Reducing the Threat of Counterfeit and Unapproved Drugs in Clinical Settings
On July 19, 2013, the Engelberg Center for Health Care Reform at Brookings Institution convened an
expert workshop to explore strategies to reduce the purchase and use of counterfeit and unapproved
drugs in clinical settings. The FDA has undertaken extensive efforts to ensure the integrity of the
pharmaceutical supply chain; however, the purchase and use of counterfeit and unapproved drugs in
clinical settings (e.g., hospitals, physician’s offices) has become an increasing problem that is
neither well understood, nor within the traditional scope of the FDA’s regulatory authority. These
illegal and unregulated products cause a serious public health concern as they may contain
dangerous substances, incorrect dosages, or no active ingredient. It is clear that combating the
emergence of counterfeit and unapproved medications within clinical settings will require broad
stakeholder input from FDA, providers, administrators, payers, patients, and others. To this end,
the Engelberg Center, in collaboration with FDA’s Office of Drug Security, Integrity, and Recalls,
brought together a diverse set of stakeholders in a neutral forum to understand existing approaches
to controlling counterfeit and unapproved drugs, identify strategies to improve communication about
and awareness of this topic among stakeholders, and develop creative, feasible solutions to deter
the use of counterfeit and unapproved products.
BeMedWise Program at NeedyMeds encourages healthcare professionals and community groups to foster patient–professional communication about medicines. However, BeMedWise does not supervise or endorse the activities of any group or professional. Discussion and action concerning medicines are solely the responsibility of the patient and their healthcare professionals, and not BeMedWise.
Please consult a licensed health care professional with questions or concerns about your medication and/or condition.