from the pharmaceutical industry for this program.

PPAG GoToWebinar

You will receive personalized login/call-in information via email a few days prior to the event.

Non-stimulant treatment options for ADHD on 28-Aug-13 2:00 PM

Wed, 28 Aug 2013 19:00:00 GMT

Non-stimulant treatment options for ADHD
Start Date: 28-Aug-13 2:00 PM
End Time: 28-Aug-13 3:00 PM
Location: PPAG GoToWebinar
Speaker: Josh Caballero, PharmD

Event Details:

This is a one-hour knowledge-based continuing education program. Pharmacists who work in the pediatric setting (particularly PPAG members) are encouraged to participate in this program.

At the end of this session, participants will be able to:

Identify the pathology of ADHD
Explain the mechanism of action of non-stimulant therapy in ADHD
Differentiate common adverse events between non-stimulants in the treatment of ADHD
Identify proper non stimulant therapy and dosing strategies given a specific patient case
Identify main counseling points when dispensing non-stimulant therapy

CEU Information
Program Number: 0180-0000-13-003-L01-P (one contact hour or 0.1 CEU)
Program Type: Knowledge-based

The Pediatric Pharmacy Advocacy Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

In order to receive credit, participants must register for the program, attend the program, and fill out a post-program survey.

This program is 100% supported through program registration fees and PPAG membership dues. PPAG has not received financial support from the pharmaceutical industry for this program.

PPAG GoToWebinar

You will receive personalized login/call-in information via email a few days prior to the event.

Effective Treatment of Psychiatric and Behavioral Problems in Children with Autism- the State of the Evidence on 25-Sep-13 2:00 PM

Wed, 25 Sep 2013 19:00:00 GMT

Effective Treatment of Psychiatric and Behavioral Problems in Children with Autism- the State of the Evidence
Start Date: 25-Sep-13 2:00 PM
End Time: 25-Sep-13 3:00 PM
Location: PPAG GoToWebinar
Speaker: Jerry McKee, PharmD, MS, BCPP

Event Details:

Forthcoming

PPAG GoToWebinar

You will receive personalized login/call-in information via email a few days prior to the event.

Get Up-To-Date with Childhood and Adolescent Vaccinations! on 6-Nov-13 2:00 PM

Wed, 06 Nov 2013 20:00:00 GMT

Get Up-To-Date with Childhood and Adolescent Vaccinations!
Start Date: 6-Nov-13 2:00 PM
End Time: 6-Nov-13 3:00 PM
Location: PPAG GoToWebinar
Speaker: Lea Eiland, PharmD

PPAG GoToWebinar

You will receive personalized login/call-in information via email a few days prior to the event.

Food and Drug Administration Safety and Innovation Act (FDASIA)

Ellen Tal Placido - noemail@ppag.org — Mon, 22 Apr 2013 20:00:00 GMT

Background

While the Food and Drug Administration has been tackling drug shortages for a number of years, it was only recently that legislative action helped bring about the Food and Drug Administration Safety and Innovation Act (FDASIA). Enacted in July 2012, it details the early notification requirements between the pharmaceutical industry and the FDA.

If the FDA is notified of a potential or current shortage, they are able to take action in a number of ways including: expediting inspections and reviews of regulatory submissions, working with the manufacturer to solve the underlying problem contributing to the shortage, identifying alternative manufacturing sources, exercising enforcement discretion for the shipment of drug with special instructions for health care providers, and using enforcement discretion for the temporary importation of non-U.S. product.

Changes since the Enactment of FDASIA

Prior to the FDASIA, a total of 251 shortages were experienced in 2011 compared to 117 shortages in 2012. Previously, only sole manufacturers of medication products were required to provide early notification of potential shortages to the FDA. Additionally, in the past all biological products had been excluded from reporting requirements. One of the critical components of this legislation included the enhanced authority of the FDA to mitigate drug shortages:

As a part of the FDASIA, manufacturers are required to report information regarding shortages to the FDA, and this act articulates the mandatory reporting requirements for manufacturers.
All biological product shortages fall within the mandatory reporting requirements.
Any product discontinuations, whether temporary or permanent, are part of the requirements of the manufacturers.
Manufacturers who do not comply with the regulations within the FDASIA will be issued a non-compliance letter to the FDA. This letter as well as the response letter from the company would be made available to the general public.

Specific provisions within the FDASIA are targeted to improve the safety and effectiveness of pediatric drugs, biological products, and medical devices used in children. Notably, the Act requires drug manufacturers to submit an earlier pediatric study plan, and provides the FDA with the authority to ensure requirements of the Pediatric Research Equity Act (PREA) are addressed in a more timely fashion to help serve as a catalyst for timely drug development and drug information for pediatric patients.

The FDA has formed a Drug Shortage Task Force to work on developing strategies that will assist in the long-term to enhance the FDA response to help prevent and mitigate drug shortages. This will include enhanced coordination, communication, and decision making within FDA and other federal agencies. Plans for effective communication in the event of a shortage are crucial to this, including who should be alerted about potential and actual drug shortages, and what information should be shared.

While the communication between the FDA and the general public is an essential component of mitigating drug shortages, it is important to note some of the most referenced material including the FDA drug shortages website1 and the ASHP2 list of shortages of primarily medically necessary products. This does not include shortages that are expected to be resolved quickly, those that involve a particular strength or package size that have available substitutes. The FDA also has a timeline3 for all elements of the FDASIA and related progress that is updated on a regular basis.

References:

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm#q17

http://www.ashp.org/menu/DrugShortages.aspx

http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313121.htm

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

http://blogs.fda.gov/fdavoice/index.php/2013/02/fda-is-asking-the-public-to-send-in-ideas-for-combating-drug-shortages/

22-Apr-13 3:00 PM

BPS Announces New Specialty in Pediatric Pharmacy

Matthew Helms - noemail@ppag.org — Tue, 16 Apr 2013 15:00:00 GMT

The American College of Clinical Pharmacy (ACCP), the American Pharmacists Association (APhA), the American Society of Health-System Pharmacists (ASHP), and the Pediatric Pharmacy Advocacy Group (PPAG) jointly submitted a petition to the Board of Pharmacy Specialties (BPS) requesting recognition of Pediatric Pharmacy Practice as a Specialty.

We are pleased to announce that the BPS Board of Directors has voted to recognize pediatric pharmacy as a BPS Specialty.

For more information from BPS, please direct your browser to: http://bpsweb.org/news/pr_041513.cfm.

The next steps in the specialty development process are outlined below:

BPS will issue a call on May 3, 2013, for nominations to serve on the Critical Care and Pediatric Pharmacy Specialty Councils. The closing date for nominations will be August 2, 2013.
BPS will appoint nine- members to each Council by September 15, 2013.
The Councils will convene, on dates to be determined, in the Fall of 2013.
Examination item writing for the new specialties will begin between the fourth quarter of 2013 and the first quarter of 2014.
The anticipated first exam will be administered in 2015.

We must thank all those involved in developing the petition for pediatric pharmacy, especially Peter Johnson, PharmD from the University of Oklahoma who represented PPAG on the joint task force. Others on the task force: Lea Eiland, PharmD (ASHP), Marcia Buck, PharmD (ACCP), and Chasity Shelton, PharmD (APhA).

This is certainly great news for pediatric pharmacy. We will continue to keep you updated as we plan for the future.

Thank you.

16-Apr-13 10:00 AM

FPPAG Recognizes the 2013 PPAG Fellow Inductees

Matthew Helms - noemail@ppag.org — Fri, 05 Apr 2013 19:00:00 GMT

PPAG is pleased to announce the 2013 FPPAG Inductees. Fellows in the Pediatric Pharmacy Advocacy Group (FPPAG) are recognized for distinguished professional accomplishments in pharmacy practice, research, and education as well as service to the pediatric pharmacy profession, especially PPAG.

The new Fellows will be introduced during the 22nd PPAG Annual Conference on May 3, 2013 in Indianapolis, IN

Kimberley Benner, PharmD, BCPS, FPASHP, FPPAG

Kimberley Benner, PharmD, BCPS, FPASHP, FPPAG has had a significant impact on pediatric pharmacy practice through her education, research, and service. Dr. Benner is a Professor at the Samford University McWhorter School of Pharmacy and a Pediatric Clinical Specialist at Children’s of Alabama in Birmingham. Dr. Benner graduated with her Doctor of Pharmacy degree from Samford University and completed an ASHP-accredited residency at Children’s Hospital in Birmingham. Dr. Benner’s research interests and areas of publication include pediatrics, infectious diseases, pharmacy and simulation education. Dr. Benner is currently serving as the Chair of the PPAG research committee after having been a member since 2006. She has attended many PPAG meetings and provided educational programs, including poster presentations. She frequently serves as a poster judge and abstract reviewer and was on the fundraising committee.

Dr. Benner has been in academia since 1997 and has precepted numerous students through pediatric clinical and academic rotations. Dr. Benner rounds daily at the Children’s Hospital. She has contributed to the scientific knowledge of caring for pediatric patients through her numerous presentations at local, state, national and international venues. Her work typically is from the critical care unit and provides practical information needed to care for the sickest children, including her most recent publication in which she was the primary author on ASHP's position statement on the use of 0.9 saline for indwelling catheters. Dr. Benner not only presents for the pharmacy practitioners, but extends her work into the medical literature which strengthens the profession of pharmacy as a whole. Notably, Dr. Benner has served as an evaluator for the 2010-11 Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics.

Michael Christensen, PharmD, BCNSP, FPPAG

Michael Christensen, PharmD, FPPAG has been directly involved in the evolution of the regulatory process in increasing pediatric labeling for dozens of drugs on the USA market. He was Associate Director for the PPRU at UTHSC and Le Bonheur Children's Medical for 10 years, and was the innovator that created the Pediatric Clinical Trial Unit at Le Bonheur. He has directly overseen hundreds of clinical trials in children, involving dozen of medications. His work has contributed our understanding of drug use in children with obesity, type II DM, pain management, cardiovascular disease, sedation, liver disease, and much more. He is among the most knowledgeable clinicians in the country in metabolism and nutrition support.

Dr. Christensen received his B.S. in Pharmacy from North Dakota State University in 1978 and a Pharm.D. from the University of Tennessee in 1982. He completed a residency in pediatric pharmacotherapy at LeBonheur Children’s Medical Center and a fellowship in pharmacokinetics and pharmacodynamics at St. Jude Children’s Research Hospital. Dr. Christensen spent 6 years at St. Jude Children’s Research Hospital as a clinical pharmacist and developed the metabolic support service. In 1990 Dr. Christensen joined the full-time faculty at the University of Tennessee, College of Pharmacy. Dr. Christensen is a board certified nutrition support pharmacist and served of the Board of Pharmaceutical Specialties Specialty Council on Nutrition Support Pharmacy for 6 years. From 1994 to 2003 he was the Co-Director for the Pediatric Pharmacology Research Unit funded by the NIH and directed the Children’s Foundation Research Center Pediatric Clinical Research Unit until 2011. In 2012 Dr. Christensen was appointed as an Associate Vice Chancellor for Research. Dr. Christensen has more than 130 published articles, book chapters and abstracts. His research interests include pharmacokinetic and pharmacodynamic studies of drugs in infants and children as well as the metabolic and nutrient requirements in infants.

Dr. Christensen has given of his considerable talent and treasure to PPAG over the last 10 years. His leadership roles including being President, Board member, speaker and a loyal supporter of the organization.

Carlton K.K. Lee, PharmD, MPH, FASHP, FPPAG

Carlton K.K. Lee, PharmD, FPPAG Dr. is one of the nation’s most respected pediatric Pharm.D’s. His consistent and superb work as the editor of the Harriet Lane Handbook Formulary Section is one of his most visible accomplishments. The Harriet Lane Handbook is a national reference for all pediatricians beginning with their intern year and continuing throughout their career. Dr. Lee has helped shape the quality pediatric program at John Hopkins over the last 20 years. He has been instrumental in implementing a number of programs that have made the clinical services on par with other outstanding program in the country. This includes the development of of a pediatric pharmacy residency program as well. Simply without Carlton, it hard to imagine the program at Johns Hopkins to be as progressive as it today.

Dr. Lee is the Clinical Pharmacy Specialist in Pediatrics for The Johns Hopkins Hospital, Associate Professor in Pediatrics for The Johns Hopkins University School of Medicine and Clinical Professor with the University of Maryland School of Pharmacy. Dr. Lee developed and continues to serve as the Residency Program Director for the PGY-2 Pediatric Pharmacy Specialty program.

Dr. Lee received his Doctor of Pharmacy degree from the University of the Pacific and Masters in Public Health from The Johns Hopkins University Bloomberg School of Hygiene and Public Health. He completed a General Hospital Pharmacy residency at The Johns Hopkins Hospital and Pharmacokinetics/ Pharmacodynamics Fellowship at The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. Dr. Lee began his career at Johns Hopkins as a Neonatal clinical pharmacist. He became the Senior Clinical Pediatric and Pediatric Clinical Coordinator in 1988 and 1990, respectively, at Hopkins. Dr. Lee has over 25 years of Pediatric Clinical Pharmacology experience with teaching responsibilities to pharmacy and medical residents and students. His clinical research experience have been in Phase I/IV pharmacokinetic/drug development studies in Cystic Fibrosis and HIV/AIDS; and developing safe tools for Pediatric Outpatient Prescribing.

Dr. Lee has published several articles and medical text chapters; most notably, he is the editor to the Formulary section to the Harriet Lane Handbook for the past 22 years. He has lectured in numerous forums on Cystic Fibrosis and Pediatric Clinical Pharmacology on the local, national and international levels. Dr. Lee has been honored to have mentored 20 PGY-2 Pediatric Pharmacy residents. Recognition of his efforts includes:- Fellowship in the American Society of Health System Pharmacists - Who’s Who in America, the East, Medicine & Healthcare, Science & Engineering, and the World. Dr. Lee has served on the Board of Directors to the Pediatric Pharmacy Advocacy Group. He had also established a non-profit Pediatric Pharmacy continuing education corporation entitled the Mid-Atlantic Pediatric Pharmacotherapy Specialists.

Stephanie Phelps, BSPharm, PharmD, BCPS, FCCP, FAPhA, FPPAG

Stephanie Phelps, BSPharm, PharmD, BCPD, FPPAG is one of the most influential pediatric pharmacists in the country. In addition to paving the way for pediatric pharmacists in clinical practice, she is editor of “The Teddy Bear Book: Pediatric Injectable Drugs”, now in its ninth edition, which has become the definitive guide for the administration of injectable drugs in pediatric patients. She also serves as editor-in-chief of the Journal of Pediatric Pharmacology and Therapeutics.

Dr. Phelps is among most knowledgeable pediatric clinicians in the country in epilepsy and the use of seizure medications. She has help define the use of new anti-seizure medications, and has contributed to clinicians understanding of use and treatment of seizure disorders through publication, education, and direct patient care.

Dr. Phelps was born in August Georgia, but spent her formative years in Niceville, Florida - a small town in the pan-handle of the state. She attended high school and junior college in the area, before moving to Birmingham, Alabama to pursue a baccalaureate pharmacy degree from Samford University (‘79). She relocated to Memphis, Tennessee where she obtained a doctorate of pharmacy from The University of Tennessee (’82) and subsequently completed post-doctoral training in pediatrics at LeBonheur Children’s Medical Center and The University of Tennessee. Dr. Phelps is currently a Professor of Clinical Pharmacy and Pediatrics at The University of Tennessee Health Science Center and Associate Dean of Academic Affairs for the College of Pharmacy. For over a decade, she served as Director, of Experiential Education of the College. She is an elected Fellow of ACCP and APhA and is a Board Certified Pharmacotherapy Specialist. Dr. Phelps has held elected offices in AACP and ASHP and has served on the Board of Directors of ASPEN and PPAG. She is the immediate past chair of the Pharmacy Academy of the National Academies of Practice, where she is a distinguished Practitioner and Fellow. She is a recipient of the 1999 APhA-Academy of Student Pharmacists Outstanding Chapter Advisor award, the 2009 Tennessee Society of Hospital Pharmacy’s Distinguished Service Award and the 2011 Helms Award recipient for Excellence in Pediatric Pharmacy Practice by PPAG.

Dr. Phelps has received numerous teaching awards and was the first pharmacy faculty member elected to the UTHSC campus Academy of Distinguished Teachers. During her career she has participated in the education of 5 post-doctoral fellows and over 60 pediatric pharmacy residents. She has published numerous manuscripts, book chapters, and reviews that focus on pediatric pharmacotherapy.

Cathy Poon, PharmD, FPPAG

Cathy Poon, PharmD, FPPAG helped shape some of the early changes in pediatric pharmacy in the Philadelphia area and has trained some of the most highly visable and successful pediatric pharmacists in practice today.

Dr. Poon is Professor of Clinical Pharmacy with tenure of the Department of Pharmacy Practice and Pharmacy Administration and Vice Dean of the Philadelphia College of Pharmacy, University of the Sciences. She graduated from St. John’s University with a Bachelor of Science in Toxicology and a Bachelor of Science degree in Pharmacy; and received her Doctor of Pharmacy degree from Medical University of South Carolina. Dr. Poon completed her Hospital Pharmacy Residency at the Medical University of South Carolina and a Specialty Residency in Pediatric Pharmacotherapy at University of Oklahoma Health Science Center.

As an academician and clinician, Dr. Poon’s primary area of interest and practice is pediatric pharmacotherapy. She practiced in the areas of neonatology, general pediatrics and pediatric critical care. Dr. Poon served as a program director and mentor for 11 pediatric pharmacy practice residents and one fellow over the past fifteen years. Her scholarship includes manuscripts published in pharmacy, medical and nursing journals, as well as serving as a review for several journals. Dr. Poon has conducted and collaborated in a number of clinical research projects related to pediatric pharmacotherapy. In addition to pediatrics, she is also passionate about developing collaborative health care education and practice programs with other healthcare professions. In addition to serving on pharmacy professional organizations, Dr. Poon was appointed by the Governor of Pennsylvania in 2006 to serve on the Advisory Health Board of the Commonwealth of Pennsylvania.

5-Apr-13 2:00 PM

PPAG Announces Board Election Results

Matthew Helms - noemail@ppag.org — Fri, 05 Apr 2013 16:00:00 GMT

PPAG is pleased to announce the new members of the Board of Directors and Executive Committee. These individuals will be joining incoming President Bill Maish, PharmD, Immediate-Past President Amy Potts, PharmD, and Directors-At-Large Jared Cash, PharmD, Michael Chicella, PharmD, Tracy Hagemann, PharmD, David Hoff, PharmD. Their term begin May 1, 2013.

PPAG is governed by an eleven (11) member Board of Directors, consisting of five (5) Executive Committee members and six (6) Director-At-Large.

President-Elect

Kay Kyllonen, PharmD, FPPAG

Dr. Kyllonen is a Clinical Specialist in the Neonatal Intensive Care Unit at the Cleveland Clinic in Cleveland, OH.

Dr. Kyllonen has been a member of PPAG for 15 years. She served as Secretary of PPAG this past year. She has served on the Board of Directors for the past two years, and the Education Committee for serveral years, and was the chairperson of the 2009 PPAG Annual Conference in Cleveland, OH. She received FPPAG recognition in 2009. She has presented during PPAG Annual Conferences.

Treasurer
Jeffrey Low, PharmD

Jeff Low is the Clinical Pharmacist Specialist-Pediatrics at the Children's Hospital at Dartmouth.

Dr. Low has served on the Board of Directors since 2006, and served as Chair from 2008-2009. Dr. Low has participated on the research & member services committees. From 2003-2005, he served as the Vice-President for Member Services, where he has worked on projects such as the PPAG website upgrades, membership survey, PPAG newsletter, and launching online CE.

This will be Dr. Low's third term as Treasurer of PPAG. In this role, he oversees the internal audit, budget development, and fiscal evaluation of programs.

Secretary
Lisa Lubsch, PharmD

Lisa Lubsch, PharmD is Clinical Assistant Professor in the Pharmacy Practice Department at the Southern Illinois University Edwardsville School of Pharmacy and Clinical Pharmacy Specialist at Cardinal Glennon Children’s Medical Center. Dr. Lubsch received the B.S. and Doctorate of Pharmacy from the St. Louis College of Pharmacy and completed a pediatric specialty residency at the Texas Tech University Health Sciences Center School of Pharmacy. She currently provides pharmacist-delivered patient care to children on the pulmonary, cardiology, and a general medicine service. Her current areas of interests are pediatric asthma, cystic fibrosis, and addiction medicine.

Dr. Lubsch served on the 2012-13 Board of Directors. Prior to her service on the Board, she served as Chair of the PPAG Education Committee. She also served as Chair of the 19th Annual PPAG Annual Meeting and Pediatric Pharmacy Conference in St. Charles, Missouri.

Director-At-Large (2013-2016)
Brady Moffett

Brady Moffett, PharmD is the Clinical Pharmacy Specialist for the Heart Center at Texas Children's Hospital and an Assistant Professor of Pediatrics at Baylor College of Medicine. He graduated from Purdue University and did residency at University of Maryland Medical Center and The Johns Hopkins Hospital. Dr. Moffett also completed a Master's in Public Health (Epidemiology) from the University of Texas Health Science Center at Houston. Dr. Moffett's interests include the use of cardiovascular medications in children, prevention of adverse drug events, and the impact of obesity on drug dosing in children.

Dr. Moffett served as the Chair of the 21st Annual Meeting Planning Committee is Houston, Texas and has presented numerous times at PPAG.

Director-At-Large (2013-2016)
Mary Worthington

Mary Worthington, PharmD is a graduate of The Ohio State University with degrees of Bachelor of Science in Pharmacy and Doctor of Pharmacy. She completed a Residency in Hospital Pharmacy at Columbus Children’s Hospital and a Residency in Pediatric Pharmacotherapy and Home Health Care at The University of Tennessee in Memphis. Dr. Worthington is currently an Asssociate Professor of Pharmacy Practice at the McWhorter School of Pharmacy at Samford University in Birmingham, Alabama. She holds a joint appointment with Children’s of Alabama as a Pediatric Clinical Pharmacy Specialist. Dr. Worthington has been actively involved as a pediatric pharmacy practitioner for 25 years. Her current patient care activities are primarily in the area of general pediatrics.

Dr. Worthington has been a member of the Pediatric Pharmacy Advocacy Group since 1997 serving on the Communication/Membership Committee. She served as Co-Chair of the Membership Committee this year, and on the 2009 International Symposium Planning Committee.

5-Apr-13 11:00 AM

A Letter from PPAG President Amy Potts

Amy Potts - noemail@ppag.org — Mon, 25 Feb 2013 19:15:00 GMT

Friends and Colleagues,

As we celebrate the start of a new year, I would like to take a moment to reflect on the accomplishments of the Pediatric Pharmacy Advocacy Group (PPAG). Through difficult economic times, the Pediatric Pharmacy Advocacy Group (PPAG) has endured several challenges and obstacles. However, with strong leadership and dedication from the Board of Directors and Executive Committee we have persevered and strengthened in our commitment and mission to pediatric pharmacy practice through our membership services, publications, advocacy, research and education.

PPAG in collaboration with ACCP, APhA, and ASHP has petitioned the Board of Pharmacy Specialties (BPS) to recognize pediatrics as a specialty. Peter Johnson, PharmD represented PPAG on the partnership to develop the petition. PPAG has consistently served as the backbone to support pediatrics as a specialty and has demonstrated this through its mission as the only international organization dedicated to providing pediatric specific resources to its membership and the community. Our educational, publishing, and networking programs and the professional activities of our members provides the justification for recognition. During the open comment period, BPS received over 400 Letters of Support for the pediatric pharmacy petition. We expect a positive decision from BPS in May. In response, the PPAG Executive Committee has appointed a taskforce, led by Lisa Lubsch, PharmD, to address the development of preparatory courses and recertification requirements offered to our membership in addition to continued collaboration with these organizations. Additionally, PPAG is eager to announce the anticipation of a peer-reviewed pediatric pharmacy textbook with editors Lea Eiland, PharmD and Tim Todd, PharmD expected publication in 2015.

I continue to see the synergy of our membership through professionalism, collaboration and volunteerism. We have consistently seen our membership and commitment to the safe and effective use of medications in pediatric patients rise over the last 5 years increasing 12% last year. Under the conservative approach of our treasurer, Jeff Low, PharmD and Executive Director Matt Helms, we have become more fiscally stable. In the past year we have made financial investments in the partnership to support pediatric board certification and saved money for future programs in a reserve fund separate from ongoing operations. And lastly, the Journal of Pediatric Pharmacology and Therapeutics (JPPT) is now available electronically and recognized as a part of the National Library of Medicine’s PubMed and indexed accordingly thanks to the dedication of its editors, Stephanie Phelps, PharmD and Sherry Luedtke, PharmD.

Through our advocacy and research we have established collaboration and a variety of professional relationships offering advanced level training and expert content review for several initiatives. Catherine Tom-Revzon, PharmD continues to lead our KidsMeds initiative (http://www.kidsmeds.info/) is a service providing kids and their families useful and pertinent information about their medicines. PPAG has also partnered with Dr. James Broselow, MD and Bob Luten, MD to bring you the Artemis Safety Initiative http://artemis.ppag.org/php/static/home.php. Under the leadership of Jared Cash, PharmD, the goal of this initiative is to develop a drug information resource and tool that can provide simple, safe and effective international standardization for acute administration of drugs.

I am pleased that PPAG has been able to provide age-based competencies, online continuing education and now more regularly scheduled webinars that have proven successful in serving our membership with pediatric-specific programs of interest and preceptor development. We are also coming up on the deadline for early registration for the 22nd Annual Conference in Indianapolis. Last year in Houston, we hosted 329 registrants including 69 students and residents, 56 poster presentations and 61 resident presentations as a part of the spring event. This year we anticipate continued growth and participation in addition to a fruitful recruitment opportunity.

Finally, I would like to personally thank the continued support, leadership and dedication demonstrated by our Executive Director, Matt Helms. He solely continues to be the constant in our organization and displays ongoing commitment to the organization, its mission to pediatric pharmacy practice and its members.

Sincerely,
Amy

25-Feb-13 1:15 PM

Drug Labeling Changes: Pregnancy and Lactation

Mon, 25 Feb 2013 19:00:00 GMT

Ji Yeon Lee, PharmD, and Tara McCabe, PharmD
Shands at the University of Florida

Background

Epidemiologic studies estimate 50 percent of pregnancies in North America are unplanned, eliciting concerns on the inadvertent exposure of toxic products to the fetus.¹ Given the likely need for pharmacologic treatment of acute and chronic disease during pregnancy, inquiries regarding the safety of medications are prevalent. In a retrospective study of over 150,000 deliveries, two-thirds of pregnant women utilized prescription drugs in the 9 months prior to delivery, quantifying the relevance of this issue.² Additionally, the question of post-delivery drug use and safety arises frequently during breastfeeding.

The purpose of this article is to review the changes in pharmacokinetics and dynamics during pregnancy, the fetal and maternal risks of treatments, and the current and proposed labeling guidelines from the Food and Drug Administration (FDA) used to provide recommendations for drug use in both pregnancy and lactation.

Pharmacokinetic and pharmacodynamic changes in pregnancy and lactation

Recognizing the physiologic changes that occur in pregnancy will provide insight into the modified drug kinetics and the expected effects of drugs. In pregnancy, gastrointestinal absorption is altered due to reduced acid production and motility, decreasing time to maximum concentration. An increase in both the plasma volume and glomerular filtration rate by 50 percent at the end of the first trimester decreases peak serum concentrations as drugs are diluted and cleared faster, particularly drugs with a relatively low volume of distribution and contained in the plasma space. The dilutional hypoalbuminemia that evolves as the result of a disproportionate increase in plasma volume compared to albumin production, as well as occupancy of protein binding sites by hormones, increases the free fraction of drug available. Despite these physiologic adjustments, the culmination of all the changes allows for relatively stable steady-state concentration of free drug in the absence of renal or hepatic dysfunction during pregnancy.³

The exposure of drugs to the fetus relies on whether or not the particular drug readily equilibrates with the placental-fetal compartment, creating a one-compartment environment, or slowly, creating a two-compartment model. Examples exhibiting the latter phenomenon, causing higher concentration of drug in the fetal circulation compared to the maternal plasma, include salicylates and diazepam. Many factors play into determining which model will be followed. Only drug that exists unbound to protein is able to cross the placental barrier. Additionally, lipid-soluble and non-ionized drugs are more likely to penetrate biologic membranes. Since fetal plasma pH is slightly more acidic than maternal, weak bases tend to remain non-ionized in maternal blood and freely diffuse across placental membranes. Once the molecule encounters the more acidic environment of the fetal blood, the weak base will ionize, preventing return to the maternal circulation in a phenomenon known as “ion trapping.” Given the immaturity of the fetal hepatic and renal elimination system, the fetus is at risk for extensive exposure and accumulation once a drug enters the fetal circulation with limited modes of excretion.³

The pharmacodynamic alterations that occur during pregnancy are varied and even more difficult to quantify than the pharmacokinetic changes. The simultaneous progression or improvement in disease makes determining therapy requirements and risks a challenge. As a general rule, selecting agents with the most extensive safety data in pregnancy and judicious dosing is recommended to minimize fetal risk when treatment is indicated.

Fetal and maternal risk with drug use

The teratogenicity of drugs is often unknown at the time of approval and marketing. Historically, the placenta was thought to protect the fetus from drug exposure. This myth was dispelled in the early 1960s when tragic limb malformations were linked with thalidomide use. The health care community’s initial remedy to limit drug-induced fetal harm was to simply advise against use around the time of conception. The need for more effective warnings was evident in the 1980s when a series of children with retinoid embryopathy were born post-isotretinoin exposure, a known animal carcinogen at that time. In 1989, the Retinoid Pregnancy Prevention Program was founded to aggressively educate women of childbearing age on the fetal risks and to enforce contraceptive use with concomitant retinoid administration.⁴ Studies conducted in Canada suggest up to 30 percent of women did not use any mode of contraception while on isotretinoin.⁵ Strides have been made in contraceptive adherence with implementation of the iPledge program in the United States, a system that mandates documentation of contraceptive use prior to prescribing and dispensing isotretinoin.

Since the thalidomide tragedy, approximately 30 drugs have proven evidence of teratogenicity in humans in clinically relevant doses.⁴ Drugs with warranted warnings in pregnancy include angiotensin-converting enzyme inhibitors, carbamazepine, hypoglycemic agents, lithium, psychoactive drugs (i.e., barbiturates, opioids, benzodiazepines), tetracyclines, valproic acid, and warfarin to name a few.⁶ Unfortunately, there have been drugs inaccurately labeled as teratogenic, like in the case of Bendectin^®, a combination pill of doxylamine and pyridoxine, used for nausea and vomiting during pregnancy. A series of lawsuits related to congenital malformations prompted removal of Bendectin^®from the market in 1982, which had been used in 40 percent of pregnant women. Despite large meta-analysis refuting this correlation, the valuable drug did not recover from the negative publicity and has remained unavailable in the United States.⁴

Current and proposed labeling system

Given the challenges in validly assessing fetal and maternal risk with drug use, the FDA has struggled to present the data and recommendations in a way that satisfied all stakeholders.

The current system used to categorize fetal risk after drug exposure, established in 1979, neglects key information helpful in making sound, evidence-based clinical decisions. Health care professionals scrutinized the five-letter classification system, summarized in table 1, as overly simplistic and misleading. The FDA acknowledged the inadequacies and the dissatisfaction with the current system and proposed a new format in 2008, which would provide more comprehensive and practical information for drug use in pregnancy and lactation. The content of the proposed labeling, outlined in table 2, provides detailed data on the fetal and maternal risk, notable clinical facts, and studies in both humans and animals. Additionally, the proposal requires publication of data from pregnancy exposure registries, which collate information on the impact of drugs prescribed to pregnant women by their physicians.

Despite the inclusion of scrupulous details of fetal risk in the proposal, during the 90-day post-proposal period, the public denoted shortcomings and issues with the proposition still. A few expressed concerns with the verbosity, as well as the difficulty of the reading level and the format and requested keeping the previous categories as a quick reference. Product manufacturers noted concerns with providing some of the data requested due to exclusion of pregnant women in clinical trials and the cost of establishing post-approval registries. Others commented on the omission of the considerable risks of not adequately treating chronic conditions and of not breastfeeding. Four years post-proposal, the FDA has yet to publically announce the official labeling guidelines.⁷ Based on the preliminary draft of the labeling proposal, the updated parameters will increase the information available to make clinical decisions on drug use during pregnancy and lactation.

Conclusion

There are numerous factors to consider when using drugs in pregnancy, including adjustment of the pharmacokinetics and dynamics and the evidence of fetal and maternal risks. The anticipated changes in the FDA labeling regarding drug use in pregnancy will help clinicians and pregnant mothers make more informed decisions during this critical period.

References:

Khanna J, VanLook P, Griffin P. Better news on population. Lancet 1992;339:1600.
Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol. 2004;191(2):398-407.
Loebstein R, Koren G. Clinical Relevance of Therapeutic Drug Monitoring During Pregnancy. Ther Drug Monit. 2002;24(1):15-22.
Koren G, Pastuszak A, Ito S. Drugs in pregnancy. N Engl J Med. 1998;338(16):1128–1137.
Pastuszak AL, Koren G, Rieder MJ. Use of the Retinoid Pregnancy Prevention Program in Canada: patterns of contraception use in women treated with isotretinoin and etretinate. Reprod Toxicol 1994;8:63-68.
Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 4th ed. Baltimore: Williams & Wilkins, 1994.
Miller K, Birch-Smith P, McKinnon R, et al. Pregnancy and Lactation Labeling. Pharmacy Times 2010 June. Available at: http://www.pharmacytimes.com/publications/issue/2010/June2010/PregnancyLabeling-0610. Last accessed November 14, 2012.
Kweder SL. Drugs and Biologics in Pregnancy and Breastfeeding: FDA in the 21st Century. Birth Defects Res A Clin Mol Teratol. 2008;82(9):605-609.

Table1: Description of FDA Categories for Drug Use in Pregnancy⁸

FDA Categories for Drug Use in Pregnancy
A	Controlled studies in humans show no fetal risk
B	Controlled studies in humans show no fetal risk despite adverse findings in animals OR in the absence of adequate human studies, animal studies show no fetal risk
C	Animal and human studies are not available OR animal studies show fetal risk and no human studies are available; Use only if potential benefits outweighs potential risks
D	Positive evidence of human fetal risk; Use only if potential benefits outweigh potential risks
X	Animal or human studies demonstrate fetal abnormalities or evidence of fetal risk; Use is contraindicated

Table 2. Overview of Pregnancy and Lactation Subsection Content⁸

Pregnancy
General Information	Contact information if pregnancy registry available General statement about background risk
Fetal Risk Summary	Characterizes the likelihood that the drug increases risk of developmental abnormalities in humans and explains other relevant risks based on all available data
Clinical Considerations	Describes any known risk to the pregnant woman and fetus from drug exposure early in pregnancy Provides information concerning dosing, adverse reactions unique to pregnancy, effects of dose, timing, and duration of exposure, and potential neonatal complications
Data	Presents human and animal data separately
Lactation
Risk Summary	Characterizes the effects of drug on milk production and presence of drug in human milk
Clinical Considerations	Describes information on ways to minimize drug exposure to the breast-fed infant and dose adjustments during lactation
Data	Presents an overview of the data that are the basis for the information in the sections above

25-Feb-13 1:00 PM

New Therapies in the Treatment of Cystic Fibrosis

Mon, 25 Feb 2013 18:00:00 GMT

Dennison Lim, PharmD candidate and Tara McCabe, PharmD

Shands Children's Hospital at the University of Florida

In the United States, over 800 people are diagnosed with Cystic Fibrosis (CF) each year. The total now stands at over 26,000 in the US alone, with the overwhelming majority of patients being Caucasian (94.3%). Median survival as of 2010 for these patients is 38.3 years.¹ CF is caused by a mutation in a gene that encodes the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which is expressed in tissues such as the lung, sweat glands, and pancreas. Although CFTR functions primarily as a chloride channel, it has been identified to affect epithelial sodium transport and therefore water in various tissues. Several classes of mutations exist, each with differing degrees of functional impairment.²

The F508del mutation, a class II mutation, accounts for two-thirds of mutated alleles in northern Europe and North America. Class II mutations are the result of protein degradation in the endoplasmic reticulum due to defects in the translated CFTR protein. The absence of phenylalanine in the 508 amino acid position of the CFTR gene leads to a folding defect of the processed protein that is consequently degraded in the endoplasmic reticulum. Patients with the F508del mutation generally lack any CFTR channel migration to the apical cell membrane, with resultant absence of chloride transport across the epithelium. The G551D mutation, a class III mutation, is a product of a glycine to aspartate substitution on the 551 amino acid position that results in the production of non-functional or reduced-function CFTR channels that reach the apical cell membrane.² In the United States, the percentage of patients having at least one copy of the F508del mutation is 88.5%, whereas only 4.4% of patients have at least one copy of the G551D mutation.¹

Clinical manifestations of CFTR channel dysfunction are broad and appear throughout life. Many children initially present with signs of pancreatic insufficiency, such as greasy stools, fat-soluble vitamin deficiencies, and may appear malnourished. Osteopenia secondary to vitamin D deficiency begins early in childhood, with osteoporosis appearing later in life. Pancreatic dysfunction progresses to glucose intolerance and insulin deficiency in adolescence and adulthood, termed cystic fibrosis related diabetes (CFRD). In CF patients, lung disease is progressive throughout life, a product of persistent inflammation, impaired mucus clearance, and airway colonization that results in recurrent infections. These are only a few of many consequences related to cystic fibrosis.²

Until now, treatments were targeted at clinical manifestations, which are secondary to underlying CFTR channel dysfunction. On January 31, 2012 the Food and Drug Administration (FDA) approved ivacaftor, a CFTR potentiator, for the treatment of patients ages 6 years or older with the G551D mutation. Ivacaftor increases the time activated CFTR channels on the apical cell membrane stay open, increasing chloride transport activity of G551D mutated channels. Marketed as Kalydeco, ivacaftor was touted as one of three new medications (together known as CFTR modulators) by Vertex Pharmaceuticals that aimed to treat the underlying cause of cystic fibrosis.³

Ivacaftor should be taken with fat-containing foods, typically one 150 mg tablet twice daily. Ivacaftor can be affected by inhibitors and inducers of CYP3A enzymes and should be taken with caution when co-administration is necessary. Prior to starting the medication, a baseline transaminase should be assessed with follow up assessment every 3 months during the first year, then annually thereafter. The most frequently reported adverse reaction is headache, followed by oropharyngeal pain, upper respiatory tract infection, and nasal congestion. Whether the tablets can be crushed or split is not currently known. (See Table 1)¹⁵

Two phase III randomized, placebo-controlled trials of ivacaftor (VX-770) were completed prior to approval, both showing significant improvement of the primary endpoint, mean absolute change from baseline in FEV1 at 24 weeks. The STRIVE study (NCT00909532)⁴ by Ramsey et al enrolled 161 subjects 12 years of age or older with at least one G551D mutation to receive 150 mg of ivacaftor twice daily or placebo for 48 weeks. Change in FEV1 from baseline through 24 weeks was found to be 10.6% greater in the ivacaftor group than in the placebo group (P<0.001). FEV1 in patients on placebo decreased 0.2% through 24 weeks. Patients receiving ivacaftor were 55% less likely to have a pulmonary exacerbation (P<0.001), weighed 2.7 kg more (P<0.001), and had 48.1 mmol per liter lower sweat chloride concentration at 48 weeks (P<0.001).⁵

The ENVISION study (NCT00909727)⁶ enrolled 52 subjects between the ages of 6 and 11 years with at least one G551D mutation. Subjects were randomized to receive ivacaftor 150 mg every 12 hours or placebo, with a similar primary endpoint of FEV1 improvement from baseline at 24 weeks. Mean absolute improvement from baseline in FEV1 was found to be 12.5% through 24 weeks, mean relative improvement from baseline was 17.4% compared to placebo. Through 48 weeks, there was a 10% mean absolute improvement from baseline and a 15.1% mean relative improvement from baseline compared to placebo. Patients receiving ivacaftor gained an average of 3.7 kg from baseline at 24 weeks and 5.9 kg through 48 weeks, compared to 1.8 and 3.1 kg in the placebo group, respectively. In terms of sweat chloride concentration, decreases of 56 mmol per liter were seen at 48 weeks, compared to 3 mmol per liter in placebo.^7,8

Vertex Pharmaceuticals published twelve weeks of data from the PERSIST trial (NCT01117012),⁹ a 96-week open-label extension study of patients who have completed 48 weeks of either ENVISION or STRIVE, focused primarily on the long term safety and durability of treatment with ivacaftor 150 mg twice daily. When people treated with a placebo during the STRIVE study rolled over to PERSIST and began receiving ivacaftor, the improvements in lung function through week 12 were similar to those observed among people treated with ivacaftor in the first 12 weeks of STRIVE. After 12 weeks of PERSIST, patients previously treated with ivacaftor improved 11.6% from baseline compared to patients previously treated with placebo that improved 10.9% from baseline.⁸

Two other CFTR modulators are currently under investigation by Vertex Pharmaceuticals. Whereas ivacaftor benefits only a minority of patients with the G551D mutation, CFTR correctors VX-809 and VX-661 target the F508del mutation that afflicts two-thirds of cystic fibrosis patients in North America and northern Europe.² Unlike CFTR potentiator ivacaftor, which acts to increase the time that activated CFTR channels on cell surface remain open, VX-809 restores F508del mutation processing and plasma membrane localization of CFTR protein, effectively increasing functional surface CFTR ion channels. The mechanism of VX-661 is not currently described.¹⁰

Clancy et alenrolled 89 subjects 18 years of age or older and homozygous for the F508del mutation in a phase II randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of VX-809 (NCT00865904).¹¹ Secondary outcomes evaluated the effect of VX-809 on sweat chloride concentration, nasal potential difference (NPD), and lung function. Patients were placed into two sequential cohorts for 28 days of treatment, with an interim safety review after completion of cohort A. Participants of cohort A were randomized to receive VX-809 once daily at doses of 25 mg, 50 mg, or placebo in a 2:2:1 ratio. After a safety review, participants of cohort B were randomized to receive VX-809 once daily at doses of 100 mg, 200 mg, or placebo in a 2:2:1 ratio. Adverse events were similar for VX-809 and placebo treated subjects. No difference was found in physician diagnosed pulmonary exacerbations between VX-809 and placebo (P = 0.62). Sweat chloride was reduced in a dose-dependent manner that was statistically significant in the 100 and 200 mg groups (P < 0.05 and P < 0.01). No differences were found for changes in NPD or lung function as measured by spirometry.¹⁰

A combination of a CFTR corrector (VX-809) and CFTR potentiator (ivacaftor) has recently been studied, which should not only increase localization of CFTR protein, but keep them functionally active. Vertex Pharmaceuticals on June 28, 2012 published final data from a phase II randomized, double-blind, placebo-controlled study that enrolled 109 cystic fibrosis patients ages 18 years of age or older with one or two copies of the F508del mutation to evaluate change in lung function as measured by FEV1 (NCT01225211).¹² Three groups of F508del homozygous patients were randomized to receive VX-809 once daily at doses of 200, 400, and 600 mg for 28 days, followed in combination with ivacaftor 250 mg twice daily for 28 days. One group of F508del heterozygous patients received 600 mg once daily of VX-809 for 28 days, followed in combination with ivacaftor 250 mg twice daily for 28 days. The placebo group included both homozygous and heterozygous patients. Compared to placebo, homozygous patients on 600 mg VX-809 in combination with ivacaftor from day 28-56 experienced a mean absolute improvement in lung function of 8.6% as measured by FEV1 (P<0.001). Of these patients, 55% experienced a >5% improvement in FEV1 and 25% experienced an improvement >10%. Patients treated with placebo experienced a decline of 2.5% over the same period of time, with 9.5% experiencing an improvement of >5% and none >10%. Sweat chloride improved 6.4 mmol per liter after 28 days of VX-809 alone (P = 0.01) and an additional 3.7 mmol per liter after 28 days of combination treatment compared to placebo, which was not statistically significant. Lung function and sweat chloride improved to a smaller extent in homozygous patients on 200 and 400 mg doses of VX-809, as well as heterozygous patients on 600 mg.¹³

Another CFTR corrector, VX-661, is in the recruitment phase of a three-part phase II randomized, double-blind, placebo-controlled study in patients 18 years of age or older who are homozygous for the F508del mutation (NCT01531673).¹⁴ Primary outcomes are safety, tolerability, and absolute change in sweat chloride through 28 and 56 days of therapy. Additional outcomes will include changes in lung function as measured by FEV1, changes in the Cystic Fibrosis Questionnaire respiratory domain score, and determinations of pharmacokinetic parameters. Estimated completion of data collection for the primary outcome is August 2013 and enrollment is expected to be 208 subjects between the three parts of the study.

Cystic fibrosis remains a challenging disease to treat, but new drug therapies that target the underlying cause now exist, with more on the horizon. Ivacaftor, released in early 2012, potentiates the action of CFTR on the apical membrane to increase chloride transport activity in patients with the G551D mutation. Drug candidates VX-809 and VX-661 from Vertex Pharmaceuticals work by increasing the concentration of CFTR protein on the apical membrane in patients with the F508del mutation. Data released by Vertex Pharmaceuticals revealed promising use of VX-809 as both monotherapy and in combination with ivacaftor to target the vast majority of patients with either mutation. If successful, VX-809 and similar drugs may be a revolutionary leap forward in treatment of cystic fibrosis and its associated complications.

References:

Anon. 2010 annual data report to the center directors. Bethesda, MD: Cystic Fibrosis Foundation Patient Registry, 2010
O'Sullivan BP, Freedman SD. Cystic fibrosis. Lancet. 2009;373(9678):1891-1904.
FDA Approves KALYDECO (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis. FDA Approves KALYDECO (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis (NASDAQ:VRTX). Vertex Pharmaceuticals Incorporated, 31 Jan. 2012. Web. 12 Aug. 2012. http://investors.vrtx.com/releasedetail.cfm?releaseid=644257.
Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation. Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2012 Aug 13]. Available from: http://clinicaltrials.gov/show/NCT00909532 NLM Identifier: NCT00909532.
Ramsey BW, et al. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011;365(18):1663-1672.
Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation. Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 with the G551D Mutation. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2012 Aug 13]. Available from: http://clinicaltrials.gov/show/NCT00909727 NLM Identifier: NCT00909727.
Phase 3 Study of VX-770 in Children Ages 6 to 11 With a Specific Type of Cystic Fibrosis Showed Profound Improvements in Lung Function (FEV1) and Other Measures of Disease Through 24 Weeks. Vertex Pharmaceuticals Incorporated, 29 Mar. 2011. Web. 13 Aug. 2012. http://investors.vrtx.com/releasedetail.cfm?releaseid=560382.
Phase 3 Study of KALYDECO (ivacaftor) in Children Ages 6 to 11 with a Specific Type of Cystic Fibrosis Showed Significant Improvements in Lung Function and Other Measures of Disease Sustained Through 48 Weeks. Vertex Pharmaceuticals Incorporated, 03 Nov. 2011. Web. 13 Aug. 2012. http://investors.vrtx.com/releasedetail.cfm?releaseid=620643.
Vertex Pharmaceuticals Incorporated; Cystic Fibrosis Foundation. Study of VX-770 in Cystic Fibrosis Subjects. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2012 Aug 13]. Available from: http://clinicaltrials.gov/show/NCT01117012 NLM Identifier: NCT01117012.
Clancy JP, et al. Results of a phase IIa study of VX-809, an investigational CFTR corrector compound, in subjects with cystic fibrosis homozygous for the F508del-CFTR mutation. Thorax. 2012;67(1):12-18.
Vertex Pharmaceuticals Incorporated. Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2012 Aug 13]. Available from: http://clinicaltrials.gov/show/NCT00865904 NLM Identifier: NCT00865904.
Vertex Pharmaceuticals Incorporated. Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2012 Aug 13]. Available from: http://clinicaltrials.gov/show/NCT01225211 NLM Identifier: NCT01225211.
Final Data from Phase 2 Combination Study of VX-809 and KALYDECO (ivacaftor) Showed Statistically Significant Improvements in Lung Function in People with Cystic Fibrosis Who Have Two Copies of the F508del Mutation. Vertex Pharmaceuticals Incorporated, 28 June 2012. Web. 13 Aug. 2012. http://investors.vrtx.com/releasedetail.cfm?releaseid=687394.
Vertex Pharmaceuticals Incorporated. Study of VX-661 Alone and in Combination With VX-770 in Subjects Homozygous to the F508del-CFTR Mutation. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2012 Aug 13]. Available from: http://clinicaltrials.gov/show/NCT01531673 NLM Identifier: NCT01531673.
"Ivacaftor: Full U.S. Prescribing Information." Vertex Pharmaceuticals Incorporated, 30 Jan. 2012. Web. 13 Aug. 2012. http://pi.vrtx.com/files/uspi_ivacaftor.pdf.
"Information for Vermont Prescribers of Prescription Drugs." Vertex Pharmaceuticals Vermont Prescribers Information. Vertex Pharmaceuticals, 31 July 2012. Web. 12 Aug. 2012. http://www.vrtx.com/vermont-prescribers-information-kalydeco.html.

Table 1: Ivacaftor Prescribing Information¹⁵
Indications	Cystic fibrosis patients ages 6 years and older who have a G551D mutation in the CFTR gene. Not effective in patients who are homozygous for the F508del mutation in the CFTR gene.
Dosage	Adults, Children ≥6 Years of Age: one 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food Hepatic Impairment (Child-Pugh Class B): one 150 mg tablet once daily or less Concomitant CYP3A Inhibitors: one 150 mg tablet twice-a-week with strong inhibitors (e.g. ketoconazole); one 150 mg tablet once daily with moderate inhibitors (e.g. fluconazole)
Dosage Forms	150 mg tablets (film coated) in 60 tablet bottles. No information is available regarding crushing tablets, splitting tablets, or administration through an enteral feeding tube.
Warnings and Precautions	Transaminase (AST or ALT) Elevations: transaminase elevations while taking ivacaftor have been reported. It is recommended to assess AST and ALT prior to initiation, every 3 months during the first year, and annually thereafter. Ivacaftor should be held if AST or ALT are 5 times the upper limit of normal. Concomitant Use of CYP3A Inducers: may reduce the therapeutic effectiveness of ivacaftor. Co-administration of ivacaftor with strong inducers is not recommended.
Adverse Reactions	Adverse reactions that occurred at a frequency of ≥8%: Headache (24%), oropharyngeal pain (22%), upper respiratory tract infection (22%), nasal congestion (20%), abdominal pain (16%), nasopharyngitis (15%), diarrhea (13%), rash (13%), nausea (12%), dizziness (9%)
Drug Interactions	Inhibitors of CYP3A: See dosage section for more information. Co-administration with grapefruit juice, a moderate CYP3A inhibitor, should be avoided. Inducers of CYP3A: Co-administration with strong CYP3A inducers is not recommended. CYP3A and/or P-gp substrates: administration of ivacaftor may increase systemic exposure of drugs which are substrates of CYP3A and/or P-gp. Caution is recommended.
Specific Populations	Pregnancy Category: B Nursing Mothers: Excretion into human milk is probable. Caution should be exercised. No human studies have investigated the effects of ivacaftor on breast-fed infants Pediatric Use: The safety and efficacy in patients with cystic fibrosis younger than age 6 have not been established. Hepatic Impairment: No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A). A reduced dose of 150 mg once daily is recommended in patients with moderate hepatic impairment (Child-Pugh Class B). Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C) but exposure is expected to be higher than in patients with moderate hepatic impairment. Use with caution at a dose of 150 mg once daily or less frequently in patients with severe hepatic impairment. Renal Impairment: No dose adjustment is necessary for patients with mild to moderate renal impairment. Caution is recommended while using ivacaftor in patients with severe renal impairment. Ivacaftor has not been studied in patients with mild, moderate, or severe renal impairment or in patients with end stage renal disease.
Pharmacokinetics	Absorption: Should be administered with fat-containing food. The exposure of ivacaftor increases 2-to-4-fold when given with fat containing food Distribution: 99% protein bound to alpha 1-acid glycoprotein and albumin. Does not bind to human red blood cells Metabolism: Extensively metabolized primarily by CYP3A with active (M1) and inactive metabolites (M6). Active metabolite M1 has approximately one-sixth the potency of ivacaftor. Excretion: The terminal half-life was approximately 12 hours following a single dose. The majority of ivacaftor is eliminated in the feces (87.8%) as metabolites. There was negligible urinary excretion of ivacaftor. Potential to Affect Other Drugs: Ivacaftor is a weak inhibitor of CYP3A and potentially CYP2C8, CYP2C9, and P-gp. Its metabolites M1 and M6 have potential to inhibit CYP3A and P-gp. Ivacaftor and its metabolites were not inducers of CYP isoenzymes. Potential for Others Drugs to Affect Ivacaftor: Ivacaftor and metabolite M1 were substrates of CYP3A enzymes (i.e. CYP3A4, CYP3A5).
Storage	Store ivacaftor at room temperature between 68°F to 77°F (20°C to 25°C)
Cost	$29,400.00 per 60 tablets or $490.00 per pill.¹⁶ Free medication or co-pay assistance may be available for eligible patients enrolled in the Vertex Guidance and Patient Support (GPS) program.³

25-Feb-13 12:00 PM

Revving up for the 2013 PPAG Annual Conference

Wed, 13 Feb 2013 14:00:00 GMT

The 22nd Annual PPAG Meeting and 2013 Pediatric Pharmacy Conference will be held in Indianapolis, Indiana May 1st through 5th at the downtown Marriott. This conference hotel is located only a short walk from the “Wholesale District,” home to many fantastic restaurants and entertainment venues in addition to the Circle Center Shopping Mall.


White River State Park, Indiana's only urban state park, offers an awesome array of attractions, entertainment and recreation including the Indianapolis Zoo, Victory Field and the NCAA Hall of Champions.	The Indianapolis Zoo has grown into a world-class facility hosting a million visitors each year and playing a major role in worldwide conservation. The completely submerged dolphin dome is the first of its kind in the world.	The Soldiers and Sailors Monument is located on Monument Circle in the center of downtown and has come to symbolize the city of Indianapolis and the state of Indiana.

Conference activities will include educational sessions, poster and platform presentations, PPAG committee meetings, networking opportunities, and more. Educational sessions will be presented in a PICU and a NICU block format.

Indianapolis is home to two exceptional children’s hospitals, Riley Hospital for Children and Peyton Manning Children’s Hospital. Riley Hospital for Children is currently ranked by U.S. News and World Report in 10 out of 10 specialties on the list of the 2012 – 2013 Best Children’s Hospitals. Peyton Manning Children’s Hospital, home to the first pediatric emergency room in the Hoosier State, also houses the largest level III NICU in the state of Indiana. During the conference, opportunities to tour both hospital facilities will be provided.

In addition to the renowned medical care, Indianapolis offers an immense selection of activities, many of which are located in the downtown area. The month of May is an exceptionally exciting time for “The Racing Capital of the World” due to the daily activities leading up to the Indianapolis 500. And if you aren’t a huge racing fan, Indianapolis still has a great number of other sporting events which you may enjoy as it is home to Pacers basketball, Colts football, and Indians baseball.


The IMS Hall of Fame Museum has one of the world's largest, most varied collections of racing, classic and antique cars including more than 30 Indianapolis 500 winning cars.	The Children's Museum of Indianapolis is the largest children's museum in the world. Dinosphere is one of the largest displays of real juvenile and family dinosaur fossils in the United States.

Indianapolis is also well known for its museums, including the Children’s Museum of Indianapolis, the NCAA Hall of Champions, and many more, all located a short distance from downtown. And finally, if you just like to stroll and take in the sights, the central canal, which is located at the White River State Park, is a beautiful waterway that offers a great way to spend time in the beautiful Indianapolis weather.


The Indiana State Museum is a hands-on overview of the best Indiana has to offer. Constructed from all Indiana materials including limestone, sandstone, steel, brick and glass, the building itself is a work of art.	This organic dairy farm is a serene break from the city hustle. Serving 100% grassfed steaks, elk, wild caught seafood, vegetarian options and, of course, award-winning cheeses and dairy products.

The city of Indianapolis has a lot to offer; don’t miss out on all of the fun while in town for the PPAG Annual Meeting!

13-Feb-13 8:00 AM

2013 Call for Abstracts

Matthew Helms - noemail@ppag.org — Thu, 17 Jan 2013 19:00:00 GMT

General Information Regarding the
Scientific and Clinical Practice Poster Session
ABSTRACT SUBMISSION DEADLINE: MARCH 15, 2013

All practitioners, investigators, and post-doctoral trainees in the field of pediatric clinical pharmacy, whether members of PPAG or not, are invited to submit abstracts of papers to be considered for platform or poster presentation at the 22nd Annual PPAG Meeting and 2012 Pediatric Pharmacy Conference. The conference will be held at the Indianapolis Marriott Hotel Downtown in Indianapolis, IN. Poster and Platform Presentations will be held on Friday May 3, 2013

All research and practice abstracts should be no longer than 450 words. Research abstracts will be published in the Journal of Pediatric Pharmacology and Therapeutics. Platform Presentations and Best Practice Awards will be chosen from the abstracts submitted. Abstract are required to have results and a conclusion to be considered for acceptance.

Submit Abstract Here

Research/Scientific Track

Research abstracts presented at PPAG report the results of a scientific investigation or a clinical observation (case report) involving some aspect of pharmacotherapy. Scientific investigations can be either clinical, basic, or translational and are either hypothesis-driven or descriptive in nature. To be accepted for presentation, research abstracts must have final results. Abstracts without results will not be accepted in this category. The abstract may be submitted in any of the following categories: Scientific, Case Report, and Encore Presentations (a poster that has been presented and published elsewhere. The original citation must accompany encore presentations).

For useful tips in drafting your abstract, please visit: Guidelines for Abstract Preparation.

All submissions will be eligible for the Young Investigator or Best Original Paper awards. The finalists will be judged by a panel of judges during the poster and platform presentation sessions. Primary authors may be considered for all awards for which they are eligible, but may win only one award.

Outstanding Original Paper

Outstanding Original Paper Investigators will be evaluated on the basis of their written abstract and the quality of their presentation at the Meeting. The winner will receive complimentary registration to next year's Annual Meeting and a framed certificate.

Christensen Memorial Young Investigator Award

PPAG Young Investigator Award is available to investigators who have been in practive five (5) years or less . This award will be granted to the investigator based on their written abstract and the quality of their presentation at the Meeting.

Deadline March 15, 2013

Submit Abstract Here

Best Practice Track

Best and Innovative Pediatric Pharmacy Practice Abstracts typically describe programs, systems, or projects that are innovative, creative, cost-effective, and improve practice in pediatric pharmacy. BPA/IPPP Posters will be selected based on achievement of excellence in each of the four areas.

Winners of the Best Practice Award will be chosen from accepted abstracts. The program, system, or project can be an individual or collaborative effort in any type of practice setting, including academia, institutional, or ambulatory care. Best Practice Abstracts should include sufficient details about the rationale, process, and hypothesis of the impact should the program, system, or project be implemented. Accepted abstracts will be published in the Journal of Pediatric Pharmacology and Therapeutics.

Submissions should include any pictures, graphs, figures and data tables that supports the summary. Each of these must be clearly labeled and described.

Lexi-Comp Best Practice Awards

PPAG will award up to two (2) Best Practice Awards during the 22nd Annual Meeting in Indianapolis, IN. The awards are given to innovative and creative pharmacy programs that advance the mission, vision, and goals of the organization. Recipients of the award receive a plaque for the practice site and a certificate recognizing each contributor to the program. Award recipients will share their best practice during a presentation at the Annual Meeting and as a poster at the Annual Meeting.

The Best Practice Awards are generously supported by Lexi-Comp.

Deadline March 15, 2013

Submit Abstract Here

17-Jan-13 1:00 PM

Rethinking Sildenafil – Knowing When Enough Is Enough

Wed, 19 Dec 2012 17:00:00 GMT

Sadie Stone, PharmD and Erica Krogsgard, PharmD
Children's of Alabama Department of Pharmacy

The recent Food and Drug Administration (FDA) Drug Safety Communication regarding use of sildenafil (Revatio^®) in children with pulmonary arterial hypertension (PAH) has raised concern among pediatric providers.¹ Sildenafil is a phosphodiesterase-5 inhibitor that has shown success in adult patients with PAH and is approved for use in patients greater than 18 years old at a maximum daily dose of 20 mg three times daily.² In short, the FDA recommends against off-label use of sildenafil in patients aged 1-17 years for PAH and has mandated the addition of a warning to the drug label stating that this drug is not recommended in pediatric patients.^1-3 These actions were influenced by the results of the landmark STARTS-1 and STARTS-2 trials, which will be added to the product labeling.

STARTS-1 is a randomized, double-blind, placebo-controlled study, which spanned 16 weeks. Children aged 1-17 years (n=235) were randomized to placebo or low-, medium-, or high-dose sildenafil. To be eligible for the trial, patients had to weigh greater than eight kilograms (kg) and have PAH that is idiopathic (IPAH), heritable (HPAH), or associated with other conditions including congenital heart disease. The study was conducted at 32 centers in 16 countries from August 2003 - June 2008. Doses were weight based (see Table), and developmentally able children performed cardiopulmonary exercise testing (CPET) to determine exercise capacity measured as percent change from baseline in peak oxygen consumption (PVO₂).^4-5 This was the primary endpoint and was performed in 115/235 patients (106 were evaluated). The data for the three sildenafil doses were combined and compared to placebo, demonstrating a statistically insignificant increase in PVO₂from baseline of 7.7± 4% (95% CI, -0.2% to 15.6%; p=0.056). When the low-dose group was omitted in a post-hoc analysis, there was a statistically significant increase from baseline PVO₂of 9.7% (95% CI, 1.3% to 18%; p=0.023) when comparing the medium- and high-dose groups to placebo. Additional endpoints included the assessment of hemodynamics, N-terminal-pro-brain natriuretic peptide levels, World Health Organization functional class, and quality-of-life measures, all of which showed improvement among the three dosing groups compared to placebo. Adverse events were mild to moderate, with headache, upper respiratory infections, diarrhea, pyrexia, vomiting, and nausea being the most commonly experienced. The latter three adverse effects appeared to be dose-related.⁴

Of the 228 patients who completed the STARTS-1 trial, 220 enrolled into the STARTS-2 study. This is currently an ongoing dose-blinded, open-label extension study evaluating the long-term safety and efficacy of sildenafil. The doses used in STARTS-1 were continued upon enrollment into STARTS-2, but dose titration is permitted. Patients requiring additional PAH-specific medications are being discontinued from the study.^4,6Preliminary data suggest a higher mortality risk among patients receiving high-dose sildenafil compared to low-dose, a trend that was noticed after 2 years of treatment.⁴ Of note, placebo-treated patients from the STARTS-1 study were not included in this analysis. At the time of publication of the STARTS-1 results, deaths were 9%, 14%, and 20% for patients randomized to low-, medium-, and high-dose sildenafil, respectively.^3,4

There is much to be learned from these studies. In the STARTS-1 trial, there was no improvement in exercise ability (as measured by PVO₂, functional class, and hemodynamics) among children receiving low-dose sildenafil. Children receiving medium- and high-dose sildenafil did see significant improvement in these measures. The authors discussed limitations of recording accurate CPET results in young children and those functionally unable to perform the test.⁴

The increased mortality seen in STARTS-2 is alarming, however the authors acknowledge that the deaths were related to etiology and baseline severity of PAH.⁴ The majority of deaths occurred in those with IPAH/HPAH, which is a population known to have increased mortality risk.^3,4 It therefore is not represented as well in the adult population, and it is not possible to adequately compare mortality of pediatric patients with this etiology of PAH to their adult counterparts. The IPAH/HPAH population of this study was also the smallest group of patients represented, accounting for only 33% of the demographic. Patients who died also had more severe disease at baseline, with values higher than the median for pulmonary vascular resistance index, mean pulmonary arterial pressure, and right atrial pressure. Also, dose titration was allowed, meaning patients originally randomized to high-dose (and being evaluated as such in the results) may have actually been taking a low dose of sildenafil. Furthermore, the highest dose of sildenafil recommended in adults of 20 mg three times daily was surpassed in the trials, with the high-dose group receiving as much as 80 mg three times daily.⁴

In closing, the data presented in the STARTS-1 and STARTS-2 studies and the subsequent FDA recommendation to discontinue sildenafil use in pediatric patients must be evaluated critically, as there are several limitations. As in many pediatric studies, the population studied was small. Furthermore, the primary endpoint used in STARTS-1 (CPET) could not be reliably performed in over half of the patients due to age or developmental ability.⁴Also, dose titration in STARTS-2 may have led to inaccurate or exaggerated results. The FDA declared after preliminary review of the STARTS-2 data that mortality was increased in high-dose patients, but the study investigators concluded that the deaths were related to etiology and baseline disease and not the sildenafil dose.^1,3,4 While sildenafil is not without risk, it may still be an option for selected pediatric patients with PAH. Risk/benefit analysis should be utilized to determine whether a thoughtfully selected dose should be considered for each patient.

References:

FDA recommends against use of Revatio in children with pulmonary hypertension. Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm317123.htm. August 30, 2012. Accessed December 13, 2012.
Revatio [package insert]. Pfizer; New York City, NY; August 2012. http://labeling.pfizer.com/showlabeling.aspx?id=645. Accessed December 13, 2012.
Revatio (sildenafil) for pediatric use: consensus statement. Pulmonary Hypertension Association Scientific Leadership Council. http://www.phassociation.org/MedicalProfessionals/ConsensusStatements/RevatioForPediatricUse. September 2012. Accessed December 13, 2012.
Barst RJ, Ivy DD, Gaitan G, et al. A randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-naïve children with pulmonary hypertension. Circulation. 2012;125:324-34.
A randomized, double-blind, placebo-controlled study of sildenafil in children with pulmonary arterial hypertension. Clinical Trials.gov Website. ClinicalTrials.gov identifier:NCT00159913. http://clinicaltrials.gov/ct2/show/NCT00159913?534m=nct00159912&rank=1. September 15, 2009. Accessed December 13, 2012.
A long-term extension study evaluating safety of sildenafil citrate when used to treat pulmonary arterial hypertension (PAH) in children. ClinicalTrials.gov Web site. Clinical Trials.gov identifier:NCT00159874. http://clinicaltrials.gov/ct2/show/NCT00159874?term=nct00159874&rank=1. October 31, 2012. Accessed December 13, 2012.

Table: Sildenafil Dosing form STARTS-1 Trial

Body Weight, kg	Sildenafil Dose, mg^†
Body Weight, kg	Low	Medium	High
≥8 to 20	NA^*	10^°	20
>20 to 45	10	20	40
>45	10	40	80

^†Doses were targeted to achieve maximum steady state concentrations of 47, 140 and 373 ng/ml.

^*NA = Not Applicable

^°Modeling for the low and medium doses were predicted to be similar for the 8 to 20 kg patients so there was no low dose for this body weight group.

Table adapted from Reference 3: Barst RJ, Ivy DD, Gaitan G, et al. A randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-naïve children with pulmonary arterial hypertension. Circulation. 2012;125:324-34.

19-Dec-12 11:00 AM

Faculty-Pediatrics-(Non tenure track)

Thu, 09 May 2013 05:00:00 GMT

Title: Faculty-Pediatrics-(Non tenure track) Description: University of Maryland School of Pharmacy, Department of Pharmacy Practice and Science is seeking qualified candidates for the following faculty positions: Assistant/Associate Professor - Pediatric Pharmacy Practice (position # 05-179-58) This faculty position is a full-time, 12 month appointment and requires teaching; service to the school, campus and the profession; and scholarly activity in the area of specialty. Faculty are expected to provide leadership and develop a clinical practice in their area of pediatrics. The University of Maryland is an Affirmative Action/Equal Opportunity/ADA Employer, and has a strong institutional commitment to the principal of diversity in all areas. Interested candidates should submit the following: Cover letter (please reference the specific position # in your letter) Statement of teaching philosophy Statement of scholarly interests Signed curriculum vitae (CV) Three letters of...

Clinical Pharmacy Coordinator - Pediatric Emergency Department

Tue, 30 Apr 2013 05:00:00 GMT

Title: Clinical Pharmacy Coordinator - Pediatric Emergency Department Description: · Clinical consultation o Provide information regarding medication dosage, pharmacokinetics, alternative agents, formulary alternatives, cost-effective options, and evidence-based treatment regimens · Codes o Respond to any codes within the emergency department § During the code assist in medication preparation, provide therapeutic recommendations and acquire medications not readily available from the department § **Note**- Pharmacist must be ACLS certified · Committee involvement o Participate in P&T, emergency-preparedness, and any other committees related to emergency medicine · Continuity of care o Assist in the transfer of patients from the emergency department to either an inpatient or outpatient setting § Inpatient · Providing important information about the patient to the receiving team § Outpatient · Contacting the...

Pharmacy Manager - Patient Care Services and Operations (Pediatrics and Nutrition Support)

Tue, 23 Apr 2013 05:00:00 GMT

Title: Pharmacy Manager - Patient Care Services and Operations (Pediatrics and Nutrition Support) Description: The Pharmacy Manager, Patient Care Services and Operations (Pediatrics and Nutrition Support) is responsible for leading and managing associated personnel, programs, services, and operations of the Pediatric Service line, pediatric pharmacy team, Nutrition Support Service, American Family Children's Hospital to provide safe, timely, efficient, equitable, effective, and patient-centered medication use. Additionally, the incumbent will be responsible for providing direction and leadership to pharmacists, pharmacy technicians, pharmacy students, pharmacy interns and pharmacy residents who provide inpatient pharmacy patient care and operational services for pediatric patients. Furthermore, the incumbent will partner with the Managers of Pharmacy Operational Improvement and the Assistant Director of Pharmacy to manage pharmacy purchasing, contracting, receiving, inventory...

Cleveland Akron Area Pediatric Pharmacists (CAAPP)

Fri, 10 May 2013 01:41:00 GMT

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22nd Annual PPAG Meeting Conference Resources

Sun, 05 May 2013 17:33:32 GMT

Welcome to the 22nd Annual PPAG Meeting. This page will serve as your one-stop shop for everything related to the Conference. General Conference Information QUICK LINKS The 22nd PPAG Annual Meeting and 2013 Pediatric Pharmacy Conference is designed for practitioners and administrators involved in drug therapy decisions for children. The Conference is designed by pediatric pharmacists who understand the unique needs of the pediatric patient. This conference will provide important educational benefits for participants who want to improve their positioning in the health care enviornment. It will also provide a new understanding of current medical and clinical trends in pediatric health care. The overall conference goals are as follows: Provide and review current information and developments pertaining to pediatric medication use in neonatal and pediatric critical care. Review new technologies that can reduce the risk of errors in...

homepage 1

Wed, 24 Apr 2013 14:33:24 GMT

- KidsMeds is your online resource for pediatric medication information. PPAG offers...

Fellow in the Pediatric Pharmacy Advocacy Group (FPPAG)

Fri, 05 Apr 2013 19:16:47 GMT

Purposes The Fellow in the Pediatric Pharmacy Advocacy Group (FPPAG) Recognition Program serves the following purposes: 1. to recognize excellence in pediatric pharmacy practice; 2. to grant recognition and to promote public awareness of pharmacists who have distinguished themselves in pediatric pharmacy practice. Authority The FPPAG Recognition Program shall be conducted under the general authority of the PPAG Board of Directors. The Board shall approve all regulations pertaining to the operation of the Recognition Program. Governance FPPAG Recognition Committee: Function and Responsibilities The program shall be administered by the FPPAG Recognition Committee, which shall be appointed by the Board of Directors, and shall have the following specific responsibilities, with respect to the FPPAG Program: to review and approve recognition eligibility criteria and, in general, to provide quality assurance for the program; to approval or not...

homepage - conference info

Mon, 25 Mar 2013 23:14:12 GMT

The 22nd PPAG Annual Meeting
and 2013 Pediatric Pharmacy Conference
Featuring Neonatal and Pediatric Critical Care Continuing Education

May 1-5, 2013
Indianapolis Marriott Downtown
Indianapolis, Indiana

History of the Pediatric Pharmacy Advocacy Group

Sun, 24 Mar 2013 16:53:41 GMT

This year the Pediatric Pharmacy Advocacy Group marks its 30 year anniversary. Like nearly all worthy causes, the idea for the Pediatric Pharmacy Advocacy Group (PPAG) started with a conversation among a small group of friends and colleagues. The Early Years In 1979 Dr. Doug Smith, Dr. Robert Poole, and Mr. Steve Allen began discussing the need for an organization aimed at helping pediatric pharmacy directors to better serve their unique patient populations. These trailblazers met informally and then formally at the American Society of Health-Systems Pharmacist's Midyear Clinical Meeting. Over the next six years, the group expanded and included Pharmacy Directors from across the United States. At these meetings a core group of leaders emerged. Mr. Doug Smith (Chicago, IL) served as President and Chairman of the Board from 1985-1995. Other members of this charter group include: Mr. Stephen Allen (Washington, DC), Mr. Joe Sceppa (Boston, MA), Mr. Henry Wedemeyer...

So You Think You Can Precept? Preceptor Development: How to precept to the different levels (Student, PGY1, PGY2)

Mon, 04 Mar 2013 15:27:02 GMT

When is the Webinar? Date: March 6, 2012 Time: 3:00 pm Eastern / 2:00 pm Central / 1:00 pm Mountain / 12:00 noon Pacific Can I get a handout in advance of the Webinar? Yes, You may download the handout using the following link: Three (3) Slides Per Page Handout (PDF files) How do I receive CE credit? Each participant must fill out the online Post-Webinar Evaluation Form in order to receive credit. The form will ask for demographic information (including your CPE Monitor ID and MM/DD birthday information). The survey will be activated AFTER the webinar has been completed. In order to complete the Evaluation you will need a code, which will be announced during the Webinar. The survey must be filled out on or before March 13, 2013 at 5:00 pm central time. Credit will be uploaded to CPE Monitor by March 27, 2013. The Evaluation can be located here: http://www.ppag.org/en/sur/?71. What are the objectives for the webinar? This is a one-hour application-based...

Online CE Programs

Fri, 22 Feb 2013 20:48:23 GMT

Welcome to PPAG Education Central, your one-stop-shop for home-based pediatric educational programs. We are pleased to offer group purchasing rates to institutions (hospitals and pharmacies). Please go to: http://www.ppag.org/CEgrouprate/ for more information. Pediatric Age-Based Competencies For more information about Aged-based Competency Series, please click here. TITLE HRS. ACPE # PRICE Physiologic and Pharmacokinetic Differences in Children, Fluids and Electrolytes and Dehydration in Children 2.5 0180-0000-11-040-H01-P MEM: $10.00 NonMEM: $30.00 Respiratory Syncytial Virus: Diagnosis, Treatment and Prevention 1 0180-0000-12-008-H01-P MEM: $5.00 NonMEM: $15.00...

Our Member Recruiters

Fri, 15 Feb 2013 20:25:33 GMT

Over 200 of our members have recruited over 385 members to the Pediatric Pharmacy Advocacy Group. Approximately 35% of active members were recruited by a member. Many recruited members have become recruiters themselves. Darlene Anderson Leigh Anderson Jason Arimura Sarah Arnold Jennifer Bair Sarah Ann Balzar Jill Bechaz Tish Sundin Bedard Sandra Benavides-Caballero Kim Benner Laura Bio Kelly Bobo Monica Bogenschutz Shawn Boland Leah Boulter Angela Brenner Leslie Briars Debbie Brown Gretchen Brummell Kristina Bryowski Marcia Buck Kelly Burch Margaret Burke Beth Carberry Jared Cash Kathy Chessman Michael Chicella Carla Christensen Michael Christensen Robbin Christensen Jeff Cies Sara Cohee Morgan Cole Michelle Condren Joshua Courter Jamie Cronin Robert Daniels Emily D'Anna James...

Committee Leadership

Fri, 15 Feb 2013 18:01:56 GMT

Advocacy Committee The Advocacy Committee consists of the following Sub-Committees; the Patient Safety and Innovation Committee, Parent Advocacy (KidsMeds), and Legislative Affairs. For more information, click here. Kristin Klein, PharmD is Co-Chair of Patient Safety and Innovation efforts at PPAG. Dr. Klein is the pediatric infectious diseases clinical pharmacist at the University of Michigan Health System (UMHS) and a Clinical Assistant Professor at the University of Michigan (UM) College of Pharmacy. Dr. Klein received her B.S. in Pharmacy from Southwestern Oklahoma State University and her Doctor of Pharmacy degree from the University of Oklahoma. She then completed a specialty residency in Pediatric Pharmacotherapy at the University of the Sciences in Philadelphia. Following her residency, Dr. Klein joined the faculty of the University of Missouri-Kansas City, where she practiced in...

So You Think You Can Precept? Preceptor Development: How to precept to the different levels

noemail@ppag.org — Wed, 06 Mar 2013 20:00:00 GMT

Objectives: