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We thank Julie Clyce for her years of service!

Matthew Helms — Thu, 29 Jul 2010 15:00:00 GMT

Hello,

Tomorrow we say goodbye to Julie Clyce, our Assistant Director, after four years of service to the Association. No amount of words can express how much she will be missed by all of us.

While at PPAG Julie helped oversee growth in member services and programs. She has provided logistical support at our terrific PPAG conferences. But her biggest contributions, though, are those that are less tangible. No matter the circumstances, she has provided a friendly "front-door" for PPAG. Her positive nature is contagious, especially during committee conference calls and conferences. Bad moods have not lasted very long in the office with her around the office.

While it has been sad and difficult in the office the past few weeks, we send our best wishes to Julie in all future endeavors. She has promised not to be a stranger and will keep in touch with us regularly on Facebook and email!

I invite you to send a quick note to Julie at julie.clyce@ppag.org. I know she will appreciate your words of thanks.

Again, thanks, Julie. You will be missed.

Sincerely,
Matt

Matthew R. Helms, MA, CAE
executive director
ppag

29-Jul-10 10:00 AM

Governing the New PPAG

Michael Christensen — Mon, 26 Jul 2010 20:00:00 GMT

Dear PPAG Members and Friends,

In the 30 year history of PPAG, the association has undergone four bylaw revisions. As PPAG has changed and grown, previous Boards have felt it necessary to amend the bylaws accordingly. Once again, we find ourselves evolving. The New PPAG is dedicated to providing opportunities for members to participate and lead the association. We feel that revising and streamlining our bylaws to provide members with direct representation is necessary. In the latest revision, we have accomplished two important things:

Simplified and streamlined our bylaws to be more consistent with association standards.
Provided membership with the opportunity to directly elect their executive leadership (President-elect, Treasurer, and Secretary).

Simplification of our Bylaws

According to the Association Law Handbook, Bylaws “are used to establish the general organization, and management of the entity needed to achieve corporate existence.” Bylaws provide a broad stroke of the fundamental provisions. After reviewing the Handbook and the bylaws of similar associations, we’ve discovered that our bylaws have described specific policies and procedures more appropriately placed in a Manual of Policies and Procedures. The manual shall provide an administrative guide and a compilation of Board resolutions. For instance, rather than describing the specific procedure in detail for appointing Committee Chairs, the bylaws should simply state that the Board has the authority to appoint Committee Chairs. The appointment process followed should be contained in a separate Policies and Procedures document maintained by PPAG. We are currently working on compiling this Manual and it will be posted on the PPAG website. Policies contained therein will be reviewed after 1-3 years, depending on the policy.

Currently, the standing Committees of PPAG are lead by “Vice Presidents.” Under the revised bylaws, the leaders of Committees shall be referred to as “Committee Chair.” Again, this reflects association standards of governance. Under each standing Committee, sub-committees and ad-hoc task force groups can be formed. The leader of these groups shall be referred to as “Chair,” as well.

Election of Executive Leadership

Currently, PPAG’s leadership is appointed by the Board from members the Board. The membership of the organization does not directly elect the leadership of the organization. We feel this structure is inconsistent with our organizational purpose, mission and values. From a practical perspective, the structure forces individuals that have completed just one year of Board service to become Chair-elect. It is from a humble perspective that the Board amends this process. Now, our President-elect, treasurer, and secretary shall be required to serve one term on the Board. This process will allow potential leaders more time to learn and grow into executive leadership positions. We also believe this will help provide a more mature “institutional” memory for PPAG. Continuity of the Board’s vision and goals is important and difficult to achieve within the current structure.

This summer we will send out a Call for Nominations for the election of officers and at-large directors. The election will take place in the fall.

Final Thoughts: Things NOT motivating the changes

Many organizations, including PPAG, have dealt with financial and other organizational challenges by changing the organizational structure (or bylaws). We do not believe that structural changes will “rescue” PPAG from the current economic climate. However, we do believe that good governance is vitally important to our success. A structure consistent with our values, specifically in the benefits of collaboration and the importance of our experience as members, will indirectly position us to achieve and grow into the future.

We invite you to comment on the new bylaws [Click here to download]. Please feel free to email me at mchriste@uthsc.eduif you have any comments, concerns, or suggestions. We appreciate the time and energy you have given PPAG. Together, we will build the New PPAG.

Sincerely,

Michael Christensen, PharmD, Chair of the Board

26-Jul-10 3:00 PM

2011 Annual Conference Announced

Matthew Helms — Mon, 26 Jul 2010 16:00:00 GMT

PPAG is pleased to announce the location and dates of the 20th Pediatric Pharmacy Conference and 2011 Annual Meeting.

PPAG will be headed to the Home of the Blues, Birthplace of Rock 'n Roll, Memphis, Tennessee. Mark your calendars for March 16-20, 2011. The meeting venue will be the Memphis Marriott Downtown. Room rates will be affordable at $119.00 per night.

We look forward to celebrating 20 years of live education with you in Memphis. This will be the first Annual Meeting offered in the spring.

Features of the Conference will include:

Hematology-Oncology Track
Neonatal Critical Care Track
Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics
Helms Award of Excellence in Pediatric Pharmacy Practice
Best Practice Awards
Young Investigator Award
Best Original Poster
Special Interest Group meetings
Residency Project Presentations
Scientific and Practice Poster sessions
New Practitioner Luncheon

Check out Memphis at www.memphistravel.com.

26-Jul-10 11:00 AM

We're Halfway There!

Matthew Helms — Mon, 26 Jul 2010 14:30:00 GMT

Four weeks into our Campaign for Growth, over sixty (65) PPAG members and friends of the organization have donated over half of our annual fundraising goal! That is $12,300! Some donors have pledged multi-year contributions as well, bringing our total gifts to $23,000 over 5 years.

The following individuals and members have contributed and/or pledged financial support to our Campaign for Growth:

Dr. Cassie Billings

Dr. Kelly Boo

Dr. Jenny Boucher

Dr. Ann Boughner

Dr. Jennifer Bonvechio

Dr. Leslie Briars

Dr. Hollan Buchanon

Dr. Marcia Buck

Dr. Kelly Burch

Mr. Lee Christensen

Drs. Robbin and Michael Christensen

Dr. Cathy Crill

Dr. Robert Daniels

Dr. Cindy Dusik

Dr. Brandon Edgerson

Dr. Lea Eiland

Dr. Sue Erwin

Dr. Elizabeth Farrington

Dr. Allyson Gaylor

Dr. Heather Graham

Dr. Kevin Graner

Dr. David Gregornik

Dr. Allison Grisso

Dr. Emily Hak

Dr. Claudia Hampton
Mr. and Mrs. Matthew Helms

Dr. and Mrs. Richard Helms

Dr. Eilza Hoernle

Dr. David Hoff

Dr. Eliza Hoernle

Dr. Collin Hovinga

Dr. Peter Johnson

Dr. Reginald King

Dr. Kitty Kline

Mr. David Knoppert

Dr. Kathleen Kopcza

Dr. Robert Kuhn

Dr. Bernard Lee

Dr. Kelley Lee

Dr. Jack Lemanowicz

Dr. Jeff Low

Dr. Sherry Luedtke

Dr. Edward Madden

Dr. and Mrs. Bill Maish

Dr. Rachel Meyers

Dr. Jaime Miller

Dr. Marita Nazarian

Dr. Katherine O'Connor

Dr. Michelle Perez

Dr. Curtis Petty

Dr. Stephanie Phelps

Dr. Raul Pino-Lay

Dr. Steven Plogsted

Dr. Amy Potts

Dr. Melissa Ray

Dr. Susan Robbins

Dr. Jasmine Sahni

Dr. Chasity Shelton

Dr. Katherine Smith

Dr. Tara Smith

Dr. Jeremy So

Dr. Jeremy Stultz

Dr. Cheryl Szof

Dr. Emma Tillman

Dr. Tim Todd

Dr. Heather VandenBussche

Dr. Christina Victor

Campaign for Growth: Building the New PPAG Member Contributions
	Received and Pledged	Pledged				Total Donations (Received and Pledged)
Year	2010	2011	2012	2013	2014
Donation Amount	$ 12,300.00	$ 3,175.00	$ 2,675.00	$ 2,425.00	$ 2,425.00	$ 23,000.00

Join your colleagues and be one of the many builders of PPAG. Donate today at http://ppag.org/en/donations/!!!

For more information about our Campaign for Growth, visit the website at http://www.ppag.org/campaign-for-growth.

26-Jul-10 9:30 AM

RSV Prevention Clinic Wins 2010 PPAG Best Practice Award

Matthew Helms — Thu, 22 Jul 2010 19:00:00 GMT

Jennifer Chow, Michael Chicella, Anthony Christensen, Eloise Woodruff, Mital Desai, Carolyn Moneymaker, John Harrington, and James Dice at the Children's Hospital of the King's Daugther (CHKD) in Norfolk Virginia are recognized for the establishment of a pharmacist-managed RSV Prevention Clinic. The group was selected from thirty (30) submissions.

Respiratory syncytial virus (RSV) is the most common cause of bronchiolitis and pneumonia in infants. It is also the leading cause of hospitalizations in infants less than a year in the United States. Palivizumab is an RSV-specific monoclonal antibody that is administered once a month during RSV season to prevent RSV infection that requires hospitalization. Non- compliance with the dosing regimen appears to be the factor commonly associated with drug failure. Studies of other pharmacist managed clinics have demonstrated that pharmacists can increase compliance and therefore improve patient outcomes.

During the 2009-2010 RSV season, a pharmacist-managed RSV Prevention Clinic was established in the General Academic Pediatrics clinic at CHKD. Once eligible patients were identified the pharmacist contacted the parents/caregivers and set up an appointment to receive palivizumab. During the appointment the pharmacist was responsible for providing education on RSV, importance of receiving palivizumab, and steps to decrease RSV exposure and transmission. The pharmacist administered palivizumab to the patient and when necessary triaged the patient to see other health-care professionals. In order to determine the impact of this clinic on patient compliance we compared data from the 2008-2009 RSV season (group 1) which was prior to the establishment of the pharmacist-managed clinic to data compiled from the 2009-2010 RSV season (group 2). Group 2 data was after the pharmacist-managed clinic was established. Data compared included demographic data, number of shots administered, RSV testing, and RSV hospitalizations (>24 hours in hospital). Compliance was determined as the number of patients who received eligible doses in consecutive months.

As a result, compliance with palivizumab dosing increased. RSV infections and hospitalizations decreased by over 50%.

[Eighty-six infants were identified as palivizumab eligible in group 1 and 75 infants were eligible in group 2. Sixty-seven infants (78%) in group 1 receive at least one dose of palivizumab, whereas 71 patients (95%) in group 2 received at least one dose of palivizumab. Nineteen infants (28%) in group 1 received all doses of palivizumab as compared to 63 infants (89%) in group 2 (p<0.01). With regard to compliance, only 18 patients (27%) in group 1 received all eligible doses in consecutive months as compared to 60 patients (85%) in group 2 (p<0.01). In group 1, eight patients developed RSV and 5 of those required hospitalization. In group 2, three patient developed RSV and one of those required hospitalization.]

The Best Practice Award lecture will be given at the 19th Pediatric Pharmacy Conference and PPAG Annual Meeting in St. Charles, Missouri on October 8, 2010 at 9:00 am. The PPAG Best Practice Award is sponsored by Lexi-Comp.

22-Jul-10 2:00 PM

PPAG Annual Conference Registration is Open.

Matthew Helms — Tue, 20 Jul 2010 20:13:04 GMT

The Pediatric Pharmacy Conference and PPAG Annual Meeting is designed for practitioners and administrators involved in drug therapy decisions for children. The Meeting 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.

Visit the conference website at: http://www.ppag.org/en/cev/43.

The overall conference goals are as follows:

Provide and review current information and developments pertaining to pediatric medication use in acute and ambulatory care settings.
Review new technologies that can reduce the risk of errors in the pediatric population.
Discuss new drugs on the market and their application to pediatric patient care.
Provide a forum for the exchange of information and ideas among pediatric practitioners.

About Historic St. Charles

Historic St. Charles, Missouri will host the 19th Annual Pediatric Pharmacy Conference and PPAG Annual Meeting. St. Charles is located in the heart of the Midwest. It is only 20 minutes from downtown St. Louis and only 10 minutes from the St. Louis Lambert International Airport. St. Charles is known for its Historic District which houses over 125 specialty and antique shops along with the 25 quaint restraurants and attractions that line the Missouri River. In St. Charles, you'll walk in the footsteps of Lewis and Clark and exprience part of America's history.

Conference Schedule and Agenda Conference Schedule and Speaker information (HTML) Conference Sessions and CE Objectives (HTML) Early Bird Deadline is August 5, 2010.	Registration Information and Policies To register online, click here. To register via mail or fax, click here Refunds will be given through September 15, 2010. A $25.00 transaction fee will be assessed per refund. After September 15, 2010 no refunds will be given, but balances can be transferred to future meetings or conferences.
Hotel Information- Affordable Rates! PPAG has secured a special room rate of $139.00 per night at the Embassy Suites St. Louis-St. Charles Hotel and Spa. Reservations can be made by calling the Hotel directly at 636-946-5544 or Embassy Suites Brand Reservations at 1-800-EMBASSY. Conference participants must identify themselves as being with the Pediatric Pharmacy Advocacy Group at the time the reservation is made in order to receive the group rate. Reservations must be made on or before September 5, 2010 at 12:00 midnight (central time) to receive the discounted rate. After the cut-off date, reservations will be subject to availability and room-rate increases. PPAG cannot guarantee any reservations after September 5, 2010.	Extras!! PPAG is offering a Preconference Symposium: Cystic Fibrosis: Beyond the Basics. The symposium is partially sponsored by Gilead. For more information, please go to: http://www.ppag.org/ac10-objectives/#CF. Join PPAG as we tour two hospitals in the St. Charles/St. Louis area. St. John's Mercy Hospital and Ranken Jordan Children's Rehabilitation Hospital. For more infromation, please visit: http://www.ppag.org/ac10-objectives/#tour You will be able to register for both or either event during the registration process. The registration fee is $75.00 for each event. The fee includes CE and meals.
Sponsorship Opportunities PPAG offers a variety of opportunities to sponsor the conference. See our Exhibitor Prospectus or contact PPAG for more information at 901-380-3617	Satellite Symposia PPAG offers satellite symposia as a forum for industry-sponsored education programs. Please see our Exhibitor Prospectus or contact PPAG for more information at 901-380-3617.

Conference Credit and Evaluation The Pediatric Pharmacy Advocacy Group is accredited by the American Council for Pharmacy Education as a provider of continuing pharmacy education. The Pediatric Pharmacy Conference is approved to provide 20 contact hours (2 CEU's) for pharmacists. To receive credit participants must attend the session and fill out the online verification of attendance and conference evlauation form. Certificates will be sent 3-4 weeks from the completion of the conference. Prticipants will not receive credit if there is a balance due. PPAG will disclose to participants any financial support received from the pharmaceutical industry during the conference. For more information about ACPE credit information, please contact the PPAG Executive Director.

20-Jul-10 3:13 PM

JPPT Apr-Jun 2010 Available Online

Matthew Helms — Fri, 16 Jul 2010 13:00:00 GMT

The April-June 2010 issue of the Journal of Pediatric Pharmacology and Therapeutics is now available online for subscribers and PPAG members.

Volume 15 Number 2 (April-June 2010)

Table of Contents

Editorials

Switching of Antiepileptic Drug Formulations
J. Nile Barnes, PharmD and Karen L Rascati, PhD

A Patient’s Voice

Stephanie J. Phelps, PharmD

Helms Award Lecture

Interplay Between Pediatric Pharmacy Practice and Research to Influence Patient Care
Milap C. Nahata, PharmD, MS

Special Article

The History of PPAG: The First 30 Years
Robert L. Poole, PharmD

Review Articles

The Controversy over Generic Antiepileptic Drugs
Susan J. Shaw, MD and Adam L. Hartman, MD

Pharmacokinetics and Drug Dosing in Obese Children
Jennifer G. Kendrick, PharmD, Roxane R. Carr, PharmD, and Mary H.H. Ensom, PharmD

Clinical Investigation

Plasma Amino Acid Concentrations in 108 Children Receiving a Pediatric Amino Acid Formulation as Part of Parenteral Nutrition
Chasity M. Shelton, PharmD, Amanda J. Clark, PharmD, Michael C. Storm, PhD, and Richard A. Helms, PharmD

Effects of Age and Weight-Based Dosing of Enoxaparin on Anti-Factor Xa Levels In Pediatric Patients
Lela S. Fung, PharmD and Christopher Klockau, BScPharm

Pharmacists’ Attitudes Towards Pediatric Cough and Cold Products and Behind the Counter Status
Sally A. Huston, PhD, Kalen B. Porter, PharmD, Tom Clements, PharmD, and Greene Shepherd, PharmD

Stability of Ziprasidone Mesylate in an Extemporaneously Compounded Oral Solution
Kelsey Green, PharmD and Roy C. Parish, PharmD

Brief Report

Opioid Infusions in the Neonatal Intensive Care Unit
Amanda Suarez, BScPharm, ACPR, David C. Knoppert, MScPharm, MSc, David S. C. Lee, BS, MB, FRCPC, Donna Pletsch, RN, MN, and Jamie A. Seabrook, MA

CLICK HERE FOR ARTICLES

16-Jul-10 8:00 AM

Introducing our Campaign for Growth

Michael Christensen — Thu, 01 Jul 2010 16:45:00 GMT

Dear PPAG Member and Supporter,

I am writing you as the President of PPAG. Many of you may be unaware how tenuous a position PPAG finds itself in during this difficult recession.

For many years, PPAG benefited from the generous support of the pharmaceutical industry. In fact, industry support accounted for 30%-40% of our average $375,000 budget. Over the years, PPAG managed to allocate moneys to a reserve fund. There have been significant changes in how Industry interacts with professional health care associations, and it is clear that we can no longer count on this support in the future.

Perhaps you have had to decide on or felt the impact of clinics, hospitals and universities reduction in travel and professional development budgets. The “trickle-down” effect has resulted in decreased participation in our live educational programs, which accounts for as much as 40% of our operating budget.

I am happy to report that previous and current volunteer leaders and professional staff have been good stewards of our resources. Over the past eight years, PPAG slowly funded a reserve fund for a rainy day. Unfortunately, that rainy day has arrived. We are currently using our rainy day funds to meet our operational needs. While our reserve fund is helping us meet our operational costs, we can not continue to rely on reserve funds since they will only sustain us for 12 months based on current expenditures.

Rest assured in response to these challenging conditions, the Board has taken action carefully and quickly. We have focused on three things:

Controlling operational expenditures. We have reduced the fixed cost of the organization by nearly $175,000 per year. We have eliminated expenditures of supplies, travel, leases, and insurances. As of July 31, PPAG will be a “virtual” organization. The Board has also made a very difficult decision to reduce full time staff support. Julie Clyce, our Assistant Director for the past three years, has been a tremendous asset for PPAG. She has helped us through tremendous growth in membership services. Julie's service to PPAG is appreciated by all of us.

Exploring new business models and revenue opportunities. One of the most promising new avenues for income has been our partnership with Zolstice, LLC to develop, promote, and deliver a standardized approach to acute pediatric medication therapy. Also, expansion of our educational programming into the community setting promises an exciting new opportunity for PPAG. Both new initiatives serve as a way for PPAG to expand membership and its influence on pediatric practice from institutional practice to community practice.

Developing a long term agenda for future success and growth. With this letter, we launch our new Campaign for Growth: Building the New PPAG. This campaign is member-focused and member-driven. We believe that PPAG has a solid foundation that will spark the necessary changes to get us through these challenging times. The Campaign website www.ppag.org/campaign-for-growth/ explains our agenda and how you can help.

We are the sole pediatric pharmacy organization in the country today. I know I am preaching to the choir, but the importance of PPAG cannot be understated. PPAG delivers value through our networking of members, our educational programming, and most importantly as a voice for safe and effective use of medications in children in the adult-dominated pharmacy world. We are increasingly being looked to lead pediatric pharmacy around the world. I surveyed other pharmacy meetings, and found few pediatric educational offerings. In fact it would take four years to find the equivalent amount of pediatric CE in other pharmacy organizations to equal what can be found in just one PPAG annual meeting.

On behalf of the PPAG Board, I hope that the “Campaign for Growth” website will provide you a sense of our new direction and give you ideas on how you can contribute.

Let's put on our hard hats and build the New PPAG!

With Warmest Regards,

Michael Christensen, PharmD
President

1-Jul-10 11:45 AM

Reed to Receive 2010 Yaffe Award

Thu, 17 Jun 2010 16:00:00 GMT

Michael D. Reed, PharmD, has been selected as the 2010 Yaffe Award winner. The award is given in recognition of significant and sustained contributions toward the improvement of children’s health through the expansion of the field of pediatric pharmacology and therapeutics.

Dr. Reed is Director of the Rebecca D. Considine Clinical Research Institute and the Division of Clinical Pharmacology and Toxicology, Children’s Hospital Medical Center of Akron (CHMCA). Dr. Reed is Professor and Associate Chair, Department of Pediatrics, Northeastern Ohio Universities College of Medicine and Pharmacy (NEOUCOM). Dr. Reed received his Bachelor of Science degree in Pharmacy and post-baccalaureate Doctor of Pharmacy degree from the University of Cincinnati. While obtaining his doctorate he concurrently served a clinical pharmacology residency in pediatrics at the Children’s Hospital Medical Center, Cincinnati.

Dr. Reed’s research interests focus on the developmental pharmacology and toxicology of drugs in humans and how these data translate into the design of optimal dosing regimens for use in infants, children, and adults. He has extensive research experience in the design, implementation, and analysis of pharmacokinetic, pharmacodynamic and pharmacogenomic interrelationships as they relate to the maturing infant, child and adolescent. Dr. Reed has authored more than 200 published works describing his original research activities, invited reviews and book chapters.

Dr. Reed will present the Yaffe Award Lecture on October 8, 2010 during the 19th Pediatric Pharmacy Conference.

17-Jun-10 11:00 AM

Kuhn to receive 2010 Helms Award

Thu, 17 Jun 2010 16:00:00 GMT

Robert Kuhn, PharmD has been selected as the 2010 recipient of the Helms Award for Excellence in Pediatric Pharmacy Practice. The award recognizes sustained and meritorious contributions to PPAG and to pediatric pharmacy practice, and contributions of importance to education, new knowledge, and outreach.

Dr. Kuhn is currently professor of pharmacy practice and science at The University of Kentucky College of Pharmacy. He holds a joint appointment as professor in the department of pediatrics and is a pediatric clinical specialist at Kentucky Children’s Hospital and serves as Associate director of Pharmacy services. Before joining the faculty in 1985, he received a Bachelor of Arts degree in philosophy from the University of Steubenville (Ohio) and Bachelor of Science degree in pharmacy from The Ohio State University. His doctor of pharmacy degree was obtained in 1984 from the University of Texas at Austin. He completed a pediatric fellowship at Columbus Children’s Hospital in 1985 under the direction of Milap Nahata.

Dr. Kuhn’s research and clinical practice has centered on pulmonary drug delivery and drug therapy in patients with cystic fibrosis. He has participated in many clinical trials of new drug therapies for patients with CF over the last 25 years and helped develop and evaluate new therapies for this disease. He has over 60 publications and help organize pharmacists involved in the care of patients with cystic fibrosis.

He currently serves as program director of the pediatric pharmacy residency program at UK and he has mentored over 30 specialty residents since joining the faculty. He has served on the Board of PPAG for seven years and served two years as President, as well as Immediate Past President and currently is Vice President for Finance for PPAG. He has received numerous awards including a membership in the National Academies of Practice and the Doug Jones Teaching Award from Dartmouth for his work in cystic fibrosis education.

The Helms Award Lecture will be given by Dr. Kuhn on October 11, 2010 at the 19th Annual Pediatric Pharmacy Conference.

17-Jun-10 11:00 AM

EPINEPHrine pre-filled syringe shortage

National Action Network (NAN) — Wed, 16 Jun 2010 22:00:00 GMT

EPINEPHrine emergency syringes 1 mg/10 mL (0.1 mg/mL) are currently on backorder from the sole manufacturer of this product. Although the shortage is expected to resolve later this summer, practitioners should be aware of risk for error created by the shortage.

Although injectable EPINEPHrine is still available in 1 mg/mL in 1 mL ampuls or vials, 1 mg/mL in 30 mL vials, and 1 mg/10 mL (0.1 mg/mL) emergency syringes with an intracardiac needle, these products may not be safe alternatives for code carts, in emergency vehicles, and for other emergency needs, for the reasons that follow:

Misuse of syringe with intracardiac needle. EPINEPHrine 0.1 mg/mL in 10 mL syringes have a 3.5 inch needle for intracardiac use, which is not removable and not compatible with needleless tubing/systems. Attempting to use this product for intravenous or endotracheal administration with the needle attached or attempting to remove the needle may result in injury to both patient and caregiver.
No option for pharmacy to prepare doses. EPINEPHrine is sensitive to light, air, and pH, with a short stability time when extemporaneously prepared, making it unsuitable for bulk compounding by pharmacy departments.
Dose miscalculations. Practitioners may not recognize or understand the difference between 1:1,000 (1 mg/mL) and 1:10,000 (0.1 mg/mL) strengths and may miscalculate when, for example, a physician orders 0.2 mg of a 1:1,000 EPINEPHrine injection. The Institute for Safe Medication Practices (ISMP) has received reports of a number of fatal events due to these miscalculations (www.ismp.org/Newsletters/acutecare/articles/20040812.asp).
Product concentration confusion with 30 mL multiple dose vials. The 30 mL vial more easily facilitates an accidental overdose by providing enough volume of drug to allow 10-fold overdoses.

Recommendations:

Pharmacists should evaluate all potential areas where EPINEPHrine emergency syringes are used, including area emergency services and response teams, and communicate information about the shortage and recommended substitute products.
Conserve current supplies of EPINEPHrine emergency syringes for code boxes and emergency responders where pharmacists would not be present during a code situation to dilute EPINEPHrine. Assess whether the number of syringes can be reduced to two per cart.
Do not stock multiple-dose 30 mL vials of injectable EPINEPHrine 1 mg/mL in code boxes. These look very similar to the 30 mL vials of topical EPINEPHrine that may also be stocked in code boxes or used in the OR.
Place auxiliary labels on intracardiac EPINEPHrine that warn against intravenous and endotracheal use, and caution practitioners about the danger of injury with attempted removal of the fixed needle. If not labeled FOR INTRACARDIAC USE ONLY, include this information as well.
If using 1 mg/1 mL ampuls or vials in lieu of emergency syringes, package the vial, diluent, and syringe label in a clear plastic bag prominently labeled with the drug name and strength. Include instructions on preparing a dilution equivalent to a prefilled 1 mg/10 mL emergency syringe (i.e., EPINEPHrine 1 mg -dilute in 9 mL of sodium chloride 0.9%).
If substituting ampuls or vials labeled as 1:1,000, provide a chart for converting doses in milligrams to mL along with instructions for preparing a dilution in code carts, and post the charts in areas where EPINEPHrine is frequently used.

16-Jun-10 5:00 PM

Pediatric Pneumococcal Vaccine Update and Recommendations

Jennifer Rogers Shenk — Tue, 15 Jun 2010 16:00:00 GMT

Background on the pneumococcal vaccine

Routine vaccination of pediatric patients with the 7-valent pneumococcal conjugate vaccine, also known as Prevnar® or PCV-7, has resulted in a 76% decrease in invasive pneumococcal disease in children less than five years of age in the United States.¹ Despite efforts among practitioners to ensure appropriate immunizations in the pediatric population, invasive pneumococcal disease caused by non-PCV7 serotypes has continued to rise.¹ In 2007, the Active Bacterial Core surveillance (ABCs) of the Emerging Infections Program network (EIP) collaborated with the Centers for Disease Control and Prevention (CDC) to obtain pneumococcal isolates for serotyping throughout 10 selected sites in the United States. Pneumococcal serotype information was available for 87% of the 493 children less than 5 years of age identified.2 Of the 427 known serotype isolates, 260 (61%) were caused by serotypes 3, 7F and 19A, which are not included in the 7-valent pneumococcal vaccine.²

Introduction of the 13-valent pneumococcal conjugate vaccine (PCV-13)

In February 2010, the Food and Drug Administration (FDA) approved the licensure of a 13-valent pneumococcal conjugate vaccine, also known as Prevnar 13™ or PCV-13, to reduce the incidence of invasive pneumococcal disease throughout the United States.3 The PCV-13 vaccine contains the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) currently found in PCV-7, and an additional six serotypes (1, 3, 5, 6A, 7F, and 19A) that have been shown to cause invasive pneumococcal disease in children.² The PCV-13 vaccine, like the PVC-7 vaccine, is indicated for children 6 weeks through 5 years of age and contains no thimerosal.³ It is available as a single-dose, prefilled syringe for intramuscular injection and should be stored in the refrigerator.

As expected, the introduction of any new vaccine raises many questions regarding its efficacy and safety. A randomized, double-blind, active-controlled trial of 663 infants in the United States was performed to evaluate the efficacy of the PCV-13 vaccine.³ Patients included in the study received at least one dose of the PCV-13 or PCV-7 vaccine. The evaluation of immunogenicity was measured by functional antibody response using the opsonophagocytosis assay. The study demonstrated that the PCV-13 vaccine resulted in comparable levels of antibodies to the PCV-7 vaccine and was protective against invasive pneumococcal disease. Data from 13 clinical trials was reviewed to assess the safety of the PCV-13 vaccine. The most common adverse reactions noted within seven days of administration were: injection-site reactions, fever, decreased appetite, irritability and increased or decreased sleep. Data suggest the safety profile of the PCV-13 vaccine is comparable to the PCV-7 vaccine.⁴ Because PCV-13 is a newly licensed vaccine, it is important to report any suspected adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) at http://vaers.hhs.gov/index.

Recommendations for PCV-13

The Advisory Committee on Immunization Practices (ACIP) recommends the PCV-13 vaccine series for all children between 2 and 59 months of age.³ Specific recommendations are as follows:

Children with underlying medical conditions should be stratified into risk groups (Table 1) and receive the PCV-13 vaccine according to ACIP recommendations (Table 2 and 3)

The PCV-13 vaccine should be used in all patients to complete the pediatric pneumococcal immunization series (Table 3)

Patients who have completed their pneumococcal vaccination series with the PCV-7 vaccine should receive one supplemental dose of the PCV-13 vaccine (Table 3)

All pneumococcal vaccines should be given 8 weeks apart (Table 2)

Role of the Pharmacist

Pharmacists play a vital role in the successful transition from the use of PCV-7 to PCV-13 vaccine at their practice site(s). Pharmacists are an important resource when developing or modifying vaccine order sets, consents forms, vaccine administration records and when providing education. It is essential that pharmacists understand the differences between PCV-7, PCV-13 and the 23-valent pneumococcal vaccine (PPSV-23; Pneumovax® 23). Major education points for pharmacy and medical staff may include the following:

The rationale for a new pediatric pneumococcal vaccine is to provide broader pneumococcal protection to children.

The difference between the PCV-13 and PCV-7 vaccine is that there are six additional serotypes are in the PCV-13 vaccine.

Refer to the ACIP recommendations (Tables 1-3) for use of the PCV-13 vaccine in the pediatric population.

The PCV-7 vaccine should be used until the PCV-13 vaccine is available at your practice site(s). Once the PCV-13 vaccine is available, transition all patients to the PCV-13 vaccine as the PCV-7 vaccine will be phased out.

The PPSV-23 vaccine is not recommended for use in infants, because polysaccharide vaccines tend to be less immunogenic than conjugate vaccines in this population and is therefore ineffective. The minimum age is 2 years.\

The licensure of the PCV-13 vaccine does not change the recommendations for administration of the PPSV-23 vaccine.

The PCV-13 vaccine should be properly stored in the refrigerator.

Whether it be providing staff education, reporting adverse events or educating parents, pharmacists are essential to promoting a safe and smooth transition to the 13-valent pneumococcal vaccine.

Table 1. Underlying medical conditions that are indications for pneumococcal vaccination among children, by risk group – Advisory Committee on Immunization Practices (ACIP), United States, 2010 ³

Table 2. Recommended routine vaccination schedule for 13-valent pneumococcal conjugate vaccine (PCV-13) among infants and children who have not received previous doses of 7-valent vaccine (PCV-7) or PCV-13, by age at first dose – Advisory Committee on Immunization Practices (ACIP), United States, 2010 ³

Table 3. Recommended transition schedule from 7-valent pneumococcal conjugate vaccine (PCV-7) to 13-valent vaccine (PCV-13) vaccination among infants and children, according to number of previous PCV-7 doses received – Advisory Committee on Immunization Practices (ACIP), United States, 2010 ³

References:

Pilishvili T, Lexau C, Farley MM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis 2010;201:32–41.
CDC. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine – United States, 2007. MMWR 2010;59:253-7.
CDC. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children – Advisory Committee on Immunization Practices (ACIP), 2010. MMWR 2010;59:258-61.
Food and Drug Administration. Vaccines: approved products. Prevnar 13 (pneumococcal 13- valent conjugate vaccine.) Available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201667.htm. Accessed March 5, 2010.

15-Jun-10 11:00 AM

Abstract Deadline Extended

Matthew Helms — Fri, 04 Jun 2010 12:00:00 GMT

Due to numerous requests, the abstract deadline for the 19th Annual Meeting has been extended to Friday, June 11, 2010.

Submit your abstract here.

See the Call for Abstracts for more information.

Thank you.

4-Jun-10 7:00 AM

An Update on the Influenza A (H1N1) Vaccine

Spencer Durham, PharmD; Sacred Heart Children's Hospital — Tue, 25 May 2010 18:00:00 GMT

The year 2009 brought about a dire situation when the influenza A (H1N1) virus spread across the globe, causing a worldwide pandemic and general public concern. Due to the late detection of this particular strain of influenza, it was not included in the annual trivalent influenza vaccine. Thus, an additional vaccine immunizing against the H1N1 strain was developed. However, as this vaccine would only initially be available in limited supply, the Advisory Committee on Immunization Practices (ACIP) issued recommendations in July 2009 for initial target groups who should receive the vaccine. The number of persons in this initial target group was estimated at 160 million. Of particular note is that all children and young adults, age 6 months to 24 years, were in this initial target group to receive the H1N1 vaccine. The ACIP further recommended that a limited vaccine subset of the initial target group have first priority to receive vaccination. This subset included children ages 6 months to 4 years and children aged 5 years to 18 years who have medical conditions that would place them at greater risk for complications following influenza infection. The initial estimate of persons meeting criteria to be placed in this subset population was initially estimated to be about 42 million, but more recent estimates place the number closer to 62 million.

In January 2010, the Centers for Disease Control and Prevention (CDC) published, in the Morbidity and Mortality Weekly Report (MMWR), the interim results of surveillance data of persons who had actually received the H1N1 vaccine between October and December 2009. In order to provide a reliable estimate of the number of persons who received the vaccine, data was analyzed from the National 2009 H1N1 Flu Survey (NHFS) as well as the Behavioral Risk Factor Surveillance System (BRFSS). The NHFS is a new, random-digit dialed telephone survey which tracks both H1N1 and seasonal influenza vaccination coverage on a weekly basis. Similarly, the BRFSS is random-digit dialed telephone survey designed to detect the prevalence of health conditions and health risk behaviors in persons 18 years of age and older. The survey specifically included questions regarding the H1N1 vaccine. The results of the analyzed data showed that, as of January 2nd, 2010, 20.3% of all persons in the United States had received the H1N1 vaccine. This included about 27.9% of persons in the initial target groups and 37.5% of those included in the limited vaccine subset. In breaking these numbers down even further, 29.4% of children aged 6 months to 18 years had been vaccinated with the H1N1 vaccine. The MMWR report notes that this was similar to the 24% to 27% of children in this same age group who received the seasonal trivalent influenza vaccine during the 2008-2009 influenza season. More specifically, approximately 33% of children 6 months of age through 4 years of age, who were included in the limited vaccine subset, had received the first dose of the H1N1 vaccine, which was again similar to rates of seasonal influenza vaccine coverage in recent seasons. For children aged 6 months to 9 years, who are recommended to receive 2 doses of the H1N1 vaccine, approximately 34.6% had received 1 dose, with 17.8% receiving both doses.

While these numbers appear promising and the winter months are behind us, the report does note that severe cases of H1N1 influenza are still occurring sporadically in the majority of regions across the United States, and a rise in incidence is certainly still possible in the upcoming months. As of April 2010, nearly 42,000 hospitalizations have been associated with diagnostically confirmed influenza A, resulting in over 2,000 deaths attributable to it with over 300 (~15%) in children. Since the H1N1 vaccine is no longer in short supply, and even though influenza season is technically over, efforts should continue to be made to vaccinate all persons as recommended by the CDC, and not just those is the target and limited subset groups. Further information about both H1N1 and seasonal influenza, as well as information about both vaccines, epidemiological data and H1N1 specific updates, may be accessed via the CDC’s website, http://www.cdc.gov/h1n1flu/update.

References:

2009 H1N1 Flu US Situation Update April 23, 2010, 11:00 AM ET
http://www.cdc.gov/h1n1flu/updates/us/index.htm. Accessed April 30, 2010
Interim results: influenza A (H1N1) 2009 monovalent vaccination coverage – United States, October – December 2009. MMWR 2010:59(02);44-48.
Prevention and control of seasonal influenza with vaccines. MMWR 2009:58(RR08);1-52.
Use of influenza A (H1N1) 2009 monovalent vaccine. MMWR 2009:58(RR10);1-8.
Update on influenza A (H1N1) 2009 monovalent vaccines. MMWR 2009:58(39);1100-1101.

25-May-10 1:00 PM

Pediatric Pharmacist Board Certification: Initial Steps

Matthew Helms — Thu, 29 Apr 2010 20:00:00 GMT

Dear Pediatric Pharmacy Practitioner,

The Board of Pharmaceutical Specialties (BPS) is re-evaluating the process for offering subspecialty exams. One of the first things that must be completed is a needs assessment. BPS will move forward on the needs assessment if there is justification to support the development of a seperate exam. A survey has been designed to get a head count of the number of pediatric practitioners who are in the United States that would consider sitting for a Pediatric Board certification exam. Completing this survey does not commit you to anything. It is for initial data collection only. The information will be sent to BPS for their evaluation.

To submit your responses to this quick and easy three (3) question survey, please CLICK HERE!

If the above link does not work, cut and paste this link to your browser:

http://www.surveymonkey.com/s/WD2VCTF

Please respond on or before June 4, 2010.

This message will be sent to all members of PPAG, the ACCP PedsPRN, and the ASHP Special Interest Group. Please pardon the cross-posting. It is important that we receive as many responses as possible. If you know of a pediatric pharmacy practitioner that is not a member of the organizations listed above, please forward this information to them, and encourage them to participate in this important survey. Please do not take the survey more than once.

For over 7 years PPAG and ACCP PedsPRN have jointly called for BPS to recognize pediatric pharmacy as a sub-specialty. Thank you for your support and participation in this important initial step toward the recognition of pediatric pharmacy as a subspecialty within pharmacy practice.

Sincerely,

Elizabeth Farrington, PharmD, FCCP, FCCM, BCPS

29-Apr-10 3:00 PM

Spotlight on KidsMeds

Pamela Lamica — Wed, 28 Apr 2010 15:00:00 GMT

The internet can be a great resource when looking to find information about healthcare. The problem, however, is making sure that what you find is accurate and reliable. This is especially true when the question at hand is regarding the care of a child. Parents need resources that provide concise, professional, correct, and up-to-date information about their child’s healthcare, specifically when it comes to medications. The Pediatric Pharmacy Advocacy Group’s (PPAG) website, KidsMeds (www.kidsmeds.info) is a great resource for parents to find exactly this kind of information.

KidsMeds provides many helpful tools to make the best decisions about your child’s medications and it comes from the most reliable source possible – pediatric pharmacists. The best feature of this site is that you have the most competent group of professionals available providing advice and helpful information about your child’s care. Not only is it great information, but it is easy to navigate and very easy to understand. One of the best features on KidsMeds are the various “info sheets and tools” that are provided. They involve many commonly encountered, relevant topics that parents frequently ask questions about including cough and cold remedies, first aid, antibiotics and many others. Each of the info sheet topics include the most relevant information laid out in a concise format that is easy to read and will most likely answer many of the any common questions that may have arisen. Specifically, the “how to administer” info sheets are a great tool because many parents aremay no’t be properly educated on how to effectively administer medications. These sheets provide a detailed description on how to use different dosage forms, including the use of pictures or diagrams. Also, the seasonal topics are a great way to group together problems that may arise during different times of the year. This can help parents prepare for the things that they could encounter with their children during the different seasons like using sunscreen or insect repellants, assembling a first-aid kit, and what to do if your child has the flu.

There are many other great aspects of the KidsMeds website that can help parents find more information, converse with other parents and healthcare professionals and manage their children’s medications. The pre-formulated medication list is a great way for parents to keep track of the medications that their children are taking. It is very important that there always be an updated record of medications being used and all healthcare professionals that are involved in your child’s care should be made aware of their medications. This sheet makes it easy for parents to do this because it serves as a template and includes all relevant information about your child. All you have to do is fill in the blanks! Networking and using blogs or discussion boards has become a common way for people to communicate about various topics, especially in healthcare. The benefit of the discussion forum on this website is that it is mediated by a professional so you can make sure that the advice and answers you are getting are correct. KidsMeds can also be accessed via Facebook and Twitter, thereby increasing its networking and making more people aware of website’s presence. It is a way to constantly update the site’s users about current findings and news reports surrounding children’s healthcare, it provides tips regarding different topics like poison prevention and it informs users what new information may be coming soon. The site has also provided an array of helpful links for parents to use including resources like www.needymeds.com for financial help with medications, and http://kidshealth.org which is a great website containing information surrounding children’s healthcare.

Finding information on the KidsMeds website is extremely simple. All of the helpful tools including the info sheets, forums and other articles are only one click away when on the main page. The contents list on the main page provides direct links to all of the different tools that the site provides which makes navigation easy and therefore makes the site very user-friendly. The “search the site” option could also be very helpful for parents that are looking for a specific topic related to their child’s health.

Overall, KidsMeds is a growing wealth of knowledge provided by the pediatric pharmacy professionals to help guide parents on the best treatment of their children. It provides reliable answers to questions that are asked every day in retail pharmacies. As a pharmacy intern, I answer questions regarding treatment of pediatric illnesses quite frequently in the retail setting. Most people are not aware of many of the current recommendations regarding treatment of children, specifically when it comes to cough and cold products and many people do n’ot bother to ask, even if they are n’ot sure what to buy. If more people were aware that easily accessible sites like this existed, they may be less likely to walk into the nearest drug store and randomly pick one of the hundreds of over the counter products for their child’s cold, and instead try to find out what is going to be best for them.

What are parents saying about KidsMeds?

"I just spent some time reading the KidsMeds page of FB [facebook] and I love it. I read about ticks and allergies and many other things with are timely for me as a mom, and important to those living in our area. What a great resource! I wish I had been going there to read up on things before now. This is not info I would easily come across in other places, but it is very relevant and important stuff. Love it, thanks so much."

"I like the FB [facebook] fanpage because of the timely articles-if there is something that catches my attention I can read about it right then and there!"

We spent some time to get the perspective of Catherine Tom-Revzon, Pharm.D., Coordinator of KidsMeds.

Pamela: How was the site developed/designed to target the specific audience – the parents

Catherine: Matt can probably answer this better, but the site was designed to provide relevant, current, and useful information on a variety of topics for parents and caregivers. We strive to make the site easy to navigate. Additionally, the articles that we post contain tips from our pediatric pharmacists to optimize the use of medicines in children and contribute to the overall general health care and safety of children.

Pamela: What kind of information can you find on the website?

Catherine: The information that can be viewed on the website include general information on disease topics (e.g. head lice, swimmer’s ear, asthma) and their management with and without medications; tips on how to select over-the-counter products like sunscreen, insect repellents, etc. There are also tips on how to administer medicines to children.

On the Facebook and Twitter sites, pertinent links to valuable information and news from other resources (including, but not limited to, the FDA, CDC, AAP, AAAAI, and other health care professionals) about keeping children healthy and safe are provided.

Pamela: Does/will the website have any focus on specific medications relevant to treatment of children (as opposed to general topics)?

Catherine: The website currently does not focus on specific medications, but will take on classes of medications used in children and identify key points that parents need to be aware of with these. For instance, we have completed a comparison of acetaminophen and ibuprofen use in children. We do have a parent forum on the website, so if questions regarding specific medications arise, they will be addressed as appropriate.

Pamela: What do you think is the most useful tool on the web site (what parents may be most drawn to)?

Catherine: The most useful tools on the website are the info sheets and the seasonal topics.

Pamela: Why is it important to have a website focusing on children’s treatment/medications?

Catherine: PPAG’s vision is to be the primary resource for effective drug therapy in children. A website focusing on children’s medication use is valuable because it is necessary to educate the public about this unique patient population and offer solutions to frustrating situations that surround this group when it comes to selecting and giving medicines. It has been said many times in many ways that “children are not miniature adults,” and this concept is driven home with tips from our pediatric pharmacists who deal with the issues on a daily basis. As parent and patient advocates, we strive to share our experiences and offer hints to help children get the most out of their treatments.

Pamela: How do pediatric pharmacists get involved with the KidsMeds web site? (, if they were interested in contributing information?)

Catherine: The members of the Advocacy Committee of PPAG are involved in contributing content to KidsMeds. Pediatric pharmacists who are interested in getting involved with KidsMeds, but are not members of the Advocacy Committee can join the committee and let the KidsMeds Coordinator (Catherine Tom-Revzon) know of their interest. Pediatric pharmacists can also contribute to the wall posts on Facebook and Twitter with comments and postings.

Pamela: How often is the current information on KidsMeds updated? Does it always contain the most current recommendations on the topics that it covers

Catherine: The information on KidsMeds contains the most current recommendations from the widely accepted guidelines and the medical literature. The information on the KidsMeds site is updated as changes or additions are made in the guidelines. Also, as new products become available and are accepted for use in children, the information is added. Otherwise, the content will be reviewed every two years.

Pamela: When can new information be expected to be posted on the website? How often are topics added/updated? Are there any upcoming tips/tools for the spring season?

Catherine: New posts can be expected to be posted monthly. In the near future, we will post more frequently. Updates to posts will be performed as needed. Updates on Facebook and Twitter occur several times a day to several times a week. Upcoming tips/tools for the spring season include allergy, fever/pain, and asthma care.

Pamela: How can parents be sure that the information provided on KidsMeds is accurate?

Catherine: References are provided at the end of each article. The articles on the KidsMeds site are also reviewed by the Members of the Advocacy Committee and the KidsMeds Coordinator prior to publication.

Pamela: What is the goal of having the forums available on the website? What things can be addressed on these forums? (Do site users know what to do with them?? There is only the one posting so far)

Catherine: The goal of having forums available on the website is to encourage conversation among parents/families and the pediatric pharmacists. If there is a question, parents and caregivers can post it there. Topics are open. Site users are aware of the forum.

Pamela: Does the site provide updates on news and updated recommendations surrounding children’s healthcare? Can users receive updates and stay connected to the site (Facebook, Twitter, etc.)? (facebook, twitter, etc.)

Catherine: From reply #2: On the Facebook and Twitter sites, pertinent links to valuable information and news from other resources (including, but not limited to, the FDA, CDC, AAP, AAAAI, and other health care professionals) about keeping children healthy and safe are provided. On Facebook, parents can become fans of KidsMeds and on Twitter, KidsMeds is http://twitter.com/kidsmeds. News of postings or updates to existing articles on the KidsMeds website are posted on Facebook and Twitter.

Pamela: How can a parent or caregiver contact KidsMeds directly?

Catherine: KidsMeds has an email address: kidsmeds@ppag.org.

Pamela: Catherine, thank you so much for your time!

28-Apr-10 10:00 AM

New FDA Drug Approval for Infantile Spasms: Vigabatrin

Dennis Wisneski — Wed, 28 Apr 2010 15:00:00 GMT

Background
Infantile spasms (IS) or West Syndrome is a rare disorder of early infancy characterized by the clinical presentation of spasms, impedance of psychomotor development and abnormalities in electroencephalogram (EEG) patterns or hypsarrhythmias. West syndrome occurs in 1.6 to 4.5 per 10,000 live births. Outcomes associated with IS are poor with a high mortality rate of 11-30% and 80% of infants experiencing developmental retardation. IS typically does not respond well to standard epileptic drug therapy. However, efficacy has been observed with vigabatrin, corticotropin (ACTH), topiramate and corticosteroids.

In August 2009, vigabatrin (Sabril) manufactured by Lundbeck Inc. received FDA approval for use in IS in patient’s 1-month to 2-years of age. Vigabatrin has had orphan drug status in the United States for IS since 2000. In Canadian labeling vigabatrin also has an indication as an adjunctive therapy for adult populations with refractory complex partial seizures who have had an inadequate response to several alternative AED therapies.

Mechanism of action
Vigabatrin is a selective irreversible inhibitor of GABA transaminase (GABA-T), the enzyme responsible for catabolism of GABA. Through this mechanism, vigabatrin (gamma-vinyl-GABA) derives its anticonvulsive effect by increasing endogenous concentrations of the major inhibitory neurotransmitter, gamma-amino butyric acid (GABA), in the central nervous system.

Dosing
Dosing should be individualized to clinical response. The recommended initial dose is 50 mg/kg/day orally in two divided doses; titrated by 25-50 mg/kg/day every 3 days to a max daily dose of 150 mg/kg/day. Vigabatrin can be taken without regards to food. Powder for an oral solution is prepared by mixing each 500 mg package in 10 mL of cold or room temperature water. The final solution concentration is 50 mg/mL. Gradual tapering regimens are recommended to prevent increased seizure risk from rapid withdrawal. It is recommended to reduce the dose by 25-50 mg/kg/day every 3-4 days.

Contraindications and Precautions
Vigabatrin has a black box warning for vision loss due to its association with permanent bilateral concentric constriction of the visual field in up to 30% of adult patients. Cases of visual loss have been described as mild to severe; vision loss can occur at any time or with any amount of exposure to vigabatrin. Loss of visual acuity has been reported to a lesser extent and may not be detected by patients or caregivers especially in infants, Therefore it is necessary for close monitoring of visual acuity for early detection.

Magnetic resonance imaging (MRI) signal abnormalities have been detected in infants administered vigabatrin, located in symmetrical patterns in the thalamus, basal ganglia, brainstem, and cerebellum. These same MRI patterns have been observed in rat models when exposed to vigabatrin. The long term effects of these changes have not been elucidated, but MRI monitoring during use of vigabatrin is currently not recommended by the FDA. Somnolence and fatigue have been reported with frequencies greater than 15% in both adults and infants. Sedation and irritability have also been reported, usually affecting infants more frequently than adults.

Vigabatrin was also found to reduce serum levels of alanine transaminase (ALT) and aspartate transaminase (AST) in up to 90% of patients. In some patients ALT/AST values were undetectable. The manufacturer indicates the measuring these enzymes may be unreliable in detecting hepatic injury.

Availability and Cost
Vigabatrin it is only available through a restricted distribution program; Support, Help and Resources for Epilepsy (SHARE). The SHARE program requires registration of prescribers, pharmacies and enrollment of patients prior to obtaining vigabatrin. More information can be found by calling 1-888-45-SHARE or visiting the web site: www.lundbeckshare.com. Vigabatrin costs about $1,500 for 50 of the 500 mg oral solution packets. This is less expensive than other therapies for IS such as corticotropin (ACTH, Acthar® Gel) which is an estimated $20,000-$23,000 for a 5 mL vial.

Monitoring
An efficacy assessment is required by the prescribing physician at 2-4 weeks in infants and within 12 weeks for adults to determine if clinical benefit from vigabatrin has occurred. If no benefit is observed, vigabatrin is to be discontinued. Eye examinations are required at baseline, within 4 weeks of initiation of vigabatrin, then every 3 months while on therapy. A final eye examination is required at 3-6 months after discontinuation of therapy. The eye exam must be performed by an ophthalmic professional having expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina. The eye professional does not have to be registered in the SHARE program.

Summary
Vigabatrin has been studied in numerous clinical trials in both adults and pediatric patients, but for now lacks strong and comprehensive long term efficacy and outcomes data. Adverse effects from vigabatrin use may result in a permanently disabling vision loss and other neurologic effects. However, the benefit of vigabatrin use in infantile spasms may outweigh the risks due to the scarcity of other therapeutic options and the poor prognosis of untreated infantile spasms.

References

Sabril [package insert]. Deerfield, IL: Lundbeck Inc; August 2009.
Arteaga R, Herranz JL, Valdizán EM, Armijo JA. Gamma-vinyl GABA (vigabatrin): relationship between dosage, plasma concentrations, platelet GABA-transaminase inhibition, and seizure reduction in epileptic children. Epilepsia. 1992;33(5):923-931.
Hoke JF, Yuh L, Antony KK, Okerholm RA, Elberfeld JM, Sussman NM. Pharmacokinetics of vigabatrin following single and multiple oral doses in normal volunteers. J Clin Pharmacol. 1993;33(5):458-462.
Clinical Pharmacology Web site. http://cpip.gsm.com.ezproxy.samford.edu/. Accessed March 3, 2010.
MicromedexHealthcareSeriesWebsite. http://www.thomsonhc.com.ezproxy.samford.edu/home/dispatch. Accessed March 3, 2010.
Elterman RD, Shields WD, Mansfield KA, Nakagawa J; US Infantile Spasms Vigabatrin Study Group. Randomized trial of vigabatrin in patients with infantile spasms. Neurology. 2001;57(8):1416-1421.
Appleton RE, Peters AC, Mumford JP, Shaw DE. Randomized, placebo-controlled study of vigabatrin as first-line treatment of infantile spasms. Epilepsia. 1999;40(11):1627-1633.
Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane Database Syst Rev. 2008;(4):CD001770. doi: 10.1002/14651858.
Lux A, Edwards SW, Hancock E, et al. The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomized controlled trial. Lancet. 2004;364(9447):1773-1778.
Chiron C, Dumas C, Jambaqué I, Mumford J, Dulac O. Randomized trial comparing vigabatrin and hydrocortisone in infantile spasms due to tuberous sclerosis. Epilepsy Res. 1997;26(2):389-395.
Vigevano F, Cilio MR. Vigabatrin versus ACTH as first-line treatment for infantile spasms: a randomized, prospective study. Epilepsia. 1997;38(12):1270-1274.
Summary Review: Vigabatrin. FDA Center for Drug Evaluation and Research. http://www.fda.gov. Accessed 1 March 2010.
Risk Evaluation & Mitigation Strategy: Vigabatrin. FDA Center for Drug Evaluation and Research. http://www.fda.gov. Accessed 1 March 2010.
Practice Parameter: Medical Treatment of Infantile Spasms: Report of the American Academy of Neurology and Child Neurology Society. Neurology 2004;62(10): 1668-81.
Cohen-Sadan S, Kramer U, Ben-Zeev B, et al. Multicenter long-term follow-up of children with idiopathic West syndrome: ACTH versus vigabatrin. Eur J Neurol. 2009 Apr;16(4):482-7

28-Apr-10 10:00 AM

"Good Search" for PPAG

Matthew Helms — Wed, 28 Apr 2010 15:00:00 GMT

What if PPAG earned a penny every time you searched the Internet? Now it can with...

GoodSearch.com is a new Yahoo-powered search engine, with a unique social mission... every time you use GoodSearch, money is generated for PPAG!

GoodSearch donates half its revenue, about a penny per search, to the charities selected by its users. The pennies quickly add up. For example, if 1,000 PPAG supporters searched just twice a day for one year, we would receive an estimated $7,300 per year to help fund our organization!

What's great is that you use GoodSearch just as you would any search engine. Again, it's powered by Yahoo!, so you get proven, high-quality results.

Just go to http://www.goodsearch.com/?charityid=822920 and begin searching as you would any other day! Please make sure that "Pediatric Pharmacy Advocacy Group" is chosen under "Who do you GoodSearch for?"

Are you wondering how it works? Find out more about GoodSearch HERE!

The more people who use this site, the more money we'll raise so please spread the word!

So, don't just search the web, "GoodSearch" the web and help PPAG!

28-Apr-10 10:00 AM

PPAG Apparel Available at Bookstore

Matthew Helms — Wed, 28 Apr 2010 15:00:00 GMT

The Pediatric Pharmacy Advocacy Group Online Bookstore is pleased to provide quality apparel that includes the PPAG logo at reasonable prices. Your purchase of such items or other items from our web-store financially benefits PPAG. And by purchasing these items for yourself or as gifts for your staff, family, and/or friends, you will be promoting PPAG in your community.

Items available for purchase include: polo shirts, t-shirts, jackets, fleeces, children's wear, hats, luggage, bags, blankets, and much more.

To view the PPAG Apparel Store, please go to: http://ppag.webstore.us.com/.

Shop now for high quality products, and help PPAG at the same time! It is a win-win!

28-Apr-10 10:00 AM

PPAG featured in American Baby Mag

Matthew Helms — Mon, 05 Apr 2010 20:00:00 GMT

PPAG member Catherine Tom-Revzon, PharmD was featured in the March 2010 issue of American Baby.

Dr. Tom-Revzon gave information about pediatric pain relief for kids older than 6 months of age. See insert (right).

Advocating on behalf of parents and patients is an important part of PPAG's mission and activities. Through member-provided information on KidsMeds (www.kidsmeds.info) and parent magazines like American Baby, PPAG continues to provide useful information to parents and patients.

American Baby magazine is a monthly publication of Meredith Parents Network. It is circulated to over 2 million expectant and new moms throughout the US.

5-Apr-10 3:00 PM