Module 2

PHARMACEUTICAL
MANAGEMENT FRAMEWORK:
OVERVIEW
 Module Goal
• To discuss the components of
the pharmaceutical framework
and its role in improving
management of
pharmaceuticals.
 Module 2 Unit 1

INTRODUCTION TO
PHARMACEUTICAL
MANAGEMENT FRAMEWORK
 Unit Objectives
By the end of the unit the participants will be
able to:
• Define Key Terms
• Describe the Pharmaceutical Management
Cycle Framework
• Discuss key aspects of each component of
the Health Commodity Management Cycle
• Explain the importance of pharmaceuticals
and pharmaceutical management
 Pharmaceuticals: Definition
Refers to all consumables required to provide health
services
e.g.
a) Medicines
b) Medical supplies e.g. dressings, syringes,
sutures, catheters
c) X-ray items (e.g. films, contrast media)
d) Laboratory items (e.g. reagents, slides)
e) Dental items (e.g. amalgam, dental cartridges)
f) Family planning Items (e.g. Pills, Condoms,
Implants)
 Pharmaceutical: Examples…
(1)
Prevention Diagnosis & monitoring
– Condoms (cont.)
– Pills – Bleach and other
– Implants disinfectants
– Intra-Uterine Devices – Microscopes
Diagnosis & monitoring – Precision pipettes
– Test kits – Centrifuges
– Automated analyzers – Incubators
– Other laboratory monitoring – Refrigerators
equipment
– Freezers
– Reagents
– Vials
– Gloves
–
– Sharps disposal bins
Needles and syringes
–
Pharmaceuticals: Examples…
(2)
Pharmaceuticals for Pharmaceuticals for
infectious Non-infectious diseases and
diseases
other complications
• Anti-infectives
(antibacterials, • Cardiac
• Renal
antifungals, and antivirals)
• Hepatic
• Antiretroviral medicines
• Neuropathic
• STI treatment
• Dermatologic
• TB treatment • Hematologic
• Analgesics and palliative- • Pulmonary
care • Gastrointestinal/diarrhea
pharmaceuticals • Oral and esophageal
• Anticancer pharmaceuticals • Psychiatric
 Importance of
Pharmaceuticals (1)
• Useful in diagnosis, prevention, treatment
of diseases and therefore improving health
• Promote trust and participation in Health
Services
• A major determinant of health services
utilization
 Importance of
Pharmaceuticals (2)
• Promotes access to complete and
comprehensive healthcare services
• Productivity of health workers depends on
the availability of medicines and medical
supplies
 Pharmaceutical Management:
Definition
A set of practices and procedures for ensuring
the:
– Availability
– Safety
– Effectiveness
– Quality
– Appropriate use
of health commodities in any health care setting /
system
Why is Pharmaceutical Management
Important?
Pharmaceuticals:
• Can save lives and improve health
• Are different from other consumer
products
• Are costly
• Promote trust and participation in health
services
Source: Management Sciences for Health
 Selection
Selection

Use Management Procurement

Support

Distribution

Policy and Legal Framework

 What is Selection?
Selection is the process of identifying and
choosing required pharmaceuticals
Approaches:
Public Sector
 Selection process conducted Nationally to
determine which items should be available
at each level of care
Private Sector
 Selection process is internal to a facility or
organization
 Why is Careful Selection of Health
Commodities Necessary?
• A wide variety of health commodities exist for
provision of health services
• Costs of similar items may vary widely and it is
important to ensure good value for money
• The limited resources available for health
commodities procurement means that
systematic prioritization is vital to ensure that
priority health needs are met
• To ensure commodities of good quality with
sustainable supply are identified
 Selection: Major
Challenges
• Poor coordination between various departments/
divisions
• Multiple funding sources with “preferred” choices
• Pressure from manufacturers and suppliers
• Local biases: schools of thought, vested interests
• Failure to systematically apply evidence-based
criteria to the selection process
• Lack of standard treatment protocols to guide the
selection process
 Procurement
Selection

Use Management Procurement

Support

Distribution

Policy and Legal Framework

 Procurement
• Procurement is the process of acquiring appropriate
quantities of the needed/selected items

• Procurement can be through purchase or donations

• This can also be done at various levels:

• national level
• regional level (In Kenya regional procurement
does not occur)
• Facility/organization level
PROCUREMENT
CYCLE
 Key Components of
Procurement
• Need to know how much to procure and for
what periods (Forecasting & Quantification)
• Who to buy from (supplier selection)
• How to buy (pooled procurement)
• How to ensure quality of the products you
buy (quality assurance)
• Systematic and sequential follow-up of the
procurement activity (procurement planning)
 Benefits of an Efficient Health
Commodity Procurement System
• Effective use of resources (i.e. ensures value for money)
• Improves availability, quality, reliability and cost of health
commodities
• Encourages accountability and responsibility in the
supply management process
• Ensures planning and follow-up of commodities within
various stages of the procurement cycle, thus avoiding
delays, unplanned deliveries of procured items, stock-
outs, e.t.c.
 Challenges in Procurement
• Weak procurement(1)
practices
– e.g. use of brand names
• Complexity of multi- source funded
(parallel) procurements
• Obstacles to access - including patents
• Quantification challenges:
– changes in treatment protocols etc
– lack of reliable & complete data
 Challenges in Procurement
(2)
• Cumbersome procurement procedures
including port clearance
• Potential for corruption due to lack of
transparency and procurement
performance monitoring
• Poor or lack of effective monitoring
systems during the procurement cycle
• Poor supplier performance
 Distribution
Selection

Use Procurement

Distribution

Policy and Legal Framework

 Distribution (2)
Distribution is a complex process
that involves:
• Transferring/transporting healthcare
commodities from one point to another
• Monitoring and follow-up mechanism
during and on completion of the
distribution process
 Distribution*: Key
Considerations
• Storage conditions & practices
• Transportation method & delivery frequency
• Centralized vs. decentralized models(e.g.
KEMSA vs. Direct Facility Deliveries)
• Vertical vs. integrated programs
• Inventory management
*includes storage & inventory management
 Distribution Challenges
• Expiry and stock-outs of products
• Erratic & unreliable transportation mechanisms
• Waste and pilferage
• Lack of trained health commodity management staff
• Poor pharmaceutical management skills
• Weak inventory control (IC) practices
• Lack of Standard Operating Procedures (SOPs) and
IC tools
• External/ Environmental factors e.g. rain, war
situations
 Use
Selection

Procurement
Use

Distribution

Policy and Legal Framework

Medicines Use Process

Managing Drug Supply 2nd ed. West Hartford, CT: Kumarian Press. MSH
1997. (Chapter 28: Figure 28.1)
 Appropriate Use
Appropriate use of medicines requires that
patients receive medications:
 appropriate to their clinical needs
 in doses that meet their individual requirements
 for an adequate period of time
 at the affordable cost to them and their community
 with appropriate directions for use and counseling
where necessary
 Challenges Related to Use
• Inadequate or missing guidelines, e.g. Standard
Treatment Guidelines, Formularies and Essential
Medicines Lists
• Lack of fora to discuss health commodity utilization
either nationally or at facility level, e.g. Medicine &
Therapeutics Committees (MTC)
• Knowledge & skill gaps among health care workers
– Poor diagnosis, prescribing, dispensing
• Poor patient education
• Poor infrastructure and inadequate equipment
Management Support (1)
Selection

Management Procurement
Use
Support

Distribution

Policy and Legal Framework

 Management Support (2)
GOOD
RECORD KEEPING
TO PROVIDE
INFORMATION
ADEQUATE
(Management FINANCING
Information
Systems)

STAFF THAT
A PROGRAM THAT
IS
IS WELL PLANNED
ADEQUATELY
AND INVOLVES
TRAINED
THE COMMUNITY
AND SUPERVISED
 Management Support: Key
Aspects
 Organization and management
 Financing and Sustainability
 Information Management
 Human Resource Management
 Management Support:
Considerations
• Information and feedback systems
• Human resources
• Training
• Supportive Supervision
• Monitoring and Evaluation
• Coordination of stakeholders e.g. donors and
local agencies
• Sourcing and allocation of financial resources
 Challenges Relating to
Management Support
• Lack of information tools
• Weak feedback systems
• Inadequate human resources
• Abseentism of staff
• Lack of structured supportive supervision
• Limited and poor allocation of financial
resources
Policy and Legal Framework
Selection

Management Procurement
Use Support

Distribution

Policy and Legal Framework

Policy & Legal Framework (2)
• Government policy e.g. Decentralization,
Integration of services/supply systems
• Quality Assurance (QA)
– Proof of safety, efficacy, and quality
– Standards, e.g. KBS, ISO
• Accreditation/licensing
– Hospitals, clinics, pharmacies, and providers
• Health sector regulations/laws
– Procurement, retail sales, importation
 Challenges Relating to Policy &
Legal Framework
• Lack of relevant and clear
government policies
• Weak enforcement structures
• Poor quality control measures
• Corruption
• Lack of political goodwill
 Quality Assurance
• This is the sum of all activities and
responsibilities intended to ensure the final
dosage form of a product has meet all the
quality specifications.
• The purpose is to make certain that each
drug reaching a patient is safe, effective
and of standard quality.
Determinants of Drug Product
Quality
• Drug production • Drug formulation
• Equipment and • Active ingredients
maintenance • Inactive ingredients
• Manufacturing • Packaging immediate
process and external
• Quality control • Handling and storage
conditions
 Consequences of Poor
Quality Pharmaceuticals
• Lack of therapeutic effect, leading to death
or prolonged illness
• Toxic and adverse reactions
• Waste of limited financial resources
• Loss of credibility of the health care
delivery system.
 Summary
• Pharmaceutical Management is a multi-
step process involving selection,
procurement, distribution, use ,
management support backed by policies,
laws and regulations.
• It contributes to ensuring availability of
pharmaceuticals which are critical in
providing healthcare.
Thank You