Abstract
Prescription of a drug outside of the indications for which it was originally approved by regulators is internationally known as "off-label" prescription. We describe off-label treatments for the diabetic foot reported in international scientific literature. This is a qualitative and descriptive bibliographical review based on the results of a search of the Medline international database. The criteria for review were publication between January 1985 and November 2013, and the MeSH (Medical Subject Heading) keywords "off-label use" OR "off-label" OR "off-label prescribing" plus "diabetic foot" were input on the search form. Nine studies were selected that contained information about off-label treatments for the diabetic foot. We conclude that the practice of off-label prescribing has potential benefits. In some situations an off-label prescription is the only treatment available for patients, either because a more targeted drug does not exist, or because other methods of treatment are ineffective or unavailable due to patient intolerance.
Highlights
Many medications are prescribed for uses that are not included in their conditions of approval for sale granted by the organ responsible for regulating the health sector in a given country
The following inclusion criteria were defined for the review: articles published from January 1985 to July 2013; using the MeSH keywords “off-label use” or “off-label” or “off-label prescribing”; plus the term “diabetic foot”; and articles that had an abstract in English available
Five major types of off-label prescription were used for treatment of the diabetic foot: antibiotics; biological dressings; hyperbaric oxygen therapy; vasodilators; and hemorheologic agents, each of which will be described in this paper (Table 1)
Summary
Many medications are prescribed for uses that are not included in their conditions of approval for sale (off-label) granted by the organ responsible for regulating the health sector in a given country. Off-label prescribing is defined as when medications are used for indications that are not mentioned on their information leaflets, in other words, prescribing a drug for a disease or patient, or using a route of administration or dosage, that have not been approved by the country’s healthcare agency. This type of prescription is legal, but healthcare regulatory organizations determine certain rules for prescribers. Several different studies have demonstrated that off-label prescribing is a common practice in medicine, showing that around 20% of prescriptions are made off-label annually.[1,2] The value of understanding this subject is incalculable, in order to provide information on which to base and improve conditions of use
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