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General Chapter <17> Prescription Container Labeling

Type of Posting: General Chapter Prospectus
Posting Date: 25–Oct–2019
Input Deadline: 24–Nov–2019
Expert Committee: Healthcare Quality & Safety Expert Committee

Suggested audience: Physicians and other prescribers, pharmacists, pharmacy technicians, regulatory authorities, pharmacy vendors, electronic health record (EHR) vendors, pharmacy systems vendors, auxiliary label manufacturers, and integrated pharmacy label manufacturers

Estimated proposal PF: 46(1) 

Background and objective:
General Chapter <17> Prescription Container Labeling provides universal standards for the format, appearance, content, and language of prescription medication instructions to promote patient understanding and reduce medication errors.  The Healthcare Quality and Safety Expert Committee would like to revise this chapter to add information to prevent oral liquid dosing errors and better inform patients of the risk of opioids.

Oral Liquid Dosing Errors
Dosing errors involving oral liquid medications administered by patients and caregivers in home settings have been a source of concern for many years. Of particular concern are medication errors involving young children, as they may be more susceptible to harm from measurement errors and overdoses. To administer most oral liquid medications, patients and caregivers must rely on the container label dosing designation to guide them in measuring out the proper dose with a dosing tool. This additional step introduces numerous opportunities for error with each administration of an oral liquid medication and, unless coordinated with dispensing of appropriate (e.g., type, volume and unit markings) oral dosing tools, can result in use of household utensils (e.g., uncalibrated teaspoons) or discordantly marked tools that can further exacerbate the risk of error1.  Therefore, an appropriately sized dosing tool can help facilitate giving the appropriate dose of oral liquid medication to patients more accurately.

Lack of Recognition of Opioids by Patients
Opioids are a class of drugs with a high risk of dependence, abuse, and addiction. It has been reported that many patients prescribed opioids for pain do not even know that they are taking an opioid. Warning labels for opioids may be especially useful because the prescription container label may be the only source of information patients utilize. At the same time, to maximize impact, it is important to ensure that this information is clear and useful to patients about the risks of prescription opioids.

Description of scope and application:  The revision to this general chapter focuses on two new elements; 1) an algorithm for an appropriate dosing tool (e.g. oral syringe) size to deliver the appropriate dose of oral liquid medication and  2) a framework to help guide the development of opioid warning label

Oral Liquid Dosage Algorithm
When oral liquid dosage forms are prescribed, the appropriate “dosing tool” (also known as a “dosing component”; examples include an oral syringe or dosing cup) must be provided to the patient or caregiver to accurately measure and administer the oral medication. Based on recent studies, patients can receive a more accurate dose of oral liquid medication when the dosing tool is an appropriate size to deliver the medication. The algorithm provides guidance on choosing the smallest dosing tool to use based on the dose volume. The dosing tool provided should be the smallest one that can hold the entire dose (e.g., for a 2-mL dose, a 5-mL capacity syringe is preferable to a 10-mL capacity syringe; for a 7.5-mL dose, a 10-mL capacity syringe is preferable to a 5-mL capacity syringe).

Opioid Warning Label Development
Auxiliary information on the prescription container label should be evidence based and presented in simple, explicit language that is minimized to avoid distracting patients with nonessential information.   The information should be presented in a standardized manner and should be critical for patient understanding and safe medication use.  The opioid warning label framework will help practitioners work with EHR vendors and auxiliary label developers to draft opioid warning labels that are concise and relay the consequences of misuse.  The label should:

  1. Address and emphasize the potential health consequences
  2. Capture the reader’s attention and have a strong impact, the warning should be frank and direct, clearly stating the serious--even fatal—consequences
  3. Provide access to additional information for the patient (e.g., pamphlet, guide, website)
  4. Be supported by established theory, such as behavior change theory, to have a public health impact
  5. Link to education and a media campaign with high visibility for the target populations
  6. Include text when icons are used
  7. Use messaging that should also be in alignment with practitioner recommendations to the patient.

Stakeholder (Design phase) activities:
Opioid Discussion Forum 2017 
Opioid Roundtable 2018
Opioid Warning Label Roundtable 2019
CDC PROTECT meeting 2017
CDC PROTECT meeting 2018
CGC PROTECT meeting 2019
NCPDP Workgroup 11 participation: e-Prescribing and Related Transaction

Anticipated implementation timing:
The proposed revision will post for public comments Jan-Mar 2020.  The final revision is intended to be published in USP–NF 2021 Issue 1 and to become official on August 1, 2021.

Contact: Donna Bohannon, R.Ph., MS, Scientific Liaison (


1 NCPDP Recommendations and Guidance for Standardizing the Dosing Designations on Prescription Container Labels of Oral Liquid Medications. Version 1.1 National Council for Prescription Drug Programs. 2014