An investigation into the feasibility of incorporating ketoconazole into solid lipid microparticles
- Authors: Jhundoo, Henusha Devi
- Date: 2015
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54701 , vital:26601
- Description: One of the major challenges of the oral administration of ketoconazole (KTZ), an inhibitor of sterol 14α demethylase, used in the management of systemic and topical mycoses in immuno-compromised and paediatric patients is the lack of availability of liquid dosage forms. In order to overcome this challenge, extemporaneous preparations have been manufactured by care-givers and health care providers by crushing or breaking solid oral dosage forms of KTZ and mixing with a vehicle to produce a liquid dosage form that can be swallowed by patients. However, the use of extemporaneous preparations may lead to under or over-dosing if the care-givers are not guided accordingly. Furthermore, the dearth of information on the stability of these KTZ-containing extemporaneous preparations may lead to ineffective antifungal therapy and complicate the problems of resistance as it is difficult to estimate the shelf-lives of these extemporaneous products under varying storage conditions due to the susceptibility of KTZ to chemical degradation. Therefore, there is a need for formulation scientists to develop novel drug delivery systems that avoid the need for extemporaneous preparations, possess well-established limits of stability and minimize the risks of systemic adverse effects to facilitate KTZ therapy. The use of solid lipid microparticles (SLM) as potential carriers for the oral administration of KTZ was investigated since solid lipid carriers are known to exhibit the advantages of traditional colloidal carriers. The research undertaken in these studies aimed to investigate the feasibility of developing and manufacturing solid lipid microparticles (SLM), using a simple micro-emulsion technique, as a carrier for KTZ. Prior to pre-formulation, formulation development and optimization studies of KTZ-loaded SLM, it was necessary to develop and validate an analytical method for the in vitro quantitation and characterization of KTZ in aqueous dispersions of SLM during development and assessment studies. An accurate, precise, specific and sensitive reversed-phase high performance liquid chromatographic (RP-HPLC) method coupled with UV detection at 206 nm was developed, optimized and validated for the analysis of KTZ in formulations. Formulation development studies were preceded by solubility studies of KTZ in different lipids. Labrafil® M2130 CS was found to exhibit the best solubilising potential for KTZ. Pre-formulation studies were also designed to determine the polymorphic behavior and the crystallinity of KTZ and Labrafil® M2130 CS that was used for subsequent manufacture of the solid lipid carriers. DSC and FTIR studies revealed that there were no changes in the crystallinity of KTZ or Labrafil® M2130 CS following exposure to a temperature of 60°C for 1 hour. In addition the potential for physicochemical interaction of KTZ with the lipid Labrafil® M2130 CS was investigated using DSC and FTIR and the results revealed that KTZ was molecularly dispersed in Labrafil® M2130 CS and that it is unlikely that KTZ would interact with the lipid. It was therefore established that KTZ and Labrafil® M2130 CS were thermo-stable at a temperature of 60°C and thus a micro-emulsion technique could be used to manufacture the KTZ-loaded SLM. Drug-free and KTZ-loaded SLM were prepared using a modified micro-emulsion technique that required the use of an Ultra-Turrax® homogenizer set at 24 000 rpm for 5 minutes followed by the use of the Erweka GmbH homogenizer. SLM were characterized in terms of particle size (PS), zeta potential (ZP), shape and surface morphology using scanning electron microscopy (SEM) and transmission electron microscopy (TEM). In addition drug loading capacity (DLC) and encapsulation efficiency (EE) of SLM for KTZ were assessed using RP-HPLC. Formulation development and optimization studies of KTZ-loaded SLM were initially aimed at selecting an emulsifying system that was able to stabilize the SLM in an aqueous dispersion. Successful formulations were selected based on their ability to remain physically stable on the day of manufacture. Pluronic® F68 used in combination with Lutrol® E40, Soluphor® P, Soluplus® produced unstable dispersions on the day of manufacture and these combinations were not investigated further. However, the formulation of a stable KTZ-loaded SLM dispersion was accomplished by use of a combination of Pluronic® F68, Tween 80 and sodium cholate as the surfactant system. Increasing amounts of Labrafil® M2130 CS resulted in the production of particles with low DLC and EE, a large PS and a relatively unchanged ZP. An optimum concentration of 10% w/v Labrafil® M2130 CS was selected to manufacture the KTZ-loaded SLM. Studies to determine the influence of KTZ loading on the quality of SLM revealed that concentrations of KTZ > 5% w/v led to a reduction in DLC and EE and an increase in PS with minimal impact on the ZP. Stability studies conducted at 25°C/65% RH and 40°C/75% RH for up to 30 days following manufacture revealed that batch SLM 15 manufactured using 10% w/v Labrafil® M2130 CS, 5% w/v KTZ and a combination of 4% w/v Pluronic® F-68, 2% w/v Tween 80 and 1% w/v sodium cholate produced the most stable dosage form when stored at 25°C/65% RH for up to 30 days. However, storage at 40°C/75% RH resulted in instability of the formulation. An aqueous dispersion of KTZ-loaded SLM has been developed and assessed and may offer an alternative to extemporaneous preparations used for KTZ therapy in paediatric and immuno-compromised patients.
- Full Text:
- Date Issued: 2015
- Authors: Jhundoo, Henusha Devi
- Date: 2015
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54701 , vital:26601
- Description: One of the major challenges of the oral administration of ketoconazole (KTZ), an inhibitor of sterol 14α demethylase, used in the management of systemic and topical mycoses in immuno-compromised and paediatric patients is the lack of availability of liquid dosage forms. In order to overcome this challenge, extemporaneous preparations have been manufactured by care-givers and health care providers by crushing or breaking solid oral dosage forms of KTZ and mixing with a vehicle to produce a liquid dosage form that can be swallowed by patients. However, the use of extemporaneous preparations may lead to under or over-dosing if the care-givers are not guided accordingly. Furthermore, the dearth of information on the stability of these KTZ-containing extemporaneous preparations may lead to ineffective antifungal therapy and complicate the problems of resistance as it is difficult to estimate the shelf-lives of these extemporaneous products under varying storage conditions due to the susceptibility of KTZ to chemical degradation. Therefore, there is a need for formulation scientists to develop novel drug delivery systems that avoid the need for extemporaneous preparations, possess well-established limits of stability and minimize the risks of systemic adverse effects to facilitate KTZ therapy. The use of solid lipid microparticles (SLM) as potential carriers for the oral administration of KTZ was investigated since solid lipid carriers are known to exhibit the advantages of traditional colloidal carriers. The research undertaken in these studies aimed to investigate the feasibility of developing and manufacturing solid lipid microparticles (SLM), using a simple micro-emulsion technique, as a carrier for KTZ. Prior to pre-formulation, formulation development and optimization studies of KTZ-loaded SLM, it was necessary to develop and validate an analytical method for the in vitro quantitation and characterization of KTZ in aqueous dispersions of SLM during development and assessment studies. An accurate, precise, specific and sensitive reversed-phase high performance liquid chromatographic (RP-HPLC) method coupled with UV detection at 206 nm was developed, optimized and validated for the analysis of KTZ in formulations. Formulation development studies were preceded by solubility studies of KTZ in different lipids. Labrafil® M2130 CS was found to exhibit the best solubilising potential for KTZ. Pre-formulation studies were also designed to determine the polymorphic behavior and the crystallinity of KTZ and Labrafil® M2130 CS that was used for subsequent manufacture of the solid lipid carriers. DSC and FTIR studies revealed that there were no changes in the crystallinity of KTZ or Labrafil® M2130 CS following exposure to a temperature of 60°C for 1 hour. In addition the potential for physicochemical interaction of KTZ with the lipid Labrafil® M2130 CS was investigated using DSC and FTIR and the results revealed that KTZ was molecularly dispersed in Labrafil® M2130 CS and that it is unlikely that KTZ would interact with the lipid. It was therefore established that KTZ and Labrafil® M2130 CS were thermo-stable at a temperature of 60°C and thus a micro-emulsion technique could be used to manufacture the KTZ-loaded SLM. Drug-free and KTZ-loaded SLM were prepared using a modified micro-emulsion technique that required the use of an Ultra-Turrax® homogenizer set at 24 000 rpm for 5 minutes followed by the use of the Erweka GmbH homogenizer. SLM were characterized in terms of particle size (PS), zeta potential (ZP), shape and surface morphology using scanning electron microscopy (SEM) and transmission electron microscopy (TEM). In addition drug loading capacity (DLC) and encapsulation efficiency (EE) of SLM for KTZ were assessed using RP-HPLC. Formulation development and optimization studies of KTZ-loaded SLM were initially aimed at selecting an emulsifying system that was able to stabilize the SLM in an aqueous dispersion. Successful formulations were selected based on their ability to remain physically stable on the day of manufacture. Pluronic® F68 used in combination with Lutrol® E40, Soluphor® P, Soluplus® produced unstable dispersions on the day of manufacture and these combinations were not investigated further. However, the formulation of a stable KTZ-loaded SLM dispersion was accomplished by use of a combination of Pluronic® F68, Tween 80 and sodium cholate as the surfactant system. Increasing amounts of Labrafil® M2130 CS resulted in the production of particles with low DLC and EE, a large PS and a relatively unchanged ZP. An optimum concentration of 10% w/v Labrafil® M2130 CS was selected to manufacture the KTZ-loaded SLM. Studies to determine the influence of KTZ loading on the quality of SLM revealed that concentrations of KTZ > 5% w/v led to a reduction in DLC and EE and an increase in PS with minimal impact on the ZP. Stability studies conducted at 25°C/65% RH and 40°C/75% RH for up to 30 days following manufacture revealed that batch SLM 15 manufactured using 10% w/v Labrafil® M2130 CS, 5% w/v KTZ and a combination of 4% w/v Pluronic® F-68, 2% w/v Tween 80 and 1% w/v sodium cholate produced the most stable dosage form when stored at 25°C/65% RH for up to 30 days. However, storage at 40°C/75% RH resulted in instability of the formulation. An aqueous dispersion of KTZ-loaded SLM has been developed and assessed and may offer an alternative to extemporaneous preparations used for KTZ therapy in paediatric and immuno-compromised patients.
- Full Text:
- Date Issued: 2015
Antibiotic stewardship: the role of clinical pharmacist
- Authors: Ramkhalawon, Shabeerah
- Date: 2015
- Subjects: Hospital pharmacies -- South Africa Pharmacists -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/10858 , vital:26830
- Description: South Africa has a high prevalence of infectious diseases; the major ones being the Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome epidemic, and tuberculosis. South Africa’s burden of resistant bacteria is also increasing. Antibiotic resistance in hospitalised patients leads to an increase in morbidity and mortality, resulting in longer hospital stays, and an increase in hospital costs. In order to counteract the problem of antibiotic resistance in hospitals and other healthcare facilities and preserve the efficacy of currently available antibiotics, there is a need for serious antibiotic management. Antibiotic stewardship initiatives have thus been put in place to guide healthcare professionals on the correct use of antibiotics. Clinical pharmacists can intervene and contribute to antibiotic stewardship owing to comprehensive knowledge of antibiotics, including the properties, uses, safety and efficacy of individual agents. There is a paucity of research to support the role of the clinical pharmacist in antibiotic stewardship in public sector hospitals. The current pharmacist staffing system within public sector hospitals does not adequately support pharmacists, in particular clinical pharmacists, to participate actively in antibiotic stewardship. The primary aim of the study was to evaluate the role of the clinical pharmacist in antibiotic stewardship in a public hospital setting. A secondary aim was to contribute towards more rational inpatient use of antibiotics in the general medical ward. The hypothesis for the study was that clinical pharmacists can make a positive contribution to the correct use of antibiotics in a public hospital setting. The study showed that the introduction of a pharmacist-driven antibiotic stewardship in the ward, using a prospective audit and feedback strategy, had a positive effect on overall appropriateness of antibiotic prescribing (Chi2=7.89; df=3; p=0.04815, Cramer’s V=0.13). However, this finding did not show any reduction in the volume of antibiotic use. Positive patient outcomes were achieved and shown through a reduction in the length of hospital stay (p=0.00487; one-way ANOVA). Although patients were not followed up on discharge to assess re-admission rates, the results are relevant in order to inform the hospital staff about the implementation of antibiotic stewardship at the public hospital setting with the aims of reducing inappropriate antibiotic prescribing and improving patient outcomes. From the results of the study, it can be concluded that the hypothesis was achieved and that the clinical pharmacist did play an integral role in antibiotic prescribing at the public hospital setting. Thus, it can be concluded that the study, though limited in its scope, achieved its aims and objectives, and showed that the clinical pharmacist does play an integral role in the rational use of antibiotics in a public hospital setting.
- Full Text:
- Date Issued: 2015
- Authors: Ramkhalawon, Shabeerah
- Date: 2015
- Subjects: Hospital pharmacies -- South Africa Pharmacists -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/10858 , vital:26830
- Description: South Africa has a high prevalence of infectious diseases; the major ones being the Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome epidemic, and tuberculosis. South Africa’s burden of resistant bacteria is also increasing. Antibiotic resistance in hospitalised patients leads to an increase in morbidity and mortality, resulting in longer hospital stays, and an increase in hospital costs. In order to counteract the problem of antibiotic resistance in hospitals and other healthcare facilities and preserve the efficacy of currently available antibiotics, there is a need for serious antibiotic management. Antibiotic stewardship initiatives have thus been put in place to guide healthcare professionals on the correct use of antibiotics. Clinical pharmacists can intervene and contribute to antibiotic stewardship owing to comprehensive knowledge of antibiotics, including the properties, uses, safety and efficacy of individual agents. There is a paucity of research to support the role of the clinical pharmacist in antibiotic stewardship in public sector hospitals. The current pharmacist staffing system within public sector hospitals does not adequately support pharmacists, in particular clinical pharmacists, to participate actively in antibiotic stewardship. The primary aim of the study was to evaluate the role of the clinical pharmacist in antibiotic stewardship in a public hospital setting. A secondary aim was to contribute towards more rational inpatient use of antibiotics in the general medical ward. The hypothesis for the study was that clinical pharmacists can make a positive contribution to the correct use of antibiotics in a public hospital setting. The study showed that the introduction of a pharmacist-driven antibiotic stewardship in the ward, using a prospective audit and feedback strategy, had a positive effect on overall appropriateness of antibiotic prescribing (Chi2=7.89; df=3; p=0.04815, Cramer’s V=0.13). However, this finding did not show any reduction in the volume of antibiotic use. Positive patient outcomes were achieved and shown through a reduction in the length of hospital stay (p=0.00487; one-way ANOVA). Although patients were not followed up on discharge to assess re-admission rates, the results are relevant in order to inform the hospital staff about the implementation of antibiotic stewardship at the public hospital setting with the aims of reducing inappropriate antibiotic prescribing and improving patient outcomes. From the results of the study, it can be concluded that the hypothesis was achieved and that the clinical pharmacist did play an integral role in antibiotic prescribing at the public hospital setting. Thus, it can be concluded that the study, though limited in its scope, achieved its aims and objectives, and showed that the clinical pharmacist does play an integral role in the rational use of antibiotics in a public hospital setting.
- Full Text:
- Date Issued: 2015
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
Formulation, development and assessment of tenofovir disoproxil fumarate-loaded pellets
- Authors: Dube, Tawanda
- Date: 2015
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54690 , vital:26600
- Description: Tenofovir disoproxil fumarate (TDF) is a novel nucleotide analog reverse transcriptase inhibitor that is recommended by the WHO for use in first line treatment of HIV infections. Due to the high dose of TDF for anti-retroviral treatment the formulation of a pellet dosage form may improve patient adherence by incorporation of a large dose in a relatively small dosage form. TDF is currently only available in tablet form. A simple, sensitive, selective, rapid, accurate, precise, stability indicating reversed-phase HPLC method was developed and validated in accordance with ICH guidelines and was successfully used for the analysis of TDF raw material and pharmaceutical dosage forms. Preformulation studies included an investigation of TDF-excipient and excipient-excipient interactions with all materials that could potentially be used to produce extruded and spheronized pellets. Nuclear Magnetic Resonance spectroscopy (NMR), Infrared Spectroscopy (IR), Differential Scanning Colorimetry (DSC) and Thermogravimetric analysis were used for identification and purity testing of TDF and all excipients. DSC data revealed that no potential interactions between TDF and the excipients occurred suggesting that incompatibility reactions were unlikely during manufacture and storage. These findings were confirmed by IR analysis that revealed that no physical interaction was likely between any of the excipients used and TDF. DSC data also reveal the existence of the α and β-polymorphs of TDF as evidenced by two enthalpy changes observed on the resultant thermograms. The existence of two polymorphs is unlikely to result in incompatibility and was confirmed by IR analysis. The IR spectra reveal that all characteristic peaks for TDF were present in 1:1 binary mixtures. Therefore TDF is compatible with all excipients tested and thermal analysis confirmed the stability of TDF under manufacturing conditions. The temperature of degradation temperature established through DSC analysis confirmed that degradation during manufacture is unlikely as the temperature of manufacture is lower than that at which degradation occurs. Extrusion and spheronization were the processes used to manufacture TDF pellets as it is a simple and economic approach for production. The effects of extruder and spheronizer speed, amount of spheronization aid and diluents on the pellet size, shape, flow properties and TDF release characteristics were examined. In order to decrease the complexity of analysis and reduce the cost of development a Taguchi orthogonal array design of experiments was successfully applied to evaluate the impact of formulation variables on product characteristics and predict an optimized formulation with a minimum number of experiments. The use of Response Surface Methodology for the development and optimization of pharmaceutical systems, including the optimization of formulation composition, manufacturing processes and/or analytical methods is well established. However the application of RSM requires that accurate, precise and reproducible experimental conditions are used for the generation of reliable data and RSM use is limited due to sensitivity to experimental variability. The benefits of using RSM for formulation optimization include the fact that more than one variable can be investigated at a time and large amounts of information can be generated at the same time ensuring a more efficient process with respect to time and cost. An added advantage of this approach is that mathematical relationships can be generated for the models that are produced and provide formulation scientists with an indication of whether the effect(s) between factors are synergistic or antagonistic. There are several statistical design approaches that use RSM and a Taguchi orthogonal array design was selected for use in this optimization process as fewer experiments are required to generate data for the same number of factors to be investigated when compared to other statistical designs such as Central Composite (CCD) and Box-Behnken designs. The use of RSM clearly demonstrates the impact of different input variables on the % TDF released at 45 min and % TDF loaded into the particles. The amount of sorbitol and Kollidon® CL-M were the only significant variables that affected the % TDF released at 45 min and both excipients had an overall synergistic effect on the in vitro release of TDF. The prediction and manufacture of an optimized formulation led to the production of pellets that met predetermined specifications which was successfully achieved using RSM. The development of a TDF containing pellet dosage form has been achieved and the formulation, manufacture and characterization of the dosage form reveal that the product has the potential to be further developed.
- Full Text:
- Date Issued: 2015
- Authors: Dube, Tawanda
- Date: 2015
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54690 , vital:26600
- Description: Tenofovir disoproxil fumarate (TDF) is a novel nucleotide analog reverse transcriptase inhibitor that is recommended by the WHO for use in first line treatment of HIV infections. Due to the high dose of TDF for anti-retroviral treatment the formulation of a pellet dosage form may improve patient adherence by incorporation of a large dose in a relatively small dosage form. TDF is currently only available in tablet form. A simple, sensitive, selective, rapid, accurate, precise, stability indicating reversed-phase HPLC method was developed and validated in accordance with ICH guidelines and was successfully used for the analysis of TDF raw material and pharmaceutical dosage forms. Preformulation studies included an investigation of TDF-excipient and excipient-excipient interactions with all materials that could potentially be used to produce extruded and spheronized pellets. Nuclear Magnetic Resonance spectroscopy (NMR), Infrared Spectroscopy (IR), Differential Scanning Colorimetry (DSC) and Thermogravimetric analysis were used for identification and purity testing of TDF and all excipients. DSC data revealed that no potential interactions between TDF and the excipients occurred suggesting that incompatibility reactions were unlikely during manufacture and storage. These findings were confirmed by IR analysis that revealed that no physical interaction was likely between any of the excipients used and TDF. DSC data also reveal the existence of the α and β-polymorphs of TDF as evidenced by two enthalpy changes observed on the resultant thermograms. The existence of two polymorphs is unlikely to result in incompatibility and was confirmed by IR analysis. The IR spectra reveal that all characteristic peaks for TDF were present in 1:1 binary mixtures. Therefore TDF is compatible with all excipients tested and thermal analysis confirmed the stability of TDF under manufacturing conditions. The temperature of degradation temperature established through DSC analysis confirmed that degradation during manufacture is unlikely as the temperature of manufacture is lower than that at which degradation occurs. Extrusion and spheronization were the processes used to manufacture TDF pellets as it is a simple and economic approach for production. The effects of extruder and spheronizer speed, amount of spheronization aid and diluents on the pellet size, shape, flow properties and TDF release characteristics were examined. In order to decrease the complexity of analysis and reduce the cost of development a Taguchi orthogonal array design of experiments was successfully applied to evaluate the impact of formulation variables on product characteristics and predict an optimized formulation with a minimum number of experiments. The use of Response Surface Methodology for the development and optimization of pharmaceutical systems, including the optimization of formulation composition, manufacturing processes and/or analytical methods is well established. However the application of RSM requires that accurate, precise and reproducible experimental conditions are used for the generation of reliable data and RSM use is limited due to sensitivity to experimental variability. The benefits of using RSM for formulation optimization include the fact that more than one variable can be investigated at a time and large amounts of information can be generated at the same time ensuring a more efficient process with respect to time and cost. An added advantage of this approach is that mathematical relationships can be generated for the models that are produced and provide formulation scientists with an indication of whether the effect(s) between factors are synergistic or antagonistic. There are several statistical design approaches that use RSM and a Taguchi orthogonal array design was selected for use in this optimization process as fewer experiments are required to generate data for the same number of factors to be investigated when compared to other statistical designs such as Central Composite (CCD) and Box-Behnken designs. The use of RSM clearly demonstrates the impact of different input variables on the % TDF released at 45 min and % TDF loaded into the particles. The amount of sorbitol and Kollidon® CL-M were the only significant variables that affected the % TDF released at 45 min and both excipients had an overall synergistic effect on the in vitro release of TDF. The prediction and manufacture of an optimized formulation led to the production of pellets that met predetermined specifications which was successfully achieved using RSM. The development of a TDF containing pellet dosage form has been achieved and the formulation, manufacture and characterization of the dosage form reveal that the product has the potential to be further developed.
- Full Text:
- Date Issued: 2015
The impact of a ward pharmacist in a surgical ward of a private hospital in the Eastern Cape
- Stone, Leanne Nicole, Burton, S F
- Authors: Stone, Leanne Nicole , Burton, S F
- Date: 2015
- Subjects: Hospital pharmacies , Pharmaceutical services -- South Africa -- Eastern Cape , Pharmacists -- South Africa -- Eastern Cape
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/5916 , vital:21012
- Description: Medication errors are becoming problematic in both hospital and outpatient settings worldwide. Inappropriate use of medication can cause harm to the patient and maintaining high levels of quality patient care is essential to protect all patients. Clinical pharmacy practice contributes to improved patient care by optimising medication therapy; and promoting health, wellness and disease prevention. The involvement of a pharmacist at a ward level has been shown to improve patient care; reduce mortality and morbidity rates; decrease healthcare costs; minimise medication errors; and improve outcomes of drug therapy. However, clinical pharmacy is a fairly new practice in South Africa and there are limited studies available. This study aimed to evaluate the perceived benefits of a ward-based pharmacist on the provision of pharmaceutical care to patients in a hospital setting and to consequently implement a ward-based pharmacy service. The objectives of the study were: (1) to assess, via a questionnaire, the perceptions and attitudes of medical practitioners and nurses to ward-based pharmacy prior to and after implementation of a ward-based pharmacy service, (2) to implement a ward-based pharmacy service in a selected hospital ward; (3) to document and analyse the nature of the work and activities that a ward pharmacist undertakes, and (4) to document and analyse the frequency and nature of ward pharmacist interventions. The study was conducted in a surgical ward of a private hospital in the Eastern Cape. The study design was an intervention study, using a mixed-methods design, with a convergent approach. A convenience sample of 106 patients was obtained over the eight week study period. Participation was voluntary and confidentiality was maintained at all times. Four data collection tools were used during the study and a pilot study was conducted to ensure their validity and reliability. The quantitative data was analysed statistically while the qualitative questions were analysed through coding the various responses. The results of the study showed that medical practitioners and nurses of a surgical ward had a positive attitude towards ward pharmacy both prior to and after the implementation of a ward pharmacy service. There were ward pharmacist interventions made in 50% (n=106) of the patients who participated in the study. A large percentage (57%; 50; n=87) of the ward pharmacist interventions were pharmacist-initiated interventions to optimise patient care while prescribing errors (51%; 19; n=37) were the most commonly occurring medication error. The majority of the medication items involved in the interventions (34%; 34; n=101) were related to the anti-microbial medication class. Overall, there was a 73% (36; n=49) acceptance rate of the ward pharmacist interventions that were made to both the medical practitioners and nurses. There were a number of factors that had a significant relationship with a ward pharmacist intervention being required which included: (1) number of medication items (p=0.001; Chi² test; p<0.0005 Student’s t-test), (2) length of hospital stay (p<0.0005; Chi² test), (3) presence of one or more chronic disease states (p=0.003; Chi² test) and (4) presence of one or more allergies (p=0.028; Chi² test). The ward pharmacist interventions were shown to be of clinical significance and to have a positive impact on the patients concerned. It can be concluded that the ward pharmacy service was beneficial to the patients, medical practitioners and nursing staff.
- Full Text:
- Date Issued: 2015
- Authors: Stone, Leanne Nicole , Burton, S F
- Date: 2015
- Subjects: Hospital pharmacies , Pharmaceutical services -- South Africa -- Eastern Cape , Pharmacists -- South Africa -- Eastern Cape
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/5916 , vital:21012
- Description: Medication errors are becoming problematic in both hospital and outpatient settings worldwide. Inappropriate use of medication can cause harm to the patient and maintaining high levels of quality patient care is essential to protect all patients. Clinical pharmacy practice contributes to improved patient care by optimising medication therapy; and promoting health, wellness and disease prevention. The involvement of a pharmacist at a ward level has been shown to improve patient care; reduce mortality and morbidity rates; decrease healthcare costs; minimise medication errors; and improve outcomes of drug therapy. However, clinical pharmacy is a fairly new practice in South Africa and there are limited studies available. This study aimed to evaluate the perceived benefits of a ward-based pharmacist on the provision of pharmaceutical care to patients in a hospital setting and to consequently implement a ward-based pharmacy service. The objectives of the study were: (1) to assess, via a questionnaire, the perceptions and attitudes of medical practitioners and nurses to ward-based pharmacy prior to and after implementation of a ward-based pharmacy service, (2) to implement a ward-based pharmacy service in a selected hospital ward; (3) to document and analyse the nature of the work and activities that a ward pharmacist undertakes, and (4) to document and analyse the frequency and nature of ward pharmacist interventions. The study was conducted in a surgical ward of a private hospital in the Eastern Cape. The study design was an intervention study, using a mixed-methods design, with a convergent approach. A convenience sample of 106 patients was obtained over the eight week study period. Participation was voluntary and confidentiality was maintained at all times. Four data collection tools were used during the study and a pilot study was conducted to ensure their validity and reliability. The quantitative data was analysed statistically while the qualitative questions were analysed through coding the various responses. The results of the study showed that medical practitioners and nurses of a surgical ward had a positive attitude towards ward pharmacy both prior to and after the implementation of a ward pharmacy service. There were ward pharmacist interventions made in 50% (n=106) of the patients who participated in the study. A large percentage (57%; 50; n=87) of the ward pharmacist interventions were pharmacist-initiated interventions to optimise patient care while prescribing errors (51%; 19; n=37) were the most commonly occurring medication error. The majority of the medication items involved in the interventions (34%; 34; n=101) were related to the anti-microbial medication class. Overall, there was a 73% (36; n=49) acceptance rate of the ward pharmacist interventions that were made to both the medical practitioners and nurses. There were a number of factors that had a significant relationship with a ward pharmacist intervention being required which included: (1) number of medication items (p=0.001; Chi² test; p<0.0005 Student’s t-test), (2) length of hospital stay (p<0.0005; Chi² test), (3) presence of one or more chronic disease states (p=0.003; Chi² test) and (4) presence of one or more allergies (p=0.028; Chi² test). The ward pharmacist interventions were shown to be of clinical significance and to have a positive impact on the patients concerned. It can be concluded that the ward pharmacy service was beneficial to the patients, medical practitioners and nursing staff.
- Full Text:
- Date Issued: 2015
The quantification of fucoxanthin from selected South African marine brown algae (Phaeophyta) using HPLC-UV/Vis
- Authors: Mubaiwa, Byron Tawanda
- Date: 2015
- Subjects: Marine algae , Brown algae , High performance liquid chromatography , Functional foods , Xanthophylls , Carotenoids , Extraction (Chemistry)
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3868 , http://hdl.handle.net/10962/d1017879
- Description: Marine brown algae (seaweeds) are a rich source of fucoxanthin, a xanthophyll carotenoid that is naturally, an accessory pigment in the process of photosynthesis of sea vegetation such as Sargassum incisifolium. Fucoxanthin has been exploited by nutraceutical companies for its anti-obesity effects that has resulted in an increase of seaweed slimming preparations such as FucoThin™. The field is getting widespread consumer attention as interest in fucoxanthin has also transcended to its widespread biological potential which include cytotoxicity, anti-diabetic, anti-oxidant, anti-inflammatory and anti-plasmodium effects. We therefore wanted to identify a reliable source(s) of fucoxanthin from diverse samples of South African marine brown algae in order to explore our medicinal chemistry interests around the cytotoxicity and anti-malarial potential of fucoxanthin. A known source, Sargassum incisifolium, was used to isolate (maceration in CH₂Cl₂/MeOH at 35 °C followed by a hexane/EtOAc step gradient silica column of the crude extract and reversed phase semi-prep HPLC) and characterize (1D and 2D NMR) fucoxanthin (reference standard) in order to develop an analytical method for its determination in selected diverse brown algae commonly found in South Africa. The HPLC [Column: Phenomenex® Synergi™ (250 x 3.0 mm i.d); Mobile phase: ACN/H2O (95:5)] method developed for this analysis was validated according the guidelines set by the International Conference on Harmonization (ICH). Fifteen species were then assessed for fucoxanthin content (μg/g of dried weight) using the developed method. Stability studies on fucoxanthin were also carried out to assess photo- and pH degradation of fucoxanthin. Zonaria subarticulata (KOS130226-18) from Kenton-On-Sea beach and Sargassum incisifolium (PA130427-1) from Port Alfred beach were found to be the highest producers of fucoxanthin with 0.50 mg/g and 0.45 mg/g dried weight respectively. Fucoxanthin was found to be both photo-labile and sensitive to both acidic and basic pH environments. However, the pigment was more photostable in pure as opposed to extract form and also showed to be more stable at pH 10.0. Our findings show that Z. subarticulata and S. incisifolium could be reliable sources of fucoxanthin and can be considered as the algae to use in optimized extraction procedures in further studies. Also, when working with fucoxanthin, it is important to protect it from light. Any consideration of taking fucoxanthin preparation orally (as a nutraceutical) should consider protecting the active from the harsh conditions of the gastrointestinal tract. Any upscale production of fucoxanthin from seaweed should consider variations such as geographical, seasonal, lifecycle stage, etc. of identified algae as these may be important factors in obtaining effective concentrations of fucoxanthin.
- Full Text:
- Date Issued: 2015
- Authors: Mubaiwa, Byron Tawanda
- Date: 2015
- Subjects: Marine algae , Brown algae , High performance liquid chromatography , Functional foods , Xanthophylls , Carotenoids , Extraction (Chemistry)
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3868 , http://hdl.handle.net/10962/d1017879
- Description: Marine brown algae (seaweeds) are a rich source of fucoxanthin, a xanthophyll carotenoid that is naturally, an accessory pigment in the process of photosynthesis of sea vegetation such as Sargassum incisifolium. Fucoxanthin has been exploited by nutraceutical companies for its anti-obesity effects that has resulted in an increase of seaweed slimming preparations such as FucoThin™. The field is getting widespread consumer attention as interest in fucoxanthin has also transcended to its widespread biological potential which include cytotoxicity, anti-diabetic, anti-oxidant, anti-inflammatory and anti-plasmodium effects. We therefore wanted to identify a reliable source(s) of fucoxanthin from diverse samples of South African marine brown algae in order to explore our medicinal chemistry interests around the cytotoxicity and anti-malarial potential of fucoxanthin. A known source, Sargassum incisifolium, was used to isolate (maceration in CH₂Cl₂/MeOH at 35 °C followed by a hexane/EtOAc step gradient silica column of the crude extract and reversed phase semi-prep HPLC) and characterize (1D and 2D NMR) fucoxanthin (reference standard) in order to develop an analytical method for its determination in selected diverse brown algae commonly found in South Africa. The HPLC [Column: Phenomenex® Synergi™ (250 x 3.0 mm i.d); Mobile phase: ACN/H2O (95:5)] method developed for this analysis was validated according the guidelines set by the International Conference on Harmonization (ICH). Fifteen species were then assessed for fucoxanthin content (μg/g of dried weight) using the developed method. Stability studies on fucoxanthin were also carried out to assess photo- and pH degradation of fucoxanthin. Zonaria subarticulata (KOS130226-18) from Kenton-On-Sea beach and Sargassum incisifolium (PA130427-1) from Port Alfred beach were found to be the highest producers of fucoxanthin with 0.50 mg/g and 0.45 mg/g dried weight respectively. Fucoxanthin was found to be both photo-labile and sensitive to both acidic and basic pH environments. However, the pigment was more photostable in pure as opposed to extract form and also showed to be more stable at pH 10.0. Our findings show that Z. subarticulata and S. incisifolium could be reliable sources of fucoxanthin and can be considered as the algae to use in optimized extraction procedures in further studies. Also, when working with fucoxanthin, it is important to protect it from light. Any consideration of taking fucoxanthin preparation orally (as a nutraceutical) should consider protecting the active from the harsh conditions of the gastrointestinal tract. Any upscale production of fucoxanthin from seaweed should consider variations such as geographical, seasonal, lifecycle stage, etc. of identified algae as these may be important factors in obtaining effective concentrations of fucoxanthin.
- Full Text:
- Date Issued: 2015
Validity and accuracy of self-reported drug allergies
- Authors: Grant, Elzaan
- Date: 2015
- Subjects: Drug allergy , Medical history taking
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/3295 , vital:20421
- Description: Purpose: Pharmacists must ensure the safe and effective use of medication, but often have only the documented patient history to guide assessment of therapy. There is a lack of information on the incidence of claimed drug allergies or the validity of these self-reported drug allergies in the South African population. Mislabelling of patients as being allergic to medication often deprives them of important therapeutic drugs and alternative agents may be more dangerous, less effective and more costly (Hung et al., 1994). The aim of the research was therefore to determine the incidence of drug allergies in patients admitted to a private hospital and to assess the validity of these self-reported drug allergies. Methods: A descriptive, non-experimental study design was used. Data was collected using a concurrent, cross-sectional approach and collected from patients admitted to hospital using Medical Chart Reviews and researcher-led, questionnaire based interviews. During the seven month sampling period, 693 patients were identified with one or more self-reported drug allergies. A subset of 99 patients (14.2%) consented to a researcher-led interview. The allergies were assigned to one of three groups based on the history: (i) High probability: signs and symptoms typical of an immunological reaction. (ii) Low probability: signs and symptoms of the reaction were predictable reactions or side effects of the drug. (iii) Unknown status: no information concerning the reaction history was available. Results: A total of 953 allergies were identified in the 693 patients, with a ratio of drug allergy to patient of 1.4:1. The majority of claimed allergies were to penicillin (39.2%), opioid analgesics (17.6%), other antimicrobials, including co-trimoxazole (13.5%), NSAIDs (9.9%) and unspecified “sulphur” allergy (8.7%). Descriptions of the “allergic” reactions were only recorded on 8.9% (62, n=693) of the reviewed charts. Only 56.5% (35, n=62) of the symptoms recorded as “allergy” were indicative of the event being allergic or immunological in nature. In total, 1.3% (9, n=693) of the patients with a self-reported allergy received the allergen while in hospital. In three cases this was the result of a pharmacist overlooking the recorded allergy, and dispensing the allergen to the patient. A total of 118 allergies were identified in the 99 interviewed patients, with a ratio of drug allergy to patient of 1.2:1. Inaccurate allergy history was found in 9.1% (9, n=99) of the interviewed patients. Overall, the majority of self-reported drug allergies (67.8%) had a “high probability” of being a true drug allergy. Allergies that were assigned into the high probability group were: penicillin (74.1%), co-trimoxazole (91.7%), NSAID‟s (55.6%) and 75.0% of opioids. Conclusion: In summary, the validity of self-reported drug allergies need to be determined before excluding medication from a patient‟s treatment options. Detailed descriptions can assist in the evaluation of self-reported allergies which would be advantageous to both prescribers and patients. Pharmacists need to play a bigger role in ensuring accurate documentation of drug allergy history, with detailed descriptions, in order to ensure safe and effective drug use within the hospital environment.
- Full Text:
- Date Issued: 2015
- Authors: Grant, Elzaan
- Date: 2015
- Subjects: Drug allergy , Medical history taking
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/3295 , vital:20421
- Description: Purpose: Pharmacists must ensure the safe and effective use of medication, but often have only the documented patient history to guide assessment of therapy. There is a lack of information on the incidence of claimed drug allergies or the validity of these self-reported drug allergies in the South African population. Mislabelling of patients as being allergic to medication often deprives them of important therapeutic drugs and alternative agents may be more dangerous, less effective and more costly (Hung et al., 1994). The aim of the research was therefore to determine the incidence of drug allergies in patients admitted to a private hospital and to assess the validity of these self-reported drug allergies. Methods: A descriptive, non-experimental study design was used. Data was collected using a concurrent, cross-sectional approach and collected from patients admitted to hospital using Medical Chart Reviews and researcher-led, questionnaire based interviews. During the seven month sampling period, 693 patients were identified with one or more self-reported drug allergies. A subset of 99 patients (14.2%) consented to a researcher-led interview. The allergies were assigned to one of three groups based on the history: (i) High probability: signs and symptoms typical of an immunological reaction. (ii) Low probability: signs and symptoms of the reaction were predictable reactions or side effects of the drug. (iii) Unknown status: no information concerning the reaction history was available. Results: A total of 953 allergies were identified in the 693 patients, with a ratio of drug allergy to patient of 1.4:1. The majority of claimed allergies were to penicillin (39.2%), opioid analgesics (17.6%), other antimicrobials, including co-trimoxazole (13.5%), NSAIDs (9.9%) and unspecified “sulphur” allergy (8.7%). Descriptions of the “allergic” reactions were only recorded on 8.9% (62, n=693) of the reviewed charts. Only 56.5% (35, n=62) of the symptoms recorded as “allergy” were indicative of the event being allergic or immunological in nature. In total, 1.3% (9, n=693) of the patients with a self-reported allergy received the allergen while in hospital. In three cases this was the result of a pharmacist overlooking the recorded allergy, and dispensing the allergen to the patient. A total of 118 allergies were identified in the 99 interviewed patients, with a ratio of drug allergy to patient of 1.2:1. Inaccurate allergy history was found in 9.1% (9, n=99) of the interviewed patients. Overall, the majority of self-reported drug allergies (67.8%) had a “high probability” of being a true drug allergy. Allergies that were assigned into the high probability group were: penicillin (74.1%), co-trimoxazole (91.7%), NSAID‟s (55.6%) and 75.0% of opioids. Conclusion: In summary, the validity of self-reported drug allergies need to be determined before excluding medication from a patient‟s treatment options. Detailed descriptions can assist in the evaluation of self-reported allergies which would be advantageous to both prescribers and patients. Pharmacists need to play a bigger role in ensuring accurate documentation of drug allergy history, with detailed descriptions, in order to ensure safe and effective drug use within the hospital environment.
- Full Text:
- Date Issued: 2015
Adolescent pregnancy: a community engaged participatory approach to design and implement an educational intervention
- Authors: Siruma, Amanda Tatenda
- Date: 2014
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54656 , vital:26597
- Description: Millennium Development Goal (MDG) 5 focuses on improving maternal health, due to global acknowledgment that no woman should have to die as a result of complications during pregnancy and childbirth. Adolescents have an increased risk of maternal death compared with older women. Adolescent pregnancy also poses a threat to the empowerment of young girls by mitigating their physical, educational, social, and economic development. In this context, maternal health promotion strategies which inclusively target adolescents are crucial, not only in improving maternal health outcomes, but also in optimising the overall transition of adolescent girls to adulthood. This study was a first time collaborative partnership of the Faculty of Pharmacy and Community Engagement Office of Rhodes University with the Angus Gillis Foundation (a non-profit community development organisation), and community participants of Glenmore and Ndwayana, two rural communities in the Eastern Cape. The aim of this study was to identify the maternal health issue of most concern to community participants and to design and implement an appropriate educational intervention for a suitable target group. During the baseline phase of this study, ten focus group discussions (FGDs) were conducted with 76 community stakeholders. Semi-structured interviews (SSIs) were conducted with two Sisters-in-Charge from each Primary Health Care (PHC) facility in the study setting. Data on the stock status of World Health Organization (WHO) identified lifesaving priority medicines for women’s health was also collected at both PHCs. Thereafter, pre- and posteducational interventions SSIs with female adolescent participants were conducted. The educational intervention was followed up with the development of a booklet on reproductive health. FGD participants identified adolescent pregnancy as the maternal health issue of most concern. They also highlighted challenges in service delivery of ambulance services for expectant mothers in urgent need of transportation to a referral hospital. A majority of preintervention SSI participants indicated coercion from both younger and older men as a factor influencing early sexual debut amongst adolescent girls in their communities. Despite availability in the PHCs, challenges in accessing contraceptives were highlighted by the participants. Additionally, a number of sexually active adolescent girls defaulted on their next allocated visit to the PHC due to myths regarding use of oral and injectable contraceptives. During the educational intervention sessions, participants recognised knowledge gaps regarding reproductive health issues and the influence of peer pressure as constraining factors in preventing adolescent pregnancy. During the post-intervention phase, participants highlighted that the educational intervention of this study had provided a forum to discuss ways of preventing adolescent pregnancy. The educational booklet developed is intended to serve as a resource tool of the educational programme on prevention of adolescent pregnancy, which is expected to be incorporated into the Angus Gillis Foundation’s existing ‘Positive Health’ Programme. The results of this study show that community-based participatory research facilitated the identification of the maternal health issue of most concern to these communities. Working synergistically with key stakeholders in designing and implementing an educational intervention for preventing adolescent pregnancy provides a good foundation for future up scaling and sustainability of this educational programme.
- Full Text:
- Date Issued: 2014
- Authors: Siruma, Amanda Tatenda
- Date: 2014
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54656 , vital:26597
- Description: Millennium Development Goal (MDG) 5 focuses on improving maternal health, due to global acknowledgment that no woman should have to die as a result of complications during pregnancy and childbirth. Adolescents have an increased risk of maternal death compared with older women. Adolescent pregnancy also poses a threat to the empowerment of young girls by mitigating their physical, educational, social, and economic development. In this context, maternal health promotion strategies which inclusively target adolescents are crucial, not only in improving maternal health outcomes, but also in optimising the overall transition of adolescent girls to adulthood. This study was a first time collaborative partnership of the Faculty of Pharmacy and Community Engagement Office of Rhodes University with the Angus Gillis Foundation (a non-profit community development organisation), and community participants of Glenmore and Ndwayana, two rural communities in the Eastern Cape. The aim of this study was to identify the maternal health issue of most concern to community participants and to design and implement an appropriate educational intervention for a suitable target group. During the baseline phase of this study, ten focus group discussions (FGDs) were conducted with 76 community stakeholders. Semi-structured interviews (SSIs) were conducted with two Sisters-in-Charge from each Primary Health Care (PHC) facility in the study setting. Data on the stock status of World Health Organization (WHO) identified lifesaving priority medicines for women’s health was also collected at both PHCs. Thereafter, pre- and posteducational interventions SSIs with female adolescent participants were conducted. The educational intervention was followed up with the development of a booklet on reproductive health. FGD participants identified adolescent pregnancy as the maternal health issue of most concern. They also highlighted challenges in service delivery of ambulance services for expectant mothers in urgent need of transportation to a referral hospital. A majority of preintervention SSI participants indicated coercion from both younger and older men as a factor influencing early sexual debut amongst adolescent girls in their communities. Despite availability in the PHCs, challenges in accessing contraceptives were highlighted by the participants. Additionally, a number of sexually active adolescent girls defaulted on their next allocated visit to the PHC due to myths regarding use of oral and injectable contraceptives. During the educational intervention sessions, participants recognised knowledge gaps regarding reproductive health issues and the influence of peer pressure as constraining factors in preventing adolescent pregnancy. During the post-intervention phase, participants highlighted that the educational intervention of this study had provided a forum to discuss ways of preventing adolescent pregnancy. The educational booklet developed is intended to serve as a resource tool of the educational programme on prevention of adolescent pregnancy, which is expected to be incorporated into the Angus Gillis Foundation’s existing ‘Positive Health’ Programme. The results of this study show that community-based participatory research facilitated the identification of the maternal health issue of most concern to these communities. Working synergistically with key stakeholders in designing and implementing an educational intervention for preventing adolescent pregnancy provides a good foundation for future up scaling and sustainability of this educational programme.
- Full Text:
- Date Issued: 2014
Cost comparison between repackaging bulk oral solid medicines and purchasing manufacturer-prepared patient-ready packs in the public sector in South Africa
- Authors: Abahamye, Aloysius
- Date: 2014
- Subjects: Packaging -- Cost control , Business logistics -- Costs , Drugs -- Packaging , Manufacturing processes
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10163 , http://hdl.handle.net/10948/d1020596 , Drugs -- Packaging
- Description: In an attempt to have medicines available in patient-ready packs (PRPs) prior to the dispensing process, the provincial medicine depots in South Africa have, for many years, been repackaging bulk medicines into PRPs. Notwithstanding the fact that bulk medicine packages may have been the only packages available from the manufacturers to service the Primary Health Care (PHC) sector, the main aim of this process was to ensure that medicines were available in PRPs for dispensing to patients, thus, minimising the time spent on each prescription by the pharmacist, pharmacist’s assistant or Nurse. Currently, some medicines are being procured in PRPs from the manufacturers, whereas others are still procured in bulk packs which must be repackaged into PRPs. After a thorough literature search, it was established that, up until this point in time, no studies have been performed to compare costs of repackaged medicines from bulk packs with costs of medicines procured from manufacturers in PRPs. There was very scanty literature comparing the use of medicines procured either in PRPs or bulk packs. However, literature on cost comparison between repackaging and purchasing of commercially available manufacturer-prepared PRPs was not identified.
- Full Text:
- Date Issued: 2014
- Authors: Abahamye, Aloysius
- Date: 2014
- Subjects: Packaging -- Cost control , Business logistics -- Costs , Drugs -- Packaging , Manufacturing processes
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10163 , http://hdl.handle.net/10948/d1020596 , Drugs -- Packaging
- Description: In an attempt to have medicines available in patient-ready packs (PRPs) prior to the dispensing process, the provincial medicine depots in South Africa have, for many years, been repackaging bulk medicines into PRPs. Notwithstanding the fact that bulk medicine packages may have been the only packages available from the manufacturers to service the Primary Health Care (PHC) sector, the main aim of this process was to ensure that medicines were available in PRPs for dispensing to patients, thus, minimising the time spent on each prescription by the pharmacist, pharmacist’s assistant or Nurse. Currently, some medicines are being procured in PRPs from the manufacturers, whereas others are still procured in bulk packs which must be repackaged into PRPs. After a thorough literature search, it was established that, up until this point in time, no studies have been performed to compare costs of repackaged medicines from bulk packs with costs of medicines procured from manufacturers in PRPs. There was very scanty literature comparing the use of medicines procured either in PRPs or bulk packs. However, literature on cost comparison between repackaging and purchasing of commercially available manufacturer-prepared PRPs was not identified.
- Full Text:
- Date Issued: 2014
Development and assessment of sustained release stavudine loaded microparticles
- Authors: Zindove, Chiedza Cathrine
- Date: 2014
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54722 , vital:26603
- Description:
Stavudine (D4T) has been used as first line treatment for HIV/AIDS and is part of highly active anti retroviral treatment (HAART). It is an affordable medicine and its use is beneficial in resource limited settings. However D4T exhibits dose dependent side effects that may lead to non-adherence in patients. This study was undertaken to formulate, develop and manufacture a dosage form that could reduce dose dependent side effects by decreasing the dose of D4T but still exhibit antiretroviral (ARV) activity. The use of sustained release (SR) formulations of D4T that ensure constant levels of the D4T in the body would not only optimize therapy but also reduce the incidence of side effects thereby increasing patient adherence. SR microparticles containing 30mg D4T were manufactured and loaded into size 3 hard gelatine capsules prior to analysis. The D4T microparticles were manufactured by microencapsulation using non-aqueous oil-in-oil solvent evaporation approach. D4T-excipient, excipient-excipient interactions and D4T purity were assessed using Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA). Copolymers synthesized from acrylic and methacrylic acid esters viz., Eudragit® RSPO and S100 were used as rate retardant materials and the effect of microcrystalline cellulose (Avicel® PH102) on the microparticles was also investigated. Magnesium stearate was used as a droplet stabilizer and n-hexane was added to harden the microspheres formed in a liquid paraffin continuous phase. The microparticles were optimized using a Box Behnken design and Response Surface Methodology (RSM). The microparticles were characterized in terms of their flow properties and encapsulation efficiency (% EE), in addition to visualization of the surface morphology with Scanning Electron Microscopy. In vitro D4T release studies were performed using USP Apparatus III in media of different pH and the samples were analysed using a validated High Performance Liquid Chromatographic (HPLC) method with ultraviolet (UV) detection that had been developed and optimized using a Central Composite Design (CCD). The method was validated according to ICH guidelines. The IR spectra and DSC thermographs revealed that D4T exhibited thermal stability and there was no evidence of D4T-excipient and excipient-excipient interactions. The microparticles that were produced were white, free flowing and were obtained in a high yield with high encapsulation efficiency. Scanning Electron Microscopy studies revealed that the microparticles were spherical and porous in nature. In vitro D4T release extended to 12 hours and the mechanism of release was established using model dependent methods by fitting the data to a Zero order, First order, Higuchi and Hixson Crowell model. It was observed that the mechanism of D4T release was diffusion-controlled and that the data was best fitted to the Higuchi model with correlation coefficients > 0.9. The release mechanism was confirmed using the Korsmeyer-Peppas model that revealed that most of the formulations exhibited anomalous transport kinetics with the release exponent, n, ranging from 0.5
- Full Text:
- Date Issued: 2014
- Authors: Zindove, Chiedza Cathrine
- Date: 2014
- Language: English
- Type: text , Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10962/54722 , vital:26603
- Description:
Stavudine (D4T) has been used as first line treatment for HIV/AIDS and is part of highly active anti retroviral treatment (HAART). It is an affordable medicine and its use is beneficial in resource limited settings. However D4T exhibits dose dependent side effects that may lead to non-adherence in patients. This study was undertaken to formulate, develop and manufacture a dosage form that could reduce dose dependent side effects by decreasing the dose of D4T but still exhibit antiretroviral (ARV) activity. The use of sustained release (SR) formulations of D4T that ensure constant levels of the D4T in the body would not only optimize therapy but also reduce the incidence of side effects thereby increasing patient adherence. SR microparticles containing 30mg D4T were manufactured and loaded into size 3 hard gelatine capsules prior to analysis. The D4T microparticles were manufactured by microencapsulation using non-aqueous oil-in-oil solvent evaporation approach. D4T-excipient, excipient-excipient interactions and D4T purity were assessed using Infrared Spectroscopy (IR), Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA). Copolymers synthesized from acrylic and methacrylic acid esters viz., Eudragit® RSPO and S100 were used as rate retardant materials and the effect of microcrystalline cellulose (Avicel® PH102) on the microparticles was also investigated. Magnesium stearate was used as a droplet stabilizer and n-hexane was added to harden the microspheres formed in a liquid paraffin continuous phase. The microparticles were optimized using a Box Behnken design and Response Surface Methodology (RSM). The microparticles were characterized in terms of their flow properties and encapsulation efficiency (% EE), in addition to visualization of the surface morphology with Scanning Electron Microscopy. In vitro D4T release studies were performed using USP Apparatus III in media of different pH and the samples were analysed using a validated High Performance Liquid Chromatographic (HPLC) method with ultraviolet (UV) detection that had been developed and optimized using a Central Composite Design (CCD). The method was validated according to ICH guidelines. The IR spectra and DSC thermographs revealed that D4T exhibited thermal stability and there was no evidence of D4T-excipient and excipient-excipient interactions. The microparticles that were produced were white, free flowing and were obtained in a high yield with high encapsulation efficiency. Scanning Electron Microscopy studies revealed that the microparticles were spherical and porous in nature. In vitro D4T release extended to 12 hours and the mechanism of release was established using model dependent methods by fitting the data to a Zero order, First order, Higuchi and Hixson Crowell model. It was observed that the mechanism of D4T release was diffusion-controlled and that the data was best fitted to the Higuchi model with correlation coefficients > 0.9. The release mechanism was confirmed using the Korsmeyer-Peppas model that revealed that most of the formulations exhibited anomalous transport kinetics with the release exponent, n, ranging from 0.5
- Full Text:
- Date Issued: 2014
Intervention to improve the level of documentation of antipsychotic related adverse drug reactions
- Authors: Purcell, Gregory Mark
- Date: 2014
- Subjects: Psychotropic drugs Psychopharmacology
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/10340 , vital:26654
- Description: Antipsychotic drugs are the mainstay of treatment for psychotic disorders according to the Standard Treatment Guidelines (2012). However, these drugs are associated with multiple severe adverse drug reactions. In order to limit the effect of adverse drug reactions on patient care, documentation is necessary. Documentation of adverse drug reactions entails recording the reaction experienced, as well as supplementary information. Proper documentation can prevent future occurrences of the same or similar adverse drug reactions. The aim of this study was to determine the effects of an educational intervention targeting increasing documentation of the adverse effects of antipsychotic drugs. The objectives of the study were: to determine the pre-intervention extent and frequency of documentation of antipsychotic-related adverse drug reactions in the patient medical record; to implement an intervention aimed at educating the relevant healthcare professionals, focusing on the adverse drug reactions of antipsychotic drugs and how to record or document these reactions; to assess the post-intervention extent and frequency of documentation of antipsychotic-related adverse drug reactions in the patient medical record; and to assess the attitude of healthcare providers towards the documentation of antipsychotic related adverse drug reactions before and after the intervention.
- Full Text:
- Date Issued: 2014
- Authors: Purcell, Gregory Mark
- Date: 2014
- Subjects: Psychotropic drugs Psychopharmacology
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/10340 , vital:26654
- Description: Antipsychotic drugs are the mainstay of treatment for psychotic disorders according to the Standard Treatment Guidelines (2012). However, these drugs are associated with multiple severe adverse drug reactions. In order to limit the effect of adverse drug reactions on patient care, documentation is necessary. Documentation of adverse drug reactions entails recording the reaction experienced, as well as supplementary information. Proper documentation can prevent future occurrences of the same or similar adverse drug reactions. The aim of this study was to determine the effects of an educational intervention targeting increasing documentation of the adverse effects of antipsychotic drugs. The objectives of the study were: to determine the pre-intervention extent and frequency of documentation of antipsychotic-related adverse drug reactions in the patient medical record; to implement an intervention aimed at educating the relevant healthcare professionals, focusing on the adverse drug reactions of antipsychotic drugs and how to record or document these reactions; to assess the post-intervention extent and frequency of documentation of antipsychotic-related adverse drug reactions in the patient medical record; and to assess the attitude of healthcare providers towards the documentation of antipsychotic related adverse drug reactions before and after the intervention.
- Full Text:
- Date Issued: 2014
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
An assessment of African traditional medicines in pregnancy and on birth outcomes: pharmacists' perceptions of complementary medicines in pregnancy
- Authors: Mupfumira, Rudo
- Date: 2012
- Subjects: Traditional medicine -- South Africa Pharmacists -- Attitudes -- South Africa Medical ethics -- South Africa Medical anthropology -- South Africa Alternative medicine -- South Africa Prenatal care -- South Africa Pregnancy -- South Africa Abnormalities, Human -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3778 , http://hdl.handle.net/10962/d1003256
- Description: Increasing numbers of medicines are being used by pregnant South African women in the public sector during pregnancy, for the treatment of different biomedical and supernatural disease states and conditions. The motivation for the research is to support the development of more local pregnancy registries in order to strengthen evidence for the safety and efficacy of medicines used in pregnancy. A mixed methods approach was used. Women in their ninth month of pregnancy in a public sector setting, and four community pharmacists were identified. The women who met the inclusion criteria were recruited. One in-depth semi-structured interview was conducted with each woman before giving birth and data on their pregnancy outcomes were collected after labour. Coincidentally, the mother of one of the participants was found to be a traditional healer. She was also interviewed on the topic. A structured questionnaire was administered to the pharmacists. Ten pregnant women between the ages of 19 to 39 who had used or were using a traditional medicine during the pregnancy were recruited. All the participants had had at least one antenatal check up during their pregnancy with one having attended five times. No abnormal results were reported from any of the check ups or tests done during the visits. All of them had been to school and had at least Standard 8/Grade 10 education. Ten babies were seen between one and four days postpartum and no birth defects were obvious or were reported for any of them. The traditional healer did not provide additional information to what the women had said and confirmed that some of the practices the women reported were known to her as traditional medicine practices. All four pharmacists indicated that they considered complementary and alternative medicines (CAMs) to be “somewhat effective” and sold them at their pharmacies although none of them were aware of whether or not they were registered with the MCC. None of the pharmacists appeared to have an in-depth knowledge of traditional, complementary and alternative medicines (TCAMs). All four pharmacists said that it is important to have a basic understanding of TCAMs before using them, although they did not agree on the reasons for this. All of them felt that pharmacists have a professional responsibility to provide information on TCAMs (especially herbal preparations) and two felt that providing this information is part of a medical doctors’ responsibility. No harm from taking TCAMs could be shown. However herbal medicines have numerous ingredients some of which are unknown and taking these medicines is risky. The pharmacists in this sample were unsure whether they were accessing unreliable CAM information. Reliable sources of information and reference materials on CAMs to assist pharmacists and other healthcare professionals are needed. The apparent widespread use of TCAM in pregnancy indicates a need for documentation about its efficacy and safety. The establishing of TCAM pregnancy registries should seriously be considered. Due to the increase in CAM use, CAM education during pharmacists’ training as well as continuing professional development (CPD) in CAM for pharmacists in practice should be encouraged.
- Full Text:
- Date Issued: 2012
- Authors: Mupfumira, Rudo
- Date: 2012
- Subjects: Traditional medicine -- South Africa Pharmacists -- Attitudes -- South Africa Medical ethics -- South Africa Medical anthropology -- South Africa Alternative medicine -- South Africa Prenatal care -- South Africa Pregnancy -- South Africa Abnormalities, Human -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3778 , http://hdl.handle.net/10962/d1003256
- Description: Increasing numbers of medicines are being used by pregnant South African women in the public sector during pregnancy, for the treatment of different biomedical and supernatural disease states and conditions. The motivation for the research is to support the development of more local pregnancy registries in order to strengthen evidence for the safety and efficacy of medicines used in pregnancy. A mixed methods approach was used. Women in their ninth month of pregnancy in a public sector setting, and four community pharmacists were identified. The women who met the inclusion criteria were recruited. One in-depth semi-structured interview was conducted with each woman before giving birth and data on their pregnancy outcomes were collected after labour. Coincidentally, the mother of one of the participants was found to be a traditional healer. She was also interviewed on the topic. A structured questionnaire was administered to the pharmacists. Ten pregnant women between the ages of 19 to 39 who had used or were using a traditional medicine during the pregnancy were recruited. All the participants had had at least one antenatal check up during their pregnancy with one having attended five times. No abnormal results were reported from any of the check ups or tests done during the visits. All of them had been to school and had at least Standard 8/Grade 10 education. Ten babies were seen between one and four days postpartum and no birth defects were obvious or were reported for any of them. The traditional healer did not provide additional information to what the women had said and confirmed that some of the practices the women reported were known to her as traditional medicine practices. All four pharmacists indicated that they considered complementary and alternative medicines (CAMs) to be “somewhat effective” and sold them at their pharmacies although none of them were aware of whether or not they were registered with the MCC. None of the pharmacists appeared to have an in-depth knowledge of traditional, complementary and alternative medicines (TCAMs). All four pharmacists said that it is important to have a basic understanding of TCAMs before using them, although they did not agree on the reasons for this. All of them felt that pharmacists have a professional responsibility to provide information on TCAMs (especially herbal preparations) and two felt that providing this information is part of a medical doctors’ responsibility. No harm from taking TCAMs could be shown. However herbal medicines have numerous ingredients some of which are unknown and taking these medicines is risky. The pharmacists in this sample were unsure whether they were accessing unreliable CAM information. Reliable sources of information and reference materials on CAMs to assist pharmacists and other healthcare professionals are needed. The apparent widespread use of TCAM in pregnancy indicates a need for documentation about its efficacy and safety. The establishing of TCAM pregnancy registries should seriously be considered. Due to the increase in CAM use, CAM education during pharmacists’ training as well as continuing professional development (CPD) in CAM for pharmacists in practice should be encouraged.
- Full Text:
- Date Issued: 2012
Foreign reference products in the registration of generic medicines in South Africa a case study
- Authors: Hwengwere, Eldinah
- Date: 2012
- Subjects: Generic drugs -- Law and legislation -- South Africa Case studies Generic drugs -- South Africa Case studies Drugs -- Law and legislation -- South Africa Case studies Pharmacy -- Law and legislation -- South Africa Case studies
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3762 , http://hdl.handle.net/10962/d1003240
- Description: Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.
- Full Text:
- Date Issued: 2012
- Authors: Hwengwere, Eldinah
- Date: 2012
- Subjects: Generic drugs -- Law and legislation -- South Africa Case studies Generic drugs -- South Africa Case studies Drugs -- Law and legislation -- South Africa Case studies Pharmacy -- Law and legislation -- South Africa Case studies
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3762 , http://hdl.handle.net/10962/d1003240
- Description: Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.
- Full Text:
- Date Issued: 2012
Illustrated medicines information for HIV/AIDS patients: influence on adherence,self-efficacy and health outcomes
- Authors: Barford, Kirsty-Lee
- Date: 2012
- Subjects: AIDS (Disease) -- Treatment -- South Africa , HIV infections -- Treatment -- South Africa , AIDS (Disease) -- Patients -- South Africa , HIV-positive persons -- South Africa , AIDS (Disease) -- Study and teaching -- South Africa , Antiretroviral agents -- South Africa , Communication in medicine -- South Africa , Communication in public health -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3863 , http://hdl.handle.net/10962/d1015678
- Description: South Africa has an estimated 920 000 patients on antiretrovirals (ARVs), the largest number of patients in any country. ARV therapy demands adherence levels in excess of 95% to avoid development of drug resistance, but adherence to ARV therapy is estimated to be only between 50% and 70%. Poor medication adherence is acknowledged as a major public health problem, reducing the effectiveness of therapy and promoting resistance to ARVs. More than two thirds of the South African population have marginal reading skills and this significantly influences a patient’s ability to read and understand health-related information. Patient education materials tailored for the South African population could be a useful aid in facilitating communication with patients and perhaps impact positively on their medicine-taking behaviour. This behaviour is influenced by patient knowledge, beliefs, attitudes and expectations and includes self-management, self-efficacy and adherence. Self-efficacy, which refers to patient confidence in the ability to self-manage medicine taking, is a key factor influencing adherence. This study aimed to develop illustrated patient information leaflets (PILs) and medicine labels for all first-line ARV regimens used in the public health sector in South Africa and, using a randomised control study design, to investigate the impact of these illustrated information materials on knowledge, medication-taking behaviours and health outcomes in HIV/AIDS patients taking ARVs. To achieve this aim, the objectives were to assess HIV/AIDS and ARV-related knowledge, as well as self-efficacy and adherence to ARV therapy; to assess the influence of demographic variables on knowledge, adherence and self-efficacy; to assess the influence of the information materials on knowledge, self-efficacy and adherence and to assess the association of knowledge with health outcomes. Medicine labels and PILs, both English and isiXhosa, were developed for ARV regimens 1a, 1b, 1c and 1d. The 8-item Morisky Medication Adherence Scale (MMAS-8) and HIV Treatment Adherence Self Efficacy Scale (HIV-ASES) instruments for measuring respectively adherence and self-efficacy, were modified to optimize clarity, simplicity and cultural acceptability and were translated into isiXhosa using a multi-stage translation-back translation. The questions and the rating scales, for both the MMAS and HIV-ASES, underwent preliminary qualitative evaluation in focus group discussions. Patients were recruited from local Grahamstown clinics. A pilot study to evaluate applicability of the instruments was conducted in 16 isiXhosa AIDS patients on ARVs and the results from this study informed further modifications to the instruments. One hundred and seventeen patients were recruited for the randomised control trial and were randomly allocated to either control group (who received standard care) or experimental group (who received standard care as well as pictogram medicine labels and the illustrated PIL). Interviews were conducted at baseline and at one, three and six months. Data were analysed statistically using the t-test, chi-squared test and ANOVA (Analysis of Variance) at a 5% level of significance. Correlations were determined using Pearson and Spearman rho correlations. Approval was obtained from Rhodes University Ethical Standards Committee, Settlers Hospital Ethics Committee and the Eastern Cape Department of Health. The results of this research showed that illustrated PILs and medicine labels enhanced understanding of HIV/AIDS and ARV information, resulting in a mean overall knowledge score in the experimental group of 96%, which was significantly higher than the 75% measured in the control group. Variable knowledge scores were measured in three areas: baseline knowledge of general HIV/AIDS-related information was good at 87%, whereas knowledge scores relating to ARV-related information (60%) and side-effects (52%) were lower. These scores improved significantly in the experimental group over the 4 interviews during the 6 month trial duration, whereas in the control group, they fluctuated only slightly around the original baseline score. There was no significant influence of gender on knowledge score, whereas health literacy, education level and age tested (at one and three months) had a significant influence on knowledge. Self-efficacy and adherence results were high, indicating that the patients have confidence in their ability to adhere to the ARV therapy and to practice optimal self-care. Age, gender and education, in most cases, significantly influenced self-efficacy, but were found to have no effect on adherence. The CD4 count improved over the trial duration which may have been influenced by a number of factors, including better knowledge of ARVs and improved adherence. No significant parametric correlation was found between knowledge score and change in CD4 count, however, Spearman's rho showed significance (rs=0.498; p=0.022). Both patients and healthcare providers were highly enthusiastic about the illustrated labels and PILs, and indicated their desire for such materials to be routinely available to public sector HIV/AIDS patients. The isiXhosa version of the PIL was preferred by all the patients. These simple, easy-to-read leaflets and illustrated medication labels were shown to increase understanding and knowledge of ARVs and HIV/AIDS in low-literate patients, and their availability in the first-language of the patients was central to making them a highly useful information source.
- Full Text:
- Date Issued: 2012
- Authors: Barford, Kirsty-Lee
- Date: 2012
- Subjects: AIDS (Disease) -- Treatment -- South Africa , HIV infections -- Treatment -- South Africa , AIDS (Disease) -- Patients -- South Africa , HIV-positive persons -- South Africa , AIDS (Disease) -- Study and teaching -- South Africa , Antiretroviral agents -- South Africa , Communication in medicine -- South Africa , Communication in public health -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3863 , http://hdl.handle.net/10962/d1015678
- Description: South Africa has an estimated 920 000 patients on antiretrovirals (ARVs), the largest number of patients in any country. ARV therapy demands adherence levels in excess of 95% to avoid development of drug resistance, but adherence to ARV therapy is estimated to be only between 50% and 70%. Poor medication adherence is acknowledged as a major public health problem, reducing the effectiveness of therapy and promoting resistance to ARVs. More than two thirds of the South African population have marginal reading skills and this significantly influences a patient’s ability to read and understand health-related information. Patient education materials tailored for the South African population could be a useful aid in facilitating communication with patients and perhaps impact positively on their medicine-taking behaviour. This behaviour is influenced by patient knowledge, beliefs, attitudes and expectations and includes self-management, self-efficacy and adherence. Self-efficacy, which refers to patient confidence in the ability to self-manage medicine taking, is a key factor influencing adherence. This study aimed to develop illustrated patient information leaflets (PILs) and medicine labels for all first-line ARV regimens used in the public health sector in South Africa and, using a randomised control study design, to investigate the impact of these illustrated information materials on knowledge, medication-taking behaviours and health outcomes in HIV/AIDS patients taking ARVs. To achieve this aim, the objectives were to assess HIV/AIDS and ARV-related knowledge, as well as self-efficacy and adherence to ARV therapy; to assess the influence of demographic variables on knowledge, adherence and self-efficacy; to assess the influence of the information materials on knowledge, self-efficacy and adherence and to assess the association of knowledge with health outcomes. Medicine labels and PILs, both English and isiXhosa, were developed for ARV regimens 1a, 1b, 1c and 1d. The 8-item Morisky Medication Adherence Scale (MMAS-8) and HIV Treatment Adherence Self Efficacy Scale (HIV-ASES) instruments for measuring respectively adherence and self-efficacy, were modified to optimize clarity, simplicity and cultural acceptability and were translated into isiXhosa using a multi-stage translation-back translation. The questions and the rating scales, for both the MMAS and HIV-ASES, underwent preliminary qualitative evaluation in focus group discussions. Patients were recruited from local Grahamstown clinics. A pilot study to evaluate applicability of the instruments was conducted in 16 isiXhosa AIDS patients on ARVs and the results from this study informed further modifications to the instruments. One hundred and seventeen patients were recruited for the randomised control trial and were randomly allocated to either control group (who received standard care) or experimental group (who received standard care as well as pictogram medicine labels and the illustrated PIL). Interviews were conducted at baseline and at one, three and six months. Data were analysed statistically using the t-test, chi-squared test and ANOVA (Analysis of Variance) at a 5% level of significance. Correlations were determined using Pearson and Spearman rho correlations. Approval was obtained from Rhodes University Ethical Standards Committee, Settlers Hospital Ethics Committee and the Eastern Cape Department of Health. The results of this research showed that illustrated PILs and medicine labels enhanced understanding of HIV/AIDS and ARV information, resulting in a mean overall knowledge score in the experimental group of 96%, which was significantly higher than the 75% measured in the control group. Variable knowledge scores were measured in three areas: baseline knowledge of general HIV/AIDS-related information was good at 87%, whereas knowledge scores relating to ARV-related information (60%) and side-effects (52%) were lower. These scores improved significantly in the experimental group over the 4 interviews during the 6 month trial duration, whereas in the control group, they fluctuated only slightly around the original baseline score. There was no significant influence of gender on knowledge score, whereas health literacy, education level and age tested (at one and three months) had a significant influence on knowledge. Self-efficacy and adherence results were high, indicating that the patients have confidence in their ability to adhere to the ARV therapy and to practice optimal self-care. Age, gender and education, in most cases, significantly influenced self-efficacy, but were found to have no effect on adherence. The CD4 count improved over the trial duration which may have been influenced by a number of factors, including better knowledge of ARVs and improved adherence. No significant parametric correlation was found between knowledge score and change in CD4 count, however, Spearman's rho showed significance (rs=0.498; p=0.022). Both patients and healthcare providers were highly enthusiastic about the illustrated labels and PILs, and indicated their desire for such materials to be routinely available to public sector HIV/AIDS patients. The isiXhosa version of the PIL was preferred by all the patients. These simple, easy-to-read leaflets and illustrated medication labels were shown to increase understanding and knowledge of ARVs and HIV/AIDS in low-literate patients, and their availability in the first-language of the patients was central to making them a highly useful information source.
- Full Text:
- Date Issued: 2012
Implementation of a standardised insulin protocol in a tertiary level referral hospital
- Authors: Smith, Charné
- Date: 2012
- Subjects: Diabetics -- Treatment -- South Africa Insulin -- Patients -- South Africa , Drugs -- Dosage forms Diabetics -- Care -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/18387 , vital:28632
- Description: In severely ill hospitalised patients with diabetes mellitus (type 1 and type 2) there is an increase in metabolic rate. Insulin requirements are increased and glycaemic control becomes more difficult to achieve. The insulin sliding-scale is a form of „top up‟ therapy used to supplement the patients existing hypoglycaemic medication. In 2002, research at Livingstone Hospital found that 14 different sliding scales were used in 38 patients (Du Plessis, 2002: 79). In 2006 the nurses and doctors working in the general medical wards at Livingstone Hospital indicated that they were willing to use a standardised insulin sliding scale protocol (Smith, 2006: 56). Thus the aim of this study was to assess whether a standardised insulin protocol can be effectively implemented. The objectives of the study were to: 1) assess insulin usage via insulin sliding scales prior to the implementation of the standardised insulin protocol; 2) implement the standardised insulin protocol; and 3) reassess insulin usage after the implementation of the standardised insulin protocol. As the study involved evaluating the use of insulin via the insulin sliding scale and the implemented insulin protocol, it occurred in four phases. The preliminary phase entailed obtaining ethical approval. The pre-intervention phase included data collection in the form of a nursing questionnaire and the auditing of patient medical records using a data collection tool. The intervention phase involved education sessions on the new insulin protocol for the nursing staff, and the implementation of a standardised insulin protocol, while the post-intervention phase comprised of post-intervention data collection, which included a nursing questionnaire, a prescribers questionnaire and the auditing of patient medical records using a data collection tool. The overall impression obtained from the comparison between the pre- and post-intervention nursing questionnaire was conflicting; in some aspects the educational intervention was successful in others not. Regardless the indication obtained was that the nursing staff require more in-service training on a more regular basis as a lack of knowledge regarding diabetes mellitus as a disease state may negatively affect patient outcomes. The overall response from the nursing staff towards the insulin protocol was positive. The prescribers‟ response to the insulin protocol was conflicted. The number of correct insulin sliding scale doses administered in the pre-intervention and post intervention phase improved by 5.25 percent. The number of incorrect insulin sliding scale doses administered during the pre- and post -intervention phase decreased by 5.25 percent. These results are positive and may be due to fewer sliding scales being prescribed in the post-intervention phase and the implemented insulin protocol. Only three (5.55%; n=54) inpatients with Type 1 diabetes mellitus were placed on the implemented protocol that is, the basal bolus regime, and rarely were dose adjustments to their insulin made rendering the effectives of the protocol undesirable. Only four (7.40%; n=54) inpatients with Type 2 diabetes mellitus were placed on the implemented protocol that is, an intermediate- to long-acting insulin (Protophane®). However all four patients experienced immediate improvements in their fasting blood glucose levels. These results indicated that by adding an intermediate- to long-acting insulin (Protophane®) to the therapy of a patient with Type 2 diabetes mellitus fasting blood glucose levels decrease. This would improve patient outcomes and decrease the risk of related diabetic complications. These limited results may indicate a clinical inertia on the part of the prescribers. Unfortunately overall the educational intervention was not successful and the implementation of the protocol was not successful and did not yield the desired results.
- Full Text:
- Date Issued: 2012
- Authors: Smith, Charné
- Date: 2012
- Subjects: Diabetics -- Treatment -- South Africa Insulin -- Patients -- South Africa , Drugs -- Dosage forms Diabetics -- Care -- South Africa
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: http://hdl.handle.net/10948/18387 , vital:28632
- Description: In severely ill hospitalised patients with diabetes mellitus (type 1 and type 2) there is an increase in metabolic rate. Insulin requirements are increased and glycaemic control becomes more difficult to achieve. The insulin sliding-scale is a form of „top up‟ therapy used to supplement the patients existing hypoglycaemic medication. In 2002, research at Livingstone Hospital found that 14 different sliding scales were used in 38 patients (Du Plessis, 2002: 79). In 2006 the nurses and doctors working in the general medical wards at Livingstone Hospital indicated that they were willing to use a standardised insulin sliding scale protocol (Smith, 2006: 56). Thus the aim of this study was to assess whether a standardised insulin protocol can be effectively implemented. The objectives of the study were to: 1) assess insulin usage via insulin sliding scales prior to the implementation of the standardised insulin protocol; 2) implement the standardised insulin protocol; and 3) reassess insulin usage after the implementation of the standardised insulin protocol. As the study involved evaluating the use of insulin via the insulin sliding scale and the implemented insulin protocol, it occurred in four phases. The preliminary phase entailed obtaining ethical approval. The pre-intervention phase included data collection in the form of a nursing questionnaire and the auditing of patient medical records using a data collection tool. The intervention phase involved education sessions on the new insulin protocol for the nursing staff, and the implementation of a standardised insulin protocol, while the post-intervention phase comprised of post-intervention data collection, which included a nursing questionnaire, a prescribers questionnaire and the auditing of patient medical records using a data collection tool. The overall impression obtained from the comparison between the pre- and post-intervention nursing questionnaire was conflicting; in some aspects the educational intervention was successful in others not. Regardless the indication obtained was that the nursing staff require more in-service training on a more regular basis as a lack of knowledge regarding diabetes mellitus as a disease state may negatively affect patient outcomes. The overall response from the nursing staff towards the insulin protocol was positive. The prescribers‟ response to the insulin protocol was conflicted. The number of correct insulin sliding scale doses administered in the pre-intervention and post intervention phase improved by 5.25 percent. The number of incorrect insulin sliding scale doses administered during the pre- and post -intervention phase decreased by 5.25 percent. These results are positive and may be due to fewer sliding scales being prescribed in the post-intervention phase and the implemented insulin protocol. Only three (5.55%; n=54) inpatients with Type 1 diabetes mellitus were placed on the implemented protocol that is, the basal bolus regime, and rarely were dose adjustments to their insulin made rendering the effectives of the protocol undesirable. Only four (7.40%; n=54) inpatients with Type 2 diabetes mellitus were placed on the implemented protocol that is, an intermediate- to long-acting insulin (Protophane®). However all four patients experienced immediate improvements in their fasting blood glucose levels. These results indicated that by adding an intermediate- to long-acting insulin (Protophane®) to the therapy of a patient with Type 2 diabetes mellitus fasting blood glucose levels decrease. This would improve patient outcomes and decrease the risk of related diabetic complications. These limited results may indicate a clinical inertia on the part of the prescribers. Unfortunately overall the educational intervention was not successful and the implementation of the protocol was not successful and did not yield the desired results.
- Full Text:
- Date Issued: 2012
Treatment of Parkinson's disease in South Africa and investigation of risk factors causing dyskinesias
- Authors: Gaida, Razia
- Date: 2012
- Subjects: Movement disorders , Parkinson's disease , Drugs
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10159 , http://hdl.handle.net/10948/d1012466 , Movement disorders , Parkinson's disease , Drugs
- Description: Background: Levodopa is still thought of as the 'gold standard' symptomatic treatment for Parkinson’s disease. However, after four to five years of treatment, levodopa efficacy tends to decline even if there was a good initial therapeutic response. The ideal treatment of Parkinson’s disease is a much debated issue with a range of guidelines available. Objectives: This study was undertaken to analyse medication use and prescribing patterns as well as to determine the risk factors involved in causing dyskinesias in Parkinson’s sufferers. Methods: The study consisted of two parts, namely a drug utilisation review (DUR) and a questionnaire survey. There were 25 523 antiparkinsonian records consisting of 5 168 patients for the year 2010. The questionnaires were verbally administered to patients diagnosed with Parkinson’s disease. A total of 43 patients were interviewed. Results: The average age of the population was 70.74±10.37 years, with the oldest patient being 100 years. Females constituted 59.17percent (5 168: n = 3 058) of the total number of patients. The most common antiparkinsonian products dispensed were combination drugs containing levodopa with a decarboxylase inhibitor and some with a COMT-inhibitor as well (46.5percent; n = 11 875). Males represented 53.49percent (43: n = 23) of the patients included in the questionnaire survey. A review of the medical records showed that patients with dyskinesias were diagnosed with Parkinson’s disease at a younger age and had experienced longer disease duration. Conclusion: Parkinson’s disease is an under-recognised condition in South Africa. Treatment needs to be individualised and based on evidence-based guidelines. Further studies in South Africa, as well as SSA (sub-Saharan Africa), need to be conducted on both the prevalence as well as the treatment of Parkinson’s disease.
- Full Text:
- Date Issued: 2012
- Authors: Gaida, Razia
- Date: 2012
- Subjects: Movement disorders , Parkinson's disease , Drugs
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10159 , http://hdl.handle.net/10948/d1012466 , Movement disorders , Parkinson's disease , Drugs
- Description: Background: Levodopa is still thought of as the 'gold standard' symptomatic treatment for Parkinson’s disease. However, after four to five years of treatment, levodopa efficacy tends to decline even if there was a good initial therapeutic response. The ideal treatment of Parkinson’s disease is a much debated issue with a range of guidelines available. Objectives: This study was undertaken to analyse medication use and prescribing patterns as well as to determine the risk factors involved in causing dyskinesias in Parkinson’s sufferers. Methods: The study consisted of two parts, namely a drug utilisation review (DUR) and a questionnaire survey. There were 25 523 antiparkinsonian records consisting of 5 168 patients for the year 2010. The questionnaires were verbally administered to patients diagnosed with Parkinson’s disease. A total of 43 patients were interviewed. Results: The average age of the population was 70.74±10.37 years, with the oldest patient being 100 years. Females constituted 59.17percent (5 168: n = 3 058) of the total number of patients. The most common antiparkinsonian products dispensed were combination drugs containing levodopa with a decarboxylase inhibitor and some with a COMT-inhibitor as well (46.5percent; n = 11 875). Males represented 53.49percent (43: n = 23) of the patients included in the questionnaire survey. A review of the medical records showed that patients with dyskinesias were diagnosed with Parkinson’s disease at a younger age and had experienced longer disease duration. Conclusion: Parkinson’s disease is an under-recognised condition in South Africa. Treatment needs to be individualised and based on evidence-based guidelines. Further studies in South Africa, as well as SSA (sub-Saharan Africa), need to be conducted on both the prevalence as well as the treatment of Parkinson’s disease.
- Full Text:
- Date Issued: 2012
Willingness to pay for pharmacist-provided services directed towards reducing risks of medication-related problems
- Authors: Mushunje, Irvine Tawanda
- Date: 2012
- Subjects: Pharmaceutical industry , Pharmacy -- Practice -- Finance , Pharmacist and patient , Prescription pricing
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10133 , http://hdl.handle.net/10948/d1008053 , Pharmaceutical industry , Pharmacy -- Practice -- Finance , Pharmacist and patient , Prescription pricing
- Description: Pharmacists as members of health care teams, have a central role to play with respect to medication. The pharmaceutical care and cognitive services which pharmacists are able to provide can help prevent, ameliorate or correct medication-related problems. There are however many barriers to the provision of these services and one of the barriers commonly cited by pharmacists is the lack of remuneration for their expert services. The aim of this study is to ascertain if patients in South Africa are willing to pay for pharmacist-provided services which may reduce medication related problems, and thereby determine the perceived value of the pharmacist-provided services, by patients. The study will also seek to determine factors that influence willingness to pay (WTP), including financial status, gender, race, age and level of education. In addition the perceived value of the pharmacist‘s role in patient care, by third party payers (SA Medical Aid providers) and their WTP for pharmacist-provided services (such as DSM) on behalf of patients through their monthly premiums will also be investigated. The study was conducted as a two-phase process: the first phase focused on the opinions of patients and the second phase on the medical aid companies. In phase-1 a convenience sample of 500 patients was recruited by fifty community pharmacies distributed throughout the nine South African provinces. Data collection, consisting of telephonic administration of the questionnaires, was conducted and the survey responses were captured on a Microsoft Excel® spreadsheet. All the captured information was analyzed using descriptive statistics, box and whisker plots, analysis of variance (ANOVA) and regression analysis. In phase-2, medical aid schemes that are registered with the Council of Medical Schemes (CMSs) of South Africa were included in this research. A fifteen point questionnaire was completed electronically via e-mail by willing medical aid participants. Data was analyzed using descriptive statistics only. Only 233 or 88.6 percent, of the 263 participating respondents, were willing to pay at least one rand towards pharmacist-provided services. On average respondents were willing to pay R126.76 as out-of-pocket expenses. Respondents‘ WTP increased as the risk associated with medication-related problems was reduced due to pharmaceutical care intervention. Of the 263 respondents who took part in this research, fifty percent were willing to pay at least R100 for a risk reduction of 30 percent, R120 for a 60 percent reduction and approximately R150 for a greater than 90 percent risk reduction. It was also found that the respondents‘ willingness to pay was influenced by their age, earnings, racial grouping, employment status, medical aid status and their level of satisfaction with pharmacist-provided care services. Of the thirty-one open medical aid schemes only eight (25.8 percent) participated in the study. Findings indicate that all the participating medical aid respondents were unwilling to pay for pharmacist-provided care services, although they perceived pharmacists as very influential healthcare providers and as having a significant role to play in reducing medication-related problems. In conclusion it was found that majority of participants were willing to pay for pharmacist-provided services directed towards reducing risks associated with medication-related problems. Until pharmacists are able to prove pharmaceutical care‘s utility and cost-effectiveness to third-party payers, pharmacists must look to the patient for reimbursement.
- Full Text:
- Date Issued: 2012
- Authors: Mushunje, Irvine Tawanda
- Date: 2012
- Subjects: Pharmaceutical industry , Pharmacy -- Practice -- Finance , Pharmacist and patient , Prescription pricing
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:10133 , http://hdl.handle.net/10948/d1008053 , Pharmaceutical industry , Pharmacy -- Practice -- Finance , Pharmacist and patient , Prescription pricing
- Description: Pharmacists as members of health care teams, have a central role to play with respect to medication. The pharmaceutical care and cognitive services which pharmacists are able to provide can help prevent, ameliorate or correct medication-related problems. There are however many barriers to the provision of these services and one of the barriers commonly cited by pharmacists is the lack of remuneration for their expert services. The aim of this study is to ascertain if patients in South Africa are willing to pay for pharmacist-provided services which may reduce medication related problems, and thereby determine the perceived value of the pharmacist-provided services, by patients. The study will also seek to determine factors that influence willingness to pay (WTP), including financial status, gender, race, age and level of education. In addition the perceived value of the pharmacist‘s role in patient care, by third party payers (SA Medical Aid providers) and their WTP for pharmacist-provided services (such as DSM) on behalf of patients through their monthly premiums will also be investigated. The study was conducted as a two-phase process: the first phase focused on the opinions of patients and the second phase on the medical aid companies. In phase-1 a convenience sample of 500 patients was recruited by fifty community pharmacies distributed throughout the nine South African provinces. Data collection, consisting of telephonic administration of the questionnaires, was conducted and the survey responses were captured on a Microsoft Excel® spreadsheet. All the captured information was analyzed using descriptive statistics, box and whisker plots, analysis of variance (ANOVA) and regression analysis. In phase-2, medical aid schemes that are registered with the Council of Medical Schemes (CMSs) of South Africa were included in this research. A fifteen point questionnaire was completed electronically via e-mail by willing medical aid participants. Data was analyzed using descriptive statistics only. Only 233 or 88.6 percent, of the 263 participating respondents, were willing to pay at least one rand towards pharmacist-provided services. On average respondents were willing to pay R126.76 as out-of-pocket expenses. Respondents‘ WTP increased as the risk associated with medication-related problems was reduced due to pharmaceutical care intervention. Of the 263 respondents who took part in this research, fifty percent were willing to pay at least R100 for a risk reduction of 30 percent, R120 for a 60 percent reduction and approximately R150 for a greater than 90 percent risk reduction. It was also found that the respondents‘ willingness to pay was influenced by their age, earnings, racial grouping, employment status, medical aid status and their level of satisfaction with pharmacist-provided care services. Of the thirty-one open medical aid schemes only eight (25.8 percent) participated in the study. Findings indicate that all the participating medical aid respondents were unwilling to pay for pharmacist-provided care services, although they perceived pharmacists as very influential healthcare providers and as having a significant role to play in reducing medication-related problems. In conclusion it was found that majority of participants were willing to pay for pharmacist-provided services directed towards reducing risks associated with medication-related problems. Until pharmacists are able to prove pharmaceutical care‘s utility and cost-effectiveness to third-party payers, pharmacists must look to the patient for reimbursement.
- Full Text:
- Date Issued: 2012
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
Monitoring and evaluation indicators of the HIV & AIDS programme in Grahamstown's public sector health care system
- Authors: Mahasele, Phehello Anthony
- Date: 2011
- Subjects: AIDS (Disease) -- Patients -- Services for -- South Africa -- Grahamstown -- Evaluation HIV-positive persons -- Services for -- South Africa -- Grahamstown -- Evaluation Public health -- South Africa -- Grahamstown -- Evaluation Antiretroviral agents -- South Africa -- Eastern Cape
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3770 , http://hdl.handle.net/10962/d1003248
- Description: South Africa is one of the countries hardest hit with the Human Immunodeficiency Virus (HIV) and Acquired Immuno Deficiency Syndrome (AIDS) epidemic. In response to the epidemic, the South African government adopted the Comprehensive HIV & AIDS Care, Management and Treatment programme strategic plan (CCMT) in 2000 (1) and developed the Operational Plan for CCMT for antiretroviral therapy rollout in 2003 (2). In order to monitor the progress of the implementation of CCMT, the National Department of Health (NDOH) adopted the Monitoring and Evaluation (M & E) framework in 2004 (3). The aim of this study was to assess the HIV & AIDS programme in Grahamstown‘s public sector health care system by using the national M & E indicators of the HIV & AIDS programme. The national M & E framework was used as the data collection tool and available information was collected from various sources such as the District Health Office (DHO), Primary Health Care (PHC) office, accredited antiretroviral sites and the provincial pharmaceutical depot. Group interviews were conducted with key stakeholder health care professionals at the District Health Office, Primary Health Care office, Settlers Hospital and the provincial Department of Health personnel. A one-on-one interview was conducted with the Deputy Director of HIV & AIDS Directorate, monitoring and evaluation in the National Department of Health. Available indicators such as budget and expenditure including antiretroviral procurement; human resources; nutrition-related indicators; prevention care and treatment indicators were collected. A group interview was conducted to document current practices, or where there was a lack of documentation, for indicators such as traditional medicines and pharmacovigilance. Most of the national M & E indicators are not required to be collected or collated by the district because the reporting format designed by the provincial Department of Health is different. Facilities, districts and provinces in South Africa are at different levels of implementation of the antiretroviral programme and hence a common format of the M & E indicators is not used by all provinces. Uniform data collection is not achieved due to human resources‘ constraints and other challenges such as continued use of manual reporting systems by the clinics. Districts are expected to report according to the formats drawn up by the provincial Department of Health (DOH) and there is a lack of awareness regarding the national M & E document amongst the Grahamstown Health Care Professionals. There is a need for training on the use of the M & E national framework so that the HCPs at the primary and secondary levels of the health care system are proficient with the process of M & E, and can provide inputs as well as take ownership of the process. The establishment of an M & E unit in Grahamstown is essential so that data collection and submission of the HIV & AIDS programme in the public sector according to the National M & E framework is addressed. However, despite all constraints and challenges in the public sector health care system in Grahamstown, available human and financial resources are being used effectively to maintain the HIV & AIDS programme.
- Full Text:
- Date Issued: 2011
- Authors: Mahasele, Phehello Anthony
- Date: 2011
- Subjects: AIDS (Disease) -- Patients -- Services for -- South Africa -- Grahamstown -- Evaluation HIV-positive persons -- Services for -- South Africa -- Grahamstown -- Evaluation Public health -- South Africa -- Grahamstown -- Evaluation Antiretroviral agents -- South Africa -- Eastern Cape
- Language: English
- Type: Thesis , Masters , MPharm
- Identifier: vital:3770 , http://hdl.handle.net/10962/d1003248
- Description: South Africa is one of the countries hardest hit with the Human Immunodeficiency Virus (HIV) and Acquired Immuno Deficiency Syndrome (AIDS) epidemic. In response to the epidemic, the South African government adopted the Comprehensive HIV & AIDS Care, Management and Treatment programme strategic plan (CCMT) in 2000 (1) and developed the Operational Plan for CCMT for antiretroviral therapy rollout in 2003 (2). In order to monitor the progress of the implementation of CCMT, the National Department of Health (NDOH) adopted the Monitoring and Evaluation (M & E) framework in 2004 (3). The aim of this study was to assess the HIV & AIDS programme in Grahamstown‘s public sector health care system by using the national M & E indicators of the HIV & AIDS programme. The national M & E framework was used as the data collection tool and available information was collected from various sources such as the District Health Office (DHO), Primary Health Care (PHC) office, accredited antiretroviral sites and the provincial pharmaceutical depot. Group interviews were conducted with key stakeholder health care professionals at the District Health Office, Primary Health Care office, Settlers Hospital and the provincial Department of Health personnel. A one-on-one interview was conducted with the Deputy Director of HIV & AIDS Directorate, monitoring and evaluation in the National Department of Health. Available indicators such as budget and expenditure including antiretroviral procurement; human resources; nutrition-related indicators; prevention care and treatment indicators were collected. A group interview was conducted to document current practices, or where there was a lack of documentation, for indicators such as traditional medicines and pharmacovigilance. Most of the national M & E indicators are not required to be collected or collated by the district because the reporting format designed by the provincial Department of Health is different. Facilities, districts and provinces in South Africa are at different levels of implementation of the antiretroviral programme and hence a common format of the M & E indicators is not used by all provinces. Uniform data collection is not achieved due to human resources‘ constraints and other challenges such as continued use of manual reporting systems by the clinics. Districts are expected to report according to the formats drawn up by the provincial Department of Health (DOH) and there is a lack of awareness regarding the national M & E document amongst the Grahamstown Health Care Professionals. There is a need for training on the use of the M & E national framework so that the HCPs at the primary and secondary levels of the health care system are proficient with the process of M & E, and can provide inputs as well as take ownership of the process. The establishment of an M & E unit in Grahamstown is essential so that data collection and submission of the HIV & AIDS programme in the public sector according to the National M & E framework is addressed. However, despite all constraints and challenges in the public sector health care system in Grahamstown, available human and financial resources are being used effectively to maintain the HIV & AIDS programme.
- Full Text:
- Date Issued: 2011