The process varies among institutions. Get to know your process.
Use and Volume
Requests for formulary consideration should include the prescribers' desired use, projected utilization volume and possible utilization offset with the new medication.
Drug and Disease
To begin, both the drug and the disease state should be reviewed. Two important concepts to consider include an understanding of the natural progression of the disease and identifying the current standard of care. This is a critical step.
A standard monograph has several sections. Each health system may have their own format depending on their patient population and individual health system needs.
References should be used as needed to document the major points being discussed, little-known points and controversial material. You should reference any background information you cite when appropriate.
Processing a Formulary Request
This section describes the initial steps once a formulary addition request is received, discusses information that the initial request should contain, and gives an overview of the information that may be contained in a monograph that is prepared for discussion at a P&T Committee meeting. More detailed monograph preparation is outlined in the Resources for Researching a Formulary Request and Key Issues to Address sections of the Resource Center.
Initiating a Request for Formulary Consideration
Each health system's process for receiving requests for formulary consideration may be different. For example, some health system's have an electronic request form while others may use the traditional paper request. These requests are submitted to a designated person, usually a pharmacist, who receives and triages the request further.
Intended Use and Anticipated Volume
Requests for formulary consideration should include the prescribers' desired use, projected utilization volume and possible utilization offset with the new medication. Each institution may tailor the need for the drug and may target use for a specific subset of patients. This is critical to know in advance as it can allow for a more focused review and save monograph preparation time. For example, targeted use can include using the medication in pediatrics or adults only as compared to using the medication in both populations or using the medication for a specific level of disease.
Who May Request a Drug be Considered for Formulary Addition
For many health systems, any health care provider may initiate a request for formulary consideration. Some health system's require that the requestor is a licensed physician. It is important that each institution follow their accepted practice to ensure the process is consistent.
Monograph Considerations - Before You Begin
To begin, both the drug and the disease state should be reviewed.
DRUG: Learn about the drug in question and understand the FDA-approved indication(s) for the drug as well as any unapproved or emerging indications.
DISEASE: You may need to review disease management guidelines, medical textbooks or other resources to become familiar with the disease state or condition.
Two important concepts to consider include an understanding of the natural progression of the disease and identifying the current standard of care. Becoming familiar with the natural progression of the disease will allow you to compare the effectiveness of the existing therapy to the new therapy within the context of the natural progression of the disease. This may also include outcomes such as pain, tolerability, mobility, and even life expectancy. You should also identify the standard of care related to the treatment of the disease or condition and how this new therapy will compare to what has existed previously. This is a critical step because if you are not familiar with what is currently being used to treat the condition in question, you will not be able to evaluate whether the new drug will have a better or worse outcome.
A standard monograph has several sections. Each health system may have their own format depending on their patient population and individual health system needs. The following sections are commonly used:
- Treatment Options
- Current formulary agents available for the therapeutic area
- Treatment Guidelines
- FDA Approved Indication(s)
- FDA Application
- New Drug Application
- Abbreviated New Drug Application
- Supplemental New Drug Application
- Biologic License Application
- Orphan Drug
- FDA Review Type
- Standard Review
- Priority Review
- Fast Track
- FDA Advisory Committee Review
- Blood, Vaccines and Other Biologics
- Human Drug Advisory Committees
- Food Advisory Committee
- Medical Devices
- Patient Engagement Advisory Committee
- Pediatric Advisory Committee
- Radiation-Emitting Products
- Risk Communication Advisory Committee
- Science Board to the Food and Drug Administration
- Toxicological Research, Science Advisory Board to NCTR
- Veterinary Medicine Advisory Committee
- Tobacco Products Scientific Advisory Committee
- Benefit Designation
- Medical Benefit
- Pharmacy Benefit
- Service Location
- Infusion Center/Dialysis Center/Radiology Clinic
- Procedural (e.g., imaging, operating room, day surgery)
- Home Infusion
- Specialty Pharmacy
- Wholesaler Distribution
- Evidence Tables
- Study #1
- Study #2
- Study #3
- Poster #1
- Poster #2
- Abstract #1
- Abstract #2
- Adverse Effects
- Drug Interactions
- Safety Considerations
- Boxed Warnings
- Warnings and Precautions
- Risk Evaluation and Mitigation Strategy (REMS) program
- Institute for Safe Medication Practice (ISMP) Alerts
- Use in Special Populations
- Pediatric Use
- Geriatric Use
- Renal Impairment
- Hepatic Impairment
- Stability and Storage
- Dosing and Administration
- Include how supplied, if not an oral agent, include whether this is an in-office injectable, self-injectable, or if it is administered at an outpatient infusion center.
- Also include the following for injectable drugs:
- Standardized concentration for adults and children
- Stability/Beyond Use Dating (BUD)
- The preferred vehicle (s) for mixing (i.e., D5W, NS, etc.)
- SMART PUMP Dose Settings (soft Min, Soft Max, Hard Max)]
- Direct Drug Acquisition Cost
- Pharmacoeconomic Evaluation
- Patient Assistance Programs
- Forecasted Utilization
- Utilization Offset: Potential shifts in utilization from existing formulary agents to the new medication and cost impact of these shifts
- Add drug to the formulary without restriction
- Add drug to the formulary with restrictions, step therapy
- Do not add drug to the formulary
Drug monographs should include references throughout that are in the appropriate format. Most commonly, the American Medical Association Manual of Style is used for citing information for medical writing that is available online and in print.
References should be used as needed to document the major points being discussed, little-known points and controversial material. You should reference any background information you cite when appropriate. References are numbered in sequence as they appear in the manuscript and are designated as superscripts outside the punctuation of the referenced statement.
The following sample format should be used when citing the prescribing information.
Cialis [package insert]. Indianapolis, IN: Eli Lilly & Co; 2003.
All authors should be listed when there are 6 or fewer authors. If 7 or more people wrote the paper, then the first 3 authors should be listed followed by et al.
Van Slooten AD, Nix DE, Wilton JH, Love JH, Spivey JM, Goldstein HR. Combined use of ciprofloxacin and sucralfate. Ann Pharmacother 1991; 25:578-82.
Busch MP, Eble BE, Khayam-Bashi H, et al. Evaluation of screened blood donations for human immunodeficiency virus Type 1 infection by culture and DNA amplification of pooled cells. New Engl J Med 1991; 325:1-5.
Letter to the Editor, Abstracts, Editorials
Wagner EH. Nonsteroidal anti-inflammatory drugs and renal disease - still unsettled (editorial). Ann Intern Med 1991; 115:227-8.
Chapters and Books
Winter ME. Basic Clinical Pharmacokinetics. 2nd Edition. Spokane WA: Applied Therapeutics, Inc., 1988:235.
Sande MA, Kapusnik-Uner JE, Mandell GL. Antimicrobial Agents. In: Gilman AG, Rall TW, Nies AS, Taylor P (Eds). Goodman and Gilman's The Pharmacological Basis of Therapeutics. New York: Pergamon Press, 1990: 1018-46.