Following the arrest of several medical professionals, the Physicians Coalition for Injectable Safety (PCIS) is urging physicians to avoid the use of and report solicitation of non-FDA approved injectables. According to the PCIS, as of August 2009 five physicians, one nurse and one practice manager from a New Jersey-based medical practice are facing fines and jail time for charges stemming from the use of non-FDA approved fillers purchased through an online pharmacy.
“Physicians fax machines and email accounts are filled with offers to buy offshore or unbranded, cheaper injectables,” said coalition leader Mark L. Jewell, MD of Eugene, Oregon. “Buying from such sources is not a naïve or innocuous act…It’s a dangerous act that can cause unexpected adverse events, and ultimately land the physician in prison.”
Warning signs of counterfeit products include:
• Misspelled brand names, unknown or unfamiliar names, or catchy marketing names
• Generic packaging that does not include serial and lot numbers for injectables that correspond to serial and lot numbers on the actual vials and syringes
• A lack of trademarks and identifying holograms
• Logos, type and packaging that are inconsistent with those of FDA-approved injectables
Physicians can visit the PCIS website at www.injectablesafety.org to review logos, packaging, brand names and other identifiers for approved products, as well as a list of all legal distributors for all currently FDA-approved injectable brands. If you have come across a suspicious product or supplier, information on reporting a suspected crime can be found on the FDA website at www.fda.gov/consumer/updates/oci072307.html.
Inga Hansen, executive editor