Med Safety Board provides consulting services to life science organizations to improve the safe use of pharmaceuticals and medication-related devices. Our relationship with our parent company, the Institute for Safe Medication Practices (ISMP), an affiliate of ECRI, makes us uniquely suited to assist global pharmaceutical, biotechnology, medical device, compounder and other healthcare technology organizations in evaluating the medication safety of their product labels and packaging.
Our heritage of medication safety best practices from ISMP, along with real-time analysis of reported errors, makes us uniquely positioned to help companies identify potential safety risks and determine how to address them. We provide consulting services that span a product or portfolio’s lifecycle, from pre-marketing assessments through in-market evaluations and line extensions.
Med Safety Board’s medication labeling & packaging consulting services can help you work through labeling and packaging requirements and safety enhancements for a single label, a group of labels, or an entire portfolio of products, whether for prescription pharmaceuticals, biologics, 503B compounded products, or over-the-counter medications.
Ideally, labeling and packaging issues should be identified prior to the launch of a new pharmaceutical product to minimize harm and expensive revisions. However, Med Safety Board can help remediate drug safety issues at any point in the life cycle of a product, including post-market implementation.
The US Food and Drug Administration (FDA) advises that proactive risk assessments should be utilized by pharmaceutical and medical device organizations to help identify potential use-related errors and to remedy any safety concerns prior to a product
reaching the market. Med Safety Board experts are able to provide these risk assessments to identify potential errors, as well as strategies for mitigating those risks.
The FDA encourages manufacturers to obtain external clinical safety and human factors expertise to perform proactive risk assessments prior to product launch. Med Safety Board is uniquely qualified to perform these evaluations, which can help you avoid costly delays in go-to market plans, as well as in- market issues that can cause patient harm. Our team consists not only of human factors engineers but also healthcare professionals who work collaboratively to offer real-world, clinical informed validation testing.
Med Safety Board also offers human factors learning opportunities for industry partners and their teams, such as in-person and virtual collaborative teaching seminars, to help you become more effective in applying human factors engineering principles in-house.
Med Safety Board can assist with medication-related device regulatory submissions and responding to regulatory agency requests related to the device labeling, medical device testing requirements and interpretation of the associated testing data, and/or conducting risk assessments to identify any safety concerns with the design of the device, whether pre- or post-submission.
Proposed new pharmaceutical brand names need to be evaluated for potential look- and/or sound-alike similarity with other pharmaceutical products in order to help avoid medication errors. Med Safety Board utilizes data from name simulation studies involving practicing healthcare practitioners, knowledge gained from product name issues reported to ISMP, name pair scores generated by the Phonetic and Orthographic Computer Analysis (POCA) system, and comparisons of product characteristics for overlapping or dissimilar attributes to complete its brand name safety testing.
Med Safety Board can design and present educational programming on medication and medication-related device safety and error prevention to any audience – industry colleagues, your customers, or to healthcare consumers. This may include topics such as how to incorporate safety recommendations into the design of a medication label, causes of medication or medication-related device errors and associated recommended strategies, and medication use systems in various care settings and how your product fits into these workflows.
Understanding how a pharmaceutical or medication-related device product will fit within the healthcare environment in which it is intended is crucial to identifying and mitigating potential risks. Med Safety Board can use our network of healthcare professionals and pharmacists working in the field to evaluate sample products, taking into consideration its setting of use and storage, to identify potential risks.
By bringing together key product users and/or medication safety thought leaders, Med Safety Board can convene focus groups to identify potential safety concerns, gain insights, validate best practice opinions, and brainstorm safety enhancement ideas for new or established pharmaceutical products and medication-related devices.
It’s estimated that more than seven million patients are affected each year by medication errors, including events that stem from error-prone products. Without a vigilant product development process to proactively identify and address risks, products that have not been properly evaluated that reach the market may result in patient harm. This may occur due to brand name confusion, inability to readily find key product information, confusing or look-alike labeling and packaging, and error-prone medication-related devices. More »
FDA hosts annual virtual event: Regulatory Education for Industry (REdI) Annual Conference, June 5-9, focused on drugs, devices and biologics May 25, 2023 2:14pm
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Similar IV Bag Labels Can Lead to Error May 18, 2023 9:38am
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Med Safety Board to present webinar with Regulatory Affairs Professional Society (RAPS) on FDA’s current guidance on safe medication container labeling January 24, 2023 11:13am
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Learn what’s new in FDA’s finalized guidance for industry – join us for a free webinar on September 15 August 10, 2022 12:26pm
On September 15 at 12 pm ET, Med Safety Board experts will review the significant changes that were incorporated into the finalized FDA guidance: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors in a free webinar. The presentation will cover recommendations on displaying certain critical information, differentiating look-alike products, and […]
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FDA finalizes guidance on safety considerations for container and carton labeling May 31, 2022 10:51am
On May 18, the US Food and Drug Administration (FDA) posted the finalized guidance for industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors. This guidance document represents FDA’s current thinking on safe medication container label and carton labeling design and is intended to help minimize medication errors associated with […]
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Download an overview of MSB May 26, 2022 12:12pm
Find out how we can help safeguard your products through proactive risk assessment, labeling & packaging reviews and other services. Download a Med Safety Board Overview
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Vice President, Global Market Intelligence & Clinical Solutions
ECRI
Plymouth Meeting, Pennsylvania
Office: 215-370-1838
amaguire@ecri.org
