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)

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

Determinants of the Effectiveness of Antimicrobial Prophylaxis among Neurotrauma Patients at a Referral Hospital in Kenya: Findings and Implications

Background: Surgical site infections can occur adding to morbidity, mortality and costs, and can be particularly problematic in low and middle income countries. This includes infections in neurosurgical patients following surgery despite antimicrobial prophylaxis. The study aimed at measuring the incidence of surgical site infections (SSIs) and identifying factors that influence the effectiveness of antimicrobial prophylaxis in a leading hospital in Kenya. Methods: Prospective cohort study from April to July 2015 in the Neurosurgical ward of a leading referral hospital in Kenya. Adult head injury patients were recruited by universal sampling. Data was collected on prophylactic antibiotics and the occurrence of SSIs. Risk factors for infection were identified by logistic regression. Results: Eighty four patients were recruited, with 69 patients eventually analysed. Incidence of SSIs was 37.7% (n=26). The most common antibiotic used for prophylaxis was ceftriaxone. Patients on prophylaxis were less likely to be infected than those who did not receive prophylaxis; however, this was not statistically significant (RR 0.87, 95% CI 0.40-1.893). The presence of epidural haematoma was a risk factor for the development of SSIs (Crude RR 2.456, 95% CI 1.474-4.090). Overall, antimicrobial prophylaxis was effective only in patients who underwent evacuation of hematoma by craniotomy (risk reduction, 62.5% (CI, 29.0% -96.0%). Conclusion: Evacuation of haematomas through craniotomy increased the effectiveness of prophylaxis, and should be considered in the future. The rationale will be explored further to see if antibiotic prophylaxis can reduce SSIs in other patients with neuro trauma

Development of a web-based application to improve data collection for antimicrobial point prevalence surveys in the public health care system in South Africa; findings and implications

Background: Surveillance of antimicrobial use is one of the main recommended strategies in combating growing antimicrobial resistance (AMR) rates and a key part of developing pertinent policies and initiatives to reduce growing AMR rates in South Africa and wider. However, determining antimicrobial utilisation at a patient-level among public hospitals in South Africa can be a challenge given personnel and resource constraints. There are also currently no standardized data collection tools. Most countries in Africa currently undertake antimicrobial utilisation surveillance using paper-based data collection tools including point prevalence surveys (PPS). Unfortunately, paper-based systems have disadvantages including the time taken to complete the forms and analyse the findings, increasing costs and manpower hurdles. Electronic tools offer many advantages including mobile and real time data collection and also the opportunity for rapid analytics. Objectives: Develop and test a web-based application (APP) for future PPS studies to successfully address identified challenges. Methods: A web based application (APP) was developed based on previous PPS in Botswana and South Africa using a paper-based data collection tool and tested during July 2017 in a leading public hospital in South Africa. The developed APP was also evaluated for data quality by measuring the number of errors, work flow, and time taken for the survey versus the previous paper-based system. User acceptance was also measured via a questionnaire to the data collectors. Results: A total of 187 patients' files were surveyed in this leading hospital using the APP whilst also documenting the challenges and areas of improvement for the APP. The identified areas of improvement have now been incorporated into the revised APP for future studies. The data collectors agreed that surveying the patients' files took appreciably less time with the APP compared to the paper based tool, and should be used in the future. In addition, data analysis was hastened using the APP. Conclusions: The APP development process has been successful and the APP is a potential tool for future PPS in South Africa and wider. The APP methodology is now being tested in new studies across South Africa to help instigate pertinent educational and other interventions to improve the future use of antimicrobials among public hospitals in South Africa

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

Developing countries subcommittee of the clinical pharmacology division : The medicines utilization research in Africa (MURIA) group and IUOHAR co-organized a workshop in botswana for the promotion of rational use of medicines

The improper use of medicines is a major cause of poor therapeutic effect as well as adverse drug reactions, and has considerable financial consequences (1-4). In the present era of global economic recession, there is a need for the judicious use of resources to benefit all citizens in developing countries. Therefore, the promotion of the Rational Use of Medicines (RUM) should be a healthcare priority in African countries. Still, there is limited information available on how appropriately medicines are prescribed and used in Africa (5)

A Critical Look at Innovation Profile and Its Relationship with Pharmaceutical Industry

Background: The pharmaceutical sector undertakes extensive research and development (R&D). Pharmaceutical industries have continued to launch an appreciable number of new medicines, different pharmaceutical formulations, new indications and other innovations that contribute to the growth of this sector. New novel medicines are increasingly essential for continued success given the number of standard medicines now available as low cost generics or biosimilars. Consequently, innovation is a fundamental element in pharmaceutical company competition. Not all innovations though are the same size, type or category with differentiation of innovation essential for commercial success. However, given the wide range of definitions used in the literature, the framing may diffuse. Currently, there are several types and categories of innovation are deficiently harmonized and poorly stratified resulting in analysis trends and provide major obstacles to innovation’s differentiation and in assessing the company's innovative dominant characteristic in the sector. The objective of this study is to stratify and organize, didactically, the field of definitions and concepts of innovation and provide a structural and operational delineation, from a critical point of view, for the classifications of innovation applied to the pharmaceutical industr