*Session 2. Developing and Maintaining a Formulary

ObjectivesDefine the formulary system concept

Understand basic formulary management principles

Describe the benefits of an effective formulary system

Identify criteria used for selection of medicines

Describe basic pharmaceutical information resources for evaluating medicines

Outline (1)IntroductionFormulary Management Principles Maintaining a Formulary SystemProcess for Selecting New MedicinesSelection Criteria for New MedicinesNonformulary Medicines

Outline (2)Restricted Pharmaceutical UseInternational Nonproprietary Pharmaceutical NamesInformation Sources for Evaluating New MedicinesFormulary ManualActivitiesSummary

Key DefinitionsFormularyA list of medicines approved for use in the healthcare system by authorized prescribers

Formulary manualThe 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 systemA system of periodically evaluating and selecting medicines for the formulary, maintaining the formulary, and providing information in a suitable manual or list

WHO Model Formulary (2004 and 2007)

Benefits of an Effective Formulary System (1) Approved and efficacious medicines that all practitioners will have available for use

Only the most effective and safest products

Medicines have been evaluated systematically

Medicines are chosen and approved to treat the diseases of the region or country

Physicians develop greater experience with fewer medicines

Benefits of an Effective Formulary System (2)Pharmaceutical therapy at lower cost

Ineffective, high-cost medicines will be excluded from system

Availability of most effective medicines leads to fewer visits, improved outcomes, and lower cost

Reduced inventory cost

Benefits of an Effective Formulary System (3)Consistent supply of medicinesRegulating the number of medicines will improve procurement and inventory managementEconomies of scale will increase availability of essential medicinesSaving money leads to consistency in purchasing essential medicines which in turn leads to increased availability

Benefits of an Effective Formulary SystemSummarySUPPLYEasier procurementLower amount of stocksImproved quality assuranceEasier dispensing

PATIENT USEFocused education effortsBetter compliance Improved availability

PRESCRIBINGMore experience with fewer medicinesIrrational alternatives not availableFocused medicine informationADRs easier to manage

COSTLower prices, more competition

Formulary Management Principles (1)Select medicines on the basis of need (diseases and conditions that have been identified locally)

Select medicines of choice

Maintain a limited number of medicines (avoid duplications)

Use INN (generic) names

Use combination (fixed-dose) products only in specific proven conditions (e.g., tuberculosis)

Formulary Management Principles (2)Use explicit selection criteria that includeEfficacy and effectivenessSafetyQualityCost

Select medicines that are consistent with national and regional formularies and standard treatment guidelines Restrict medicines use to appropriate practitioners

Maintaining a Formulary

Evaluate new medicine requests and deletions regularly

Conduct a systematic review of therapeutic groups and classes

Steps to Add or Delete a New Medicine

Steps to Evaluate a Medicine Compile information resourcesPerform evaluation using established criteriaWrite medicine monograph describing the evaluation and resultsDevelop formulary recommendations to present to the DTCObtain expert opinion and recommendationsMake a decision at the DTC meetingDisseminate the results of the evaluation and DTC recommendations

Criteria for Evaluating and Selecting Medicines for Formulary (1)Disease patternsEfficacy and effectivenessSafetyQuality (pharmaceutical products and suppliers)

Criteria for Evaluating and Selecting Medicines for Formulary (2)Cost and cost-effectiveness of the medicineWell-known medicines Health system personnel and expertise available to manage the medicineFinancial resources available to buy the medicine

Nonformulary MedicinesOpen formulariesClosed formulariesManagement of nonformulary medicinesLimit number of nonformulary medicinesLimit accessKeep a register of all requests for nonformulary medicines (medicine name, quantity, indication)Review frequently and discuss in DTC meetings

Restricted Medicines (1)Medicines to be used by specific staff or for specific conditions only

Defined and enforced by the DTC

Necessary to control the use of medicines that should only be used by medical staff with specialized skills

Monitor carefully to ensure the appropriate use

Restricted Medicines (2)ExamplesCertain antimicrobials for infectious disease specialists

Antipsychotic medicines for mental health professionals

Antineoplastic products for oncologists and internal medicine specialists

International Nonproprietary NamesTrade or brand names

Disadvantages

Nonproprietary or generic names

Advantages in the health care system

Information ResourcesPrimary Resources Secondary Resources

Tertiary Resources

Primary LiteratureExamplesBritish Medical JournalLancetNew England Journal of MedicineJournal of the American Medical AssociationAnnals of Internal MedicineAmerican Journal of Health-System Pharmacists (AJHP)

Secondary LiteratureExamplesMedical letters, newsletters, or bulletins produced by national bodies that monitor medicine efficacy, safety, and cost Medical Letter (USA), Drug & Therapeutics Bulletin (UK), The International Society of Drug BulletinsPeer-reviewed journalsAustralian Prescriber, Journal Watch, Prescrire Electronic databasesMEDLINE and EMBASE abstractsInternational pharmaceutical abstractsCochrane Library abstracts and evaluations

Tertiary SourceExamplesMartindale: The Extra PharmacopoeiaBritish National FormularyUSP DI Drug Information

American Hospital Formulary Service (AHFS) Drug Information

British National Formulary

Internet ResourcesExamplesMEDLINEWorld Health OrganizationCenters for Disease Control and Prevention National Institutes of HealthU.S. Food and Drug Administration Cochrane CollaborationAgency for Healthcare Research and Quality

Formulary Manual (1)Listing of formulary medicinesAlphabeticalTherapeutic category

Medicine information sectionGeneric nameDose and strengthsIndications, contraindications, precautionsSide effects Dosage scheduleInstructions, warnings, interactions

Formulary Manual (2)Supplementary information for medicinesPriceRegulatory categoryStorage guidelinesPatient counseling informationLabeling informationBrand names and synonyms

Formulary Manual (3)Prescribing and dispensing guidelinesRational prescribing techniquesPrescription writing principles Guidelines on quantities to be dispensedControlled medicine requirementsADR reporting requirementsDispensing guidelinesList of precautionary labelsMedicine interaction tables

Formulary Manual (4)Treatment protocolsIV medication administration guidelinesMedicines used in pregnancy and lactationMedicines used in renal failurePoison guidelinesPrescribing for the elderly

Formulary Manual (5)Other components Metric tablesADR reporting formProduct quality reporting formRequest form for adding or deleting medicinesRequest form to use nonformulary medicinesAbbreviationsIndexes

Formulary Manual (6)Acceptance of a formulary manual requires buy in by Opinion leadersHospital administrationSenior staffProfessional associations

Manuals must be prepared carefully Evidenced-based informationWritten by expertsReviewed frequently to be kept up to date

Examples of Rational Drug Selection, Delhi, India*The essential medicines list (EML) was developed by a multidisciplinary group of experts using criteria of efficacy, safety, and cost

Revised EML saved nearly 30% of money which was used for procuring more medicines resulting in an 80% improved availability in health facilities

Activity 1. Adding a New Antibiotic to the FormularyYour DTC received an application to add cefapime to the hospital formulary. See Participants Guide for more information about this new drug and its use.

What criteria are necessary to evaluate this medicine for addition to the formulary?

Using the principles of formulary management, what major concerns do you have before adding this medicine to the formulary?

What pharmaceutical information resources would be used to analyze this medicine for the DTC? Which sources would be the most useful?

Activity 2. Formulary Management of NSAIDsReview the list of nonsteroidal anti-inflammatory drugs provided in the Participants GuideDo you think the listed medicines appear logical and well chosen?

How many chemical entities are available on the formulary?

How many NSAID medicines are necessary for a formulary?

What medicines would you recommend to be added or deleted? What is the best method to list medicines in a formulary? Is this list easy to read and understand?

Summary (1)

Formulary management principlesSelect 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)

Summary (2)Formulary management principles (cont)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 nonformulary medicines

Restrict medicines to use by appropriate practitioners

Summary (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 DTC and the formulary system

**The WHO Model Formulary is considered to be a useful resource for countries wishing to develop their own national formulary. Electronic copies are available.

National or institutional committees can use the text of the Model Formulary for their own needs by adapting the text, or by adding or deleting entries to align the formulary to their own list of essential medicines.

The WHO Model Formulary is compatible with the list of essential medicines.

*The BNF is a joint publication of the British Medical Association and the Royal Pharmaceutical Society of Great Britain. It is designed for rapid reference.

It is published biannually under the authority of a Joint Formulary Committee, which comprises representatives of the two professional bodies and of the UK Health Departments.

Information on medicines is drawn from the manufacturers' product literature, medical and pharmaceutical literature, regulatory authorities, and professional bodies. Advice is constructed from clinical literature and reflects, as far as possible, an evaluation of the evidence from diverse sources.

The Dental Formulary Subcommittee oversees the preparation of advice on the pharmaceutical management of dental and oral conditions.

The BNF aims to provide prescribers, pharmacists, and other health care professionals with sound, up-to-date information about the use of medicines. The BNF includes key information on the selection, prescribing, dispensing, and administration of medicines.