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USP 797 STANDARDS THREATEN TO DISRUPT PATIENT CARE IN NEW HAMPSHIRE.
WHAT IS USP 797?
The United States Pharmacopeia is an organization that creates pharmacy-related standards. Chapter 797 (or “USP 797”) outlines robust standards for the compounding of sterile products. Some states have adopted these guidelines into statute. New Hampshire is one of them.
On November 17, 2017 the New Hampshire Board of Pharmacy issued a statement requiring infusion providers to comply with USP 797 or stop delivering infusions in the office. You can read the letter text here. The Board expects applying these regulations to provider’s offices, home infusion, and hospital outpatient infusion centers will help avoid “a significant risk to patient health and safety.”
INTENDED OUTCOME FOR REGULATION
The New Hampshire Board of Pharmacy’s intention with extending the compounding regulations to offices is due to concerns that there could be a “risk to patient health and safety” if the medications are not compounded in compliance with their rules. However, there is a lack of evidence to support a correlation between patient risk and current medication preparation practices.
ACTUAL OUTCOME OF REGULATION
USP 797 requires providers who administer IV products to compound these according to Board of Pharmacy rules. Beginning January 1, those practices who have not already complied with these requirements will be penalized with citations, resulting in fines. In the worst case and most probable scenario, practices will be forced to stop administering all infusions in the office.
WHY IS THIS A PROBLEM?
Compliance with these pharmacy standards will require doctor offices to purchase and maintain very expensive commercial-grade equipment used in pharmacy clean rooms. It’s unnecessary and financially infeasible.
Hundreds of millions of infusions have been prepared and delivered in doctor’s offices across the country without incident. As long as your healthcare providers continue to prepare your infusions using aseptic technique and in accordance with the manufacturer’s labeling, patient safety is not a concern.
Applying these pharmacy standards to your doctor’s office may actually be harmful to you if your access to therapy is disrupted and/or delayed, rather than improve safety.
HOW WILL THIS AFFECT PATIENTS?
If the decision to enforce these pharmacy standards in physicians’ offices is not reversed, patients may be forced to go to the hospital for infusions instead of the doctor’s office or local Infusion Center. Most doctor offices will not be able to continue treating patients with complex chronic illnesses who desperately need their medications and cannot afford their treatments to be interrupted.
This will likely increase out-of-pocket costs for receiving infusions, as the hospital is the most expensive site of care. Transitioning treatment to a hospital will take some time, which could disrupt your care.
Some insurance companies do not cover the cost of infusion treatments in hospital settings, which could leave patients without an accessible site of care.
Disruptions in care can significantly increase the physical, emotional, and financial burden of these serious conditions.