A drug utilisation review of lithium at a public sector psychiatric hospital
- Authors: Mapfumo, Charlotte
- Date: 2020-04
- Subjects: Lithium -- Therapeutic use , Psychiatric hospitals -- South Africa -- Grahamstown , Drug utilization , Psychiatric hospital care , Manic-depressive illness , Lithium -- Toxicology , Drug monitoring
- Language: English
- Type: text , Thesis , Masters , M.Pharm
- Identifier: http://hdl.handle.net/10962/150541 , vital:38983
- Description: Bipolar disorder (BD) is a common mental condition that affects about 60 million people globally. Lithium is among the drugs of choice used to treat BD and other affective disorders such as schizoaffective disorder (SD). Lithium is a mood stabiliser with antimanic, antidepressant and anti-suicidal properties. Lithium has complex mechanisms of action and a narrow therapeutic index (NTI). Therapeutic drug monitoring (TDM) is a vital component of lithium therapy due to its NTI. Lithium toxicity can occur at therapeutic levels and is characterised by symptoms such as blurred vision and convulsions. Lithium interacts with a number of drugs resulting in lithium toxicity or diminished effects of lithium. Symptoms of lithium toxicity range from abdominal pain, convulsions and death. Lithium use is associated with serious adverse effects on renal and thyroid function. Other adverse effects include tremor and weight gain. Monitoring of lithium serum levels, renal and thyroid function are therefore recommended for patients on lithium therapy. Monitoring of these parameters assists in the early detection of any problems associated with lithium use. The metabolic monitoring of lithium is vital due to the adverse effect profile of lithium and the current South African Standard Treatment Guidelines Hospital level: Adults, do not have any recommendations for the monitoring of metabolic parameters. The National Institute for Health and Care Excellence (NICE) may be used and adapted for the South African setting. Aim and Objectives: The general aim of the study was to conduct a drug utilisation review (DUR) on lithium through investigating its prescribing and monitoring patterns in both inpatients and outpatients at Fort England Hospital. Methodology: The study was in the form of a retrospective DUR. Data was collected from 40 files (n=40) of patients who were on treatment with lithium between 1 January 2017-31 December 2017 at Fort England Hospital. The data was collected retrospectively for both in- and outpatients. Compliance of the monitoring requirements with both South African and international guidelines was analysed. Results and Discussion: In 87.50% (n=37) of the cases, patients had been on lithium therapy before 2017 with most patients (n=13; 37.50%) being maintained on 500 mg of lithium. Non-compliance with the South African and NICE guidelines for renal baseline monitoring was 65.00% (n=26) in both guidelines. Non-compliance for baseline thyroid monitoring was 70.00% (n=28) for both guidelines. There was non-compliance in 45.00% (n=18) of the cases for lithium serum level monitoring for both guidelines. Non-compliance with follow-up renal monitoring was 47.50% (n=19) for both guidelines. Compliance with the NICE guidelines for follow-up metabolic monitoring was 67.50% (n=27). Conclusion: There was non-compliance in most cases leaving room for clinical improvement in the monitoring of lithium. Healthcare professionals should be educated on the recommended monitoring guidelines to promote the rational use of lithium in South Africa. Pharmacists should be more involved in the TDM of lithium to promote its safe and effective use.
- Full Text:
- Authors: Mapfumo, Charlotte
- Date: 2020-04
- Subjects: Lithium -- Therapeutic use , Psychiatric hospitals -- South Africa -- Grahamstown , Drug utilization , Psychiatric hospital care , Manic-depressive illness , Lithium -- Toxicology , Drug monitoring
- Language: English
- Type: text , Thesis , Masters , M.Pharm
- Identifier: http://hdl.handle.net/10962/150541 , vital:38983
- Description: Bipolar disorder (BD) is a common mental condition that affects about 60 million people globally. Lithium is among the drugs of choice used to treat BD and other affective disorders such as schizoaffective disorder (SD). Lithium is a mood stabiliser with antimanic, antidepressant and anti-suicidal properties. Lithium has complex mechanisms of action and a narrow therapeutic index (NTI). Therapeutic drug monitoring (TDM) is a vital component of lithium therapy due to its NTI. Lithium toxicity can occur at therapeutic levels and is characterised by symptoms such as blurred vision and convulsions. Lithium interacts with a number of drugs resulting in lithium toxicity or diminished effects of lithium. Symptoms of lithium toxicity range from abdominal pain, convulsions and death. Lithium use is associated with serious adverse effects on renal and thyroid function. Other adverse effects include tremor and weight gain. Monitoring of lithium serum levels, renal and thyroid function are therefore recommended for patients on lithium therapy. Monitoring of these parameters assists in the early detection of any problems associated with lithium use. The metabolic monitoring of lithium is vital due to the adverse effect profile of lithium and the current South African Standard Treatment Guidelines Hospital level: Adults, do not have any recommendations for the monitoring of metabolic parameters. The National Institute for Health and Care Excellence (NICE) may be used and adapted for the South African setting. Aim and Objectives: The general aim of the study was to conduct a drug utilisation review (DUR) on lithium through investigating its prescribing and monitoring patterns in both inpatients and outpatients at Fort England Hospital. Methodology: The study was in the form of a retrospective DUR. Data was collected from 40 files (n=40) of patients who were on treatment with lithium between 1 January 2017-31 December 2017 at Fort England Hospital. The data was collected retrospectively for both in- and outpatients. Compliance of the monitoring requirements with both South African and international guidelines was analysed. Results and Discussion: In 87.50% (n=37) of the cases, patients had been on lithium therapy before 2017 with most patients (n=13; 37.50%) being maintained on 500 mg of lithium. Non-compliance with the South African and NICE guidelines for renal baseline monitoring was 65.00% (n=26) in both guidelines. Non-compliance for baseline thyroid monitoring was 70.00% (n=28) for both guidelines. There was non-compliance in 45.00% (n=18) of the cases for lithium serum level monitoring for both guidelines. Non-compliance with follow-up renal monitoring was 47.50% (n=19) for both guidelines. Compliance with the NICE guidelines for follow-up metabolic monitoring was 67.50% (n=27). Conclusion: There was non-compliance in most cases leaving room for clinical improvement in the monitoring of lithium. Healthcare professionals should be educated on the recommended monitoring guidelines to promote the rational use of lithium in South Africa. Pharmacists should be more involved in the TDM of lithium to promote its safe and effective use.
- Full Text:
Application of quality by design to the manufacture of a multiparticulate prednisone dosage form
- Authors: Manda, Arthur
- Date: 2020-04
- Subjects: Drugs -- Quality control , Drugs -- Design -- Quality control , Drugs -- Dosage forms , Drug development -- Quality control , Pharmaceutical industry -- Quality control , Prednisone , High throughput screening (Drug development)
- Language: English
- Type: text , Thesis , Masters , MSc (Pharmacy)
- Identifier: http://hdl.handle.net/10962/117986 , vital:34583
- Description: For many years, quality by testing was the only approach to guarantee quality of drug products before the Food and Drug Administration launched the concept of current Good Manufacturing Practice. In order to gain more knowledge of the manufacturing process, a new system known as Quality by Design was introduced into the pharmaceutical industry. Quality by Design is based on thorough understanding of how materials, process parameters and interaction thereof impact final product quality. Quality by Design is a systematic approach to product development which ensures that quality is built into a product during product development and not just tested into it. The aim of Quality by Design is to achieve optimum product quality with consistent dosage form performance and minimal risk of failure in patients. The objective of these studies was to implement a Quality by Design approach to establish a design space for the development and manufacture of a safe, effective and stable multi-partite solid oral dosage form for prednisone as an alternative to currently marketed prednisone formulations. Multi-particulate dosage forms offer significant advantages over conventional technologies. In addition to lowering the incidence of gastrointestinal irritation they exhibit a reduced risk of dose dumping and a large surface area which favours dissolution. Furthermore, their free flowing nature facilitates reproducible capsule filling and consequently uniformity of dosing. Different multi-particulate dosage forms exist however a multiple-unit pellet system was investigated during these studies. Quality by Design principles were used to develop and establish a reversed-phase high performance liquid chromatographic method for quantifying prednisone from solid oral dosage forms. A Central Composite Design was used to generate multivariate experiments and to investigate the impact of input variables on the quality and performance of the analytical method. The optimized method was validated according to International Council for Harmonization guidelines and was found to be linear, precise, accurate and specific for the quantitation of prednisone. Pre-formulation studies were conducted and included the assessment of particle size, particle shape, powder flow properties and compatibility studies. Carr’s index, Hausner ratio and the Angle of Repose were used to evaluate powder flow properties and results generated from all studies suggest the need for adding a glidant and lubricant to improve pellet flow. The images generated from Scanning Electron Microscopy were used to analyze particle shape and size. Differential Scanning Calorimetry and Fourier Transform Infrared Spectroscopy were used to evaluate API-excipient compatibility. All excipients investigated were found to be compatible with prednisone and suitable for formulation development studies. Extrusion-spheronization was used to manufacture prednisone pellets. Extrusion-spheronization is a multi-step process involving many factors. Quality risk management tools particularly an Ishikawa Fishbone (cause and effect) diagram and failure mode and effects analysis were used to narrow down potentially significant factors to a reasonable number that could be investigated experimentally. Risk priority numbers were used to quantify risk and factors above a set threshold value were considered to be of high risk. A total of eleven risk factors were identified as high. A Plackett-Burman study was conducted to narrow down the eleven high risk factors to identify the most impactful factors viz., microcrystalline cellulose content, sodium starch glycolate content, extrusion speed and spheronization time. Evaluation of four factors was carried over to optimization studies using a Box-Behnken Design and following identifaction of the optimum process settings and excipient content a design space for the manufacture of a multi-partite dosage form containing prednisone was established.
- Full Text:
- Authors: Manda, Arthur
- Date: 2020-04
- Subjects: Drugs -- Quality control , Drugs -- Design -- Quality control , Drugs -- Dosage forms , Drug development -- Quality control , Pharmaceutical industry -- Quality control , Prednisone , High throughput screening (Drug development)
- Language: English
- Type: text , Thesis , Masters , MSc (Pharmacy)
- Identifier: http://hdl.handle.net/10962/117986 , vital:34583
- Description: For many years, quality by testing was the only approach to guarantee quality of drug products before the Food and Drug Administration launched the concept of current Good Manufacturing Practice. In order to gain more knowledge of the manufacturing process, a new system known as Quality by Design was introduced into the pharmaceutical industry. Quality by Design is based on thorough understanding of how materials, process parameters and interaction thereof impact final product quality. Quality by Design is a systematic approach to product development which ensures that quality is built into a product during product development and not just tested into it. The aim of Quality by Design is to achieve optimum product quality with consistent dosage form performance and minimal risk of failure in patients. The objective of these studies was to implement a Quality by Design approach to establish a design space for the development and manufacture of a safe, effective and stable multi-partite solid oral dosage form for prednisone as an alternative to currently marketed prednisone formulations. Multi-particulate dosage forms offer significant advantages over conventional technologies. In addition to lowering the incidence of gastrointestinal irritation they exhibit a reduced risk of dose dumping and a large surface area which favours dissolution. Furthermore, their free flowing nature facilitates reproducible capsule filling and consequently uniformity of dosing. Different multi-particulate dosage forms exist however a multiple-unit pellet system was investigated during these studies. Quality by Design principles were used to develop and establish a reversed-phase high performance liquid chromatographic method for quantifying prednisone from solid oral dosage forms. A Central Composite Design was used to generate multivariate experiments and to investigate the impact of input variables on the quality and performance of the analytical method. The optimized method was validated according to International Council for Harmonization guidelines and was found to be linear, precise, accurate and specific for the quantitation of prednisone. Pre-formulation studies were conducted and included the assessment of particle size, particle shape, powder flow properties and compatibility studies. Carr’s index, Hausner ratio and the Angle of Repose were used to evaluate powder flow properties and results generated from all studies suggest the need for adding a glidant and lubricant to improve pellet flow. The images generated from Scanning Electron Microscopy were used to analyze particle shape and size. Differential Scanning Calorimetry and Fourier Transform Infrared Spectroscopy were used to evaluate API-excipient compatibility. All excipients investigated were found to be compatible with prednisone and suitable for formulation development studies. Extrusion-spheronization was used to manufacture prednisone pellets. Extrusion-spheronization is a multi-step process involving many factors. Quality risk management tools particularly an Ishikawa Fishbone (cause and effect) diagram and failure mode and effects analysis were used to narrow down potentially significant factors to a reasonable number that could be investigated experimentally. Risk priority numbers were used to quantify risk and factors above a set threshold value were considered to be of high risk. A total of eleven risk factors were identified as high. A Plackett-Burman study was conducted to narrow down the eleven high risk factors to identify the most impactful factors viz., microcrystalline cellulose content, sodium starch glycolate content, extrusion speed and spheronization time. Evaluation of four factors was carried over to optimization studies using a Box-Behnken Design and following identifaction of the optimum process settings and excipient content a design space for the manufacture of a multi-partite dosage form containing prednisone was established.
- Full Text:
Evaluating the prescribing and management practices of clozapine at a public sector psychiatric hospital
- Authors: Mukoko, Vimbisai Millicent
- Date: 2020-04
- Subjects: Clozapine , Schizophrenia -- Chemotherapy , Schizophrenia -- South Africa -- Treatment
- Language: English
- Type: text , Thesis , Masters , M.Pharm
- Identifier: http://hdl.handle.net/10962/123266 , vital:35422
- Description: Approximately one percent (1%) of the South African population suffers from schizophrenia. Clozapine has proven to be more effective than conventional antipsychotics in the treatment of schizophrenia, particularly in alleviating positive symptoms. Clozapine is primarily indicated for treatment-resistant schizophrenia due to its severe adverse effect profile. The prescribing guidelines recommend a trial of at least two different antipsychotic drugs before the initiation of clozapine. At least one should be a non-clozapine second generation antipsychotic. Compared to other atypical antipsychotics, clozapine poses the greatest risk of causing a haematological event, such as neutropenia and agranulocytosis. Agranulocytosis (estimated prevalence of 1.3%) is a life-threatening adverse effect. Common adverse effects include weight gain and metabolic syndrome, hypersalivation and constipation. These can also predispose the patient to co-morbid diseases which further complicate their current diagnosis. Haematological and metabolic monitoring is paramount throughout the duration of clozapine therapy. International (NICE guidelines, Clozapine REMS, and Maudsley prescribing guidelines) and national (South African STGs, SASOP treatment guidelines and the SAMF) guidelines recommend these monitoring patterns to assist with the prevention and management of the adverse effects of clozapine.
- Full Text:
- Authors: Mukoko, Vimbisai Millicent
- Date: 2020-04
- Subjects: Clozapine , Schizophrenia -- Chemotherapy , Schizophrenia -- South Africa -- Treatment
- Language: English
- Type: text , Thesis , Masters , M.Pharm
- Identifier: http://hdl.handle.net/10962/123266 , vital:35422
- Description: Approximately one percent (1%) of the South African population suffers from schizophrenia. Clozapine has proven to be more effective than conventional antipsychotics in the treatment of schizophrenia, particularly in alleviating positive symptoms. Clozapine is primarily indicated for treatment-resistant schizophrenia due to its severe adverse effect profile. The prescribing guidelines recommend a trial of at least two different antipsychotic drugs before the initiation of clozapine. At least one should be a non-clozapine second generation antipsychotic. Compared to other atypical antipsychotics, clozapine poses the greatest risk of causing a haematological event, such as neutropenia and agranulocytosis. Agranulocytosis (estimated prevalence of 1.3%) is a life-threatening adverse effect. Common adverse effects include weight gain and metabolic syndrome, hypersalivation and constipation. These can also predispose the patient to co-morbid diseases which further complicate their current diagnosis. Haematological and metabolic monitoring is paramount throughout the duration of clozapine therapy. International (NICE guidelines, Clozapine REMS, and Maudsley prescribing guidelines) and national (South African STGs, SASOP treatment guidelines and the SAMF) guidelines recommend these monitoring patterns to assist with the prevention and management of the adverse effects of clozapine.
- Full Text:
Evaluating the prescribing and management practices of venlafaxine at a public sector psychiatric hospital
- Authors: Naidu, Bavika
- Date: 2020-04
- Subjects: Venlafaxine , Anxiety disorcers -- Treatment , Depression, Mental -- Treatment
- Language: English
- Type: text , Thesis , Masters , M.Pharm
- Identifier: http://hdl.handle.net/10962/123200 , vital:35414
- Description: Neuropsychiatric conditions have been ranked third in South Africa according to some of the most recent reviews of disease burden, following human immunodeficiency virus/acquired immune deficiency syndrome and other infectious diseases (Bateman, 2012:70; South African Depression and Anxiety Group, 2018). For depressive disorders, the conventional selective serotonin reuptake inhibitors (e.g. fluoxetine), are common first-step treatments due to their relatively low toxicity and high tolerability (Rush et al., 2006:1231). The class of selective noradrenaline reuptake inhibitors (e.g. venlafaxine) is relatively new on the market. The first SNRI to be marketed in the United States was venlafaxine immediate-release (IR). It was approved by the United States FDA in 1993 (Sansone and Sansone, 2014:37) and was soon followed by the introduction of a micro-encapsulated extended-release (XR) formulation in 1997. Currently there is no published or readily available information concerning the prescribing and management patterns of venlafaxine as well as the incidence and types of adverse effects experienced by patients in the public health sector of South Africa besides the established increased in blood pressure.
- Full Text:
- Authors: Naidu, Bavika
- Date: 2020-04
- Subjects: Venlafaxine , Anxiety disorcers -- Treatment , Depression, Mental -- Treatment
- Language: English
- Type: text , Thesis , Masters , M.Pharm
- Identifier: http://hdl.handle.net/10962/123200 , vital:35414
- Description: Neuropsychiatric conditions have been ranked third in South Africa according to some of the most recent reviews of disease burden, following human immunodeficiency virus/acquired immune deficiency syndrome and other infectious diseases (Bateman, 2012:70; South African Depression and Anxiety Group, 2018). For depressive disorders, the conventional selective serotonin reuptake inhibitors (e.g. fluoxetine), are common first-step treatments due to their relatively low toxicity and high tolerability (Rush et al., 2006:1231). The class of selective noradrenaline reuptake inhibitors (e.g. venlafaxine) is relatively new on the market. The first SNRI to be marketed in the United States was venlafaxine immediate-release (IR). It was approved by the United States FDA in 1993 (Sansone and Sansone, 2014:37) and was soon followed by the introduction of a micro-encapsulated extended-release (XR) formulation in 1997. Currently there is no published or readily available information concerning the prescribing and management patterns of venlafaxine as well as the incidence and types of adverse effects experienced by patients in the public health sector of South Africa besides the established increased in blood pressure.
- Full Text:
Science engagement with school learners for microbial quality testing of water in Makhanda
- Authors: Nqowana, Thandiswa
- Date: 2020-04
- Language: English
- Type: text , Thesis , Masters , MSc (Pharmacy)
- Identifier: http://hdl.handle.net/10962/124754 , vital:35677
- Description: Expected release date-April 2022
- Full Text: false
- Authors: Nqowana, Thandiswa
- Date: 2020-04
- Language: English
- Type: text , Thesis , Masters , MSc (Pharmacy)
- Identifier: http://hdl.handle.net/10962/124754 , vital:35677
- Description: Expected release date-April 2022
- Full Text: false
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