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Red Book® Online News & Features
Red Book Online subscribers can stay up-to-date with important news and features such as
- Status of Licensure and Recommendations for New Vaccines – New
- Breaking News—Red Book Online Special Alerts (including archives)
♦ Special Alert: Errata to 2009 Red Book Posted 1/13/10
The American Academy of Pediatrics posted the following important errata for the 2009 edition of Red Book.
- Section 3, Pneumocystis jirovecii Infections – Treatment: In the first paragraph, second sentence (page 539 [carried over from the heading Chemoprophylaxis on page 538]), a portion of the text should be changed from “and 1 performed at 24 months of age or older” to “and 1 performed at 4 months of age or older.”
- Section 4, Drugs for Parasitic Infections – Table 4.9 (Pneumocystis jiroveci): The pediatric dosage for atovaquone (page 804) for children over 24 months should be changed from “>24mos: 30 mg/d PO x 21d” to “>24mos: 30 mg/kg/d PO x 21d.”
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2009 Red Book Errata ♦ Special Alert: 2010 Childhood and Adolescent Immunization Schedules Released Posted 1/4/10
The annual recommended immunization schedules for children and adolescents in the United States for 2010 were approved by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians. There are three immunization schedules: 0 to 6 years of age, 7 to 18 years of age, and a catch-up immunization schedule for those who start late or fall behind. Included are updated recommendations for meningococcal, poliovirus and HPV vaccines, as well as a reference to the current recommendations for use of the 2009 H1N1 influenza vaccine.
Links to these new immunization schedules can be found on the home page of Red Book Online.
2010 Immunization Schedule for Ages 0-6 [PDF]
2010 Immunization Schedule for Ages 7-18 [PDF]
2010 Catch-up Immunization Schedule [PDF]
♦ Special Alert: H1N1 FluMist Recall Posted 12/23/09
MedImmune is conducting a non-safety-related voluntary recall of 13 lots of monovalent 2009 (H1N1) nasal spray vaccine, representing 4.7 million doses. Routine testing found the potency had fallen below a pre-specified limit or was at risk of falling below that limit in the next week. This slight decrease in vaccine potency is not expected to have an impact on the protective response to vaccination. Therefore, there is no need to recall patients who received doses of vaccine from the recalled lots, and extra doses of vaccine are not required. There are no safety concerns with these lots of 2009 H1N1 vaccine. All lots successfully passed prerelease testing for purity, potency and safety. However, because their potency is now or might soon be below the specified lower limit, MedImmune will send providers directions for returning any unused vaccine from these lots.
Since most lots were shipped in October and early November, it is likely most of the vaccine was used while it was still within specified potency. The CDC has prepared a fact sheet on this recall.
The affected lot numbers are:
500751P
500754P
500756P
500757P
500758P
500759P
500760P
500761P
500762P
500763P
500764P
500765P
500776P
Additional information is available from MedImmune:
http://www.medimmune.com/pdf/H1N1_Recall_QandA_122209.pdf
http://www.medimmune.com/pdf/H1N1_Recall_letter_122209.pdf
CDC Fact Sheet on Recall
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: Non-Safety Related Voluntary Recall of H1N1 Vaccine Posted 12/16/09
Sanofi Pasteur is conducting a non-safety-related voluntary recall of 4 lots of monovalent influenza A 2009 H1N1 vaccine because of a small decrease in antigen content found during ongoing testing routinely done after vaccine distribution. This voluntary recall applies only to Sanofi Pasteur's single-dose pediatric vaccine in pre-filled syringes.
According to the CDC, there (1) are no safety concerns with these lots and (2) no need to revaccinate children who have received vaccine from these lots since the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response.
Affected lots:
0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
UT023DA
UT028DA
UT028CB
0.25 mL pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
UT030CA
For more information and questions and answers related to the withdrawn vaccine please visit the CDC Web site.
CDC Web site
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: AAP Reaffirms Children at High Risk for Serious Outcomes from H1N1 Posted 11/4/09
The AAP reaffirms the previous information regarding conditions which place children at highest risk of serious outcomes from H1N1 influenza and are highlighted as follows:
- Neurological disorders and neuromuscular conditions (e.g. muscular dystrophy)
- Chronic respiratory diseases associated with impaired pulmonary function and/or difficulty handling lung secretions (such as asthma)
- Moderate to profound intellectual disability (mental retardation) or developmental delay
- Deficiencies in immune function or immune system conditions that require medications or treatments
- Cardiovascular disease including congenital heart disease
- Significant metabolic (e.g., mitochondrial) or endocrine disorders
- Renal, hepatic, hematological (including sickle cell disease) disorders
- Receiving chronic aspirin therapy
- Pregnancy or up to 2 weeks post-partum regardless of how the pregnancy ended
- Detailed information about high-risk categories from the AAP
- CDC 2009-2010 Algorithm for triage of children (up to 18 years) with influenza-like illness
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: 2009 H1N1 Influenza Vaccine Issues Posted 11/4/09
Due to the novel nature of the 2009 H1N1 strain and its slower than expected growth in culture, the supply of H1N1 vaccine is less than originally anticipated. As a result, practitioners are facing some difficult situations with regard to both H1N1 and seasonal influenza vaccine supply.
The AAP addresses the topic of supply and distribution of the 2009 H1N1 influenza vaccine, as well as intervals, dosing, and administration with other vaccines.
For additional information on the 2009 H1N1 influenza vaccine, click on the following links:
- Information on where to receive the influenza vaccine (seasonal and H1N1)
- CDC state/jurisdiction H1N1 vaccine contact information
- State and county health departments list
- General information on H1N1 vaccine distribution
Go to Red Book text:
Section 1, Sources of Vaccine Information
Section 3, Influenza
♦ Special Alert: Emergency Use of Peramivir Posted 11/4/09
The FDA has granted Emergency Use Authorization for the intravenous influenza antiviral, peramivir to treat hospitalized children with documented or suspected 2009 H1N1 influenza who cannot tolerate the currently licensed oral or inhaled antiviral medications. The FDA has not approved peramivir for routine use in adults or children.
For additional information on the use of peramivir, read the recently published AAP News article.
AAP News Room H1N1 page | Red Book Online Influenza Resource Page
Go to Red Book text:
Section 3, Influenza
Section 4, Antiviral Drugs
♦ Special Alert: Algorithm for Children With Flu-Like Illness Posted 10/20/09
The AAP and the CDC have released a chart, "2009-2010 Influenza Season Triage Algorithm for Children With Influenza-Like Illness" to assist physicians and those under their supervision in identifying indicators of and responses to flu-like symptoms in children. The algorithm can be used regardless of whether or not the child has been vaccinated for influenza.
AAP News Room H1N1 page | Red Book Online Influenza Resource Page
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: New AAP H1N1 Handout on Patient Education Online Posted 10/9/09
To help pediatricians inform parents and patients about the H1N1 virus, the American Academy of Pediatrics (AAP) created the handout “2009 H1N1 Flu (Swine Flu),” which is available on the AAP Web site Patient Education Online. This new handout includes information about the H1N1 virus, including symptoms, when to call the doctor, prevention, and treatment.
For the latest H1N1 information from the AAP and Centers for Disease Control and Prevention (CDC), visit the AAP News Room H1N1 page and the Red Book Online Influenza Resource Page.
2009 H1N1 Flu (Swine Flu) handout
AAP News Room H1N1 page | Red Book Online Influenza Resource Page
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: CDC Recommendations on Recall of Patients for Hib Booster Dose Posted 10/5/09
In the September 18, 2009 Morbidity and Mortality Weekly Report (MMWR), the Centers for Disease Control and Prevention (CDC) updated its June 26, 2009 advisory on Haemophilus influenzae Type b (Hib) booster administration. With the licensure of monovalent Hib vaccine (Hiberix) for the booster dose, CDC recommends that providers begin a recall of all children in need of the booster dose as soon as feasible and when Hib vaccine supply in the office is adequate.
Updated Recommendations for Hib booster dose:
- Infants should receive their primary Hib series at ages 2, 4, 6 months, and a Hib booster dose on time at 12 through 15 months of age.
- Children aged 12 months through 4 years (before fifth birthday) who did not receive a booster dose because of the recent shortage of Hib vaccine should receive a booster with any of the available Hib-containing vaccines at the earliest opportunity.
- With licensure of Hiberix and anticipated distribution, the increased supply of Hib-containing vaccines will be sufficient to support a provider-initiated notification process to contact all children whose Hib booster dose had been deferred.
- Until supplies are adequate, providers should continue to follow previous recommendations to provide the booster dose at the child's next regularly scheduled visit.
Note for your planning purposes: Recent conversation with GSK order desk indicated Hiberix will not be shipped until mid-October 2009.
For more information, see the CDC MMWR for September 18, 2009.
Go to Red Book text:
Section 3, Haemophilus Influenzae Infections
♦ Special Alert: Red Book Associate Editor Receives AAP Award Posted 10/5/09
The American Academy of Pediatrics (AAP) is pleased to announce that Sarah S. Long, MD, FAAP, Associate Editor of the 2006 and 2009 Red Book, received the 2009 AAP Award "Lifetime Contribution to Infectious Diseases Education."
This award recognizes a section member who has devoted lifetime efforts to the postgraduate education of physicians, specifically those who have participated in the education of AAP members.
To view all the 2009 AAP award winners, please visit AAP News.
♦ Special Alert: Potential Medication Errors with Tamiflu for Oral Suspension Posted 9/25/09
Today the U.S. Food and Drug Administration (FDA) alerted prescribers and pharmacists to potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension. U.S. health care providers usually write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45 and 60 mg. The Agency has received reports of errors where dosing instructions for the patient do not match the dosing dispenser.
Health care providers should write doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.
If prescription instructions specify administration using mL, the dosing device accompanying the product should be replaced with a measuring device (e.g., a syringe) calibrated in mL.
Visit the FDA Web site for additional information, including Tamiflu dosing for children over one year of age.
FDA Public Health Alert
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: FDA Licenses Four Vaccines for H1N1 Influenza Virus Posted 9/22/09
On September 15, the U.S. Food and Drug Administration (FDA) announced that it approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.
The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.
In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.
FDA news release
AAP Web Site - Novel Influenza A (H1N1) Virus (Swine Flu) Information for Health Care Professionals
Go to Red Book text:
Section 1, Active Immunization | Section 3, Influenza
♦ Special Alert: Early Release: H1N1 Vaccine Coding Guidance From the AAP Pediatric Coding Newsletter Posted 9/22/09
The October 2009 (Volume 5, Number 1) issue of the AAP Pediatric Coding Newsletter, the monthly peer-reviewed coding and nomenclature newsletter of the American Academy of Pediatrics, includes an important electronic-only article on coding for novel H1N1 influenza (swine flu) immunization services.
The article, "Reporting H1N1 Influenza Immunization Services Provided to Patients Covered Under Commercial Insurance - Updated September 7, 2009," has been posted as an early release on AAP Pediatric Coding Newsletter Online. The article can be found under the "News and Events" column on the left-hand side of the site's home page.
You do not need to be an AAP Pediatric Coding Newsletter subscriber to view this important and timely coding article, though subscribers can log-in for additional comprehensive pediatric coding information from the American Academy of Pediatrics.
Coding article | Subscribe to AAP Pediatric Coding Newsletter
AAP Web Site - Novel Influenza A (H1N1) Virus (Swine Flu) Information for Health Care Professionals
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Appendix III, CPT and ICD-9 Codes for Commonly Administered Pediatric Vaccines/Toxoids and Immune Globulins
♦ Special Alert: Alternatives to Erythromycin Ophthalmic Ointment Posted 9/9/09
A serious national shortage of erythromycin (0.5%) ophthalmic ointment has resulted in some hospitals depleting their supplies of this product and others having only a limited supply. To address this shortage, the Centers for Disease Control and Prevention (CDC) recommended alternate medications to use for prophylaxis of ophthalmia neonatorum when erythromycin ophthalmic ointment is not available. These include azithromycin (1%) ophthalmic solution, gentamicin (0.3%) ophthalmic ointment, or tobramycin (0.3%) ophthalmic ointment. The Food and Drug Administration (FDA) is working to secure additional supplies of erythromycin ophthalmic ointment.
Read the AAP News article on options for obtaining erythromycin eye ointment.
Click on the following links for additional information on the erythromycin (0.5%) ophthalmic ointment shortage:
- FDA statement on the shortage
- CDC recommendations for alternatives to erythromycin ophthalmic ointment in newborns
- CDC guidance on the shortage of erythromycin ophthalmic ointment
Go to Red Book text:
Section 5, Gonococcal Ophthalmia
♦ Special Alert: Erythromycin Eye Ointment Shortage Posted 9/1/09
The recommended prophylaxis for ophthalmia neonatorum, erythromycin (0.5%) ophthalmic ointment, has been identified as being in short supply by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). During the shortage, the following recommendations are made to health care providers to manage supplies:
- Review your supplies of erythromycin eye ointment routinely.
- Reserve current supplies for neonatal prophylactic use only.
- Check with your pharmacies, and make them aware erythromycin ophthalmic ointment should be used only for newborns.
FDA Statement
Go to Red Book text:
Section 5, Gonococcal Ophthalmia
♦ Special Alert: AAP Modifies RSV Recommendations Posted 8/25/09
Passive immunoprophylaxis with the monoclonal antibody palivizumab (SynagisTM) is the only FDA-licensed intervention to reduce the risk of respiratory syncytial virus (RSV) infection in high-risk infants. The American Academy of Pediatrics (AAP) recommends a set of criteria to identify infants who are eligible for prophylaxis. Upon review of recent research, the AAP modified its recommendations to more accurately identify infants most likely to benefit from this expensive intervention. The new policy statement, "Modified Recommendations for the Use of Palivizumab for the Prevention of Respiratory Syncytial Virus Infections," supports the recommendations in the 2009 Red Book and addresses the following issues:
- Refinement of definition of RSV season onset/offset by region and duration of season.
- Number of doses needed for infants of 32 to 35 weeks gestation.
- Risk factors associated with increased hospitalization.
AAP News Article | AAP Policy Statement
Go to Red Book text:
Section 3, Respiratory Syncytial Virus
♦ Special Alert: Polio Vaccine Recommendations Reduce Confusion Posted 8/25/09
Updated recommendations regarding routine poliovirus vaccination have been issued by the CDC's Advisory Committee on Immunization Practices (ACIP) and published in the Aug. 7, 2009 issue of Morbidity and Mortality Weekly Report (MMWR. 2009;58 (30):829-830). The recommendations were updated in part to reduce possible confusion resulting from the introduction of three combination vaccines containing inactivated polio vaccine over the past few years and to modify and clarify the use of the minimal intervals recommended for accelerated vaccination schedules. For more information, read the AAP News article.
AAP News Article
Go to Red Book text:
Section 3, Poliovirus Infections
♦ Special Alert: Vaccine Approved as a Hib Booster Dose Posted 8/24/09
On August 19, 2009, the U.S. Food and Drug Administration (FDA) approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, NC and Philadelphia, PA.
A nationwide shortage of Hib vaccine began in December 2007 due to a voluntary recall by the manufacturer and subsequent production suspension of PedvaxHIB and COMVAX, two of four vaccines licensed in the United States for primary and booster immunization against invasive disease due to Hib. Both PedvaxHIB and COMVAX vaccines are manufactured by Merck & Co. Inc. (Whitehouse Station, NJ).
This shortage resulted in a recommendation by the U.S. Centers for Disease Control and Prevention (CDC) to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored. This deferral was in effect from December 18, 2007 through June 25, 2009.
Although current vaccine supply is sufficient to reinstate the booster dose and begin catch-up vaccination, it is not yet ample enough to support mass vaccination of all children whose boosters were deferred.
The entire article can be viewed on the FDA's Web site.
The Red Book Online Vaccine Status Table has been updated to include Hiberix.
FDA Web site | Vaccine Status Table
Go to Red Book text:
Section 3, Haemophilus Influenzae Infections
♦ Special Alert: CDC Releases New Exclusion Period Guidance for Influenza Posted 8/11/09
New guidance released August 6 from the Centers for Disease Control and Prevention recommends that patients with influenza-like illness should stay away from others for 24 hours after their fever is gone, whether or not antivirals were used. Fever is defined as a temperature of 100° Fahrenheit or 37.8° Celsius or greater. The previous recommendation called for individuals to stay home a full week.
The new exclusion guidance applies to schools, camps, businesses and other community settings, but not to health care settings, where the recommendation continues to advise individuals to remain home for seven days from symptom onset or until 24 hours after resolution of symptoms, whichever is longer.
More stringent guidelines and longer exclusion periods may be made at the community level, however.
Read the complete revised guidance at www.cdc.gov/h1n1flu/guidance/exclusion.htm.
CDC Web site
Go to Red Book text:
Section 3, Influenza
♦ Special Alert: Immunizations: Best Business Practices Module is Live Posted 7/28/09
The "Immunizations: Best Business Practices" PediaLink module is now available to help pediatricians identify effective ways to make immunizations a successful part of the practice. With this PediaLink Essential course, users will learn how to lower office costs through ordering/purchasing vaccines, storing vaccines, calculating office overhead, administering vaccines, coding, and much more. Visit the PediaLink Learning Center to find the course, which is also available for free by registering at http://www.cispimmunize.org/pro/bbpregistration.cfm.
PediaLink Learning Center | Course Registration
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Section 1, Sources of Vaccine Information
♦ Special Alert: FDA Revises Gardasil Labeling Posted 7/21/09
The FDA's Center for Biologics Evaluation and Research has revised the label for the human papillomavirus vaccine Gardasil, which protects against cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. The revised label includes new information in the Warnings and Precautions section noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.
Information on syncope has been in Gardasil's labeling for both health care providers and patients since 2007. However, the FDA and the CDC continue to receive reports of traumatic injuries in individuals who have fainted and fallen after receiving Gardasil. The addition of this information to the Warnings and Precautions section is intended to remind health care providers that Gardasil recipients should be observed closely for 15 minutes after vaccination. The FDA Web site has more information on these label changes.
FDA Web site
Go to Red Book text:
Section 3, Human Papillomaviruses
♦ Special Alert: AAP Releases Influenza Statement for 2009-2010 Posted 7/16/09
The AAP 2009-2010 influenza policy statement, "Recommendations for Prevention and Control of Influenza in Children" is now available. This statement will prepare AAP Membership for the upcoming influenza season which is expected to be complicated by 1) the likely concurrent circulation of Novel influenza A H1N1 (Swine Flu) along with the strains of influenza A and B currently covered by the 2009-10 formulations of trivalent influenza vaccine and 2) the anticipated concurrent circulation of multiple strains of influenza with different antiviral susceptibility patterns.
The statement highlights the current recommendations for routine use of trivalent seasonal influenza vaccines and antiviral medications for the prevention and treatment of influenza in children. Trivalent seasonal influenza vaccines should be offered to all children as soon as vaccine is available, even as early as August or September. Also, because of ongoing circulation of Novel influenza A H1N1 (Swine Flu) in the United States this summer, and the development and possible use of an additional monovalent pandemic influenza vaccine in the 2009-2010 season, the statement also highlights the critical need for providers to be aware of their local and state health department recommendations concerning Novel influenza A H1N1.
Up-to-date information can be found at the CDC H1N1 (Swine Flu) Web site and on the Red Book Online Influenza Resource page. Details regarding novel strain influenza A (H1N1) virus for pediatricians and families will be updated frequently on the AAP Web site.
Influenza Resource Page | AAP Web site - H1N1 Flu (Swine Flu) Information | CDC H1N1 (Swine Flu) Web site
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Section 3, Influenza
♦ Special Alert: Update on Use of Palivizumab Posted 7/6/09
Palivizumab is highly effective for the prevention of respiratory syncytial virus (RSV) infection and the AAP endorses its use for high-risk newborns. Recently, significant concerns have been raised about its use. The AAP and its Committee on Infectious Diseases have again reviewed the available data and have reaffirmed the recommendations for RSV as published in the 2009 Red Book. An upcoming AAP policy statement and commentary will further address this issue.
AAP resources on RSV, including the Red Book chapter, the July 2009 AAP News article, and the summary of changes in recommendations from the previous policy statement, are now posted in the AAP Member Center.
AAP News - July 2009 Issue
Go to Red Book text:
Section 3, Respiratory Syncytial Virus
♦ Special Alert: CDC Reinstates Hib Booster Dose Due to Improving Supply Posted 6/25/09
Due to an improving supply of Haemophilus influenzae type b (Hib) vaccine, the Centers for Disease Control and Prevention (CDC), in consultation with the American Academy of Pediatrics and the American Academy of Family Physicians, reinstated the booster dose of Hib vaccine for all children 12 through 15 months of age on June 25th. Recommendations for reinstatement of Hib booster dose
- Infants should receive their primary Hib series at ages 2, 4 and 6 months, and a Hib booster dose on time at 12 through 15 months of age.
- Older children for whom a Hib booster dose was deferred should receive the Hib booster at the next routinely scheduled visit or medical encounter.
- Mass recall of children for their catch-up Hib booster dose is not recommended at this time because physicians may encounter supply problems during such a massive recall.
Although Merck has not yet returned to market with its Hib-containing vaccines, sanofi pasteur has increased production of monovalent Hib vaccine, PRP-T (ActHIB), and DTaP-IPV/Hib (Pentacel). Enough Hib-containing vaccine is now available for distribution to allow a return to the full dose schedule for all children 12 through 15 months of age and for children 15 through 60 months who come in for routine health services and who did not receive their booster dose. Providers should expect some additional doses of Hib vaccine each month. However, supplies are not yet adequate to support a mass recall of children whose booster dose was delayed.
For more information, see the article in the July 2009 issue of AAP News, in addition to the Morbidity and Mortality Weekly Report (MMWR) dispatch. The MMWR dispatch includes additional recommendations to ensure that eligible patients receive all currently recommended doses of this important immunization.
AAP News - July 2009 Issue | CDC MMWR | Additional Resources
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Section 3, Haemophilus influenzae Infections
♦ Special Alert: New 2009 Edition of Red Book now on Red Book Online Posted 6/18/09
The newly revised and updated Red Book: 2009 Report of the Committee on Infectious Diseases, 28th Edition is now available on Red Book Online. Included in this edition are new and updated sections, chapters, and appendices, updated references to AAP policy recommendations, standardized vaccine abbreviations, and much more. In addition, over 200 new images were added to the Visual Library.
Search the latest findings and clinical guidelines for diagnosis, treatment, and prevention of pediatric infectious diseases.
View a list of the changes in the Summary of Major Changes or the Red Book Spotlight Section on the Red Book Online home page.
♦ Special Alert: Shortage of Acyclovir Posted 3/2/09
Manufacturers of acyclovir for injection have experienced a recent increase in demand, resulting in a national shortage of parenteral acyclovir. The AAP Committee on Infectious Diseases recommends that existing supplies of intravenous acyclovir be conserved to improve availability for neonatal herpes simplex virus (HSV) infections, herpes simplex encephalitis (HSE), and HSV and varicella-zoster virus (VZV) infections in immunocompromised patients, including more ill pregnant women with visceral dissemination of either virus. When parenteral acyclovir is not available, intravenous ganciclovir should be substituted.
Alternative regimens to intravenous acyclovir and alternatives for non-priority conditions are outlined in an exclusive Red Book Online Intravenous Acyclovir Shortage Table at http://aapredbook.org/news/acyclovir.dtl.
The March issue of AAP News addresses the acyclovir shortage.
Red Book Online Intravenous Acyclovir Shortage Table | AAP News
Go to Red Book text:
Section 3, Herpes Simplex
Section 3, Varicella-Zoster Infections
♦ Special Alert: Updated Guidelines for Rotavirus Vaccine Use Posted 3/2/09
Two rotavirus vaccine products are now licensed for use in infants in the United States: RV1 (Rotarix), which was approved in 2008, and RV5 (RotaTeq), which was approved in 2006. The two vaccines differ in composition and dosing schedule. The AAP Committee on Infectious Diseases has revised its rotavirus recommendations to guide pediatricians in administering these vaccines.
See the statement and the article in the March issue of AAP News.
AAP News
Go to Red Book text:
Section 3, Rotavirus Infections
♦ Special Alert: Time to Order Influenza Vaccine for 2009-2010 Season Posted 3/2/09
It is time to order influenza vaccine for the 2009-2010 season. When ordering next season's supply of vaccine, the AAP reminds pediatricians that the current recommendation is to immunize all children aged 6 months through 18 years. Pediatricians should consider partnering with schools and community clinics to fulfill the increased need for flu vaccination. See the article in the March issue of AAP News.
AAP News
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Section 3, Influenza
♦ Special Alert: AAP Posts Statement on Autism Ruling Posted 2/12/09
The American Academy of Pediatrics (AAP) posted a statement on February 12, 2009 acknowledging that autism is a serious condition that has profound effects on a child and the child's family. Further research is needed to better understand the cause of autism spectrum disorders and the most effective treatments. Meanwhile, the AAP is supporting its pediatricians with knowledge about autism screening and current approaches to therapy, through resources such as the Autism Toolkit.
The U.S. Court of Federal Claims today found the scientific evidence is "overwhelmingly contrary" to the theory that MMR vaccine and thimerosal in vaccines is linked to autism. This decision is in keeping with the numerous medical studies that have been performed worldwide. The AAP hopes the determination by the Special Masters will reassure parents that vaccines do not cause autism.
The full reports of the Special Masters are available on the U.S. Court of Federal Claims Web site.
Additional information on this statement is available at the AAP Member Center.
Parent resources:
The Childhood Immunization Schedule: Why is it Like That?
Questions and Answers About Vaccine Ingredients
Immunization information
♦ Special Alert: Data Show HPV4 Vaccine Safe Posted 1/26/09
Data demonstrating the safety of the quadrivalent human papillomavirus vaccine (HPV4) recently were presented to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
A little over two years after licensure of HPV4 and with more than 20 million doses distributed in the United States, no safety issues have been detected through the Vaccine Adverse Event Reporting System (VAERS), a post-licensure study being performed within the CDC’s Vaccine Safety Datalink (VSD) project and a Clinical Immunization Safety Assessment Network (CISA) study of rare neurologic events. However, media reports and misinterpretation of the adverse events submitted to VAERS have caused some parents to become concerned.
Based on an analysis of the current safety and efficacy data, the Academy continues to recommend HPV4 vaccine for all 11- to 12-year-old girls and catch-up immunization of all girls and women 13 through 26 years of age.
Go To Source ♦ Special Alert: Hepatitis A Vaccine Now Available Posted 1/26/09
According to the CDC, Merck & Co had previously experienced production delays that resulted in temporarily not accepting orders for Pediatric and Adult hepatitis A vaccines (Pediatric & Adult VAQTA®). As of December 1, 2008, Merck's Pediatric/Adolescent formulation of hepatitis A vaccine, VAQTA®, is available for ordering. Based on current information, it is estimated that the Adult formulation of VAQTA® will be available in second quarter 2009. GSK production and supply of their Pediatric and Adult hepatitis A vaccine (Pediatric & Adult Havrix®) and their Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) are currently in good supply to meet demand.
Go To Source ♦ Special Alert: Interim Antiviral Therapy Recommendations for Oseltamivir Resistance to H1N1 Influenza A Strains Posted 12/29/08
Early Centers for Disease Control and Prevention (CDC) influenza surveillance data, which indicate growing resistance to oseltamivir (Tamiflu®) by circulating H1N1 influenza A strains isolated so far this year, have led the CDC to issue interim recommendations for the use of antiviral therapy.
The oseltamivir resistant H1N1 strains remain susceptible to zanamivir (Relenza®), an antiviral medicine which can only be used in children 7 years of age and older, and to amantadine/rimantadine.
All H3N2 influenza A strains and influenza B strains analyzed to date are susceptible to both oseltamivir and zanamivir.
More details and interim treatment guidance are provided by the CDC.
Pediatric doses of all influenza antivirals are available in the AAP Policy Statement.
Fortunately, the influenza strains examined to date appear well-matched for this year’s influenza vaccine. This highlights the critically important value in giving influenza vaccine to all children 6 months through 18 years of age and to everyone who lives with, provides care for, or comes in contact with children.
♦ Special Alert: Hib Shortage Update Posted 12/29/08
In December 2007, Merck announced a recall of Hib vaccine and temporarily stopped selling the vaccine in the U.S. market as they changed manufacturing processes. In response to the decrease in vaccine supply, the Centers for Disease Control and Prevention (CDC) and the AAP provided interim recommendations for Hib vaccination. These were to continue the three dose primary series of Hib vaccine but defer the booster dose given at 12 to 15 months because it was unlikely that there would be adequate supplies of vaccine to fully vaccinate all children with four doses of the Hib vaccine. At that time, Merck anticipated returning their vaccine to the market in late 2008.
Now Merck states that they will not return to the Hib vaccine market until mid-2009. At this time, the CDC and the AAP are not changing the interim Hib vaccine recommendations, but will closely monitor the Hib vaccine supply situation and will make appropriate recommendations if the need arises. More information is available through the CDC Web site.
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Section 3, Haemophilus influenzae Infections ♦ Special Alert: Recommendations for Influenza Vaccine, 2008-2009 Posted 12/29/08
The American Academy of Pediatrics (AAP) expanded its recommendations of annual influenza immunization to include all children, both healthy and with high-risk conditions, 6 months through 18 years of age. The recommendations of annual influenza immunization also include household contacts and out-of-home care providers of children with high-risk conditions and healthy children younger than 5 years; any female who will be pregnant during influenza season; and, health care professionals.
The purpose of this policy statement is to update the recommendations for routine use of influenza vaccine in children. To view this policy statement in its entirety, please click here.
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Section 1, Sources of Vaccine Information
♦ Special Alert: Pediatric Luminary Dies at Age 70 Posted 10/3/08
A man known for his broad-reaching contributions to the field of infectious diseases and remembered by colleagues and those he mentored for his warmth, caring and compassion, Ralph D. Feigin, M.D., FAAP, of Houston, died Aug. 14 of lung cancer at age 70. Dr. Feigin was a lifetime nonsmoker.
Dr. Feigin was looking forward to assuming the role of editor of Pediatrics on Jan. 1. He served as the journal’s associate editor for 14 years (1994-’08). He also was author or co-author of 15 books, including six editions of the Textbook of Pediatric Infectious Diseases, was co-editor of Oski’s Pediatrics: Principles and Practice and editor of UpToDate in Pediatrics, among other scholarly publications. He published more than 500 articles. His research uncovered a better understanding of diseases such as bacterial meningitis, leptospirosis, osteomyelitis, septic arthritis and measles.
Go To Source ♦ Special Alert: HPV Vaccine: AAP Update Posted 7/23/08
Rumors have begun to circulate about the safety of Gardasil® human papillomavirus (HPV) vaccine based on a news story about adverse events being reported. Most adverse events following administration of a vaccine are mild and self limited and include pain and redness at the injection site.
Based on the risk/benefit profile of HPV vaccine, the American Academy of Pediatrics continues to recommend routine HPV vaccination for 11-12 year old girls and catch up vaccination for 13-18 year old girls. As with any vaccine, continuous monitoring for and review of adverse events that occur after HPV vaccine administration, with follow-up as necessary, will assure that our HPV vaccine program is as safe as possible. This monitoring includes physician and parent reports to the VAERS system.
Centers for Disease Control and Prevention and Food and Drug Administration are conducting an ongoing study of VAERS reports describing adverse events following Gardasil.
The CDC-FDA information on Gardasil safety is now posted on the Immunization Safety and FDA CBER Web sites.
Additional information for providers and parents about HPV, HPV vaccine and a summary of Gardasil reports to VAERS can be found at the following websites:
CDC: HPV Vaccination page
CDC: HPV vaccine safety Q and A’s for the public.
CDC: HPV vaccine Q and A for public
Summary of Gardasil reports to VAERS
Go to HPV in Red Book Online.
♦ Special Alert: Measles outbreaks in the United States: Public health preparedness, control and response in healthcare settings and the community Posted 4/16/08
The CDC issued a Health Advisory on April 2, 2008 regarding a measles outbreak in Arizona that was linked to an importation from Switzerland. The first case, with rash onset on February 12, 2008, occurred in an adult visitor from Switzerland who was hospitalized with measles and pneumonia. Through March 31, 2008, nine confirmed cases were reported to the Arizona Department of Health Services.
For the entire health advisory, please click on the CDC link below.
CDC Link
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Section 3, Measles
♦ Special Alert: Hib Booster Doses Suspended Due to Shortage of Hib Vaccines Posted 12/20/07
The recent suspension of production by Merck & Co., Inc. of PedvaxHIB® and COMVAX® and Merck's subsequent voluntary recall of certain lots of both vaccines on December 13th have led to a significant disruption in the supply of Haemophilus influenzae type b (Hib) containing vaccines. The Centers for Disease Control and Prevention (CDC) is making some Hib vaccine available from its stockpile and sanofi pasteur is increasing production of its licensed Hib vaccine, ActHIB®, to attempt to meet the current demand for Hib vaccine in the United States. However, a significant temporary shortage of Hib containing vaccines is now expected. AAP has been working with the CDC and other stakeholders to develop an interim strategy to best meet the needs of children during the shortage. A CDC Dispatch published today in Morbidity and Mortality Weekly Report provides additional details on the expected shortage and interim recommendations.
In brief, recommendations include:
- Temporary deferral of the routine Hib vaccine booster dose administered at 12-15 months of age except for children who are at increased risk for invasive Hib disease, as described below. A register and tracking system should be developed to facilitate recalling these children when vaccine supply improves.
- Children at increased risk for invasive Hib disease should continue to receive the recommended booster dose of Hib vaccine at 12-15 months of age. Children at increased risk include: American Indian and Alaskan Native children (AI/AN), and children with sickle cell disease, HIV infection, anatomic or functional asplenia, malignancies or other immunocompromising conditions. Any Hib containing vaccine licensed for use at 12-15 months of age (PedvaxHIB®, ActHIB® or TriHIBit®) can be administered. TriHIBit® is only licensed to be administered at the 12-15 month of age visit.
- The primary series for all children should be completed on schedule with 2 doses of a PRP-OMP containing Hib conjugate vaccine (PedvaxHIB® or COMVAX®) given at 2 and 4 months of age or 3 doses of a PRP-T containing conjugate vaccine (ActHIB®) given at 2, 4 and 6 months of age.
- Hib vaccines are considered interchangeable for primary immunization. Therefore, either vaccine can be used to complete the primary series. However, if only one of the two first doses given at 2 and 4 months of age was a PRP-OMP containing vaccine, a total of three doses of Hib containing vaccine is needed to complete the primary series.
- Physicians who serve predominantly AI/AN populations should attempt to give a PRP-OMP containing vaccine as the first dose because of the high risk of invasive Hib disease at an early age in this population and the more rapid protective antibody response seen with PRP-OMP. The CDC will prioritize distribution of remaining stocks of PRP-OMP containing vaccines for use in AI/AN children living in predominantly AI/AN communities.
- The appropriate number and timing of doses of Hib vaccine for children who are behind schedule is available in the 2006 Red Book (pages 28-32) and online at Red Book Online.
- All isolates of H. influenzae from sterile sites should be serotyped and cases promptly reported to your state health department.
- To allow maximum distribution of available Hib vaccine, physicians should order only the number of doses of vaccine required to meet their needs for the next 4 weeks.
CDC Link
♦ Special Alert: CDC Updates Recommendations for Treatment of Gonococcal Infections Posted 4/25/07
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Section 3, Haemophilus influenzae Infections
The Centers for Disease Control and Prevention (CDC) has updated its sexually transmitted diseases treatment guidelines and "no longer recommends the use of fluoroquinolones for the treatment of gonococcal infections and associated conditions such as pelvic inflammatory disease (PID)." Click here for the full MMWR article.CDC Link
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Section 3, Gonococcal Infections
Section 3, Pelvic Inflammatory Disease
♦ Special Alert: AAP Recommends Universal Immunization for Hepatitis A Posted 4/11/07
In a new 2007 policy statement, the American Academy of Pediatrics has recommended that all children should receive hepatitis A vaccine at 1 year of age (12–23 months) as a 2-dose regimen. The 2-dose series should be administered at least 6 months apart.AAP Policy Statement (PDF) | Red Book Online Vaccine Status Table
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Section 3, Hepatitis A
♦ Special Alert: Two Doses of Varicella Vaccine Now Recommended By AAP Posted 4/11/07
In a new 2007 policy statement, the American Academy of Pediatrics has published its recommendation of a 2-dose varicella immunization strategy. Children 12 months through 12 years of age should receive two 0.5 ml doses of varicella vaccine, separated by at least 3 months. Children 13 years of age or older without evidence of immunity, should receive two 0.5 ml doses of varicella vaccine separated by at least 28 days.AAP Policy Statement (PDF) | Red Book Online Vaccine Status Table
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Section 3, Varicella-Zoster Infections
See all Red Book Online news stories - Section 3, Pneumocystis jirovecii Infections – Treatment: In the first paragraph, second sentence (page 539 [carried over from the heading Chemoprophylaxis on page 538]), a portion of the text should be changed from “and 1 performed at 24 months of age or older” to “and 1 performed at 4 months of age or older.”
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