1. MEDICINES SELECTION & FORMULARY MANAGEMENT
Charles Ouma
Management Sciences for Health

2. Outline Essential Medicines Concept Formulary system
Key definitions
Interrelationships- STGs, EML, Formulary Manual
Formulary Management Principles
Challenges and opportunities

3. Issues and Complexities with Medicine Use (1)
Numerous medicinal products are available in the world
Several therapeutic groups and medicines are available to treat many diseases
New medicinal products and new information about existing medicines are emerging

4. Issues and Complexities with Medicine Use (2)
Developing countries spend up to 40% of their health care budgets on medicines
An estimated 70% of medicines are considered duplicative or non-essential
Lack of access to medicines is a major and chronic issue in resource-constrained settings
In low- and middle-income countries, most people pay for medicines out-of-pocket
Source: Management Sciences for Health MDS-3: Managing Access to Medicines and Health Technologies. Arlington, VA: Management Sciences for Health.

5. Essential Medicines Concept
Select & use “essential medicines” that-
Satisfy the priority health care needs of the population
Selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness
Intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information and at a cost that individuals and the community can afford

6. Formulary System and Management

7. Key Definitions
Formulary—A list of medicines approved for use in the healthcare system by authorized prescribers
Formulary manual—The document that describes medicines that are available for use in a hospital or clinic (i.e., indications, dosage, length of treatment, interactions, precautions, and contraindications)
Formulary system—A system of periodically evaluating and selecting medicines for the formulary, maintaining the formulary, and providing information in a suitable manual or list

8. Interrelationships- STGs, EML & Essential Medicines Formulary

9. Benefits of an Effective Formulary System—Summary
Prescribing
More experience with fewer medicines
Irrational alternatives not available
Focused medicine information
ADRs easier to manage
Cost
Lower prices, more competition
Supply
Easier procurement
Lower amount of stocks
Improved quality assurance
Easier dispensing
Patient Use
Focused education efforts
Better compliance
Improved availability

10. Steps to Add or Delete a New Medicine
Written request
DTC Secretary
Drug literature
evaluation
Written report;
formulary
recommendations
DTC Meeting
Request
approved/rejected
Information
disseminated
Physician or
pharmacist
Transparent decision
making
MTC Secretariat
MTC
Healthcare
Workers

11. Process- Selection & Formulary Changes
Health Care workers
Submission of motivations or requests
Use formulary for procurement and Patient Management
MTC
Secretariat
Receipt and processing of motivation
Transparency, fairness,
feedback to ‘motivators’
MTC Secretariat
Technical Evaluation of motivation
Compilation of summary document for presentation to MTC or Formulary sub- committee
MTC or
Formulary sub-committee
Discussion of motivations based on evidence
Composition of committee
Timely decision making
Communication of decisions to motivators
Dissemination of approved changes to HCWs
Printing and distribution of new Formulary
Key success factors

12. Formulary Management Principles (1)
Select medicines on the basis of need (diseases and conditions that have been identified locally)
Select “medicines of choice”
Avoid duplications and use INN (generic) names
Use combination (fixed-dose) products only in specific proven conditions (e.g., TB)

13. Formulary Management Principles (2)
Evaluate and select new medicines according to agreed-upon explicit criteria (including efficacy, safety, quality, cost)
Ensure consistency between the formulary list and the recommended standard treatment guidelines
Regularly review and update the formulary
Monitor and control the use of non-formulary medicines
Restrict medicines to use by appropriate practitioners

14. Formulary Management Principles (3)
Maintain reliable resources (human, financial, references) for evaluating medicines
Keep the formulary process ethically correct and transparent
Enlist support of key policy makers and influential health professionals to advocate for the MTC and the formulary system

15. Challenges Weak (formulary) management systems
Relentless push by HCWs for inclusion of new, costly agents without considering formulary management principles
Weak (formulary) management systems
Lack of comprehensive treatment guidelines
Ad-hoc requests for changes & non-involvement of all stakeholders
Lack of comprehensive guidelines for submitting requests & evaluating motivations/evaluations
Issues of transparency

16. Challenges (2)
Lack of resources and or expertise to conduct evaluations and or pharmacoeconomic analyses at institutional/ local setting to provide cost-effectiveness data that is more relevant to the local setting
Non integration of medicine selection with guidelines and formulary development

17. Formulary Management: Success Factors
Robust compliance environment is required to operationalize a formulary system
procurement and use of essential medicines should be guided by the formulary
MTC comprising multi-disciplinary health workers that is responsible for reviewing applications for changes
An active body at the hospital responsible for coordinating the formulary management process (MTC secretariat)
High level institutional leadership and/or support for the formulary process
Transparency and feedback

18. Results — What should be measured
What are the expected results
Improved outcomes
Standardization of care
Most effective treatments prescribed
Improved procurement and supply
Forecast compares with utilization
Efficient use of funds

19. Thank you