Original Research Article | OPEN ACCESS
Development of an updated version of NAFDAC drug labelling regulation: Perspective of healthcare providers in Lagos, Nigeria

Rametu O Momodu1 , Waka A Udezi2

1Drug Evaluation and Research, NAFDAC Office Complex, Isolo Industrial Estate, Isolo, Lagos; 2Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, University of Benin, Benin City.

For correspondence:-  Rametu Momodu   Email: momodurametu@yahoo.com   Tel:+234803315977

Published: 29 December 2018

Citation: Momodu RO, Udezi WA. Development of an updated version of NAFDAC drug labelling regulation: Perspective of healthcare providers in Lagos, Nigeria. J Sci Pract Pharm 2018; 5(2):256-266 doi:

© 2018 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: The general objective of this study was to demonstrate how responses from stakeholders can be used to update regulations that affect healthcare. Specifically, we aim to measure the level of satisfaction of healthcare practitioners with the elements in the current NAFDAC drug labelling regulations and propose an expanded version as an update of the regulation for use by NAFDAC in Nigeria.

Methods: Two structured questionnaires were developed from NAFDAC labeling check list used in vetting manufacturers’ proposed product labels and from items that are not part of the current NAFDAC regulations but have been listed by WHO and other international regulatory bodies as essential elements in protecting the health of the public. These instruments were then used to collect data from healthcare providers in Lagos, Nigeria. A Likert scale of 1-5 was used to measure how satisfied respondents will be in having any of the items as part of NAFDAC labeling regulation. Cronbach’s alpha, factor loading and summary mean scores that indicate level of satisfaction for a specific item were computed. A score ≥3.0 was interpreted as having a high level of satisfaction or acceptance with the implication that such items should be part of the labeling regulations. Inferential analysis was done and values of P<0.05 were interpreted as significant.

Results: The satisfaction score for the current NAFDAC labeling regulatory items ranged from 4.02 to 4.67 and 3.47 to 4.51 for proposed items to be added. Thus giving a range of 3.47 to 4.67 for an expanded or updated labeling regulation. Stating the direction for reconstitution on labels on bottles of dry powder medications for reconstitution had the highest satisfaction score of 4.67 ± 1.03 for the current NAFDAC regulations. ‘Ensuring adequate font size’ had the highest mean score in the updated version (4.51 ± 0.79). Doctors seemed to significantly have a higher level of satisfaction for the updated regulations in all the extracted components except in components which deal with drug compounding and safety where pharmacists had the greatest level of satisfaction p<0.05.

Conclusion: The current NAFDAC drug labeling regulation is found to be satisfactory, and an expanded version of the regulation that contains new labeling elements to eliminate some of its limitations was also highly rated by healthcare providers.

 

 

 

Keywords: Satisfaction, drug label, regulation, NAFDAC


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