Short- and long-term impacts of the National Essential Medicines Policy on drug availability, price, and usage in a deprived rural county in southwestern China: an interrupted time series analysis across 8 years.

Background: China's National Essential Medicines Policy (NEMP) has been implemented for over 15 years; yet empirical evidence on its long-term impacts is lacking, particularly in remote and rural regions. This study aims to assess the short-and long-term effects of NEMP on the drug availability, price, and usage in a deprived rural county in southwestern China. Methods: A quasi-experimental design was employed, featuring a single-group pre-and-post comparison. We gathered 74,436 procurement records spanning from 2009 to 2016 from the drug warehouses of local medical institutions. Pharmaceutical data were analyzed quarterly, considering various policy and therapeutic attributes. Fisher's Drug Price Index (DPI-F) was calibrated for the retail and wholesale prices of a consistent collection of 405 medications. We conducted interrupted time-series analysis to examine the immediate and enduring impacts of NEMP's initial (commencing in January 2011) and second (starting from December 2015) stages. Results: After initiation of NEMP, the number of available essential medicines surged by 115 but subsequently faced a steady quarterly decline (-9.1) in township healthcare centers (THCs, primary care). Conversely, county hospitals (secondary care) initially saw a reduction of 40 in drug availability but later exhibited a steady increase (+4.2 per quarter) up to the second-stage NEMP. Regarding price, THCs encountered abrupt (-26.1%/-15.9% in retail/wholesale price) and sustained (-0.2%/-0.3% per quarter) price drops after NEMP. The immediate price change after NEMP in county hospitals were milder but significant in non-essential medicines, and long-term declines were also observed in all drugs. As for total sales, a significant long-term disparity emerged between THCs (+0.9% per quarter) and county hospitals (+3.3% per quarter). Following the second-stage NEMP, retail prices in county hospitals further decreased, although wholesale prices did not; however, following price upward trends were observed in both THCs and county hospitals. Lastly, the influences of NEMP varied across different therapeutical categories of medicines. Conclusion: NEMP has successfully regulated drug prices in primary and secondary healthcare facilities in remote and rural areas, both short-term and long-term. However, a remarkable disparity in medicine availability and utilization was observed between different levels of facilities over time. Continuous monitoring is essential, with increased attention needed on the uneven impacts of the policy on diverse drugs, facilities, regions, and demographics.

Factors affecting the essential medicine prescribing behavior among general practitioners in Beijing, China: a cross-sectional study with structural equation model.

BACKGROUND: The aim of this study is to explore the influence of GPs'information, motivation and behavior skills on EM prescribing behavior in urban and suburban districts. METHOD: A cross-sectional study was conducted from June to November 2022 cross 3 urban districts and 4 suburban districts in Beijing. The structural equation model was used to analyze the factors influencing the essential medicine prescription behavior among general practitioners in urban and suburban districts. RESULTS: A total of 511 valid questionnaires were collected. There was a statistically significant difference in mean scores for personal motivation and behavioral skills between urban GPs and suburban GPs. For urban GPs, the path analysis revealed that the social motivation had a direct effect on the essential medicine prescribing behavior (ß = 0.225, p < 0.05). In contrast, for suburban GPs, both social motivation and personal motivation had a direct effect on the essential medicine prescribing behavior, respectively (ß = 0.175, p < 0.05; ß = 0.193, p < 0.01). CONCLUSION: Social motivation of urban GPs were positively and significantly associated with essential medicine prescribing behavior. Social motivation and personal motivation of suburban GPs were positively and significantly associated with essential medicine prescribing behavior. Therefore, various corresponding policies and measures should be developed to promote the National Essential Medicines Policy in China.

Four successive cases of human fasciolosis in Japan.

Fasciolosis is a food-borne parasitic disease, caused by the large liver fluke, Fasciola. Humans acquire infection by ingesting fresh or undercooked water plants, on which infective metacercaria encyst. In spite of the rarity of the disease in Japan, we encountered four successive fasciolosis patients within a short period, who were all living in the same area. The patients were 70-82 years old, three females and the husband of one of the female patients. They started complaining of non-specific symptoms, such as fever, general fatigue, appetite loss, and abdominal pain, almost at the same time. All patients showed prominent peripheral blood eosinophilia, and the medical imaging indicated multiple hepatic lesions. No parasite eggs or worms were detected in any of the patients. Diagnosis was made serologically and they were treated with praziquantel and/or triclabendazole. No cattle or sheep were farmed in the area, but the wild sika deer, Cervus nippon, inhabited adjacent to the residential area. The intermediate host snail, Austropeplea ollula, were found near the residence of the patients, and one of the collected snails was positive for F. hepatica/gigantica hybrid type rediae. Our report should alarm the medical professionals for this rare and unfamiliar parasitic disease.

The Availability of Essential Antimicrobials in Public and Private Sector Facilities: A Cross-Sectional Survey in a District of North India.

(1) Background: There is a need to assess the availability of essential antimicrobials, as the availability of an antimicrobial is a critical element of its rational use. We aimed to assess the availability of antimicrobials listed in the National List of Essential Medicines 2015, India (primary list), and a selected (secondary) list comprised of agents indicated for commonly encountered infectious illnesses in various healthcare settings and to identify the reasons for their non-availability. (2) Methods: A cross-sectional survey of 25 public, private, and other sector pharmacies was carried out in Rohtak, a district of the North Indian state of Haryana, from April to June 2022. (3) Results: Most of the antimicrobials surveyed were optimally available in various sector pharmacies with the exception of benzathine benzylpenicillin, benzylpenicillin, cloxacillin, cefazolin, cefuroxime, cefadroxil, amphotericin B, and antimalarials. The most frequent reasons for limited availability were low demand, no prescriptions, and the non-listing of drugs in the state's essential medicine list. (4) Conclusions: Enough evidence needs to be generated with respect to the status of availability of essential antimicrobials from different regions of India as well as other lower-middle-income countries to devise measures for ascertaining better availability of these agents, especially antibiotics at regional, national, and global scales.

Burden of alcohol use and inclusion of alcohol use disorder medications in the essential medicine lists across 132 countries: An observational study.

Harmful use of alcohol effects the health of the population. The treatment coverage of alcohol use disorders (AUD) varies among countries. The study aimed to determine the inclusion of AUD medicines in various national Essential Medicine Lists (EMLs) and its association with alcohol consumption. It was a secondary data analysis of alcohol consumptions and AUD related medicines in EML. Data were extracted from the WHO Global Essential Medicines database and the WHO Global Status Report on Alcohol and Health 2018. Data were extracted for 194 countries. Only 132 of 194 countries (68.0%) had EML, and among the 132 countries only 27.3% had included AUD medicines in their EML. Only 36 countries had included any of the AUD medicines in their EML. Disulfiram was included by 23 countries, while Acamprosate and Naltrexone was included by only four and 19 countries, respectively. Among the countries, 36.1% were from upper-middle income countries and 16.65 from low-income countries. The inclusion of AUD medicines in national EML was neither associated with alcohol consumption parameters nor the alcohol consumption related policy parameters. Considering the high prevalence of AUD and its complications, there is an urgent need to focus on including AUD medicines in national EML for making AUD treatment available and accessible across the world.

Evaluation of alignment of the reimbursement medicines list for children in Albania with the WHO essential medicines list for children.

Background: The WHO Essential Medicine List for Children was released on the 30th anniversary of the general Essential Medicine List in 2007, to recognise special needs for medicines in children, and to promote the inclusion of paediatric medicines in national procurement programmes. This study aimed to investigate the alignment of the medicines included in the Albanian reimbursement medicines list of the Mandatory Healthcare Insurance Fund (AMHIF) and the Essential Medicine List for Children. Methods: A quantitative evaluation was performed to compare the paediatric medicines included in the 2022 list of the AMHIF and the 2021 WHO Essential Medicine List for Children. In addition, vaccines in the Albanian vaccination programmes for children were compared to the ones listed on the WHO Essential Medicine List for Children. Results: Both lists had a total of 284 active ingredients in common, whereas 14 of 24 vaccines were found to be in common in the Essential Medicine List for Children list and the Albanian vaccination programmes. Conclusions: This is the first study in Albania to investigate the alignment of the WHO EMLc and AMHIF list. In case of the same active ingredient there were many deviations in terms of dosage form, strength and indication.

Ketamine as adjunctive or monotherapy for post-intubation sedation in patients with trauma on mechanical ventilation: A rapid review.

Background: The effectiveness of ketamine as adjunctive or monotherapy for post-intubation sedation in adults with trauma on mechanical ventilation is unclear. Methods: A rapid review of systematic reviews of randomized controlled trials, then randomized controlled trials or observational studies was conducted searching three electronic databases (PubMed, Embase, Cochrane Library) and one clinical trial registry on June 1, 2022. We used a prespecified protocol following Cochrane rapid review methods. Results: We identified eight systematic reviews of randomized controlled trials and observational studies. Among the included reviews, only the most relevant, up to date, highest quality-assessed reviews and reviews that reported on critical outcomes were considered. Adjunctive ketamine showed a morphine sparing effect (MD -13.19 µmg kg-1 h-1, 95 % CI -22.10 to -4.28, moderate certainty of evidence, 6 RCTs), but no to little effect on midazolam sparing effect (MD 0.75 µmg kg-1 h-1, 95 % CI -1.11 to 2.61, low certainty of evidence, 6 RCTs) or duration of mechanical ventilation in days (MD -0.17 days, 95 % CI -3.03 to 2.69, moderate certainty of evidence, 3 RCTs).Adjunctive ketamine therapy may reduce mortality (OR 0.88, 95 % CI 0.54 to 1.43, P = 0.60, very low certainty of evidence, 5 RCTs, n = 3076 patients) resulting in 30 fewer deaths per 1000, ranging from 132 fewer to 87 more, but the evidence is very uncertain. Ketamine results in little to no difference in length of ICU stay (MD 0.04 days, 95 % CI -0.12 to 0.20, high certainty of evidence, 5 RCTs n = 390 patients) or length of hospital stay (MD -0.53 days, 95 % CI -1.36 to 0.30, high certainty of evidence, 5 RCTs, n = 277 patients).Monotherapy may have a positive effect on respiratory and haemodynamic outcomes, however the evidence is very uncertain. Conclusion: Adjunctive ketamine for post-intubation analgosedation results in a moderate meaningful net benefit but there is uncertainty for benefit and harms as monotherapy.

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.

Global, regional and national availability of essential medicines for children, 2009-2020: a systematic review and meta-analysis.

BACKGROUND: Access to essential medicines is a vital component of universal health coverage. The low availability of essential medicines for children (EMC) has led the World Health Organization (WHO) to issue a number of resolutions calling on member states on its improvement. But its global progress has been unclear. We aimed to systematically evaluate the progress of availability of EMC over the past decade across economic regions and countries. METHODS: We searched eight databases from inception to December 2021 and reference lists to identify included studies. Two reviewers independently conducted literature screening, data extraction and quality evaluation. This study was registered with PROSPERO, CRD42022314003. RESULTS: Overall, 22 cross-sectional studies covering 17 countries, 4 income groups were included. Globally, the average availability rates of EMC were 39.0% (95%CI: 35.5-42.5%) in 2009-2015 and 43.1% (95%CI: 40.1-46.2%) in 2016-2020. Based on the World Bank classification of economic regions, income was not proportional to availability. Nationally, the availability rate of EMC was reasonable and high (> 50%) in only 4 countries, and low or very low for the rest 13 countries. The availability rates of EMC in primary healthcare centers had increased, while that for other levels of hospitals slightly declined. The availability of original medicines decreased while that of generic medicines was stable. All drug categories had not achieved the high availability rate. CONCLUSION: The availability rate of EMC was low globally, with slight increase in the last decade. Continuous monitoring and timely reporting of the availability of EMC are also needed to facilitate targets setting and inform relevant policy making.

Study on essential medicine system from the perspective of coordinated with centralized volume-based procurement policy / 中国药房

OBJECTIVE To provide a reference for further improvement of the essential medicine system. METHODS Statistical analysis method and comparative analysis method were used to explain the necessity of coordination between the two systems from the direct correlation and indirect impact of centralized volume-based procurement on the essential medicine system at the present stage. The relevant suggestions were put forward for the development of the essential medicine system in the new era from the perspective of improving institutional synergy. RESULTS & CONCLUSIONS There was a direct correlation between the policy of centralized procurement and the essential medicine system in terms of policy objectives and medicines selection. However， it also indirectly affects the use of essential medicines in medical institutions through production and supply， coincidence degree between the essential medicine list and the selected variety， and the consistency evaluation of generic drugs. It is suggested that in the selection of essential medicine list in the future， priority should be given to the selection of varieties through centralized procurement， and improve the drug supply guarantee capacity under the dual policy linkage； at the same time， incentive assessments for the allocation and use of essential medicines by various entities should be further strengthened to promote the further improvement and development of the essential medicine system.

Framework design of WHO and typical national essential medicine lists and its implications for China / 中国药房

OBJECTIVE To sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML. METHODS The latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONS The common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.

Comparison and enlightenment of anti-infective medicines between WHO model list of essential medicines for children，essential medicine list of WHO and national essential medicine list / 中国药房

OBJECTIVE To provide suggestions and reference for enriching the selection of anti-infective medicines for children in China and promoting the establishment of the Essential Medicine List for Children in China. METHODS Descriptive analysis method was used to statistically compare the differences and similarities of anti-infective medicines included in the World Health Organization Model List of Essential Medicines for Children （EMLc）， World Health Organization Model List of Essential Medicines （EML） and National Essential Medicine List （NEML） in terms of drug category， variety， dosage form， specification， symbol mark， etc. RESULTS All anti-infective medicines of EMLc were covered by EML （85.3%）. NEML lacked the information of anti-infective medicines relatively， and contained few new categories； for example， the third-generation and above cephalosporins in EMLc were not included， and the drug dosage forms were also relatively limited （mainly tablets， capsules and injections）， but the specifications were relatively rich. CONCLUSIONS With reference to EMLc， the guidance on the use of essential medicines for children in China should be added from the aspects of age， body weight， combined medication， etc.， and the dosage forms suitable for children such as oral liquid preparations and scored tablets should be added to NEML； when updating the NEML the newer drugs suitable for children such as cefixime and dacatavir should be included. Finally， with reference to the continuity of EML and EMLc， the Essential Medicine List for Children in China should be established based on NEML to meet the drug needs of children and promote the safe use of drugs in children.

Current Status of Pharmacokinetic Research in Children: A Systematic Review of Clinical Trial Records.

BACKGROUND: Many medications have different pharmacokinetics in children than in adults. Knowledge about the safety and efficacy of medications in children requires research into the pharmacokinetic profiles of children's medicines. By analysing registered clinical trial records, this study determined how frequently pharmacokinetic data is gathered in paediatric drug trials. METHODS: We searched for the pharmacokinetic data from clinical trial records for preterm infants and children up to the age of 16 from January 2011 to April 2022. The records of trials involving one or more drugs in preterm infants and children up to the age of 16 were examined for evidence that pharmacokinetic data would be collected. RESULTS: In a total of 1483 records of interventional clinical trials, 136 (9.17%) pharmacokinetic data involved adults. Of those 136 records, 60 (44.1%) records were pharmacokinetics trials involving one or more medicines in children up to the age of 16. 20 (33.3 %) in America, followed by 19 (31.6 %) in Europe. Most trials researched medicines in the field of infection or parasitic diseases 20 (33.3%). 27 (48.2%) and 26 (46.4%) trials investigated medicines that were indicated as essential medicine. CONCLUSION: The pharmacokinetic characteristics of children's drugs need to be better understood. The current state of pharmacokinetic research appears to address the knowledge gap in this area adequately. Despite slow progress, paediatric clinical trials have experienced a renaissance as the significance of paediatric trials has gained international attention. The outcome of paediatric trials will have an impact on children's health in the future. In recent years, the need for greater availability and access to safe child-size pharmaceuticals has received a lot of attention.

Experience of Pharmacists with Anti-Cancer Medicine Shortages in Pakistan: Results of a Qualitative Study.

This study aimed to examine the current situation of anti-cancer drug shortages in Pakistan, namely its determinants, impacts, adopted mitigation strategies, and proposed solutions. Qualitative semi-structured, in-depth interviews were conducted with 25 pharmacists in oncology hospitals in Pakistan from August to October 2021. Data were collected in person and online, recorded, and subjected to inductive thematic analysis after being transcribed verbatim. Most participants experienced anti-cancer drug shortages that increased during the pandemic. Etoposide, paclitaxel, vincristine, dacarbazine, and methotrexate were frequently short. Important causes included the compromised role of regulatory authorities, lack of local production, and inventory mismanagement. The impacts were delayed/suboptimal treatment and out-of-pocket costs for patients, patients' prioritization, increased workload, negative work environment, and patients' trust issues for pharmacists. The participants proposed that a cautious regulator's role is needed to revise policies for all stakeholders and support all stakeholders financially at their level to increase access to these medicines. Based on the outcomes, it is clear that anti-cancer medicine shortages are a current issue in Pakistan. Governmental authorities need to play a role in revising policies for all levels of the drug supply chain and promoting local production of these drugs. Stakeholders should also collaborate and manage inventory.

Accessibility of essential anticancer medicines for children in the Sichuan Province of China.

Background: Compared with high-income countries, the survival rate of childhood cancer is lower in low- and middle-income countries. Access to essential anticancer medicines is an indispensable component of pediatric cancer treatment, which is still a big challenge in low- and middle-income countries. Objective: To assess the accessibility of essential anticancer medicines for children in public hospitals in the Sichuan Province of China. Methods: Based on the data of the Sichuan Province Drug Use Monitoring Platform in 2020, a retrospective study was conducted to investigate the original brands and generics of 34 anticancer and three supportive essential medicines for children (a total of 97 specific strengths) in Sichuan Province. The availability, price, and affordability of surveyed medicines were evaluated in all 152 tertiary public hospitals (120 general hospitals, 31 children's hospitals, and one cancer hospital) that could diagnose and treat cancer for children. Results: The average availability of generics and original brands was 18.5% and 2.6%, respectively. In regions with different gross domestic product (GDP) per capita levels, the average availability was similar, but the city with lower GDP per capita levels had fewer tertiary public hospitals. The prices of most original brands were higher than the lowest-priced generics, and the median price ratios of 31 lowest-priced generics and 16 original brands were 0.744 (P25~P75, 0.446~2.791) and 2.908 (1.719~6.465). After paying medical insurance for medicines, the affordability of essential anticancer medicines was improved. The monthly medicine cost did not exceed 10% of the monthly household income for 78.9% (30/38) of the lowest-priced generics and 50.0% (8/16) of the original brands. Conclusion: The availability of lowest-priced generics was higher than original brands in public hospitals, but the availability of both was low, which was similar to previous studies in low- and middle-income countries. About half of the lowest-priced generics and 87.5% of the original brands cost more than 1.5 times the International Reference Price. Although the National Basic Medical Insurance greatly improved the affordability of essential anticancer medicines for children, higher subsidies for essential medicines for cancer treatment to limit catastrophic health expenditures are still recommended.

Anti-cancer medicine shortages in an oncology tertiary hospital of Pakistan: A five-year retrospective study.

OBJECTIVE: Anti-cancer medicine shortages are advancing challenges for patients and hospitals. This study aims to evaluate anti-cancer and supportive medicine shortages in a tertiary hospital in Pakistan and propose solutions. METHOD: A retrospective observational research was performed in a tertiary care hospital in Pakistan from 2016 to 2020. Data was retrieved from the hospital database using a questionnaire regarding short medicines' generic name, brand, dosage, source, total source, frequency, causes, impact, management, and analyzed by Microsoft Excel 2013. RESULTS: Between January 2016 and December 2020, 43 individual medicine shortages were observed, with an average of 8.6 shortages per year. There were shortages of 22 medicines, including 8 anti-cancer (36.4%) and 14 supportive agents (63.6%). Total shortage days were 27,100, with an average of 1232 days (SD 757) per medicine. Supportive medicines' shortages were frequent, but oncology agents' shortages were constant. The most affected dosage form was injection. Cardiovascular drugs and alkylating agents were the most affected class in supportive and anti-cancer medicines, respectively. The use of "alternative medicine" and "patient needs based importation" were the most common mitigation strategies. CONCLUSION: Shortages of oncology medicines are challenging in Pakistan. The most prominent causes are the lack of updated governmental regulations, registration, and import issues. The tertiary care hospital has very few sources of supply, so it imports these drugs on a need basis to manage the shortages. But it is still concerning because of the huge financial burden on patients and institutions due to expensive import, and therapy become delayed as the import process takes time. Moreover, the most affected drug class was alkylating agents, and dosage was both injectable and oral medicines.

Evaluation of Availability, Prices, and Affordability of Selected Essential Medicines in Balochistan, Pakistan.

Objectives: The study aimed to evaluate the availability, prices, and affordability of selected essential medicines in Balochistan, Pakistan. Methods: Cross-sectional research was conducted in several cities of Balochistan, Pakistan, using the World Health Organization/Health Action International methodology to assess the availability and cost of 50 originator brand (OB) and lowest priced generic (LPG) drugs. The medicine costs were compared to international reference prices (IRPs) to calculate the median price ratio. The daily wage of the lowest paid unskilled government employee was used to determine affordability. Results: The mean availability was low for OBs (9.8%) and fairly high (49.4%) for LPGs. The OBs and LPGs' mean availability in the private sector were fairly high, 51.8% and 42.6%, respectively. It was surprising to see that Balochistan's public sector has only 24.3% of the National Essential Medicine List when the medicines on this list are supposed to be adequately available. Conclusion: The standard treatment cost with OBs is steep, exceeding the minimum daily wage. Treatment with LPG medications seems affordable. Furthermore, essential LPG medicines are economical when used solely for medication therapy.

Factors influencing the prescription pattern of essential medicines from the perspectives of general practitioners and patients: a qualitative study in China.

OBJECTIVES: This qualitative study aimed to explore the factors influencing the prescription patterns of essential medicines (EMs) from the perspectives of general practitioners (GPs) and patients in Beijing, China. DESIGN: The qualitative study was conducted using individual in-depth interviews. SETTING: This study was conducted from January to August 2020, in community health service centres (CHSCs) across six urban districts of Beijing, China. PARTICIPANTS: A total of 17 GPs from 17 CHSCs in 6 urban districts and 22 patients with non-communicable diseases from three CHSCs in the three urban districts of Beijing were recruited using the purposive sampling method and a three-stage sampling strategy, respectively. RESULTS: Five major themes were identified among factors influencing the prescription pattern of EMs: (1) efficacy and safety of medicines, (2) prescription recommendations from physicians in tertiary or secondary hospitals, (3) patients' medication preference, (4) financial status of patients and (5) minimum requirement for the prescription of EMs. CONCLUSION: The findings of this study contribute to our understanding of the factors influencing the prescription patterns and utilisation of EMs from the perspectives of GPs and patients, respectively. Policymakers should implement policies and measures to promote the National Essential Medicines System in China.