Current shortages of injectable cancer medications present an opportunity for the introduction of non–Food and Drug Administration (FDA)-approved products into the US drug supply. This could result in serious harm to patients.
In fact, the FDA is aware of sales of unapproved injectable cancer medications directly to clinics in the US. Some medications may already have been administered to patients. A high percentage of the products purchased include sterile injectable medications and medications whose quality could be negatively affected if not transported or stored under precise temperatures.
Examples include unapproved versions of FDA-approved medications such as:
- Faslodex (fulvestrant)
- Neupogen (filgrastim)
- Rituxan (rituximab)
- Herceptin (trastuzumab)
The current shortages of injectable cancer medications are a concern that the FDA is actively engaged in addressing. However, a number of the unapproved medications that have been purchased through direct-to-clinic solicitations are not currently in short supply. FDA-approved versions are readily available from wholesale distributors licensed in the US.
To protect the safety of your patients, the FDA recommends the following steps:
1. Obtain and use only FDA-approved injectable cancer medications purchased directly from the manufacturer or from wholesale distributors licensed in the US. Click here to determine if the wholesale distributor is licensed in the state(s) where it is conducting business.
2. Determine if the medication you have received is FDA-approved by checking the Orange Book or Drugs@FDA.
3. Question whether a price sounds too good to be true. Deep discounts may be offered because the product is stolen, counterfeit, or unapproved.
4. Carefully inspect the product and packaging. Providers should be alert for these signs that the product is not FDA-approved:
- Packaging looks different
- Labeling is not in English
- Dosing recommendations are unfamiliar
- Dosage form or route of administration is different (eg, ampule instead of prefilled syringe)
5. If you receive multiple complaints about the same product, such as a new side effect or lack of therapeutic effect, these may signal a product quality issue.
6. Report product quality issues and adverse events to FDA using the MedWatch system.
7. Report suspicious activity regarding marketing and distribution of unapproved injectable cancer medications to FDA’s Office of Criminal Investigations and click on “Report Suspected Criminal Activity.”
Source: FDA.