Ilisa Bernstein, Pharm.D., J.D., Deputy Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance, shares her thoughts on the important role drug supply chain integrity plays in patient safety and quality care.
Purchasing decisions and patient health
I’ve seen a growing trend of health care professionals and medical practice administrators who purchase prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain. While the U.S. drug supply chain is one of the most secure in the world, drugs purchased from rogue wholesale drug distributors put patients at risk of not getting the treatment they need or even worse, experiencing harmful effects.
Drugs sold by rogue distributors may be counterfeit, adulterated or may not have been evaluated by FDA for safety and effectiveness. Because FDA has not evaluated these products, there is no way of knowing if these drugs were made using quality manufacturing practices, contain harmful ingredients, or if they were stored under proper conditions. For these reasons and more, it is important that health care professionals know the source of their prescription drugs.
I’m a firm believer in the saying, “If an offer sounds too good to be true – it probably is.” When it comes to purchasing prescription drugs, deep discounts may indicate that the products are stolen, counterfeit, or unapproved.
Rogue wholesale drug distributors target doctors using aggressive marketing tactics and offering medications at deeply discounted rates. Nevertheless, there are many steps that doctors can take to help ensure that the drugs they are providing to their patients are safe, effective, and meet U.S. standards for quality.
First, doctors should ensure they are receiving FDA-approved prescription drugs. Drugs that are not FDA-approved may have unknown or harmful ingredients, or may not have been manufactured, transported, or stored under proper conditions. By purchasing from only state-licensed wholesale drug distributors, doctors can help prevent unsafe and ineffective drugs from reaching their patients.
Once a drug is received, there are additional safety steps that can be taken. Doctors should check the packaging to determine if the packaging or the product differs in any way from the FDA-approved packaging and product. The label and other safety information and warnings should be in English. Also, check the dosing to ensure the dosing recommendations, form and route of administration are familiar.
And finally, patient feedback can also be an indication that there may be a problem with a product. If several patients report that they are experiencing a new side effect or lack of therapeutic effect from the same product, consider that the drug may be substandard or counterfeit. Health care professionals and patients should report adverse events related to the use of a suspect product and drug quality issues to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Protecting the drug supply chain
To reduce the public health threat posed by potentially dangerous drugs bought by health care professionals from outside the legitimate supply chain, FDA issues letters to doctors informing them that they may have obtained counterfeit or unapproved drugs from a rogue distributor, and provides tips on safe purchasing practices. These tips are part of our recently launched “Know Your Source” program, which works to inform doctors about how to protect their patients from unsafe drugs.
Also, FDA is working with prescription drug manufacturers, wholesale distributors, repackagers, and dispensers (trading partners) to establish and implement a new system that allows product tracing, verification and identification as drugs travel through the U.S. market. This effort is part of FDA’s implementation of the Drug Supply Chain Security Act (DSCSA) - Title II of the Drug Quality and Security Act signed into law on November 27, 2013.
The DSCSA was enacted to further enhance the safety of the U.S. supply chain and protect consumers from potentially unsafe drugs. Under the DSCSA, doctors who dispense or administer prescription drugs to patients are required to purchase their prescription drugs only from authorized trading partners licensed by or registered with the state or federal government. These measures will help protect patients by minimizing the chance of exposure to potentially dangerous and illegal drugs.
Our goal: ensuring safe, effective, quality drugs
Our goal is to protect public health by helping health care professionals to purchase prescription medications from distributors within the legitimate, regulated supply chain. Together, we can work to ensure that prescription drugs are purchased from authorized trading partners so that patients receive only safe, effective, quality drugs.
Dr. Bernstein started her career with FDA in 1988 as a Pharmacokinetic Reviewer in CDER’s Office of Clinical Pharmacology. From 1991 to 2010, she was a Senior Policy Advisor and then Director of Pharmacy Affairs in the Office of the Commissioner. Since 2010, Dr. Bernstein has served as Deputy Director of CDER’s Office of Compliance. Dr. Bernstein received a Doctor of Pharmacy degree from the University Michigan College Of Pharmacy and her Juris Doctor degree from American University Washington College of Law, and completed a post-doctoral residency at the National Institutes of Health. Dr. Bernstein briefly left FDA from 2002 to 2003 to serve as a Senior Associate Director in the Regulatory Liaison Office at Pfizer, Inc.
- State-licensed wholesale drug distributors
- FDA’s MedWatch Safety Information and Adverse Event Reporting Program
Find clinically important safety information and report serious problems with human medical products. Know Your Source: Protecting Patients from Unsafe Drugs
- Drug Supply Chain Security Act
FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs