Study: Misunderstanding of OTC cold product directions common
ELK GROVE VILLAGE, Ill. A study published Tuesday on the journal Pediatrics’ Web site determined that misunderstanding of dosage directions for pediatric over-the-counter cold products is common and could result in harm if medications are not given appropriately.
Researchers, however, used “old” kids cough-cold labeling as part of the study — labeling that advises parents to “consult a physician” in children under the age of 2. Today, kids’ cough-cold medicines advise parents to “not use” any cough-cold product in children under the age of 2; the industry voluntarily removed all products carrying the previous label recommendation from store shelves in fall 2007. And in January 2008, the Food and Drug Administration made it official — no kids’ cough-cold product could be marketed to children under the age of 2.
“While this study focuses on products that are not available, it does shine light on an issue that is still very germane,” commented Heinz Schneider, VP science and medical affairs, Consumer Healthcare Products Association. “In contrast to the artificial scenario created by the study authors who asked a small cohort of caregivers to look only at the front of product packages to determine appropriate use, the makers of OTC medicines want to remind parents to read the entire label before giving any medicine to a child. There is no substitute for reading and following the OTC Drug Facts label. The label provides specific dosing instructions, including when to contact a doctor for more information.”
Researchers interviewed 182 caregivers of infants of less than 1 year in age; 87% were the infants’ mother, the mean education level was 12.5 years and 99% had adequate literacy skills, though only 17% had greater than 9th-grade mathematical skills.
When examining the front of the product label, 86% of the time parents thought these products were appropriate for use in children less than 2 years of age. More than 50% of the time, parents stated they would give these OTC products to a 13-month-old child with cold symptoms. Caregivers were influenced by the dosing directions only 47% of the time.
HHS partners with Ad Council, Sesame Workshop to develop PSAs on H1N1
WASHINGTON Health and Human Services secretary Kathleen Sebelius on Friday announced that HHS is joining the Ad Council and Sesame Workshop, the nonprofit educational organization behind “Sesame Street,” to launch a national public-service advertising campaign designed to encourage American families and children to take steps to protect themselves from the 2009 H1N1 flu virus.
“Since the outbreak of the H1N1 flu, many Americans have expressed concern about how they can protect themselves from being infected,” stated Peggy Conlon, president and CEO of the Ad Council. “We are proud to continue our longstanding partnership with the Department of Health and Human Services for this critical campaign that will educate parents and children about how to stay healthy. We are also grateful to Sesame Workshop for providing their resources and talent for the PSAs.”
As part of HHS and the Ad Council’s campaign, Sesame Workshop produced a television PSA featuring “Sesame Street’s” Elmo and Gordon explaining the importance of such healthy habits as washing your hands, avoid touching your eyes, nose and mouth, and sneezing into the bend of your arm.
The campaign was unveiled Friday morning by Sebelius at the HHS/Department of Education Childcare Center in Washington, D.C. The PSAs will be distributed nationwide and will be supported in airtime donated by television stations.
The new PSA campaign focuses on the importance of providing parents, teachers and children with accurate information about how to practice healthy habits, highlighting proper hand-washing and simple everyday actions that lead to staying healthy and keeping germs away. Created by Sesame Workshop, the television PSAs encourage audiences to visit www.cdc.gov to get more information on how to stay healthy. The PSAs are an extension of Sesame’s Healthy Habits for Life initiative, which helps young children and their caregivers establish an early foundation of healthy habits.
The Ad Council will be distributing the PSAs via satellite to television stations nationwide.
Sanofi Pasteur announces U.S. government order of H1N1 vaccine
SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Monday announced it has received the first of what is expected to be a series of orders from the U.S. Department of Health and Human Services to commence production of a vaccine to help protect against the novel H1N1 influenza virus. The order is in the amount of $190 million.
“This initial order for A(H1N1) vaccine received [today] under our existing contract is part of a major effort by Sanofi Pasteur to support global public health efforts to prepare the world for the possibility of an influenza pandemic,” stated Wayne Pisano, president and CEO of Sanofi Pasteur. “Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side. Previously, we developed and licensed the first pre-pandemic vaccine for H5N1, and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1).”
The dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials, which could begin as early as August, the company stated. Final formulation, filling and distribution of the vaccine also have not been established at this time.
Sanofi Pasteur is awaiting receipt of the seed virus to be used for vaccine production from the Centers for Disease Control and Prevention, which could be delivered as early as the end of May, according to a CDC press conference held Friday.
Sanofi Pasteur is prepared to commence commercial scale production in June following certification of the working seed by the Food and Drug Administration. The company currently estimates it will have the first bulk concentrate vaccine in a few months. However, the company will be better able to determine the timing once the seed virus is received and development of working seed is underway.