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  Barriers that Restrict Patient Involvement in Drug Development: An Industrial Perspective

  (2021) Roy, Ria Rose

  Objective: 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.
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  The Study of the Role of Digital Transformation on the Pharmaceutical Manufacturing Process in the Nigerian Pharmaceutical Industry.

  (2021) Oluderu, Motunrayo

  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.
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  The Study of the Key Challenges Facing Pharmaceutical Manufacturing Industry in Lagos, Nigeria, With Emphasis on Cost and Access to Quality Raw Material

  (2021) Olatokunbo, Ojo Nathaniel

  The 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.
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  Effects of GMP Trends on the Pharmaceutical Industry in Nigeria

  (2021) Olalekan Onafuwa, Olanrewaju

  The 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.
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  Impact of Post Marketing Surveillance on Falsified Medicine in Nigeria

  (2021) Mgboko, Chukwudi Anthony

  The 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.