Evaluation of the Patient Information Leaflets (PIL) of drugs marketed in Cameroon
Journal Title: IOSR Journal of Humanities and Social Science - Year 2018, Vol 23, Issue 5
Abstract
In the last five decades, cases of serious adverse effects, toxicity, controversial management or regulation of medicines have raised and increased the public’s need of appropriate risk communication. As it became widely known that there is no medicine without risk, people increasingly wish to know more about medicines they receive [1,2]. Patient Information Leaflet (PIL) is related to a written and comprehensible information providedby Marketing Authorization Holder (MAH) in order to guarantee an appropriate and safe use of the product by patients [6, 7]. The primary endpoint of this study was to assess the quality of information contained on PILs of drugs registered in Cameroon. Materials and Method: Data have been collected from PILs in a community pharmacy located in Yaoundé-Cameroon through a surveyof 35 items. In the sampling process, we supposed that all the PILs of each laboratory have the same design. Consequently, only one sample of drug has been included per Marketing Authorization Holder (MAH). Results: A total of 143 PILs related to 116 international nonproprietary names have been evaluated.12% of the MAHs were from Africa, 63.63% from EU and 23,77% from Asia. Apart from indication and contraindication, none of the other important informations required were present in all the leaflets. There was a great heterogeneity between the designs and the content of PILs. While some were empty, the others were very lengthy with usefulness information for the patient. Discussion: While informations were not missing, their understanding was not guaranteed for all the readers. Nevertheless, Package leaflet coming from EU had more information and better presentation than those from Africa and Asia. The Regulatory Authorities should design guidelines related to the readability and comprehensibility of the PIL which is one of the three (3) key documents of post-marketing risk communication.
Authors and Affiliations
Maurice Mbwe Mpoh, Vandi Deli, Marie-Pierre Barrouillet, Olivier Ewane
Keywords
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- EP ID EP419174
- DOI 10.9790/0837-2305101725.
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