Limitations Impacting Local Manufacturing of Vaccines: A Nigeria Case Study

Vaccination 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

R&D innovative technologiesin the pharmaceutical sector and the challenges in their implementation in the EU

The 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

Antidepressants among Healthcare Professionals in South India

1.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

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

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

The Technological Readiness of Pharmaceutical Companies in Ireland facing Pharma 4.0

The 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

The 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

An Analysis Of Factors Contributing To Successful Implementation Of Flu Vaccine Programmes In Ireland

Influenza 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

Impact of Post Marketing Surveillance on Falsified Medicine in Nigeria

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

The Role and Impact of Process Analytical Technology (PAT) on Solid Dose Manufacturing in Nigeria

This 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

A Quantitative Study on Factors Associated with the Implementation and Uptake of Paediatric Vaccination in India and Ireland

Vaccinations 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