MEDICINES SELECTION & FORMULARY MANAGEMENT Charles Ouma Management Sciences for Health

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

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

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. 2012. MDS-3: Managing Access to Medicines and Health Technologies. Arlington, VA: Management Sciences for Health. http://www.msh.org/resource-center/publications/upload/MDS3-Ch16-Selection-Mar2012.pdf

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

Formulary System and Management

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

Interrelationships- STGs, EML & Essential Medicines Formulary

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

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

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

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)

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

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

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

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

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

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

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