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12 Articles in Volume 12, Issue #1
Ask the Expert: Escalating Opioids
Can Yoga and Stretching Exercises Relieve Chronic Low Back Pain?
Cortisol Screening in Chronic Pain Patients
Editor's Memo: FDA Removes Homeopathic HCG; Helps Legitimate Use In Pain Treatment
Formulation: The Four Perspectives of a Patient in Chronic Pain
Guide to Chronic Pain Assessment Tools
How to Select an In-Office Electromagnetic Field Device
Letters to the Editor: Hormone Therapies
Managing Pain in Active or Well-Controlled Systemic Lupus Erythematosus
PPM Editorial Board Examines Steps to Prevent Accidental Overdoses
Saliva Drug Screening in the Office Setting: Detection of Drug Use and Abuse
Understanding the Toxicology of Diazepam

Saliva Drug Screening in the Office Setting: Detection of Drug Use and Abuse

Gaining steam in the past decade, saliva drug testing can be an effective and quantitative tool for uncovering drug use and misuse in the chronic pain patient population.

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 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.

Study Objectives
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.

The patients were examined for the relevant symptoms and signs during each visit. No controlled substances were prescribed for more than 30 days at one time. No medication was prescribed without an actual visit and examination. No phone prescription requests were granted. Tampering with any prescription resulted in immediate dismissal from the practice. Evidence of drug dealing resulted in immediate dismissal. Receipt of any “anonymous” phone call regarding drug behavior resulted in immediate dismissal where there was proof of drug dealing and of complete curtailing of controlled substances if the patient could not present proof that the call was groundless. Thus, the saliva drug testing was performed within a clinical context in which the patients were fully aware of clinical, management, or legal consequences of illicit behavior.

Results
Of the 411 patients tested, only 140 (34%) took the medicines as prescribed—there was no gender difference. The remaining 271 patients tested (66%) took more than one non-prescribed medication and/or illicit drug. Of those 271 patients, 93 (34%) used illicit drugs in addition to the non-prescribed medication. There was a gender difference in the use of illicit drugs: 54 (58%) were men and 39 (42%) were women.

Table 3 (page 56) lists, by age groups, the medications prescribed and taken by patients of both genders. As stated earlier, those individuals comprised established and new patients who underwent the testing as praxis during their first visit to the clinic. Most individuals were prescribed at least two medications. The most prevalent prescribed medication was hydrocodone and acetaminophen (Vicodin) (21%). The median age group was 50 to 59 years. This table refers to the group of 140 patients who took the medications as prescribed, did not take any medication that was not prescribed by the physician (or previous physician), and did not take illicit drugs. Thus, the percentage of tested individuals who followed the physician’s instructions and did not “deviate” was 34%.

Table 4 (page 58) shows the medications taken by the remaining 271 patients (66%) that were not prescribed by the physician. The most prevalent drug taken by those individuals was oxycodone (29%). The gender distribution was similar for all age groups. The most prevalent age groups were 40 to 49 years and 50 to 59 years for women and men, respectively.

One hundred individual illicit drugs were taken in addition to nonprescribed medications (see Table 5, page 58). The most prevalent drug was tetrahydrocannabinol (marijuana) (48%). Across all age groups, more men than women used this drug. The most prevalent age group for illicit drug use was 40 to 49 years. A total of 93 individuals used illicit drugs in the group tested—that is, 23% of the total group or 34% of the group who took medicines not prescribed by the physician.

Discussion

The clinical setting in which the patients were investigated and treated followed rather strict rules of conduct. These included 19 points of a “pain contract” initialed at each paragraph by the patient and signed and witnessed, as well as a “per visit contract” (see Box). The latter reminds the patient about the essentials of the drug management rules.

Prior to the use of the saliva drug screening, urine drug testing was used for several years. That testing was stopped because it was qualitative, indicating only “positive” or “negative” findings; and the testing was performed at the hospital laboratory where the sampling could not be witnessed. The patient received a lab form and, although it was expected that the test was to be done within minutes of exiting the office, the actual testing time lag was very variable. Thus, the physician could not be sure of any tampering with the requested sample. On a number of occasions, the testing was actually tampered with or not performed at all. In such a climate, one could not reach any conclusions regarding the validity of the test as practiced.

The saliva drug screening was performed as part of the visit, always in the presence of the physician’s assistant. The test sampling was always processed according to the reference lab instructions within several minutes after the sampling was done. The results used in the study were tabulated by reference number only, with no mention of the names of the patients. They indicated the following:

• Of the 411 patients tested, 49.6% were women and 50.4% were men

• Only 34% took the medicines in accordance with the instructions and the “pain contract”

• Of the remaining 271 patients, most took several drugs that were not prescribed by the physician and without the physician’s knowledge. Because the number reflects the multiplicity of drugs, the data are considered only in percentage format. The same applies to those who took illicit drugs in addition to the drugs not prescribed by the physician

• The most prevalent illicit drug used was tetrahydrocannabinol (THC), or marijuana, taken by 48% of illicit drug users. The most common nonprescribed prescription drug used by both genders was oxycodone, used by 29% of individuals

When questioned, most patients stated that the sources of the drugs were family, friends, and neighbors. A few mentioned visits to the dentist or emergency department; however, they could not offer proof. No one mentioned any drug dealing. A few patients acted surprised and questioned the physician about possible sources of “contamination” such as use of mouthwash or their remote presence in a setting where cannabis was smoked by other people. A good number acted surprised but eventually admitted to “recreational” use.

Was there a significantly different gender pattern for the illicit drug use? There are not sufficient data to warrant a statistical conclusion on this subject. However, the trend of illicit drug use was that of relatively higher cannabis use in men and equal use of alcohol and cannabis in women.

The data are considered for both genders combined. However, there were a number of differences that are worth mentioning. The total number of diagnoses was considerably larger for the men than for the women in the study. The most common diagnoses were similar for both genders, for example, 724.2 (lumbago) followed by 724.4 (back lumbar neuritis). Chronic back pain was the most common complaint in both genders, followed by upper limb pain of varied etiology in women and arthritic pain in men.

When a patient tests positive for an illicit drug or a non-prescribed controlled substance, the policy of the office is to consult with the patient and show them the evidence. The patient is then offered two options: 1) dismiss themselves from the practice immediately, or 2) stay in the practice but no longer be prescribed a controlled substance.

About 33% of patients left the practice immediately. Of those who chose to remain, about one-half stopped coming within 3 months. Of the rest, the outcome was much better. To date, when repeat saliva testing was performed, none of the patients tested positive for illicit drugs or prescribed narcotics.

Conclusions
Saliva drug screening has proven an effective and quantitative tool for the detection of patterns of drug use and misuse in a chronic pain patient population from the Ohio Valley, encompassing the border areas of Ohio, West Virginia, and Pennsylvania.

The results of the testing showed that only 34% of the patient population respected the “pain contract” and followed the instructions for proper use. Of the patients tested, 271, or 66%, did not respect the “pain contract” and used prescription medications that were not prescribed to them. Of the 271 persons in this category, 93, or 34%, also used illicit drugs.

The results of the saliva drug screening in an office setting show rather sobering statistics. The question remains as to how representative they are of the rest of the country. Further large-sample clinical saliva drug screening in different regions of the country and across varied ethnicities is needed to elucidate this question.

Last updated on: July 8, 2020
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