The role of government agencies and other actors in influencing access to medicines in three East African countries.

The WHO Model List of Essential Medicines (MLEM) has since 1977 helped prioritize and ensure availability of medicines especially in low- and middle-income countries. The MLEM consists mainly of generic medicines, though recent trends point towards listing expensive on-patent medicines and increasing global support for medicines against non-communicable diseases. However, the implications of such changes for national essential medicines list (NEML) updates for access to essential medicines has received relatively little attention. This study examined how government agencies and other actors in Kenya, Uganda and Tanzania participate in and influence the NEML update process and subsequent availability of prioritized medicines; and the alignment of these processes to WHO guidance. A mixed study design was used, with qualitative documentary review, key informant interviews and thematic data analysis. Results show that NEML updating processes were similar amongst the three countries and aligned to WHO guidelines, albeit conducted irregularly, with tendency to reprioritization during procurement stages, and were not always accompanied by revision of clinical guidelines. Variations were noted in the inclusion of medicines against cancer and hepatitis C, and the utilization of health technology assessment (HTA). For medicines against diseases with high global engagement, such as HIV/AIDS and TB, national stakeholders had more limited inputs in prioritization and funding. Furthermore, national actors were not influenced by the pharmaceutical industry during the NEML update process, nor were any conflicting agendas identified between health, trade and industrial policies. Hence, the study suggests that more attention should be paid to the combination of HTAs and NEMLs, particularly as countries work towards universal health coverage, in addition to heightened awareness of how global disease-specific initiatives may confound national implementation of the NEML. The study concludes with a call to strengthen country-level policy and procedural coherence around the process of prioritizing and ensuring availability of essential medicines.

Essential tobacco dependence medicines in 137 countries.

AIMS: To use a database of national essential medicine lists to determine how many include the three tobacco dependence medicines: nicotine replacement therapy, varenicline and bupropion. METHODS: Retrospective observational study using national essential medicine lists for 137 countries. RESULTS: Of the 137 countries, 34 listed at least one of the three tobacco dependence medicines included in this analysis. Bupropion was listed by 23 countries, nicotine replacement therapy by 17 countries and varenicline by eight countries. CONCLUSIONS: Tobacco dependence medicines do not appear on the essential medicines lists of most countries.

[Valor terapéutico potencial de medicamentos en México: el caso de los antibióticos].

Introduction: The relevance of medications for health depends on their quality, accessibility and appropriate use. Objective: To determine the potential therapeutic value of antibiotics that are not included in the World Health Organization Essential Medicines List (EML) but that are part of the National Essential Medicines List (NEML) of the Mexican Ministry of Health, and categorize them according to their intrinsic value. Method: Descriptive analysis of antibiotics not included in the 2013 World Health Organization EML; literature review to obtain efficacy and safety evidence; and application of quality and intrinsic value scales. Results: Four hundred and fifty-two abstracts were identified for 19 antibiotics; 56.9 % were excluded; 195 clinical trials were reviewed in full-text articles, out of which 37.9 % were of good quality, and intrinsic value was determined; 54 % were superiority studies, whereas 46 % were non-inferiority or equivalence studies; 32 % of the antibiotics were classified without intrinsic value and nearly 50 % were inconclusive. Conclusion: An elevated proportion of antibiotics of the NEML had uncertain or no intrinsic value, which favors their inappropriate use, bacterial resistance and puts the population at risk.

Introducción: La relevancia de los medicamentos para la salud depende de su calidad, acceso y correcto uso. Objetivos: Determinar el valor terapéutico potencial de los antibióticos no incluidos en la lista de medicamentos esenciales (LME) de la Organización Mundial de la Salud pero que forman parte del Cuadro Básico de Medicamentos (CBM) de la Secretaría de Salud de México y categorizarlos por su valor intrínseco. Método: Análisis descriptivo de los antibióticos no incluidos en la LME de la Organización Mundial de la Salud 2013, revisión de la literatura para obtener evidencia de eficacia y seguridad y aplicación de escala de calidad y de valor intrínseco. Resultados: Se identificaron 452 resúmenes para 19 antibióticos, se eliminaron 56.9 %. In extenso se revisaron 195 ensayos clínicos; 37.9 % fueron de calidad y se determinó valor intrínseco; 54 % fueron estudios de superioridad y 46 % de no inferioridad o equivalencia; 32 % de los antibióticos fueron clasificados sin valor intrínseco y aproximadamente 50 % fueron dudosos. Conclusión: Una elevada proporción de antibióticos del CBM tuvo valor intrínseco dudoso o nulo, lo que favorece su uso inapropiado, resistencia bacteriana y coloca a la población en riesgo.

Valor terapéutico potencial de medicamentos en México: el caso de los antibióticos / Potential therapeutic value of drugs in Mexico: the case of antibiotics

Resumen Introducción: La relevancia de los medicamentos para la salud depende de su calidad, acceso y correcto uso. Objetivos: Determinar el valor terapéutico potencial de los antibióticos no incluidos en la lista de medicamentos esenciales (LME) de la Organización Mundial de la Salud pero que forman parte del Cuadro Básico de Medicamentos (CBM) de la Secretaría de Salud de México y categorizarlos por su valor intrínseco. Método: Análisis descriptivo de los antibióticos no incluidos en la LME de la Organización Mundial de la Salud 2013, revisión de la literatura para obtener evidencia de eficacia y seguridad y aplicación de escala de calidad y de valor intrínseco. Resultados: Se identificaron 452 resúmenes para 19 antibióticos, se eliminaron 56.9 %. In extenso se revisaron 195 ensayos clínicos; 37.9 % fueron de calidad y se determinó valor intrínseco; 54 % fueron estudios de superioridad y 46 % de no inferioridad o equivalencia; 32 % de los antibióticos fueron clasificados sin valor intrínseco y aproximadamente 50 % fueron dudosos. Conclusión: Una elevada proporción de antibióticos del CBM tuvo valor intrínseco dudoso o nulo, lo que favorece su uso inapropiado, resistencia bacteriana y coloca a la población en riesgo.

Abstract Introduction: The relevance of medications for health depends on their quality, accessibility and appropriate use. Objective: To determine the potential therapeutic value of antibiotics that are not included in the World Health Organization Essential Medicines List (EML) but that are part of the National Essential Medicines List (NEML) of the Mexican Ministry of Health, and categorize them according to their intrinsic value. Method: Descriptive analysis of antibiotics not included in the 2013 World Health Organization EML; literature review to obtain efficacy and safety evidence; and application of quality and intrinsic value scales. Results: Four hundred and fifty-two abstracts were identified for 19 antibiotics; 56.9 % were excluded; 195 clinical trials were reviewed in full-text articles, out of which 37.9 % were of good quality, and intrinsic value was determined; 54 % were superiority studies, whereas 46 % were non-inferiority or equivalence studies; 32 % of the antibiotics were classified without intrinsic value and nearly 50 % were inconclusive. Conclusion: An elevated proportion of antibiotics of the NEML had uncertain or no intrinsic value, which favors their inappropriate use, bacterial resistance and puts the population at risk.

Analysis of the Anticancer Drug List between the National Essential Medicines List (2018) and the WHO Model List of Essential Medicines (2017) / 中国药学杂志

OBJECTIVE: To analyze the variation of the anticancer drug list in the National Essential Medicines List (NEML-2018) and compare with the WHO Essential Model List (WHO-EML-2017) considering the epidemic characteristics and current national conditions, in order to provide the reference and advice for the revision of NEML in the future. METHODS: The category, content, formulation, dosage forms, medicines for children and indication for use of anticancer drug list between the NEML-2018 and WHO-EML-2017 were compared, and the deficiency existing in the NEML-2018 was analyzed. RESULTS: Compared with the NEML-2012, the category and content of the anticancer drug list have been improved in the 2018th edition, which is more reasonable for clinical request. However, disadvantages still exist in the aspect of the content, formulation, dosage forms, medicines for children and indication for use compared with the WHO-EML-2017. CONCLUSION: Although the rationality of the category and content has been improved in the NEML-2018, it still needs to be further improved compared with the WHO-EML-2017, which provides guidance and indication for the revision of anticancer drug list of the NEML in the future.

China issues the National Essential Medicines List (2018 edition): Background, differences from previous editions, and potential issues.

On October 25, 2018, the National Health Commission of China issued the National Essential Medicines List (2018 edition) [NEML (2018)]. The NEML (2018) contains 685 drugs, which consist of 417 chemicals and biological products and 268 Chinese patent medicines. Compared to the 2012 version of the NEML, a total number of 165 drugs were added, representing an increase of 31.7%. The biggest increase (90.9%) is in Chinese patent medicines for surgical use. The NEML (2018) set up the category of pediatric medications for the first time, and 11 cancer drugs were added. The NEML (2018) is characterized by: "basic" to "comprehensive" coverage, it includes both Chinese and Western medicines, it now includes pediatric drugs, and more cancer drugs have been added. There are several issues with the new NEML such as the link between the essential medicines system and the medical insurance system and establishment of firm support for implementation.

The Impact of the National Essential Medicines Policy on Rational Drug Use in Primary Care Institutions in Jiangsu Province of China.

BACKGROUND: Essential medicine policy is a successful global health policy to promote rational drug use. The aim of this study was to evaluate the impact of the National Essential Medicines Policy (NEMP) on the rational drug use in primary care institutions in Jiangsu Province of China. METHODS: In this exploratory study, a multistage, stratified, random sampling was used to select 3400 prescriptions from 17 primary care institutions who implemented the NEMP before (Jan 2010) and after the implementation of the NEMP (Jan 2014). The analyses were performed in SPSS 18.0 and SPSS Clementine client. RESULTS: After the implementation of the NEMP, the percentage of prescribed EML (Essential Medicines List) drugs rose significantly, the average number of drugs per prescription and average cost per prescription were declined significantly, while the differences of the prescription proportion of antibiotics and injection were not statistically significant. BP (Back Propagation) neural network analysis showed that the average number of drugs per prescription, the number of using antibiotics and hormone, regional differences, size of institutions, sponsorship, financial income of institutions, doctor degree, outpatient and emergency visits person times were important factors affecting the prescription costs, among these the average number of drugs per prescription has the greatest effect. CONCLUSION: The NEMP can promote the rational use of drugs in some degree, but its role is limited. We should not focus only on the EML but also make comprehensive NEMP.

Impact of the zero-markup drug policy on hospitalisation expenditure in western rural China: an interrupted time series analysis.

OBJECTIVES: To assess the long-term effects of the introduction of China's zero-markup drug policy on hospitalisation expenditure and hospitalisation expenditures after reimbursement. METHODS: An interrupted time series was used to evaluate the impact of the zero-markup drug policy on hospitalisation expenditure and hospitalisation expenditure after reimbursement at primary health institutions in Fufeng County of Shaanxi Province, western China. Two regression models were developed. Monthly average hospitalisation expenditure and monthly average hospitalisation expenditure after reimbursement in primary health institutions were analysed covering the period 2009 through to 2013. RESULTS: For the monthly average hospitalisation expenditure, the increasing trend was slowed down after the introduction of the zero-markup drug policy (coefficient = -16.49, P = 0.009). For the monthly average hospitalisation expenditure after reimbursement, the increasing trend was slowed down after the introduction of the zero-markup drug policy (coefficient = -10.84, P = 0.064), and a significant decrease in the intercept was noted after the second intervention of changes in reimbursement schemes of the new rural cooperative medical insurance (coefficient = -220.64, P < 0.001). CONCLUSIONS: A statistically significant absolute decrease in the level or trend of monthly average hospitalisation expenditure and monthly average hospitalisation expenditure after reimbursement was detected after the introduction of the zero-markup drug policy in western China. However, hospitalisation expenditure and hospitalisation expenditure after reimbursement were still increasing. More effective policies are needed to prevent these costs from continuing to rise.

Current Situation and Trends of Quality Standard for Chinese Patent Medicine Types Included in National Essential Medicine List / 中国药房

OBJECTIVE:To evaluate the level of quality standard for Chinese patent medicine types included in National Essen-tial Medicine List(2012 edition),and to provide reference for the selection of Chinese patent medicine types in the next edition of National Essential Medicine List. METHODS:By retrieving the relevant national standards of Chinese patent medicine,collecting the key information about their quality standard,database establishment and data analysis were conducted for quality standard of Chinese patent medicine. RESULTS&CONCLUSIONS:There were 371 preparations included in the 2012 edition of National Essen-tial Medicine List. Among them,267 preparations were included in part I of Chinese Pharmacopoeia(2015 edition);71.97% car-ried out pharmacopoeia quality standard. The quality standard system was perfect;the quality control items and the detection meth-ods were abundant;and the safety control technology was strengthened. The quality standard of 104 TCM preparations carried out non-pharmacopoeia standards,accounting for 28.03% of the total;among which,the quality standard for 18 TCM preparations were from Medicine Standard of Ministry of Public Health of Peoples Republic of China·Preparation Containing Traditional Chi-nese Medicine;the quality standard for 6 TCM preparations came from National Standards Compilation for Chinese Patent Medi-cines;both were relatively early quality standards. There are some problems,such as absence of identification and content determi-nation,few ingredient for identification,few index and components for measurement. The quality standards of preparations are to be improved.

Utilization Analysis of TCM National Essential Medicines in Our Hospital during 2013-2015 / 中国药学杂志

OBJECTIVE: To investigate and analyze the use of TCM national essential medicines in our hospital, so as to provide reference for clinical rational use. METHODS: The variety number, consumption sum and constituent ratio, defined daily dose system(DDDs), defined daily cost(DDC)and drug use distribution in departments of TCM national essential medicines in our hospital were statistic analyzed during 2013-2015. RESULTS: The variety number of TCM national essential medicines were relatively stable in our hospital, but the consumption sum and proportion showed a downward trend year by year. The consumption sum and DDDs of essential medicines changed less during 3 years, and the drug with large sales amount were relatively fixed, which showed that the clinical selection of essential medicines were relatively centralized, and the category and DDDs continuity of essential medicines was fairly good. The concentration ratio of TCM essential drug use were lower in clinical departments, and the consumption sum ratio were lower in TCM department. CONCLUSION: We must pay more attention to the rational use of essential medicines, and formulate relevant policies and measures to encourage clinical use essential medicines preferentially.

Hospital pharmacists' knowledge of and attitudes towards the implementation of the National Essential Medicines System: a questionnaire survey in western China.

BACKGROUND: In 2009, Chinese government launched a new healthcare reform, one of the key points of which is to establish National Essential Medicine System (NEMS). Hospital pharmacists are directly related to the implementation of NEMS. This study is to examine knowledge of and attitudes towards the implementation of the NEMS among hospital pharmacists in western China. METHODS: We conducted a questionnaire survey of pharmacists from different types of medical institutions in Shaanxi Province in November 2014. We gathered demographic information about the participants, collected the data about their knowledge of and attitudes towards the implementation of NEMS, and identified the influencing factors of cognitive level. We analyzed the data and compared public secondary/tertiary hospitals and primary healthcare institutions. RESULTS: Of the 704 participants (response rate = 70.2 %), the majority had positive and moderate knowledge (39.2 and 53.3 %) and attitudes (35.8 and 62.9 %) towards NEMS. The most participants were aware of the implementation time of NEMS (89.8 %) and zero mark-up policy (85.5 %) while the least learned of the adjustment time of National Essential Medicines List (NEML). Pharmacists from public secondary/tertiary hospitals tended to know more and have more positive attitudes. There was no statistical correlation between knowledge and attitude scores. The education level (p = 0.022) and number of training sessions attended (p = 0.028) were the only demographic variables linked to knowledge scores. CONCLUSIONS: Hospital pharmacists in Shaanxi Province had moderate knowledge of and attitudes towards the implementation of NEMS. Pharmacists from public secondary/tertiary hospitals showed better understanding. The government should therefore focus on improving the understanding of pharmacists in primary healthcare institutions and also address existing problems, especially the supply and distribution systems.

Comparisons of the 2015 edition of WHO model list of essential medicines for children and the 2012 edition of list of national essential medicines for children / 国际药学研究杂志

This study focuses on comparing the 2015 edition of WHO model list of essential medicines for children with the 2012 edition of list of national essential medicines for children in respects of drug categories,dosage forms,specifications and medica?tion information. The number of essential medicines available for children in China roughly equals to that of WHO model list of essen?tial medicines for children. Though China′s list provides more specific and children-agreeable specifications,it lags behind the WHO list with respect to the number of dosage forms and information concerning pediatric weight limitation ,drug combination and alterna?tives. It is recommended that research and development on dosage forms for children should be strengthened to solve the problem of pe?diatric drugs shortage. Also,more clinical trials should be developed as supporting evidence. Based on adapting to the needs of basic health services of children,essential medicines list for children in China should be established.

Investigation and Analysis of Shortage Situation of Essential Medicines and Exploration of Intervention Mea-sures in Changchun / 中国药房

OBJECTIVE:To provide reference for solving the shortage of national essential medicines in Changchun. METH-ODS:According to preliminary work,a questionnaire was conducted to investigate and statistically analyze the shortage situation of essential medicines in 22 higher than secondary and 50 basic medical and health institutions in Changchun;ABC analysis was used to analyze the national essential medicines in shortage;the bid results and shortage causes of the primary and secondary nation-al essential medicines in shortage were inquired. RESULTS:Totally 72 questionnaire were send out,and 72 were recycled with ef-fective recovery of 100%. The investigation results showed there were 19 shortage breeds(22 dosage forms),which lost the bid-ding,and 99 breeds(111 dosage forms)of national essential medicines in shortage,which won the bidding,including 85 kinds of chemical medicines and biological products,14 kinds of Chinese patent medicine in Changchun. Cardiovascular system drugs shows the largest number in the bid chemical medicines and biological products,and the Chinese patent medicine were mainly Fu-zheng agent and Quyu agent(internal medicine). Results of ABC analysis showed,among the 111 bid shortage dosage forms,17 were primary and 23 were secondary. The main causes for them were price raising in raw materials,lack of production,no produc-ing in manufacturers and purchase price higher than winning bids. CONCLUSIONS:Low accessibility of raw material drugs,low enthusiasm to production,lower drug price than a reasonable level,and small clinical requirements can lead to the shortage of na-tional essential medicines. It is suggested to intensify in supervising the raw materials’marketing,raising the enthusiasm of manu-facturers,perfecting the system of drug bidding,developing fixed-point production and building drug reserve system to guarantee the production and supply of national essential medicines,and satisfy clinical demands.

Comparisons of the 2015 edition of WHO model list of essential medicines for children and the 2012 edition of list of national essential medicines for children / 国际药学研究杂志

This study focuses on comparing the 2015 edition of WHO model list of essential medicines for children with the 2012 edition of list of national essential medicines for children in respects of drug categories, dosage forms, specifications and medication information. The number of essential medicines available for children in China roughly equals to that of WHO model list of essential medicines for children. Though China’s list provides more specific and children-agreeable specifications, it lags behind the WHO list with respect to the number of dosage forms and information concerning pediatric weight limitation, drug combination and alternatives. It is recommended that research and development on dosage forms for children should be strengthened to solve the problem of pediatric drugs shortage. Also, more clinical trials should be developed as supporting evidence. Based on adapting to the needs of basic health services of children, essential medicines list for children in China should be established.

Utilization Analysis of National Essential Medicines in Antibiotics in 3 Second-level General Hospitals from Chongming Area of Shanghai from 2011 to 2013 / 中国药房

OBJECTIVE:To provide reference for promoting the rational use of national essential medicines in antibiotics. METHODS:The use of national essential drugs in antibiotics in 3 second-level general hospitals from Chongming area of Shanghai from 2011 to 2013 were statistically analyzed. RESULTS:The sales amount of antibiotics was in an increasing trend,with an aver-age growth rate of 28.16%;while the proportion of sales amount accounted for the total sales amount of drugs were still relatively low,with an average growth rate of 2.16%. The proportion of total sales amount of top 3 antibiotics from 2011 to 2013 accounted for the total sales amount of drugs were respectively 87.92%,93.60% and 95.54%,with an increasing trend;while compared with 2011,the DDDs of national essential medicines in antibiotics was decreased a little during 2012-2013;the top 2 DDDs were Cefuroxime axetil tablets and Amoxicillin capsules,the top 1 sales amount was Cefuroxime sodium for injection. Varieties with the sales amount/ DDDs close to 1 were relatively less,indicating that the sales amount of drugs and the number of drug use was not synchronous. CONCLUSIONS:There are still some problems in the utilization of national essential medicines in antibiotics. It needs to be continuously improved in the related work to further improve medication rationality and economy,and progressively re-alize the institutionalized and normalized antibiotics in clinical use management.

Analysis of the Utilization of National Essential Medicines in a Cancer Hospital of Shandong Province in the First Half Year of 2014 / 中国药房

OBJECTIVE:To provide reference for the further implementation of national essential medicines. METHODS:The drugs consumption data of outpatients and inpatients in our hospital from Jan. 1 to Jun. 30,2014 were statistically analyzed. RE-SULTS:Variety numbers of national essential medicines in our hospital occupied 37.38%(228/610) in total drugs variety numbers of the whole hospital,consumption sum of national essential medicines occupied 9.80%(817.02 million yuan/8 338.12 million yu-an) in all drugs consumption sum. The first 20 national essential medicines listed in consumption sum were mainly anti-cancer drugs and water,electrolyte and acid-base balance regulation drugs. CONCLUSIONS:In the utilization of national essential medi-cines,variety proportion and consumption sum ratio in our hospital are relatively low. It is suggested to make clear the use require-ments of national essential medicines in cancer hospitals to make more reasonable and scientific selection of anti-tumor medicines in National Essential Medicines List and reasonably increase the assistant medicines related to the treatment of neoplastic diseases;hos-pitals should take effective measures to promote the usage rate of national essential medicines.

Research on the Standardized Package of Metformin Tablets / 中国药房

OBJECTIVE:To explore the standardized package of Metformin tablets to meet clinical needs. METHODS:Statis-tics was conducted for the utilization data of Metformin tablets in medical and health institutions from 6 cities of China;question-naires were designed to investigate and analyze the evaluation for the suitability of physicians,pharmacists and patients in the pre-scription,deployment and use links to Metformin tablets with different packaging loaded amount in Beijing and Haikou. RE-SULTS:For 0.5 g/tablet,the daily dose of 1.5 g accounted for the largest proportion (32.23%-69.91%) in 5 cities except for Chengdu. Totally 490 questionnaires about package suitability of Metformin tablets in outpatient department were sent out,includ-ing 478 valid questionnaires with effective rate of 97.5%. Results showed that packaging quantity with 4 weeks was considered as appropriate by physicians,pharmacists and patients in Beijing;however,packaging quantity with 1-2 week(s) was considered as appropriate by physicians,pharmacists and patients in Haikou;300-500 tablets of packaging quantity were preferred to be appropri-ate with the matching degree of automatic dispensing machines in both places. CONCLUSIONS:Considering the results in 2 plac-es,for 0.5 g/tablet,2 weeks is appropriate for the packaging loaded amount in outpatient department,that is 0.5 g×45 tablets/box;and 300-500 tablets/box is appropriate for inpatient pharmacies.