Drug-drug, drug-allergy interaction checks for CPOE

Clarifications:

• There is no standard required for this certification criterion.
• The scope of this criterion is on the health IT system’s ability to perform drug-drug, drug-allergy interaction checks during CPOE. Certification to this criterion does not require the system to perform drug-drug, drug-allergy interaction checks in other cases, such as when medications are reviewed or medication/medication allergy lists are updated. [see also 75 FR 44602; 77 FR 54206; 80 FR 62618]
• No standards are required for this criterion, but checks are only expected to be performed based upon structured data. [see also 75 FR 44602]
• For testing and certification purposes, drug-allergy contraindications include adverse reaction contraindications. [see also 77 FR 54208]
• This criterion is separate and distinct from the § 170.315(a)(9) "Clinical decision support" criterion. [see also 77 FR 54208]
• How the interventions are automatically indicated to a user is at the discretion of the developer and they have the flexibility to implement this functionality based on their customer preferences and in line with their user-centered design requirements.

Technical outcome – Interventions should automatically occur during CPOE and before the medication order is completed and acted on.

Clarifications:

• A Health IT Module is only expected to perform drug-drug, drug-allergy interaction checks based on medication and medication allergy information included in the system as structured data. The Health IT Module is not expected to be capable of reading or accessing information in non-structured formats (e.g., scanned documents, images) for this provision. [see also 75 FR 44602]

Technical outcome – The health IT allows a user to adjust the level for drug-drug interaction interventions provided.

Clarifications:

• This functionality does not need to be provided to every user; testing and certification will ensure that the functionality exists for authorized users. [see also 77 FR 54208]
• This functionality only adjusts what may display to an end user. It does not change the severity level/clinical significance of an interaction or contraindication but allows authorized users to tailor the interventions the users receive.

Technical outcome – The ability to adjust drug-drug, drug-allergy interactions should be able to be limited to an identified set of users.

Clarifications:

• “Identified set of users’’ means that the technology must enable a provider to assign only certain users (e.g., specific providers, system administrator) with the ability to adjust severity levels for drug-drug, drug-allergy interaction interventions. [see also 77 FR 54208]