Consumers' Perception of Generic Medicines and Evaluation of In Vitro Quality Control Parameters of Locally Manufactured Paracetamol Tablets in Asmara, Eritrea: A Cross-Sectional Study.

Idris Mohammed Idris,Rahwa Zerabruk Araya,Dawit G Weldemariam,Diyae Nesredin Hassan,Hanan Abdelkadir Hassen,Ali Khani Jeihooni

doi:10.1155/2021/6642826

Idris Mohammed Idris, Rahwa Zerabruk Araya + Show 4 more

Open Access

https://doi.org/10.1155/2021/6642826

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Journal: BioMed research international	Publication Date: Mar 26, 2021
Citations: 4	License type: CC BY 4.0

Affiliation: University of Asmara

Abstract

Generic medicines are clinically equivalent and can be used interchangeably for their intended use. Globally, the usage of generic medicines is highly recommended because of their affordability and accessibility. However, consumers hold a negative perception and attitude of using generic medicine as they consider it poor and having inferior quality compared to branded medicines. This study was conducted to assess the consumers' general view of generic medicines and in vitro evaluation of a locally produced generic medicine, paracetamol. An analytical and cross-sectional study was conducted in three selected hospitals, and in vitro quality control evaluation was done in National Drug Quality Control Laboratory between October 26 and November 21, 2017, in Asmara, Eritrea. A systematic random sampling design was employed, and the data was collected using a questionnaire and a check-list for recording the quality control parameters of paracetamol tablets. A total of 403 respondents were included in the study. The majority of the study participants were females (61.8%). Generally, about half (49.1%) of the respondents choose locally manufactured paracetamol over the imported ones. More than half (68.5%) of the respondents did not believe expensive medicines are of better quality. The main reason consumers prefer the local paracetamol (Azemol) tablet to the imported one was due to their good experience (62.1%). About three-fourths (78.1%) of the consumers also believed that medicines manufactured abroad confer higher quality. At the multivariate level, having educational backgrounds such as elementary (AOR = 4.19, 95% CI: 1.251, 14.035) and junior (AOR = 2.4, 95% CI: 1.146, 5.028) was associated with preferability to local paracetamol as a pain killer over the brand ones. The in vitro test of the local paracetamol met the standard specification for the identification test, weight variation test, pharmacopeial test, friability test, disintegration test, and dissolution test. In conclusion, the majority of the consumers considered local paracetamol as having an inferior quality when compared with brand paracetamol. However, the reality revealed that the local paracetamol was of the same quality as the brand ones. To facilitate widespread use of generic medicines, healthcare professionals should educate consumers on the advantages of these medicines.

Highlights

Generic medicines (GMs) provide similar and a cost-effective alternative to branded medicines
According to the World Health Organization (WHO), GM is defined as “a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights” [1, 3]
Williams et al found that 37.6% of the consumers agreed to take GM when the respondents were asked if they would rather take generic medicine rather than branded medicines [20], but two Indian studies showed that 25.6% [21] and 64% [2] of the study participants preferred using a brand formulation of paracetamol over its generic counterpart

Summary

Introduction

Generic medicines (GMs) provide similar and a cost-effective alternative to branded medicines They consist of equal active ingredients, the same strength as branded medicines [1, 2]. Generic medicines are required to be equivalent to the originator product in terms of their strength, safety, efficacy, quality, pharmaceutical dosage form, and route of administration, and they can differ in excipients, color, and BioMed Research International shape [1, 4, 5]. The United States Food and Drug Administration (US-FDA) defines bioequivalence as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study [7]

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