Tools
Drug Labeling
Definition/Introduction
On January 24, 2006, The Food and Drug Administration (FDA), an entity of the United States Department of Health and Human Services, published a final rule on the content and format of labeling for human prescription drugs and biologics.[1][2][3] These regulations are within Title 21 of the Code of Laws of the United States of America. The term “drug labeling” in this article generally refers to any information provided with prescription drugs under the regulation of the FDA in the United States. The exact definitions of “drug” and “labeling” have been included in the U.S. Code of Laws. Under this law, the definition of a drug is: “(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any articles specified in clause (A), (B), or (C)...” And label and labeling are defined as the following: “(a) Labeling includes all written, printed, or graphic matter accompanying an article at any time while such an article is in interstate commerce or held for sale after shipment or delivery in interstate commerce. (b) A label means any display of written, printed, or graphic matter on the immediate container of any article, or any such matter affixed to any consumer commodity or affixed to or appearing upon a package containing any consumer commodity.”[3][4][5][6]
The FDA’s primary purpose of drug labeling is to ensure patient safety by giving healthcare professionals a summary of the safety and efficacy of a drug. The labeling is not aimed at a patient population because prescription drug administration is always under the supervision of a healthcare practitioner who is licensed to prescribe the medication.[7][8][9][10]
The following list is an outline of the requirements for a drug label:
- Highlights (a concise summary of label information)
- Full prescribing information
- Limitations statement
- Product names
- Date of initial U.S. approval
- Box warnings
- Recent major changes
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions (listing of most common adverse reactions)
- Drug interactions
- Use in specific populations
- Patient counseling information statement
Additional information on the drug label is as follows.
- Overdose
- Clinical pharmacology
- Nonclinical toxicology (carcinogenesis, mutagenesis, and fertility impairment)
- Clinical studies
Issues of Concern
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Issues of Concern
Over 50% of medication use errors in terms of dosing, intervals, route of administration, etc, are associated with poor prescription drug labeling.[11] Although the FDA’s main purpose in drug labeling is to aid the healthcare provider, the patient’s misunderstanding of labeling is a major cause of medication-related morbidity, mortality, and cost. The most common reasons for medication use errors include name confusion and inability to read or understand prescription drug labels. Research has found that medication errors would be reduced if patient-centered labeling were implemented with standardization of labeling text, scheduling, indication, language, typography, and other display standards. These evidence-based recommendations generally focus on standardizing and simplifying medication labeling for patients to better self-manage their medication use.[11][12]
Clinical Significance
Medication error due to misunderstanding prescription drug labeling is the most common iatrogenic error leading to injury, hospitalization, and adverse medication reactions.[13] This is especially problematic in patients who have low health literacy or receive prescriptions for multiple medications.[14] In the United States, The Food and Drug Administration (FDA) is responsible for regulating and enforcing drug labeling to protect and ensure the safety and efficacy of prescription drugs. However, the FDA’s labeling requirements are not meant to be patient-centered. The United States Pharmacopeia (USP) has made recommendations based on the Institute of Health’s report on medical errors. The USP recommends patient-centered prescription labels, simplifying language, using explicit text, including the reason for prescription, improved readability, labeling in a patient’s preferred language, supplemental information, and standardized patient directions.[15] The drug labeling information for biosimilars compares the reference product more comprehensively than traditional generic drugs. This ensures that prescribers have clear access to the source of information, enabling them to understand the therapeutic profile associated with each biosimilar agent.[16]
Nursing, Allied Health, and Interprofessional Team Interventions
The healthcare team, eg, physicians, pharmacists, and nurses, must work together to ensure that patients use medications safely. The healthcare team needs to enthusiastically educate patients on correctly storing and administering their medications, especially for pediatric and geriatric patients. The findings of a recent study reveal that a significant number of households in the United States fail to comply with proper medication storage guidelines, thereby increasing the risk of compromising the sterility and stability of the drugs. The findings underscore the importance of pharmacist-led education initiatives to empower patients with the knowledge needed for proper medication storage, ultimately minimizing the risk of accidental ingestion and ensuring optimal therapeutic outcomes.[17] Physicians should discuss the medication with the patient, and the medication administration and storage instructions should be reinforced by the nurse and pharmacist, for example, in an ambulatory care setting.
References
Lal R, Kremzner M. Introduction to the new prescription drug labeling by the Food and Drug Administration. American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists. 2007 Dec 1:64(23):2488-94 [PubMed PMID: 18029957]
Food and Drug Administration, HHS. Requirements on content and format of labeling for human prescription drug and biological products. Final rule. Federal register. 2006 Jan 24:71(15):3921-97 [PubMed PMID: 16479698]
Food and Drug Administration, HHS. Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule. Federal register. 2003 Dec 11:68(238):69009-20 [PubMed PMID: 14672084]
Gassman AL, Nguyen CP, Joffe HV. FDA Regulation of Prescription Drugs. The New England journal of medicine. 2017 Feb 16:376(7):674-682. doi: 10.1056/NEJMra1602972. Epub [PubMed PMID: 28199811]
Aikin KJ, O'Donoghue AC, Swasy JL, Sullivan HW. Randomized trial of risk information formats in direct-to-consumer prescription drug advertisements. Medical decision making : an international journal of the Society for Medical Decision Making. 2011 Nov-Dec:31(6):E23-33. doi: 10.1177/0272989X11413289. Epub 2011 Jun 20 [PubMed PMID: 21690303]
Level 1 (high-level) evidenceGruber MF. The US FDA pregnancy lactation and labeling rule - Implications for maternal immunization. Vaccine. 2015 Nov 25:33(47):6499-500. doi: 10.1016/j.vaccine.2015.05.107. Epub 2015 Aug 6 [PubMed PMID: 26256527]
Food and Drug Administration, HHS. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling. Final rule. Federal register. 2014 Dec 4:79(233):72063-103 [PubMed PMID: 25509060]
Ramoz LL, Patel-Shori NM. Recent changes in pregnancy and lactation labeling: retirement of risk categories. Pharmacotherapy. 2014:34(4):389-95. doi: 10.1002/phar.1385. Epub 2014 Jan 4 [PubMed PMID: 24390829]
Food and Drug Administration, HHS. Amendment of regulations regarding certain label statements on prescription drugs. Final rule. Federal register. 2002 Feb 1:67(22):4904-7 [PubMed PMID: 11829025]
Food and Drug Administration, HHS. Use of Symbols in Labeling. Final rule. Federal register. 2016 Jun 15:81(115):38911-31 [PubMed PMID: 27311137]
Jeetu G, Girish T. Prescription drug labeling medication errors: a big deal for pharmacists. Journal of young pharmacists : JYP. 2010 Jan:2(1):107-11. doi: 10.4103/0975-1483.62218. Epub [PubMed PMID: 21331202]
Yin HS, Parker RM, Sanders LM, Mendelsohn A, Dreyer BP, Bailey SC, Patel DA, Jimenez JJ, Kim KA, Jacobson K, Smith MCJ, Hedlund L, Meyers N, McFadden T, Wolf MS. Pictograms, Units and Dosing Tools, and Parent Medication Errors: A Randomized Study. Pediatrics. 2017 Jul:140(1):. doi: 10.1542/peds.2016-3237. Epub [PubMed PMID: 28759396]
Level 1 (high-level) evidenceWolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. Journal of general internal medicine. 2016 Dec:31(12):1482-1489 [PubMed PMID: 27542666]
Ryan R, Santesso N, Lowe D, Hill S, Grimshaw J, Prictor M, Kaufman C, Cowie G, Taylor M. Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews. The Cochrane database of systematic reviews. 2014 Apr 29:2014(4):CD007768. doi: 10.1002/14651858.CD007768.pub3. Epub 2014 Apr 29 [PubMed PMID: 24777444]
Level 1 (high-level) evidenceInstitute of Medicine (US) Roundtable on Health Literacy. The Safe Use Initiative and Health Literacy: Workshop Summary. 2010:(): [PubMed PMID: 24983047]
Science of Biosimilars., Harvey RD,, Journal of oncology practice, 2017 Sep [PubMed PMID: 28898589]
Funk OG, Yung R, Arrighi S, Lee S. Medication Storage Appropriateness in US Households. Innovations in pharmacy. 2021:12(2):. doi: 10.24926/iip.v12i2.3822. Epub 2021 May 5 [PubMed PMID: 34345509]