Application of a quality by design approach to optimise an existing product
- Authors: Maxwell, Taryn Lee
- Date: 2018
- Subjects: Pharmaceutical chemistry , Drugs -- Design Pharmaceutical technology
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/32752 , vital:32341
- Description: Quality by design is a science and risk based approach whereby quality is built into the product or process during the pharmaceutical development. although quality by design is encouraged for pharmaceutical development. it is possible to apply quality by design to optimize an existing product as part of a continual improvement strategy. the purpose of this study is to determine which factors should be considered to justify the application of quality by design to optimize an existing product.
- Full Text: false
- Date Issued: 2018
- Authors: Maxwell, Taryn Lee
- Date: 2018
- Subjects: Pharmaceutical chemistry , Drugs -- Design Pharmaceutical technology
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/32752 , vital:32341
- Description: Quality by design is a science and risk based approach whereby quality is built into the product or process during the pharmaceutical development. although quality by design is encouraged for pharmaceutical development. it is possible to apply quality by design to optimize an existing product as part of a continual improvement strategy. the purpose of this study is to determine which factors should be considered to justify the application of quality by design to optimize an existing product.
- Full Text: false
- Date Issued: 2018
Barriers to picking and packing in pharmaceutical warehousing and distribution in South Africa
- Authors: Kemp, Nicholas
- Date: 2018
- Subjects: Pharmaceutical industry -- Materials management , Warehouses -- Management Pharmaceutical industry -- South Africa Physical distribution of goods -- Management
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/30627 , vital:30994
- Description: Barriers within the supply chain play an evident role in decreasing its efficiency. The supply chain system is not well documented in the pharmaceutical sector. The aim of this study was to identify any barriers to the movement of picking and packing operators within 6 distribution facilities throughout South Africa using a time and motion analysis. A pilot study was initially conducted to choose the stopwatch application for Android® devices and to ensure reliability of the tools utilised. The motions during the processes of fulfilling an order were identified during the case picking, bulk picking and packing processes by direct observation of operators. The direct observation was performed using a stopwatch application for Android® devices and a tool on Microsoft Excel®. The data was analysed using Microsoft Excel®, using a student’s T-test and an analysis of variance (ANOVA) approach to identify similarities and differences between the facilities. The data was further analysed using a descriptive statistics approach to identify the common barriers amongst the distribution centres. Thereafter, the data was analysed by identifying a value-quotient. The value-quotient was used to identify how much time was spent on value-adding activities with each facility. The observation of the operators was done randomly at each facility to avoid subjectivity and bias. Results: The pilot study identified which stopwatch application was to be utilised. The pilot study aided to improve upon the design of the data collection tool used for the transcribing of the timing operation. The student’s T-test and ANOVA revealed that there were statistically significant differences in case picking amongst facilities, namely using the radio frequency identification devices (RFID), picking and transfer of stock. In the bulk picking process, there was a statistically significant difference amongst the facilities, namely using the RFID, pick and transfer of stock. In the packing process there was a statistically significant difference amongst the facilities in the packing process. The analysis of barriers within the distribution centres revealed that the 16 common barriers amongst the picking processes at the facilities included raising the platform, waiting for colleagues to depart an aisle, RFID malfunctions and answering their phones. No common barriers during the packing process was identified. The value-quotient revealed that most of the facilities spent more than 50 percent of their time on value-adding activities during the case picking, bulk picking and packing processes. A time and motion analysis proved to be an effective method to identify similarities and barriers between the six facilities. It was recommended to investigate a few of the basic operations to improve upon, as well as the possibility of implementing a barcoded system to the stock.
- Full Text:
- Date Issued: 2018
- Authors: Kemp, Nicholas
- Date: 2018
- Subjects: Pharmaceutical industry -- Materials management , Warehouses -- Management Pharmaceutical industry -- South Africa Physical distribution of goods -- Management
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/30627 , vital:30994
- Description: Barriers within the supply chain play an evident role in decreasing its efficiency. The supply chain system is not well documented in the pharmaceutical sector. The aim of this study was to identify any barriers to the movement of picking and packing operators within 6 distribution facilities throughout South Africa using a time and motion analysis. A pilot study was initially conducted to choose the stopwatch application for Android® devices and to ensure reliability of the tools utilised. The motions during the processes of fulfilling an order were identified during the case picking, bulk picking and packing processes by direct observation of operators. The direct observation was performed using a stopwatch application for Android® devices and a tool on Microsoft Excel®. The data was analysed using Microsoft Excel®, using a student’s T-test and an analysis of variance (ANOVA) approach to identify similarities and differences between the facilities. The data was further analysed using a descriptive statistics approach to identify the common barriers amongst the distribution centres. Thereafter, the data was analysed by identifying a value-quotient. The value-quotient was used to identify how much time was spent on value-adding activities with each facility. The observation of the operators was done randomly at each facility to avoid subjectivity and bias. Results: The pilot study identified which stopwatch application was to be utilised. The pilot study aided to improve upon the design of the data collection tool used for the transcribing of the timing operation. The student’s T-test and ANOVA revealed that there were statistically significant differences in case picking amongst facilities, namely using the radio frequency identification devices (RFID), picking and transfer of stock. In the bulk picking process, there was a statistically significant difference amongst the facilities, namely using the RFID, pick and transfer of stock. In the packing process there was a statistically significant difference amongst the facilities in the packing process. The analysis of barriers within the distribution centres revealed that the 16 common barriers amongst the picking processes at the facilities included raising the platform, waiting for colleagues to depart an aisle, RFID malfunctions and answering their phones. No common barriers during the packing process was identified. The value-quotient revealed that most of the facilities spent more than 50 percent of their time on value-adding activities during the case picking, bulk picking and packing processes. A time and motion analysis proved to be an effective method to identify similarities and barriers between the six facilities. It was recommended to investigate a few of the basic operations to improve upon, as well as the possibility of implementing a barcoded system to the stock.
- Full Text:
- Date Issued: 2018
Delivery of pharmaceutical services and care at three primary healthcare clinics with different dispensing models in the Nelson Mandela Bay Health District
- Authors: Bobbins, Amy Claire
- Date: 2018
- Subjects: National health insurance -- South Africa , Community health services -- South Africa Pharmaceutical services -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/23580 , vital:30583
- Description: As South Africa moves into an era of National Health Insurance (NHI), the idea of primary health care (PHC) re-engineering is placed at the forefront; however, the role of the pharmacist in this process remains vague. Task-shifting of the dispensing process to pharmacist’s assistants and nurses in PHC clinics is a common phenomenon, but the implications of this on the provision of pharmaceutical services and care to patients is largely unstudied. Thus, this study aims to explore these pharmacist-based, pharmacist’s assistant-based and nurse-based dispensing models present in PHC clinics. A two-phase, mixed methods approach was utilised, comprising of a pharmaceutical services audit and semi-structured interviews. The interviews provided insight into the lived experiences of personnel and patients of pharmaceutical care provision. Results revealed that although basic pharmaceutical services may be available at clinics with each of the three dispensing models, the quality is of a varying standard due to challenges in infrastructure and maintenance and poor personnel support. Furthermore, the provision of quality pharmaceutical care is minimal with all three dispensing models, resulting in a missed opportunity to optimise patient health outcomes in patient-centred PHC.
- Full Text:
- Date Issued: 2018
- Authors: Bobbins, Amy Claire
- Date: 2018
- Subjects: National health insurance -- South Africa , Community health services -- South Africa Pharmaceutical services -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/23580 , vital:30583
- Description: As South Africa moves into an era of National Health Insurance (NHI), the idea of primary health care (PHC) re-engineering is placed at the forefront; however, the role of the pharmacist in this process remains vague. Task-shifting of the dispensing process to pharmacist’s assistants and nurses in PHC clinics is a common phenomenon, but the implications of this on the provision of pharmaceutical services and care to patients is largely unstudied. Thus, this study aims to explore these pharmacist-based, pharmacist’s assistant-based and nurse-based dispensing models present in PHC clinics. A two-phase, mixed methods approach was utilised, comprising of a pharmaceutical services audit and semi-structured interviews. The interviews provided insight into the lived experiences of personnel and patients of pharmaceutical care provision. Results revealed that although basic pharmaceutical services may be available at clinics with each of the three dispensing models, the quality is of a varying standard due to challenges in infrastructure and maintenance and poor personnel support. Furthermore, the provision of quality pharmaceutical care is minimal with all three dispensing models, resulting in a missed opportunity to optimise patient health outcomes in patient-centred PHC.
- Full Text:
- Date Issued: 2018
Future role of community pharmacy in the national health insurance
- Authors: Aluko, Olubusola Aderonke
- Date: 2018
- Subjects: National health insurance -- South Africa , Health care reform -- South Africa Community health services -- South Africa Pharmacy -- Practice -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/21472 , vital:29525
- Description: Governments all over the world have shown interest in the healthcare system and various policies and measures have been adopted to ensure optimum health of the people. Inequity in health provision in South Africa is a great challenge. In South Africa, the healthcare system is currently characterised by distinctly different public and private sectors. The public sector serves approximately 84% of the population while the private sector services the smaller portion, 16% of the population. However, the expenditure in both the private and public sectors is almost the same, with approximately five times more being spent per capita in the private sector than in the public sector. The South African health care system is therefore unbalanced with respect to expenditure per capita resulting in inequitable access to, and quality of, health services. In particular, relative to the population it serves and the disease burden that it carries, the public sector is under-resourced. In order to address the inequities characteristic of the current two-tiered system, the South African Government is in the process of implementing a National Health Insurance (NHI). The NHI will provide a means of pooling all healthcare funding, thereby providing a means of cross subsidization within the public sector. Funding contributions will be linked to the ability of an individual to pay and benefits will be determined by an individual’s need for care. A core principle of NHI is to provide access to quality care. It has been suggested that within a NHI system private pharmacies may be contracted through service agreements to provide both chronic and acute medicines. However, there are currently no policies specifying the roles and functions of pharmacists in the NHI or in a re-engineered Primary Health Care system, although it has been suggested that for South Africa to have a successful healthcare system it requires the support and assistance of pharmacists. Research suggests that the majority of pharmacists do not believe that the NHI is a suitable means to address South Africa’s healthcare problems and many do not agree with the principles behind it. This study describes the perceptions and attitudes of community pharmacists and the lay public in Nelson Mandela Bay Metropole toward NHI and the potential role of community pharmacists within the NHI. A qualitative approach was used to provide an in-depth exploration of the attitudes and perceptions of community pharmacists and the lay public in Nelson Mandela Bay Metropole (NMBM). It is envisaged that this understanding will provide a basis for addressing pharmacists’ concerns and may contribute towards the further development of the role and the scope of practice of community pharmacists in the NHI. Semi-structured, in-depth interviews were conducted with both community pharmacists and with members of the public. The interviews were digitally recorded and then transcribed. The transcriptions were coded and analysed thematically. The analysis of the themes identified revealed that while community pharmacists and the public are aware of NHI they are uncertain as to how it is being implemented. However, both community pharmacists and patients see NHI as an advantage and display a positive attitude towards NHI.
- Full Text:
- Date Issued: 2018
- Authors: Aluko, Olubusola Aderonke
- Date: 2018
- Subjects: National health insurance -- South Africa , Health care reform -- South Africa Community health services -- South Africa Pharmacy -- Practice -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/21472 , vital:29525
- Description: Governments all over the world have shown interest in the healthcare system and various policies and measures have been adopted to ensure optimum health of the people. Inequity in health provision in South Africa is a great challenge. In South Africa, the healthcare system is currently characterised by distinctly different public and private sectors. The public sector serves approximately 84% of the population while the private sector services the smaller portion, 16% of the population. However, the expenditure in both the private and public sectors is almost the same, with approximately five times more being spent per capita in the private sector than in the public sector. The South African health care system is therefore unbalanced with respect to expenditure per capita resulting in inequitable access to, and quality of, health services. In particular, relative to the population it serves and the disease burden that it carries, the public sector is under-resourced. In order to address the inequities characteristic of the current two-tiered system, the South African Government is in the process of implementing a National Health Insurance (NHI). The NHI will provide a means of pooling all healthcare funding, thereby providing a means of cross subsidization within the public sector. Funding contributions will be linked to the ability of an individual to pay and benefits will be determined by an individual’s need for care. A core principle of NHI is to provide access to quality care. It has been suggested that within a NHI system private pharmacies may be contracted through service agreements to provide both chronic and acute medicines. However, there are currently no policies specifying the roles and functions of pharmacists in the NHI or in a re-engineered Primary Health Care system, although it has been suggested that for South Africa to have a successful healthcare system it requires the support and assistance of pharmacists. Research suggests that the majority of pharmacists do not believe that the NHI is a suitable means to address South Africa’s healthcare problems and many do not agree with the principles behind it. This study describes the perceptions and attitudes of community pharmacists and the lay public in Nelson Mandela Bay Metropole toward NHI and the potential role of community pharmacists within the NHI. A qualitative approach was used to provide an in-depth exploration of the attitudes and perceptions of community pharmacists and the lay public in Nelson Mandela Bay Metropole (NMBM). It is envisaged that this understanding will provide a basis for addressing pharmacists’ concerns and may contribute towards the further development of the role and the scope of practice of community pharmacists in the NHI. Semi-structured, in-depth interviews were conducted with both community pharmacists and with members of the public. The interviews were digitally recorded and then transcribed. The transcriptions were coded and analysed thematically. The analysis of the themes identified revealed that while community pharmacists and the public are aware of NHI they are uncertain as to how it is being implemented. However, both community pharmacists and patients see NHI as an advantage and display a positive attitude towards NHI.
- Full Text:
- Date Issued: 2018
Impact of South African patient law on medicines and generic substitution
- Authors: Jaganath, Bhavrith
- Date: 2018
- Subjects: Drugs -- South Africa -- Generic substitution , Generic drugs -- South Africa Patent laws and legislation Patents
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/22243 , vital:29907
- Description: Generic substitution of medicine is a mandatory cost- saving alternative made available to the public in South Africa . the availability of registered genetic medicine in the country is controlled by the South African Health products regulatory authority (SAHPRA), Formally known as the medicines control council (MCC), through the medicines and related substances act, No. 101 of 1965.
- Full Text:
- Date Issued: 2018
- Authors: Jaganath, Bhavrith
- Date: 2018
- Subjects: Drugs -- South Africa -- Generic substitution , Generic drugs -- South Africa Patent laws and legislation Patents
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/22243 , vital:29907
- Description: Generic substitution of medicine is a mandatory cost- saving alternative made available to the public in South Africa . the availability of registered genetic medicine in the country is controlled by the South African Health products regulatory authority (SAHPRA), Formally known as the medicines control council (MCC), through the medicines and related substances act, No. 101 of 1965.
- Full Text:
- Date Issued: 2018
Medicine use in swallowing-impaired patients: Pharmacists’ knowledge, practice and information needs
- Authors: Masilamoney, Mehrusha
- Date: 2018
- Subjects: Deglutition disorders , Drugs -- Administration , Oral medication -- Administration , Pharmacists -- Practice , South African Pharmacy Council
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/61940 , vital:28086
- Description: Dysphagia, or swallowing impairment, is a growing problem that affects 13.5% of the general population. The ability to swallow is essential for patients taking oral medicines, so this presents a challenge for swallowing-impaired (SI) patients as tablets and capsules will usually require modification prior to ingestion. Pharmacists should play a central role in advising SI patients about their medicine use, as well as problems that may impact on safety, adherence and therapeutic outcome. However, little is known about pharmacists’ level of knowledge, their practice and their information needs when dealing with SI patients and their use of medicines. The aim of this study was to investigate pharmacist knowledge, practice and information needs relating to the support of SI patients and their medicine-related needs. The study design included both quantitative and qualitative methods. A quantitative questionnaire was developed to collect data on the knowledge, practice and information needs of pharmacists and was piloted in 10 pharmacists, which resulted in minor modifications. The questionnaire was converted to a web-based survey and emailed to all pharmacists registered with the South African Pharmacy Council. Two knowledge scores were generated by summating correct responses: knowledge of dysphagia (KOD) and knowledge of medicine use (KOMU) in SI patients. Correlation analysis was used to investigate the strength of the relationship between specific variables with KOD and KOMU using the Pearson correlation coefficient. Qualitative semi-structured interviews were conducted with pharmacists from community, hospital and primary healthcare clinics in both a small town and a major metropole. The aim was to gain deeper understanding of issues arising from the survey, and to explore preferences for topic-specific information materials. All interviews were audio-recorded and transcribed verbatim. Thematic analysis was used to analyse the data. A total of 439 pharmacists responded to the survey, with 67% being females.The mean KOD score out of a maximum score of 10 was 6.1 ± 1.8. KOD was inadequate (<5) in just over one-third (37.8%) of pharmacists. The mean KOMU score achieved (maximum score 17) was 9.4 ± 2.0, with inadequate knowledge (<10) being established in just over two-thirds of pharmacists (70.8%). Age, length of registration as a pharmacist, and years of practice in a setting with direct patient interaction were significantly but weakly correlated with KOMU, whereas KOD showed no significant association with these variables. Qualification significantly influenced both KOD and KOMU; the highest group with adequate knowledge had either a Masters or a PharmD degree. Fewer than half the pharmacists (44%) never ask patients about their swallowing ability, and most (86%) reported no knowledge of locally available viscosity enhancers. Almost all pharmacists were interested in receiving information materials on assisting SI patients with their medicine use. Three major themes emerged from the semi-structured interviews. Pharmacists recognised their knowledge deficit and felt that lack of both undergraduate training and formal training during practice, as well as limited exposure to SI patients, were contributing factors. Barriers to their practice with SI patients included lack of time, lack of institutional support and lack of easily accessible references on the pharmacists’ role in supporting medicine use in SI patients. Lastly, most pharmacists were not prepared to take ownership of medicine-related problems in SI patients and had conflicting opinions of the pharmacists’ role, usually shifting the responsibility of medicine use in SI patients to nurses. This is the first study to investigate pharmacist knowledge of medicine use in SI patients. The findings indicate that pharmacists do not have the requisite knowledge when dealing with SI patients and their medicine-taking issues despite being the most highly trained healthcare professionals in this field. Lack of undergraduate training, in-house training and limited exposure to SI patients were reported to contribute to poor knowledge. Current practice revealed that there appears to be poor communication among different healthcare professionals, pharmacists were reluctant to work with and/or train nurses on appropriate medicine use in SI patients, and there appeared to be ambiguity surrounding the role of a pharmacist. This research identified that pharmacists regard this topic to be highly relevant to their everyday practice and are keen to receive more information and training relating to this area of study. Information materials were designed and will be made accessible to all pharmacists registered in South Africa.
- Full Text:
- Date Issued: 2018
Medicine use in swallowing-impaired patients: Pharmacists’ knowledge, practice and information needs
- Authors: Masilamoney, Mehrusha
- Date: 2018
- Subjects: Deglutition disorders , Drugs -- Administration , Oral medication -- Administration , Pharmacists -- Practice , South African Pharmacy Council
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/61940 , vital:28086
- Description: Dysphagia, or swallowing impairment, is a growing problem that affects 13.5% of the general population. The ability to swallow is essential for patients taking oral medicines, so this presents a challenge for swallowing-impaired (SI) patients as tablets and capsules will usually require modification prior to ingestion. Pharmacists should play a central role in advising SI patients about their medicine use, as well as problems that may impact on safety, adherence and therapeutic outcome. However, little is known about pharmacists’ level of knowledge, their practice and their information needs when dealing with SI patients and their use of medicines. The aim of this study was to investigate pharmacist knowledge, practice and information needs relating to the support of SI patients and their medicine-related needs. The study design included both quantitative and qualitative methods. A quantitative questionnaire was developed to collect data on the knowledge, practice and information needs of pharmacists and was piloted in 10 pharmacists, which resulted in minor modifications. The questionnaire was converted to a web-based survey and emailed to all pharmacists registered with the South African Pharmacy Council. Two knowledge scores were generated by summating correct responses: knowledge of dysphagia (KOD) and knowledge of medicine use (KOMU) in SI patients. Correlation analysis was used to investigate the strength of the relationship between specific variables with KOD and KOMU using the Pearson correlation coefficient. Qualitative semi-structured interviews were conducted with pharmacists from community, hospital and primary healthcare clinics in both a small town and a major metropole. The aim was to gain deeper understanding of issues arising from the survey, and to explore preferences for topic-specific information materials. All interviews were audio-recorded and transcribed verbatim. Thematic analysis was used to analyse the data. A total of 439 pharmacists responded to the survey, with 67% being females.The mean KOD score out of a maximum score of 10 was 6.1 ± 1.8. KOD was inadequate (<5) in just over one-third (37.8%) of pharmacists. The mean KOMU score achieved (maximum score 17) was 9.4 ± 2.0, with inadequate knowledge (<10) being established in just over two-thirds of pharmacists (70.8%). Age, length of registration as a pharmacist, and years of practice in a setting with direct patient interaction were significantly but weakly correlated with KOMU, whereas KOD showed no significant association with these variables. Qualification significantly influenced both KOD and KOMU; the highest group with adequate knowledge had either a Masters or a PharmD degree. Fewer than half the pharmacists (44%) never ask patients about their swallowing ability, and most (86%) reported no knowledge of locally available viscosity enhancers. Almost all pharmacists were interested in receiving information materials on assisting SI patients with their medicine use. Three major themes emerged from the semi-structured interviews. Pharmacists recognised their knowledge deficit and felt that lack of both undergraduate training and formal training during practice, as well as limited exposure to SI patients, were contributing factors. Barriers to their practice with SI patients included lack of time, lack of institutional support and lack of easily accessible references on the pharmacists’ role in supporting medicine use in SI patients. Lastly, most pharmacists were not prepared to take ownership of medicine-related problems in SI patients and had conflicting opinions of the pharmacists’ role, usually shifting the responsibility of medicine use in SI patients to nurses. This is the first study to investigate pharmacist knowledge of medicine use in SI patients. The findings indicate that pharmacists do not have the requisite knowledge when dealing with SI patients and their medicine-taking issues despite being the most highly trained healthcare professionals in this field. Lack of undergraduate training, in-house training and limited exposure to SI patients were reported to contribute to poor knowledge. Current practice revealed that there appears to be poor communication among different healthcare professionals, pharmacists were reluctant to work with and/or train nurses on appropriate medicine use in SI patients, and there appeared to be ambiguity surrounding the role of a pharmacist. This research identified that pharmacists regard this topic to be highly relevant to their everyday practice and are keen to receive more information and training relating to this area of study. Information materials were designed and will be made accessible to all pharmacists registered in South Africa.
- Full Text:
- Date Issued: 2018
Method validation for the quantification of casticin in vitex agnus castus fruit using an ftir multivariate chemometric model
- Authors: Du Toit Louw, Philippus
- Date: 2018
- Subjects: Drugs -- Analysis -- Methodology -- Evaluation , Alternative medicine -- Research , Liquid chromatography
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/30917 , vital:31222
- Description: The Complementary and Alternative Medicines (CAMS) and dietary supplement industry is an R8.84 billion a year industry in South Africa, with the sector expected to grow 12% annually. The industry has largely been unregulated up until 15 November 2013, when the South African government amended the Medicines and Related Substance Control Act (Act 101 of 1965) to include the definition of “Complementary Medicines” and “Health Supplements”. The emphasis of the new regulations is largely on the quality and safety of CAMS products. Manufacturers therefore need to demonstrate that the active ingredients used in manufacturing will be of an appropriate and consistent quality. The research question therefore is: Can a chemometric multivariate model be used to develop a rapid, cost effective method to quantify casticin, the major chemical constituent of Vitex agnus-castus (VAC) that can be used during routine quality control procedures? The primary aim of this study was to prepare a validated method using fourier transform infrared spectroscopy (FTIR) to quantify the casticin content in VAC fruit. The results from the HPLC analysis were as follows; the penduletin eluted at a retention time of 12.419 ± 0.376 minutes. The casticin eluted at a retention time of 12.943 ± 0.018 minutes. The casticin content for the samples ranged from 0.0115 – 0.0147% m/m casticin content with an average of 0.0134%. This is well below the pharmacopoeia requirement of not less than (NLT) 0.08% casticin content as described in the British Pharmacopoeia (BP). The results obtained from the HPLC analysis were used to construct the FTIR calibration model. The calibration model consisted of 18 spectra with 530 selected data points. The model was specific for casticin as spectral regions in the calibration model can be correlated to a known IR spectral response associated with the carbonyl group of casticin. The calibration equation in the xii form of % m/m casticin content had a coefficient of determination (R2) value of 0.9855 and a root mean square error of cross-validation (RMSECV) of 0.000119. The accuracy of the model had recoveries of between 98 - 102% for the actual vs true prediction. The percentage relative standard deviation (%RSD) between nine repeated measurements was 3.46%, this does not meet the International Conference of Harmonisation (ICH) requirement for precision of not more than (NMT) 2% RSD. The range of the calibration model was between 0.01147 and 0.01469 % m/m casticin content as established by the calibration model. The robustness of the method was assessed by challenging the model with samples that fall outside of the concentration of range of the model. This was established by quantifying previously scanned samples of VAC that is not part of the calibration set. The model was able to verify if the tested samples prediction was outside of the validated calibration range. The method was subsequently also challenged with a sample of a different identity to VAC. The model indicated that the sample tested does not fall in the range of the method and was clearly recognised as an outlier. The method was rapid and does not require any expensive solvents or timeconsuming sample preparation. However, the method does not meet the ICH requirements for method validation, the method does show potential and further method development and expansion of the calibration model can ensure that the method be validated.
- Full Text:
- Date Issued: 2018
- Authors: Du Toit Louw, Philippus
- Date: 2018
- Subjects: Drugs -- Analysis -- Methodology -- Evaluation , Alternative medicine -- Research , Liquid chromatography
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/30917 , vital:31222
- Description: The Complementary and Alternative Medicines (CAMS) and dietary supplement industry is an R8.84 billion a year industry in South Africa, with the sector expected to grow 12% annually. The industry has largely been unregulated up until 15 November 2013, when the South African government amended the Medicines and Related Substance Control Act (Act 101 of 1965) to include the definition of “Complementary Medicines” and “Health Supplements”. The emphasis of the new regulations is largely on the quality and safety of CAMS products. Manufacturers therefore need to demonstrate that the active ingredients used in manufacturing will be of an appropriate and consistent quality. The research question therefore is: Can a chemometric multivariate model be used to develop a rapid, cost effective method to quantify casticin, the major chemical constituent of Vitex agnus-castus (VAC) that can be used during routine quality control procedures? The primary aim of this study was to prepare a validated method using fourier transform infrared spectroscopy (FTIR) to quantify the casticin content in VAC fruit. The results from the HPLC analysis were as follows; the penduletin eluted at a retention time of 12.419 ± 0.376 minutes. The casticin eluted at a retention time of 12.943 ± 0.018 minutes. The casticin content for the samples ranged from 0.0115 – 0.0147% m/m casticin content with an average of 0.0134%. This is well below the pharmacopoeia requirement of not less than (NLT) 0.08% casticin content as described in the British Pharmacopoeia (BP). The results obtained from the HPLC analysis were used to construct the FTIR calibration model. The calibration model consisted of 18 spectra with 530 selected data points. The model was specific for casticin as spectral regions in the calibration model can be correlated to a known IR spectral response associated with the carbonyl group of casticin. The calibration equation in the xii form of % m/m casticin content had a coefficient of determination (R2) value of 0.9855 and a root mean square error of cross-validation (RMSECV) of 0.000119. The accuracy of the model had recoveries of between 98 - 102% for the actual vs true prediction. The percentage relative standard deviation (%RSD) between nine repeated measurements was 3.46%, this does not meet the International Conference of Harmonisation (ICH) requirement for precision of not more than (NMT) 2% RSD. The range of the calibration model was between 0.01147 and 0.01469 % m/m casticin content as established by the calibration model. The robustness of the method was assessed by challenging the model with samples that fall outside of the concentration of range of the model. This was established by quantifying previously scanned samples of VAC that is not part of the calibration set. The model was able to verify if the tested samples prediction was outside of the validated calibration range. The method was subsequently also challenged with a sample of a different identity to VAC. The model indicated that the sample tested does not fall in the range of the method and was clearly recognised as an outlier. The method was rapid and does not require any expensive solvents or timeconsuming sample preparation. However, the method does not meet the ICH requirements for method validation, the method does show potential and further method development and expansion of the calibration model can ensure that the method be validated.
- Full Text:
- Date Issued: 2018
Patients and healthcare professionals’ experiences of medicine unavailability at a primary healthcare centre in the Nelson Mandela Bay Metropole
- Authors: Ndzamela, Sisipo
- Date: 2018
- Subjects: Primary care (Medicine) -- South Africa -- Nelson Mandela Bay Municipality , Pharmacy -- Practice -- South Africa -- Nelson Mandela Bay Municipality Medical economics
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/22431 , vital:29969
- Description: Medicine stock-outs and shortages are being increasingly reported throughout South Africa. Primary healthcare centres are largely affected as many of them don’t have pharmacists and pharmacist support personnel to manage medicine stock levels. With the efforts to improve medicine availability and accessibility healthcare professionals have adopted informal networks through a borrowing system of medicines with other facilities The aim of this study was to explore and describe the experiences of patients and healthcare professionals of the unavailability of medicines at a primary healthcare (PHC) centre in the Nelson Mandela Bay Metropole. Using a qualitative approach, indepth interviews were conducted with 8 patients and 12 healthcare professionals including doctors, a pharmacist, pharmacy support personnel and nurses at a primary healthcare centre. These interviews were digitally recorded, transcribed and thematically analysed using Atlas.ti® network. The following major themes were identified; types of medicines that are unavailable, causes of stock-outs, psychological influence on both patients and healthcare professionals, compensatory measures and the central chronic dispensing and distribution program. Patient experiences included dissatisfaction and loss of confidence in the healthcare service delivery. Dissatisfied patients expressed emotions of anger and frustration. Also, unavailability of medicines resulted in stressed and burnt out healthcare professionals who have endured violence and verbal abuse from patients because of medicine stock-outs. Participants suggested that medicine stock-outs and shortages are most often due to delays in the delivery of stock by the depot. To counteract these effects healthcare professionals have adopted a borrowing system with other clinics. Furthermore, it was evident that the Central Chronic Medicine Dispensing and Distribution program (CCMDD) implemented by the Department of Health to improve availability and accessibility of medicines was perceived to be ineffective. Therefore, the issue of medicine stock-outs negatively affects service delivery, and those involved experience psychological harm which then affects inter-professional relationships. Overcoming this issue would promote a better healthcare system within the country.
- Full Text:
- Date Issued: 2018
- Authors: Ndzamela, Sisipo
- Date: 2018
- Subjects: Primary care (Medicine) -- South Africa -- Nelson Mandela Bay Municipality , Pharmacy -- Practice -- South Africa -- Nelson Mandela Bay Municipality Medical economics
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/22431 , vital:29969
- Description: Medicine stock-outs and shortages are being increasingly reported throughout South Africa. Primary healthcare centres are largely affected as many of them don’t have pharmacists and pharmacist support personnel to manage medicine stock levels. With the efforts to improve medicine availability and accessibility healthcare professionals have adopted informal networks through a borrowing system of medicines with other facilities The aim of this study was to explore and describe the experiences of patients and healthcare professionals of the unavailability of medicines at a primary healthcare (PHC) centre in the Nelson Mandela Bay Metropole. Using a qualitative approach, indepth interviews were conducted with 8 patients and 12 healthcare professionals including doctors, a pharmacist, pharmacy support personnel and nurses at a primary healthcare centre. These interviews were digitally recorded, transcribed and thematically analysed using Atlas.ti® network. The following major themes were identified; types of medicines that are unavailable, causes of stock-outs, psychological influence on both patients and healthcare professionals, compensatory measures and the central chronic dispensing and distribution program. Patient experiences included dissatisfaction and loss of confidence in the healthcare service delivery. Dissatisfied patients expressed emotions of anger and frustration. Also, unavailability of medicines resulted in stressed and burnt out healthcare professionals who have endured violence and verbal abuse from patients because of medicine stock-outs. Participants suggested that medicine stock-outs and shortages are most often due to delays in the delivery of stock by the depot. To counteract these effects healthcare professionals have adopted a borrowing system with other clinics. Furthermore, it was evident that the Central Chronic Medicine Dispensing and Distribution program (CCMDD) implemented by the Department of Health to improve availability and accessibility of medicines was perceived to be ineffective. Therefore, the issue of medicine stock-outs negatively affects service delivery, and those involved experience psychological harm which then affects inter-professional relationships. Overcoming this issue would promote a better healthcare system within the country.
- Full Text:
- Date Issued: 2018
Pharmacist perceptions of pharmacy support personnel in the pharmaceutical manufacturing sector in Port Elizabeth
- Authors: Worthington, Nicole
- Date: 2018
- Subjects: Pharmacists -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/42434 , vital:36659
- Description: Pharmacy support personnel (PSP) are employed across multiple pharmaceutical sectors in South Africa. They assist pharmacists in the manufacturing sector, while under their direct, personal supervision, to carry out the pharmacists’ functions listed in the South African Good Manufacturing Practice guidelines, within a defined scope of practice. Prior to 2013, all PSP training was workplace-based. The recent introduction of a university-based qualification for PSP has resulted in two routes for students to qualify as PSP. This study employed a qualitative, phenomenological design using semistructured interviews with pharmacists employed in pharmaceutical manufacturing. Their perceptions regarding PSP who had trained via the two training routes where interpreted through thematic analysis in order to determine whether a perceived difference in the abilities of the two cadres of PSP exists. Pharmacists generally expressed a more positive perception of PSP who qualified through the university-based programme. Strengths and weaknesses of both routes of training were identified, with areas of possible improvement identified for both programmes. Furthermore, a mutually supportive pharmacist – PSP relationship was deemed important in order to achieve optimal functionality in the workplace. The need for both pharmacists and PSP to be made aware of the roles that they play in this relationship was highlighted.
- Full Text:
- Date Issued: 2018
- Authors: Worthington, Nicole
- Date: 2018
- Subjects: Pharmacists -- South Africa -- Port Elizabeth
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/42434 , vital:36659
- Description: Pharmacy support personnel (PSP) are employed across multiple pharmaceutical sectors in South Africa. They assist pharmacists in the manufacturing sector, while under their direct, personal supervision, to carry out the pharmacists’ functions listed in the South African Good Manufacturing Practice guidelines, within a defined scope of practice. Prior to 2013, all PSP training was workplace-based. The recent introduction of a university-based qualification for PSP has resulted in two routes for students to qualify as PSP. This study employed a qualitative, phenomenological design using semistructured interviews with pharmacists employed in pharmaceutical manufacturing. Their perceptions regarding PSP who had trained via the two training routes where interpreted through thematic analysis in order to determine whether a perceived difference in the abilities of the two cadres of PSP exists. Pharmacists generally expressed a more positive perception of PSP who qualified through the university-based programme. Strengths and weaknesses of both routes of training were identified, with areas of possible improvement identified for both programmes. Furthermore, a mutually supportive pharmacist – PSP relationship was deemed important in order to achieve optimal functionality in the workplace. The need for both pharmacists and PSP to be made aware of the roles that they play in this relationship was highlighted.
- Full Text:
- Date Issued: 2018
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