Zita Ekeocha - Academia.edu (original) (raw)

Papers by Zita Ekeocha

The purpose of this study was to explore ways of improving the pharmacovigilance quality system e... more The purpose of this study was to explore ways of improving the pharmacovigilance quality system employed by the Pharmacy and Poisons Board of Kenya. The Pharmacy and Poisons Board of Kenya employs a hybrid system of pharmacovigilance that utilizes an online system of reporting pharmacovigilance incidences and a physical system, where a yellow book is physically filled by the healthcare worker and sent to the Pharmacy and Poisons Board for onward processing. This system, even though it has been relatively effective compared to other systems employed in Africa, has one major flaw. It is a slow and delayed system that captures the data much later after the fact and the agency will always be behind the curve in controlling the adverse incidents and events. This means that the incidences might continue to arise or go out of control. This project attempts to develop a system that would be more proactive in the collection of pharmacovigilance data and more predictive of pharmacovigilance incidences. The pharmacovigilance system should have the capacity to detect and analyze subtle changes in reporting frequencies and in patterns of clinical symptoms and signs that are reported as suspected adverse drug reactions. The method involved carrying out a thorough literature review of the latest trends in pharmacovigilance employed by different regulatory agencies across the world, especially the more stringent regulatory authorities. A review of the system employed by the Pharmacy and Poisons Board of Kenya was also done. Pharmacovigilance data, both primary and secondary, were collected and reviewed. Media reports on adverse drug reactions and poor-quality medicines over the period were also collected and reviewed. An appropriate predictive pharmacovigilance tool was also researched and identified. It was found that the Pharmacy and Poisons Board had a robust system of collecting historical pharmacovigilance data both from the healthcare workers and the general public. However, a more responsive data collection and evaluation system is proposed that will help the agency achieve its pharmacovigilance objectives. On analysis of the data it was found that just above half of all the product complaints, about 55%, involved poor quality medicines; 15% poor performance, 13% presentation, 8% adverse drug reactions, 7% market authorization, 2% expired drugs and 1% adulteration complaints. A regulatory pharmacovigilance prioritization tool was identified, employing a risk impact analysis was proposed for regulatory action.

Quality control (QC) laboratories are critical components in drug manufacturing and running them ... more Quality control (QC) laboratories are critical components in drug manufacturing and running them efficiently contributes to better, consistent supply of cost-effective quality products, while also and preventing deaths due to untimely delivery or unavailability of medicines. Having a resource modelling tool to estimate resources needed to handle a particular demand in a given system is essential for efficient running of QC laboratory. This study was done to establish such a model at XYZ Pharmaceuticals. The list of all products manufactured by XYZ Pharmaceuticals Southern Africa was reviewed; and product families for all products were identified. Analysts 'hands on time (HOT) to process one sample of each of the product families was estimated. The number of analysts required to support the workload at XYZ Pharmaceuticals was calculated using the HOTs for the different product families and the Maslaton's Calculation Model. A baseline resource model was established.

With the global increase in the use of traditional and complementary remedies for the prevention ... more With the global increase in the use of traditional and complementary remedies for the prevention and treatment of illness, the quality and safety of these medicines have become a significant concern for all regulatory authorities. Herbal medicines are the most commonly used form of traditional and complementary medicines in the world and the efficacy and safety of herbal medicines, like conventional medicines, largely depends on their quality from planting to harvesting, preprocessing and final processing. Due to the inherent complexity of herbal medicines, often containing an array of active compounds, the primary processing of herbal medicines has a direct influence on their quality. Quality concerns are the reason why the medicines regulatory agencies insist that manufacturers of medicines strictly follow Good Manufacturing Practices since it is an essential tool to prevent instances of contamination, mix-ups, deviations, failures and errors. However, a strict application of GMP requirements is expensive and would drive the prices of the manufactured products up. As a result, a maturity level grading of facilities is proposed as a way of justifying the costs incurred for manufacturers desiring to reach a broader market and investing in continuous improvement. 36 Good Manufacturing Practice (GMP) inspection reports of local herbal manufacturers conducted by National Drug Authority were analyzed to establish the type and extent of deficiencies to GMP requirements for local herbal manufacturers in Uganda. The different GMP chapters and related sub-parameters constituted the variables used for the analysis of conformity to requirements. The primary outcome variable was the conclusion regarding compliance or noncompliance of the inspected local herbal manufacturing facility. GMP parameters that were frequently defaulted by local herbal manufacturers and the corresponding frequencies were identified. The Pearson Chi-square test was applied independently on each category to find the association that existed between conformity and the questions in each category. Only 22% (8) of the 30 inspected facilities were found to comply with GMP requirements, as per National Drug Authority (NDA) guidelines; while the majority of the facilities, 28 (78%), were found not to comply. Of the facilities inspected, 25 were undergoing GMP inspection for the first time. A total of 1,236 deficiency observations were made in the 36 inspection reports reviewed for the study. The mean for all deficiencies was 34.3, and the standard deviation was 15.829. 91.5% of the facilities did not have mechanisms for a record of market complaints; 80.9% did not meet documentation requirements; 78.9% did not have quality control measures in place, and 65.7% did not meet stores requirements. By encouraging a culture of self/voluntary improvement through the introduction of listing of manufacturers based on a maturity level grading, the National Drug Authority will improve the Herbal Medicines sector as per the mandate of improving the herbal medicine industry. Also, increased sensitization of all relevant stakeholders regarding the requirements for GMP should be intensified.

This is a study of nonconformances experienced by a laboratory of a pharmaceutical manufacturing ... more This is a study of nonconformances experienced by a laboratory of a pharmaceutical manufacturing facility in East Africa. There has been an increase in nonconformances from 216 nonconformances in 2017 to 229 in 2018 and by September 2019, 306 nonconformances were already logged. Increasing nonconformances result in delayed release of tested materials and many resources are wasted (e.g. chemicals, man hours and equipment). Analysts become frustrated, which may result in inexhaustive investigations. Understanding the reason for the increase in nonconformances will enable the facility to derive effective solutions to the identified causes, hence reducing the number of nonconformances and improving the productivity and morale of employees. This quantitative, nonexperimental, longitudinal survey study was intended to evaluate and understand the reason for increasing nonconformances. Trends of the nonconformances, previous investigations, procedure for investigation and the training given to analysts have been reviewed. Laboratory incidences were the most recurring nonconformances; and these were mainly caused by analyst errors. Corrective and Preventive Actions (CAPAs) were derived by cross functional teams whenever root causes were identified. Procedure for investigation of nonconformances refers to investigative tools. Identification of root causes to nonconformances recently became mandatory. Analysts have limited advanced industrial training on investigation of nonconformances. Another study should be carried out to understand the cause of analyst errors. The study can be rolled out to other departments at the manufacturing facility to create similar improvements. Analysts should enroll into advanced courses of industrial pharmacy to gain advanced industrial skills which they can apply in investigations to find root causes to nonconformances.

Unregistered traditional medicines pose a huge public health threat as the safety and efficacy of... more Unregistered traditional medicines pose a huge public health threat as the safety and efficacy of these products is unknown. The issue this study addresses is the inadequate regulatory measures for herbal medicines in Zimbabwe. This project was done to describe the current registration process of traditional medicines in Zimbabwe, and to identify the gaps and opportunities they present to improve the regulatory landscape. Regulations and laws governing the registration of herbal medicines in the country and published research on legislation of herbal medicines were reviewed. Two parallel regulatory bodies both registering and controlling the sale of herbal medicines were identified. The Medicines Control Authority of Zimbabwe (MCAZ) and the Traditional Medical Practitioners Association (TMPA) both derive their authority to regulate from the ministry of health and were established through the act of parliament which gives these authorities power to regulate the quality and sale of traditional medicines without giving a prescriptive way of doing it. The registration process, and product evaluations for the two authorities are different. While the MCAZ has a clearly defined registration process, the TMPA does not. However, MCAZ has not been very successful in registering local products with the majority of the registered herbal products being imports and only 2% of total registered products being local herbs. As a recommendation, there is need for collaboration between the regulatory bodies for consistence in quality of herbal products on the market and to improve registration of local herbal products. Developing monographs for local herbs commonly used in the country will also assist local manufacturer to fulfill the quality requirements and successful compilation of dossiers for product registration.

Knowledge is an essential organisational asset that contributes to organisational effectiveness w... more Knowledge is an essential organisational asset that contributes to organisational effectiveness when carefully managed. Knowledge sharing (KS) is a vital component of knowledge management that allows individuals to engage in new knowledge creation. Until it's shared, knowledge is considered useless since it resides within the human brain. Public organisations specifically, are more involved in providing and developing knowledge and hence can be classified as knowledge-intensive organisations. Scholarly research conducted on KS has proposed a number of models to help understand the KS process between individuals but none of these models is specifically for a public organisation. Moreover, to really reap the benefits that KS brings to an organization, it's imperative to apply a model that is attributable to the unique characteristics of that organisation. This study reviews literature from electronic databases that discuss models of KS between individuals. Factors that influence KS under each model were isolated and the extent of each of their influence on KS in a public organization context, were critically analysed. The result of this analysis gave rise to factors that were thought to be most critical in understanding KS process in a public sector setting. These factors were then used to develop a KS model by categorizing them into themes including organisational culture, motivation to share and opportunity to share. From these themes, a KS model was developed and proposed for KS in a medicines regulatory authority in East Africa. The project recommends that an empirical study be conducted to validate the applicability of the proposed KS model at a medicines regulatory authority in East Africa.

Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in We... more Approximately 90% of the pharmaceutical inspectors in a pharmacy practice regulatory agency in West Africa have not updated their training on Good Manufacturing Practice (GMP) inspection in at least eight years. However, in the last two years the inspectors relied on learning-on-the job skills. During this time, the agency introduced about 17% of its inspectors to hands-on GMP trainings. GMP is the part of quality assurance that ensures the production or manufacture of medicinal products is consistent in order to control the quality standards appropriate for their intended use as required by the specification of the product. Inspection reports on the Agency's GMP inspection format in-between 2013 to 2019 across the six geopolitical zones in the country were reviewed retrospectively for gap analysis. Sampling was done in two phases. During the first phase sampling of reports was done by random selection, using a stratified sampling method. In the second phase, inspectors from the Regulatory Agency from different regions were contacted on phone to send in four reports each by email. For those that forwarded four reports, two, were selected. However for those who forwarded one or two, all were considered. Also, the Agency's inspection format/checklist was compared with the World Health Organization (WHO) GMP checklist and the GMP practice observed. The purpose of this study was to evaluate the reporting skills and the ability of inspectors to interpret findings vis-à-vis their proficiency in inspection activities hence the efficiency of the system. Secondly, the study seeks to establish shortfalls or adequacies of the Agency's checklist with the aim of reviewing and improving in-line with best global practices. It was observed that different inspectors have different styles and methods of writing reports from the same check-list/inspection format, leading to non-conformances. Interpretations of findings were found to be subjective. However, it was also observed that inspection reports from the few inspectors with the hands-on training in the last two year were more coherent. This indicates that pharmaceutical inspectors need to be trained regularly to increase their knowledge and skills in order to be kept on the same pace. It was also observed that there is a slight deviation in placing sub indicators under the GMP components in the Agency's GMP inspection format, as compared to the WHO checklist.

Pharmacy Education

Background: Some countries in sub-Saharan Africa combat the proliferation of substandard medicine... more Background: Some countries in sub-Saharan Africa combat the proliferation of substandard medicines using anti-counterfeiting devices. An alternative measure involves advanced pharmaceutical education. The Biotechnology Innovation and Regulatory Science (BIRS) educate students in pharmaceutical Good Manufacturing Practices (GMP) and quality control (QC). Objective: This study assessed the African BIRS programme’s efforts to initiate and sustain the manufacturing of quality medicines. Method: Qualitative case studies were used to assess the impact of the BIRS professional training intervention. A convenient purposeful sample of alumni students working in pharmaceutical manufacturing and quality control (QC) participated. Quantitative parametric methods were used to test the hypothesis that participants would significantly increase over the years if the programme met its objectives in the region. Results: Alumni from ten countries implemented and sustained projects in Good Manufacturin...

Good Distribution Practice (GDP) refers to the regulatory guidelines governing the wholesale and ... more Good Distribution Practice (GDP) refers to the regulatory guidelines governing the wholesale and distribution of medicinal products to ensure that their quality and integrity are maintained throughout the supply chain from the manufacturer to the end users. A standard assessment tool for GDP is necessary in order to conduct a robust assessment on GDP on pharmaceutical industries. The observed agency's policy and operational documents in addition to GDP Guidelines from World Health Organization and related organizations from various countries were reviewed. The observed Regulatory Agency does not have a separate assessment tool for GDP inspection. Few core GDP parameters are captured in a section of the GMP reporting format. The included parameters addressed the activities in the production areas and do not address the major distribution activities and processes. Thus, it is unlikely that a robust inspection will be carried out in the absence of a separate GDP assessment tool. There is need for a separate and robust GDP assessment tool, training of inspectors in line with the tool and a separate GDP inspection, outside the GMP inspection, Majority of the GDP guidelines reviewed from various countries were in line with the World Health Organization's GDP guideline. Based on the findings, an Assessment Tool for Good Distribution Practice was developed for the agency, to be applied to all distributors, coordinated wholesale centres, wholesalers and retailers. There is need for the agency to adopt the Assessment Tool, develop its own guidelines for GDP and train all pharmaceutical inspectors on uniform assessment and interpretation of indices, reporting of observations and conclusions.

Patient information leaflets (PILs) and labels are important for rational use of medicines as the... more Patient information leaflets (PILs) and labels are important for rational use of medicines as they provide additional information for patients on the medicines dispensed to them. In developing countries, this potential cannot be fully harnessed unless manufacturers provide medicines with labels and PILs that meet regulatory standards for content and user-friendliness. In South Sudan, it is not known if manufacturers uphold standards of these labels and PILs once their products are approved for distribution in the country. This study explored the degree to which medicines distributed in South Sudan comply with regulatory requirements for labels and PILs. A cross-sectional survey was conducted at selected pharmacies in Juba, the capital city of South Sudan. Labels and PILs from tracer medicines (based on the WHO priority list of medicines for children and women) were retrieved and assessed for compliance with regulatory requirements. Clients leaving the pharmacies were also interviewed about their prescriptions and understanding of the PILs. This study demonstrated that availability of essential medicines for maternal and child health is limited in the private sector is limited (66% overall). Furthermore, the availability and quality of labels and PILs leave a lot to be desired (79% complied with labeling requirements; 68% complied for PIL. There was a tendency for compliance of products from certain countries to be particularly poor. PILs were given out for only 38% of medicines dispensed. Most patients (92%) leaving the pharmacy did not know contraindications for the medicines dispensed, while majority (83%) had no idea what they should do if they had forgotten to take their medicine on time. Limited availability of essential medicines in the private sector has implications on universal health coverage, as a good proportion of patients seek health care services through the private sector. Labels and PILs are essential for education on their medication and impact on rational use of medicines. Moving forward, the regulatory authority in South Sudan would benefit from establishing and implementing strict guidelines that compel importers to adhere to licensing conditions related to labels and PILs up to the last mile of the supply chain. Frequent post-marketing authorization inspections should be used to check on these aspects with punitive measures taken against noncompliant distributors.

The purpose of this study was to understand the status quo of quality sample testing in the labor... more The purpose of this study was to understand the status quo of quality sample testing in the laboratory unit. A quantitative research method was used. An extensive laboratory documents (protocol, worksheets, laboratory analytical plan, standard operating procedures and manuals) review was performed and a networking approach to both management and lab staff at all levels was reviewed in order to identify all non-conformities occurred in the past three years. Results identified 36 number of results deviated from reference standards among different test performed, 400 number of samples lost, the number of laboratory personnel who were not sufficiently trained to take the task properly decreased from 16 in 2016 to 6 in 2018 after conducting training on laboratory quality management system, 36 controlled documents including sample management standard operating procedure, bench job aids were missing and 8 customer complains about the delay of results and quality laboratory of services have...

A review of the East African Community (EAC) joint regulatory review process was conducted, regis... more A review of the East African Community (EAC) joint regulatory review process was conducted, registration timelines analyzed and key milestones, challenges and opportunities documented for the period of July 2015 to January 2020. A total of 113 applications were submitted for joint scientific review. Among these, 109 applications were assessed, 57 were recommended for marketing authorisation, 52 applications had queries to applicants and four applications were under review. A total median approval time for all products ranged from 53 to 102 days. The maximum time taken by a regulator to review the dossier was 391 days and the minimum time was 44 days. For applicants, the maximum time to respond to queries was 927 days and the minimum time was nine days. The total median time for granting marketing authorisation by the National Medicines Regulatory Authorities (NMRA) decreased from 174 to 39 working days in 2015 and 2019 respectively. However, not all EAC NMRA has granted marketing au...

This project aimed at investigating online damages of packaging materials generated during produc... more This project aimed at investigating online damages of packaging materials generated during production because of imperfectness of production processes. These online damages may lead to upsurge in production cost and/or market returns, causing the company to experience losses and even damage its reputation. Data on online damages were collected for 20ml, 40ml and 100ml labels of an acaricide product for the period between July 2018 and June 2019 and statistically analyzed. Investigation was done on the causes of online damages, then corrective and preventive actions carried out. Analysis of online damages of labels of the three pack sizes revealed a loss of 1.01% on labels alone during the year under analysis. After implementing corrective and preventive actions, there was a reduction of online damages of labels.

The research was a retrospective study of twenty-five Good Manufacturing Practice (GMP) inspectio... more The research was a retrospective study of twenty-five Good Manufacturing Practice (GMP) inspection reports (from March 2017 through to December 2018) of a national medicine regulatory agency, drug Inspectorate, in West Africa, designed to assess the inspectors’ expertise in the act of inspection report writing. The investigation examined a paper-based tool of thirteen pre-registration Inspection reports and twelve GMP reassessment reports written prior and following an intervention program by external GMP trainers to enhance inspectors’ skill in pharmaceutical cGMP inspection. The study made use of quantitative analysis to investigate each team’s expertise in the act of writing GMP inspection report. Likewise, each report’s compliance with the requirements of three regulatory standards on GMP inspection report writing was ascertained. Impact of intervention program on lead inspectors’ competence was assessed. Lastly, gap in each team writing effectiveness, and lead inspectors’ abili...

Purpose: To provide a robust, efficient synthesis of the malaria drug piperaquine for potential u... more Purpose: To provide a robust, efficient synthesis of the malaria drug piperaquine for potential use in resource-poor settings. Methods: We used in-process analytical technologies (IPAT; HPLC) and a program of experiments to develop a synthesis of piperaquine that avoids the presence of a toxic impurity in the API and is optimized for overall yield and operational simplicity. Results: A green-chemical synthesis of piperaquine is described that proceeds in 92 – 93 % overall yield. The chemistry is robust and provides very pure piperaquine tetraphosphate salt (> 99.5 %). The overall process utilizes modest amounts (about 8 kg/kg) of 2-propanol and ethyl acetate as the only organic materials not incorporated into the API; roughly 60 % of this waste can be recycled into the production process. This process also completely avoids the formation of a toxic impurity commonly seen in piperaquine that is otherwise difficult to remove. Conclusion: An efficient synthesis of piperaquine is des...

The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle... more The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (...

Pharmacy Education