Uniquely suited to assist global pharmaceutical, biotechnology, medical device, 503B compounder, and other healthcare technology organizations in evaluating the safety of their products
Med Safety Board is dedicated to providing pharmaceutical regulatory consulting services to the healthcare industry to ensure the safe use of pharmaceuticals and medication-related medical devices.
Our heritage of clinical and medication safety expertise, along with real-time analysis of reported errors, uniquely positions us to help companies identify potential safety risks and determine how to address them.
We can provide consulting services that span a product’s or portfolio’s life cycle, from pre-FDA 510(k) or drug/biological submission assessments to medication labeling & packaging consulting and all the way through to post-market evaluations and line extensions.
Med Safety Board’s Drug Labeling & Packaging Review, Drug and Medication Device Risk Assessments, Human Factors Testing, and Medication-Related Device Regulatory Support Consulting Services can help you address issues outlined below.
Drug Labeling & Packaging: Design & Safety Review
It has been estimated that a third of all medication errors reported in the US are due to labeling and packaging confusion. Additionally, labeling- and packaging-related adverse events continue to be one of the most frequent types of voluntary reports submitted to the ISMP National Medication Errors Reporting Program (ISMP MERP).
Common causes of these errors include visual label similarities, confusing or missing important information, and error-prone packaging.
Ideally, labeling and packaging issues should be identified prior to the launch of a new pharmaceutical or drug-device combination 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.
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.
Drug and Medical Device Risk Assessments
The US Food and Drug Administration (FDA) advises that proactive risk assessments should be utilized by pharmaceutical and medical device regulatory or marketing professionals to help identify potential use-related errors and to remedy any safety concerns prior to a product reaching the market. Specifically, FDA recommends the use of failure mode and effects analysis (FMEA) and simulated use (human factors) testing as tools to support conducting a risk assessment of a pharmaceutical or medical device.
Med Safety Board experts are able to provide these risk assessments to identify potential errors, as well as strategies for mitigating the risks.
Our assessments are typically used to evaluate a unique aspect of a product, such as a change in presentation, special use requirements, or a new device design, and are conducted in the development or pre-market stage before submission to regulatory agencies for marketing approval or clearance.
Human Factors Testing and Usability
Medication errors are one of the greatest contributors to healthcare errors overall, as is commonly cites by the Institute for Medicine (IOM) and other reporting agencies. In response, FDA has developed significant guidance to assist industry professionals in maximizing the likelihood that new drugs and medication-related devices will be safe for intended users. This includes specific guidance for following appropriate human factors and usability engineering processes.
One of the permeating themes in the FDA recommendations is that it is critical that medications and medication-related devices are thoroughly reviewed in real-world clinical settings with clinicians to validate that products can be used safely, without design-related use errors, before being introduced into the market.
Pharmaceutical and medical device manufacturers are encouraged to obtain external clinical safety and human factors expertise to perform proactive risk assessments before product launch.
Our human factors experts at Med Safety Board have extensive expertise in product design and usability evaluations across the product development life cycle and can provide testing in simulated use-case environments.
FDA 510(k) Pre-Market & In-Market Regulatory Support
Med Safety Board can assist with medication-related device regulatory submissions and responding to regulatory agency requests by providing guidance on the device labeling, clinical interpretation of device testing data, and regulatory submission content and justifications. Med Safety Board can also support companies by conducting a risk assessment to identify any safety concerns with the design of the device.
Drug Name Review
Proposed new pharmaceutical brand names need to be evaluated for potential look-alike 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 brand name safety testing.
Education on Medication and Medication-Related Device Safe Practices
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.
Drug Safety Labeling & Packaging Field Testing
Understanding how a pharmaceutical product or medication-related device will fit within its intended healthcare environment 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 labeling and packaging of pharmaceutical or drug-device combination products, taking into consideration their setting of use and storage, to identify potential risks.
Medication Safety Insights and Qualitative Research
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.
Med Safety Board can also conduct searches of the ISMP National Medication Error Reporting Program (ISMP MERP) and FDA medication and device adverse databases for error reports related to a certain product, type of product, or topic. Expert analysis of these event reports by Med Safety Board provides insight into the types of errors that are occurring and their contributing factors, as well as strategies that could be implemented to address the identified safety risks.
In order to provide the widest breadth of safety services, we can also collaborate with other companies, including market research and human factors engineering agencies, to help you facilitate that process, if needed.