Should wound care nurse carry out off-label use order?

off-label

A reader submitted a question about a physician ordering her to crush two Flagyl tablets and sprinkle them onto a patient wound.

wound care

By Nancy J. Brent, MS, JD, RN

The nurse knew this was not the correct way to administer the medication. However, she is concerned that since the physician ordered this method of administration that she is obligated to follow the order.

Part of this nurse’s conflict is that this method of administration is not generally consistent with current standards or practice.

But in many facilities and home care agencies, the use of Flagyl tablets in this way is a common and customary practice, as we discuss in our blog, “We’ve Always Done It This Way:  Flagyl Crushing & Other Wound Care Bad Habits.”

However customary such a use may be, it can create potential legal liabilities for you.

Let’s define off-label drug use

Using a drug off-label is defined as prescribing a medicine by a physician or an advanced practice registered nurse for an indication or using a dosage or dosage form that has not been approved by the Federal Drug Administration, according to a Mayo Clinic Proceedings journal article.

As mentioned in our blog, the Federal Food and Drug Administration approves Flagyl for oral use and use in the body. The FDA does not regulate the practice of medicine nor the practice of nursing, so once a drug is approved by the FDA off-label use can become common.

However, the use is not without potential liability, including professional negligence if a patient’s wound does not heal or the patient dies as a result of such use.

For a discussion about professional negligence, read my blog “Wound Care Specialist Has Legal Concerns When Asked About Clinical Issues ‘On The Fly.’ ”

Moreover, if the patient’s informed consent for the off-label use is not obtained, additional liability exists.

Violation(s) of State Nurse Practice Act

Aside from the legal concerns of off-label use of a drug, you may also face a professional disciplinary action by your state board of nursing.

The basis for such an action are in the act itself or its rules. As examples, state nurse practice acts or rules require any nurse licensed in a particular state to:

  • Adhere to current nursing standards of practice
  • Practice competently
  • Be accountable for one’s nursing actions
  • Practice ethically
  • Advocate for the patient

The use of Flagyl off-label may raise a breach of these obligations, whether or not a patient injury occurs.

Pharmacy practice or nursing practice?

The scope of pharmacy practice in state pharmacy practice acts includes the compounding of medications. Generally, compounding is described as the preparation and mixing of components of a medication in those acts.

When the nurse in the submitted situation — or you, for that matter — are asked to crush Flagyl and place the medication in a wound bed, does the act of crushing or mixing it with another medication equate to compounding?

If so, the result is you are practicing pharmacy without a license and not nursing with a license.

Although nurse practice acts don’t currently include this in the scope of a nurse’s practice, its omission does not provide permission to do so in wound care.

What should you do in this situation?

An easy resolution doesn’t exist when presented with such an order. However, it is essential to keep in mind that as your nurse practice act and ethical codes state, you are responsible and accountable for your own practice.

As a result, whatever anyone else tells you to do, you and only you must decide if the order is included in your scope of practice and is consistent with current standards of wound care nursing practice.

One immediate solution to the situation would be to clearly explain to the physician that you are uncomfortable with the order because it is for an older treatment that is not effective because of the need to have the medication absorbed by the GI system, and your nurse practice act’s scope of practice does not include crushing medications.

You could then suggest that if the physician wants the Flagyl administered in this way, he or she can do so.

Documentation of the discussion and outcome should be placed in the patient’s medical record, and the nurse’s supervisor or another administrative superior notified.

Sharing your concerns with the physician and not carrying out the order avoids a potential liability risk for you and clearly advocates for the patient.

A proactive approach is always better than an ad hoc solution in the field. As discussed in “Nurses and Off Label Drug Use,” additional approaches are indicated.

One such measure is to suggest your facility or clinic develop and adopt policies and procedures that govern the prescribing, dispensing and administration of off-label drugs. You also need to actively participate in their formation.

The policies and procedures should incorporate accepted, current standards of medicine, pharmacy and nursing practice.

In addition, requiring the informed consent of the patient, or the patient’s legal representative, for any off-use drug treatment is essential.

Last, but by no means least, keeping abreast of the latest developments in wound care — including what medications are used and how they are to be administered — is vital.

Take one of our wound care courses or certification refreshers to keep your knowledge up to date.

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Nancy J. Brent, MS, JD, RN, received her Juris Doctor from Loyola University Chicago School of Law and concentrates her solo law practice in health law and legal representation, consultation and education for healthcare professionals, school of nursing faculty and healthcare delivery facilities. Brent has conducted many seminars on legal issues in nursing and healthcare delivery across the country and has published extensively in the area of law and nursing practice. She brings more than 30 years of experience to her role of legal information columnist. Brent’s posts are designed for educational purposes only and are not to be taken as specific legal or other advice. Individuals who need advice on a specific incident or work situation should contact a nurse attorney or attorney in their state. Visit The American Association of Nurse Attorneys website to search its attorney referral database by state.

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