by 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.
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:
- 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.
- 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.
Contributed by The Doctors Company. For more patient safety articles and practice tips, visit www.thedoctors.com/patientsafety.