May 14, 2013
10 PDT/11 MDT/12 CDT/1 EDT
Attendees: Francis Kwakwa, Co-Chair; Doris Auth, Pamela Ball, Mark Baczkowski, Rod Campbell, Kathy Chappell, Stephanie Cordato, Lisa Fennell, Cynthia Kear, Linda Kitlinski, Joanna Krause, Tom McKeithen, Raj Patel, Nikki Reyes, Marissa Seligman, Valerie Smothers, John Sweeney, Dimitra Travlos, John West, and Julie White.
1 Review minutes of last call
The minutes were accepted as submitted.
2 Discuss FDA versioning of REMS documents
Doris provided an update on her meeting with the Office of Communications at FDA. They are planning to support versioning using the drugs @ FDA website (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm) . You can type in the drug name in the shaded blue box; you will receive approval history, label information, REMS. They will use REMS link and change the name to the current REMS, which will take you to the current REMS document. If you click on approval history you get approval letters, and any old REMS would be held there. It would go to the link that would have version date and approval.
Francis asked if you want to reference previous ones, does it have its own address. Doris answered each version is associated with an approval. You would click on the approval history with action date and that is where you would find the REMS link. It will link you to those REMS that were approved on that day. She can type out more specific instructions; we have a solution and didn’t think there would be difficulties. Valerie asked if those web addresses would stay consistent over time. Doris confirmed it doesn’t change. She said the group could email her if they had any questions.
Valerie began the discussion related to Cynthia’s note, linked from the agenda. Cynthia brought up an interesting point: that there are lots of nurse practitioners who can prescribe schedule three but not schedule two drugs and we should accommodate that within our standard. The current definitions do not accommodate that. Cynthia commented that Anne Norman of AAANP raised the point. PA’s often fall into the same situation. In many states they can’t prescribe schedule two drugs but can prescribe schedule three drugs. There is no question; it could cut off valuable metrics. They’ve compressed this into one question that allows several response options.
Valerie suggested coming back to the definitions on the MedBiquitous website. These definitions are used when conveying data from from CE providers to accreditors and from accreditors to the central data base. Before we had definitions for schedule two and three registered prescribers. The proposal is to change the wording to:
An individual clinician who is registered with the DEA, eligible to prescribe Schedule 2 and/or 3 drugs, and has written at least one ER/LA opioid script in the past year.
More detailed data (how many are registered for schedule 3 only vs how many are registered for schedule 2 and 3) would not be sent on to accreditors and FDA but could be useful for needs assessment.
Linda requested clarification from the FDA regarding the 320000 active prescribers in 2011 that serves as the denominator for REMS performance goals. Is that number based on those who have written an ER/LA opioid prescription in the past year? Doris confirmed that is correct. Linda recapped that early data has shown that a fair number of those eligible to prescriber ER/LA opioids are participating in the CE, but many of those individuals had not prescribed ER/LA opioids in the past year. There are multiple reasons for that, not comfortable or not educated enough about it. Or it could be folks that are in a capacity managing patients in a hospital.
Valerie edited the definitions page, all of the changes are marked in red text. Valerie asked if the revised definitions works for everybody. Linda asked Doris, from an FDA perspective, if the data should include those registered to prescribe schedule 3 drugs only. Doris stated she will talk to somebody that can provide the historical perspective and get back to the group with an answer.
Julie White mentioned the list Valerie shared with the group at 7:30 a.m. this morning had some corrections to it. Julie will correct that and send it out again. Francis asked if there was anymore discussion on questions posed by Cynthia. Cynthia asked if we were adopting the questions she submitted. Valerie mentioned the way the question is worded should work for lots of people. But the exact wording is not required. Some providers may want to collect the answer as a yes or no. Francis clarified that is not required data but could be used for needs assessment.
4 Review proposed changes to implementation guidelines
Joanne mentioned to hold off on combined list, she will be sending updates shortly. Valerie highlighted the other changes. On page eighteen there is a section describing the number of schedule 2 or 3 registered prescribers successfully completing. The title has changed, the text and/or or just or. The URL is different for the category definition. Additional changes that were made on April 26th were the number of participants successfully completing. On page twenty-three there is the inclusion of sample questions; the list of professions is more detailed than what we have in the implementation guidelines. It gives them the data they need and it will map to the subset we are using to convey data about professions. Valerie noted she changed one of Boston Univerity’s questions to include a slash or, at the bottom of page twenty-three.
Tom asked Julie about the question, “are you currently licensed to prescribe schedule two or three”, with numerator only the yes responses. What would you do with the not sure? Julie responded what we are trying to provide context. Joanna clarified they are reporting yes as the numerator. It is helpful to have a drop down menu.
Valerie asked if everyone agrees this is a valuable addition to the implementation guidelines. No objections were heard, so we will move forward. Valerie mentioned that Boston University has decided to hold off on sharing evaluation questions for now; CORE has made the same decision. Julie commented they want proof of concept, and to work out the kinks before we make them public.
Linda noted we should hear from Doris to make sure the FDA is good with the approach discussed.
Pam had two questions on 3.3.1 and 3.3.2 in the implementation guide. Valerie answered she needed the specific URL but Doris said the FDA is going to maintain previous versions of REMS for ER-LA Opioids for REMS. We are waiting on specific URL to make sure we have it right. Francis suggested to Pam to wait on the FDA and then we can start using it.
Valerie explained the MedBiquitous process is such that working groups sign off first, then we send to the Standards Committee. There is a public review that last six weeks, balloting for another six weeks. She thought it sounded like we will just be tying up loose ends and we’ll be done unless the working group finds a problem. If there have been any problems from CORE or BU, please come back to the group and let us know what those are.
5 Open discussion
Linda asked Doris how soon we can hear back from the FDA confirming the use of “and/or” is OK. She noted they have assessment s coming due on July 9th, and the data cut off for those were this past Friday. Doris answered she can get back to the group by the end of the week.
Revised definitions of ER/LA_opioid_prescriber, schedule_2_or_3_registered_prescriber, and schedule_2_or_3_registered_prescribers_successfully_completing were accepted.
- Valerie will update the link to rems in the implementation guidelines when dated versions become available on the fda website.
- Valerie will accept changes in the implementation guideline and definitions related to schedule 2 and/or schedule 3 substances.
- Boston University will send updates to the Implementation Guidelines appendix.
- Doris will confirm acceptability of definition changes to FDA.