US Pharm. 2014;39:1):24-26.
People often drink to socialize, celebrate, and relax. As a result, alcohol is one of the most consumed drugs in the world. Over time, alcohol consumption may result in adverse health effects and negative social consequences owing to its intoxicating and dependence-inducing properties. Furthermore, alcohol accounts for approximately 80,000 deaths each year and is the third leading cause of preventable death in the United States, respectively.1,2 Therefore, for public safety, it is important to ensure that people are not driving under the influence of alcohol.
The purpose of this article is to introduce a new, FDA-approved alcohol breath analyzer and assess its efficacy in determining the blood alcohol content (BAC) (FIGURE 1). Though law enforcement has used breathalyzers for many years, driving under the influence (DUI) awareness and the legal and financial consequences of driving while intoxicated have made these devices popular with parents, bars that monitor patrons’ alcohol consumption, and those who simply want to know if they are impaired before driving.
EpidemiologyAlcohol abuse or risky use of alcohol is one of the most common causes of preventable death in the U.S.3 Risky use of alcohol is defined as drinking more than three drinks per day or seven drinks per week for women and four drinks per day or 14 drinks per week for men. Alcohol dependence, or alcoholism, refers to the state in which individuals frequently consume large amounts of alcohol and need increasing amounts to achieve the same effects. These individuals will also have frequent cravings for alcohol and experience withdrawal symptoms if cravings are not fulfilled. Four percent and 21% of adults report physical dependence and risky use of alcohol, respectively.4
The prevalence of binge drinking is also very high. Binge drinking consists of drinking many drinks on one occasion: five or more drinks for men and four or more drinks for women. Approximately 38 million Americans engage in binge drinking, resulting in an even higher risk of morbidity and mortality.5 Moreover, many alcohol-related deaths are due to motor vehicle accidents in young people. In fact, 37% of traffic deaths among young people between 16 and 20 years of age involve alcohol.4 To this end, alcohol abuse is clearly a serious problem that must be addressed.
PathophysiologyWhen alcohol is consumed, approximately 90% is quickly absorbed from the stomach and intestines into the bloodstream.6 Depending on the rate of absorption, the full effects of a drink may be felt within 45 to 90 minutes.6 Once a drink is absorbed, alcohol dehydrogenase (ADH) converts the alcohol to acetaldehyde in the liver, and this is further metabolized to acetate. Acetate is subsequently converted into water and carbon dioxide for easy elimination.7 The rate at which alcohol is metabolized is 0.015 of the BAC every hour.8 If the BAC is higher than 0.015, the body becomes saturated and, as a result, alcohol accumulates in the blood and tissues until it can be metabolized. The remaining 10% of the alcohol consumed is lost through urine, sweat, or breath.6 As such, a person’s breath may be tested to determine the BAC.
State LawsAlthough the National Minimum Drinking Age Act was enacted by Congress in 1984, the minimum drinking age is actually determined by each state. Depending on the state, the legal drinking age ranges from 18 to 21 years of age. However, states that do not prohibit persons under the age of 21 years from purchasing or publicly possessing alcoholic beverages may have federal highway funds withheld by Congress.9 All states currently prohibit minors from possessing alcoholic beverages. Nonetheless, the aforementioned law does not seem to eliminate underage drinking since studies show that people aged 12 to 20 years drink 11% of all alcohol consumed in the U.S.10 Studies also demonstrate that, on average, more drinks are consumed by underage drinkers during a drinking occasion than by adult drinkers.11
There is a parallel relationship between the level of intoxication and the probability of having an accident. For example, reducing the BAC threshold for DUI from 0.10 to 0.08 has decreased the number of alcohol-related fatalities.12 Additionally, by the time an intoxicated driver reaches a BAC of 0.08, critical driving tasks such as braking and changing lanes are significantly impaired.13 As a result, all states have adopted the 0.08 BAC level as evidence that a driver is under the influence of alcohol.14 As of late, the National Transportation Safety Board has called on state authorities to reduce the legal limit to 0.05, but this reduction has not yet been implemented.15
PAS Alcovisor Satellite: How It WorksApproved by the FDA in April 2013, the PAS Alcovisor Satellite Breath Alcohol Analyzer is a new device that measures alcohol content in the breath. The Alcovisor Satellite device is one of the newest products from PAS Systems International, Inc., a company that specializes in passive alcohol sensors. The unique amenities of this device include a rechargeable battery, convenient size, and the ability to charge other devices such as mobile phones. To use the device, a person must blow into it for at least 6 seconds.16 The person’s breath is drawn into an electrochemical fuel cell, and a reaction commences between the alcohol in the user’s breath and the fuel cell, resulting in the conduction of electricity. Because the amount of electricity produced is proportional to the amount of alcohol ingested, the BAC can be calculated. User instructions are shown in TABLE 1.
EfficacyIn order to gain approval from the FDA, this device had to demonstrate efficacy in measuring the BAC.16 The PAS Alcovisor Satellite was compared to a National Highway Traffic Safety Administration–approved Evidential Breath Tester. Participants who consumed differing amounts of alcohol were self-tested while employing the Alcovisor Satellite and subsequently examined by a professional using the Evidential Breath Tester shown in FIGURE 2. There was a positive correlation between the blood alcohol values from both devices in each participant, establishing that the Alcovisor Satellite has comparable accuracy to the Evidential Breath Tester. Under a BAC of 0.10, the Alcovisor Satellite will be accurate within 0.01.18 Data also demonstrate that the device is easy to use, as the participants were able to follow instructions accurately even while under the influence of alcohol.
ConclusionAlthough policy interventions such as alcohol taxes, raising the minimum legal drinking age, zero-tolerance laws, lowering the BAC level, license revocation laws, and server liability policies have been instituted, abuse or risky use of alcohol continues to be a problem among teenagers and adults in the U.S. The PAS Alcovisor Satellite has been developed to encourage responsible drinking behavior and to identify impaired drivers and underage drinkers. More information about this product may be found at www.pasintl.com or by calling (540) 372-3431.
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16. Section 5: 501(K) Summary. Fredricksburg, VA: PAS Systems Intl Alcohol Sensor Systems; 2013. www.accessdata.fda.gov/cdrh_docs/pdf12/K123470.pdf. Accessed October 28, 2013.
17. 510(k) Substantial Equivalence Determination—Decision Summary. Food and Drug Administration. 2013. www.accessdata.fda.gov/cdrh_docs/reviews/K123 470.pdf. Accessed on October 28, 2013.
18. Alcovisor Satellite Operating Manual. Fredericksburg, VA: 2013. PAS Systems Intl; 2013.
19. Kelsey J, Newchok D, Calderon L. Consumer Field Evaluation of the PAS Alcovisor Satellite. 510(k) Report K123470 Section 18 (V). Fredericksburg, VA: 2012. PAS Systems Intl.
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