Off-label use is a medical term, which is used for the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. They are used for various kinds of treatments including surgical or non-surgical operations, dental or cavity problems, chronic diseases along with various others. The declaration of off-label medicines, drugs or various processes are declared by government as well as non-government authorized agencies, which depend from country to country throughout the world. As far as approval of such medicines in USA is concerned, FDA (Food and Drug Administration) and Center for Drug Evaluation and Research (CDER) are authorized to review a company’s NDA (New Drug Application) from data from clinical trials to see if the results support the drug for a specific use or indication.
If the governing authorized bodies i.e. FDA & CDER satisfy with the dug that it’s effective and safe, the FDA and the medicines manufacturers agrees on specific language description dosage, route of administration and other information to be included on the label of medicine’s packet. Moreover, additional detailed information is included and inserted inside the drug’s package. FDA is also responsible for continuation to regulate the pharmaceutical industry’s promotional campaigns or activities for the drug through the work of the OPDP (Office of Prescription Drug Promotion). OPDP is formerly known as the DDMAC (Division for Drug Marketing, Advertisement and Communication).
As far as dental treatments are concerned, there are many healthcare professionals who follow off-label medicines, or medical processes. These professionals may include a nurse, community nurse, midwife, chiropodist / podiatrist, physiotherapist, optometrist, pharmacist or radiographer. There may also be inclusion of many other professionals, who can recommend off-label medicines such as independent nurse independent prescribers, optometrist independent prescribers as well as pharmacist independent prescribers. There are various kinds of dental treatments in which off-label medicines or medical processes are followed by healthcare professionals.
These dental treatments may include maxillofacial surgery, dental implant surgery, oral surgery procedures, endodontic procedures, periodontics treatment along with various others. These kinds of medicine are also used in conservative dental treatment. Off-label use is not considered as good for any kind of treatments; however these are used for some critical situations and diseases like cancer along with various others. In chemotherapy, which is used for cancer treatments, various off-label medicines and drugs are used. This process is considered to be effective for the patients. Thus, off-label medicines or processes may be effective in some conditions.