Off-label Considerations for Mid-level Practitioners

Posted By Kate Harper, Friday, January 18, 2019

Off label

By Patrick O'Brien, J.D., Legal Coordinator for the American Med Spa Association

We'e discussed the issues and legalities with prescribing drugs for uses other than what the FDA originally approved them for here. Known as "off-label use" the practice is often routine and generally acceptable as the FDA does not control the practice of medicine. Most of the current discussion looks at off-label use from the perspective of licensed physicians. Generally, physicians are permitted to prescribe drugs for off-label purposes without restriction as part of their license to practice medicine. However, this isn't necessarily the case for mid-level prescribers such as physician assistants (PA) and nurse practitioners (NP). Below we'll discuss some of the common limitations and concerns mid-levels face in prescribing off-label.

One of the least common types of off-label restrictions are placed on particular drugs or for particular purposes. A few states have adopted specific prohibitions against off-label uses for certain classes of drug or for treatment of specific conditions. These tend to be passed in relation to controversial topics or as a result of a publicized scandal. As an example, Mississippi prohibits all off-label uses for drugs prescribed for the sole treatment of weight loss. And in North Carolina prescribers working through telemedicine are prohibited from prescribing medications for the purpose of inducing an abortion and this extends to any drug with a known off-label use as well.

Far more common are discretionary restrictions that a supervising physician may place on a mid-level practitioner. In most states, PAs and NPs derive their prescriptive authority from a collaborating or supervising physician. This is normally embodied in a mutually written agreement between the physician and mid-level, sometimes requiring board approval. These are known by various terms such as "practice guidelines" or "supervision agreements". These agreements typically outline the procedures and scope of practices that the mid-level is able to perform. Where these agreements define the scope of the mid-levels prescription authority it will include the types or classes of drugs prescribe and the situations and conditions when they can prescribe them. So the ability of PAs and NPs to prescribe off-label in these states is largely dependent on if they are authorized by their physician. This is the case in North Carolina where a PA's prescriptive authority is governed by their written supervisory agreement with a physician. They have no blanket restrictions on off-label uses but a supervising physician could restrict their PA to only prescribing for on-label uses in the practice agreement.

Most states do not have explicit prohibitions on off-label prescribing by mid-level licensees. Instead, they may have more general rules on mid-level prescribing that may indirectly impact their ability to prescribe off-label. These more general rules usually take the form of a Formulary or a restriction as to the standard of care. A formulary is a list of included or excluded drugs that are within the mid-levels prescriptive authority. They are usually collectively developed and maintained by the medical, nursing or pharmacy boards. Unless each board maintains their own. For instance, Oklahoma maintains separate formularies for both PAs and NPs. Each formulary includes a list of drugs the licensees are prohibited from prescribing on their own and the PA also lists classes of drugs that are permitted. It is in these formularies where some off-label uses for certain drugs may be prohibited directly or indirectly by excluding entirely a class of drugs and not accounting for alternative uses.

Restrictions on prescribing under "standards of care" are typically found in the statute that grants the prescribing rights to the PA or NP. The prescription is usually worded to allow prescribing for approved uses unless certain requirements can be met. Usually, the requirements are that the off-label use is supported by studies or peer-reviewed and is included in the current standard of care for that ailment. For instance in Pennsylvania the formulary for PAs allows them to prescribe for a purpose other than what the FDA has listed as indications only if two requirements are met: 1)the supervising physician must authorize the particular off-label use and 2) the use must be supported by peer-reviewed literature from a "recognized body of knowledge". So PAs in Pennsylvania would be able to prescribe off-label generally if their supervising physician approves it and if the use is already tested and supported by research. A similar "standard of practice" prescribing restriction can be found in for NPs in Texas. The Texas Board of Nursing's administrative code limits NPs to ordering and prescribing medication only for FDA approved uses unless the use is part of an official trial or review board or if the use is both supported by evidence-based research and within the current standard of care for treatment of that particular condition. While those carve-outs will allow Texas APRNs to prescribe medications for many off-label situations it limits them to only those mainstream off-label uses. NPs in Alabama have similar requirements to only prescribe off-label if it is part of the current standard of care, supported by evidence-based research, and approved by the collaborating physician. Oregon has a more lax form of this "standard of care" restriction. NPs in Oregon have fully independent prescriptive practice; they don't have to collaborate separately with a physician. Oregon NPs are specifically permitted to prescribe for off-label uses but only so long as there are appropriate indications and documentation for those uses.

Restrictions like these can have substantial restrictions on PAs and NPs practicing in medical spas and other similar settings. Many of the more innovative procedures offered in medical spas do not necessarily have an FDA approved indication and may be too new or too niche to be backed up by the required peer-reviewed studies or research. Mid-level practitioners who practice in medical spas need to be sure that their state doesn't have any explicit restrictions on the drugs or the uses that they plan to practice within the medical spa. But in addition to that, they will want to ensure that they have sufficient documentation and research on file to support these off-label uses as being part of the "standard of care".

If you are a physician assistant or nurse practitioner in the aesthetic medical field and are interested in learning about new procedures and legal issues surrounding medical spas you should consider attending the Medical Spa Show taking place in Las Vegas, NV, February, 8-10, 2019.

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