Document No: OF/QA/ HO-16

Company Name:

የኢትዮጵያ መድሃኒት አቅራቢ ኤጀንሲ

Ethiopian Pharmaceuticals Supply Agency
Title: Effective date : 13/09/19
External and Internal Issues Analysis
Rev. No.: 0 Page 1 of 8
Form

Assessment/Review Date: __August 2019__

Next Review Period: ___June 2020___

PREPARED BY APPROVED BY

Name: QMS Task Force Name:

Signature: Date: Signature: Date:

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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Introduction:
This organizational context analysis has been developed by QMS Task Force and has got
approval by top management after a thorough discussions and subsequent amendment. It is
intended to support directors and top management of EPSA or others who have a leading role in
the organization to understand the internal and external issues of the organization and to manage
the effects associated with these factors. The external and internal contexts shall be monitored on
routine basis and reviewed by top management for their adequacy and relevance.

1. Internal Contexts of EPSA: The internal environment’s within which EPSA seeks
to achieve its objectives and which affects its ability to achieve the intended result of the
quality management system are;
i. Organizational Mandate:
Vision: To see all citizens fulfilled their needs for quality assured pharmaceuticals by
2030
Mission: Ensure sustainable supply of quality assured pharmaceuticals to health
facilities at affordable price through establishing committed demand,
pooled procurement, robust inventory management and direct
distribution, efficient fund administration, Integrated Management
Information System and building competent institutional capacity.
Values:
 Serving our consumers
 Commitment
 Teamwork
 Excellence
 Professionalism

ii. Governance, organizational structure, roles and accountabilities; EPSA has

established and communicated the organizational structure, including definitions of
responsibilities and authorities. An organizational chart has been established, which
provides an overview of EPSA’s management structure. The revised organogram is
depicted in the following chart.

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ External and Internal Issues Analysis
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እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ
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 There is clear understanding of the structure/hierarchy and positions of the organization
as depicted in the organizational chart above. EPSA has clearly identified;
 Who sets the policies and strategic directions of the organization?
 Who coordinates and manages the operations?
 Who is involved in support activities?
 The functions outsourced to external providers.

These roles and authorities are defined in job description and all employees are
communicated with.

iii. Policies, objectives, and strategies:

The products and services delivered at EPSA are directed with a clear policy and
objectives. The policy and objectives are guided by the national health policy, national
drug policy, the national growth and transformation plan, health sector development
program and the pharmaceuticals logistic master plan.

EPSA established Pharmaceuticals Supply Transformation Plan (PSTP) for the period
of 2015/16 -2019/20(2008 -2012 EFY) which addresses;
 Situational analysis (internal and external)
 Strategic issues and priorities
 Strategic Objectives
 Costing and Financing
 Governance and implementation arrangements
 Monitoring and evaluation framework

List of Strategic Objectives identified in PSTP are presented in the following table.
Perspective Strategic Objectives
Community Enhance community ownership &
satisfaction
Financial Stewardship Improve effectiveness and efficiency
Internal Process  Improve forecasting and supply
planning
 Improve procurement and contract
management
 Improve storage and inventory
management
 Improve distribution and fleet
management
 Enhance rational medicine use

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ

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 Improve Medical Equipment

Management System
 Improve fund management system
 Enhance good governance
 Improve internal control and quality
assurance
 Strengthen Monitoring and Evaluation
Learning and Growth  Improve development and
management of human resources for
supply chain
 Expansion and rehabilitation of supply
chain infrastructure
 Improve Use of Information
Technology and Innovation
 Improve supply chain policies and
procedures

iv. Physical and Technological Resources: EPSA determines and avails the
resources needed to meet its objectives. Among which are;
a) Warehouses:
Implementing efficient warehouses and inventory management
system is one of the prime focus areas of EPSA and so far established 19
warehouses at different regions taking into consideration the road
network, population density, and geographic access rather than
administrative boundaries.

b) Transportation
Strengthening distribution capacity has been considered as one of the
strategic issues in the past few years and will be considered the major
priority area in the future so as to ensure availability and accessibility of
pharmaceuticals when and where they are needed. Currently available
transportation resources are presented in the following table by type, number
and capacity with their age profile.

Vehicle Make / Quantity Fleet Capacity Age Profile

TYPE (100Kg)
Heavy IVECO 12 350 83% over 10

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ External and Internal Issues Analysis
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years old
IVECO Vans 20 50 All under 5
682 years old
(2014)
ISUZU FSR 24 70 All under 5
years old
(2012)
ISUZU NPR 32 35 All under 5
New years old
(2012)
ISUZU NPR 02 35 All over 10
Old years old
(1999)
Hyundai 03 70 All under 5
Refrigerated years old
(2014)
Hyundai 17 35 All under 5
Refrigerated years old
(2014)
Hyundai Vans 35 35 All over 5
years old
(2009)

2. External Context of EPSA: These are issues that are external to EPSA or outside
of the organization’s control and which can positively or negatively affects EPSA
to realize its objectives.
i. Political Factors:
ii. Social and Cultural Factors:
iii. Legal and Regulatory Factors :
iv. Technological Factors:
v. Economic Factors:
vi. Market Factors:

The effects of these external issues have been thoroughly discussed in the PSTP
document and the summary of positive and effects to EPSA’s business process
described in the SWOT analysis presented in the table below

እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ External and Internal Issues Analysis
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SWOT analysis of EPSA based on the internal and external contexts described above.
Strengths
• Development of procurement list
• Improved Top level management commitment
for change
• Technology support of activities (GPS,
surveillance system)
• Procurement process improvement
(framework agreement, placement)
• Process oriented system on progress (BPT)
• Improved access to information for customers
(the implementation of free toll line for public
comment and questions , website , Telegram )
• modern waste disposal system
• Presence of HRM strategy
• Improved availability of essential
pharmaceuticals
• Expanded storage and storage capacity
• Increased volume and line item number of
pharmaceuticals made available
• Increased volume and line item number of
distributed pharmaceuticals
• Increased direct delivery to health facilities for
program pharmaceuticals
• Presence of strong partnership in
pharmaceutical supply chain
• Improved coordination at federal, region and
zone levels of the health sector
• Increased number of health facilities
implementing IPLS
• Revision of the agency proclamation
እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ
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Weaknesses
• Poor management in supply of specialty
medicines
• Interruption in the availability of essential
medicines, chemicals and reagents at health
facilities
• Inadequate inventory management system
• Inadequate safety and security system
• Delay in procurement and weakness in
contract management
• Weak contract management system
• Poor fleet management system
• Delays in installation and commissioning of
medical equipment
• Inadequate preventive and regular
maintenance capacity for medical equipment,
cold chain system, vehicles, and warehouse
equipment
• Inadequate supportive supervision to
strengthen DTCs, rational medicine use
activities and pharmaceuticals supply
management at health facilities.
• Inadequate financial management system
(delays in bank reconciliation, delays in
branch reconciliation, inadequate budget
control, backlogs in financial audit)
• Poor pharmaceutical waste management
system
• Weak ( Poor) human resource development
and motivation system
• Weak (Absence of) internal quality assurance
system
• Inadequate monitoring, evaluation and
feedback system
• Limitation in identifying, compiling and
scaling-up best practices
• Inadequate integrated pharmaceuticals fund
and supply information system
External and Internal Issues Analysis
Form, OF/QA/ HO-22, 0, 13/09/2019

Opportunities
• The presence of strong political commitment
and reform from the government (modified)
• The introduction of health insurance system
(as it is)
• Increase in the number of health facilities (as
it is)
• The expansion in road and rail way
construction (as it is)
• Technological advancement (as it is)
• Industrialization (increase in local production
of drugs and equipment by local
manufacturer(modified)
• NEW arrangement of EPSA board /Active
engagement of other sectors /(new)
• Improved health care seeking behaviors of
the community (new)
• Increment of foreign investment attraction
that will provide foreign currency (new)
• Improved attention for supply chain from
government
 Review of EPSA proclamation
EPSA Monitors and reviews information related to interested parties and their relevant
requirements at least on yearly basis.
እባክዎ በዚህ ሰነድ ከመጠቀምዎ በፊት ትክክለኛ መሆኑን ያረጋግጡ
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• Poor documentation, reporting and data
management system (HCMIS)
• Substandard pharmaceuticals distribution
practice
Threats
• Unavailability of some specialty medicines on
the global market (economies of scale) eg
kidney transplant , anti cancer drugs …
• Inadequate capacity & collaboration of local
pharmaceuticals manufacturers
• Global pharmaceuticals price variance
(frequent price increment) ; challenge on
budget allocation
• Difficulty of procuring pharmaceutical based
on the existing PPA manual and directives
(less threshold for non-ICB tenders)
• Reduced trust from the public
• high demand of regional states to have
independent pharm. supply chain(less
collaboration)
• Data quality and visibility problem (Health
facilities/MOH) eg cons. Data, SOH, ….
• Data insecurity due to Cyber attacks
• Turnover of experienced staff ( better salary
& incentives from external companies)
• Decline of financial support by partners.
• import/export trade imbalance (Lack of
Foreign currency)
• Insufficient budget allocation for health
facilities to purchase pharmaceutical (unable
to payback credit)
External and Internal Issues Analysis
Form, OF/QA/ HO-22, 0, 13/09/2019