Saliva Drug Screening in the Office Setting: Detection of Drug Use and Abuse
Recent report by the Centers for Disease Control and Prevention (CDC) shines a spotlight on the deadly toll that abuse of prescription pain medications is taking. According to the CDC report, “Overdose deaths involving opioid pain relievers [OPR] have increased and now exceed deaths involving heroin and cocaine combined.”1
In 2007, approximately 28,000 people died from unintentional drug overdoses, driven mostly by prescription drugs. Additionally, in 2010, 4.8% of the US population aged >12 years used OPR nonmedically—a 20% increase since 2002.1 Further, visits by individuals to hospital emergency rooms involving the misuse or abuse of pharmaceutical drugs have doubled over the past five years.
Balancing the potential risk of misuse with the benefits of properly prescribed opioids continues to be a challenge. According to the CDC report, “Public health interventions to reduce prescription drug overdose must strike a balance between reducing misuse and abuse and safeguarding legitimate access to treatment.”1
Physicians who prescribe opioids are under intense scrutiny by the Drug Enforcement Agency (DEA) as well as state medical and pharmacy boards. To strike a balance, health-care providers should only use OPR in carefully screened and monitored patients when non-OPR treatments have not been sufficient to treat pain, as recommended in evidence-based guidelines. “Long-acting and extended-release opioids have benefit when used properly and are necessary components of pain management for certain patients,” said FDA Commissioner Margaret A. Hamburg, MD.2
This article will highlight the results of a study of 411 patients living in the the Ohio Valley—which encompasses the northern panhandle of West Virginia, Western Pennsylvania, and Southeastern Ohio—who underwent saliva drug testing as part of an outpatient monitoring program during 2011.
Choosing a Screening Technique
There are a number of screening techniques that use a variety of tissue collection modalities, including urine, blood, saliva, hair, and sweat.3-7 All testing modalities have their advantages and disadvantages, which include differences in the physiology of distribution of any drug substances in a particular body fluid or tissue, pharmacokinetics, the possibility of false positive or negative findings, and possible contamination.8-15
The most common drug testing methodology is urine testing. The author has used urine drug testing for many years, but was concerned about the potential for sample tampering that has been raised. Chiefly, that the physician and/or assistant does not witness the patient providing the sample.
Saliva drug screening has become an appropriate alternative to urine testing for detecting use and misuse of both prescription and illicit drugs.16,17 Because of its ease of use, saliva drug screening has numerous usages, including therapeutic drug monitoring, drug pharmacokinetics, legal and employment applications, and general use as a diagnostic tool.18-22 The saliva test is done in the office in front of the clinician and/or assistants, versus in the privacy of a restroom. Moreover, the urine screen is mainly qualitative, whereas the saliva test is quantitative.
Therefore, after due consideration, the decision was taken to proceed with saliva drug screening on all the current or new patients treated with DEA-restricted medications. To do less than a total patient population investigation would have brought ethical questions. This process is an ongoing task.
The Ohio Valley is known as an area that has a high prevalence of drug abuse. According to the National Drug Intelligence Center, anecdotal reporting from treatment providers throughout West Virginia indicates that pharmaceutical abuse is endemic and a way of life for many West Virginians, with members of various socioeconomic classes and age groups abusing these drugs.23 This study will hopefully throw some light on the reality of drug use and misuse in the region and perhaps in the rest of the country as well.
The study patients had a number of chronic pain–related disorders. Most patients had a combination of diagnoses that referred at times to the same body region or to two or more regions. The body regions and main symptoms are described in Table 1 (page 54). The most prevalent pain region was the back (63.8%), and its distribution was rather similar in both genders. The most prevalent diagnosis for either gender was 724.2 (lumbago), followed closely by 724.4 (back neuritis).
Patients were either established clinic patients who underwent the drug screen on a random basis or new patients who underwent the drug screening on their first visit.
The study objectives included:
• Verification of the number or percentage of persons who took the medicines prescribed without any deviation from the prescription instructions
• Verification of the number or percentage of persons who did not take the medications prescribed and instead took prescription medications not prescribed by the physician
• Verification of the number or percentage of persons who took illicit drugs in addition to medications not prescribed by the physician
Participants and Methods
All of the individuals tested resided in the tristate area of the Ohio Valley. Of the 411 patients enrolled in the study, 204 were women (49.6%), 207 were men (50.4%), and 97% were white (Table 2, page 54). Ages ranged between 19 and 89 years, with the median age slightly “younger” for women (ie, more women fell into the 40-to-49-year age group) versus 50 to 59 years for men. The age of most patients tested was between 30 and 69 years.
The testing was strictly performed according to the reference laboratory instructions (AFTS Labs, Huntington, NY) and was conducted in the office during patient visits. The test was administered and witnessed by one of the medical assistants in the office. Upon completion of the saliva test, the sample was placed in a lab bag, sealed in front of the patient, and then transported via 2-day delivery to the lab. Testing was performed using a saliva collection device with a volume adequacy indicator (Quantisal). The testing method used by the reference laboratory was an immunoassay followed by liquid chromatography–tandem mass spectrometry.
The test results were obtained within 3 to 5 days from the day of screening and were communicated to the patients as soon as possible. Each patient tested was informed of the actual results and meaning of results, including the medical-legal issues, as warranted.