NABP is recommending that the state boards of pharmacy prohibit the use of the abbreviation “APAP” on prescription labels, and require that “acetaminophen” be spelled out to assist in preventing the well recognized danger of acetaminophen induced hepatotoxicity. In situations where the board is unable to mandate such a provision, NABP recommends that the boards strongly encourage practitioners to follow this guideline. The recommendation is based on established policy and a letter, sent by Food and Drug Administration (FDA) to state boards of pharmacy on January 22, 2004, regarding the pharmacist’s role in educating patients about acetaminophen induced hepatotoxicity caused by unintentional overdose. In the letter, FDA indicated some of the reasons for unintentional overdoses and recommended that drugs containing acetaminophen should be adequately labeled on the container and that the use of the abbreviation “APAP” for acetaminophen should be avoided.
The NABP Task Force on Uniform Prescription Labeling, which met December 6, 2008, stated in its report that the purpose of the prescription label is to provide critical information to the patient. The task force recommended that the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy be amended to ensure that prescription labels are organized in a patient-centered manner, that certain data elements appear on the prescription label, and that critical label information should never be truncated. The task force report also emphasized that the prescription label is designed to supplement patient counseling and not replace it in any way.
FDA supports NABP in this assertion that the boards of pharmacy can assist in the prevention of acetaminophen induced hepatotoxicity by mandating proper prescription labeling and appropriate patient counseling, thus furthering their efforts to protect the public health. Edwin Kuffner, VP of OTC Medical Affairs and Clinical Research for McNeil Consumer Healthcare, has also stated that requiring all acetaminophen product labels to include the drug name, not an abbreviation, will help ensure that consumers know when an over-the-counter or prescription drug contains the ingredient. Kuffner, at the FDA's June 24-25 public workshop on developing a guidance for naming, labeling, and packaging practices to reduce medication errors, also recommended allowing the use of a graphic icon for acetaminophen product labels.
NABP understands that pharmacies may not be able to immediately implement new labeling requirements or recommendations and acknowledges that an implementation period may be necessary. The FDA Safe Use Initiative and NABP will work with interested pharmacy organizations to identify best processes to eliminate the use of “APAP,” and use, in its place, the word “acetaminophen,” and will work with pharmacy organizations to incorporate a reasonable implementation period for new requirements or recommendations related to this issue.