Unit 2

1. Supply Management of
Antiretroviral Drugs: Selection,
Procurement, Distribution and
Use
Unit 2
HIV Care and ART: A Course for
Healthcare Providers by Salahadin M.Ali

2. 2
Learning Objectives
 Explain the Ethiopian National Policy on ARV drugs’
supply and use
 Identify the factors that influence selection of ARV drugs
 Understand the importance of ensuring a steady supply of
quality ARV drugs in Ethiopia
 Understand the different factors that affect estimation of
ARV drug requirements at different level
 Recognize the peculiarity of ARV drugs procurement
processes.
 Understand the special precautions required for handling
and distribution of ARV drugs.
 Realize the importance of using appropriate PMIS for the
proper management of ARV drugs

3. 3
The Drug Supply Management Cycle
Selection
Procurement
Distribution
Use
Management
Support
THE DRUG MANAGEMENT CYCLE
Use Procurement
Distribution
Policy & Legal Framework

4. 4
The National ARV Policy
 Policy approved in July 2002
 Objectives of the policy:
 Reduce MTCT
 Prolong and improve the quality of lives of PLWHA
 Reduce accidental HIV infection within health
institutions

5. 5
ARV Policy: Governments Commitment and
Strategy
1. Coordination, Leadership & Systems Strengthening
 Coordinates & facilitates the supply of ARVs
 Builds capacity for making available safe, effective and
quality antiretroviral drugs, and for ensuring the
appropriate use of these drugs
 Ensures sustainable supply of ARVs by encouraging
involvement of all stakeholders
 Encourages research on modern and traditional
HIV/AIDS treatment
 Establishes strong systems to monitor ARVs supply
and use

6. 6
ARV Policy: Governments Commitment and
Strategy (2)
2. Selection of ARVs helps
 Determine the type of ARVs to be used in Ethiopia
 Incorporate selected ARVs into the national drug list
 Permit the import of ARVs that are not included in the national drug
list
3. Supply of ARVs
 Exempts Tax for ARVs
 Encourages local production of ARVs encouraged
4. Use of ARVs
 Prepares and implements standardized prescription paper
 Prepares and implements national guidelines for safe and effective
use of ARVs
 Educates the public on the use of ARV drugs

7. 7
ARV Policy: Governments Commitment and
Strategy (3)
5. Research and Development
 Encourages research on modern and traditional
HIV/AIDS treatment
 Ensures that the rights and benefits of citizens
enrolled in research studies shall be respected
 Ensures that national and international ethical norms
and values in human experimentations are observed

8. 8
ARV Drugs Selection
 The selection of ARV drugs is based on:
 The purpose of use
• ART (Adult, pediatrics)
• PEP
• PMTCT
 The level of available health institution (hospitals,
drug retail outlets)
 Availability of authorized prescribers and dispensers
 Guidelines for the use of ARV drugs in Ethiopia
 National drug lists

9. 9
Quantification of ARV Drugs
 Quantification of ARV drugs is impacted by a
complex web of factors related to:
 ARV product
 ART
 Demand (continuation and scaling up/rollout)
 Supply

10. 10
Quantification of ARV Drugs (2)
 Issues related to ARV Product:
 Shelf Life
• Short expiry date
 Cost
• Expensive
 Handling Requirements
• Require secure storage
• Require refrigeration/temperature control

11. 11
Quantification of ARV Drugs (3)
 Issues related to ART:
 Rapidly evolving scientific field
 Impact of stock out
 Taken for life
 Used for post exposure prophylaxis and treatment
 Requires multiple drug therapy (3 or more and all
must be available)
 Multiple regimens
 Resistance evolves quickly and is inevitable

12. 12
Quantification of ARV Drugs (4)
 Issues related to demand:
 Availability of historical consumption data
 Efficient patient tracking (Up-to-date patient information):
• Deaths
• Lost for follow-up
• Transfer out, transfer in
• Treatment interruptions
 Unpredictable scale up
 Capacity to deliver services
 Changes in regimen (Wt., pregnancy, Rx failure, ADR)
 Pediatrics (change in regiment/dose, wastage of liquids)

13. 13
Quantification of ARV Drugs (5)
 Issues related to supply:
 Capacity to overcome handling costs of large stock
 Delays in disbursement of funds by donors
 Level of available funding
 Very few suppliers
 Rapidly changing market
 Prequalification/regulatory approval
 Special pricing/donation
 Unpredictable and long lead time

14. 14
Quantification of ARV Drugs (6)
 Issues to consider when quantifying ARV drug
requirements:
 Consumption data at each health facilities
 Working and buffer stock kept at different levels
 Quantity of stock on hand and on back order
 Lead time (time taken from ordering to delivery)
 Expected consumptions during the lead time

15. 15
Quantification of ARV Drugs (7)
 Expected consumption is influenced by:
 Number of current patients and their regimen
 Anticipated scaling-up pattern
• New patients on 1st line, 2nd line (adult and pediatrics)
 Likely changes in prescribing patterns due to:
• Revised STG, changes in registration status of ARV
drugs, procurement constraints, varying composition of
patient groups, non-naïve patients with non-standard
regimen

16. 16
Quantification of ARV Drugs (8)
 Procurement Cycle without scale up
Working Stock Working Stock Working Stock
Buffer Stock
Lead time Lead time
Lead time Lead time

17. 17
Quantification of ARV Drugs (9)
 Procurement cycle during scale up
Working Stock
Working Stock
Working Stock
Buffer Stock
Lead time
Lead time
Lead time
Lead time

18. 18
Quantification of ARV Drugs (10)
 Other quantification issues
 Reduced NVP requirements due to initial phase is not
usually accounted for
 ARV drugs for PMTCT when guidelines change
• Affect the stock for ART patients (e.g. if NVP 
HAART)
• Over stock of the old PMTC product (e.g. NVP)
 Quantification for PEP requirements

19. 19
ARV Drugs Procurement
 The procurement cycle involve the following steps:
 Reviewing drug selection
 Determining quantities needed
 Reconciling needs and funds
 Selecting procurement method
 Locating and select suppliers
 Specifying contract terms
 Monitoring order status
 Receiving and check drugs
 Making payment
 Distributing drugs
 Collecting consumption information

20. 20
ARV Drugs Procurement (2)
 Essential factors for calculating order quantity
 Average monthly consumption
 Supplier lead time
 Safety stock
 Stock on order
 Stock in inventory

21. 21
Quality Assurance
 No ARV drugs shall be marketed or made
available for use unless their safety, efficacy and
quality, including packaging materials, is
approved by DACA, prior to importation
 Only ARV drugs on the List of Drugs for Ethiopia
(LIDE) shall be imported or locally
manufactured, except for DACA-authorized
research

22. 22
Quality Assurance (2)
 Drug quality is affected by:
 Manufacturing process
 Packaging
 Transportation
 Storage conditions

23. 23
Quality Assurance (3)
 Possible consequences of poor quality drugs:
 Lack of therapeutic effect leading to death or
prolonged illness
 Toxic and adverse reactions
 Wastage of limited financial resources
 Loss of credibility of the health care delivery system

24. 24
Quality Assurance (4)
 Defining and assessing drug quality:
 Identity
 Purity
 Potency
 Uniformity of dosage forms
 Bioavailability
 Stability

25. 25
Quality Assurance (5)
 Maintaining drug quality
 Appropriate storage and transport
 Appropriate dispensing and use
 Monitoring drug quality
 Product problem reporting system
 Product recalls

26. 26
Distribution and Use of ARV Drugs
 Effective drug distribution relies on good system design
and good management
 A well run distribution system should:
 Maintain a constant supply of ARV drugs
 Keep drugs in good condition throughout the distribution process
 Minimize drug losses due to spoilage and expiry
 Maintain accurate inventory records
 Rationalize drug storage points
 Use available transport as efficiently as possible
 Reduce theft and fraud
 Provide information for forecasting drug needs

27. 27
Distribution and Use of ARV Drugs (2)
 The distribution cycle include the following steps:
 Port clearing
 Receipt and inspection
 Inventory control
 Storage
 Requisition of supplies
 Delivery (push or pull)
 Dispensing to patients
 Reporting consumption

28. 28
Distribution and Use of ARV Drugs (3)
 After being received at health facilities, ARV drugs
require special handling:
 Appropriate storage warehouses
• Adequate space/size
• Clean
• Shelves or pallets
• Ventilated
• Secured
 Availability of equipment/facilities
• Refrigerators
• Lockable cupboards
• AC (hot regions)

29. 29
Distribution and Use of ARV Drugs (4)
 Intensive recording and stock monitoring
 Stock cards, bin cards, stock movement cards
 Expiry date tracking chart
 Temperature monitoring chart
 Ordering and receiving forms, models
 Regular reporting of stock status
 At least monthly

30. 30
Supply Chain and Information Tracking
At Supplier Level
PFSA
Central Store
PFSA
Branches
FACILITY
Main Stores
Distribution Formats, Stock/Bin Cards, Expiry
Date Tracking Charts, and To Recording Charts
Distribution Formats, Ordering & Receiving/
Requisition & Reporting Form, Stock/Bin Cards,
Expiry Date Tracking Charts and To Recording Charts
Ordering and Receiving Form/ Requisition &
Reporting Form, Receiving Voucher (Model 19),
Receiving Discrepancy Reporting Form, Stock/
Bin Cards, Expiry Date Tracking Charts and
To Recording Charts
MIS (Info Tracking) Formats

31. 31
Supply Chain and Information Tracking (2)
At Facility Level
FACILITY
Main Stores
Dispensaries
Patients
Ordering and Receiving Form/ Requisition &
Reporting Form, Issuing Voucher (Model 22), Stock/
Bin Cards, Expiry Date Tracking Charts, Expiry and
Damage Inventory Sheet and To Recording Charts
Ordering and Receiving Form, ARV Drugs and
Patient Information Sheets, Dispensing Registers,
Stock Movement Cards, Monthly ARV Drugs
Dispensing and Consumption Summary Sheet,
Patient Tracking Charts and To Recording Charts
ARV Drugs and Patient Information Sheets,
Patient Tracking Charts
MIS (Info Tracking) Formats

32. 32
ARV Drugs Management Information System
(DMIS)
 DMIS is an organized system for collecting,
processing, reporting and using information for
decision-making
 Coordinating the elements of a drug supply
system requires accurate and timely information
 Such information is collected by means of
 Record-keeping documents, a combination of
registers, ledgers and filing systems
 Data reporting forms
 Feedback reports

33. 33
ARV Drugs Management
Information System (DMIS) (2)
 Following are examples of key information
tracking formats currently in use

34. 34

35. 35

36. 36

37. 37
ARV Drugs Management Information System
(DMIS) (6)
 Information/data generated from such sources is
the basis for quantification and procurement
 Errors made at any step (during recording or
reporting) will add up and bring about an impact
on the national volumes of procurement
•  Destroys the balance between demand and supply
•  Shortage of ARV Drugs
•  National Crisis
 Every one involved in ART should try his/her
level best in generating and reporting reliable
data/information

38. 38
Lab Supply Management Information
System (LSMIS)
 The procurement and distribution of laboratory
supplies follow similar procedures to that of ARVs
 Lab supply should be managed in the same way
as ARV drugs
 The laboratory management information system
uses similar tools to that of ARV drugs

39. 39
Discussion: Barriers and Solutions
 Discuss:
 What are the barriers (structural, systemic, etc…) to
ARV Drugs Supply in Ethiopia?
 What are strategies for overcoming these barriers?

40. 40
Key Points
 ARV policy has been developed, guidelines have been prepared &
revised, and training is being conducted in Ethiopia on continuous basis
 Ensuring sustainable supply of ARV drug program requires coordinated
efforts of all stakeholders.
 The guidelines for the procurement, storage, inventory control,
distribution, recording and reporting of ARV drugs should be properly
followed.
 The quantification and hence procurement of ARV drugs is impacted by
a complex web of factors that require special considerations.
 The handling and use of ARV drugs involves quite expensive procedures
that need the commitment of health professionals and facility managers.
 Reporting on a regular basis (monthly) is expected from each health
facility.
 The quality of the data/information obtained from health facilities is as
important as the ARV drugs itself.