How to prepare and manage pharmaceutical recalls during the busiest time of year.
In the 2015 calendar year, there was an influx of the number of drugs that were recalled—many of which were amidst the holiday season. These recalls can be disastrous throughout the year, but can be even more so around the holidays.
According to one source, “[m]anufacturing defects account for the majority of recalls.” These defects can occur when something goes wrong during the manufacturing process, “such as when a batch of drugs produced at a facility deviates from their proper design specifications, or the drugs are adulterated or contaminated with other substances.”
Kevin Pollack—Vice President of Stericycle ExpertSOLUTIONS, a firm that handles product recalls—participated in a Q&A about what manufacturers can do to prepare for the busiest time of the year and protect themselves from a recall crisis taking place during the holiday season.
Q: Compared to the rest of the year, how many pharmaceutical recalls have been known to happen around the holiday season?
Pollack: Pharmaceutical recalls do not significantly increase—or decrease—around the holidays. However, at this time of year, many people are especially busy with gift giving, family gatherings, and office parties—making them even less aware of recalls than usual. This is in addition to the year end or close of quarter reporting that companies are focused on. Companies need to keep this in mind when facing recalls around the holiday season.
Q: What are some of the ways that manufacturers can better prepare for the holiday season?
Pollack: The most important step a manufacturer can take to prepare for the holidays is to develop a recall plan. Thousands of companies are impacted by recalls each year. Without an appropriate plan, expertise, and systems in place, a recall can cause irreparable brand damage to these companies, no matter the time of year. Secondly, it is crucial that predetermined recall team members are ready to enact a recall plan if and when necessary. Conducting a dry run of a recall helps educate these individuals on how to best handle and communicate during a crisis before it becomes an imminent matter.
A few procedures found in a recall plan include:
- Notifying affected consumers
- Establishing a recall-focused website
- Retrieving and processing the affected product
- Storing and/or destroying the product
Any and all recall data should be collected in a central repository to ensure complex regulatory compliance and reporting needs are satisfied as well. This can be an incredibly difficult task and working with a recall expert to execute the plan can help ensure all benchmarks are met. If a recall strikes during the holidays, manufacturers that have a recall readiness plan in place will be well equipped to handle the situation.
Q: Should a crisis happen, what is one of the first things that a manufacturer or professional in the pharmaceutical field should see to?
Pollack: Manufacturers should take a step back and evaluate how the recall fits into their planned recall strategy. Consider whether or not the recall can be managed with said plan. Likewise, gauge resource availability and determine whether or not outside support is necessary. The next steps include quickly notifying all affected consumers and relevant stakeholders, removing the product from the marketplace, and ensuring compliant transportation, storage, and eventual destruction methods.
Q: What are some of the key mistakes pharmaceutical manufacturers make in the face of a recall?
Pollack: Many manufacturers choose to not work with a recall expert capable of successfully navigating crises. During a recall, manufacturers tend underestimate the time and effort required to execute an effective recall plan, and working with a third-party partner can help alleviate any challenges and ensure effective management of any recall scenario.
Q: Where, would you say, is there room for improvement in recall readiness? How can manufacturers best improve this?
Pollack: Pharmaceutical recalls continue to rise, with 79 percent of them affecting the entire nation. Therefore, it is increasingly important for manufacturers to have a recall plan in place. Facilitate an environment of open, transparent communication between the company, manufacturers, stakeholders, and consumers. In addition, practicing the recall plan in regular, contained mock scenarios will ensure optimal recall preparedness.
Q: Where are pharmaceutical manufacturers often very strong in their recall readiness? Why do you think that is?
Pollack: Due to the pharmaceutical industry growing increasingly global, supply chain managers have become more proficient in streamlining the supply chain. This change in commerce has enabled manufacturers to locate the source of a recall and take appropriate action to protect the public quicker than ever before.
Q: What do you see for the future of pharmaceutical recalls?
Pollack: As the FDA continues to pass stricter laws, the likelihood of future pharmaceutical recalls will naturally increase. Recalls will likely become more complex as drugs increasingly cross international borders. During Q2 of 2015 there were 78 pharmaceutical recalls—a 77 percent increase over the previous quarter. The amount of affected units is also on the rise, strengthening the case for why manufacturers should maintain a recall plan.