The pharma industry continues to experience a rise in recalls, despite a heightened awareness of patient safety that FDA and industry managers have exerted in recent years. According to the ExpertRECALL Quarterly Index, 107 drug and pharmaceutical recalls were documented in the first quarter of 2013, an increase of 32% from the previous quarter and higher than the average number of events last year. In addition to the increase in recalls generally, the number of Class I recalls of prescription drugs doubled from the previous quarter.

Pharma companies know that with increasingly complex supply chains, it’s not a matter of if they face a recall, it’s when. In addition, the ever-changing regulatory landscape and threat of litigation are making recalls more multifaceted and, if mismanaged, more costly every day. That’s why next week, hundreds of industry professionals will gather at the second annual CBI Bio/Pharmaceutical and Medical Device Midwest Product Recalls Summit on June 11 and 12 in Indianapolis, to dive deep into preparation and communication strategies for the efficient and compliant execution of product recalls, including conducting mock recalls. Whether you’re attending or not, below are some key points to consider to protect the public and maintain trust in your brand in the event of a recall.

Whether a drug recall involves danger to public health and safety, or simply a point-of-purchase labeling error, speed is a critical component to maintain public trust. In order to move quickly and with accuracy, companies should prepare a comprehensive recall plan in advance that takes into account the company’s corporate structure (supply chain operations, distribution centers, retailers, consumer consignees, etc.) and designates a recall coordinator and a recall management team. The plan should also identify responsibilities and processes for regulatory agency notification, internal recall team, establish communication guidelines and define a policy for closing out a recall.

One of the most important aspects to consider in advance of a recall is customer communication. Drug and pharma product recalls can create significant concern, particularly when children or the elderly are affected. In order to calm a concerned customer, companies must communicate with their stakeholders in the most effective and efficient ways. When addressing health concerns, it’s critical to provide a “human touch,” with call centers available to reassure consumers and provide accurate, up-to-date information. Companies should also consider effectively preparing their websites for a high volume of hits to ensure consumers are never in the dark.

With the threat of class action litigation after major drug recalls, companies must also consider how they will track, process and store recalled products in a way that complies with FDA and other federal regulations. Sometimes, a company must store drugs for years because of the threat of litigation, tying up valuable warehouse space. In addition, special attention must be given to storing drugs classified as narcotics, which demand a reinforced, secured storage facility as well as a staff with the proper clearances to handle the drugs.
 
The best way to test the thoroughness of a recall plan is to host a mock recall simulation. A mock recall can help identify any holes or problems with a recall plan before a company is forced to put it in motion, allowing recall teams to make improvements where necessary. Involving your suppliers ensures that the recall plan is prepared and tested on every level of the supply chain, from initial material sourcing to the final product on store shelves. Also, regularly testing the recall plan allows a company to continuously update and improve its practices, incorporating newer strategies and technologies.

When planning a recall simulation, your organization should address the following eight questions:

1. Does upper management fully support and encourage recall preparation?
2. Do you have a recall coordinator and team in place? If so, is each member fully aware of his or her responsibilities?
3. Have third-party allies been identified and are they on board to assist as needed with legal, medical, laboratory, communications and logistics issues?
4. What are your company’s most likely recall scenarios?
5. What unforeseen challenges might arise during your company’s most likely recall scenarios?
6. Are communications directives and systems in place?
7. Are you prepared to handle notifications, customer responses, product returns, storage and disposition, effectiveness checks, termination requests, and maintaining all this data for several years?
8. Do you have a means by which to collect data and run reports throughout each step of the recall process?

Working through these questions will help to guide the simulation, guaranteeing that the mock recall is as realistic as possible. By conducting a realistic simulation, you can be confident that you are testing your recall plan to the fullest extent and that when the inevitable occurs, you’ll be ready.

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Mike Rozembajgier is vice president of Recalls for Stericycle ExpertRECALL. Mr. Rozembajgier is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives and product enhancements. He has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL, Mr. Rozembajgier held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.