Pharmaceutical Research

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"A comparative assessment of current and future pharmacovigilance in developed and developing countries - A case study of Ireland and Nigeria" by OLANREWAJU JIMOH

Medicine majorly constitutes the use of prescribing and administering drugs by healthcare professionals majorly the pharmacist and the medical doctors. The importance of these two professions is very paramount in fighting diseases and promoting good healthcare as well as the general well-being of humans. Also, the current drug discovery and research within the pharmaceutical industry have led to the will for the need for the safety and efficacy of drug products. The safety of the drug has been a major concern aftermarket authorization due to limited clinical trials which cannot prove the safety of the public health after consumption. Adverse drug reaction has always been a major challenge in the life of drug users and this cannot be avoided but rather can be prevented. The standard clinical trial phases include phase 1 which usually comprises a certain number of humans, mostly less than 20, and their safety with a lesser dosage of the drug, phase 2 is 50 to 100 towards the adequate dosage specifications. Phase 3 is usually carried towards a specific condition at which the drug is being produced for the effectiveness in treating a certain condition while phase 4 is conducted to identify the long term effects of the drug after the approval and enters the market. All these phases have led to pharmacovigilance activities of ADR reporting on how drug products are working after taking and the safety of the people using it.

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Objectives:

The thesis objectives are to compare and evaluate the factors about reporting Adverse Drug Reactions in the developed and developing countries among healthcare professionals (Medical doctors and Pharmacists) using Ireland and Nigeria as a case study.

Methodology:

A questionnaire survey and phone interviews for quantitative and qualitative analysis are carried out respectively within the two regions (Ireland and Nigeria). The challenges faced by medical professionals concerning ADR reporting are achieved based on their knowledge and awareness to determine an effective recommendation to help improve both regions using the comparison results and works of literature gathered.

Findings:

An Overall total of 122 respondents from both Nigeria and Ireland are received which consists of 47 respondents from Ireland (12 medical doctors and 35 pharmacists) and 75 respondents from Nigeria (32 medical doctors and 43 pharmacists) showing a response rate of 60.0% and 87.5% from 20 and 45 medical doctors and pharmacist from Ireland and response rate of 71.1% and 95.5% out of 45 respondents respectively from both medical doctors and pharmacist from Nigeria. Surprisingly, 98.0% of the correspondents which consist of 12 medical doctors and 35 pharmacists from Ireland responded to knowing how to report ADRs to compare to 71.0% from Nigeria which is quite above average consisting of 26 medical doctors and 27 pharmacists responded to knowing how ADRs is being reported. However, it shows that pharmacists had better knowledge, awareness, understanding, and experience over the medical doctors regarding ADRs reporting. However, 92.0% and 96.0% of respondents of both groups from Nigeria and Ireland respectively opted to ADR reporting being made compulsory as a professional obligation towards achieving and improving pharmacovigilance.

Analysis:

It shows that the challenges affecting ADR reporting in Nigeria are associated with the inaccessibility of ADR report forms when needed, complex reporting processes while too busy and lack of time remained the most common challenging factor among this too regions. The least common challenges reported at both regions are level of clinical trial knowledge, a concern that ADR report mighty is wrong among, fear of legal liabilities, and fear of exposure to legal liabilities from patient or drug manufacturer.

Conclusions:

Proper comparison and recommendation from both sides from the country shows the need for better improvement in awareness among healthcare professionals in Nigeria been the country with the highest level of challenges compare to their counterpart healthcare professionals and this could be achieved by organizing pharmacovigilance conferences, continuous education programs included in their professional courses and training to improve knowledge of ADR reporting. Establishment of ADR departments in healthcare institutions headed by ADR specialists and offering professional recognition rather than financial rewards are the sustainable recommendation to put in practice in both regions to further improve the practice of ADR reporting in Nigeria and Ireland. To wrap it up, the need for the regulatory bodies from the developing countries to work in hand with the developed countries to better improves awareness, knowledge, and improvement towards ADRs reporting system.
"A COMPARATIVE STUDY ON LEAN AND SIX-SIGMA IMPLEMENTATION AT VARIOUS PHARMACEUTICAL INDUSTRIES IN INDIA AND IRELAND." by Dr Bala Sneha Chavva

The research was set out to compare the extent of LSS implementation and different tools used in India and Ireland in various pharmaceutical manufacturing sectors. For this, the main objectives were to compare differently sized industries like small, medium and large. To achieve this, a qualitative method was implemented and the data sourcing was done by primary and secondary methods with the questionnaire being the main source of the data. A study population of 11 participants who were presently working in the pharmaceutical manufacturing sectors of India and Ireland filled out the questionnaire. The study found out that there is not much gap in LSS implementation of these two countries. Top five facilitators, barriers and benefits were summarized, with cultural differences being the most important factor to be considered among the two countries. The study also found out that there is no gap in the LSS implementation in various industries in Ireland, as the small-scale industries too were found using the tools.

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Objectives:

There main aim of this research was to carry out qualitative research on comparison between implementation methods and tools used in LSS in both India and Ireland. The macro-level objectives were:

To compare the extent of LSS implementation and different tools used in India and Ireland.

To compare the differences in LSS implementation and tools in Large Vs Small- medium-sized pharmaceutical manufacturing sectors in India and Ireland.

Micro-level objectives:

To find out the factors which help in implementing the LSS.

To identify the factors that deteriorate the LSS.

To list out the possible solutions to the factors that pull back the improvement in LSS.

Methodology:

The research method selected and used by the researcher will involve the use of surveys by employees of pharmaceutical companies, knowledgeable and expert in the field of LSS, which will provide the researcher with a better understanding of the barriers and facilitate the implementation of LSS by Irish and Indian Pharmaceutical Companies. Research Philosophy: Interpretivism. Research Approach: inductive. Design: Qualitative and Quantitative.

Findings:

The findings of this thesis were:

The extent of implementation of LSS in India and Ireland was almost the same, there was not much difference as many other studies said while comparing a developed and developing nation.

The usage of tools is always dependant on the requirement for the projects, size of the industry etc., tools implemented in India and Ireland were compared and their patterns were analysed and found out that Ireland has a wide of LSS tools in use when compared to India, irrespective of the size of the organization.

Process map, FMEA and Fishbone were widely used and the least used tool was ridge cost analysis.

When the size of the organizations was taken into consideration, Ireland had more SME’s than in India, while India had more large-scale industries.

In India especially in the large-scale industries, LSS is implemented in the entire organization, while in Ireland, the equal number of participants opted to say that LSS is implemented in a few departments and only in their departments. But, in both countries, LSS implementation is still at infancy or not yet established in the small-scale industries or lower.

There is a very strong agreement that the cultural differences among both the countries are causing a huge variation in the pattern of LSS implementations.

Analysis:

A cross-sectional analysis was done on the results, for this analysis the questionnaire of 23 questions was grouped into 4 subcategories namely,

i. Demographics and Personal information: This section includes the information obtained from questions 1, 5, 6, 7, 8 and 13. Areas covered as per these questions were demographics, their present role, number of years of experience, size of their industry, similar role experience in India/ Ireland and years of experience with LSS.

ii. Knowledge on LSS: It includes questions 2 and 12 which analyze the person’s knowledge and their certification in LSS. iii. LSS Implementation in the industry: This section has got questions 3, 4, 14, 15 and 16. It briefs about the scope of LSS implementation in the participant’s organization, tools being used and their recommendations on additional tools to be used by their organization.

iv. Opinions: This section is huge and remains crucial in analyzing the results. Questions 9, 10, 11, 17, 18, 19, 21, 21, 22 and 23 belong to opinions. It gathers the opinions from the participant about the success factors/ facilitators, barriers, benefits of LSS, their level of agreement about cultural impact and benefits that LSS has done to their organization.

Conclusions:

In the end, the findings of this thesis were:

The extent of implementation of LSS in India and Ireland was almost the same, there was not much difference as many other studies said while comparing a developed and developing nation.

The usage of tools is always dependant on the requirement for the projects, size of the industry etc., tools implemented in India and Ireland were compared and their patterns were analysed and found out that Ireland has a wide of LSS tools in use when compared to India, irrespective of the size of the organization.

Process map, FMEA and Fishbone were widely used and the least used tool was ridge cost analysis.

When the size of the organizations was taken into consideration, Ireland had more SME’s than in India, while India had more large-scale industries.

In India especially in the large-scale industries, LSS is implemented in the the entire organization, while in Ireland, the equal number of participants opted saying that LSS is implemented in a few departments and only in their departments. But, in both the countries, LSS implementation is still at infancy or not yet established in the small-scale industries or lower.

There is a very strong agreement that the cultural differences among both the countries are causing a huge variation in the pattern of LSS implementations.

The major differences between India and Ireland in terms of LSS were answered by the participants who had a similar experience in both the countries, they answered this as:

- there isn’t a huge corporate culture gap, but surely there are national culture differences, India is under vigorous development unlike last century in terms of the pharma sector, the small-scale industries may not be able to enough funds and resources from the government in India, unlike Ireland.

- State of the industry.

- Levels of maturity.

- Corporate culture

- Cultural differences and ownership of the activity.

The justification for the usage of current tools and why not the other, the answers reported were:

- These tools were sufficient to cover their manufacturing activities

- To remove non-value task

- To understand the current state, to simplify processes, to ensure adequate controls are in place

- Standard tools are used, Proven track record that these tools work. Our company do not exclude any particular tools.

- The tools used have given the desired outcome

- I think they are well for our industry size

- Tools will be packed based on their application

The recommendations on other tools that the participant’s come need to implement was:

- Continuous processing with Process Analytical Tools

- Design for Six Sigma. TRIZ

- Error proofing answered by 2 participants

- Pareto charts, control charts

Majority of the study participants agreed that their organization has been benefited from the LSS in terms of waste reduction, reduction in the financial burden, increased customer compliance and quality of the products.

The top facilitators in LSS implementation were:

- Management commitment and capability
- Linking LSS to business strategy
- Training o Organizational culture and ownership and
- Leadership style.

Where is the top 5 barriers were:

- Lack of leadership from the top executives.
- Poor execution
- Fear of change in organizational culture
- Failure to recognize the need for change and
- Lack of resources.

And the benefits reported on the top 5 list were:
- Improvement in business and quality
- Standardization
- Helps in gaining experience in quality management.
- Organizational growth and
- Ensuring compliance.
"An Analysis of Factors Influencing Environmental Behaviours in Irelands’ Biopharmaceutical Industry Employees" by Ciara Heverin

The environment, depending on its state, can impact our health and well-being in a positive or negative way. This study analyses the factors influencing positive environmental behaviours in Irelands’ biopharmaceutical industry employees . Ireland is at a crucial point in time, where decisions made for our environment, to manage and protect it, will have ripple effects. Evidence of which will be seen for generations to come. Driven by environmental regulations and increasingly so, the biopharmaceutical industry has a social responsibility to reduce any negative environmental impact to safeguard our natural amenities and the health of Ireland’s people.

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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.
"An Analysis of The Use of Wearable Technology as A Means of Controlling Drug Delivery Systems and The Challenges Facing Its Usage in Ireland" by BOLATITO TEMITAYO ADEWUMI

This research is based on using wearable devices in controlled drug delivery and the challenges involved in the design, manufacturing, and sales of the devices. It is only focused on controlled drug delivery systems and does not include its use in other forms of drug delivery. It is aimed at determining the challenges affecting the use of this technology in Ireland by discussing with experts the pharmaceutical and medical devices industry. It will examine how the public and potential customers perceive such creation and how it will be potentially received in the market.

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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.