Off-label Use of Prescription Medication: A Literature Review

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Author(s): 
Robert G. Smith, DPM, MSc, RPh, CPed
Start Page: 
78
End Page: 
86

Abstract: The following review will describe the available literature and outline the concept and practice of off-label prescribing. Phenytoin, misoprostol, and nifedipine will be critically reviewed with emphasis on their functional components, mechanisms of action, and patient considerations regarding wound healing. Recipes of off-label medications also will be offered.



     Wound management guidelines have been established to assist healthcare professionals in providing the most advantageous treatment to promote wound closure. Organized decisions that are often grounded in clinically based evidence from the medical compendium are essential tools wound care specialists employ to promote healing. Unfortunately, the multitude of advertisements for wound dressings possibly eclipses the fact that only small, poor-quality trials exist to support the use of many products.1 Nonetheless, attempts have been made to provide the educational tools necessary for making informed decisions using evidence-based medicine to select wound care products.2 Determining the most appropriate treatment or selection of a wound care product to satisfy a particular patient’s needs requires a delicate balance between knowledge and art. Secundum artem is a Latin phrase meaning “according to the art.” In medicine it is often taken to mean, “use your skill and judgment.”

     Agents that have been approved by the US Food and Drug Administration (FDA) to treat wounds include anesthetics, antibiotics, anti-infectives, enzymes for debridement, granulation stimulants, growth factors, and moisture enhancers. Numerous wound care dressings and topical medications line the shelves of pharmacies and hospitals, which makes the selection process even more difficult. Despite the plethora of approved products, some wound care patients have healthcare needs that off-the-shelf prescription medicines do not meet. Off-label prescribing of customized medicines to help promote dermal wound closure has been employed by wound care specialists to meet these needs.

     The concept of off-label prescribing of approved pharmaceuticals has created much attention and led to myths and misconceptions regarding its practice. Case studies exist in the literature regarding the use of topical phenytoin, misoprostol, and nifedipine to treat wounds. It is for this reason that this review article has been written; to allow data from previously published literature to be presented and evaluated in the context of clinically based evidence to justify the current practice of prescribing of these agents off-label.

     A review of the available literature outlining the concept and practice of off-label prescriptions is offered to serve as a foundation. Secondly, specific medications are critically reviewed regarding their mechanisms of action and patient considerations in the context of wound healing. Recommended off-label medication compounds are presented for the treatment of cutaneous wounds (Table 1).

Off-label Prescribing

     Healthcare providers do not all fully understand the drug development and regulatory issues that exist. Two factors that motivate a wound care specialist to choose one therapy over another when attempting to close a particular wound are: 1) an understanding of the scientific basis for a drug’s activity in a given disease state, and 2) the belief in the drug’s efficacy in achieving wound closure.

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