FDA Plans to Track Drugs and Stymie Counterfeiters

The US Food and Drug Administration (FDA) has started planning the implementation of the new federal Drug Quality and Security Act, laying the groundwork for an eventual medication-tracking system to counter drug diversion and counterfeiting, a problem that has been growing due to recurring international drug shortages in recent years.

The law, signed by President Obama in November 2013, has made headlines because of its new voluntary registration and regulation system for drug-compounding facilities. The registration system was prompted by a deadly 2012 outbreak of fungal meningitis associated with tainted steroids.

Related: Drug Shortage Crisis is Easing, but Underlying Problems Persist

Since the law is new, regulations to implement it are still being worked out. At a December 2013 press conference, FDA officials admitted to not being sure how many drug-compounding facilities are operating in the United States, and that it was not yet clear just how the new law applies to biolologics.

However, the new law does clearly require the development of a national drug-tracking system—an attempt by Congress to counter the increasing reports of counterfeit and diverted drugs, and the “gray market” in diverted medications.¹ Some hospitals and clinics, facing recent drug shortages, have turned to new middle-men brokers; this factor increases the risk that counterfeit or unsafe drugs will be administered to patients, according to FDA officials.

Counterfeiting is not the only concern. Complex ingredient and finished-drug supply chains between manufacturers, distributors, outsourcing facilities and repackagers, as well as pharmacies, provide ample opportunity for drug theft or diversion and resale; furthermore, diverted drugs are not always stored or transported under appropriate temperatures or conditions, the agency noted.²

“Deep discounts may be offered because the product is stolen, counterfeit, substandard, or unapproved,” cautioned the FDA.³

In 2007, the FDA’s Office of Criminal Investigations reported 31 new counterfeit drug cases. By 2010, the number of new investigations had climbed steadily to 72.² In 2012 and 2013, the FDA announced that counterfeit bevacizumab (Avastin®) was circulating in the United States.³

Related: FDA Warns of Counterfeit Avastin (Bevacizumab), Issues Letters to 19 Medical Practices

Counterfeits or altered medications can be diluted or inert, denying patients the therapeutic benefits. But they can also be downright dangerous. In China, off-label use of what turned out to be counterfeit bevacizumab as a treatment for neovascular macular degeneration was implicated in an outbreak of acute ocular inflammation in 80 patients in 2010.⁴

Drug-tracking “pedigree” laws already exist in some states, but this patchwork of state laws will be replaced by the planned federal drug-tracking system. By 2018, FDA officials explained that the agency will require manufacturers and repackagers nationwide to affix unique product identifiers to each medication package, carrying that drug’s National Drug Code (NDC), a serial number, lot number, and expiration date. By 2020, wholesalers and pharmacies will be restricted to distributing only medications carrying unique product identifiers. According to the agency’s timeline, by late 2023, a national digital system will exist to provide real-time product and transaction histories for individual drug packages—a true digital pedigree for each vial of medication.

Meanwhile, however, it falls to health care professionals to maintain vigilance against administering dangerous and ineffective drugs to patients. (See Box.)

How to Spot Counterfeit Drugs To minimize the risk of disseminating counterfeit, contaminated, or improperly stored medications, the FDA advises health care professionals to be wary “if the price of a medicine sounds too good to be true.”3 The FDA advises that health care professionals also: Carefully inspect product packaging and look for the following red flags: Medicine has a different name than that ordered Label or packaging looks new or different from what you usually see Portions, or all, of the label are not in English Dosing recommendations are different or unfamiliar Dosage form or route of administration is different (eg, ampule instead of prefilled syringe) The product does not display a National Drug Code (NDC) number Determine if the medicine is FDA-approved (check the Orange Book or [email protected]) Be vigilant to new side effects or a lack of therapeutic effect, and report product quality issues and adverse events to the FDA using MedWatch. Fill out a report online: www.fda.gov/MedWatch/report.htm. Alternatively, call 1-800-332-1088 or download a report form and fax the completed report to 1-800-FDA-0178.

For more FDA information about counterfeit medications, see: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/default.htm

References

1. Furlow B. Drug shortage crisis is easing, but underlying problems persist. Chemotherapy Advisor. September 13, 2012. https://www.cancertherapyadvisor.com/home/cancer-topics/general-oncology/drug-shortage-crisis-is-easing-but-underlying-problems-persist/. Accessed January 3, 2014.
2. Bernstein IBG. FDA efforts: counterfeit drugs. Office of Compliance, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA). 2012. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm299777.pdf. Accessed January 3, 2014.
3. US Food and Drug Administration. Health care provider alert: Another counterfeit cancer medicine found in United States. 2013. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/
   CounterfeitMedicine/ucm338283.htm. Accessed January 3, 2014.
4. Sun X, Xu X, Zhang X. Counterfeit bevacizumab and endophthalmitis. N Engl J Med. 2011;365(4):378-379.