Risk Evaluation and Mitigation Strategies (REMS) requirements oversee riskier medications and review the serious medication safety concerns frequently. This podcast will review REMS pearls and provide REMS Resources. Join us to learn how to monitor, prevent, and manage serious risks associated with REMS medications.
The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
(upbeat music) - Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy. - Thanks for joining us in this episode of Hot Topics and Specialty Pharmacy, where we chat with practitioners and leaders to discuss topics relevant to the specialty pharmacy workforce, business, practice in our profession. My name is Rebecca Young, and I'm the Director of Compliance Quality and Performance Improvement at Vanderbilt University Medical Center, Specialty Pharmacy in Nashville, Tennessee, and I will be your host for today's episode. Joining me today is Jed Johnson, Kate Gordon, and Kate Lewis. In this episode, we will be discussing risk evaluation and mitigation strategies. Join us to learn how to monitor, prevent, and manage serious risks associated with REMS medications. Welcome, Kate, Jed, and Kate. Thank you for joining me today, and I'll let each of you introduce yourselves during the chat. We are excited to discuss the topic of the management of REMS medications and programs in health systems, specialty pharmacy practices. To start us off, Kate Gordon, can you describe how your organization manages REMS requirements? - Yes, hi, my name is Kate Gordon, and I am the pharmacy manager for specialty pharmacy services at Eskenazi Health at Indianapolis, Indiana, and I will be the first speaker today. Before I explain our organizational approach, it is important to understand management of REMS requirements, and that they can't be varied depending on the product. Most REMS include a communication component about the specific safety risk or risks that the REMS is intended to mitigate. Some REMS include additional requirements, such as clinical activities that the healthcare providers may need to perform prior to prescribing or dispensing a medication to the patient. Documents describing the specific requirements for each participant in the REMS, as well as materials to support the REMS, can be found on the REMSAT FDA website. In addition, manufacturers often make REMS materials available at a product or REMS specific website. At Eskenazi Health, we review what the requirements are and take whatever steps are necessary to follow them. Some REMS requirements are as easy as providing the patient with the medication guide. On some of the stricter requirements, like Quasapine or Accutane, we have hard blocks in our dispensing system to ensure that the pharmacist checks and documents what is required prior to dispensing the medication. - Thanks, Kate. Jit, would you briefly introduce yourself and describe how your organization manages REMS requirements? - Thanks, Becky, yes. My name is Jit Johnson, and I'm a program director for quality, compliance and performance improvement at the Vanderbilt University Medical Center, specialty pharmacy in Nashville, Tennessee. In addition to helping our operation from any compliance with state boards of pharmacy, accrediting bodies and manufacturer and payer requirements, I'm involved in managing our REMS programs. For these REMS programs, which as Kate described, can have an array of requirements, our organization has moved to a centralized setup where rather than having a different clinical expert service, the authorized representative for each drug or in each disease state, we have a single staff member whose primary responsibility is to manage compliance with our REMS programs. This was necessitated as we gained access to more drugs with REMS requirements, which also increased our responsibilities related to auditing and reporting on these REMS programs. This change has streamlined our operations as we now have been able to standardize our processes and we have a single point person who can communicate with REMS administrators and auditors. Because of the many similarities among the different REMS programs, especially those using the same administrator, this has made the onboarding, enrollment and audit processes much more manageable for us. Our clinical staff, of course, are still heavily involved in the REMS dispensing process, including in patient enrollment and counseling, assisting prescribers to complete required steps and reviewing patient lab worker pregnancy tests. Finally, to ensure that we are meeting the REMS dispensing requirements on individual prescriptions, we utilize the pharmacy switch service to halt processing of a REMS drug at the adjudication phase of the dispensing process. We'll train all staff on the requirements of each REMS and the meanings of these hard stops to ensure that users don't bypass them, but instead alert a REMS trained pharmacist for assistance. That pharmacist then reviews the prescription, completes and documents and your required steps and authorizes the prescription to proceed on due dispensing process. - Thanks, Jed. All right, now to our final panelists, Kate Lewis. Tell us about yourself and your organization's REMS activities. - Hi, my name is Kate Lewis and I am the pharmacy compliance coordinator at Frader Health Pharmacy Solutions in Milwaukee, Wisconsin. My role overseas are outpatient accreditation, including URAC, CHAP, ACHC, and Home Infusion Joint Commission. I ensure that we're upholding our state and federal regulations while providing staff education and students' phenomenal rotations. Currently, REMS is managed by the inpatient, retail and specialty leaders alongside the medication utilization team. Each medication has an authorized representative that oversees the requirements in their practice area. Inpatient and outpatient pharmacy maintain policy and procedures for each REMS medication that they dispense and administer by an online resource site for frader staff. The medication utilization team assists in meeting the REM certification renewals and audits for inpatient pharmacy, whereas specialty and retail pharmacies independently manage their REMS requirements. Clinical staff are educated on the regulations and each of our leaders and reach out to our leaders with any questions or concerns. We need to hear new REMS medications come to the market and has demonstrated the need for our role to oversee REMS requirements across the enterprise. So let's talk about staff involvement in the REMS process. Tate Lewis, do you utilize technicians or learners to manage REMS requirements? We utilize pharmacy students to assist in drafting REMS policy and procedures and staff education training presentations if needed. All staff, pharmacists and technicians are trained on how to manage the REMS medications requirements that are applicable to their role. Kate, how do you approach this at your institution? Technicians are aware of the requirements and involve the pharmacist as needed. As for learners, we use them in a limited capacity, but some good ideas for leveraging learners can be to assist the authorized representative complete the certification or re-certification process. Generally, the authorized representative enrolls the pharmacy to ensure pharmacists complete the required training, jurors, policies, and procedures are put in place and ensure staff are trained and comply with the REMS requirements. Learners can help facilitate in those areas as projects on rotation or as additional work tasks. - Kate, we have a similar setup at Vanderbilt. We train all staff on REMS requirements and involve technicians in many aspects of the dispensing process, but only pharmacists are responsible for the actual REMS elements. This can include residents depending on the clinical rotation. And although our student pharmacists might be exposed to aspects of the REMS programs while on rotation, we don't involve them in actually meeting the REMS requirements. - Thanks, Judd. That answer raises a good question about staff training. Can you describe in more detail how your organization provides REMS medication training and education to staff? - Absolutely, Becky. We utilize the same learning management software that our health system uses for annual training. We'll train all staff on hire and then annually thereafter. This helps us ensure that no staff members have missed training when we're being selected for an audit. Some manufacturers do require additional annual training such as on procedures for adverse event reporting. With our existing LMS infrastructure, it's pretty easy to incorporate these manufacturer trainings into the ones covering our REMS processes. And Kate, is this similar to the processes that you've established? - Yes, that's going to help. We require staff to sign an attestation that they have received, understand, and will complete the required action. - Yes, we provide staff REMS training during onboarding and staff meetings as applicable. We have also have access to the REMS medication policies and presentations. Staff free education, if applicable, is another training provided to avoid any gaps and also to assist with staff transitions. - So how do you track REMS medication certification renewals? Kate Lewis, we can start with you. - Frater has an internal audit process. We monitor the patient's receiving REMS medication throughout the network. The audit report reminds us to renew certifications, authorize representative information and sponsor database submissions. The manufacturer reminders and FDA updates also reminds us to renew REMS medication certifications and contracts. - I agree that those FDA updates can be very helpful. I subscribe to the REMS at FDA listserv and that sends out a monthly summary of REMS program changes that helps keep me up to date. As far as our program renewals, we only have one drug that requires a regular renewal of the REMS enrollment and that program does send out reminders before expiration. However, we have found that many REMS programs will, on an audit, want to see documentation that we have processes in place to ensure that, for example, there's always an authorized representative on staff. Could be, you know, in the case of the current authorized representative retiring or getting a promotion or something like that. So as such, we have started writing this process into the template standard operating procedure that we use for all new REMS drugs. Other statements we found to be useful to have in our SOP on audit include the circumstances under which we would transfer stock of a REMS drug, how we would verify eligibility of the receiving pharmacy, how and for how long we maintain records of the REMS program and REMS dispenses, and how we'd report an adverse event for a REMS drug. Many of these items are referenced in the REMS document that's approved by FDA for each drug. So if you've been tasked with writing an SOP, that REMS document that's available on FDA's website is the best place to start. Keep in mind that your pharmacy might have additional requirements based on your access agreement. - So what are the key considerations when evaluating the implementation of REMS programs for specialty medications? Kate Gordon, how does your institution approach this? - Currently, we have limited resources to help with oversight of REMS. So we must ask ourselves a few different crucial questions. The first being, can we be compliant? And following that, some other questions, how do we enforce compliance? Do we have the skills and technical ability to do what it's needed? Are the requirements a reasonable ask of staff? And we have to ask ourselves if we can meet the requirements because if the REMS has pharmacy requirements, the pharmacy may be subject to an audit by the FDA, the manufacturer, or third party on behalf of the manufacturer to assess if the pharmacy is meeting the requirements. An audit may result in enforcement actions such as product seizure, junction, or civil money penalties if issues found during the REMS inspections are not swiftly and appropriately corrected. Kate, what is your approach up freighter? - We complete a NAP analysis at freighter. We attempt to validate the medication prescription frequency inpatient at the infusion center by home infusion and/or specialty pharmacy. We also review if any internal or external contracts are required to obtain the access to the medication. I highly recommend reviewing all the REMS medication requirements. So we're easy just adding a pamphlet when dispensing the medications and others are complex and require patient, provider, pharmacy, and the clinic to be REM certified. Some medications or contracts also require the daily or monthly data reports, which usually relies on data analysts' involvement with the REMS medication obligations. - I agree and also think it's very important to consider which drugs your pharmacy is going to have access to. Many manufacturers may choose or be forced to adopt a limited distribution strategy because of the complexity of REMS requirements. And so it can be difficult or impossible to break into some of these networks. In certain cases, though, it's possible that your negotiations could be helped if your pharmacy can demonstrate evidence of having successfully managed some of these complicated requirements in the past. You'll also need to consider, as Kate just mentioned, that many REMS with elements to assure safe use required daily reporting of dispense and patient status data. These reports can often be automated to a certain extent, but that does require a pretty heavy lift or multiple teams at the pharmacy, as you might need to pull data from multiple sources, like the dispensing software, medical record, and the therapy management system. In some cases, you have to have ongoing documentation in these systems from the data that you might collect from clinical and dispensing team members. At our institution, I'll sometimes coordinate these reports from a very high level, but I have to rely pretty heavily on our IT teams to get these set up because they fill a knowledge gap that I don't have. And then it's important to consider that you'll need a staff member to review and maintain these reports. And together, this really requires many hours of work and coordination from staff. And depending on the size and the scale of your operation, maybe time that you don't have. And this leaves into a final consideration, which Kate touched on, that with the amount of time required by some of these REMS programs, you'll have to consider the anticipated utilization. If you're a new pharmacy with limited resources, which drugs should you prioritize so that you can serve the most patients? Maybe ones that have manageable requirements and high utilization. If you're an established pharmacy, maybe you've already got the resources in place to support one of these more complex REM programs that has difficult requirements, but low utilization. And this way, you can provide a needed therapy for your patients. - Okay, thank you all for that discussion. The next question to my panelists, how do you leverage data analytics and technology to ensure compliance with REMS requirements? Jed, let's start with you. - Sure, yeah, we mentioned earlier that we used a pharmacy switch to ensure that orders are not processed until a pharmacist has reviewed all REMS requirements for completion. We also document relevant data that's required by each REMS in our patient management software in dedicated assessments, which are unique for each REMS drug. We'll use these reports to aggregate the data that we have to send in daily reports to the REMS program. And these reports also allow us to pull data at a later date, and we'll use this feature to review all the expenses as part of both an annual self audit for all of our REMS drugs, and also use it when we're providing data to a third party on an external audit. - Jed, we have a similar process in that we leverage hard stops in WAM, especially at the expense to make sure a task has been completed for a product that has director REMS requirements. Kate, what about you? - We continue to add best practice alerts in our electronic medical record. We are pursuing adding additional REMS medication flags in our retail software system in the future. Data analytics is utilized to run the required REMS medication reports and helps monitor and audit the REMS requirements. - And our final topic for discussion. Kate Lewis, how do you ensure continuity of care for patients transitioning between different REMS medications or therapies? - Many of the REMS medications require a benefits investigation which allows our team to document the medication transitions in the medical record. We also try our best to manage the patient, but if we are unable to dispense the REMS medication, we attempt to handle their maintenance and support of care medications to assist in the continuity of care, and in who are the prior authorizations and financial assistance are renewed proactively to avoid medication pauses. - The transition between medications for REMS likewise tends to be a reactive process for us, but we do whatever is required for each medication. If we must change a medication, we contact the provider and patient to let them know what we are doing and why. It is almost always due to an insurance issue. - We unfortunately also run into this issue more than we'd like. Although we try to enroll in REMS programs for multiple therapies, within a single disease state, so that we could continue to serve a patient who is switching drugs, the reality is that we're often prevented from doing so by limited distribution networks. So a large responsibility falls on our clinical form assists who will continue to assist our patients with enrollment, prior authorizations, and financial assistance like Kate mentioned, even for the drugs that we're unable to fill. - Well, that's all the time we have for today. I want to thank our speakers for joining us today to discuss risk evaluation and mitigation strategies. If you haven't before, I encourage you all to check out ASHP's online resources for specialty pharmacy practitioners at ASHP.org. You can find member exclusive offerings, such as the Specialty Pharmacy Resource Center, which includes examples of best practices, business development resources, and more. Thanks again for joining us for this episode of Hot Topics in Specialty Pharmacy. - Thank you for listening to ASHP official, the voice of pharmacists advancing healthcare. Be sure to visit ashp.org/podcast to discover more great episodes, access show notes, and download the episode transcript. If you loved the episode and want to hear more, be sure to subscribe, rate, or leave a review. Join us next time on ASHP official. (upbeat music) (upbeat music)
