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
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.
Editor's Notes
Notes:
Unit 2 should take approximately 2 hours, 10 minutes to implement:
Step 1 – Overview of Unit Learning Objectives and drug supply management cycle (Slides 2-3) – 5 minutes
Step 2 – ARV drug policy (Slides 4-7) – 8 minutes
Step 3 - ARV Drug Selection, Quantification, Procurement and Use (Slides 7 – 38) – 47 minutes
Step 4 –Discussion: Barriers and Solutions (Slides 39) – 25 minutes
Step 5 – Key Points (Slides 40) – 5 minutes
Notes:
Step 1 – Overview of Unit Learning Objectives (Slides 2) – 3 minutes
Begin by reviewing the unit aim and objectives.
The aim of this unit is to understand patient flow frameworks, forms, and tools for improving ARV patient care for adults.
Ask if the participants have any questions before continuing.
Notes:
This is part of Step 1: should not take more than 2 minutes
Describe the management cycle just briefly:
The process of managing drug supplies is depicted by a drug supply management cycle which is composed of four major components each representing key functions involved in the process. For the cycle to operate optimally should get sufficient management support. The whole drug supply management process rests up on the policy and legal framework existing in the country.
Note:
Step 2 – ARV drug policy brief overview (Slides 4-7) – 8 minutes
Notes:
Supply of ARVs:
Encourages the establishment of international drug initiatives
Creates an enabling environment for drug research
Encourages the private sector to produce generic drugs locally
Encourages all stakeholders to supply drugs to the community
ARVs Use
Prescribing in authorized health institutions by trained physicians using the national treatment guideline
Dispensing in authorized retail outlets by trained pharmacists or pharmacy personnel
Establishing a system of ensuring patient adherence
Note:
Step 3: ARV Drug Selection, Quantification, Procurement, Use and ARVs management information system (Slides 8 – 38) – 47 minutes
Note:
Based on field data, observation and experience, drug regimen may need to be changed, sometimes without lead time. Once started ART cannot be stopped without serious consequences to patient and program. Therefore, stock out is unthinkable.
Notes:
Lead time refers to time required based on historical data/experience.
Note that it will not be the same for all drugs; some are readily available and are delivered fast others are not and different suppliers have different constraints.
Note:
Buffer stock is the amount of drug a center will keep above and beyond the working stock…this is also based on center’s experience and historical data. Currently, the treatment group has recommended a minimum of 3-month buffer stock for Ethiopia. This obviously should be adjusted based on available hospital data.
Notes:
Step 4: Barriers to the supply of ARV drugs (Slide 39) – 25 minutes
This discussion helps health care providers help each other address different structural, systemic and other barriers to the supply of ARV drugs in the country. It first asks participants to identify the various barriers and then to brainstorm solutions together.
Ask participants to identify the variety of structural, systems and other challenges required to ensure uninterrupted supply and efficient management of ARVs in Ethiopia. To help start the discussion, remind participants that these barriers can include anything that challenges the implementation of the types of processes, systems, and procedures that have been discussed in the workshop training so far. Possible answers might include the following: shortage of staff, staff turnover, unreliable supply of drugs, shortage of Lab supplies, affordability of drugs for patients, lack of adequate space, lack of commitment to or unfamiliarity with multidisciplinary team model, etc. (10-15 minutes)
Have participants brainstorm about the ways to overcome some of these barriers given existing national, regional, and/or local and other constraints. Help participants recognize that some barriers are more easily surmountable than others, and some require collective efforts while others can be undertaken at the individual level. An example of the latter might be ensuring the presence of efficient inventory control system to update the stock status on daily basis. Mmaintaining strong team work between the prescribers and dispensers, ensure ing rational ARVs prescribing practice, etc… Other examples should also be identified. (10-15 minutes)
Note:
Step 5 – Key Points (Slides 40) – 5 minutes
Summarize the presentation, review the Key Points presented in the Session, and answer final questions.