USP 800 compliance after the public health emergency
By ION
Practices need to be ready for USP 800 requirements to be enforced - at any time. The standards apply to all health care personnel who handle hazardous drug preparations and all individuals or entities that store, prepare, transport, or administer hazardous drugs.
During the pandemic, certain drugs were not available or on longer delivery times making it more difficult for practices to have the right treatments on hand. Practices looked to other vendors or changed their own internal processes in order to meet their patients’ needs.
As enforcement of the compliance guidelines is expected to return (and in some states, it has already begun), practices should ask themselves several questions:
- Have they done a complete risk assessment and analysis of the controls and SOPs within their practice, as related to the handling of hazardous drugs?
- Was staff trained adequately to ensure that they continued to maintain safe practices during this time? And as new staff were employed, were they adequately trained?
- Were all processes – even the most minor of adaptations - documented?
Some practices do not have the personnel to review that all
their procedures met the updated guidelines and be assured they could return to
the more restrictive procedures after the public health emergency. The
procedures, to ensure the safety of patients, staff, and general public, as
well as make accommodations for environmental protection, are expected to be
enforced to ensure that compliance is maintained – and was maintained the past
several months.
To ensure your practice has met the guidelines and are ready
to return to the more restrictive guidelines, consider speaking to one of our
business consulting team members. With years of experience in community
practices, they can partner to ensure your practice is performing to its
optimal capabilities, while still meeting all the compliance guidelines. The
team can be reached at: practiceconsulting@amerisourcebergen.com.
