National Vector Borne Disease Control Programme (NVBDCP)

Of Directorate General of Health Services, Ministry of Health and Family Welfare

22, Sham Nath Marg, Delhi

DRAFT No.4

STANDARD OPERATING PROCEDURES MANUAL FOR STATE DRUG STORES

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STANDARD OPERATING PROCEDURES MANUAL FOR STATE DRUG STORES

CONTENTS

Subject Page No

Introduction 7

Receipt of Drugs at State Drug Stores 13Issues/ Dispatches by State Drug Stores 19Inventory Management 23Assessment of Logistics Requirement 31Location & Storage Arrangements 35Expiry Management 39Physical Verification 43Communication and Information Technology Infrastructure 47Staffing Requirements 49Secure Custody 51

Arrangements for Transportation 53MIS for Drug Logistics 55

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APPENDICES TO THIS MANUAL

Appendix I: Operational Formats

Appendix 2: MIS Formats

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ABBREVIATIONS ACI Advanced Consignment Intimation ACT Aretemisinin Combination Therapy ADR Additional Drug Request ADS Adequacy of Drug Stocks API Annual Parasite Incidence ASHA Accredited Social Health Activist AWW Angan Wadi Workers CIT Communication & Information Technology CQ Chloroquine DDT Dichloro Dipheyl Trichloroethane DIV District Issue Voucher DOE Date of Expiry DTA Drugs Transfer Advice DMC District Malaria Centre DMO District Malaria Officer FEFO First Expiry First Out FTD Fever Treatment Depot GFATM The Global Fund to fight AIDS, Tuberculosis and Malaria GMSD Government Medical Store Depot CRC /CAC Goods Receipt Acknowledgement Note ICMR Indian Council of Medical Research IM Inventory Management IRS Indoor Residual Spraying ITN Insecticide- Treatment Net LLIN Long Lasting Insecticidal Net LQAS Lot Quality Assurance Sampling MDA Mass Drug Administration MIS Management Information System MO Medical Officer MoHFW Ministry of Health and Family Welfare MSS Monthly Stock Statement MPHS Multi Purpose Health Supervisor MPHW Multi Purpose Health Worker NVBDCP National Vector Borne Diseases Control Programme Pf Plasmodium falciparum PHC Peripheral Health Center

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Pv Plasmodium vivax PVS Physical Verification Sheet MRDL Monthly Report on Drug Logistics RDK Rapid Diagnostic Kit RDT Rapid Diagnostic Test SDS State Drug Store SIV State Issue Voucher SN Stocking Norms SO Supply Order SR Stock Register SPO State Programme Officer SP Sulphadoxine- Pyremethamine UOM Unit of Measurement VBD Vector- Borne Disease WRDR Worksheet for Reporting Drug Requirement

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INTRODUCTION The Directorate of National Vector Borne Diseases Control Programme (NVBDCP) is the National level Technical Nodal office equipped with Technical Experts in the field of Public Health, Entomology, Toxicology and Parasitological aspects of Malaria and other vector borne diseases. The Directorate is responsible for framing Technical guidelines & policies for guidance to states for implementation of Programme strategies. One of the most important components of Malaria Programme is ensuring an uninterrupted supply of drugs for which the programme is introducing a monitoring system through this Manual to strengthen the current health systems. This can be ensured only if there is a robust inventory management system in place in the programme. The system should allow for accurate information to provide the right material, of right quantity, at the right time & from a right source. A good monitoring system is extremely important, allowing for rapid assessment of progress and problems so that timely corrective actions can be taken.

The drug management function encompasses the activities of Selection, Procurement, Distribution, Usage, Monitoring, Reporting and Quality Assurance. Selection A list of the Drugs, Insecticides, Larvicides, Rapid Diagnostic Kits (RDKs), Long Lasting Insecticidal Nets (LLINs) used under National Vector Borne Disease Control Programme are given in Appendix 1- M Procurement The anti malarial drugs, insecticides, larvicides, Rapid Diagnostic Kits, Bed nets are being provided by the Centre to various states for distribution at the PHC ,CHC and for further distribution to sub-centres/ peripheries etc. The Central Govt provides the following materials:

• All required quantities of antimarials, insecticides, larvicides, commodities like RD Kits and Bed nets, equipments etc.( RITES)

• DDT from Hindustan Insecticides Ltd.(HIL) • Vehicles under World Bank Project

Currently, eight drugs like Tab Chloroquine Phosphate, Tab Quinine Sulphate 300 mg, Tab Primaquine 2.5mg, Tab Primaquine 7.5 mg, Inj Quinine Di—Hydrochloride, Temephos, Pyrethrum Extract and BTI (WP) / BTI (AS) have been decentralized completely. Small quantities of drugs/ insecticides/ larvicides apart from the Central supplies can be made available locally during emergencies after getting the concurrence of Directorate of NVBDCP. However, DDT is fully procured & supplied to states/ UTs through centralized procurement. Central level procurement is primarily done by NVBDCP for both World Bank & GFATM funded states on an annual basis.. Once these drugs are supplied to the states, it becomes their responsibility to ensure availability of adequate stocks of these items at all levels. Procurement (both for World Bank and GFATM funded states) is done at the level of Ministry of Health & Family Welfare (MOHFW), Govt. of India from ‘WHO Pre-qualified Suppliers’ defined as Good Manufacturing Practices (GMP) compliant manufacturers as assessed by WHO Pre-qualification Programme.

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Distribution Distribution of drugs to the range of service delivery outlets under the programme has to be carefully monitored, so as to ensure uninterrupted availability of quality drugs. Requirements at drug stocking points are worked out on the basis of blood slides collected, blood slides examined, plasmodium falciparum rate and plasmodium vivax rate data collected through entomological reports. Distribution of Pesticides and Larvicides should be carried out by trained personnel or under proper supervision. Proper packaging is also important to ensure the confinement of the product and its safe handling. The original packaging is intended to ensure safe distribution; when repackaging is necessary, the new packing should meet the specification of the original packaging. Distribution of nets should be done as soon as these are received at the centre as per activities planned for organizing camps for use by the BPL households & keeping records of distribution, as these are voluminous & need large storage spaces. The drug distribution process is depicted in Table 1 on the page overleaf and summarized below:

Distribution of drug supplies is primarily effected from the manufacturer to:

a) Government Medical Stores Depots (GMSDs) at Karnal, Mumbai, Kolkata, Chennai, Guwahati and Hyderabad

b) The State Drug Stores (SDS) of respective states.

Usage The Anti-Malarial drugs are dispensed to the patients through the PHCs, CHCs, Sub Centers, ANMs, ASHAs and Multipurpose Health workers at the village level. Along with timely diagnosis through blood slide collection or through Rapid Diagnostic Test, availability of drugs to the patients after diagnosis and thorough dispensing instructions need to be provided to the patient. Monitoring Monitoring of drug supplies and other items with regard to requirement and consumption is done through a system of Monthly Reports, tracking the drug stock position at each district by providing details of the following:

a) Number of Blood Slides Collected and Blood Slide Examined b) Number of P(f) and P(v) cases c) Quantities of different drug items consumed during the month. d) Stock of different drug items received during the month e) Closing stock of drug items. f) Drug requirements of the Districts. g) Drugs and Diagnostics supplied to Sub Centres and ASHAs.

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State Drug Stores For the long-term sustainability of the programme, as well as to facilitate its fast expansion, it has become necessary to decentralize aspects of drug management, to the states. An important initiative in the context of the above has been the establishment of State Drug Stores (SDS) at implementing states. SDSs facilitate the distribution of anti-malarial drugs & other items within the State by sharply reducing lead-times for fulfilling drug requests, thereby help ensure uninterrupted supply of these items. There is obvious need for all states to have atleast one SDS and some of the larger states may need more than one. Advantages of establishing SDSs include the following:

a) Reduced complexity of logistics management for NVBDCP and GMSDs, as intra-State, district level drug requirements, shall be fulfilled directly by SDSs.

b) Significantly improved response times for fulfilling the emergency drug requirements of DMCs, as these shall be serviced from geographically proximate SDS

c) Sharply improved management of drugs inventory at DMCs through the SPOs’ ability

to micro-manage and access more current information on drug availability and requirements, etc.

Standard Operating Procedures (SOPs) for SDSs This manual documents standard operating procedures recommended for SDSs, covering interalia, the following activities:

1. Receipt of Drugs at State Drug Stores Procedures to be followed for the receipt of drugs & other items at the SDS and the subsequent updation of stock records

2. Issues/ Dispatches by State Drug Stores Procedures to be followed for the issue and dispatch of drugs & other items by the SDS

3. Inventory Management Procedures for tracking and replenishment of inventory at the SDS and subordinate stocking points within the state

4. Assessment of Logistics Requirements Procedures for assessing the requirements of Antimalarials, insecticides, larvicides etc as per norms set under the programme

5. Expiry Management Procedures to be followed for management of short-expiry drugs and other items at the State, district & sub-district levels

6. Physical Verification & Reconciliation of Drug Stocks Procedures to be followed for the periodic physical verification and reconciliation of stocks at the SDS

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7. Communication & Information Technology Infrastructure (CIT) Communication and Information Technology infrastructure required by the SDS 8. Staffing Requirements Staffing requirements for the efficient discharge of stores and logistics functions

9. Location, Space & Storage Arrangements Location, space and storage arrangements to be created at the time of establishing the SDS

10. Secure Custody of Drugs Measures to be taken to ensure the secure custody of drugs and other items at the SDS

11. Arrangements for Transportation of Drugs Arrangements required to be made for the transportation of drugs from the SDS to various stocking units in the State

12. Quality Assurance Procedures instituted by NVBDCP to maintain the quality of drugs, throughout their shelf life.

The manual documents detailed procedures to be followed for the above activities by concerned NVBDCP functionaries. Additionally, Operational Forms for reports, records and registers to be maintained have also been provided. Role of State Programme Officer/District Malaria Officer(DMO) The State Programme Officer (SPO)/District Malaria Officer (DMO) plays a vital role in implementing SDS and DMC procedures described in this manual and ensuring the institution of effective drug management systems in the state. Key responsibilities of the SPO/ DMO include the following:

1. Overall supervision of SDS/ DMC operations and Inventory Management of drugs and other items.

2. Review of stock adequacy at all levels, ensuring their uninterrupted supply.

3. Timely submission of the monthly reports by Subcentres, District and State.

4. Timely corrective action to prevent expiry of items.

5. Timely action to redistribute drugs to prevent local and/or focal shortages.

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Quality Assurance Maintaining quality control of drugs is a critical programme requirement. This is enabled through pre-dispatch testing of drugs, wherein testing is arranged by the Procurement Agency either through their own Quality Assurance Division or by out-sourcing through an accredited (by Regulatory Authority/WHO/ISO) testing laboratory. Additionally, the state health authorities (Public Health Laboratories) also carry out independent Quality Assurance of the products supplied under the project.

NVBDCP envisages to implement the Lot Quality Assurance Sampling (LQAS) based system of annual/ biannual/ quarterly survey to obtain quality data on availability of diagnosis and treatment within 24 hours, on utilization of Bed Nets and quality IRS coverage and its acceptance.

TABLE 1

DEPICTION OF DRUG DISTRIBUTION PROCESS

DISTR IBU TI ON

Consi gn ee Lis t

NVBDCP

Proc ur em en t Ag enc y

Ma nuf act ur er

GMSD s

SDS

Distric ts

R.O as pe r MRPM LSuppl y O rd er

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RECEIPT OF DRUGS AT STATE DRUG STORES

This section deals with procedures to be followed for the receipt of drugs at the State Drug Stores (SDS) and immediate next steps for the updation of stock records and storage/ stacking of materials. Overview SDSs may receive drugs from multiple sources including:

1. Manufacturer(s)

2. Government Medical Store Depots (GMSDs)

3. SDSs of other states

4. DMCs/ SDSs of the same state Receipts from Manufacturer(s) comprises of procurements planned by National Vector Borne Disease Control Programme (NVBDCP), Delhi under their Supply Chain Management & Procurement Plan for the year . Procurement function has also been decentralized to States for some of the drugs & consumables under the programme. Receipts from GMSDs/ SDSs (in other states) are coordinated by National Vector Borne Disease Control Programme (NVBDCP), Delhi and are usually in response to monthly reports/ additional stock requests made by State Programme Officers (SPO). Receipts from SDSs in other States may in some cases comprise transfers authorized by NVBDCP, to adjust excessive drug stocks accumulating with the concerned SDS. Returns/ transfers from DMCs/ SDSs (in the same state) are usually a direct consequence of instructions issued by the SPO to correct stock imbalances observed within the state. Procedures recommended for the above transactions are described below. Receipt of Drugs from Manufacturer(s) Drug requirements for the programme are determined annually by NVBDCP and communicated to the Procurement Agency. Requirements as above are conveyed by the Procurement Agency to the Manufacturer(s) in the form of supply schedules. Historically, supply schedules have provided for the direct supply of a proportion of the requirement of consuming districts, with a more significant proportion being supplied to the SDS. Supplies made to districts under this mechanism, have typically had no relationship with stocks already available and/or immediately required by them, but are instead based on the blood slides collected and Pf & Pv cases detected. Pursuant to establishment of SDSs in most of the states, direct drug supplies to SDSs, have commenced.( SDSs are established in all the state) The Storekeeper shall perform the following functions on receipt of drugs from Manufacturer(s):

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1. Ensure that an approved copy of the Notification of Award (NOA), prepared by the Procurement Agency, is received either before or along with the consignment. The NOA serves as an authorization document, enabling the SDS to receive the consignment of drugs.

2. Additionally ensure that a complete set of transmission documents (including the Supplier’s Invoice, Delivery Challan, Packing List, Copy of Inspection Certificate / Dispatch Clearance, Copy of Insurance Cover Note, Consignee Receipt Certificate (CRC) / Consignee Acceptance Certificate (CAC) Consignee Copy of Lorry/ Courier Receipt, etc.) describing the contents of the shipment, is handed over by the transporter, along with the incoming shipment of drugs.

3. Check whether all specified terms and conditions stated in NOA have been complied

with especially w.r.t. packaging, transportation, cold chain management and other specifications stated therein.

Deviations noticed shall be brought to the notice of SPO & other concerned officer incharge of drugs at SDS. Significant deviations shall immediately be brought to the notice of NVBDCP, Delhi & the Procurement Agency for further necessary action.

4. Shelf Life: Shelf- life of drugs and insecticides is a critical component of inventory management. While acknowledging receipt of drugs, it needs to be ensured whether sufficient shelf life is available such that it could be administered to patient before the date of expiry of drugs. It should be noted that at least 5/6th of shelf life is available at the time of drugs reaching the GMSD/SDS from the manufacturer. Accordingly, the storekeeper shall ensure and confirm that drugs received from the manufacturer has more than 5/6th of remaining shelf life, in case of expirable items.

5. Check the contents of the incoming consignment to ensure conformity with NOA and

specifications as per the supplier’s transmission documents, as above

(Notes:

a) The check shall be limited to visual inspection and count of the number of cartons received and matching the same with the Invoice and Challan of the supplier. The Storekeeper will not ordinarily open sealed cartons unless:

i. The seal and/or exterior suggests damage or shortage ii. Shortages have been frequently observed in the recent past, suggesting that

it would be prudent to verify contents. In such cases, verification may be carried out for a period of time or in respect of a specific Manufacturer or Transporter.

b) There could also be instances where the supplier has opted to make part

shipments. In such cases, the Storekeeper shall flag the NOAs in question and record details of drugs received and the balance quantity pending supply. The Storekeeper shall follow-up closely with the supplier in respect of all flagged NOAs, ensuring that balance supply is made at the earliest)

6. In case of shortages and/ or transit damages determined through visual inspection, the

same shall be brought to the attention of the transporter. Details of the shortage/ damage should be noted on the Supplier’s Delivery Challan / Invoice and the transporter’s attestation thereof obtained by means of signature.

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(Notes:

a) In the case of shortage/ damage determined by the Storekeeper through visual

inspection s/he shall take the precaution of opening the seals of all cartons received and carefully checking their contents.

b) Ideally, SDS should take custody only of undamaged stock from the perspective

of the drugs in question being in a good enough condition to be administered to patients. SDS shall simultaneously report details of damaged stocks received, if any, to the Manufacturer, Procurement Agency and NVBDCP. Based on the SDS report, NVBDCP would liaise with the Procurement Agency, for the early replacement of damaged stocks through the Manufacturer. SDS shall segregate and preserve damaged stocks till the time of their replacement).

7. After visual inspection, acknowledge drugs received in Supplier’s Challan / Invoice and

return it to the transporter. The Storekeeper shall retain a copy of the above document in the stores receipts file. In the exceptional cases, where shortages/ transit damages are noticed, the Storekeeper shall forward a photocopy of the transporter attested Supplier’s Challan/ Invoice to the SPO, for onward transmission to the Manufacturer to highlight shortage/ transit damage.

8. Thoroughly check the contents of consignments received down to the lowest packaging

unit, prior to acknowledging the same in the CRC /CAC. The Storekeeper shall forward one copy each of CRC /CAC to the Manufacturer, Procurement Agency and NVBDCP, within 15 days of receipt, retaining a copy of the same in the stores receipts file

(Note: CRC /CAC is raised by the Manufacturer and sent directly to the SDS or as part of the complete set of documents forwarded through the transporter, accompanying the consignment of drugs)

9. Record complete details of the drug consignment actually received (viz. Supplier,

Invoice Particulars, Batch Reference, Date of Expiry, etc.) in the Bin Card (BC: Form Reference 1-A).. These cards are to be placed on the racks in front of the stock so as to ensure that the closing stock is visible clearly. Following this, an entry into the relevant folio of the Stock Register (SR: Form Reference 1-B)

(Note: In the case of shortage/ damage/ discrepancy in the quantity of drugs actually received vis-à-vis that indicated as per the transmission/ authorization document, record complete details of the same in the ‘Remarks’ column of the SR and highlight the same).

Receipt of Drugs from GMSDs Receipt of drugs from GMSDs, on the basis of Release Orders generated by NVBDCP (NVBDCP-RO: Form Reference 1-C), comprises an arrangement when sufficient quantity of drugs as per stocking norms may not be available in the State. NVBDCP may then release drugs from the GMSD keeping in view the drugs in the pipeline and/or expiry position of the drugs in the GMSD. Alternatively, there may be cases where short-expiry drugs have got accumulated at the GMSD whilst fresh stocks are still being received by the State from the manufacturers. In such cases, NVBDCP may also issue additional drugs from the GMSD to the States to avoid expiry of the drugs at the GMSDs. The States shall make suitable arrangements to pick up drugs from the GMSD within 15 days of the Release Order after coordinating with the GMSD on the same.

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The Storekeeper shall repeat steps (1) to (5) and (7) detailed at pares above on the receipt of drugs from GMSDs, with the exception that the authorization document in this case shall be the NVBDCP-RO and the acknowledgement to the transporter of drugs received shall be made on the Issue Voucher of GMSD. Additional copies of acknowledged Issue Voucher shall also be sent to GMSD and NVBDCP. Transfer of Drugs from SDSs (Inter-State Transfers) Pursuant to the monthly review of State reports, NVBDCP may periodically authorize transfer of drugs to the SDS from other States/SDSs to adjust stock imbalances and ensure timely utilization of close to expiry drugs. A formal Drugs Transfer Advice (DTA: Form Reference 1-D), should be emailed/ faxed to both the transferor/ sending unit and the transferee/ recipient unit, progressed by a hard copy of the same. Following this, the Storekeeper of the transferor/ sending unit shall generate a State Issue Voucher (SIV: Form Reference1-E). On receipt of the transferred drugs the Storekeeper of the recipient unit shall repeat steps (1) to (5) and (7) detailed at paras above on the receipt of drugs transferred from other SDSs, with the exception that the authorization document in this case shall be the SIV/DTA and acknowledgement of the drugs received shall be made by signing the same. Acknowledged copies of the DTA shall be sent to the SPO, as well as the transferring SDS. Intra-State Return/ Transfer of Drugs (Diversions) In the normal course, the SDS shall receive drugs either from Manufacturer(s) or GMSDs. However, pursuant to the monthly review of district reports, the SPO may authorize returns/ transfers from DMCs or multiple SDSs within the state, to adjust stock imbalances and/or ensure the timely utilization of close to expiry drugs. A formal DTA should be generated by the SPO for the purpose and emailed/ faxed to the transferor/ sending unit and the transferee/ recipient unit, progressed by a hard copy of the same. In the same manner as stated above, the Storekeeper of the transferor/ sending unit shall generate a SIV/DIV and arrange for the dispatch of drugs as requested. The Storekeeper of the recipient unit shall repeat steps (1) to (5) & (7) detailed at paras above on the receipt of drugs transferred from other SDSs within the state, with the exception that the authorization document in this case shall be the SIV or DIV (District Issue Voucher). Acknowledgement of drugs received shall be made by signing the SIV, as the case may be. Acknowledged copies of the SIV shall be sent to the SPO, as well as the transferring SDS. Monthly Receipt Report Storekeeper shall proceed with preparation of Monthly Receipt Report (MRR; Form Reference 1-F) in respect of drugs received during the month from various sources. This report shall comprise of information in respect of receipt of all drugs, insecticides, larvicides and other items received under the programme with complete reference of Purchase Order, NOAs, Invoice, Voucher No., and other relevant details. Monthly Receipt Report shall facilitate in monitoring receipt against supply orders/release orders placed by NVBDCP or the State.

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Advance Intimation

Receipts at the SDS should ideally be preceded by advance intimation and a copy of the NOA shall serve this purpose. The NOA shall enable the Storekeeper to make space and other arrangements for receiving the drugs. The Manufacturer’s may also send pre-dispatch information to all concerned Consignee’s/ State Drug Stores, with request to arrange for Road Permits for such supplies. The Storekeeper shall track receipt of drug supplies within the timelines indicated in the NOA. In case supplies are delayed by more than a fortnight vis-à-vis the timelines indicated, s/he must bring the delay to the attention of the drug supplier and Procurement Agency by fax/ email, marking a copy of the same to NVBDCP/SPO/ Dy. SPO/ Second Medical Officer in charge of drug logistics, to appropriately escalate attention. In some cases, the SDS may not receive copy of NOA. In such situations, the Storekeeper should accept the drugs, provided that the shipment is accompanied by necessary documents. The Storekeeper should immediately inform the SPO of the receipt of drug supplies for further necessary action. Road Permits Local taxes are levied by some states and payable at border entry/ check-posts, as the drug supplies enter the state. In the case of such states, availability of a ‘Road Permit’ along with the drug supplies ensure that levies as above are not attracted, as the drugs are meant for free distribution to patients and supplied under a National Health Programme. Accordingly, manufacturers shall request ‘Road Permits’ from consignees in states attracting local taxes in advance, giving complete details of the drugs being dispatched by them. State Programme Officers shall direct the concerned officials to arrange Road Permits as per the request received from manufacturer. Delays in furnishing of Road Permits may cause inordinate delays in receipts of drugs, and may also be subjected to demurrage etc. Accordingly it becomes the responsibility of concerned SDS to ensure availability of Road Permits to manufacturer’s within prescribed timelines and avoid inordinate delays thereof. (Note: Road Permits may be obtained from the Sales Tax Office. Four copies of the same are to be filled-up by the consignee, giving complete details of the Supplier’s Name, Description of Drugs and their Quantities, as per information provided in advance by the manufacturer. Three copies of the road permit shall be forwarded to the manufacturer and the fourth retained by the consignee for record. Drugs should not be dispatched, without the Road Permit, by the manufacturer. One copy of the Road Permit shall accompany the drugs to the consignee, one copy shall be retained by the manufacturer and one copy submitted to the Sales Tax authorities, by the manufacturer).

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Custody/ Stacking of Incoming Material The Storekeeper shall perform the following functions in this regard:

a. Ensure that different drug items are clearly segregated and stacked on separate racks within the store

b. Within each drug item, ensure that separate 'lots' of drugs with separate dates of

manufacture and expiry are clearly segregated and stored together

c. Separate 'lots' of drugs with different dates of manufacture and expiry are stored so as to facilitate First Expiry First Out (FEFO) issue viz. drug 'lots' with the most recent expiry are issued first

d. Mark ‘Expiry Dates’ in Bold Letters 3” to 4” in size, on the drug cartons with a

Marker Pen, for the easy identification and control of drugs, immediately on their arrival.

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IISSSSUUEESS // DDIISSPPAATTCCHHEESS BBYY SSTTAATTEE DDRRUUGG SSTTOORREESS

This section deals with procedures to be followed for the issue and dispatch of drugs by State Drugs Stores (SDS)

Overview SDSs shall issue and dispatch drugs under the following circumstances:

a. Routine monthly supplies to District Malaria Centres (DMCs)

b. Supplementary supplies to DMCs in case of outbreaks/ emergencies

c. Transfers to other SDS(s) in the same state

d. Transfers to SDS(s) in other states

Issues for the purpose of routine monthly supplies to DMCs, supplementary supplies in case of outbreaks/emergencies etc or transfers to other SDSs in the same state, shall be determined by the SPO/ Dy. SPO / Second MO/ Other Responsible Officer (authorized by the SPO for the purpose), primarily on the basis of analysis of Monthly Reports on Drug Logistics and/ or specific instructions by SPO or NVBDCP at the time of outbreaks or emergencies. Transfers to SDSs in other states, if any, shall be made on the basis of instructions from NVBDCP.

Implementing District Malaria Centers shall be linked to the most convenient State drug Stores.(in terms of proximity and transportation arrangements), in the case of states having more than one SDS. Ideally DMCs shall only receive supplies from the associated SDS, identified through the above process.

Procedures recommended for the above transactions, are detailed in the paragraphs that follow.

Monthly Supplies to DMCs Monthly replenishment of drug to districts shall be based upon the Monthly Report on Drug Logistics (MRDL: Form Reference 1-G) submitted by them, providing complete details of opening and closing stocks, receipts, utilization and anticipated requirement. Apart from status of drug stocks at District Drug Stores, the stocks available at Block PHCs and other stocking points shall also be considered for preparation of MRDL for district.

Information in respect of drugs & other items contained in MRDL received from various districts, shall be incorporated in the Worksheet for Reporting Drug Requirement (WRDR-DMC : Form Reference 1-H) to help determine the drug requirement of each district for the next month, considering drug stocks availability, utilization/ consumption of drugs during the month and stocking norms etc.

WRDRs shall be discussed and approved by the SPO and followed by preparation of a State Release Order (State RO: Form Reference 1-I ) for release of monthly supplies to DMCs. State RO shall serve the purpose of advance intimation to DMCs for release of drugs by SDS.

Approved copies of the State RO & WRDR shall be handed over to the Storekeeper for release & dispatch of drugs to DMCs. Imbalances noticed in drug stocks availability at

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various districts shall be corrected through generation of Drugs Transfer Advices (DTA) for effecting transfers. .

(Note: WRDR shall be used for authorizing issue/ supply of drugs from SDS. Drug transfers across DMCs to adjust stock imbalances and/or ensure the timely utilization of close to expiry drugs shall be effected on the basis of DTAs).

The SDS Storekeeper shall perform the following activities on receipt of WRDR:

1. Ensure proper authorization of WRDR & State RO

2. Prepare three copies of the State Issue Vouchers (SIV) for the purposes of recording issue of drugs from stores

3. Identify and segregate drugs to be issued as per the WRDR, ensuring strict application of FEFO principles

4. Dispatch Section will prepare the Packing Challan detailing number of cartons which shall be mentioned in the SIV.

5. Hand-over drugs to transporter for onward dispatch, along with first and second copies of SIV

6. Obtain Consignor’s copy of Lorry Receipt and acknowledgement from transporter on third copy of SIV, retaining and filing the same for store records

7. Update the Stock Register & Bin Cards for issues made

8. Receive back and file the second copy of SIV (consignee copy), duly acknowledged by the concerned DMC.

(NOTE: While Storekeeper shall strictly follow FEFO principles, it is also expected of him to exercise due prudence in case of short expiry drugs, the distribution shall be on rational basis keeping in view the utilization pattern of each district to ensure timely consumption of such close to expiry drugs)

Supplementary Supplies to DMCs in case of outbreaks /emergencies In case of sudden outbreak of any vector borne disease, the SPO/NVBDCP may direct the SDS to dispatch drugs immediately without complying with regular formalities. In such cases, the storekeeper shall do so on basis of an Authorization letter from the SPO directing him/her to dispatch drugs to specified districts which shall be sufficient in case of such distress situations. However, the issue of drugs should be accompanied with proper documentation by way of authorized SIVs along with entries in the stock register & the bin cards.

The SDS Storekeeper shall repeat steps (1) to (7) described as above for the purposes of issuing additional drugs to DMCs, with the exception that the authorization document for this transaction shall be the Authorization letter from the SPO, instead of the WRDR.

In the above case, the SDS Storekeeper may dispatch drugs using the designated transporter used in the normal course.

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Transfers to State Drug Stores in the same state The monthly review cycle by SPO/ Dy. SPO/ Second MO (please refer to the above paras), may suggest benefit from the transfer of temporarily excess drug stocks available at any one SDS to the other(s), within the same state. Transfer as above shall be done through the means of DTA, generated by the SPO.

The Storekeeper shall repeat steps (1) to (8) detailed as above, with the exception that the authorization document for this transaction shall be the DTA.

Transfers to State Drug Stores in other states Similarly, the monthly review of state-level MRDL carried out by NVBDCP may suggest benefit from the transfer of drugs across SDSs in different states to adjust stock imbalances and/or ensure the timely utilization of close to expiry drugs. Transfer as above shall be done through the means of DTA generated by NVBDCP.

The Storekeeper shall repeat steps (1) to (8) detailed as above, with the exception that the authorization document for this transaction shall be the DTA.

(Note: Transportation arrangements for effecting transfers have been discussed in the chapter on Transportation in this manual. Frequently, direct transportation links from districts of one state to districts of another, may not be available. Accordingly, inter-state transfers should be effected at the SDS and not the district level. This limitation should be recognized by NVBDCP at the time of recommending inter-state transfer of drug stocks).

Monthly Stock Statement The SDS Storekeeper shall prepare a Monthly Stock Statement (MSS) on drugs stocks available in its stores providing details of receipts, issues, and opening/ closing balance of drug items, as at the last day of each calendar month. MSS shall be sent to the SPO by the 7th of every month, by all the SDSs, in the state. The statement shall facilitate determination of drug stocks available with SDS(s) within the state.

MSS shall thereafter be forwarded to NVBDCP through the SPO, by the 10th of every month, after due validation of the report. In the case of more than one/ multiple SDSs within the state, the MSSs shall additionally be consolidated, prior to their being forwarded to NVBDCP.

Refusal to Accept Drugs

Shipment of drugs from NVBDCP Directorate to SDS or from SDS to DMC is essentially based upon projected requirement of concerned SDS or the DMC. At times the drugs are also dispatched with a view to ensure utilization within their shelf life, such dispatches again are based upon the projected utilization of DMC and/or SDS.

Accordingly the SDS or DMC, in any case shall not refuse acceptance of such drugs in their stores. Even in case of short expiry drugs the delivery shall not be refused by the consignee unit. It would be more appropriate to immediately contact the NVBDCP Directorate or the concerned State Programme Officer, rather than refusing accepting delivery of drugs sent. The refusal entails unnecessary costs and issues concerning transporting back these drugs.

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INVENTORY MANAGEMENT This section of the manual suggests procedures for on-going tracking and replenishment of the inventory of anti-malarial drugs at the State Drug Store (SDS) and all subordinate stocking points, ensuring that these are maintained at or close to the stocking norms suggested by NVBDCP (National Vector Borne Disease Control Project). Inventory management (IM) practices described in this section, have been developed for the SDS, but can equally be applied to subordinate stocking points. Overview IM refers to the gamut of activities to be carried out by the senior officer in-charge of the logistics function at the SPO’s Office including: 1. Determination of drug stock status at the SDS and DMCs/ subordinate stocking points 2. Review of adequacy of drug stocks at the above 3. Correction of imbalances through transfers 4. Replenishment of stock at DMCs to recommended levels 5. Requisitioning for the replenishment of SDS stocks. The above elements of IM are discussed in the paragraphs that follow. Determination of Drug Stock Status Monthly Report on Drug Logistics (MRDL) is to be filled and submitted by all drug-stocking points and comprises the most important report for Inventory Management. MRDL incorporates drug stocks and utilization reported by all subordinate units. In case the reporting unit has close to expiry drugs, details thereof should also be reported in the MRDL. Reporting DMC shall ensure that utilization reported is the actual consumption at various stocking points. Issues to subordinate or down the line units should not be considered as utilization in MRDL. The managerial challenge for the Officer in Charge of drugs logistics at the SPO’s Office (usually the Deputy SPO or Second Medical Officer), shall be to ensure that MRDLs are filled and submitted on a timely basis by DMCs and Block PHCs, after compiling the reports of subordinate stocking units upto PHC’s/Sub-centre level. An additional challenge shall be, to ensure that the MRDLs provides correct information on drug stock status, corresponding with stocks physically available at various stocking points. The regular process of supply of new stock of drugs to the SDS begins only when the States submit their monthly drug stock status reports. The reports of the stocking units need to be submitted by the following dates:

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Report of Stocking unit Date of submission of report Fortnightly Report by ASHAs, ANMs, Health Workers to Sub-centre

3rd week of the same month & 1st week of each subsequent month

Monthly Report by Sub-centres to Block PHCs

10th of the subsequent month

Block PHCs to DMCs 15th of subsequent month DMCs to SDS / SPO/ NVBDCP 20th of the subsequent month

The MRDL shall be validated by the designated officer, on receipt, at the SPOs Office. The designated officer shall confirm the following:

1. Closing stock reported in the previous MRDL has been correctly carried forward as opening stock in the current MRDL

2. Dispatches/ transfers authorized by the SPO in the previous month have been

executed and the correct quantities reflected in the monthly report.

3. Utilization / Consumption of various drugs are proportional to number of patients reported in the District.

Stocking Norms A key deliverable of NVBDCP is to ensure uninterrupted supply of drugs, and stocking norms have been developed, with a view to meet this end-objective. It is currently planned that drug stocks equivalent to nine months utilization, shall be maintained with implementing states. SDS(s) and DMCs, comprising the principal stock points of the state, shall each maintain buffer stocks equivalent to three and two respectively. These stocks shall be utilized for replenishing supplies from SDS to DMCs and from DMCs to Block PHCs, after validating consumption indicated in the monthly reports of the latter. Drugs kept with the ASHAs, ANMs, HWs etc are consumption points and should maintain adequate quantities of drugs for the ongoing administration of anti-malarial drugs including a buffer to cater to fresh patient arrivals. It is planned that drug stocks equivalent to two months utilization shall be maintained as a buffer with each Sub-centre, at the commencement of the month, and an additional one month buffer with each Block PHC. The DMC shall maintain two months of buffer stocks & the SDS another 3 months buffer. Stocks at Sub-centres & Block PHCs need to be closely monitored, to ensure drug adequacy. Stocking norms may thus be depicted as follows:

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State Level (9 months) (Comprising three months buffer at SDS, two months buffer at Districts, one month buffer each a t the Block PHCs & the sub-centres, one month for utilization and one month buffer

with ASHAs, ANMs, HWs etc)

District Level (6 months) (Comprising two months buffer at DMC, one month buffer each at the Block PHC & the sub-

centre, one month for utilization and one month buffer with ASHAs, ANMs, HWs etc)

Block Periphery Health Centres (4 months) (Comprising one month buffer each at the Block PHC & the sub-centre, one month for

utilization and one month buffer with ASHAs, ANMs, HWs etc)

Sector Periphery Health Centres

Sub Centre (3 months)

(Comprising one month buffer at the sub-centre, one month for utilization and one month buffer with ASHAs, ANMs, HWs etc)

ASHAs, ANMs, HWs etc (2 months) (Comprising one month for utilization and one month buffer with ASHAs, ANMs, HWs etc)

The above stocking pattern may be denoted as the 3-2-1-1-1(SDS-District-PHC-Sub-centre) inventory-stocking norm, aggregating 9 months inventory on a state-wide basis.

Adequacy of Drug Stocks Adequacy of Drug Stocks (ADS: Form Reference 2-A) with DMCs is to be reviewed on a monthly basis by the officer designated in charge of drug logistics at the SPO’s Office. This shall be done by comparing drug stocks reported in the District MRDL, with the stocking norm suggested by NVBDCP, for the same. Based on the above, the designated logistics officer should flag all DMCs that are significantly under/ over stocked. DMCs with severe drug shortages, which shall not be able to continue treatment of patients, without interim replenishment before the end of the month, shall obviously need to be attended to right away. Needs as above are typically addressed through the Additional Drug Request or Drug Transfer Advice (DTA) mechanism.

Conversely the Review of Drug Adequacy may also indicate excessive stocks of ‘close to expiry’ drugs, which may not be fully utilizable at their current stocking units and run the risk of expiry. Such situations shall also be corrected by the use of DTAs.

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Correction of Imbalances through Transfers Drug stock imbalances (viz. significantly under/ over stocking situations and/or ‘close to expiry’ drug stock balances evidently facing the risk of expiry) are usually corrected through the transfer mechanism. However, there is a cost for executing transfers and this must be carefully evaluated by the designated logistics officer, who shall decide whether incurring the expense is justifiable and preferable to correcting the imbalance in the normal course, by adjusting the next monthly replenishment. It should be noted that transfers shall only be authorized by the SPO. The intention is to discourage the indiscriminate use of the transfer mechanism and the consequent costs incurred. Additionally, transfer of drugs needs to be carefully documented by both the transferor and the transferee DMC, to ensure proper reporting of drug stock balances. This end-objective is best served by restricting the number of agencies who can authorize the DTA. Replenishment of stocks with ASHAs, ANMs, HWs etc

The ASHAs, ANMs, HWs etc are peripheral health workers which come in direct contact with the fever cases & constitute the primary source of data related to actual drug consumption. All these ASHAs, ANMs, HWs etc submit a fortnightly report on their drug stocks to their sub-centre, based on which the sub-centre replenishes their consumed stocks. The report submitted by them is the M1 Report (Form Reference: 1-J) which gives details of the blood slides collected, the Pf & Pv patients identified & the number of patients put on Anti-Malarial drugs along with the drugs consumed & closing stocks of all drugs available with them at the end of the 1st fortnight. At this stage, the sub-centre should simply replenish the drugs consumed as per the report. However, the 2nd fortnightly report needs to be consolidated at the sub-centre taking into account the stocks consumed & the balance available at the ASHAs, ANMs, HWs level along with the stocks available at the sub-centres.

The requirement of drugs is thus worked out by the input of information into the Worksheet for Reporting Drug Requirement - WRDR – Sub-centre (Form Reference: 1 H). The WRDR shall help in working out total drug availability and estimating the requirement of drugs for the next month for the sub-centre.

Multiple factors are automatically considered while filling the WRDR including stocks available, stocking norms, number of patients put on treatment during the previous month and/or adjustments thereto, etc.

The WRDR is carefully reviewed by the Medical Officer at the sub-centre and subsequent to his/ her sign-off, progressed with the release of drugs for the month.

The above process has been depicted as below:

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Replenishment of stocks with Sub-centres

All the Sub-centres under the Block PHCs shall submit a monthly report on their drug stocks to their respective Block PHC, based on which the Block PHC shall replenish their stocks. The report submitted by the sub-centre is the M4 Report (Form Reference: 1 K) which gives details of the blood slides collected, the Pf & Pv patients identified & the number of patients put on Anti-Malarial drugs along with the drugs consumed & closing stocks of all drugs available with them at the end of the month. Reports from all the sub-centres shall again be consolidated taking into account the stocks consumed & the balance available at the sub-centres along with the stocks available at the Block PHC.

The requirement of drugs is now worked out by the input of information into the Worksheet for Reporting Drug Requirement - WRDR – Block PHC (Form Reference: 1 H) The WRDR shall help in not only working out the drugs required to be issued to the sub-centres but also consolidating the total drug availability at the block PHC level and estimating the requirement of drugs for the next month for the Block PHC.

The WRDR is carefully reviewed by the Medical Officer at the Block PHC and subsequent to his/ her sign-off, progressed with the release of drugs for the month.

The above process may be depicted as below:

ASHA -1 ASHA-2 ANM-1 HW-1

Sub-Centre A

Sub-Centre own Stocks

WRDR-Sub-centre Drug Requirement

Assessment of Each ASHA, ANM, HW

etc

MRDL – Sub-Centre A

Fortnightly Report from ASHA /MPW/Health Facility (M1)

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Replenishment of stocks with Block PHCs

All the Block PHCs under the District Malaria Centre (DMC) shall submit a monthly report on their drug stocks to their DMC, based on which the DMC shall replenish the stocks to the PHCs. The report submitted by the Block PHC is the M4 Report which gives details of the blood slides collected, the Pf & Pv patients identified & the number of patients put on Anti-Malarial drugs along with the drugs consumed & closing stocks of all drugs available with them at the end of the month. Reports from all the Block PHCs shall again be consolidated taking into account the stocks consumed & the balance available at the PHC along with the stocks available at the DMC.

The requirement of drugs is now worked out by the input of information into the Worksheet for Reporting Drug Requirement - WRDR – DMC. The WRDR shall help in not only working out the drugs required to be issued to the Block PHCs but also consolidating the total drug availability at the DMC level and estimating the requirement of drugs for the next month for the DMC.

The WRDR is carefully reviewed by the Medical Officer at the DMC and subsequent to his/ her sign-off, progressed with the release of drugs for the month.

Sub – Centre A Sub-Centre B Sub-Centre C Sub-Centre D

Block PHC-1 Block PHC -1 own

stocks

WRDR-Block PHC 1 Drug Requirement

Assessment of Each Sub-Centre

MRDL – Block PHC 1

Monthly Report from PHC (M4)

Sector PHC

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The above process may be depicted as below:

Replenishment of stocks with District Malaria Centre

All the DMCs shall submit a monthly report on their drug stocks to the State as well as to NVBDCP. Based on the MRDS - DMC report, the State shall validate these reports for any discrepancies prior to replenishing the stocks to the DMCs, as per the stocking norms instituted for the DMC level.

Apart from the drug stock status, the report submitted by the DMC gives details of the blood slides collected, the Pf & Pv patients identified & the number of patients put on Anti-Malarial drugs. It may be appropriate at this level for the State to compare the number of patients put on treatment vis-à-vis the drugs consumed. This shall give a rough idea of the accuracy of the drug stock report submitted by the DMC. A variation of 5-10% may be justified but a larger difference may point towards inaccuracy in either not consolidating the lower level reports or incorrect consolidation etc. In such cases, it may be appropriate to bring the same to the attention of the District Malaria Officer so that appropriate measures to rectify the same could be taken at the earliest to ensure an accurate report for the next month.

Reports from all the DMCs shall be consolidated by the State taking into account the stocks consumed & the balance available at the DMCs along with the stocks available at the DMC. The requirement of drugs is now worked out by the input of information into the Worksheet for Reporting Drug Requirement - WRDR – State. The WRDR shall help in not only working out the drugs required to be issued to the DMCs but also consolidating the total drug availability at the State level and estimating the requirement of drugs for the next month for the State.

The WRDR- State shall be carefully reviewed by the SPO/ Designated officer for drug logistics at the State level and subsequent to his/ her sign-off, progressed with the release of drugs for the month to the DMCs.

Block PHC 1 Block PHC 2 Block PHC 3 Block PHC 4

DMC - A

DMC - A own Stocks

WRDR-DMC A Drug Requirement

Assessment of Each Block PHC

MRDS – DMC A

Monthly Report from DMC (M4)

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Replenishment of SDS Stocks NVBDCP shall also validate the DMC reports independently of the State. Based on these reports & the State Drug Store report, NVBDCP shall review the drug stock status to ensure drug adequacy as per stocking norms for the state. The pipe-line supplies ie. supplies expected to reach the State directly from the manufacturers shall also be taken into account at NVBDCP while review of drug stocks at the State level. In case of expected shortage, NVBDCP shall issue a Release Order to the State from the stocks available at the GMSDs It is very important to make sure that every health facility in the State has an adequate supply of anti-malarial drugs. Timely initiation of treatment is not possible if the supply of drugs is inadequate. In the following paragraphs the basis for stocking adequate amount of drugs at various levels are described.

Level Stock for utilization

Reserve stock Drug Requirements

ASHAs, ANMs,HWs etc

1 month 1 month (Monthly consumption x 2) – (existing stock with the ASHAs, ANMs, HWs etc at end of the month)

Sector PHC 1 month 1 month

Sub-Centres 0 month 1 month (Monthly consumption x 3) – (existing stock in sub-

centre including stock with ASHAs, ANMs, HWs etc at end of the month)

Block PHCs 0 month 1 month (Monthly consumption x 4) – (existing stock in the Block PHC including all sub-centre stocks at end of the month)

DMC drugstore 0 months 2 months (Monthly consumption x 6) – (existing stock in DTC drug store including all Block PHC stocks at end of the month)

SDS 0 months 3 months (Monthly consumption x 9) – (existing stock in SDS including stocks at all districts at end of the quarter)

Thus the quantity of reserve stocks at each level at the start of the month (considering the receipt from one higher level) should be as follows:

Level Utilization Reserve stocks Total stock ASHA, ANMs, HWs etc 1 month 1 month 2 months Sub-Centre 1 month 1 month 3 months Sector PHC - Block PHC drug store - 1 month 4 months DMC drug store - 2 months 6 months State drug store - 3 months 9 months

Forecasting at National/ State/ District level

Forecasting is the process of estimating events or value of events which may occur in the future. It is an estimate based on the values projected from past utilization pattern. Forecasting should include the requirement of buffer stocks that is likely to be required during high consumption periods viz. transmission season. Additionally, it is important that the current stocks are also taken into consideration when calculating the requirements for the next year. The basis of calculation for all items may be on the following lines:

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a. Incidence of Pf malaria for injection Artemisinine. b. Incidence of Pf malaria in areas under second line treatment for surveillance in

the project areas for requirement of RDKs c. Distribution of bed nets/LLINs to BPL population and high endemic areas d. Requirement of Synthetic Pyrethroid (liquid/tablet) for treatment of bed nets

provided under the project and for community owned bed nets which is calculated on the basis of a study carried out by CMIS, indicating that 40% of the community uses bed nets.

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ASSESSMENT OF LOGISTICS REQUIREMENTS This section of the manual suggests procedures for assessing the requirements of antimalarials/ insecticides / larvicides in the State based on the norms set under the programme. Though this can be used to calculate the annual requirement of the logistics, it is imperative that a close track of the stocks available in the State is kept to ensure no excess procurement resulting in possible expiry of the same. At the same time, stock-out situations even in circumstances like unforeseen outbreaks and procurement delays should be kept in mind when assessing the requirements.

Procurement function is the responsibility of NVBDCP Directorate, New Delhi, however with a view to expedite the process funds are now being provided to States for procuring some of the anti-malarial drugs. This function has become a bit of challenge for States especially in terms of assessment of logistics requirement, though the procurement has to be according to action plan based upon positive malaria cases of the last completed year, the space required for storing drugs turn out to be very critical component of drug logistics & inventory management.

Essential Factors for Assessment of Logistics Requirement Following factors need to be carefully reviewed while finalizing the procurement plans at State & National Level:- • Quantity of drugs including buffer to be procured (as per practice 25% of requirement is

taken as buffer) • Drug stocks balance likely to be available at the time of arrival of fresh supplies against

yearly procurement • Whether sufficient storage space would be available at State Drug Stores and/or at

District Drug Stores • Whether the fresh supplies can be staggered into two/three tranches, for management

of storage requirements (this would additionally ensure long shelf-life of the drugs) • Whether the drugs are directly to be shipped to State or the Districts • Whether the bulk of drugs to be stored at GMSDs for regulating supplies to States

according to Stocking Norms • Whether the bulk of drugs to stored at State Drug stores for regulating supplies to

Districts according to Stocking Norms Norms for calculation of anti-malarials The norms for calculation of anti-malarial drugs can be enumerated as follows:

a) The data of positive malaria cases of the last completed year is taken as basis for calculation.

b) 25% additional quantity is to be taken as buffer c) Requirement for each specific drug is based upon treatment regimen in high &

low endemic areas; the requirement has been reflected by way of formula. Considering that an inventory equivalent to six months utilization has to be maintained at District Levels, the requirement has accordingly been multiplied by six in confirmation with stocking Norms. Needless to mention, the drug stocks available shall be deducted for arriving out the requirements/drugs to be issued to each district.

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1. Chloroquine Phosphate: Requirement of Chloroquine tablets (in nos.) = (No of blood slide collected * 30% +25% additional quantity is to be taken as buffer.

2. Primaquine (2.5mg): Requirement for Primaquine - 2.5mg Tabs (in nos.) =

(Total No. of P-vivax cases x 40% x 4 x 14) + 25% additional quantity is to be taken as buffer

3. Primaquine (7.5 mg): Requirement Primaquine 7.5mg for Adult with Pv

Cases = (No. of Pv cases x 60% x 2 x 14) + 25% additional quantity is to be taken as buffer

Primaquine 7.5 mg for Adult with Pf Cases = (Total No. of Pf Cases x 60% x 6) + 25% additional quantity is to be taken as buffer

Primaquine 7.5 mg for Children with Pf Cases = (Total No of Pf cases x 40% x 4 ) + 25% additional quantity is to be taken as buffer

Total Requirement of Primaquine 7.5mg Adult = a+b

4. ACT Combi Pack (only for adult patients): Requirement ACT Combi Pack = (Number of Pf cases *60%*1) + 25% additional quantity is to be taken as buffer

5. ACT PEDIATRIC REQUIREMENT a) Under 1 yr = (No. of Pf cases x 0.4x 0.1) + 25% additional quantity is to be

taken as buffer. b) 1 – 4 Yr age = (No. of Pf cases x 0.4x 0.22) + 25% additional quantity is to be

taken as buffer. c) 5-8 Yr age = (No. of Pf cases x 0.4x 0.3) + 25% additional quantity is to be

taken as buffer. d) 9-14 Yr age = (No. of Pf cases x 0.4x 0.38) + 25% additional quantity is to be

taken as buffer. Total Requirement of ACT Pediatric = a+b+c+d

6. Arteether injection. Requirement of Arteether Injection (in nos.) = (No. of Pf cases x 60 x 10% x 3) + 25% additional quantity is to be taken as buffer.

7. Quinine Injection Requirement of Quinine Injection (in nos.) = (No. of Pf cases x 40% x 10% x 10) + 25% additional quantity is to be taken as buffer. 8. Quinine Sulphate Tab.: Requirement of Quinine Sulphate tablets (in nos.) = (No. of Pf cases x 40% x10% x 30) + 25% additional quantity is to be taken as buffer.

9. Requirement of Rapid Diagnostic Kits (RDKs)

RDKs are to be used in remote, inaccessible and Pf predominant areas where laboratory facilities are not readily available. Around 100 million blood Slides are collected in the country of which 40% are from high Pf endemic areas. Out of it around 40% are from remote inaccessible area. The Programme is

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endeavoring to train ASHAs in the use of RDKs and administration of malaria drugs. RDK use is to be scaled up along with the training of ASHAs. Once the trained ASHAs are deployed in theses areas, around 16 million RDKs would be required; however the present capacity is below 60%.

Requirement of Arteether Injection (in nos.)=Blood Slide Collected (BSC) x 40%+ 25% buffer.l’;,m

10. Long Lasting Insecticidal Nets (LLINs)

LLIN are distributed in high endemic areas and the quantity depends upon the number household & population of each district/states. The distribution of LLINs is based upon supply schedules, and normally inventory is not maintained for regular distribution. The logistic arrangements as such are largely required for interim period between the receipts & onward distribution. Cubic feet volume of a bag of 100 LLIN with dimension of (33” x 33” x 14”) works out to around 8.823 cu ft. and accordingly 100000 LLIN would required storage space of around 8823 Cu Ft. Considering that storage can be made upto 12 ft height, store with floor area of 40’ x 18.5’ can easily accommodate around 1000 bags of 100 LLINs. Additional provision for around 30% space shall be made for movement area.

Storage Space Assessment Ideally the cartons shall be kept in steel racks/shelves and in case sufficient racks are not available the storage can be done on wooden/plastic pellets so as to keep the boxes atleast more than 6” to 8” above the ground level. The cartons/boxes of a particular drug shall be stacked one over the other however such stacking shall normally not exceed more than 8 feet in height; this would eventually take care of the boxes at lower levels from sagging. Storage space is based upon the cubic feet/cubic meter volume of the drug boxes/cartons to be stored upto 8 feet height. The volume of drug stocks thus arrived at shall be converted into floor area of the stores, additionally upto 50 to 70% space shall be estimated for moving area, receipt & dispatch section for State Drug Stores.

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35

LOCATION & STORAGE ARRANGEMENTS

This section of the manual deals with matters relating to location, space and storage arrangements that are required to be instituted at the time of establishing State Drug Stores LOCATION The SDS should be properly located. Key criteria for selecting the site for the SDS are enumerated below:

(1) Access: Insofar as possible, the SDS should have direct/ easy access to transportation vehicles facilitating free movement of drugs to and from the store

(2) Drainage: The location selected should be elevated with a good drainage system

and not be prone to flooding.

(3) Communication: The site/ location selected should have telephone and internet connectivity.

(4) Adequacy of Space Requirement: The SDS should have sufficient space for

accommodating Staff, Equipments & Records as well apart from adequate space for storage of drugs & insecticides.

SHELVES & RACKS Various options for racks & shelves are now available, pre-fabricated slotted angle racks provide most convenient options according to size of the store. Racks can be fabricated according to requirement to accommodate maximum cartons on the shelves and ensure easy identification and movement of drugs and other items. Storage shelves should be fabricated ensuring sufficient ‘gap’ between cartons from the ceiling, floor and walls, facilitating ventilation and the free movement of air. Shelves should be positioned away from the walls so that there is no possibility of seepage into cartons. In case of a long and narrow room, racks should be positioned against the wall. In the case of a broad room, there shall be multiple rows of racks, all parallel to one another. There should be sufficient space between parallel blocks of racks, to facilitate free movement of men and trolleys for the smooth stacking and removal of cartons.

Cartons should rest on shelves and not on each other, to prevent the eventual sagging of the cartons in the bottom row

Other Specifications for the Drug Store Other specifications for the SDS include the following:

(1) The store should preferably comprise one large room. Where multiple rooms already exist, these should be contiguous or proximate to each other

(2) The ceiling must have a height of at least 3 meters

(3) A lockable door

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(4) At least one window with grill

(5) Proper lighting

(6) An even-level, ‘pukka’ floor

(7) Overhead exhaust fan

(8) Plastered walls and ceiling with whitewash without any kind of seepage in the room

(9) Ceiling and side walls should preferably be insulated, ensuring that the ambient temperature during peak summer does not result in damage to anti-malarial drugs.

STORAGE ARRANGEMENTS

Proper organization and maintenance of storage arrangements ensure that quality of supplies particularly of drugs is maintained, theft is minimized and materials are efficiently issued or dispensed for utilization. RDKs & Arteether Injections are required to be stored at specified temperature therefore, proper arrangement for storing the items should be made. The temperature should be maintained during transportation also. Safety from rodents, termites, pests & other insects should be ensured especially for RDKs & Bed Nets. Adequate precautionary measures shall be taken and equipments & gadgets shall be installed to provide safety from menace of rodents & pests. Storage of Insecticides & Larvicides Insecticides & Larvicides must be separately stored away from areas where people or animals are housed and away from water sources, well and canals. They should be located on high ground and fenced, with access only for authorized persons. However, there should be easy access for delivery vehicles and ideally access from at least three sides of the building for fire fighting vehicles and equipment in case of emergencies. Insecticides & Larvicides should not be exposed to direct sunlight, water, or moisture, which could affect their stability. Storehouse should be secure and well ventilated. Containers should be arranged to minimize handling and thus avoid mechanical damage which could give rise to leaks. Containers and cartons should be stacked safely, with the height of the sack limited to ensure stability. Guidelines for Proper Storage

• Store Drugs & Other Supplies in a dry, well-lit, and well-ventilated storeroom, out of direct sunlight.

• Clean and disinfect storeroom regularly. • Secure the storeroom from water penetration. • Ensure that fire safety equipment is available and accessible, and that personnel are

trained to use it. • Store Insecticides & Larvicides separately from drugs.

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• Maintain cold storage, including a cold chain, for commodities that require it. • Store flammable products separately using appropriate safety precautions. • Stack cartons at least 6” to 8” off the floor, and 10” to 12” away from the walls and

other stacks, and no more than 8 ft high. • Store medical supplies separately, away from insecticides, chemicals, old files, office

supplies, and other materials. • Arrange cartons so that arrows point up, and ensure that identification labels, expiry

dates, and manufacturing dates are visible. • Drugs of similar description shall be kept together for easy monitoring & identification • Bin Cards shall be maintained for each drug & other supplies • Store drugs in a manner accessible for FEFO, counting, and general management. • The damaged or expired drugs shall be stored separately.

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EXPIRY MANAGEMENT This section of the manual deals with procedures to be followed for the management of short expiry drugs and immediate steps in dealing with the same so as to ensure their utilization within their shelf-life. The procedures recommended are generic and can be extended to all locations maintaining significant inventories of anti-malarial drugs. Short Expiry Drugs, as the name suggests, are drugs which are left with a short shelf-life & need to be utilized immediately to avoid their expiry. Shelf-life of drug is defined as a period during which the drug will last without deterioration. Overview The storekeeper is expected to install appropriate tools to periodically monitor controls over the expiry position of drugs held in stocks mainly through storage of drugs of a particular description at one place, expiry-wise stacking and marking expiry dates on cartons/drug boxes with marker pens. While acknowledging receipt of drugs, the Storekeeper shall ensure whether sufficient shelf life is available such that it could be administered to patient before the date of expiry of drugs. At least 5/6th of shelf life is required to be available at the time of drugs reaching the GMSD /SDS from the manufacturer. It becomes the responsibility of the storekeeper to confirm that drugs received from the manufacturer have at least 5/6th of balance shelf life. The storekeeper shall strictly follow FEFO (First-Expired-First-Out) principles. However it is also expected of him to exercise due prudence in case of short expiry drugs, wherein the distribution shall be on a rational basis keeping in view the utilization pattern of each district to ensure timely consumption of such close to expiry drugs. Divergence from FEFO principles, at times is necessitated primarily to ensure consumption within the shelf life and accordingly it shall not be taken adversely. The shelf- life of drugs & insecticides accordingly becomes a critical component of inventory management. Shelf-life of Anti-Malarial Drugs The table below gives details of shelf life of anti-malarial drugs procured and minimum available shelf-life that must be available for diversion to any other State:

Expiry Details of Anti-Malarial Drugs procured by NVBDCP

Minimum shelf-life to be available for diversion at State level

Name of Drug Expiry (No. of Years)

Chloroquine Tab

5

Primaquine 2.5mg Primaquine 7.5mg 1 Year Quinine Sulphate Tab Synthetic Pyrethroid (Flow)

2

Arteether Injection Rapid Diagnostic Kits 6 months Artesunate+ Sulphadoxine

Pyremethamine (ACT)

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As is seen from the above table, the shelf-life of Anti-Malarial drugs ranges from 2-5 years after which the chances of losing efficacy and side-effects thereof increase rapidly. Hence, it is important to ensure that appropriate steps are taken as soon as the drugs reach the critical stage, as indicated in the table above to ensure their usage well within their shelf-life. In case of ACT Combination Therapy there are two different dates of expiries, one for Artesunate tab and other for Sulphadoxine Pyremethamine tab, whichever date is earlier of the two date of expiries should be considered as the date of expiry of the ACT Combi blister pack. Shelf Life Analysis of Drug Stocks Detailed analysis of the shelf-life of inventory of anti-malarial drugs shall be done regularly at the time of preparing drug stock reports with a view to identify short expiry drugs which may not be used within their shelf-life and run the risk of getting expired. This analysis shall also be extended to drugs available at various District Malaria Centres to assess consumption of drug stocks within available shelf life.

Remaining Shelf Life Analysis of Drugs (RSLAD: Form Reference 2-B) shall be prepared at SPO’s Office to help achieve the following objectives:

1. Identification of ‘close to expiry’ drugs stocks and conversely stocks with close to ‘full term’ life

2. Determination of balances at risk requiring early corrective action

3. Utilization assessment of such drugs across various DMCs

4. Preparation of Diversion Plan to address the problem of short shelf life drugs, requiring approval by the SPO

The analysis shall be done under close supervision of State Programme Officer (SPO)/ Deputy SPO/Other Authorized Officer, such that immediate steps for diversion of drugs prone to expiry may be taken to ensure their utilization within shelf life. Issue of short-expiry drugs to districts As soon as a decision has been arrived at by the State as regards the quantity of drugs to be issued & diverted, immediate steps for preparation of Drug Transfer Advice shall be taken. Necessary transportation & logistics arrangements shall be made for diversion from one DMC to other DMC or State Drug Stores. Once the DTA is finalized, based upon requirement & utilization assessment of each district, the DMOs need to accept these drugs. Ideally atleast three months shelf life shall remain before the drugs are diverted from one district to another district. The DIVs prepared for such drugs should very clearly state in the ‘Remarks’ column that these are short-expiry drugs and should be used within their shelf-life. The transferee District Malaria Officer (DMO) shall also be impressed upon to make necessary arrangements to ensure utilization of such short expiry drugs within the given shelf life.

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Diversion of short-expiry drugs from the State The States shall frequently assess the availability of anti malarial drugs vis-à-vis the utilization across the State. In case the drugs are in excess far beyond its utilization within the available shelf-life, such drugs shall necessarily be required to be diverted to other States. However it may not be always logistically convenient & feasible to divert drugs from one state to other and ensure utilization in that state. In case the drugs to be diverted are scattered across the state, it becomes all the more difficult and information pertaining to such drugs may not be fully reliable. The drugs to be diverted would need to be transported back to State Drugs Stores from all the DMCs. States shall gather accurate inventory & available shelf life of such drugs and make reasonable assessment of transportation time from District Malaria Centres to State Drugs Stores. Ideally, atleast six months shelf life shall be available when such drugs reach the other State so as to ensure their utilization before expiry. Considering that transportation from District to State Drug Stores and onward transportation to other State may involve atleast three to four months the process of diversion between states shall be initiated in a fairly reasonable time. Accordingly the States are expected to regularly assess the status of drugs availability and utilization thereof especially after taking cognizance of available shelf life of the drugs. Information in respect of excess drugs availability with available shelf-life shall be provided to NVBDCP Directorate, with a request to divert such drugs to other States. On receipt of requests for diversion NVBDCP shall identify the States which can utilize these drugs within the given shelf-life. Both states, transferor as well as transferee shall work in close co-ordination to sort out all transportation & logistics issues after getting the go ahead from the NVBDCP Directorate. Drug Transfer Advice (DTA) shall be sent by NVBDCP to both the States for diversion of drugs, and the states shall put all their acts together so as to ensure utilization before expiry.

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43

PHYSICAL VERIFICATION This section of the manual deals with procedures to be followed for the physical verification at the State Drug Store (SDS) and immediate next steps for dealing with discrepancies determined, if any. The procedures recommended are generic and can be extended to all locations maintaining significant inventories of anti-malarial drugs. Overview Physical verification of the inventory of anti-malarial drugs thereof with store records shall be carried out under the supervision of the State Malaria Officer (SPO)/ Deputy SPO/Other Authorized Officer at the following times:

Regularly at the end of each month Surprise checks during the year At the year-end.

Procedures recommended for the above are detailed in the paragraphs that follow. Monthly Verification The SDS Storekeeper shall perform the following activities under the supervision of the Second MO (or other officer nominated by the SPO) on the last working day of every month:

Count and determine the number of Cartons / Boxes / Strips physically available at the store, for each of the drugs dealt with by the programme and record details thereof in the Physical Verification Sheet (PVS: Form Reference 1 L) Also record the number of Cartons/ Boxes/ Strips that should be available at the SDS as per the Bin card & the Stock Register, for all drugs. The quantity in the bin card, the stock register & the physical quantities must tally at all times. Determine and record discrepancies between stocks as per physical count and the SR, in the PVS Attempt to eliminate discrepancies between stocks as per physical count. The following common causes for discrepancies shall be checked during this process: Confirm that all transactions have been properly incorporated in the SR viz.: Determine all transaction documents for the specified period on the basis of first and last pre-numbered authorized documents. For example, consider all Issue Vouchers pertaining to the SDS for the particular month, etc. Ensure that all of the above have been posted to the SR (Note: The above steps would readily apply only to issues, where SDS Issue Vouchers are consecutively numbered. In the case of receipts- there are multiple source documents e.g. SO, RO, CRC /CAC, SIV of transferor stocking unit, etc. and these are not consecutively numbered for the SDS. For such cases, SDS shall have to request each consignor to list all transaction documents raised by them during the period, so that these can be traced into the SR.)

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Where it is found that transaction documents have not been posted to the SR, it suggests that either there has been an omission, or alternately, stocks are still in transit and have yet to be received

Confirm that all pre-numbered documents for receipts and issues for the period have been posted to the SR

Check totals of all receipts and issues, ensuring that there are no arithmetical inaccuracies Correlate issues with the number of patients put on treatment during the period

The SPO/ Deputy State Programme Officer/ Second Medical Officer/ Nominated Officer shall review and sign-off the PVS after thorough verification, comprising the following steps:

Validate that all receipts have been recorded in the SR, based on first and last and/or discrete numbers of related documents confirmed by the suppliers Validate that all issues have been recorded in the SR, based on first and last and/or discrete numbers of related issue documents Compare transaction entries in the SR with related documents such as the set of documents received along with/ after the receipt of drug consignment, etc. Verify that details of Batch of Manufacture and Date of Expiry of anti-Malaria drugs are consistently recorded in the SR at the time of receipt of each consignment. Also that the SR indicates expiry details in respect of drugs available in inventory Confirm evidence of periodic, independent checking of the SR through the recording of observations/ comments and signatures of concerned programme officers Compliance with key best practices such as First Expiry First Out (FEFO), proper stacking and housekeeping, etc Un-reconciled discrepancies determined through the above process should be reported to the SPO, Health Secretary for the State and NVBDCP. (Note: In the case of shortage, steps must be initiated for recovery of the cost of discrepant drugs from the person responsible. If the SPO assesses there is genuine reason for the discrepancy, he may recommend waiver of recovery to the Competent Authority. Only the Competent Authority for the State should authorize waiver of recovery. This should be allowed in exceptional cases only). Pursuant to review as above, the PVS shall be forwarded to the SPO in the first week (i.e. by the 7th day) of the next month.

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Surprise Checks during the Year The State Malaria Officer (STO)/ Deputy State Malaria Officer shall conduct surprise verification of anti-Malarial drug stocks at each of the State Drug Stores in the state. Procedures to be followed for surprise verification shall be on the same lines described above for monthly verification. PVS documenting outcomes of physical verification should be immediately sent to NVBDCP, in case of unexplained discrepancies. Year-end Verification and Reconciliation Procedures described in paragraphs above for monthly verification are also to be repeated on the last working day (i.e. March 31) of every financial year. The PVS documenting outcomes of this exercise shall be sent to NVBDCP in the first week (i.e. by the 7th day) of April. (Notes: Cases of shortage or damage to drugs, due to rodents/ pests/ fire/ seepage/ pilferage or expiry of drugs found during physical verification, shall be fully investigated by the SPO’s Office and reasons for the same incorporated in the year-end PVS, prior to forwarding to NVBDCP) Copy of PVS prepared at the time of monthly/ surprise check/ annual physical verification of drug stocks should be filed securely/ hard bound periodically and available with the SDS at all times).

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47

COMMUNICATION AND INFORMATION TECHNOLOGY INFRASTRUCTURE

This section of the manual deals with Communication and Information Technology (CIT) infrastructure needs, that are required to be established at the State Drug Store (SDS) and District Malaria Centers (DMCs). Overview CIT infrastructure comprises the backbone for the efficient functioning of the programme and its importance cannot be overemphasized. The following CIT infrastructure facilities are anticipated for the smooth functioning of the SDS(s) and DMCs: Telephone Computer Fax Internet. Facilities at SDS CIT infrastructure needs for SDS(s) are discussed in more detail in the paragraphs that follow. Telephone Each SDS should have an independent telephone connection. The telephone facility is essential for coordination and follow-up with NVBDCP, Manufacturer(s), GMSD(s) and/or other SDS(s), to ensure timely receipt of drugs. Conversely, the direct phone line shall enable DMCs and subordinate units to contact the SDS for the purposes of requisitioning and following-up for the timely dispatch of drugs. The dedicated telephone line shall also facilitate monitoring of the drug situation at DMCs and various units by the SDS Storekeeper and making arrangements for the emergency supply of drugs to units, as necessary. Direct (not shared) phone access is assessed to be critical for the SDS and an independent telephone line is recommended, even where the store is a part of the SPO’s Office or a Hospital or a Health Center, having existing telephone facilities. Depending on local needs, the SDS Storekeeper may be expected to spend several hours daily at the SPO’s Office, during which period the telephone at the SDS shall remain unattended. To deal with such situations, the telephone number of the Deputy SPO should be circulated to DMCs and subordinate units, so that important messages can be taken and relayed to the SDS Storekeeper through the Deputy SPO’s Office.

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Computer Each SDS should preferably have an independent computer*. The computer shall be required to enable the functions of Inventory Tacking, Reporting, Analysis and Demand Forecasting to be carried out by the SDS. The computer shall also facilitate the exchange of correspondence by the SDS through email, regarding the receipt/ issue of drugs, sending/ receiving inventory reports and related matters. (* The term computer includes Internal/ External Modem, Printer, UPS and Computer Table) In cases where the SDS is located at and is part of the SPO’s Office and it is not possible to provide the store with an independent computer, it shall share the computer available at the SPO’s Office. Fax Fax facility shall be needed by the SDS primarily for receiving advance intimation of supplies, copies of reports, Additional Drug Requests from DMCs, etc. (Note: It is likely that with improvements in internet connectivity, across the country, there shall eventually be no need for fax facilities at SDSs/ DMCs. However, given the current state of connectivity and the fact that several participants in the drugs logistics chain viz.- PHC’s/ SubCentres/ Transporters, etc.- today have easier access to fax machines- there is presently a clear need for fax facilities. Additionally, documents generated by external/ third parties and not available on the computer system, shall require to be scanned prior to their transmission and this function is performed simultaneously by the fax machine). In cases where the SDS Storekeeper spends a significant part of his working day at the SPO’s Office, an independent fax machine may not be necessary and incoming faxes can instead be received at the SPO’s fax machine. The fact that the fax machine is a shared facility should be emphasized in internal directories circulated to NMCP units and message senders requested to clearly mark all fax messages ‘Attention: SDS Storekeeper.’ An independent fax machine is preferable, even in cases where the SDS is located at a Hospital or a Health Centre that already has a fax machine. In case an independent fax machine cannot be provided, it should be ensured that all the faxes for the SDS are being forwarded to it by the Hospital / Health Center without fail, delay or confusion. Internet Connectivity Internet connectivity shall be required by the SDS for receiving and sending reports on drug logistics and email communication with various entities. The SDS computer would have to be email enabled for the purpose (viz. fitted with an internal/ external modem and wired accordingly). Additionally, the SDS and/or the Storekeeper would require an email id, as well as a dial-up account or equivalent facility, to connect with the Internet. Direct internet connectivity is assessed to be critical for the SDS and an independent internet connection is recommended, even where it is a part of a Hospital or a Health Center, with existing internet facilities. The SDS shall share internet facilities available at the SPO’s Office where it does not have a direct computer. An independent email id for the SDS and/or storekeeper shall however, still be required.

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STAFFING REQUIREMENTS

This section of the manual deals with staffing and reporting requirements for the efficient discharge of the stores and logistics function at the State Drug Store (SDS) and other stocking units of the programme. Overview SDSs and other stocking units shall generally need the following staff to deal with the stores and logistics function: Pharmacist Helper Staffing and reporting requirements in respect of the above resources at the SDS and other stocking units are summarized in the matrix given below: Staff/ Reporting SDS DMC Block -PHC Sub Centre Staffing Requirement:

Pharmacist/storekeeper Required Required Not Required* Not Required*

Reporting by above Drug Stores Staff:

Deputy SPO/ Second Medical Officer

DMO/ MO In-charge

MO In-charge of PHC

* If Pharmacist is not available, the MTS/SMS (Malaria Technical Supervisor/ Superintendent Medical Supervisor) shall take care of the work. Qualifications/ skills required to be possessed by staff at the SDS are discussed in the paragraphs that follow. Pharmacist The Pharmacist shall be responsible for all operations at the store including the upkeep of stores records. The educational qualification of the Pharmacist shall comprise a degree or diploma in pharmacy. In addition, the Pharmacist should also possess excellent computer skills, as s/he shall be required to prepare and analyze inventory reports. Helper In addition to the above regular positions, the stocking unit shall hire the services of a watchman/ helpers, on a need basis, for the purpose of loading/ unloading / stacking drugs from or to the store.

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SECURE CUSTODY This section of the manual discusses arrangements to be instituted at the State Drug Store for assuring secure custody of drugs to safeguard against the occurrence of theft, fire, seepage, ingress of pests, etc. Key practices that may be instituted in this context are discussed below. Storage under Lock and Key A simple precaution to safeguard drugs is to restrict access to authorized persons and ensure that the store is locked when unattended or after office hours. The work place of the storekeeper may be at a separate location and s/he would visit the store only for the purposes of receipt/ issue of drugs or similar transaction. In all such cases, the drug store should always be locked whenever the storekeeper is not on site. There should be only a single duplicate key to the store and this should be in the custody of the concerned, superior officer. Security Guard (Optional)

1) Hiring of security guard may be considered if it is assessed that the value of the drugs on hand and at risk, warrants this expenditure (e.g. at the State Drug Store where significant quantities of drug stocks are maintained).

2) A security agency may be engaged for this purpose. Liability of the security agency for theft of materials from stores should be established under a binding contract.

3) Liability as above shall not limit the accountability of the SDS Storekeeper for all loss of drug stocks from stores.

4) Duties and responsibilities of the security guard should be carefully framed. His involvement with in-store transactions should be limited to validation of the quantity of incoming and outgoing materials vis-à-vis authorized documents.

Prevention of Fire

1. Outbreak of fire can be minimized, by preventing the following activities in stores:

a) Smoking b) Storage of flammable materials c) Lighting of stoves, burners, heaters, etc.

2. Fires are frequently caused by electrical faults. Possibility of occurrence can be

minimized through periodic inspection of the condition of electrical wiring, preferably by an electrical engineer.

3. During inspections, evaluation should also be made of the capacity of the electrical meter and wiring to withstand the maximum load of installed equipments. Corrective steps should be initiated in case of imbalance.

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Fire Extinguishers

1. In addition to the above preventive steps, fire-fighting equipment should in any case be installed to deal with the outbreak of fire.

2. Multiple fire extinguishers should be installed commensurate with the area of the store and materials at risk.

3. Storekeeper and security guards (if any), should be trained to operate the fire extinguishers.

4. Fire extinguishers should be frequently inspected to ensure that they are always in working condition.

5. Timely change/ refill of chemicals inside the fire extinguishers should be ensured through an AMC with a reliable contractor.

Periodic Inspection Periodic inspection should be carried out (at least once in a quarter), in respect of the following:

(1) Electrical wiring (2) Fire extinguishers (3) Any seepage / dampness in the roof / walls (4) Termites, pests, rodents etc.

Timely corrective steps should be initiated in case of any negative observation.

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ARRANGEMENTS FOR TRANSPORTATION

This section of the manual discusses arrangements for the transportation of drugs from the State Drug Store (SDS) to various stocking units constituted within the state under the programme. The SPO shall enter into an agreement with one or more transporters for the distribution of supplies from the State Drug Store(s) to DMCs, with provision for onward distribution there from to PHCs. The State should ensure that the transportation arrangements being contracted would be speedy and economical and that the transporter would adhere to good transportation practices so as to maintain drug quality.(Note: The above shall be applicable only in case the state does not have arrangements for transporting drugs and the SDS is used exclusively for storing anti-malarial drugs). It is also important that the transporter is alerted beforehand that due care needs to be taken when transporting Pesticides as these should not be transported in the same vehicle as items such as agricultural produce, food, clothing, drugs etc as these items could get contaminated. The agreement with the transporter shall define rates to be charged on a per carton/ per km or alternate basis for transportation from the SDS(s) to each of the DMCs and/or other locations, within the State. The following preparatory activities performed by the Deputy SPO/ Second Medical Officer/ Other Authorized Officer, shall typically precede the execution of the transporter agreement: 1) In consultation with the SPO, compile a list of all locations that are covered/ likely to be

covered by the NVBDC Programme during the year, such as, all SDSs and DMCs within the state, SDSs in neighboring states, GMSDs in the region, etc. In case there is more than SDS in the state, SDSs along with their routine feeding districts shall be enlisted.

2) Identify leading transporters operating at the state-level and national level with the fleet-size and reach to service destinations as above.

3) Request priced quotations/ bids from the above, indicating per carton/ per km freight rate and guaranteed pick-up and delivery times valid through the year for shipments from SDS to various district destinations.

4) Review bids received from transport companies and shortlist on the basis of economy, demonstrable experience, coverage of destinations and turnaround time efficiency.

5) Discuss shortlisted options with SPO and make final selection. (Note: It may also be a good idea to share details of rates negotiated with SPOs in neighboring states, as similar rates are likely to prevail in the region).

6) The agreement executed with the selected transporter should incorporate the following

clauses:

a) Guaranteed pick-up within 24 hours of request

b) Guaranteed delivery within 24-72 hours (may be increased in case of remote or difficult to reach locations) of pick-up to all district destinations

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c) Provision for freight payment, both on, ‘Paid Basis’ or ‘To Pay Basis’ d) Submission of Proof of Delivery (POD) along with bills for freight charges

e) Compliance with all documentation needs of the project

f) No escalation of freight rates during the contract period.

g) Liability for in-transit shortage/ breakage/ damage.

h) Recourse to alternate transportation arrangements in case of failure by transporter to

lift goods within the agreed turnaround time. The transporter shall be liable to pay additional costs incurred over the contracted rate in all such cases.

i) Recourse to pre-defined penal adjustments to freight rates in the case of delay in lifting and/or receipt of drugs at districts vis-à-vis agreed turnaround times.

j) Vehicle break down, seasonal variations in access routes, safety along specific supply lines and other local factors should also be included in the planning process

These guidelines contemplate use of the transporter for dispatches from the SDS to DMCs only. Onward dispatches from DMCs to PHCs are currently expected to be effected through the existing system.

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MIS FOR DRUG LOGISTICS This section of the manual describes a tentative Management Information System (MIS) serving the managerial control needs of the officer designated to oversee drug logistics at the SPO’s Office. Traditionally two parameters are considered to be critical with respect to drug logistics:

(1) Ensuring uninterrupted supply of antimalarials to patients

(2) Safe guarding against expiry of drugs Reporting protocols for SDS instituted under the programme have attempted to address the above. The additional reports proposed in this section of the manual endeavor to provide enhanced managerial control over drug stock adequacy and expiry:

(1) Adequacy of Drug Stocks (ADS: Form Reference 2 – A)

(2) Remaining Shelf-life Analysis of Drugs (RSLAD : Form Reference 2– B) The above reports are discussed in the paragraphs that follow. Adequacy of Drug Stocks (ADS) The ADS Report shall enable the following:

(1) Monthly review of the adequacy of drug balances with stocking units vis-à-vis recommended stocking norms.

(2) Provide information for the purposes of stock transfers and/or early replenishment

action Remaining Shelf-life Analysis of Drugs (RSLAD) The RSLAD Report enables the following:

(1) Identification of ‘close to expiry’ drugs stocks and conversely stocks with close to ‘full term’ life

(2) Determination of balances at risk requiring early corrective action (3) Preparation of a tentative plan to address the problem of short shelf life drugs,

requiring approval by the SPO Formats and detailed descriptions in respect of each of the above reports have been provided in Appendix 2 to this manual.

Appendices

56

Appendices

57

AAPPPPEENNDDIIXX 11

(List of Operational Formats Available in this Appendix)

Title Reference

Bin Card (BC) 1–A

Stock Register (SR) 1–B

NVBDCP Release Order (NVBDCP-RO) 1–C

Drugs Transfer Advice (DTA) 1–D

State Issue Voucher (SIV) 1–E

Monthly Receipt Report (MRR) 1–F

Monthly Report on Drug Logistics (MRDL) 1-G

Worksheet for Reporting Drug Requirement: WRDR:DMC/Sub-centre/Block PHCs

1–H

State Release Order (State RO) 1 - I

M1 Report 1–J

M4 Report 1–K

Physical Verification Sheet (PVS) 1–L

List of the Drugs, Insecticides, Larvicides, Rapid Diagnostic Kits (RDKs), Long Lasting Insecticidal Nets (LLINs) used under National Vector Borne Disease Control Programme

1-M

Appendices

58

Appendices

59

Appendix 1–A BIN CARD (BC)

Drug Item: Unit of Measurement (UOM):

Particulars of Receipts & Issues Quantity wise date of

expiry of balance (Qty.) S.No.

Date of Tran-saction (Receipt/ Issue)

Name of Party (SDS/ DMC)

Invoice No. Receipt Voucher No.(For Receipts only)

Issue Voucher No. (For Issues only)

Date of Invoice/ Receipt Voucher/ Issue Voucher

Batch No.

Date of Expiry

Receipt (Qty.)

Issue (Qty.)

Balance

(Qty.)

Expiry Date (…)

Expiry Date (……)

a B C D e F g h i J k L m

Notes: 1) Please use separate Bin Cards for different drug items 2) In case the receipt/ issue transaction involves more than one batch, please use separate rows for

separate batches 3) Fresh balance is to be struck on each transaction date, comprising the brought forward balance quantity

plus receipts and less issues 4) Expiry date columns are for enabling tracking of expiry of drugs on hand. Expiry date shall be

superscribed on the top of the column at the time of receipt of drugs and the quantity in the appropriate row. This quantity will be carried forward without change, till the time of an issue or receipt, involving that batch of drugs

5) The total of quantities reflected in columns l, m, n and o, should be equal to balance quantity reflected in column k.

Appendices

60

Appendix 1–B STOCK REGISTER (SR)

Drug Item: Unit of Measurement (UOM): Folio No.:

Sl. No.

Particulars of Receipts & Issues Receipt (Qty.)

Issue (Qty.)

Balance (Qty.)

Date-wise expiry details of balance (Qty.)

Signa-ture of Store-Keeper

Remarks

Date (Dd/ mm/ yy) of

Tran-saction

(Receipt/ Issue)

Name of Party

(Supplier/ GMSD/ SDS/ DTC)

Invoice No./ Receipt

Voucher No. (For Receipts

only)

Issue Voucher No. (For Issues only)

Date of Invoice/Receipt Voucher

/Issue Vou-cher

Batch No.

Date of Expiry

Expiry Date (…)

Expiry Date (……)

Expiry Date (……)

Expiry Date (……)

a b C D e f g H I j k l m N o p Q

Opening Balance

Notes: 6) Please use separate Folios (viz. Stock Register Sheets) for different drug items 7) In case the receipt/ issue transaction involves more than one batch, please use separate rows for

separate batches 8) Fresh balance is to be struck on each transaction date, comprising the brought forward balance quantity

plus receipts and less issues 9) Expiry date columns are for enabling tracking of expiry of drugs on hand. Expiry date shall be

superscribed on the top of the column at the time of receipt of drugs and the quantity in the appropriate row. This quantity will be carried forward without change, till the time of an issue or receipt, involving that batch of drugs

10) The total of quantities reflected in columns l, m, n and o, should be equal to balance quantity reflected in column k.

Appendices

61

Appendix 1–C No. 14-1/2008-09-NVBDCP/EVBDCP-Diversion (All ITEMS)

Government of India Directorate of National Vector Borne Disease Control Programme

22 – Sham Nath Marg, Delhi – 110 054

Dated: ……………… To Govt. Medical Store Depot, (Address of GMSD) (Telephone & Fax Number) Subject: Diversion of ____________________ (Malaria) from GMSD, ____________to SPO,

_____________ state. Sir,

The release order for supply of ___________ nos. of ______________ for Malaria is hereby placed on you as per consignee address given below. You are requested to divert the material immediately on receipt of mode of transportation from the consignees end.

Yours faithfully

Joint Director Copy to: Consignee 1:

1. Joint Director (Consignee 1) : Address 2. Sate Programme Officer / State Drug Store : Address 3. Regional Director : Address

Consignee 2:

4. Joint Director (Consignee 2) : Address 5. Sate Programme Officer / State Drug Store : Address 6. Regional Director : Address

Name of the GMSD Stock in GMSD (Qty

in Nos.)

Details Consignee with full Address

Qty. to be dispatched

Govt. Medical Store Depot, ___________________. ___________________ ___________________

Nos. with DOE as

The Joint Director (Consignee 1) ____________________ ____________________ ____________________

__________

The Joint Director (Consignee 2) _____________________ _____________________ _____________________

__________

Total ________ Total ________

Appendices

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Appendix1–D

DRUG TRANSFER ADVICE (DTA) No. Dated:

Name of State (SDS)/District: ______________________________________

Full Name of SPO/DMO: _________________________________________

Office Phone of SPO/DMO (Pl. includes STD Code): _______________________

Please ensure transfer of anti-Malarial drugs to _________________________ (Name of District with Complete Address and Phone No.) under the charge of Dr.____________________________ (Name of SPO/DMO), as per the details below, under advice to us.

Sl. No. Drug UOM Quantity Transfer Date

(a) (b) (c) (d) (e)

Authorized Signatory: Date:

Notes: 1. This form shall be used for directing transfer of drugs by NVBDCP from one SDS to other, and also by

SPO for transfer of drugs from one district to other district. 2. Transferor shall send copy of Issue Voucher (SIV or DIV) to the authorizer of this DTA, in confirmation of

execution of transfer, along with details of transporter. 3. In case DTA is generated by SDS/SPO then SPO shall be the authorized signatory to DTA. If NVBDCP

generates DTA then Director (NVBDCP)/CMO (NVBDCP)/Authorized Officer, NVBDCP, shall be the authorized signatory.

4. Transferee district shall send the acknowledged copy of SIV or DIV, in confirmation of receipt of drugs, along with the folio of the Stores Register in which receipt of the drug item has been recorded.

5. In case of short expiry drugs, a cautionary note should be placed on SIV or DIV, urging immediate utilization.

6. Officials from both, transferor as well as transferee shall coordinate, to ensure quick execution of transfer.

Appendices

63

Appendix 1–E STATE ISSUE VOUCHER (SIV)

Issue Particulars: Dispatch Particulars:Issued To (Name of DMC/SDS)……… 1. Dispatched By (Name of

DMC/SDS)…………………

SIV No. ……………… 2. Name of Transporter: …………….

SIV Date ………….. 3. LR/ RR/ ST No.: ……………

Issue Authorization Document: WRDR/ADR/DTA/with Date of Approval………………….

4. LR/ RR/ ST Dated: ……………………..

S. No.

Drug UOM Quantity Issued

Batch No.

Date of Expiry

Stores Register Folio No. of Issuer

Stores Register Folio No. of Recipient

Remarks

(a) (b) (c) (d) (e) (f) (g) (h) (i) DRUGS

1 Chloroquine Tablet

2 Primaquine 2.5mg Tablet

3 Primaquine 7.5mg Tablet

4 Artisunate Tablet

5 Sulphadoxine Pyremethamine Tablet

6 Combi Pack ACT Tablet

7 Combi Blister Pack (CQ+PQ) Tablet

9 Arteether Inj Vials

12 Plain Bed Nets

13 LLINs

14 Malathion Technical Wdp

15 Synthetic Pyrethriod Wdp

16 Temephos Ltrs

17 Pyrethrum Extract Ltrs

KEY: UOM: Unit of Measurement; LR: Lorry Receipt; RR: Railway Receipt; ST: State Transport Receipt

Signature of Issuing Storekeeper:

Signature and Stamp of Transporter:

Signature of Recipient Storekeeper:

Signature of Issuing Officer:

Signature of Recipient Officer:

Notes:

1. Stores Register Folio No. is to be given both by the issuer and recipient of drug stocks and comprises the page number of the Stock Register on which the issue/ receipt is recorded

2. Signature and stamp of the storekeeper/ authorized signatory of both the issuing and the recipient unit are to be provided in the SIV.

Appendices

64

Appendix 1–F MONTHLY RECEIPT REPORT (MRR)

Name of the State:

Month:

Supply status of Anti-Malarial Drugs/ Insecticides/ Larvicides/ RDKs & Bed Nets

S.No Name of the commodity

Quantity Received (Unit of Measurement)

NOA Reference/Order No.

Date of Receipt

Date of Manufacture

Date of Expiry

Name of Supplier/ Received from

Anti- Malarial Drugs 1 Chloroquine Phosphate Tab. 2 Primaquine Phosphate 2.5 mg Tab. 3 Primaquine Phosphate 7.5 mg Tab. 4 Quinine Sulphate Tab. 5 Combi Pack (CQ+PQ) 6 ACT combiblister pack 7 Sulphadoxine Pyremethamine Tab. 8 Artesunate Tab. 9 Injection Arteether

10 Quinine Injection 11 RD Kits for Malaria Insecticides

12 SP(wdp) 13 Synthetic pyrethroid liquid 14 Synthetic pyrethroid(wdp) 15 DDT 50 % Larvicides

16 Temephos 17 Pyrethrum Extract 2 % 18 Primiphos Methyl Bednets/ITN

19 LLINs 20 Mosquito Bed nets Kala-Azar

21 SSG Inj 22 Amphotericine B Inj 23 RK39(Kala Azar) 24 Cap. Miltefosine 10 mg 25 Cap. Miltefosine 50 mg Filaria

26 Albebdazole Tab. 400mg 27 DEC Tab.

Appendices

65

Appendix 1–G

Monthly Stock Repot of District (MRDL-DMC)

Approved by: District Malaria Officer

S. No.

Drugs Opening Balance first day of the

month (DMC+PHC)

Quantity Received Trf. out (to District)

if any

Total (f)

Consumption at PHCs in this

month

Balance as on last day of the

month

Quantity with Date of Expiry

(a) SDS (b)

Supplier (c)

Trf. In (from District) if any

(d)

(e) f=a+b+c+d-e

(g) h=f-g Quantity Date of Expiry

1

- -

2

- -

3

- -

4

- -

5 6 7

Appendices

66

Monthly Stock Repot of State (MRDL-SDS)

Approved by: State Programme Officer

S. No.

Drugs

Opening Balance

first day of the month

Quantity Received Trf. out to State if any

Total Quantity

(f)

Quantity issued to

the Districts

Balance as on last day of the

month

Quantity with Date of Expiry

(a) GMSD (b)

Supplier (c)

Trf. In from State if any

(d)

(e) f=a+b+c+d-e

(g) h=f-g Quantity Date of Expiry

1

- -

2

- -

3

- -

4

- -

5 6 7

Appendices

67

Appendix 1–H

WORKSHEET FOR REPORTING DRUG REQUIREMENT: (WRDR - DMC)

Consolidation of PHC Drug Stores at District level S.NO Stocking Unit

PHCs Opening Balance

Received during the

month Transfer

In Transfer Out

Total Quantity Utilization

Issues to Block PHCs

Closing Balance

Qty Reqd

DMC SDS 1 PHC-1 XXXX XXXX XXXX XXXX 2 PHC-2 XXXX XXXX XXXX XXXX 3 PHC-3 XXXX XXXX XXXX XXXX 4 PHC-4 XXXX XXXX XXXX XXXX

Sub Total

District own stock XXXX XXXXXX

Total

Appendices

68

WORKSHEET FOR REPORTING DRUG REQUIREMENT: (WRDR - STATE)

Consolidation of District Drug Stores at State level

S.NO Stocking Unit

Districts Opening Balance

Received during the month

Transfer In

Transfer Out

Total Quantity Utilization

Issues to DMCs

Closing Balance

Qty Reqd

SDS Supplier/GMSD 1 DMC-1 XXXXXX XXXXX 2 DMC-2 XXXXXX XXXXX 3 DMC-3 XXXXXX XXXXX 4 DMC-4 XXXXXX XXXXX

Sub Total

State own stock XXXX XXXXX

Total

Appendices

69

Appendix 1–I

STATE RELEASE ORDER (STATE-RO)

Dated: …………………

(OFFICE MEMORANDUM (SDS --------------/Year/ No… )

Sub: Supply of Anti-Malarial drugs to District Malaria Centres of ______________(State/UT)

Please supply the following anti Malaria drugs to District Malaria Centre

………………….. : -

S. No. Drugs A/U Qty. DOE 1 2 3 4 5 6 7 8 9 10

State Programme Officer To State Drug Store - Address Copy to: - District Malaria Centre (Address)

Appendices

70

Appendix 1–J

Format M1 for ASHA, ANMs, HWs (Drug Logistic Part)

Stock Position RDT

Combi-blister pack CQ

ACT packs

AS tablets

SP tablets

PQ small

PQ Large Slides Lancets

Opening Balance

Received during the month

Total of above

Utilization

Balance

Appendices

71

APPENDIX 1–K

Format M4 for Sub-Centres and PHCs (Drug Logistic Part)

Stock Position RD

T

Com

bi-b

liste

r pa

ck

CQ

AC

T pa

cks

AS

tabl

ets

SP ta

blet

s

Inj A

rtee

ther

at

PH

C

PQ s

mal

l

PQ L

arge

Slid

es

Lanc

ets

Opening Balance

Received during the month

Total of above

Utilization

Balance

Appendices

72

APPENDIX 1–L

PHYSICAL VERIFICATION SHEET (PVS)

Reporting Unit: SDS/ DMC

Date of Physical Verification conducted:

KEY: UOM: Unit of Measurement; QTY: Quantity; SR: Stock Register

PREPARED BY: ____________ REVIEWED BY: __________

APPROVED BY: ______

S. NO. Drug UOM Qty & DOE as per stock

register

Qty & DOE as per

physical count

Discrepancy between stock

register and physical

count

Nature of discrepancy

How discrepancy was dealt with

Remarks

(a) (b) (c) (d) (e) (f=d-e) (g) (h) (i)

Appendices

73

APPENDIX 1–M

List of the Drugs, Insecticides, Larvicides, Rapid Diagnostic Kits (RDKs), Long Lasting Insecticidal Nets (LLINs) used under National Vector Borne

Disease Control Programme

Centralized Drugs, Insecticides, Larvacides, Rapid Diagnostic Kits, LLINs under NVBDCP

MalariaSl. No Name of the Items 1 Chloroquine Tab 250 Mg

2 Combi Pack ACT(Artisunate Tab + Sulphadoxine Pyremethamine Tab)

3 Artisunate Tab 50 mg 4 Sulphadoxine Pyremethamine Tab 500 mg 5 Artheeter Inj 150 mg 6 Quine Diahydrochloride inj 2 ml 7 Rapid Diagnostic Kits 8 Synthetic Pyrethroid (wdp) 9 Synthetic Pyrethroid (liquid) 10 Mosquito Bed Net 11 Long lasting insecticide treated Bednets 12 DDT(MTs) 13 Malathion (Technical) 14 Malathion 25 % (wdp) 15 Temephos 50% EC (Clean water) 16 Pyrethrum Extract 2% 17 Primiphos Methyl (polluted water)

Kala Azar1 Rapid Diagnostic Kits 2 Miltefosine Cap 50 mg 3 Miltefosine Cap 10 mg 4 Sodium Stibo Gluconate inj 30 ml 5 Amphotericin B 50 mg 6 DDT (MTs) for Kala Azar Filaria1 Diethlcarbamazine citrate tab (DEC) 100 mg 2 Albendazole 400 mg

Miscellaneous Items1 Vehicles 2 Stirrup Pump 3 Other Consumables

Appendices

74

Appendices

75

AAPPPPEENNDDIIXX 22

List of MIS Formats Available in this Appendix

Title Reference

Adequacy of Drug Stocks (ADS) 2–A

Remaining Shelf-life Analysis of Drugs (RSLAD) 2 –B

Appendices

76

Appendices

77

APPENDIX 2–A

ADEQUACY OF DRUG STOCKS (ADS)

Stocking Unit: _____________ Month Ending: __________

Transfers

in / (out)(a) (b) (c) (d) (e) (f) (g) [h=(e/g)] [h=(g * SN)] [i=(h-e)] (j) [k = (e±j)] (l)

Monthly U tilization

Availability in terms of monthly utilization

Requirem ent for next

quarter (Qty)

Shortfall in availability

Adjusted closing stock

R emarksS. N o.

SSU Drug UOM Closing Stock

Quarterly Utilization

KEY: SN: Stocking Norm; SSU: Sub-Stocking Unit

PREPARED BY: __________________ APPROVED BY: _________________

Appendices

78

APPENDIX 2–B REMAINING SHELF-LIFE ANALYSIS OF DRUGS (RSLAD)

Month/ Quarter Ending: _______________

(a) (b) (c ) (d) (e) (f) (g) (j) (k) (l) (m) (n)

Recommended ActionMonth

( )Month ( )

Month ( )

Month ( )

Next six months ( - )

Next six months ( - )

More than 18 months

Name of Drug

Stocking Unit (SDS/ DMC)

Closing Balance

(Qty.)

Expiry-wise breakup of drugs held in stocks i.e. drugs expiring within :-(Name the months in respective columns in ascending order)

Average monthly

utilization

Appendices

79