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  • "An Analysis of Loopholes in the Pharmaceutical Supply Chain, and Methods for Improving Control of Counterfeit Drugs in Nigeria." by Ojima Precious Yakubu. - 08.2020

    Ojima Precious Yakubu

    In Nigeria, the term counterfeit drug refers to drugs that have outlived their shelf life, mislabeled drugs, drugs kept under inappropriate temperatures, and drugs produced under unfavorable conditions. The supply of counterfeit drugs is an issue of great concern for the government, regulatory bodies, and industry professionals in Nigeria. Though policies and guidelines exist to control the supply, a significant amount of operating results have not been achieved yet. In Nigeria, the drug supply system needs to be carefully managed to safeguard the flow of genuine drugs throughout the supply chain.

     

     

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     Objectives:

    The purpose of this dissertation is to achieve these objectives;

    1. To study the pharmaceutical distribution system in Nigeria and the drivers that aid the infiltration of counterfeit drugs.

    2. To evaluate the challenges faced with implementing Pharmaceutical Distribution laws in Nigeria, and to assess the challenges posed by the open market which facilitate the distribution of counterfeit drugs.

    3. To look at supply chain reforms and recommend improvements that can facilitate control measures to minimize the distribution of counterfeit drugs in Nigeria.

    Methodology:

    The methodology applied in this research was a pragmatic philosophy, the researcher applied a mixed-method approach considering the two types of participants involved in the study. The data collection was a combination of online distributed questionnaires and a semi-structured interview with industry stakeholders (distributors and pharmacists), which amounted to a total of 270 participants in total. The researcher uses both qualitative and quantitative approaches to understand the level of awareness of the consumers on the present technologies and also gain new insights and learn from the experience and perception of industry experts' response and also get new suggestions and recommendations.

    Findings:

    From the data gathered, it was deduced that the presence of unskilled workers, and open market, are the drivers that aid the infiltration of counterfeit drugs. It can further be extracted that, the poor implementation of laws is a result of greed and corruption on the part of the regulatory bodies. Some of the challenges the open market pose are during the out of stock period, a lot of counterfeit drugs are produced and supplied to unsuspecting pharmacists and consumers. Hence the need to implement proper anti-counterfeit technologies is necessary. One of the reforms recommended is the need to facilitate awareness amongst consumers and for distributors to buy from the approved pharmaceutical supply chain. Finally as mentioned by two participants, border controls need to be enforced strictly to monitor the drugs coming into the country.

    Analysis:

    The ratio of females to males was 53% to 47%. The ratio of participants residing in rural areas to those in the urban was 11% to 89%. This section of the interview gave the researcher insight into the characteristics of people who responded to the survey. 80% of participants are aware of the MAS technology, but those who used it always or often where 8% and 7%. 58% of respondents admitted that the feature is friendly but 38% rated the response time 3 over 5 which can be interpreted as fair. This implies that the majority of participants are aware of the MAS feature but as seen from the response more awareness needs to be done on the need to use it.

    Conclusions:

    The loopholes in the pharmaceutical supply chain are the presence of the open market as highlighted by participants in the interview. Furthermore, these open markets which are as a result of greed and poverty are the catalyst that facilitates the distribution of counterfeit drugs. Corruption, poor implementation of laws, and the presence of unskilled individuals in the channel are factors that also facilitate the loophole in the pharmaceutical supply chain. As extracted from primary data the regulatory bodies need to be more strict on who they approve to operate a pharmacy, this will reduce the operation of the open markets and also the spread of counterfeit drugs. From the data gathered, one of the methods that can improve the control of counterfeit drugs is consumer awareness. The need for consumers to be aware of the drugs they purchase and where they purchase it from is important.

  • "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.

  • "An Analysis on the Assessment and Reporting of Adverse Drug Reactions in Tertiary Hospitals in Lagos State, South-West Nigeria." by Zainab Abolanle Atobatele

    Zainab Atobatele

    Due to the repeated occurrence of serious, unexpected ADR over the years, lots of professionals and public attention has been drawn to ADRs, and this has led to more focused attention on drug safety surveillance system. ADR incidence is associated with high rate of morbidity and mortality and this incidence cuts across all age groups with a large number of hospitalization, and huge financial burden on Nigeria healthcare system and society. Unfortunately, the assessment, monitoring, and reporting system of ADR in Nigeria healthcare system still have lots of room for improvements, especially with the involvement of tertiary hospitals in Nigeria.

     

     

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     Objectives:

    This research aims to identify bottlenecks and loopholes that hinder effective ADR practice in tertiary hospitals in Lagos state Nigeria. The research involved major stakeholder of pharmacovigilance activities which includes; HCPs (Doctors, Nurses, and pharmacists) and patients.

    1) To assess the knowledge, attitude, and practice of HCPs towards Pharmacovigilance and ADR in Lagos state tertiary hospitals.

    2) Determine HCPs' perception towards direct patient reporting of ADR.

    3) To elicit patients' experience regarding ADR reporting and evaluate its impacts on pharmacovigilance structure.

    4) To make sustainable recommendations which invariably will contribute to the overall pharmacovigilance system in place in the hospitals.

    Methodology:

    This research was modelled on a mixed-method approach that was underlined by a deductive approach and positivist philosophy. The primary data was collected using an online survey and phone interview. The survey was targeted at 450 participants, and a total of 405 respondents were obtained in return in which 270 were patients, and 135 were HCPs (doctors, nurses, and pharmacists) recording a response rate of 90%. For the interview, 12 people were scheduled to be interviewed but 6 responses were obtained which includes 2 doctors, 2 nurses, and 2 pharmacists recording a response rate of (50%).

    Findings:

    From the analysis conducted a significant number of HCPs participants have basic understanding of ADR but have no knowledge of causality assessment and they established that they are not sufficiently trained on how to assess and report ADR. Several bottlenecks such as lack of knowledge/awareness, lack of feedback from NPC, unavailability of ADR reporting forms, insufficient staffs, and excessive workload were established as most challenging issues. However, a highly significant number 92% are willing to update their knowledge on ADR practice and opted to make it a mandatory obligation to help resolve underreporting issues faced by the country. A significant number of Patients participants established they are not familiar with ADR and the importance of reporting, while HCPs acknowledged they are not aware that patients can report ADR directly neither do they think it’s a good idea because they are of the perception that patients can’t generate valid/quality ADR reports.

    Analysis:

    Although the regulatory agency in Nigeria (NAFDAC) has set in place the ideal models needed for reporting, however, their performance towards awareness and publicity of ADR was rated poorly and this in turn is a huge barrier in promoting drug safety practice and pharmacovigilance system in Nigeria. However, from reviewed literature and findings obtained from the study, it can be deduced that global underreporting issues are significantly associated with lack of knowledge and adequate resources dedicated to identify, assess, monitor, and report potential ADRs effectively. The reporting and assessing medium in Nigeria tertiary hospitals are inadequately efficient and somehow being underutilized by Nigerians including its HCPs and healthcare providers due to lack of dedicated resources to the process, and persistent focus on knowledge acquisition instead of its implementation and feasibility. The resulting effect of this act is the burden of ADR faced by the country and inability to achieve required ADR reported cases despite the high mortality and morbidity rate associated with ADR cases in the country.

    Conclusions:

    Nigeria is earmarked as a fast developing country and a leading nation in the future, therefore the country has to be established in all aspects especially the healthcare system starting with its HCPs and regulatory agency. Patients should be educated, encouraged, and actively involved on ADR reporting because they have the potential to add value to generated reports by providing more detailed reports which can help detect likely causality and impact on patients’ lives. Creating more awareness, organising frequent training, workshop, and seminars to update the knowledge of HCP, dedicating adequate resources, incorporating ADR module into the curriculum of HCPs during their undergraduate and orientation program when newly employed, establishing an active pharmacovigilance centres in tertiary hospitals to help monitor and guide ADR practice, educating and encouraging patients on ADR reporting and its importance, are sustainable recommendations that will improve ADR practice and contribute invariably to pharmacovigilance system in Nigeria.

  • "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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