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.

 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.