Thought Leadership

A recent survey found that pharmaceutical recalls are among the types consumers consider most important – the ones most likely to catch their attention. With that kind of interest, it is vital for companies to execute recalls effectively and compliantly. And the key steps for managing pharmaceutical recalls are as complex as the regulations that govern them.

How to quickly locate and remove a recalled product Test your recall procedures with mock recalls Determine dangerous vs. defective recall products When President Barack Obama signed the 21st Century Cures Act into law in December 2016, he

It’s budgeting season, and most leaders are hoping and planning for a banner year. New product developments. Innovative strategies. Expanded market share. Everyone hopes they will avoid any sort of crisis in the coming year, and as a result, few plan for one. But one of the most disruptive crises medical device and pharmaceutical companies will face is also among the most likely – product recalls. Consider this: Through Q3 2017, 144 companies experienced more than one pharmaceutical or medical device recall.

Pharmaceutical recall activity saw a disturbing rise not only in the volume of products recalled last quarter, but also in the severity of risk to consumers, according to the Q2 2017 Recall Index. Pharmaceutical recalls increased 6 percent over the previous quarter to 86. More jarring, the volume of recalled drug units circulating in homes and store shelves climbed 444 percent over the previous quarter, making it the most active quarter since Q4 2014.

When it comes to pharmaceutical recalls, those at the patient level are often very different from those that only affect hospitals, clinics, and other providers. First, there is the challenge of effectively notifying patients. For prescription drugs, the manufacturer typically notifies pharmacies, who then contact patients. Over-the-counter (OTC) medications usually leave no way of contacting the consumer directly, although there are some exceptions, such as retailer loyalty programs.