Several states have formularies by which certain mid-level practitioners must abide in order to prescribe legend drugs, devices, and/or controlled substances. There are two types of formularies. An inclusionary formulary describes the products that a mid-level practitioner may prescribe. An exclusionary formulary describes the products that a mid-level practitioner may not prescribe. Some formularies are product-specific, while others are organized by product category or disease state. In order to have a compliant drug sampling program, it is important to know the states and practitioners whose scope of prescriptive authority is limited by formulary.
Of states with formularies, Ohio is the most detailed and comprehensive. The Ohio State Board of Nursing has developed a formulary that is both inclusionary and exclusionary. It lists specific medications and devices that an advanced practice registered nurse may and may not prescribe. It also describes clinical situations where a physician consult is required prior to prescribing certain products. Other states have less detailed inclusionary formularies. For example, the Pennsylvania State Board of Podiatry has established an inclusionary formulary in its regulations. This formulary lists only broad drug categories that a podiatrist may administer and prescribe. Rather than listing drugs or drug categories that can be prescribed, the Hawaii Board of Nursing has an exclusionary formulary by which advanced practice registered nurses must abide when exercising prescriptive authority. Pursuant to the Hawaii formulary, the advanced practice nurse can prescribe anything but for the few drugs that have been excluded. Notwithstanding the breadth of the formulary, all mid-level practitioners are limited in their prescriptive authority by the bounds of their scope of practice.
Finally, when interacting with mid-level practitioners, it is important to remember that certain individuals may be further restricted in their practice by a collaborative agreement with a supervising physician. Certain states, such as Oklahoma and West Virginia, require that the physician select from a list those broad categories of drugs that their particular mid-level practitioner may prescribe. As such, two mid-level practitioners working under the same physician may have drastically different prescriptive authority.
In putting together a compliant mid-level sampling program, it is essential to consider the states with formularies and to determine whether your product may be prescribed pursuant to the relevant state formulary.