ASHP, Healthcare Groups Urge FDA, State Regulators to Investigate, Regulate Direct Access Infusion Businesses

ASHP, the National Home Infusion Association, National Association for Home Care and Hospice, American Society for Parenteral and Enteral Nutrition, National Infusion Center Association , and Infusion Nurses Society issued a statement calling on the U.S. Food and Drug Administration (FDA) and state regulatory agencies to investigate unregulated direct access infusion businesses, which provide individuals with intravenous solutions absent the recommendation of a licensed prescriber. The groups asked the regulators to assess the impact of direct access infusion businesses on critical drug shortages and for states to regulate such businesses in a manner comparable to medical, pharmacy, and home health providers to reduce shortages of critical parenteral products, ensure safety, and protect the public.

Direct access infusion businesses promote IV services to the general public without a medical assessment or prescriber order. The situations being treated (i.e., hangovers, exercise recovery, elevation sickness) can usually be resolved with oral medications or through other means—making IV treatment unnecessary. The result is the diversion of scarce resources—many of which appear on the FDA’s drug shortage list—from patients who have legitimate medical needs.

In addition, the clinics, which operate on a cash basis rather than through medical insurance plans, often escape licensure and other requirements that are prerequisites for traditional providers of pharmacy, home health nursing, and medical services. For example, licensed infusion pharmacies must achieve and maintain independent accreditation to ensure compliance with accepted standards of practice for personnel competency, sterile drug preparation and administration, infection control, record keeping, and more.

To ensure safety and address critical shortages of medical products the groups recommend the following:

1. Investigate and assess the extent to which direct access infusion businesses are contributing to the ongoing national shortages of parenteral drugs, nutrition components, and diluents/solutions.
2. Require all businesses that sell direct access infusion therapies to the general public to comply with licensure and regulations applicable to the services offered.
3. Investigate claims of health benefit, treatment, or cure, and require businesses that sell direct access infusion therapies to disclose the lack of evidence and unique risks of administering compounded IV products that are not medically necessary.
4. Establish a licensure category for businesses that sell direct access infusions.