Griffith Open: No conditions. Results ordered -Date Deposited. 2024-03-28T17:48:04ZEPrintshttps://go.griffith.ie/images/sitelogo.pnghttp://go.griffith.ie/2022-01-19T21:51:00Z2022-01-19T21:51:00Zhttp://go.griffith.ie/id/eprint/509This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5092022-01-19T21:51:00ZR&D innovative technologiesin the pharmaceutical sector and the challenges in their implementation in the EUThe pharmaceutical industry is constantly changing, and patients necessities waiting for treatment are numerous. New diseases and those that do not have treatment are constant factors demanding the pharmaceutical industry look at recent trends in R&D, search for different scientific solutions, and focus on innovation. It is essential to know the R&D innovative technologies, applications, and development in the current landscape, driving the pharmaceutical sector forward. In the new context, where the European Union has 27 countries, the European Medicines Agency (EMA) regulates approvals and population worldwide lives in the context of the Covid-19 pandemic. The vision of opting for new technology, knowing the trends in R&D, science, and innovation opens a panorama of opportunities and challenges for the pharmaceutical sector. The study comprises qualitative and quantitative approaches to investigated innovative technologies and their challenges in pharmaceutical R&D. Data generation have been carried out with scientists working in R&D, pharmaceutical professionals, and regulatory professionals, followed by an analysis of information available through documentary research. Findings have shown that the most challenging factor influencing the R&D innovative technology approval is regulatory standardization. This factor has led to the major constraint in implementing innovative technologies, while Technology cost has been identified as the second challenging constraint. R&D innovative technologies represent an advantage in a COVID-19 pandemic context through gene therapies and digital transformation with access to big data in real-time. R&D management performs a principal role in the implementation of new technology. As Claud-based data management has been the main Pharma 4.0 element implemented in the EU in recent years, Policy and regulatory activity and Data integrity and cybersecurity will represent the pharmaceutical sector's major challenges in the next ten years.Berenice Erreguin Luna2022-01-19T21:41:31Z2022-01-19T21:41:31Zhttp://go.griffith.ie/id/eprint/506This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5062022-01-19T21:41:31ZThe Study of the Key Challenges Facing Pharmaceutical Manufacturing Industry in Lagos, Nigeria, With Emphasis on Cost and Access to Quality Raw MaterialThe Nigerian pharmaceutical manufacturing industry is very important to the economy of Nigeria. From empirical research already done on the Nigerian pharmaceutical industry, it was
gathered that several challenges drag the development of the sector. This gave good understanding about this work which aims to study the challenges facing the pharmaceutical
manufacturing industry in Lagos, Nigeria with emphasis on cost and access to quality raw materials.
Considerably, 25% of the pharmaceutical products required by Nigerians are locally delivered by Nigeria’s pharmaceutical industry. The excess 75% are imported from other developed
nations like UK, India and China (WHO/PQT, 2014).
The Research Onion proposed by Saunders and his colleagues Lewis and Thornhill in 2009 forms the bases and provides the structure for the research process used in this study. Central
in the context of this dissertation is the research philosophy of interpretivism. The research approach was deductive and aimed to collect data and build a theory based on the results
(Saunders, Lewis and Thornhill, 2009). A case study strategy was used to properly understand the challenges especially in the area of cost and access to quality raw materials, facing the four pharmaceutical manufacturing firms employed in this study. A mono method research choice (only qualitative research strategy) was adopted for the collection of data. Then data were collected and analysed into themes which assisted in the overall research findings. The results from this study on the accessibility of raw material reveal that all the pharmaceutical firms in Nigeria rely heavily on the importation of raw materials. On the affordability of quality
raw materials, all data collected pointed to the fact that the prices of quality materials are becoming increasingly expensive and unaffordable. On the impact of accessibility to quality raw materials on the production capacity, this study revealed that accessibility to quality materials dramatically influences the production capability of pharmaceutical firms in Nigeria.
Lastly, on the impact of cost of quality raw materials on the production capacity, this study revealed that the cost of the materials is prohibitive.Ojo Nathaniel Olatokunbo2022-01-19T21:25:51Z2022-01-19T21:25:51Zhttp://go.griffith.ie/id/eprint/507This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5072022-01-19T21:25:51ZA Quantitative Study on Factors Associated with the Implementation and Uptake of Paediatric Vaccination in India and IrelandVaccinations are the simplest, safest and cost-effective method to protect population from infectious diseases by boosting a person’s immune system. It is important to enhance Paediatric immunogenicity as they are at high risk of getting serious infectious disease by harmful germs. Parents and healthcare professionals play an important role in the coverage rate of vaccination among children. Despite the success of Paediatric vaccination, the coverage rate of child immunization is very less in certain countries. It is essential to evaluate parental behaviour and knowledge of healthcare professionals about child immunization and to identify the factors associated with the implementation and uptake of childhood vaccination to improve the practice of Paediatric vaccination.
Method:
A cross-sectional quantitative study was undertaken on parents and healthcare professionals, who live in Ireland and India. A total of 133 participants; 69 parents and 64 healthcare professionals were involved in the study. Specifically developed questionnaire used to collect data from participants through email and mobile apps.Nithya Maria George2022-01-17T12:12:41Z2022-01-17T12:12:41Zhttp://go.griffith.ie/id/eprint/504This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5042022-01-17T12:12:41ZBarriers that Restrict Patient Involvement in Drug Development: An Industrial PerspectiveObjective:
To explore the barriers restricting the implementation of patient involvement in drug development(PIDD)from an industrial perspective and to get insights on knowledge and awareness of pharmaceutical employees around PIDD and its various facets.
Methods:
A questionnaire-based survey (n=51) was conducted among the pharmaceutical employees currently working in Research and Development, to seek information regarding barriers pertaining to patient involvement in drug development. The study participants were evaluated for their understanding and awareness around the subject to get insights on the persisting knowledge gaps. The data was analysed descriptively and interpretatively, based on the type of responses obtained.
Results:
In the study, 74% of the respondents considered lack of dedicated groups as a likely factor hurdling the execution of PIDD. In addition, a total of 62% of the employees corresponded lack of industrial confidence in patient knowledge and skills to hinder the effective industrial implementation of the concept, while 16% of the participants considered proper representation of patient population for PIDD activities unlikely to cause hurdles. Insights on participant’s knowledge and awareness on PIDD and its support organisation, revealed it to beaverage, considering their close associations with drug development activities. Recommendations for improving the current state of patient involvement in drug development were primarily directed towards enhancing knowledge base around the topic, reforming the current industrial practices to better involve patients and strengthening regulations around PIDD.
Conclusion:
Despite increasing efforts from patient organisations in promoting PIDD within industrial practices by empowering patients through trainings and by coming up with recommendations to recognize patients as equal partners in the venture, there still exists barriers that hinder its practicality. Bridging the gap between the conceptual theories and functionalism is necessary and requires identifying the factors posing challenges and overcoming them by establishing means to improve patient involvement. Assessing the value of methods offered for PIDD execution, expanding the population range and utilising information from regulatory database to gain insights on the state of PIDD, allows for further research.Ria Rose Roy2022-01-17T11:56:06Z2022-01-17T11:56:06Zhttp://go.griffith.ie/id/eprint/503This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5032022-01-17T11:56:06ZThe Study of the Role of Digital Transformation on the Pharmaceutical Manufacturing Process in the Nigerian Pharmaceutical Industry.In this dissertation, an exploration of the role of digital transformation in the Nigerian pharmaceutical manufacturing industry was studied. The study was constructed around descriptive primary exploratory research design and a qualitative research method was used in achieving a robust understanding of the relevance of digital transformation and various advanced digital tools in a pharmaceutical manufacturing operation in the wake of the recent industrial 4.0 revolution and hence pharma 4.0 concept which entails being smart and efficient in achieving manufacturing excellence. To achieve this aim, a purposive snowballing sampling technique was used in enlisting Ten (10) pharmaceutical industry experts who are familiar with pharmaceutical manufacturing operations and knowledgeable on the various industrial developments around them. Using mobile phone calls, five (5) separate in-depth semi-structured interviews were successfully conducted with the five of the experts who were sourced from different secondary drug-producing companies in Nigeria. In the interviews conducted, sixteen (16) questions, formulated through inductive reasoning, were used as a guide and all responses were audiotaped, transcribed into text equivalent, and analyzed using thematic content analysis. In the analysis of the interview data, six major themes were identified and discussed. The study found out that while there is an awareness of the concept of digital transformation in the Nigerian pharmaceutical industry environment, the industry is nevertheless “digitally immature” as the manufacturing process is exclusively driven by traditional. It is as well found out in the study digital transformation comes with the potential to achieve operational excellence (measured in term of reduced waste, decreased error/batch defect rate, improved product quality, less equipment downtime, etc.) and contribute to business excellence by positively impacting the business model of pharma companies in Nigeria which is based on speed to market and competitive pricing that requires efficient production and effective cross-functional supply chain integration). While these were identified as some of the endless potentials of digital transformation in pharma manufacturing, cultivating a digital mindset was found to be an integral initiative in achieving digital transformation in the Nigerian manufacturing industry environment which is not free of challenges. Factors including poor infrastructural developments, lack of investment and resources were identified as “general barrier/challenges” while factors including knowledge gap, lack of expertise, and regulatory hurdles were identified as “industry-specific barriers/challenges” faced by Nigerian pharmaceutical companies in embracing pharma 4.0 model and achieving digital transformation and hence making the industry to be digitally immature.Motunrayo Oluderu2022-01-17T11:50:07Z2022-01-17T11:50:07Zhttp://go.griffith.ie/id/eprint/502This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5022022-01-17T11:50:07ZThe Impact of Lean and Modularity on Pharmaceutical Facilities in IrelandModularity is a systematic process where the various modules of a system or product can be combined in multiple ways to form a different product or system while Lean is a user-centric approach that focuses on continuous improvement, waste elimination and project management. This piece of research is an exploratory study aimed at investigating the adoption of Modularity and Lean in pharmaceutical facilities in Ireland. This research analyzed Pharmaceutical production managers, quality managers and construction Engineers who have implemented Lean and Modularity in the development or operation of production facilities. A mixed method questionnaire survey was sent to pharmaceutical personnel involved in the implementation of Lean and Modularity to analyze the critical areas of Lean manufacturing and modular manufacturing within the pharmaceutical industry. The various Topics associated with Modularity and Lean such as benefits, challenges and contributing factors to implementation success were examined within the questions. The results obtained show that facilities implemented Modularity extensively in the production area and its components while there has been a moderate to extensive implementation of lean across critical areas. It was concluded that pharmaceutical facilities valued scalability, flexibility, order, and waste elimination.Ayodeji Awe2022-01-17T11:42:00Z2022-01-17T11:42:00Zhttp://go.griffith.ie/id/eprint/501This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5012022-01-17T11:42:00ZAntidepressants among Healthcare Professionals in South India1.Background
Antidepressants are drugs which are used to relieve the symptoms of depressive disorders. The clinical awareness about physical, mental and social factors of a patient is very keen in deciding an optimal antidepressant therapy. The rational use of antidepressant must be monitored very carefully as inappropriate use can lead to its abuse and overuse
2. Purpose
This study aims to evaluate the knowledge and attitude towards, antidepressant drugs among the healthcare professionals working in South India. This is to analyse the issues involved in practicing antidepressant therapy and review the methods to ameliorate and enhance the implementation of antidepressants.
3. Design and methodology
The study involved deductive approach as well as qualitative and quantitative analysis was done for the questionnaire-based survey conducted among 50 healthcare professionals in South India. The secondary data was acquired from an analysis of current research articles on antidepressants and its abuse and overuse and the measures to curtail these issues.
4. Findings
Eighty four percent of the participants reported that the main cause for antidepressant abuse and overuse is the inappropriate use of antidepressants. Considering, pharmaceutical companies’ intervention, there was a strong agreement from the study group at seventy four percent while twenty four percent gave a neutral response. A large proportion of the healthcare professionals agree that outpatients pressurise them to prescribe or dispense antidepressants.
5. Conclusion
The participants had adequate understanding of general antidepressant use. Lack of knowledge can be curtailed by the implementation of antidepressant awareness programs. Healthcare professionals should be motivated to attend training programmes to reduce the abuse and overuse of antidepressants.Athul Mathew2022-01-17T11:35:00Z2022-01-17T11:35:00Zhttp://go.griffith.ie/id/eprint/500This item is in the repository with the URL: http://go.griffith.ie/id/eprint/5002022-01-17T11:35:00ZAn Analysis Of Factors Contributing To Successful Implementation Of Flu Vaccine Programmes In IrelandInfluenza is a contagious respiratory illness caused by the influenza virus. Influenza epidemics result in higher hospitalization and medical costs, as well as higher labour absence and poorer productivity. Vaccination is a simple, safe, and effective way to protect people from contagious viruses when they make contact with them. This study focuses on the factors that contribute to the successful implementation of flu vaccine programmes among the Irish population. The study also focuses on to the perspective of Irish population towards flu vaccine as well as the situation in Ireland regarding the Flu. The study was conducted in Ireland’s capital, Dublin.
OBJECTIVE:
To outline the situation in Ireland with regard to Flu vaccinations, to identify the major determining factors for the effective implementation of flu vaccination programs among Irish citizens and to identify the perspective of Irish population towards flu vaccinations .
METHODOLOGY:
It is a cross-sectional quantitative study. The primary data was collected through the survey conducted with the help of a closed ended questionnaire. 185 people participated in the survey and their response to the questions were considered as the basis of this study.
RESULTS:
Result of the study found that the factors including Place to get vaccination, source of information, mandatory vaccination programmes, cost, time, safety issues etc plays a critical role successful implementation of flu vaccine programmes in Ireland.
CONCLUSION:
The vaccine coverage in the country can be improved by providing maximum education, awareness programmes and campaigns by tackling myths, hurdles, and misunderstandings of flu vaccination.Jeethumol George2022-01-17T11:26:08Z2022-01-17T11:26:08Zhttp://go.griffith.ie/id/eprint/499This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4992022-01-17T11:26:08ZThe Technological Readiness of Pharmaceutical Companies in Ireland facing Pharma 4.0The aim of this research was to measure the technological readiness of pharmaceutical companies in Ireland facing Pharma 4.0. Also, describe the triggers and challenges in adhering to the operational model implementation. Through the application of surveys to employees belonging to the pharmaceutical industry workforce, valuable data could be obtained, which was quantified. Using digital maturity measurement instruments was possible to locate the Irish pharmaceutical industry is in the visibility stage which represents a basic level of Pharma 4.0 implementation.
Motivated by the increase in its production, but challenged by the monetary and logistical implications of acquiring new technologies.
The significance of this study is that it allows obtaining a general description of the level of presence of Pharma 4.0 in the entire pharmaceutical industry. Allowing to show the strength and weaknesses in the capabilities currently present in the industry.Karla Iveth Rodriguez Lagos2022-01-17T11:17:29Z2022-01-17T11:17:29Zhttp://go.griffith.ie/id/eprint/498This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4982022-01-17T11:17:29ZLimitations Impacting Local Manufacturing of Vaccines: A Nigeria Case StudyVaccination is an age long science that has been proven to prevent some deadly diseases, especially in children below the age of 5years. Therefore, it is empirical for any nation to stimulate the process of immunization and ensure that children and adults are protected from some of these infectious and deadly diseases. This will bring about a safe, healthy, and productive society where every individual within the system contributes their quota to the Gross Domestic Product (GDP) rather than treating the overall consequences of the lack of vaccination.This research work was initiated to critically consider the limitations that impact local manufacturing of vaccines in Nigeria. A review of various literature from articles, journals, workshop presentations at different scientific conferences and other sources on related topics, to see trends and events as it relates to effort made in local vaccines manufacturing. From the literature reviewed, it was evident that most of the vaccines production are from developed countries like china, India, Russia, Vietnam, United States of America, Europe with very few Africa countries currently manufacturing vaccines locally.In this research, qualitative method and Interpretivism philosophy of interviews arranged with experts on this subject matter were employed. Due to the prevailing pandemic ravaging the world, the researcher could not have a face-to-face interview with the identified experts contacted to be part of this research. Therefore, zoom meetings were set up and responses to the questions asked were all recorded and transcribed during the data analysis process. This process adequately ensured that the data collection process was effectively managed and with the use of thematic analysis, which is considered the most effective and preferred method used in qualitative data analysis based on its enormous benefits.From the data analyzed using the answers provided by the experts interviewed in this research work, some findings inferred. There is no vaccine currently manufactured locally in Nigeria. Advocacy could be considered a strong tool in achieving local manufacturing of vaccines. There are available government policies on local manufacturing of vaccines, but the problem majorly is the lack of policy implementation.Although the pharmaceutical industries are willing to engage in local manufacturing of vaccines. Also, the challenges facing the pharmaceutical industries in achieving local manufacturing of vaccines are numerous but could be upturned with government support. My researcher work has been able to identify some solution through the various recommendations and suggestions as discussed in chapter 5 of this dissertation. If these highlighted issues are implemented, then achieving local manufacturing of vaccines could be easily achieved and in good time.Omoniyi Sunday Adesanya2022-01-17T10:58:45Z2022-01-17T10:58:45Zhttp://go.griffith.ie/id/eprint/496This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4962022-01-17T10:58:45Z1A comparative study of Regulatory systems and Quality management practices in the manufacturing process of different pharmaceutical companies in Nigeria.This thesis aims to examine and compare different pharmaceutical manufacturing companies in Nigeria(local and foreign). There will be an examination of regulatory systems and quality management practices in the company and their impact on the quality and availability of medicinal products in the region. The opinion of medical doctors, pharmacists and consumers concerning the products from foreign and Nigerian pharmaceutical companies would also be considered when examining the impact of company quality system on the products. This aim would be achieved by way of conducting quantitative questionnaire survey and qualitative reviews of literature.A cross-sectional survey with 50 participants including medical doctors, pharmacists and consumers was carried out and literature about the regulatory systems and quality management practices of the were reviewed and the results showed the regulatory system in Nigeria is not effective and the entire pharmaceutical sector of has loopholes that make the system inefficient. The research was also able to identify the factors that influence the quality and availability of medicinal products manufactured in Nigeria which include Socio Economic status of the country,Inadequate laws or poor enforcement of the existing regulations/guidelines for manufacturing of good quality medicinal products,Inadequate funding/support for Nigerian pharmaceutical manufacturing companies,Demand exceeding supply and high cost of good quality medicinal product. NAFDAC has put in efforts over the years to improve their system but there are still important changes that need to be made. The study recommend that NAFDAC makes the Nigerian Pharmaceutical sector more transparent with its activities and more funding should be made available to the Nigerian pharmaceutical companies. Also should be set up to ensure that the NAFDAC officials carry out their duties effectively and they should be paid properly for it.Anyiam Chioma Awele2022-01-17T10:47:02Z2022-01-17T10:47:02Zhttp://go.griffith.ie/id/eprint/495This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4952022-01-17T10:47:02ZThe Role and Impact of Process Analytical Technology (PAT) on Solid Dose Manufacturing in NigeriaThis research investigated the role and impact of Process Analytical Technology (PAT) on solid dose manufacturing in the Nigerian pharmaceutical industry. PAT has been generally adjudged to be a promising technology that can significantly improve manufacturing efficiency and reduce the cost of production. There is evidence to back this point of view based on the automotive industry and other industries that have successfully implemented PAT. However, regardless of the demonstrated benefits of PAT, manufacturers in the pharmaceutical industry seem too slow to implement it in their manufacturing process. Realising this, the United States Food and Drug Administration (FDA) enacted a series of initiatives to drive a regulatory framework that could motivate manufacturers in the pharmaceutical industry to implement PAT. Nigeria represents one of the biggest pharmaceutical market in the world by virtue of its population which is estimated to be the biggest in Africa where PAT could help deliver quality medication at affordable rates. To investigate the role and impact of PAT in the Nigerian pharmaceutical industry, this research adopted a quantitative approach whereby self-administered questionnaires were sent to manufacturers through an online Google Form. The list of registered pharmaceutical manufacturers was obtained from NAFDAC, the regulator of the industry in Nigeria. Out of about 130 established manufacturers, 62 responses were obtained. Based on inferential statistics, the results show that indeed PAT plays a role in the Nigerian pharmaceutical industry albeit an insignificant one. Out of about twenty-one (21) identified challenges, eleven (11) were statistically significant. The most significant challenges that the respondents agreed the strongest to relate to the cost of implementing PAT. Although the hypotheses tested revealed that PAT has a significant effect on the price, quality and effectiveness of solid dosage forms, the general experience of health practitioners could not justify PAT adoption. Therefore, it is recommended that manufacturers in the Nigerian pharmaceutical industry must think long term in order to overcome the hurdle of the initial cost of implementing PAT. The regulator of the industry must find strategies of making pharmaceutical manufacturing attractive so as to drive innovation from the manufacturers.Chinedu Nnadozie Chukwu2022-01-17T10:41:40Z2022-01-17T10:41:40Zhttp://go.griffith.ie/id/eprint/494This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4942022-01-17T10:41:40ZImpact of Post Marketing Surveillance on Falsified Medicine in NigeriaThe thesis aims to evaluate the impacts of post marketing surveillance on falsified medicines among healthcare professionals (medical doctors and pharmacists) and consumers in Nigeria by conducting a questionnaire-based survey for quantitative research. in order to achieve this, the awareness and knowledge of falsified medicines, factors affecting effective post marketing surveillance in Nigeria and recommendations to improve adequate post marketing surveillance of falsified medicine in Nigeria.
The healthcare professionals (medical doctors and pharmacists) and consumers were evaluated to ascertain their level of awareness and knowledge of falsified medicines, healthcare professionals’ direct experiences to post marketing surveillance guidelines and frequencies of falsified medicine cases during their experience. The efficiency of Mobile Authentication Services (MAS). Sixty-six (66) respondents voluntarily participated and responded accordingly to the questionnaire structured survey.20 (30.0%) respondents were medical doctors, 24 (36.0%) respondents were pharmacists while 22 (33.0%) respondents were consumers. There was an absolute 100.0% respondents to willingness to update their knowledge about guidelines and regulations of post marketing surveillance of falsified medicine. Their most preferred method was through current guidelines from regulatory bodies.
There were factors associated with inadequate impacts of post marketing surveillance which included NAFDAC regulatory policies, social economic status of the country and cost implications. Increasing awareness of falsified medicines was recommended to be implemented by continuous advertisements through internet, radios and newspapers. Designing and implementing new applicable regulations to help improve post marketing surveillance.Chukwudi Anthony Mgboko2022-01-17T10:34:45Z2022-01-17T10:34:45Zhttp://go.griffith.ie/id/eprint/493This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4932022-01-17T10:34:45ZEffects of GMP Trends on the Pharmaceutical Industry in NigeriaThe pharmaceutical industry is important to the economies of the world and for the preservation and promotion of the health of the human society. It is the industry that narrows the gap existing between health-span (disease-free lifetime) and lifespan, so that human beings can live longer and better lives. Therefore, good manufacturing practices are regulations/rules put in place to guide the conduct and operations of pharmaceutical firms to safeguard public health and safety from counterfeit, contaminated or falsified medications. There are trends that have emerged within the GMP space in the pharmaceutical industry which is what this research study has tried to investigate within the pharmaceutical industry in Nigeria. The gaps that exist in the subject area after literature search informed the objectives of the study which seeks to examine the perceptions of professionals regarding GMP trends in the pharmaceutical industry in Nigeria; evaluate the impact of technology in the implementation of GMP on the pharmaceutical industry in Nigeria; find out the impact of quality assurance as part of GMP trends on the pharmaceutical industry in Nigeria; and examine the effects of new drug safety issues as part of GMP trends on the pharmaceutical industry in Nigeria. To execute the study, exploratory design using qualitative research method in whichfive(5)participants were selected through the convenience sampling technique was deployed. Semi-structured interviews were initiated through Google Meet to collect qualitative data from the interviewees. Gioia qualitative data analysis technique was employed to analyse the collected qualitative data. The study reveals that (i) based on professionals’ perceptions, GMP trends in the pharmaceutical industry in Nigeria are characterised by trust, safety and quality; (ii) technology in the implementation of GMP trends in the pharmaceutical industry affects the entire product life cycle of pharmaceutical products; (iii) quality assurance as part of GMP trends in the pharmaceutical industry inNigeria improves public health; and lastly (iv) new drug safety issues as part of GMP trends influence continuous drug products’ monitoring for public safety.Findings show that GMP trends in the pharmaceutical industry have improved the industry but there is still room for growth and further development if the industry is to rival its counterparts in the rest the developed world especially in the area of greater technology adoption and tightening of the regulatory framework guiding the industry. The contribution of the current study will benefit academic researchers, regulators, pharmaceutical products’ manufacturers, consumers and government.Olanrewaju Olalekan Onafuwa2022-01-17T10:26:03Z2022-01-17T10:26:03Zhttp://go.griffith.ie/id/eprint/492This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4922022-01-17T10:26:03ZAn Analysis of Drug Distribution and Medication Errors to Improve Pharmaceutical Services in NigeriaThe problem of medication errors represents risks in public health with negative consequences on patient’s wellbeing. Globally, healthcare sectors face more challenges addressing the incidents of medication errors due to underlining factors such as severe funding shortfalls, low patient-physician ratio, inadequate infrastructure and low technological inputs amongst others. Given the foregoing, this study employed a qualitative research design aided with a key informant interview of seven public healthcare experts to examine the drug distribution and administration system of Nigeria's public healthcare setting. The primary data derived from public health experts with both theoretical and practical knowledge of Nigeria's public hospital settings were examined against the secondary data derived from the review of extant literature. The outcomes suggest that systemic problems such as the weak political will of the government to effectively fund its healthcare sector, low workers engagement, weak supervision, anemic enforcement, non-adherence to standard procedures, shortage of healthcare professionals (HCP), low patient awareness, poor organizational culture amongst others represent factors precipitating medication errors. To reverse these significant problems, the study made recommendations comprising the reimagining of the boards and the personnel administration of the hospitals to include individuals from the organized private sector, to enhance best practices and modern HRM practices. Others include the government should boost public funding for the sector, incentivize skilled and experienced HCPs to exercise better supervision, deploy automation to digitally safeguard the system, incentivize medical and nursing education to sustain recruitment pipeline, mandate periodic training for HCP, and the introduction of a mandatory patient awareness booklet to boost public awareness of what constitutes medication errors, the introduction of a mandatory clinical audit review of public hospitals to be conducted by a third party from the private sector, and reorganizing the governance boards of government administered to include non-bureaucrats and seasoned professionals. These are needed to greatly reduce the incident of medication errors in Nigeria's hospital settings.Talabi Babatunde Muyiwa2021-06-22T15:08:12Z2021-06-22T15:08:12Zhttp://go.griffith.ie/id/eprint/445This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4452021-06-22T15:08:12ZAn Analysis of The Use of Wearable Technology as A Means of Controlling Drug Delivery Systems and The Challenges Facing Its Usage in IrelandIn 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.Adewumi Bolatito Temitayo2021-06-22T14:57:56Z2021-06-22T15:00:18Zhttp://go.griffith.ie/id/eprint/443This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4432021-06-22T14:57:56ZThe Impact of Blockchain Technology on Clinical Trial Data IntegrityIn 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.Karl Cullen2021-06-21T11:45:58Z2021-06-21T11:45:58Zhttp://go.griffith.ie/id/eprint/439This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4392021-06-21T11:45:58ZEnhancing pharmacovigilance in Nigeria: Challenges faced
by NAFDAC in monitoring of Adverse Drug Reactions in
NigeriaThis 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 welldesigned 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.Chinedum Odigbo2021-06-21T11:36:27Z2021-06-21T11:36:27Zhttp://go.griffith.ie/id/eprint/438This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4382021-06-21T11:36:27ZThe impacts of Drug Importation Regulation on Local Pharmaceutical manufacturers in Lagos
NigeriaThe 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.Osuchukwu Chisom Lawrence2021-06-21T11:27:48Z2021-06-21T11:27:48Zhttp://go.griffith.ie/id/eprint/437This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4372021-06-21T11:27:48ZAssessment of the best theories of collaboration for conducting academic-industry collaborations in the pharmaceutical industryResearch 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.Ayush Vasudeva2021-06-21T11:20:14Z2021-06-21T11:20:14Zhttp://go.griffith.ie/id/eprint/436This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4362021-06-21T11:20:14ZAn Analysis on the Assessment and Reporting of Adverse
Drug Reactions in Tertiary Hospitals in Lagos State,
South-West NigeriaDue 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.Zainab Abolanle Atobatele2021-06-21T11:13:06Z2021-06-21T11:13:06Zhttp://go.griffith.ie/id/eprint/435This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4352021-06-21T11:13:06ZAn Analysis Of How Collaboration Between Physicians And Pharmacists Might Facilitate Improved Healthcare In NigeriaThe 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.Moyosore Oluwatoyosi Osoko2021-06-21T11:01:25Z2021-06-21T11:01:25Zhttp://go.griffith.ie/id/eprint/434This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4342021-06-21T11:01:25ZAn Analysis of Factors Influencing Environmental Behaviours in Irelands’ Biopharmaceutical Industry EmployeesThis 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.Ciara Heverin2021-06-21T10:54:48Z2021-06-21T10:54:48Zhttp://go.griffith.ie/id/eprint/433This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4332021-06-21T10:54:48ZA comparative assessment of current and future pharmacovigilance in developed and developing countries - A case study of Ireland and NigeriaThe 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.Olanrewaju Saheed Jimoh2021-06-21T09:56:12Z2021-06-22T15:32:45Zhttp://go.griffith.ie/id/eprint/432This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4322021-06-21T09:56:12ZAn Analysis Of The Impact Of Nafdac (National Agency For Food And Drugs Administration And Control) In Drugs Quality Improvement In NigeriaCounterfeit 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.Oweh Omovogho love2021-06-21T09:37:05Z2021-06-21T09:37:05Zhttp://go.griffith.ie/id/eprint/431This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4312021-06-21T09:37:05ZA Comparative Study on Lean and Six-Sigma Implementation at
Various Pharmaceutical Industries in India and Ireland.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.Bala Sneha Chavva2021-06-21T09:27:09Z2021-06-21T09:27:09Zhttp://go.griffith.ie/id/eprint/430This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4302021-06-21T09:27:09ZAnalysis of Customer Satisfaction and Drug Product Quality in exploring Pharmaceutical Manufacturing Operational Excellence in Lagos state, Nigeria.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, NigeriaOmotayo Temitope Babatunde2021-06-21T09:09:50Z2021-06-21T09:09:50Zhttp://go.griffith.ie/id/eprint/428This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4282021-06-21T09:09:50ZChallenges impacting the reporting of Adverse Drug Reactions among healthcare professionals: Improving pharmacovigilance in Nigeria.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.Saliu Adeleke Yusuf2021-06-21T09:00:58Z2021-06-21T09:00:58Zhttp://go.griffith.ie/id/eprint/427This item is in the repository with the URL: http://go.griffith.ie/id/eprint/4272021-06-21T09:00:58ZThe impact of serialisation on operational efficiency and productivity in Irish pharmaceutical sitesDaniel O'Mahony2021-05-19T09:43:28Z2021-06-22T12:10:33Zhttp://go.griffith.ie/id/eprint/398This item is in the repository with the URL: http://go.griffith.ie/id/eprint/3982021-05-19T09:43:28ZMonoclonal Antibodies as Promising Therapeutic Agents in the Pharmaceutical Industry and Their Current Challenges.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.Alara Ozen