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Reporting Drug Quality Problems

Would you know what to do if your medication didn't seem right? What if it were discolored, chipped, or labeled with the incorrect product name? These are examples of drug quality problems that should be reported to the Food and Drug Administration's (FDA) Drug Quality Reporting System (DQRS).

FDA created the system in 1971 to minimize consumer exposure to unsafe, ineffective, and poor quality drugs. Reporting drug quality problems is voluntary, but essential.

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“One DQRS report can lead to a drug recall,” says Jay Schmid, DQRS Team Leader in FDA's Division of Compliance Risk Management and Surveillance. Drug quality reports help identify trends and can lead to several types of FDA actions:

  • drug recalls
  • drug safety alerts
  • product label changes
  • seizure of products
  • repackaging or reformulation of products

Types of Quality Problems

Here are some of the primary reasons for DQRS reports:

  • suspected mislabeled drugs
  • inaccurate or unreadable product labels/labeling (including the package insert)
  • packaging that is torn or punctured
  • sterile containers or vials that are punctured or leaking
  • packaging or product mix-ups
  • abnormal odor or taste
  • capsule leakage
  • chipped, cracked, or splitting tablets
  • tablet or capsule discolorations
  • broken, cracked, or chipped syringes
  • suspected product contamination
  • sterile syringes with floating objects or growth
  • vials with foreign floating objects or growth
  • container closure defects
  • leaking vials

“We review and triage reports as soon as we get them,” says Capt. Juliaette Johnson, DQRS program manager at FDA. The reports can fall into three priority classifications depending on the severity of the problem. Reports are classified as

  • Priority 1- Imminent or serious health hazard
  • Priority 2- Potentially significant manufacturing problem
  • Priority 3- Routine follow-up

Priority 1 and 2 reports are sent to the appropriate FDA offices and divisions for immediate follow-up recommendations and investigation.  “Not all reports need an immediate follow-up,” says Johnson.

Tips for Reporting

Consumers and health care professionals can report drug quality problems. “We encourage consumers to contact their pharmacists first if they have drug quality concerns or complaints,” says Johnson. “This allows for a screening process. Pharmacists can provide essential information regarding the product and the product labeling.”

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