World Health Organization Essential Medicines Research Articles

Availability, price, and affordability of anti-hepatitis B virus drugs: a cross-sectional study in China.

The global prevalence of hepatitis B virus (HBV) has presented a persistent challenge for public health prevention and treatment. However, studies that assess the public's access to anti-HBV drugs are absent. To examine the availability, pricing, and affordability of anti-HBV drugs in Jiangsu province, China and provide recommendations for improvement. An enhanced methodology developed by the World Health Organization (WHO) and Health Action International was applied in a cross-sectional study that included 1026 healthcare facilities distributed in 13 prefectural-level cities in Jiangsu province. Since almost all drugs had an availability of less than 30%, the accessibility of anti-HBV drugs was notably low. Primary healthcare facilities had the lowest availability, reporting 1.4% for Original Brands (OBs) and 1.7% for lowest-priced generics (LPGs). Furthermore, the northern Jiangsu region recorded the lowest availability at 0.7%. LPGs demonstrated higher availability than OBs, with median availability probabilities of 2.6% and 1.4%, respectively. The drugs listed on the WHO Essential Medicines List exhibited higher availability than those on other lists. The median price ratios for OBs, LPGs, and volume-based purchasing drugs were 0.83, 0.50, and 0.27, respectively, less than 1.5 times the international reference price. Despite favorable pricing, affordability rate was 23% for urban residents and 0% for rural residents, which was discouraging. Low availability and affordability of anti-HBV drugs were observed. Policy recommendations should emphasize the improvement of LPG availability by incentivizing priority prescribing. Healthcare subsidies should be provided more effectively and equitably.

Bacterial Contamination of Blood Products Stored at Room Temperature on Agitator in Lagos State, Nigeria

Abstract BACKGROUND: The relevance of some plasma-based medicinal products, especially platelet concentrates in modern medical care, is confirmed by their inclusion in the World Health Organization Essential Medicines. Therefore, this study characterized bacterial contamination in blood donor’s platelet concentrates in Lagos State. METHODS: A total number of 10 units of screened blood were collected and platelet concentrates were serially sampled following an aseptic procedure and stored for a period of 8 days (day 1 to day 8). The samples were incubated at 37°C on a daily basis for 7 days in brain–heart infusion growth medium and thioglycolate broth, respectively. The identities of the isolated organisms were determined by following standard microbiological techniques. The resistance pattern of isolates to selected antimicrobial agents was also determined by disc diffusion method. RESULTS: The results obtained showed that the overall prevalence of bacterial contamination in platelet concentrates stored at room temperature was 20% (2/10), with the growth on the 1st day of culture. The pattern of the bacterial isolates was Staphylococcus aureus – 10% (1/10) and Staphylococcus epidermidis – 10% (1/10) from 10 platelet concentrates with agitation for 8 days with no evidence of co-bacterial contamination. The resistance pattern of the bacterial isolates to different selected antibiotics ranged from 50% to 100%. There was no significant difference in P value obtained in the comparative analysis of the proportions of S. aureus and S. epidermidis in platelet concentrates (P = 1.000; P > 0.05). The findings of this study also confirmed the presence of multidrug-resistant Gram-positive bacteria in the blood component for transfusion studied in Lagos; the organisms isolated were S. aureus and S. epidermidis. The resistance pattern of the bacteria to the antibiotics ranged from 50% to 100%. CONCLUSION: This work revealed evidence of bacterial contamination in platelet concentrates prepared for transfusion with an overall bacterial contamination of 20% (S. aureus – 10%; S. epidermidis – 10%) with no evidence of co-bacterial contamination but with evidence of S. aureus and S. epidermidis multidrug resistance, hence the need for proper storage and screening of platelet concentrates for bacterial contamination before transfusion to avoid platelet aggregation that may lead to fatal complications in the recipient.

Drug Prescribing Pattern among the Inpatients in the Surgery Department of Tertiary Hospital of Eastern Nepal

Background: Prescription is a written instruction by a health care personnel to pharmacist to dispense drug(s). Irrational drug prescribing is a global problem, particularly in developing and transitional countries. This study was conducted to see the status of World Health Organization (WHO) core prescription indicators, complementary indices and prescription errors. Methods: It was a quantitative cross-sectional descriptive study carried out among inpatients of general surgery of tertiary hospital in eastern Nepal. Ethical approval for the study was obtained from the Institutional Review Committee. It was a convenience sampling. Calculated Sample size was 224. Enrollment of patients started on 16 May 2018 with the last case being enrolled on 1 Oct 2019 after obtaining informed consent. Relevant data was entered in a semi-structured proforma. Microsoft excel 2016 and IBM Statistical Package for the Social Sciences (SPSS) v. 21 were used for descriptive statistics. Results: Median age of inpatients was 40 (24 - 54) years with male: female ratio being 1.05. Total 1492 drugs were prescribed in 224 prescriptions. Mean number of drugs prescribed was 6.66 ± 2.33. Percentage of drugs prescribed by generic name was 25.60%. Prescriptions with at least one antimicrobial agent was 89.3%. Prescriptions with at least one injection was 92.9%. Percentage of drugs prescribed from the WHO Essential Medicine List was 66.48%. Other complementary prescribing indicators and prescription errors were also calculated. Conclusions: Most prescription indicators were inadvertently deviated away from WHO standards. Prescription errors were comparable to other studies.

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.

Antibiotics use evaluation among hospitalized adult patients at Jimma Medical Center, southwestern Ethiopia: the way to pave for antimicrobial stewardship

BackgroundAn irrational antibiotic use is a common problem in developing countries like Ethiopia, which makes empiric antibiotics use difficult. It is considered to be the greatest health problem in our time and future unless intervened. Therefore, this study aimed to assess the patterns of antibiotics use among hospitalized adult patients to pave the way for antimicrobial stewardship.MethodsA hospital-based prospective observational study was conducted at Jimma Medical Center, southwestern Ethiopia, from 30 October 2020 to 29 January 2021 with 360 adult hospitalized patients participating. A semi-structured questionnaire and consecutive sampling technique was used for data collection. The data were collected through medical record reviews and patient interviews. The collected data were entered into Epi-data and exported to SPSS® version 23.0 for analysis. Days of therapy (DOT) and essential medicine lists “Access, Watch, and Reserve (AWaRe)” antibiotics classification were used to assess antibiotic use pattern among participants.ResultsThe majority of study participants were females (55.3%), attended formal education (59.4%), and live in rural areas (61.4%) with mean age ± (SD) of 37.65 ± (16.75). The overall rate of antibiotics consumption during the study was 111 days of therapy per 100 bed-days and about two-thirds (66%) of the prescribed antibiotics were from the “Watch” group antibiotics. The indicator level of antibiotics use for “Access” group antibiotics was 34% in this study based on the World Health Organization Essential Medicine List. Cephalosporins were the most commonly used class of antibiotics (93.9%).ConclusionHigher antibiotics exposure and their consumption frequently observed among adult hospitalized patients in the study setting. There was a rapid increase in “Watch” group antibiotics use and about two-thirds of the prescribed antibiotics were from this group. The third-generation cephalosporin were the most commonly used class of antibiotics. Generally, higher consumption and inappropriate antibiotics use among hospitalized adult patients showed the need for urgent interventions by implementing Antimicrobial Stewardship Programs in hospitals.

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.

Access to and Affordability of World Health Organization Essential Medicines for Cancer in Sub-Saharan Africa: Examples from Kenya, Rwanda, and Uganda.

Cancer mortality is high in sub-Saharan Africa (SSA), partly due to inadequate treatment access. We explored access to and affordability of cancer treatment regimens for the top 10 cancers utilizing examples from Kenya, Uganda, and Rwanda. Population, healthcare financing, minimum wage, and cancer incidence and mortality data were obtained from the WHO, World Bank, public sources, and GLOBOCAN. National Essential Medicines List (NEML) alignment with 2019 WHO EML was assessed as a proportion. Cancer regimen pricing was calculated using public and proprietary sources and methods from prior studies. Affordability through universal healthcare coverage (UHC) was assessed as 1-year cost <3× gross national income per capita; and to patients out-of-pocket (OOP), as 30-day treatment course cost <1 day of minimum wage work. A total of 93.4% of the WHO EML cancer medicines were listed on the 2019 Kenya NEML, and 70.5% and 41.1% on Uganda (2016) and Rwanda (2015) NEMLs, respectively. Generic chemotherapies were available and affordable to governments through UHC to treat non-Hodgkin's lymphoma, cervical, breast, prostate, colorectal, ovarian cancers, and select leukemias. Newer targeted agents were not affordable through government UHC purchasing, while some capecitabine-based regimens were not affordable in Uganda and Rwanda. All therapies were not affordable OOP. All cancer treatment regimens were not affordable OOP and some were not covered by governments. Newer targeted drugs were not affordable to all 3 governments. UHC of cancer drugs and improving targeted therapy affordability to LMIC governments in SSA are key to improving treatment access and health outcomes.

Poly(trehalose methacrylate) as an Excipient for Insulin Stabilization: Mechanism and Safety.

Insulin, the oldest U.S. Food and Drug Administration (FDA)-approved recombinant protein and a World Health Organization (WHO) essential medicine for treating diabetes globally, faces challenges due to its storage instability. One approach to stabilize insulin is the addition of poly(trehalose methacrylate) (pTrMA) as an excipient. The polymer increases the stability of the peptide to heat and mechanical agitation and has a low viscosity suitable for injection and pumps. However, the safety and stabilizing mechanism of pTrMA is not yet known and is required to understand the potential suitability of pTrMA as an insulin excipient. Herein is reported the immune response, biodistribution, and insulin plasma lifetime in mice, as well as investigation into insulin stabilization. pTrMA alone or formulated with ovalbumin did not elicit an antibody response over 3 weeks in mice, and there was no observable cytokine production in response to pTrMA. Micropositron emission tomography/microcomputer tomography of 64Cu-labeled pTrMA showed excretion of 78–79% ID/cc within 24 h and minimal liver accumulation at 6–8% ID/cc when studied out to 120 h. Further, the plasma lifetime of insulin in mice was not altered by added pTrMA. Formulating insulin with 2 mol equiv of pTrMA improved the stability of insulin to standard storage conditions: 46 weeks at 4 °C yielded 87.0% intact insulin with pTrMA present as compared to 7.8% intact insulin without the polymer. The mechanism by which pTrMA-stabilized insulin was revealed to be a combination of inhibiting deamidation of amino acid residues and preventing fibrillation, followed by aggregation of inactive and immunogenic amyloids all without complexing insulin into its hexameric state, which could delay the onset of insulin activity. Based on the data reported here, we suggest that pTrMA stabilizes insulin as an excipient without adverse effects in vivo and is promising to investigate further for the safe formulation of insulin.

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.

Rational Use of Antibiotics: An Area of Concern

Published on:June 2022Journal of Young Pharmacists, 2022; 14(2):165-168Review Article | doi:10.5530/jyp.2022.14.31 Authors: Sougata Sarkar,1 Vartika Srivastava,2,*Shambo Samrat Samajhdar,1 Chaitali Pattanayak,2 Santanu Tripathi3 1Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, West Bengal, INDIA. 2Department of Pharmacology, Kalinga Institute of Medical Sciences, Bhubaneswar, Odisha INDIA.3Department of Pharmacology, Netaji Subhas Medical College and Hospital, Patna, Bihar, INDIA. Abstract: Most of the IPD (Inpatient department) and OPD (Outpatient department) patients receive a course of antibiotics either for treatment or prevention of infection or during discharge. The therapeutic outcome with an antibiotic depends mostly on choice of appropriate agent. The selection of antibiotic depends on causative agent, patient factors, clinical pharmacology of antibiotics and its cost effectiveness. Antimicrobial resistance (AMR) occurs when microbes like bacteria, parasites, viruses and fungi become resistant to antimicrobial drugs that are used for treatment of various diseases leading to decreased effectiveness, difficulty in treatment of disease and hence requiring multiple therapeutic options. Antimicrobial stewardship is a coordinated intervention, designed to improve and measure the appropriate use of antimicrobial agents, by promoting the selection of optimal antimicrobial drug regimen including dosing, duration of therapy and route of administration. To strengthen the implementation of rational antibiotic use and reduction of antimicrobial resistance, WHO (World Health Organisation) in 2019 introduced “AWaRe” classification of antibiotics that includes details of 180 antibiotics classified as Access, Watch or Reserve, their pharmacological classes, Anatomical Therapeutic Chemical (ATC) codes and WHO Essential Medicines List status. One health approach is the collaborative effort of multiple health science professions to attain optimal health for people, domestic animals, wildlife, plants, and environment. Recently, WHO issued new guidelines regarding the use of antimicrobials in animals producing food, recommending the restricted use of such medicines in growth promotion or prevention of disease in healthy animals. Hence rational use of antibiotics is important for successful treatment outcome and prevention of emerging drug resistance for broader community.Key words: Antibiotics, Antibiotic resistance, Antibiotic stewardship, AWaRe Classification, One health approach.

Mechanistic Insights on the Mechanosynthesis of Phenytoin, a WHO Essential Medicine**

In recent years, mechanochemistry has enriched the toolbox of synthetic chemists, enabling faster and more sustainable access to new materials and existing products, including active pharmaceutical ingredients (APIs). However, molecular‐level understanding of most mechanochemical reactions remains limited, delaying the implementation of mechanochemistry in industrial applications. Herein, we have applied in situ monitoring by Raman spectroscopy to the mechanosynthesis of phenytoin, a World Health Organization (WHO) Essential Medicine, enabling the observation, isolation, and characterization of key molecular‐migration intermediates involved in the single‐step transformation of benzil, urea, and KOH into phenytoin. This work contributes to the elucidation of a reaction mechanism that has been subjected to a number of interpretations over time and paints a clear picture of how mechanosynthesis can be applied and optimized for the preparation of added‐value molecules.

Mapping the selection, availability, price and affordability of essential medicines for mental health conditions at a global level.

To provide a cross-country analysis of selection, availability, prices and affordability of essential medicines for mental health conditions, aiming to identify areas for improvement. We used the World Health Organization (WHO) online repository of national essential medicines lists (EMLs) to extract information on the inclusion of essential psychotropic medicines within each country's EML. Data on psychotropic medicine availability, price and affordability were obtained from the Health Action International global database. Additional information on country availability, prices and affordability of essential medicines for mental disorders was identified by searching, up to January 2021, PubMed/Medline, CINAHIL, Scopus and the WHO Regional Databases. We summarised and compared the indicators across lowest-price generic and originator brand medicines in the public and private sectors, and by country income groups. A total of 112 national EMLs were analysed, and data on psychotropic medicine availability, price and affordability were obtained from 87 surveys. While some WHO essential psychotropic medicines, such as chlorpromazine, haloperidol, amitriptyline, carbamazepine and diazepam, were selected by most national lists, irrespective of the country income level, other essential medicines, such as risperidone or clozapine, were included by most national lists in high-income countries, but only by a minority of lists in low-income countries. Up to 40% of low-income countries did not include medicines that have been in the WHO list for decades, such as long-acting fluphenazine, lithium carbonate and clomipramine. The availability of generic and originator psychotropic medicines in the public sector was below 50% for all medicines, with low-income countries showing rates lower than the overall average. Analysis of price data revealed that procurement prices were lower than patient prices in the public sector, and medicines in the private sector were associated with the highest prices. In low-income countries, the average patient price for amitriptyline and fluoxetine was three times the international unit reference price, while the average patient price for diazepam was ten times the international unit reference price. Affordability was higher in the public than the private sector, and in high-income than low-income countries. Access to medicines for mental health conditions is an ongoing challenge for health systems worldwide, and no countries can claim to be fully aligned with the general principle of providing full access to essential psychotropic medicines. Low availability and high costs are major barriers to the use of and adherence to essential psychotropic medicines, particularly in low-and middle-income countries.

A human rights-based approach to improve access to insulin and other aspects of diabetes care

Many nations struggle to provide adequate diabetes care. Legal as well as moral obligations may facilitate access. International human rights law places obligations on governments to ensure the accessibility and affordability of insulin (a World Health Organization essential medicine), and other components of diabetes care. Despite this obligation, the global reality is that access remains deficient. A human rights approach facilitating the improvement of diabetes services and equitable access to insulin provides a strong framework, theoretically and practically, for advocacy and policymaking changes. This approach links governments to their international obligations, fosters the ideal of, and adherence to, national essential medicine lists, complements the pursuit of international goals in non-communicable diseases, and should influence the actions of pharmaceutical and device companies. This approach empowers patients, families, and communities living with diabetes, and grounds actions by governments, clinicians, and non-government organisations in the principles of dignity, non-discrimination, and equity of access.

Cost and consequences of using 7.1\u2009% chlorhexidine gel for newborn umbilical cord care in Kenya

BackgroundOmphalitis is an important contributor to neonatal mortality in Kenya. Chlorhexidine digluconate 7.1 % w/w (CHX; equivalent to 4 % w/w chlorhexidine) was identified as a life-saving commodity for newborn cord care by the United Nations and is included on World Health Organization and Kenyan Essential Medicines Lists. This pilot study assessed the potential resource savings and breakeven price of implementing CHX for neonatal umbilical cord care versus dry cord care (DCC) in Kenya.MethodsWe employed a cost-consequence model in a Kenyan birth cohort. Firstly, the number of omphalitis cases and cases avoided by healthcare sector were estimated. Incidence rates and treatment effect inputs were calculated from a Cochrane meta-analysis of randomised clinical trials (RCTs) (base case) and 2 other RCTs. Economic outcomes associated with omphalitis cases avoided were determined, including direct, indirect and total cost of care associated with omphalitis, resource use (outpatient visits and bed days) and societal impact (caregiver workdays lost). Costs and other inputs were sourced from literature and supplemented by expert clinical opinion/informed inputs, making necessary assumptions.ResultsThe model estimated that, over 1 year, ~ 23,000 omphalitis cases per 500,000 births could be avoided through CHX application versus DCC, circumventing ~ 13,000 outpatient visits, ~ 43,000 bed days and preserving ~ 114,000 workdays. CHX was associated with annual direct cost savings of ~ 590,000 US dollars (USD) versus DCC (not including drug-acquisition cost), increasing to ~ 2.5 million USD after including indirect costs (productivity, notional salary loss). The most-influential model parameter was relative risk of omphalitis with CHX versus DCC. Breakeven analysis identified a budget-neutral price for CHX use of 1.18 USD/course when accounting for direct cost savings only, and 5.43 USD/course when including indirect cost savings. The estimated breakeven price was robust to parameter input changes. DCC does not necessarily represent standard of care in Kenya; other, potentially harmful, approaches may be used, meaning cost savings may be understated.ConclusionsEstimated healthcare cost savings and potential health benefits provide compelling evidence to implement CHX for umbilical cord care in Kenya. We encourage comprehensive data collection to make future models and estimates of impacts of upscaling CHX use more robust.