Objectives:

• To evaluate the knowledge and practice of ADR reporting in India.

• To assess the behavior, attitude and awareness related to PV of biological medicines among HCPs in India.

• To identify the factors and challenges in reporting ADR of biological medicines.

• To suggest methods to expand and increase the ADR reporting of biosimilars.

Methodology:

A cross-sectional observational study was carried out using a pre-designed questionnaire consisting of 24 questions. Both qualitative and quantitative approaches were chosen to investigate among 100 HCPs (doctors, nurses and pharmacists) selected by non-probability convenience sampling method in Kerala, India. The statistical analysis of the quantitative data was performed using SPSS statistics software. Association between dependent and independent variables was found by using Pearson’s Chi-Square Test were p < 0.05 was considered to be statistically significant. The responses to the qualitative questions were interpreted using coding method and thematic analysis using Pareto chart was used to draw out conclusion.
 
Findings:

The study found that the knowledge and attitude of HCPs towards ADR reporting is improving and the practice of reporting ADR is still deficient. A good proportion of the HCPs are aware about the importance of pharmacovigilance of biological medicine and biosimilars. They also know the significance of traceability of these products. However, 73% of the participants stated that they never conducted any additional monitoring for new biological medicines. Around 50% of the participants identified lack of knowledge and busy schedule as the major challenge in reporting ADR of biologicals.73 % of the participants pointed out the need for more training sessions on pharmacovigilance. It is clear from the responses that clinical pharmacists and doctors seems to have better knowledge on pharmacovigilance when compared to nurses and other pharmacists.

Analysis:

The data collected from the questionnaire were analyzed both quantitatively and qualitatively. All the quantitative analysis was performed using SPSS statistics software. The analysis included analyzing the frequency and mean of responses and also Pearson’s Chi-Square test. The open-ended questions are descriptively explained and analyzed using Pareto charts. The questionnaire were subdivided into following topics and analysed accordingly: Knowledge on PV and ADR, Reporting of ADR, PV of biologicals, Traceability of biological products ,Knowledge on PV and ADR monitoring of biologicals , Familiarity with biosimilars, Training programs, Reporting ADR of biologicals.

Conclusions:

The knowledge and attitude towards ADR reporting of biological medicines and biosimilars are gradually improving whereas the practice of reporting ADR is still deficient. A substantial proportion of doctors, nurses, and pharmacists have been found to lack trust in their own awareness of ADR reporting, demonstrating the value of ongoing pharmacovigilance education and training for HCP. The challenges identified in this study on reporting of ADR in general and that of ADR of biologicals are in agreement with the results found by different authors in different parts of the world. The majority of the respondents suggested that more frequent training sessions are required to improve knowledge on PV and ADR reporting. Among the professionals working in the hospital, the doctors and clinical pharmacists seems to have better knowledge about the PV and ADR reporting of biologicals. From the comparison of responses of HCPs, it is clear that the HCPs working in hospital set up has more exposure towards biologicals when compared to community pharmacists.

Objectives:

Three objectives as follows have been implemented to achieve this:

1) Identify factors that have the potential to positively impact environmental behaviours.

2) Identify factors that have the greatest potential to positively impact environmental behaviours of employees within the Irish biopharmaceutical industry.

3) Analyse current efforts to implement these factors within the Irish biopharmaceutical industry.

 
Methodology:

In terms of ontology and epistemology this study lies in the area of relativism, more specifically constructivism. Relativism also known as subjectivist or nominalist poses a reality where truths are subjective and circumstantial. It is recognised that there can be multiple truths with the potential to conflict but this remains the truth of the study. It is accepted that observations can change. Realities are influenced by social factors and experiences. A singular data collection was completed through survey to realise the research objectives.

Findings:

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.
 
Analysis:

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.

Conclusion:

Company culture is the strongest factor that influences employee behaviour but one that requires extensive work in order to bring about results. To do so requires changes to profitability driven frameworks and is seen as a long-term task. For the short to medium term regulations and infrastructure are recommended to propel positive employee environmental behaviours. Current efforts to implement these factors within the Irish biopharmaceutical industry are moderate and must be improved on in order to reduce negative environmental impact. In Ireland’s current situation, following covid-19 government led quarantine a new normal was created with increased working from home to prevent spread of this virus. A positive from this is the opportunity to capitalise on this new way of work reduces commuting to site thus reducing emissions and also reduces paper usage as it forces employees to utilise electronic avenues over paper with lack of printing facilities in the home.

 Objectives:

The objectives of this research traversed:

(1). Analysis of the inter-professional collaboration among healthcare professionals, specifically physicians and pharmacists in Nigeria.

(2). Evaluating the factors that hinder this collaboration in Nigeria.

(3). Evaluating the factors that improve this collaboration in Nigeria.

(4). Suggesting feasible solutions that will bolster the collaboration between physicians and pharmacists in Nigeria.

Methodology:

The research methodology employed was a mixture of qualitative and quantitative approaches through a mixed-method questionnaire making use of the online platform, google forms. The questionnaire was devoid of bias, no personal questions were asked and there was no interference on the part of the author to the responses garnered. The qualitative approach was phenomenological centered around the daily experiences of physicians and pharmacists. The questionnaire was dispersed to physicians and pharmacists in government hospitals, primary care centers, community pharmacists and patients in these environments. Likert scales were employed in measuring the varying views on the subject. The patients were also asked their opinion of physicians, pharmacists and the quality of healthcare they receive.
 
Findings:

The research confirmed a finding from the literature review that in this relationship, community pharmacists are indispensable as they account for the majority of pharmacists in Nigeria. This is also important because they interact the most with patients. The research also showed a current scarcity of interactions between physicians and pharmacists which shows why this has been foreign in Nigeria's healthcare sector. Physicians and pharmacists that have interacted have had an amenable relationship, this shows that the relationship is welcome and has the capacity to improve healthcare in Nigeria. Finally, patients visit their pharmacists for the more common ailments highlighting their importance and the possibility of a good relationship when these two professionals work hand in hand.
 
Analysis:

This research to the best of my knowledge was the first of its kind in Nigeria. It is important because for a developing country, healthcare is an important sector that cannot be overlooked. In developed countries, inter-professional collaboration has been widely researched and confirmed to improve the healthcare of their patients and the goal of the research is to test the veracity of this knowledge in a developing country like Nigeria. This was done by gathering responses from physicians, pharmacists and patients by employing a mixed method questionnaire, seeking their opinion because it directly affects them. The result showed that this collaboration is almost non-existent in Nigeria and a lot of work needs to be done by the government, healthcare professionals, the governing bodies of these professions and even the public in order to bring this collaboration to fruition and cause good clinical outcomes.

Conclusions:

A major discovery of this body of work from the secondary research was that community pharmacists have a huge role to play in this relationship, findings from primary research also confirmed this. This relationship also has not been developed effectively in Nigeria, but it is welcome nonetheless. Unsurprisingly also, physicians in Nigeria do not view pharmacists as colleagues, they have little respect for this profession this is enhanced by lack of proper communication between these professionals and even the patients. The Nigerian government need to be more proactive and invest in the Nigerian healthcare system, the study of this relationship should also be introduced into the curriculum of medical and pharmacy students. Finally, there should be establishment of electronic medical records and accountable care organizations that enhances access to patient information under the strictest regulations.

 Objectives:

The purpose of this dissertation is to achieve these objectives;

1. To study the pharmaceutical distribution system in Nigeria and the drivers that aid the infiltration of counterfeit drugs.

2. To evaluate the challenges faced with implementing Pharmaceutical Distribution laws in Nigeria, and to assess the challenges posed by the open market which facilitate the distribution of counterfeit drugs.

3. To look at supply chain reforms and recommend improvements that can facilitate control measures to minimize the distribution of counterfeit drugs in Nigeria.

Methodology:

The methodology applied in this research was a pragmatic philosophy, the researcher applied a mixed-method approach considering the two types of participants involved in the study. The data collection was a combination of online distributed questionnaires and a semi-structured interview with industry stakeholders (distributors and pharmacists), which amounted to a total of 270 participants in total. The researcher uses both qualitative and quantitative approaches to understand the level of awareness of the consumers on the present technologies and also gain new insights and learn from the experience and perception of industry experts' response and also get new suggestions and recommendations.

Findings:

From the data gathered, it was deduced that the presence of unskilled workers, and open market, are the drivers that aid the infiltration of counterfeit drugs. It can further be extracted that, the poor implementation of laws is a result of greed and corruption on the part of the regulatory bodies. Some of the challenges the open market pose are during the out of stock period, a lot of counterfeit drugs are produced and supplied to unsuspecting pharmacists and consumers. Hence the need to implement proper anti-counterfeit technologies is necessary. One of the reforms recommended is the need to facilitate awareness amongst consumers and for distributors to buy from the approved pharmaceutical supply chain. Finally as mentioned by two participants, border controls need to be enforced strictly to monitor the drugs coming into the country.

Analysis:

The ratio of females to males was 53% to 47%. The ratio of participants residing in rural areas to those in the urban was 11% to 89%. This section of the interview gave the researcher insight into the characteristics of people who responded to the survey. 80% of participants are aware of the MAS technology, but those who used it always or often where 8% and 7%. 58% of respondents admitted that the feature is friendly but 38% rated the response time 3 over 5 which can be interpreted as fair. This implies that the majority of participants are aware of the MAS feature but as seen from the response more awareness needs to be done on the need to use it.

Conclusions:

The loopholes in the pharmaceutical supply chain are the presence of the open market as highlighted by participants in the interview. Furthermore, these open markets which are as a result of greed and poverty are the catalyst that facilitates the distribution of counterfeit drugs. Corruption, poor implementation of laws, and the presence of unskilled individuals in the channel are factors that also facilitate the loophole in the pharmaceutical supply chain. As extracted from primary data the regulatory bodies need to be more strict on who they approve to operate a pharmacy, this will reduce the operation of the open markets and also the spread of counterfeit drugs. From the data gathered, one of the methods that can improve the control of counterfeit drugs is consumer awareness. The need for consumers to be aware of the drugs they purchase and where they purchase it from is important.

 Objectives:

This research aims at exploring how wearables devices can be incorporated in the control of drug delivery systems. Therefore the objectives of this research are to:

1. To define the process involved in the research, development, manufacture, and sale of the wearable device-controlled drug delivery system in Ireland.

2. To identify the risks and challenges involved in the process in Ireland.

3. To examine the effectiveness of this novel technology in Ireland.

4. To define the potential market target and general view about the technology in Ireland. 


Methodology:

The Philosophy of this Research is Pragmatism as a combination of both Quantitative and Qualitative Methodology was used. The Research Approach was an Inductive one and the Research Strategy was to use two Survey methods which are:

1. Questionnaire distributed online, it contains 5 sections with 26 questions and involved 219 respondents Who are Currently Living in Ireland.

2. Interviews via Zoom of 10 – 30 minutes of conversations involving 3 Experts from the Medical Device Industry The Primary Data was analyzed by using Microsoft Excel (Chart Presentation) for the Quantitative method and Thematic Analysis for the Qualitative method
 
Findings:

The popularity of the use of wearable devices in controlling drug delivery systems was determined and only 21% of the participants were familiar with this type of technology (the commonly known one is the insulin pumps). The willingness of the participant to buy or use this technology was tested and 84% of the participants would consider using this technology. To better understand the views of Irish society, the factors influencing the choice of the device was determined. Comfort, Effectiveness and Ease of use had 73.9%, 71.6% and 65.6% of the participants votes respectively. According to the experts, the industry involved is mainly the medical device company and some of the challenges listed were: heavy regulations, market penetration and high cost involved in the Research and Development in form of the time, money, and resources
 
Analysis:

The present market for the wearable device-controlled drug delivery system is very small and the only commonly known one is the insulin pump. However, this study was able to demonstrate that many people in Ireland would like to use this new technology in Ireland. The Irish people would prefer to use these systems instead of the traditional method of using medications. But the choice of use of this type of drug delivery system in Ireland is based on the Size, Look, Comfort, Ease of use, Cost, Effectiveness, Reduced Side Effect and Safety of the devices. It was also established that the manufacture of different drug delivery systems such as insulin pumps, API infused contact lenses and drug-coated stents by different medical devices companies are common in Ireland, and some of these devices are being sold globally. The production of these wearable device-controlled drug delivery systems involves collaboration between medical device companies and pharmaceutical companies.

Conclusions:

The use of wearable device-controlled drug delivery systems in Ireland is at an early stage, but this is expected to change considering that Ireland houses many multinational companies producing these devices. The findings give hope that this will change very soon once the awareness of these products increased. The use of wearable device-controlled drug delivery systems is expected to be the next era in pharmaceuticals especially with the advancement in technologies such as Artificial Intelligence and IoT. There are different use of wearable devices and the market for wearable devices is constantly growing. Its use in vital monitoring and diagnosis is vast. Theoretically, the use and application of this type of drug delivery system is endless and has amazing benefits that will/are revolutionizing healthcare worldwide.

 Objectives:

This research aims to identify bottlenecks and loopholes that hinder 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.

1) To assess the knowledge, attitude, and practice of HCPs towards Pharmacovigilance and ADR in Lagos state tertiary hospitals.

2) Determine HCPs' perception towards direct patient reporting of ADR.

3) To elicit patients' experience regarding ADR reporting and evaluate its impacts on pharmacovigilance structure.

4) To make sustainable recommendations which invariably will contribute to the overall pharmacovigilance system in place in the hospitals.

Methodology:

This research was modelled on a mixed-method approach that was underlined by a deductive approach and positivist philosophy. 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 which includes 2 doctors, 2 nurses, and 2 pharmacists recording a response rate of (50%).

Findings:

From the analysis conducted a significant number of 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, 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 HCPs acknowledged they are not aware that patients can report ADR directly neither do they think it’s a good idea because they are of the perception that patients can’t generate valid/quality ADR reports.

Analysis:

Although the regulatory agency in Nigeria (NAFDAC) has set in place the ideal models needed for reporting, however, their performance towards awareness and publicity of ADR was rated poorly and this in turn is a huge barrier in promoting drug safety practice and pharmacovigilance system in Nigeria. However, from reviewed literature and findings obtained from the study, it can be deduced that global underreporting issues are significantly associated with lack of knowledge and adequate resources dedicated to identify, assess, monitor, and report potential ADRs effectively. The reporting and assessing medium in Nigeria tertiary hospitals are inadequately efficient and somehow being underutilized by Nigerians including its HCPs and healthcare providers due to lack of dedicated resources to the process, and persistent focus on knowledge acquisition instead of its implementation and feasibility. The resulting effect of this act is the burden of ADR faced by the country and inability to achieve required ADR reported cases despite the high mortality and morbidity rate associated with ADR cases in the country.

Conclusions:

Nigeria is earmarked as a fast developing country and a leading nation in the future, therefore the country has to be established in all aspects especially the healthcare system starting with its HCPs and regulatory agency. Patients should be educated, encouraged, and actively involved on ADR reporting because they have the potential to add value to generated reports by providing more detailed reports which can help detect likely causality and impact on patients’ lives. Creating more awareness, organising frequent training, workshop, and seminars to update the knowledge of HCP, dedicating adequate resources, incorporating ADR module into the curriculum of HCPs 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 its importance, are sustainable recommendations that will improve ADR practice and contribute invariably to pharmacovigilance system in Nigeria.

Objectives:

• To gain insights on the challenges faced in academic-industrial collaboration in the pharmaceutical industry
• To understand and explore the theories of collaboration and their themes that supplement Academic- Industry collaborations
• To analyse and determine the degree of applicability of the theories in academic-industry collaborations in the pharmaceutical industry 

Methodology:

The paradigm and philosophical approach was chosen to be Interpretivist, as the nature of the study had involved interpreting the data collected in the primary research by the use of a narrative analysis approach. The responses of the interviewees selected were taken in the forms of their stories, which was composed of the knowledge and experiences that they had as professionals involved in academic-industry collaborations in the pharmaceutical industry. The strategy involved was to frame questions for the interview in a manner that enabled me to receive responses in the form of stories of the interviewees that have been interviewed.

Findings:

i. Every theme in different theories of collaboration is connected and related, in terms of specific applicability in dealing with the listed challenges The themes used in the theories were used as codes for application to the transcripts generated from the interviews conducted for the participants in the dissertation study.

ii. Knowledge sharing, networking and stakeholder focus are more prevalent and applicable than their corresponding counterparts at resolving specific challenges in academic-industry collaborations. The codes generated were compared after generating their relations map via creative coding. The data tools of MAXQDA revealed that these themes were more omnipresent than the other selected themes, making them desirable for being used in combined theme applications.

iii. Combinational themes generated better outcomes than individual themes: An analysis of the codes used was generated and the codes were compared to understand their utilisation and need, as per the in-depth interviews conducted.

Analysis:

The data analysis approach included producing a coding system based on the theories of collaboration explored in the literature review. Transcripts from the interview were generated from each participant, and the codes produced for each theory were matched with the responses provided by the participants. This approach led to understanding the application of the chosen theories to the experiences of the academic and industry professionals with collaborative experience and revealed the utilisation of said theories in specific circumstances in academic-industry collaborations. MAXQDA was applied as an analysis tool, using its transcription mode to transcribe the recordings of the interviews and were coded using the same. All the findings coded produced a pattern of the different uses of theories under a variety of circumstances in the collaborations coded and analysed by using a narrative analysis approach. A creative coding function was used visualize the coded system produced.

Conclusion:

The findings determined by me will be essential in assisting academic and industry professionals involved in academic-industry collaborations to conduct collaborations that utilize the themes determined, and their principles explored. The collaborations conducted on a global scale will benefit from the findings produced as a result of the analysis conducted. The themes should be inculcated in the training period for personnel and awareness of the same should be checked routinely for those involved in collaborations by experienced and knowledgeable collaborators involved in the collaboration. Future research should focus extensively on developing new theories in line with emerging trends and arising challenges. Also, a variety of theories developed by theorists that are not directly focusing on collaboration but on the themes identified should be explored, in order to rummage through for knowledge that can be translated into a novel practice, one that has not been discovered thus far.

 Objectives:

The author explored the knowledge, attitude and experience of ADR spontaneous reporting among medical doctors and pharmacists in line with established guidelines and regulations by the relevant authorities in Nigeria. Although current spontaneous reporting practices are less than optimal, this research dissertation was aimed at articulating effective strategies that could be optimally leveraged to improve the frequency and quality of reporting while driving better positive health outcomes for patients across Nigeria. An outline of the research objectives include:

1. To evaluate the knowledge and awareness of ADR reporting among healthcare professionals in Nigeria

2. To assess challenges among healthcare professionals in the practice of ADR reporting in Nigeria.

3. To make sustainable recommendations to improve ADR reporting among healthcare professionals in Nigeria.

Methodology:

Primary and secondary research methods were utilised by the author through the electronic dissemination of questionnaires, phone interviews and literature reviews. The secondary research was first carried out to explore relevant current literature from reputable research databases and journals on ADR reporting to determine the gaps as it pertains to the established research objectives. Attempts to fill these gaps were subsequently carried out through primary research by distributing questionnaires to 140 medical doctors and pharmacists (74.3% response rate), which constituted the approach for quantitative analysis. Phone interviews were further conducted for qualitative analysis with 10 highly experienced healthcare professionals (over 10 years of experience). The author applied the positivism and interpretivism philosophies to analyse the questionnaire and phone interview findings respectively.

Findings:

Both groups of healthcare professionals were compared to determine their opinions on frequency of observed and reported ADRs, reasons for high underreporting rates, awareness of ADR reporting methods, guidelines and regulations as well as the NAFDAC regulatory body responsible for handling submitted ADR reports. A total of 104 out of 140 responded to the survey, of whom 53 (75.7%) were medical doctors and 51 (72.9%) were pharmacists. 34.0% of medical doctors who responded did not know how to report ADRs compared to just 5.9% of pharmacists who responded. In ascertaining familiar ADR reporting method, 39.0% of respondents selected yellow cards/ADR forms, 11.0% of respondents selected the ADR e-reporting form while 25.0% of respondents were familiar with both methods. 25.0% of respondents were unfamiliar with any of the methods for reporting ADRs in Nigeria. 36.0% of respondents admitted having reported an ADR within the past 12 months. The majority 57.0% of respondents indicated not to have reported an ADR in the past 12 months while 7.0% of respondents were unsure if they did. An overwhelming 90.0% of respondents opted for ADR reporting being made compulsory as a professional obligation towards pharmacovigilance.

Analysis:

Analysis showed that medical doctors and pharmacists have only an average knowledge and awareness of ADR reporting in Nigeria. They can correctly identify ADRs and the criteria for reporting but effective reporting remains a challenge. Pharmacists had better knowledge, awareness and experience over medical doctors regarding ADR reporting in Nigeria. However, despite overall poor attitudes to reporting ADRs, both groups exhibited a willingness to do better if proper continuous education and training is made available. NAFDAC performed poorly in raising awareness, providing training and encouraging better drug safety practices and pharmacovigilance. Very few healthcare professionals are aware of the guidelines or regulations governing the ADR reporting system in Nigeria. The authorities rarely acknowledge or follow up on reported ADRs which results in poor reporting rates. Factors varied among both groups as the challenges faced by medical doctors does not translate to the same challenge faced by pharmacists. However, both groups of HCPs agree that ADR reporting should be made a professional obligation to improve ADR reporting in Nigeria. Despite an overwhelming acceptance of the authors' recommendations, some opposed extra remunerations for every ADR reports made as it might distract from the ideal purpose of ADR reporting and pharmacovigilance- improving drug and patient safety in Nigeria.

Conclusions:

Factors ranging from indifference to ADR reporting, poor knowledge and accessibility of reporting methods, poor awareness of guidelines surrounding the reporting procedures are to great extent the same as observed from other studies in Nigeria and other countries. While few studies on ADR reporting in Nigeria compare multiple groups of healthcare professionals, this study demonstrates that pharmacists are more predisposed to favorable outcomes regarding ADR reporting than their medical doctor counterparts. Improving ADR reporting in Nigeria would greatly reduce the healthcare costs and mortality rates and further reduce the incidence of ADRs observed. As suggested by both groups of healthcare professionals, a review of regulations to make ADR reporting compulsory as a professional obligation towards patient safety bears great potential. The course content of the medical and pharmaceutical students should be reviewed to include modules on ADR reporting and tutorials on pharmacovigilance and drug safety practices prior to graduation. Health institutions should establish ADR departments headed by ADR specialists to improve reporting rates in Nigeria and foster liaison with the National Pharmacovigilance centers.

 Objectives:

The aim of the present work is to explore the practice of community pharmacy in Lagos state through the eyes of community pharmacists and their perception on the use of the novel information and communication technology ICT, and its effective implementation in the practice of community pharmacy in state and hence the Nigerian communities. Other objectives include:

• Exploration of the professionalism, work practice and ethics of community pharmacist in Lagos state, Nigeria

• Exploration of the observed non-adoption and hence ineffective usage of ICT-based techniques such as the use of computerized network in recording, storing and accessing patients’ health information; electronic prescription as well as telecare services by community pharmacists in the research study locality.

• Identify the bottlenecks and hence barriers responsible for non-employment/ineffective use of ICT in the practice of community pharmacy which overshadowed the field in Nigeria.

• Explore the importance of and how ICT-based techniques usage in the practice of community pharmacy would improve and thus benefit all stakeholders associated with the Nigerian healthcare system.

• Proffer novel and insightful ideas and solutions that can lead to the effective adoption and full implementation of ICT techniques across various community pharmacies in Lagos state and thus improving the Nigeria health care system 

Methodology:

The present work was modelled on qualitative research pedagogy and relied on the use of deductive survey questions. The research study was conducted specifically in the selected locality of Eti-Osa, EtI-Osa Local government area within the Lagos State metropolis, Nigeria. This was facilitated through a conducted semi-structured interview that led to the generation of in-depth explanatory data obtained from a small sample of licensed and practicing community pharmacists (those in stand-alone stores) using the pre-drafted qualitative survey questions as research tool
 
Findings:

Based on the research findings obtained from semi-structured interviews conducted on licensed and practicing pharmacists in Eti Osa LGA, Lagos metropolis, it is found that information and communication technology just like how it always enhances and thus redefine professional functions in every work station, can also redefine community pharmacy practice in Nigeria. In the present research study area community pharmacists, which discharge their professional duties in a standalone pharmacy were well conversant with the concept of ICT application which is somehow lacking in the practice of community pharmacy in developing countries such as Nigeria,
 
Analysis:

For the present study, the research data from the respondents were analyzed through Deductive Thematic Analysis approach. This qualitative method of data analysis follows six models which include (1) Reading through transcribed text and establishing data correspondence with the research focus; (2) “Coding” of texts to bring out the salient points and similar response pattern from respondents; (3) Using the coded texts to generate a themes; (4) Reviewing the generated themes so as to offset data anomaly and research bias; (5) Renaming the themes as the case may be; and (6) Writing up a theme to aptly capture and project a particular research observation.

Conclusions:

The findings made shows the non-existent or usage of ICT-based techniques such as Electronic Prescription in the line of duty of community pharmacists strained these health professionals who had to deal with the enormous workload that comes with manual filling of medication prescriptions, while researchers including Afolabi and Oyebisi (2007) as well Leung and colleagues (2013) opined that the professional duties of community pharmacists in Nigeria do not measure up greatly as ICT-based techniques which would help offset the never ending problems of medication error were lacking. Consequently, community pharmacists in the present studies advocated for the introduction of such ICT based techniques into their work station and laid much emphasis on the need of real technical and professional training on the use of these ICT techniques which they regard as one of the key determinants that would make them to be flexible while discharging their professional functions, saving them a sizeable time that had been chunked and helping combat problems such as medication errors.

 Objectives:

The research objectives of this study are as follows;

To gain a deeper understanding of the some of the key issues surrounding clinical research data integrity

To evaluate the current knowledge and awareness of Blockchain within the clinical research industry

To determine the suitability of Blockchain in addressing the key issues surrounding clinical data integrity from a clinical data management perspective through quantitative and qualitative research

Methodology:

A pragmatist inductive approach was undertaken with this study of which the research purpose was considered exploratory. The research method used was a complementary quantitative and qualitative mixed methods approach. The sources of data consisted of an online survey while the sampling methods employed were non-probability and purposive homogenous sampling. A thematic analysis approach was then taken in order to analyze the data produced from the qualitative questions and the quantitative data was analyzed in conjunction with the qualitative data to support one another.
 
Findings:

Favor in support of Blockchain-enabled clinical trials was overwhelmingly positive from participants who took part in the study. Participants were chosen who best represented those who would have prior knowledge and understanding of Blockchain, however it was found that not all participants were even aware of Blockchain prior to the study. Blockchain understanding was quite mixed, however, all participants stated they would use Blockchain over legacy data management systems despite in depth knowledge of its functionalities. All participants stated they were aware of ongoing clinical data concerns concerning its integrity and that Blockchain could possess the architectural structure to alleviate those concerns that would benefit all stakeholders from the regulators to the patients.
 
Analysis:

Although Blockchain has been in existence since 2009 , it has formally been associated with cryptocurrency transactions and therefore it is still a relatively nascent technology still within its infancy of implementation within the clinical industry. While Blockchain is making strides in other industries, it is only beginning to be recognized as a potential platform to manage, store and share clinical data in a secure, transparent and immutable manner. Complexity and lack of understanding of the technology appeared multiple times throughout the study analysis and may act as a possible prohibitory factor towards its potential uses. Participants pointed out the increasing importance for clinical data integrity especially during the Covid-19 pandemic, and highlighted the potential beneficial applicatory functionalities of Blockchain within vaccine research.

Conclusions:

It was concluded that there exists extensive data-related issues within clinical research that contribute to a lacking of integrity in the data. There is still a degree of misunderstanding regarding the functionalities of Blockchain as a standalone platform dissociated from cryptocurrencies and there appears to be still a lack of basic awareness of its existence within the clinical research industry. The key conclusion derived from this study was that there are substantial obstacles that must be overcome before the technology could even be considered for implementation. Issues involving GDPR, ownership of data, data privacy, a lack of Blockchain experts and regulatory oversight concerns all must be solved. Blockchain has far reaching benefits not just for data integrity but for many other aspects of clinical research such as improving patient trust, acting as a decentralized repository for clinical data especially within vaccine research and could also be used alongside smart wearables to accurately record an auditable data trail from the point of origin that is fully immutable and tamper-proof.

Objectives:

The purpose of this research is to assess the impact of serialisation on the efficiency and productivity of Irish pharmaceutical sites. The first objective of this research was to determine if the assumptions and predictions outlined in the literature regarding the impact of serialisation on production efficiency were correct. The next objective was to quantify the impact of serialisation on operational efficiency using measurements such as Operational Equipment Effectiveness (OEE) and production line availability measures.

Methodology:

The methodology chosen for the study was a mixed method incorporating both qualitative and quantitative tools. A semi structured interview method was used that was suitable for use with a low respondent population. Ireland’s exports of fully packaged pharmaceuticals are valued in billions of euros. However, there are less than two dozen sites contributing to most of this value. The semi structured interview process was also chosen because of the Covid-19 pandemic. Face to face interviews were not feasible due to Government mandated travel restrictions as well as Covid 19 policies adopted by manufacturers.

Findings:

The average OEE loss reported by the companies surveyed was 2.71%. The ISPE article predicts a maximum loss of just 5% after 12 months. One manufacturer continued to see a loss of 10% compared to its pre-serialisation situation. One contributor described the serialisation process as adding between 10 – 15 minutes to each batch setup. Participants cited several factors for improvements in OEE post serialisation. Operator training, the development of subject matter experts and knowledge sharing between pack-line teams all contributed to better pack-line effectiveness. Four companies in the survey were able to identify a cost per pack associated with serialisation. Cost to serialise a pack ranged from 2.5 cents to 6 cents. The average cost was 4.1 cents. The average increase in cost of goods reported was 2.6%. Most companies interviewed considered the serialisation process to still be in the project phase rather than the business as usual phase.

Analysis:

The research points to a limited implementation of OEE systems in Irish pharmaceutical manufacturing sites. While 89% of the sites surveyed gathered OEE data it seemed there was a lack of benchmarking of OEE data prior to serialisation Nine of the eleven companies (81%) reported that they were actively increasing batch sizes to achieve productivity gains. One participant described how sales and marketing team members needed to understand that pack line machines were built for high volume production rather than small batch runs. Among large volume manufacturers 90% of respondents agreed that serialisation processes had put extra strain on changeover times and efficiencies.

Conclusion:

The impact of serialisation on unit cost and cost of goods is not insignificant. Using a depreciation calculation the researcher could calculate the impact of serialisation on unit cost as an increase of 2.7%. Based on Irish Central Statistics office figures this represents an increase in the cost of packaged pharmaceutical goods exported from Ireland of between €36m - €143m per annum (depending on whether distribution or intra-company pricing is used) Some participants in the survey complained that their businesses were expected to absorb these additional costs. Research would indicate that these additional costs are ultimately passed onto patients and payer organizations. Some companies had calculated a cost per pack for serialisation. The average cost per pack was 4.1 cents. For large volume sites the annual cost of serialisation is significant running to millions of euro per annum.