Are generic immunosuppressants safe and effective? Clinical experience is reassuring and regulation is strict, now we need definitive evidence

Increasing use of generic drugs is essential to maintain comprehensive and equitable healthcare, given current pressure on budgets through, for instance, ageing populations. Initiatives among health authorities to promote generic prescribing include educational initiatives (which in the United Kingdom has resulted in high levels of prescribing of international non-proprietary name (INN) drugs in over 80% of all prescriptions), compulsory generic substitution in pharmacies, and patients paying extra “out of pocket” expenses for a proprietary drug.[1-3] Concerns remain, however, about generic prescribing or compulsory substitution in certain drugs and drug classes, including lithium, theophyllines, some anti-epileptic drugs, and the immunosuppressants evaluated in the linked study by Molnar and colleagues (doi:10.1136/bmj.h3163)

Implications of antibiotic exposure among children in low-income and middle income countries

Günther Fink and colleagues are to be congratulated for their analysis of antibiotic exposure among children younger than 5 years in low-income and middle-income countries (LMICs) with a range of common illnesses, including cough, fever, diarrhoea, and malaria.1 The authors explain that their study1 is the first to use a robust method to comprehensively quantify cumulative antibiotic exposure among children in LMICs by obtaining nationally representative data from surveys of households and formal-sector health-care facilities. Quantifying exposure is important, as previous surveys have only had limited coverage in low-income settings, particularly in sub-Saharan African countries, which have the highest incidence of infectious diseases globally.2,3 However, quantifying true antibiotic use in LMICs might be difficult if antibiotics are frequently purchased without a prescription due to issues with affordability and access. Obtaining antibiotics in this way accounts for up to 93% of all antibiotics dispensed in some LMICs.4,5 The remaining 7% or more include antibiotics obtained from ambulatory care and inpatient hospital care.2 Antimicrobial resistance is a growing publi

Knowledge, attitudes and practices of health care professionals towards adverse drug reaction reporting in public sector primary health care facilities in a South African district

Purpose: Adverse drug reactions (ADRs) have an appreciable impact on patients’ health. Little is known however about ADR reporting in ambulatory care environments especially in low- and middle-income countries. Consequently, our aim was to determine knowledge, attitudes and practices (KAP) among health care professionals (HCPs) towards ADR reporting in primary health care (PHC) facilities in South Africa. The findings will be used to direct future activities. Methods: Descriptive, cross-sectional design using quantitative methodology among 8 public sector community health care centres and 40 PHC clinics in the Tshwane Health District, Gauteng Province. A self-administered questionnaire was distributed to 218 HCPs, including all key groups. Results: A total of 200 responses were received (91.7%). Although an appropriate attitude towards ADR reporting existed, the actual frequency of ADR reporting was low (16.0%). Of the respondents, 60.5% did not know how to report, where to report or when to report an ADR and 51.5% said the level of their clinical knowledge made it difficult to decide whether or not an ADR had occurred. Over 97.5% stated they should be reporting ADRs with 89% feeling that ADR reporting is a professional obligation and over 70% that ADR reporting should be compulsory. When results were combined, the overall mean score in terms of positive or preferred practices for ADR reporting was 24.6% with pharmacists having the highest scores. Conclusion: Under-reporting of ADRs with gaps in KAP was evident. There is a serious and urgent need for education and training of HCPs on ADR reporting in South Africa

Consumption of antihistamines in Serbia in the period 2011–2015 and the correlation with adverse drug reaction reports

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Cost driver analysis of statin expenditure on Australia’s pharmaceutical benefits scheme

The Australian Pharmaceutical Benefits Scheme (PBS) provides universal access to subsidised medicines. In 2013, statins as a class had the highest expenditure on the PBS. To assess the influence of policies and drivers affecting PBS statin utilisation and expenditure between 1992 and 2013. Analyses conducted from 1992 to 2013 and over three distinct time periods, including monthly expenditure/prescription, annual utilisation (calculated as Defined Daily Doses/1000 inhabitants/day) and statin strengths dispensed. The major driver of increased PBS expenditure for statins was increased volumes. After adjusting for inflation, the average PBS expenditure on statin prescriptions was the major negative driver. Other influential drivers included the increased use of newer statins and increased strength of statins dispensed. Whilst the inflation-adjusted reimbursed price of statins decreased, increased utilisation, including increased use of patented statins, increased total statin expenditure. Successful measures adopted by other countries could be applied to Australia to decrease total medicines expenditure

Quality prescribing in general practice

To implement continuous improvement of prescribing in general practice with a model closely linking the work of general practitioner and a clinical pharmacist aiming to improve the safety and efficiency of treatment with medicine. Emphasise is on polypharmacy (multiple medications) which is increasing across countries and although appropriate especially in patients with multiple comorbidities it can cause serious problems to patients and is a major challenge for the health care systems. Problems include adverse drug reactions and harmful drug interactions with reduced quality of life, increased overall morbidity, mortality and increased costs to health care systems

Liver enzyme elevations in a cohort of HIV/AIDS patients on first-line antiretroviral therapy in Namibia: Findings and implications

Introduction: All antiretroviral therapies (ARTs) are potentially toxic to the liver. In sub-Saharan Africa, the rising incidence of ART induced adverse events has complicated treatment leading to recent revisions of Namibian ART guidelines. Unfortunately there have been limited studies to date evaluating ART induced liver injury in Namibia to guide further revisions if needed. Objective: Determine the current patterns and grades of ALT elevation in Namibia’s HIV/AIDS. Methods: Retrospective cohort analysis. Patterns of alanine amino transferase (ALT) liver enzyme elevation were determined in a cohort of ART naïve HIV patients on firstline ART regimen in a referral hospital in Namibia over a 1 year treatment period. Patterns of ALT changes at baseline, 3 months and 6 months were analyzed using ANOVA and Bonferroni test for pairwise comparisons. Results: Of 79 eligible patients, 72 developed significant ALT elevation within 3 months of ART initiation (F (3, 76) = 6.4, p = 0.002, η2 = 0.193). Four 4 (5.6%) and 1 (1.38%) patient respectively developed grade 2 and grade 3 ALT elevation by month 3. There was no significant difference between mean ALT levels at baseline and month 6. A CD4 count of <350 cells/mm3; female gender and age over 40 years were the main factors associated with moderate or severe ALT elevation. Conclusions: First line ART commonly induces mild self-limiting liver enzyme elevation in Namibian HIV patients especially in the first 3 months. Consequently, there is a need to monitor ALT levels for at least 3 months after initiation mainly in high risk patients to reduce side-effect concerns. This is already happening