Balancing REMS and Medication Utilization
October 2012 - Vol.9 No. 10
- Page #34
Q&A with
Scott Drugan, PharmD
Pharmacy Purchasing & Products: What do risk evaluation and mitigation strategies (REMS) seek to provide to patients and health care providers?
Scott Drugan: Fundamentally, REMS seek to provide both health care providers and patients with specific safety information for medications that may have an increased risk as indicated by the FDA. The detailed information found in most REMS allows providers to perform a risk-benefit evaluation for specific patients.
REMS seek to establish a process to educate patients and permit them to determine their own willingness to use the medication given the known risks. While some view the typical REMS as highlighting only the risks of a certain medication—a concept inherent in the acronym itself—the intent of a REMS should be to create a balanced view of the benefits as well, so that the potential outcomes of using the medication are fully explored and clarified before proceeding with therapy.
PP&P: How do facilities balance the extra steps involved in adding a REMS medication to formulary with the benefits gained by using that medication?
Drugan: The intent of creating or modifying a medication formulary is not only to determine what medications will be used, but also how they should be used. Given this, a REMS can actually provide a focused scope-of-use for the specific medication. However, the presence of a REMS may imply additional administrative steps or documentation will be required to use that medication, which can take time and effort to implement.
Ultimately, determining whether to include a REMS medication on formulary should not differ from the process for any other medication. The facility normally weighs the benefits against the drawbacks of medications being considered for formulary. For a medication with a REMS, the cost of using that medication should include all measures required by the REMS, but the benefits, which can be significant, also must be taken into account. Simply put, the presence of a REMS alone should not deter the institution from adding a medication to formulary.
Scott Drugan: Fundamentally, REMS seek to provide both health care providers and patients with specific safety information for medications that may have an increased risk as indicated by the FDA. The detailed information found in most REMS allows providers to perform a risk-benefit evaluation for specific patients.
REMS seek to establish a process to educate patients and permit them to determine their own willingness to use the medication given the known risks. While some view the typical REMS as highlighting only the risks of a certain medication—a concept inherent in the acronym itself—the intent of a REMS should be to create a balanced view of the benefits as well, so that the potential outcomes of using the medication are fully explored and clarified before proceeding with therapy.
PP&P: How do facilities balance the extra steps involved in adding a REMS medication to formulary with the benefits gained by using that medication?
Drugan: The intent of creating or modifying a medication formulary is not only to determine what medications will be used, but also how they should be used. Given this, a REMS can actually provide a focused scope-of-use for the specific medication. However, the presence of a REMS may imply additional administrative steps or documentation will be required to use that medication, which can take time and effort to implement.
Ultimately, determining whether to include a REMS medication on formulary should not differ from the process for any other medication. The facility normally weighs the benefits against the drawbacks of medications being considered for formulary. For a medication with a REMS, the cost of using that medication should include all measures required by the REMS, but the benefits, which can be significant, also must be taken into account. Simply put, the presence of a REMS alone should not deter the institution from adding a medication to formulary.
PP&P: When a REMS consists of additional requirements beyond a medication guide, what approach should pharmacy take?
Drugan: The majority of REMS are vehicles to verify that patients and providers are aware of and understand the details of the medication guide, which includes the risks of using the medication. Beyond this, additional REMS guidance can include elements for safe use such as ensuring specific lab tests are performed and monitored in a precise way, requiring patients to sign a document indicating they are aware of the risks, or enrolling the patients and prescribers in a program to educate them on the risks of the specific drug.
Managing medications with REMS should be a function of the procedures designed in response to the REMS itself, thereby enabling compliance. In other words, closely review the specifics of the REMS, make sure all relevant parties are aware of those requirements, develop a procedure to follow the guidelines of the REMS, and monitor compliance to these procedures. All of these steps should be in place prior to utilizing a drug with a REMS.
PP&P: Are REMS static documents?
Drugan: REMS can change over time as evidenced by the experience with the medication Nplate (romiplostim). The manufacturer originally created a REMS for Nplate that included elements to assure safe use, which required enrollment of institutions, physicians, and patients in a safety monitoring program as a means to educate physicians and patients about treatment risks and benefits, and to define the long-term safety profile. Although I do not know the specifics behind the change, the REMS was modified to eliminate these elements. Thus, over time, data submitted to the FDA can influence an evolution in the management of a specific medication, and in this case, reduce the requirements of the strategy. REMS should not be viewed as set in stone.
PP&P: Are there any credible reasons to avoid medications with REMS attached?
Drugan: The decision to use or not use a medication in a facility should be based on a number of factors, the presence of a REMS being one of several. As with any product or service, a facility must determine whether they have the ability—including the clinical expertise, staff, budget, and technology resources—to sustain that product or service.
If a facility offers a service that involves a potential treatment using a drug with a REMS, it would be rather difficult to provide this service without considering the use of this drug. Simply stated the question of prescribing and administering a medication should not be limited to whether it has a REMS; rather, the question should focus on whether the facility feels compelled to offer a treatment option that happens to involve medications that pose an elevated risk.
Conversely, if a facility does not offer the primary service that would potentially benefit from a drug with a REMS, given the added risk and the added concern over compliance with the REMS, the drug would probably not be added to the formulary for those rare occasions that it may be prescribed.
PP&P: From pharmacy’s standpoint, how can REMS be managed to overcome negative perceptions?
Drugan: It is important to remember that REMS are developed to highlight the risks in using a medication, but from pharmacy’s perspective, the goal is to present the medication in a balanced way. Therefore, the practitioner needs to recognize and make transparent the risks, but also is responsible for communicating the benefits that are driving the recommendation of the medication in the first place. If the focus is placed solely on the risk, patients may be scared away from a product that could provide significant benefits. Internally, a hospital should comply with the REMS and make sure the risks are clear to practitioner and patient alike; when it comes to the hospital’s relationship with the patient, it is their responsibility to define and present the benefits of that medication as well.
PP&P: Ultimately, how do REMS enable better care for unique patients?
Drugan: First of all, there may be some medications available for unique patients that would not be on the market if not for the fact that there is a strategy to mitigate the risk of using those medications. The conditions described within the REMS for these agents will attempt to confirm that risks are adequately considered, and may include the description of a monitoring plan also designed to reduce the risk to the patient. In general, REMS are designed to create a more robust process for using a specific drug, be it additional lab monitoring or making sure the patient has an opportunity to discuss concerns with a clinician prior to the initiation of therapy. Invariably, all REMS involve a process to ensure that the risks are considered and/or monitored while using a medication with specific safety concerns.
Drugan: The majority of REMS are vehicles to verify that patients and providers are aware of and understand the details of the medication guide, which includes the risks of using the medication. Beyond this, additional REMS guidance can include elements for safe use such as ensuring specific lab tests are performed and monitored in a precise way, requiring patients to sign a document indicating they are aware of the risks, or enrolling the patients and prescribers in a program to educate them on the risks of the specific drug.
Managing medications with REMS should be a function of the procedures designed in response to the REMS itself, thereby enabling compliance. In other words, closely review the specifics of the REMS, make sure all relevant parties are aware of those requirements, develop a procedure to follow the guidelines of the REMS, and monitor compliance to these procedures. All of these steps should be in place prior to utilizing a drug with a REMS.
PP&P: Are REMS static documents?
Drugan: REMS can change over time as evidenced by the experience with the medication Nplate (romiplostim). The manufacturer originally created a REMS for Nplate that included elements to assure safe use, which required enrollment of institutions, physicians, and patients in a safety monitoring program as a means to educate physicians and patients about treatment risks and benefits, and to define the long-term safety profile. Although I do not know the specifics behind the change, the REMS was modified to eliminate these elements. Thus, over time, data submitted to the FDA can influence an evolution in the management of a specific medication, and in this case, reduce the requirements of the strategy. REMS should not be viewed as set in stone.
PP&P: Are there any credible reasons to avoid medications with REMS attached?
Drugan: The decision to use or not use a medication in a facility should be based on a number of factors, the presence of a REMS being one of several. As with any product or service, a facility must determine whether they have the ability—including the clinical expertise, staff, budget, and technology resources—to sustain that product or service.
If a facility offers a service that involves a potential treatment using a drug with a REMS, it would be rather difficult to provide this service without considering the use of this drug. Simply stated the question of prescribing and administering a medication should not be limited to whether it has a REMS; rather, the question should focus on whether the facility feels compelled to offer a treatment option that happens to involve medications that pose an elevated risk.
Conversely, if a facility does not offer the primary service that would potentially benefit from a drug with a REMS, given the added risk and the added concern over compliance with the REMS, the drug would probably not be added to the formulary for those rare occasions that it may be prescribed.
PP&P: From pharmacy’s standpoint, how can REMS be managed to overcome negative perceptions?
Drugan: It is important to remember that REMS are developed to highlight the risks in using a medication, but from pharmacy’s perspective, the goal is to present the medication in a balanced way. Therefore, the practitioner needs to recognize and make transparent the risks, but also is responsible for communicating the benefits that are driving the recommendation of the medication in the first place. If the focus is placed solely on the risk, patients may be scared away from a product that could provide significant benefits. Internally, a hospital should comply with the REMS and make sure the risks are clear to practitioner and patient alike; when it comes to the hospital’s relationship with the patient, it is their responsibility to define and present the benefits of that medication as well.
PP&P: Ultimately, how do REMS enable better care for unique patients?
Drugan: First of all, there may be some medications available for unique patients that would not be on the market if not for the fact that there is a strategy to mitigate the risk of using those medications. The conditions described within the REMS for these agents will attempt to confirm that risks are adequately considered, and may include the description of a monitoring plan also designed to reduce the risk to the patient. In general, REMS are designed to create a more robust process for using a specific drug, be it additional lab monitoring or making sure the patient has an opportunity to discuss concerns with a clinician prior to the initiation of therapy. Invariably, all REMS involve a process to ensure that the risks are considered and/or monitored while using a medication with specific safety concerns.
Scott Drugan, PharmD, has held numerous leadership roles in hospitals, health care systems, and the pharmaceutical industry. He is former director of pharmacy at the Los Angeles County + University of Southern California (USC) Medical Center; director of pharmacy services at the Los Angeles County Department of Health Services; vice president of clinical diagnostic and therapeutic services at City of Hope Medical Center; and director of marketing at Amgen, Inc. Scott earned his BS in biochemistry from UCLA and his PharmD from the USC School of Pharmacy.
Risks of IVIG Administration
Q&A with Rosalyn Scherf, RNC
PP&P: Are the indications for IVIG therapy different for pediatrics than for adults?
Rosalyn Scherf: While most indications are the same for both populations, there are some additional indications for pediatrics, such as pediatric intractable Guillain-Barré syndrome, cystic fibrosis, recurrent otitis media, and primary humoral immunodeficiency in children two years old and older. IVIG also has been approved for treating pediatric patients with HIV type 1 and there are studies looking at the effects of IVIG on childhood epilepsy. It is important to note that the safety and efficacy of IVIG for patients under the age of two continues to be studied.
PP&P: What are the risks to pediatric patients treated with IVIG therapy?
Scherf: Generally, the risks are similar for adults and pediatrics, but sensitivity to the common side effects of IVIG administration can fluctuate significantly among children, so a slower infusion rate is recommended. It also is essential that patients are not volume depleted prior to infusion. As with adults, pediatric patients with antibodies to IgA have a greater risk of developing potentially severe reactions and aseptic meningitis syndrome (AMS) may occur more frequently with high doses or rapid infusion of IVIG in any patient.
PP&P: What resources are available to help educate providers and patients on managing risk?
Scherf: In my personal experience as a patient and as an IVIG infusion nurse, drug information inserts and Web resources are available from IgG manufacturers. But it is really left to nurses, pharmacists, and physicians to provide patients and care givers with detailed information on the risks of IVIG administration. For children, The Immune Deficiency Foundation publishes a wonderful booklet on IVIG administration titled Our Immune System by Sara LeBien. For a free download, visit www.primaryimmune.org
Rosalyn Scherf, RNC, is a nursing clinical educator for South Florida Pediatric Homecare and is certified in neonatal intensive care nursing. Rosalyn has over forty years experience in home infusion therapy and pediatric and neonatal intensive care. Login
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