Proposed data requirements

no equivalent

proposal:

RelatedToRegulation (element)

The value would be the URL of the specific REMS.

Prescribers successfully completing the activity

Successful means:

a learner completing education that FDA has defined as REMS compliant:

1) includes all elements of the FDA Blueprint;

2) includes a post-course knowledge assessment of all the sections of the FDA Blueprint;

3) is offered by accredited provider to licensed prescribers; and

4) is subject to independent audit to confirm that conditions of REMS training have been met.

Prescriber must be defined. FDA does not define prescriber but refers to it in these contexts:

• Those DEA-registered clinicians who are eligible to prescribe Schedule 2 and 3 drugs (specified in REMS document section I.B.1.f)
• REMS CE performance goals*: “active prescribers” (based on the 2011 estimate of 320,000 “active prescribers” specified by the FDA in the REMS document section I.B.1.b)
• An individual clinician who has written at least one ER/LA opioid script in the past year (specified in REMS Supporting Document page 24 section VII.A.1.c “Evaluation 1: Study Population”)

ParticipantsByCategory

this field lets you indicate a number associated with a category you define. For example:

Participants by category
(category=prescriberssuccessfullycompleting): 25

But this does not let you indicate that you are using the FDA definitions of prescriber and successful.

We could restructure and add a URL field to this element that lets you define the category

Participants by category 
  Category Name=prescriberssuccessfullycompleting
  Category Definition=http://medbiq.org/mems/definitions#prescribers_successfully_completing
  Number = 25

Structuring these as XML elements may provide greater clarity.

The definitions of prescriber and successful will need modification based on the FDA comments.

We could add a MultipleCategories element to address any need for describing the number of participants meeting multiple categories (for example, physicians with a specialty of pediatrics that are active prescribers).

Multiple categories

  Profession = Nurse practitioner

  Specialty = Pediatrics

  Category

     Category Name = PrescribersSuccessfullyCompleting

     Category Definition = http://medbiq.org/mems/definitions#prescribers_successfully_completing

  Number = 36

Input from CE stakeholders has indicated that there is value seen in capturing the full census of CME in support of the FDA REMS.

Classification element of LOM

This would require Healthcare LOM to create a new classification purpose, regulatory blueprint. Classification could point to the URL of the REMS blueprint and then indicate the components addressed.

See Using Lom Classification Element

RegulatoryClassification

Relation (instruction addresses or assessment addresses)

Regulation (URL to REMS)

ComponentID

ComponentTitle

ParticipantsByProfession

References Healthcare LOM's recommended list of professions. See: http://medbiq.org/working_groups/learning_objects/HealthcareLOMSpecification.pdf Appendix 2.

Specialty of participants (optional)

ParticipantsBySpecialty

References Healthcare LOM's recommended list of specialties. See Specialties from Healthcare LOM.

Jointly accredited

no equivalent

There is no checkbox for jointly accredited activities, but the credit element does allow you to indicate multiple types of credit offered and for each type of credit, the accrediting body that sets the quality standards and is the source of the accreditation process. 

proposal: Add an element called JointlyAccredited.

Audit consent

ACCME proposed a “We consent to be audited” field.

no equivalent 

proposal: Add an AuditConsent.

Long term assessment

ACCME proposed, Does this activity include an FDA defined long term assessment Y/N. Would require definition of long term assessment.

no equivalent 

We would need to define long term assessment or find an FDA definition. Is long term 3 months or more after the educational intervention is complete?

RPC feedback indicated that long term assessments would be independent of the funded CE activities.