Abstract
Table of Contents
Background
The risk evaluation and mitigation strategies (REMS) program is a medication safety program implemented by the FDA to ensure high-risk medications provide benefits that outweigh their risks. Manufacturers may be required to implement strategies that vary by medication,creating a challenging environment for health care providers and patients to ensure documentation compliance. Our institution, University of California San Diego Health, addressed this by implementing a standardized pharmacist workflow for REMS medications using a wildcard in the readiness instructions for certain REMS medications. The wildcard reminded pharmacists to fill out an intervention note and attest that all required documentation was completed before dispensing the medication. The objective of this study was to determine the effectiveness of the simple addition of a wildcard to the medication preparation instructions of a pharmacist’s medication verification activity to improve Risk Evaluation and Mitigation Strategy (REMS) documentation compliance.
Methods
We conducted a comparative study of the pre- and postimplementation periods. To assess compliance,we tracked the percentage of i-Vents completed by pharmacists for verified orders of the 3 REMS medications for wich the wildcard was used. The study period was from March 25,2021,to January 25,2022,for the preimplementation period,and from January 26,2022,to September 26,2022,for the postimplementation period. A 2×2 χ2 test for independence was conducted to assess the significance of the change in compliance rate before and after implementation.
Results
In the preimplementation period, 162 out of 226 orders (71.7%) had i-vents documenting REMS elements necessary for compliance. In the postimplementation period, 191 out of 193 orders (99.0%) were compliant. The test revealed a statistically significant difference in the compliance rates between the pre- and postimplementation period (P < .000001).
Also to be considered:
Our institution’s solution of using a wildcard in the preparation instructions was effective in achieving nearly global compliance.
Introduction
The FDA started the Risk Evaluation and Mitigation Strategy (REMS) program in 2008 to allow the prescribing of certain medications with serious safety concerns to help ensure the benefits of medications outweigh their risks. REMS are not designed to mitigate all the adverse effects of a medication but are focused on preventing, monitoring, and/or managing specific serious risks by informing, educating, and reinforcing actions to reduce the frequency and/or severity of the event.1
An example of a medication that requires a REMS program is riociguat (Adempas; Bayer). Riociguat is a guanylate cyclase stimulator used to treat pulmonary hypertension. Riociguat is an efficacious medication, but it is indeed associated with a risk of embryo-fetal toxicity.2 The riociguat REMS program requires that the prescribing provider, patient, and pharmacy be enrolled before prescribing, taking, and dispensing this medication. Requiring training to participate in the use of a high-risk medication such as riociguat ensures that proper precautions and monitoring parameters are known to all before the patient begins pharmacotherapy.3
Adherence with REMS requirements can be challenging for several reasons. The program’s complexity makes it tough for institutions to adopt a one-size-fits-all approach to complying with REMS requirements. Manufacturers are responsible for creating and curating their individual REMS programs under FDA oversight. As each medication has different requirements due to varying risks, it can be difficult for health systems to adhere to all requirements. In a survey of 14 hospitals within the Vizient network, 10 responded that the REMS program’s lack of standardization and complexity were the most significant barriers to compliance.4
Noncompliance with REMS requirements can have large financial implications for heal
This study has shown the feasibility and effectiveness of implementing a simple wildcard hard stop to the pharmacist preparation instructions field with a reminder for pharmacists to ensure REMS requirements are met before verifying a medication.This approach is novel because it bypasses prescriber order entry, places a hard stop on verification to ensure that all REMS requirements and documentation are met before final dispensing of the medication, and allows the prescriber to continue without interrupting their workflow (Figures 2 and 3). Other i
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Future directions for this study include expanding the use of the wildcard hard stop to other REMS medications,such as alvimopan and bosentan,in the next phase of growth. Using a standardized approach to applying the wildcard to all REMS medications that require compliance documentation helps maintain consistent compliance. Pairing this with a template for the required REMS components is a highly effective way to ensure institutions are following safe medication practices and complying with regulatory requirements. Utilization of this wildcard in pharmacist preparation instructions also has the potential to optimize other areas of pharmacist practise that require consistent pharmacist intervention or documentation, such as factor unit tracking, with fewer interruptive alerts and without the need to target physicians.
Also to be considered:
The REMS program is intended to ensure the safe use of high-risk medications, but a lack of standardization creates challenges in documenting compliance. Our institution’s solution of using a wildcard in the preparation instructions was effective in achieving nearly universal compliance. The solution was simple to implement,applicable to all REMS requirements,and minimally disruptive to workflow.
REFERENCES
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Risk Evaluation and Mitigation Strategies | REMS. FDA. Accessed March 3, 2023.
https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems -
Lippmann E. Risk Evaluation and Mitigation Strategies (REMS). FDA. June 2017. Accessed August 17, 2023.
https://www.fda.gov/media/105565/download -
Riociguat Shared System REMS Accessed March 3, 2023.
What is the Inflation Reduction Act? The Inflation Reduction Act of 2022 is a landmark United States federal law that aims to lower healthcare costs, address climate change, and raise taxes on large corporations. President Joe Biden signed the bill into law on August 16,2022,marking a significant legislative achievement for his governance.
The Act represents a compromise between the Biden administration’s initial proposals and the constraints of a narrowly divided Congress. It focuses on three key areas: reducing the federal deficit, lowering prescription drug costs for seniors on Medicare, and investing in clean energy and climate change mitigation. The name “Inflation Reduction Act” is somewhat contested, as economists debate the extent to which the law will directly reduce inflation in the short term. However, proponents argue that its long-term effects will help stabilize prices.
According to the Congressional Budget Office (CBO), the Inflation reduction Act is projected to reduce the federal deficit by $300 billion over the next ten years. Source: CBO Report. This reduction is achieved through a combination of tax increases on corporations and prescription drug savings.
Key Provisions of the Inflation Reduction Act
The Inflation Reduction Act contains several key provisions impacting healthcare, climate, and taxation.These provisions are designed to work together to achieve the law’s overarching goals.
- Healthcare Costs: Allows Medicare to negotiate the prices of certain prescription drugs, starting with a limited number of high-cost medications in 2026. It also extends enhanced Affordable Care Act (ACA) subsidies through 2025, preventing premium increases for millions of Americans.
- Climate Change: Invests approximately $369 billion in clean energy and climate change initiatives, including tax credits for renewable energy production, electric vehicles, and energy efficiency improvements.
- Taxation: Imposes a 15% minimum tax on corporations with over $1 billion in profits and increases funding for the Internal Revenue Service (IRS) to improve tax enforcement.
The Medicare drug price negotiation provision is particularly significant, as it represents a major shift in the U.S. healthcare system. For decades, Medicare was prohibited from directly negotiating drug prices with pharmaceutical companies. Source: CMS Fact Sheet
Impact on Climate Change
The Inflation Reduction Act represents the largest investment in climate action in U.S. history. It aims to considerably reduce greenhouse gas emissions and accelerate the transition to a clean energy economy.
The law provides tax credits and incentives for a wide range of clean energy technologies, including solar, wind, geothermal, and carbon capture. It also supports the development of clean energy manufacturing and infrastructure. These investments are expected to create jobs in the clean energy sector and reduce reliance on fossil fuels.
Analysis by Princeton University’s Zero-carbon Analysis for Policymakers (ZCAP) estimates that the Inflation Reduction Act could reduce U.S. greenhouse gas emissions by roughly 40% below 2005 levels by 2030.Source: Columbia university Analysis. While this falls short of the Biden administration’s initial goal of a 50-52% reduction, it still represents a substantial step forward.
Economic Effects and tax Implications
The Inflation Reduction Act’s economic effects and tax implications are complex and subject to ongoing debate. The law is projected to have a modest impact on inflation in the short term, but its long-term effects on economic growth and price stability are uncertain.
The 15% minimum tax on large corporations is expected to generate significant revenue, but some businesses argue that it will discourage investment and innovation. The increased funding for the IRS is intended to improve tax compliance and reduce tax evasion, but it has also faced criticism from those who argue that it will lead to increased audits of middle-class taxpayers.
The Joint Committee on Taxation estimates that the corporate minimum tax will raise approximately $315 billion over ten years. Source: Joint Committee on Taxation. The increased IRS funding is projected to generate an additional $124 billion in revenue over the same period.
Political Context and Passage
The Inflation Reduction Act was passed along party lines in the Senate through a process called budget reconciliation, which allowed it to bypass a filibuster. It then passed the House of Representatives and was signed into law by President Biden.
The bill faced significant opposition from Republicans, who argued that it would harm the economy and increase taxes. Democrats defended the bill as a necessary step to address climate change, lower healthcare costs, and reduce the deficit. The passage of the Act was a major victory for the Biden administration and a demonstration of the Democrats
