Antiretroviral drugs are successful in controlling HIV/AIDS and reducing disease progression. Antiretroviral regimens are stopped in up to 25% of all patients during their initial treatment therapy as a result of adverse drug effects, failing treatment and nonadherence within the initial eight months of treatment (Sharma et al., 2007: 235). A pharmacovigilance surveillance system makes it possible for physicians, pharmacists and other healthcare providers to report suspected ADRs. The purpose of this system is to operate as a guide in identification of new ADRs and predisposing risk factors to known ADRs. The objective of this study was to assess the prevalence and documentation of adverse drug reactions (ADR) in the private and public antiretroviral clinics in Maseru district, with special reference to zidovudine (AZT) and tenofovir (TDF) - based regimens. The empirical investigation was divided into two phases. The first phase was a cross-sectional quantitative retrospective drug utilisation review study which focused on the occurrence of adverse drug reactions in patients taking zidovudine (AZT) and tenofovir (TDF). The second phase, a survey in a form of questionnaires for the health professionals. Drug utilisation review: The sample size of patients was 300. Of the 44 patients who experience ADRs, 72.73% (n = 32) were female and 27.27% (n = 12) were male. A greater number of patients who experienced ADRs were females with 43.18% (n = 19) presenting with skin rash, 27.27% (n = 12) with nausea/vomiting, and 2.27% (n = 1) with diarrhoea. In male patients, 2.27% (n = 1) had peripheral neuropathy, 18.18% (n = 8) skin rash, 2.27% (n = 1) Fanconi syndrome, 2.27% (n = 1) nausea/vomiting, and 2.27% (n = 1) diarrhoea. Patients whose ART regimen changed due to ADRs were five. 60% (n = 3) of the patients were females and 40% (n = 2) were males. There was an estimated increase of 0.0025 cell/mm³, 0.0026 cell/mm³, 0.0024 cell/mm³, 0.0025 cell/mm³, and of 0.0019 cell/mm³ in CD4 cell count per day according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. An estimated increase of 0.00021 g/dL, 0.00022 g/dL, 0.00018 g/dL, 0.00022 g/dL, and of 0.00020 g/dL in Hb profile per day occurred according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. There was an estimated increase of 0.000062%, 0.000046%, 0.000068%, 0.000062%, and of 0.00017% in neutrophil count according to sex, age group, weight group, initial ART regimen, and ADRs per day, respectively. There was an estimated increase of 0.000044 IU/L, 0.000043 IU/L, 0.000046 IU/L, and of 0.000028 IU/L in ALT according to sex, age group, weight group, and initial ART regimen per day, respectively. An estimated decrease of 0.000013 IU/L in ALT according to ADRs per day also occurred. There was an estimated decrease of 0.00038 μmol/L, 0.00039 μmol/L, 0.00040 μmol/L, 0.00040 μmol/L, and of 0.00028 μmol/L in serum creatinine per day according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. There was an estimated decline of 0.00023 mmol/L, 0.00022 mmol/L, 0.00023 mmol/L, 0.00024 mmol/L, and of 0.00015 mmol/L per day in urea according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. Health professional’s questionnaire: 49 health professionals responded to the questionnaire. 100% (n= 49) of the participants showed that they did not use the yellow card scheme to report ADRs. 34.65% (n = 17) use the individual case safety reports. 57.14% (n = 28) used the structured databases to report ADRs. 85.71% (n = 42) documented in the patient bukana, and 6.12% (n = 3) used the HIV/AIDS ART card to document ADRs occurrence. 91.84% (n = 45) of the health professionals never filled the ADR reporting form in their working environment. In conclusion, adverse drug reactions occurring in a hospital or healthcare facility should be recorded and reported by the medical practitioners, nurses, pharmacists, and the pharmacy technicians. Therefore, it is important to assess the continuous evaluation of the benefits and harm of medicines which will help in achieving the ultimate goal of making safer and more effective treatment available for patients. As well as to help the health professionals to participate in the very important process of continuous surveillance of safety and efficacy of pharmaceutical products used in clinical practice. / MPham (Pharmacy Practice), North-West University, Potchefstroom Campus, 2014

Antiretroviral drugs are successful in controlling HIV/AIDS and reducing disease progression. Antiretroviral regimens are stopped in up to 25% of all patients during their initial treatment therapy as a result of adverse drug effects, failing treatment and nonadherence within the initial eight months of treatment (Sharma et al., 2007: 235). A pharmacovigilance surveillance system makes it possible for physicians, pharmacists and other healthcare providers to report suspected ADRs. The purpose of this system is to operate as a guide in identification of new ADRs and predisposing risk factors to known ADRs. The objective of this study was to assess the prevalence and documentation of adverse drug reactions (ADR) in the private and public antiretroviral clinics in Maseru district, with special reference to zidovudine (AZT) and tenofovir (TDF) - based regimens. The empirical investigation was divided into two phases. The first phase was a cross-sectional quantitative retrospective drug utilisation review study which focused on the occurrence of adverse drug reactions in patients taking zidovudine (AZT) and tenofovir (TDF). The second phase, a survey in a form of questionnaires for the health professionals. Drug utilisation review: The sample size of patients was 300. Of the 44 patients who experience ADRs, 72.73% (n = 32) were female and 27.27% (n = 12) were male. A greater number of patients who experienced ADRs were females with 43.18% (n = 19) presenting with skin rash, 27.27% (n = 12) with nausea/vomiting, and 2.27% (n = 1) with diarrhoea. In male patients, 2.27% (n = 1) had peripheral neuropathy, 18.18% (n = 8) skin rash, 2.27% (n = 1) Fanconi syndrome, 2.27% (n = 1) nausea/vomiting, and 2.27% (n = 1) diarrhoea. Patients whose ART regimen changed due to ADRs were five. 60% (n = 3) of the patients were females and 40% (n = 2) were males. There was an estimated increase of 0.0025 cell/mm³, 0.0026 cell/mm³, 0.0024 cell/mm³, 0.0025 cell/mm³, and of 0.0019 cell/mm³ in CD4 cell count per day according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. An estimated increase of 0.00021 g/dL, 0.00022 g/dL, 0.00018 g/dL, 0.00022 g/dL, and of 0.00020 g/dL in Hb profile per day occurred according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. There was an estimated increase of 0.000062%, 0.000046%, 0.000068%, 0.000062%, and of 0.00017% in neutrophil count according to sex, age group, weight group, initial ART regimen, and ADRs per day, respectively. There was an estimated increase of 0.000044 IU/L, 0.000043 IU/L, 0.000046 IU/L, and of 0.000028 IU/L in ALT according to sex, age group, weight group, and initial ART regimen per day, respectively. An estimated decrease of 0.000013 IU/L in ALT according to ADRs per day also occurred. There was an estimated decrease of 0.00038 μmol/L, 0.00039 μmol/L, 0.00040 μmol/L, 0.00040 μmol/L, and of 0.00028 μmol/L in serum creatinine per day according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. There was an estimated decline of 0.00023 mmol/L, 0.00022 mmol/L, 0.00023 mmol/L, 0.00024 mmol/L, and of 0.00015 mmol/L per day in urea according to sex, age group, weight group, initial ART regimen, and ADRs, respectively. Health professional’s questionnaire: 49 health professionals responded to the questionnaire. 100% (n= 49) of the participants showed that they did not use the yellow card scheme to report ADRs. 34.65% (n = 17) use the individual case safety reports. 57.14% (n = 28) used the structured databases to report ADRs. 85.71% (n = 42) documented in the patient bukana, and 6.12% (n = 3) used the HIV/AIDS ART card to document ADRs occurrence. 91.84% (n = 45) of the health professionals never filled the ADR reporting form in their working environment. In conclusion, adverse drug reactions occurring in a hospital or healthcare facility should be recorded and reported by the medical practitioners, nurses, pharmacists, and the pharmacy technicians. Therefore, it is important to assess the continuous evaluation of the benefits and harm of medicines which will help in achieving the ultimate goal of making safer and more effective treatment available for patients. As well as to help the health professionals to participate in the very important process of continuous surveillance of safety and efficacy of pharmaceutical products used in clinical practice. / MPham (Pharmacy Practice), North-West University, Potchefstroom Campus, 2014

HIV/AIDS is already the leading cause of death worldwide (Unicef et al., 2004:10) with more than 5 million people out of a total of 46 million South Africans that were HIV positive in 2004, giving a total population prevalence rate of 11 per cent (Dorrington et al., 2004:1). Many people infected do not have access to even the basic drugs needed to treat HIV-related infections and other conditions (Wikipedia, 2004:3). The relative high price of many of the antiretroviral (ARV) drugs and diagnostics on the other hand are one of the main barriers to their availability in developing countries (Unicef et al., 2004:77). ARV drugs registered in South Africa include the Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and Protease Inhibitors (PIs) (MCC, 2004:1). The objective of this study was to review, analyse and interpret the prescribing patterns of antiviral drugs, with special reference to antiretroviral drugs, in the private health care sector in South Africa by using a medicine claims database. A quantitative, retrospective drug utilisation review was performed. The data ranging from 1 January 2001 to 31 December 2001, 1 January 2002 to 31 December 2002, and 1 January 2004 to 31 December 2004 were used, dividing each year into three four-month periods, namely January to April, May to August, and September to December. It was found that 0.38 per cent (n=1 475 380) for 2001, 0.72 per cent (n=2 076 236) for 2002, and 1.68 per cent (n=2 595 254) for 2004 of all studied prescriptions for the research periods 2001, 2002, and 2004 respectively, contained ARV drugs. ARV drugs constituted 0.33 per cent (n=2 951 326) for 2001, 0.87 per cent (n=4 042 145) for 2002, and 1.92 per cent (n=5 305 882) for 2004 of the total number of medicine items prescribed for the study years 2001, 2002 and 2004 respectively. The total cost of ARV drugs amounted to R4 990 784.29, thus constituting 1.31 per cent of the total cost (R379 708 489) of all medicine items on the database for 2001, increased to R18 235 075.75, thus constituting 3.03 per cent of the total cost (R601 350 325) of all medicine items on the database for 2002, and increased to R34 714 483.64, thus constituting 5.25 per cent of the total cost (R661 223 146) of all medicine items on the database for 2004. It was found that 35.31 per cent (n=5 599) for 2001, 52.68 per cent (n=15 004) for 2002, and 74.27 per cent (n=43 482) for 2004 of all studied antiviral prescriptions for the research periods 2001, 2002, and 2004 respectively, contained ARV drugs. ARV drugs constituted 46.25 per cent (n=21 183) for 2001, 70.20 per cent (n=50 246) for 2002, and 85.87 per cent (n=118 718) for 2004 of the total number of antiviral medicine items prescribed for the study years 2001, 2002 and 2004 respectively. The total cost of ARV medicine items, represented 67.33 per cent (n=R4 990 784.29) during 2001, 84.72 per cent (n=R18 235 075.75) during 2002, and 91.20 per cent (n=R34 714 483.64) during 2004 of the total cost of all antiviral medicine items claimed through the database (n=R7412577.73 for 2001, n=R21523365.56 for 2002, and n=R38 064 347.38 for 2004). The average cost per ARV medicine items for 2004 increased from R317.93i190.80 for the period January to April to R369.2W219.50 for the period May to August, and decreased to R324.79±212.48 for the period September to December and resulted in a cost saving of R41 044.35 for the period May to August versus September to December for the ARV medicine items. The implementation of the pricing regulations could thus be a possible reason for this cost saving, due to fact that the single exit price only came into effect from May 2004. The weighted average number of ARV medicine items per prescription was 1.75*0.31 for 2001, increased to 2.35±0.03 to 2002 and remained stable on 2.35±0.02 for 2004. It was found that majority of prescriptions contained more combination ARV medicine items than single ARV medicine items, ranging from 6 834 (69.76 per cent; n=9 796) prescriptions containing combination ARV medicine items in 2001 and 32 941 (93.39 per cent; n=35 271) prescriptions containing combination ARV medicine items in 2002 to 98 805 (96.93 per cent; n=101 938) prescriptions containing combination ARV medicine items in 2004. Lastly, it was perceived that didanosine was the active ingredient with the largest prevalence for all three four-month periods of 2001 and also for the periods January to April and May to August of 2002, whilst efavirenz represented the active ingredient with the largest prevalence for the period September to December of 2002, and also for all three four-month periods of 2004. Didanosine represented the active ingredient with the highest total cost for the period January to April of 2001, whilst the combination of lamivudine/zidovudine represented the active ingredient with the highest total cost for the periods May to August and September to December of 2001, and also for all three-four month periods of 2002 and 2004. Nelfinavir has the highest average cost for period January to April of 2001, ritonavir for period May to August of 2001, and saquinavir mesylate for period September to December of 2001. Nelfinavir has the highest average cost for all three-four month periods of 2002, while didanosine has the highest average cost for all three four-month periods of 2004. / Thesis (M.Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2006

Thesis (M.Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2006.

HIV/AIDS is already the leading cause of death worldwide (Unicef et al., 2004:10) with more than 5 million people out of a total of 46 million South Africans that were HIV positive in 2004, giving a total population prevalence rate of 11 per cent (Dorrington et al., 2004:1). Many people infected do not have access to even the basic drugs needed to treat HIV-related infections and other conditions (Wikipedia, 2004:3). The relative high price of many of the antiretroviral (ARV) drugs and diagnostics on the other hand are one of the main barriers to their availability in developing countries (Unicef et al., 2004:77). ARV drugs registered in South Africa include the Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and Protease Inhibitors (PIs) (MCC, 2004:1). The objective of this study was to review, analyse and interpret the prescribing patterns of antiviral drugs, with special reference to antiretroviral drugs, in the private health care sector in South Africa by using a medicine claims database. A quantitative, retrospective drug utilisation review was performed. The data ranging from 1 January 2001 to 31 December 2001, 1 January 2002 to 31 December 2002, and 1 January 2004 to 31 December 2004 were used, dividing each year into three four-month periods, namely January to April, May to August, and September to December. It was found that 0.38 per cent (n=1 475 380) for 2001, 0.72 per cent (n=2 076 236) for 2002, and 1.68 per cent (n=2 595 254) for 2004 of all studied prescriptions for the research periods 2001, 2002, and 2004 respectively, contained ARV drugs. ARV drugs constituted 0.33 per cent (n=2 951 326) for 2001, 0.87 per cent (n=4 042 145) for 2002, and 1.92 per cent (n=5 305 882) for 2004 of the total number of medicine items prescribed for the study years 2001, 2002 and 2004 respectively. The total cost of ARV drugs amounted to R4 990 784.29, thus constituting 1.31 per cent of the total cost (R379 708 489) of all medicine items on the database for 2001, increased to R18 235 075.75, thus constituting 3.03 per cent of the total cost (R601 350 325) of all medicine items on the database for 2002, and increased to R34 714 483.64, thus constituting 5.25 per cent of the total cost (R661 223 146) of all medicine items on the database for 2004. It was found that 35.31 per cent (n=5 599) for 2001, 52.68 per cent (n=15 004) for 2002, and 74.27 per cent (n=43 482) for 2004 of all studied antiviral prescriptions for the research periods 2001, 2002, and 2004 respectively, contained ARV drugs. ARV drugs constituted 46.25 per cent (n=21 183) for 2001, 70.20 per cent (n=50 246) for 2002, and 85.87 per cent (n=118 718) for 2004 of the total number of antiviral medicine items prescribed for the study years 2001, 2002 and 2004 respectively. The total cost of ARV medicine items, represented 67.33 per cent (n=R4 990 784.29) during 2001, 84.72 per cent (n=R18 235 075.75) during 2002, and 91.20 per cent (n=R34 714 483.64) during 2004 of the total cost of all antiviral medicine items claimed through the database (n=R7412577.73 for 2001, n=R21523365.56 for 2002, and n=R38 064 347.38 for 2004). The average cost per ARV medicine items for 2004 increased from R317.93i190.80 for the period January to April to R369.2W219.50 for the period May to August, and decreased to R324.79±212.48 for the period September to December and resulted in a cost saving of R41 044.35 for the period May to August versus September to December for the ARV medicine items. The implementation of the pricing regulations could thus be a possible reason for this cost saving, due to fact that the single exit price only came into effect from May 2004. The weighted average number of ARV medicine items per prescription was 1.75*0.31 for 2001, increased to 2.35±0.03 to 2002 and remained stable on 2.35±0.02 for 2004. It was found that majority of prescriptions contained more combination ARV medicine items than single ARV medicine items, ranging from 6 834 (69.76 per cent; n=9 796) prescriptions containing combination ARV medicine items in 2001 and 32 941 (93.39 per cent; n=35 271) prescriptions containing combination ARV medicine items in 2002 to 98 805 (96.93 per cent; n=101 938) prescriptions containing combination ARV medicine items in 2004. Lastly, it was perceived that didanosine was the active ingredient with the largest prevalence for all three four-month periods of 2001 and also for the periods January to April and May to August of 2002, whilst efavirenz represented the active ingredient with the largest prevalence for the period September to December of 2002, and also for all three four-month periods of 2004. Didanosine represented the active ingredient with the highest total cost for the period January to April of 2001, whilst the combination of lamivudine/zidovudine represented the active ingredient with the highest total cost for the periods May to August and September to December of 2001, and also for all three-four month periods of 2002 and 2004. Nelfinavir has the highest average cost for period January to April of 2001, ritonavir for period May to August of 2001, and saquinavir mesylate for period September to December of 2001. Nelfinavir has the highest average cost for all three-four month periods of 2002, while didanosine has the highest average cost for all three four-month periods of 2004. / Thesis (M.Pharm. (Pharmacy Practice))--North-West University, Potchefstroom Campus, 2006

This non-experimental, retrospective, descriptive and correlational study investigated adherence to antiretroviral drugs among HIV positive patients at Mpilo Central Hospital in Bulawayo Zimbabwe. Data among 118 patients was extracted from clinic registers and patient facility held medical records to determine level of adherence to ART using pharmacy refills (a non-immunological adherence parameter) and compared to CD4 cell count ( an immunological adherence parameter). Adherence levels obtained in this study using pharmacy refills was low (62.7%) and a relatively high non-adherence level of 37.3%. The pharmacy refill adherence level obtained was comparable to CD4 cell count adherence level of 64.6% (as indicated by a 50% CD4 cell count gain). These findings would seem to indicate the need for more education on the importance of adherence and further the need for better adherence monitoring systems / Health Studies / M.A. (Public Health)

This non-experimental, retrospective, descriptive and correlational study investigated adherence to antiretroviral drugs among HIV positive patients at Mpilo Central Hospital in Bulawayo Zimbabwe. Data among 118 patients was extracted from clinic registers and patient facility held medical records to determine level of adherence to ART using pharmacy refills (a non-immunological adherence parameter) and compared to CD4 cell count ( an immunological adherence parameter). Adherence levels obtained in this study using pharmacy refills was low (62.7%) and a relatively high non-adherence level of 37.3%. The pharmacy refill adherence level obtained was comparable to CD4 cell count adherence level of 64.6% (as indicated by a 50% CD4 cell count gain). These findings would seem to indicate the need for more education on the importance of adherence and further the need for better adherence monitoring systems / Health Studies / M.A. (Public Health)