ABSTRACT
BACKGROUND: Hypertension is a major predisposing factor to organ damage leading to loss of vision, heart and kidney conditions. The increased demand for Amlodipine as well as other antihypertensives makes it a candidate for fakers. Consumption of counterfeit Amlodipine tablets will have a deleterious impact on the health of the consumer hence the justification for continuous monitoring and training on identification of such spurious products. Periodic analysis of drugs in the community pharmacy using simple assay methods such as weight uniformity assessment, Friability tests and Disintegration rate assessment can be invaluable in helping pharmacists identify counterfeit and substandard products.
METHOD: A descriptive cross sectional randomized study was carried out in Oredo Local government area in Benin city. A total of 10 community pharmacists practicing in community pharmacy premises in the local government were randomly interviewed using a validated structured questionnaire. Also ten different brands of Amlodipine 5mg were purchased from ten different community pharmacies and assessed for weight uniformity, Friability, and Disintegration rate using standard physical methods.
RESULT: Of the ten Pharmacists surveyed, 6(60%) were male, 7(70%) were aged between 26-35, 5(50%) had Pharm D as their highest degree and 6(60%) had been in practice for less than 5years. 8(80%) reported not to have had any form of training on the identification of counterfeit drugs, 5(%) were confident of being able to identify counterfeit medications and 7(70%) had not come across any patient presenting with adverse drug reactions as a result of consuming suspected counterfeit Amlodipine purchased from community pharmacies. Also, all the brands of Amlodipine tested met the official requirements for uniformity of weight, friability and disintegration rate tests with only one having a disintegration time of up to 5 minutes.
CONCLUSION: Majority of respondents had little or no form of training on identification of counterfeit drugs and only half of them were confident of being able to identify counterfeit drugs in their community pharmacies. The assay method used in this study is reliable, simply and cost-effective and can be applied routinely in the assay of Amlodipine tablets.
