Possible Changes and Trends in Non-COVID-19 Vaccine-Prescribing Patterns before and during COVID-19 Pandemic.

Due to the COVID-19 pandemic, many children missed their routine vaccinations globally. There is insufficient evidence on the trends in vaccination coverage in the private healthcare sector in South Africa. This study explored the changes in childhood vaccination patterns (non-COVID vaccines) in the private healthcare sector in South Africa using medicine claim data. Using the information on medication claims from a South African pharmaceutical benefit management (PBM) company, we performed a quantitative cross-sectional analysis comparing the period before (2018-2019) and during the COVID-19 pandemic (2020-2021). All patients who made claims within the study period were included. This study included 67,830 children aged two years and younger. In particular, from 2018 to 2021, boys (52%) outnumbered girls (48%). Pharmacists consistently held the predominant prescriber role before and during the COVID-19 pandemic. The proportion of children receiving non-COVID-19 vaccines was higher before the pandemic (60%) than during the pandemic (55%). Furthermore, there was a notable decline of 5% in measles vaccination rates during the children's first year of life, while a notable increase was observed for measles (5%), hepatitis A (7.7%), and the pentavalent vaccine (5%) during the second year of life. Governments and private healthcare providers must take action to enhance vaccination coverage rates for children in their first year of life to prevent a resurgence of vaccine-preventable diseases. The results obtained in this study underscore the significance of implementing vaccine catch-up campaigns to address missed vaccination opportunities arising from the impact of the COVID-19 pandemic. Moreover, pharmacists emerged as the predominant healthcare providers responsible for administering vaccinations within the private healthcare sector in South Africa, both prior and during the COVID-19 pandemic. Their pivotal role in the vaccination process warrants due recognition and should not be underestimated.

Treatment Cost and Psychological Impact of Burkitt Lymphoma on Ghanaian Families and Caregivers.

OBJECTIVE: Before June 2022, the treatment cost of Burkitt lymphoma (BL) in Ghana was mainly borne by the child's family or caregiver. We determined the treatment cost of BL in children and its psychological impact on parents and caregivers. METHOD: This prospective observational study assessed the direct medical and nonmedical costs (US dollars [USD]) incurred during the treatment of a child with BL for 6 consecutive months using a cost diary. Productivity losses and the psychological impact on parents and caregivers were assessed using a self-administered questionnaire and the Caregiver Quality of Life Index-Cancer (CQOLC). RESULTS: Of the 25 participants, 7 abandoned the treatment of their children, and 4 withdrew because the children passed away. The median (Q1, Q3) cost for treating BL per child for caregivers/parents (N = 12) was USD 947.42 (USD 763.03, USD 1953.05). Direct medical costs formed 71% (USD 11 458.97) of total treatment costs. Working hours of parents before the child's cancer diagnosis decreased from a median (Q1, Q3) of 44.00 (20.00, 66.00) hours to 1.50 (0, 20.00) hours after the diagnosis. The mean (SD) CQOLC score was 107.92 (15.89), with higher scores in men (111.00 [17.26]), married participants (111.26 [17.29]), Higher National Diploma certificate holders (113.00 [1.41]), and participants earning a monthly income more than USD 84.60. CONCLUSION: Treatment costs reduced the overall household income of 5 families. Parents and caregivers experienced reduced work hours and loss of employment. CQOLC scores were higher in married participants, those with a higher educational background, and those with higher income.

Development of a checklist for the assessment of pharmacovigilance guidelines in Southern Africa: a document review.

Introduction: National regulatory systems in Southern Africa reflect various stages of maturity, and pharmacovigilance (PV) practices are not aligned. In the absence of guidance for formulating PV guidelines in Southern African Development Community (SADC) countries, this study aimed to create a checklist that may be used to assess the rigour of PV guidelines in this region and provide guidance for the National Medicines Regulatory Agency (NMRA) authors. Methods: A document analysis was performed based on harmonised international guidelines (n = 22) that prescribed methods of PV regulation to identify themes and items to incorporate into a checklist. The contextualisation of the checklist to the African pharmaceutical environment was accomplished by referencing peer-reviewed journal articles (n = 7). The checklist was subjected to face and content validation by non-experts and PV experts. Results: The document review yielded 5 themes, 18 sub-themes, and 73 items structured into the checklist. Themes encompassed PV systems, definitions, individual case safety reporting, aggregate reporting, and risk management. Under PV systems, aspects of the quality management system were outlined, that is, the legal basis for PV, a description of the marketing authorisation holder's (MAH's) PV system, archiving of data, contracting of PV tasks, and the duties of the person responsible for the MAH's PV obligations. Definitions of the key terms and major stakeholders were identified. Reporting of individual case safety reports (ICSRs) was explicated by considering the criteria for reporting, categories of reportable information, expedited reporting requirements, reporting timelines, and ICSR reporting format. Aggregate report submission during the development and post-marketing phases was addressed. Risk management encompassed signal detection, re-evaluation of the benefit-risk ratio, the safety decision-making process, risk management planning, risk minimisation and safety communication. Conclusion: The developed checklist can contribute towards assisting SADC NMRAs to formulate national PV guidelines that reflect current international practice, with local context incorporated. Plain Language Summary: Developing a checklist for the evaluation of medicine safety guidelines in Southern Africa Introduction: In Southern African Development Community (SADC) countries, the guidelines for medicine safety [pharmacovigilance (PV)] that marketing authorisation holders (MAHs) and healthcare professionals need to adhere to, are not aligned. We saw the need to develop a checklist that can be used to evaluate these guidelines.Methods: We studied international documents issued by the World Health Organization (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Council for International Organizations of Medical Sciences (CIOMS) and the European Medicines Agency (EMA). On the organisational websites, we obtained 22 documents and identified 73 checklist items. All the items were arranged under 5 themes and 18 sub-themes to create the checklist. We adapted the checklist to the local context by using seven journal articles addressing PV concerns in Africa. Experts checked the content and usability of the checklist.Results: The themes were PV systems, definitions, individual case safety reporting (ICSR), combined reporting and risk management. PV systems had six sub-themes: legal structure, description of the MAH's PV system, contractual agreements, information storage, the qualified person responsible for PV (QPPV) and where the QPPV is located. We included the definitions of keywords and role-players. The ICSR theme had five sub-themes, i.e. criteria for reporting, categories of reportable information, expedited reporting, reporting timelines, and reporting format. Submission of summary reports comprised an overview of the safety profile of a medicine once it is approved by regulators, as well as during clinical trials. Risk management included signal detection, re-evaluation of the benefit-risk ratio, safety decision-making process, risk management planning, risk minimisation, and safety communication. The checklist is applied by allocating yes/no scoring per item.Conclusion: The checklist may be used by regulators within SADC to assess their PV guidelines for alignment with international standards and suitability to the local environment.

Adherence and clinical outcomes of HIV patients switching to a fixed-dose combination regimen.

Background: The efficacy of antiretroviral therapy (ART) is monitored using clinical markers such as viral load (VL) and CD4 counts. Adherence to ART has been associated with viral suppression and improved clinical outcomes. Objectives: To determine the relationship between adherence status with multiple-tablet regimens (MTR) and fixed-dose combination (FDC) regimens, to weight, CD4 count and VL of patients living with HIV. Method: An observational, descriptive study was conducted on a closed cohort of patients living with HIV and attending a primary health care clinic in Northern Cape in South Africa between 01 January 2013 and 31 December 2015. Patients were on an MTR and changed to an FDC regimen. Adherence was measured using the medicine possession ratio (MPR). Results: Statistically significant differences exist between the mean MPR of the 30-day (p = 0.0308) and 28-day supply (p < 0.0001) of the MTR when compared to FDC regimen. No statistically significant differences could be found between adherence and clinical outcomes such as weight, CD4 count and VL for either MTR or FDC regimens. The suppressed VL values measured for MTR were n = 299 (89.25%) and n = 415 (93.05%) for FDC regimen. Conclusion: Adherence improved when patients were switched to FDC, but no statistically significant differences in clinical outcomes measured as weight, CD4 count and VL between adherence status and regimen type could be found. Contribution: This study contributes to much-needed information about ART adherence and clinical outcomes (such as weight, CD4 count and VL) of adult HIV-positive patients in a public healthcare clinic in the Northern Cape, South Africa.

Coexisting Conditions among Children and Adolescents with Cancer in a Section of the South African Private Health Sector: Perspectives from Drug Utilization Data.

Coexisting conditions are relatively common in children with cancer, however, there is a paucity of information on the prevalence of coexisting conditions in children with cancer in South Africa. This cross-sectional study aimed at investigating the common coexisting conditions occurring in children and adolescents younger than 19 years undergoing cancer chemotherapy in a section of the South African private health sector. Medicine claims data from 1 January 2008 to 31 December 2017 were queried to identify coexisting conditions using the International Classification of Diseases, Tenth Revision (ICD-10) codes indicated on reimbursed claims. Where ICD-10 codes per claim were non-specific, the pharmacological drug classes of non-cytotoxic medications claimed alongside these codes were categorized using the Monthly Index of Medical Specialties (MIMS) classification system and analyzed using the drug utilization 90% (DU90%) principle. Analysis of sub-pharmacologic drug classes was stratified according to gender and age groups. The reimbursement category of these medicines was noted. Data were analyzed descriptively. A total of 173 participants were included in the study. ICD-10 codes were available for 13.65% (N = 2631) of medicine claims. Diseases of the respiratory system (J00-J99, 7.15%), gastrointestinal tract (K00-K95, 1.60%), and skin disorders (L00-L99, 0.95%) were the most prevalent specific diagnoses identified. Non-specific ICD-10 codes were recorded on 86.35% (n = 2272) of non-cytotoxic medicine claims. The most frequently utilized pharmacological classes of medications included antimicrobial agents (17.40%), respiratory system agents (13.91%), and analgesics (10.64%). As determined from ICD-10 codes and medication claimed on reimbursed claims, children and adolescents being treated for cancers mostly suffered from acute conditions, in particular, microbial infections and diseases of the respiratory system. This indicates the need for the integration of antimicrobial surveillance programs into childhood and adolescent cancer care to curb antimicrobial infections.

Childhood cancers in a section of the South African private health sector: Analysis of medicines claims data.

BACKGROUND: Although childhood cancers are rare, increases in incidence have been observed in recent times. There is a paucity of data on the current incidence of childhood cancers in South Africa. AIM: This study described the epidemiology of childhood cancers in a section of the private health sector of South Africa, using medicines claims data. SETTING: This study was designed on a nationally representative medicine claims database. METHOD: A longitudinal open-cohort study employing children younger than 19 years and diagnosed with cancers between 2008 and 2017 was conducted using medicine claims data from a South African Pharmaceutical Benefit Management company. Cases were identified using International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes C00 to C97, together with a medicine claim reimbursed from oncology benefits. Crude incidence rates were calculated per million persons younger than 19 years on the database and standardised using the Segi 1960 world population. Temporal trends in incidence rates, analysed using the joinpoint regression, were reported as annual percentage changes (APCs). RESULTS: Overall, 173 new cases of childhood cancers were identified in the database, translating into an age-standardised incidence rate (ASR) of 82.3 per million. Annual incidence of cancer decreased from 76.7 per million in 2008 to 58.2 per million in 2017. More incident cases were identified in males (68.8%). The highest proportion of incident cases was recorded for leukaemias (39.9%), the 5-9 year age group (34.1%) and the Gauteng Province (49.7%). CONCLUSION: The incidence of childhood cancers decreased over time in the section of the private health sector studied. Leukaemias were the major drivers of childhood cancer incidence.

Childhood cancers in a section of the South African private health sector: Analysis of medicines claims data

Background: Although childhood cancers are rare, increases in incidence have been observed in recent times. There is a paucity of data on the current incidence of childhood cancers in South Africa.Aim: This study described the epidemiology of childhood cancers in a section of the private health sector of South Africa, using medicines claims data.Setting: This study was designed on a nationally representative medicine claims database. Method: A longitudinal open-cohort study employing children younger than 19 years and diagnosed with cancers between 2008 and 2017 was conducted using medicine claims data from a South African Pharmaceutical Benefit Management company. Cases were identified using International Classification of Diseases, Tenth Revision (ICD-10) diagnostic codes C00 to C97, together with a medicine claim reimbursed from oncology benefits. Crude incidence rates were calculated per million persons younger than 19 years on the database and standardised using the Segi 1960 world population. Temporal trends in incidence rates, analysed using the joinpoint regression, were reported as annual percentage changes (APCs). Results: Overall, 173 new cases of childhood cancers were identified in the database, translating into an age-standardised incidence rate (ASR) of 82.3 per million. Annual incidence of cancer decreased from 76.7 per million in 2008 to 58.2 per million in 2017. More incident cases were identified in males (68.8%). The highest proportion of incident cases was recorded for leukaemias (39.9%), the 5­9 year age group (34.1%) and the Gauteng Province (49.7%).Conclusion: The incidence of childhood cancers decreased over time in the section of the private health sector studied. Leukaemias were the major drivers of childhood cancer incidence

Antirheumatic Medicine Prescribing Patterns and Direct Medicine Costs in the South African Private Health Sector.

OBJECTIVES: To describe antirheumatic medicine prescribing patterns and to estimate the total annual direct medicine cost of rheumatoid arthritis (RA) in the private health sector of South Africa. METHODS: A retrospective, cross-sectional drug utilization study was performed on medicine claims data from January 1, 2014, to December 31, 2014, for a total of 4,352 patients with RA. Patients were divided into those with RA only and those with RA and other chronic disease list conditions. Antirheumatic treatment was categorized into bridge therapy (nonsteroidal anti-inflammatory drugs [NSAIDs] and corticosteroids only) and therapy for advanced disease (NSAIDs, corticosteroids, and disease-modifying antirheumatic drugs [DMARDs] or biologics). Cost-driving products, the 90% drug utilization (DU90%) segment, mean, and median medicine item costs were calculated. RESULTS: Annual direct RA medicine cost summed to €4,115,569.70. The mean ± SD (median) cost per medicine item was €45.87 ± €250.35 (€9.01). DMARDs represented 47.6% (n = 42,699) and biologics 2.4% (n = 2,150) of the 89,728 medicine items claimed. The DU90% of bridge therapy products accounted for 92.8% of the total medicine cost, with celecoxib as the main cost driver because of high volume and mean cost. The therapy for advanced disease DU90% segment accounted for 34.7% of the total medicine cost, with adalimumab as the main cost driver because of high mean cost. CONCLUSIONS: The direct medicine treatment cost of RA in the South African private health sector is driven by the high volume of DMARDs and the high mean costs of biologics, particularly adalimumab.

Methylphenidate and atomoxetine prescribing trends in children in the Western Cape Province of South Africa, 2005-2013.

BACKGROUND: There is paucity of data on methylphenidate and atomoxetine prescribing patterns in South African children. AIM: To describe the prescribing trends of these agents in children residing in the Western Cape Province. SETTING: South African private health sector. METHODS: Longitudinal drug utilisation study on medicine claims data from 2005-2013, focussing on the number of patients and prescriptions per patient. RESULTS: The total number of patients increased by 29.5% from 2005 to 2013. The majority were boys (male:female ratio, 3.5:1), and between the ages of > 6 and ≤12 years in 2005 and >12 and ≤18 years in 2013. More than 75% of patients received methylphenidate or atomoxetine in the City of Cape Town Metropolitan municipality. Prescriptions for methylphenidate and atomoxetine increased by 45.5% overall from 2005 to 2013 (p < 0.001), with that for methylphenidate and atomoxetine increasing by 36.0% and 314.5%, respectively. The average number of annual methylphenidate prescriptions per patient increased from 3.96 ± 2.92 (95% CI, 3.69-4.23) in 2005 to 4.38 ± 2.85 (95% CI, 4.14-4.61) in 2013 (Cohen's d = 0.14) and for atomoxetine from 2.58 ± 1.86 (95% CI, 1.80-3.37) in 2005 to 4.85 ± 3.66 (95% CI, 3.84-5.86) in 2013 (Cohen's d = 0.62). CONCLUSION: Although the total number of patients and prescribing of methylphenidate and atomoxetine increased significantly from 2005 to 2013, a slight downward trend was observed in the mean number of prescriptions per patient per year from 2008 onwards. These prescribing patterns warrant further research.

Chronic disease list conditions in patients with rheumatoid arthritis in the private healthcare sector of South Africa.

INTRODUCTION: Little is known about the burden of rheumatoid arthritis (RA) in South Africa. The aim of this study was to establish the prevalence of RA and coexisting chronic disease list (CDL) conditions in the private health sector of South Africa. METHODS: A retrospective, cross-sectional analysis was performed on medicine claims data from 1 January 2014 to 31 December 2014 to establish the prevalence of RA. The cohort of RA patients was then divided into those with and those without CDL conditions, to determine the number and type of CDL conditions per patient, stratified by age group and gender. RESULTS: A total 4352 (0.5%) patients had RA, of whom 69.3% (3016) presented with CDL conditions. Patients had a median age of 61.31 years (3.38; 98.51), and 74.8% were female. Patients with CDL conditions were older than those patients without (p < 0.001; Cohen's d = 0.674). Gender had no influence on the presence of CDL conditions (p = 0.456). Men had relatively higher odds for hyperlipidemia (OR 1.83; CI 1.33-2.51; p < 0.001) and lower odds for asthma (OR 0.83; CI 0.48-1.42; p = 0.490) than women. In combination with hyperlipidemia, the odds for asthma were reversed and strongly increased (OR 6.74; CI 2.07-21.93; p = 0.002). The odds for men having concomitant hyperlipidemia, hypertension, type 2 diabetes mellitus and hypothyroidism were insignificant and low (OR 0.40; CI 0.16-1.02; p = 0.055); however, in the absence of hypothyroidism, the odds increased to 3.26 (CI 2.25-4.71; p < 0.001). CONCLUSION: Hypothyroidism was an important discriminating factor for comorbidity in men with RA. This study may contribute to the body of evidence about the burden of RA and coexisting chronic conditions in South Africa.

A cross-sectional analysis of the association between age and gender and prescribed minimum benefit chronic disease list conditions among South Africans with concomitant hypertension, diabetes and dyslipidaemia.

BACKGROUND: Prescribed Minimum Benefit Chronic Disease List (PMB CDL) conditions are a regulated list of conditions most common to South Africa. OBJECTIVES: To investigate the prevalence and association between PMB CDL conditions and age and gender among patients with concomitant hypertension, diabetes and dyslipidaemia. METHODS: The study population consisted of patients (n = 17 866) with a prescription containing at least one co-prescribed antilipemics, antihypertensive and antidiabetic (identified using the MIMS Desk Reference). ICD-10 codes on claims for PMB CDL conditions were counted. RESULTS: 39.5% of patients had a PMB CDL condition. Women had higher odds for hypothyroidism (OR 6.30, 95% CI; 5.52, 7.19, p < 0.001) and lower odds for coronary artery disease (CAD) (OR 0.63, 95% CI; 0.55, 0.72, p < 0.001) than men. In combination with hypothyroidism the odds for CAD were reversed and strongly increased; 3.54 (95% CI; 2.38, 5.25, p < 0.001). The odds for females having cardiac failure (CF) was insignificant and low (OR 0.87, 95% CI; 0.75, 1.01, p = 0.063); however combined with hypothyroidism, the odds increased to 5.35 (95% CI; 3.52, 8.13, p < 0.001). CONCLUSION: Hypothyroidism was an important discriminating factor for co-morbidity in women with concomitant hypertension, diabetes and dyslipidaemia, in particular with cardiovascular disease.

Surveillance of antibiotic use in the private sector in Namibia using sales and claims data.

INTRODUCTION: Antibiotics are among the most commonly used therapeutic agents for humans globally, and their use has been associated with the development of resistance. The objective of this study was to identify sources for quantifying antibiotic usage patterns and to assess such use in ambulatory patients in the private health sector of Namibia. METHODOLOGY: A retrospective analysis of prescription claims data and sales data for the period 2008 to 2011 was conducted. Antibiotic use was expressed in the number of antibiotic-containing prescriptions and volume of units sold and then standardized using defined daily dose per 1,000 inhabitants per day. RESULTS: Antibiotic usage was highest in females (53%), in people 18-45 years of age (41%), and in Windhoek (34%). Overall, wholesale data showed higher antibiotic use than prescription claims data. However, both sources showed similar patterns of antibiotic use. Penicillins were the most used pharmacological group, with amoxicillin/clavulanic acid combination being the most used of the agents. CONCLUSION: Antibiotic use in the private sector of Namibia is comparable to that of high-consuming European countries such as Italy. A trend observed in this study was the decrease in the use of narrow-spectrum antibiotics in favour of broad-spectrum and newer antibiotics. Since this was the first study to assess antibiotic use in the private sector of Namibia, it could serve as a starting point for continued monitoring of antibiotic use in the whole of Namibia in the context of the World Health Organization's Global Action Plan to contain antibiotic resistance.

Medicine possession ratio as proxy for adherence to antiepileptic drugs: prevalence, associations, and cost implications.

OBJECTIVE: To determine the adherence status to antiepileptic drugs (AEDs) among epilepsy patients; to observe the association between adherence status and age, sex, active ingredient prescribed, treatment period, and number of comorbidities; and to determine the effect of nonadherence on direct medicine treatment cost of AEDs. METHODS: A retrospective study analyzing medicine claims data obtained from a South African pharmaceutical benefit management company was performed. Patients of all ages (N=19,168), who received more than one prescription for an AED, were observed from 2008 to 2013. The modified medicine possession ratio (MPRm) was used as proxy to determine the adherence status to AED treatment. The MPRm was considered acceptable (adherent) if the calculated value was ≥80%, but ≤110%, whereas an MPRm of <80% (unacceptably low) or >110% (unacceptably high) was considered nonadherent. Direct medicine treatment cost was calculated by summing the medical scheme contribution and patient co-payment associated with each AED prescription. RESULTS: Only 55% of AEDs prescribed to 19,168 patients during the study period had an acceptable MPRm. MPRm categories depended on the treatment period (P>0.0001; Cramer's V=0.208) but were independent of sex (P<0.182; Cramer's V=0.009). Age group (P<0.0001; Cramer's V=0.067), active ingredient (P<0.0001; Cramer's V=0.071), and number of comor-bidities (P<0.0001; Cramer's V=0.050) were statistically but not practically significantly associated with MPRm categories. AEDs with an unacceptably high MPRm contributed to 3.74% (US$736,376.23) of the total direct cost of all AEDs included in the study, whereas those with an unacceptably low MPRm amounted to US$3,227,894.85 (16.38%). CONCLUSION: Nonadherence to antiepileptic treatment is a major problem, encompassing ~20% of cost in our study. Adherence, however, is likely to improve with the treatment period. Further research is needed to determine the factors influencing epileptic patients' prescription refill adherence.

Prescribing patterns of non-steroidal anti-inflammatory drugs in chronic kidney disease patients in the South African private sector.

Background Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used pharmaceutical agents worldwide. NSAIDs are considered nephrotoxic and should therefore be used with caution or be avoided completely in high risk patients, such as chronic kidney disease (CKD) patients. Objective This study aimed to investigate the prescribing of NSAIDs in CKD patients in order to generate awareness and improve the outcome of these patients. Setting The study was conducted using medicine claims data in the private health sector of South Africa. Method A descriptive, quantitative study was performed, using retrospective data obtained from a Pharmaceutical Benefit Management company. Data from 1 January 2009 to 31 December 2013 were analysed. The study population consisted of all patients with an ICD-10 code for a CKD (N18), in association with a paid claim for an NSAID. Main outcome measure The stratification of NSAID prescribing volume among the CKD population in terms of gender, age, NSAID type, dosage and prescriber type. Results The prescribing of NSAIDs in CKD patients varied between 26 and 40 % over the 5 year study period. No association between gender and CKD patients who received NSAIDs versus those who did not was found, with p > 0.05 and Cramer's V < 0.1 for each year of the study. The association between age groups and CKD patients who received NSAIDs versus those who did not was statistically significant, but practically weak (p < 0.05; Cramer's V ≥ 0.1). Most NSAID prescriptions (52-63 %) were for patients aged 35-64 years. Diclofenac (34.25 %) was the single most frequently prescribed NSAID, but the COX-2-inhibitors (celecoxib, meloxicam and etoricoxib) were the preferred NSAID class to be prescribed. The majority (61.6 %) of the NSAIDs were prescribed by general medical practitioners in dosages meeting and even exceeding the recommended daily dosage of patients with normal kidney function. Conclusions Even though NSAIDs are regarded as nephrotoxic drugs, they are still being prescribed to at-risk CKD patients, in particular, the elderly.

Cost-Effectiveness Modelling of Sofosbuvir-Containing Regimens for Chronic Genotype 5 Hepatitis C Virus Infection in South Africa.

BACKGROUND: The recently launched nucleotide polymerase inhibitor sofosbuvir represents a significant turn in the treatment paradigm of chronic hepatitis C. While effective, sofosbuvir is also associated with a considerable cost. OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of sofosbuvir-containing regimens in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 5 (HCV-G5) mono-infection in South Africa (SA). DESIGN: We constructed a lifetime horizon decision-analytic Markov model of the natural history of HCV infection to evaluate the cost effectiveness of sofosbuvir-ledipasvir (SOF/LDV) monotherapy against sofosbuvir triple therapy (SOF-TT) (sofosbuvir + pegylated interferon and ribavirin [peg-INF/RBV]) and the current standard of care (SOC) (peg-INF/RBV) for patients with chronic HCV-G5 in the South African context. The model was populated with data from published literature, expert opinion and South African private sector cost data. The price modelled for sofosbuvir was the predicted South African private sector price of 82,129.32 South African rand (R) (US$7000) for 12 weeks. The analysis was conducted from a third-party payer perspective. OUTCOME MEASURES: The outcome measures were discounted and undiscounted costs (in 2015 South African rand and US dollars) and quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: Outcomes from the cost-effectiveness model show that SOF/LDV yields the most favourable future health economic outcomes compared with SOF-TT and the current SOC in SA. Findings relating to the lifetime incremental cost per QALY gained for patients infected with HCV-G5 indicate that SOF/LDV dominated both SOF-TT and SOC, i.e. SOF/LDV is less costly and more effective. CONCLUSION: Outcomes from this analysis suggest that at a price of R123,190 ($US10,500) for 12 weeks of SOF/LDV might be cost effective for South African patients infected with HCV-G5.

The impact of HIV/AIDS on compliance with antidepressant treatment in major depressive disorder: A prospective study in a South African private healthcare cohort.

BACKGROUND: MDD and HIV/AIDS have a high prevalence worldwide with severe consequences for patients. In both conditions, compliance with treatment is key to successfully treat these disorders. In the current study, we examine the effect of MDD on the compliance with ADs in patients diagnosed with co-morbid HIV/AIDS and how different classes of ADs influence compliance in this group of patients. METHODS: A prospective, cohort study design was used to analyse nationally representative medicine claims data submitted to a privately-owned South African Pharmaceutical Benefit Management (PBM) company. Two groups were distinguished in the database, namely patients with only MDD and patients with both MDD and HIV/AIDS, over a six-year study period. The study population was determined by the following inclusion criteria: patients older than 18 years, MDD should be diagnosed by a psychiatrist supported by an appropriate ICD-10 code, and all patients have to be on combination antiretroviral treatment (cARV) treatment. The medicine possession ratio (MPR) was used as proxy to determine patient compliance with AD medication. RESULTS: 127 patients (i.e. 0.24%) met the criteria of co-morbid MDD and HIV/AIDS. Females have a significantly higher prevalence of MDD and HIV/AIDS when compared to males. Patients diagnosed with both HIV/AIDS and MDD (74.43. ± 32.03, 95% Cl: 71.51-77.34) have a statistical significantly (p < 0.0001) lower compliance with AD treatment vs. MDD patients (80.94% ± 29.44, 95% Cl: 80.56-81.33), but the practical significance thereof, is low (Cohen's d = 0.2255). In this group only 26.83% of TCA had acceptable compliance compared to the 58.57% of SNRIs. Noteworthy observations were that 75% (p < 0.0217; Cramer's V = 0.0388) of venlafaxine and 28.6% (p < 0.0197; Cramer's V = -0.0705) of the paroxetine items were compliant in patients diagnosed with both HIV/AIDS and MDD. CONCLUSIONS: AD compliance is statistical significantly lower in depressed HIV/AIDS vs. depressed non-HIV/AIDS patients. However, these differences is of low practical or clinical significance, meaning that depressed HIV/AIDS patients would have missed approximately two AD doses (6.5% of a 30-day treatment period) more than the non-HIV/AIDS depressed patient over the same treatment period.

Assessment of the Appropriateness of Antibiotic Prescriptions in Lesotho Public Hospitals: A Novel Methodology Based on Principles of Antibiotic Prescribing.

The study primarily aimed at assessing the appropriateness of antibiotic prescriptions in a section of public health institutions in Lesotho using an assessment tool formulated from principles of antibiotic prescribing. Relevant data on procedures of infection diagnosis and prescribed antibiotics were collected from both inpatient and outpatient case reports for a one-month period in five public hospitals in Lesotho. These were analyzed for the appropriateness of the prescribed antibiotics. Prescription appropriateness assessment was based on conformities of prescribed antibiotics to criteria developed from pertinent principles of antibiotic prescribing. Assessed prescriptions, 307 inpatient and 865 outpatient prescriptions in total, were classified into categories of appropriateness based on extents to which they satisfied conditions defined by combinations of criteria in the assessment tool. Antibiotic prescriptions from inpatient and outpatient departments of study site hospitals were categorized into groups of different degrees of appropriateness. A total of 32.2% inpatient prescriptions and 78.4% outpatient prescriptions assessed were appropriately written for the empiric treatment of infections for which bacterial pathogens were considered absolute or possible etiologies. The use of prescription assessment tools based on principles of antibiotic prescribing is a feasible option of assessing the appropriateness of antibiotic prescriptions, particularly in low-income countries where expert panels cannot be formed.

The Impact of Appropriate Antibiotic Prescribing on Treatment Evaluation Parameters.

The therapeutic impact of inappropriate prescribing of antibiotics is debatable, particularly in situations where infections are treated empirically with multiply prescribed antibiotics. Prescribers may remain under the illusion that such prescriptions are appropriate on the basis of any observed positive treatment outcomes, even though an antibiotic prescribed in such combination therapy may actually be infective against infecting pathogens. This, inevitably, promotes inappropriate antibiotic prescribing. Prescribers may be motivated to make more conscious attempts to prescribe antibiotics appropriately if it is proven that judicious prescribing of antibiotics has positive impacts on treatment outcomes. The objective of this study was to determine the impact of appropriate prescribing of antibiotics on treatment outcomes, days of patient hospitalization and costs related to antibiotic treatment. Observational data on antibiotic treatment were collected for a one-month period from case notes of all inpatients (n=307) and outpatients (n=865) at five government and mission hospitals in Lesotho. Prescriptions were classified into categories of appropriateness based on extents to which antibiotics were prescribed according to principles. Treatment success rates, mean days of hospitalization and costs of antibiotic treatments of inpatients treated with specified prescription categories were determined. Appropriate prescribing of antibiotics for inpatients had positive impacts on treatment outcomes, patients' days of hospitalization for infections and costs of antibiotic treatments. In outpatient settings, appropriate prescribing of antibiotics failed to show any significant impact on costs of antibiotics. Appropriate prescribing of antibiotics had a positive impact on patients' recovery and costs of antibiotic treatments in inpatient settings.

The application of pharmacoeconomic modelling to estimate a value-based price for new cancer drugs.

RATIONALE, AIMS AND OBJECTIVES: Value-based pricing has recently been discussed by international bodies as a means to estimate a drug price that is linked to the benefits it offers patients and society. The World Health Organization (WHO) has recommended using three times a country's per capita gross domestic product (GDP) as the threshold for economic value. Using the WHO criteria, pharmacoeconomic modelling was used to illustrate the application of value-based price towards bevacizumab, a relatively new drug that provides a 1.4-month survival benefit to patients with metastatic colorectal cancer (mCRC). METHODS: A decision model was developed to simulate outcomes in mCRC patients receiving chemotherapy ± bevacizumab. Clinical data were obtained from randomized trials and costs from Canadian cancer centres. Utility estimates were determined by interviewing 24 oncology nurses and pharmacists. A price per dose of bevacizumab was then estimated using a target threshold of $CAD117,000 per quality adjusted life year gained, which is three times the Canadian per capita GDP. RESULTS: For a 1.4-month survival benefit, a price of $CAD830 per dose would be considered cost-effective from the Canadian public health care perspective. If the drug were able to improve patient quality of life or survival from 1.4 to 3 months, the drug price could increase to $CAD1560 and $CAD2180 and still be considered cost-effective. DISCUSSION: The use of the WHO criteria for estimating a value-based price is feasible, but a balance between what patients/governments can afford to pay and the commercial viability of the product in the reference country would be required.