Providers may view off label drug use (OLDU) for wounds as the "new wave". However, if there is little or no scientific evidence supporting the practice, it can possibly lead to more problems than good. Keep in mind that not every health care setting embraces off label drug use. For example, state surveyors view OLDU differently in long-term care versus home care. Providers should avoid any risk of being involved in a pressure injury investigation. OLDU may be considered a factor in the event of such an investigation. Hospice patients are considered to be in more of a "dying with dignity" category, therefore OLDU may be considered more acceptable.

Legal Issues Associated with Off Label Drug Use

When a provider writes an order for medications to be mixed, crushed, or sprinkled in wound and skin treatment application, it is putting the clinician in a sticky situation legally. It is imperative that a pharmacist compounds any "mixed" medications that are prescribed. To help avoid potential legal issues resulting from OLDU, providers are encouraged to write "layer", instead of "mix" in their documentation. With this being said, it is important to remember the antibiotic, if being prescribed, is applied to the wound bed first for deepest penetration. Mixing creams and ointments can also deactivate certain drug mechanisms, and applying oral medications to a wound can ultimately be cytotoxic. Providers should be aware of these drug interactions before writing an order for OLDU for their patients and evaluate the risks associated with OLDU before prescribing treatment.

Common Off Label Drugs and Compounds Used in Wound Care

Procardia® (nifedipine)
Cytotec® (misoprostol)
Trental® (pentoxifylline)
Tea tree oil
Frankincense
Carafate (sucralfate)
Flagyl (metronidazole), crushed
Flagyl (metronidazole ), crushed, mixed with Collagenase SANTYL® Ointment
Dilantin (phenytoin) suspension
Nitropaste (nitroglycerin) topical
Milk of Magnesia
Medical grade honey gel mixed with Collagenase SANTYL® Ointment
Silvadene® (silver sulfadiazine) mixed with Flagyl (metronidazole)

While I realize that many of the off label drugs used to enhance wound healing can be effective, my reasoning for this blog is to help providers be more aware of medical malpractice and state survey deficiencies use may present. It is the responsibility of the provider, wound care specialist, and the dispensing pharmacist to make certain that any off label use of a drug is supported by credible, evidence-based literature. Existing compounded formula recipes should demonstrate the drugs are safe and effective in treating different wound types. **Providers that prescribe OLDU do not violate FDA or state law.

Sources:
Center for Medicare Advocacy. CMA Report: Medicare Coverage for Off-Label Drug Use. http://www.medicareadvocacy.org/cma-report-medicare-coverage-for-off-la…. Accessed July 13, 2016.

Center for Medicare Advocacy. Off-Label Drug Use Is Common and Hurts Nursing Home Residents. http://www.medicareadvocacy.org/off-label-drug-use-is-common-and-hurts-…. Accessed July 13, 2016.

Treadwell T. Off-Label Use of Medications and Therapies in Wound Care. Wounds. http://www.woundsresearch.com/content/off-label-use-medications-and-the…. April 1, 2010. Accessed July 13, 2016.

About the Author
Cheryl Carver is an independent wound educator and consultant. Carver's experience includes over a decade of hospital wound care and hyperbaric medicine. Carver single-handedly developed a comprehensive educational training manual for onboarding physicians and is the star of disease-specific educational video sessions accessible to employee providers and colleagues. Carver educates onboarding providers, in addition to bedside nurses in the numerous nursing homes across the country. Carver serves as a wound care certification committee member for the National Alliance of Wound Care and Ostomy, and is a board member of the Undersea Hyperbaric Medical Society Mid-West Chapter.