Q&A with Michael Fotis, BS Pharm,
and Juhi Jain, PharmD, BS
Pharmacy Purchasing & Products: What is the impetus behind the risk evaluation and mitigation strategies (REMS) program?
Michael Fotis and Juhi Jain: Of the four major reasons for introducing REMS, the first is straightforward: to improve the safety of newly approved medications. The second is to enhance the medication use system by using recent studies to design safety initiatives. As a result, physicians and pharmacists are efficiently alerted to a new drug’s risk potential and can apply the most current information to their prescribing practices. Third, REMS equip patients to play a more active role in their medical decisions by providing quality information. Working with their physicians, patients can identify the right questions to ask based on a better understanding of their options. After this discussion, patients are equipped to gauge whatever risks are identified. Many patients want to be involved in their treatment, especially when dealing with a serious illness. Lastly, REMS supports a system in which physicians and pharmacists collect valuable observational data about the safety of selected medications. Fulfilling the REMS requirements is mandatory for every medication included in the program.
PP&P: What is the purpose of the medication guide?
Fotis and Jain: Most REMS require only the medication guide or the medication guide and a communication plan (see Table 1 for a list of drugs with more in-depth REMS requirements). The guide is meant to be provocative—not to deter patients from using a potentially useful drug but to generate discussion between the prescriber, the pharmacist, and the patient about the risks and benefits of the medication. It is common for patients to have concerns about a medication, but a patient may not know what questions to ask. Pharmacists can help patients frame questions to their physicians. Even when not involved in the prescribing decision, pharmacists have the background and should use their role as medication safety advocates to direct patients back to prescribers for further discussion. This is a unique and valuable role for pharmacists, and patients are typically grateful for this guidance.
PP&P: How can pharmacy leadership overcome staff perceptions that REMS are a nuisance?
Fotis and Jain: Any inconvenience should be perceived in the light of taking active steps to improve patient safety. We are all well aware of the limitations of our current systems and as medication safety leaders, pharmacists must actively oppose the idea that all safety steps are a nuisance. All parties recognize that the four goals of REMS are valuable, but pharmacy leadership should emphasize these goals, both in staff education and daily routine. It is pharmacy’s responsibility to provide educational leadership on REMS, so pharmacy must turn the focus away from the difficulties and foster a positive, forward-thinking attitude.
PP&P: Why and how do REMS evolve over time?
Fotis and Jain: To account for the evolving nature of risk and safety data, each REMS is a dynamic, rather than static document. At the time of FDA approval, certain risks or complications may be unknown about a new drug. The value in implementing REMS with preliminary data is that it creates an opportunity to track observational information about the newly approved drug and to react efficiently to safety concerns raised by new studies. REMS will change when new information comes to light, such as learning that patients with renal failure or diabetes are at greater risk for certain adverse events when taking a specific drug.
We need to change the way we present educational programming by linking information about REMS to information about a new medication. In any presentation, paper, or discussion, it is important to state when and why a drug has a REMS, in much the same way its indication, generic name, brand name, and manufacturer would be presented. Also, the speaker should list the steps required for compliance.
At this point it is too early to determine the overall effect of mitigation strategies on health care. The next five years will be crucial to determining the effectiveness of REMS.
PP&P: What is the value of using automation to manage REMS?
Fotis and Jain: For increased efficiency, automation in general, and computerized prescriber order entry (CPOE) in particular, are key. When used correctly, automation ensures information remains current, reduces reliance on memorization, and maximizes patient education opportunities. A well-integrated CPOE system will alert the prescriber that a REMS exists for a drug and summarize the rationale and strategy. Even if the strategy is simply to provide a medication guide, the CPOE system will prompt the prescriber to link to and print the most up-to-date guide for the patient. Using CPOE to remind and direct physicians to fulfill a REMS for a specific drug leaves less to memory and ensures compliance. However, avoid using the technology simply to automate a manual process. Having safety stops in place only improves processes if those measures are employed.
Northwestern Memorial Hospital in Chicago has an online formulary in its CPOE software that is updated as new information becomes available. It can be accessed from any computer in the hospital, which streamlines the process and facilitates communication about updates. For those drugs that must be sourced from a specialty pharmacy, there is a direct link to that pharmacy with all necessary forms included to ensure ease of use. We have also automated our documentation process so that the system prompts prescribers with the question, “Did you educate the patient about the prescription?” Consider including an additional prompt that asks, “Did you review the medication guide with the patient?” This way, it is easy to document that the guide was provided to the patient.
If a facility has to manage REMS manually, significant diligence is required in keeping the REMS and all records up to date. This method substantially increases workload, and requires pharmacy to take a leadership role in ensuring timely, accurate records are maintained.
PP&P: What can the health care industry do to help improve REMS compliance?
Fotis and Jain: Drug manufacturers and technology vendors can help educate physicians about which drugs have REMS and what those REMS entail. Compliance with REMS regularly goes undiscussed; too often, prescribers are not even aware that a REMS exists for a certain drug. A tremendous opportunity exists for manufacturers and technology vendors to improve this situation by delivering more prescriber education as well as more effective technology solutions. The hospital also should play a key role in disseminating information. For example, some REMS require the prescribing physician to receive specific training on the drug. At Northwestern Memorial that information is incorporated into the CPOE system and the online formulary, with a link to inform the physician where to receive training.
PP&P: For a product with a REMS, what additional factors should be considered during formulary evaluation?
Fotis and Jain: Clearly the safety evaluation is paramount. Both the requester and the sponsor need to communicate that there is a REMS for the drug and explain why it was created and what is required. The requester should delineate the plans for using the drug so the P&T committee can evaluate it for safety and identify a plan to mitigate risks. Just as smart pumps help prevent errors, hospitals need a smart formulary that anticipates and mitigates error risks. For example, if a drug should not be used to treat certain patients, what system can the facility set up to identify and protect those patients? CPOE can be of great assistance in this effort. If a drug must be discontinued in patients experiencing renal failure, for instance, a system that matches laboratory diagnoses to medication ordering and elicits a warning about such a combination would be extremely useful. REMS present an opportunity to move away from an approach of simply reacting to side effects, and instead develop a proactive process that identifies patients at risk for serious side effects and presents options to reduce that risk.
Pharmacists can help by supporting formalized processes within the P&T committee. When a REMS is added to a drug already on the formulary, pharmacy should evaluate the workflow changes that need to be made to incorporate the REMS, then present that information to the P&T committee. At Northwestern Memorial, pharmacy-sponsored presentations and educational sessions during P&T committee meetings help drive the creation of unified, hospital-wide policies for medication management.
PP&P: What impact does proper management of REMS have on pharmacy staffing?
Fotis and Jain: Managing REMS efficiently is like managing any other task in the hospital pharmacy: good planning and prioritization are critical. Employing effective time management skills—identifying the most important tasks and focusing energy on the essential areas, while delegating less critical tasks to junior team members—allows pharmacy leaders to accomplish their goals. Tasks should be assigned to staff at the top of their skill sets. Each employee needs to be the right employee for the task; technicians complete tasks for technicians, nurses fulfill nursing responsibilities, and pharmacists complete tasks that can only be completed by pharmacists. For example, a technician could contact a patient’s community pharmacy to determine the date for the first prescription for teriparatide, while a pharmacist would be needed to determine a patient’s indication for dronedarone. As few facilities have unlimited resources and additional staff are often not a viable option, pharmacy leaders must think creatively about time management and maximize each individual’s unique skill set.
PP&P: How did you develop the model at Northwestern Memorial for implementing REMS?
Fotis and Jain: We conducted a study on the effects of properly managing patients taking six medications with REMS: bosentan, exenatide, teriparatide, dronedarone, tolvaptan, and quinine.1 The objectives were to develop a formal process for identifying practical mitigation possibilities and to provide data on the need for monitoring, outcomes, and time commitment. The team included pharmacists, residents, and students. Students’ contributions to the project were a major focus in order to increase their confidence in asking physicians the right questions as they would in daily practice and to further their pharmacy education. A mitigation manual was developed, which includes monitoring parameters and protocols for each medication.
After formal training on how to use the manual and an evaluation to ensure mastery, students monitored patients using a daily report to measure the appropriateness of monitoring and ease of use. A pharmacist oversaw the students to check their work and provide guidance. After the student’s review, the resident (a licensed pharmacist) consulted with the student on the questions to ask the physician. The student, pharmacist, and physician then discussed whether a medication needed to be ordered, as well as monitoring needs. This collaborative effort produced a sustainable model to use going forward when implementing REMS. The results indicate that managing REMS appropriately added only a few minutes to pharmacy’s workload.
PP&P: Any final thoughts on the future of managing REMS?
Fotis and Jain: Information on REMS needs to be made more readily available. Publications that report on pharmaceuticals should indicate when a REMS exists for a certain drug and what it entails. Educational programs, whether live or Web-based, should inform prescribers if the product discussed has a REMS. Pharmacy leaders need to educate themselves so they can help other staff members stay current and maximize safety. Managing REMS provides pharmacy an additional opportunity to showcase the value pharmacists bring to patient safety. Patients expect us to offer them a safe medication system, and as our families and neighbors are our patients, how can we do less?
Juhi Jain, PharmD, BS, is currently a PGY2 pharmacy informatics resident at Indiana University Health in Indianapolis. She received a BS from Benedictine University and a PharmD from Midwestern University Chicago College of Pharmacy. Having recently completed a PGY1 pharmacy practice residency at Northwestern Memorial Hospital in Chicago, Juhi’s professional interests involve safety-related initiatives involving pharmacy informatics solutions to work towards increased patient safety.
Michael Fotis, BS Pharm, is the residency PGY1 director and the manager for drug information at Northwestern Memorial Hospital in Chicago. He is the director of educational affairs for the Illinois Council of Health-System Pharmacists and was named outstanding volunteer in 2008 and pharmacist of the year in 2009. Michael was selected as preceptor of the year by the Drake University class of 1993. He is the author of more than 40 publications and 100 presentations, covering topics such as medication safety, drug use policy, leadership, and mentoring. Michael was recently named 2010 alumnus of the year by the University of Illinois.
Sample Statement for Discussing Medication Guides
The following template was developed as a guide for pharmacists discussing Victoza with patients:
“As you know, all medicines have side effects. When a medication is brand new we do not always know what side effects to expect. Keep in mind that one day you may have serious side effects if you do not treat your diabetes. I have a pamphlet for you to read. This pamphlet was written by the company that sells this medication. It lists some of the conditions that might increase a person’s chances of having a side effect. Most people do not have one of these conditions, and even if you do there is nothing to be alarmed about. Please look these over and tell your doctor if you or any family member has ever had one of the conditions that are listed. If you have, your doctor will explain why this medication is necessary for you. Your doctor is expecting to have this conversation with you so please do not hesitate to discuss your concerns with her (him). If you are not sure how or what to discuss with your doctor, please let me know so I can help you.”
Examples of REMS Interventions
Patient on Teriparatide:
Patient on Dronedarone:
Student: “I am reviewing your patient on dronedarone in which liver function tests are required but have not been ordered. Can you order them?”
Floor Pharmacist: “I can order the liver function tests if you want. Did you not see any orders?”
Student: “No, I did not see any ordered or drawn since admission.”
Floor Pharmacist: “OK, I will order them.”
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