S17: Assessing the Safety of Pediatric CAM

Sunita Vohra1, Denise Adams2, Paula Gardiner3, Trish Dryden4

1University of Alberta, Edmonton, Alberta, Canada; 2University of Alberta, Edmonton, Alberta, Canada; 3Boston Unviersity Medical Center, Boston, MA, USA; 4Centennial College, Toronto, Ontario, Canada


Pediatric use of complementary and alternative medicine (CAM) is common, and offers numerous research questions about diverse therapies and conditions. Although research priorities for CAM have been identified, they have not specifically focused on pediatric populations. Building on previous work, the PedCAM Network initiated an international consensus-based Delphi process to develop a pediatric CAM research agenda. Safety was consistently rated as the first priority among respondents.     Data on safety can be collected prospectively or retrospectively. Prospective data collection includes passive and active surveillance. Passive surveillance primarily refers to spontaneous (voluntary) reporting of events by health professionals or consumers. Like drug-related adverse events (AEs), natural health product (NHP) AEs are typically monitored by the relevant national regulatory agency through a passive surveillance system that is entirely based on voluntary reporting. This method may bring to light new or rare AEs, but there are serious concerns with its use, including under-reporting and poor quality reports. Spontaneous reporting depends on many factors including media attention and indications for use of product. Passive surveillance cannot estimate the incidence of AEs because it does not provide reliable numerator data (due to under-reporting of numbers of AEs) or any accurate denominator (number of people exposed to NHPs). Active surveillance “seeks to ascertain completely the number of adverse events via a continuous pre-organized process”. This can be done with sentinel sites, event monitoring, or registries. Compared to passive surveillance, active surveillance provides increased rates of reporting, with more comprehensive and better quality reports. The examples we will use to illustrate these issues will be based on NHP-drug interactions and spinal manipulation therapy.    Retrospective data collection includes systematic review of studies about harm. We will discuss the current standards of harms reporting and present novel work to improve synthesis of safety information. The examples we will use to illustrate these issues will be NHPs, spinal manipulation therapy, massage therapy, and acupuncture in children.  Finally, the symposium will conclude with a participant discussion moderated by Trish Dryden, a Steering Committee member of the PedCAM Network and a CAM provider with extensive experience in research and education.