As a result of the recent outbreak of fungal meningitis cases, practitioners and patients across the nation have become aware of the risks inherent in purchasing drugs from vendors who are potentially unsafe. This meningitis outbreak has required significant time and effort on the part of physicians, facilities, and their staff members in tracking and treating the patients who were, or potentially could be, affected by these drugs. The purpose of this article is to address concerns about purchasing drugs from ‘unregulated’ sources.
The Food, Drug & Cosmetic Act (FDCA) gives the U.S. Food and Drug Administration (FDA) the authority to supervise the safety of food, drugs, and cosmetics in the United States. The FDCA’s oversight on medications includes their manufacture, processing, labeling, and distribution. FDCA regulations prohibit the sale of drugs which are not approved by the FDA. The drugs purchased from ‘unregulated sources’ have not been subjected to testing and research by the FDA before they are marketed in the United States. As such, these drugs run a high risk of being tainted, counterfeit, or even contaminated.
Drug contamination is one of the main risks when purchasing drugs from ‘unregulated sources’ as such drugs can cause serious patient harm, even death. However, drug contamination is not the only risk to consider. When buying drugs from a disreputable seller, a practitioner or facility could also find they have purchased counterfeit drugs. These are carefully made up pills, capsules, and vials that look like their approved counterpart. The counterfeit drug, however, does not contain the actual drug in appropriate form or dosage.
The use of drugs obtained from unapproved foreign sources also exposes patients to the risk of injury or inadequate treatment when the medication is either poorly made, is contaminated or does not even contain the active medication it purports to contain. If a practice or facility has used these unapproved medications, they will be required to spend the same kind of time and effort in tracking and potentially treating affected patients as required with contaminated medications. This situation may have further ramifications such as a failure to treat a diagnosis adequately, etc. With these concerns in mind, practitioners and facilities should take steps to assure that their supply of medication is obtained from an appropriate source in the interest of patient safety and to minimize future liability.
In addition to the possibility of civil liability, the administration of unapproved drugs exposes the practitioner or facility to criminal liability, in the form of a variety of charges under the FDCA, depending on the circumstances. These may include allegations of:
- Introducing adulterated or misbranded drugs into interstate commerce
- Receiving adulterated or misbranded drugs through interstate commerce, and offering them for sale
- Health care fraud for billing a benefit program for adulterated or misbranded drugs
- False claims (if billing was done and the physician or facility knew the drugs were adulterated or misbranded)
- Mail and wire fraud (if the mails or wires were used in an intentional plan to sell adulterated or misbranded drugs)
- Bank fraud (if the physician was involved in an intentional plan to sell adulterated or misbranded drugs)
- Money laundering
- Smuggling
- Drug re-importation (exporting a drug to a foreign country and re-importing it again for sale)
The last six of these charges apply to physicians who knowingly participate in plans to import unapproved medications and sell them as approved. Penalties for these charges, if proved, can be substantial and the Federal government reserves the right to exclude physicians implicated in these situations from involvement in any federal health care programs, such as Medicaid and Medicare.
While, fortunately, few physicians have intentionally elected to take part in this type of activity, a growing number of physicians and facilities have been unknowingly victimized by those physicians and/or pharmacies that have set up these importation schemes. Physicians and facilities who have been victimized in this manner may nonetheless still be subject to the first three criminal charges. But, physicians and facilities caught in a situation like this may not face criminal liability if they can prove that they were unaware of the nature of the drugs they purchased.
Criminal liability notwithstanding, practices caught in this situation will also need to deal with Medicare, and any other benefit programs they have billed. Medicare’s rules note that Part D plans may only pay for drugs which are approved by the FDA for sale in the United States. Other benefit plans may have similar language. It is possible that one or more plans, especially Medicare, may require repayment of money it reimbursed the physician or facility for these drugs.
In an attempt to avoid tainted drugs:
- Check the FDA website drug listing which gives the drug name, approval information, manufacturer, and (when available) an image of the label http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
- Check with the state Department of Health (DOH) to make sure that your supplier is registered with, and approved by the state http://www.state.nj.us/health/foodanddrugsafety/wdmdr.shtml
- You can also verify that your supplier is licensed in your state by going to http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/default.htm \
- Sign up at the FDA website to receive notice of all recalls, market withdrawals, and safety alerts of drugs http://www.fda.gov/Safety/Recalls/default.htm
- Consider buying medications directly from the manufacturer
In an attempt to avoid purchasing unapproved medications from foreign countries:
- As above, your supplier should be registered with, and approved by the state DOH
- As above, your supplier’s license and registration should be verifiable through the FDA’s website
- The medications you receive should have appropriate manufacturer’s labels, and you can verify the manufacturer on the FDA website
- Labels or packaging that have one or more foreign languages on it should be considered suspect and be reported to the FDA’s Office of Criminal Investigation (OCI) by calling 1-800-551-3989 or using their website http://www.fda.gov/OCI
- As above, consider buying directly from the manufacturer of the medication
In an attempt to avoid purchasing counterfeit medication:
- Follow all the above tips for avoiding purchase of unapproved medications from foreign countries
- Only purchase drugs through the Internet if:
- The pharmacy you are purchasing from is licensed and located in the United States
- The pharmacy you are purchasing from is accredited by the National Association of Boards of Pharmacy (NABP) http://www.nabp.net/programs/accreditation/vipps
- You are certain the site is secure (for instance an ‘https’ address) and can protect your credit card information
- Share information about the risks of internet medication purchases with your patients by directing them to http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/default.htm
Contaminated medications can cause illness, death, and financial loss; the circumstances involving contaminated medications also often engendered multiple lawsuits. Such circumstances have made it abundantly clear that each practitioner and facility must make careful decisions when purchasing medications.