Thoughts on Zicam: How to Best Handle Adverse Event Reporting

Today, FDA warned consumers to stop using Zicam intranasal medications, for fear that they could lead to a loss of smell in those who take them. We sought some expertise as to how Matrixx Initiatives might have averted this situation, and what companies can do to better track adverse events in patients. Chris Huang, senior product manager and drug safety guru at Sparta Systems, volunteers a few opinions:

 

PhM: Based upon what we know about Zicam, how do you think that the product passed quality and regulatory muster?

Huang: These issues didn’t appear all at once but gradually – the FDA has received reports of loss of smell associated with the products since 1999. My guess is that the incidents were isolated enough so that they didn’t warrant a recall at first, but that there may have been a greater number of recent incidents that ultimately resulted in the agency taking a closer look and deciding to finally issue the recall.

PhM: Should there have been additional QC done? (That is, how could this have been prevented?)

Huang: It’s possible, but I don’t have enough knowledge about the specific Zicam situation to comment on whether or not this is something that could have been caught in the manufacturing process. Regardless, companies need to have closed loop processes in place to handle customer complaints and report adverse events so an event of this scale does not occur again in the future.

PhM: What can companies do to further enhance their product knowledge and quality management programs?

Huang: Pharma companies are facing longer supply chains and are sourcing ingredients from more locations and suppliers than ever before. Managing the quality of these ingredients and grading the overall operations of their suppliers in terms of the risk they pose is vital to ensuring the safety of the finished product. Generally speaking, companies can implement supplier quality management processes that will enable them to evaluate their suppliers using a risk-based model, so that the ingredients they’re sourcing end up posing as little risk as possible to the finished product and, as a result, to the consumer.

PhM: How can other incidents like this be avoided?

Huang: From our perspective, it calls for centralized management of quality processes regardless of regulatory oversight, as this is not always enough to guarantee that the finished product won’t face quality issues. The key is proactive management of all quality processes, including corrective and preventative actions (CAPAs), deviations, customer complaint handling and adverse event reporting. When all these systems are being hosted from a centralized location within the organization, companies are better equipped to identify and manage quality issues long before the finished product reaches store shelves.

PhM: How should companies like Matrixx manage adverse events so that they can anticipate situations like this, and deal with them better when they arise?

Huang: This should mainly be done by implementing escalation procedures within the organization so that when an adverse event does appear in the manufacturing process the right people are notified at the right time. When this is implemented correctly, adverse events are reported effectively and resolved early on in the process so as not to impact the development of the product when it is too late.  

--PWT