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COVID-19: Handling SAEs in the era of the biggest social adverse event

Despite the FDA pulling back from in-facility inspections, and your own company personnel possibly working from home, you are still responsible for filing adverse events records for supplements.

Business marches on—even when it doesn’t. That means that even if your lead QA/QC person is working from home, and even if most other staff is not in the facility, supplement companies still must abide by the governing regulations around properly accounting for serious adverse events (SAEs) filed by consumers.

“You can’t lose sight of obligations under the FDA to protect the consumer,” said Tamika Cathey, independent consultant with EAS, which consults on FDA regulatory matters. “Serious adverse events must be submitted within 15 days of the SAE.”

According to 21 CFR 111.7, the federal bylaw covering SAEs, an adverse event is any health-related event associated with the use of a dietary supplement. A serious adverse event is an adverse event that results in death, a life-threatening experience, an in-patient hospitalization, a significant disability or a birth defect. These SAEs require a medical or surgical intervention to treat the event. Examples of specific SAEs include vomiting, diarrhea, low blood pressure, wheezing, rash, itching, fatigue, appetite loss and more.

Even before the coronavirus hit, records must be maintained for six years—even including discontinued SKUs—and must be available during inspections.

Now that the pandemic has resulted in the FDA announcing it is otherwise engaged and not looking to conduct nearly the number of in-facility inspections, and even with support staff potentially out of office, the rules still apply, according to Cathey.

“The first step to mitigate this challenge,” said Cathey, “is to assess the current system to ensure a written complaint handling procedure is in place per 21 CRF 111.553.”

The procedures should include the basic elements of:

  • Instructions on the pathway or process flow of how product complaints will be handled from intake to closure.
  • Identifying the person responsible for evaluating and reviewing product complaints for escalation and investigation. If the lead person within the quality department is out, a secondary person should be used—and in fact should already be part of any company’s SOPs.
  • The quality control personnel should have authority to review and approve decisions.
  • Instructions on how to ensure a record retention system, such as paper or electronic, for SAEs and complaints.

“Now, more firms are working remotely,” said Cathey. “It is important to ensure that a secure, electronic repository is used to house written procedures, a complaint file, SAEs and any regulatory correspondence if applicable.”

Common electronic repositories include Dropbox, Google Docs and SharePoint. Even Word or Excl files work but are not usually as secure as a Dropbox file.

“Data stored in electronic repositories are temporary,” she noted. “Re-integration of these records into normal record retention process much be considered once post-pandemic operations resume.”

The basic steps to complaint handing include intake, investigation and closing the file.

“The complaint intake is one of the most critical steps in assessing a product complaint because information is key,” said Cathey. “Probing and cascading questions during the initial intake process can assist firms to make concise, informed decisions on how to properly route, handle and trend product complaints in a timely manner.”

When short-staffed, it’s important to make a note that there have been business limitations due to Covid-19 in records. These roadblocks can affect the level of investigation.

Some solutions to roadblocks include collaborating with technical experts, taking a post-market surveillance of similar products to see if there are similar complaints with what’s already on the market, reviewing the scientific literature—even looking at social media and patient blogs to see if similar complaints have been cropping up.

“These are tools to come up with a scientific rationale, and you can use these solutions to come up with a scientific rationale,” said Cathey, “but it’s still important to state that you had to use these solutions because you had limited personnel due to covid-19.”

 

TAGS: Supplements
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