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Questions asked of the group

1. Please review the list of specialties by profession<> on the wiki. We are considering guidance that would enable the RPC to collect data on the specialty of learners in ER/LA Opioid REMS CE. Note that this would obviate the need for data on practice type.

a. Would you support collecting data on the primary specialty of learners (ie asking learners to select the most appropriate choice), or do you feel another approach would be more appropriate and provide the FDA with the data they seek?

b. Is the level of granularity appropriate, or are more or fewer specialties needed?

c. Would you support limiting the specialty choices to what is shown or referenced in the document, refraining from an "other" fill in the blank? When transferring data, a "no answer provided" field could be used for those who did not answer the question.

d. Are there other suggestions or feedback you have with regards to specialty data of REMS learners?

2. The FDA has requested the REMS CE providers collect data on years in practice. Please provide any feedback on the following categorization of years in practice:

a. 0-5
b. 6-10
c. 11-15
d. 16-20
e. >21 3.

Please review the ER/LA Opioid REMS definitions<> and provide feedback. We are especially interested in learner opinions regarding questions that would get at a provider's status.

Julie White Response

Hello Valerie - we have feedback to provide. It would be our recommendation that the question about institutional license not be asked separately, as it will result in adding potentially 2 additional questions to a very long registration questionnaire. We would recraft our registration questions as noted below (additional language is highlighted):

Are you currently registered with the DEA, or under an institutional DEA license, to prescribe or write orders for, schedule II and/or schedule III opioid analgesics?

Within the last 12 months, have you prescribed or written orders for opioids for any patients for equal to/greater than 3 months?

Within the last 12 months, have you prescribed or written opioids for extended release long-acting (ER/LA) opioids?

Regarding institutional licenses, our Dean confirmed with colleagues at our institution and another nearby academic medical center that residents use the institutional DEA licenses. Our Dean said that his hospitalist colleagues tell him that hospitalists likely are using their own DEA numbers. They are unaware of anyone using an institutional DEA. Hope this is helpful ! Julie

Tom McKeithen 

(Regarding the use of a single definition of prescriber as opposed to breaking into separate individual and institutional definitions)

I am not answering for CO*RE, but I think it's an excellent solution.

Marsha Stanton

Valerie - I certainly agree with this, but cannot make the determination for the entire RPC. Could we respond in the next week or so? Thank you - Marsha

Jack Kues

No objection. I think it makes sense and is probably easier. Jack

Cynthia Kear

Dear Folks, Here is feedback from CO*RE regarding issues discussed on our last call:

1. CO*RE supports language changes to include gathering data on learners who may use an institutional license. CO*RE recommends that the final language is consistent among all parts of the question.

2. CO*RE explored and considered the utilization of data relating to specialties and geographic region. It would be extremely helpful to know if there is significant, meaningful response to these questions (by learners and then by those who seek to use this data) before finalizing these two data decisions. If, for example, the vast majority of learners state they are part of family practice, is it really worthwhile to collect info on other specialties?

CO*RE has several compelling concerns I'd like to share:

Our current scantron is a single sheet printed on both side. Any additions will increase the size of that scantron.

Such increase may:

a. Present more of a barrier to learner engagement than the current form.

b. Present more cost in creating/managing a larger scantron.

c. Present more cost in processing a larger scantron by our vendor. FYI, the overwhelming majority of CO*RE 564 CE/CME activities happen via live events, hence our sensitivity to and concern about potential additional burden at those events. Further, in our 4 years of doing this work we have had 3 partners drop out due to the burdensome nature of the ER/LA Opioid education. Therefore, we want to be as certain as we can be that any new requests do truly have meaningful utility.

3. CO*RE requests and strongly suggests that any and all changes to questions and in data collection be done at one time, vs dribbled out, for obvious reasons.

Thanks much for everyone's consideration. Best, Cynthia

Gordon Ringler, Danemiller

Hello Valerie,

We have done extensive research on specialty options for our USER PROFILES in our online education system and website.  The attached list is not what we currently have setup in our user database profile.  It would require an extensive amount of developer work on our user profile databases to implement the proposed. In working with our Joint Providers, we have found that none of the User Profile data collected is the same. Although I completely understand the initiative, Dannemiller is not in favor of the proposed change.

Sara Floros, Pri-Med

Attached you will find the Pri-Med list of specialties that we currently ask our members. The specialty field is not mandatory for any of members when registering/ creating their member profile.

It will be difficult to change our company’s system based on MedBiquitous outline – since there are so many that are similar/overlapping; would what we already have in place be a problem when reporting? Also, as an organization the specialty field is not a requirement for members, having this field be mandatory for all REMS completers would be an issue, as we could only report on those that we have the data available.


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