Know Your Source: Protect Your Patients and Your Practice from Unsafe Medications

Susan Marr, MSA, LHRM, CPHRM, Senior Patient Safety Risk Manager, The Doctors Company

The U.S. has one of the safest drug and medication supply systems in the world, in part due to careful regulation in the face of globalization and increasing threats to the supply chain. However, according to the FDA, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market. To combat this threat, the FDA has launched the Know Your Source campaign to ensure physicians are aware of the problem and to help them play their part in protecting the integrity of the U.S. drug supply chain. In addition, the FDA is participating in a collaborative initiative targeting drug safety on a global level.

Dangerous Drugs in the Supply System

How real is the threat? There have already been cases where adulterated, diverted, stolen, unapproved, or counterfeit drugs made their way into the American drug supply system. Counterfeit Avastin made it into the U.S. in 2012. Altuzan, a non-FDA-approved drug equivalent to Avastin but only approved to be sold in Turkey, arrived in the country in a counterfeit form in 2013. In 2012 and 2015, counterfeit Botox was found in the U.S. The FDA has indicated that anti-depressants, hormone replacement therapies, sleep aids, cholesterol medications, and seizure medications are reaching the U.S. as well.

What does this mean for patients? They may receive a medication containing harmful ingredients or they may receive medications containing no active ingredients at all. Issues include the purity of the medication, whether harmful ingredients have been added, or whether it contains active ingredients. In addition, many drugs must be stored and transported within specific temperature guidelines in order to maintain effectiveness—and rogue distributors do not follow these precautions.

In certain parts of the world, counterfeit or substandard anti-malarial drugs constitute one-third of the supply. The result is a malaria patient population that may not be receiving lifesaving treatment. Additionally, the counterfeit drug creates a situation in which the parasites become resistant to the real medications. Fortunately, the FDA has found a solution to this problem and is sharing that solution globally.

Guide Patients to Safe Websites

Rogue distributors have expanded their efforts to advertise FDA-approved prescription drugs on unofficial websites with familiar-sounding names. The clear intent is to fool patients into thinking they are dealing with trusted entities. In addition to health risks, patients who order from these websites are at risk of credit card fraud and identify theft.

Commonly ordered medications on these sites are:

  • Avandaryl (a non-FDA-approved Glimepiride).
  • Non-FDA-approved Generic Celebrex.
  • Levitra Super Force, a non-FDA-approved medication to treat erectile dysfunction.

The FDA has cooperated with Interpol to place a warning on such sites, but physicians are encouraged to educate their patients about the risks of these websites. Direct patients to the FDA’s resource for safe pharmacies: BeSafeRx: Know Your Online Pharmacy.

What Doctors Should Do

Which doctors are the main targets? While any specialty could be at risk, most of the counterfeit drugs in the U.S. targeted to physicians are expensive medicines, and the targeted specialties are often oncology, dermatology, plastic surgery, and dentistry.

Regardless of your specialty, these tips can help ensure that your practice is ordering safe medications:

  • In situations where there is a medication in short supply, the FDA may authorize limited importation of such medications from approved international suppliers. When that occurs, information will be available on the FDA drug shortages website.
  • Beware of e-mail blasts and faxes that advertise the option of buying expensive medications at a discount. Remember the adage, “If it sounds too good to be true, it probably is.”
  • Emphasize to staff, especially those in charge of ordering medications for patients, that it is illegal and ill-advised to buy medications and drugs from outside the U.S. The FDA is often aware of practices that order drugs from outside the U.S. and may initiate contact with the practice in order to educate employees. The FDA’s involvement may also trigger contact from a state’s Board of Medicine.
  • “Know Your Source” means know that a supplier of drugs and medications is legitimate. Practices can verify this through the FDA. Select a state and click on the link to the agency that can verify that the supplier is legitimate. Once you’ve verified a supplier, rechecking once a year is sufficient—as long as there are no changes in the name, address, and other information from the supplier.
  • Keep the “pedigree sheets” that are shipped with the product. Under federal law, they should contain:
    • Proprietary and established name of the drug.
    • Dosage.
    • Container size.
    • Number of containers.
    • Lot or control numbers.
    • Business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer.
    • The date of each prior transaction.
  • Keep a log of drugs and medicines ordered, the supplier information, and when the legitimacy of the supplier was checked.
  • Be sensitive to any complaints by patients that might indicate there is a problem with the integrity of a product.

The FDA also has extensive information on its website about protecting the U.S. drug supply chain.

The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.


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