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1、ASIAN DEVELOPMENT BANKPHARMACEUTICAL SUPPLY CHAIN ASSESSMENT FOR SRILANKAMARCH 2025ASIAN DEVELOPMENT BANKPHARMACEUTICAL SUPPLY CHAIN ASSESSMENT FOR SRILANKAMARCH 2025Creative Commons Attribution 3.0 IGO license(CC BY 3.0 IGO)2025 Asian Development Bank6 ADB Avenue,Mandaluyong City,1550 Metro Manila,

2、PhilippinesTel+63 2 8632 4444;Fax+63 2 8636 2444www.adb.orgSome rights reserved.Published in 2025.ISBN 978-92-9277-233-8(print);978-92-9277-234-5(PDF);978-92-9277-235-2(ebook)Publication Stock No.TCS250093-2DOI:http:/dx.doi.org/10.22617/TCS250093-2 The views expressed in this publication are those o

3、f the authors and do not necessarily reflect the views and policies ofthe Asian Development Bank(ADB)or its Board of Governors or the governments they represent.ADB does not guarantee the accuracy of the data included in this publication and accepts no responsibility for any consequence of their use

4、.The mention of specific companies or products of manufacturers does not imply that they are endorsed or recommended by ADB in preference to others of a similar nature that are not mentioned.By making any designation of or reference to a particular territory or geographic area inthis document,ADB do

5、es not intend to make any judgments as to the legal or other status of any territory or area.This publication is available under the Creative Commons Attribution 3.0 IGO license(CC BY 3.0 IGO)https:/creativecommons.org/licenses/by/3.0/igo/.By using the content of this publication,you agree to be bou

6、nd bytheterms of this license.For attribution,translations,adaptations,and permissions,please read the provisions andterms of use at https:/www.adb.org/terms-use#openaccess.This CC license does not apply to non-ADB copyright materials in this publication.If the material is attributed toanother sourc

7、e,please contact the copyright owner or publisher of that source for permission to reproduce it.ADB cannot be held liable for any claims that arise as a result of your use of the material.Please contact pubsmarketingadb.org if you have questions or comments with respect to content,or if you wish too

8、btain copyright permission for your intended use that does not fall within these terms,or for permission to use theADB logo.Corrigenda to ADB publications may be found at http:/www.adb.org/publications/corrigenda.Note:In this publication,“$”refers to United States dollars and“SLR”refers to Sri Lanka

9、 rupees.Cover design by Joe Mark Ganaban.Printed on recycled paperCONTENTSTABLES,FIGURES,BOXES,AND CASE HIGHLIGHTS vACKNOWLEDGMENTS viiABBREVIATIONS viiiEXECUTIVE SUMMARY xREPORT BACKGROUND xviiChapter 1:INTRODUCTION 1Chapter 2:OBJECTIVES 5Chapter 3:CONCEPTUAL FRAMEWORK 6Chapter 4:METHODOLOGY 94.1 D

10、ata Collection 94.2 Data Analysis 114.3 Presentation and Review of Findings 11Chapter 5:FINDINGS 125.1 Systems for Ensuring Quality,Safety,and Efficacy 125.2 Appropriate Use of Medical Products 165.3 Access 185.4 Pharmaceutical Supply Chain Management 255.5 Enabler Factors 375.6 Market Ecosystem 425

11、.7 Summary:Performance Against Selected Key Indicators 43Chapter 6:DISCUSSION 466.1 Governance and Rational Product Selection 476.2 Forecasting and Strategic Procurement 496.3 Warehousing and Distribution 516.4 Use of Data for Decision-Making 56ivContentsivChapter 7:PROGRAM AND POLICY OPTIONS 587.1

12、Pathway 1:Governance,Rational Prescribing,andProduct Selection 597.2 Pathway 2:Strategic Procurement 607.3 Pathway 3:Optimized Distribution 617.4 Pathway 4:Data Visibility 627.5 Pathway 5:Quality Assurance and Improved Medicine Regulatory System 637.6 Pathway 6:Capacity Building 657.7 Pathway 7:Regi

13、onal Medicines Access 66APPENDIXES 671 Methodology and Questionnaire Resource Pack 672 Good Storage Practices of Pharmaceutical Stores Assessed 92SELECTED REFERENCES 94TABLES,FIGURES,BOXES,AND CASE HIGHLIGHTSTABLES1 Selected Performance Indicators for the Pharmaceutical Supply Chain 7 Assessment Fra

14、mework2 Sample Sizes for Facilities Assessment 93 Quality Decisions by the National Medicines Regulatory Authority,20212023 134 Pharmacovigilance Reports Received and Analyzed by the National Medicines 15 Regulatory Authority5 Last Update Dates of Some Sample National Treatment Guidelines 176 Value

15、of Health Commodity Loss Due to Expiry,November 2022October 2023 207 Percentage of Product Value Lost(excluding COVID-19 items)Due to Expiry,20 November2022October 20238 Number of Health Facilities in SriLanka,2020 219 Percentage of Estimate Over Consumption of Tracer Products,20192022 2710 Prices o

16、f Items Locally Procured by Hospitals 3011 Procurement Performance and Prices for the Orders to Be Delivered,31 November 2022October 202312 Good Storage Practices Maintained 3213 On-Time and In-Full Delivery to Health Facilities 3314 Pharmaceutical Waste Disposal Practice 3515 Current Procurement Po

17、licies and Practices 3816 Number of Days Taken for Decision-Making on Registration 3917 Number of Days Taken for Decision-Making on Registration,2024 3918 Pharmacist Positions for Institutions Owned by the Ministry of Health 4019 Pharmaceutical Supply Management Positions at Subnational Level 4120 L

18、ocal Manufacturing of Essential Medicines 4221 Performance Against Selected Key Indicators 4322 Different Models of Pharmaceutical Supply Chain 46FIGURES1 Flow of Commodities and Flow of Estimates 22 Pharmaceutical Supply Chain Assessment Framework 63 Current System for Ensuring Quality,Safety,and E

19、fficacy 124 Current Ministry of Health System for Ensuring the Access of Pharmaceuticals 185 Availability of Medicines at Point of Care as Reported by Patients and Facilities,2023 196 Annual Pharmaceutical Procurement Budget,20202023 227 Patient Satisfaction with Pharmaceutical Services 238 Patients

20、 Perception on Waiting Time and Instructions Received 249 Procurement and Supply Chain Management System of the Ministry of Health 2510 Forecasting,Procurement,and Supply Cycle in Sri Lanka 2611 Road Map to an Improved Pharmaceutical Supply Chain in Sri Lanka 58viTables,Figures,Boxes,and Case Highli

21、ghtsviBOXES1 Key Gaps Identified in Quality,Safety,Efficacy,and Appropriate Use 172 Key Identified Gaps in Availability,Accessibility,Affordability,and Acceptability 243 Key Identified Gaps in Pharmaceutical Supply Chain Management in SriLanka 374 Key Identified Gaps in Governance and Human Resource

22、s 425 Key Identified Gaps in Market Ecosystem 456 Pathway 1Options for Strengthening Pharmaceutical Supply Chain Governance 597 Pathway 2Options to Employ Strategic Procurement 608 Options for Optimizing the Storage and Distribution Network 629 Options to Improve Data Visibility and Use Data Analyti

23、cs 6210 Options to Strengthen Quality Assurance and Medicine Regulatory System 6411 Options to Build Pharmaceutical Supply Chain Workforce Capacity 6512 Options for Exploring Opportunities to Set Up a Regional Mechanism 66 for Greater Medicine AccessCASE HIGHLIGHTS1 Delhi,IndiaRational Use of Medici

24、nes 482 Pharmac New ZealandStreamlined Product Selection andPricing Strategies 493 National Immunization Program in Sri Lanka 514 South AfricaDirect Delivery to Facilities 535 Pharmaceutical Supply Chain Management in the Peoples Republic of China 546 Indonesias E-Katalog System 55ACKNOWLEDGMENTSThi

25、s report and assessments were prepared by an assessment team from the Asian Development Bank(ADB)under the guidance of the MinistryofHealth(MOH)and the Ministry of Finance(MOF)of the Government of Sri Lanka.Much gratitude is due to several development partners including the World Health Organization

26、(WHO),United Nations Childrens Fund(UNICEF),and World Bank,which took part in and supported this assessment in various capacities.TheHigh-Level Technical Working Group(TWG)comprised of experts from relevant government units,development partners,and representatives from industry and professional asso

27、ciations in Sri Lanka provided overall guidance and leadership to this assessment.The data collectors and members of the TWG are much appreciated for their wholehearted support.Valuable support and cooperation were likewise received from the key informants,focus group discussion participants,and hea

28、lth facilities that the assessment team visited.The assessment team was led by Hasibul Haque,ADB senior pharmaceutical supply chain consultant,and co-led by Shalutha Athauda,pharmaceutical industry consultant,under the supervision of Dai-Ling Chen,health specialist.The ADB team members include Herat

29、hbanda Jayasundera,senior social development officer;Kumari Navaratne,senior public health consultant;and Nayana Fernando,public health consultant.Uhjin Kim,regional advisorEssential Drugs and Medicines,WHO Regional Office for Southeast Asia;Sapumal Dhanapala,national professional officerEmergency R

30、isk Management,WHO Country Office for Sri Lanka;Innocent Dube,supply chain manager,UNICEF Supply Division;Wisdom Dube,supply chain systems strengthening consultant,UNICEF Supply Division;Mohan Wickramasinghe,supply and logistics officer,UNICEF Country Office for SriLanka;Kasun Rambukwella,registrarM

31、edical Administration,MOH;and Asita de Silva,ADB senior pharmacologist consultant provided comments and contributions as technical reviewers at various stages of the report.All units including the National Medicines Regulatory Authority,Medical Supplies Division of MOH,State Pharmaceutical Corporati

32、on,and National Medicine Quality Assurance Laboratory extended their full support to the assessment.The support and guidance from the National Planning Department of MOF is greatly appreciated.The cooperation from the private sector including manufacturers,importers,and third party logistics provide

33、rs contributed significantly.Finally,participants of the National Consultation Workshop including the Honorable Minister of Health,Secretary of Health,Director General of Health Services,Additional Secretaries of MOHProcurement,Development,Medical Services,and Pharmaceuticals are gratefully acknowle

34、dged for their valuable time and contribution.ABBREVIATIONSADB Asian Development BankAMR antimicrobial resistanceAPI active pharmaceutical ingredientASEAN Association of Southeast Asian NationsCTD common technical dossierDGHS Director General of Health ServicesDMS Department of Management ServicesEM

35、L Essential Medicine ListERP enterprise resource planningFGD focus group discussionGS1 Global Standards 1HRH Human Resources for HealthHTA Health Technology AssessmentICH International Council on HarmonizationKII key informant interviewMEC Medicine Evaluation CommitteeMOH Ministry of HealthMSD Medic

36、al Supplies DivisionNDTC National Drug Therapeutic CommitteeNMQAL National Medicine Quality Assurance LaboratoryNMRA National Medicines Regulatory AuthorityNSCA national supply chain assessmentPMCU primary medical care unitPSS pharmaceutical system strengtheningQMS Quality Management SystemRMSD Regi

37、onal Medical Supplies DivisionSLACPT Sri Lanka Association of Clinical Pharmacology and TherapeuticsSLPMA Sri Lanka Pharmaceutical Manufacturers AssociationSLR Sri Lankan rupeeSPC State Pharmaceutical CorporationSPMC State Pharmaceutical Manufacturing CorporationTOR terms of referenceTWG technical w

38、orking groupUNICEF United Nations Childrens FundWHO World Health OrganizationixAbbreviationsWEIGHTS AND MEASURESIU international unit mcg microgram mg milligram ml milliliterEXECUTIVE SUMMARYBackground.The pharmaceutical supply chain consists of all structures,people,resources,processes,and their in

39、teractions within the broader health system and market ecosystem.It seeks to ensure equitable and timely access to safe,effective,quality-assured pharmaceutical products and related services.An effective and efficient pharmaceutical supply chain promotes the appropriate and cost-effective use of pha

40、rmaceuticals to improve health outcomes.Sri Lankas pharmaceutical supply chain consists of the Ministry of Health(MOH);National Medicines Regulatory Authority(NMRA)including the National Medicine Quality Assurance Laboratory(NMQAL),Medical Supplies Division(MSD),State Pharmaceutical Corporation(SPC)

41、,and State Pharmaceutical Manufacturing Corporation(SPMC);local importers;and manufacturers.They have helped to ensure that the pharmaceuticals provided served the country well in the past in achieving commendable health outcomes compared to other countries of the same economic level.In the current

42、structure,NMRA is responsible for regulation of pharmaceuticals to ensure the quality and safety of medicines and pharmaceutical products.Central procurement and supply of medicines,surgical items,consumables,diagnostics,and devices for all provincial and centrally managed health facilities fall und

43、er the purview of the central MOH with the MSD of MOH initiating and leading the process.The SPC serves as the procurement agent for the MSD.The forecasting,distribution,and monitoring of supplies are overseen by the MSD,in collaboration with 26 regional MSDs and based on an annual call for estimati

44、on of requirements from each hospital in the country.Since 2019,a series of events including the easter bomb attack in 2019,the coronavirus disease(COVID-19)pandemic from 2020 to 2022,and the economic crisis from 2021 to 2023 have had major effects on MOHs pharmaceutical supply chain.This has led to

45、 associated stock-out issues and exposed some vulnerabilities and areas of improvement in the pharmaceutical supply chain system in Sri Lanka.These include issues in the areas of pharmaceutical supply chain governance,product registration system,forecasting,procurement process,storage and distributi

46、on,information system,rational use of medicines,staff shortage,and technical capacities.Against this backdrop,the MOH and the Ministry of Finance,with support from the Asian Development Bank and other development partners,undertook an assessment from September 2023 to May 2024 aimed at fostering a c

47、omprehensive understanding of the Sri Lankas pharmaceutical supply chain,identifying barriers,and analyzing improvement options.Methodology.The mixed-methods approach employed for this assessment covered the areas of regulatory systems and quality assurance,appropriate use of medicines,medicines acc

48、ess,procurement and supply chain management,governance,human resources,information systems,and the market ecosystem.Data collection methods included desk reviews,assessment of facilities based on stratified random sampling across the whole country,patient satisfaction surveys,key informant interview

49、s,focus group discussions,and a national consultation workshop.Data were analyzed qualitatively and quantitatively according to the conceptual areas.xiExecutive SummaryFindings.Results show that thanks to the presence of a government health facility within a 5-kilometer reach by the population,as we

50、ll as provisions for free medicines,Sri Lanka has attained high accessibility and affordability of medical products contributing to high patient satisfaction.Further,pharmaceuticals and supplies were fully funded by the Government of Sri Lanka,except during 2023 and 2024 when donor financing was req

51、uested to meet the funding shortfall to purchase pharmaceuticals.Sri Lankas achievement of health indicators,commitment to free and equitable health care services,and resilience in recovering from the COVID-19 pandemic offer valuable lessons for countries with similar economic conditions.As Sri Lank

52、a recovers from the effects of the economic crisis,there are areas that can further improve the efficiency and effectiveness of the pharmaceutical supply chain.These include areas related to governance,procurement,rational use of medicines,logistics systems,fund flow,enhanced data analytics,quality

53、assurance,capacity building and market shaping,which are detailed below.(i)Governance.The MOH is responsible for overall governance of the pharmaceutical supply chain and its performance monitoring.Overall,the roles of procurement and logistics management are segregated between SPC and MSD respectiv

54、ely,but MSD directly manages procurement under the buyback agreements with SPMC and other local manufacturers.The roles of technical standards setting,policy making,and oversight are led by technical committees including NMRA but are not clearly segregated with a mechanism for ensuring accountabilit

55、y.This creates a vulnerability for the pharmaceutical supply chain that can be affected by possible external interference and corruption.(ii)Procurement.The long lead time for forecasting,procurement,and supply is making it increasingly challenging to improve forecasting accuracy,align procurement w

56、ith the annual budgetary cycle,and prepare realistic supply plans.Improving the process of forecasting,reducing the long procurement lead time by using appropriate procurement strategies,digitization,and supply planning would contribute to more efficient procurement,avoid shortage of supply,and help

57、 achieve lower prices for medicines.(iii)Rational use of medicines.The National List of Essential Medicines(EML)of Sri Lanka that includes 383 medicines was firstly published in 2013-2014 and further revised in 2021.In2023,a“priority list of medicines”of about 850 items were also adopted in parallel

58、.However,compared to global and regional standards,both lists should be further reduced.The two lists should also be consolidated to avoid duplication and confusion.This requires changes in the institutional mechanisms to further rationalize product selection based on the principles of medicine opti

59、mization to achieve maximum therapeutic efficacy,minimum product variations,and optimum cost-effectiveness.Enhancing the rational use of medicines,optimizing product selection,aligning national treatment guidelines,and having an EML would reduce the need for procuring increased numbers of medicine v

60、ariations,consolidate the demands in a relatively small medicines market,and achieve greater economies of scale.xiiExecutive Summary(iv)Logistics system.The current storage and distribution network is not optimized for operational efficiency or for a predictable level of delivery service to the heal

61、th facilities.Optimizing the storage and distribution network for direct delivery to health facilities and reducing the tiers in the supply chain would shorten delivery lead time,reduce the risk of quality loss,and minimize stock holding costs.(v)Funds flow.During the economic crisis period,the phar

62、maceutical supply chain suffered from a lack of predictable funding and available foreign currency leading to a series of emergency decisions.Aligning procurement of pharmaceuticals to the annual allocation of the necessary funding and with assuring predictable release of funds are preconditions to

63、stabilizing and improving the pharmaceutical supply chain in the postcrisis period.(vi)Enhanced data analytics.The pharmaceutical supply chain can immensely benefit from better use of available data analytics,more effective monitoring and evaluation,and evidence-based decision-making.This can be sup

64、ported by improved digitalization,including the scaling up use of the pharmaceutical IT system such as management dashboards and standardized Global Standards 1(GS1)labelling,to improve the efficiency of the pharmaceutical supply chain.(vii)Quality assurance.Premarketing quality assurance in Sri Lan

65、ka is mainly carried out at the time of product registration.Quality assurance during the procurement process is inadequate and lacks stringent quality checks,including routine prequalification at the manufacturer and importer levels.The point-of-entry quality control is inadequate and lacks physica

66、l infrastructure,capacity,and human resources to implement a comprehensive approach.Pharmacovigilance process and the practice are also at the nascent level.Quality tests are carried out mainly following the reporting of clinical quality failures and therefore,the high rate of quality test failures

67、indicates the need for more proactive quality assurance mechanisms to prevent the possibility of substandard and falsified items entering the supply chain to continue public confidence in medicines available at the government health facilities.(viii)Capacity building.Institutional training courses o

68、n pharmaceutical supply chains are not available in SriLanka and there is a lack of trained pharmaceutical supply chain professionals.Ensuring adequate human resources and orienting and refreshing professionals on pharmaceutical supply chain management would increase efficiency of the supply chain.(

69、ix)Market shaping.Current procurement practices lack market-shaping strategies and do not take advantage of framework agreements and other strategic procurement methods that encourage the markets to meet the requirements of the buyer.Strategic procurement practices,market shaping strategies,and use

70、of framework agreements and pooled procurement mechanisms would reduce time,cost,and vulnerability of SriLankas public health pharmaceutical supply chain to market volatility.xiiiExecutive SummaryRecommendations.Based on global best practices,different models of supply chain including a more segment

71、ed and coordinated supply chain,using third party and fourth party logistics providers for direct delivery of health products to the health facilities,and using e-catalog and e-marketplace system are identified for Sri Lankas consideration.For example,the role of MOH can be setting technical standar

72、ds;conducting demand forecasting,prequalification,and price negotiation;formulating of framework agreements with the suppliers;setting quantity caps for end users;and setting up an e-marketplace system through that end users would be able to place and receive orders directly.Currently,Sri Lanka is p

73、racticing a centralized supply chain model led by MSD with a few vertical programs having their own segmented supply chain.SriLanka would benefit from incorporating key features of other models of supply chain.Synthesizing the findings and analysis,the following pathways and recommended policy and p

74、rogram actions are identified for further improvement of and efficiency gains in SriLankas public health-led pharmaceutical supply chain.Pathway 1:Strengthen pharmaceutical supply chain governance(i)Review and revise the organizational structure of current pharmaceutical governance systems to better

75、 streamline it for improving the efficiency of the pharmaceutical supply chain.(ii)Optimize mechanisms used for product selection and rational use.(iii)Review the pharmaceutical supply chain governance mechanism related to product selection and rational use.(iv)Set up and/or strengthen necessary str

76、uctures by clearly segregating the technical standards setting,policy making,regulatory,market shaping,procurement,logistics,and oversight roles.Implement adequate coordination and accountability.(v)Set up units or enhance and empower technical committees within MOH for clinical excellence to take c

77、are of clinical standards,national treatment guidelines,national formulary,EML,and health technology assessments.(vi)Update and streamline the practice of implementing and revising guidelines,including the EML and national treatment guidelines.(vii)Implement the practice of generic prescription and

78、prescription audits.(viii)Develop an electronic tool for rational product selection.(ix)Establish a National Institute of Clinical Excellence.(x)Conduct periodic drug resistance monitoring surveys.xivExecutive SummaryPathway 2:Employ strategic procurement(i)Use historical consumption data together w

79、ith epidemiological and service delivery data for defining strategic procurement.(ii)Develop policies and standard operating procedures for national forecasting and supply planning.(iii)Integrate forecasting and supply planning modules within the currently practiced IT system(SWASTHA)and switch to n

80、ew forecasting and supply planning practices.(iv)Develop procurement strategies for different products(high and low value,high and low volume,shelf-life and half-life of the pharmaceutical etc.)and train relevant people to determine the most efficient and cost effective procurement methods and instr

81、uments.(v)Introduce framework agreements.(vi)Utilize an interoperable enterprise resource planning for procurement(epromise.lk).(vii)Introduce prequalification,price negotiation,and e-catalog/e-market place where pre-qualified suppliers and products are listed with negotiated price for purchasers to

82、 place online order.Pathway 3:Optimize storage and distribution network(i)Undertake distribution network analysis and distribution system optimization exercises.(ii)Address the storage condition issues in health facilities by allocating sufficient space,procuring sturdy shelves and pallets,and insta

83、lling temperature and humidity monitors,smoke detectors,and air conditioners.(iii)Set up more efficient inventory control and distribution policies.(iv)Fill in vacant staff positions for pharmaceutical supply management.(v)Train staff on inventory control,good storage,and distribution practice.(vi)R

84、edesign the distribution network based on options analysis.Pathway 4:Improve data visibility and use data analytics(i)Optimize the use of SWASTHA for electronic health records,electronic logistics management information system,forecasting,monitoring and evaluation,and early warnings.(ii)Orient staff

85、,managers,and decision makers on interpreting supply chain data and using supply chain data for decision-making.xvExecutive Summary(iii)Deploy and roll out information systems for NMRA,SPC,and MSD for product selection and specifications,product registration,procurement processing and management,e-c

86、atalog and e-procurement,quality assurance of medical products,and pharmacovigilance.(iv)Develop a road map for implementing Global Standards 1 and barcode system.(v)Strengthen the relevant committee within MOH for oversight,monitoring,and evaluation of the performance of pharmaceutical supply chain

87、.Pathway 5:Strengthen quality assurance and medicine regulatory system(i)Strengthen NMRA and NMQAL by hiring and training the required number of staff.(ii)Develop a road map for NMQAL to be an ISO certified and/or prequalified laboratory of the World Health Organization(WHO).(iii)Implement a more co

88、mprehensive national quality assurance strategy including strengthening a risk-based point-of-entry testing mechanism.(iv)Set up a national network of collaborative quality assurance laboratories with NMQAL taking the national reference laboratory and leadership role.(v)Strengthen SPCs quality assur

89、ance laboratory.(vi)Leverage WHO collaborative laboratory network.(vii)Optimize product registration process,harmonize the common technical dossier(CTD)used by NMRA,and institutionalize accelerated and reliance pathways for product registration.Pathway 6:Build pharmaceutical supply chain workforce c

90、apacity(i)Orient key leaders,policy makers,and managers on pharmaceutical supply chain management.(ii)Conduct a pharmaceutical supply chain workforce assessment and develop a workforce development plan.(iii)Develop training courses and make preservice and in-service training arrangements for pharmac

91、eutical supply chain workforce.(iv)Implement pharmaceutical supply chain workforce development plan.(v)Implement online training platform for in-service training on pharmaceutical supply chain.(vi)Introduce pharmaceutical supply chain management courses in appropriate academicprograms.xviExecutive S

92、ummaryPathway 7:Explore opportunities for setting up a regional mechanism for greater medicine access(i)Conduct feasibility study for SriLanka to set up or take part in a regional and/or international quality assurance,market access,and pooled procurement mechanism.(ii)Set up a commission or unit un

93、der MOH for employing price negotiation,market shaping,and pricing strategies.(iii)Initiate setting up or taking part in a regional or international quality assurance,market access,and pooled procurement mechanism.REPORT BACKGROUNDThe purpose of this report is to understand the systemic vulnerabilit

94、ies of the pharmaceutical supply chain and identify areas of further improvements to upgrade Sri Lankas pharmaceutical supply chain to the next level of efficiency and effectiveness.The data collection period for this assessment was not ideal,as it was marked by the COVID-19 pandemic back to back wi

95、th an economic crisis affecting the pharmaceutical supply chain.Further,the pharmaceutical usage pattern was modified given the COVID-19 prevention and control efforts,and the required data was either not available or could not be verified against data from previous years.Nevertheless,the assessment

96、 tried to provide a high-level overview of Sri Lankas pharmaceutical supply chain system,its organization,functions,strengths,and areas of improvement to increase its efficiency and reduce its vulnerabilities in the future.Opinions expressed in this report are those of the assessment team and do not

97、 necessarily represent the opinions of the Asian Development Bank,development partners,Ministry of Health,Ministry of Finance,or Technical Working Group members who supported this assessment.Chapter 1INTRODUCTIONSri Lanka has achieved commendable health outcomes compared to other countries of the sa

98、me economic level.Sri Lanka has witnessed advancements in vital health measures;enhanced life expectancy;and eradication of diseases like malaria,measles,filariasis,polio,and neonatal tetanus.Nevertheless,the nations health system needs to be upgraded to meet challenges from the changing economic,de

99、mographic,and epidemiological landscapes.The country needs more efficient health interventions to meet the demands of the aging population and increasing noncommunicable diseases,which currently contribute to around 75%of deaths.1The public sector accounts for 95%of in-patient care and almost 100%of

100、 preventive care in SriLanka.Meanwhile,the private health care sector is growing and accounts for 50%of the out-patient care,and 5%10%of inpatient care,which remains accessible only to a portion of the population due to high costs.The public sector curative service delivery reaches the population th

101、rough 1,159health facilities,out of which 59larger Teaching and Specialized hospitals are administered by the central government,with approximately 50%of beds and more than two-thirds of specialist beds.Preventive health service is delivered through 356 preventive Medical Officer of Health areas,whi

102、ch are geographically defined areas with dedicated preventive health staff providing services to demarcated areas.Sri Lanka provides all health services(preventive and primary,secondary,tertiary level curative care)free of charge to all citizens at point-of-delivery.In addition,the public sector emp

103、loyees have access to a social health insurance scheme(the Agrahara insurance scheme)for selected services.Other limited insurance schemes are also available for some large-scale private sector company employees.With a per capita current health expenditure of$166.18,government health expenditure sta

104、nds at around 4%of gross domestic product.Around 7%of the total budget is allocated to the health sector,and only about 4%of the total health expenditure by the government comes from external sources.However,around 44%of the current health expenditure comes from out-of-pocket expenses.2 More than 30

105、%of the annual health budget is spent on pharmaceuticals,which amounts to over$360millionof annual pharmaceutical procurement by the government.3 Sri Lankas pharmaceutical supply chain is a mix of centrally managed and decentralized structures with procurement of pharmaceuticals managed at the centr

106、al level.The key stakeholders in the current pharmaceutical governance systems include the Ministry of Health(MOH);National Medicines Regulatory Authority(NMRA)including the National Medicine Quality Assurance Laboratory(NMQAL),Medical Supplies Division(MSD),and 26 Regional Medical Supplies Division

107、s(RMSD);drugstores in each health care institution;State Pharmaceutical Corporation(SPC);State Pharmaceutical Manufacturing Corporation(SPMC);local medicine importers;and local manufacturers.1 Government of SriLanka,Ministry of Health.2020.Annual Health Bulletin.2 World Health Organization(WHO).2023

108、.Regional Health ObservatorySouth East Asia.Updated 5 December 2023.3 SriLanka Association of Clinical Pharmacology and Therapeutics.Evidence Synthesis on Essential Medicines Policy Reform Options forSriLanka.World Health Organization(Project No.2022/1279296-0).2Pharmaceutical Supply Chain Assessmen

109、t for Sri LankaThe NMRA is responsible for ensuring quality,safety,and efficacy of pharmaceutical products through product registration,quality assurance,and pharmacovigilance.As the national regulatory authority,NMRA exercises oversight on various regulatory functions including evaluation and regis

110、tration of medicines for ensuring quality,safety,and efficacy,as well as for price regulation.4 Itis also the institutional home of the NMQAL,which is responsible for analyzing the quality of any medicine and medical devices.NMRA has a partnership with the University of Colombo to conduct pharmacovi

111、gilance activities.Estimation,procurement initiation,storage,distribution,and monitoring of medical products fall under the purview of MSD in the MOH.The State Pharmaceutical Corporation serves as the procurement agent for MOH.Forecasting,distribution,and monitoring of supplies to the drug store of

112、each health care institution are overseen by the MSD,in collaboration with 26 RMSDs based on an annual call for estimation of requirements from each health care facility in the country(Figure 1).4 Government of SriLanka.2015.National Medicines Regulatory Authority Act.Figure 1:Flow of Commodities an

113、d Flow of EstimatesMSD=Medical Supplies Division,OPD=outpatient department,RMSD=Regional Medical Supplies Division,SPC=State Pharmaceutical Corporation.Source:Government of SriLanka,Ministry of Health and Nutrition.2008.Manual on Management of Drugs.Second Revision.MSD stocksProcurement(SPC)Annual n

114、ationalestimates(MSD)Annual estimates of line ministryhealthinstitutionsAnnual estimatesof regionalhealthinstitutionsRMSDstockProvincialhealthinstitutionsLine ministryhealthinstitutionsInstitutional stockIndoor and outdoor stockInstitutional estimatesWardsOPDClinicsTheatersPatientsDispensingIntroduc

115、tion3In addition to estimating,storing,and distributing medical products,MSD also operates the Secretariat of the National Drug and Therapeutic Committee chaired by the Director General of Health Services.The National Drug and Therapeutic Committee creates the national procurement list for medicines

116、 and other supplies,currently also referred to as the priority list of pharmaceuticals,based on the Essential Medicines List(EML)albeit longer.Medicines that do not appear on the EML or priority list are at times included in the procurement list on the case-by-case requests by physicians and patient

117、 advocacy groups knowledgeable on new treatment modalities or their related aspects.Once MSD has listed and quantified the medicines required by the health system,the list goes to SPC.Created in 1971,SPC is a semigovernment agency that is SriLankas central purchaser and main supplier of pharmaceutic

118、als,surgical consumable items,laboratory chemicals,and equipment to government health facilities.The functions of SPC include importation and purchase of medical products,contribution to retail pharmaceutical sales by operating 105 franchise pharmacies and 11authorized retailers,and distributing to

119、private retail pharmacies.Over 180 private local pharmaceutical establishments are currently registered as NMRA importers.These include local conglomerates that act as local representatives distributing medicines from multinational companies as well as wholesalers and distributors for smaller region

120、al manufacturers.In SriLanka,16.4%of the pharmaceutical market is captured by local manufacturers including the SPMC.5 The SPMC is the largest state-owned drug manufacturer in SriLanka,providing 43medicines to the MOH.Currently,20 manufacturers approved by the NMRA are in operation and about 5 new f

121、acilities are being commissioned.The publicly available EML was revised in 20132014 and then in 2021.6 MSD made a formulary revision and published an approved list of pharmaceutical items in 20162017,which was updated in 2019.The formulary revision in 2019 included a total of 1,346 medicines categor

122、ized as vital(14items),essential(675 items),and nonessential(657 items)in their different dosage forms for purchase for the public sector.The EML itself has 383 medicines that include 675 items in different dosage forms.Themost recent revision of the list of medicines for the hospitals was made in F

123、ebruaryApril2023,chaired by the director general of Health Services with representatives of specialty colleges and associations.The 2023 revision identified a priority list of 850 items including 643normal stock items,21rawmaterials,10 antidotes,77 items for special campaigns,2miscellaneous items,an

124、d 97 items to be supplied on a named patient basis.7 From previous studies and reports,it appears that irrational use of medicines is prevalent in the country including polypharmacy,irrational use of antimicrobials,and self-medication.85 SriLanka Chamber of Pharmaceutical Industry.2019.The Future of

125、 Pharmaceutical Manufacturing in SriLanka.6 Government of SriLanka.Medical Supply Division.Ministry of Health.7 Government of SriLanka.2024.MOH Circular No.01/14-2023.4 April(Internal).Ministry of Health.8 G.P.Senadheera et al.2017.Practice of Self-Medication with Antibiotics in the Colombo District

126、,SriLanka.Ceylon Med J.62(1).pp.7072.4Pharmaceutical Supply Chain Assessment for Sri LankaRecent reportsincluding two reports by Sri Lanka Association of Clinical Pharmacology and Therapeutics,9 the Special Report by the Auditor General,10 and the Report of the Public Expenditure Review Committee11h

127、ave reiterated pressing challenges including lengthy product registration system,suboptimal forecasting process,long procurement lead time,absence of efficient information systems,frequent stockouts of health commodities,staff shortage,and weak technical capacities faced by the pharmaceutical supply

128、 chain system in SriLanka.Against this backdrop,the MOHtogether with the Ministry of Finance of SriLanka with support from ADB and other development partnersundertook this assessment to examine the status,bottlenecks,and opportunities for improvement at all levels of the public health supply chain m

129、anagement in SriLanka and identify actionable options for the government for graduating to a more efficient and resilient pharmaceutical supply chain.9 SriLanka Association of Clinical Pharmacology and Therapeutics.Evidence Synthesis on Essential Medicines Policy Reform Options for SriLanka.World He

130、alth Organization(Project No.2022/1279296-0);SriLanka Association of Clinical Pharmacology and Therapeutics.2023.Challenges and Barriers for Effective Supply of Medicines to the State Sector and Recommendations to the Ministry of Health SriLanka.10 Government of SriLanka,Office of the Auditor Genera

131、l.2022.Auditor Generals Special Report on Procedures Taken to Avoid the Shortage of Pharmaceuticals in Government Hospitals by 13 May 2022.11 Government of SriLanka,Public Expenditure Review Committee.2023.Report of the Public Expenditure Review Committee on Rationalization of Government Expenditure

132、 Relating to the Ministry of Health.OBJECTIVESChapter 2The specific objectives of the assessment are as follows:(i)Generate an overall understanding of the current organization and functioning of the public health pharmaceutical supply chain in SriLanka.(ii)Diagnose the key barriers and identify the

133、 factors affecting the efficiency and effectiveness of the pharmaceutical supply chain.(iii)Analyze well-informed options for addressing the identified gaps and develop models for enhancing the capability and performance of the pharmaceutical supply chain by drawing insights from appropriate good an

134、d promising practices.(iv)Outline specific areas requiring future investments to strengthen the supply chain in SriLankas health sector,while optimizing resource allocation.CONCEPTUAL FRAMEWORKChapter 3For the assessment,an ecosystem-based pharmaceutical systems strengthening approach was employed.P

135、harmaceutical systems strengthening is defined as“The process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and toenhance its performance for

136、achieving better health outcomes.”12 As presented in Figure 2,the pharmaceutical supply chain consists of all structures,people,resources,processes,and their interactions within the broader health system and market ecosystem to ensure equitable and timely access to safe,effective,and quality-assured

137、 pharmaceutical products and related services and promote their appropriate and cost-effective use to improve health outcomes.12 M.Soucy Brown et al.2021.PSS Insight v2.0A Framework and Indicators for Measuring Pharmaceutical Systems Strengthening.p.13.Figure 2:Pharmaceutical Supply Chain Assessment

138、 FrameworkSource:Asian Development Bank assessment team.International standards,guidelines,and collaboration Pharmaceutical industry and market dynamics Market access mechanisms Health system governance Human resources Information technology Finance Service delivery Availability Acesssibility Aforda

139、bility Acceptibility Product selection and quantification Procurement Storage and distribution End use information Rational use of medicine Medicine optimizationMarket ecosystemCountry healthsystemPharmaceuticalsupply chain systemAccessAppropriate usequality,safety,efcacyConceptual Framework7The ass

140、essment investigated the following conceptual areas for a comprehensive review of SriLankas pharmaceutical supply chain:(i)Systems in place for ensuring quality,safety,and efficacy of medical products.(ii)Appropriate use of medical products including rational use of medicines and medicine optimizati

141、ons.(iii)Access to medical products including availability,service delivery,accessibility,finance,affordability,and acceptability.(iv)Pharmaceutical supply chain system including(a)product selection,(b)quantification,(c)procurement,(d)warehousing,(e)transportation and distribution,(f)end use informa

142、tion including digital information systems,(g)waste disposal,and(h)drug resistance monitoring.(v)Enabling factors including governance(policy and regulatory framework)and human resources.(vi)Market ecosystem including pharmaceutical industry and market dynamics,international collaboration,and market

143、 access mechanisms.A list of 25 performance indicators drawn from the National Supply Chain Assessment 2.0.2 Toolkit13 and Pharmaceutical System Strengthening Insight14 were selected to assess key aspects of this framework.The indicators are presented in Table 1.13 United States Agency for Internati

144、onal Development.2023.Global Health Supply Chain Program.NSCA 2.0.2 Took Kit.14 M.Soucy Brown et al.2021.PSS Insight v2.0A Framework and Indicators for Measuring Pharmaceutical Systems Strengthening.Table 1:Selected Performance Indicators for the Pharmaceutical Supply Chain Assessment FrameworkAreaI

145、ndicatorAppropriate use of medicinesPercentage availability of National Treatment Guidelines that have been reviewed or updated within the last 3 yearsAppropriate use of medicinesPercentage of medicines prescribed according to National Treatment GuidelinesQualityPercentage of samples received by the

146、 National Medicine Quality Assurance Laboratory that failed quality control testingSafety:PharmacovigilancePercentage of recorded adverse event reports that were assessed for causalityEfficacyPresence of an Essential Medicine List(EML)continued on next page8Pharmaceutical Supply Chain Assessment for

147、 Sri LankaAreaIndicatorAvailabilityProportion of health facilities that have a core set of relevant essential medicines(according to the National Formulary)available and affordable on a sustainable basisAvailabilityPercentage of product losses by value due to expired medicines or damage or theft per

148、 value receivedService delivery and accessibilityAverage distance of households from a dispensing facility or pharmacyFinance and affordabilityOut-of-pocket expenditure on pharmaceuticals out of total out-of-pocket expenditure for healthAcceptabilityPercentage of patients surveyed satisfied with pha

149、rmaceutical services from their last visit to a public health facilityProduct selectionPercentage of medicines selected from EML over the total number of medicinesprocured Forecasting and supply planningMean percentage of variation between the forecast and actual consumption for asetof tracer produc

150、tsProcurement Percentage of median international price paid for a set of tracer medicines that was part of the last procurement ProcurementPercentage of supplier with on-time and in full delivery(disaggregated by three types of procurement:regular procurement,local procurement,and emergencyprocureme

151、nt)Warehouse and distributionPercentage of key storage conditions satisfiedWarehouse and distributionPercentage of orders received on-time and in-full Warehouse and distributionPercentage of temperature-controlled vehicles in the total distribution fleetEnd use:Logistics Management Information Syste

152、m(LMIS)Percentage of health facilities that submit complete LMIS reports on time to their reporting unitInformation systemData on safety,efficacy,and cost effectiveness of medicines available and used to inform essential medicines selectionEnd use:Drug resistance monitoringPercentage of key action i

153、tems implemented from the National Action Plan on Antimicrobial ResistanceEnd use:Waste disposalPercentage of pharmaceutical wastes disposed according to the appropriateguidelinesGovernance,policies,and regulatory framework Existence of a policy or strategy that sets standards for collection and man

154、agement of pharmaceutical supply chain information for monitoring and evaluation Index to assess the relevance and appropriateness of the current pharmaceutical procurement guidelines in meeting the specific needs and challenges of the healthcare system Average number of days for decision making on

155、a medicine application forregistrationHuman resourcesProportion of pharmaceutical supply chain positions that are filled in with licensed pharmacists,pharmacy technicians,or pharmacy assistantsMarket ecosystemPercentage of products on EML that are currently manufactured or comanufactured within the

156、countrySource:Asian Development Bank assessment team.Table 1 continuedMETHODOLOGYChapter 4The assessment was guided by a technical working group(TWG)comprising experts from relevant government units,development partners,and representatives from industry and professional associations in SriLanka.The

157、assessment was facilitated and supported by an assessment team(aninternational expert in pharmaceutical supply chain as principal investigator,and a local consultant as co-investigator)mobilized by ADB,with participation from the World Health Organization(WHO)and United Nations Childrens Fund(UNICEF

158、).The team carried out the assessment from August 2023 to May 2024 and employed multiple methods to achieve objectives:desk reviews,evaluation of facilities based on stratified random sampling across the whole country,patient satisfaction surveys,key informant interviews,focus group discussions,and

159、a national consultation workshop.Details of the comprehensive methodology,questionnaires,and data set are provided in Appendix 1.4.1 Data CollectionThe study followed a mixed methods approach comprising both qualitative and quantitative data collection methods.(i)Desk review.Review of policy documen

160、ts,operational guidelines,administrative records,and historical data was done by the principal investigator.(ii)Facilities assessment.An island-wide descriptive cross-section assessment was done selecting a sample of 79 health facilities.The sample size was calculated using a standard formula for a

161、stratified random sampling.The desired number of facilities were selected from each stratum randomly as indicated in Table 2.Table 2:Sample Sizes for Facilities AssessmentType of FacilityTotal Number of FacilitiesFacilities SelectedTertiary care facility517Base hospital A367Base hospital B453Distric

162、t hospital A6610District hospital B14712District hospital C27217Primary medical care unit54223Total1,15979Sources:Ministry of Health and Asian Development Bank assessment team.10Pharmaceutical Supply Chain Assessment for Sri Lanka A pretested questionnaire was administered by two trained data collec

163、tors who visited all the selected facilities and filled in the questionnaire through interviews and observations.Additionally,the assessment team visited 12 facilities including MSD and RMSD,as well as facilities from different levelsnational hospitals,provincial hospitals,teaching hospitals,base ho

164、spitals,district hospitals,and primary medical care unitsin three provinces(western,central,and southern)for facilities assessment,insights gathering,and onsite verification.(iii)Patient satisfaction survey.A sample of patients(110)selected from different levels of health facilities were assessed fo

165、r their satisfaction on service using an interviewer-administered questionnaire.Three trained data collectors were employed for this task.(iv)Key informant interviews.A series of in-depth interviews with key stakeholders,including health officials,supply chain managers,health care practitioners,and

166、industry representatives were conducted by the principal investigator and co-investigator to gather insights and information on the participants area of knowledge and experience.A structured interviewer guide was utilized to direct the conversation.Saturation point was reached after interviewing eig

167、htrespondents.(v)Focus group discussions.The principal investigator and co-investigator conducted five focus group discussions(FGDs)with the private sector,MSD,SPC,NMRA,and Health Informatics Team of MOH to gather perspectives on challenges,root causes,opportunities for improvement,and policyrecomme

168、ndations.(vi)National consultative workshop.The TWG organized a 2-day national consultative workshop on 2425 November 2023 in Colombo with the participation of all levels of stakeholders involved in the pharmaceutical supply chain in Sri Lanka.The workshop provided the opportunity to engage in discu

169、ssions and to build consensus on priority issues and preferred options.Methodology114.2 Data AnalysisData collected from the qualitative and quantitative methodologies were analyzed thematically by the principal investigator with assistance from the team of experts assigned by ADB,WHO,and UNICEF.Qua

170、ntitative data collected from the facilities surveys and patient satisfaction surveys were analyzed using Microsoft Excel.Final results of data analysis were grouped and presented according to the areas of the conceptual framework that cut across the entire pharmaceutical supply chain of SriLanka.4.

171、3 Presentation and Review of FindingsKey findings and policy options from the report were further presented to and reviewed by the TWG on 27 May 2024 and at a high-level stakeholder meeting convened by the Ministry of Health on 6 June 2024.Chapter 5FINDINGS5.1 Systems for Ensuring Quality,Safety,and

172、 EfficacyAccording to the SriLanka Procurement Guidelines 2022,quality,safety,and efficacy are ensured in the pharmaceutical supply chain upon authorization of quality tests at each of the following points(see also Figure 3):15(i)preshipment inspection in exporting countries;(ii)prepurchase testing

173、of samples supplied by suppliers.However,significantly the Guidelines states that:“.samples may not be representative of the product that will be actually sold or delivered”and hence recommends:“.analysis of individual batches either by itself or through international quality control organizations/l

174、aboratories in order to ensure that the product to be sourced meet with the stipulated criteria.”15 See Quality Assurance on pages 42 and 43 in Government of SriLanka.2022.Guidelines for Procurement of Pharmaceutical and Medical Devices of a Consumable Nature(accessed March 2023).Figure 3:Current Sy

175、stem for Ensuring Quality,Safety,and EfficacySources:Ministry of Health and Asian Development Bank assessment team.Pre-marketingPoint of entryDuring procurementPost-marketing product registration prequalification facility inspectionand licensing surveillance facility monitoring eligibility criteria

176、quality certifications identifying falsified and substandard products quality testingQualitySafetyEfcacyFindings13(iii)laboratory testing of random batch samples,mandatory for new suppliers and manufacturers;(iv)microbiological tests and pharmacological tests for selected pharmaceutical products;(v)

177、prepurchase and/or preshipment testing by an independent or WHO-recognized laboratory;and(vi)postshipment laboratory testing of random batch samples and locally sourced products.5.1.1 QualityQuality assurance refers to systems for monitoring and taking action to ensure that pharmaceutical products i

178、n the distribution system meet specified quality standards;and for detecting,evaluating,and preventing product-related quality problems.The National Medicines Regulatory Authority was established as the responsible authority to conduct postmarketing surveillance on quality,safety,and adverse reactio

179、n to the medicines;on medical devices;and on oversight of import(see footnote 4).At present,quality assurance is mostly limited to analyzing test samples of medicines provided by suppliers at the time of applying for registration.A limited practice of testing of random samples taken from the market

180、for postregistration testing has also been observed.However,due to limited capacity and human resources,NMRA cannot fully perform a more proactive and premarketing quality assurance role to prevent substandard and falsified medical products from entering the supply chain.Concerns have emerged that t

181、he quality assurance gap may create the possibility of entry of substandard and falsified medicines to the market,which in the longer term may erode public confidence in the quality of medicines,especially those dispensed through the public health care institutions.As mentioned,NMQAL conducts limite

182、d postmarketing quality tests for mostly the products submitted for registration and products with complaints.Table 3 presents the quality assurance-related decisions made by NMRA from 2021 to 2023.Table 3:Quality Decisions by the National Medicines Regulatory Authority,20212023202120222023Batch or

183、product withdrawn424460Batch or product withheld202834Revoked22100Discontinued141Total858695Source:National Medicines Regulatory Authority.14Pharmaceutical Supply Chain Assessment for Sri LankaThe NMRA particularly the NMQAL have been suffering from severe staff shortages.The NMRA reported that it w

184、ould require over 500 staff to be able to perform its role comprehensively and at full capacity.However,the current total number of cadres for NMRA approved by the Department of Management Services is 269.Against these requirements,NMRA currently has only 127 existing cadre including 112 permanent c

185、adre and 15 MOH employees.16The NMQAL is particularly hardest-hit and has been running at 25%required staff positions(only11staff are currently available)as no staff recruitment has taken place since 2015.Thelaboratory facilities of NMQAL need to be upgraded and the building needs to be renovated to

186、 support testing activities that meet aspects of good laboratory practices as well as quality assurance of test results.The staff competency needs to be strengthened to assure the quality of the testing results.Also,NMQAL needs to be ISO-certified and prequalified by WHO to gain recognition as a nat

187、ional testing control laboratory.(i)Premarketing quality assurance.At present,premarketing quality assurance in SriLanka mostly relies on the certificate of product registration with NMRA and licensing of manufacturing facilities.Ensuring product quality during procurement was not carried out or was

188、 compromised in some cases of emergency procurement especially in 2022/2023.As the procurement agent of the MOH,SPC is also not conducting prequalification at the manufacturer level for all its procurement,and point-of-entry quality check is not adequately practiced.It has been reported that quality

189、 issues in some medicines were not detected until after most of the batch had already been distributed and even used.(ii)Quality assurance of donated products.Another area of quality concern is that during the economic crisis period,medicines received through donations from other countries and priva

190、te organizations or individuals were supplied to hospitals without the required regulatory oversight and quality assurance.In some instances,product labeling regulations had been violated,where the labeling had been in a different language,making it very difficult for doctors and nurses to identify

191、and confirm the medicine being administered to patients.Insome cases,stocks of expired or short-expiry medicines,those that were not needed,andinappropriate dosage forms were received as donations.17Although there are medicines donation guidelines developed by the WHO18 and adopted in SriLanka for p

192、harmaceutical donations,it seems these guidelines were not followed in receiving manydonated medicines during the economic crisis period.16 Government of SriLanka,Department of Management Services.2024.Quarterly Cadre Information Sheet.5 June.17 SriLanka Association of Clinical Pharmacology and Ther

193、apeutics.Evidence Synthesis on Essential Medicines Policy Reform Options for SriLanka.World Health Organization(Project No.2022/1279296-0).18 WHO.2011.Guidelines for Medicine Donations Revised 2010(accessed January 2024).Findings155.1.2 SafetySafety focuses on minimizing the risks associated with th

194、e use of medicines and involves a system for detecting,evaluating,and preventing drug-related adverse reactions known as pharmacovigilance.According to a WHO Global Benchmarking Assessment(2019),19 NMRA has an organization chart that includes the Pharmacovigilance Division with allocated human resou

195、rces but the roles and responsibilities of the staff members responsible for pharmacovigilance are not appropriately defined.A general SOP for pharmacovigilance exists;however,not all processes are described.TheQuality Management System is not well implemented for pharmacovigilance,although the NMRA

196、 has initiated the Quality Management System in other functions.The staff development and training plans are in the development stage and a communication plan needs to be developed.As seen in Table 4,pharmacovigilance reporting was extremely low in 2021 and 2022.In 2023,the reporting numbers improve

197、d due to an effort by NMRA to promote pharmacovigilance reporting including reporting via electronic means.A total of 300 adverse events out of the total 335 reports were analyzed for causality in 2023.19 Source:WHO.2019.Benchmarking of the National Regulatory Authority(NRA)GBT.Rev VI,ver.1.SriLanka

198、.20 Government of SriLanka,Ministry of Health.2012.National Guidelines on Immunization Safety Surveillance:Surveillance of Adverse Effects Following Immunization.Table 4:Pharmacovigilance Reports Received and Analyzed by the National Medicines Regulatory AuthorityPeriodNo.of Reports ReceivedNo.of Re

199、ports AnalyzedPercentage of AnalysisJanuaryDecember 20213131100JanuaryDecember 20221313100JanuaryOctober 202333530090Source:National Medicines Regulatory Authority.The current practice related to pharmacovigilance is based on spontaneous reporting of adverse events by the treatment providers.The cha

200、llenge with a spontaneous reporting system is low reporting and lack of a denominator to analyze the reports and detect the“signals”needing required actions.There is no targeted spontaneous or active surveillance system in place for pharmacovigilance of new and high-risk medicines.In February 2024,t

201、he country took the initiative to report to the WHO Programme for International Drug Monitoring(Uppsala Monitoring Centre)for Pharmacovigilance.As of March 2024,the country was not using any digital information system for reporting and analyzing adverse drug reactions and adverse events except an ad

202、verse event following immunization(AEFI)database for vaccines managed by the Epidemiology Unit.20 16Pharmaceutical Supply Chain Assessment for Sri Lanka5.1.3 EfficacyEfficacy indicates the ability of a medicine to produce the desired therapeutic effect under specific conditions.While NMRA considers

203、quality,safety,and efficacy of a medicine during registration,countries maintain an EML based on efficacy and cost-effectiveness to limit the variations in prescribing and product selection within the same therapeutic group.Although SriLanka has an EML that was introduced by MOH,there is no health t

204、echnology assessment unit to support evaluation of efficacy and cost-effectiveness of medicines listed in the Essential Medicine List.There is no dedicated technical unit to take care of the EML apart from MSD hosting the secretariat of an EML technical committee.In SriLanka,the national procurement

205、 list of medicinal products is developed by the National Drugs and Therapeutics Committee composed of relevant experts as well as the Director General of Health Services.However,there are no standardized terms of reference for the National Drug Therapeutic Committee to implement national medicine po

206、licies.It was reported that decisions pertaining to the requirement of medicines were often taken by the Formulary Revision Committee through the National Procurement List.This missed the opportunity for a detailed assessment of therapeutic efficacy and cost-effectiveness of medicines by relevant ex

207、perts before a medicine was included in the national procurement list.5.2 Appropriate Use of Medical ProductsAppropriate use of medical products refers to the judicious and responsible utilization of safe,high-quality,and efficacious medications and other medical products in a manner that aligns wit

208、h established clinical guidelines and patient-specific considerations.Service providers prescribing medicines are expected to follow rational prescribing,use generic names and standard treatment guidelines to avoid poly pharmacy,brand preference,and overprescribing.A desk review on the availability

209、of national treatment guidelines that have been reviewed or updated within the past three years or since 2021 finds the guidelines to be limited(Table 5).Implementation of the national treatment guidelines is not being monitored in a systematic manner.Likewise,development of these guidelines is ad h

210、oc and there is no dedicated unit or institute taking care of treatment standards.Currently,there is no systematic mechanism to promote or monitor the rational use of medicines.There are no prescription audits carried out and rational prescribing is not always practiced due to poor training and limi

211、ted awareness on national treatment guidelines.In the absence of strict implementation of national treatment guidelines,prescribing patterns differ among specialists even in the same field,generating the need for a wide variety of medical products to be procured.Findings17Table 5:Last Update Dates o

212、f Some Sample National Treatment GuidelinesNational Treatment GuidelineUpdating EntityLast UpdatedGuidelines on Management of Dengue Fever and Dengue Hemorrhagic Fever in Children and AdolescentsSriLanka College of Pediatricians2012Diabetes Mellitus Management GuidelinesSriLanka College of Endocrino

213、logists2018The Guideline Use of AntiretroviralDrugs for Treating andPrevention of HIV InfectionNational STD AIDS Control Programme,Ministry of Health,SriLanka2014National GuidelineFor Management of HypertensionFor Secondary and TertiaryHealth Care LevelDirectorate of Non-Communicable Diseases,Minist

214、ry of Health2021Source:From a review of National Treatment Guidelines.Box 1 summarizes the quality,safety,and efficacy issues besetting the pharmaceutical supply chain in SriLanka.Box 1:Key Gaps Identified in Quality,Safety,Efficacy,and Appropriate Use Need for an institutionalized regular mechanism

215、 to review,revise,and approve clinical standards and national treatment guidelines.Quality assurance activity could be more comprehensive in addition to testing samples for product registration and samples with complaints.Post marketing surveillance does not test adequate number of samples due to th

216、e capacity constraint of National Medicines Regulatory Authority and National Medicine Quality Assurance Laboratory.Inadequate pre-marketing quality assurance mechanism hinders the prevention of substandard and falsified medical products entering the supply chain The National Medicines Regulatory Au

217、thority and National Medicine Quality Assurance Laboratory cannot function optimally due to shortage of trained staff.No digital information system is used for collecting,storing,and analyzing pharmacovigilance reports.Rational prescribing based on the principles of limiting prescription variations,

218、selecting products based on therapeutic efficacy and cost-effectiveness,and ensuring rational use of medicines are not adequately practiced.Source:Asian Development Bank assessment team.18Pharmaceutical Supply Chain Assessment for Sri Lanka5.3 AccessAccess comprises availability,accessibility,afford

219、ability,and acceptability(Figure 4).5.3.1 AvailabilityAvailability involves the consistent presence of quality-assured medicines and other medical products in health care settings,ensuring a stable supply to meet the demand.Out of the 108 patients who responded during the patient satisfaction survey

220、s conducted from September to November 2023,45.4%reported nonavailability of one or more prescribed medicines at the health facility.For the health facilities assessed during the same period,in response to the question if all essential medicines(according to National Formulary Revision 2019)were ava

221、ilable at the health facility,only 11.5%of total 78 responses said yes(Figure 5).Figure 4:Current Ministry of Health System for Ensuring the Access of PharmaceuticalsSources:Ministry of Health and Asian Development Bank assessment team.Available at pointof care servicedeliveryNetwork ofgovernmenthea

222、lth facilitieswith minimumdistance to point-of-careFree of chargemedicines atgovernmenthealth facilitiesOccasionalpatientsatisfactionsurveysAvailabilityAccessibilityAfordabilityAcceptabilityFindings19In contrast to these findings,previous studies on the availability of essential medicines in SriLank

223、a,ingeneral,showed good availability and access to medicines.21While there were pervasive product availability issues,there were still some issues related to products expiring on the shelf without being consumed.Table 6 presents an analysis of data on product expiry cases captured from the medical s

224、upply management information system(MSMIS)used prior to June 2023 and the new system,Swastha is a Sanskrit word meaning“health and well-being.”launched from June 2023.22 Results show that the total value of reported health commodity loss due to expiry in the 12 months period starting from 1 November

225、 2022 to 31 October 2023 was 4,064,170,083Sri Lankan rupees(SLR)or around$12,418,401.23 However,more than two-thirds value of this expiry was related to COVID-19 commodities,which had a short shelf life.21 B.M.R.Fernandopulle et al.Patient Experiences of Access to NCD Medicines in SriLanka:Evidence

226、of the Success Story Towards Universal Coverage.Medicine Access Point of Care;WHO.2015.Medicines in Health Care Delivery:SriLanka Situational Analysis.22 MSMIS-SWASTHA is an integrated electronic health records and logistics management information system introduced in 2023 to replace the MSMIS(Pront

227、o).MSMIS(Pronto)was introduced in 2015 to link MSD with SPC,RMSDs,hospitals,and selected provincial hospitals.23$1=SLR327.27 as of 30 October 2023(source:poundsterlinglive).Figure 5:Availability of Medicines at Point of Care as Reported by Patients and Facilities,2023 Note:Data collected through the

228、 facilities assessment questionnaire and patient satisfaction surveys.020406080100%of patients that receivedall prescribed medicines%of facilities that reported availabilityof all essential medicinesYesNo20Pharmaceutical Supply Chain Assessment for Sri LankaTable 6:Value of Health Commodity Loss Due

229、 to Expiry,November 2022October 2023CategoryItem%ExpiredValue of Expired Lots (SLR)Value of Expired Lots ($)COVID-19COVID-19 Vaccines68.92,800,363,8358,556,739COVID-19COVID-19 Tests3.4137,860,046421,243 Value of Total COVID-19 ProductsExpired72.32,938,223,8818,977,981Non-COVID-19Expired at RMSD1.352

230、,937,940161,756Expired at Other Facilities26.41,073,008,2623,278,664Value of Total Non-COVID-19 Products Expired27.71,125,946,2023,440,420Total Value of Expired Products100%4,064,170,08312,418,401COVID-19=coronavirus disease,MSMIS=Medical Supply Management Information System,RMSD=regional medical su

231、pply division,SLR=Sri Lankan rupee.Note:$1=SLR327.27 as of 30 October 2023(source:poundsterlinglive).Source:Analysis of data from SWASTHA and MSMIS(Pronto).Table 7 provides further analyses of percentage of stock value lost due to product expiry excluding COVID-19 items.Table 7:Percentage of Product

232、 Value Lost(excluding COVID-19 items)Due to Expiry,November2022October 2023Place of ExpiryValue of TotalStock (SLR)Value of Total Stock ($)Total Value of Expired Items (SLR)Total Value of Expired Items ($)Portion of Expired Value (%)MSD14,597,544,16944,603,979000.0Facilities17,458,538,46753,345,9791

233、,125,946,2023,440,4206.4Total32,056,082,63697,949,9581,125,946,2023,440,4203.5COVID-19=coronavirus disease,MSD=Medical Supply Division,MSMIS=Medical Supply Management Information System,SLR=SriLankan rupee.Note:$1=SLR327.27 as of 30 October 2023(source:poundsterlinglive).Source:Analysis of data from

234、 SWASTHA and MSMIS(Pronto).Among non-COVID-19 expired items,the five top value items that expired at facilities were Hemofiltration Solution 5-liter bag for continuous renal replacement therapy machines,Metaraminol injection 10 milligram(mg)in 1 milliliter(ml)ampoule,Flumazenil injection 500microgra

235、m(mcg)in 5ml vial/ampoule,strips for cholesterol meter,and nucleic acid extraction kits.On the other hand,thetop five high-value items that expired at the RMSD level were Cefuroxime Sodium injection 250mg vial,Dried Factor VIII fraction 200IU-350IU vial,strips for cholesterol meter,sodium chloride f

236、or IVuse 0.9%,and Flumazenil injection 500 mcg in 5ml vial/ampoule.Findings21It is noted that no items expired at the MSD level as MSD usually transfers items that are close to expiry to RMSD and health facilities.However,the percentage of stock value lost due to the items expired at the drug stores

237、 of the health care facilities was 6.4%of the total stock value at the facilities.While product expiry during the COVID-19 pandemic was exceptional,expiry of non-COVID-19 items indicates potential issues related to product selection,minimum stock requirement for procurement,inaccurate forecasting,ov

238、erstocking,stock imbalance,and poor management of stocks.5.3.2 Service Delivery and AccessibilityAccessibility encompasses the ease with which individuals can obtain medicines and pharmaceutical services.Accessibility is closely linked with the service delivery system through the organization of int

239、erconnected facilities,transport,processes,and information flows to ensure the cost-effective and efficient delivery of products or services where they are needed.SriLanka has set up an excellent health service delivery network for curative and preventive services with a total 1,159healthfacilities

240、and 354MOH areas across the country(Table 8).24 L.Rajapaksa et al.2021.SriLanka Health System Review.World Health Organization Regional Office for South-East Asia.Table 8:Number of Health Facilities in SriLanka,2020Level of CareHealth Facility TypeNumber of HospitalsLine MinistryProvincial MinistryT

241、otalTertiary Care National hospital 2 02Teaching hospital10 010Specialized teaching hospital6 06 Other specialized hospital8 4 12 Provincial general hospital2 02 District general hospital13 6 19 Secondary Care Base hospital Type A 6 3036 Base hospital Type B144 45Primary Care Divisional hospital Typ

242、e A1 6566 Divisional hospital Type B1146 147Divisional hospital Type C1271 272Primary medical care unit8534 542TOTAL591,1001,159Source:Government of Sri Lanka,Ministry of Health.2020.Annual Health Bulletin 2020.This network has brought the government health services within a 5-kilometer average prox

243、imity to the population.2422Pharmaceutical Supply Chain Assessment for Sri Lanka5.3.3 Affordability and FinanceAffordability is ensuring that the cost of medicines is reasonable and within financial reach for individuals and health systems irrespective of their economic standing.The Government of Sr

244、iLanka is committed to offer free health services and medications to its people.Thus,all prescribed medicines are offered free of charge at the point-of-care of the government health facilities,making access to medicines very affordable to SriLankans.Sri Lankas health system is designed in such a wa

245、y to make sure that health care users receive required medicines free of charge through the public procurement system.Yet 34%of out-of-pocket expenditures for health are spent for pharmaceuticals.25 Possible reasons for out-of-pocket expenditures for pharmaceuticals include preference for obtaining

246、services in the private sector,lackof availability of prescribed medicines at the government facility,brand preference among patients and medical professionals,and high pharmaceutical costs at the private facilities.According to the National Health Accounts,the SriLankan government allocates$8 perca

247、pita for the procurement of pharmaceuticals.26 Figure 6 presents the annual revised budget for pharmaceutical procurement segregated by disbursement entities,i.e.,SPC,SPMC,MSD,and hospitals.Historically,all pharmaceutical procurements were 100%covered by domestic sources in Sri Lanka although with i

248、ssues related to lack of timely payment to all suppliers.However,the economic crisis and the resulting shortage of foreign currency in 2021 and 2022 led to major gaps in the flow of funds for ordering the pharmaceuticals.As a direct result,the pharmaceutical supply chain was severely 25 WHO.2023.Acc

249、ess to Medical Products in the South-East Asia Region.26 Government of SriLanka,Ministry of Health.2022.National Health Accounts SriLanka 2017&2018.Human Resource Management Coordinating Unit.Figure 6:Annual Pharmaceutical Procurement Budget,20202023 (SLR billion)MSD=Medical Supplies Division,SPC=St

250、ate Pharmaceutical Corporation,SPMC=State Pharmaceutical Manufacturing Corporation,SLR=Sri Lankan rupee.Source:Ministry of Health.14012010080604020020202021SPC20222023SPMCMSD and hospitalsTotalFindings23affected,as availability of foreign currency was not predictable during this period.The country h

251、ad to postpone and cancel many procurements and there was a significant backlog payment to be cleared.According to the Auditor Generals Special Report,the total amount payable to suppliers and banks by 20 April 2022 for medical supplies ordered by SPC from the local market was around SLR4.3billion(a

252、pproximately US$15 million)and the MOH owed around SLR35 billion(approximately US$115million)to SPC until 2023.27Further,to address the“emergency”situation of nonavailability of pharmaceuticals,emergency procurement procedures were utilized using the donor-financed funds that were made available fro

253、m 2022 onward.By 2023,an unprecedented 46.6%of the pharmaceutical procurement budget came from foreign sources.5.3.4 AcceptabilityAcceptability refers to acknowledging cultural,social,and patient-specific factors that may influence the willingness of individuals to accept and adhere to prescribed me

254、dicines.Even though 45.4%of patients interviewed mentioned lack of one or more prescribed medicines at the health facility they visited,thanks to convenient access and free health service,74%patients expressed high satisfaction and 14%expressed moderate satisfaction with the pharmaceutical services

255、they received.Figure 7 shows the results of patient satisfaction from 108 responses when patients were asked“Ona scale of 1 to 10,how satisfied are you with the overall pharmaceutical services you received at this health facility?(1 being very dissatisfied and 10 being very satisfied).”27 Government

256、 of SriLanka,Office of the Auditor General.2022.Auditor Generals Special Report on Procedures Taken to Avoid the Shortage of Pharmaceuticals in Government Hospitals by 13 May 2022.Figure 7:Patient Satisfaction with Pharmaceutical Services (N=108)Note:1=very dissatisfied and 10=very satisfied.Source:

257、Data collected through the patient satisfaction surveys.010203040%10(0)0(0)1(0.9)1(0.9)11(10.2)7(6.5)8(7.4)31(28.7)27(25.0)22(20.4)234567891024Pharmaceutical Supply Chain Assessment for Sri LankaAbout 79%of patients interviewed,however,reported that they experienced some delay in receiving their med

258、icines from the health facility they visited.The waiting time ranged from 30 minutes to 5hours with a median of 23 hours.When patients were asked“Did the health care staff provide clear instructions on how to take your medications?”,most patients(93%)responded“No.”These findings show that patients w

259、ere not receiving adequate instructions on the medication they received.Thiscould lead to an unknown proportion of wastage of drugs that can lead to reduced acceptance of the care received.Hospital quality management units are expected to carry out patient satisfaction surveys regularly that assess

260、pharmacy service as one component.All institutions visited were unable to show data on those surveys specifically aiming at pharmacy service.Box 2 summarizes the issues confronting access in SriLankas pharmaceutical supply chain.Figure 8:Patients Perception on Waiting Time and Instructions Received

261、(%)Source:Data collected through the patient satisfaction surveys.1009080706050403020100YesNoExperience long waiting timeReceived clear instructions on medicationBox 2:Key Identified Gaps in Availability,Accessibility,Affordability,and Acceptability Frequent stock out of priority medicines 3.5%of to

262、tal stock(excluding COVID-19 items)was lost due to product expiry Around 47%of current health expenditure is out-of-pocket expenditure.34%of out-of-pocket expenditure is spent on pharmaceuticals High waiting time for obtaining pharmaceutical services at hospitals Inadequate instructions provided to

263、patients during dispensingCOVID-19=coronavirus disease.Source:Asian Development Bank assessment team.Findings255.4 Pharmaceutical Supply Chain ManagementThe procurement and supply chain management system of MOH can be broken down into eight segments(Figure 9):product selection,qualification,procurem

264、ent,storage,transportation,end use information,waste disposal,and drug resistance monitoring.Figure 9:Procurement and Supply Chain Management System of the Ministry of HealthAMR=antimicrobial resistance,MSD=Medical Supplies Division,RMSD=Regional Medical Supplies Division,SPC=State Pharmaceutical Co

265、rporation.Sources:Ministry of Health and Asian Development Bank assessment team.Sent by health facilitiesand consolidated by MSDCentral procurement bySPC and MSDProduct selection initiatedby hospitals andconsultant physiciansNational AMR Planin placeStorage by MSD,RMSD,and healthfacility drugstoresT

266、ransportation by MSDfleet and RMSD vehiclesConducted undersupervisionThrough electroniclogistics managementinformation systemQuantificationProcurementProduct SelectionStorageTransportationDrug ResistanceMonitoringWaste DisposalPharmaceuticalSupply ChainManagementEnd UseInformation26Pharmaceutical Su

267、pply Chain Assessment for Sri Lanka5.4.1 Product SelectionProduct selection refers to selecting products and dosage forms for essential pharmaceutical product lists and deciding which products will be available at each level of the health system.Thecountry procured 1,028 items in 2023,including 850

268、items from the Priority List dated 4 April 2023.28 Besides the listed stock items and named patient items in the 2023 priority list,the country needed to procure 178 additional items based on clinical consultants requests.There is a lack of written policies and criteria for selecting products beyond

269、 the EML.Selecting products not included in the EML also indicates missed opportunities for product selection optimization by limiting treatment variations and consolidating total demand for a therapeutic class.5.4.2 QuantificationForecasting and supply planning,which is also referred to as quantifi

270、cation,is the process of determining the quantities and timing of supply of products needed to satisfy future demand through scientific and systematic methods.The MSD uses a“pull system”each year to ask for estimates from all hospitals and health facilities and then validates and collates them to de

271、velop national annual estimations.Item lists received from health facilities are examined by the specific stock control officer and the assistant director of MSD for list deviations,unrealistic estimations,andapproval from institutional national drug and therapeutic committees.According to the Manua

272、l on Management of Drugs,29 the estimation process begins in August of the current year(year 1)with the preparation of institutional estimates for the next year(year 2).Institutions send their estimates by October of the current year(year 1)to MSD,which consolidates the estimates,forecasts the annua

273、l requirements,and places the orders with the SPC by January of next year(year 2).Orders requested for year 2 are scheduled to be supplied during year 3(Figure 10).28 Government of SriLanka,Ministry of Health.2023.Priority List for PharmaceuticalsTotal 850 Items.Circular No.01-14/2023.4 April.Medica

274、l Supplies Division.29 Government of SriLanka,Ministry of Health and Nutrition.2008.Manual on Management of Drugs.Second Revision.Figure 10:Forecasting,Procurement,and Supply Cycle in Sri LankaMSD=Medical Supplies Division,SPC=State Pharmaceutical Corporation.Sources:Ministry of Health and Asian Dev

275、elopment Bank assessment team.AugustOctober:Institutions sendestimatesOctoberJanuary:MSD consolidatesand forecasts annualrequirementsJanuary:MSD placesorders with SPCYear 1STEP 1STEP 2STEP 3STEP 4Year 2Year 3FebruaryDecember:SPC conductsprocurementQuarter 1:Supplies receivedby MSDand are distributed

276、to institutionsFindings27As illustrated in Figure 10,due to long forecasting and procurement lead times,there are mismatches between the forecasting and receiving supply(quantities forecast for year 2 are received in year3),and between budget and procurement cycle(budget for year 2 is used for recei

277、ving items in year 3).Themismatches and long lead time make it extremely challenging to enhance forecast accuracy.The whole process of consolidating the estimates and placing orders for procurement takes around 6months and involves pharmacy staff from all health facilities and around 60 stock contro

278、l officers at MSD.Although consumption data is available at the central level,data analytics is not systematically used.There are no systematic methods or tools used for forecasting and supply planning,and estimation is often based on a mere 10%15%increase from the previous years order.Table 9 provi

279、des the percentage of estimate over consumption for a set of 13 vital and 25 most used products from 2019 to 2022.Table 9:Percentage of Estimate Over Consumption of Tracer Products,20192022ItemShare(%)2019202020212022Amoxicillin capsule 250 mg127180346110Hydrochlorothiazide tablet 25 mg114132164143F

280、urosemide(Frusemide)tablet 40 mg141136159185Prazosin tablet 1 mg128135206235Enalapril tablet 5 mg147153163166Losartan Potassium tablet 50 mg126133147126Glyceryl Trinitrate tablet 0.5 mg170178181166Amlodipine Besylate tablet 5 mg110131165214Nifedipine Extended-Release tablet 20 mg130159157152Aspirin

281、Enteric coated tablet 75 mg165187170242Clopidogrel tablet 75 mg111161153179Streptokinase injection 1,500,000 IU20851321580Atorvastatin tablet 10 mg122140154112Tenecteplase injection 40 mg vial183236227209Paracetamol tablet 500 mg124185257154Sodium Valproate tablet 200 mg124178163303Sodium Chloride f

282、or Intravenous Infusion 0.9%w/v,500 ml bottle124181167152Dextrose/Glucose injection 5%w/v 500 ml Bottle141254189191Folic Acid tablet 1 mg157154155144Disposable intravenous solution giving sets for single use139204179192Salbutamol(Albuterol)tablet 2 mg11516526092Beclomethasone dry powder capsule 400

283、mcg115149197245continued on next page28Pharmaceutical Supply Chain Assessment for Sri LankaItemShare(%)2019202020212022Cetirizine tablet 10 mg147159194142Chlorphenamine(Chlorpheniramine)tablet 4 mg116158238120Adrenaline and/or Epinephrin injection 1 mg/1 ml ampoule134168151130Anti-Rabies serum injec

284、tion 1,000 IU in 5 ml ampoule245206209242Gliclazide tablet 40 mg123192177152Metformin tablet 500 mg130141155170Thyroxine tablet 50 mcg172201142148Hydrocortisone Sodium Succinate for injection 100 mg vial12722422990Prednisolone tablet 5 mg120163250111Domperidone tablet 10 mg121173180159Omeprazole cap

285、sule or tablet 20 mg109141172119Diclofenac tablet 50 mg141310239178Atropine Sulphae injection 600 mcg in 1 ml ampoule152176189166Suxamethonium(Succinylcholine)Chloride injection 100 mg in 2 ml ampoule159180201168Dantroline Sodium injection 20 mg vial200252149188Average141186191164IU=international un

286、it,mcg=microgram,mg=milligram,ml=milliliter.Source:Data captured in SWASTHA and MSMIS.It can be noticed that except for a few products where the estimations were lower than actual consumption,in general,estimations were 10%413%higher than the consumption.The mean variations between the forecast and

287、actual consumption for the set of tracer products presented above indicate an opportunity for efficiency gain through better quantification practices using data analytics and other scientific methods.5.4.3 ProcurementProcurement refers to the activities associated with acquiring products or services

288、,including procurement planning,sourcing,contract management,receiving,and quality assurance in procurement in line with procurement laws,policies,and regulations.(i)Procurement by State Pharmaceutical Corporation The SPC manages sourcing,price negotiation,purchasing,and importation of medical produ

289、cts.SPC purchases products from suppliers and manufacturers with funds received directly from the government Treasury,then settles with the MOH with an additional service charge.Table 9 continuedFindings29The approach of SPC to procurement is guided by both the National Procurement Agencys 2006 gene

290、ral government standard procurement guidelines,and the 2006 and 2022 Guidelines for Procurement of Pharmaceuticals and Medical Devices.30 Although the guidelines for procurement of pharmaceuticals asks for prequalification of suppliers and allows flexibility as required by framework agreements with

291、flexible quantities and staggered delivery,SPC solely depends on traditional procurement methods including international competitive bidding,restricted bidding,and direct quotations.It was observed that SPC maintains prequalification only for multisource products for restricted bidding cases and rar

292、ely conducts postqualification of suppliers.(ii)Procurement from State Pharmaceutical Manufacturing Corporation and LocalManufacturersAs mentioned earlier,SPMC enjoys the first right to supply of medicines to MSD.There are 15 other private,registered manufacturers in the country participating in a“b

293、uyback”agreement,in which prices for all products are set at a 20%markup over the manufacturing cost.Prices for medicines purchased from SriLanka-based manufacturers are set in negotiations among the MOH,Ministry of Trade and Industry,SriLanka Pharmaceutical Manufacturers Association,NMRA,and SriLan

294、ka Standards Institute,MSD and SPC inputs.For products manufactured by SPMC,MSDis authorized to negotiate and purchase directly if SPMCs unit price is lower than the unit price received in the previous tender for the product.It has been noted that using the first right to supply,SPMC forms joint ven

295、tures with local and international manufacturers with local operations to supply medicines to MSD.Although SPMC does not add any value in the joint ventures arrangement,they charge 6%mark-up for the commodities supplied under the joint ventures.Local manufacturers have raised the concern that the fi

296、rst right to supply by SPMC and joint ventures arrangements are distorting a level playing field and fair market competition.Some local experts also said that government should evaluate if the buyback agreement is being implemented as intended.(iii)Urgent(Emergency)Procurement“Urgent procurement”is

297、used when there are unforeseen shortages,most often due to quality problems with purchased products.This method allows the government to source“very limited quantities”of an item to cover the gap until the normal supply can be resumed.This approach can also be used on a case-by-case basis for indivi

298、dual patients facing a grave or life-threatening situation.The urgent or emergency procurement is also used when an emergency has been declared by the government due to disasters or disease outbreaksand for the procurement of single-source products.30 Government of Sri Lanka,National Procurement Age

299、ncy.2006.Guidelines for Procurement of Pharmaceuticals and Medical Devices;Government of SriLanka.2022.Guidelines for Procurement of Pharmaceutical and Medical Devices of a Consumable Nature.30Pharmaceutical Supply Chain Assessment for Sri LankaAlthough the urgent procurement method should be the ex

300、ception,frequent use of urgent procurement was observed during the economic crisis period.This reiterates concerns that urgent procurement methods might have been misused in cases of administrative failures other than real emergencies,asregular procurement processes were often delayed or postponed l

301、eading to a situation of perpetual emergency to be able to use the urgent procurement methods.(iv)Local PurchaseThe hospitals purchase out-of-stock and urgently needed items at the local level after approval by the hospital administration and MSD.During October 2022September 2023,the total value of

302、local purchase by hospitals for this 12 months was estimated to be only 1%of the total procurement value of the country,which is much lower than the current share.When asked if the facility did any local purchase of medicines over the past 12 months,only 9 facilities(11%)out of 79 facilities intervi

303、ewed reported any local purchase.Table 10 presents the list of items procured locally by hospitals and their price comparison with international reference prices.Table 10:Prices of Items Locally Procured by HospitalsItemUnit Price(SLR)Unit Price($)International Reference Price(SLR)International Refe

304、rence Price($)Share of International Reference Price (%)Fluorouracil1,0003.1N/AN/AN/ADocetaxel4,75014.512,96039.637Irinotrican3000.91,8465.616Amiodorone injection1,1503.53201.0360Sodium bicarbonate injection5501.715714.835Dextrose 25%690.2N/AN/AN/ATranexam injection3,75011.51,6965.2221Dobutamine inj

305、ection9602.93481.1276Vasoprasin injection1,4004.3N/AN/AN/AMedizolam injection8822.7N/AN/AN/AMarcain injection8952.7N/AN/AN/AHydrating wound set4,31713.2N/AN/AN/AParacitic acid9,50029.0N/AN/AN/AMetachlopramide injection1000.3N/AN/AN/AIron Sucrose injection1,6335.01,7565.493Clarithromycin syrup8962.78

306、582.6104Ondantrecvin injection1300.41120.3116N/A=not available,SLR=SriLankan rupee.Note:$1=SLR327.27 as of 30 October 2023(source:poundsterlinglive).Source:Data collected through the facilities assessment interviews.Findings31(v)Procurement Price,Lead Time,and On-Time DeliveryTable 11 presents the t

307、otal number of procurement orders to be delivered by SPC,SPMC,and MSD from 1 November 2022 to 31 October 2023,actual number of orders delivered,and percentage of international reference price paid for the top 15 20 items based on volume,unit cost,and procurement value.Table 11:Procurement Performanc

308、e and Prices for the Orders to Be Delivered,November 2022October 2023SPCSPMCMSDTotalNumber of orders due for delivery198289431918Number of orders delivered130141202473Share of orders delivered66%49%47%52%Average no.of days from order placement to delivery(for the items delivered)532251241324Mean sha

309、re of international reference price paid for top1520 high-volume procurement99%68%53%58%Mean share of international reference price paid for top1520 high-unit-price procurement208%256%86%206%Mean share of international reference price paid for top1520 high-value procurement146%92%102%115%MSD=Medical

310、 Supplies Division,SPC=State Pharmaceutical Corporation,SPMC=State Pharmaceutical Manufacturing Corporation.Source:Analysis of data captured in SWASTHA and Medical Supply Management Information System.During the economic crisis,MSD and SPC had to extend,postpone,or cancel orders frequently to deal w

311、ith the foreign currency shortage.Only around 52%of orders placed were delivered(and not necessarily on-time and in-full)according to the delivery schedule.The price variations compared to international reference prices indicate that the country achieved economies of scale by pooling public sector d

312、emand and centrally procuring medicines in bulk.However,the central procurement did not result in cost saving for procuring high-unit-price and low-volume products.Also,for the locally produced high-unit-price and low-volume items,the prices were significantly higher than the international reference

313、 price,indicating a lack of economies of scale in producing those items locally for a small market.The nonbulk purchase of named patient drugs by SPC incurred high administrative burdens and did not achieve any economies of scale.5.4.4 Storage and Transportation(i)Warehousing and Inventory ControlWa

314、rehousing refers to maintenance of storage conditions,including cold chain maintenance from port of entry to end user.It also includes infrastructure facilities and effectiveness of inventory management system.There are nearly 20 bulk warehouses and 5 cold rooms in the MSD central medical stores,32P

315、harmaceutical Supply Chain Assessment for Sri Lankaproviding storage facilities for pharmaceuticals,surgical and medical devices,laboratory chemicals and devices,diagnostic agents and devices,radioactive items,narcotics,and printed forms.Furthermore,there are three bulk warehouses at Angoda,five at

316、Wellawatta,one at Digana,and one at Welisara.Thecurrent MSD store capacity is 35,932 cubic meters.31Additionally,MSD has a network of 26 regional warehouses(RMSDs)at the district level.These are managed by the provincial councils of SriLankas nine provinces,which supply the items to health instituti

317、ons.Each institution has a main drugstore and sub-stores in the indoor and outdoor dispensaries to provide the wards,clinics,and outpatient departments with their requirements.As can be seen in the result of good storage practice status assessment of pharmaceutical stores in Appendix 2,93%of facilit

318、ies had their storage secured under lock and key;98%of the facilities followed“First Expiry First Out”method to rotate their stock;and 80%conducted regular stock count.However,91%of the facilities did not specify designated areas for different functions of store management;98%didnot have any smoke d

319、etector,fire alarm,and fire safety equipment in place;and 91%did not have any bin cards attached to the stack of products.For a few facilities visited by the assessment team,facilities were asked about the reason for not having a bin card.Facilities mentioned that it was not necessary as they had th

320、e information in the SWASTHA electronic system.However,while checking the SWASTHA,the information was not updated.This indicates a weakness in physical inventory management deviating from good storage practices.Most of the stores throughout the supply chain did not maintain basic storage requirement

321、s,with 82%of the facilities reporting that they did not follow any policy for minimum and maximum stock of a product to prevent stockout or overstocking.Using scoring for fully observed,partially observed,and unobserved practices for the 82 stores assessed against 25 criteria provided in Appendix 2,

322、mean percentages of good storage practices were calculated.Table 12 provides a summary of store conditions observed.31 M.D.A.Krishanth,I.M.S.M.Rajakaruna,and K.E.S.Fernando.2023.Sensible Factors that Need Strategic Change to Improve the Medical Drug Availability across Healthcare Institutions in Sri

323、Lanka.International Journal of Current Science Research and Review.6(7).pp.4721472.Table 12:Good Storage Practices MaintainedFacility TypeNo.of Stores AssessedMean%of Good Storage Practice ObservedMedical Supplies Division Central270Regional Medical Supplies Division170Tertiary care hospitals563Base

324、 hospital A565Base hospital B369District hospital A1060District hospital B1558District hospital C1951Primary medical care unit2257TOTAL8258 Source:Analysis of data from store assessment visits.Findings33Overall,58%of health institutions with good storage practices indicate ample room for improvement

325、.Especially,most of the stores need to install temperature monitors,smoke detectors,fire alarms,location labels,bin cards,and stock cards.Staff need to be trained in good storage and distribution practices.(ii)Transportation to Dispensing FacilitiesTransportation refers to the movement of supplies t

326、hrough a network of transportation and transit points from warehouses to end-users.MSD mostly follows the current administrative network of central,provincial,and district level facilities and transports commodities accordingly.The distribution system is mostly reactive as to receiving and rationing

327、 supplies and a“pull system”is used when requests are made by line ministry institutions and RMSDs to the MSD to arrange dispatch of items.It was observed that vaccines cold chain was well ensured throughout the supply chain with the use of temperature-controlled refrigerators and carrying boxes(sup

328、ported by UNICEF).However,for other medicines requiring cold chain,there is a risk of breakage of the cold chain during transportation and storage.Currently,MSD has a fleet of 34 vehicles of which only 50%had air conditioners and around 60%of the air conditioners required repair.More than one-third

329、of the vehicles were more than 30 years old and around one-fourth of the vehicles were not in running condition(under repair).This indicates a serious issue of transporting pharmaceuticals and other medical products in suboptimal and nontemperature-controlled conditions with possible effect on quali

330、ty,safety,and efficacy of medicines.The RMSD also reported transport delays due to the limited number of trucks at RMSD.As a result,the receiving facilities often needed to arrange their own transport to pick up supplies from MSD or RMSD.Due to uncertainty in procuring and receiving commodities,tran

331、sport schedules were organized on an ad hoc basis requiring more trips than ideally required in an organized fleet management and distribution system.Out of the facilities surveyed,only 15%of orders were delivered on time and in full.Table 13 shows the details of number of items requested by health

332、facilities from MSD or RSMD and number of items received on-time and in-full during the past 12 months.Table 13:On-Time and In-Full Delivery to Health FacilitiesType of FacilityNo.of ResponsesNo.of Items OrderedNo.of Items ReceivedOTIF Delivery(%)Tertiary care73,14657518Base hospital A692000Base hos

333、pital B319200District hospital A102612811District hospital B1071223333District hospital C12537163Primary medical care unit223988922Total706,16694115OTIF=on time and in full.Source:Data collected through the facilities assessment questionnaire and onsite visits.34Pharmaceutical Supply Chain Assessment for Sri Lanka5.4.5 End Use Information and Digital Information Systems(i)Logistics Management Info