1. Session 2. Developing and Maintaining a Formulary

2. Objectives Define 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

3. Outline (1) Introduction Formulary Management Principles
Maintaining a Formulary System
Process for Selecting New Medicines
Selection Criteria for New Medicines
Nonformulary Medicines

4. Outline (2) Restricted Pharmaceutical Use
International Nonproprietary Pharmaceutical Names
Information Sources for Evaluating New Medicines
Formulary Manual
Activities
Summary

5. 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

6. WHO Model Formulary (2004 and 2007)
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.

7. 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

8. 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

9. Benefits of an Effective Formulary System (3)
Consistent supply of medicines
Regulating the number of medicines will improve procurement and inventory management
Economies of scale will increase availability of essential medicines
Saving money leads to consistency in purchasing essential medicines which in turn leads to increased availability

10. 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

11. 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)

12. Formulary Management Principles (2)
Use explicit selection criteria that include—
Efficacy and effectiveness
Safety
Quality
Cost
Select medicines that are consistent with national and regional formularies and standard treatment guidelines
Restrict medicines use to appropriate practitioners

13. Maintaining a Formulary
Evaluate new medicine requests and deletions regularly
Conduct a systematic review of therapeutic groups and classes

14. Steps to Add or Delete a New Medicine

15. Steps to Evaluate a Medicine
Compile information resources
Perform evaluation using established criteria
Write medicine monograph describing the evaluation and results
Develop formulary recommendations to present to the DTC
Obtain expert opinion and recommendations
Make a decision at the DTC meeting
Disseminate the results of the evaluation and DTC recommendations

16. Criteria for Evaluating and Selecting Medicines for Formulary (1)
Disease patterns
Efficacy and effectiveness
Safety
Quality (pharmaceutical products and suppliers)

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

18. Nonformulary Medicines
Open formularies
Closed formularies
Management of nonformulary medicines
Limit number of nonformulary medicines
Limit access
Keep a register of all requests for nonformulary medicines (medicine name, quantity, indication)
Review frequently and discuss in DTC meetings

19. 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

20. Restricted Medicines (2)
Examples—
Certain antimicrobials for infectious disease specialists
Antipsychotic medicines for mental health professionals
Antineoplastic products for oncologists and internal medicine specialists

21. International Nonproprietary Names
Trade or brand names
Disadvantages
Nonproprietary or generic names
Advantages in the health care system

22. Information Resources
Primary Resources
Secondary Resources
Tertiary Resources

23. Primary Literature—Examples
British Medical Journal
Lancet
New England Journal of Medicine
Journal of the American Medical Association
Annals of Internal Medicine
American Journal of Health-System Pharmacists (AJHP)

24. Secondary Literature—Examples
Medical 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 Bulletins
Peer-reviewed journals
Australian Prescriber, Journal Watch, Prescrire
Electronic databases
MEDLINE and EMBASE abstracts
International pharmaceutical abstracts
Cochrane Library abstracts and evaluations

25. Tertiary Source—Examples
Martindale: The Extra Pharmacopoeia
British National Formulary
USP DI Drug Information
American Hospital Formulary Service (AHFS) Drug Information

26. British National Formulary
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.

27. Internet Resources—Examples
MEDLINE
World Health Organization
Centers for Disease Control and Prevention
National Institutes of Health
U.S. Food and Drug Administration
Cochrane Collaboration
Agency for Healthcare Research and Quality

28. Formulary Manual (1) Listing of formulary medicines
Alphabetical
Therapeutic category
Medicine information section
Generic name
Dose and strengths
Indications, contraindications, precautions
Side effects
Dosage schedule
Instructions, warnings, interactions

29. Formulary Manual (2) Supplementary information for medicines Price
Regulatory category
Storage guidelines
Patient counseling information
Labeling information
Brand names and synonyms

30. Formulary Manual (3) Prescribing and dispensing guidelines
Rational prescribing techniques
Prescription writing principles
Guidelines on quantities to be dispensed
Controlled medicine requirements
ADR reporting requirements
Dispensing guidelines
List of precautionary labels
Medicine interaction tables

31. Formulary Manual (4) Treatment protocols
IV medication administration guidelines
Medicines used in pregnancy and lactation
Medicines used in renal failure
Poison guidelines
Prescribing for the elderly

32. Formulary Manual (5) Other components Metric tables ADR reporting form
Product quality reporting form
Request form for adding or deleting medicines
Request form to use nonformulary medicines
Abbreviations
Indexes

33. Formulary Manual (6)
Acceptance of a formulary manual requires buy in by—
Opinion leaders
Hospital administration
Senior staff
Professional associations
Manuals must be prepared carefully
Evidenced-based information
Written by experts
Reviewed frequently to be kept up to date

34. 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

35. Activity 1. Adding a New Antibiotic to the Formulary
Your 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?

36. Activity 2. Formulary Management of NSAIDs
Review the list of nonsteroidal anti-inflammatory drugs provided in the Participants’ Guide
Do 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?

37. Summary (1) Formulary management principles
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)

38. Summary (2) Formulary management principles (con’t)
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

39. 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