The first of a five-part series examining product recalls and compliance issues in various business sectors.
Pharma companies facing increasing regulatory scrutiny could be in hot water for ineffective product recall management. The FDA and other authorities regularly recall pharma products for mislabeling, packaging errors, unsafe ingredients, potential contamination, and other reasons. Drug manufacturers and distributors that don’t comply with the authorities — or don’t recall products on time — not only jeopardize public safety but could receive up to $1 million in fines.
In the first of a new five-part series, Trievr reviews three regulatory compliance issues that pharma companies face in 2021.
1. An Over-Reliance on Manual Methods for Product Recall Management
Some pharma compliance teams still rely on manual methods for product recall management, like spreadsheets. Other compliance teams might check the FDA website for recall information a few times a year. Tracking product recalls manually like this is just poor recall management. Problems like human error occur when tracking recalls via spreadsheets, and compliance teams might miss time-critical compliance notices if they track recalls irregularly.
With ever-stringent government regulations, pharma teams of all sizes can no longer afford to use manual methods for recall management. Investing in digital technologies, where teams can automate recall processes, increases compliance significantly.
Did you know the FDA issued 240 recall enforcement reports for prescription drugs and 43 enforcement reports for over-the-counter drugs in one year?
2. Inefficient Product Recall Management Technologies
Some pharma companies realize the risks of regulatory noncompliance but lack the technologies required for proper product recall management. There are two technology-related reasons for ineffective recall management:
- Outdated software makes it difficult to track product recall management, respond to product recall notices, and communicate recall safety to team members/departments.
- Too many programs hinder effective recall management. Using multiple tools for tracking and responding to safety notices increases misunderstandings and miscommunication between team members/departments. (For example, a pharma company’s compliance department encountering problems when sharing a recall notice with the legal department.)
Investing in new software requires an outlay, and the cost might be difficult for small pharma teams to justify. But using the latest software prevents many of the problems associated with product recall management and provides teams with an investment return. Centralizing recall processes into one system also proves useful. There’s less room for human error, and teams can access compliance information in one place.
Did you know the average number of units for every recalled pharmaceutical product in the United States totaled 311,560 in the second quarter of 2019?
3. Ever-Changing Regulatory Responsibilities
The FDA and other authorities have introduced stringent regulations in recent years for pharma products. Teams might notice that guidelines change quickly. Therefore, many pharma and life sciences organizations find it hard to manage product recalls. Not paying attention to the latest legislation and rules, however, could have enormous ramifications for pharma teams.
The best recall management tools make it easy to track the latest issues facing the pharma industry, with features like auto-reminders that notify teams about the newest legislative and regulatory changes.
The COVID-19 pandemic has brought significant regulatory changes to drug development in the U.S., including enhanced supply chain security and new research and manufacturing strategies. However, many pharma companies struggle to keep up with these changes.
The FDA, for example, has removed some of the “red tape” that hinders pharmaceutical product development to speed up the production of new vaccines, medications, and therapies that fight COVID-19. But this means pharma companies need to understand a raft of new rules and regulations that could affect recalls.
“In expediting development programs, FDA focused on clarifying strategies for product characterization, process validation, scale-up, and ensuring stability,” says PharmTech.
Again, using the latest technologies makes it easy to manage product recalls post-pandemic. Features like real-time reporting and dashboards let teams track and monitor recalls and respond at the right time. Software with collaborative tools, meanwhile, lets different departments in pharma companies control recall management — legal teams, PR teams, manufacturing teams, etc. Using the right program makes it easy to avoid penalties and remove unsafe products from the market quickly.
How Trievr Solves Recall Management Problems for Pharma Teams
Using a tool like Trievr solves the above issues. Trievr is a modern SaaS-based recall management platform for pharma companies that want to centralize product recall information in one place, with features such as product recall templates, auto-alert reminders, collaborative tools, real-time reporting, real-time dashboards, and more. The result? Pharma companies can speed up recall response times, improve communication, and avoid expensive fines for noncompliance. Meet Trievr here.
Before You Go
A lack of proper product recall management puts the public at risk, damages reputations, and increases the likelihood of fines. As the government cracks down on product safety, pharma companies like yours need to implement effective product recall management strategies — or face the unfortunate consequences.
Trievr makes it simple for pharma and life sciences companies to manage product recalls and compliance issues with an all-in-one SaaS solution that speeds up response times. Benefit from product recall management on-demand. Click here for a live demo or contact Trievr to learn more.