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Griffith Open collects, preserves and makes freely available research publications by Griffith College staff and learners. These can include, but are not limited to, theses, peer-reviewed articles, book chapters, working papers and conference papers, professional presentations, exhibitions and teaching resources. Where material has already been published it is made available subject to the open-access policies of the original publishers. This service is maintained by Griffith College Library.

Recent Submissions

A Study of The Key Challenges in the Nigerian Pharmaceutical Industry, With Emphasis on the Regulation and Quality of Medical Devices
(Innopharma, 2023) Osidele, Mosopefoluwa; Vasquez-Robinet, Cecilia
The Nigerian pharmaceutical manufacturing sector holds significant importance for Nigeria's economy, particularly in relation to medical devices. Extensive research conducted on the Nigerian medical device industry has highlighted numerous challenges that hinder the sector's development. This study aims to investigate the challenges faced by the Nigerian pharmaceutical industry, with emphasis on the regulation and quality aspects of medical devices. Usar et al. (2017, p. 86-91). emphasize the weak state of pharmaceutical regulation in Nigeria, characterized by irregular inspections, inadequate enforcement, widespread violations, and resultant negative health outcomes. To structure the research process, the study adopts the Research Onion framework proposed by Saunders, Lewis, and Thornhill in 2009. The interpretivist research philosophy plays a central role in this dissertation's context. Employing a deductive research approach, the study aims to collect data and formulate a theory based on the obtained results Saunders et al. (2019, p. 207). A case study strategy is employed to gain in-depth understanding of the challenges, particularly in the regulatory and quality aspects, faced by the two selected medical device manufacturing firms and the regulatory authorities that restrict their performance. The research design involves a mono-method approach for data collection. The gathered data is then analyzed thematically, contributing to the overall research findings. The study reveals significant weaknesses in the current regulatory framework for medical devices, including poor implementation of guidelines, lengthy processing times, and inadequate post-marketing surveillance. Regarding challenges related to the manufacturing of high-quality medical devices, the study identifies the lack of raw materials and the unavailability of custom-made machine parts as key factors affecting the production capabilities of medical device manufacturing firms in Nigeria. Insufficient funding, policy inconsistencies, regulatory duplication, and high inspection costs are identified as factors contributing to the ineffectiveness of medical device regulation and registration. Finally, in terms of the efficacy of quality and safety management practices, the study concludes that the existing practices are inadequate in ensuring the utmost safety of the public.ts.
Evaluating the Impact, reaction, and building of resiliency among public and professionals caused by the disturbed Pharmaceutical Supply Chain due to the Russia-Ukraine War
(Innopharma, 2023) Mukunda Wankhade, Vishake; Alvarez, Yolanda
The focus of this research is to look into the influence of the Russia-Ukraine conflict on the Pharmaceutical Supply Chain as seen by the general public and supply chain specialists. The study also investigates the public's reaction and the development of resiliency among professionals, industry, and institutions. The major factors that affected the supply chain, particularly in the pharmaceutical business, such as Covid-19 and Brexit, are explained first. Following that, the primary crisis caused by the Russia-Ukraine war and its consequences are examined. The literature review indicates the impact of the conflict on policies, product manufacturing (particularly pharmaceuticals and medical devices), and clinical trials. Furthermore, the study looks at how different governments and businesses manage their supply networks and other departments during catastrophes. It highlights the individual nature of each crisis and the varying responses by different countries by highlighting examples from Covid-19 and the Russia-Ukraine war. Surveys and questionnaires were used to collect information from the general public and specialists on product shortages during the war, with a focus on their business continuity plans in different crises scenarios. The study concludes by outlining the categories of items that experienced shortages and highlighting the efforts taken by professionals at both the personal and corporate levels to mitigate supply chain interruptions. Using a realistic perspective, this study presents an examination of reality as experienced by all survey and interview participants.
Challenges in the Adoption of Biosimilars in India
(Innopharma, 2023) Jayachandran , Jayalakshmi Punchaparamban; Cheidozi, Chiamaka
The main aim of this research was to identify the main challenges faced by the pharmaceutical companies of India for the adoption of biosimilar drugs in the most recent scenario. Although there are several factors affecting the wide development and usage of biosimilars, in this study it was found that the lack of consumer or patient awareness followed by concerns on the safety and efficacy of biosimilars and lastly the lack of physician education and the inadequate regulatory framework for their development and approval. It was also noted that most of the study participants believe that India has a promising future for biosimilar drugs and the market is attractive for investment. The primary methodology of the study was quantitative survey which was carried out among 158 random pharmaceutical professionals of India to get their insights on the factors hindering on biosimilars. In addition, market analysis was carried out to provide comprehensive understanding of biosimilar landscape in India and a case study on a safety incident of biosimilar product approved in India showed how a more streamlined regulatory network could help in raising the quality of biosimilar drugs to other international standards. The multiple linear regression was carried out on the collected survey data and the findings showed there is no significant relationship between the experience of pharmaceutical professionals to the knowledge on biosimilar products and to the willingness to adopt a biosimilar product. Inorder to overcome the barriers, public education initiatives, trainings for healthcare professionals and conducting thorough pharmaceutical surveillance for analyzing the safety and efficacy of biosimilars can be carried out. Overall, by identifying and examining the key challenges, this research adds to the ongoing discussions about the adoption of biosimilars in India. The outcomes can guide future policy choices and strategic actions aimed at encouraging the widespread use of biosimilars, which will ultimately result in improved access to reasonably priced and high-quality biologic therapies in India.
Attitude and Challenges of Consumers and Pharmacists Towards Reporting Counterfeit Medicines in Lagos State, Nigeria
(Innopharma, 2023) Sinclair Chibuzor, Hillary; Chiedozie, Chiamaka
Counterfeit medicines are drugs deliberately misbranded, mislabeled, or adulterated with the intention of deceiving people into thinking they are genuine. Consumers and pharmacists play vital roles in reducing their circulation by reporting suspicious products to the authorities. Such information provides the regulatory authorities with valuable insights, enabling them to take necessary actions to stop the distribution and sale of these drugs. This study aimed to evaluate the knowledge of consumers and pharmacists in Lagos regarding the presence of counterfeit drugs in the Nigerian market, their associated risks, and their attitudes toward reporting such drugs. Additionally, the study investigated the challenges these groups faced when reporting such drugs and provided recommendations for overcoming these obstacles. The study collected primary data through an online questionnaire survey and phone interviews. The survey received responses from 182 consumers and 126 pharmacists, while the phone interviews were conducted with 8 highly experienced pharmacists to obtain their personal perspectives on the subject matter. Analysis of the collected data revealed that consumers and pharmacists in Lagos exhibited a high level of awareness about the presence of counterfeit medicines in Nigeria and the health risks associated with them. However, both groups demonstrated reluctance to report such medicines. The study revealed that the two groups faced similar challenges when reporting counterfeit medicines, with the most common problems, as noted by the majority of respondents in each group being a lack of knowledge on how to report (70.9% consumers, 51.6% pharmacists), difficulty in identifying counterfeit medicines (69.8% consumers, 64.3% pharmacists), and lack of confidence in the regulatory authority’s effort in combating the issue (69.8% consumers, 54.8% pharmacists). ress these challenges, the study proposed providing education and awareness programs to teach people how to identify and report counterfeit medicines, as well as providing feedback to individuals regarding the status of their reports and investigations. The researcher recommended that NAFDAC prioritize addressing the challenges which were identified by the largest number of participants in both groups to improve the reporting of counterfeit medicines in Lagos.
Assessing the Impact of Anti-Falsification Technology on Patient Choice of Prescription Medicines in Four Teaching Hospitals in Nigeria
(Innopharma, 2023) Yagazie Okechukwu, Anonye; Chiedozie, Chiamaka
Background: Falsified medicines over the years have had a major impact on both patients, manufacturing companies and national health budgets/insurance thus causing both economic and humanistic losses to stakeholders. It has caused an estimated loss of over 500 billion naira (625 million euros) to both local and foreign investors in the Nigerian pharmaceutical industry. This review analyzes data that was gathered between February 2023 to April 2023, through questionnaires designed to assessthe attitude of patients who were filling prescriptions with the background knowledge of falsified medicine detection. Aim: This study’s author theorized that authenticating labels and technology could affect the way patients see medicines and fill prescriptions. Methods: The study participants of 115 comprised of physicians 10%, pharmacist 47%, registered nurses 19%, medical laboratory scientists 15%, radiographer 2%, optometrists 3% and dentists 2% practicing across four teaching hospitals in Nigeria who participated through surveys. Data analysis was done using Microsoft Excel to produce charts, graphs and tables. Results: The analyzed data shows patients who have little or no awareness and those who gained awareness from their pharmacist or prescriber of medicine anti-falsification technology are likely to request for their prescriptions in its original packaging at a similar frequency. Whereas the data tilts and shows that those with little awareness are two-times less likely to suspect that a medicine is falsified when their treatment therapy fails and would often request for a change of brand or inform their prescriber as compared to the aware group who would immediately confirm suspicions that the medicine is “fake”. However, both groups would request for a known brand or generic whenever the prescription medicine lacks features for verification rather than seek reassurance of quality from their prescriber or pharmacist. Some of the recommendations provided by respondents to stop the spread of falsified medicines is the purposeful reeducation of the public on the dangers of falsified medicines and ways to detect them using technology and report them as a way of cleaning up the supply chain. The study participants recorded an 85.2% willingness to report identified falsified medicines to the regulators and may opt for a stepwise approach through their healthcare providers or hospital authority or a more direct approach to the national authorities. This is also a notable indication of the public resisting falsified medicines spread in their various capacities. The participants also confirmed an 6.1% willingness to use mobile authentication service technology and other features to verify if their medicines are original, but a higher 20.2% of respondents would always prefer to use the NAFDAC registration number alone or in combination, while a 10.5% would depend on the presence of other verification features like insignias and seals. Conclusion: The study demonstrates that there is a good awareness of anti-falsification technology and that knowledge affects how patients interact with their prescription medicines and causes a bias for known brands/generics while blaming therapy failures on suspected falsified medicines.