Audit of intravenous antifungal therapy used for Candida infections at a South African private hospital
- Authors: Van Dyk, Jacklyn Kate
- Date: 2020
- Subjects: Candidiasis
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46380 , vital:39600
- Description: The epidemiological landscape of the candida species has changed with the emergence of MDR strains globally and in South Africa. The aim of this study was to critically evaluate the compliance to guidelines in the use of intravenous antifungal therapy when treating invasive Candidainfections in a South African private hospital.Objective One was to determine the prevalence of Candida auris(C.auris) in the sample. Objective Two examined the relationship between high-risk patients and positive microbiological cultures. Objective Three studied the prescribing utilisation of the intravenous antifungalsin the form of a clinical audit. Objective Four compared these prescribing patternsto current guidelines by evaluating whether the antifungal course was non-compliant, of suboptimal compliance or compliant. Objective Five was to design a protocol for ward pharmacists to use when assessing antifungal treatment for candidiasis. The research design consisted of a retrospective, non-experimental, cross-sectional analysis of intravenous antifungal use in the management of systemic Candida infections in a private sector hospital in the Gauteng province, South Africa.A positive research paradigm with a quantitative clinical audit was used in this study. The most prevalent species cultured was C.auris with 31 of the 77 positive cultures. Risk stratifying patients was validated with 70% of high risk patients (Candida Score >2.5 and positive β-D-glucan) having a corresponding positive culture. Echinocandins were the most frequently utilised antifungal class, with caspofungin being the most used antifungal in the sample. The average duration of therapy for the echinocandins ranged between 11 and 16 days. Compliance to guidelines was evaluated accordingto: reason for initiation; drug choice and drug dose. Three levels of compliance were determined: non-compliant, sub-optimal compliance and compliant. xivThe overall compliance,according to recommended treatment guidelines,was found to be suboptimal, with anidentified need foranintervention which targets thedosing of the antifungals used. In conclusion, the research findings highlight the importance of reviewing antifungal prescribing habits and the need for antifungal stewardship programmes.
- Full Text:
- Date Issued: 2020
- Authors: Van Dyk, Jacklyn Kate
- Date: 2020
- Subjects: Candidiasis
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46380 , vital:39600
- Description: The epidemiological landscape of the candida species has changed with the emergence of MDR strains globally and in South Africa. The aim of this study was to critically evaluate the compliance to guidelines in the use of intravenous antifungal therapy when treating invasive Candidainfections in a South African private hospital.Objective One was to determine the prevalence of Candida auris(C.auris) in the sample. Objective Two examined the relationship between high-risk patients and positive microbiological cultures. Objective Three studied the prescribing utilisation of the intravenous antifungalsin the form of a clinical audit. Objective Four compared these prescribing patternsto current guidelines by evaluating whether the antifungal course was non-compliant, of suboptimal compliance or compliant. Objective Five was to design a protocol for ward pharmacists to use when assessing antifungal treatment for candidiasis. The research design consisted of a retrospective, non-experimental, cross-sectional analysis of intravenous antifungal use in the management of systemic Candida infections in a private sector hospital in the Gauteng province, South Africa.A positive research paradigm with a quantitative clinical audit was used in this study. The most prevalent species cultured was C.auris with 31 of the 77 positive cultures. Risk stratifying patients was validated with 70% of high risk patients (Candida Score >2.5 and positive β-D-glucan) having a corresponding positive culture. Echinocandins were the most frequently utilised antifungal class, with caspofungin being the most used antifungal in the sample. The average duration of therapy for the echinocandins ranged between 11 and 16 days. Compliance to guidelines was evaluated accordingto: reason for initiation; drug choice and drug dose. Three levels of compliance were determined: non-compliant, sub-optimal compliance and compliant. xivThe overall compliance,according to recommended treatment guidelines,was found to be suboptimal, with anidentified need foranintervention which targets thedosing of the antifungals used. In conclusion, the research findings highlight the importance of reviewing antifungal prescribing habits and the need for antifungal stewardship programmes.
- Full Text:
- Date Issued: 2020
Compliance with good distribution practice guidelines for cold chain products among pharmaceutical wholesalers in South Africa
- Authors: Masebe, Zandisile
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46390 , vital:39581
- Description: Background: The South African pharmaceutical cold chain distribution industry is highly regulated. Cold chain pharmaceutical products require storage in a cold room, in a temperature-controlled environment between (2°C-8°C) and the cold chain must be maintained at all times throughout the distribution process. The incorrect handling, storage, transport and distribution of cold chain products may reduce the potency and therapeutic effectiveness of the product which in turn may result in treatment failure. The research was aimed at determining the level of compliance to current Good Distribution Practice guidelines for cold chain products among pharmaceutical wholesalers and distributors in South Africa. Methodology: The study made use of quantitative research techniques. A purpose designed online questionnaire was used as a data collection tool from the study participants. The judgmental sampling technique was used in this study as it was found to be the most appropriate method for the research question. Phase one of the study was to conduct a pilot study at two Port Elizabeth pharmaceutical wholesalers. The data was analysed using Microsoft Excel®, chi-square test for goodness of fit and content analysis. The data was further analysed using a descriptive and inferential statistics approach to determine the level of compliance to regulatory guidelines for cold chain products.Results:The results obtained from the empirical study revealed that less than 50% of the study respondents indicated compliance to the factors listed in the regulatory guidelines for cold chain products distribution.These factors include cold chain monitoring, alternative power sources, validation of cold chain boxes and route transport validation.Conclusion:The wholesale pharmaceutical industry is experiencing challenges to comply with factors necessary to ensure compliance with GDP guidelines for cold chain products. Through the study it was proven that there is evidence of commitment by the industry to implement the GWP and GPP amendment guidelines, despite less than 50% of the respondents reporting compliance to the guidelines. Recommendations were provided to improve the level of compliance to guidelines for cold chain products by pharmaceutical wholesalers in South Africa.
- Full Text:
- Date Issued: 2020
- Authors: Masebe, Zandisile
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46390 , vital:39581
- Description: Background: The South African pharmaceutical cold chain distribution industry is highly regulated. Cold chain pharmaceutical products require storage in a cold room, in a temperature-controlled environment between (2°C-8°C) and the cold chain must be maintained at all times throughout the distribution process. The incorrect handling, storage, transport and distribution of cold chain products may reduce the potency and therapeutic effectiveness of the product which in turn may result in treatment failure. The research was aimed at determining the level of compliance to current Good Distribution Practice guidelines for cold chain products among pharmaceutical wholesalers and distributors in South Africa. Methodology: The study made use of quantitative research techniques. A purpose designed online questionnaire was used as a data collection tool from the study participants. The judgmental sampling technique was used in this study as it was found to be the most appropriate method for the research question. Phase one of the study was to conduct a pilot study at two Port Elizabeth pharmaceutical wholesalers. The data was analysed using Microsoft Excel®, chi-square test for goodness of fit and content analysis. The data was further analysed using a descriptive and inferential statistics approach to determine the level of compliance to regulatory guidelines for cold chain products.Results:The results obtained from the empirical study revealed that less than 50% of the study respondents indicated compliance to the factors listed in the regulatory guidelines for cold chain products distribution.These factors include cold chain monitoring, alternative power sources, validation of cold chain boxes and route transport validation.Conclusion:The wholesale pharmaceutical industry is experiencing challenges to comply with factors necessary to ensure compliance with GDP guidelines for cold chain products. Through the study it was proven that there is evidence of commitment by the industry to implement the GWP and GPP amendment guidelines, despite less than 50% of the respondents reporting compliance to the guidelines. Recommendations were provided to improve the level of compliance to guidelines for cold chain products by pharmaceutical wholesalers in South Africa.
- Full Text:
- Date Issued: 2020
Evaluation of product x pre and post cpv implementation
- Authors: Killian, Christopher Grant
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46447 , vital:39577
- Description: Purpose: Stage 3 of the pharmaceutical process validation lifecycle, is called continued process verification (CPV). CPV is the final stage of lifecycle management and is intended to provide ongoing assurance that during routine production that a process remains in a state of control. Since CPV is a relatively new focus area for regulators, many legacy products will not have undergone Stage 3 process validation. Therefore, an opportunity existed to review the impact and challenges of implementing CPV on a legacy product. Methodology: This study employed quantitative analysis to evaluate the impact of CPV on process stability and end product quality for Product X, a legacy product manufactured at a generics manufacturing facility. Initial Stage 3a CPV was used to review historical process data and identify special cause variation. Corrective and preventative actions were taken to address these statistical outliers and the impact of these process changes were evaluated in Stage 3b. Results: CPV implementation appeared to have an effect on process control, stability and capability for Product X. In Stage 3b, an increase in statistical outliers along with significant changes to process mean and standard deviation were seen for the critical process parameters, average mass and hardness. An improvement in process capability for the critical quality attributes, assay and dissolution, was also seen. Conclusion: The largest benefit of CPV implementation, especially for a legacy product, is the process knowledge gained. This provided opportunities for process improvement and ultimately benefited patient safety.
- Full Text:
- Date Issued: 2020
- Authors: Killian, Christopher Grant
- Date: 2020
- Subjects: Pharmaceutical industry
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46447 , vital:39577
- Description: Purpose: Stage 3 of the pharmaceutical process validation lifecycle, is called continued process verification (CPV). CPV is the final stage of lifecycle management and is intended to provide ongoing assurance that during routine production that a process remains in a state of control. Since CPV is a relatively new focus area for regulators, many legacy products will not have undergone Stage 3 process validation. Therefore, an opportunity existed to review the impact and challenges of implementing CPV on a legacy product. Methodology: This study employed quantitative analysis to evaluate the impact of CPV on process stability and end product quality for Product X, a legacy product manufactured at a generics manufacturing facility. Initial Stage 3a CPV was used to review historical process data and identify special cause variation. Corrective and preventative actions were taken to address these statistical outliers and the impact of these process changes were evaluated in Stage 3b. Results: CPV implementation appeared to have an effect on process control, stability and capability for Product X. In Stage 3b, an increase in statistical outliers along with significant changes to process mean and standard deviation were seen for the critical process parameters, average mass and hardness. An improvement in process capability for the critical quality attributes, assay and dissolution, was also seen. Conclusion: The largest benefit of CPV implementation, especially for a legacy product, is the process knowledge gained. This provided opportunities for process improvement and ultimately benefited patient safety.
- Full Text:
- Date Issued: 2020
Perceptions of the preparedness of pharmacy graduates for internship responsibilities in the industrial pharmacy
- Putsoane, Mathabelo Maliboche
- Authors: Putsoane, Mathabelo Maliboche
- Date: 2020
- Subjects: Pharmacy students
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46395 , vital:39593
- Description: Pharmacy graduates in South Africa are expected to undertake a compulsory one-yearinternship in diversepharmacy settings. These settings includethe industrial pharmacy sector,where they are expected to integrate furtherthe knowledge and skills they have acquired during their undergraduate training before entering into the pharmacy profession. The success of graduatesduring the internship,therefore, depends amongst other thingson their perceptions of preparedness. However, the perceptions of South African pharmacy graduates preparedness for the industrial pharmacy settingis not reportedin light of the shift in global pharmacy education from product-based to patient-based education which thus provided the impetus for this study.Semi-structured interviews with individual pharmacy graduateswere utilised to explorethe perceptions of the preparedness regarding the technical and generic skills required of an industrial pharmacy intern. Inductive data analysisculminated in thedevelopment of themes and subthemes. A lack of preparedness as perceived by graduateswas a result of a lack of industrial pharmacy experientialwork-basedpractical training and patient-focused education. Graduates perceived themselves to be fairly prepared with communication and teamwork skills; however, their problem-solving skills werenot clear due tothe scope of work ofanintern pharmacist which hinders them from solvingproblems.Though graduates expressed that they had acquired adequate theoretical training, the lack of practical application resulted in inadequate technical skills preparedness. Graduatespreparedness for the industrial pharmacy can be improved by work-based placements of students in the industry pharmacy setting which will assist students to integrate theory with practice.
- Full Text:
- Date Issued: 2020
- Authors: Putsoane, Mathabelo Maliboche
- Date: 2020
- Subjects: Pharmacy students
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/46395 , vital:39593
- Description: Pharmacy graduates in South Africa are expected to undertake a compulsory one-yearinternship in diversepharmacy settings. These settings includethe industrial pharmacy sector,where they are expected to integrate furtherthe knowledge and skills they have acquired during their undergraduate training before entering into the pharmacy profession. The success of graduatesduring the internship,therefore, depends amongst other thingson their perceptions of preparedness. However, the perceptions of South African pharmacy graduates preparedness for the industrial pharmacy settingis not reportedin light of the shift in global pharmacy education from product-based to patient-based education which thus provided the impetus for this study.Semi-structured interviews with individual pharmacy graduateswere utilised to explorethe perceptions of the preparedness regarding the technical and generic skills required of an industrial pharmacy intern. Inductive data analysisculminated in thedevelopment of themes and subthemes. A lack of preparedness as perceived by graduateswas a result of a lack of industrial pharmacy experientialwork-basedpractical training and patient-focused education. Graduates perceived themselves to be fairly prepared with communication and teamwork skills; however, their problem-solving skills werenot clear due tothe scope of work ofanintern pharmacist which hinders them from solvingproblems.Though graduates expressed that they had acquired adequate theoretical training, the lack of practical application resulted in inadequate technical skills preparedness. Graduatespreparedness for the industrial pharmacy can be improved by work-based placements of students in the industry pharmacy setting which will assist students to integrate theory with practice.
- Full Text:
- Date Issued: 2020
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