Pharmaceutical Labels
Introduction
Pharmaceutical labels are an important form of technical communication in global society, yet there is not a significant amount of research on it within the realm of technical communication. In the United States, over half of the population takes at least one prescription drug daily, and at least a quarter of the population takes at least four. [1] This is a huge audience of people who need important information on what drugs they are taking. Information included on a pharmaceutical label includes dosage amount, side effects, and simple instructions for use. Technical communicators have the ability to provide this information in a clear and concise way in which patient safety is protected. This article introduces pharmaceutical labels as a genre of technical communication and provides technical communicators with what they need to know about PDL's (Pharmaceutical Drug Labels).
Origin of Pharmaceutical Labels
In the early 20th century drug manufacturing was wildly unregulated. There were no federal laws overseeing drug manufacturing and distribution until the Wiley Act was passed In 1906. The Wiley Act, also known as the Food and Drugs Act, prevented drugs from being sold in any condition other than what was stated on the label. Food and drug labels could not contain any misleading or false information and specific dangerous ingredients such as alcohol had to be mentioned on the label. [7]
The Wiley Act progressed into many other federal provisions surrounding drug manufacturing and distribution, including the Drug Amendments of 1962 [8] which did the following...
Recognized that no drug is safe unless it is also effective
Required established effectiveness of the drug prior to marketing
Required adverse reaction reports be sent to the FDA
Drug advertising must include the risks and benefits
Today pharmaceutical labels are overseen by the Center for Drug Evaluation and Research (CDER), a branch of the FDA. CDER oversees the drugs that are put out into the market and ensures that the drugs are safe and effective. They are in charge of accepting whether or not a pharmaceutical drug label meets the FDA requirements.
Purpose of Pharmaceutical Labels
Providing safe and accurate information about pharmaceutical drugs is essential for protecting patient health and safety. Any known information about a specific drug must be provided to the CDER (Center for Drug Evaluation & Research) who then provides the information to the physician prescribing the drug, the pharmacist instructing the patient, and the patient ingesting the drug. Doing so limits the liability of each actor/audience in the PDL network while ensuring that federal requirements are met.
Product Liability
Product liability is important for technical communicators to understand because of the legal implications. In the 1970s, a pharmaceutical company was approved to market a new birth control device. After four years, the product was pulled off the market due to safety concerns, thousands of women had experienced spontaneous abortions, infertility and sometimes death. The courts ended up finding the company guilty of misleading the public about the safety of the product, and the company was forced to file for bankruptcy despite setting aside $615 million for settlement funds. [4]
This demonstrates how clear and accurate pharmaceutical labels are essential for the safety of the patients using the product as well as the technical communicator engaged in creating the labels.
In "Technical Communications and the Law" Herb Smith writes...
Manuals, instructions, safety labels, and health care information are examples of technical information that not only need to be written clearly, and concisely, but also must be legally defensible. With product liability cases becoming more and more commonplace, technical writers and information specialists can perform an added valuable service to their companies by knowing the legal standards that govern their written documents [5]
It is important for technical communicators to think about the legal implications of their work, especially when it comes to creating pharmaceutical drug labels. The process of producing a pharmaceutical drug label is described below.
Production of Pharmaceutical Labels
Pharmaceutical labeling is overseen by the FDA's Center for Drug Evaluation and Research (CDER). This is mandated by Federal Regulations Title 21. [2] When producing a pharmaceutical drug label, it must be written to address all of the sites of action in the network of pharmaceutical drug labels. This network is described in the table below.
Table 1: Kessler & Graham (2018), "Terminal Node Problems
Description: This table details the different sites of action in the process of producing a prescription drug label (PDL). This table highlights the different audiences that a PDL will encounter, which is important for TCers to understand when creating one that way all the necessary information is included.
Pharmaceutical drug labels must address each aspect of the PDL network as well as meet the requirements that the Food and Drug Administration has established for them, these requirements are listed below.
FDA Regulations for Pharmaceutical Labels
Pharmaceutical drug labels must meet the following FDA requirements In order to be approved by the CDER for market distribution. Regulations for PDL's created by the FDA are listed below. [3]
Name of product
Drug facts
Active Ingredients
Proper use and Purpose
Warnings
Directions
Side effects and Allergic Reactions
Inactive Ingredients
Creative Commons Image from “Education Understanding Prescription Medication Labels.” Rx Outreach, 28 July 2022
Description: This photo shows an example of a prescription drug label and all of its required components. These requirements are important for TCers to acknowledge when creating a PDL.
How TCers can Improve Pharmaceutical Labels
Improving Documentation In the Pharmaceutical Industry
There is little research on pharmaceutical drug labels within technical communication. [1] Technical communicators have the ability to improve how pharmaceutical labels are written and therefore offer better protection for the patient using the drugs and the pharmaceutical company supplying it.
As a former consultant for both small and large pharmaceutical companies, Stephen A. Bernhardt draws on his experiences and offers technical communicators advice on how to produce higher quality documentation within the development of prescription drug products. [6]
These recommendations include:
Create a document management plan that acknowledges, time, cost and resources
Stage and structure reviews of drafts
Ensure review commentary is high quality
Utilize electronic review tools
These recommendations are meant to provide technical communicators with new practices to implement when creating pharmaceutical labels and other documentation. Improving the production of pharmaceutical drug labels will ensure that patient safety is protected while also limiting the liability of the pharmaceutical company and the technical communicator.
References
[1] Molly M. Kessler & S. Scott Graham (2018) Terminal node problems: ANT 2.0 and prescription drug labels, Technical Communication Quarterly, 27:2, 121-136, DOI: 10.1080/10572252.2018.1425482
[2] “Code of Federal Regulations Title 21.” Code of Federal Regulations , National Archives and Regulations Administration, https://www.ecfr.gov/current/title-21.
[3] Center for Drug Evaluation and Research. “FDA's Labeling Resources for Human Prescription Drugs.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/drugs/laws-acts-and-rules/fdas-labeling-resources-human-prescription-drugs.
[4] Horwitz , Rainey. “The Embryo Project Encyclopedia.” The Dalkon Shield | The Embryo Project Encyclopedia, 10 Jan. 2018, https://embryo.asu.edu/pages/dalkon-shield.
[5] Smith, H. (1990). Technical Communications and the Law: Product Liability and Safety Labels. Journal of Technical Writing and Communication, 20(3), 307–319. https://doi.org/10.2190/T04M-EPWJ-9D4D-26BH
[6] Bernhardt, S. A. (2003). Improving Document Review Practices in Pharmaceutical Companies. Journal of Business and Technical Communication, 17(4), 439–473. https://doi-org.proxy.lib.pdx.edu/10.1177/1050651903255345
[7] Janssen, Wallace F. “The Story of the Laws Behind the Labels.” FDA Consumer Magazine, June 1981.
[8] Commissioner, Office of the. “Part I: The 1906 Food and Drugs Act and Its Enforcement.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/part-i-1906-food-and-drugs-act-and-its-enforcement.
Last Updated by Kali Steeves 11/06/22