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PPAG Joins Coalition for BCPA/PREA

Matthew Helms - noemail@ppag.org — Fri, 03 Feb 2012 18:00:00 GMT

PPAG recently joined seven other organizations (The American Academy of Child and Adolescent Psychiatry, the American Academy of Pediatrics, the American Society of Pediatric Nephrology, the American Thoracic Society, the Elizabeth Glaser Pediatric AIDS Foundation, and the March of Dimes) who support the reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).

BPCA and PREA: An Overview

Children are not just small adults. Drugs work differently in children than in adults and must be studied specifically for their use.

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) are two laws that encourage and require the study of drugs in children. Data resulting from BPCA and PREA studies are added to drug labels to give parents and providers essential information on the safety and efficacy of drugs used in children.

PREA requires drug companies to study adult drug indications in children when the product is likely to be used in a significant number of children or represents a meaningful therapeutic benefit over existing therapies. While PREA is a requirement, it cannot delay access to the adult version of the product.

BPCA is an incentive for drug companies to conduct FDA-requested pediatric studies—especially for off-label drug uses—in return for an additional six months of marketing exclusivity.

A Track Record of Success

BPCA and PREA have changed pediatric practice because all studies result in labeling changes that provide valuable new pediatric information. These studies have resulted in new dosing information, new indications of use, new safety information, and new data on effectiveness. Drugs studied under BPCA and PREA treat a wide range of diseases in children, including cancer, HIV/AIDS, diabetes, allergy and asthma.

426 drug labels have been revised with important pediatric information (181 under PREA, 147 under BPCA, 50 under both BPCA and PREA, and 48 under precursor regulations).

Before BPCA and PREA, the vast majority of drugs—more than 80%—used in children were used off-label, without data on their safety or efficacy. Today that number has been reduced to approximately 50%. While there has been significant success, more progress is needed.

Priorities for Reauthorization

Reauthorize these important laws. BPCA and PREA expire on October 1, 2012. These laws must be reauthorized to continue these important advances for children. PREA should be made permanent law—basic safety and efficacy provisions for adults do not expire and they should not for children. In addition, the program that funds the study of older off-patent drugs at the National Institutes of Health (NIH) should also be reauthorized.

Plan pediatric studies earlier. The precursor to PREA, the Pediatric Rule, required that drug companies discuss and plan for pediatric studies no later than the end of phase 2. Since PREA replaced the Pediatric Rule, the pediatric plan submission under PREA cannot occur until the time a company submits its drug application. This can lead to insufficient and inappropriate study plans and delays of important pediatric data. Drug companies should begin discussions with FDA at the end of phase 2 of the drug development process, similar to the Pediatric Rule.

Improve accountability. PREA studies can be waived or deferred to a later time post-market. Deadlines for deferred studies, however, are missed a vast majority of the time. Of all deferred PREA studies due after September 27, 2007, an alarming 78% are currently late or were submitted late. The FDA should distinguish between reasonable and unreasonable delays and have enforcement tools comparable to those for post-market requirements in adults to ensure that pediatric data is gathered as soon as possible.

Promote studies in younger age groups. Studying drugs in neonates—the smallest children—is very difficult. The GAO found that FDA lacks neonatal expertise. Increase neonatal expertise at FDA and encourage additional discussion of neonates and younger age groups.

Increase transparency. Pediatric researchers cannot access information on what drugs are currently being studied under BPCA. BPCA study requests declined by drug companies—evidence of important gaps in pediatric data—are never made public. Some pediatric data submitted prior to 2007 has also not been made public. Improve transparency provisions to increase access to important pediatric information.

Special thanks to the American Academy of Pediatrics for their assistance authoring this article.

3-Feb-12 12:00 PM

PPAG Endorses Drug Shortages Prevention Act: Call to Action

Matthew Helms - noemail@ppag.org — Thu, 02 Feb 2012 21:30:00 GMT

On February 1, 2012, U.S. Representatives John Carney (D-DE) and Larry Bucshon (R-IN) introduced the Drug Shortage Prevention Act to address the scarcity of certain pharmaceutical drugs in the marketplace.

PPAG members and other healthcare professionals have been dealing with drug shortages for well over a year. Last September, PPAG leadership participated in the FDA's National Drug Shortage Summit, where healthcare leaders deemed the drug shortage problem a national healthcare crisis.

The new legislation (H.R.3839), which PPAG endorses, mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first place and it requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. Two additional bills, S. 296 entitled "Preserving Access to Life Saving Medications Act" and its companion bill, H.R. 2245 "Preserving Access to Life-Saving Medications Act of 2011" were introduced last year.

PPAG members and constituents are encouraged to contact their legislators to express support for these bills. Together we can really make a difference with this issue.

Please take the time to write to your legislator today and spread the word to your colleagues and friends.

To find and write your elected officials, follow the step-by-step directions below:

Visit http://www.congress.org
Enter your 9-digit zip code
Click on the elected official
Click on "contact," then "web form.
Insert your letter and submit.

Here is a sample letter of support for the legislation.

Tips for a good letter to your elected officials:

Make in personal- tell them who you are.
Make it short.
Stay on point- address only one issue.
Cite a specific bill - by number if possible.
Send the letter by mail.
Send it to your legislators only. Put your home address and zip code in your letter. (Many legislators will only accept mail and email from their own constituents).

Special thanks to A.S.P.E.N., who also endorses HR 3839, for their assistance authoring this article.

2-Feb-12 3:30 PM

FDA Approval of ONFI™ (clobazam) for Adjunctive Therapy for the Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS)

Thu, 02 Feb 2012 21:00:00 GMT

On October 21, 2011, the FDA approved ONFI™ (clobazam) as an adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years of age. Clobazam is an antiepileptic drug of the benzodiazepine class. It has been approved in other countries since the late 1970’s for the treatment of anxiety and epilepsy, and received Orphan drug designation on December 18, 2007, for the treatment of LGS in the U.S.

The effectiveness and safety of ONFI for the adjunctive treatment for LGS was evaluated in two controlled studies in about 300 patients with LGS. The exposure-response analysis of these data indicated that there are clear exposure-response relationships for both efficacy and safety. All three studied dose groups (10 mg, 20 mg, and 40 mg per day) were statistically significantly superior to the placebo groups with regard to the drop seizure rates, the primary efficacy endpoint. This effect was dose-dependent manner, with the greatest mean seizure reduction observed at the highest studied dose of 40mg/day. Sedation-related adverse events (i.e., sedation, somnolence, sleepiness, drowsiness, lethargy and listlessness) were the most common adverse reactions. Results showed that patients assigned to doses greater than 5 mg/day experienced a higher percentage of sedation-related adverse events than the placebo group. However, no significant difference between 20 mg/day and 40mg/day doses was observed.

ONFI should be administered in divided doses twice daily (the 5 mg dose can be administered as a single daily dose) and should be dosed according to body weight. Within each body weight group, dosing should be individualized based on clinical efficacy and tolerability. Dose escalation should not proceed more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state.

Table 1. Recommended Total Daily Dosing by Weight Group

	≥30 kg Body Weight	>30 kg Body Weight
Starting Dose	5 mg	10 mg
Starting Day 7	10 mg	20 mg
Starting Day 14	20 mg	40 mg

Clobazam is extensively metabolized in the liver, with 82% of the administered dose recovered in urine (2% unchanged) and 11% in feces (1% unchanged). The major metabolic pathway of clobazam involves N-demethylation, primarily by CYP3A4 and to a lesser extent by CYP2C19 and CYP2B6. N-desmethylclobazam, known to have intrinsic benzodiazepine like activity, is the major circulating metabolite in humans, and its plasma concentrations are 3-5 times higher than those of clobazam. This metabolite is further metabolized by CYP2C19. In CYP2C19 poor metabolizers, levels of N-desmethylclobazam were 3-5-fold higher than that in CYP2C19 extensive metabolizers. In healthy adults and patients, the mean terminal half-life of clobazam (t_1/2) is 36 to 42 hours. The mean terminal half-life of N-desmethylclobazam is 71 to 82 hours.

Clobazam is an inhibitor of CYP2D6; thus, drugs metabolized by CYP2D6 may require dose adjustment when used with Onfi. Clobazam is a mild inducer of CYP3A4; dose adjustments are unnecessary for most 3A4 substrates considering the relatively small inducing effect. However, the effectiveness of some hormonal contraceptives metabolized by CYP3A4 may be diminished when given with ONFI. Additional non-hormonal forms of contraception are recommended when using ONFI.

Because the active metabolite N-desmethylclobazam is primarily metabolized by CYP 2C19, dosage adjustment is recommended when strong and moderate CYP2C19 inhibitors are used concomitantly with ONFI.

CYP3A4 inducers (phenobarbital, phenytoin, and carbamazepine), CYP2C9 inducers (valproic acid, phenobarbital, phenytoin, and carbamazepine), and CYP2C9 inhibitors (felbamate and oxcarbazepine) had no significant impact on the pharmacokinetics of clobazam and N-desmethylclobazam.

Dosing adjustments (i.e., starting dose at 5 mg/day, then be titrated according to weight, but to half the dose presented in Table 1 as tolerated; if necessary and based upon clinical response, an additional titration to the maximum dose [20 mg/day or 40 mg/day, depending on weight] may be started on day 21) are recommended for the following specific populations:

Geriatric patients had slower clobazam clearance, thus dosing adjustment is recommended.
CYP2C19 poor metabolizers had approximately 3- to 5-fold higher N-desmethylclobazam exposure (Cmax and AUC), compared to extensive metabolizers, respectively, with insignificant change in exposure to the parent drug. Dosing adjustment is recommended for patients who are known to be CYP2C19 poor metabolizers.
Clobazam is primarily metabolized in the liver. Dosing in patients with hepatic impairment should be adjusted for mild and moderate hepatic impairment patients. No dosing recommendation can be provided for patients with severe hepatic impairment because of inadequate data.

The exposure (C_max and AUC) of clobazam and N-desmethylclobazam were not significantly increased with mild and moderate renal impairment in a dedicated study; therefore, no dosing adjustment is recommended for patients with mild and moderate renal impairment. There is no experience with ONFI in patients with severe renal impairment or end stage renal disease (ESRD). It is not known if clobazam or N-desmethylclobazam is dialyzable.

Full prescribing information is available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202067s000lbl.pdf

By Ta-Chen Wu, Senior Clinical Pharmacologist, Angela Yuxin Men, Team Leader, Division of Clinical Pharmacology 1, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA

2-Feb-12 3:00 PM

Pharmacogenetic changes to the FDA-approved PLATINOL® (cisplatin) label include safety update regarding cisplatin-induced hearing loss in children

Thu, 02 Feb 2012 21:00:00 GMT

The FDA updated the PLATINOL^® (cisplatin) product label on December 29, 2011 to include new safety information pertaining to the association of variants in the thiopurine S-methyltransferase (TPMT) gene and an increased risk of cisplatin-induced ototoxicity in children. Cisplatin was originally approved as PLATINOL^® by the FDA in 1978 and is currently indicated for the treatment of metastatic testicular tumors, metastatic ovarian tumors, and advanced bladder cancer.

Cisplatin’s toxicity profile includes risk for ototoxicity. Ototoxicity is manifested by tinnitus and high-frequency hearing loss which is often bilateral, typically irreversible, and can be progressive despite cessation of cisplatin. Hearing loss can occur following a single cisplatin dose, but tends to become more frequent and severe following repeated dosing. Ototoxic effects may be related to peak plasma concentrations of cisplatin. While cisplatin-induced ototoxicity can occur in both adults and children, its prevalence in children is estimated to be as high as 60% and the ototoxic effects can be particularly devastating on a child’s cognitive, speech, language, and socio-emotional development.

A retrospective study¹ involving an initial cohort and a replicative cohort totaling 162 children who received conventional doses of cisplatin revealed an association between variants in the TPMT gene (e.g., TPMT*3B and TPMT*3C) and an increased risk of cisplatin-induced hearing loss (Odds Ratio of 17.0 [95% CI 2.3-125.9]). Patients were administered a median cumulative cisplatin dose of 400 mg/m² for a median treatment duration of 4-5 weeks. Although only 26 of the 162 patients (16%) had one or more TPMT gene variants, 25 of the 26 (96%) developed severe ototoxicity. For Caucasians and African Americans, approximately 11% of the population inherit one or more of these TPMT variants. Children who do not have one of these TPMT gene variants remain at risk for ototoxicity. Other genetic factors may also contribute to cisplatin-induced ototoxicity.

The updated label is expected to inform healthcare providers about the association between genetic factors and cisplatin-induced ototoxicity in children and to stress the importance of monitoring and management strategies for hearing loss. The label recommends that all children receiving cisplatin should have audiometric testing at baseline, prior to each subsequent dose of drug, and for several years post therapy. The use of advanced audiometric testing methods may allow for earlier detection of hearing loss and rapid initiation of interventions that can limit the potential adverse impact of hearing impairment on a child’s cognitive and social development.

Full prescribing information is available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018057s081lbl.pdf

By Dionna Green, M.D., Pediatric Clinical Pharmacologist, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA

Ross, C.J., Katzov-Eckert H., et al. Genetic variants in TPMT and COMT are associated with hearing loss in children receiving Cisplatin chemotherapy. Nat. Genet.2009;41:1345-1349.

2-Feb-12 3:00 PM

2012 Call for Board Nominations

Matthew Helms - noemail@ppag.org — Wed, 18 Jan 2012 16:45:00 GMT

Deadline: February 17, 2012

The PPAG Board of Directors is requesting nominations for President-Elect, Secretary, Treasurer, and three (3) at-large Board positions that will begin April 2012.

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: Three (3) 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 one in-person Board meeting and participate in at least 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 February 17, 2012, 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.

18-Jan-12 10:45 AM

Renew and Recruit: A Letter from the PPAG President

Dave Knoppert - noemail@ppag.org — Fri, 13 Jan 2012 03:00:00 GMT

Dear PPAG Members and Friends,

When the Board of Pharmacy Specialties (BPS) announced that they would conduct a Role Delineation Study for Pediatrics a few months ago, we all became quite excited. BPS subsequently announced the members of the Pediatric Specialty Task Force, most of whom are PPAG members, and that process has begun.

However, many of you still wish to help in some way. During the past few weeks we have received questions about this at PPAG. Many of you have asked "What I can do to help with the Board Certification process?" Our answer may have been somewhat disappointing to you: “there is not much more we can do than wait”. However, there IS something tangible (and easy) that you can do.

The decision to approve a Board Certified Specialty is based on many factors. Proving that there is a critical mass of individuals interested in taking the Certification Exam is extremely important. PPAG survey data suggest that over 1,500 people would be interested in taking the exam. But surveys are only one way to measure interest.

Another way to gauge interest in specialty certification is participation in professional pharmacy associations like PPAG. Indeed, the number of PPAG members and the number of pediatric practitioners within ASHP and ACCP are vitally important factors to BPS.

So, what can YOU do? Keep your membership up-to-date and make sure that you renew it. Encourage your Pediatric colleagues to join PPAG. Discuss with them why Board Certification is important to Pediatric Pharmacy.

There IS something that we can ALL do to help. I encourage each and every one of you to do these simple things that I have suggested above. If each of us does this then we will help increase the critical mass of Pediatric Pharmacists that is so important to the certification process.

If you have any questions or suggestions please feel free to contact me or any member of the Board of PPAG.

Best regards,

David Knoppert, MScPhm
President
PPAG
2011-12

12-Jan-12 9:00 PM

Pfizer Fesoterodine Study

Edress Darsey - noemail@ppag.org — Fri, 13 Jan 2012 02:00:00 GMT

Pfizer is setting up a clinical study in the US to investigate fesoterodine in children aged 6 to 16 years old with neurogenic detrusor overactivity (NDO).

The purpose of the study is to characterize the effects of fesoterodine in that population, more specifically on wetting episodes, catheterizations or frequency of passing urine, and bladder function, as well as the side effect profile, as it has not yet been approved in that population. A comparison with oxybutynin XL will be incorporated.

If you require further details, and/or know of any physicians and research centres who might be interested in participating in the study, please contact Edress Darsey at edress.darsey@pfizer.com or 404-386-0516.

Thank you.

12-Jan-12 8:00 PM

2012 Call for Abstracts

Matthew Helms - noemail@ppag.org — Thu, 08 Dec 2011 20:00:00 GMT

General Information
February 24, 2012 for Practice-based and Scientific Abstracts
March 30, 2012 for Residency Project Abstracts

All practitioners, investigators, and post-doctoral trainees in the field of pediatric clinical pharmacy, whether members of PPAG or not, are invited to submit abstracts of papers to be considered for platform or poster presentation at the 21st Annual PPAG Meeting and 2012 Pediatric Pharmacy Conference. The conference will be held at the Houston Marriott at the Texas Medical Center in Houston, TX. Poster and Platform Presentations will be held on Friday, April 20, 2012.

All research and practice abstracts should be no longer than 450 words. Research abstracts will be published in the Journal of Pediatric Pharmacology and Therapeutics. Platform Presentations and Best Practice Awards will be chosen from the abstracts submitted.

There are two tracks for abstract submissions:

Research/Scientific Track: February 24, 2012 deadline
Practice Based Track: February 24, 2012 deadline
Residency Project Track: March 30, 2012 deadline

Submit Abstract Here

Research/Scientific Track

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

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

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

Outstanding Original Paper

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

Christensen Memorial Young Investigator Award

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

Deadline February 24, 2012

Submit Abstract Here

Best Practice Track

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

Winners of the Best Practice Award will be chosen from accepted abstracts. The program, system, or project can be an individual or collaborative effort in any type of practice setting, including academia, institutional, or ambulatory care. Unlike Research Abstracts, Best Practice Abstracts are not required to have final or preliminary data, but should include sufficient details about the rationale, process, and hypothesis of the impact should the program, system, or project be implemented. Accepted abstracts will be published in the Journal of Pediatric Pharmacology and Therapeutics.

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

Lexi-Comp Best Practice Awards

PPAG will award up to two (2) Best Practice Awards during the 21st Annual Meeting in Houston, TX. The awards are given to innovative and creative pharmacy programs that advance the mission, vision, and goals of the organization. Recipients of the award receive a plaque for the practice site and a certificate recognizing each contributor to the program. Award recipients will share their best practice during a presentation at the Annual Meeting and as a poster at the Annual Meeting.

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

Deadline February 24, 2012

Submit Abstract Here

Residency Project Presentations and Showcase

Each year the Pediatric Pharmacy Advocacy Group offers an opportunity for Post-doctoral trainees (Residents and Fellows) to present their projects to pediatric pharmacy practitioners from across North America.

Residents will be able to present their projects during the Bruce Parks Memorial Showcase on Thursday, April 19, 2012 or Saturday, April 21, 2012 during the 21st Annual PPAG Meeting and 2012 Pediatric Pharmacy Conference.

Presentations will be limited to 10 minutes in length. The format for the presentations is similar to the format used at regional residency conferences. Presentations can be on any pediatric-based project and may be a work-in-progress.

Abstracts can be no longer than 450 words in length. For useful tips in drafting your abstract, please visit: Guidelines for Abstract Preparation.

Deadline March 30, 2012

Submit Abstract Here

8-Dec-11 2:00 PM

Local Community Spotlight: Gateway Pediatric Pharmacy Group

Mon, 05 Dec 2011 14:00:00 GMT

The Gateway Pediatric Pharmacy Group (GPPG), a local community of PPAG, held its very first meeting in November 2010. GPPG has been busy ever since with every other month meetings rotating locations between the four major pediatric institutions around St. Louis. These include:

St. Louis Children’s Hospital
Cardinal Glennon Children’s Medical Center
Mercy Children’s Hospital
Ranken Jordan

Dr. Brandy Bratcher was elected to serve as the inaugural local coordinator along with four institutional representatives. Not only did Brandy include time within meeting agendas for discussion on the hot topics (i.e. drug shortages), but she also organized accredited continuing education through PPAG for most meetings. More importantly, GPPG replaced one meeting with fundraising and participated as a group in our local ‘Cure Search’ walk. GPPG raised over $1,000 for the Children’s Oncology Group.

Dr. Bratcher stated, "We believe we have really met our group’s goal this past year of ‘connecting pediatric pharmacists that serve in the Greater Saint Louis area by providing networking opportunities, an avenue to exchange ideas and best practices, and volunteer and leadership opportunities’. We look forward to expanding our group to local pharmacy students from the Southern Illinois University Edwardsville School of Pharmacy and the St. Louis College of Pharmacy."

What a great year for pediatric pharmacy in St. Louis!

5-Dec-11 8:00 AM

PPAG Unveils New Journal Website

Matthew Helms - noemail@ppag.org — Mon, 28 Nov 2011 22:00:00 GMT

The Pediatric Pharmacy Advocacy Group has unveiled a new website for the Journal of Pediatric Pharmacology and Therapeutics (JPPT). The new journal site offers abstract view, full-text views, article sharing and exporting, and citation tracking.

Individual subscribers and members of PPAG have individual access to the Journal. If you are a member you must register on the site.

The new site also offers institutional subscriptions for hospitals, libraries and universities. Through an insitutional subscription, all individuals within an institution can access Journal content for free (within the local network). Please contact PPAG for more information.

Please visit the new website at http://www.jppt.org.

We are working on our archive. Soon, volumes 8 through volume 16 will be available on the site and PubMedCentral.

The Journal of Pediatric Pharmacology and Therapeutics is the official journal of the Pediatric Pharmacy Advocacy Group. JPPT is a peer-reviewed multi disciplinary journal that is devoted to promoting the safe and effective use of medications in infants and children. To this end, the journal publishes practical information for all practitioners who provide care to pediatric patients. Each issue includes review articles, original clinical investigations, case reports, editorials, and other information relevant to pediatric medication therapy.

The Journal focuses all work on issues related to the practice of pediatric pharmacology and therapeutics. The scope of content includes pharmacotherapy, extemporaneous compounding, dosing, methods of medication administration, medication error prevention, and legislative issues.

The Journal contains original research, review articles, short subjects, case reports, clinical investigations, editorials, and news from such organizations as the Pediatric Pharmacy Advocacy Group, the FDA, the American Academy of Pediatrics, the American Society of Health-System Pharmacists, and so on.

28-Nov-11 4:00 PM

PPAG Webinars... There's an App for That!

Matthew Helms - noemail@ppag.org — Mon, 28 Nov 2011 20:00:00 GMT

You can now attend a PPAG sponsored webinar using your smart phone or iPad. PPAG provides webinars and other collaborative events through GoToMeeting and GoToWebinar.

GoToMeeting is the easiest and most convenient way to attend online meetings – and now you can take it to go! The app is free. Download it today. View slide presentations, design mockups, spreadsheets, reports – whatever meeting presenters choose to share on-screen.

After you download, all you will need is conference identification access numbers.

Click the appropriate link below for more information about the app!

iPad and iPhone App: Download iPhone/iPad App

Android Market: Download Android App

The next PPAG webinar on Pediatric Pain Management (Jared Cash, PharmD speaker) will be held on January 25, 2011. For more information, please go to: http://www.ppag.org/en/cev/77

28-Nov-11 2:00 PM

Neonatal Small Grant Recipient Announced

Matthew Helms - noemail@ppag.org — Thu, 17 Nov 2011 20:00:00 GMT

Oscar Rafael Herrera, PharmD, a Fellow in the Department of Clinical Pharmacy at the University of Tennessee Health Science Center College of Pharmacy in Memphis, TN has received the 2011 Neonatal Pharmacy Resident/Fellow Research Grant for the proposed project, Optimum concentration of eicosapentaenoic acid and docosahexaenoic acid on bile acid induced apoptosis in HepG2 cells. The grant will be used to purchase laboratory supplies and assay kits.

Now in its 3rd year, the Neonatal Pharmacy Resident/Fellow Research Grant supports research in neonatal medication use conducted by pharmacy residents (e.g., PGY-1, PGY-2 pediatric pharmacy resident) and fellows. The primary purpose of the research award is to improve safe and effective use of medications in neonates. Research projects can comprise a wide range of medication-use topics, including but not limited to: technology, safety, and/or pharmacotherapy. A secondary goal of the program is to develop and strengthen the skills of pharmacy residents and fellows by fostering development of mentoring relationships with more experienced senior investigators. For more information about the grants, please go to the following website: http://www.ppag.org/neonatalgrant/.

17-Nov-11 2:00 PM

Pediatric Pharmacy Events at ASHP Midyear

Matthew Helms - noemail@ppag.org — Thu, 17 Nov 2011 19:00:00 GMT

The Pediatric Pharmacy Advocacy Group is pleased to announce pediatric-related educational programs at ASHP's Midyear Meeting.

Drug Therapy Updates in Neonatology (201-L01)

DATE:Monday, December 05, 2011
TIME: 2:00 PM to 5:00 PM
TRACK:Education Sessions (CE)
Planned in cooperation with the Pediatric Pharmacy Advocacy Group
ACPE Activity # 204-000-11-201-L01P
Level of Content: Advanced
3.0 Contact Hour / Application-based

Learning Objectives:

Evaluate a neonatal parenteral nutrition order and identify areas for improved practice based on current evidence.
Develop patient specific drug regimens for infants with bronchopulmonary dysplasia which address the individual lung abnormalities observed.
Develop a drug therapy plan for the management of a neonate presenting with seizures to optimize neurological outcomes.

2:00 p.m. - 2:05 p.m. Announcements

2:05 p.m. - 2:50 p.m. Neonatal Parenteral Nutrition: Are You Aggressive Enough?
Kathleen M. Gura, PharmD, BCNSP, FASHP,Clinical Pharmacist GI / Nutrition, Children's Hospital Boston, Boston, MA

2:50 p.m. - 3:00 p.m. Questions, Answers, and Discussion

3:00 p.m. - 3:50 p.m. Neurophysiology of the Preterm Infant: The Impact of Anticonvulsants
Peter Gal, PharmD, FASHP, Director, Graduate Pharmacy Education, Greensboro AHEC, Moses Cone Health System, Greensboro, NC

3:50 p.m. - 4:00 p.m. Questions, Answers, and Discussion

4:00 p.m. - 4:50 p.m. Less Is More: Respiratory Management Updates in Neonates
Sherry Luedtke, PharmD, FPPAG, Associate Professor, Texas Tech HSCSchool of Pharmacy, Amarillo, TX

4:50 p.m. - 5:00 p.m. Questions, Answers, and Discussion

ADHD: Treatment Myths and Controversies (216-L01)

DATE:Monday, December 05, 2011
TIME: 4:00 PM to 5:00 PM
TRACK:Education Sessions (CE)

ACPE Activity # 204-000-11-216-L01P
Level of Content: Intermediate
1.0 Contact Hour / Knowledge-based

Learning Objectives:

Compare and contrast recent American Academy of Pediatrics (AAP) and American Heart Association (AHA) recommendations for cardiac monitoring in patients treated with stimulants in Attention Deficit Hyperactivity Disorder (ADHD).
Describe the contradictory evidence on the usefulness of electrocardiogram (ECG) monitoring to predict acute cardiac death.
Evaluate the myth that treatment of Attention Deficit Hyperactivity Disorder (ADHD) with stimulants increases substance abuse in later life.

Moderator:Elizabeth Farrington, PharmD, FCCP, Pharmacist III, New Hanover Regional Medical Center, Wilmington, NC

Pediatrics: How to Knock 'em Out and Lock 'em Out (227-L01)

DATE:Tuesday, December 06, 2011
TIME: 8:00 AM to 10:30 AM
TRACK:Education Sessions (CE)

Planned in cooperation with the ASHP Section of Clinical Specialists & Scientists
ACPE Activity # 204-000-11-227-L01P
Level of Content: Advanced
2.5 Contact Hour / Knowledge-based

Learning Objectives:

Evaluate current NICU sedation practices and review literature supporting these practices.
Explore the effects of sedation on neurodevelopment and examine alternative agents.
Design a sedation regimen for a pediatric patient in whom traditional sedation options have failed.
Interpret data on antibiotic lock therapies in pediatric patients.

Moderator:Melissa Heigham, PharmD, BCOP, Manager, Clinical Pharmacy Services, St. Louis Children's Hospital, St. Louis, MO

8:00 a.m. - 8:05 a.m. Announcements

8:05 a.m. - 8:50 a.m. Sedation Challenges in the NICU
Christopher McPherson, PharmD, Clinical Pharmacist, Neonatal ICU, St. Louis Children's Hospital, St. Louis, MO

8:50 a.m. - 9:00 a.m.
Questions, Answers, and Discussion

9:00 a.m. - 9:45 a.m. Sedation Challenges in the PICU
Amanda Thompson, PharmD, BCPS, Clinical Specialist, Pediatric Critical Care & Pediatrics, Medical University of South Carolina, Charleston

17-Nov-11 1:00 PM

Highlighting Member Publications: Emily Gish, PharmD

Wed, 21 Sep 2011 17:00:00 GMT

The PPAG Research Committee will be highlighting recent articles published by PPAG members in various peer-reviewed Journals. In this article the Committee discusses Dr. Emily Gish's dosing evaluation of intravenous fentanyl infusion in overweight children. The complete citation:

Gish EC, Harrison D, Gormley AK, Johnson PN. Dosing evaluation of continuous intravenous fentanyl infusion in overweight children: A pilot study. Journal of Pediatric Pharmacology and Therapeutics 2011;16(1):39-46.

Emily C. Gish is a clinical pharmacist at Primary Children’s Medical Center in Salt Lake City, Utah. She works primarily in the pediatric and cardiac intensive care units, but also provides pharmacy services to a dedicated unit for neurology, neurosurgery and trauma patients. She is an alumna of Washington State University, where she received her Bachelor of Science in Biological Sciences in 2006 and her Doctor of Pharmacy in 2008. Following graduation, Dr. Gish completed two years of residency training at the University of Oklahoma Health Sciences Center with a PGY2 Pediatric Residency under the tutelage of Tracy M. Hagemann, Pharm.D., FCCP.

Practicing in an area with a high incidence of pediatric obesity, Dr. Gish and colleagues developed a research question regarding the dosing of lipophilic medications in this patient population. During her post-graduate year one residency, Dr. Gish completed her research project entitled “Dosing evaluation of continuous intravenous fentanyl infusions in overweight children: a pilot study” which was published in the most recent issue of the Journal of Pediatric Pharmacology and Therapeutics. This study investigates the appropriateness of utilizing weight-based dosing of fentanyl for sedation and analgesia administered as a continuous infusion in overweight and obese children.

This study retrospectively identified 15 overweight and obese and 16 normal-weight children who received fentanyl via continuous infusion for at least 4 days. No significant difference was found in the number of dosage changes per day between groups. There was a numerical increase in the amount of “as needed” sedative and analgesic bolus doses given per day to the obese and overweight patients versus the normal-weight control group. With the small sample size of the study, one cannot discern the exact dosing requirements for overweight and obese children. Larger studies are needed to identify if certain variables indicate that larger doses of fentanyl would be required to maintain adequate sedation in overweight and obese children.

21-Sep-11 12:00 PM

NICHD to host Pediatric Formulations Initiative Workshop

Wed, 21 Sep 2011 17:00:00 GMT

2011 Pediatric Formulations Initiative Workshop

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) would like to invite you to participate in the 2011 Pediatric Formulations Initiative (PFI) Workshop which is taking place on November 1–2, 2011 in Potomac, MD.

This workshop will address scientific, regulatory, and economic barriers to the development of pediatric formulations, current gaps in knowledge, and new technology by bringing together researchers and experts to discuss issues and challenges and find ways to stimulate further research in the field.

For the workshop agenda, click here.

Meeting Registration and Hotel Reservations

Please visit the workshop Web site to register and view logistics information. Your registration type for the Web site is “General participant.”

Hotel reservations at the Bolger Center can also be secured via the workshop Web site at the rate of $169 plus 13 percent tax for a single/double room. All room charges will be at the expense of your organization. No reimbursement will be offered by the NICHD.

YOU MUST GUARANTEE YOUR FIRST NIGHT ARRIVAL. We do not charge your credit card unless you do not arrive on the night indicated and do not inform Circle in advance of your change in plans.

If you need to change your hotel reservation after you have reserved your room online, please contact Brandy Weathersby at PFIworkshop@circlesolutions.com, 703-738-4921 no later than Friday, October, 7. Please do not contact the hotel directly.

Travel Reservations

Please work with your organization to make your own travel arrangements based on the meeting start and end times. All airline and ground transportation costs will be at the expense of your organization. The NICHD will not provide reimbursement for travel expenses or meals and incidental expenses (M&IE).

Please register before Friday, October 7. We look forward to seeing you in November!

GO TO WORKSHOP WEB SITE

21-Sep-11 12:00 PM

FDA Center for Drug Evaluation and Research Hosting Drug Shortage Workshop

Kathy Pharm - noemail@ppag.org — Mon, 22 Aug 2011 19:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and Research (CDER) to address drug shortages. PPAG encourages members to attend the workshop, if available.

This public workshop is intended to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons about the causes and impact of drug shortages and possible strategies for preventing or mitigating drug shortages. The input from this public workshop will help to develop topics for further discussion with industry, professional societies, and other stakeholders and may help the Agency better address drug shortage issues.

DATE: September 26, 2011
TIME: 8:30 a.m. to 4:30 p.m.
LOCATION: 10903 New Hampshire Ave., Bldg. 31, rm. 1503 B and C (Great Room), Silver Spring, MD 20993
REGISTRATION: To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to dsworkshop@fda.hhs.gov by September 19, 2011.

For the announcement in the Federal Register, please click here.

Registration is free for the public workshop. Seating will be available on a first-come, first-served basis.

22-Aug-11 2:00 PM

Adverse Drug Events Drop 42% at Children's Hospitals, Study Finds

Matthew Helms - noemail@ppag.org — Tue, 16 Aug 2011 17:15:00 GMT

According to a study published in Pediatrics, adverse drug events (ADE) dropped 42% in one year at children's hospitals that participated in an ADE collaborative. There was a 51% drop in opioid-related ADEs.

Thirteen free-standing children's hospitals participated in the collaborative targeting the medication delivery system. Collaborative-developed interventions focused on standardizing medication orders, medication dispensing, improving the patient safety culture, and providing clinical decision support.

For more information, please see the complete abstract at:

http://pediatrics.aappublications.org/content/early/2011/06/29/peds.2010-3772.abstract

16-Aug-11 12:15 PM

Survey: Use of Direct Thrombin Inhibitors in Pediatrics

Alex Oschman - noemail@ppag.org — Tue, 16 Aug 2011 14:30:00 GMT

Even though venous thromboemoblisms (VTE) are thought to occur rarely in the pediatric population, there are situations where use of newer anticoagulants such as the direct thrombin inhibitors (DTI’s: argatroban, bivalirudin, or lepriudin) may be necessary. Unfortunately, there is a lack of data to help us direct our use as well as dosing for direct thrombin inhibitors in pediatrics.

This survey is the first step in a more extensive project which is being supported by PPAG’s Research Committee. The research committee has a goal of providing an infrastructure to complete multi-center data collection and research. This survey will help us gain a better understanding of the use of DTI’s across the United States. With the results of the survey, we hope to develop a multi-institutional dose finding study for direct thrombin inhibitors in pediatric patients. This survey has received institutional review board approval and the results will be used to design a multicenter prospective study regarding DTI use in pediatrics.

The survey should take approximately 15-20 minutes to complete depending on the use of DTI’s at your institution. We appreciate your time and effort in helping us to improve medication use in pediatrics.

To participate in the survey, please direct your browser to: http://www.surveymonkey.com/s/XNM6SNZ

16-Aug-11 9:30 AM

PPAG is Accepting Applications for Neonatal Small Grants

Matthew Helms - noemail@ppag.org — Mon, 15 Aug 2011 15:45:00 GMT

Application Deadline: September 15, 2011

PPAG is pleased to announce a funding opportunity for pharmacy resident/fellow research in the area of neonatology.

The Neonatal Pharmacy Resident/Fellow Research Grant supports research in neonatal medication use conducted by pharmacy residents (e.g., PGY-1, PGY-2 pediatric pharmacy resident) and fellows. The primary purpose of the research award is to improve safe and effective use of medications in neonates. Research projects can comprise a wide range of medication-use topics, including but not limited to: technology, safety, and/or pharmacotherapy. A secondary goal of the program is to develop and strengthen the skills of pharmacy residents and fellows by fostering development of mentoring relationships with more experienced senior investigators.

To learn more about the program and eligibility requirements, please go to the following website: http://www.ppag.org/neonatalgrant/.

15-Aug-11 10:45 AM

In Memoriam - Dr. Sumner J. Yaffe

Matthew Helms - noemail@ppag.org — Thu, 11 Aug 2011 20:00:00 GMT

It is with great sadness that we announce the death of Dr. Sumner J. Yaffe. He died on August 10, 2011 at the age of 88.

May 9, 1923 – August 10, 2011

Dr. Yaffe was born in Boston, graduated from Boston Latin School, and Harvard College (with an interruption during World War II to serve in the Armed Forces). He received his BA in chemistry, then pursued an MA in Pharmacology at Harvard, and finally his MD from the University of Vermont. He returned to Harvard to complete his pediatric training at Children's Hospital in Boston. After a Fullbright Scholarship at St. Mary's Hospital in London, and a fellowship in metabolism at Harvard, he joined the faculty at Stanford University as Director of the Clinical Research Center for Premature Infants. It is here that his interest in neonatal pharmacology grew. In 1963, he moved to SUNY Buffalo as Professor of Pediatrics and Adjunct Professor of Biochemical Pharmacology. In 1975, he moved to the Children's Hospital of Philadelphia to establish the first Division of Pediatric Clinical Pharmacology.

During his distinguished academic career, he published upwards of 300 scientific articles and books dealing with a wide range of developmental science. His work included studies on the ontogeny of drug metabolizing enzymes, including effects of malnutrition, vitamins, protein intake, and drugs on drug metabolism in the developing fetus and child, bilirubin metabolism, and the excretion of drugs in breast milk. He inspired and mentored countless young pediatric investigators who owe much of their career directions to his teaching.

In 1980, Dr. Yaffe took the position as Director of the Center for Research for Mothers and Children at the National Institute of Child Health and Human Development. During his 20 years at NICHD, Dr. Yaffe's vision for improved pharmacotherapy for children came to fruition. He tirelessly pursued an agenda for increased research in diseases of childhood. He fostered the development of research networks including a neonatal and fetal/maternal medicine network, and most crucial to pediatric and developmental pharmacology, the Pediatric Pharmacology Research Units.

Dr. Yaffe's vision of improved therapy for sick children has become a reality. He inspired an entire generation of pediatric clinical pharmacologists to grow the field into a mature and evolving scientific discipline. The Pediatric Pharmacy Advocacy Group named its lifetime achievement award in pediatric pharmacology and therapeutics after him. More about the Yaffe Award.

In 2002 he gave an address to the members of the PPAG upon receiving the 1st Annual Yaffe Award titled, "Pediatric Pharmacology: Its time has come." You can view the article here.

The family requests that tributes be sent to the Sumner J. Yaffe Scholarship at the University of Vermont College of Medicine at https://alumni.uvm.edu/giving/com/default.asp.

11-Aug-11 3:00 PM