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
The natural product chemistry of South African Plocamium species
- Authors: Knott, Michael George
- Date: 2003
- Subjects: Marine algae -- South Africa Red algae -- South Africa Green algae -- South Africa Halimeda -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3820 , http://hdl.handle.net/10962/d1004920
- Description: The brine shrimp lethality assay was used as a preliminary tool to screen eighteen seaweeds collected from the South African coast. Of the seaweeds tested, the red algae Plocamium corallorhiza and Hypnea rosea, and the green alga Halimeda sp., showed the most potent activity. The chemical investigation of P. corallorhiza resulted in the isolation and structural elucidation of five previously undescribed secondary metabolites, along with three known compounds and four possible artifacts of the extraction process. Standard spectroscopic methods and comparison with known compounds were used to determine the structures of the new metabolites. The new compounds included the linear halogenated monoterpenes 4,8-dibromo-1, 1-dichloro-3,7-dimethyl-2,6-octadiene (99), 4,6-dibromo-l, 1-dichloro-3,7-dimethyl-2,7-octadiene (100), 4,8-dibromo-l, 1,7-trichloro-3,7-dimethyl-2,5-octadiene (101) and 3,4,6,7-tetrachloro-3,7-dimethyl-l-octene (102) and the cyclic monoterpene 5-bromo-5-bromomethyl-I-chlorovinyl-2,4-dichloro-methylcyclohexane (103) while the known compounds were identified as 4-bromo-5-bromomethyl-1chlorovinyl-2,5-dichloro-methylcyclohexane (35), 1,4,8-tribromo-3, 7 -dichloro-3,7-dimethyl-1,5-octadiene (94) and 8-bromo-1,3,4,7-tetrachloro-3,7-dimethyl-1,5-octadiene (96). The four methoxylated compounds (104-107) were presumably formed via a standard substitution reaction between the halogenated monoterpenes 96 and 101 and MeOH, which was used as a component in the extraction solvent. With over 100 000 natural products having been reported, it has become necessary to employ an efficient dereplication strategy to quickly identify known compounds. A simple Gas Chromatography-Mass Spectrometry (GC-MS) method for the efficient physicochemical screening, identification and dereplication of Plocamium metabolites was developed. In this study the crude extracts of P. corallorhiza, P. cornutum and P. maxillosum were screened by GC-MS and the retention times and mass spectral fragmentation patterns of compounds 94, 96, 99 - 107 were used to quickly identify known and new compounds in the crude extracts of P. cornutum and P. maxillosum. This data indicated that compounds 99, 100, 103 were present in both P. corallorhiza and P.cornutum, while compound 102 was found to be present in P. corallorhiza, P. cornutum and P. maxillosum. These studies also indicated that ecotypes and chemotypes are not a significant feature of P. corallorhiza and P. cornutum. Different species of Plocamium (namely: P. corallorhiza, P. cornutum, and P. maxillosum) have very different chemical profiles, and GC may therefore have appreciable taxonomic application in the identification of the different Plocamium spp. which are endemic to South Africa.
- Full Text:
- Date Issued: 2003
- Authors: Knott, Michael George
- Date: 2003
- Subjects: Marine algae -- South Africa Red algae -- South Africa Green algae -- South Africa Halimeda -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3820 , http://hdl.handle.net/10962/d1004920
- Description: The brine shrimp lethality assay was used as a preliminary tool to screen eighteen seaweeds collected from the South African coast. Of the seaweeds tested, the red algae Plocamium corallorhiza and Hypnea rosea, and the green alga Halimeda sp., showed the most potent activity. The chemical investigation of P. corallorhiza resulted in the isolation and structural elucidation of five previously undescribed secondary metabolites, along with three known compounds and four possible artifacts of the extraction process. Standard spectroscopic methods and comparison with known compounds were used to determine the structures of the new metabolites. The new compounds included the linear halogenated monoterpenes 4,8-dibromo-1, 1-dichloro-3,7-dimethyl-2,6-octadiene (99), 4,6-dibromo-l, 1-dichloro-3,7-dimethyl-2,7-octadiene (100), 4,8-dibromo-l, 1,7-trichloro-3,7-dimethyl-2,5-octadiene (101) and 3,4,6,7-tetrachloro-3,7-dimethyl-l-octene (102) and the cyclic monoterpene 5-bromo-5-bromomethyl-I-chlorovinyl-2,4-dichloro-methylcyclohexane (103) while the known compounds were identified as 4-bromo-5-bromomethyl-1chlorovinyl-2,5-dichloro-methylcyclohexane (35), 1,4,8-tribromo-3, 7 -dichloro-3,7-dimethyl-1,5-octadiene (94) and 8-bromo-1,3,4,7-tetrachloro-3,7-dimethyl-1,5-octadiene (96). The four methoxylated compounds (104-107) were presumably formed via a standard substitution reaction between the halogenated monoterpenes 96 and 101 and MeOH, which was used as a component in the extraction solvent. With over 100 000 natural products having been reported, it has become necessary to employ an efficient dereplication strategy to quickly identify known compounds. A simple Gas Chromatography-Mass Spectrometry (GC-MS) method for the efficient physicochemical screening, identification and dereplication of Plocamium metabolites was developed. In this study the crude extracts of P. corallorhiza, P. cornutum and P. maxillosum were screened by GC-MS and the retention times and mass spectral fragmentation patterns of compounds 94, 96, 99 - 107 were used to quickly identify known and new compounds in the crude extracts of P. cornutum and P. maxillosum. This data indicated that compounds 99, 100, 103 were present in both P. corallorhiza and P.cornutum, while compound 102 was found to be present in P. corallorhiza, P. cornutum and P. maxillosum. These studies also indicated that ecotypes and chemotypes are not a significant feature of P. corallorhiza and P. cornutum. Different species of Plocamium (namely: P. corallorhiza, P. cornutum, and P. maxillosum) have very different chemical profiles, and GC may therefore have appreciable taxonomic application in the identification of the different Plocamium spp. which are endemic to South Africa.
- Full Text:
- Date Issued: 2003
An illustrated information leaflet for low-literate HIV/AIDS patients on antiretroviral therapy : design, development and evaluation
- Authors: Ramela, Thato
- Date: 2009
- Subjects: Antiretroviral agents -- South Africa HIV-positive persons -- Care -- South Africa AIDS (Disease) -- Study and teaching -- South Africa HIV infections -- Treatment -- South Africa AIDS (Disease) -- Treatment -- South Africa AIDS (Disease) -- Africa, Sub-Saharan -- Statistics Communication in medicine -- South Africa Communication in public health -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3834 , http://hdl.handle.net/10962/d1007563
- Description: South Africa's HIV prevalence rate is estimated to be 5.7 million and at the end of2007 a total of 45845 HIV/AIDS adult patients were taking antiretroviral therapy (ART). The global incidence of HIV/AIDS has been slowly decreasing over the years but is still widespread. This disease is still more prevalent in sub-Saharan Africa than in other parts of the world, with more than 60% people living with HIV/AIDS. Highly active antiretroviral therapy (HAART), the treatment of choice, slows the progression of the human immunovirus but demands a high adherence rate in excess of 95%. Patients who are poorly informed about antiretrovirals (ARVs) and misunderstand medicine-taking instructions or experience unexpected side effects may interrupt therapy, predisposing them to the development of resistance. Such patients need information but, given the poor literacy skills prevalent in South Africa, written information is often not fully comprehended and is often written at too high a reading level. The objectives of this research project were to design, modify and evaluate HIV / AIDS patient education materials for low-literate isiXhosa speaking adults residing in Grahamstown and to examine their impact on the understanding of various aspects of the disease and its treatment. Pictograms illustrating common side effects of ARVs (e.g. stavudine, efavirenz, lamivudine), as well as various sources 'for purchasing nonprescription medicines, storage and medicine-taking instructions were designed and evaluated both qualitatively, using group discussions, and quantitatively through individual interviews where interpretation of the pictograms was assessed. These pictograms were incorporated in a patient information leaflet (PIL) which had been specifically designed for people with limited reading skills and was a simple document containing the minimum of essential text. A previously developed PIL was modified in collaboration with the target population and two versions were produced, one incorporating pictograms illustrating side effects, the other with none. Pictograms were used in both to illustrate other medicine-taking instructions. The PILs were tested objectively to assess the readability, format, content, and general design. They were translated into isiXhosa prior to being qualitatively and quantitatively evaluated in a low-literate isiXhosa speaking population. Understanding of the PILs was assessed by asking a series of questions about the PIL content. Participant opinion of the readability and appearance of the PIL was recorded. The relationship between PIL understanding and selected demographic variables was investigated. Findings from this study illustrated that well designed pictograms assist in the location of information in written leaflets and they may enhance understanding of the information. It was further demonstrated that education influences total understanding of PIL content thus emphasizing the need for tailor-written information in accordance with the education level of the target population. A desire to receive PILs incorporating pictograms was expressed by the majority of participants. Collaboration with the intended target population is essential to design culturally acceptable, easily interpreted pictograms and to produce user-friendly, easy-to-read, comprehensible patient education materials. The rigorous, iterative design, modification and testing process described in this study is one that should be adopted in producing all health-related education materials.
- Full Text:
- Date Issued: 2009
- Authors: Ramela, Thato
- Date: 2009
- Subjects: Antiretroviral agents -- South Africa HIV-positive persons -- Care -- South Africa AIDS (Disease) -- Study and teaching -- South Africa HIV infections -- Treatment -- South Africa AIDS (Disease) -- Treatment -- South Africa AIDS (Disease) -- Africa, Sub-Saharan -- Statistics Communication in medicine -- South Africa Communication in public health -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3834 , http://hdl.handle.net/10962/d1007563
- Description: South Africa's HIV prevalence rate is estimated to be 5.7 million and at the end of2007 a total of 45845 HIV/AIDS adult patients were taking antiretroviral therapy (ART). The global incidence of HIV/AIDS has been slowly decreasing over the years but is still widespread. This disease is still more prevalent in sub-Saharan Africa than in other parts of the world, with more than 60% people living with HIV/AIDS. Highly active antiretroviral therapy (HAART), the treatment of choice, slows the progression of the human immunovirus but demands a high adherence rate in excess of 95%. Patients who are poorly informed about antiretrovirals (ARVs) and misunderstand medicine-taking instructions or experience unexpected side effects may interrupt therapy, predisposing them to the development of resistance. Such patients need information but, given the poor literacy skills prevalent in South Africa, written information is often not fully comprehended and is often written at too high a reading level. The objectives of this research project were to design, modify and evaluate HIV / AIDS patient education materials for low-literate isiXhosa speaking adults residing in Grahamstown and to examine their impact on the understanding of various aspects of the disease and its treatment. Pictograms illustrating common side effects of ARVs (e.g. stavudine, efavirenz, lamivudine), as well as various sources 'for purchasing nonprescription medicines, storage and medicine-taking instructions were designed and evaluated both qualitatively, using group discussions, and quantitatively through individual interviews where interpretation of the pictograms was assessed. These pictograms were incorporated in a patient information leaflet (PIL) which had been specifically designed for people with limited reading skills and was a simple document containing the minimum of essential text. A previously developed PIL was modified in collaboration with the target population and two versions were produced, one incorporating pictograms illustrating side effects, the other with none. Pictograms were used in both to illustrate other medicine-taking instructions. The PILs were tested objectively to assess the readability, format, content, and general design. They were translated into isiXhosa prior to being qualitatively and quantitatively evaluated in a low-literate isiXhosa speaking population. Understanding of the PILs was assessed by asking a series of questions about the PIL content. Participant opinion of the readability and appearance of the PIL was recorded. The relationship between PIL understanding and selected demographic variables was investigated. Findings from this study illustrated that well designed pictograms assist in the location of information in written leaflets and they may enhance understanding of the information. It was further demonstrated that education influences total understanding of PIL content thus emphasizing the need for tailor-written information in accordance with the education level of the target population. A desire to receive PILs incorporating pictograms was expressed by the majority of participants. Collaboration with the intended target population is essential to design culturally acceptable, easily interpreted pictograms and to produce user-friendly, easy-to-read, comprehensible patient education materials. The rigorous, iterative design, modification and testing process described in this study is one that should be adopted in producing all health-related education materials.
- Full Text:
- Date Issued: 2009
Identifying, recording and monitoring adverse effects associated with antriretroviral treatment
- Authors: Mulinge, Florence Muthoni
- Date: 2010
- Subjects: Highly active antiretroviral therapy , Antiretroviral agents -- South Africa -- Uitenhage , HIV infections -- Treatment -- South Africa -- Uitenhage , AIDS (Disease) -- Treatment -- South Africa -- Uitenhage
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10131 , http://hdl.handle.net/10948/1491 , Highly active antiretroviral therapy , Antiretroviral agents -- South Africa -- Uitenhage , HIV infections -- Treatment -- South Africa -- Uitenhage , AIDS (Disease) -- Treatment -- South Africa -- Uitenhage
- Description: South Africa, with an estimated 5.7 million people living with HIV, continues to have one of the largest epidemics in the world. The introduction of HAART resulted in prolonged and improved quality of life of many infected patients. However, adverse effects caused by these drugs have become a major concern as they affect the adherence of patients and in some cases even result in the death of patients. Although much research has been and is still being conducted in the area of understanding, preventing and management of ARV adverse effects, there is still a need for patients to be actively involved in self-monitoring for adverse effects. This will assist health care professionals in early identification of serious or potentially serious ARV effects. This study aimed at evaluating the usefulness of strategies developed and employed in the identification, recording and monitoring of adverse effects. The study was conducted with patients receiving HAART from a private HIV and AIDS clinic in Uitenhage, Eastern Cape, South Africa. The research project was approved by the Nelson Mandela Metropolitan University Research and Ethics Committee and the research site. This was an experimental, randomized controlled study carried out over a period of three months (August to October 2009), with a sample size of 160 patients divided into four study groups of 40 patients each. Two monitoring strategies, namely an ARV adverse effect monitoring tool and a patient self-monitoring diary were developed and used for the identification and recording of adverse effects. The four study groups included a Control group, a Tool group, a Diary group and a Tool-Diary group. Willing patients, after signing an informed consent form, were randomly assigned to one of the four groups by participating health care workers at the study site. Data was retrieved from the patient files by the researcher. Descriptive statistical analysis of the findings of the study was conducted using SPSS®. One hundred and forty nine patients were included in the final data analysis. Of the 80 diaries handed out to patients, only 33 were returned and due to errors only 31 were suitable for analysis. Monitoring tools were completed and analysed for 36 patients. The tool was found to be more effective in identifying adverse effects of a physical nature (such as peripheral neuropathy and lipodystrophy) than the usual methods of monitoring employed by the clinic, whilst the diary, used alone, was found to be less effective. Use of the tool and diary combined resulted in the most significant identification and recording of central nervous system related adverse effects and physical adverse effects. However due to the low return rate of the diaries and the majority of the monitoring tool not being completed in many instances the results of this study may not be generalisable. The study results did however suggest that combining the tool and the diary methods of adverse effect identification, yielded the most favourable results when compared to each method alone. This may be attributed to the fact that the tool is useful in identifying objective symptoms and the diaries subjective symptoms, particularly in instances where the patients forget to report their symptoms to healthcare professional whilst at the clinic. The diaries were also reported to improve adherence for more than 90 percentage (n=31) of the patients. More research would be needed in order to verify the exact significance of the tool and the diary in identifying and recording adverse effects and symptoms of adverse effects.
- Full Text:
- Date Issued: 2010
- Authors: Mulinge, Florence Muthoni
- Date: 2010
- Subjects: Highly active antiretroviral therapy , Antiretroviral agents -- South Africa -- Uitenhage , HIV infections -- Treatment -- South Africa -- Uitenhage , AIDS (Disease) -- Treatment -- South Africa -- Uitenhage
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10131 , http://hdl.handle.net/10948/1491 , Highly active antiretroviral therapy , Antiretroviral agents -- South Africa -- Uitenhage , HIV infections -- Treatment -- South Africa -- Uitenhage , AIDS (Disease) -- Treatment -- South Africa -- Uitenhage
- Description: South Africa, with an estimated 5.7 million people living with HIV, continues to have one of the largest epidemics in the world. The introduction of HAART resulted in prolonged and improved quality of life of many infected patients. However, adverse effects caused by these drugs have become a major concern as they affect the adherence of patients and in some cases even result in the death of patients. Although much research has been and is still being conducted in the area of understanding, preventing and management of ARV adverse effects, there is still a need for patients to be actively involved in self-monitoring for adverse effects. This will assist health care professionals in early identification of serious or potentially serious ARV effects. This study aimed at evaluating the usefulness of strategies developed and employed in the identification, recording and monitoring of adverse effects. The study was conducted with patients receiving HAART from a private HIV and AIDS clinic in Uitenhage, Eastern Cape, South Africa. The research project was approved by the Nelson Mandela Metropolitan University Research and Ethics Committee and the research site. This was an experimental, randomized controlled study carried out over a period of three months (August to October 2009), with a sample size of 160 patients divided into four study groups of 40 patients each. Two monitoring strategies, namely an ARV adverse effect monitoring tool and a patient self-monitoring diary were developed and used for the identification and recording of adverse effects. The four study groups included a Control group, a Tool group, a Diary group and a Tool-Diary group. Willing patients, after signing an informed consent form, were randomly assigned to one of the four groups by participating health care workers at the study site. Data was retrieved from the patient files by the researcher. Descriptive statistical analysis of the findings of the study was conducted using SPSS®. One hundred and forty nine patients were included in the final data analysis. Of the 80 diaries handed out to patients, only 33 were returned and due to errors only 31 were suitable for analysis. Monitoring tools were completed and analysed for 36 patients. The tool was found to be more effective in identifying adverse effects of a physical nature (such as peripheral neuropathy and lipodystrophy) than the usual methods of monitoring employed by the clinic, whilst the diary, used alone, was found to be less effective. Use of the tool and diary combined resulted in the most significant identification and recording of central nervous system related adverse effects and physical adverse effects. However due to the low return rate of the diaries and the majority of the monitoring tool not being completed in many instances the results of this study may not be generalisable. The study results did however suggest that combining the tool and the diary methods of adverse effect identification, yielded the most favourable results when compared to each method alone. This may be attributed to the fact that the tool is useful in identifying objective symptoms and the diaries subjective symptoms, particularly in instances where the patients forget to report their symptoms to healthcare professional whilst at the clinic. The diaries were also reported to improve adherence for more than 90 percentage (n=31) of the patients. More research would be needed in order to verify the exact significance of the tool and the diary in identifying and recording adverse effects and symptoms of adverse effects.
- Full Text:
- Date Issued: 2010
Optimisation of pharmacological management of diabetes mellitus in a primary health care setting
- Authors: Dickason, Beverley Janine
- Date: 2007
- Subjects: Diabetes , Diabetes -- Treatment
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10161 , http://hdl.handle.net/10948/846 , http://hdl.handle.net/10948/d1012902 , Diabetes , Diabetes -- Treatment
- Description: Levels of diabetic care in primary health care settings in South Africa have been found to be sub-optimal. Knowledge deficits and inadequate practices have been implicated in the poor quality of local diabetes care. Type 2 diabetes and hypertension are commonly associated chronic conditions hence to optimise diabetic care, tight control of blood pressure is essential. Although guidelines for the overall management of diabetes in a primary health care setting have been published (Working Group of the National Diabetes Advisory Board, 1997; Society for Endocrinology, Metabolism and Diabetes of South Africa, 2002a), adherence to these guidelines has not yet been optimised in the primary health care setting. The objectives of the study were: to design and implement an educational intervention aimed at nursing staff, based on the South African guidelines for type 2 diabetes and hypertension, at a public sector primary health care clinic; to determine the impact of the educational intervention on the level of knowledge and attitudes of the nursing staff, and on the level of diabetic and blood pressure control achieved in the patient population, and to determine the impact of the educational intervention on pharmacological management of patients. A questionnaire was used to quantitatively assess the nursing staffs’ knowledge of the management of type 2 diabetes and hypertension at a primary health care level. A qualitative evaluation of the nursing staff attitudes was obtained using focus group interviews. The educational intervention, in the form of lectures and based on national diabetes and hypertension guidelines (Working Group of the National Diabetes Advisory Board, 1997; Society for Endocrinology, Metabolism and Diabetes of South Africa, 2002a; Milne et al., 2003), was then implemented and directed at the nursing staff at a primary health care clinic. A post-intervention evaluation was performed after four months by repeating the questionnaire and focus group interviews. Comparisons between the pre- and post-intervention questionnaire and focus group interviews evaluated the impact of the educational intervention on the knowledge and attitudes of nursing staff towards the management of type 2 diabetes. Pre- and post-intervention patient data was collected from patient medical files and compared to determine if the management of diabetes and hypertension improved in the patient population after the implementation of the educational intervention. The patient population consisted of 103 patients. The educational intervention resulted in an extremely significant improvement in the level of knowledge of the nursing staff [93 correct responses (28.3 percent; n = 329 (pre-intervention)) vs 223 correct responses (67.8 percent; n = 329 (post-intervention)); p < 0.0001, Fisher’s Exact test]. The educational intervention resulted in improved attitudes of nursing staff towards the management of diabetes. Ideal random blood glucose concentrations improved significantly [16 percent; n = 100 (pre-intervention) vs 22 percent; n = 100 (post-intervention); p = 0.0003; Student t test]. The number of patients with a compromised HbA1c level (> 8 percent) decreased by 2 [51; 49.5 percent, n = 103 (pre-intervention) vs 49, 47.5 percent, n = 103 (post-intervention)] which was not a significant improvement. Ideal blood pressure control improved by one from 38 patients [36.9 percent; n = 103 (pre-intervention)] to 39 patients [37.9 percent; n = 103 (post-intervention)] which was not significant. Optimal change of pharmacological management following the referral of an uncontrolled diabetic patient was only noted for 18 patients (20.2 percent, n = 89) referred in the post-intervention phase. Clinical inertia was identified as a major limitation to the optimisation of diabetes care. Implementation of an educational intervention based on the South African diabetes and hypertension guidelines at a public sector primary health care clinic was successful in improving the knowledge levels and attitudes of nursing staff
- Full Text:
- Date Issued: 2007
- Authors: Dickason, Beverley Janine
- Date: 2007
- Subjects: Diabetes , Diabetes -- Treatment
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10161 , http://hdl.handle.net/10948/846 , http://hdl.handle.net/10948/d1012902 , Diabetes , Diabetes -- Treatment
- Description: Levels of diabetic care in primary health care settings in South Africa have been found to be sub-optimal. Knowledge deficits and inadequate practices have been implicated in the poor quality of local diabetes care. Type 2 diabetes and hypertension are commonly associated chronic conditions hence to optimise diabetic care, tight control of blood pressure is essential. Although guidelines for the overall management of diabetes in a primary health care setting have been published (Working Group of the National Diabetes Advisory Board, 1997; Society for Endocrinology, Metabolism and Diabetes of South Africa, 2002a), adherence to these guidelines has not yet been optimised in the primary health care setting. The objectives of the study were: to design and implement an educational intervention aimed at nursing staff, based on the South African guidelines for type 2 diabetes and hypertension, at a public sector primary health care clinic; to determine the impact of the educational intervention on the level of knowledge and attitudes of the nursing staff, and on the level of diabetic and blood pressure control achieved in the patient population, and to determine the impact of the educational intervention on pharmacological management of patients. A questionnaire was used to quantitatively assess the nursing staffs’ knowledge of the management of type 2 diabetes and hypertension at a primary health care level. A qualitative evaluation of the nursing staff attitudes was obtained using focus group interviews. The educational intervention, in the form of lectures and based on national diabetes and hypertension guidelines (Working Group of the National Diabetes Advisory Board, 1997; Society for Endocrinology, Metabolism and Diabetes of South Africa, 2002a; Milne et al., 2003), was then implemented and directed at the nursing staff at a primary health care clinic. A post-intervention evaluation was performed after four months by repeating the questionnaire and focus group interviews. Comparisons between the pre- and post-intervention questionnaire and focus group interviews evaluated the impact of the educational intervention on the knowledge and attitudes of nursing staff towards the management of type 2 diabetes. Pre- and post-intervention patient data was collected from patient medical files and compared to determine if the management of diabetes and hypertension improved in the patient population after the implementation of the educational intervention. The patient population consisted of 103 patients. The educational intervention resulted in an extremely significant improvement in the level of knowledge of the nursing staff [93 correct responses (28.3 percent; n = 329 (pre-intervention)) vs 223 correct responses (67.8 percent; n = 329 (post-intervention)); p < 0.0001, Fisher’s Exact test]. The educational intervention resulted in improved attitudes of nursing staff towards the management of diabetes. Ideal random blood glucose concentrations improved significantly [16 percent; n = 100 (pre-intervention) vs 22 percent; n = 100 (post-intervention); p = 0.0003; Student t test]. The number of patients with a compromised HbA1c level (> 8 percent) decreased by 2 [51; 49.5 percent, n = 103 (pre-intervention) vs 49, 47.5 percent, n = 103 (post-intervention)] which was not a significant improvement. Ideal blood pressure control improved by one from 38 patients [36.9 percent; n = 103 (pre-intervention)] to 39 patients [37.9 percent; n = 103 (post-intervention)] which was not significant. Optimal change of pharmacological management following the referral of an uncontrolled diabetic patient was only noted for 18 patients (20.2 percent, n = 89) referred in the post-intervention phase. Clinical inertia was identified as a major limitation to the optimisation of diabetes care. Implementation of an educational intervention based on the South African diabetes and hypertension guidelines at a public sector primary health care clinic was successful in improving the knowledge levels and attitudes of nursing staff
- Full Text:
- Date Issued: 2007
Neuroprotective mechanisms of nevirapine and efavirenz in a model of neurodegeneration
- Authors: Zheve, Georgina Teurai
- Date: 2008
- Subjects: HIV infections -- Treatment AIDS (Disease) -- Treatment AIDS dementia complex -- Treatment Nervous system -- Degeneration -- Treatment Melatonin Neurotoxic agents Quinolinic acid
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3807 , http://hdl.handle.net/10962/d1003285
- Description: AIDS Dementia Complex (ADC) is a neurodegenerative disorder implicated in HIV-1 infection that is associated with elevated levels of the neurotoxin, quinolinic acid (QA) which causes a cascade of events to occur, leading to the production of reactive oxygen species (ROS), these being ultimately responsible for oxidative neurotoxicity. In clinical studies, Non-nucleoside reverse transcriptase inhibitors (NNRTIs), efavirenz (EFV) and nevirapine (NVP) have been shown to potentially delay the progressive degeneration of neurons, thus reducing the frequency and neurological deficits associated with ADC. Despite these neuroprotective implications, there is still no biochemical data to demonstrate the mechanisms through which these agents offer neuroprotection. The present study aims to elucidate and further characterize the possible antioxidant and neuroprotective mechanisms of NVP and EFV in vitro and in vivo, using QA-induced neurotoxicity as a model. Research has demonstrated that antioxidants and metal chelators have the ability to offer neuroprotection against free radical induced injury and may be beneficial in the prevention or treatment of neurodegeneration. Hence the antioxidant and metal binding properties of these agents were investigated respectively. Inorganic studies, including the 1, 1-diphenyl-2 picrylhydrazyl (DPPH) assay, show that these agents readily scavenge free radicals in vitro, thus postulating the antioxidant property of these agents. The enhancement of superoxide radical generation and iron mediated Fenton reaction by QA is related to lipid peroxidation in biological systems, the extent of which was assayed using the nitroblue tetrazolium and thiobarbituric acid method respectively. Both agents significantly curtail QA-induced lipid peroxidation and potentially scavenge superoxide anions generated by cyanide in vitro. Furthermore, in vivo results demonstrate the ability of NVP and EFV to protect hippocampal neurons against lipid peroxidation induced by QA and superoxide radicals generated as a consequence thereof. The alleviation of QA-induced oxidative stress in vitro possibly occurs through the binding of iron (II) and / or iron (III), and this argument is further strengthened by the ability of EFV and not NVP to reduce iron (II)-induced lipid peroxidation in vitro directly. In addition the ferrozine and electrochemistry assay were used to measure the extent of iron (II) Fe[superscript 2+] and iron (III) Fe[superscript 3+] chelation activity. Both assays demonstrate that these agents bind iron (II) and iron (III), and prevent redox recycling of iron and subsequent complexation of Fe[superscript 2+] with QA which enhances neuronal damage. Both NNRTIs inhibit the endogenous biosynthesis of QA by inhibiting liver tryptophan 2, 3-dioxygenase activity in vivo and subsequently increasing hippocampal serotonin levels. Furthermore, these agents reduce the turnover of hippocampal serotonin to 5-hydroxyindole acetic acid. NVP and not EFV increase 5-hydroxyindole acetic acid and norepinephrine levels in the hippocampus. The results of the pineal indole metabolism study show that NVP increases the synthesis of melatonin, but decreases N-acetylserotonin, 5-hydroxyindole acetic acid and 5-hydroxytryptophol levels. Furthermore, it shows that EFV decreases 5-hydroxyindole acetic acid and melatonin synthesis. Behavioural studies using a Morris water maze show that the post-treatment of rats with NVP and EFV significantly improves QA-induced spatial memory deficits in the hippocampus. This study therefore provides novel information regarding the neuroprotective mechanisms of NVP and EFV. These findings strengthen the argument that these NNRTIs not only have antiviral effects but possess potential neuroprotective properties, which may contribute to the effectiveness of these drugs in the treatment of ADC.
- Full Text:
- Date Issued: 2008
- Authors: Zheve, Georgina Teurai
- Date: 2008
- Subjects: HIV infections -- Treatment AIDS (Disease) -- Treatment AIDS dementia complex -- Treatment Nervous system -- Degeneration -- Treatment Melatonin Neurotoxic agents Quinolinic acid
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3807 , http://hdl.handle.net/10962/d1003285
- Description: AIDS Dementia Complex (ADC) is a neurodegenerative disorder implicated in HIV-1 infection that is associated with elevated levels of the neurotoxin, quinolinic acid (QA) which causes a cascade of events to occur, leading to the production of reactive oxygen species (ROS), these being ultimately responsible for oxidative neurotoxicity. In clinical studies, Non-nucleoside reverse transcriptase inhibitors (NNRTIs), efavirenz (EFV) and nevirapine (NVP) have been shown to potentially delay the progressive degeneration of neurons, thus reducing the frequency and neurological deficits associated with ADC. Despite these neuroprotective implications, there is still no biochemical data to demonstrate the mechanisms through which these agents offer neuroprotection. The present study aims to elucidate and further characterize the possible antioxidant and neuroprotective mechanisms of NVP and EFV in vitro and in vivo, using QA-induced neurotoxicity as a model. Research has demonstrated that antioxidants and metal chelators have the ability to offer neuroprotection against free radical induced injury and may be beneficial in the prevention or treatment of neurodegeneration. Hence the antioxidant and metal binding properties of these agents were investigated respectively. Inorganic studies, including the 1, 1-diphenyl-2 picrylhydrazyl (DPPH) assay, show that these agents readily scavenge free radicals in vitro, thus postulating the antioxidant property of these agents. The enhancement of superoxide radical generation and iron mediated Fenton reaction by QA is related to lipid peroxidation in biological systems, the extent of which was assayed using the nitroblue tetrazolium and thiobarbituric acid method respectively. Both agents significantly curtail QA-induced lipid peroxidation and potentially scavenge superoxide anions generated by cyanide in vitro. Furthermore, in vivo results demonstrate the ability of NVP and EFV to protect hippocampal neurons against lipid peroxidation induced by QA and superoxide radicals generated as a consequence thereof. The alleviation of QA-induced oxidative stress in vitro possibly occurs through the binding of iron (II) and / or iron (III), and this argument is further strengthened by the ability of EFV and not NVP to reduce iron (II)-induced lipid peroxidation in vitro directly. In addition the ferrozine and electrochemistry assay were used to measure the extent of iron (II) Fe[superscript 2+] and iron (III) Fe[superscript 3+] chelation activity. Both assays demonstrate that these agents bind iron (II) and iron (III), and prevent redox recycling of iron and subsequent complexation of Fe[superscript 2+] with QA which enhances neuronal damage. Both NNRTIs inhibit the endogenous biosynthesis of QA by inhibiting liver tryptophan 2, 3-dioxygenase activity in vivo and subsequently increasing hippocampal serotonin levels. Furthermore, these agents reduce the turnover of hippocampal serotonin to 5-hydroxyindole acetic acid. NVP and not EFV increase 5-hydroxyindole acetic acid and norepinephrine levels in the hippocampus. The results of the pineal indole metabolism study show that NVP increases the synthesis of melatonin, but decreases N-acetylserotonin, 5-hydroxyindole acetic acid and 5-hydroxytryptophol levels. Furthermore, it shows that EFV decreases 5-hydroxyindole acetic acid and melatonin synthesis. Behavioural studies using a Morris water maze show that the post-treatment of rats with NVP and EFV significantly improves QA-induced spatial memory deficits in the hippocampus. This study therefore provides novel information regarding the neuroprotective mechanisms of NVP and EFV. These findings strengthen the argument that these NNRTIs not only have antiviral effects but possess potential neuroprotective properties, which may contribute to the effectiveness of these drugs in the treatment of ADC.
- Full Text:
- Date Issued: 2008
The development and assessment of sustained release nevirapine tablets
- Authors: Mwila, Chiluba
- Date: 2013
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54667 , vital:26598
- Description: The use of antiretroviral (ARV) agents in the management of HIV/AIDS has significantly improved the lifestyle and wellbeing of patients. Despite the success that has been achieved with the use of ARV therapy, the occurrence of adverse effects and unpredictable bioavailability associated with most of these drugs remains a major concern. Nevirapine (NVP) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that is used in combination with other ARV compounds for the treatment of HIV-1 infections. It is also used for the prevention of mother to child transmission of the HIV-1 virus. NVP is a Biopharmaceutics Classification System (BCS) Class II compound. Although NVP exhibits good oral absorption, it induces self-metabolism leading to low and sometimes unpredictable bioavailability. NVP is commercially available as an immediate release and extended release dosage form, viz., Viramune® XR. Formulation of a generic sustained release (SR) dosage form for once daily dosing would result in delivery of constant amount of the drug to the circulation, reduce dose related adverse effects, improve patient compliance to medication and reduce the costs of therapy. A simple RP-HPLC method was developed and optimised using a central composite design approach. The method was validated using ICH guidelines and was found to be linear, precise, specific and accurate for the analysis of NVP both in bulk and dosage forms. Direct compression was used as the method of tablet manufacture. Different polymers were assessed for suitability as rate retarding polymers and included Methocel® K4M, Carbopol® 71G NF and Eudragit® RSPO. Powder blends were assessed for flow properties using the angle of repose, bulk and tapped density, Carr’s Compressibility index and Hausner’s ratio. The traditional approach of changing the amount of polymers and diluents systematically to achieve a desired NVP release profile was used for the development of a preliminary formulation. Response surface methodology was used for the optimisation of the formulation using a Box-Behnken quadratic design. Physical characteristics of the tablets such as thickness, weight, hardness, tensile strength and friability were assessed and the tablets passed Pharmacopoeial testing. NVP assay and content uniformity were assessed using a validated RP-HPLC method. Initially, USP Apparatus 2 was used to study NVP release over a 24 hour period and subsequently dissolution studies were performed using USP Apparatus 3 as it can be used to simulate GIT conditions. The dissolution profiles generated were used to determine the agitation rate for USP Apparatus 3 that would be equivalent to an agitation rate of 50 rpm when using USP Apparatus 2. The effect of the mesh screen pore size, buffer molarity strength and concentration of surfactant on NVP release were also investigated in order to select discriminatory dissolution test conditions for the test formulation. Dissolution profiles were compared to those of the commercially available Viramune® XR using the FDA recommended difference (f1) and similarity (f2) factors. The calculated values for f1 and f2 revealed that the dissolution profile for the optimised formulation that was identified was statistically similar to Viramune® XR. In vitro release data were fitted to different kinetic models to study the release kinetics of NVP. The overall mechanism of NVP release was best described using the Korsmeyer-Peppas diffusion exponent value, n. NVP release was found to be anomalous, implying that the release was influenced by a combination of diffusion, swelling and polymer chain relaxation. The Hixson-Crowell model revealed that there was constant change in surface area of the dosage form suggesting that erosion and swelling were significant factors affecting NVP release from the hydrophilic matrix technology. The release kinetics data were also used to design the optimised formulation. Tablets manufactured using the optimised formulation were subjected to water uptake and erosion studies and the results revealed that swelling and erosion occur simultaneously. The effects of pH and molarity on the swelling and erosion of the tablets were also investigated. The data suggest that increase in pH resulted in a slight increase in swelling while an increase in molarity did not have a significant effect on swelling. The change in pH did not have a significant effect on erosion while an increase in molarity strength resulted in a decrease in matrix erosion. The effect of HPMC grade on swelling, erosion and NVP release revealed that the grade of HPMC used had a significant effect on NVP release, with the release rate decreasing, swelling increasing and erosion decreasing as the viscosity of the HPMC grade increased. The effect of the particle size of MCC on NVP release was also studied by manufacturing tablets containing different grades of MCC and these studies revealed that particle size did not appear to have a significant effect on NVP release. Similarly the use of different types of lactose did not appear to have a significant impact on NVP release. In conclusion a sustained release NVP tablet formulation that has the potential for further development and optimisation has been developed, assessed and manufactured successfully and has been shown to exhibit similar dissolution behaviour to Viramune® XR, a commercially available NVP extended release product.
- Full Text:
- Date Issued: 2013
- Authors: Mwila, Chiluba
- Date: 2013
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54667 , vital:26598
- Description: The use of antiretroviral (ARV) agents in the management of HIV/AIDS has significantly improved the lifestyle and wellbeing of patients. Despite the success that has been achieved with the use of ARV therapy, the occurrence of adverse effects and unpredictable bioavailability associated with most of these drugs remains a major concern. Nevirapine (NVP) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that is used in combination with other ARV compounds for the treatment of HIV-1 infections. It is also used for the prevention of mother to child transmission of the HIV-1 virus. NVP is a Biopharmaceutics Classification System (BCS) Class II compound. Although NVP exhibits good oral absorption, it induces self-metabolism leading to low and sometimes unpredictable bioavailability. NVP is commercially available as an immediate release and extended release dosage form, viz., Viramune® XR. Formulation of a generic sustained release (SR) dosage form for once daily dosing would result in delivery of constant amount of the drug to the circulation, reduce dose related adverse effects, improve patient compliance to medication and reduce the costs of therapy. A simple RP-HPLC method was developed and optimised using a central composite design approach. The method was validated using ICH guidelines and was found to be linear, precise, specific and accurate for the analysis of NVP both in bulk and dosage forms. Direct compression was used as the method of tablet manufacture. Different polymers were assessed for suitability as rate retarding polymers and included Methocel® K4M, Carbopol® 71G NF and Eudragit® RSPO. Powder blends were assessed for flow properties using the angle of repose, bulk and tapped density, Carr’s Compressibility index and Hausner’s ratio. The traditional approach of changing the amount of polymers and diluents systematically to achieve a desired NVP release profile was used for the development of a preliminary formulation. Response surface methodology was used for the optimisation of the formulation using a Box-Behnken quadratic design. Physical characteristics of the tablets such as thickness, weight, hardness, tensile strength and friability were assessed and the tablets passed Pharmacopoeial testing. NVP assay and content uniformity were assessed using a validated RP-HPLC method. Initially, USP Apparatus 2 was used to study NVP release over a 24 hour period and subsequently dissolution studies were performed using USP Apparatus 3 as it can be used to simulate GIT conditions. The dissolution profiles generated were used to determine the agitation rate for USP Apparatus 3 that would be equivalent to an agitation rate of 50 rpm when using USP Apparatus 2. The effect of the mesh screen pore size, buffer molarity strength and concentration of surfactant on NVP release were also investigated in order to select discriminatory dissolution test conditions for the test formulation. Dissolution profiles were compared to those of the commercially available Viramune® XR using the FDA recommended difference (f1) and similarity (f2) factors. The calculated values for f1 and f2 revealed that the dissolution profile for the optimised formulation that was identified was statistically similar to Viramune® XR. In vitro release data were fitted to different kinetic models to study the release kinetics of NVP. The overall mechanism of NVP release was best described using the Korsmeyer-Peppas diffusion exponent value, n. NVP release was found to be anomalous, implying that the release was influenced by a combination of diffusion, swelling and polymer chain relaxation. The Hixson-Crowell model revealed that there was constant change in surface area of the dosage form suggesting that erosion and swelling were significant factors affecting NVP release from the hydrophilic matrix technology. The release kinetics data were also used to design the optimised formulation. Tablets manufactured using the optimised formulation were subjected to water uptake and erosion studies and the results revealed that swelling and erosion occur simultaneously. The effects of pH and molarity on the swelling and erosion of the tablets were also investigated. The data suggest that increase in pH resulted in a slight increase in swelling while an increase in molarity did not have a significant effect on swelling. The change in pH did not have a significant effect on erosion while an increase in molarity strength resulted in a decrease in matrix erosion. The effect of HPMC grade on swelling, erosion and NVP release revealed that the grade of HPMC used had a significant effect on NVP release, with the release rate decreasing, swelling increasing and erosion decreasing as the viscosity of the HPMC grade increased. The effect of the particle size of MCC on NVP release was also studied by manufacturing tablets containing different grades of MCC and these studies revealed that particle size did not appear to have a significant effect on NVP release. Similarly the use of different types of lactose did not appear to have a significant impact on NVP release. In conclusion a sustained release NVP tablet formulation that has the potential for further development and optimisation has been developed, assessed and manufactured successfully and has been shown to exhibit similar dissolution behaviour to Viramune® XR, a commercially available NVP extended release product.
- Full Text:
- Date Issued: 2013
Development and manufacture of sustained release captopril beads
- Authors: Mhaka, Farai Arthur
- Date: 2015
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54712 , vital:26602
- Description: Hypertension has a high mortality rate in developing countries such as South Africa. Although the prevention and control of hypertension is a health priority, efforts to decrease the global burden of hypertension and improve control over the condition are inadequate. The use of angiotensin converting enzyme (ACE) inhibitors such as captopril (CPT) have been effective for the management of hypertension when used as first line therapy alone or in combination. Commercially available immediate release dosage forms containing 12.5, 25 and 50 mg of CPT are administered two or three times a day to treat hypertension. CPT degrades in aqueous media with the sulfhydryl functional moiety responsible for adverse effects such as hypersensitivity, taste disturbances and/or presenting with a dry hacking cough. CPT has a short elimination half-life of between 1.6 and 1.9 hours, which means that the compound is a suitable candidate for inclusion in sustained release (SR) dosage forms. Manufacturing a SR dosage form of coated beads for twice daily dosing may reduce the incidence and intensity of undesirable adverse effects, improve the stability of CPT and improve patient adherence. A stability indicating reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed and optimised using a central composite design approach. As part of this approach the interactive effects of input factors, viz. pH, methanol (MeOH) content and column temperature on retention time, were investigated to achieve a separation with well-resolved and symmetrical peaks for CPT and salicylic acid. The method was validated using ICH guidelines and was found to be simple, linear, precise, accurate, selective and rapid for the in vitro quantitation of CPT. The method was successfully applied for the analysis of both commercially available and test formulations. Preformulation studies were undertaken to establish the physical and chemical properties of CPT, excipients and dosage forms to ensure the production of stabile and bioavailable products. Powder blends were assessed for flow properties using angle of repose (AOR), and bulk and tapped density, which were subsequently used to calculate Carr’s Index (CI) and the Hausner ratio (HR). The addition of talc resulted in the most powder blends with AOR, CI and HR that were within a range indicative of satisfactory to good flow properties. The use of talc was necessary to ensure that blending prior to wet granulation and extrusion-spheronisation would produce homogenous powders. Thermogravimetric analysis (TGA), differential scanning calorimetry (DSC) and Fourier Transform Infrared Spectroscopy (FT-IR) were used for the identification and purity of CPT alone and 1:1 binary mixtures with excipients in an effort to establish if CPT was likely to undergo physical and/or chemical modification during production. The DSC thermograms for all CPT-excipient mixtures revealed the presence of a melting endotherm that was wider, occurring at 110.93 °C (Tpeak for pure CPT). The characteristic peaks for specific functional groups were present in the FT-IR spectra for powder mixtures, indicating the absence of incompatibilities. Dialysis studies were used to investigate if the ammonium oleate present in Surelease® E-7-19010 interacted with CPT. The results suggests that an interaction between CPT and Surelease® E-7-19010 during processing of CPT beads was unlikely to occur. Preliminary investigations reveal that Methocel® K100M, Methocel® E4M, Avicel® PH102, Eudragit® RS PO, Surelease® E-7-19010 and talc are compatible with CPT and could be used for the manufacture of SR CPT beads. CPT beads were manufactured using extrusion-spheronisation and coated using a fluidised bed drier fitted with a Wurster insert. The amount of granulating fluid, coating levels, curing time and formulation composition were varied to achieve CPT release with specific criteria to develop a preliminary formulation. The coated beads met all desired quality attributes in respect of micromeritic and flow properties, content uniformity and friability. Response Surface Methodology was used to further optimise the SR CPT formulation. The Plackett-Burman design was used for this process to produce an SR dosage form with desirable quality attributes achieved by altering formulation composition, extrusion-spheronisation variables and coating parameters. ANOVA data revealed significant responses for yield, aspect ratio, sphericity, coating efficiency and cumulative percent CPT released at 2 and 12 hours. Formulations in which the high molecular weight HPMC were used in increased concentrations resulted in the formation of a sticky wet mass and extrudate, resulting in a decrease in yield. The application of a permeable, but insoluble Surelease® coat onto the surface of the beads formed a barrier that complements the activity of the hydrophilic matrix in preventing rapid dissolution and retarding the release of CPT from the beads. The amount of CPT released over 12 hours revealed that increasing the Methocel® K100M content entrapped CPT and retained it more efficiently in the hydrated matrix, resulting in a slow rate of CPT release. In vitro release data were fitted to a number of models in an attempt to elucidate mechanistic aspects of transport processes specific to CPT from the coated bead formulations. The results of fitting data from optimised batches revealed that the goodness of fit based on the adjusted correlation coefficient ranged between 0.953 and 0.976 for the Higuchi model, indicating that diffusion is a predominant factor that controls CPT release from the coated beads. The results of fitting data to the Korsmeyer-Peppas model suggest that the mechanism of CPT release includes transport of the dissolution medium from the vessel reservoir into the core of the bead due to osmotic potential, dissolution of CPT, mass transfer of the dissolved CPT within the core, partitioning between the solution and polymeric film, mass transfer of dissolved CPT through the film to ultimately reach the bulk dissolution fluid. A SR CPT bead formulation that has potential for further development and optimisation for scaled-up production using RSM approaches and Design of Experiments such as CCD or Box-Behnken has been successfully developed and manufactured using extrusion, spheronisation and coating processes. Assessment of all batches of beads manufactured exhibited satisfactory to good flow properties and demonstrated SR profiles over 12 hours that met USP criteria for SR dosage forms.
- Full Text:
- Date Issued: 2015
- Authors: Mhaka, Farai Arthur
- Date: 2015
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54712 , vital:26602
- Description: Hypertension has a high mortality rate in developing countries such as South Africa. Although the prevention and control of hypertension is a health priority, efforts to decrease the global burden of hypertension and improve control over the condition are inadequate. The use of angiotensin converting enzyme (ACE) inhibitors such as captopril (CPT) have been effective for the management of hypertension when used as first line therapy alone or in combination. Commercially available immediate release dosage forms containing 12.5, 25 and 50 mg of CPT are administered two or three times a day to treat hypertension. CPT degrades in aqueous media with the sulfhydryl functional moiety responsible for adverse effects such as hypersensitivity, taste disturbances and/or presenting with a dry hacking cough. CPT has a short elimination half-life of between 1.6 and 1.9 hours, which means that the compound is a suitable candidate for inclusion in sustained release (SR) dosage forms. Manufacturing a SR dosage form of coated beads for twice daily dosing may reduce the incidence and intensity of undesirable adverse effects, improve the stability of CPT and improve patient adherence. A stability indicating reversed-phase high performance liquid chromatographic (RP-HPLC) method was developed and optimised using a central composite design approach. As part of this approach the interactive effects of input factors, viz. pH, methanol (MeOH) content and column temperature on retention time, were investigated to achieve a separation with well-resolved and symmetrical peaks for CPT and salicylic acid. The method was validated using ICH guidelines and was found to be simple, linear, precise, accurate, selective and rapid for the in vitro quantitation of CPT. The method was successfully applied for the analysis of both commercially available and test formulations. Preformulation studies were undertaken to establish the physical and chemical properties of CPT, excipients and dosage forms to ensure the production of stabile and bioavailable products. Powder blends were assessed for flow properties using angle of repose (AOR), and bulk and tapped density, which were subsequently used to calculate Carr’s Index (CI) and the Hausner ratio (HR). The addition of talc resulted in the most powder blends with AOR, CI and HR that were within a range indicative of satisfactory to good flow properties. The use of talc was necessary to ensure that blending prior to wet granulation and extrusion-spheronisation would produce homogenous powders. Thermogravimetric analysis (TGA), differential scanning calorimetry (DSC) and Fourier Transform Infrared Spectroscopy (FT-IR) were used for the identification and purity of CPT alone and 1:1 binary mixtures with excipients in an effort to establish if CPT was likely to undergo physical and/or chemical modification during production. The DSC thermograms for all CPT-excipient mixtures revealed the presence of a melting endotherm that was wider, occurring at 110.93 °C (Tpeak for pure CPT). The characteristic peaks for specific functional groups were present in the FT-IR spectra for powder mixtures, indicating the absence of incompatibilities. Dialysis studies were used to investigate if the ammonium oleate present in Surelease® E-7-19010 interacted with CPT. The results suggests that an interaction between CPT and Surelease® E-7-19010 during processing of CPT beads was unlikely to occur. Preliminary investigations reveal that Methocel® K100M, Methocel® E4M, Avicel® PH102, Eudragit® RS PO, Surelease® E-7-19010 and talc are compatible with CPT and could be used for the manufacture of SR CPT beads. CPT beads were manufactured using extrusion-spheronisation and coated using a fluidised bed drier fitted with a Wurster insert. The amount of granulating fluid, coating levels, curing time and formulation composition were varied to achieve CPT release with specific criteria to develop a preliminary formulation. The coated beads met all desired quality attributes in respect of micromeritic and flow properties, content uniformity and friability. Response Surface Methodology was used to further optimise the SR CPT formulation. The Plackett-Burman design was used for this process to produce an SR dosage form with desirable quality attributes achieved by altering formulation composition, extrusion-spheronisation variables and coating parameters. ANOVA data revealed significant responses for yield, aspect ratio, sphericity, coating efficiency and cumulative percent CPT released at 2 and 12 hours. Formulations in which the high molecular weight HPMC were used in increased concentrations resulted in the formation of a sticky wet mass and extrudate, resulting in a decrease in yield. The application of a permeable, but insoluble Surelease® coat onto the surface of the beads formed a barrier that complements the activity of the hydrophilic matrix in preventing rapid dissolution and retarding the release of CPT from the beads. The amount of CPT released over 12 hours revealed that increasing the Methocel® K100M content entrapped CPT and retained it more efficiently in the hydrated matrix, resulting in a slow rate of CPT release. In vitro release data were fitted to a number of models in an attempt to elucidate mechanistic aspects of transport processes specific to CPT from the coated bead formulations. The results of fitting data from optimised batches revealed that the goodness of fit based on the adjusted correlation coefficient ranged between 0.953 and 0.976 for the Higuchi model, indicating that diffusion is a predominant factor that controls CPT release from the coated beads. The results of fitting data to the Korsmeyer-Peppas model suggest that the mechanism of CPT release includes transport of the dissolution medium from the vessel reservoir into the core of the bead due to osmotic potential, dissolution of CPT, mass transfer of the dissolved CPT within the core, partitioning between the solution and polymeric film, mass transfer of dissolved CPT through the film to ultimately reach the bulk dissolution fluid. A SR CPT bead formulation that has potential for further development and optimisation for scaled-up production using RSM approaches and Design of Experiments such as CCD or Box-Behnken has been successfully developed and manufactured using extrusion, spheronisation and coating processes. Assessment of all batches of beads manufactured exhibited satisfactory to good flow properties and demonstrated SR profiles over 12 hours that met USP criteria for SR dosage forms.
- Full Text:
- Date Issued: 2015
Relationship between migraine triggers, auras and treatment
- Authors: Louwrens, Bernadette
- Date: 2017
- Subjects: Migraine -- Treatment Headache -- Treatment , Insomnia
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/18266 , vital:28611
- Description: Background: Migraine trigger factors are precipitating factors that can contribute to an attack by increasing the probability of a migraine occurring. For some migraineurs, the headache phase is preceded by a transient disturbance in neurological function (an aura). An aura could be visual or sensory in nature. There are medications that can be used to treat a migraine attack when it occurs (acute medication) and medication that can be used to reduce frequency and severity of migraine attacks (prophylactic medication). Objectives: The primary aim of the study was to identify if there was a relationship between migraine trigger factors, auras and treatment. Methods: The study was conducted in 2014 in Port Elizabeth and consisted of two self-administered questionnaire-based surveys, one for pharmacists and one for migraine patients. Migraine patient questionnaires were distributed to migraine patients who frequented pharmacies, physiotherapy practices and health shops. A total of 18 pharmacist questionnaires and 173 migraine patient questionnaires were analysed. Results: Experiencing an aura before a migraine attack was reported by 43.9% of respondents and only “sometimes” by 22.5% of respondents. Visual auras were experienced by 92.0% of respondents who indicated that they suffered from migraine with aura and sensory auras were experienced by 71.5% of respondents, with 62.8% of respondents experiencing both visual and sensory auras. Trigger factors were experienced by 89.0% of respondents. There was no statistical relationship between aura and trigger factors, but there was a statistical relationship between trigger factors and visual aura at the 5% level (Chi-square = 7.966, d.f. = 1, p-value = 0.005). Cramér’s V showed a small practical significance at 0.218. About 80.0% of respondents used over-the-counter (OTC) medication and only 12.6% used migraine specific medication to abort a migraine attack. There was no statistical relationship between aura (visual or sensory) and abortive medication. There was a statistical relationship between abortive medication and the presence of trigger factors (Chi-square = 8.775, d.f. = 3, p-value = 0.032). Cramér’s V showed a small practical significance at 0.244. There was no statistical relationship in the presence of trigger factors between aura and abortive medication. Conclusion: Migraine is a complex disease which affects people of all ages. There appears to be a statistical relationship between visual auras and trigger factors and between abortive medication and trigger factors. There was, however, no statistical relationship between aura and abortive medication in the presence of trigger factors. Further studies need to be conducted to substantiate these findings.
- Full Text:
- Date Issued: 2017
- Authors: Louwrens, Bernadette
- Date: 2017
- Subjects: Migraine -- Treatment Headache -- Treatment , Insomnia
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/18266 , vital:28611
- Description: Background: Migraine trigger factors are precipitating factors that can contribute to an attack by increasing the probability of a migraine occurring. For some migraineurs, the headache phase is preceded by a transient disturbance in neurological function (an aura). An aura could be visual or sensory in nature. There are medications that can be used to treat a migraine attack when it occurs (acute medication) and medication that can be used to reduce frequency and severity of migraine attacks (prophylactic medication). Objectives: The primary aim of the study was to identify if there was a relationship between migraine trigger factors, auras and treatment. Methods: The study was conducted in 2014 in Port Elizabeth and consisted of two self-administered questionnaire-based surveys, one for pharmacists and one for migraine patients. Migraine patient questionnaires were distributed to migraine patients who frequented pharmacies, physiotherapy practices and health shops. A total of 18 pharmacist questionnaires and 173 migraine patient questionnaires were analysed. Results: Experiencing an aura before a migraine attack was reported by 43.9% of respondents and only “sometimes” by 22.5% of respondents. Visual auras were experienced by 92.0% of respondents who indicated that they suffered from migraine with aura and sensory auras were experienced by 71.5% of respondents, with 62.8% of respondents experiencing both visual and sensory auras. Trigger factors were experienced by 89.0% of respondents. There was no statistical relationship between aura and trigger factors, but there was a statistical relationship between trigger factors and visual aura at the 5% level (Chi-square = 7.966, d.f. = 1, p-value = 0.005). Cramér’s V showed a small practical significance at 0.218. About 80.0% of respondents used over-the-counter (OTC) medication and only 12.6% used migraine specific medication to abort a migraine attack. There was no statistical relationship between aura (visual or sensory) and abortive medication. There was a statistical relationship between abortive medication and the presence of trigger factors (Chi-square = 8.775, d.f. = 3, p-value = 0.032). Cramér’s V showed a small practical significance at 0.244. There was no statistical relationship in the presence of trigger factors between aura and abortive medication. Conclusion: Migraine is a complex disease which affects people of all ages. There appears to be a statistical relationship between visual auras and trigger factors and between abortive medication and trigger factors. There was, however, no statistical relationship between aura and abortive medication in the presence of trigger factors. Further studies need to be conducted to substantiate these findings.
- Full Text:
- Date Issued: 2017
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
Gradient high performance liquid chromatographic method for the simultaneous analysis of efavirenz, emtricitabine and tenofovir
- Authors: Koekemoer, Sonya Mariana
- Date: 2016
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54679 , vital:26599
- Description: In 2014, approximately 6.8 million people in South Africa were HIV-positive, and the majority of those affected are aged 15 or older. A fixed-dose combination (FDC) antiretroviral (ARV) dosage form containing one non-nucleotide reverse transcriptase inhibitor (efavirenz) and two nucleotide reverse transcriptase inhibitors (emtricitabine and tenofovir) was licensed in South Africa in April 2013. New consolidated guidelines for HIV management and prevention of mother to child transmission (PMTCT) were published by the South African Department of Health in December 2014 and the FDC is now the recommended first-line treatment for HIV-positive patients. According to these guidelines all such people aged 15 and older, and weighing more than 40 kg, with a CD4 count of ≤ 500/ μl will be eligible for antiretroviral therapy (ART) using the FDC. In addition every pregnant and breastfeeding woman is eligible for lifelong ART regardless of CD4 count and EFV can be used as first-line treatment for pregnant women regardless of the length of gestation state of the pregnancy at that time. The use of this simplified regime is likely to promote much needed and improved adherence to therapy. An investigation into the development of a stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous quantitation of EFV, FTC and TNF was undertaken. Isocratic HPLC analysis was found to be unsuitable due to the highly polar FTC molecule eluting in the void. Therefore a gradient HPLC method was developed and validated. The method was validated according to the International Conference on Harmonisation, now known as International Council for Harmonization (ICH). Correlation coefficients > 0.999 were obtained for each assessment of linearity and FTC, TNF and EFV are linear in the range 0.4-40 μg/ml, 0.6-60 μg/ml and 1.2-120 μg/ml. The equation of the best-fit least squares regression lines for FTC, TNF and EFV were y = 0.0191x+0.0007, y = 0.0163x+0.0116 and y = 0.01x+0.016, respectively. The method is accurate as the y-intercept was < 2% of the detector response for all ARV, and the method is precise in terms of intra- and inter-assay precision as all % RSD < 2%. The stability-indicating nature of the method was demonstrated under acidic, alkaline and oxidative stress in addition to UV exposure and elevated temperatures, and the individual chromatograms were overlaid using Empower® 3 Software to establish whether there was interference with the peaks of interest. The forced degradation studies demonstrated the selectivity of the method for the ARV compounds. The method was applied to assay and in vitro dissolution studies of commercially available tablets. The amount of each active ingredient released from Atripla® was determined and compared to the amount of each drug released from Aspen Efavirenz® and Truvada® (a combination of FTC and TNF). The percent FTC released from Atripla® and Truvada® was similar based on the acceptance criteria for immediate-release BCS class 1 compounds. Statistical analysis was undertaken to compare the dissolution profiles of FTC, TNF and EFV. The percent of these compounds released in these studies indicate that bioequivalence testing would be required to declare these products interchangeable. The validated RP-HPLC and in vitro dissolution test method are suitable for routine quality control testing of solid oral dosage forms containing EFV, FTC and TNF, and as the dissolution method can discriminate between different formulations of the same molecule, these tools can also be used for analysis during formulation development studies. The method is not suitable for the analysis of the ARV plasma due to lack of sensitivity and an inability to quantitate the compounds at the required concentration levels. The use of HPLC with mass spectroscopy for quantitation would enhance the sensitivity of the method and may eliminate the quantitation of the molecules in the presence of interference that was observed when using UV detection. Fixed dose combination tablets are convenient for patient therapy and it is likely that in the future more molecules will be formulated into such dosage forms. However formulations such as these can pose significant difficulties when developing and using analytical methods for the quantitation of all compounds in the dosage form at the same time, in particular when the compounds have vastly different physico-chemical properties that impact the quality of a separation and therefore the analysis. Therefore when embarking on the development of FDC product cognisance of the difficulties of developing single methods for the analyses is required and approaches to overcome these difficulties should be considered.
- Full Text:
- Date Issued: 2016
- Authors: Koekemoer, Sonya Mariana
- Date: 2016
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54679 , vital:26599
- Description: In 2014, approximately 6.8 million people in South Africa were HIV-positive, and the majority of those affected are aged 15 or older. A fixed-dose combination (FDC) antiretroviral (ARV) dosage form containing one non-nucleotide reverse transcriptase inhibitor (efavirenz) and two nucleotide reverse transcriptase inhibitors (emtricitabine and tenofovir) was licensed in South Africa in April 2013. New consolidated guidelines for HIV management and prevention of mother to child transmission (PMTCT) were published by the South African Department of Health in December 2014 and the FDC is now the recommended first-line treatment for HIV-positive patients. According to these guidelines all such people aged 15 and older, and weighing more than 40 kg, with a CD4 count of ≤ 500/ μl will be eligible for antiretroviral therapy (ART) using the FDC. In addition every pregnant and breastfeeding woman is eligible for lifelong ART regardless of CD4 count and EFV can be used as first-line treatment for pregnant women regardless of the length of gestation state of the pregnancy at that time. The use of this simplified regime is likely to promote much needed and improved adherence to therapy. An investigation into the development of a stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous quantitation of EFV, FTC and TNF was undertaken. Isocratic HPLC analysis was found to be unsuitable due to the highly polar FTC molecule eluting in the void. Therefore a gradient HPLC method was developed and validated. The method was validated according to the International Conference on Harmonisation, now known as International Council for Harmonization (ICH). Correlation coefficients > 0.999 were obtained for each assessment of linearity and FTC, TNF and EFV are linear in the range 0.4-40 μg/ml, 0.6-60 μg/ml and 1.2-120 μg/ml. The equation of the best-fit least squares regression lines for FTC, TNF and EFV were y = 0.0191x+0.0007, y = 0.0163x+0.0116 and y = 0.01x+0.016, respectively. The method is accurate as the y-intercept was < 2% of the detector response for all ARV, and the method is precise in terms of intra- and inter-assay precision as all % RSD < 2%. The stability-indicating nature of the method was demonstrated under acidic, alkaline and oxidative stress in addition to UV exposure and elevated temperatures, and the individual chromatograms were overlaid using Empower® 3 Software to establish whether there was interference with the peaks of interest. The forced degradation studies demonstrated the selectivity of the method for the ARV compounds. The method was applied to assay and in vitro dissolution studies of commercially available tablets. The amount of each active ingredient released from Atripla® was determined and compared to the amount of each drug released from Aspen Efavirenz® and Truvada® (a combination of FTC and TNF). The percent FTC released from Atripla® and Truvada® was similar based on the acceptance criteria for immediate-release BCS class 1 compounds. Statistical analysis was undertaken to compare the dissolution profiles of FTC, TNF and EFV. The percent of these compounds released in these studies indicate that bioequivalence testing would be required to declare these products interchangeable. The validated RP-HPLC and in vitro dissolution test method are suitable for routine quality control testing of solid oral dosage forms containing EFV, FTC and TNF, and as the dissolution method can discriminate between different formulations of the same molecule, these tools can also be used for analysis during formulation development studies. The method is not suitable for the analysis of the ARV plasma due to lack of sensitivity and an inability to quantitate the compounds at the required concentration levels. The use of HPLC with mass spectroscopy for quantitation would enhance the sensitivity of the method and may eliminate the quantitation of the molecules in the presence of interference that was observed when using UV detection. Fixed dose combination tablets are convenient for patient therapy and it is likely that in the future more molecules will be formulated into such dosage forms. However formulations such as these can pose significant difficulties when developing and using analytical methods for the quantitation of all compounds in the dosage form at the same time, in particular when the compounds have vastly different physico-chemical properties that impact the quality of a separation and therefore the analysis. Therefore when embarking on the development of FDC product cognisance of the difficulties of developing single methods for the analyses is required and approaches to overcome these difficulties should be considered.
- Full Text:
- Date Issued: 2016
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
Evaluation of the acceptability of ambulatory blood pressure monitoring in a semi-rural, Eastern Cape population
- Authors: Chiwanza, Farisai
- Date: 2017
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/59161 , vital:27447
- Description: Expected release date-April 2019
- Full Text:
- Date Issued: 2017
- Authors: Chiwanza, Farisai
- Date: 2017
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/59161 , vital:27447
- Description: Expected release date-April 2019
- Full Text:
- Date Issued: 2017
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
South African community pharmacists’ self-perception of their professional identity and job satisfaction
- Authors: Smith, Robert Mark Houston
- Date: 2017
- Subjects: Pharmacy -- Practice -- South Africa Pharmacists -- Job satisfaction -- South Africa , Community health services -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/20637 , vital:29363
- Description: The role of the community pharmacist has changed over the past two decades. The traditional specialist roles of pharmacists, such as compounding and preparation of medications, are now infrequent activities and the profession has moved to a more patient-centred focus. Furthermore, pharmaceutical care has been developed and adopted as a practice philosophy to add value and bring care for patients back into the profession. However, there is still much debate in academic and policy literature concerning the reluctance of community pharmacists to adopt and implement pharmaceutical care in practice environments. Empirical evidence has suggested that the professional identity of pharmacists is both ambiguous and multifaceted. However, the practice of pharmaceutical care has been demonstrated to increase organisational identity of pharmacists, as well as their job satisfaction. In addition, pharmacists in a clinical role have been shown to have higher levels of job satisfaction than their counterparts in nonclinical roles. This study has identified, described and analysed the self-perceived professional identities of community pharmacists within a South African context. Furthermore, it sought to determine their current levels of job satisfaction. The relationships between professional identity, job satisfaction and role were analysed in an attempt to understand the influence of professional identity on job satisfaction and behaviour of pharmacists. This study made use of a mixed method of inquiry, online questionnaire, administered to a large sample, which allowed the researcher to take a broad view of the research foci at a specific moment in time. This study found the existence of six professional identities amongst South African Community Pharmacists; namely the practitioner, the jaded pharmacist, the social carer, the professional, the medicine supplier and the entrepreneur. South African community pharmacists were, generally, satisfied with their jobs, professed to practice pharmaceutical care and adopted it as a practice philosophy. South African Community pharmacists were, in general, committed to their profession. Correlation between a pharmacist’s professional identity and their job title, job satisfaction and their commitment were found to be statistically significant. A pharmacist’s level of job satisfaction was statistically correlated to their practice of pharmaceutical care. No statistically significant relationship was found to exist between a pharmacist’s identity and their work load or tasks performed. Characterising South African community pharmacists’ identities is of great significance in an effort to better understand the forces that drive our profession of pharmacy. In doing so, have found that identity affects many elements of work life such as job satisfaction, professional commitment and the practice of patient care.
- Full Text:
- Date Issued: 2017
- Authors: Smith, Robert Mark Houston
- Date: 2017
- Subjects: Pharmacy -- Practice -- South Africa Pharmacists -- Job satisfaction -- South Africa , Community health services -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/20637 , vital:29363
- Description: The role of the community pharmacist has changed over the past two decades. The traditional specialist roles of pharmacists, such as compounding and preparation of medications, are now infrequent activities and the profession has moved to a more patient-centred focus. Furthermore, pharmaceutical care has been developed and adopted as a practice philosophy to add value and bring care for patients back into the profession. However, there is still much debate in academic and policy literature concerning the reluctance of community pharmacists to adopt and implement pharmaceutical care in practice environments. Empirical evidence has suggested that the professional identity of pharmacists is both ambiguous and multifaceted. However, the practice of pharmaceutical care has been demonstrated to increase organisational identity of pharmacists, as well as their job satisfaction. In addition, pharmacists in a clinical role have been shown to have higher levels of job satisfaction than their counterparts in nonclinical roles. This study has identified, described and analysed the self-perceived professional identities of community pharmacists within a South African context. Furthermore, it sought to determine their current levels of job satisfaction. The relationships between professional identity, job satisfaction and role were analysed in an attempt to understand the influence of professional identity on job satisfaction and behaviour of pharmacists. This study made use of a mixed method of inquiry, online questionnaire, administered to a large sample, which allowed the researcher to take a broad view of the research foci at a specific moment in time. This study found the existence of six professional identities amongst South African Community Pharmacists; namely the practitioner, the jaded pharmacist, the social carer, the professional, the medicine supplier and the entrepreneur. South African community pharmacists were, generally, satisfied with their jobs, professed to practice pharmaceutical care and adopted it as a practice philosophy. South African Community pharmacists were, in general, committed to their profession. Correlation between a pharmacist’s professional identity and their job title, job satisfaction and their commitment were found to be statistically significant. A pharmacist’s level of job satisfaction was statistically correlated to their practice of pharmaceutical care. No statistically significant relationship was found to exist between a pharmacist’s identity and their work load or tasks performed. Characterising South African community pharmacists’ identities is of great significance in an effort to better understand the forces that drive our profession of pharmacy. In doing so, have found that identity affects many elements of work life such as job satisfaction, professional commitment and the practice of patient care.
- Full Text:
- Date Issued: 2017
Pharmacists’ perceptions of the effects of the Consumer Protection Act of 2008 on the pharmacy profession in South Africa: an exploratory study
- Authors: Cumberlege, Karin
- Date: 2019
- Subjects: South Africa -- Consumer Protection Act, 2008 , Consumer protection -- Law and legislation -- South Africa Pharmacists -- Legal status, laws, etc. -- South Africa Pharmacy -- Practice -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/38057 , vital:34312
- Description: The pharmacy profession is highly regulated through a number of statutes and codes all of which are devised in the public interest. The Consumer Protection Act, No 68 of 2008 (CPA) is a relatively recent addition to these regulatory measures and purports to protect consumers in their relations with suppliers, which includes the pharmacist-patient relationship. Heightened consumer awareness is increasing litigious consumer behaviour, making it important for pharmacists to be aware of their legal duties as providers of pharmaceutical care to consumers and therefore, to appreciate the potential implications of the CPA. This study aimed to determine South African pharmacists’ perceptions of the potential effect of the CPA on the pharmacy profession. Specific objectives included establishing the extent to which pharmacy law and ethics are incorporated into pharmacy curricula at various tertiary pharmacy institutions. The literature review identified the pharmacy categories providing pharmaceutical care services, whilst investigating medico-legal aspects of such services. Selected consumer rights in the CPA were considered in the context of pharmacists’ ethical obligations to consumers, thereby identifying potential areas of liability for pharmacists. Content and curriculum development pertaining to pharmacy education and training, focusing on pharmacy law and ethics, were assessed. A mixed methods research design was used to achieve the aim of the study. This included focus groups, telephone interviews, and a questionnaire survey amongst registered pharmacists. The themes identified in the focus groups were included in the telephone interviews. Likewise, themes identified from both the focus groups and telephone interviews, were incorporated in the questionnaire survey. The results identified a disparity in pharmacists’ education and training received from the respective tertiary pharmacy institutions. The results showed that pharmacists do not necessarily appreciate the potential implications of the CPA for pharmacists, portending an increased likelihood of liability. This finding also has implications for the training of pharmacists.
- Full Text:
- Date Issued: 2019
- Authors: Cumberlege, Karin
- Date: 2019
- Subjects: South Africa -- Consumer Protection Act, 2008 , Consumer protection -- Law and legislation -- South Africa Pharmacists -- Legal status, laws, etc. -- South Africa Pharmacy -- Practice -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/38057 , vital:34312
- Description: The pharmacy profession is highly regulated through a number of statutes and codes all of which are devised in the public interest. The Consumer Protection Act, No 68 of 2008 (CPA) is a relatively recent addition to these regulatory measures and purports to protect consumers in their relations with suppliers, which includes the pharmacist-patient relationship. Heightened consumer awareness is increasing litigious consumer behaviour, making it important for pharmacists to be aware of their legal duties as providers of pharmaceutical care to consumers and therefore, to appreciate the potential implications of the CPA. This study aimed to determine South African pharmacists’ perceptions of the potential effect of the CPA on the pharmacy profession. Specific objectives included establishing the extent to which pharmacy law and ethics are incorporated into pharmacy curricula at various tertiary pharmacy institutions. The literature review identified the pharmacy categories providing pharmaceutical care services, whilst investigating medico-legal aspects of such services. Selected consumer rights in the CPA were considered in the context of pharmacists’ ethical obligations to consumers, thereby identifying potential areas of liability for pharmacists. Content and curriculum development pertaining to pharmacy education and training, focusing on pharmacy law and ethics, were assessed. A mixed methods research design was used to achieve the aim of the study. This included focus groups, telephone interviews, and a questionnaire survey amongst registered pharmacists. The themes identified in the focus groups were included in the telephone interviews. Likewise, themes identified from both the focus groups and telephone interviews, were incorporated in the questionnaire survey. The results identified a disparity in pharmacists’ education and training received from the respective tertiary pharmacy institutions. The results showed that pharmacists do not necessarily appreciate the potential implications of the CPA for pharmacists, portending an increased likelihood of liability. This finding also has implications for the training of pharmacists.
- Full Text:
- Date Issued: 2019
The role of the community pharmacist in cardiovascular disease management
- Venter, Ignatius Johannes Erhardt
- Authors: Venter, Ignatius Johannes Erhardt
- Date: 2007
- Subjects: Pharmacist and patient -- South Africa -- Port Elizabeth , Phamaceutical services -- Patients , Cardiovascular system -- Diseases
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10150 , http://hdl.handle.net/10948/652 , Pharmacist and patient -- South Africa -- Port Elizabeth , Phamaceutical services -- Patients , Cardiovascular system -- Diseases
- Description: Cardiovascular disease contributes to mortality and morbidity statistics worldwide and in South Africa. The current focus in health care revolves around activities aimed at preventing the development of cardiovascular disease, rather than the treatment of disease. The identification of risk factors that can predispose a patient to the development of cardiovascular disease is an essential component of any cardiovascular disease management programme. It is necessary that in the management of these risk factors, they are not considered to be isolated, but inter-related. Through the provision of point-of-care cardiovascular risk screening and monitoring services as well as disease-related counselling, the community pharmacist, as a readily accessible source of healthcare, can play an essential role in the cardiovascular disease management process. The aim of this study was to describe the nature of the services provided by community pharmacists with respect to cardiovascular risk and disease management in the Nelson Mandela Metropole. The research design was a non-experimental, descriptive study using a crosssectional survey method. Data was obtained through the utilisation of a questionnaire. The questionnaire consisted of three sections and was administered to community pharmacies in the Nelson Mandela Metropole, that provided cardiovascular point-of-care screening services. The community pharmacists correctly identified cardiovascular risk factors such as obesity (76.6 percent; 36, n=47) and smoking (27.7 percent; 13, n=47). Other cardiovascular risk factors such as abdominal obesity (4.2 percent; 2, n=47), gender (2.1 percent; 1, n=47) and family history (4.2 percent; 2, n=47) were largely ignored by the pharmacists. Point-of-care testing services were readily available in the pharmacies, with all of the pharmacies providing blood glucose and blood pressure measurements. Blood cholesterol measurements were only provided in 87.8 percent (36, n=41) of the pharmacies. The services were generally provided in a clinic facility, with 90.2 percent (37, n=41) of the pharmacies having a clinic facility available. Pharmacists were involved in the provision of point-of-care services, with 85.4 percent (35, n=41) of the pharmacies indicating that the pharmacists participated. Pharmacists readily provided counselling prior (70.7 percent; 29, n=41) to and after (80.5 percent; 33, n=41) the conduction of the screening services on areas such as lifestyle modification and treatment options. Only 15 percent (7, n=47) of the pharmacists indicated that they were aware of Cardiovascular Risk Calculator Tools and none of the pharmacists indicated that they had utilised such a tool. Pharmacists recommended frequent monitoring (60.5 percent; 26, n=43) and lifestyle modification (67.4 percent; 29, n=43) to patients, if the result of their screening service was within normal limits. However, the majority of the pharmacists indicated that they would refer patients, if the results obtained were out of the normal range. Conclusions based on the findings indicated that the pharmacists are readily providing cardiovascular risk screening services. The pharmacists were also able to identify the presence of any risk factors that can lead to the development of cardiovascular disease in the patients. However, active pharmaceutical involvement in further cardiovascular disease monitoring seemed to be lacking. Recommendations were made on areas such as reimbursement for pharmaceutical care services, increased utilisation of support staff and Continuing Professional Development events that could assist in improving the role of the community pharmacist in cardiovascular disease management.
- Full Text:
- Date Issued: 2007
- Authors: Venter, Ignatius Johannes Erhardt
- Date: 2007
- Subjects: Pharmacist and patient -- South Africa -- Port Elizabeth , Phamaceutical services -- Patients , Cardiovascular system -- Diseases
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10150 , http://hdl.handle.net/10948/652 , Pharmacist and patient -- South Africa -- Port Elizabeth , Phamaceutical services -- Patients , Cardiovascular system -- Diseases
- Description: Cardiovascular disease contributes to mortality and morbidity statistics worldwide and in South Africa. The current focus in health care revolves around activities aimed at preventing the development of cardiovascular disease, rather than the treatment of disease. The identification of risk factors that can predispose a patient to the development of cardiovascular disease is an essential component of any cardiovascular disease management programme. It is necessary that in the management of these risk factors, they are not considered to be isolated, but inter-related. Through the provision of point-of-care cardiovascular risk screening and monitoring services as well as disease-related counselling, the community pharmacist, as a readily accessible source of healthcare, can play an essential role in the cardiovascular disease management process. The aim of this study was to describe the nature of the services provided by community pharmacists with respect to cardiovascular risk and disease management in the Nelson Mandela Metropole. The research design was a non-experimental, descriptive study using a crosssectional survey method. Data was obtained through the utilisation of a questionnaire. The questionnaire consisted of three sections and was administered to community pharmacies in the Nelson Mandela Metropole, that provided cardiovascular point-of-care screening services. The community pharmacists correctly identified cardiovascular risk factors such as obesity (76.6 percent; 36, n=47) and smoking (27.7 percent; 13, n=47). Other cardiovascular risk factors such as abdominal obesity (4.2 percent; 2, n=47), gender (2.1 percent; 1, n=47) and family history (4.2 percent; 2, n=47) were largely ignored by the pharmacists. Point-of-care testing services were readily available in the pharmacies, with all of the pharmacies providing blood glucose and blood pressure measurements. Blood cholesterol measurements were only provided in 87.8 percent (36, n=41) of the pharmacies. The services were generally provided in a clinic facility, with 90.2 percent (37, n=41) of the pharmacies having a clinic facility available. Pharmacists were involved in the provision of point-of-care services, with 85.4 percent (35, n=41) of the pharmacies indicating that the pharmacists participated. Pharmacists readily provided counselling prior (70.7 percent; 29, n=41) to and after (80.5 percent; 33, n=41) the conduction of the screening services on areas such as lifestyle modification and treatment options. Only 15 percent (7, n=47) of the pharmacists indicated that they were aware of Cardiovascular Risk Calculator Tools and none of the pharmacists indicated that they had utilised such a tool. Pharmacists recommended frequent monitoring (60.5 percent; 26, n=43) and lifestyle modification (67.4 percent; 29, n=43) to patients, if the result of their screening service was within normal limits. However, the majority of the pharmacists indicated that they would refer patients, if the results obtained were out of the normal range. Conclusions based on the findings indicated that the pharmacists are readily providing cardiovascular risk screening services. The pharmacists were also able to identify the presence of any risk factors that can lead to the development of cardiovascular disease in the patients. However, active pharmaceutical involvement in further cardiovascular disease monitoring seemed to be lacking. Recommendations were made on areas such as reimbursement for pharmaceutical care services, increased utilisation of support staff and Continuing Professional Development events that could assist in improving the role of the community pharmacist in cardiovascular disease management.
- Full Text:
- Date Issued: 2007
Simulated learning: integrating clinical knowledge into the dispensing process
- Authors: Klitsie, Monique
- Date: 2019
- Subjects: Medicine -- Study and teaching -- Simulation methods , Pharmacy -- Study and teaching Hospital pharmacies -- South Africa Pharmacy management -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/42239 , vital:36638
- Description: Pharmacy education has experienced a continual shift in the emphasis of the practice of pharmacy, requiring pharmacists to practice high levels of competence in performing the dispensing process while incorporating clinical knowledge using complex levels of cognitive skill. This highlights the need for opportunities within the learning environment which both require and facilitate the integration of clinical knowledge-based cognitive skills into the dispensing process. Simulation-based education has been demonstrated to assist in gradually increasing the level of complexity of tasks requiring performance by students in clinical settings. This study explored ways in which a computer-based dispensing program, MyDispense, could be used to facilitate the integration of clinical knowledge-based cognitive skills into the dispensing process. In the study, simulated patient scenarios for MyDispense were developed, which required the integration of a hierarchy of cognitive skills into the dispensing process. These were evaluated in order to assess the level of cognitive skills required to complete the clinical scenarios created. The developed MyDispense-based clinical scenarios were then piloted with a group of pharmacy students, after which a focus group was used to explore the students’ experience of the ability of MyDispense to integrate clinical knowledge into the dispensing process. This qualitative study adopted an exploratory approach in order to understand the potential benefit of computer-based simulated learning as a means of integrating clinical knowledge-based cognitive skills into the dispensing process. Purposive and convenience sampling was used in this study and data collection was through the completion of purpose-designed assessment forms by pharmacy lecturers and focus groups with student participants. Data from the assessment forms was used as feedback to further refine the clinical scenarios, and the focus group recording was transcribed and analysed using a thematic analysis approach. The scenarios assessed by the pharmacy lecturers were shown to require high levels of cognitive skills as described by Bloom’s Revised Taxonomy (Anderson & Krathwohl, 2001) and necessitated that the students plan, construct, design, and generate information to complete the scenarios. The pharmacy students successfully practiced the MyDispense scenarios as an adjunct to a clinical module and reported that the scenarios had assisted them in learning for the clinical module. The students acknowledged that they were required to apply their clinical knowledge and make clinical decisions while completing the scenarios. This study demonstrates that simulation-based education can be used as a beneficial educational tool for teaching the application of complex clinical knowledge-based cognitive skills to the dispensing process. It provides a valuable means of preparing students for professional work-based pharmacy practice.
- Full Text:
- Date Issued: 2019
- Authors: Klitsie, Monique
- Date: 2019
- Subjects: Medicine -- Study and teaching -- Simulation methods , Pharmacy -- Study and teaching Hospital pharmacies -- South Africa Pharmacy management -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/42239 , vital:36638
- Description: Pharmacy education has experienced a continual shift in the emphasis of the practice of pharmacy, requiring pharmacists to practice high levels of competence in performing the dispensing process while incorporating clinical knowledge using complex levels of cognitive skill. This highlights the need for opportunities within the learning environment which both require and facilitate the integration of clinical knowledge-based cognitive skills into the dispensing process. Simulation-based education has been demonstrated to assist in gradually increasing the level of complexity of tasks requiring performance by students in clinical settings. This study explored ways in which a computer-based dispensing program, MyDispense, could be used to facilitate the integration of clinical knowledge-based cognitive skills into the dispensing process. In the study, simulated patient scenarios for MyDispense were developed, which required the integration of a hierarchy of cognitive skills into the dispensing process. These were evaluated in order to assess the level of cognitive skills required to complete the clinical scenarios created. The developed MyDispense-based clinical scenarios were then piloted with a group of pharmacy students, after which a focus group was used to explore the students’ experience of the ability of MyDispense to integrate clinical knowledge into the dispensing process. This qualitative study adopted an exploratory approach in order to understand the potential benefit of computer-based simulated learning as a means of integrating clinical knowledge-based cognitive skills into the dispensing process. Purposive and convenience sampling was used in this study and data collection was through the completion of purpose-designed assessment forms by pharmacy lecturers and focus groups with student participants. Data from the assessment forms was used as feedback to further refine the clinical scenarios, and the focus group recording was transcribed and analysed using a thematic analysis approach. The scenarios assessed by the pharmacy lecturers were shown to require high levels of cognitive skills as described by Bloom’s Revised Taxonomy (Anderson & Krathwohl, 2001) and necessitated that the students plan, construct, design, and generate information to complete the scenarios. The pharmacy students successfully practiced the MyDispense scenarios as an adjunct to a clinical module and reported that the scenarios had assisted them in learning for the clinical module. The students acknowledged that they were required to apply their clinical knowledge and make clinical decisions while completing the scenarios. This study demonstrates that simulation-based education can be used as a beneficial educational tool for teaching the application of complex clinical knowledge-based cognitive skills to the dispensing process. It provides a valuable means of preparing students for professional work-based pharmacy practice.
- Full Text:
- Date Issued: 2019
Management of type 2 diabetes mellitus : a pharmacoepidemiological review
- Authors: Saugur, Anusooya
- Date: 2011
- Subjects: Diabetes , Diabetes -- Management , Diabetes -- Diet therapy , Diabetes -- Prevention , Insulin -- Therapeutic use , Hypoglycemia
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10129 , http://hdl.handle.net/10948/1635 , Diabetes , Diabetes -- Management , Diabetes -- Diet therapy , Diabetes -- Prevention , Insulin -- Therapeutic use , Hypoglycemia
- Description: Type 2 diabetes mellitus (DM) is a progressive disease characterised by hyperglycaemia caused by defects in insulin secretion and insulin action. In early stages of type 2 DM, dietary and lifestyle changes are often sufficient to control blood glucose levels. However, over time, many patients experience β cell dysfunction and require insulin therapy, either alone or in combination with oral agents. There are guidelines available to structure the management of this disease state, including both the use of oral hypoglycaemic agents and or insulin. Besides health complications, there are economic burdens associated with the management of type 2 diabetes mellitus. The aim of this study was to determine the management of type 2 DM in a South African sample group of patients drawn from a large medical aid database. The objectives of the study were: to establish the prevalence of type 2 DM relative to age, examine the nature of chronic comorbid disease states, establish trends in the prescribing of insulin relative to other oral hypoglycaemic agents, investigate cost implications, and determine trends in the use of blood and urine monitoring materials by patients. The study was quantitative and retrospective and descriptive statistics were used in the analysis. DM was found to be most prevalent amongst patients between 50 and 59 years old. Results also demonstrated that 83% of DM patients also suffered from other chronic comorbid diseases, with cardiovascular diseases, especially hypertension and hypercholesterolaemia being the most prominent. This study also revealed that DM is predominantly managed with oral hypoglycaemic agents. Changes in drug prescribing, for chronic disease states such as DM may have medical, social and economic implications both for individual patients and for society and it is envisaged that the results of this study can be used to influence future management of DM. Keywords: Pharmacoepidemiology, management, type 2 diabetes mellitus
- Full Text:
- Date Issued: 2011
- Authors: Saugur, Anusooya
- Date: 2011
- Subjects: Diabetes , Diabetes -- Management , Diabetes -- Diet therapy , Diabetes -- Prevention , Insulin -- Therapeutic use , Hypoglycemia
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10129 , http://hdl.handle.net/10948/1635 , Diabetes , Diabetes -- Management , Diabetes -- Diet therapy , Diabetes -- Prevention , Insulin -- Therapeutic use , Hypoglycemia
- Description: Type 2 diabetes mellitus (DM) is a progressive disease characterised by hyperglycaemia caused by defects in insulin secretion and insulin action. In early stages of type 2 DM, dietary and lifestyle changes are often sufficient to control blood glucose levels. However, over time, many patients experience β cell dysfunction and require insulin therapy, either alone or in combination with oral agents. There are guidelines available to structure the management of this disease state, including both the use of oral hypoglycaemic agents and or insulin. Besides health complications, there are economic burdens associated with the management of type 2 diabetes mellitus. The aim of this study was to determine the management of type 2 DM in a South African sample group of patients drawn from a large medical aid database. The objectives of the study were: to establish the prevalence of type 2 DM relative to age, examine the nature of chronic comorbid disease states, establish trends in the prescribing of insulin relative to other oral hypoglycaemic agents, investigate cost implications, and determine trends in the use of blood and urine monitoring materials by patients. The study was quantitative and retrospective and descriptive statistics were used in the analysis. DM was found to be most prevalent amongst patients between 50 and 59 years old. Results also demonstrated that 83% of DM patients also suffered from other chronic comorbid diseases, with cardiovascular diseases, especially hypertension and hypercholesterolaemia being the most prominent. This study also revealed that DM is predominantly managed with oral hypoglycaemic agents. Changes in drug prescribing, for chronic disease states such as DM may have medical, social and economic implications both for individual patients and for society and it is envisaged that the results of this study can be used to influence future management of DM. Keywords: Pharmacoepidemiology, management, type 2 diabetes mellitus
- Full Text:
- Date Issued: 2011
Traditional, complementary and alternative medicine use in HIV-positive patients
- Authors: Lunat, Imran
- Date: 2011
- Subjects: HIV infections -- Alternative treatment -- South Africa -- Nelson Mandela Metropolitan Municipality
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10137 , http://hdl.handle.net/10948/1388 , HIV infections -- Alternative treatment -- South Africa -- Nelson Mandela Metropolitan Municipality
- Description: The standard anti-retroviral drugs (ARVs) used for the treatment of HIV/AIDS have significant side effects resulting in a lack of adherence and the emergence of multidrug resistant viral strains. These drugs are also expensive, making it essential to investigate all alternatives to classical HIV/AIDS treatment. A wide variety of nonconventional medicines are used by patients for the treatment HIV and for symptoms associated with HIV. So long as they are safe and effective, traditional, complementary and alternative medicines (TCAMs) may be considered more advantageous for developing countries as they are relatively cheap, more accessible and widely accepted by local populations. The aim of this study was to determine the prevalence of TCAM use in HIV-positive patients, prior to, and during ARV therapy. The study was exploratory, cross sectional and observational in nature. Participants were selected via convenience sampling from the Nelson Mandela Bay Municipality, and included 244 HIV-positive patients, 29 health care professionals (HCPs) and 30 traditional, complementary and alternative practitioners (TCAMPs). A wide variety of TCAMs were used by the sample population. These medicines were more commonly used by non-ARV patients (36 percent) compared with ARV patients (22 percent). A significant statistical difference in TCAM use between the ARV and non- ARV population was found in relation to education, employment, period of status awareness, patient opinion of personal health and the reasons for TCAM use. Amongst the HCPs, 24 percent recommended TCAM use prior to ARVs, and 55 percent were aware of patients self-prescribing before and during ARV treatment. Amongst the TCAMPs, 90 percent provided a wide range of TCAMs for HIV, with some giving consideration to conventional management. TCAMs are commonly used by HIV-positive patients on ARVs, as well as by those not on ARVs. These medicines are also the preferred form of treatment for those not seeking conventional treatment. TCAMs are widely available and recommended by TCAMPs as well as some HCPs. Due to public health concerns, clinical trials of the widely used TCAMs are crucial in order to establish the safety and efficacy of these medicines in HIV.
- Full Text:
- Date Issued: 2011
- Authors: Lunat, Imran
- Date: 2011
- Subjects: HIV infections -- Alternative treatment -- South Africa -- Nelson Mandela Metropolitan Municipality
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10137 , http://hdl.handle.net/10948/1388 , HIV infections -- Alternative treatment -- South Africa -- Nelson Mandela Metropolitan Municipality
- Description: The standard anti-retroviral drugs (ARVs) used for the treatment of HIV/AIDS have significant side effects resulting in a lack of adherence and the emergence of multidrug resistant viral strains. These drugs are also expensive, making it essential to investigate all alternatives to classical HIV/AIDS treatment. A wide variety of nonconventional medicines are used by patients for the treatment HIV and for symptoms associated with HIV. So long as they are safe and effective, traditional, complementary and alternative medicines (TCAMs) may be considered more advantageous for developing countries as they are relatively cheap, more accessible and widely accepted by local populations. The aim of this study was to determine the prevalence of TCAM use in HIV-positive patients, prior to, and during ARV therapy. The study was exploratory, cross sectional and observational in nature. Participants were selected via convenience sampling from the Nelson Mandela Bay Municipality, and included 244 HIV-positive patients, 29 health care professionals (HCPs) and 30 traditional, complementary and alternative practitioners (TCAMPs). A wide variety of TCAMs were used by the sample population. These medicines were more commonly used by non-ARV patients (36 percent) compared with ARV patients (22 percent). A significant statistical difference in TCAM use between the ARV and non- ARV population was found in relation to education, employment, period of status awareness, patient opinion of personal health and the reasons for TCAM use. Amongst the HCPs, 24 percent recommended TCAM use prior to ARVs, and 55 percent were aware of patients self-prescribing before and during ARV treatment. Amongst the TCAMPs, 90 percent provided a wide range of TCAMs for HIV, with some giving consideration to conventional management. TCAMs are commonly used by HIV-positive patients on ARVs, as well as by those not on ARVs. These medicines are also the preferred form of treatment for those not seeking conventional treatment. TCAMs are widely available and recommended by TCAMPs as well as some HCPs. Due to public health concerns, clinical trials of the widely used TCAMs are crucial in order to establish the safety and efficacy of these medicines in HIV.
- Full Text:
- Date Issued: 2011