Availability of essential medicines: A primary health care perspective

The present study was undertaken to assess the availability of the essential medicines to the people of Kunijarla, Khammam district, AP. This was done in two steps: 1) Comparison of PHC-EML (primary health care essential medicines list) with AP-EML (Andhra Pradesh essential medicines list) and NEML (National essential medicines list); and 2) Assessment of availability of the listed medicines in adequate quantity to meet the needs of people of kunijarla. Results showed that the PHC-EML is on par with AP-EML and NEML. The hospital has 100% availability of the listed medicines; however, there was a need for certain add-on drugs like phenytoin tablets, valproic acid, and activated charcoal since they were prescribed frequently and were not included in PHC-EML. All the drugs which were listed in PHC-EML were being used and none were considered as non-utility supply. Suggestions were given for the revision of PHC-EML according to the criteria for identifying medicines for inclusion in the revised list which was mentioned in NEML.     

A review of existing and emerging digital technologies to combat the global trade in fake medicines

Introduction: The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally.

Areas covered: We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging ‘digital’ solutions to combat fake medicines. Our review identified five distinct categories of technology including mobile, radio frequency identification, advanced computational methods, online verification, and blockchain technology.

Expert opinion: Digital fake medicine solutions are unifying platforms that integrate different types of anti-counterfeiting technologies as complementary solutions, improve information sharing and data collection, and are designed to overcome existing barriers of adoption and implementation. Investment in this next generation technology is essential to ensure the future security and integrity of the global drug supply chain.     

山东省公立医疗机构2018—2019年抗肿瘤类基本药物配备使用情况及药学服务能力分析

目的对比分析《国家基本药物目录(2018年版)》颁布前后各一年,山东省公立医疗机构抗肿瘤类基本药物配备使用情况的变化,并对药学服务能力进行调研。方法利用山东省卫健委大数据平台进行数据提取,并结合问卷调查的方式,对2018—2019年山东省二级及以上公立医疗机构中抗肿瘤类基本药物的采购金额、医疗机构配备使用情况、日治疗费用、药学服务能力等进行调研分析。结果山东省17地市中,济南市抗肿瘤类基本药物采购金额最大,潍坊市采购金额增幅最大。二级医疗机构抗肿瘤类基本药物的配备率低于三级医疗机构。靶向药物、辅助用药、激素类、烷化剂类药物的采购金额呈增长趋势,抗代谢药、抗生素、植物成分药、其它类抗肿瘤药物用量减少。首次进入《国家基本药物目录》的5种新型抗肿瘤药物使用金额较前增长明显。表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)中,目前吉非替尼的使用量居首位,且日治疗费用最低。对于医疗机构肿瘤患者随访工作,药师参与度低;不良反应收集与上报是抗肿瘤药物安全监测与评价的主要手段。结论山东省各地市各级医疗机构中,各类抗肿瘤类基本药物间的配备使用情况差距大;《国家基本药物目录(2018年版)》的颁布有效促进了抗肿瘤药物在山东省内各级医疗机构的配备和使用;目录新纳入药物,特别是新型抗肿瘤药物,在医疗机构中的配备使用增加明显;医疗机构整体抗肿瘤药学服务能力有待提高。     

中成药基本药物质量标准与控制分析

对我国中成药基本药物质量标准与控制现状进行综合分析并就如何提高和完善标准提出合理化建议,为科学评价基本药物安全风险、加强基本药物质量监管提供科学依据。     

基于供应链风险视角的我国药品短缺原因及其应对策略分析

目的：分析我国药品短缺的原因，并提出应对策略。方法：基于供应链风险视角，分别对药品供应链的内生短缺风险、外生短缺风险进行分析。结果：药品供应链内生短缺风险来源于药品供需各主体自身的经营管理活动，以及主体之间的信息风险或道德风险；药品供应链外生短缺风险来源于政策风险和市场需求风险。结论：针对内生短缺风险，可明确主体职责、加强信息共享及风险防范、加大垄断查处力度；针对外生短缺风险，应均衡市场和政府的关系，完善价格形成机制及药品采购制度、提高监管效率及其合理性，并完善药品供应保障激励性措施。     

世界卫生组织与20国抗菌药基本药物目录比较分析

目的:着重20国基本药物目录中抗菌药比较,以全面理解我国基本药物的重要价值和用药水准.方法:检索WHO官方网站、各国卫生部和药物监管部门官方网站,收集各国的基本药物目录.通过自制数据表格,比较20国经济水平、健康投入和产出情况以及目录的时效性,着重比较抗菌药品种的种类、数量和具体药物.结果:人均GDP、人均卫生费用和卫生费用占GDP比例均以澳大利亚最高(46 710 I$,4 242 I$,11.0%).而阿富汗、巴基斯坦和印度尼西亚分别位列最低,人均GDP为330 I$,人均卫生费用63 I$和卫生费用占GDP的2.4%.WHO目录含抗菌药29个,中国含21个,20国的中位数为29个.目录中含最少抗菌药的国家是马来西亚(11个),最多的是叙利亚,涵盖最多的是青霉素类品种(14个)、头孢菌素类品种(第一代至四代头孢菌素)、大环内酯类品种(7个)和氨基糖苷类品种(6个).结论:由于各国经济、细菌耐药情况和医疗卫生服务水平不同,各国收录的抗菌药品种数量差异较大,但具体品种差异较小.我们可借鉴澳大利亚、印度、加纳等国的经验,优化基本药物的遴选机制和标准治疗指南,使国家基本药物目录更趋完善.     

药学干预对精神分裂症患者用药依从性和生活质量的影响

目的 探讨药学干预对精神分裂症患者用药依从性和生活质量的影响.方法 选择64例精神分裂症患者,随机分为对照组(32例)和观察组(32例),分别给予常规治疗和常规治疗联合药学干预.观察两组的用药依从性以及干预前后的日常生活能力量表(ADL)和社会功能缺陷筛选量表(SDSS)评分变化情况,并进行比较.结果 观察组的用药依从性显著高于对照组,(P＜0.05);经过不同的干预之后,两组患者在日常生活能力量表(ADL)评分方面经比较差异有统计学意义,(P＜0.05),观察组显著高于对照组;两组患者在社会功能缺陷筛选量表(SDSS)评分方面经比较差异有统计学意义,(P＜0.05),观察组显著低于对照组.结论 药学干预可以有效提高精神分裂症患者的用药依从性,并改善其生活质量.     

甘精胰岛素与糖尿病患者遵医行为和糖尿病控制情况的临床研究

目的探讨甘精胰岛素对糖尿病患者遵医行为的影响。方法选择本院60例门诊糖尿病患者分为两组,观察组给予甘精胰岛素联合口服降糖药治疗,对照组给予常规胰岛素治疗,比较两组患者遵医行为和糖尿病控制情况。结果观察组的遵医用药、和糖尿病控制情况都优于对照组。结论甘精胰岛素联合口服药物治疗是患者易于接受的治疗方案,它帮助患者提高遵医行为的自觉性,改善了患者的糖尿病控制情况。     

Strategies for the identification, control and determination of genotoxic impurities in drug substances: a pharmaceutical industry perspective

Regulations alarmed the control of genotoxic impurities in drug substances at lower level based on the threshold of toxicological concern and daily dose. This review explores the details of various regulations and guidances, toxicology assessment, identification of structural alerts, synthetic origins, different synthetic approaches for elimination or control, various analytical determination strategies and pharmaceutical industry concern towards genotoxic impurities.     

数量化、专业化的技术指标用于评价消毒供应中心质量的效果观察

目的 研究观察数量化、专业化的技术指标用于评价消毒供应中心（central sterile supply department,CSSD）质量的效果,为CSSD质量管理提供理论依据.方法 选择我院改进前后的400例次消毒供应工作项目作为研究对象,分别为改进前200例次和改进后200例次.另选择100批次检查情况进行分析,分别为改进前50批次和改进后50批次.在CSSD中运用数量化、专业化的技术指标进行评价后,统计并对比改进前后的质控效果情况以及改进前后检查情况.结果 改进后的质量控制效果显著优于改进前,差异有统计学意义（P＜0.05）.改进后的数据采集情况评分、质量标准掌握评分以及表格填写、录入及统计评分均显著高于改进前,差异有统计学意义（P＜0.05）.结论 将数量化、专业化的技术指标应用在CSSD质量管理可提升管理质量,值得推广.     

A comparative evaluation of price and quality of some branded versus branded-generic medicines of the same manufacturer in India

Objective:

To compare and evaluate the price and quality of “branded” and branded-generic equivalents of some commonly used medicines manufactured by the same pharmaceutical company in India.

Materials and Methods:

Five commonly used medicines: alprazolam, cetirizine, ciprofloxacin, fluoxetine, and lansoprazole manufactured in branded and branded-generic versions by the same company were selected. Price-to-patient and price-to-retailers were found for five “pair” of medicines. Both quantitative and qualitative analysis were performed following the methods prescribed in the Indian Pharmacopoeia 2007 on five pair of medicines. The tests performed were identification test, chemical composition estimation test, uniformity of contents test, uniformity of weight, and dissolution studies.

Main Outcome Measures:

Price-to-patient, retailer mark-up and qualitative analysis of branded and branded-generic medicines.

Results:

Retailer margin for five branded medicines were in the range of 25-30% but for their branded-generics version manufactured by the same company it was in the range of 201-1016%. Price-to-patient for the branded version of cetirizine, fluoxetine, ciprofloxacin, lansoprazole, and alprozolam was higher by 41%, 33%, 0%, 14%, and 31% than branded-generic. Both versions of five medicines were within their permissible range for all the quantitative and qualitative parameters as prescribed in Indian Pharmacopoeia.

Conclusion:

Difference in price-to-patient was not as huge as it is expected for generics but margins for retailer were very high for branded-generics. Quality of branded-generics is same as for their branded version. The study highlights the need to modify the drug price policy, regulate the mark-ups in generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders.     

A new validated method for the simultaneous determination of benzocaine, propylparaben and benzyl alcohol in a bioadhesive gel by HPLC

A new HPLC-RP method has been developed and validated for the simultaneous determination of benzocaine, two preservatives (propylparaben (nipasol) and benzyl alcohol) and degradation products of benzocaine in a semisolid pharmaceutical dosage form (benzocaine gel). The method uses a Nucleosil 120 C18 column and gradient elution. The mobile phase consisted of a mixture of methanol and glacial acetic acid (10%, v/v) at different proportion according to a time-schedule programme, pumped at a flow rate of 2.0 ml min⁻¹. The DAD detector was set at 258 nm. The validation study was carried out fulfilling the ICH guidelines in order to prove that the new analytical method, meets the reliability characteristics, and these characteristics showed the capacity of analytical method to keep, throughout the time, the fundamental criteria for validation: selectivity, linearity, precision, accuracy and sensitivity. The method was applied during the quality control of benzocaine gel in order to quantify the drug (benzocaine), preservatives and degraded products and proved to be suitable for rapid and reliable quality control method.     

Validation in pharmaceutical analysis. Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data

Validation of analytical procedures is a vital aspect not just for regulatory purposes, but also for their efficient and reliable long-term application. In order to address the performance of the analytical procedure adequately, the analyst is responsible to identify the relevant parameters, to design the experimental validation studies accordingly and to define appropriate acceptance criteria.

Establishing an acceptable analytical variability for the given application is of central importance as many other acceptance criteria can be derived from such a precision. Acceptable precision ranges for types of control tests and/or analytes can be obtained from validation, but also related activities such as transfer, control charts, or extracted from routine applications such as batch release or stability studies (data mining). Apart from compiling a database for general benchmarking, during such an information-building process, the reliability of the analytical variability of the specific procedure is more and more increased. This is important as a reliable target variability facilitates to detect or investigate atypical or out-of specification behaviour of analytical data in a routine application, thus improving the data quality and reliability.

According to the life-cycle concept of validation, measures should be taken to maintain and control the validated status of analytical procedures during long-term routine application, such as monitoring relevant performance parameters (system suitability tests), control charts, etc.

If the analytical system is demonstrated to be stable, i.e. under statistical control, a major variability contribution in LC originating from the standard preparation and analysis can be reduced. A concept of quantification by pre-determined calibration parameters instead of the classical approach of simultaneous calibration is described.