An Introductory Guide to Medical Foods
Hippocrates, “The Father of Medicine” stated “Let food be thy medicine and medicine be thy food.” The benefits of food as medicine have been known for years. However, did you know that there are medical foods that can be dispensed in a pharmacy setting?
Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, the definition of a medical food is found in the Food and Drug Administration‘s 1988 Orphan Drug Act Amendments. They are defined as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Medical foods can be classified into the following categories:
- Nutritionally complete formulas– A formula is considered to be nutritionally complete if it provides 100 percent of the recommended values of carbohydrates, protein, fat, vitamins and minerals and can be used as a sole source of nutrition.
- Nutritionally incomplete formulas– A formula is considered to be nutritionally incomplete if it cannot alone fulfill the complete nutritional needs of a patients with normal or specific characteristics due to certain pathologies. This includes modular nutrients constituted by a module of isolated nutrients or a combination of some of them.
- Formulas for metabolic disorders– These are formulas that deal with patients where the chemical processes in the body do not function properly and may cause various health problems.
- Oral rehydration products – These are products that are an ideal solution for replacing fluids lost by overheating, vomiting or diarrhea.
Medical foods are regulated by the US Food and Drug Administration under the Food Drug and Cosmetic Act regulations. 21 CFR 101.9(j) and are not required to undergo premarket review or approval by the FDA.
Medical foods are often a necessity to those living with various medical conditions. A medical food is intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foods. Patients may have special medically determined nutrient requirements. Some patients may not be able to process certain amino acids due to genetic conditions and need specially formulated nutritional formulas. Patients may have needs that cannot be achieved by the modification of the normal diet alone.
Medical foods while not prescription items are dispensed and written under the supervision of a physician. Medical foods may be covered by health insurances through prescription benefits or through medical benefits. They often require a prior authorization from the insurance company that is provided by the prescribing doctor. The doctor’s office indicates the need of the medicinal food to the insurance company by providing diagnosis codes and other information to the insurance provider.
Nexus Patient Services in Phoenix, Arizona is a provider of Medical Foods for a variety of metabolic genetic conditions. Nexus facilitates the process of access to these medical foods to patients which increases adherence rates and outcomes for patients. Nexus is also able decrease barriers to obtaining medical foods by providing benefits to the patient when medication is not covered. Nexus works with patients, providers and insurances to allow increased affordability to the patient. This also allows for increased compliance and best results to the patient in managing their disease state.
Medical foods are an important way for many patients to be able to live their best day to day life. Nexus Patient Services is proud to offer these services to our patients and would invite any questions here or at www.nexuspatientservices.com
Lisa King Rph – Lisa King is a pharmacist of 32 years and is the Pharmacist in Charge at Nexus Patient Services.