Health Organization Essential Medicines List Research Articles

Variations in global prices of chemotherapy for childhood cancer: a descriptive analysis.

The stark disparity in survival for children with cancer across the world has inspired a global call to expand chemotherapy access in low and middle income countries. Among the numerous barriers to success, a paucity of reliable information regarding chemotherapy pricing hinders the ability of governments and other key stakeholders to make informed budget decisions or negotiate lower medication prices. The aim of this study was to generate comparative price information on both individual chemotherapy agents and comprehensive treatment regimens for common childhood cancers using real-world data. Chemotherapy agents were selected based on their inclusion in the World Health Organization (WHO) Essential Medicines List for Children (EMLc) and their use in frontline regimens for the tracer cancer types prioritized by the WHO's Global Initiative for Childhood Cancer (GICC). Sources included IQVIA MIDAS data, obtained under license from IQVIA, and publicly available data from Management Sciences for Health (MSH). Data on chemotherapy prices and purchase volumes spanning 2012-2019 were aggregated according to WHO region and World Bank (WB) income classification. Cumulative chemotherapy prices for treatment regimens were compared across WB income classification. Data representing an estimated 1.1 billion doses of chemotherapy were obtained for 97 countries: 43 high income countries (HICs), 28 upper middle income countries (UMICs), and 26 low and lower middle income countries (LLMICs). Median drug prices in HICs were 0.9-20.4 times those of UMICs and 0.9-15.5 times those of LMICs. Regimen prices were generally higher for HICs, hematologic malignancies, non-adapted protocols, and higher risk stratification or stage, albeit with notable exceptions. This study represents the largest price analysis to date of chemotherapy agents used globally in childhood cancer therapy. The findings of this study form a basis for future cost-effectiveness analysis in pediatric cancer and should inform efforts of governments and stakeholders to negotiate drug prices and develop pooled purchasing strategies. NB received funding support from the American Lebanese Syrian Associated Charities and Cancer Center Support grant (CA21765) from the National Cancer Institute through the National Institutes of Health. TA received funding through the University of North Carolina Oncology K12 (K12CA120780) and the University Cancer Research Fund from the UNC Lineberger Comprehensive Cancer Center.

Bispecific antibodies mimicking factor VIII in hemophilia A: converting innovation to an essential medicine

Preventive subcutaneous treatment of severe hemophilia A with bispecific antibodies that mimic the action of coagulation factor VIII (FVIII) is emerging as an effective alternative to replacement therapy with intravenous administration of FVIII concentrates, either derived from plasma or produced by biotechnology. Access to this innovative therapeutic approach for a growing number of patients worldwide increasingly appears to be a priority public health strategy. Inclusion of FVIII mimetic bispecific antibodies on the World Health Organization essential medicines list would contribute to health equity in lower-income countries.

Anticancer medicines in Pakistan: An analysis of essential medicines lists.

The lack of anticancer drugs for curative and supportive purposes is the critical reason for the low survival rate in low-and-middle-income countries. This study aims to analyze whether the National Essential Medicines List (NEML) and Registered Essential Medicines List (REML) are in concordance with the World Health Organization (WHO) Essential Medicines List (EML) and whether the formularies prevalent in the country are parallel to each other and to the NEML. An observational study design was used in which antineoplastic drugs from the 2021 NEML and REML were compared with 2021 WHO EML to evaluate their availability in Pakistan. Market access was determined. Moreover, the formularies of six different hospital types were compared with each other and with the NEML, and REML to estimate the availability within hospitals. There were 66 anticancer drugs in 2021 WHO EML and all were found in Pakistan's 2021 NEML but only 48 drugs (73%) were found in the REML. Hydroxycarbamide and dasatinib were two registered drugs absent in all hospitals' formularies. The market access for anticancer medicines was 73% (48 of 66). Semigovernment hospital (86%) has the highest availability, followed by the government hospital (80%). All the hospitals have unregistered drugs including bortezomib, lenalidomide, and mesna. Pakistan's NEML adopts WHO EML abruptly but all medicines are not registered. The hospitals are trying their best to increase availability but optimum drug regulations to revise NEML based on the country's requirements and emphasizing registration of anticancer medicines are needed to improve the country's availability of antineoplastic agents.

Micellar eco-friendly HPLC method for simultaneous analysis of ternary combination of aspirin, atorvastatin and ramipril: application to content uniformity testing

BackgroundCardiovascular disease medications such as aspirin (ASP), statins like atorvastatin (ATR), and blood pressure-lowering drugs including ACE inhibitors like ramipril (RAM) have been included in the World Health Organization (WHO) Essential Medicines List (EML) for many years. Therefore, there is a strong demand to develop a simple, rapid, and sensitive analytical method that can detect and quantitate the ternary mixture of these analytes in pharmaceutical preparations in a short run time. Lately, the analytical community focused on eliminating or reducing hazardous chemicals and solvents usage.ResultsA green, fast, selective, and cost-effective micellar HPLC method was established and validated for the concurrent determination of ternary combination of ASP, ATR, and RAM in the pure form and pharmaceutical preparations. Resolution of the three drugs was achieved by using a monolithic column and a micellar mobile phase consists of 0.3% triethylamine (TEA) in 90: 10 an aqueous solution of 0.12 M sodium dodecyl sulfate (SDS): n-propanol, (v/v). The pH was adjusted to 2.5 using orthophosphoric acid and a flow rate of 1.5 mL/min. was applied. To ensure method reproducibility, Valsartan (VAL) was utilized as an internal standard (IS). The UV detection of the studied drugs was performed at 210 nm. Good linearity for the three drugs was obtained over the concentration ranges of 1.0-200.0 mg/mL, 0.5-200.0 mg/mL, and 5.0-100.0 mg/mL with correlation coefficients of 0.9998,0.9999 and 0.9999 for ASP, ATR, and RAM respectively. The method sensitivity was revealed by the relatively small values of limits of detection (LOD) (0.19, 0.13 and 0.30 mg/mL) and limits of quantitation (LOQ) (0.63, 0.44 and 0.99 mg/mL) for ASP, ATR, and RAM, respectively. The retention times of ASP, ATR and RAM were 1.50, 2.3 and 4.3 min., respectively.ConclusionsThe suggested technique was employed for the analysis of the three drugs in their prepared tablets maintaining the recommended pharmaceutical ratio without any interference from excipients. The method was further extended to content uniformity testing of RAM. The results were validated according to international council for harmonisation (ICH) guidelines.

Essential medicines for mental disorders: comparison of 121 national lists with WHO recommendations

BackgroundTo compare the medicines for mental disorders included in national essential medicines lists with the World Health Organization (WHO) essential medicines list and assess the extent to which economic status and WHO Region account for the differences.MethodsWe searched WHO repository and government sites for national essential medicines lists and we abstracted medicines for mental disorders. We calculated the proportion of WHO essential medicines included, the total number of differences (counting both additions and deletions) between national and WHO model list and the proportion of lists including one second-generation oral antipsychotic plus one new-generation antidepressant. Non-parametric statistics was used to investigate whether these indicators were dependent on economic status and WHO Region.ResultsAmongst the 121 identified national lists, the total number of medicines for mental disorders ranged from 2 to 63 (median: 18; IQR: 14 to 25). The median proportion of WHO essential medicines for mental disorders included was 86% (IQR: 71–93%), with 16 countries (13%, 95% CI 7.75–20.5%) including all WHO essential medicines, while the median number of differences with the WHO EML was 11 (IQR: 7 to 15). Country economic level was positively associated with both the proportion of WHO essential medicines included (Spearman's rho = 0.417, p < 0.001) and the number of differences (Spearman's rho = 0.345, p < 0.001), implying that countries with higher income level included more WHO essential medicines, but also more additional medicines. Significant differences were observed in relation to WHO Region, with the African and Western Pacific Region showing the lowest proportions of WHO essential medicines, and the European Region showing the highest median number of differences. Overall, 88 national lists (73%, 95% CI 63–80%) included at least one second-generation oral antipsychotic and new-generation antidepressant, with differences by income level and WHO Region.ConclusionsThe degree of alignment of national lists with the WHO model list is substantial, but there are considerable differences in relation to economic status and WHO Region. These findings may help decision-makers to identify opportunities to improve national lists, aiming to increase access to essential medicines for mental disorders.

Reporting on antibiotic use patterns using the WHO Access, Watch, Reserve classification in the Caribbean.

To assess antibiotic use in three hospitals in three Caribbean countries based on data from 2013 and 2018 using the World Health Organization Essential Medicines List "Access, Watch, Reserve" (AWaRe) classification. A retrospective observational study, which analyzed the World Health Organization Point Prevalence Survey data from three hospitals in three Caribbean countries, to examine proportional AWaRe group antibiotic use for the top ten inpatient indications. The Access-to-Watch ratio was calculated, and the top three antibiotics prescribed in each hospital were determined. The final data set included 376 prescriptions for the top ten indications in 766 inpatients. The hospital antibiotic use point prevalence for Hospital 1 was 35.6%, Hospital 2 was 48.6%, and Hospital 3 was 47.1%. The Access-to-Watch ratio for the top ten indications was 2.45, 1.36, and 1.72 in the three hospitals. Access group prevalence was 71.0% in Hospital 1, 57.6% in Hospital 2, and 63.2% in Hospital 3. There were no Reserve antibiotics prescribed in any of the institutions. The most common indication for Watch prescription was skin and soft tissue infections in Hospital 1 and pneumonia in Hospital 2 and 3. This study draws urgent attention to evidence of a high proportion of Watch antibiotic prescribing and lack of Reserve group antibiotics in three Caribbean countries. This research provides data that may inform national formulary and antimicrobial stewardship policy-making across the settings analyzed and the wider region.

Abstract 11314: Essential and Evidence-Based Cardiovascular Disease Medicine Availability in Low-Cost Generic Drug Plans

Introduction: Patients’ lack of access to affordable cardiovascular disease (CVD) medicines poses a crucial barrier to achieving desired cardiovascular outcomes. Many pharmacies have launched low-cost generic programs (LCGP) to expand medication accessibility. It is uncertain whether LCGPs include CVD drugs recommended by World Health Organization Essential Medicines List (WHO EML) and promote evidence-based prescribing. Our study aimed to estimate the availability of essential and guideline-recommended CVD medicines on LCGP in the United States (US). Methods: We selected 6 CVD conditions: atrial fibrillation (AF), heart failure (HF), hyperlipidemia (HLD), hypertension (HTN), stable angina (SA), and secondary prevention (SPX). LCGPs in the US with publicly available formularies were identified in February 2022. We used the 22 nd WHO EML edition and Class 1A recommendations (1ARec) from current CVD guidelines as reference standards. Availability was estimated using the proportion of coverage for each LCGP overall, and by condition. Results: Nineteen LCGPs were included. There were 122 WHO EML and 155 1ARec CVD drugs. No LCGPs offered at least 50% of WHO EML and 1ARec. Both WHO EML and 1ARec analyses showed that 9 of 19 LCGPs covered at least 30% of listed medications. Out of the 19 LCGPs, the proportion of essential and evidence-based CVD medicine availability was highest at Kroger (46.3% and 47.9%) and lowest at Costco (5.0% and 6.1%), respectively. Higher availability was observed for HLD medications: only TOPS and the Mark Cuban Plan had at least 80% of WHO EML available, and only the Mark Cuban Plan had at least 80% of 1ARec medications covered. HTN drugs were least available for both. Conclusion: The accessibility of CVD medicines is low in LCGP formularies with variation in availability by pharmacy and condition. To optimize the accessibility of CVD medicines and health outcomes, pharmacies with LCGPs should offer more essential and evidence-based CVD medicines.

Global Consumption Trend of Antifungal Agents in Humans From 2008 to 2018: Data From 65 Middle- and High-Income Countries.

BackgroundUnderstanding the trend of global antifungal agent consumption could assist with identification of global healthcare policy inadequacies and promote accessibility and availability of antifungal agents.MethodsUsing pharmaceutical sales data from the IQVIA-multinational integrated data analysis system database, we assessed use of systemic antifungal agents in humans in 27 middle- and 38 high-income countries from 2008 through 2018.ResultsConsumption of systemic antifungal agents increased from 0.50 (in 2008) to 0.92 defined daily dose (DDD)/1000 inhabitants/day (in 2018), with a compound annual growth rate of 6.2%. High-income countries remain major consumers of antifungal agents with large variance in quantities consumed, with a gradual decline in consumption in recent years. Consumption in middle-income countries increased. Itraconazole (0.32 DDD/1000 inhabitants/day), terbinafine (0.30 DDD/1000 inhabitants/day), and fluconazole (0.23 DDD/1000 inhabitants/day) were the most commonly used antifungal agents in middle- and high-income countries in 2018. Following incorporation into the World Health Organization Essential Medicines List, itraconazole consumption in middle-income countries surged. Consumption of ketoconazole slowly declined, with 5.04% annual decrease, probably due to labelling changes in 2013 to reflect hepatotoxicity concerns. The use of polyenes (0.004 DDD/1000 inhabitants/day) and echinocandins (0.003 DDD/1000 inhabitants/day) were lowest among all the antifungal drug classes.ConclusionGlobal consumption of triazoles and terbinafine has gradually increased in middle- and high-income countries. Life-saving antifungal agents, including echinocandins and polyenes, are available only parenterally and may be underutilized, mainly in middle-income countries. Future research on country-specific epidemiology is warranted to guide health policy coordination to ensure equitable access to appropriate use of antifungal agents.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40265-022-01751-x.

Carbetocin: a therapy advance for prevention of postpartum haemorrhage

Postpartum haemorrhage (PPH) is the major cause of maternal death. To prevent PPH, the routine administration of a uterus-contracting (‘uterotonic’) agent is a standard practice across the world. Oxytocin is the standard uterotonic agent recommended for this purpose, and is recommended for all women giving birth. Oxytocin is problematic as it requires cold storage and transport, and in low-resource settings, the cold chain is not commonly available. Heat-stable carbetocin is a promising alternative to oxytocin. Because of its heat stability, it can overcome the persistent problems with oxytocin quality as it does not require cold chain for storage and transport. Considering the totality of the evidence, it appears to have some additional desirable effects compared with oxytocin and a very favourable side effect profile similar to oxytocin. With a standardized dosing of single injection recommendation, it can address the variations in dosing regimen as is with oxytocin. Carbetocin has been added to the World Health Organization (WHO) essential medicines list of uterotonics for the prevention of excessive bleeding after childbirth, we might see a new standard of care in coming months for prevention of uterine atony.

High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75 countries.

Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antibiotic, the approval status was assessed by either registration with the United States Food and Drug Administration (US FDA) or inclusion on the World Health Organization (WHO) Essential Medicines List (EML). A total of 119 antibiotic FDCs were identified, contributing 16.7 x 109 SU, equalling 22% of total antibiotic consumption in 2015. The most sold antibiotic FDCs were amoxicillin-clavulanic acid followed by trimethoprim/sulfamethoxazole and ampicillin/cloxacillin. The category with the highest consumption volume was aminopenicillin/β-lactamase inhibitor +/- other agents. The majority of antibiotic FDCs (92%; 110/119) were not approved by the US FDA. Of these, the most sold were ampicillin/cloxacillin, cefixime/ofloxacin and metronidazole/spiramycin. More than 80% (98/119) of FDC antibiotics were not compatible with the 2017 WHO EML. The countries with the highest numbers of FDC antibiotics were India (80/119), China (25/119) and Vietnam (19/119). There is high consumption of FDC antibiotics globally, particularly in middle-income countries. The majority of FDC antibiotic were not approved by either US FDA or WHO EML. International initiatives such as clear guidance from the WHO EML on which FDCs are not appropriate may help to regulate the manufacturing and sales of these antibiotics.

Two prophylactic pain management regimens for medical abortion ≤63 days' gestation with mifepristone and misoprostol: A multicenter, randomized, placebo-controlled trial

ObjectiveTo determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion. Study designWe conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction. ResultsWe enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0001). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness (p = 0.004), headache (p = 0.03), and vomiting (p < 0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group (p = 0.05); overall abortion satisfaction did not differ by group (p = 0.44). ConclusionsCompared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects. ImplicationsGiven that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion.

Pharmacological profile of prescriptions containing antidepressants

Background: The prescription of antidepressants is increasing due to the increasing incidence of depression and the use of antidepressants in other indications. There is a need to monitor their prescription practices not only to ensure evidence-based clinical use but also to align classroom teaching with the current clinical trends. Materials and Methods: This observational study was conducted in the department of psychiatry of a tertiary care hospital in western Maharashtra on anonymized prescriptions received within the study period. Results: A total of 214 prescriptions were analyzed with 268 instances of antidepressant prescription. 59.05% of prescriptions were of selective serotonin reuptake inhibitors (SSRIs), 18.11% of atypical antidepressants, 16.92% of tricyclic antidepressants (TCAs), and 5.90% of serotonin-noradrenaline reuptake inhibitors. 46% percent of prescriptions were as per defined daily doses (DDDs), 26% more than DDD and 28% less than DDD. Escitalopram and mirtazapine were the most commonly prescribed drugs. Both did not find mention in the National List of Essential Medicines and World Health Organization–Essential Medicines List (EML). Out of 214 prescriptions, 209 prescriptions were for psychiatric indications and the rest 5 were for nonpsychiatric indications. TCAs were prescribed more for psychiatric indications other than depression, while SSRIs were prescribed equally for depression and other psychiatric indications. Conclusion: Prescription trend in this study is in consonance with other contemporary studies. Extensive use of mirtazapine is a peculiar finding requiring further exploration. As in other studies, SSRIs have been used in doses more than their defined daily dose. Off-label use of antidepressants is widespread, but it should be backed by drug-specific robust evidence. EMLs and clinical usage derive from each other and need to be in mutual sync.

Antimicrobial Prescribing during Infant Hospital Admissions in a Birth Cohort in Dhaka, Bangladesh.

Empirical antimicrobial use is common in hospitalized infants and may contribute to antimicrobial resistance in low- and middle-income countries. In this observational birth cohort study nested in a randomized controlled trial in Dhaka, Bangladesh, inpatient antimicrobial prescription data were extracted from serious adverse event forms completed for hospitalizations of infants (0–12 months of age). The primary outcome was the proportion of inpatient admissions where systemic antimicrobials were prescribed. Infant and hospitalization-related factors associated with antimicrobial prescriptions were determined. Among 1254 infants, there were 448 admissions to 32 facilities from 2014 to 2016. Antimicrobials were prescribed in 73% of admissions with a mean antimicrobial exposure rate of 0.25 antimicrobials per day of admission [95% confidence intervals (95% CIs): 0.24–0.27]. The most common antibiotics were aminoglycosides (29%), penicillins (26%) and third-generation cephalosporins (25%). In all, 58% of antibiotics were classified as ‘access’, 38% ‘watch’ and 1% ‘reserve’ using the World Health Organization (WHO) Essential Medicines List classification. WHO-recommended antimicrobial regimens were used in 68% of neonatal sepsis and 9% of lower respiratory tract infection (LRTI) admissions. ‘Watch’ antimicrobials were used in 26% of neonatal sepsis and 76% of LRTI admissions. Compared with private facilities, antimicrobial prescription rates were lower at government [rate ratio (RR) 0.71; 95% CI: 0.61–0.83] and charitable facilities (RR 0.39; 95% CI: 0.28–0.53), after adjustment for household wealth index and parental education. Younger infant age, older maternal age and longer admission were associated with higher prescription rates. These findings highlight the need for paediatric antimicrobial stewardship programs in Bangladesh.

519 Evaluating world health organization essential medicines list for dermatologic disease

The World Health Organization (WHO) Model List of Essential Medicines (MLEM) provides lists of medicines needed for basic healthcare systems. This study aims to appraise the dermatologic section of the WHO MLEM with respect to top Global Burden of Disease (GBD) skin disease entities. Skin burden data was extracted using the GBD results tool. Based on the top 13 GBD skin disease entities, dermatologic essential medicines were appraised with respect to Treatment of Skin Disease, 5th edition and Evidence-Based Dermatology, 3rd edition.

A cross sectional study on prescription pattern of drugs in upper respiratory tract infections in a tertiary care hospital

Background: Upper respiratory tract infections are one of the leading causes of hospital visits worldwide. Judicious use of antibiotics is challenging for upper respiratory tract infections (URTIs) in developing countries like India. This leads to inappropriate use of antibiotics causing many dreaded conditions like antibacterial resistance among other things. Hence rational use of drugs, mainly antibacterial, is a priority to reduce the burden of treatment failure. The objective of this study is to study the prescribing patterns and rationality of drugs prescribed in the management of URTIs.Methods: This was a cross-sectional study. Data was collected from records of 300 outpatients clinically diagnosed as URTIs from SSIMS and RC Hospital, Davangere between January 2015 and June 2016. The prescribing patterns, approval status and listing of drugs in World Health Organization (WHO) essential medicines list/ National List of Essential Medicines (NLEM) were analysed. The data was presented as percentages, mean and standard deviations.Results: A total of 300 cases were studied. Among these, acute pharyngitis (29%) and acute sinusitis (26%) are the most common infections. Of the 300 cases studied, 283 (94.3%) were prescribed antimicrobials. Of the total 740 medications prescribed, 393 (53.1%) were fixed-dose combinations (FDCs). A total of 724 medications (97.8%) were approved by Drugs Controller General of India and 248 (33.5%) by Food and Drug Administration. Only 5.8% of the prescribed drugs have been listed in WHO’s and NLEM. The most common class of antibacterials prescribed was Beta-lactams.Conclusions: Oral formulations were preferred over parenteral formulations and FDCs were preferred over single drug formulations. Beta-lactams comprised the major class of antibacterial prescribed.

World Health Organization Essential Medicines List: Multiple sclerosis disease-modifying therapies application

Introduction: The World Health Organization (WHO) publishes a biennial Essential Medicines List (EML) to assist governments in low-resource settings to prioritize their spending on medicines. Currently, no medicines on the EML have a multiple sclerosis (MS) indication. Multiple Sclerosis International Federation (MSIF) prepared an application for inclusion of MS disease-modifying therapies (DMTs) for the 2019 EML together with the regional Committees for Treatment and Research in Multiple Sclerosis (TRIMS) and the World Federation of Neurology. Rationale: The MSIF taskforce categorized 15 DMTs according to their efficacy and risk profiles to ensure the ability to treat as many different clinical scenarios as possible. Three DMTs were selected: glatiramer acetate, fingolimod, and ocrelizumab. Outcome: The WHO Expert Committee did not recommend the addition of any of the DMTs to the EML. They acknowledged the public health burden of MS, the need for effective and affordable MS medications, and the high volume of letters received in support of the application but requested a revised application. Discussion: Despite the negative outcome, the repeated recognition of MS as a global public health burden is sending a powerful message to governments globally that a range of affordable and good quality medications need to be available to health systems and people affected by MS.

Update the WHO EML to improve global paediatric rheumatology.

The World Health Organization (WHO) Essential Medicines List (EML) informs policy makers about which medications should be prioritized and is particularly important for countries with limited resources. However, the EML lacks vital medicines used in paediatric rheumatology, the inclusion of which could transform the lives of many children around the world.

Improving Medication Adherence in Cardiovascular Disease Prevention: What's New?

Improving Medication Adherence in Cardiovascular Disease Prevention: What's New?

MAMBO: Measuring ambulation, motor, and behavioral outcomes with post-stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial

BackgroundSSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA. AimTo determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania. MethodsOpen-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days.The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires. ConclusionsExpanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.

Essential and forgotten antibiotics: An inventory in low- and middle-income countries

The World Health Organization Essential Medicines List (WHO-EML) includes 'access' antibiotics, judged essential to treat common infections. The European Society of Clinical Microbiology and Infectious Diseases Study Group for Antimicrobial Stewardship defined a list of 'forgotten' antibiotics, some old and often off-patent antibiotics, which have particular value for specific indications. To investigate which WHO-EML 'access' and 'forgotten' antibiotics are approved at national level in a sample of low- to middle-income countries (LMICs). The Scientific Committee used a consensus procedure to select 26 WHO-EML 'access' and 15 'forgotten' antibiotics. Paediatric formulations were explored for 14 antibiotics. An internet-based questionnaire was circulated to 40 LMIC representatives. Antibiotics were defined as approved if an official drug regulatory agency and/or the national ministry of health licensed their use, making them, at least theoretically, available on the market. Twenty-eight LMICs (11 in Africa, 11 in Asia and six in America) were surveyed. Nine WHO-EML 'access' antibiotics (amoxicillin, ampicillin, benzylpenicillin, ceftriaxone, clarithromycin, ciprofloxacin, doxycycline, gentamicin and metronidazole) were approved in all countries, and all 26 'access' antibiotics were approved in more than two-thirds of countries. Among the 15 'forgotten' antibiotics, only one was approved in more than two-thirds of countries. The median number of approved antibiotics per country was 30 (interquartile range 23-35). Six of 14 paediatric formulations (amoxicillin, amoxicillin-clavulanic acid, oral antistaphylococcal penicillin, cotrimoxazole, erythromycin and metronidazole) were approved in more than two-thirds of countries. WHO-EML 'access' antibiotics and the most frequently used formulations for paediatrics were approved in the vast majority of the 28 surveyed LMICs. This was not the case for many of the 'forgotten' antibiotics, despite their important role, particularly in areas with high prevalence of multi-drug-resistant bacteria.