PPAG Articles RSS Feed

340B Pricing

Matthew Helms — Thu, 26 Aug 2010 14:00:00 GMT

There are some components or portions of the Patient Protection and Affordable Care Act, as modified by the Health Care and Education Reconciliation Act, which offer pharmacists opportunities and may benefit the pharmacy profession. Unfortunately, free-standing children’s’ hospitals are being excluded from a benefit afforded to other hospitals.

Hospitals that serve low-income populations participate in a discount drug program known as 340B. Healthcare reform legislation expanded this discount program to free-standing cancer centers, critical care hospitals, and rural referral centers. However, the expansion of the program excluded orphan drugs from discounted pricing for entities that were newly made eligible in the healthcare reform law. In a seemingly well-intentioned mistake, free-standing children’s hospitals were included in the newly expanded list. But free-standing children’s hospitals began participating in the 340B program in September 2009, months before healthcare reform became law. Exclusion from 340B pricing for orphan drugs may cost the free standing children’s hospitals in excess of $109 million annually.

The orphan drugs make-up a majority of the savings (50-90%) with 340B pricing for the children’s hospitals and includes drugs such as Botox, Remicade, IVIG, Myozyme, and chemotherapy agents to name a few. For many years the free standing children’s hospitals were barred from access to the 340B program because we were not included in the Public Health Service (PHS) Act. After years of working through the legislative process, children’s hospitals were finally included as 340B covered entities under the PHS Act in September 2009. Several organizations such as the National Association of Children’s Hospitals and Related Institutions (NACHRI), Child Health Corporation of America (CHCA), and Safety Net Hospitals for Pharmaceutical Access (SNHPA) diligently worked to obtain access. The recent exclusion is a set-back for free-standing children’s’ hospitals. We are now working to reverse this unfavorable portion of health-care legislation.

On July 14, 2010, the House of Representatives passed H.R. 5712, known as the Veterans’, Seniors’, and Childrens’ Health Technical Corrections Act of 2010. On July 19, 2010, the bill was placed on the Senate Legislative Calendar under General Orders (Calendar No. 465), but does not yet have a number.

Currently, Senator Sherrod Brown (D-Ohio) is obtaining signatures in a letter urging Majority Leader Harry Reid (D-Nev) to correct this mistake “at the earliest opportunity” in the Senate. Twelve senators have signed Brown’s petition. Despite the challenging political environment, we must encourage others in the US Senate to support legislation, which will allow pediatric pharmacotherapists in children’s hospitals to provide basic care for children who cannot speak for themselves.

The Pediatric Pharmacy Advocacy Group is encouraging all of its members to join in the effort to restore 340B pricing for children’s Hospitals. [Download a sample letter here].

We also encourage all pharmacy associations and related organizations, such as APhA, ASHP, and ACCP to join PPAG in this effort. We respectfully request that these organizations and their members contact or write their Senator alerting them to the issue. PPAG will keep you informed as the issue moves through the legislative process.

In addition, PPAG has sent a letter to HHS Secretary Kathleen Sebelius to delay HRSA implementation of any action or promulgation of rules surrounding the 340B changes until we correct this mistake in the legislation.

For more information regarding 340B pricing, please contact:

James E. Dice, PharmD, FPPAG
Director of Pharmacy
Children’s Hospital of The King’s Daughters
601 Children’s Lane
Norfolk, VA 23320
james.dice@chkd.org

26-Aug-10 9:00 AM

2010 Call for Board Nominations

Matthew Helms — Wed, 25 Aug 2010 17:45:00 GMT

Deadline: September 15, 2010

The PPAG Board of Directors is requesting nominations for President-Elect, Secretary, Treasurer, and two (2) at-large Board positions that will begin April 2011.

President-Elect:

The President of the organiation presides over all meetings of the membership and Board of Directors. The President is the official spokesperson of PPAG, and makes a report of his/her administration at the Annual Conference and make recommendations deemed necessary. The President-Elect performs these duties in the absence of the President and will become President at the end of the term.

To be eligible to serve as President-Elect, a candidate must be a current or previous Director of PPAG.

Secretary:
The Secretary attests all documents of the organization, reviews and updates policies and procedures manual, and services as ex-officio member of any governing task force.

To be eligible to serve as Secretary, a candidate must be a current or previous Director of PPAG.

Treasurer:

The Treasurer chairs the Finance Committee, reviews monthly financial statements, and develops and monitors the Annual Budget.

To be eligible to serve as Treasurer, a candidate must be a current or previous Director of PPAG.

At-Large Director: Two (2) positions:

To be eligible as a candidate for a Board of Director position the following criteria apply:

Be a member of PPAG in good standing for at least three years
Be committed to attend all Board Meetings and conference calls (one-in person meeting)
Actively participate throughout the year
Support the mission, vision, values, and goals of PPAG.
Candidate has made contributions to the practice of pediatric pharmacy.

Board member responsibilities include, but are not limited to:

Attend the two live Board meetings and participate in four conference calls each year as specified in the bylaws
Attend activities, special events, Board retreats, and general membership meetings
Fairly consider other points of view, make constructive suggestions, reach consensus, and help the Board make decisions that benefit children, PPAG members, or others served by the PPAG mission
Assume Board leadership roles
Represent and promote PPAG to individuals, the public, Industry and other organizations
Actively participate in the fundraising efforts of the organization
Coverage of individual travel and meeting attendance costs

Any member of PPAG may nominate an individual, including oneself.

The deadline for submitting nominations is September 15, 2010, 12:00 midnight (eastern time).

Submit all nominations electronically to Matthew Helms, Executive Director of PPAG. Please include name, contact information, and a brief summary of why you feel this person will make a qualified member of the Board of Directors. Send nominations to: Matthew.helms@ppag.org.

25-Aug-10 12:45 PM

Campaign for Growth Update

Robert Kuhn — Mon, 16 Aug 2010 21:00:00 GMT

We want to thank all those who have participated in PPAG’s Campaign for Growth in the last few weeks. The initial response has been promising.

Just six weeks into our Campaign, eighty-seven people have contributed about $14,000 towards our $20,000 annual goal. Below, we’ve included recognition of these donors. In addition to these generous members and friends, many others have rejoined the organization or recruited a new member to PPAG. We have seen about a one-hundred member surge over this time last year. And, over 150 people have registered for our Pediatric Pharmacy Conference and Annual Meeting so far. This is great news for PPAG.

As two members who have been heading up the financial oversight of PPAG, we have worked closely with the Board and staff to adapt to the new economic climate for associations like PPAG. Naturally, associations usually feel the impact of economic “bulls” and “bears” one year after the businesses, institutions, or individuals they represent. As we moved forward, we feel we are positioned well to handle a protracted down-cycle. And, we are not alone. Other national pharmacy associations are downsizing staff and cutting budgets 15% or more in response to decreases in membership, program participation, industry support, and other funding sources.

We are confident that PPAG can continue to adapt to the new economy. PPAG is positioning itself as a social entrepreneur, combining a mission-driven focus with marketable and profitable products for use within and outside of our membership. Thanks to the generosity of our members, PPAG has made progress toward achieving the major initiatives of the “New PPAG.” Our medication safety initiatives have moved from the idea stage to the design and strategy stage.

However, we hope that more can help! Please join us in helping us exceed our goals. Continue to build the new PPAG by volunteering for a committee, recruiting a new member, convincing a colleague to join us in St. Charles, MO for our Annual Conference, or making a financial contribution (http://www.ppag.org/en/donations/).

We’re just $6,000 away from our goal. Let’s make it happen. Together, we are building the New PPAG. For more information about the Campaign, go to www.ppag.org/campaign-for-growth.

Respectfully yours,

Robert Kuhn, Pharm.D. and Jeff Low , Pharm.D.
Finance Committee

DONOR RECOGNITION

As of August 16, 2010, the following individuals and members have contributed and/or pledged financial support to our Campaign for Growth. About 13% of our membership has participated in our campaign.

Mr. Kenneth Adams
Dr. Kim Benner

Dr. Cassie Billings

Dr. Kelly Bob

Dr. Jenny Bouche

Dr. Ann Boughner

Dr. Jennifer Bonvechi

Dr. Leslie Briars

Dr. Holland Buchanon

Dr. Marcia Buck

Dr. Kelly Burch

Dr. Jennifer Chow

Jean and Lee Christensen

Drs. Robbin and Michael Christensen

Dr. Cathy Crill

Dr. Robert Daniels

Dr. Spencer Durham

Dr. Cindy Dusik

Dr. Brandon Edgerson

Dr. Lea Eiland

Dr. Sue Erwin

Dr. Elizabeth Farrington

Dr. Sherri Flatt

Dr. Karen Garlitz

Dr. Allyson Gaylor

Dr. Heather Graham

Dr. Kevin Graner

Dr. David Gregornik

Dr. Alison Grisso

Dr. Kathy Gura

Dr. Emily Hak

Dr. Claudia Hampton
Mr. and Mrs. Matthew Helms

Dr. and Mrs. Richard Helms
Dr. Andree Hest

Dr. Eliza Hoernle

Dr. David Hoff

Dr. Eliza Hoernle

Dr. Collin Hovinga

Dr. Franklin Huggins

Dr. Reginald King
Dr. Kristin Klein

Dr. Kitty Kline

Mr. David Knoppert

Dr. Kathleen Kopcza

Dr. Karen Kovey

Dr. Robert Kuhn

Dr. Bernard Lee

Dr. Kelley Lee

Dr. Jack Lemanowicz

Dr. Anne Lesko

Ms. Katie Long

Dr. Jeff Low

Dr. Sherry Luedtke

Dr. Edward Madden

Dr. and Mrs. Bill Maish

Dr. Rachel Meyers

Dr. Jaime Miller

Dr. Marita Nazarian

Dr. Laurie Niewoehner

Dr. Katherine O'Connor

Dr. Michelle Perez

Dr. Curtis Petty

Dr. Stephanie Phelps

Dr. Raul Pino-Lay

Dr. Steven Plogsted
Dr. Kalen Porter

Dr. Amy Potts

Dr. Luke Probst

Dr. Melissa Ray

Dr. Susan Robbins

Dr. Jasmine Sahni

Dr. Deidre Schmidt

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. Catherine Tom-Revzon

Dr. Kimberly Tu

Dr. Heather VandenBussche

Dr. Christina Victor

Dr. Susan Warrington

Dr. Heather Ann Wier

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	$ 14,020.00	$ 2,675.00	$ 2,675.00	$ 2,425.00	$ 2,425.00	$ 24,220.00

16-Aug-10 4:00 PM

Make your hotel reservations by September 5!

Matthew Helms — Thu, 12 Aug 2010 16:45:00 GMT

For more information and to register: http://www.ppag.org/en/cev/43

HOTEL INFORMATION:
Make your reservations by September 5, 2010

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.

It is important to note that PPAG must secure a room-block so that we can offer you discounted rates. We encourage you to make your reservations with PPAG today!

EDUCATIONAL TRACKS

This year we are pleased to offer various educational tracks that meet the need of our professionally diverse membership. Level 1 programs provide a review of current practices in the topic identified and are appropriate for both new practitioners and those seeking to update their knowledge base. Level 2 programs provide an advanced review of the identified topic and new developments in the field. Level 2 programs are appropriate for the advanced level practitioner. Worskops dedicated to general pediatric practice, research, and advocacy will also be offered.

HOSPITAL TOURS

Join PPAG as we tour St. John's Mercy Children's Hospital and Ranken Jordan Children's Rehabilitation Hospital. Friday, October 8, 2010 at 4:30-7:30pm. Tours are $75.00 and pre-registration is required. The registration fee includes continuing education credit, transportation, and dinner. For more information about the Hospital Tours, go to: http://www.ppag.org/ac10-objectives/#tour.

KEYNOTE SPEAKER

After graduating from Dartmouth College with honors in economics, Dr. Broselow obtained his medical degree from NJ College of Medicine and Dentistry and entered the field of family practice, in which he became board certified and practiced in Frankenmuth Michigan. He continued on to become board certified in Emergency Medicine. It was while working in the emergency department of a community hospital in Hickory, North Carolina, that he recognized how difficult and stressful it was for him and his team to care for acutely ill or injured children. He has conducted original research concerning the correlation between length and weight in children, from which the “Broselow Tape” was born.

He has worked with Dr. Allen Hinkle on the Broselow-Hinkle organizer and co-developed the Broselow tape and subsequent Broselow-Luten System with Robert Luten, MD . He has recently taken a position on the faculty of the University of Florida so that he can work more closely with Dr. Luten as they continue to develop their pediatric patient safety system. Currently, he is the Medical Director of PPAG's Artemis Safety Initiative. Through his numerous and significant innovations in pediatric care, the Broselow name has become one of the most widely recognized in the field of emergency medicine.

For more information about the conference and to register, go to: http://www.ppag.org/en/cev/43

12-Aug-10 11:45 AM

Retraction of Lancet Article Linking MMR Vaccine to Autism

Wed, 11 Aug 2010 16:00:00 GMT

On February 2, 2010, the highly reputable British medical journal, Lancet, formally announced the full retraction of their publication of the controversial 1998 Andrew Wakefield article which suggested a link between the measles-mumps-rubella (MMR) vaccine and autism. This retraction followed the judgment of the United Kingdom General Medical Council (GMC) on January 28, where they found that several elements of the study were false.

The editors of the Lancet said, “Following the judgment of the UK General Medical Council’s Fitness to Practise Panel, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to findings of an earlier investigation. In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore, we fully retract this paper from the published record.”

In the 1998 study, Dr. Wakefield, an English gastroenterologist, and his colleagues described 12 children consecutively referred to the department of gastroenterology at Royal Free Hospital with a history of a pervasive developmental disorder with loss of acquired skills and intestinal symptoms. The author claimed that 9 of the 12 children exhibited autistic behaviors following the administration of the MMR vaccine.

In 2004, the Lancet disclosed that Dr. Wakefield had acted in contrary to his duties as lead author of this publication because he failed to fully disclose conflicts of interest to the Journal’s editorial board. It was revealed that Wakefield was a paid advisor for the Legal Aid Board through an attorney who hoped to find a link between MMR vaccine and autism in order to take legal action against the manufacturer. In addition, Dr. Wakefield failed to disclose that he had filed a patent application for a new vaccine. As a result, ten of the 13 authors of the original paper attempted to retract the paper. The Lancet only partially retracted the paper at that time due to lack of evidence to support full retraction.

According to the GMC, an independent regulator which oversees physicians in Britain, Dr. Wakefield abused his position, subjected children to overly invasive procedures such as lumbar puncture, imaging and colonoscopy that were not clinically indicated, financially compensated subjects to participate in the study, carried out research that breached the conditions of ethics committee approval, and brought the medical profession to disrepute.

The journal’s editor-in-chief, Dr. Richard Horton, which issued the retraction, had the following to say regarding this error, “This was a system failure. We failed, I think the media failed, I think the government failed, I think the scientific community failed. And we all have to very critically examine what part we played in this.” Dr Horton went on to say, “I certainly hope that our retraction [today] will help reassure parents that there really isn’t anything to be concerned about with the vaccine…And you know, we are going to see many, many more vaccines available to the general public, and we all have to be very vigilant about making sure that we build trust and confidence in these vaccines, which are going to transform the landscape of health over the next generation.”

Dr. Wakefield found the allegations by the GMC, “unfound and unjust.” However, along with two other colleagues Professor John Walker-Smith (retired professor of pediatric gastroenterology) and Professor Simon Murch (professor of pediatric and child health), Wakefield is defending himself against allegations of serious professional misconduct brought by the GMC. The charges relate to ethical aspects of the project, not its findings. The GMC stripped Dr. Wakefield of his right to practice medicine in Britain on May 24, 2010, on the grounds of serious professional misconduct. This decision went into effect on June 21, twenty-eight days after its decision.

Despite the fact that numerous studies investigating the safety of vaccines have been published since 1998, no other investigator has been able to find a link between vaccines and autism. Worry from parents that the vaccine causes autism may be in part because the signs of this disease tend to appear around the age of 2 when many childhood vaccinations are administered. In 1995, research showed that 0.77% of U.S. children were not immunized with the MMR vaccine. Following the release of this article in Lancet, this statistic rose to 2.1% in 2000. Likewise, in 1998, national rates of MMR coverage in Britain fell from 92% to 73%, with rates in parts of London as low as 50%. This decrease in coverage resulted in measles outbreaks and the first measles-related death in the United Kingdom in more than a decade. Vaccine safety experts, including representatives of the Center for Disease Control (CDC) and the American Academy of Pediatrics (AAP), agree that MMR vaccine is not responsible for the increase in the number of children with autism. Furthermore, in 2004, a report by the Institute of Medicine (IOM) concluded that there is no link between autism and MMR vaccine.

In conclusion, the retraction of this article from the Lancet acts as a reminder that even reputable pieces of literature may unknowingly publish inaccurate and misleading information. As a result, it is vital that health care professionals have access to accurate information and are able to respond appropriately to parental concerns in order to guarantee successful immunization practices.

References

Bedford HE. MMR vaccine and autism. BMJ. 2010;340:655.
Deer B. Schoolboy, 13 dies as measles makes a comeback. The Sunday Times. April 2, 2006. Available at: www.timesonline.co.uk/tol/news/uk/article701151.ece.
Dyer C. Lancet retracts Wakefield’s MMR paper. BMJ. 2010;340:696.
Garfield B. A Shot of Reality: National Public Radio. http://www.onthemedia.org. Updated February 5, 2010. Accessed March 18, 2010.
Hodgson H. A statement by The Royal Free and University College Medical School and The Royal Free Hampstead NHS Trust. Lancet. 2004;363;824.
Hornig M, Briese T, Buie T, Bauman ML, Lauwers G, et al. Lack of association between Measles Virus Vaccine and Autism with Enteropathy: A Case Control Study. PLoS ONE. 2008;3(9):e3140.
Murch S. MMR and autism: the debate continues. Lancet. 2004;363:568-69.
Smith MJ, Ellenburg SS, Bell LM, Rubin DM. Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States. Pediatrics. 2008;121:836-843.
Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet.1998;351:637-641.
Zhang L, Lopez P, He T, Yu W, Ho DD. Retraction of an interpretation. Science. 2004;303:467.

11-Aug-10 11:00 AM

We thank Julie Clyce for her years of service!

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

Hello,

On July 30th, we said 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!

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