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  • "AN ANALYSIS OF THE IMPACT OF NAFDAC (NATIONAL AGENCY FOR FOOD AND DRUGS ADMINISTRATION AND CONTROL) IN DRUGS QUALITY IMPROVEMENT IN NIGERIA" by Oweh Omovogho Lov

    Oweh Omovogho LoveTrading and use of substandard and counterfeit drugs have been reported by WHO as one of the causes of high morbidity, mortality, and lack of public confidence in the health sector worldwide. Fake and substandard drugs are non-authentic drugs: that are manufactured using incorrect amounts of ingredients, and subsequently reducing the potency of the drugs. Over recent years, these high instances of counterfeit medicines around the globe have given rise to the anti-counterfeiting epoch that dovetails the fight against the hazard. The Federal Government of Nigeria created NAFDAC in 1993 with the task of safeguarding the nation's health by providing effective regulation of the economy's food, drug, and chemical industry. One of the agency's goals was to make sufficient supplies of drugs that are reliable, secured, accessible, and of good quality available to the Nigerian population at all times. The death of 150 children due to error in the formulation of drug syrup ‘My Pikin’ triggered the introduction of this agency in Nigeria.

     


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    Objectives:

    1. To understand the perception of various group of individuals in Nigeria about the drugs produced/consumed in the country

    2. To find out the preferred type of drugs (locally produced or foreign) bought by consumers or prescribed by medical practitioners in Nigeria.

    3. To identify the major contributing factors to the production and distribution of low-quality drugs in Nigeria

    4. To identify the control measures used by NAFDAC in ensuring the production of good quality drugs

    5. To determine the degree to which the objective of drug quality improvement has been achieved in Nigeria.

    Methodology:

    Research Methodology is to be the major aspect of an investigation work as it helps the overall work in the proper direction to reach a suitable outcome. The researcher’s core consideration is to choose the most appropriate methodology to carry out the work in an appropriate manner. The investigation into actual action is based on the evaluation of analyzing the impact NAFDAC has on drug quality improvement in Nigeria. The aim is to investigate the major reason for fake drug consumption and the impact of NAFDAC in improving drug quality in Nigeria. A descriptive research design would be adopted by the study. A descriptive survey centers on describing the important facts about people, their opinion, motivations, and attitudes. The researcher chose the descriptive research design because the main aim of the research is to describe the impact or role of NAFDAC in drug quality improvement or control. It will allow the researcher to get the opinions of the workers in pharmaceutical, doctors, consumers, pharmacists and NAFDAC staffs about their views on the role of NAFDAC in the control of drug quality in Nigeria. The research design determines the strategy chosen and as this study follows a descriptive research style, the most suitable research strategy to implement is a quantitative strategy. In addition, implementing a quantitative approach would allow the researcher to collect data from a good number of individuals as the researcher wished to study a large population.

    Findings:

    Findings from the study have revealed how individuals from different professional backgrounds who are involved in the production and distribution of medical products in Nigeria, as well as the random consumers, perceive medical products produced in Nigeria, the factors influencing the production and distribution of low-quality drugs, the role of NAFDAC in improving drug quality, and the current situation of Nigeria with respect to drug quality. The study had five objectives that summarily boiled down to understanding the role of NAFDAC in improving drug quality in Nigeria. From the first objective, it was concluded that the respondents, mainly the NAFDAC staff and the medical practitioners believe that drugs produced in Nigeria are of low quality. Also, findings from the second objective pointed out that the professionals, as well as the consumers, prefer to recommend and /or purchase foreign-made drugs to the locally (Nigerian) made ones. Furthermore, it was deduced from the third objective that the high cost of good quality drugs, inadequate laws, or poor enforcement of the existing drug quality control regulations and the inadequate drug distribution monitoring system were the three major factors influencing the production and distribution of low-quality drugs in Nigeria. More so, setting up enforcement officers for control and routine inspection, provision of mobile authentication of original drugs to help consumers identify which drugs are fake or original are some of the control measures put up by NAFDAC to combat fake drug production and distribution in Nigeria; Finally, findings from the last objective revealed that there was an equal percentage of agreement and disagreement as to whether the problem of fake drug production and distribution has reduced in Nigeria in the last 10 years; it also revealed that majority of the consumers indicated they cannot ascertain whether the drugs they purchase are fake or original.
     
    Analysis:

    The Data used for this research was obtained through responses from the questionnaires disseminated to a different group of people ranging from Professionals working in the pharmaceutical industry, Pharmacists, NAFDAC staff to the drug consumers, to ascertain their opinions concerning the drug situation and the role of NAFDAC in the improvement of drug quality in Nigeria. Various segment was used to analyze this dissertation topic in accordance with the research objective and the questionnaires that was distributed and from the results it showed that there was high rate of low quality drugs and most people preferred to use drugs from abroad than from Nigeria.

    Some of the questionnaires are as followed:

    1. What is your opinion about the quality of medicinal products in Nigeria?

    a. Do you agree or disagree with the statement that medicinal products in Nigeria are low quality?

    b. Do you agree or disagree with the statement that pharmaceutical companies based in Nigeria are producing and distributing low quality medicine?

    2. As a medical professional what is your experience (observation) in the use of medicinal products that is produced in Nigeria or medicinal products that are manufactured in different countries?

    3. Do you think drugs produced in Nigeria are of better quality than that produced abroad?


    Conclusion:

    In conclusion, NAFDAC is doing its best to combat the problematic drug situation in Nigeria, but more efforts and awareness are still needed to make them more effective as to help to stop the spread of fake drugs and also to protect various group of individuals. Also, from my research in conclusion it shows that most individuals still need an awareness to the distribution and purchasing of counterfeit medicinal products and the control measures put in place by NAFDAC will need to be improved. The researcher, therefore, recommends that the cost of producing drugs in Nigeria should be subsidized by the government as these would make good quality drugs affordable for the consumers so that they would have no reason to purchase drugs of lower quality. More stringent drug laws/policies and punishments for defaulters should also be enforced to discourage fake drug production and distribution in the country. Again, the researcher further recommends that NAFDAC should increase the awareness for the use of the mobile authentication service so as to help the consumers identify the fake drug products from the original ones. In these ways, the problem of the production and distribution of fake medical products would be reduced in Nigeria. The awareness of counterfeit medicinal products should be well known by individuals as NAFDAC work on all there control measures that have been put in place by improving on it and also they should work on the officials put in place for distribution of medicinal products to check all medicinal products are well numbered and labelled appropriately.

  • "Enhancing pharmacovigilance in Nigeria: Challenges faced by NAFDAC in monitoring of Adverse Drug Reactions in Nigeria." by Chinedum Odigbo

    Moyosore Oluwatoyosi OsokoNigeria, for a long have time been characterised by challenges in the medical sphere. This has given rise to increased mortality and morbidity rates in Nigeria. Apart from the challenges faced, there exists a low level of monitoring of adverse drug reactions. Drugs being authorised into the market are scarcely monitored to ascertain if there exist other side effects not observed in the clinical trials. Regulatory agency(NAFDAC) responsible for monitoring of drugs in the post-market authorisation period have not been effective in the dispensing of their duties which has contributed to the increased rate of mortality and morbidity in Nigeria.


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     Objectives:

    1. To determine if NAFDAC possesses the capability to monitor and address reported ADR cases.

    2. To identify the factors that hinder NAFDAC from effectively monitoring ADR in Nigeria.

    3. To proffer solutions that will help boost ADR monitoring by NAFDAC.

    Methodology:

    RESEARCH APPROACH: Quantitative
    RESEARCH METHODS: Descriptive research method.
    RESEARCH PHILOSOPHY: Positivism.
    PROBABILITY SAMPLING: Simple random sampling method.
    SAMPLE SIZE DETERMINATION: Cochran’s formula was adopted.
    METHODS OF DATA COLLECTION: Primary research was used.
    RESEARCH INSTRUMENT: Close-ended electronic survey questionnaire.
    VALIDITY OF THE RESEARCH INSTRUMENT: Face validity and content validity
    RELIABILITY OF THE RESEARCH INSTRUMENT: Cronbach’s alpha coefficient was used.
    METHOD OF DATA ANALYSIS: Statistical Package for Social Sciences using descriptive statistics.
    ACCESS & ETHICAL CONSIDERATION: Participants were given the free will to decide to participate in the study or not, were duly informed about keeping their identities hidden and information confidential.
     
    Findings:

    As revealed by the research findings, one of the challenges affecting NAFDAC’s effective monitoring of ADR is the inconsistent training of staff on latest developments in ADR monitoring. Not keeping staff abreast with recent developments in the monitoring of ADRs is a significant factor that hinders the effective practice of ADR monitoring by the regulatory agency. As a result, regular trainings where staff’s knowledge are updated with current trends with respect to ADR monitoring should be conducted. It is without doubt that ADR monitoring stems from the reporting of ADRs. One of the factors limiting NAFDAC’s ineffective monitoring of ADR is the reluctance of medical practitioners and consumers to report ADR cases. And the when ADR cases are not reported, the practice of monitoring cannot be carried out.
     
    Analysis:

    The analysis of this study have revealed that most NAFDAC staff understand the concept of ADR monitoring.This has provided the study with a solid foundation for answering its research questions because responses given by the study’s participants can be trusted due to their understanding of the study’s main subject matter – ADR monitoring. It was discovered from the analysis that monitoring of ADRs would impact positively on the safety of public health and that a positive relationship exists between ADR monitoring and reduction in ADR cases. These findings reveal the significant role ADR monitoring plays in safeguarding the public health of the people of a nation. In the health sector of every nation, it is advisable for ADR monitoring to be taken seriously due to the significant role it plays in protecting the strength of a nation.

    Conclusions:

    The researcher concludes that of a truth the Nigerian regulatory agency, NAFDAC has the capability to effectively monitor and address ADR issues but that attention should be given to the use of technological solutions in the carrying out of ADR monitoring practices as seen in Kenya. This would in turn increase the agency’s effectiveness in the monitoring of ADRs in the nation. Moreover, the staff revealed some other factors that hinder the effective monitoring of ADRs by NAFDAC. These factors include; poor and inconsistent training of staff, poor administration of the agency, corruption and conflict of interest, lack of qualified manpower, reluctance of most healthcare professionals to report ADR issues, and consumers who refuse to report ADR experiences after consumption of a drug.

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