DEVELOPING NATIONAL FORMULARIES BASED ON THE WHO MODEL FORMULARY Tisocki K, Laing RL, Hogerzeil H, Mehta DK, Ryan RSM

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 the CD-Rom will have files in multiple languages and manual on how to produce a National Formulary

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

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

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

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

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

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

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

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

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