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A diagnosis is the assessment that a particular medical condition is present while an indication is a reason for use. [3] The opposite of an indication is a contraindication , [ 4 ] a reason to withhold a certain medical treatment because the risks of treatment clearly outweigh the benefits.
This pitfall is particularly common with medical terms that are used in legal contexts, with related but significantly different meanings. (See the Manual of Style.) In addition, note that: Technical terms. Approved and indicated mean different things and should not be used interchangeably. Indications refer to common medical uses for a drug.
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about ...
The SPC is not intended to give general advice about treatment of a condition but does state how the product is to be used for a specific treatment. It forms the basis of information for health professionals to know how to use the specific product safely and effectively. The package leaflet supplied with the product is aimed at end-users. [3]
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare. Such documents have been in use for thousands of years during the entire history of ...
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.
The use of cannabis (also known as marijuana) for medical purposes is a notable medical necessity case. Cannabis is a plant whose active ingredients are widely reported by patients to be effective in pain control for various conditions, usually neuropathic in nature, in which common painkillers have not had great benefit.