More people living with HIV/AIDS reside in South Africa than any other country in the world, and the nation faces colossal challenges in broadening its response to the now-mature and widespread HIV epidemic (WHO, 2005:1). According to South Africa's Medical Research Council, HIV/AIDS has now become the single largest cause of death in South Africa (Dorrington et a/., 2001:6) and has triggered a prominent transferal in the pattern of mortality from the elderly to the young, particularly among young women (Dorrington, 2001:4). The routine treatment of HIV/AIDS with antiretroviral drugs has transformed HIV-infection from an unvaryingly rapidly terminal illness to a somewhat expensive treatable, chronic disease. Triple therapy or highly active antiretroviral therapy (three-drug combinations of ARVs or HAART) in particular have had paramount impacts on HIV-related morbidity and mortality in settings where these drugs are generally accessible. Objectives of ARV treatment are "maximum, durable suppression of viral load, restoration and/or preservation of immune function, improvement of quality of life and reduction of HIV related morbidity and mortality" (Martinson et a/., 2003:236; Martinez et a/., 2007:251; Hellinger, 2006:1; Kumarasamy, 2004:3). The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated that a total of 111 827 South Africans were accessing free antiretroviral treatment in the 200 public health sector facilities across 53 districts and a further 60 000 via the private sector by late December 2005 (UNAIDS, 2005:1). The objective of this study was to review, analyse and interpret the usage and prescribing patterns of antiretroviral drugs in a section of the South African private health care sector for the period 1 January 2005 to 31 December 2006 by utilising a medicine claims database of a pharmacy benefit management company, and to investigate the costs associated with these drugs by performing a quantitative, retrospective drug utilisation review. It was found that the prevalence as well as the total medicine cost of ARV medicine items had increased during the study period but the average number of ARV medicine items per prescription as well as both the average cost per ARV medicine item and the average cost per ARV prescription decreased during the study period. Original innovator ARV medicine items and original ARV medicine items with no generic were found to be relatively expensive in comparison with ARV medicine items in general. Conversely, generic ARV medicine items were ascertained to be relatively inexpensive with reference to ARV medicine items in general. It was perceived that the average cost of ARV medicine items and prescriptions for both genders decreased from 2005 to 2006, while there was an increase in the prevalence of medicine items and prescriptions claimed for both female and male patients. The prevalence and cost of all types of ARV medicine items were found to be higher for female patients in general. It was also established that the prevalence of patients receiving antiretroviral treatment in the private health care sector peaks at the age of >30 to 244 years, in comparison with the lower age of >25 to 239 years in the public health care sector. ARV medicine items claimed for patients in the age group >35 to 239 years represented the highest percentage of the total medicine cost incurred during both study years for all ARV medicine types. The majority of ARV medicine items were prescribed by general medical practitioners, and most ARV medicine items were dispensed by community or private institutional pharmacies. It was determined that combinations of 2NRTI + NNRTI were prescribed with the highest frequency, which is compliant with traditional HAART or 'triple therapy' regimens. Lastly, it was found that none of the top 20 prescriptions for one, two and six ARV medicine items were compliant with the National Antiretroviral Treatment (ART) Guidelines. The majority of the top 20 prescriptions for three ARV medicine items (92.67 per cent during 2005 and 89.94 per cent during 2006) were compliant with the National ART Guidelines. Finally, less than half of the top 20 prescriptions for four ARV medicine items (49.60 per cent during 2005 and 36.11 per cent during 2006) were compliant with the National ART Guidelines. Only 5.56 per cent and 3.92 per cent of the top 16 prescriptions for five ARV medicine items were compliant with the National ART Guidelines during the two study years respectively / Thesis (M. Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2009.

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for systemic control of acute and chronic pain and inflammation (Lin et ah, 2000:1129), but usage problems and side-effects that occur during the post-marketing phase of these drugs are well documented (Thiefin & Beaugerie, 2005:287). Following the demonstration of the value of anti-inflammatory therapy in diseases like rheumatoid arthritis (Boardman & Dudley Hart, 1967:268), new NSAIDs appeared on the market (Dieppe et al., 2004:867), and the indications steadily broadened from inflammatory diseases to almost any painful condition. Studies have indicated that NSAID-associated serious upper gastro-intestinal (GI) adverse events result in 103 000 hospitalisations (Bombardier, 2002:4) and 165 000 deaths per year in the United States. A study in South Africa in 2002 indicated that NSAID utilisation contributed considerably to the total cost of all medicine items from a medicine claim database in the private health care sector (Joubert, 2002:260). The objective of this study was to determine the prevalence and cost of non-steroid anti-inflammatory drugs in a section of the private health care sector, and specifically to determine the prevalence, usage and cost of Coxib (Specific cyclo-oxygenase-2 inhibitor) medicine items before and after the withdrawal of Vioxx® from the market in September 2004 (Merck, 2004). Data from two medicine claim databases for the years 2004, 2005 and 2006 (medicine claim database I) and the years 2005 and 2006 (medicine claim database M), were analysed by means of a retrospective drug utilisation review (DUR) study. The usage of Coxib medicine items was determined, and compared for the periods before and after the withdrawal of Vioxx® in September 2004. It was found that between 9 and 10.5 per cent of prescriptions dispensed through both medicine claim database I and medicine claim database M during the study period were NSAID prescriptions. NSAID medicine items on medicine claim database I represented between 3.9 % (R25 942 986) and 2.9 % (R8 073 034) of the total cost of all medicine items claimed from 2004 to 2006. NSAIDs represented 3.1 % (R58 290 412) and 2.8 % (R57 752 267) of the cost of all medicine items claimed through medicine claim database M during 2005 and 2006 respectively, indicating similar trends in the two medicine claim databases. The prevalence of Coxibs on medicine claim database I decreased from almost 20 % (47 938) in 2004 to 8.4 % (13 276) in 2005, but showed an increase again to 10.9 % (12 355) in 2006. The prevalence of both cyclo-oxygenase (COX) inhibitors, and Coxibs demonstrated a change during 1 September 2004 to 31 December 2004 when COX-inhibitors showed an increase in use, while Coxibs showed and almost equal but opposite trend with a decrease in use. This could possibly be related to perceptions of providers and public with regard to Coxibs and their related safety after the withdrawal of Vioxx® on 30 September 2004 (Merck, 2004) and other Coxibs such as Bextra® (FDA, 2005) in 2005 in USA. It is concluded that most patients who were using Coxibs before the withdrawal of Vioxx®, substituted Coxibs for COX-inhibitors, that are known for their possible gastro-intestinal side-effects. Recommendations for future research regarding NSAID use were also made, and included an investigation of the usage of Coxibs in different age groups, as well as the combination of NSAIDs with gastro-protective medicines in long-term use. / Thesis (M.Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2009.

More people living with HIV/AIDS reside in South Africa than any other country in the world, and the nation faces colossal challenges in broadening its response to the now-mature and widespread HIV epidemic (WHO, 2005:1). According to South Africa's Medical Research Council, HIV/AIDS has now become the single largest cause of death in South Africa (Dorrington et a/., 2001:6) and has triggered a prominent transferal in the pattern of mortality from the elderly to the young, particularly among young women (Dorrington, 2001:4). The routine treatment of HIV/AIDS with antiretroviral drugs has transformed HIV-infection from an unvaryingly rapidly terminal illness to a somewhat expensive treatable, chronic disease. Triple therapy or highly active antiretroviral therapy (three-drug combinations of ARVs or HAART) in particular have had paramount impacts on HIV-related morbidity and mortality in settings where these drugs are generally accessible. Objectives of ARV treatment are "maximum, durable suppression of viral load, restoration and/or preservation of immune function, improvement of quality of life and reduction of HIV related morbidity and mortality" (Martinson et a/., 2003:236; Martinez et a/., 2007:251; Hellinger, 2006:1; Kumarasamy, 2004:3). The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated that a total of 111 827 South Africans were accessing free antiretroviral treatment in the 200 public health sector facilities across 53 districts and a further 60 000 via the private sector by late December 2005 (UNAIDS, 2005:1). The objective of this study was to review, analyse and interpret the usage and prescribing patterns of antiretroviral drugs in a section of the South African private health care sector for the period 1 January 2005 to 31 December 2006 by utilising a medicine claims database of a pharmacy benefit management company, and to investigate the costs associated with these drugs by performing a quantitative, retrospective drug utilisation review. It was found that the prevalence as well as the total medicine cost of ARV medicine items had increased during the study period but the average number of ARV medicine items per prescription as well as both the average cost per ARV medicine item and the average cost per ARV prescription decreased during the study period. Original innovator ARV medicine items and original ARV medicine items with no generic were found to be relatively expensive in comparison with ARV medicine items in general. Conversely, generic ARV medicine items were ascertained to be relatively inexpensive with reference to ARV medicine items in general. It was perceived that the average cost of ARV medicine items and prescriptions for both genders decreased from 2005 to 2006, while there was an increase in the prevalence of medicine items and prescriptions claimed for both female and male patients. The prevalence and cost of all types of ARV medicine items were found to be higher for female patients in general. It was also established that the prevalence of patients receiving antiretroviral treatment in the private health care sector peaks at the age of >30 to 244 years, in comparison with the lower age of >25 to 239 years in the public health care sector. ARV medicine items claimed for patients in the age group >35 to 239 years represented the highest percentage of the total medicine cost incurred during both study years for all ARV medicine types. The majority of ARV medicine items were prescribed by general medical practitioners, and most ARV medicine items were dispensed by community or private institutional pharmacies. It was determined that combinations of 2NRTI + NNRTI were prescribed with the highest frequency, which is compliant with traditional HAART or 'triple therapy' regimens. Lastly, it was found that none of the top 20 prescriptions for one, two and six ARV medicine items were compliant with the National Antiretroviral Treatment (ART) Guidelines. The majority of the top 20 prescriptions for three ARV medicine items (92.67 per cent during 2005 and 89.94 per cent during 2006) were compliant with the National ART Guidelines. Finally, less than half of the top 20 prescriptions for four ARV medicine items (49.60 per cent during 2005 and 36.11 per cent during 2006) were compliant with the National ART Guidelines. Only 5.56 per cent and 3.92 per cent of the top 16 prescriptions for five ARV medicine items were compliant with the National ART Guidelines during the two study years respectively / Thesis (M. Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2009.

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for systemic control of acute and chronic pain and inflammation (Lin et ah, 2000:1129), but usage problems and side-effects that occur during the post-marketing phase of these drugs are well documented (Thiefin & Beaugerie, 2005:287). Following the demonstration of the value of anti-inflammatory therapy in diseases like rheumatoid arthritis (Boardman & Dudley Hart, 1967:268), new NSAIDs appeared on the market (Dieppe et al., 2004:867), and the indications steadily broadened from inflammatory diseases to almost any painful condition. Studies have indicated that NSAID-associated serious upper gastro-intestinal (GI) adverse events result in 103 000 hospitalisations (Bombardier, 2002:4) and 165 000 deaths per year in the United States. A study in South Africa in 2002 indicated that NSAID utilisation contributed considerably to the total cost of all medicine items from a medicine claim database in the private health care sector (Joubert, 2002:260). The objective of this study was to determine the prevalence and cost of non-steroid anti-inflammatory drugs in a section of the private health care sector, and specifically to determine the prevalence, usage and cost of Coxib (Specific cyclo-oxygenase-2 inhibitor) medicine items before and after the withdrawal of Vioxx® from the market in September 2004 (Merck, 2004). Data from two medicine claim databases for the years 2004, 2005 and 2006 (medicine claim database I) and the years 2005 and 2006 (medicine claim database M), were analysed by means of a retrospective drug utilisation review (DUR) study. The usage of Coxib medicine items was determined, and compared for the periods before and after the withdrawal of Vioxx® in September 2004. It was found that between 9 and 10.5 per cent of prescriptions dispensed through both medicine claim database I and medicine claim database M during the study period were NSAID prescriptions. NSAID medicine items on medicine claim database I represented between 3.9 % (R25 942 986) and 2.9 % (R8 073 034) of the total cost of all medicine items claimed from 2004 to 2006. NSAIDs represented 3.1 % (R58 290 412) and 2.8 % (R57 752 267) of the cost of all medicine items claimed through medicine claim database M during 2005 and 2006 respectively, indicating similar trends in the two medicine claim databases. The prevalence of Coxibs on medicine claim database I decreased from almost 20 % (47 938) in 2004 to 8.4 % (13 276) in 2005, but showed an increase again to 10.9 % (12 355) in 2006. The prevalence of both cyclo-oxygenase (COX) inhibitors, and Coxibs demonstrated a change during 1 September 2004 to 31 December 2004 when COX-inhibitors showed an increase in use, while Coxibs showed and almost equal but opposite trend with a decrease in use. This could possibly be related to perceptions of providers and public with regard to Coxibs and their related safety after the withdrawal of Vioxx® on 30 September 2004 (Merck, 2004) and other Coxibs such as Bextra® (FDA, 2005) in 2005 in USA. It is concluded that most patients who were using Coxibs before the withdrawal of Vioxx®, substituted Coxibs for COX-inhibitors, that are known for their possible gastro-intestinal side-effects. Recommendations for future research regarding NSAID use were also made, and included an investigation of the usage of Coxibs in different age groups, as well as the combination of NSAIDs with gastro-protective medicines in long-term use. / Thesis (M.Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2009.

Objectives. To study medication utilization and adherence to prescribed therapy in a female population in central Sweden. To study usage of hormone replacement therapy (HRT) in this population and to assess how HRT users compare to non-users regarding symptom reporting, general health and other variables. To evaluate symptom prevalence adjusted for potential symptom affecting variables. Material and methods. A cross-sectional postal questionnaire study was performed in 1995 in seven counties in central Sweden. A questionnaire was sent to a random sample of 4,200 women aged 35-64, of whom 2,991 responded (71.2%). The questionnaire contained questions on psycho-socio-economic background, quality of life, self-reported health, height and weight, climacteric symptom prevalence, and menopausal status and symptoms. It also comprised questions on medication prescribed during the past year. Results. 40% used prescribed medication and 12% took four drugs or more. Age, educational level, self-rated health, and BMI remained significantly correlated to drug use in multivariate analysis. Adherence ranged from 15%-98% depending on age, a scheduled check-up, perceived importance of medication, concern about medication, taking cardiovascular and respiratory disease drugs. The highest adherence was found for hormonal medication the lowest for musculoskeletal medication. HRT was used by 15% of the women. 13 % used other symptom relieving therapy. HRT users reported higher score of vasomotor symptoms, except for sweating during the daytime. Prevalence of general symptoms did not necessarily increase with age. Especially symptoms related to stress-tension-depression decreased with age. Four different symptom prevalence patterns were found. Conclusions. Age, health status, educational level and body mass index (BMI) appear to affect drug use. Adherence to therapy is highest among elderly women who regard their medication as important and have a scheduled check-up. HRT relieves some vasomotor symptoms but does not affect other symptoms or self-rated health. Prevalence of symptoms related to Stress-tension-depression appears to decrease with age.

Analysis of utilisation and spontaneous adverse events reports related to human papillomavirus vaccines Author: Tereza Schrommová Supervisor: PharmDr. Eva Zimčíková, Ph.D. Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University INTRODUCTION: HPV vaccination is one of the most effective types of prevention against the human papillomavirus infection that can lower the probability of its incidence up to 80-90 %. Besides the benefits of vaccination, there can also occur among many individuals certain risks and adverse effects. Spontaneous adverse events reports are used to identify these serious and unexpected adverse effects, their monitoring leads to increasing safety of therapy. Drug consumption is monitored to uncover the ratio of population exposure to certain drug during specific time in specific socioeconomic group. OBJECTIVE: The objective of this diploma was analysis of spontaneous adverse events reports of vaccines against the human papillomavirus that are registered in database of State Institute for Drug Control in the period from May 2007 to October 2017. Another aim of this work was to evaluate consumption of HPV vaccines in the Czech Republic in the period from 2006 to 2019 using data from State Institute for Drug Control again. METHODS:...

About 30.00% of schizophrenic patients fail to respond to conventional antipsychotics. Clozapine shows superior efficacy, for both the positive and negative symptoms of schizophrenia, over conventional antipsychotics. The reputation of clozapine lies mainly with its repeated proven efficacy in the treatment of refractory schizophrenia. However, clozapine has quite a severe side effect profile. Patients receiving clozapine therapy may develop serious adverse effects such as agranulocytosis, neutropenia and metabolic syndrome. Therefore guidelines are required which recommend that regular haematological and metabolic monitoring be performed. These monitoring guidelines should assist medical practitioners in the early detection and reporting of serious adverse effects associated with clozapine therapy. South Africa lacks uniform provincial or national guidelines regulating practices in the treatment of mental disorders. International guidelines may be considered, which are not specifically adapted for the South African setting. These guidelines recommend both the haematological and metabolic monitoring of clozapine. At present there are no South African guidelines recommending the metabolic monitoring of clozapine. The general aim of the study was to determine the prescribing and monitoring patterns of clozapine at Elizabeth Donkin Hospital in the Nelson Mandela Metropole. Due to the absence of specific South African guidelines and the severe side effect profile of clozapine, some of the research objectives were to determine whether the initiation of clozapine, as well as the haematological and metabolic monitoring performed, was compliant with international clinical guidelines. In this pharmacoepidemiological study a retrospective drug utilisation review was performed. The study was observational in design and included quantitative data. Data were collected from the files of 65 patients (N=65) discharged on clozapine between 1 December 2010 and 29 February 2012. Follow-up investigations were performed at the clinics and long-term care centres both three months and six months after discharge. In 52.30% (n=34) of the cases clozapine was previously prescribed. Compliance with the National Institute for Health and Clinical Excellence (NICE) guidelines for the appropriate initiation of clozapine was 63.10% (n=41). Compliance with the Standard Treatment guidelines for the initiation of clozapine by a psychiatrist was 63.10% (n=41). Noncompliance with the recommended guidelines for haematological monitoring occurred in 77.40% of patients in the hospital setting (n=48) as well as in 95.70% of patients during the three-month follow-up at the clinics (n=44). Non-compliance with the guidelines for metabolic monitoring occurred in all the observed patients in the hospital setting (n=62) as well as in 45.70% of patients in the clinic setting (n=21). It was found that 71.00% (n=46) of patients were still on clozapine three months after discharge and 65.00% (n=42) were still on clozapine six months after discharge from hospital, resulting in discontinuation rates of 29.00% and 35.00% respectively. It was found that clozapine was inadequately monitored although in most cases the initiation of clozapine was compliant with the recommended guidelines. However, practitioners should be trained on the existing prescribing and monitoring guidelines to promote the rational use of clozapine in the public health sector of South Africa. / MPham (Pharmacy Practice), North-West University, Potchefstroom Campus, 2014

About 30.00% of schizophrenic patients fail to respond to conventional antipsychotics. Clozapine shows superior efficacy, for both the positive and negative symptoms of schizophrenia, over conventional antipsychotics. The reputation of clozapine lies mainly with its repeated proven efficacy in the treatment of refractory schizophrenia. However, clozapine has quite a severe side effect profile. Patients receiving clozapine therapy may develop serious adverse effects such as agranulocytosis, neutropenia and metabolic syndrome. Therefore guidelines are required which recommend that regular haematological and metabolic monitoring be performed. These monitoring guidelines should assist medical practitioners in the early detection and reporting of serious adverse effects associated with clozapine therapy. South Africa lacks uniform provincial or national guidelines regulating practices in the treatment of mental disorders. International guidelines may be considered, which are not specifically adapted for the South African setting. These guidelines recommend both the haematological and metabolic monitoring of clozapine. At present there are no South African guidelines recommending the metabolic monitoring of clozapine. The general aim of the study was to determine the prescribing and monitoring patterns of clozapine at Elizabeth Donkin Hospital in the Nelson Mandela Metropole. Due to the absence of specific South African guidelines and the severe side effect profile of clozapine, some of the research objectives were to determine whether the initiation of clozapine, as well as the haematological and metabolic monitoring performed, was compliant with international clinical guidelines. In this pharmacoepidemiological study a retrospective drug utilisation review was performed. The study was observational in design and included quantitative data. Data were collected from the files of 65 patients (N=65) discharged on clozapine between 1 December 2010 and 29 February 2012. Follow-up investigations were performed at the clinics and long-term care centres both three months and six months after discharge. In 52.30% (n=34) of the cases clozapine was previously prescribed. Compliance with the National Institute for Health and Clinical Excellence (NICE) guidelines for the appropriate initiation of clozapine was 63.10% (n=41). Compliance with the Standard Treatment guidelines for the initiation of clozapine by a psychiatrist was 63.10% (n=41). Noncompliance with the recommended guidelines for haematological monitoring occurred in 77.40% of patients in the hospital setting (n=48) as well as in 95.70% of patients during the three-month follow-up at the clinics (n=44). Non-compliance with the guidelines for metabolic monitoring occurred in all the observed patients in the hospital setting (n=62) as well as in 45.70% of patients in the clinic setting (n=21). It was found that 71.00% (n=46) of patients were still on clozapine three months after discharge and 65.00% (n=42) were still on clozapine six months after discharge from hospital, resulting in discontinuation rates of 29.00% and 35.00% respectively. It was found that clozapine was inadequately monitored although in most cases the initiation of clozapine was compliant with the recommended guidelines. However, practitioners should be trained on the existing prescribing and monitoring guidelines to promote the rational use of clozapine in the public health sector of South Africa. / MPham (Pharmacy Practice), North-West University, Potchefstroom Campus, 2014

Thesis (M. Pharm.)--North-West University, Potchefstroom Campus, 2008.

In South Africa, significant changes in health care have taken place since the first democratic elections in 1994. The change had lead to a position of integrated service delivery with specific reference to primary health care. Increasingly in developing countries, the private sector impacts significantly on the rights to education and the highest attainable standard of health. Inappropriate prescribing e.g. prescribing a drug without an acceptable indication, specifying an incorrect dosage, schedule or duration of treatment, duplicating therapeutic agents and prescribing drugs without adequate regard to potential interactions, can cause adverse outcomes, deplete health care resources, compromise the quality of care and possible increase in health costs. One approach monitoring prescribing practices is drug utilisation review. The general objective of this study was to review and interpret aspects of drug usage patterns in a private primary health care setting, with special reference to the top ten diagnoses made and the top twenty medicine items prescribed as well as the associated costs. A quantitative, retrospective drug utilisation review as well as certain aspects of managed and primary health care, pharmacoeconomics, pharmacoepidemiology, medicine formularies and standard treatment guidelines were reviewed in the literature as a base for the study. The results of the empirical study showed that 83648 patients consulted at the nine medicentres during the study period (1 January to 31 December 2001). A total number of 132591 patient visits (consultations) were made, 140723 medical conditions (diagnoses) performed and 516177 medicine items prescribed during the study period. Analysis of medicine usage patterns and associated costs of the top ten diagnoses made and top twenty medicine items prescribed in the study population, revealed the following: The top ten diagnoses determined accounted for 29.07% of the total number of diagnoses made, . a total medicine treatment cost accounting for 32.11% in the study population, . the top twenty medicine items determined accounted for 56.23% of the total medicine items prescribed and . a total medicine treatment cost accounting for 28.63% in the study population. The highest prevalence of diagnoses made and medicine items prescribed was found in age groups 4 and 5 (Le. patients between the ages of 19 to 40 years) and was also found to be more prevalent in the female than in the male population. In completion of the research, recommendations to review the medicentres medicine treatment protocols and on provision of primary health care education were made. Reference to the investigation of environmental factors is also made. / Thesis (M.Pharm.)--North-West University, Potchefstroom Campus, 2004.