Fatima Suleman

The relevance of systematic reviews on pharmaceutical policy to low- and middle-income countries

Background Low- and middle-income countries (LMICs) rely on available evidence when devising and implementing pharmaceutical policies. Aim of the review To provide a critical overview of systematic reviews of pharmaceutical policies, with particular focus on the relevance of such reviews in low- and middle-income countries. Methods A search for systematic reviews (SRs) of studies of the interventions of interest was conducted until May 2009 in MEDLINE, EconLit, CINAHL, the Cochrane site, ProQuest, EMBASE, JOLIS, ISI Web of Science, International Pharmaceutical Abstracts, International Network for Rational Use of Drugs, National Technical Information Service, Public Affairs Information Service, SourceOECD, the System for Information on Grey Literature in Europe, and the WHO library database. The search was updated to July 2013, based on the yields of the initial search strategy. Results 20 SRs that met all inclusion criteria were retrieved in full text. Four SRs were subsequently rejected on the basis of quality considerations and the findings of 16 SRs were extracted and their applicability in LMICs considered. Of these, 5 were Cochrane Reviews. All included SRs were published in English. SRs related to registration and classification policies, marketing policies, prescribing policies, reimbursement policies, policies on price and payments, co-payments and caps and multi-component policies were retrieved. No SRs related to patent and profit policies, sales and dispensing policies, policies that regulate the provision of health insurance, or policies on patient information were retrieved. Conclusion Only one of the systematic reviews retrieved utilised a study conducted in a developing country. The direct applicability of the evidence from these SRs in LMICs is limited. However, as middle-income countries move towards universal health coverage, the multi-component policies that govern reimbursement for medicines, and which impose caps on payments and co-payments by patients, may become more applicable. As such they will have direct implications for the practice of clinical pharmacy in such settings. Considerable effort will be needed to systemically review the available primary evidence from studies conducted in developing country settings, where such data exist.

Quality teaching and learning in the Health Sciences

Quality teaching is a central tenet to the retention and success of students in higher education but teaching quality measures and indicators have not enjoyed sufficient debate and discourse within the higher education sector. The Faculty of Health Sciences at the University of KwaZulu-Natal investigated the use of various programme and module statistics as well as student and peer evaluations of teaching to inform quality improvements in teaching and learning. Quantitative data allowed benchmarking in relation to internal University targets and national norms and pointed to the student cohorts who collectively required teaching and learning interventions but was found to have limited use in improving individual teaching practice. Qualitative data from students and peers was best able to highlight strengths and weaknesses and provided the most useful data to inform changes in teaching practice as it engendered and enhanced reflective practice. The Organization for Economic Co-operation and Development (OECD) report on quality teaching in higher education found that most evaluation instruments were related to teaching input indicators and that there was a dearth of instruments to evaluate the impact of teaching, i.e. there was no explicit evaluation criteria linking teaching input to learning outcome. The challenge for the second cycle of institutional reviews/audits will thus be (1)identifying suitable qualitative indicators/measures for quality teaching , (2) striking the correct balance between quantitative and qualitative teaching quality indicators/measures, and (3), ensuring that such indicators, both quantitative/qualitative address teaching impact/learning outcomes in addition to teaching inputs.

Selection of essential medicines for South Africa - an analysis of in-depth interviews with national essential medicines list committee members

BackgroundThe South African (SA) public health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) in the public sector since 1996. To date no studies have reported on the process of selection of essential medicines for SA EMLs and how this may have changed over time. This study reports on the decision making process for the selection of essential medicines for SA EMLs, over the years, as described by various members of the National Essential Medicines List Committee (NEMLC) and their task teams.MethodsQualitative in-depth interviews, guided by an interview questionnaire, were conducted with 11 members of the SA NEMLC and their task teams (both past and present members) during the period January – April 2015. Interviews were recorded and transcribed verbatim. Transcripts were then coded by the first author and verified by the second author before being reconciled and input into NVIVO, a qualitative software, to facilitate analysis of the data.ResultsThe interviews conducted suggest that the NEMLC process of medicine selection has been refined over the years. This together with the EML review process is now essentially predominantly an evidence based process where quality, safety and efficacy of a medicine is considered first followed by cost considerations which includes pharmacoeconomic evaluations, and pricing of medicines.ConclusionsThis is the first study in SA to report on how decisions are taken to include or exclude medicines on SA national EMLs and provides insight into the SA EML medicine selection, review and monitoring processes over time. The results show that the NEMLC has undergone tremendous transformation over the years. Whilst the membership of the committee largely remains unchanged, the committee has developed its policies and processes over the years. However there is still a need to strengthen the monitoring and evaluation aspects of the SA EML policy process.

Price, availability and affordability of medicines

Abstract Background Medicines play an important role in healthcare, but prices can be a barrier to patient care. Few studies have looked at the prices of essential medicines in low- and middle-income countries in terms of patient affordability. Aim To determine the prices, availability and affordability of medicines along the supply chain in Swaziland. Setting Private- and public-sector facilities in Manzini, Swaziland. Methods The standardised methodology designed by the World Health Organization and Health Action International was used to survey 16 chronic disease medicines. Data were collected in one administrative area in 10 private retail pharmacies and 10 public health facilities. Originator brand (OB) and lowest-priced generic equivalent (LPG) medicines were monitored and these prices were then compared with international reference prices (IRPs). Affordability was calculated in terms of the daily wage of the lowest-paid unskilled government worker. Results Mean availability was 68% in the public sector. Private sector OB medicines were priced 32.4 times higher than IRPs, whilst LPGs were 7.32 times higher. OBs cost 473% more than LPGs. The total cumulative mark-ups for individual medicines range from 190.99% – 440.27%. The largest contributor to add-on cost was the retail mark-up (31% – 53%). Standard treatment with originator brands cost more than a days wage. Conclusion Various policy measures such as introducing price capping at all levels of the medicine supply chain, may increase the availability, whilst at the same time reducing the prices of essential medicines for the low income population.

Quantitative evaluation of essential medicines lists: the South African case study

BackgroundThe South African (SA) health system has employed an Essential Medicines List (EML) with Standard Treatment Guidelines (STGs) since 1996. To date no studies have reported the changes in SA STG/EMLs. This study describes these changes over time (1996–2013) and compares latest SA STG/EMLs with the latest World Health Organization (WHO) Model EMLs to assess alignment of these lists.MethodsA quantitative evaluation of SA STGs/EMLs at 2 levels of healthcare was performed to assess changes in the number and ratio of molecules, dosage forms, and additions and deletions of medicines. The most recent WHO EMLs (18th list, 4th list for children) and 2012 priority life-saving medicines for women and children (PMWC) list were compared to the most recent available SA STG/EMLs (Primary Health Care (PHC 2008), Adult Hospital 2012, and Paediatric Hospital 2013) at the time of the research.ResultsThe number of molecules over the years increased for PHC STG/EMLs but decreased slightly for Adult and Paediatric hospital STG/EMLs. The most additions and deletions over time occurred in the Adult hospital level STG/EML (27 in 2006 and 44 in 2012). A comparison between the most recent SA STG/EMLs and WHO Model EML (18th list) showed that a total of 112 medicines were absent on all SA STG/EMLs. A comparison of medicines for children between the 2013 SA Paediatric Hospital level STG/EML and PMWC indicated that these lists were somewhat aligned for most conditions as only 3 of 14 medicines and 11 of 20 vaccines were absent from SA STG/EMLs.ConclusionThis is the first study in SA to investigate changes in National EMLs over time in relation to molecules, dosage forms and therapeutic classes. It is also the first to compare the latest SA STG/EMLs to the WHO Model lists. The results therefore provide insight into the trends and SA STG/EML processes over time.

Efforts to secure universal access to HIV/AIDS treatment: a comparison of BRICS countries

This article illustrates how the BRICS countries have been building their focused leadership, making important high level commitment and national policy changes, and improving their health systems, in addressing the HIV/AIDS epidemics in respective settings. Specific aspects are focused on efforts of creating public provisions to secure universal access to ARVs from the aspects of active responsive system and national program, health system strengthening, fostering local production of ARVs, supply chain management, and information system strengthening. Challenges in each BRICS country are analyzed respectively. The most important contributors to the success of response to HIV/AIDS include: creating legal basis for healthcare as a fundamental human right; political commitment to necessary funding for universal access and concrete actions to secure equal quality care; comprehensive system to secure demands that all people in need are capable of accessing prevention, treatment and care; active community involvement; decentralization of the management system considering the local settings; integration of treatment and prevention; taking horizontal approach to strengthen health systems; fully use of the TRIPS flexibility; and regular monitoring and evaluation to serve evidence based decision making.

Pharmaceutical Policy in South Africa

South Africa has implemented a number of important medicine policies in the post-apartheid era, informed by the 1996 National Drug Policy. Despite considerable resistance, firstly from the transnational pharmaceutical industry but later from a wider range of stakeholders, a number of legal reforms have been successfully implemented. In the public sector, medicine use is governed by standard treatment guidelines and essential medicines lists. However, these do not apply in the more fragmented private sector. Nonetheless, generic utilisation in the private health sector has increased over time. Maximum dispensing fees have also been introduced in the private sector but may need to be complemented by more sophisticated professional remuneration models that more effectively advance the responsible use of medicines. Greater use of pharmacoeconomics will help to inform rational selection and reimbursement policies, especially as the country moves towards universal health coverage in the form of National Health Insurance. The state tender system will also need to be reconsidered, as the separation between public and private healthcare financing and delivery becomes blurred. Major changes are in progress at the national medicines regulatory authority, which faces a considerable backlog in applications for marketing authorisation.

Evaluating the effect of a proposed logistics fee cap on pharmaceuticals in South Africa - a pre and post analysis

BackgroundSouth Africa has proposed the implementation of a maximum logistics fee paid by pharmaceutical manufacturers to wholesalers and distributors. However very little knowledge exists of the effects, unintended or otherwise, of the implementation of these proposed regulations, which are required to guide further policy development and implementation. The objectives of this study was to therefore evaluate the effects of the proposed logistics fee cap on different pharmaceuticals and different dosage forms, as well as to observe the logistics fee contribution to the Single Exit Price.MethodsPrivate sector medicine prices were sourced from the South African Medicine Price Registry as at 20 December 2013. For each medicine the maximum logistics fee was calculated based on the 2012 proposed government guidelines. The logistics fee as a percentage of the final Single Exit Price was calculated, as part of the analysis of results.ResultsOut of the 47 medicines in the overall sample from the current study, only 16 medicines showed a decrease in the Single Exit Price with the application of the maximum logistics fee cap.ConclusionThis study reveals the need for greater transparency of the mark ups along the distribution chain as well as further research with regards to the costing of logistics fees of similar pharmaceuticals.

Evaluating adverse drug reactions among HAART patients in a resource-constrained province of South Africa

The high prevalence of HIV in KwaZulu-Natal Province, South Africa, has greatly increased the demand for antiretroviral therapy (ART), resulting in an exponential increase in the number of patients initiated on highly active antiretroviral treatment (HAART). However, little information about adverse drug reactions in these patients was forthcoming from public health facilities in KwaZulu-Natal. A compulsory system of reporting adverse drug reactions was established among patients attending accredited ART sites, with minimal resource requirements. The study sought to evaluate the adverse drug reactions reported through the new compulsory system. A retrospective audit was performed on the reporting forms received during the first year of the new system, pertaining to all patients on HAART who had experienced an adverse drug reaction that resulted in a request for a change in antiretroviral (ARV) drug or regimen. The forms for documenting adverse drug reactions were completed by prescribers who would confirm the event or reaction by specifying the diagnosis as well as the relevant clinical and laboratory values. In total, 3 923 forms, submitted between 1 May 2007 and 31 May 2008, were available for audit. Adverse drug reactions were documented in 78.7% of the reports and 74% of the patients that presented with an adverse event were females. Of the forms recording a serious adverse drug reaction, 84.7% pertained to patients taking the three-drug combination stavudine, lamivudine and either efavirenz or nevirapine. Of those reports, stavudine was implicated as the possible causative agent of an adverse drug reaction in 93% of the cases. In 73.6% of the total reports the proposed new regimen was zidovudine, lamivudine and efavirenz or nevirapine. The compulsory system of reporting greatly improved the reporting of adverse drug reactions associated with HAART among patients in the province. This system may be similarly implemented in other low-resourced settings to actively encourage the reporting of adverse drug reactions associated with ARV use.

Cost-effectiveness analysis of low versus high dose colistin in the treatment of multi-drug resistant pneumonia in Saudi Arabia

Background Gram negative pathogens are increasingly resistant to commonly used first line antibiotics and colistin is in most cases the only medicine available. There is very limited information available comparing the effectiveness and costs of low versus high dose colistin with studies showing efficacy with both doses and with variable levels of adverse effects. The absence of a definite dosing strategy makes a model to compare low dose and high dose colistin invaluable in making decisions regarding the appropriate use of colistin. Objective This study was designed to evaluate the cost effectiveness of low versus high dose colistin in the treatment of Pneumonia caused by colistin-only sensitive gram negative bacteria from the perspective of a tertiary care hospital in Saudi Arabia. Setting 300-bed tertiary care hospital in Saudi Arabia. Method A retrospective review was conducted to compare the costs and outcomes of treatment of pneumonia with low versus high dose colistin. The model followed an average patient from initiation of treatment until clinical cure or failure. Main outcome measures The main outcomes were cure, nephrotoxicity, total direct costs per episode, cost per additional cure and cost per nephrotoxicity avoided. Results There was no significant difference between high and low dose colistin with regards to clinical cure (30% vs. 21%; p = 0.292). Significantly more patients experienced nephrotoxicity with high versus low dose colistin (30% vs. 8%; p = 0.004). With low dose colistin the incremental costs per nephrotoxicity avoided was SAR—3056.28. One-way sensitivity analyses did not change the overall results. Conclusion Low dose was not inferior to high dose colistin in terms of clinical cure and had a lower incidence of nephrotoxicity resulting in significant cost avoidance.