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 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.”
Report through MedWatch. FDA receives drug quality reports through its MedWatch Program. MedWatch FDA Form 3500 is used for product quality reports. This form is also used to report adverse events (unexpected side effects) that occur while using FDA-regulated products such as prescription and over-the counter drugs, medical devices, and special nutritional products such as dietary supplements.
Be assured that reporting is confidential and secure. Your information is confidential. Health care professionals are sometimes afraid to make the reports, according to Johnson. “If an adverse event is possibly associated with product quality, health care professionals sometimes worry that they will be singled out," Johnson says. "But if a reporter chooses not to have his or her identity disclosed, the reporter will remain anonymous; their name and contact information will not be released to anyone outside of FDA without their permission.”