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  • Improving Equitable Access to Essential Medicines: Learning from the Experience of Pharmacists within Médecins Sans Frontières (Doctors Without Borders)

    Connor, S; Forrister, D; Karir, V; Kauffman, Y; Sochacki, M (Wiley, 2020-04-04)
    Two billion people worldwide currently lack access to basic essential medicines. Compounding this challenge, there is also inequity in relation to medication quality, particularly within resource‐constrained settings. Shortages in qualified pharmacy staff exacerbate these problems in poorer countries, with many non‐governmental organizations attempting to fill these gaps. Médecins Sans Frontières (MSF; also known as Doctors Without Borders) is an independent non‐profit organization founded in 1971 that provides free medical humanitarian care for populations in need. Pharmacists are an integral part of MSF's medical activities and are engaged in multiple functions within the organization. They serve as a liaison between logistics, supply, and medical departments, and facilitate delivery of patient care. Moreover, pharmacists ensure the medication use process is intact from project planning to distribution of medications. Pharmacist aid workers within MSF assume many roles including field worker, project manager, project coordinator, access to essential medicines advocate, and many others. We highlight the work of MSF pharmacists via vignettes, sharing their experiences from countries around the world. Working with MSF is a challenging yet rewarding endeavor; becoming an aid worker in the organization preferably requires prior experience working in resource‐limited settings, as well as humanitarian work experience. The role of the pharmacist within MSF is evolving, with increased emphasis on clinical pharmacy services, rational drug use, and antimicrobial resistance. Pharmacists are essential to humanitarian work in ensuring quality and safety in the care of patients served.
  • Effect of high-dose rifampicin on efavirenz pharmacokinetics: drug-drug interaction randomized trial

    Atwine, D; Baudin, E; Gelé, T; Muyindike, W; Mworozi, K; Kyohairwe, R; Kananura, K; Orikiriza, P; Nyehangane, D; Nanjebe, DKT; et al. (Oxford University Press, 2020-01-30)
    Background: High-dose rifampicin is considered to shorten anti-TB treatment duration but its effect on antiretroviral metabolism is unknown. Objectives: To assess the effect of doubling the rifampicin dose (to 20 mg/kg/day, R20) on efavirenz pharmacokinetics (PK) in HIV/TB coinfected patients. Methods: Open-label Phase 2 drug-drug interaction randomized trial. Pulmonary TB, ART-naive adults were randomized to R20 and either efavirenz 600 mg (EFV600) or 800 mg (EFV800), or rifampicin 10 mg/kg/day (R10) and EFV600 with a 1:1:1 ratio. Patients were first started on TB treatment and 2-4 weeks later started on ART. They were switched to R10 and EFV600 after 8 weeks. Full PK sampling was done 4 weeks (on rifampicin) and 24 weeks (off rifampicin) after ART initiation. Transaminases, plasma HIV-1 RNA and sputum cultures were monitored. The efavirenz geometric mean ratio (GMR) of AUC at 4 and 24 weeks after ART initiation within the same patient was calculated in each arm and its 90% CI was compared with a preset range (0.70-1.43). Results: Of 98 enrolled patients (32 in the R20EFV600 arm, 33 in the R20EFV800 arm and 33 in the R10EFV600 arm), 87 had full PK sampling. For the R20EFV600, R20EFV800 and R10EFV600 arms, GMRs of efavirenz AUC were 0.87 (90% CI: 0.75-1.00), 1.12 (90% CI: 0.96-1.30) and 0.96 (90% CI: 0.84-1.10). Twelve weeks after ART initiation, 78.6%, 77.4% and 72.4% of patients had HIV-1 RNA below 100 copies/mL and 85.7%, 86.7% and 80.0% had Week 8 culture conversion, respectively. Two patients per arm experienced a severe increase in transaminases. Conclusions: Doubling the rifampicin dose had a small effect on efavirenz concentrations and was well tolerated.
  • “Without antibiotics, I cannot treat”: A qualitative study of antibiotic use in Paschim Bardhaman district of West Bengal, India

    Nair, M; Tripathi, S; Mazumdar, S; Mahajan, R; Harshana, A; Pereira, A; Jimenez, C; Halder, D; Burza, S (Public Library of Science, 2019-06-27)
    Background Misuse of antibiotics is a well-known driver of antibiotic resistance. Given the decentralized model of the Indian health system and the shortage of allopathic doctors in rural areas, a wide variety of healthcare providers cater to the needs of patients in urban and rural settings. This qualitative study explores the drivers of antibiotic use among formal and informal healthcare providers as well as patients accessing care at primary health centers across Paschim Bardhaman district in West Bengal. Materials and methods We conducted 28 semi-structured, in-depth interviews with four groups of healthcare providers (allopathic doctors, informal health providers, nurses, and pharmacy shopkeepers) as well as patients accessing care at primary health centers and hospitals across Paschim Bardhaman district. Qualitative data was analyzed using the framework method in an inductive and deductive manner. Results Our results indicate that patients demand antibiotics from healthcare providers and seek the fastest cure possible, which influences the prescription choices of healthcare providers, particularly informal health providers. Many allopathic doctors provide antibiotics without any clinical indication due to inconsistent follow up, lack of testing facilities, risk of secondary infections, and unhygienic living conditions. Pharmaceutical company representatives actively network with informal health providers and formal healthcare providers alike, and regularly visit providers even in remote areas to market newer antibiotics. Allopathic doctors and informal health providers frequently blame the other party for being responsible for antibiotic resistance, and yet both display interdependence in referring patients to one another. Conclusions A holistic approach to curbing antibiotic resistance in West Bengal and other parts of India should focus on strengthening the capacity of the existing public health system to deliver on its promises, improving patient education and counseling, and including informal providers and pharmaceutical company representatives in community-level antibiotic stewardship efforts.
  • Stock-outs of antiretroviral and tuberculosis medicines in South Africa: A national cross-sectional survey

    Hwang, B; Shroufi, A; Gils, T; Steele, SJ; Grimsrud, A; Boulle, A; Yawa, A; Stevenson, S; Jankelowitz, L; Versteeg-Mojanaga, M; et al. (Public Library of Science, 2019-03-12)
    Background HIV and TB programs have rapidly scaled-up over the past decade in Sub-Saharan Africa and uninterrupted supplies of those medicines are critical to their success. However, estimates of stock-outs are largely unknown. This survey aimed to estimate the extent of stock-outs of antiretroviral and TB medicines in public health facilities across South Africa, which has the world’s largest antiretroviral treatment (ART) program and a rising multidrug-resistant TB epidemic. Methods We conducted a cross-sectional telephonic survey (October—December 2015) of public health facilities. Facilities were asked about the prevalence of stock-outs on the day of the survey and in the preceding three months, their duration and impact. Results Nationwide, of 3547 eligible health facilities, 79% (2804) could be reached telephonically. 88% (2463) participated and 4% (93) were excluded as they did not provide ART or TB treatment. Of the 2370 included facilities, 20% (485) reported a stock-out of at least 1 ARV and/or TB-related medicine on the day of contact and 36% (864) during the three months prior to contact, ranging from 74% (163/220) of health facilities in Mpumalanga to 12% (32/261) in the Western Cape province. These 864 facilities reported 1475 individual stock-outs, with one to fourteen different medicines out of stock per facility. Information on impact was provided in 98% (1449/1475) of stock-outs: 25% (366) resulted in a high impact outcome, where patients left the facility without medicine or were provided with an incomplete regimen. Of the 757 stock-outs that were resolved 70% (527) lasted longer than one month. Interpretation There was a high prevalence of stock-outs nationwide. Large interprovincial differences in stock-out occurrence, duration, and impact suggest differences in provincial ability to prevent, mitigate and cope within the same framework. End-user monitoring of the supply chain by patients and civil society has the potential to increase transparency and complement public sector monitoring systems.
  • Changes to intellectual property policy in South Africa: putting a stop to evergreening?

    Hill, J E (Informa Healthcare/Expert Reviews, 2014-08)
    South Africa is a middle-income country with the world's largest HIV patient cohort and a growing burden of communicable and non-communicable diseases - a prime location for pharmaceutical companies looking to expand their markets. Yet, 20 years after the country's first democratic elections, poor health indicators and an over-burdened public health system belie persistently stark levels of socioeconomic inequality. As the South African government revises national intellectual property (IP) policies, the pharmaceutical industry and global access to medicines movement are watching, aware of ramifications South Africa's actions will have on patent laws and the availability of generic medicines in other middle-income countries and across Africa. South Africa's draft IP policy is meeting fierce resistance from industry, although proposed reforms are compliant with the Agreement on trade related aspects of intellectual property (TRIPS) and in line with on-going policies and actions of both developing and developed countries. Could the establishment of a patent examination system and new patentability criteria rein in evergreening and lead to lower medicine prices? What will be the potential impact of reform on medical innovation? And why is it both necessary and urgent that the South African government seek a fairer balance between private and public interests?
  • Paediatric pharmacovigilance: use of pharmacovigilance data mining algorithms for signal detection in a safety dataset of a paediatric clinical study conducted in seven african countries

    Kajungu, D K; Erhart, A; Talisuna, A O; Bassat, Q; Karema, C; Nabasumba, C; Nambozi, M; Tinto, H; Kremsner, P; Meremikwu, M; et al. (Public Library of Science, 2014-05)
    Pharmacovigilance programmes monitor and help ensuring the safe use of medicines which is critical to the success of public health programmes. The commonest method used for discovering previously unknown safety risks is spontaneous notifications. In this study we examine the use of data mining algorithms to identify signals from adverse events reported in a phase IIIb/IV clinical trial evaluating the efficacy and safety of several Artemisinin-based combination therapies (ACTs) for treatment of uncomplicated malaria in African children.
  • Alogliptin: A new dipeptidyl peptidase-4 inhibitor for the management of type 2 diabetes mellitus

    Ndefo, U A; Okoli, O; Erowele, G (American Society of Health System Pharmacists, 2014-01-15)
    The pharmacology, pharmacodynamics, pharmacokinetics, safety, efficacy, and place in therapy of alogliptin and its combinations for managing type 2 diabetes mellitus are reviewed.
  • Substandard medicines in resource-poor settings: A problem that can no longer be ignored

    Caudron, J M; Ford, N; Henkens, M; Macé, C; Kiddle-Monroe, R; Pinel, J; Médecins Sans Frontières, Geneva, Switzerland; AEDES Foundation, Brussels, Belgium (2008-07-08)
    The circulation of substandard medicines in the developing world is a serious clinical and public health concern. Problems include under or over concentration of ingredients, contamination, poor quality ingredients, poor stability and inadequate packaging. There are multiple causes. Drugs manufactured for export are not regulated to the same standard as those for domestic use, while regulatory agencies in the less-developed world are poorly equipped to assess and address the problem. A number of recent initiatives have been established to address the problem, most notably the WHO pre-qualification programme. However, much more action is required. Donors should encourage their partners to include more explicit quality requirements in their tender mechanisms, while purchasers should insist that producers and distributors supply drugs that comply with international quality standards. Governments in rich countries should not tolerate the export of substandard pharmaceutical products to poor countries, while developing country governments should improve their ability to detect substandard medicines.
  • Global trade and access to medicines: AIDS treatments in Thailand.

    Wilson, D; Cawthorne, P; Ford, N; Aongsonwang, S; Médecins Sans Frontières, Bangkok, Thailand. (Elsevier, 1999-11-27)