Calling the increased use of e-cigarettes among children an “epidemic,” the Federal Drug Administration (FDA) has announced actions to penalize manufacturers, distributors and retailers who are illegally selling these products to underage children.According to a press release issued by the FDA and this from CNN, FDA Commissioner Dr. Scott Gottlieb warned the FDA might require companies to change their sales and marketing practices, stop distributing products to retailers who sell to kids and remove flavored e-cigarette products from the market.
"I use the word epidemic with great care," Gottlieb said. "E-cigs have become an almost ubiquitous -- and dangerous -- trend among teens. The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. It's simply not tolerable."
These electronic cigarettes, which are also popularly known as “vapes” and “e-cigs” and clinically designated as “electronic nicotine delivery systems” (ENDS), were originally brought to the marketplace as smoking cessation tools for adults. They were designed to deliver nicotine without the smoke and smell of combustible cigarettes.
Brands such as Juul, MarkTen, Vuse, Blu and Logic control 97 percent of the e-cigarette market, the FDA said. In the next 60 days, the agency plans to investigate the five e-cigarette companies' marketing and sales practices, with possible "boots on the ground inspections."
An FDA Educational Campaign is Launched
The FDA is bringing additional resources to this e-cigarette challenge in the form of a marketing campaign that focuses on the “low risk” attitude of children. The federal drug agency noted that “awareness of these potential health risks remains low, with about 80 percent of youth saying they do not see great risk of harm from regular use of e-cigarettes. For youth, this low-risk mentality could have devastating consequences.”
The agency’s press announcement stated that “as part of FDA's ongoing efforts to protect youth from the dangers of tobacco use, the agency is expanding its successful youth tobacco prevention campaign, ‘The Real Cost,’ to reach the more than 10 million youth ages 12-17 who have used e-cigarettes or are open to trying them.”
The campaign urges these teens to “know the real cost of vaping,” with advertising designed to snap teens out of their “cost-free” mentality by educating them about the potential risks of using e-cigarettes. The marketing effort will reach teens where they spend most of their time: in school and online. In addition to a suite of digital content on “The Real Cost” campaign website and social media channels, new ads will run on digital platforms where age is verified, including Hulu, Facebook, Spotify, and YouTube.
Bright Futures is a Counseling Tool for E-Cig Cessation
Based on the comments posted on the online pediatric resource SOAPM about the subject, it is clear that the pediatricians who are fighting this battle against electronic cigarettes are searching for better ways to identify and counsel children about their health risks. PCC EHR can assist clinicians in this challenge.
The PCC platform includes an innovative counseling tool from the American Academy of Pediatrics called Bright Futures. In the section regarding Anticipatory Guidance, “Tobacco Smoke Exposure and Tobacco Use Cessation,” author Dana Best, MD, MPH outlines why and how it is important for pediatricians to include anticipatory guidance for tobacco use cessation in most well-visits.
This chapter notes that “most adult tobacco users want to quit and have already made one or more quit attempts. They are receptive to cessation advice from their child’s pediatrician. Pharmacotherapies including a variety of nicotine replacement therapies (NRTs) are a part of this process. Patients younger than 18 need a prescription, even for over-the-counter (OTC) products, because use among this age group is off label.”
The Bright Futures guidelines also suggest ways a pediatrician can screen and counsel cessation for nicotine use in children. It involves the “5 A’s:”
- Ask - Obtain an applicable history from patients and their families.
- Advise - Look for teachable moments by using clear, strong messaging about the health dangers of nicotine.
- Assess - Determine if the patient or parent is willing to make a behavioral change.
- Assist - Provide cessation information, strongly urge a nicotine-free home and car, help set reasonable “quit” goals.
- Arrange for follow-up - Schedule an in-person or telephone follow-up after important anniversaries such as quit dates.
- Personal history of nicotine dependence
- Other specified personal history (e.g. second hand smoke) presenting hazards
- Toxic effects of tobacco used when the pediatrician documents a child’s illness is exacerbated by tobacco
- Tobacco abuse counseling
- Smoking and tobacco use cessation counseling (greater than three minutes, less than 10 minutes)
- Intensive counseling, longer than 10 minutes
Pediatricians are (Once Again) on the Front Lines of This Battle
Pediatricians were aware of this e-cig problem long before the FDA stepped in. Research notes that more than 2 million middle and high school students were current users of e-cigarettes in 2017, and e-cigarettes were the most commonly used tobacco product by youth. Youths are more likely than adults to vape, according to the US Centers for Disease Control and Prevention.
One of the many challenges facing pediatricians for intervening in this ENDS epidemic is the lack of screening tools. Despite the existence of more than 75,000 ICD - 10 diagnoses, there are only a few that deal with nicotine addiction. This makes screening for this condition by leveraging an EHR very challenging.
In response to this FDA decision to crack down on this underage vaping, Chip Hart, the Director of PCC’s Pediatric Solutions consulting group and author of the popular blog Confessions of a Pediatric Practice Consultant said,
“As a pediatric EHR vendor, we constantly search for meaningful improvements we can make that help our pediatricians take better care of their patients. It's the most important work PCC can do."
“Unfortunately, there are no 'best practices' nor even official nomenclature for the purpose of distinguishing among those children and teens who smoke cigarettes, smoke marijuana, vape, or chew tobacco. And there's no good method for determining changes in habit, which is crucial for measuring intervention success.
“We understand that changes are coming - they can't come too soon!”
Research on the Effects of E-Cigs is Just Beginning
Because of the enormity of this problem, research is beginning to occur.
Here are two studies:
In this study it was noted that, unlike smoking, which is systematically captured by clinicians through routine screening and discrete documentation fields in the EHR, the extent to which clinicians are documenting patients' use of ENDS is unknown.
"Natural language processing” was used to assess the incidence rates of documentation of patients' ENDS use in unstructured tobacco comments in the EHR. The words most frequently documented in relation to ENDS were: ‘e-cig,’ ‘electronic cigarettes’, and ‘vape.’ The authors of the study noted that “the relatively low observed number of patients with ENDS terms in the EHR suggested vast under documentation.”
In other words, the research is showing that data on e-cigs are more difficult to obtain than that of traditional nicotine products.
Another study suggested ways an EHR can be used for population health surveillance and research:
The authors pointed out that it is currently unknown whether ENDS pose a real health risk to users or those passively exposed to their vapor. “With the increased use of these devices, the goal of this study was to examine if and how their use is being documented in the EHR and the associated implications for clinical research.” The results highlight that “improved and consistent EHR discrete data entry for ENDS with associated clinical standards for documentation and representation of potential exposures are needed for enabling effective population health surveillance and research.”
In layman’s terms, this study suggests that more accurate EHR data, which can be used in population health, can result from consistent clinical standards for documentation.