Promethazine Prescribing Patterns in Pediatric Inpatients Younger Than Two Years Before and After the Product Black Box Warning

Kessler, Tiffany L.; Harrison, Donald L.; Hagemann, Tracy M.
May 2010
Hospital Pharmacy;May2010, Vol. 45 Issue 5, p389
Academic Journal
Purpose: A black box warning was added to promethazine's labeling in November 2004 related to reports of respiratory depression in children younger than 2 years. The objective of this study was to determine what effect the changes in product labeling had on prescribing practices for promethazine at a pediatric hospital 1 year before (2004), 1 year immediately after (2005), and 2 years after (2006). Methods: A retrospective chart review of orders for promethazine in pediatric inpatients (2 years and younger) admitted between 2004 and 2006 was conducted. Information collected included patient demographics and specifics about orders for promethazine (dose in mg/kg, route, indication, and number of as-needed doses received). Results: A total of 255 orders for promethazine met study criteria. Though the number of promethazine orders decreased each year, there was no significant difference in promethazine use observed between 2004 and 2005 (P = 0.223). However, a significant decrease in promethazine use occurred between 2005 and 2006 (P = 0.017), a full year after the initial black box warning was released. Conclusion: The black box warning has affected the prescribing patterns at a pediatric institution, causing a decrease in promethazine use. The response to the warning was slow for some services, which indicates a need for better communication and dissemination of prescribing information to medical staff and health care professionals.


Related Articles

  • Evaluating the off-label use of medications in children. Eiland, Lea S.; Knight, Patrice // American Journal of Health-System Pharmacy;6/1/2006, Vol. 63 Issue 11, p1062 

    The article presents the study that evaluates the frequency of off-label medication use in a general pediatric population admitted to the hospitals in the U.S. It was shown that only one third of medications were prescribed for off-label use in children admitted to a pediatric teaching service....

  • Promethazine.  // AHFS Consumer Medication Information;Oct2017, p1 

    Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma...

  • Prescription of respiratory medication without an asthma diagnosis in children: a population based study. Zuidgeest, Mira G. P.; van Dijk, Liset; Smit, Henriette A.; van der Wouden, Johannes C.; Brunekreef, Bert; Leufkens, Hubert G. M.; Bracke, Madelon // BMC Health Services Research;2008, Vol. 8, Special section p1 

    Background: In pre-school children a diagnosis of asthma is not easily made and only a minority of wheezing children will develop persistent atopic asthma. According to the general consensus a diagnosis of asthma becomes more certain with increasing age. Therefore the congruence between asthma...

  • Off label prescribing to children in primary care in Germany: restrospective cohort study. Bucheler, Reinhild; Schwab, Matthias; Morike, Klaus; Kalchthaler, Bernhard; Mohr, Hartmut; Schroder, Helmut; Schwoerer, Peter; Gleiter, Christoph H // BMJ: British Medical Journal (International Edition);6/1/2002, Vol. 324 Issue 7349, p1311 

    Analyzes the extent of prescribing off labelled products in a representative cohort of children in primary care in Germany. Patients, methods, and results; Finding that 13.2 percent of prescriptions were off label; Suggestion that efforts to improve the quality of pharmacotherapy in children...

  • Off label prescribing in children. Banner Jr, William // BMJ: British Medical Journal (International Edition);6/1/2002, Vol. 324 Issue 7349, p1290 

    Editorial. Refers to three studies in this issue about the problem of off label prescribing in children, which means drugs being used in populations or disease states not listed as indicated in the package insert. Details of how the U.S. Food and Drug Administration deals with this problem;...

  • Unlicensed and off label drug use by children in the community: cross sectional study. Schirm, Eric; Tobi, Hilde; de Jong-van den Berg, Lolkje T W // BMJ: British Medical Journal (International Edition);6/1/2002, Vol. 324 Issue 7349, p1312 

    Determines the number of prescriptions for unlicensed drugs for children and investigates pediatric labelling of all drugs with a product license to determine the extent of off label use in the Netherlands. Participants, methods, and results; Indication that many licensed drugs are poorly...

  • TYPICAL ENTRY.  // Monthly Prescribing Reference;Jan2011, Vol. 27 Issue 1, p233 

    The article offers information on various key labels in prescription products including the brand name, pharmacologic or chemical class, and legal category.

  • Utilisation and Off-Label Prescriptions of Respiratory Drugs in Children. Schmiedl, Sven; Fischer, Rainald; Ibáñez, Luisa; Fortuny, Joan; Klungel, Olaf H.; Reynolds, Robert; Gerlach, Roman; Tauscher, Martin; Thürmann, Petra; Hasford, Joerg; Rottenkolber, Marietta // PLoS ONE;Sep2014, Vol. 9 Issue 9, p1 

    Respiratory drugs are widely used in children to treat labeled and non-labeled indications but only some data are available quantifying comprehensively off-label usage. Thus, we aim to analyse drug utilisation and off-label prescribing of respiratory drugs focusing on age- and indication-related...

  • TREATMENT OF RECURRENT RESPIRATORY PAPILLOMATOSIS IN CHILDREN WITH THE MICRODEBRIDER. Rowe, Mark; Patel, Nalin; Tunkel, David // Annals of Otology, Rhinology & Laryngology;Jan2003, Vol. 112 Issue 1, p7 

    The mainstay of treatment of children with recurrent respiratory papillomatosis has been CO[sub 2] laser laryngoscopy. Powered microdebriders allow precise removal of laryngeal lesions without thermal damage. The microdebrider may reduce costs by reducing operative time and limiting the need for...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics