Questionnaires for Partners English Version 19 June 07, Ghana Field Testing 2

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2 Questionnaires for Partners English Version 19 June 07, Ghana Field Testing 2

3 Questionnaire for Mapping Partners and Financial Flows to Support Medicines Procurement and Supply Management Systems in the Public Health Sector Questionnaire No 1: PARTNERS Country: Name of Partner/Donor or Program: Person Interviewed/Completed the questionnaire: Position: Date: Address: Tel: Fax If there are different focal persons in your organization managing different product categories please complete one questionnaire for each product category. In this case, also provide the following information: Name of program to which product category belongs Name of focal person in the organization. Name of person interviewed.. The mapping of the procurement and supply management system will be on the following category of products : 1. Essential Medicines and medical supplies including : 2. HIV/AIDS medicines 3. Antimalarial 4. TB medicines 5. Medicines for opportunistic infections 6. Pediatric formulations for HIV/AIDS and malaria 7. Vaccines 8. Contraceptives 9. Condoms 10. Medical supplies 11. Reagents for blood safety including HIV test Questionnaires for Partners English Version 19 June 07, Ghana Field Testing 3

4 1. Which of the following category of products are being supported by this organization in procurement and supply management of essential medicines and medical supplies? For each product category, please state the starting year, when it is foreseen to end, if support is technical or financial and type of financial support. Category of Products Yes No Starting Year Year foreseen to end Support State type of support (Financial, technical, others..) State type of financial support ( loan, grant, donation others..) Questionnaires for Partners English Version 19 June 07, Ghana Field Testing 4

5 2. List in the table below the amount spent in 2006 and budget allocation for 2007 for the procurement of medicines and supplies in each product category, Pleases specify the main products financed in each program component. Category of Products Amount Spent in 2006 (USD) Allocated Budget for 2007(USD) Suppliers International supplier International manufacturer Local Distributor Local Manufacturer US$ (2006) US$ (2006) US$ (2006) US$ (2006) 3. The products to be procured in each product category are selected by: a The Donor Agent Yes No.. b The Ministry of Health Yes No.. c The Program Manager Yes No.. d Others (please specify) Yes No 4. Who is responsible for the quantification of needs a. The Donor Agent Yes No.. b The Ministry of Health Yes No.. c The Program Manager Yes No.. d. The central medical stores Yes No.. e Others (please specify) Yes No 5. Which of the following criteria is considered for procurement of medicines and medical supplies: a Procurements are limited to products on the EML Yes No. b. Procurements are made on the basis of a plan Yes No.. c. Procurements are made according to needs Yes No

6 6. Do you belong to a working group in the country that coordinates procurement activities? Yes No.. If yes, which of the following leads this working group? a. Ministry of Health Yes No b. UNICEF Yes No c. World Bank Yes No d. WHO Yes No e. UNDP Yes No f. Others(Please specify) 7. How often does this working group meet? Monthly Quarterly Yes No Yes No 2 times a year Yes No Yearly Yes No Others (Please specify) 8. Which of the following Agencies are responsible for the procurement (preparing tender and awarding contract) of products financed by this partner? a. Ministry of Health Yes No. b. Central Medical Store Yes No c. Privately contracted Agent Yes No d. The organization itself Yes No e. Others (Please specify) Yes No 9. Do you as a partner organization have a specific policy for the procurement of essential medicines and medical supplies? Yes No 10. If yes, Which of the following criteria are considered in procuring products? a. WHO pre-qualified suppliers and products Yes No b. Products registered in the country of origin Yes No c. Products registered in the importing country Yes No d. Others (Please specify) 11. Who is responsible in making an order for products financed by you as partner? a. Ministry of Health Yes No b. A procurement agent (UNICEF etc) Yes No c. World Bank Yes No English version 08 July 07 TCM/MPM 6

7 d. The Partner Yes No e. The CMS Yes No f. Others (Please specify) 12. Which of the following criteria are used to monitor supplier performance? a. Products received conform to what was ordered Yes No.. b. Delivery dates are respected Yes No c. Storage conditions during transportation are respected Yes No. d. Rapidly address problems identified during procurement Yes No. e. Others (Please specify) If yes, provide copy of SOP for procurement 13. Are samples systematically taken from batches procured and sent for quality analysis? Yes No 14. If yes, to which of the following laboratories are the samples sent?: a. National Quality Control Laboratory (NQCL) Yes No. b. Regional Quality Control Laboratory (RQCL) Yes No c. Laboratory in Donor country (LDC) Yes No d. Others(please specify) (0) Yes No 15. Has your organization as a Partner provided special tools to manage the following: a. Daily dispensing Yes No.. b. Delivery/receipt of products Yes No.. c. Discrepancy report Yes No.. d. Expired products Yes No.. e. Inventory Control Yes No.. f. Issue Voucher Yes No.. g. Requisition form Yes No.. h. Stock card Yes No.. i. Others (Please specify) 16. Which of the following structures is responsible for the distribution of products procured by you as a Partner? a. Ministry of Health Yes No English version 08 July 07 TCM/MPM 7

8 b. Central Medical Store Yes No c. Privately contracted Agent Yes No d. The Partner itself Yes No e. Others (Please specify) Yes No 17. Does the procurement plan consider some budget allocation for the following activity areas? No Activity area Yes No If Yes, Budget in (US$) A B C D E F Medicines & medical supplies distribution Warehousing and storage Remuneration for warehousing staff Staff training for supply chain management Computerization of inventory control Quality Control English version 08 July 07 TCM/MPM 8

9 18. Delivery Points: Indicate for each product category supported by your organization which of the following is the first, second and third points of deliveries of products after procurement? a Central Medical Stores (CMS) b. Regional Stores (RS) c. District Stores (DS) d. Health facility (HF) e. Others (Please specify) Category of Products First Point of delivery Second Point of delivery Third Point of delivery English version 08 July 07 TCM/MPM 9

10 Questionnaire for in-depth Assessment of Medicines Procurement and Supply Management Systems including financial flows in the Public Health Sector No 2 Questionnaire: MINISTRY OF HEALTH Country:... Address : Tel/Fax/ . Name of Minister :.. Name of Director of Pharmacy and laboratories : List of assessors : Surname/First name Structure/Function Tel : List of persons interviewed : Date of interview Surname, first name of person interviewed Function Tel : Note: The assessment of medicines procurement and supply management system will be on the following category of products : Essential Medicines and medical supplies including : HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives English version 08 July 07 TCM/MPM 10

11 Condoms Medical supplies Reagents for blood safety including HIV test A. STRUCTURE A.1. Is there a central medical stores(cms) for the public sector? Yes No A.2. If yes, what is the name of the CMS A.3. Statute and date of creation of CMS (Please attach organizational structure) a. State structure Yes No Date of creation :... b. Public for profit organization Yes No Date de creation :... c. Non-governmental Organization Yes No Date de creation :... d. Others (Please specify) Yes No Date de creation :... A.4. What are the core functions of your central medical stores? a. Selection b. Quantification c. ordering d. ware housing e. Distribution f. others, please specify A.5. The CMS is responsible for the procurement of which of the following categories of products? Category of Product Yes No Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines English version 08 July 07 TCM/MPM 11

12 Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits Others (please specify) A.6. Does the central medical store have autonomous management? Yes No : A.7. Which other structures at the central level are involved in the procurement of medicines and medical supplies? Ministry of Health Structures Yes No Product Category HIV/AIDS Program Malaria Program TB Program EIP Family Planning Program Private wholesalers (give name and nos.) Faith-based organization Partners (UNDP, USAID, MSF etc Others, please specify If no, who is responsible for the activity A.8. Does the central medical store (CMS) have Regional stores? Yes No A.9. If yes, what is the statute and how many? Statute Yes No Numbers Area (S) Branch of the central medical stores Structure of Regional Health Ministry Branch of private wholesalers Branch of Faith Base structure English version 08 July 07 TCM/MPM 12

13 Other, specify A.10. Do the regional medical stores have autonomous management? Yes No : A.11. Are there medical stores at the district level? Yes No A.12. If yes, what is the statute and the number of district depots? Statute Yes Not Numbers Branch of the central medical stores Structure of Regional Health Ministry Branch of private wholesalers Branch of Faith Base structure Other, specify A.13. Do the district depots have autonomous management?. Yes No A.14. State for each level, the number and type of health facility involved in the dispensing of medicines and medical supplies: Level Central Regional District Health Facilities/Dispensaries Others, please specify Public: Type & number of facilities (eg UTH..) Private: Type & number of facilities (e.g clinics, dispensaries) Faith Based: Type and number of facilities(e.g. hospital, dispensary) Civil Society Type and number of facilities Others, specify A.15. Is there a law which imposes on all public health facilities to procure medicines from the national public supply system? Yes No English version 08 July 07 TCM/MPM 13

14 If yes, attach a copy A.16. If not, and in case of stock-out in the national system, health facilities are authorized to procure from which of the following suppliers? a. Private wholesalers Yes No... b. Private pharmacies Yes No... c. Faith-based structures Yes No... d. Local manufacturers Yes No... e. Local distributors Yes No.. f. International manufacturers Yes No.. g. International distributors Yes No.. h. Others, please specify Yes No.. A.17. Is the public procurement system decentralized? Yes No A. 18. If yes, for which category of products and what levels are decentralized procurement authorized? Level Category of Products Central( UTH.) Regional Store Regional facilities District ware house District facilitie s Health facilitie s Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives English version 08 July 07 TCM/MPM 14

15 Condoms Medical supplies Reagents for blood safety including HIV test kits A 19. Decentralized procurement is authorized at which of the following suppliers? a. Private wholesalers Yes No.. b. Private pharmacies Yes No... c. Faith-based structures Yes No... d. Local manufacturers Yes No... e. Local distributors Yes No.. f. International manufacturers Yes No.. g. International distributors Yes No.. h. Others, please specify Yes No o.. A 20. Which of the following financing mechanism is available to support procurement of medicines and medical supplies? a. State budget Yes No.. b. Cost recovery (out of pocket) Yes No... c. National Health insurance Yes No... d. Communal insurance Yes No... e. Private insurance Yes No.. f. Donor support Yes No.. h. Others, please specify Yes No.. English version 08 July 07 TCM/MPM 15

16 A. 21. Please state the various sources of financing available to the CMS for the procurement of each category of the following products? Give expenditures in 2006, the budget for 2007 and the type of financing: English version 08 July 07 TCM/MPM 16

17 Category of Products Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Sources of Funds (Government, Global Fund, MSF ) 2006 Expenditure US$ 2007 Budget US$ % budget increase Reagents for blood safety including HIV test Type of financing (Drug revolving Fund, Loan, grant, subsidy ) English version 08 July 07 TCM/MPM 17

18 kits A.22. Is available funding adequate for procurement of forecasted quantities? Yes Non A.23. If not, for what reasons? a. Insufficient government allocations for procurement of medicines Yes No Yes No. b. Delay in the release of government budget Yes No... c. Inadequate funding from partners Yes No... d. Delay in the release of funds from partners Yes No.. e. Inadequate capital for the CMS Yes No... f. Others, specify Yes No... B. SELECTION OF PRODUCTS B.1. Are there Essential Medicines Lists (EML) Yes No B.2. If yes, please specify the last date of review (attach copy). B.3. Which of the following categories of products are included in the EML: Please state the number of products by category and by type of structure Product category Yes No No. of No of Products Products UTH Region al Hosp District Hosp Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Health centre English version 08 July 07 TCM/MPM 18

19 Condoms Medical supplies Reagents for blood safety including HIV test Others, specify Total number of products in the EML B.4. Are there Standard Treatment Guidelines (STG)? Yes No B.5. Are there specific Treatment Guidelines for the following? (Attach copies) a No STG Yes No N/A Date of last Review Anti-retroviral Therapy in adult b c d e f Anti-retroviral Therapy in children Treatment of malaria Treatment of Tuberculosis Treatment of opportunistic infection Others (Please specify) B.6. Is there a national committee for the development of the EML Yes No B.7. If no, what is the process of selecting medicines for the EML? B.8. At what levels are the STG and EML distributed? Level of Facility Central Regional District EML STG Yes No Yes No English version 08 July 07 TCM/MPM 19

20 Health facility Private clinics Faith based Others, specify B.9. Is there a National Medicines Policy (NMP) document? B.10. Is government procurement limited to medicines on the EML? Yes No B.11. Is there a National Policy for medicines donation? Yes No B.12. If yes, are procurements for donations limited to the EML? Yes No C. QUANTIFICATION/FORECASTING C.1. Which department or service is responsible at the national level for the quantification of needs for the following category of products? Please specify for each category of products the department or facility involved in the quantification Product category Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test Department/Facility responsible for quantification Qualification of staff (medical doctor, nurse etc) C.2. Is there a procurement plan? Yes No English version 08 July 07 TCM/MPM 20

21 If yes, provide a copy and answer questions C6 to C8 If no, skip to questions in section D C.3. C.4. C.5. Is there a committee responsible for the development of the procurement plan? Yes No If yes, attach list of members... Does the national procurement plan include medicines and supplies financed by partners? NA... Yes No Is there a mechanism in place to coordinate procurement among the various partners? Yes No... If yes, briefly state the mechanism C.6. Which of the following information is provided by in national procurement plan? Information provided in the national procurement plan Description of products Category of products (ARVs, Antimalarial.) Corresponding programs (HIV/SIDA, malaria ) if it exists Origin of the funds (government, partners ) Average monthly consumption Available stock Forecasted needs Budget estimates Structure/department responsible for the procurement Necessary procurement process Structure responsible for placing of order Delivery schedule (e.g 1x, 2x ) Delivery period (lead time) Recipient of funds from partners (govt, CMS etc ) Others, to specify Yes No English version 08 July 07 TCM/MPM 21

22 D. PROCUREMENT D.1. Is there a code for public tender? Yes No... D.2. If yes, which is the procurement method defined by this code and criteria of choice? Tender Process International competitive bidding Selective bidding (suppliers pre-selected) Negotiated tender National competitive bidding Direct procurement Others (specify) Ye s No Criteria used in the choice of each method (e.g amount procured, monopoly..) D.3. Does the code for public tender defines the type of contract to be signed with the suppliers for essential medicines and medical supplies D.4. If yes, what type of contract is offered to the suppliers? a. Contract on basis of purchase order Yes No b. Installment Delivery Contract Yes No c. Others, specify Yes No D.5. Which structure is responsible for award of contract for procurement of medicines and medical supplies for public health facilities? Give the composition of commission. Public Procurement structures Ministry of Health Central Medical Stores Structure responsible for award of contract National commission for public tenders Tender's board for the CMS Regional commission for public tenders Others, specify English version 08 July 07 TCM/MPM 22

23 Programs (HIV, Malaria, TB ) Health facility or decentralized depots D.6. Is there a standard reference at national level with regard to technical specifications for the procurement of medicines and medical supplies? If yes, attach a copy Yes No D.7. State in US$ the amount of contract awarded in 2006 by each of the following structures for procurement of medicines and medical supplies: a. Ministry of health b. Central medical stores. c. HIV/AIDS program.. d. Malaria program. e. TB program. f. EIP Program.. g. Family Planning Programme D.8. What duties (taxes, customs duties ) are paid in the following category of products: Product category Essential Medicines List of taxes, duties, taxes etc.. Percentage HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms English version 08 July 07 TCM/MPM 23

24 Medical supplies Reagents for blood safety including HIV test E. STORAGE/ STOCK MANAGMENT E.1. What is the volume of medicines and medical supplies procured in 2006?... Public Procurement structures No. 40 ft container No 20 ft container Volume m3 by sea freight Vol m3 by air freight Others, specify Ministry of Health Central Medical Stores HIV/AIDS program Malaria program TB program EIP Program Family Planning Programme HIV/AIDS program Malaria program Others, specify E.2. Are donations from partners limited to the NEML? Name of the partner Donations limited to the NEML Yes No Sometimes If no, what are the reasons? E.3. Is there adequate storage capacity for forecasted quantities of medicines and medical supplies at the following levels? Level (country to define adequacy) Adequate storage capacity English version 08 July 07 TCM/MPM 24

25 Central Regional District Health Facility Yes No E.4. Are there adequate storage conditions for medicines and medical supplies at the following levels? Level Central Regional District Health Facility Adequate storage capacity Yes No E.5. Did the Ministry of Health experience stock out of essential products in 2006? No Yes If yes, which products and explain briefly the reasons and period of stock out. F. DISTRIBUTION F.1. Are there regulations defining good distribution practices? Yes No F.2. Is distribution done on a Push basis? Yes No F.3. Is the distribution of products coordinated? Yes No F.4. If not which of the following categories of products have specific distribution systems: Category of Products Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Existence of a specific system Yes No In case of Yes, give name of Partner and briefly describe the distribution system English version 08 July 07 TCM/MPM 25

26 Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits G. QUALITY ASSURANCE SYSTEM G.1. Which of the following criteria are used to ensure the quality of medicines procured? a. Products registered in the country Yes No b. Products from pre-selected suppliers Yes No c. Products pre-qualified by WHO Yes No d. Products registered in a country with high pharmaceutical regulation (ICP/ICH Yes No e. Others Yes No G.2. Is it obligatory that samples of each batch procured are systematically taken for quality control analysis? Yes No... G.3. Where have the above samples (see G.2) been tested? a. The quality control laboratory of the CMS Yes No B. The government quality control laboratory Yes No C. Sub-regional quality control laboratory Yes No D. An external laboratory Yes No G.4. Are the laboratories used for the quality control of products? English version 08 July 07 TCM/MPM 26

27 a. Pre-qualified by WHO? Yes No b. Accredited in accordance with the ISO17025 or EN45002? Yes No c. Accepted by a Regulatory Authority ICP/ICH Yes No G.5. Is there a team of pharmaceutical inspectors at the MOH? Yes No G.6. If yes, are inspections routinely carried out? G.7. How many pharmaceutical inspections have been carried out?... G.8. Please specify for each level if inspections of the following activities are carried out: Activities Levels Central Central Medical stores Regiona l Regiona l stores District District stores Health Facilitie s Yes/No Verify Good Storage Practices If yes specify how many inspections and results in 2006 Take samples for quality control analysis If yes, specify the number of samples and % result that did not conform to quality standard in 2006 Verify Good Distribution Practices If yes, specify number of inspection carried out in 2006 and important resultants. G.9. If regular inspections are not carried out, what are the reasons? a. Lack of inspectors b. Lack of finances c. Lack of vehicles d. Others, please specify. English version 08 July 07 TCM/MPM 27

28 G.10. Is there a Pharmacovigilance system? Yes No.. G.11. If yes, is it functional? Yes No.. G.12. How many reasons for alert were registered in 2006? Number Reasons for alert H. RATIONAL USE H.1. Are prescribers trained on Rational Use of Medicines? Yes No.. If yes, number of prescribers trained in H.2. Are pharmacists and logistics management staff trained on good stock management practices? Yes No.. If yes, number of staff trained in 2006 H.3. Are pharmacists and logistics management staff trained on Good dispensing practices? Yes No.. If yes, number of staff trained in 2006 I. FINANCING I.1. Is there budgetary allocations for medicines distribution and stock management in the government budget allocated for the procurement of medicines and medical supplies? Yes No.. If yes, what percentage of the drug budget? I.2. Is the State budget for the procurement of medicines and medical supplies allocated directly to the following? Yes No.. a. Programs b. Central medical stores c. Health facilities d Others, please specify. English version 08 July 07 TCM/MPM 28

29 I.3. Where cost recovery is involved, is there a national pricing policy defining mark ups on sales prices at each level Yes No.. If yes attach a copy I.4. In case of cost recovery, please specify for each level where revenues from sales of medicines and medical supplies are deposited Bank Accounts Levels Public Treasury account Private bank account Management committee of health facility Others, specify Central Medical stores Regiona l Regiona l stores District Yes/No District stores Health Facilities J. INFORMATION MANAGEMENT J.1. Is a national medicines management information system (MMIS)?.. Yes No J.2. If not, which procedure is used to obtain and validate the data necessary for quantification?... J.3. If yes, what logistics information is monitored at each level? Information monitored Levels Quantities received Average monthly consumption Expiry Stock on hand Central Medical stores Regiona l Regiona l stores District Yes/No District stores Health Facilities English version 08 July 07 TCM/MPM 29

30 Expiry dates Others, specify J.4. Are there reports available on logistics information systems? No.. Yes J.5. If yes, at what frequencies are reports submitted to the hierarchy? Trace the flow of reports with frequency. J.6. What is the approximate percentage of reports received on time at the following levels? a. Central level.. b. Regional level.. c. District level. If the results is less than 100%, explain why. K. MONITORING AND EVALUATION K.1. If a national plan for procurement exists, does the MOH monitor that procurement conforms with the plan? Yes No.. If yes, at what frequency?... K.2. Is there a national system for monitoring of the health system? Yes No.. K.3. If yes, is the monitoring of procurement included in this system? If not, why?... K.4. At what levels are monitoring visits carried out and at what frequency? a. Central level.. Yes No Frequency. b. Regional level.. c. District level. e. Health facility level K.5. Is the schedule for monitoring respected Yes No.. K.6. If not for which of these reasons? a. Lack of supervisors English version 08 July 07 TCM/MPM 30

31 b. Lack of finances c. Lack of vehicles d. Others, please specify.. K.7. Which of the following activities are carried out during supervision visits?. Activities Levels Central Medical stores Regiona l Regiona l stores District Yes/No District stores Health Facilities Review of need quantification Review of ordering process Checking the conditions of storage Physical inventory Checking stock cards and reports Monitoring financial Need assessment to improve performance Training Others, specify K.8. Which performance indicators for procurement are regularly evaluated at the Ministry of Health? Performance Indicator Yes No % availability No of stock out days % expiry % products not in conformity Customer satisfaction Others, specify L. HUMAN RESOURCES L.1. State the numbers per category of professional staff involved in procurement and supply management of medicines. Specify if the number is adequate. English version 08 July 07 TCM/MPM 31

32 Professional Levels category Central CMS Regional Regional stores Pharmacist Medical doctor Medical assistant Nurse Computer specialist Administrative officer Other, specify District District stores Health facilities L.2. Has initial training been offered the staff involved in procurement and supply management Yes No :... L.3. Is regular continuous training offered to staff involved in procurement and supply management? Yes No : English version 08 July 07 TCM/MPM 32

33 Questionnaire for in-depth Assessment of Medicines Procurement and Supply Management Systems including financial flows in the Public Health Sector N 3 Questionnaire: Programs Country:... Name of Central medical stores: Adress : Tel/Fax/ . Name of Program Manager:.. Qualification of Manager:. List of assessors : Surname/First name Structure/Function Tel : List of persons interviewed : Date of interview Surname, first name of person interviewed Function Tel : English version 08 July 07 TCM/MPM 33

34 Note: The assessment of medicines procurement and supply management system will be on the following category of products : Essential Medicines and medical supplies including : HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test A. STRUCTURE A.1. What is the starting date of program (Please attach organization structure) A.2. What are the functions of the central medical stores of the program? A.3. Which of the following categories of products are managed by the Program? Category of Product Yes No Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits Others (please specify) If yes which one? English version 08 July 07 TCM/MPM 34

35 A.4. Is the program responsible for the following activities? If the activities performed are dependent on the product, please specify the category of products relevant to each activity Product selection Activities Yes No Product Category Quantification of needs Procurement (arranging call for tenders etc) Making orders Storage Stock management Distribution Dispensing Others, specify If no, who is responsible for the activity A.5. Does the Program have Regional offices?. If yes, how many?... Yes No B. SELECTION OF PRODUCTS B.1. Is the Essential Medicines List available at the Program level Yes No If yes, please specify the last date of review... B.2. Is there a Standard Treatment Guideline for the program? If yes, please specify the last date of review... B.3. Does the program limit procurement to the NEML? Yes No Yes No B.4. If not, arrange in order of priority the three main reasons for which the Program procures out of the NEML? Reasons for procuring out of the NEML Ye s No Ranking of priority (No 1 is the most English version 08 July 07 TCM/MPM 35

36 a. Limiting procurement to the NEML is not defined in the pharmacy law b. The last version of the NEML is not available c. The NEML has not been revised and does not conform with recent STG d. The NEML does not address local need or demand e. The prescribers are not familiar with the STG f. The prescribers do not agree with the STG g. The products on the NEML are not available from the suppliers (CMS, regional warehouse, district warehouse ) h. Others (Please specify) important and 3 the least) C. QUANTIFICATION/FORECASTING C.1. Who is responsible for quantifying the needs of the program? Product category Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test Staff responsible for quantification Qualification of staff C.2. Which of the following information is used in need quantification for medicines and other medical supplies? If the information used pertains to a specific product, please specify the category of product. English version 08 July 07 TCM/MPM 36

37 Information used in the quantification of needs Available finances Consolidating decentralized forecasts or quantification Consolidating distribution data (issue data at each level) Demographic data or disease prevalence/morbidity Dispensed-to-user data ( consumption) Donations provided by partners/donors Seasonal and regional variations Standard Treatment Guidelines (STG) Stock on hand at all level Stock out duration The expiry dates of stock on hand Others (please specify) Ye s No Category of products C.3. Are any of these tools employed in the quantification of medicines and medical supplies? (Quantimed, Esther software, management software, support manual..) Yes No If yes, indicate in the table what specific tool is used for each category of product Product Category Tools Used Developed by Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits C.4. Over what time period are needs for medicines and medical supplies quantified? If the period varies with the category of please specify the product accordingly. English version 08 July 07 TCM/MPM 37

38 Quantification Period Yes No Product Category Yearly Every 2 years Every 3 years Others (pleasy specify) C.5. Is there a procurement plan? Yes No If yes, provide a copy and answer questions C6 to C8 If no, skip to questions in section D C.6. C.7. Is there a committee responsible for the development of the procurement plan? Yes No If yes, attach list of members... Does the procurement plan include medicines and supplies financed by partners? Yes No NA... C.8. If yes, is there a mechanism in place to coordinate procurement among the various partners? Yes No... If yes, briefly state the mechanism D. PROCUREMENT Answer questions D1 through D16 only if the program is responsible for procurement (organization of tenders...), otherwise go on to question D17 D.1. Who is responsible in the program for the procurement of the following category of products? Product category Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for Staff responsible for procurement Qualification of staff English version 08 July 07 TCM/MPM 38

39 HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits D.2. In the table below, indicate the criteria that determines each tender process chosen. State the percentage of procurement in 2006 for each tender process. Tender Process Ye s No Criteria used in the choice of each method (Cost of procurement, monopoly, process imposed by partners, emergency etc ) % Procurement in 2006 International competitive bidding Selective bidding (suppliers pre-selected) Negotiated tender National competitive bidding Direct procurement Others (specify) D.3. What is the average lead time for each of the following tender process? : Tender Process International competitive bidding Selective bidding (suppliers pre-selected) Negotiated tender National competitive bidding Direct procurement Others (specify) Average lead time in days (from the publication of tender to signing a contract with the supplier) D.4. What type of contract is offered to the suppliers? a. Contract on basis of purchase order Yes No b. Installment Delivery Contract Yes No English version 08 July 07 TCM/MPM 39

40 c. Others, specify Yes No D.5. Has the Program an SOP/document for call of tender specific for the procurement of medicine and medical supplies? Yes No... If yes, attach copy D.6. Is there pre-selection of suppliers by the Program? Yes No If yes, attach a copy of document on pre-selection process D.7. Which of the following Incoterms are used for contracting procurement? If Incoterm varies with category of product, specify accordingly in the table Incoterm Yes No Category of Product FOB (Free On Board) Free carrier CIF (Cost Insurance and Freight) DDU (Delivered Duty Unpaid) DDP (Delivered Duty Paid) Others, please specify D.8. Arrange in the order of priority the three main criteria considered in awarding contracts? Criteria for award of contract Quality of product Performance of supplier Price Stated delivery time (lead time) National preference Supplier terms of payment (100% in advance, 100% after delivery..) Impact on bulk procurement Supplier quotations Others, please specify Yes No Order of priority (No 1 is the most important to 3 the least) English version 08 July 07 TCM/MPM 40

41 D.9. Are the criteria for contract award clearly defined in an SOP/tender documents? Yes No... D.10. Is there a technical committee to analyse tenders? Yes No.... If yes, attach list of members D.11. Is the award of tender done by a committee? Yes No D.12. If yes, which of these? a. National Commission for Public Tenders? Yes No b. Tender 's Board for the Program? Yes No c. Others (please specify) Yes No d. Please specify the composition of the commission D.13. Are the procurement prices compared to standard reference prices? Yes No.... If yes, which standards? D.14. Are the results of the tender published? Yes No D.15. What is the frequency of procurement? If the period varies with the category of products, please state the product category accordingly. Frequency of procurement 2 times a year 1 time a year Every 2 years Others, specify Yes No Category of Product D.16. State in US$ the contract award in 2006 for each category of product at the various suppliers mentioned in the table below: (Put No/NA where applicable) Sources of Procurement Category of Products International International Local Local Others English version 08 July 07 TCM/MPM 41

42 supplier manufacturer Distributor Manufacturer Specify US$ US$ US$ US$ US$ Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits D.17. What are the purchased prices to the Program in 2006 for the following products? No Tracer Products Purchase price to Program English version 08 July 07 TCM/MPM 42

43 19 20 English version 08 July 07 TCM/MPM 43

44 E. ORDERING Answer questions E1 through E9 only if the programme is responsible for order placement, otherwise go on to section F. E.1. What is the frequency of for orders at the Program? If the frequency varies according to the product, specify the category of the product concerned Frequency of orders Yes No Category of product Quarterly Semi-annual Annual According to the needs Others, to specify E.2. What is the average lead time for deliveries by suppliers through the following routes? a. By sea... b. By air... c. By land. E.3. How far is the Program store (in km) from the following? a. The airport... b. The sea port... c. Other point of delivery (border) E.4. What is the average time it takes to remove products from the following? a. The port?... b. The airport?... c. The border?... E.5. Which are the major problems encountered during the removal of products from: a. the sea port b. the airport c. the border? E.6. What is the average time it takes to transport products to the Program store from the following: a. The sea port b. The airport c. The border E.7. Is the performance of the supplier monitored? Yes No... E.8. If yes, which of these performance indicators are evaluated? a. Products delivered conforms to the order Yes No.... English version 08 July 07 TCM/MPM 44

45 b. Respect of agreed delivery time schedule Yes No.... c. Respect of storage conditions Yes No..... d. Quality of service after sales Yes No... e. Others, please specify Yes No... E.9. What was the volume of medicines and medical supplies imported in 2006 for the Program? Volume of Imports in 2006 Number of 40 feet containers Number of 20 feet containers Volume in m3 for the maritime or surface shipping Volume in m3 by airfreight Others, specify F. STORAGE/ STOCK MANAGMENT Answer questions F1-F10 only if the Program has specific storage facility for its products. If not go to section G F.1. What is the storage capacity in cubic meters at the CMS?... F.2. Is there adequate storage capacity for forecasted quantities of medicines and medical supplies? Yes No... F.3. Are there clearly defined and separated areas in the store for the following: Storage area Yes No Reception of products Quarantine of products Storage of dangerous products Product requiring cold chain <8 C Main storage Products returned from customers Expired/damaged products Delivery of products Products from various partners Others, specify F.4. Are storage conditions of the central medical stores in conformity with the following? English version 08 July 07 TCM/MPM 45

46 Conditions of storage Yes No NA There is a method in places to control Temperature The windows can be opened or vents are available No direct sunlight on products Area is free from moisture Products are not stored directly on the floor Storage equipment is available Adequate storage equipment There is cold chain storage with temperature chart Products are stored in a systematic way (alphabetical, galenic form ) There is no evidence of pest in the area The doors to the store have adequate locks and keys Security measures are in place to avoid burglary (guard, ) F.5. Which of the following stock management techniques are used in the Program? If a technique is used specifically for a product, specify the category of the product. Techniques of stock management Yes No Category of product Stock cards are available Specific supports stock management tools exists for products financed by the partners (if so, name the partner and attach a copy) The distribution of products is done on basis of first expired, first out The traceability of the batches is assured Minimum stock level (threshold of alarm) is defined, if yes specify the equivalent in month of stock Maximum stock levels are defined, If yes specify the equivalent in month of stock The replenishing of stocks is done when the minimum stock level is reached English version 08 July 07 TCM/MPM 46

47 Stocks are renewed on scheduled dates Renewal of stock is based on another method, specify F.6. At what intervals are inventory controls carried out? Specify the category of the product if the frequency varies according to the product Frequency per Yes No Category of products year Once Twice Thrice Others, specify F.7. For the following tracer products, what is the % of availability and the average number of stock out days in 2006 No Tracer Products Availability in % Number of stock out days F.8. From the following proposals, rank the 3 main causes of stock out in the Program : English version 08 July 07 TCM/MPM 47

48 Causes of stock out Yes No Ranking of priority (No 1 is the most important to 3 the least) Delay in delivery Quantities delivered not in conformity with quantities ordered Transport means not available Funds not available for the order Stock cards are not up to date Minimum and maximum stock levels not regularly updated Error in forecasts No stock control Insufficient staff Unqualified staff Others, specify F.9. Percentage of products that expired in the Progam in 2006?... (value of expired products/value of stock) x100 F.10. From the following proposals, arrange in order of priority the main causes of expiry: Causes of Expiry Non respect of the rule first expired, first out Error in the forecasts None compliance to the STG by prescribers Modification of the STG in the course of the financial year No stock control Insufficient staff Unqualified staff Others, specify Yes No Order of priority (No 1 is the most important to 3 the least) English version 08 July 07 TCM/MPM 48

49 If the central medical stores manages donations from partners, answer the following question: F.11. Are donations from partners limited to the NEML? Name of the partner Donations limited to the NEML Yes No Sometimes If no, what are the reasons? G. DISTRIBUTION G.1. Which of the following structures are responsible for the distribution of medicines and medical supplies from the Program to customers? Specify the number for each type of structure Type of structure Yes No Number The programme ensures distribution/dispensing Central medical store Structures at central level (Teaching hospital, national laboratories...) Regional stores Regional structures (Regional Hospital, Regional Health Direction...) District stores District structures (District hospital, Divisional Health Office...) Health facilities (health centres...) Private wholesalers Private pharmacies Faith-based structures Non-governmental Organizations Others, specify English version 08 July 07 TCM/MPM 49

50 If the program itself insures the distribution/dispensation of the products of the program, answer questions G2 through G8, otherwise go on to G9 G.2. Which of the following method is used for the distribution of medicines and medical supplies from the CMS to customers? If the method of distribution varies according to the product, specify the category of product concerned. Methods of distribution Yes No Category of product On the basis of a schedule for distribution Distribute according to the orders received Ensure delivery to the customers The customers collect the products by their own means Others, specify G.3. What is the frequency of distribution? If the frequency varies depending on the customer and the product, specify the type of customer and the category of product concerned. Frequency Yes Not Type of customer Upon request Weekly Twice/month Monthly Quarterly Other, specify Category of product G.4. Is transportation managed by a private company? Yes No..... If yes, give name of the transporter and level of performance... G.5. If no, what is the number, the type and the capacity of the vehicles available to the central medical stores? Number of vehicles Type of vehicle Capacity of the vehicle in m3 English version 08 July 07 TCM/MPM 50

51 G.6. Has the CMS adequate number of vehicles to pick up and distribute medicines and medical supplies? Yes No.... G.7. In general, are orders delivered to customers within the deadlines? Yes No.... G.8. If not, arrange in order of priority the 3 main problems encountered during the delivery/pick up of medicines and medical supplies? Problems encountered Yes No Order of priority Lack vehicle Poor condition vehicles High cost of transport No driver Poor road network Dangerous road network Long distance to cover Climatic problems Others, specify (No 1 is the most important to 3 the least) G.9. Is there a specific distribution system for products financed by partners? Yes No... G.10. If yes, which of the following categories of products have a specific system of distribution? Category of Products Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Existence of a specific system Yes No If yes, briefly describe the system of distribution English version 08 July 07 TCM/MPM 51

52 Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Medical supplies Reagents for blood safety including HIV test kits H. QUALITY ASSURANCE SYSTEM Answer questions H1 through H7 only if the programme is responsible for procurement, otherwise go on to H8 H.1. Which of the following criteria are used to ensure the quality of medicines procured? a. Products registered in the country Yes No b. Products from pre-selected suppliers Yes No c. Products pre-qualified by WHO Yes No comments d. Products registered in a country with high pharmaceutical regulation (ICP/ICH Yes No e. Others Yes No H.2. Among the following products bought in 2006, to which quality standards did they conform? No Tracer Products Quality standards (e.g NDRA, WHO prequalified etc English version 08 July 07 TCM/MPM 52

53 H.3. Are samples of each batch procured systematically taken for quality control analysis? Yes No... H.4. If yes, what is the percentage of registered products that did not comply in 2006?... H.5. What are the main causes of nonconformity?... H.6. H.7. Which structure is used for the quality control of products procured? a. The quality control laboratory of the CMS Yes No B. The national quality control laboratory Yes No C. Sub-regional quality control laboratory Yes No D. An external laboratory Yes No Is the laboratory used for the quality control of products? a. Pre-qualified by WHO? Yes No b. Accredited in accordance with the ISO17025 or EN45002? Yes No c. Accepted by a Regulatory Authority Yes No H.8. Has a pharmaceutical inspection been performed at the CMS within the 3 last years? Yes No.. If yes, specify the year and 3 main positive and negative results H.9. Does the CMS have a written procedure for the following processes? Yes No If yes, attach a copy English version 08 July 07 TCM/MPM 53

54 Processes Yes No NA Selection of the products Quantification of needs Placing of order Reception Storage Stock management Inventory control Destruction of expired/damaged products Returned products Redistribution of products in overstock Distribution Dispensing Quality assurance Financial management Monitoring/evaluation/supervision Recruitment of personnel Others, specify I. RATIONAL USE I.1. What pharmaceutical information sources are available to the central medical stores? Information Sources Yes No British National Formulary Donation Guidelines Essential Medicines List Internet Manufacturers information Martindale National Formulary Standard Treatment Guidelines Others, specify English version 08 July 07 TCM/MPM 54

55 J. FINANCING J.1. Please state the various sources of financing available to the CMS for the procurement of each category of the following products? Give expenditures in 2006, the budget for 2007 and the type of financing: Category of Products Essential Medicines HIV/AIDS medicines Antimalarial TB medicines Medicines for opportunistic infections Pediatric formulations for HIV/AIDS and malaria Vaccines Contraceptives Condoms Sources of Funds (Government, Global Fund, MSF ) 2006 Expenditure US$ 2007 Budget US$ % budget Type of financing (Drug revolving Fund, Loan, subsidy ) English version 08 July 07 TCM/MPM 55