Data management and dispensary: missing link contributing to antiretroviral loss to follow-Up in Lejweleputswa District
- Moatlhodi, Charlotte Motshele
- Authors: Moatlhodi, Charlotte Motshele
- Date: 2022-09
- Subjects: Health services administration , Drug monitoring , Antiretroviral agents
- Language: English
- Type: Master's theses , text
- Identifier: http://hdl.handle.net/10353/26973 , vital:66207
- Description: Background and aim: The widespread use and access to Anti-Retro Viral Treatment (ART) world-wide has contributed to full preventive and therapeutic benefits. An estimated amount of 68percent of HIV positive people received ART in South Africa (SA) as of 2018. However, reports from TIER.Net and DHIS (District Health Information System), indicate that the retention of patients on ART (specifically first line triple combination therapy Tenofovir Emtricitabine Efavirenz (TEE)) continues to decline. Meanwhile, data on TEE dispensed from the dispensary shows increasing quantities patients across the Free State province on a monthly basis. The aim of this study is to determine factors contributing to the discrepancy between Fixed Dose Combination (FDC) TEE dispensing data and patients on FDC TEE captured on TIER.Net and Health Patient Registration System (HPRS), as a means of improving identification and monitoring of patients that carry the potential risk of being lost to subsequent follow-ups (ART collection / clinical visits). Methods: A retrospective, quantitative, and descriptive record review of 382 medical records of HIV positive patients, along with TIER.Net and Health Patient Registration System (HPRS) reports, was conducted at five primary healthcare (PHC) facilities, each representing the five sub-districts found in Lejweleputswa district using a self-designed data collection tool. Descriptive statistics was used to summarise and present data. Results: Sixty five percent the TEE collected from the dispensary was captured on TIER. Net. It could not be determined on none of the medical records whether or not the administrative clerk captured dispensed TEE on the same date of collection from the dispensary on TIER.Net. Subsequently, the actual date of capturing the TEE dispenses on TIER.Net following collection of the treatment from the dispensary could also not be determined. The overall data on TEE dispensed/collected from the dispensary the same was not the same as the data captured on TIER.Net. Thirty five percent of patients were reported to have collected their ART according to dispensary data than that reported on TIER.Net. Eighty percent of the TEE collected from the dispensary was captured on HPRS. Eighty percent of facilities had an area and computer dedicated for HPRS and TIER.Net but none had a backup computer in cases of theft/breakage. None of the facilities had access to back up connectivity, a manual capturing process in the form of paper-based head count registers was instead utilised as back-up. Conclusion: The following factors were found to contribute to the discrepancy between the TEE dispensing data, TIER.net and HPRS: Poor records keeping, unauthorised dispensing of prescriptions, poor data management, delays and non-capturing of ART medical records and infrastructural and human resource challenges that exist in the data management of the patient medical records. There is a need to address these gaps in order to improve reliability of dispensary data, as well as reports from TIER.Net and HPRS, in order to streamline the identification and monitoring of patients at risk of becoming lost to follow-up. , Thesis (MPA) -- Faculty of Health Sciences
- Full Text:
- Date Issued: 2022-09
- Authors: Moatlhodi, Charlotte Motshele
- Date: 2022-09
- Subjects: Health services administration , Drug monitoring , Antiretroviral agents
- Language: English
- Type: Master's theses , text
- Identifier: http://hdl.handle.net/10353/26973 , vital:66207
- Description: Background and aim: The widespread use and access to Anti-Retro Viral Treatment (ART) world-wide has contributed to full preventive and therapeutic benefits. An estimated amount of 68percent of HIV positive people received ART in South Africa (SA) as of 2018. However, reports from TIER.Net and DHIS (District Health Information System), indicate that the retention of patients on ART (specifically first line triple combination therapy Tenofovir Emtricitabine Efavirenz (TEE)) continues to decline. Meanwhile, data on TEE dispensed from the dispensary shows increasing quantities patients across the Free State province on a monthly basis. The aim of this study is to determine factors contributing to the discrepancy between Fixed Dose Combination (FDC) TEE dispensing data and patients on FDC TEE captured on TIER.Net and Health Patient Registration System (HPRS), as a means of improving identification and monitoring of patients that carry the potential risk of being lost to subsequent follow-ups (ART collection / clinical visits). Methods: A retrospective, quantitative, and descriptive record review of 382 medical records of HIV positive patients, along with TIER.Net and Health Patient Registration System (HPRS) reports, was conducted at five primary healthcare (PHC) facilities, each representing the five sub-districts found in Lejweleputswa district using a self-designed data collection tool. Descriptive statistics was used to summarise and present data. Results: Sixty five percent the TEE collected from the dispensary was captured on TIER. Net. It could not be determined on none of the medical records whether or not the administrative clerk captured dispensed TEE on the same date of collection from the dispensary on TIER.Net. Subsequently, the actual date of capturing the TEE dispenses on TIER.Net following collection of the treatment from the dispensary could also not be determined. The overall data on TEE dispensed/collected from the dispensary the same was not the same as the data captured on TIER.Net. Thirty five percent of patients were reported to have collected their ART according to dispensary data than that reported on TIER.Net. Eighty percent of the TEE collected from the dispensary was captured on HPRS. Eighty percent of facilities had an area and computer dedicated for HPRS and TIER.Net but none had a backup computer in cases of theft/breakage. None of the facilities had access to back up connectivity, a manual capturing process in the form of paper-based head count registers was instead utilised as back-up. Conclusion: The following factors were found to contribute to the discrepancy between the TEE dispensing data, TIER.net and HPRS: Poor records keeping, unauthorised dispensing of prescriptions, poor data management, delays and non-capturing of ART medical records and infrastructural and human resource challenges that exist in the data management of the patient medical records. There is a need to address these gaps in order to improve reliability of dispensary data, as well as reports from TIER.Net and HPRS, in order to streamline the identification and monitoring of patients at risk of becoming lost to follow-up. , Thesis (MPA) -- Faculty of Health Sciences
- Full Text:
- Date Issued: 2022-09
A self-emulsifying delivery system loaded with efavirenz: The case for flax-seed oil
- Authors: Mazonde, Priveledge
- Date: 2021-10-29
- Subjects: Drug delivery systems , Linseed oil , Antiretroviral agents , HIV (Viruses) , Drug carriers (Pharmacy) , Solubility , High performance liquid chromatography , Efavirenz
- Language: English
- Type: Master's theses , text
- Identifier: http://hdl.handle.net/10962/192944 , vital:45283
- Description: The feasibility of incorporating efavirenz (EFV), an antiretroviral agent against HIV into a lipid-based self-emulsifying drug delivery system (SEDDS) containing vegetable oils was investigated. EFV has poor aqueous solubility and is classified under the Biopharmaceutical Classification System (BCS) as a class II compound with highly permeability, its aqueous solubility is less than 10 mg/ml and is defined as a practically insoluble compound with a consequent poor bioavailability of approximately 40%, and erratic dissolution behaviour. SEDDS formulations have been shown to improve the aqueous solubility and consequently the bioavailability of BCS II compounds such as EFV. EFV is a first line antiviral agent used in combination with other agents in antiretroviral therapy (ART). Among the number of NNRTIs approved for use in HIV treatment, EFV is one of the most commonly prescribed drug. Statistical methods and Design of Experiments (DoE) using Response Surface Methodology (RSM), specifically a Central Composite Design (CCD), were used to facilitate the development of a reversed-phase high performance liquid chromatographic (HPLC) method for the quantitation of EFV during formulation product and process development studies. A rapid, accurate, precise and sensitive HPLC method with ultraviolet (UV) detection was developed, optimised and validated for the in-vitro analysis of EFV in a total run time under 10 minutes for the elution of both EFV and loratidine which was used as the internal standard (IS). The method was then successfully applied to the determination of EFV in commercially available tablets. Excipient screening was undertaken using solubility studies and revealed that EFV had highest solubility in flaxseed oil in comparison to soybean, macadamia, grapeseed, sunflower and olive oils. The non-ionic Tween® 80 and Span® 20 were selected as surfactant and co-surfactant, respectively with ethanol co-solvent as they exhibited improved miscibility with co-solvent. Pre-formulation studies were undertaken to investigate the compatibility of the API with excipients and to identify a nano-emulsion region and other emulsion types using pseudoternary phase diagrams. The phase behaviour of crude cold pressed flaxseed oil with the selected non-ionic surfactants revealed an area within pseudo-ternary phase diagrams for different surfactant-mixtures formed gels/semisolid structures which can be exploited for other drug delivery strategies that require such properties. Fourier transform infrared spectroscopy (FT-IR), powder x-ray diffraction (XRD) and Raman spectroscopy were used to identify and assess the compatibility of EFV with chosen excipients. 2 A reduction in the peak intensity was observed for EFV when combined with each hydrophobic/lipid excipient evaluated revealing that there was a marked reduction in the crystallinity of the EFV. A decrease in crystallinity in comparison with the bulk API may indicate that EFV were amorphous or sequestered in a molecular dispersion and exhibited an increased solubility for the molecule. Flaxseed oil was used as the oil phase in studies for the optimization of surfactant mixtures undertaken using DoE, specifically a D-optimal mixtures design with the flaxseed oil content set at 10% m/m was performed. Solutions from the desired optimization function were produced based on desirability and five nanoemulsion formulations were produced and characterized in terms of in vitro release of efavirenz, drug loading capacity, Zeta Potential, droplet sizes and polydispersity index (PDI). Kinetically stable nanoemulsions containing 10% m/m flaxseed oil were successfully manufactured and assessed. Droplet sizes ranged between 156 and 225 nm, Zeta Potential between −24 and −41 mV and all formulations were found to be monodisperse with polydispersity indices ≤ 0.487. SEDDS formulations of EFV in nano-sized carriers were developed and optimised, in vitro drug release varied with varying amounts of ethanol in the formulation producing formulations that exhibited differently modulated drug in-vitro release profiles that may be further manipulated for better performance and therapeutic outcomes in terms of solubility and possibly bioavailability of EFV when delivered using SEDDS rather than using tablets which in turn may lead to better therapeutic outcomes for patients with HIV. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2021
- Full Text:
- Date Issued: 2021-10-29
- Authors: Mazonde, Priveledge
- Date: 2021-10-29
- Subjects: Drug delivery systems , Linseed oil , Antiretroviral agents , HIV (Viruses) , Drug carriers (Pharmacy) , Solubility , High performance liquid chromatography , Efavirenz
- Language: English
- Type: Master's theses , text
- Identifier: http://hdl.handle.net/10962/192944 , vital:45283
- Description: The feasibility of incorporating efavirenz (EFV), an antiretroviral agent against HIV into a lipid-based self-emulsifying drug delivery system (SEDDS) containing vegetable oils was investigated. EFV has poor aqueous solubility and is classified under the Biopharmaceutical Classification System (BCS) as a class II compound with highly permeability, its aqueous solubility is less than 10 mg/ml and is defined as a practically insoluble compound with a consequent poor bioavailability of approximately 40%, and erratic dissolution behaviour. SEDDS formulations have been shown to improve the aqueous solubility and consequently the bioavailability of BCS II compounds such as EFV. EFV is a first line antiviral agent used in combination with other agents in antiretroviral therapy (ART). Among the number of NNRTIs approved for use in HIV treatment, EFV is one of the most commonly prescribed drug. Statistical methods and Design of Experiments (DoE) using Response Surface Methodology (RSM), specifically a Central Composite Design (CCD), were used to facilitate the development of a reversed-phase high performance liquid chromatographic (HPLC) method for the quantitation of EFV during formulation product and process development studies. A rapid, accurate, precise and sensitive HPLC method with ultraviolet (UV) detection was developed, optimised and validated for the in-vitro analysis of EFV in a total run time under 10 minutes for the elution of both EFV and loratidine which was used as the internal standard (IS). The method was then successfully applied to the determination of EFV in commercially available tablets. Excipient screening was undertaken using solubility studies and revealed that EFV had highest solubility in flaxseed oil in comparison to soybean, macadamia, grapeseed, sunflower and olive oils. The non-ionic Tween® 80 and Span® 20 were selected as surfactant and co-surfactant, respectively with ethanol co-solvent as they exhibited improved miscibility with co-solvent. Pre-formulation studies were undertaken to investigate the compatibility of the API with excipients and to identify a nano-emulsion region and other emulsion types using pseudoternary phase diagrams. The phase behaviour of crude cold pressed flaxseed oil with the selected non-ionic surfactants revealed an area within pseudo-ternary phase diagrams for different surfactant-mixtures formed gels/semisolid structures which can be exploited for other drug delivery strategies that require such properties. Fourier transform infrared spectroscopy (FT-IR), powder x-ray diffraction (XRD) and Raman spectroscopy were used to identify and assess the compatibility of EFV with chosen excipients. 2 A reduction in the peak intensity was observed for EFV when combined with each hydrophobic/lipid excipient evaluated revealing that there was a marked reduction in the crystallinity of the EFV. A decrease in crystallinity in comparison with the bulk API may indicate that EFV were amorphous or sequestered in a molecular dispersion and exhibited an increased solubility for the molecule. Flaxseed oil was used as the oil phase in studies for the optimization of surfactant mixtures undertaken using DoE, specifically a D-optimal mixtures design with the flaxseed oil content set at 10% m/m was performed. Solutions from the desired optimization function were produced based on desirability and five nanoemulsion formulations were produced and characterized in terms of in vitro release of efavirenz, drug loading capacity, Zeta Potential, droplet sizes and polydispersity index (PDI). Kinetically stable nanoemulsions containing 10% m/m flaxseed oil were successfully manufactured and assessed. Droplet sizes ranged between 156 and 225 nm, Zeta Potential between −24 and −41 mV and all formulations were found to be monodisperse with polydispersity indices ≤ 0.487. SEDDS formulations of EFV in nano-sized carriers were developed and optimised, in vitro drug release varied with varying amounts of ethanol in the formulation producing formulations that exhibited differently modulated drug in-vitro release profiles that may be further manipulated for better performance and therapeutic outcomes in terms of solubility and possibly bioavailability of EFV when delivered using SEDDS rather than using tablets which in turn may lead to better therapeutic outcomes for patients with HIV. , Thesis (MSc) -- Faculty of Pharmacy, Pharmacy, 2021
- Full Text:
- Date Issued: 2021-10-29
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