August 03, 2011 08:42 ET

NCPDP Continues the Charge for Patient Safety, Providing Guidance on Prescription Container Labels for Drugs Containing Acetaminophen

White Paper Calls for Harmonization With OTC Labeling for Acetaminophen to Improve Awareness, Education and Patient Safety

SCOTTSDALE, AZ--(Marketwire - Aug 3, 2011) - The National Council for Prescription Drug Programs (NCPDP) brings patient safety to the forefront with its latest white paper, "NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen." Liver injury from acetaminophen overdose remains a serious public health problem. The white paper details recommendations to provide consistency across over-the-counter (OTC) and prescription container labels. It also calls for the harmonization of standards across the industry to make it easier for patients and consumers to recognize when prescription medicines contain acetaminophen and to support the safe use of these medicines.

"FDA applauds NCPDP's leadership in encouraging industry to implement voluntary measures that will complement FDA regulatory and educational efforts to improve the safe use of these medicines," said Janet Woodcock, MD, director of FDA's Center for Drug Evaluation and Research.

Standards and regulations for acetaminophen labeling and warnings exist for OTC medicines but not for prescription medicine container labels. OTC medicines include a complete spelling of acetaminophen and concomitant use and liver damage warnings on their labels, while prescription medicine container labels may instead only include an abbreviation, acronym or truncation of the word acetaminophen, such as "Acet" or "APAP." The goal of the white paper is to recommend industry-wide best practices to help patients: identify when a prescription medicine contains acetaminophen; compare active ingredients with OTC medicine labels; and avoid unintentional overdose.

The recommendations for prescription container labels for medicine containing acetaminophen include:

1. Complete spelling of acetaminophen
2. A standardized acetaminophen concomitant use and liver damage warning label
3. Prioritization of the warning label to print within the top 3 warnings for a medicine

The white paper also includes recommendations to promote patient readability and understanding of the prescription container label and calls on pharmacists and physicians to participate in patient education on the appropriate use of acetaminophen.

"This is a powerful call to action for the pharmacy industry to demonstrate yet again its ability to mobilize and adapt to protect patient safety because it's the right thing to do," explained Lee Ann Stember, President of NCPDP.

This initiative is part of NCPDP's decades-long commitment to providing the industry forum that addresses challenges and drives solutions that improve the patient experience. For over 30 years NCPDP has been the forum for healthcare, pharmacy and government stakeholders to convene on specific issues and create solutions that support the level of care consumers, clinicians and pharmacists rely on today.

"NCPDP's role in the industry makes it uniquely positioned to convene the wide array of stakeholders involved in the prescribing and dispensing of prescription medications to address the leading cause of acute liver failure in the U.S. in such a timely fashion," observed American Society of Health-System Pharmacists (ASHP) Assistant Vice President of Drug Information, Dr. Gerald McEvoy, a key participant in the white paper's development. "This represents a critical first step in educating patients about the presence of acetaminophen in many of the most widely prescribed medications, particularly combination products used to treat moderate to severe pain, and to help prevent unintentional acetaminophen overdose and severe toxicity."

The white paper, "NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen" can be downloaded at

To view a sample acetaminophen drug facts label excerpt, click here.

To view a sample acetaminophen prescription container label, click here.

Founded in 1977, NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with over 1,600 members representing virtually every sector of the pharmacy services industry. Our diverse membership provides leadership and healthcare business solutions through education and standards, created using the consensus building process. NCPDP has been named in federal legislation, including HIPAA, MMA, and HITECH. NCPDP members have created standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for e-Prescribing, the Manufacturers Rebate Standard and more to improve communication within the pharmacy industry. Our data services include the NCPDP Provider Identification Number, a unique identifier of over 75,000 pharmacies, and HCIdea, "The Prescriber Identity Solution." NCPDP's RxReconn™ is a legislative tracking product for real-time monitoring of pharmacy-related state and national legislative and regulatory activity. For more information about NCPDP Standards, Data Services, Products, Educational Programs and Work Group meetings, go online at or call (480) 477-1000.

Contact Information

    Janet Cabibbo
    Amendola Communications for NCPDP
    480-664-8412 ext. 15
    Email Contact