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.
Whether it’s because of the flu or seasonal allergies, diabetes or epilepsy, pregnant women must often take prescription medication—usually while worrying about the potential impact on their developing babies.
With studies showing the average woman takes from three to five medications while pregnant, the Food and Drug Administration (FDA) encourages drug makers and moms-to-be to participate in pregnancy registry studies that track the risks from drugs taken during pregnancy or breastfeeding.
“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 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
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
“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.”