1. ABSTRACT Title: Developing National Formularies Based on the WHO Model Formulary Authors: Tisocki K 3, Laing RL 1, Hogerzeil H 1, Mehta DK 2, Ryan RSM 2 Institution: 1 Department of Essential Drugs and Medicines Policy, World Health Organization; 2 Royal Pharmaceutical Society of Great Britain; 3 Faculty of Pharmacy, Kuwait University Problem Statement: Formularies are increasingly employed in many countries to ensure access to essential medicines, control costs, and improve prescribing by promoting evidence-based pharmacotherapy practices. The first edition of the World Health Organization (WHO) Model Formulary, based on the WHO Model List of Essential Medicines, was published in 2002 and is intended to serve as a resource for countries in developing their own formularies. Although the WHO Model Formulary contains high-quality evidence-based information, it is critical that locally relevant information is added during the adaptation process, allowing the creation of a practical and pertinent information source for prescribers and other health care workers. Objective: To develop a locally focused manual to complement the WHO Model Formulary in designing appropriate country-specific formularies. Intervention: A concise manual was developed to assist editors and members of National Formulary Committees who wish to utilize the WHO Model Formulary during the development of their own national formularies. The manual discusses the essential steps necessary for the development of a national formulary, including the creation of relevant organizational structures. Emphasis is placed on how to utilize the existing text from the WHO Model Formulary while also ensuring the creation of high-quality, locally relevant additional material. Practical examples from existing national and regional formularies in developing countries are used to illustrate how additional local information such as price, brand name, regulatory guidelines, and treatment guidelines can be incorporated. The manual also highlights the importance of a well-planned dissemination and implementation strategy to maximize the use and impact of the national formulary in the local setting. Conclusions: Development and maintenance of a national formulary requires thorough planning, excellent organization, and adequate resources. The WHO Model Formulary, along with a locally relevant manual, can serve as key resources and should significantly simplify the task of preparing the first draft of a national formulary text. Regular updates of the WHO Model Formulary will also support the necessary periodic revision of national formularies.

2. WHO Model Formulary (WMF) Purpose –To promote safe and cost-effective use of medicines included in the WHO Essential Medicines List –To serve as model for national, local or institutional formularies Brief history 1995 recommendation to develop Model Formulary by WHO Expert Committee 2000 Start of validation and final editing of draft 2002 first edition out in print, CD-Rom and online on the WHO website 2004 the second revised edition is now available in print and online http://mednet3.who.int/eml/modelFormulary.asp http://mednet3.who.int/eml/modelFormulary.asp the CD-Rom will have files in multiple languages and manual on how to produce a National Formulary

3. WHO Model Formulary (WMF) Reflects evidence-based recommendations of WHO and other reputable clinical guidelines Validated using current, reputable drug information resources & WHO documents Design and organization is modeled on the successful and widely used British National Formulary (BNF) Produced in collaboration between –BNF editorial team, Royal Pharmaceutical Society of Great Britain and –The Essential Medicine Department of WHO

4. Anatomy of WMF Front matter General Advice to prescribers –e.g. prescription writing, adherence Essential Medicines List List of deletion, additions, changes to Essential Medicines List Main body 27 Sections organized into therapeutic categories –Within each section general discussion of therapeutic options and safety issues, followed by individual monographs Rear Matter Appendices: –Interactions, Pregnancy, Breastfeeding, Renal impairment, Hepatic impairment Index: includes disease and drug terms

5. How the WMF can be used? As… a resource and model for developing national and institutional formularies a high quality, independent drug information resource during the review of existing formularies an essential medicines/ clinical guideline resource for individual prescribers

6. Developing/maintaining national formularies based on WMF Planning Development Production/ of draft Distribution Formulary & Advisory Committee Editorial team Agree on plan & budget Start by using WMF text Add local info Review and approve final text Final editing & layout Print Distribute Implement Evaluation & Review using updated WMF

7. Important local information in national formulary Front matter Policies and procedures of National Formulary Committee Instruction on how to use formulary National policies & regulations on prescribing/ dispensing Main body Local guideline recommendations Local, product-specific information New monographs, if local medicine is not in WMF Note: Use local advisory committee for writing / reviewing draft Rear matter Additional safety, pharmaceutical and administrative info e.g. incompatibilities, poisoning information, dose calculators, ADR reporting form, contact details

8. Production issues WMF text will be available as Word® files for developing local formulary text Need skilled editor when modifying, deleting WMF text in order to maintain integrity of information – Careful copy-editing and proofreading Design a user friendly format –Slim, light, durable Select good quality, affordable printing methods

9. Once the printed copy is out… It is essential to have: –Good distribution mechanism –Implementation: launch, promotional, training activities –Evaluation to measure impact of formulary on local prescribing –Mechanism for collecting feed-back from users Carefully document errors during time between revisions –Plans for next review and update

10. Review & Update Planning for revisions – WMF will be updated every two years –Formulary revision may be linked to national guidelines review –Updates of WMF should be checked for changes, especially in general therapeutic information section –Consider information from evaluation and feed-back from users Extensive involvement of local experts in review and approval of updated text is important

11. Summary WMF provides current evidence-based therapeutic and medicine information Using existing WMF files in development of local formulary can greatly reduce workload and ensure inclusion of valid information but –careful planning, –skilled editorial team –involvement of local experts –adequate resources and time will be still essential for successful production and implementation of local formulary