MSc in Pharmaceutical Business and Technology

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A comparative assessment of current and future pharmacovigilance in developed and developing countries - A case study of Ireland and Nigeria
(Griffith College, 2020) Saheed Jimoh, Olanrewaju
The thesis objectives are to compare and evaluate the factors about reporting Adverse Drug Reactions in the developed and developing countries among healthcare professionals (Medical doctors and Pharmacists) using Ireland and Nigeria as a case study. Which a questionnaire survey and phone interviews for quantitative and qualitative analysis are carried out respectively within the two regions (Ireland and Nigeria). The challenges faced by medical professionals concerning ADR reporting are achieved based on their knowledge and awareness to determine an effective recommendation to help improve both regions using the comparison results and works of literature gathered. From the author results and analysis, both groups of healthcare professionals from the two regions were compared to determine their opinion in respect to observation and reporting of ADRs under the categories of under-reporting, ADR reporting methods, regulations and guidelines pertaining ADR report in both Ireland and Nigeria as HPRA and NAFDAC are the regulatory body responsible for handling submitted ADR reports. An Overall total of 122 respondents from both Nigeria and Ireland are received which consists of 47 respondents from Ireland (12 medical doctors and 43 pharmacists) and 75 respondents from Nigeria (32 medical doctors and 43 pharmacists) showing a response rate of 60.0% and 87.5% from 20 and 45 medical doctors and pharmacist from Ireland and response rate of 71.1% and 95.5% out of 45 respondents respectively from both medical doctors and pharmacist from Nigeria. Surprisingly, 98.0% of the correspondents which consist of 12 medical doctors and 35 pharmacists from Ireland responded to knowing how to report ADRs to compare to 71.0% from Nigeria which is quite above average consisting of 26 medical doctors and 27 pharmacists responded to knowing how ADRs is being reported. However, it shows that pharmacists had better knowledge, awareness, understanding, and experience over the medical doctors regarding ADRs reporting. However, 92.0% and 96.0% of respondents of both groups from Nigeria and Ireland respectively opted to ADR reporting being made compulsory as a professional obligation towards achieving and improving pharmacovigilance. Furthermore, the challenges affecting ADR reporting in Nigeria are associated with the inaccessibility of ADR report forms when needed, complex reporting processes while too busy and lack of time remained the most common challenging factor among this too regions. The least common challenges reported at both regions are level of clinical trial knowledge, a concern that ADR report mighty is wrong among, fear of legal liabilities, and fear of exposure to legal liabilities from patient or drug manufacturer. Finally, after proper comparison and recommendation from both sides from the country it shows the need for better improvement in awareness among healthcare professionals in Nigeria been the country with the highest level of challenges compare to their counterpart healthcare professionals and this could be achieved by organizing pharmacovigilance conferences, continuous education programs included in their professional courses and training to improve knowledge of ADR reporting. Establishment of ADR departments in healthcare institutions headed by ADR specialists and offering professional recognition rather than financial rewards are the sustainable recommendation to put in practice in both regions to further improve the practice of ADR reporting in Nigeria and Ireland. To wrap it up, the need for the regulatory bodies from the developing countries to work in hand with the developed countries to better improves awareness, knowledge, and improvement towards ADRs reporting system.
A Comparative Study on Lean and Six-Sigma Implementation at Various Pharmaceutical Industries in India and Ireland.
(Griffith College, 2020) Sneha Chavva, Bala
The research was set out to compare the extent of LSS implementation and different tools used in India and Ireland in various pharmaceutical manufacturing sectors. For this, the main objectives were to compare differently sized industries like small, medium and large. To achieve this, a qualitative method was implemented and the data sourcing was done by primary and secondary methods with the questionnaire being the main source of the data. A study population of 11 participants who were presently work in the pharmaceutical manufacturing sectors of India and Ireland filled out the questionnaire. The study found out that there is not much gap in LSS implementation of these two countries. Top five facilitators, barriers and benefits were summarized, with cultural differences being the most important factor to be considered among the two countries. The study also found out that there is no gap in the LSS implementation in various industries at Ireland, as the small-scale industries too were found using the tools.
A Study to Assess the Challenges of Healthcare Professionals in Spontaneous Identification of Falsified Drugs: Upgrading Pharmacovigilance in Nigeria
(Griffith College, 2020) Nwankwo, Chimezie Chris
Drug Frauds are on the increase, falsified drugs are giving sleepless nights to both patients, healthcare professionals as well governments of different countries, and thus the regulation prohibiting the sales and production of falsified drugs cannot succeed with any form technological intervention. The study aims to evaluate several criteria that as contributed to the challenges of identifying falsified drugs among healthcare professionals- medical doctors, pharmacists, and other healthcare professionals in Nigeria. Through a questionnaire-based survey and phone interview for both the quantitative and qualitative analyses, respectively a review would be done. For this to be achieved the knowledge, awareness, and possible challenges faced by the professionals concerning falsified drug identification were considered to recommend an effective recommendation on different ways to improve such practice of pharmacovigilance in Nigeria. In this thesis all the groups of healthcare professionals a comparison was made to ascertain different opinions on frequency observed on falsified drugs, ways of detecting falsified drugs, the technology used in identifying falsified drugs, as well as regulatory agency responsible for reporting of falsified drugs in Nigeria. A total of 131 responded to the survey of whom 62 (45.80%) were medical doctors and 43 (32.82%) were pharmacists as well as 43 (32.82%) were other healthcare professionals. It was fascinating to see that 62% of the respondents agreed to the fact that they know how to identify falsified drugs (40 medical doctors, others 18, pharmacist 23) while 42%(13 medical doctors, others 17, pharmacist 12) of the respondents did not know. Only 6% of the healthcare professionals (7 medical doctors, 1 pharmacist) are not sure if they can detect fake drugs in Nigeria. From the study conducted it was unfortunate to note that pharmacists had average knowledge, awareness in comparison to a medical doctor who had better awareness of the in identifying fake drugs. However, 95% of all the respondents all agreed that identifying falsified drugs and reporting it should be made compulsory as part of the way of upgrading pharmacovigilance in Nigeria. Some of the challenges that all respondents majorly agreed to are inadequate existing laws, ignorance among healthcare professionals, presence of non-health professionals in the health sector business, high cost of quality drugs,and finally the high level of corruption. All respondents also agreed that continuous learning can create more awareness of the challenges of falsified drugs, including heavy fines and sanctions on defaulters and also creating a special department that would be tasked with the responsibility of monitoring falsified drugs in the market.
An Analysis of Factors Influencing Environmental Behaviours in Irelands’ Biopharmaceutical Industry Employees
(Griffith College, 2020) Heverin, Ciara
This study analyses the factors influencing environmental behaviours in Irelands’ biopharmaceutical industry employees utilising secondary research and qualitative primary research methods. The secondary research undertaken indicates that several factors positively impact environmental behaviours including convenience and belonging to a group with positive environmental intentions i.e. peer influence. Within an industry setting, a combination of factors is evident. This includes individual factors e.g. beliefs and environmental awareness, group factors e.g. feedback and financial incentive, organisational factors e.g. culture and management support and external factors e.g. actions at home and legislation. The primary research carried out with employees of 10 biopharmaceutical companies in Ireland shows that several individual, group, organisational and external factors impact the behaviours of employees, thereby reflecting the secondary research findings. The data shows that to optimise efforts a combination of these factors is required. However, company culture, infrastructure and regulation were found to be the most influential factors. Company culture improvements must move from a profit driven mindset, to improve environmental behaviour through voluntary corporate social responsibility. Research suggests a culture shift is a long-term change. In the short to medium term regulation and infrastructure changes are advised. Introducing requirements to align with positive environmental action through regulation drives companies to ensure compliance, as not doing so can affect release of product and lead to financial cost. Both infrastructure and regulation serve to make the positive environmental choice the most obvious. The presence of environmental infrastructure makes the choice easy resulting in employee cooperation. This research indicates that current efforts within the biopharmaceutical industry to ensure optimal environmental impact is moderate. Therefore, further work is required in this area to improve the effort of both the individual and the company and to lessen the environmental impact going forward. The findings of this study may be used within the biopharmaceutical and similar industries to analyse, promote and improve current efforts of ensuring positive environmental behaviour.
An Analysis Of How Collaboration Between Physicians And Pharmacists Might Facilitate Improved Healthcare In Nigeria.
(Griffith College, 2020) Oluwatoyosi Osoko, Moyosore
The relationship between healthcare professionals impacts the delivery of quality healthcare. Interprofessional collaboration among healthcare workers has been proven repeatedly to increase good clinical outcomes and cause patient satisfaction which is the goal of healthcare. The collaboration between physician and pharmacist is the most impactful of this interprofessional collaboration because physicians come in contact most with patients and as professionals have an in-depth knowledge of the pharmacology and therapeutic effects of medicines. Hence pharmacists can directly influence the health and wellbeing of patients. This research aimed to analyze how the collaboration between physicians and pharmacists might facilitate improved healthcare in Nigeria by seeking the opinion of physicians, pharmacists and patients, identifying factors that may hinder this collaboration and exploring ways of establishing and improving this relationship in a developing country like Nigeria. The methodology employed used a mixed-method questionnaire consisting of both qualitative and quantitative approaches with the aim of getting relevant results that are unbiased. Secondary research indicated that if this collaboration is established and enforced properly, it does facilitate improvement of healthcare. This research was undertaken to confirm or dispute this fact. To this end, 150 questionnaires was sent out to a cohort of respondents consisting of physicians, pharmacists and patients garnering an 80% response rate. The patients responded the most, followed by the pharmacists, then physicians. Community pharmacists showed the most responses confirming the finding from primary research that they are overlooked a lot but have the most interaction with patients. The results also showed that physicians trust pharmacists and acknowledge their contribution to quality healthcare delivery and will therefore welcome the relationship, patients also had more trust in their pharmacists, causing physicians to work with them. Consequently, the government in Nigeria can create accountable care organizations to bridge the gap of information access and confidentiality that hampers the relationship. Such an approach would likely involve the two main bodies governing both professions (the Nigerian Medical Association and the Pharmaceutical Society of Nigeria) so they can potentially introduce the study of this relationship into the modules of physicians and pharmacists’ education programs to ensure that graduates in these disciplines have an extensive knowledge of this collaboration and ultimately lead to improvement of healthcare in Nigeria.
An Analysis of Loopholes in the Pharmaceutical Supply Chain, and Methods for Improving Control of Counterfeit Drugs in Nigeria
(Griffith College, 2020) Yakubu, Ojima Precious
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. A high level of monitoring and evaluation must be enforced at all levels of the supply chain to ensure the activities of counterfeit drug peddlers are reduced as much as possible. The purpose of this research is to identify and analyze the current challenges which facilitate the loopholes in the pharmaceutical supply chain in Nigeria and propose methods that can reduce how counterfeit drugs enter the supply chain. This research aims to interact with distributors and pharmacists because they are directly involved in the supply chain and are important contact points before a drug reaches consumers. Response Rate: A total of 20 people were scheduled to be interviewed, 10 distributors, and 10 pharmacists. A total of 13 participants responded to the interview, 7 pharmacists and 6 distributors with two responding via text, recording a response rate of 65% The survey was distributed to a total of 370 participants. 70 pharmacists and 300 consumers. A total of 55 pharmacists responded to the survey and a total of 202 consumers responded to the survey giving a total of 257 responses. Hence, recording a response rate of 69.45%. The loopholes facilitating the infiltration of counterfeit drugs are that the number of unqualified workers in the supply chain is greater than the number of qualified workers, the presence of open markets, and poor implementation of laws. To control the supply of counterfeit drugs more consumer awareness needs to be done and industry experts need to familiarize themselves with more anti-counterfeit technologies and to exercise greater care in sourcing drugs.
An Analysis Of The Impact Of Nafdac (National Agency For Food And Drugs Administration And Control) In Drugs Quality Improvement In Nigeria
(Griffith College, 2020) Omovogho love, Oweh
Counterfeit drugs are non-authentic drugs that have been manufactured using incorrect amounts or incorrect ingredients to either reduce or nullify the potency of the drugs. Trading and use of counterfeit drugs have been reported by WHO(World Health Organization) as one of the causes of high morbidity, mortality in the Nigerian health sector. This study aims to identify the impact of NAFDAC on drug quality control in Nigeria. A cross-sectional survey of 37 participants, including medical professionals, NAFDAC staff, pharmacists and consumers was done using a questionnaire. Results from the study revealed that the drug situation in Nigeria is not good and 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 major factors influencing the production and distribution of low-quality drugs in Nigeria. NAFDAC has set up enforcement officers for control and routine inspection, providing mobile authentication of services to help consumers differentiate fake from original drugs to combat this issue. In conclusion, NAFDAC is trying its best to combat the drug issues in Nigeria but more efforts are needed to make it effective. This study recommends that the government should subsidise the cost of drugs, put up more stringent drug laws and punishment for defaulters to discourage production and distribution of counterfeit drugs in Nigeria.
An Analysis of The Use of Wearable Technology as A Means of Controlling Drug Delivery Systems and The Challenges Facing Its Usage in Ireland.
(Griffith College, 2020) Bolatito Temitayo, Adewumi
In this study, the possible/existing use (in Ireland) of wearables (such as the smartwatches, patches, and contact lenses) in controlling drug delivery systems (such as pumps and nanoparticles) was analysed. The challenges affecting the use of this technology in Ireland were determined. The public and potential customers' perception of the novel technology was examined along with how the creation will be potentially received in the market. Ireland was the country of choice because the researcher resides there and because of the heavy presence of many pharmaceutical companies in the country. The secondary research was conducted by looking into the concept of controlled drug delivery and how it works. The history, uses and the market for wearable devices was explored globally and in Ireland. The concept of wearable device-controlled drug delivery systems was then introduced. The different commercially available ones were analysed and the challenges facing the use were examined. The data collection involved quantitative research via questionnaire (219 participants) to establish the challenges facing the development and manufacture of this type of drug delivery system. The knowledge and views of Irish consumers concerning the use of this technology were established. Qualitative data was also collected via interviews (of 3 industry experts) to further explain these technologies and determine the level of progress in the research & development and manufacture of the devices in Ireland. The use of wearable devices in controlling drug delivery systems is still at its early stage in Ireland and some people have little or no knowledge of the use of this type of drug delivery system. Majority of the participants were interested in using the technology (83.5%), 65.6% would rather use this wearable device-controlled drug delivery system because more than half of the participants trust that this type of drug delivery system is more effective. Some of the limitations of the use of this type of drug delivery system from the consumers’ point of view are based on the concerns on the high cost, efficiency, and accuracy of this type of drug delivery system. The size, look, comfort, and ease of use of these devices influence the use of this type of drug delivery system. According to the industry experts, challenges like heavy regulations and the massive amount of time, money, and resources involved in the Research & Development affect the manufacture and use of wearable device-controlled drug delivery systems in Ireland.
An Analysis on the Assessment and Reporting of Adverse Drug Reactions in Tertiary Hospitals in Lagos State, South-West Nigeria.
(Griffith College, 2020) Abolanle Atobatele, Zainab
Due to 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 cut across all age groups with a large number of hospitalisation, and huge financial burden on Nigeria healthcare system and the 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. Due to the above-stated problems, the assessment and analysis of ADR are critical to promptly detect the likely safety and security issues that might be associated with medicinal products; hence this research aims to analyse assessment and reporting of ADR in Tertiary Hospitals in Lagos State, South-West Nigeria”. The purpose of this research is to identify bottlenecks and loopholes in the system that hinders 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 of tertiary hospitals. It aims to interact with HCPs to determine their perception towards direct patient reporting of ADR. Also patients were considered in the study to determine their level of awareness/knowledge towards ADR reporting. 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 in which 2 were doctors, 2 were nurses, and 2 were pharmacist recording a response rate of (50%). From the analysis conducted a significant number of the 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, cumbersome procedures, 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 the HCPs also acknowledge that they are not aware that patients can report ADR directly neither do they think it is a good idea because they are of the perception that patients can’t generate a valid/quality ADR reports. Creating more awareness for both HCPs and general public, organising frequent training, workshop and seminars to update the knowledge of HCPs, providing adequate resources, incorporating ADR module into the curriculum of HCPs both 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 it is importance, are sustainable recommendations that will improve ADR practice and contribute invariable to pharmacovigilance system in Nigeria.
Analysis of Customer Satisfaction and Drug Product Quality in exploring Pharmaceutical Manufacturing Operational Excellence in Lagos state, Nigeria.
(Griffith College, 2020) Temitope Babatunde, Omotayo
The thesis analysed customer satisfaction and drug product quality which are both elements of Operational Excellence in the pharmaceutical manufacturing industry in Lagos state, Nigeria through quantitative and qualitative research methods (a questionnaire-based survey and phone interviews). The perspectives of drug consumers and NAFDAC regulatory personnel as regards satisfaction with pharmaceutical products, factors influencing customer satisfaction, level of drug product quality and factors affecting drug quality were evaluated to ascertain the state of Operational Excellence of the local pharmaceutical manufacturing industry and promote recommendations for its improvement. Both groups of regulatory personnel and customers were compared to determine their perspectives on the quality of drug products and level of satisfaction with locally manufactured drugs in terms of purity levels, appropriate drug components, drug efficacy, safety, availability, affordability and packaging. A total of 280 out of 309 participated in the survey, of which 202 (72.1%) were customers and 78 (27.9%) were NAFDAC regulatory personnel. Interestingly, only 14 (5%) respondents evaluated the overall quality of locally manufactured drugs to be poor with 10 (12.8%) of them being regulatory personnel, while 55 (19.5%) respondents were generally indifferent about the quality of drugs in the state, 40 (51.3%) of them being regulatory personnel. The larger percentage, 211 (75.5%) respondents were either of the opinion that drug quality in the state was somewhat good or very good. Of this category, 69 (24%) respondents, all of which were customers believed locally manufactured drugs in the state were 100% good quality drugs. From the analysis conducted, 193 (68.9%) of the respondents were satisfied with the price, availability, efficacy and safety of locally manufactured drugs in Lagos state, 36 (18.7%) of which were regulatory personnel and 147 (76.1%) being customers. The rest were either indifferent or unsatisfied of which the majority were indifferent. Inadequate funding of the industry by the government to improve standard of operations and insufficient regulatory checks on manufacturing processes and products remained the most challenging factors affecting product quality of locally manufactured drugs in the state while inadequate training of the manufacturing staff to ensure compliance with standard procedures was the least reported challenge. Frequent regulatory checks on pharmaceutical manufacturing companies, indefinite shutdown of consistently defaulting pharmaceutical manufacturing companies and seizure or destruction of substandard products will be effective in ensuring utmost quality of locally manufactured drug products in the state. Adequate product evaluation and testing by regulatory authorities before products are released into the market and provision of customer complaint platforms by pharmaceutical manufacturing companies are sustainable recommendations to improve product quality and customer satisfaction with locally manufactured drugs in Lagos, Nigeria
Challenges impacting the reporting of Adverse Drug Reactions among healthcare professionals: Improving pharmacovigilance in Nigeria.
(Griffith College, 2020) Anaedu, Prosper Chibuikem Henry
The thesis aims to evaluate factors pertaining to reporting Adverse Drug Reactions (ADRs) among healthcare professionals- medical doctors and pharmacists- in Nigeria by conducting a questionnaire-based survey and phone interviews for quantitative and qualitative analysis respectively. To achieve this, the knowledge, awareness and challenges faced by medical professionals in relation to ADR reporting were considered in order to determine effective recommendations to improve ADR reporting practices and pharmacovigilance in Nigeria. Both groups of healthcare professionals were compared to determine their opinions on frequency of observed and reported ADRs, reasons for high underreporting rates, awareness of ADR reporting methods, guidelines and regulations as well as the NAFDAC regulatory body responsible for handling submitted ADR reports. A total of 104 out of 140 responded to the survey, of whom 53 (75.7%) were medical doctors and 51 (72.9%) were pharmacists. Interestingly, 34.0% of medical doctors who responded did not know how to report ADRs compared to just 5.9% of pharmacists who responded. From the analysis conducted, the pharmacists had better knowledge, awareness and experience over medical doctors regarding ADR reporting in Nigeria. However, an overwhelming 90.0% of both groups of respondents opted for ADR reporting being made compulsory as a professional obligation towards pharmacovigilance. The inaccessibility of ADR report forms when needed, complex reporting procedures, busy work schedules and lack of time remained the most challenging factors to ADR reporting while fear of legal liabilities or the clinical knowledge to identify ADRs were among the least challenges reported. Organising pharmacovigilance conferences and continuous education programs to improve awareness among healthcare professionals and including ADR reporting courses during undergraduate professional training will improve knowledge of ADR reporting. Establishing ADR departments in healthcare institutions headed by ADR specialists and offering incentives in the form of professional recognition rather than financial rewards are sustainable recommendations to improve the practice of ADR reporting in Nigeria.
Challenges impacting the reporting of Adverse Drug Reactions among healthcare professionals: Improving pharmacovigilance in Nigeria.
(Griffith College, 2020) Yusuf, Saliu Adeleke
The introduction of the concept of pharmaceutical care as well as integration of ICT-based techniques into the practice of community pharmacy has reshaped the professional job functions of modern day community pharmacists as attention is being given in continuum to patient-oriented services. Consequently, issues such as medication error, undue waiting time, prescription problems to mention a few are being effectively addressed and managed courtesy of ICT-based techniques such as e-prescription, telecare, barcode scanning to etc. usage in the work station of community pharmacists. These techniques among others have also been observed and reported to reduce the workload of community pharmacists which in turn create more time to offer patient-focused services. The present study explored the use of ICT-based techniques as well as the level of professionalism pharmacists in the practice of community pharmacy in Nigeria. Community pharmacy is one of the facilities in the Nigerian primary health sector rendering health services to patients of which majority are financially constrained and not covered by health insurance. The study was modelled on qualitative research pedagogy and specifically conducted in the selected locality of Eti-Osa LGA, Lagos state Nigeria. Fifteen (15) licensed and practicing community pharmacists were sourced for the exploratory research study using purposive and snowballing sampling techniques and seven (7) were successfully engaged with 10 pre-drafted questions through semi-structured interview that averaged 37.5 minutes on mobile phone conversation. Each of the interview sessions was audiotaped, transcribed, coded and subjected to thematic data analysis. Five key themes were identified based on respondents’ opinions and it was found that community pharmacists in study’s locale are aware of the use of ICT-based techniques such as Health Information Technology, Electronic Prescription and Telecare services in their line of duty as seen in the developed world but their use in the Nigerian environment is inexistent. This study unraveled the factors including poor infrastructural facilities, lack of technical skills, financial constraints, poor public reception as the major bottlenecks behind the nonexistent of these ICTbased techniques in the professional workstation of of community pharmacist in Nigeria. Consequently, this paper proffered measures to bring about the existence of these techniques as respondents welcomed the idea of their introduction and felt it would enhance their professional job functions. Interestingly, the present work also established a theorized concept of “Professional Marginalization” and “Professional Exclusion” as engaged community pharmacists overtly stated that they had no well-defined place in the Nigerian public health system owing to the fact that they enjoyed little or no “professional rapport” with other health professionals when it comes to patients’ health issues. Non-existence of ICT-based techniques was said to contributed to this and respondents thus call for a way to be involved by integrating ICT-based techniques explored here along with others seen in the advanced world in their work station. Respondents felt that their professional stance can be redefined with ICT-based technique. The research thus conclusively calls for future research to the done in staking claim for the theorized concept of professional marginalization and professional exclusion established here.
Enhancing pharmacovigilance in Nigeria: Challenges faced by NAFDAC in monitoring of Adverse Drug Reactions in Nigeria. Masters thesis
(Griffith College, 2020) Odigbo, Chinedum
This study aims at identifying the challenges being faced by NAFDAC in the monitoring of adverse drug reactions (ADRS) and to proffer solutions for the purpose of enhancing pharmacovigilance activities in Nigeria. To achieve this, the study sought to determine if NAFDAC has the capability to monitor and address reported ADR cases, to identify the factors that hinder the effective monitoring of ADRs and to suggest recommendations that can improve the level of ADR monitoring in Nigeria. In conducting this study, the quantitative approach was used. A sample size of 152 was generated and data was collected through the aid of close-ended electronic survey questionnaires. Out of the 152 questionnaires administered to respondents, only 139 was answered and submitted. This shows a response rate of 91%. Descriptive statistics with the aid of the Statistical Package for Social Sciences (SPSS) version 20.0 was used to analyse obtained data and results were presented in frequencies and percentages in tables, pie charts and bar charts. In testing the study’s hypotheses, simple linear regression and Karl Pearson’s correlation were used. Findings from the study revealed that poor and inconsistent training of staff on recent developments in ADR monitoring, neglect of latest technological solutions in the monitoring of ADR, reluctance of most healthcare professionals to report ADR issues and the refusal of drug users to report experienced ADR issues remain the main factors that hinder NAFDAC from effectively carrying out ADR monitoring in the nation. The study recommends that regular trainings where staff’s knowledge are updated with current trends regarding ADR monitoring should be conducted. Also, NAFDAC should adopt the use of latest technological solutions in the monitoring practice of ADRs. Emphasis should be placed on the use of digitised reporting system to make the tracking of ADR cases easier and faster and a well-designed educational program should be implemented to enlighten medical practitioners and users of pharmaceutical products on the need for the reporting of known ADR issues. Effecting these recommendations would improve the level of ADR monitoring in the nation.
Exploration of the Impact of Information and Communication Technology (ICT) Development on Community Pharmacy Practices in in Nigeria
(Griffith College, 2020) Saliu Adeleke, Yusuf
The introduction of the concept of pharmaceutical care as well as integration of ICT-based techniques into the practice of community pharmacy has reshaped the professional job functions of modern day community pharmacists as attention is being given in continuum to patient-oriented services. Consequently, issues such as medication error, undue waiting time, prescription problems to mention a few are being effectively addressed and managed courtesy of ICT-based techniques such as e-prescription, telecare, barcode scanning to etc. usage in the work station of community pharmacists. These techniques among others have also been observed and reported to reduce the workload of community pharmacists which in turn create more time to offer patient-focused services. The present study explored the use of ICT-based techniques as well as the level of professionalism pharmacists in the practice of community pharmacy in Nigeria. Community pharmacy is one of the facilities in the Nigerian primary health sector rendering health services to patients of which majority are financially constrained and not covered by health insurance. The study was modelled on qualitative research pedagogy and specifically conducted in the selected locality of Eti-Osa LGA, Lagos state Nigeria. Fifteen (15) licensed and practicing community pharmacists were sourced for the exploratory research study using purposive and snowballing sampling techniques and seven (7) were successfully engaged with 10 pre-drafted questions through semi-structured interview that averaged 37.5 minutes on mobile phone conversation. Each 9 | P a g e of the interview sessions was audiotaped, transcribed, coded and subjected to thematic data analysis. Five key themes were identified based on respondents’ opinions and it was found that community pharmacists in study’s locale are aware of the use of ICT-based techniques such as Health Information Technology, Electronic Prescription and Telecare services in their line of duty as seen in the developed world but their use in the Nigerian environment is inexistent. This study unraveled the factors including poor infrastructural facilities, lack of technical skills, financial constraints, poor public reception as the major bottlenecks behind the nonexistent of these ICTbased techniques in the professional workstation of of community pharmacist in Nigeria. Consequently, this paper proffered measures to bring about the existence of these techniques as respondents welcomed the idea of their introduction and felt it would enhance their professional job functions. Interestingly, the present work also established a theorized concept of “Professional Marginalization” and “Professional Exclusion” as engaged community pharmacists overtly stated that they had no well-defined place in the Nigerian public health system owing to the fact that they enjoyed little or no “professional rapport” with other health professionals when it comes to patients’ health issues. Non-existence of ICT-based techniques was said to contributed to this and respondents thus call for a way to be involved by integrating ICT-based techniques explored here along with others seen in the advanced world in their work station. Respondents felt that their professional stance can be redefined with ICT-based technique. The research thus conclusively calls for future research to the done in staking claim for the theorized concept of professional marginalization and professional exclusion established here.
Monoclonal Antibodies as Promising Therapeutic Agents in the Pharmaceutical Industry and Their Current Challenges.
(Griffith College, 2020) Ozen, Alara
Monoclonal antibody discovery and their use as therapeutic agents have made a revolutionary transformation in the research focus of the pharmaceutical industry which reflected to market growth with their promising profile for considerably severe diseases which are lacking in a complete treatment such as cancer and autoimmune disorders. However, their biochemical aspects bring various complexity and challenges in the development and use. This study evaluates the impact that monoclonal antibody therapeutics have made on the pharmaceutical industry, identifies the success in the generation of different monoclonal antibody formats over time, finds out the current bottlenecks within the development and therapeutic use of monoclonal antibodies, and assesses their potential as therapeutic agents for currently untreatable diseases, with a special emphasis on their promising implementation into COVID-19. The study comprises qualitative and quantitative approach and was carried out with a group of 98 professionals that consisted of scientists, medical doctors, regulatory professionals, pharmaceutical/biotechnology professionals. Findings show that the most challenging factor in the development of monoclonal antibody therapeutics is the drug design and formulation, while high costs was identified as the most challenging factor for their use. Even though the bottlenecks in the development and use of monoclonal antibodies, challenges are considered manageable in the close future as a consequence of the growing interest in improving monoclonal antibodies, and global focus for their use against COVID- 19, as well as patent expirations which will lead to biosimilar alternatives.
ssessment of the best theories of collaboration for conducting academic-industry collaborations in the pharmaceutical industry.
(Griffith College, 2020) Vasudeva, Ayush
Research question: What are the best theories of collaboration for conducting academic-industry collaborations in the pharmaceutical industry? This thesis assesses the best theories of collaboration necessary to conduct academicindustry collaborations in the pharmaceutical industry. It involved conducting interviews for both, academic and industry professionals, which provided deep and impactful insights about how each side of the collaboration operates and works in union with one another to achieve targets and accomplish project goals. In order to better understand the best theories of collaboration, it was necessary to include the history of what academic-industry collaborations are and the key challenges involved in academic-industry collaborations in the pharmaceutical industry and in other industries. Theories of collaboration were further explored, including how their themes have been applied earlier in academic-industry collaborations in other industries, but focuses particularly on those that functioned in the pharmaceutical industry. The professionals included academic chairs, senior academic professors and researchers, as well as industry professionals. The approach to gathering information was based on a narrative analysis approach, which was framed on the basis of gathering the stories and experiences of the participants in this dissertation study and was interpreted on those grounds. A total of 4 professionals from the academic side and 4 from the industry side were interviewed, wherein their experiences and stories from their career progression in academic-industry collaborations in the pharmaceutical industry was analysed and coded for determining whether the selected theories had impactful contributions for resolving the challenges identified. The findings, including the importance of themes being used in combinations and the prevalence of some themes over others in resolving certain challenges fell in line with the literature review conducted and has supplemented the research objectives and the established research question. The professionals explained what their best collaborations were, the greatest challenges they faced, their history of being involved in academic-industry collaborations and the quantity and quality of their work experience, which enabled them to conduct such collaborations. The theories included in the literature review were applied to the in-depth interview findings, and there was a strong link found between the theories of collaboration and the most successful collaborations conducted by the interviewed professionals. This is an area that still requires a lot more research to understand as to how academia and industry need to collaborate, how should the conduct and mindset of those involved in such collaborations be, and what exactly are the best theories of collaboration for conducting such collaborations.
The Impact of Blockchain Technology on Clinical Trial Data Integrity
(Griffith College, 2020) Cullen, Karl
In this study it was shown how a new and emerging technology known as Blockchain, a data management platform, possesses the potential to address some of the predominant issues pertaining to clinical data integrity within clinical trial research studies. However, many obstacles and challenges persist with its implementation and these must be addressed, understood and solved before the technology can be utilized to manage clinical data. The main research objective of this study was to examine how Blockchain could be suited to address the concerns relating to clinical data integrity and to address the perceptions of participants involved with clinical data management to the technology and its potential application within clinical trials. Through an exploratory quantitative and qualitative mixed methods approach aligned with a pragmatist research philosophy, primary data was collected from participants who were purposively selected from a homogenous sampling pool that consisted of those with backgrounds in clinical data management. Primary data produced from this study highlighted the correlation of data issues that contribute towards the lack of integrity of clinical data with those found in secondary research. It was also found that the perception of Blockchain was generally positive and favorable towards its adoption within clinical trials. However, there was a degree of uncertainty surrounding the security of data within Blockchain. Various challenges were identified, primarily, the complexity of the technology and challenges related to compliancy with data protection laws. The conclusive determination of Blockchain’s suitability to address clinical data concerns, however, remains unanswered and further research is needed to test the application of Blockchain in real-world clinical trial environments. Further research and studies are also necessary to address the many challenges that face Blockchains implementation with clinical data management.
The impact of serialisation on operational efficiency and productivity in Irish pharmaceutical sites.
(Griffith College, 2020) O'Mahony, Daniel
Serialisation Technology was introduced to protect the pharmaceutical supply chain from infiltration by falsified and substandard medicines. The implementation of serialisation systems required a substantial investment by pharmaceutical manufacturers. This study investigated the impact of serialisation on the operational efficiency and and productivity in Irish pharmaceutical sites. [...] The study identified a trend where Irish pharmaceutical sites are moving away smaller batch production and moving toward larger batches so as to gain greater efficiencies. The research also proposed the use of a serialisation depreciation factor [...] as a method to determine the impact of serialisation on the cost of goods sold.
The impacts of Drug Importation Regulation on Local Pharmaceutical manufacturers in Lagos Nigeria
(Griffith College, 2020) Chisom Lawrence, Osuchukwu
The thesis aims at evaluating the impacts of drug Importation regulation on local pharmaceutical manufacturers in Lagos Nigeria by carrying out a questionnaire-based surrey and zoom interviews for quantitative and qualitative analysis respectively. In achieving the objectives of the study, the knowledge, awareness, and drawbacks faced by the local pharmaceutical industry were appropriately considered in order to derive at effective recommendations to improve local drug manufacturing in Lagos Nigeria. Both groups (local drug manufacturers/importers) in the pharmaceutical industry were compared to derive at their perspective on the impacts of drug importation regulations on their business. A total of 77 out of the 117 participated actively in the survey, of whom they combine pharmaceutical importation and local pharmaceutical manufacturing. Interesting, 83% of the participants admitted that the importation regulations in Nigeria are outdated and ineffective/inconsistent and have impacted negatively to the growth of the industry. However, an overwhelmingly majority of the local drug manufactures/importers also attributed the frequent taxation from state and non-state regulators as a major draw backs to local drug manufacturing that have yielded to the 25% capacity production of the Nigeria local drug manufacturing. Furthermore, most of the respondent admitted that the lack of basic infrastructures like power, road networks, water etc. from the Nigeria government have drastically discouraged local drug manufacturing and encouraging drug importation chiefly from India. On the contrary, majority of local manufacturers/importers agreed that the foreign CMOs have widen the scope of pharmaceuticals available in Nigeria and encouraged the circulation of fake and substandard drugs and affected the growth of the local manufacturing negatively. In conclusion, the local manufacturers recommended that the growth of the depends majorly onnthe contributions of the government in providing soft loans, shutting down the open drug market in Nigeria, implementation of the drug regulations, setting up a vision for the industry, provision of tax breaks, investment in R&D, reviewing of the importation regulations to encourage local drug manufacturers, and lastly government should patronize made in Nigeria drug products.

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