January 22, 2013
10 AM PST/11 AM MST/12 PM CST/1 PM EST
Call in Number
Attending: Francis Kwakwa, Chair; Pamela Ball, Mark Baczkowski, Rod Campbell, Tony D’Ambrosio, Jennifer Dunleavy, John Fitgerald, Ilana Hardesty, Brad Hill, Edward Kennedy, Linda Kitlinski, Joanna Krause, Leah LaRue, Anjum Malkana, Shelly Rodrigues, Cynthia Kear, Valerie Smothers, Lorraine Spencer, John Sweeney, Dimitra Travlos, John West, Julie White, Mary Willy, Jemma Contreras.
- Review minutes of last meeting
The new members of the working group introduced themselves. Cynthia is the Senior VP at California Academy of Family Physicians, along with Shelly who is the Deputy Executive VP. They are involved in CO*RE, the Collaborative for REMS Education, which is working to develop REMS CE for prescriber/learners.
The minutes were accepted as submitted.
2. Discuss clarification from FDA
Valerie reviewed that on the last call Julie asked whether verification of DEA registration was required. Doris said she would get clarification on that. Doris emailed Valerie with the clarification linked from the agenda. Francis clarified that all this data will be self-reported.
Valerie sent links to the definitions. She explained that they are used in the context of specification we are developing. Francis asked if clinician meant MD. Valerie shared it’s much broader than just an MD; several other professions are able to prescribe these medications. Francis asked if successfully completing meant you have successfully completed all six components. Valerie answered yes, if they have completed all components and if it’s a REMS compliant activity the answer is yes.
The last one is sort of a new thing. Julie and Valerie were discussing professional activity, and they asked themselves what do we really want to know about people attending professional activities? We want to know what kind of practice they have. Practice type is a description of the clinician's practice by broad category, for example, primary care. For a vocabulary of practice types related to the evaluation of pain management, see the Medical Education Metrics Vocabularies. There are further practice types in the vocabulary. Valerie thanked Linda and Julie, thinking through this to come up with this list and also for forwarding examples of questions that Julie had sent me from their survey questions.
The group then discussed professions and the example survey question sent by Julie White. Julie continued explaining these professions are able to prescribe Opioids. They debated about including veterinarians. Even though vets could be approached by drug seeking owners of pets, they didn’t want to include them because it could be misleading to the target audience. Their list includes some non-prescribers. Other members of the health team would benefit from participating. They did put subgroups under non-prescribers, psychologists, other mental health professions, nurses, and an Other category. Valerie commented that when people write in other, it could be mapped to larger list in HealthCare LOM. Julie thought that would be easier to do, the broader list is pretty extensive.
Valerie noted profession is one of the items the FDA is requiring, the CE provider would collect data and send to the accreditor and then the accreditor would send to the RPC data base. The accreditor would need to be able to have a system to handle all that data. Francis asked if we were going to be able to change this list on the fly. Valerie noted this is part of the standard. One of reasons we have the definitions on the website is because we want this standard to work for future projects. By pulling things out of the specification, it gives us a more flexible way of referring to them and the flexibility the vocabulary can be changed. We have this nice list of professions that will serve us well; what is the best way to use them from a provider standpoint? Boston University doesn’t want to overwhelm the learner with choices. They are interested in making the process more learner-friendly while still collecting data they need. Julie stated the challenge is to make the data uniform and get at what we need without overwhelming participants.
Valerie thought that was more of a best practice question. How do you ask that question? You can collect as much detail as you want, but ultimately the accreditor and compiling database may require something less granular. Valerie will update what is on the website with Julie’s information and receive comments from people. Linda asked what would be the time frame for additional comments? They want to be able to make sure providers have some draft specifications and can go to accrediting bodies and make sure they feel the categorization is feasible, collect data without being onerous and burdensome. Valerie stated close of business on Jan 29th would be reasonable to everyone. Valerie will send a note to the whole working group asking for comments by that date. Linda thought that would be terrific.
The group reviewed Practice Type definitions.
The Primary Care definition is adapted from AAFP definition. The specialist definition is adapted from the ABMS. Pain Specialist is adapted from the American Academy of Pain Medicine.
The Practice types are not required by the FDA. Linda, Valerie, and Julie were wrestling with the specialty question, and this was one approach to address questions regarding the types of clinicians participating in the activity. Julie looked at specialties and distributed a sub-list of HCLOM specialty list, distributed in email this morning. Medical Genetics, nuclear medicine and radiology diagnostic were removed. Valerie noted the American Board of Family Practice uses the term Family Medicine, we can’t go back and change Healthcare LOM version 1. We just need to clarify what we present to the learner. Julie added that they discussed with the course director, and they were afraid that when we asked someone their specialty, they would be annoyed if you then asked if they were a PCP. So they put the questions side by side.
Linda commented they intend to allow providers to have flexibility in how they ask the questions but have uniformity of language when data is aggregated so it can be compiled meaningfully. Francis asked Linda if she didn’t think we needed an “other”. Linda thought that would be a good idea to do that. Ilana agreed. Valerie mentioned that MedBiquitous avoids using the other category because it dilutes the value of the list. Everybody could see themselves somewhere on this list. We run the risk of losing data quality by allowing people to categorize themselves with predefined terms or an other. Francis commented if somebody believes that other is their category they can write it in. Valerie noted that the provider can always decide to do that and then map it back to the MedBiquitous vocabulary. Julie commented that once coded they can’t change it. Whatever we agree on to do we should do it now and not try and go back and change it. Valerie asked if anybody had strong feelings.
Dimitra suggested running this by a focus group. She thought the majority of learners would fit into these boxes. You would need a focus group to determine where the less likely people fit. Valerie asked what % of people would be covered by the existing terms - 90%? Julie thinks more. Lorraine said we could go another way, and create a final choice on the list that says, not listed. She gave the example of dentistry; none of the choices are going to yield a specialty choice for a dentist. Francis agreed and recommended adding dental specialties. Valerie commented we have a dentist listed as a profession but specialty was separate.
Ilana stated there are nine recognized dental specialties, according to the American Dental Association. Francis asked how many of those nine prescribed opiates. Valerie asked Ilana to share that link and she would send it around to the group. Dimitra asked if there are specialties in Professionals, or does everyone personalize for themselves. The list will be huge. They have board certification for pharmacists, they don’t have pharmacist pain specialty. Pharmacists fall out of these practice types. Specialty and Practice Type don’t quite fit the arena of pharmacy. Valerie agreed to follow-up with Dimitra. We may just need to point to existing lists and recommend using those existing lists.
Valerie noted specific recommendations of practice types would be helpful too. Julie would welcome that, going to profession and drilling down deeper would help us uncover a group that needs more attention and that is useful information. Valerie will work on mapping various professions to the appropriate specialties for each profession. Work with that in collaboration with colleagues on the call.
Valerie continued with the illustration of data the specification will allow you to capture. All information is fictional for discussion purposes. Pam asked about the first slide activity ID. Is URI the only type of identifier that can be conveyed? Valerie noted other types of identifiers could be used.
The Regulatory information begins page four shows what data would look like for a course that only addressed section 1 of the blueprint. There is a URL pointing to regulation, then it indicates what component is addressed by the instruction. It also allows the provider to indicate what components are addressed in the assessment. There is also a field for consent to audit. Alternately those courses that are fully compliant would use the data structure shown on page five, Complaint to regulation.
Ilana asked what audit consent means. Valerie replied that is a field the accreditors can use to track consent if they are serving as the auditors of REMS CE. Linda asked how the documentation would work for activities that contain multiple events or interventions. Valerie commented that the multiple events/interventions would be counted as one activity that addressed the full blueprint. Francis asked how that would work with the reporting time frame; if the events are 6 months apart, and the reporting period is 6 months, you may not have any learners completing. Valerie noted that is why the reporting time frame is so important. You may report data on June 30 but have the cohort finish until July 30th, in which case there would be no completion data to report. The duration of the activity has to be taken into account when you are looking at the numbers. We can offer more information on that in the implementation guidelines.
Pam asked if this illustration is going to be what we are going to give to our members to follow. Valerie replied no, the illustration is for our discussion purposes only.
The next slide is Participation Metrics showing the exact number of registered participants, the number receiving credit, and participants by profession. Participants by category allows us to define our own categories. Valerie commented we should update that URL, that points you to get definition of prescribers. We can use that same format to describe prescribers successfully completing. Slide 7 illustrates how you would convey data on those meeting multiple categories, for example, the total number of Internal Medicine physician prescribers.
Valerie added that additional fields had been added to the multiple categories element at the suggestion of Andy Rabin. Now you could indicate how many internal medicine physician prescribers received credit, were targeted, etc. That data is beyond the REMS requirements and should not impact the REMS at all. But it could be useful data for evaluation.
Valerie encouraged anyone to send questions to the mailing lists and we can go through it as a group. The goal is to have a draft specification by February 1. Jan 29th would be a good deadline for comments.
5. Open discussion
- Valerie will send a note to the working group asking for feedback on the list of professions used for REMS CE data, with feedback due Jan 29.
- Add information representing on multiple intervention CE activities and taking into account the reporting period to the wiki page for implementation guideline topics.
- In the illustration, Valerie will update the URL for prescribers.
- Valerie will ask the group to submit comments on the spec Jan 29.