FDA’s BeSafeRx Campaign Warns Against Illegal Online Pharmacies

An estimated 30,000 to 40,000 illegal online pharmacies operate at any given time, according to the National Association of Boards of Pharmacy (NABP). The FDA’s BeSafeRx campaign, outlined in the podcast, is striving to educate consumers and healthcare professionals about the dangers of buying medicine from unsafe online pharmacies and how to identify the online pharmacies that are safe.

“Unsafe online pharmacies may sell medicines without requiring a prescription, putting consumers at risk. These websites may sell products that, while being passed off as authentic, may contain too much or too little of the active ingredient, contain the wrong ingredients altogether, or even contain harmful substances,” explained Lysette Deshields, PharmD, JD, a regulatory officer in the Supply Chain Security Branch in the Office of Drug Security, Integrity and Response, Office of Compliance, within the FDA’s Center for Drug Evaluation and Research, and a commander in the Pharmacy category of the Commissioned Corps of the U.S. Public Health Service. “This, of course, can lead to a number of serious and even potentially life-threatening consequences, ranging from ineffective treatment to drug interactions, side effects and dangerous allergic reactions.”

It’s not always easy to spot a fake online pharmacy, Dr. DeShields said. “Criminals can use fake storefronts and other methods to deceive consumers.”

However, there are a few red flags to keep in mind. “Beware of websites that offer deep discounts or prices that seem too good to be true, or websites that send unsolicited mail, email, or other spam offering cheap medicines,” Dr. DeShields said. “You also want to avoid any online pharmacies that are located outside of the United States and those that state their medicines will be shipped from a foreign country.”

If a patient has already ordered from an online pharmacy, Dr. DeShields advised that they check for packaging that is broken or damaged, contains misspellings or is missing an expiration date (or has one that has already expired). “Those are signs that this is a medication that is not FDA approved,” she said.

She also offered four key steps to verify that an online pharmacy is safe:

1. Make sure that it requires a prescription from a licensed healthcare provider.
2. Check that it provides a physical address and telephone number in the United States.
3. Verify that the pharmacy is licensed in the state where it operates as well as the state where the patient is ordering from, if they are different.
4. Confirm that it has a licensed pharmacist on staff to answer patients’ questions.

Several reference sites can take some of the guesswork out of confirming this information.

“A great lookup tool we use and recommend is called ‘Locate a State-Licensed Online Pharmacy,’’’ Dr. DeShields said. “This locator tool allows you to click on a state to check an online pharmacy’s license. If a pharmacy isn’t listed in the database, it shouldn’t be used.”

And even if it is, she added, a user should still confirm the availability of a physical address and phone number in the United States, a licensed pharmacist who will speak with patients, and the requirement for a healthcare provider’s prescription.

Dr. DeShields also advised checking with the NABP’s “Buy Safely” tool to ensure that a website is safe, at https://safe.pharmacy.

“If someone believes they have found a website that may be illegally selling medicines, we encourage them to submit the information through the Report Unlawful Sales webpage available on the FDA website,” she said. “If someone receives a medicine from an online pharmacy and experiences unexpected or serious side effects, they can report that information to FDA using MedWatch, FDA’s medical product safety reporting program.”

The FDA highlighted the risks associated with illegal online pharmacies and the red flags that healthcare professionals should warn their patients about in a recent episode of its “Q&A With FDA” podcast.

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