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The study of an OLDU database is an untapped research resource in medicine
Lower Lobby
The study of an OLDU database is an untapped research resource in medicine
Saint James School of Medicine
Patient-centered health care has seen positive results by way of physicians prescribing medications off-label. Historically, the FDA releases drugs safe for the market and strongly recommends that they... Read more

Description

Patient-centered health care has seen positive results by way of physicians prescribing medications off-label. Historically, the FDA releases drugs safe for the market and strongly recommends that they be used for their respective indications. More and more, physicians are prescribing drugs off-label; “off-label use is the use of pharmaceutical drugs for an unapproved indication”. While the FDA has thorough regulations in place to approve a drug before it hits the market, the process is often expensive and time-consuming ranging from 10-15 years.

Research and innovation is the foundation of medicine, in which undoubtedly pharmaceuticals play a huge role in efficacious patient treatment. In certain scenarios, when a first line drug is not beneficial and after other options have been eliminated, physicians have reached for pharmaceuticals that are market approved albeit, may not be indicated for the purpose they are being used for.

Trends over the past decade have shown that physicians are prescribing treatments off- label increasingly more often. Undoubtedly, off label drug use has become an alternative treatment method that has yielded both great and devastating results, and is being used more and more often. Why then, do we not monitor OLDU? An effective way to monitor OLDU statistics is vital to pharmaceutical research.

OLDU should not be viewed as simply an alternative treatment therapy, it is a widely used accepted mechanism in clinical practice and rather than disregard OLDU; it is becoming increasingly more important to monitor every time a drug is used off-label. The patients currently using these drugs for unindicated purposes are not part of phase I,II or III clinical trials, but perhaps more significantly, they are currently facing severe illnesses and have not responded to the first line therapies for their respective diseases.

Unequivocally, the analysis of drugs that are being used for alternative indications as well as, what the proposed side effects may be and which patients can benefit from this is in fact a novice form of clinical research in pharmaceuticals; the experimental study of clinically approved drugs on the market.

Specifically, in the field of Dermatology with diseases often being systemic and causing multiple symptoms, what works in one patient may not work in another. A prime example of this is in patients with skin disease vitiligo. Vitiligo is a lack of pigmentation caused by defective melatonin. Currently, the topical ointment Protopic is not indicated as a first line treatment for vitiligo, it is in fact indicated for eczema. However, when prescribed off-label, tacrolimus ointment has shown great results in patients, including myself, and yet, even today; there are patients for whom various other first line treatments have been ineffective and their physicians are not provided with this option.

Undeniably, the study of OLDU is an untapped resource in research and medicine.

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