There’s no doubt the COVID-19 pandemic has heightened everyone’s concern about safety.
Everywhere you look along the pharmaceutical and medical-device supply chain, workers are wearing disposable rubber gloves and protective facemasks. Workers frequently and carefully wash hands and make liberal use of hand-sanitizer. At the slightest sign of cold or flu symptoms, employees are encouraged to go home to recover.
That includes everyone at Stericycle. When we go in to help manage even the most routine pharmaceutical recall, we go in wearing rubber gloves and protective gear. But these aren’t new steps we’re taking. And we’d venture to say that they aren’t entirely new for pharmaceutical, medical device or healthcare companies either. We’re just more mindful of it now.
In fact, nearly all the companies we work with are taking strict precautions. But they aren’t stopping there. Companies are reassuring business partners, customers and consumers that appropriate safeguards are in place with regular email and social media updates.
When it comes to strict manufacturing practices, quality and safety protocols, and minimizing health risks, the pharmaceutical industry may be the most well-equipped to respond to the types of challenges presented by the coronavirus pandemic. After all, understanding the cause and progression of illness, finding treatments and vaccines, identifying and communicating about potential health effects and complications, and preventing adverse health events are all business-as-usual activities for them.
That’s for good reason. The reassurance in and of itself has power to protect brands and build goodwill in this environment of uncertainty. It also has the added benefit of serving as a reminder to everyone in supply chain that safety and diligence are important and that preventive measures are in place up and down the supply chain.
But here’s the challenge facing the industry. Doing everything you can in good faith to prevent the spread of COVID-19 could inadvertently open the door to more recalls and regulatory enforcement down the road. Why?
Because it’s a perfect storm of risks.
Most Recalls Totally Unrelated to COVID-19
Before considering the impact of COVID-19 on the industry, it’s important to set the stage. Start with the fact that inconsistency in Current Good Manufacturing Practices (cGMP deviations) has been the top reason for pharmaceutical recalls for the last four quarters. In fact, cGMP deviations accounted for 26.9% of all recalls and 55% of all recalled units in the first quarter of this year. This includes at least 14 recalls linked to NDMA impurities – another hot topic when it comes to regulatory enforcement and product safety risks.
If these types of issues are a constant threat during “normal” times, when on-site audits and inspections by internal staff and outside regulators happen regularly, we can only expect the risk of a slip in good manufacturing practices to increase in this current environment. That brings us to the next threat.
Regulatory Inspections and Enforcement Actions Are Limited
Current oversight activities are significantly limited. This is in part a result of the significant decrease in on-site inspections and the limitations of paper-based audits. Add to that the impact of enforcement discretion and emergency authorizations.
As regulators and the entire healthcare industry – from pharmaceutical and medical device manufacturers to frontline medical professionals – take an all-hands-on-deck approach to pandemic response, other activities are being delayed if they even happen at all. For example, the FDA may give more consideration to the risk-benefit analysis in the immediate short term, and temporary permissions are being granted for why and how drugs and devices can be used.
These activities are being conducted in good faith by all parties during a global crisis, but the FDA maintains the right to reverse course later once the enforcement discretion and emergency authorizations are lifted – likely by publicly demanding more detailed information about your product.
Add to that the recent publicity from Bloomberg Law that the FDA is allowing overseas pharmaceutical plants “with checkered safety and quality records" to make medicine for American consumers. Some of the agency’s first stops during an on-site inspection tour could be these overseas manufacturers who have a history of violations but have stepped in to prevent or lessen product shortages. In some cases, these companies may be the API manufacturers that were under scrutiny before this outbreak started.
So until FDA inspectors can get back on the road, we may see a slight dip in recalls and other enforcement activity. But keep in mind that could change once regulatory staff start catching up with the backlog of inspections and have more time to proactively inquire about products that may have been granted permission for new or different uses under emergency authorizations.
The Trifecta of Supply, Demand and Workforce Challenges
Managing global pharmaceutical supply chains has always been a challenging endeavor. But the risks and challenges are even greater as demand evolves, shortages occur, and your facilities are unable operate in a business-as-usual fashion. Production of most pharmaceutical products is in overdrive right now. In some cases, supply chains are working overtime to make up for any shortages.
Throw in the prolonged stress and pressure felt by individuals up and down your organization, and the harsh reality is that mistakes are much more likely to occur.
Knowing that, take extra care to identify vulnerabilities and assess potential risks. Pinpoint possible missteps that could cause a slip in quality or potential contamination and implement additional measures to prevent them. But also realize reputational risks aren’t exclusively tied to your quality and safety departments. Is your sales team adequately prepared to work with retailers and business partners and do they have answers to tough questions about product sourcing and safety procedures? Can your customer service team handle consumer call volume?
One significant recall could have a profound impact on consumer health, which places added pressure on regulators and companies to effectively manage the event. The challenge facing the company is even greater if the quality-assurance team is forced to work remotely. But if a recall of an in-demand pharmaceutical product does occur, it could put further strain on the supply chain and create a product shortage.
Increased Pressure to Get it Right
Not only are the business and operational challenges greater as a result of COVID-19, but the risk of damage to your brand is elevated if your response to safety issues is perceived as falling short.
It comes back to where we started. The “over-communication” that’s occurring now across industries must be continued. At the same time, the personal stress, frustration, and fatigue experienced by individuals everywhere must be carefully monitored and managed because they indicate potential problems. Whether you want to take a new product to market or warn about a safety issue, it will be exponentially harder to break through the noise and ensure your messages reach the doctors, nurses, medical professions, patients and consumers. You’ll need to be persistent.
When it comes to recalls, that means posting additional notifications on social media, and making extra outreach to share any over-the-counter or prescription drug news with consumer media. It also means taking extra care to work with retailers and pharmacies to get products off shelves and to be ready to manage news media inquiries.
But keep in mind that a silver lining exists in all of this. Pharmaceutical companies, known by critics as “Big Pharma,” have long been a target of consumer activists, plaintiffs’ attorneys and even the news media. But those companies that deliver safe, effective vaccines and medicines in a timely manner during this urgent moment of need are likely to emerge as heroes.
Well-managed companies with the resources and capacity to respond to the challenge of researching, testing, and delivering effective treatment and vaccines are doing just that. Those developments will bring with them a sense of calm and normalcy that consumers want.
There has never been a more important time to prepare for a product safety crisis. This is particularly true given the global nature of supply chains and the fact that your own quality and safety professionals often cannot travel freely to be present on a supplier’s production floor. The simple fact remains that it’s significantly harder to ensure the safety of the product being produced under current circumstances.
That means doubling down on efforts to secure your supply chain, ensure regulatory compliance, taking care of your workers, and providing for patients the very best way you can.
And when a new challenge comes your way, communicate like the future of your company depends on it. Because it does.