Medication Safety
Institute for Safe Medication Practices, Horsham, PA
Over the past couple of years, one of the persistent safety concerns related to medication safety was the growing threat of substandard and falsified drugs. In fact, this topic was in ECRI’s Top 10 Patient Safety Concerns for 2025. This is a safety concern that persists but can be minimized with system and practice changes.
Substandard and falsified drugs (i.e., counterfeit or fake drugs made to resemble genuine pharmaceutical manufacturers’ medications) pose a significant threat to patient safety. For example, medications are increasingly being purchased from unregulated online marketplaces posing as legitimate pharmacies.
Approximately 95% of so-called online pharmacies selling prescription drugs operate illegally. Many illegal online pharmacies may be disguised as Canadian pharmacies providing low-cost medications, making it difficult for patients to tell the difference between a legitimate and a fake website.
Although substandard and falsified medications are often associated with illicit drug use, fake drugs represent a threat to all, from young people seeking help with ADHD to older adult patients looking for the lowest price for their prescriptions.
Potentially lethal ingredients
Substandard and falsified drugs are frequently adulterated with potentially lethal ingredients, including fentanyl, fueling the epidemic of accidental overdose deaths plaguing the United States. The ease of purchasing products through social media has increased fatal overdose risk.
Other harmful substances found in substandard and falsified drugs include rat poison, cement, and heavy metals (e.g., arsenic, mercury). Even when not contaminated with dangerous materials, substandard and falsified drugs often lack the active ingredients to be effective.
Safe practice recommendations
Educate staff about the potential for patients presenting to different health care settings with adverse reactions after knowingly or unknowingly taking substandard and falsified drugs. Monitor patients for unexpected outcomes (e.g., increased adverse effects, medication not working as it previously had) and consider if substandard and falsified medications could be the cause. When reviewing a patient’s medication history, include a scripted open-ended question asking where they obtain their medications.
Share warning signs with patients that may indicate an online pharmacy could be selling substandard and falsified drugs. Refer them to resources such as the FDA BeSafeRx campaign. Educate patients about the National Association of Boards of Pharmacy’s searchable list of accredited digital pharmacies that comply with quality assurance criteria. Encourage patients to check for a licensed pharmacist’s availability at any online pharmacy they are considering, which can help determine the pharmacy’s legitimacy.
Inform patients that when a pharmacy does not require a provider’s prescription to dispense a prescription medication, or when a provider issues a prescription without an online or in-person visit, the facility is likely illegal and unsafe.
Advise patients to review medication packages and labeling for spelling errors, which are common on counterfeit products. Inform patients that, although manufacturers may change products or pharmacies may provide different generic products, any concerns about differences in a medication’s size, color, or shape should be treated with caution.
Ensure the drug description on the pharmacy label matches that of the drug inside the container. Explain to patients that legitimate medications will have a factory-made appearance. Patients should be suspicious if tablets are cracked, have a bubbled-up coating, are crumbly or moldy, or come in jars containing excess powders or crystals. If the original manufacturer’s packaging has been opened, has a broken seal, appears to have been tampered with, comes in different packaging, has no packaging, is missing the label, or just does not look right, patients should check with a health care provider before taking the medication.
Practitioners can help patients by also sharing resources from government agencies that offer information to combat substandard and falsified drugs, such as CDC and FDA. ■