Understanding current medication safety initiatives allows clinicians to educate patients on the safety of newly approved drugs and vaccines. It also provides a mechanism for them to report any concerns regarding the safety of medications and biologics.
The Center for Drug Evaluation and Research (CDER) is a vital component of the Food and Drug Administration (FDA). It ensures the safety and effectiveness of over-the-counter and prescription medications. The safety initiatives of the CDER ensure the appropriate evaluation and research of new drug entities and provide mechanisms for post-market surveillance.
The CDER’s work also spans multiple other components of drug safety. These include streamlining the drug development process and providing patients and healthcare providers with drug information. It also helps regulates the labeling process.
Related: Understanding the FDA’s Medication Safety Initiatives
Safety First Initiative
Initially launched in 2008, the Safety First Initiative establishes the framework to support an equal evaluation of medication safety during pre- and post-market surveillance. Using multidisciplinary teams, the CDER evaluates issues of post-market safety and develops steps to evaluate and manage these safety concerns.
The Safety First Initiative provides mechanisms for the CDER to request additional research for continued marketing approval. When the risk-benefit ratio of a medication changes, the CDER can establish risk evaluation and mitigation strategies (REMS). This ensures the safe monitoring of drugs, request labeling changes, and remove drugs from the market. This oversight protects patients from the potential harm of newly approved therapeutics as they are used in larger populations.
Safe Use Initiative
The Safe Use Initiative was developed to address issues affecting the safe use of medications beyond the pre- and post-market surveillance programs of the FDA. This medication safety initiative supports research to address areas associated with the inappropriate use and misuse of medications.
With this initiative, the CDER aims to reduce the harm caused by errors in the prescribing and use of medications. Examples of the research this initiative supports include:
- The Nurse Pain Educator Pilot Program
- Integrated Clinical Decision Support System to Advance the Safe Use of Antibiotics
Equal Voice Initiative
This initiative impacts the pre-market evaluation of new drug applications. The premise of this initiative is to give each scientific team an equal opportunity to raise concerns about the approval of a new medication. This process engages the entire approval team in a scientific discussion and makes sure every point of view is heard. While the decisions are not always unanimously supported, this initiative promotes healthy debates from all perspectives.
Critical Path Initiative
The Critical Path Initiative assists a national effort to modernize the process by which products are developed, evaluated, and manufactured. The goal of this initiative is to improve process efficiency in bringing new products from the laboratory to consumers. This is a process supported by efforts from the drug industry, patient advocate groups, academic researchers, professional associations, and government agencies.
Sentinel Initiative
The goal of the Sentinel Initiative is to create a national, integrated electronic system (the Sentinel System). This system allows the FDA to securely and quickly monitor safety issues. The Sentinel System accesses currently available electronic medical data from healthcare data holders. This data may include electronic health record systems, administrative and insurance claims databases, and registries that assist the FDA in post-market surveillance.
Transparency Initiative
In attempts to comply with 2009 Presidential memoranda, this initiative encourages the development of strategies to improve the transparency of the FDA’s activities and decision-making processes. This initiative’s goal is to promote consumer confidence, as well as promote innovation through publicly available datasets.
While not an exhaustive list of the medication safety initiatives of the CDER, it does provide a general overview. Each initiative provides individualized support to make them effective and achieve the overall goal of promoting and enhancing medication safety.
FDA Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS) database is a vital resource that collects reports on adverse events, medication errors, and product quality complaints linked to adverse events submitted to the FDA. This database plays an essential role in supporting the FDA’s ongoing safety surveillance program for drug and therapeutic biologic products.
This electronic submission system assists industry stakeholders in making regulatory submissions in an electronic format to the FAERS database. This is particularly relevant for review by the CDER and the CBER.
As part of the FAERS database, MedWatch is an essential program established by the FDA for the safety reporting of medical products. This is aimed at health professionals, patients, and consumers. This program underscored the importance of healthcare professionals in reporting adverse drug reactions as a vital measure for ensuring medication safety.
MedWatch acts as the FDA’s portal for the voluntary reporting of serious adverse reactions, product quality concerns, therapeutic ineffectiveness, and errors in product use associated with a range of human medical products. This includes drugs, biologics, medical devices, dietary supplements, infant formulas, and cosmetics.
Addressing serious safety concerns
Risk evaluation and mitigation strategies (REMS) are critical drug safety programs required by the FDA for medications with serious safety concerns. These programs ensure that the benefits of a drug outweigh its risks by promoting safe use practices and allowing access to potentially risky medications.
The FDA may require a REMS during the drug approval process, including New Drug Applications (NDAs) and biological license applications. If new safety information emerges post-market, the FDA may mandate a REMS. The drug manufacturer develops the REMS program, while the FDA reviews and approves it, focusing on specific safety risks associated with the medication.
Factors contributing to REMS
Key factors considered by the FDA in determining the need for a REMS include:
- The population size likely to use the drug
- The seriousness of the disease
- Expected drug benefits and duration of treatment
- Known or potentially serious adverse events
A REMS may be comprised of multiple elements, such as Medication Guides, communication plans, and “elements to assure safe use” (ETASU). These elements aim to mitigate the identified risks and often include requirements for provider training, patient monitoring, and registry enrollment.
To minimize the burden, the ETASU must be proportional to the specific risks. It cannot, however, significantly hinder patient access, especially for those with serious conditions. Each REMS includes a timetable for assessments to evaluate its effectiveness. These occur at least every 18 months, 3 years, and 7 years post-approval. This ensures that the REMS can be modified or suspended if necessary.
Overall, REMS are an essential element of medication safety initiatives. REMS help manage the safety of high-risk medications and balancing patient safety with drug availability.
Conclusion
The FDA is actively committed to ensuring that all medications approved for use in the United States are not only safe but also effective. In recent years, these organizations have made notable advancements in improving the quality and accessibility of drug safety information for both healthcare providers and consumers. This includes the provision of timely notifications and comprehensive, actionable content regarding medication safety.
In addition, the FDA has adopted various medication safety initiatives. These successfully integrate data into systems such as electronic medical records at the point of care. It is crucial for healthcare providers to use these communication resources to disseminate accurate and timely information to pharmacies, patients, and the public. Engaging with this data can lead to significant improvements in the safe use of medications, inform the drug development process, and enhance overall drug safety practices.
