New York Pharmacies Must Now Inform Patients of Certain Drug Recalls

Published on November 7, 2019 by Sandy Liebhard

Pharmacies across New York must now inform customers whenever a prescription medication is subject to a Class I drug recall.

Signed last month by Governor Andrew Cuomo, the new law requires that patients be notified within three days of a recall announcement, either by phone or by mail.

People deserve to know when a medication that’s supposed to make them feel better may actually make them sicker, and it’s common sense that pharmacies communicate that information to patients in real time,” Cuomo said during October 18^th signing ceremony. “This measure will help ensure patients get the facts about a recalled drug quickly so they can talk to their doctor about safer alternatives.”

The new requirements were effective immediately.

FDA Drug Recalls and Classes

The U.S. Food & Drug Administration (FDA) is charged with regulating:

• Human drugs
• Animal drugs
• Medical devices
• Radiation-emitting products
• Vaccines
• Blood and blood products
• Transplantable human tissue
• Animal feed
• Cosmetics
• Around 80 percent of the foods eaten in the United States

The agency announces thousands of recalls every year. Prescription drugs and other products included in Class I recalls have a high probability of causing serious adverse health consequences.

Class II product recalls include drugs and other products that might cause a temporary health problem or have a slight chance of causing serious adverse events. Some of the more prominent Class II actions have included the ongoing recalls for generic valsartan, losartan, and irbesartan tablets that might be contaminated with potentially cancer-causing chemicals, as well as recent recalls for Zantac and other ranitidine-containing heartburn drugs.

Class III recalls include products that are unlikely to cause any adverse reactions, but violate FDA labeling or manufacturing laws. In 2010, for example, the agency announced a Class III recall for certain children’s medicines that were potentially contaminated with small pieces of plastic during the manufacturing process.

How FDA Recalls are Conducted

The FDA may discover a defective drug or other product in one of several ways:

• A company finds a problem and contacts the FDA.
• The FDA inspects a manufacturing facility and determines the potential for a recall.
• The agency receives reports of health problems through various reporting systems.
• The Centers for Disease Control and Prevention (CDC) contacts the FDA.

Most drug recalls, regardless of class, are voluntary, as the FDA will rarely order manufacturers to remove a product from the market. However, it is up to the agency to oversee the company’s recall strategy and ensure the adequacy of the action.

If a recalled product has been widely distributed, the FDA might issue a press release, convene a press conference, and post regular updates to its website to inform the public. Nevertheless, many consumers miss these announcement and often remain unaware of urgent recalls.

While not all FDA recalls are subject to a public announcement, all are listed in the agency’s Weekly Enforcement Reports, which also notes the class designation, as well as the corrective action being taken by the recalling company.