EM
ESSENTIAL MEDICINES
Dr. Chikafuna Banda
Page 1: Context
Introduction to the topic of Essential Medicines (EMs)
Page 2: Overview
Topics Covered:
Why Worry about Medicines
Public Health Objectives and the Essential Medicines Concept
Defining & Improving Access to Essential Medicines
Zambia Medicines Policy: Goals and Elements
Challenges in Pharmaceutical Management
Key Lessons for Zambia in Pharmaceutical Management
Zambia’s Position on TRIPS (Trade-Related Aspects of Intellectual Property Rights)
Page 3: Objective
Aim: To describe current issues and opportunities in access to Essential Medicines
Page 4: Introduction to Medicines
Historical Context: Interest in human health spanning centuries
Impact of Modern Pharmaceuticals:
Significant reduction in mortality from infections in developed countries
Developing countries face a deficit, with an estimated 60-80% lacking regular access to EMs
Relationship between access to EMs and income level: Lack of access directly proportional to income
Page 5: Importance of Medicines
Medicines save lives and enhance public health
Encourage trust and participation in health services
Economics of Medicines:
Medicines incur costs
Distinction from other consumer products
Potential for substantial improvements in the supply and use of medicines
Page 6: Key Pharmaceutical Concepts
Drug Information
Essential Medicines & Rational Drug Use
Adverse Drug Reaction (ADR) Monitoring
Drug Utilization & Policy
Page 7: Public Health Objectives and Essential Medicines Concept
Public Health Programs aim to maximize health improvements using available resources
Definition from WHO (1975): Essential Medicines are indispensable for health needs, available at all times in proper dosage forms
Guiding principles:
Good selection (e.g., Zambia Essential Medicines List - ZEML)
Good use (e.g., Drug & Therapeutics Committees - DTCs)
Efficient procurement and distribution of limited medicines
Page 8: Defining Access to Essential Medicines
Access to healthcare, including EMs, as a fundamental human right
Four dimensions of Access:
Availability: Type and quantity provided vs. needed
Affordability: Pricing vs. ability to pay
Accessibility: Location of product vs. user
Acceptability: Satisfaction vs. expectations
Page 9: Access to Medicines Policy Environment in Zambia
National Medicines Policy established in 1996
Generic procurement policy for EMs
Goals:
Increase availability and accessibility to quality EMs
Economic objectives: Lower costs, sustainable financing, job creation
National development goals: Skills in pharmacy management
Page 10: Access to Medicines Policy: Selection and Procurement
Zambia's National Essential Medicines List (NEML) is kept current
National Formulary Committee oversees formulary activities
Budget planning & procurement has seen steady increases
Page 11: Distribution
Ministry of Health (MoH) aiming for equitable distribution systems for EMs via decentralization
Six operational provincial hubs established
Page 12: Use of Essential Medicines
Development of key documents by MoH to enhance the use of medicines
New editions (2013) available:
Zambia National Formulary (ZNF)
Standard Treatment Guidelines (STGs)
Updated NEML and guidelines for Medicines and Therapeutic Committees
Page 13: National Challenges in Pharmaceutical Management
Financing and Sustainability: Public health diseases (HIV/AIDS, TB, Malaria) as high-cost categories
Inefficiencies in the public supply system: Weak distribution
Behavioral changes required: Addressing irrational use of medicines
Regulatory challenges in ensuring quality
Issues with procurement procedures
Page 14: TRIPS vs Access in Zambia
Medicines viewed as sacred commodities, essential for quality of life
Claim to the right for dignified health
Call for PERMANENT exemptions from TRIPS conditions
Page 15: Structured Overview
Key Topics:
Definition of EMs
Criteria for selection of EMs
Guidelines for establishing national EM programmes
Advantages and disadvantages of EM lists
Overview of 18th EM list and 4th EM list for children (2013)
Salient features & evaluation of national EM list (2011)
Conclusion
Page 16: Insightful Quote
"The desire to take medicines is one feature which distinguishes man from his fellow creatures. It is one of the most serious difficulties with which we have to contend." - William Osler (1891)
Page 17: Definition of Essential Medicines
Concept: A limited range of carefully selected essential medicines ensures better healthcare, improved drug management, and reduced costs.
Definition:
Essential Medicines are those that satisfy priority healthcare needs of the majority, essential for the population, available at all times, in adequate amounts, in suitable dosage forms and at affordable prices.
Page 18: History of the WHO Model List of Essential Medicines
1977: First Model List published with ± 200 active substances
Regular updates every two years by WHO Expert Committee
18th WHO Model EML published in April 2013, showing ongoing relevance and value of the concept after nearly 36 years.
Page 19: Criteria for Selection of Essential Medicines
WHO Model List of Essential Medicines operates on guiding criteria:
Quality: Only drugs with adequate safety and efficacy data are selected.
Pattern of Prevalent Disease: Effective drugs for locally prevalent diseases are prioritized.
Page 20: Additional Selection Criteria
3. Cost: Consider the overall treatment cost, not just the price of single units.
Page 21: Continuing Selection Criteria
4. Benefit-Risk Ratio:
Preference for drugs with favorable ratios when multiple options exist.
Give preference to the best understood drug, those with broader clinical utility, favorable pharmacokinetics, and local manufacturing stability.
Page 22: More Criteria for Selection
6. Dosage Forms: Selection based on utility and availability to limit the number of preparations.
7. Financial Resources: Consider that approximately 20% of total health expenditures are on drugs.
Page 23: Additional Considerations
8. Demographic & Environmental Factors
9. Mortality and Morbidity Statistics
Local Manufacturing & Storage Facilities
Continuous Selection Process: Selection should be updated regularly.
Rational Treatment Guidelines should inform the selection.
Page 24: Guidelines for National Programme Establishment
Establishment of a standing committee of healthcare professionals for technical advice.
Use International Non-Proprietary Names (INN) for drugs; provide a cross-index of proprietary and non-proprietary names to prescribers.
Page 25: Additional Guidelines
Prepare concise, accurate, and comprehensive drug information as a pocket guide.
Ensure quality through testing and specify that suppliers provide documentation of compliance with specifications.
Page 26: Success Factors for Essential Medicines Programme
Success depends on:
Efficient administration of supply
Adequate storage
Effective distribution from manufacturers to end-users
Procurement policies should be based on detailed records of turnover.
Page 27: Selection of Antimicrobial Agents
Consider the sensitivity of microorganisms, prevalence of infection types, resistance to agents, and availability (safety, effectiveness, affordability).
Page 28: Periodic Updates
Emphasize the necessity for yearly reviews and flexibility to accommodate changes in treatment needs.
Page 29: Counterfeit Drugs
WHO has a database for reporting counterfeit drugs and developed methodologies to assess the prevalence of counterfeit and substandard products.
Page 30: Advantages of Essential Medicine Lists
Promote cost-effective drug management, better safety, simplified usage, and improved identification and avoidance of ADRs
Encourage local drug formulation and production.
Page 31: Disadvantages of Essential Medicine Lists
Limit choices, potentially create monopolies favoring single products, and reduce opportunities for innovation.
Page 32: Core List vs. Complementary List
Core List: Minimum essential medicines needed for basic health care; includes the most efficacious, safe, and cost-effective medicines.
Complementary List: Medicines for priority diseases requiring specialized diagnostics, monitoring, or training.
Page 33: Additions to the 18th WHO Model List
New substances introduced, including Loratadine, Fomepizole, Pegylated interferon for hepatitis C.
Page 34: Further Additions
Fixed-dose combinations for malaria treatment and various essential blood components added to the core list in 2013.
Page 35: Deletions from the 4th Essential Medicine List
Chlorpheniramine deleted due to inferior safety compared to second-generation antihistamines.
Page 36: Conceptual Clarification
Essential drugs do not suggest that all non-listed drugs are useless; many serve as expensive alternatives or address less common maladies.
Page 37: Take Home Message
Efficacy
Safety and Suitability
Storage and Stability
Ease of Administration
Need of Population
Total Cost
Avoid Irrational Combinations
Availability and Affordability
Regular Listing and Updating
Page 38: Nutritional Food Supplements - Challenges
Prevalence of stunting in Zambia at 35% (DHS 2018), down from 40% in 2014.
9% of children have low birth weight.
Maternal malnutrition can lead to lower than normal development.
Sub-optimal feeding practices prevalent; many newborns not weighed at birth.
Page 39: Key Statistics (ZDHS 2018)
76% children breastfed within an hour of birth
70% exclusively breastfed (0-6 months)
Only 23% of children (6-23 months) fed with recommended dietary diversity
13% of children (6-23 months) fed with recommended minimum acceptable diet.
Page 40: Micronutrient Deficiencies
Common issues among children include anemia, prevalent at 58% among children aged 6-59 months.
Lack of significant reduction over the past two decades.
Page 41: Micronutrient Statistics
Vitamin A deficiency prevalence at 54% among children under five.
Only 53% of households have adequately iodized salt.
Page 42: Promotion of Healthy Diets
Focus on preventing obesity and reducing NCDs through dietary guidelines, media campaigns, and nutrition counseling.
Page 43: Micronutrient Supplementation Strategies
Use of micronutrient powders for home fortification and types of fortified foods.
Page 44: Nutritional Anthropometry
Focus on low birth weight, iodine deficiency disorders, prevalence of goitre, and urinary iodine levels.
Page 45: Addressing Micronutrient Deficiencies
Address prevalence of vitamin A deficiency and interventions to combat iron deficiency anemia.
Page 46: Composition of Breast Milk
Components include:
Live cells, proteins, amino acids, oligosaccharides, enzymes, growth factors, hormones, vitamins, minerals, antibodies, long-chain fatty acids, and microRNAs that regulate gene expression.
Page 47: Exclusive Breast Feeding Guidelines
Definition: Infant receives only breast milk for six months with no other liquids or solids (excluding oral rehydration solution or vitamins/minerals/medicines).