Managing Procurement and Logistics of HIV/AIDS Drugs and

Related Supplies

Abuja, NigeriaMay/June 2005

Storage, LMIS, Inventory Management and Distribution

Timothy O’Hearn, MPHJohn Snow, Inc. / DELIVER Project

Key Topics for the Day

•Storage •LMIS• Inventory Control

•All are part of inventorymanagement!

Topic Discussions Today Will Include:• Some commonly faced constraints

(Storage, LMIS and Inventory Control)• Examine some of the interventions that

have been developed to face those constraints

• Provide some resource material• We will be focusing on the broader

picture today, and not looking at specific details of supply chain management.

DELIVER’s Logistics Cycle

Cross-Cutting Issues

1. Full supply or limited supply commodities

2. Integrated Systems or Vertical Systems

• These issues are not unique to anyindividual topic area, but can have major ramifications on all elements their supply chain.

What is Full Supply?

• Full Supply – Commitment and financing available to purchase enough of the commodity to cover all the demand or need.

What is Limited Supply?

• Limited Supply – Are those products for which the demand far exceeds the program or system’s capacity to supply them.

Why is it Important to Know if Products Are in Full or Limited Supply Relating to SCM?

• Full Supply – Forecasting can be done for full supply products

• Limited Supply – Short-term quantification

• Using Pull Vs. Push Systems -relating to full and limited supply

Integrated Systems Vs. Vertical Systems• What is meant by these terms?• What are you doing in your countries?• Have HIV/AIDS programs been Integrated

in other essential drug systems?

Integrate Vs. Not to IntegrateThese are critical issues to consider – for special program commodities such as those for HIV/AIDS, TB or malaria, do you integrate (or not) into existing systems?

Integrated Systems Vs. Vertical Systems (Contd.)

• The decision you make will determine different strategies for inventory management, storage and distribution.

1st Topic - Storage

1. Purpose of Storage -Protect the quality of the product and its packaging throughout the supply chain.

2. Make product available for distribution.

Key Issues To Consider For Storage

• Type of product(cold chain/temperature)

• Type of facility• Equipment

(racking, material handling equipment, etc.)

• Distribution

Constraints For Storage of HIV/AIDS Commodities

General Constraints:• Inadequate space• Inadequate security (locking shelves)• Temperature/cold chain requirements)• Lack of storage equipment• Operating according to FEFO (first-to-expire,

first-out)• Disposal of expired products• Short shelf lives

Shelf Life - Constraints For HIV/AIDS Commodities

• For HIV test kits – shelf life can range from 6 months to 18 months

• For ARVs – average shelf life ranges from 12 months to 18 months

• Shelf Life - New Products Vs. Older Products that have been on the market for a long time.

• Example – Depo-Provera

Cold Chain - Constraints for HIV/AIDS Commodities• HIV/AIDS commodities that require cold

chain (some HIV test kits, such as Unigoldand some ARVs such as Kaletra)

• Unigold – which has a storage temperature of 2-270 C – does not necessarily need refrigeration, but temperatures in many facilities may reach well into the 30’s

• HIV/AIDS commodities that require cold chains are not necessarily different than other commodities that require cold chains

Example: Kaletra• Capsules are stable and potent for 2

months when stored at 25ºC• One day at being stored at 45ºC >

capsules become soft, sticky and break apart when separated from each other.

• Abbott recommendation: do not dispense more than 30 days supply when in hot climates.

Storage - Determine HIV Test Kits• Determine is a rapid HIV test that is commonly

used in the testing algorithm of resource limited countries.

• Is Determine HIV test used in your country?• Do you know what storage conditions are

required for Determine?Two Key Items:1. Storage temperature is between 2 & 300 C2. Shelf life for the chase buffer (11-13 months)

is different from the shelf life for the test (12-18 months).

Security Constraints -HIV/AIDS Commodities

• Security Management – carries over to all products, but why do ARVs have special security considerations?

• The value of ARVs in terms of cost as well as life-saving potential can createan incentive for mismanagement and pilferage.

Your Experience – Storing HIV/AIDS Commodities

• Disposal of expired products• Do you have guidelines for how to dispose

expired products?• Why may there be different considerations for

HIV/AIDS commodities as opposed to any other essential drugs?

• Are you using nevirapine syrup in PMTCT programs?

• Donations of NVP syrup from BoehringerIngelheim.

Storage – Central Level and Facility Level

• Equipment Needs – Central level may need extensive shelving systems, pallets, forklifts, material handling equipment, etc.

• Facility Level – Security or adequacy of space may be an issue

Interventions For Storage• Buying needed equipment, such as pallets,

shelves, racking, locking shelves, refrigerators, etc.

• Integrating appropriate HIV/AIDS products (e.g. Long ELISAs, Kaletra, etc.) with other cold chain supply chains

• Developing and implementing a policy for what to do with expired products

• Facility level: constructing a lockable/impenetrable room; developing security procedures around access to ARVs or valuable commodities

Knowing Storage Constraints Can…..• Influence the design of the logistics system

• If there is a lack of storage space, you could have shorter review periods and increase the frequency of the shipments, which would lower the levels of required stock at one time. This can also prevent expiries and pilferage.

Storage Resources/Tools

• Storage guidelines – some of these guidelines do not always require the input of policy-makers or large amounts of money, while others may.

• Some solutions may be expensive and require structural changes, etc.

• Other solutions are within the storekeeper’s ability, are low or at no cost and can help in prolonging the shelf life commodities.

Summary of Storage Session• Storage conditions vary in each of the

countries represented in this workshop and the guidelines reviewed in this session have been developed for use in most situations.

• Adapting for local needs is acceptable, but the basic purpose of storage guidelines is the same: to protect the quality and integrity of commodities while at the same time making them available to users.

2nd Topic - LMIS For HIV/AIDS Commodities• What is LMIS (Logistics Management Information

Systems)?• A well-functioning LMIS provides decision

makers throughout the supply chain with accurate, timely, and appropriate logistics data.

• Logistics managers use these data to make key decisions, such as how much of each product to order or re-supply, identify potential supply problems at facilities, forecasting demand and planning procurements.

• LMIS is to improve management decisions that govern the logistics system.

Differences Between LMIS and HMIS• Information in logistics systems tend to be

more time sensitive than other forms of health information. HMIS may collect, summarize and report data on an annual basis, but logistics data needs to be reported more frequently to avoid system failures.

• Types of analyses required in logistics systems is different from those in HMIS.

• Adapting one information system – HMIS or LMIS – to achieve full integration of all data requirements is unworkable, becomes unwieldy and tends to present information that is not necessary at certain locations.

LMIS For HIV/AIDS Commodities• How is a LMIS for HIV/AIDS products

different for LMIS for other commodities?

1. Scaling up treatment programs means unpredictable trends in consumption

2. Need for specific patient data3. HIV/AIDS programs are often managed

outside established systems

2 key decisions in LMIS

1. What data to collect

2. What format the LMIS should be

3 Essential Data Items

1. Stock on Hand

2. Rate of Consumption

3. Losses/Adjustments

Essential Data Items• Stock on Hand – quantities of USUABLE stock

available at all levels of the system at a point in time• Rate of Consumption – the average quantity of

commodities DISPENSED TO USERS during a particular time period

• Losses/Adjustments (L/A) – losses are the quantity of health commodities removed from the distribution system for any reason OTHER THAN consumption by clients (e.g., losses, expiry, damage). Adjustments may include receipt or issue of supplies to/from one facility to another at the same level (e.g., transfer, or a correction for an error in counting). L/A may therefore be a negative or positive number.

Example of Essential Data Items

• Clinic X can track the number of ARV drugs dispensed to patients for a given time period.

• The clinic can do this for four months to figure out their trend in consumption.

M1+ M2 + M3 + M4 = Quantity per 4 months

1700 + 1700 + 1170 + 1500 = 6,070/4 = 1,518 = AMC

• The clinic can then use their stock balance information to calculate when they need more drugs and could also use that information to re-order their new supply before they run out of drugs.

Situation Without All Three Essential Data Items

• Would not be able to predict how long their stock would last

• Clinic would order to much, to soon, which is expensive for the program if every clinic in the country is doing this or wait until they stock out, and that would be dangerous to the patient.

LMIS Data Forms

• The next slides demonstrate the essential data items wanted on their LMIS forms in their respective countries.

Revised 3/2003

ORIGINAL MINISTRY OF HEALTH

MONTHLY REPORT & REQUEST FOR LABORATORY REAGENTS Facility Name District: Province: Facility Type: Laboratory Other Report of Period Beginning 20 Ending 20

Table 1: Monthly Total Quantities Used by Each Type of Service

Reagent Name

Unit Pack

Clinical Diagnois

Blood

Screening

VCT

PMTCT

Other

Total Tests

Determine

Test

Unigold

Test

InstantScreen Other

Enzygnost

Test

Vironostika

Test

Other Test

Hep B SAH

Test

Murex Anti HCV

Test

Other

RPR

Test

Other Test Total #

Tests

Total # Clients

Table 2: Status of Testing Equipment, Storage Facility and Trained Personnel

Type of Machine, Equipment Date of Last Service

Number of trained staff

Condition/Comments

Managed by: GOK NGO Private

Revised 3/2003 TRIPLICATE

MINISTRY OF HEALTH MONTHLY REPORT & REQUEST FOR LABORATORY REAGENTS

Facility Name District: Province: Facility Type: Laboratory Other Report of Period Beginning 20 Ending 20

A B C D E F G H Earliest expiry date of stock

Reagent Name

Unit Pack

Begining Balance

Received This Period

Total Tests Used

Total Tests Issued

Adjustments (*)

Physical Count

Date

Qty

Qty Needed

Determine

Test

Unigold

Test

Instant Screen Test Other Test

Enzygnost

Test

Vironostika

Test

Other Test

Hep B SAH

Test

Murex Anti HCV

Test

Other Test

RPR

Test

Others Test

Test

Test

Comments: Submitted by:

Name Signature Designation: Date: * - In Column E put (E) for Expired, (W) for Withdrawn, (A) for Stock Adjustment or (O) for Other

Managed by: GOK NGO Private

MONTHLY FACILITY REPORT OF HIV TEST USAGE Ministry of Health / Ghana Health Services

Republic of Ghana

Facility Name: Report Period:

District: month/year

Region: Date Prepared day/month/year

For each test type, include tests used for initial screening, confirmatory tests, and tie-breaker tests (if applicable).

Note: Re-supply quantities are based on the number of tests used during the month/quarter. Under-reporting the number of tests used will result in insufficient re-supply and could lead to stock outs at the testing facility.

Client/Patient Testing Facility Use

Item Description (Test Type) Blood Safety

Voluntary Counseling and Testing

(VCT)

Prevention of Mother to

Child Transmission

(PMTCT)

Clinical Diagnosis

Sentinel Surveillance Lab Controls Quality

Testing Testing

Wastage

Total Number of Tests Used

during the Month

Stock on Hand at the End of the

Month

A B C D E F G H I = A + B + C + D + E + F + G

+ H J

Rapid Assay HIV Test Kits Determine HIV 1/2 (Abbot) Rapi-Test HIV 1/2 Long ELISA HIV Test Kits Vironostika Uniform II HIV 1/2 plus O (Organon)

Remarks:

Prepared by: Name/Signature: Designation: Date:

Reviewed by:

Name/Signature: Designation: Date:

MONTHLY REPORT FOR HIV TEST KITS AND CONSUMABLE LABORATORY SUPPLIES FOR HIV TESTING Ministry of Health / Ghana Health Services

Republic of Ghana

Region:

Report Period:

month/year

Maximum Stock Level: 3 Months

Date Prepared

day/month/year

Opening Balance

Total Qty. Received during the

Month

Total Monthly Issues

Losses/ Adjustments

(+ / -)

Closing Balance

Months of Stock on Hand

Total No. Days Out of Stock Serial

No. Item Description No.

Tests per Kit

Basic Unit

A B C D E = A + B – C +/- D F = E/C G

Rapid Assay HIV TEST KITS 1 Determine HIV 1/2 (Abbot) 100 1 test 2 Rapi-Test HIV 1/2 100 1 test 3 1 test

ELISA HIV Test Kits 4 Vironostika Uniform II HIV 1/2 plus O (Organon) 576 1 test 5 1 test

Consumable Laboratory Supplies for HIV Testing 6 Pipette Tips (Small) 5 - 40 microliter (venipuncture) 7 Pipette Tips (Big) 40 - 200 microliter (venipuncture) 8 Pasteur Pipettes graduated with bulb, Non-Sterile 9 Disposable Plastic [for venipuncture assay]

10 Vacutainers - 10ml 11 Vacutainer plain/serum Tubes 4 ml [plastic] 12 Vacutainer multi-sampler 21 Gauge needles

Remarks:

Prepared by: Name/Signature: Designation: Date:

Name/Signature:

Designation:

Date:

Reviewed by:

Name/Signature: Designation: Date:

MONTHLY LOGISTICS AND NEW PATIENTS REPORT – JCRC FREE DRUGS

Facility Name: Report Period: Maximum Stock Level 2 months

District: month/year

Delivery Zone: Date Prepared Minimum Stock Level 1month day/month/year

REPORT NEW PATIENTS

Opening Balance

Total Qty. Received during the

Month

Total Monthly Consumption

Losses/ Adjustments

( +/- )

Closing BalancesFacility Stores + Dispensing Area

E = A + B - C +/- D

Estimated number of NEW patients on this drug for next

month Serial No. Drug Product 1 Basic

Unit

A B C D E F

NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS 1 Zidovudine (AZT, ZDV) 100mg Capsule 2 Zidovudine (AZT, ZDV) 300mg Tablet 3 Zidovudine (AZT, ZDV) 10mg/ml oral solution Btl 240ml 4 Lamivudine (3TC) 150mg Tablet 5 Lamivudine (3TC) 10mg/ml oral solution Btl 240ml 6 Stavudine (D4T) 20mg Capsule 7 Stavudine (D4T) 30mg Capsule 8 Stavudine (D4T) 40mg Capsule 9 Didanosine (DDI) 25mg Tablet 10 Didanosine (DDI) 100mg Tablet 11 Didanosine (DDI) 200mg Tablet

Republic of GhanaMinistry of Health/Ghana Health Services

MONTHLY LMIS REPORT FOR ANTIRETROVIRAL DRUGS

Facility: Central Medical Stores TEMA Month/Year: Maximum Stock Level: __10__ Months

Region : Greater Accra Region Minimum Stock Level: ___7__ Months

A B C1 C2 D E F G H I J

CMS CMS CMS ART Sites CMS CMS CMS CMS CMS MAXIMUM QUANTITYTOTAL Total Total MONTHS STOCK TO ORDER

TOTAL TOTAL TOTAL Losses/ CLOSING Quantity No. Days OF STOCK QUANTITY QUANTITY UNIT [Rounded upSerial Basic OPENING QUANTITY QUANTITY MONTHLY Adjustments BALANCE2 to Expire in Out of ON HAND3 (C2 x Maximum TO ORDER PACK to Pack Size)No. Unit BALANCE RECEIVED ISSUED1 ONSUMPTIO (+ / -) A+B-C1(+/-D) 3 Months Stock ( E / C2 ) Stock Level) ( G - E ) SIZE ( H / J )

FIXED DOSE COMBINATIONS1 Zidovudine 300mg/Lamivudine 150mg Tablet 60

NON-NUCLEOSIDE REVERSETRANSCRIPTASE INHIBITORS

2 Nevirapine (NVP) 50mg/5ml oral suspension (BI) 240ml Bottle 13 Nevirapine (NVP) 10mg/ml oral suspension (BI) 20ml Bottle 14 Nevirapine (NVP) 200mg Tablet 60

5 Efavirenz (EFV) 30mg/ml syrup ???ml Bottle 16 Efavirenz (EFV) 50mg Capsule 307 Efavirenz (EFV) 100mg Capsule 308 Efavirenz (EFV) 200mg Capsule 909 Efavirenz (EFV) 600mg Tablet 30

NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS

10 Zidovudine (AZT) 10mg/ml syrup 200ml Bottle 111 Zidovudine (AZT) 100mg Capsule 10012 Zidovudine (AZT) 300mg Tablet 60

13 Lamivudine (3TC) 10mg/ml oral solution 240ml Bottle 114 Lamivudine (3TC) 150mg Tablet 60

15 Stavudine (d4T) 1mg/ml PFR for oral sol 200mg/Bottle 116 Stavudine (d4T) 15mg Capsule 6017 Stavudine (d4T) 20mg Capsule 6018 Stavudine (d4T) 30mg Capsule 6019 Stavudine (d4T) 40mg Capsule 60

20 Didanosine (ddI) 10mg/ml oral sol 2Gm PFR 4oz Bottle 121 Didanosine (ddl) 25mg Tablet 6022 Didanosine (ddl) 50mg Tablet 6023 Didanosine (ddl) 100mg Tablet 6024 Didanosine (ddI) 150mg Tablet 6025 Didanosine (ddI) 200mg Tablet 60

26 Abacavir (ABC) 20mg/ml oral sol 240ml Bottle 127 Abacavir (ABC) 300mg Tablet 60

NUCLEOTIDE REVERSETRANSCRIPTASE INHIBITOR

28 Tenofovir (TFD) 300mg Tablet 30

PROTEASE INHIBITORS29 Nelfinavir Mesylate (NFV) 50mg/g PFR 144g/Bottle 1

[50mg per 1.25ml scoop]30 Nelfinavir Mesylate (NFV) 250mg Tablet 270

31 Lopinavir+Ritonavir (LPV/r) 400mg/100mg/5ml 300ml Bottle 132 Lopinavir+Ritonavir (LPV/r) 133.3mg/33.3mg Capsule 180

1 The Total Quantity Issued from CMS during the month (Column C1) should equal the sum of the Total Quantity Received by all ART Facilities during the month. 2 The Closing Balance at CMS is calculated by subtracting the Total Quantity Issued (Column C1) during the month.3 The Months of Stock on Hand at CMS is calculated using the Total Monthly Consumption at all ART sites (Column C2).

Drug Product

DRAFT for reviewJSI/DELIVER Nov 2004

Monthly Summary Report of ART PatientsFacility: __________________________________ Month: ______________________

District: _________________________________ Year: __________

Region: __________________________________

Total No.Patients on

To From Regimen atregimen regimen end of Month

B C D E = (A+B+C)-D

A ADULT 1st Line RegimensA1 AZT 300mg/3TC 150mg + NVP 200mg

A2 AZT 300mg/3TC 150mg + EFV 600mg

A3 d4T(30) + 3TC 150mg + NVP 200mg

A4 d4T(40) + 3TC 150mg + NVP 200mg

A5 d4T(30) + 3TC 150mg + EFV 600mg

A6 d4T(40) + 3TC 150mg + EFV 600mg

B ADULT 2nd Line RegimensB1 TDF 300mg + ddI 250mg + NFV 250mg

B2 TDF 300mg + ddI 250mg + LPV/r 133.3mg/33.3mg

B3 ABC 300mg + ddI 150mg + NFV 250mg (< 60kg)

B4 ABC 300mg + ddI 200mg + NFV 250mg (> 60kg)

B5 ABC 300mg + ddI 150mg + LPV/r 133.3mg/33.3mg (< 60kg)

B6 ABC 300mg + ddI 200mg + LPV/r 133.3mg/33.3mg (> 60kg)

ADULT Other RegimensB7 AZT 300mg/3TC 150mg + NFV 250mg

B8 AZT 300mg/3TC 150mg + ABC 300mg

B9 AZT 300mg + ddI 150mg +NFV 250mg (< 60kg)

B10 AZT 300mg + ddI 200mg + NFV 250mg (> 60kg)

B11 d4T(30) + 3TC 150mg + NFV 250mg (< 60kg)

B12 d4T(40) + 3TC 150mg + NFV 250mg (> 60kg)

B13 d4T(30) + 3TC 150mg + LPV/r 133.3mg/33.3mg (< 60kg)

B14 d4T(40) + 3TC 150mg + LPV/r 133.3mg/33.3mg (> 60kg)

B15 d4T(30) + 3TC 150mg + ddI 150mg (< 60kg)

B16 d4T(40) + 3TC 150mg + ddI 200mg (> 60kg)

B17 d4T(30) + ddI 150mg + EFV 600mg (< 60kg)

B18 d4T(40) + ddI 200mg + EFV 600mg (> 60kg)

B19 ddI 150mg + 3TC 150mg + NFV 250mg (< 60kg)

B20 ddI 200mg + 3TC 150mg + NFV 250mg (> 60kg)

No of shiftsduring the month

Republic of Ghana Ministry of Health/Ghana Health Service

No. Patients No. of New

Treatment Regimen

Patientson Regimen end of Month

A

on Regimen

of Monthat Beginning

Format of LMIS• LMIS consists of data and the format that the

data is recorded and reported• Format –1. How many items should be collected2. How they are organized on the data

collection form3. What kinds of reports to use4. How many levels there are and how the data

gets presented and shared5. Is the LMIS manual or automated or both

Records and Reports• Types of Records – (1) storekeeping, (2)

transaction, and (3) consumption records• Reports – using the above record data,

and to make data useful, it must be made available to managers in a form suitable for decision making

• What type of records and reports are you using?

• Frequency of reporting as it relates to HIV/AIDS

Level of Aggregation• What is aggregating data?• What level should this take place (central, or at

the lower levels in their systems)?• Is anyone aggregating ARV data at the facility

level?• Why would a program might want to have

aggregated versus disaggregated?• Pros and cons one each method, but

aggregating data should be done at the level where the aggregation is needed in order to make crucial decisions

Integrated Vs. Vertical LMIS Considerations• What are your experiences with integrating

LIMS with different types of commodities? • Who has integrated LMIS for HIV test kits,

ARVs, and other “special program”commodities with other LMIS (pros & cons)?

• For those who have kept commodities for “special programs” in a vertical LMIS, what factors went into that decision?

• What would the LMIS design be like for full supply Vs. limited supply products?

Interventions to Address Some of the Challenges in Designing LMIS• Assessment of LMIS• Design LMIS• Determining the data to collect• Selecting automation as a

solution to immediate data requirements

• Participatory approach

3rd Topic - Inventory Control

• Purpose of an inventory control system – is to maintain an appropriate stock level of all products, avoiding shortages and oversupply

• Key questions about inventory control – who places the order, when are orders placed, how are orders made, what commodities are ordered?

Types of Inventory Control Systems• Maximum-Minimum is a common inventory

control system (recommended for programs with full supply availability)

• Max-Min systems are appropriate for managing any type of product

• Min is set at a level high enough to ensure that the facility never runs out of stock

• Max is set low enough to ensure that all of the stock fits in the storeroom, and it doesn’t sit there long enough to expire before being used

Basic In-Country Supply Pipeline

Key Concepts in Mix/Man

• We discuss Max/Min in terms of months of supply.

• Example – an SDP may have a 3-month maximum stock level and 1-month minimum, while a central warehouse may have a 9-month maximum stock level and a 5-month minimum level of stock

Factors in Setting Max/Min

• The order interval (the longer the order interval, the higher the max)

• Lead time – how long does it take to make an order and receive the supplies

• Buffer against uncertainty. This includes things like reliability of the supplier, spikes in demand, wastage/pilferage/loss factors, etc.

• Increasing your maximum levels increases the length of your pipeline

How Do You Shorten the Pipeline?

• Shorten the min/max stock levels at each facility by shortening the order interval, increasing dependability of transportation

• You can also eliminate levels in the system, for example, bypassing the regional and district levels and distributing straight from the central level to facilities

Advantages of Having a Shorter Pipeline• Fewer points at which ARV drugs and HIV test

kits will be stored, thereby decreasing the number of sites to be monitored, facilitating timely submission of reports and training staff in the management of these commodities

• Fewer locations needing increased or reinforced security for ARV drugs

• Reduced need for buffer stock throughout the system, thus maximizing the use of available resources for treatment

Other Types of Inventory Control Systems

• “Just in Time” (JIT)• Top Up

• Experiences with inventory control systems?

Interventions for Inventory Control• Assessment of inventory control system• Design of appropriate max/min inventory

control systems• Dedicated distribution specifically for

ARVs• Shortening the pipeline• Keeping stocks at facilities on an as

needed basis only (e.g., 2nd line ARV drugs)

DELIVER’s Logistics Cycle

No Product, No Program!

THANK All of YOUFOR YOUR ATTENTION