In 2015, the World Health Organization (WHO) released its global action plan (GAP) on antimicrobial resistance (AMR) as a blueprint for the design of national action plans for AMR containment. Bangladesh, with 80% rural household ownership of at least one livestock, introduced its national action plan in May 2017. The objective of this study was two-fold: (i) to perform a policy content evaluation of the Bangladesh National Action Plan (BNAP) against the GAP with a focus on veterinary AMR containment strategies; and (ii) to assess the evidence on the implementation of veterinary AMR containment strategies of the BNAP. The BNAP was evaluated against the GAP to identify commonalities and policy gaps. A scoping review of peer-reviewed and grey literature was performed to identity evidence of policy implementation and practice gaps. The BNAP is strongly aligned with the GAP. However, the study identified policy gaps, including an explicit financing modality, specifications for antimicrobial stewardship (AMS) in the veterinary sector, and rigorous operational and monitoring & evaluation frameworks. More evidence on implementation is needed in terms of incorporation of AMR in the curriculum of veterinarians, AMS plans throughout the veterinary sector, and infection prevention and control protocols and implementation. Closing the identified gaps is essential for successful veterinary AMR containment in Bangladesh but will require sustained and significant investment in institutional and human resource development in the coming years.
1 March 2017 in Bulletin of the World Health Organization
A major hurdle in pediatric formulation development is the lack of safety and toxicity data on some of the commonly used excipients. While the maximum oral safe dose for several kinds of excipients is known in the adult population, the doses in pediatric patients, including preterm neonates, are not established yet due to the lack of evidence-based data. This paper consists of four parts: (1) country-specific perspectives in different parts of the world (current state, challenges in excipients, and ongoing efforts) for ensuring the use of safe excipients, (2) comparing and contrasting the country-specific perspectives, (3) past and ongoing collaborative efforts, and (4) future perspectives on excipients for pediatric formulation. The regulatory process for pharmaceutical excipients has been developed. However, there are gaps between each region where a lack of information and an insufficient regulation process was found. Ongoing efforts include raising issues on excipient exposure, building a region-specific database, and improving excipient regulation; however, there is a lack of evidence-based information on safety for the pediatric population. More progress on clear safety limits, quantitative information on excipients of concern in the pediatric population, and international harmonization of excipients’ regulatory processes for the pediatric population are required.
3 November 2021 in The American Journal of Tropical Medicine and Hygiene
: Antimicrobial resistance (AMR), largely driven by irrational use of antimicrobials, is a global, multifaceted problem calling for a complete understanding of all contributory factors for effective containment. In conflict settings, war-wounds and malnutrition can combine with existing social determinants to increase demand for antibiotics, compounding irrational use. In this study, we focus on Yemen, a low-income country with active conflict for the last 5 years, and analyze the current status of awareness and stewardship efforts regarding AMR. We performed a survey of prescribers/physicians and pharmacists to describe perceptions of AMR prevalence, antibiotic use practices, and stewardship in Yemen, supported by a nonsystematic scoping literature review and a key informant interview. Participants (96%, N = 54) reported a perceived high AMR prevalence rate. Prescribers (74%, 20/27) reported pressure to prescribe broad-spectrum antibiotics. In the majority of cases (81%, 22/27), antimicrobial sensitivity tests (AST) were not performed to inform antibiotic choice. The main barrier to AST was cost. Most pharmacists (67%, 18/27) sold antibiotics without prescriptions. Amoxicillin (including amoxicillin-clavulanate) was the most-commonly prescribed (63%, 17/27) or dispensed (81%, 22/27) antibiotic. AST was rated the least important solution to AMR in Yemen. While there was awareness of a high AMR rate, stewardship is poor in Yemen. We note that barriers to the use of AST could be addressed through the deployment of reliable, affordable, quality rapid diagnostics, and AST kits. Compulsory continuing education emphasizing the use of AST to guide prescribing and patients’ awareness programs could help avoid irrational use.
3 September 2021 in Archives of Disease in Childhood
Introduction The WHO Essential Medicine List for children (EMLc) is used for promoting access to medicines. The age-appropriateness of enteral (oral and rectal) formulations for children depend on their adaptability/flexibility to allow age-related or weight-related doses to be administered/prescribed and the child’s ability to swallow, as appropriate. There is scant information on the age-appropriateness of essential enteral medicines for children. Objective To evaluate the age-appropriateness of enteral essential medicines. Materials and methods Age-appropriateness of all enteral formulations indicated and recommended in the EMLc 3rd to 7th (2011–2019) editions were determined by assessing swallowability and/or dose adaptability for children under 12 years, stratified into five age groups. Results Enteral formulations in the EMLc were more age-appropriate for older children aged 6–11 years than for younger children. In the 3rd edition, for older children, 77%, n=342, of formulations were age-appropriate. For younger children, age-appropriateness decreased with age group: 34% in those aged 3–5 years, 30% in those aged 1–2 years, 22% among those aged 28 days to 11 months and 15% in those aged 0–27 days. Overall, similar proportions were found for the 7th edition. In contrast, the majority of medicines in the 7th list were age-appropriate in targeted diseases like HIV and tuberculosis. Conclusion Most recommended enteral essential medicines in EMLc 2011 and 2019 were not age-appropriate for children <6 years. Medicines which are not age-appropriate must be manipulated before administration, leading to potential issues of safety and efficacy. Evaluation of the age-appropriateness of formulations for medicines to be included in EMLc could improve access to better medicines for children in the future.
Policies to improve access to medicines for children in low- and middle-income countries, such as Nigeria, should consider the growing threat of non-communicable diseases. The aim of this pilot study was to scope availability, price and affordability of essential cardiovascular medicines for children in selected states in Nigeria. The study was a descriptive longitudinal survey conducted in three phases. Availability was determined as percentage of facilities having the medicine on the survey date. Medicines with good availability (>80%) were noted. Prices were cross-referenced against international Reference Prices and the Nigerian National Health Insurance Scheme Prices. Affordability was calculated using the Least-Paid Government Worker method. For medicines compounded to improve availability, a model for calculating affordability was proposed. In Phase I, the availability of all 17 strengths of the cardiovascular medicines or diuretics listed in the Essential Medicines List for Children (2015) were surveyed in two conveniently selected states using the WHO/HAI questionnaire. Data were collected from 17 hospitals and pharmacies. Phases II and III focused on tablet formulations (enalapril, furosemide, hydrochlorothiazide and spironolactone) in three purposively selected state capitals: Lagos, Abuja and Yenagoa. In Phase II, 11 private pharmacies were surveyed in December 2016: Phase III tracked price changes in Abuja and Yenagoa in August 2018. Only furosemide and hydrochlorothiazide tablets had good availability. Oral liquids were unavailable. Prices for four generic oral tablets were 2–16× higher than the International Reference Prices; prices for two of these did not change significantly over the study period. Affordable medicines were generic furosemide and hydrochlorothiazide tablet. Where a fee is charged, compounded medicines were also not affordable. While the small sample sizes limit generalization, this study provides indicative data suggesting that prices for cardiovascular medicines remain high and potentially unaffordable in the private sector in these selected states, and when compounded. Regular systematic access surveys are needed.