oa SA Pharmaceutical Journal - Consumer information about the nontherapeutic use of aspirin in South African children : a public health challenge : original research
|Article Title||Consumer information about the nontherapeutic use of aspirin in South African children : a public health challenge : original research|
|© Publisher:||Medpharm Publications|
|Journal||SA Pharmaceutical Journal|
|Affiliations||1 University of Cape Town|
|Publication Date||Nov 2012|
|Pages||35 - 42|
|Keyword(s)||Aspirin, Children, Labelling, Patient information and Reye's syndrome|
Objective : Aspirin should not be given to children, except for specific therapeutic purposes. A 2007-2008 study found that some South African children had received aspirin inappropriately. This study aimed to determine whether over-the-counter (OTC) aspirin-containing products provided caregivers with appropriate information about the risks of aspirin in children, and based on the findings, to make appropriate recommendations about this information to the Medicines Control Council (MCC).
Design and setting : All available OTC aspirin-containing products in two supermarkets were purchased in 2007 and 2011. Patient information on the use of aspirin in children was documented and compared with the standards that are required by the MCC and regulatory authorities in Europe, Australia and the USA. Pertinent information in the South African Medicines Formulary (SAMF) and the Monthly Index of Medical Specialities (MIMS) was reviewed.
Results : The information on the products' packaging was inadequate or inappropriate in all instances, with one exception; there was inconsistency between products; the presentation of the information in the leaflets did not always meet local and international standards; and only one product contained a patient information leaflet. Age-specific dosages for some products in the MIMS were inconsistent with statements in the SAMF.
Conclusion : The content and presentation of the information on the survey products were unsatisfactory. The MCC should review consumer information on aspirin usage, and particularly age-specific dosages in children and teenagers with respect to these products. This information should meet that of its own, as well as the SAMF and international standards. There should be an enforced requirement that patient information leaflets are included with aspirin-containing products.
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