The War Against Prescription Drug Abuse
Prescription drug misuse and abuse has skyrocketed to unprecedented proportions, forming an epidemic in the United States.
Opioid prescribing has increased 500% over the past decade, without a corresponding increase in painful conditions warranting such potent medications. Health care providers wrote 259 million prescriptions for painkillers in 2012, enough for every adult American to fill a month-long supply. The United States leads the world in opioid consumption, and hydrocodone/APAP is the most frequently prescribed medication in the nation. In the past 15 years, fatal overdose from prescription painkillers has increased 700% nationwide, resulting in 16,000 lives lost annually – more than firearm-related homicides or motor vehicle collisions. 12 million Americans freely self-report using painkillers for non-medical purposes, with the true number likely to be much higher.
Painkiller abuse is particularly on the rise in adolescents who mislead prescribing physicians or divert narcotics from friends and family members. Celebrities glamorize pharmaceutical drug abuse in songs like “Purple Pills” and “Sippin’ on Some Syrup.” High school and college students trade medications at school, with reports of “pharm parties” where teenagers pool supplies of painkillers and anxiolytics to potentiate their euphoric effects. Addicts seek prescriptions from physicians for what they informally call “The Holy Trinity,” or oxycodone, carisoprodol, and alprazolam.
Prescription dealers frequently approach elderly patients and other legitimate pain patients, who are tempted to supplement their limited fixed incomes by requesting increasing supplies of their opioids to divert to the black market. Medicaid patients, for example, can receive medications with a street value of up to $20,000 for a total out-of-pocket price less than $5 monthly according to current Department of Community Health benefit schedules. Prescription dealers historically sold to socioeconomically depressed patients on fixed government welfare subsidies, but now are increasingly targeting wealthy teenagers in affluent suburbs including those in Cobb County due to increased profit margins. The result has been an alarming increase in drug-related overdoses amongst our children and neighbors in our own communities, and is unacceptable by any standard. Legislators like Sen. Judson Hill are actively determined to form local task forces to combat the situation.
Compounding the issue has been the recent proliferation of illegitimate pain clinics, or “pill mills.” Such rogue clinics typically have illicit ownership ties to organized drug cartels, employ physicians without board-certification in pain medicine, do not offer non-narcotic therapies, dispense narcotics directly, employ armed guards, maintain minimal record keeping, and deal exclusively with cash pay patients from distant states. They function as thinly disguised narcotic traffickers to known drug abusers and distributors. South Florida was until recently the epicenter of pill mills in the United States due to its history as a narcotic trafficking hub since the 1970s. Following the establishment of stringent state regulations in Florida in 2011, many pill mill operators simply moved their operations to Georgia, with a 1400% increase in the number of rogue pain clinics that prompted our own statewide crackdown on this scourge.
There are also national security issues associated with opioid overprescribing. Afghanistan leads the world in poppy cultivation, with production surging to record highs in recent years. According to the State Department, the majority of illicit Afghan opium is smuggled to Pakistan en route to India, which is where most multinational pharmaceutical companies obtain their raw opium supplies due to the low cost. The explosion in American opioid consumption directly funds profiteering warlords and crime syndicates who often have ties to extremist groups that in turn target American lives.
Adding to clinicians’ confusion is pressure from patient advocacy groups to avoid undertreatment of pain. Patients with legitimate pain generators often confound the effects of analgesia and euphoria, posing a clinical challenge to their treating physicians. This is coupled with the inherent difficulty of treating pain, which is ultimately a subjective psychological perception.
Patients do not know if their pain is nociceptive or neuropathic. They cannot distinguish "muscle spasms" from radiculitis or vascular claudication. They do not understand the definition of a migraine or the concept of rebound headaches. They simply know that they hurt, and they are increasingly demanding of a pill that makes them "feel" better instantly. This potentially perilous scenario is even riskier in patients with coexisting anxiety and depression, which afflict a disproportionate amount of patients suffering from chronic pain.
Unfortunately, there is no evidence that opioids alone, without multimodal analgesic strategies to achieve functional restoration, provide any meaningful long-term benefit for chronic non-cancer pain. On the contrary, chronic opioid therapy for non-cancer pain is often associated with worse outcomes including confusion, frequent falls, motor vehicle collisions, opioid-induced hyperalgesia, and death. In other words, escalating long term usage of opioids often leads to a perpetuation of the symptoms they are intended to treat.
With such a precarious atmosphere of risk to both patients and prescribing physicians, it is easy to see why even the best trained and most well-intentioned clinicians on the front line have difficulty in treating difficult patients with complex pain. Furthermore, it behooves every clinician to be aware of the relevant regulations, policies, and programs recently enacted by the Georgia legislature, Georgia Composite Medical Board, State Board of Pharmacy, Drug Enforcement Agency, and Medical Association of Georgia to address this epidemic.
GCMB Rule 360-3-06 requires patients who are prescribed chronic opioid therapy to be seen and monitored for compliance at least every 90 days as well as a random basis with documented medical history, physical examination, informed consent, toxicology results, and appropriate diagnostic records. Schedule II narcotics must be personally signed by a physician with wet ink on tamper-resistant security paper. Physicians who prescribe Schedule II or III substances for chronic pain for greater than 50% of their annual patient population must document board certification or eligibility in pain medicine or palliative medicine.
House Bill 178 establishes licensing requirements for clinics treating greater than 50% of their patient load with Scheduled II or III controlled substances – any person operating such a clinic without a license is guilty of a felony. The DEA recently reclassified hydrocodone containing products as Scheduled II narcotics, which must be prescribed by a licensed physician, and tramadol is now a controlled substance in Georgia. MAG has done its part to help by organizing a grassroots marketing campaign named “Think About It” to educate patients regarding the risks of controlled substance diversion.
The new regulations make it clear that practitioners must refer patients to appropriate specialists such as board-certified pain physicians when indicated – as a medicolegal expert witness in professional liability cases of opioid overprescribing, I can personally add that this is emerging as a standard of care. Pain medicine is a medical subspecialty with its roots tracing back to the origins of anesthesiology in the late 1800s.
Surgical pioneers such as Karl Koller, William Halsted, James Corning, August Bier, and Theodore Tuffier experimented with regional anesthetic blockade using cocaine to render neural structures insensate. Modern pain medicine originated when John Bonica established an anesthesiology pain clinic at Tacoma General Hospital and published The Management of Pain in 1953. By the 1970s, luminaries like P. Prithvi Raj, Gabor Racz, Harold Carron, and Alon Winnie firmly established pain medicine as a subspecialty of anesthesiology - I myself am honored to have been trained by one of Dr. Winnie’s disciples.
Pain specialists recognize the utility of opioids in targeting receptors of the substantia gelatinosa but are also trained in utilizing peripheral interventions to reduce overall opioid exposure. Board-certified anesthesiology pain specialists typically prescribe opioids only within a well-defined patient-physician agreement that clearly outlines the risks of opioid therapy and offers such therapy as an adjunct to a multimodal plan of care with the goal of reducing opioid exposure to as low as reasonably achievable. Ideally, pain specialists can also offer an interdisciplinary plan of care involving pain psychologists, psychiatrists, and rehabilitation therapists as indicated.
Percutaneous radiofrequency ablation is perhaps the safest and most effective intervention offered by board-certified pain specialists, with excellent literature evidence of efficacy and high quality randomized controlled trials. RF ablation is medically necessary for pain mediated by the nerves that innervate zygapophyseal facet joints when bending and twisting the spine. Clinically, any patient who complains of activity-limiting pain when extending or rotating the neck or back should be evaluated by a pain specialist before initiating opioids to determine if the pain is indeed facet-mediated and amenable to RF ablation.
During RF ablation, the nerves that innervate spinal joints and cause overlying muscle spasms are stimulated until these muscles contract – once the location of the appropriate nerves is verified using electrical stimulation, the needle is heated to induce tissue thermocoagulation, endoneurial disruption, and impairment of pain signal axonal transport. The procedure is performed percutaneously in less than 15 minutes with minimal discomfort, does not require any incisions, and provides excellent relief of axial back pain that is superior to spinal surgeries such as laminectomy or spinal fusion.
For years, one of the mainstays of a pain specialist’s armamentarium was offering epidural injections to target neuraxial pain generators.
Epidural injections can be administered via an interlaminar, transforaminal, or caudal approach – the transforaminal route offers the most targeted administration of injectate volume to the site of disc pathology implicated in radicular pain. Increasing evidence is mounting that epidural injections with local anesthetic alone offer long-term therapeutic benefit in patients with radicular and/or discogenic pain by flushing away proinflammatory cytokines and densitizing dorsal root ganglia. The clinical significance cannot be understated, since administering local anesthetic only avoids the need for steroids and nearly eliminates concerns of iatrogenic risks of hyperglycemia, endocrine suppression, osteoporosis, meningitis, particulate embolization, and serious neural injury from epidural injections, while potentially avoiding the need for invasive surgery.
Fluoroscopic guidance can also improve outcomes of intraarticular joint injections and allow patients with degenerative joint disease to avoid invasive surgical intervention. In addition, there is increasing evidence that opioids exert effects on peripheral nociceptors in addition to central receptors, and that targeted fluoroscopic intraarticular or perineural opioid administration may provide profound analgesic effects while minimizing systemic exposure.
Spinal cord stimulation is medically necessary for intractable neuropathic pain of the trunk and limbs. This revolutionary treatment has a long track record of safety since the 1970s, but only recently has computer technology evolved to the point of offering increasingly sophisticated technological advancements such as improved programming algorithms, MRI compatibility, wireless recharging, and patient positional feedback. Spinal cord stimulation is typically offered to patients with post-laminectomy failed back surgery syndrome or complex regional pain syndrome (CRPS) / reflex sympathetic dystrophy (RSD) affecting the limbs.
Referring physicians should also be aware it is proven to be effective in treating refractory angina pectoris and vascular claudication not amenable to revascularization, as well as other difficult to treat syndromes that cause pain such as irritable bowel syndrome (IBS), ulcerative colitis and Crohn's disease, pancreatitis, interstitial cystitis, prostatitis, and pelvic pain. The sympathectomy effects of spinal cord stimulation not only reduce pain but can also modulate bowel and genitourinary function to improve quality of life.
In conclusion, here are twelve simple suggestions for the clinician confronted with a patient suffering from chronic non-cancer pain:
1.) Do not undertreat pain, but recognize your limitations in resources, training, and skillset if you cannot offer a true multimodal analgesic plan for your patients. Follow analgesic guidelines from the World Health Organization, obtain relevant imaging studies, and refer to a board-certified pain specialist when appropriate.
2.) Do not initiate chronic opioid therapy to treat degenerative conditions without considering evaluation by a board-certified pain specialist who offers multimodal analgesic strategies to keep opioid dosing as low as reasonably achievable
3.) The majority of acute tissue injury and inflammation severe enough to require opioids typically subsides within 72 hours. Supplies of potent opioids for acute pain should ideally be limited to this time frame. I personally do not recommend prescribing potent opioids for acute pain for longer than 5-10 days.
4.) All hydrocodone containing products are now classified by the DEA as Scheduled II controlled substances. Consider tramadol instead when appropriate. Remaining Scheduled III opioids include Tylenol #3 and Butrans, which is a topical patch containing a partial opioid agonist that is difficult to abuse or divert and lasts 7 days. I personally recommend Butrans as the opioid of choice for chronic degenerative conditions if patient access and tolerance are available. Notably, Butrans is now covered by Georgia Medicaid for less than $3 out-of-pocket.
5.) Patients requesting a refill of opioids should strongly be considered for referral to a board-certified pain specialist. Do not prescribe opioid supplies for greater than 72 hours by telephone
6.) Do not prescribe opioids for fibromyalgia – the therapy of choice for fibromyalgia is aerobic exercise.
7.) Do not prescribe opioids for headaches. If occipital neuralgia or cervicogenic headache is suspected, a pain specialist referral is indicated. Otherwise, consider evaluation by a neurologist.
8.) Take great precautions in prescribing opioids to young patients. Early exposure to opioids is correlated and often causative of misuse and abuse. Federal guidelines identify patients under 25 as at high risk for opioid aberrancy issues. Personally, I recommend careful evaluation and heightened risk stratification of any patient under the age of 40 requesting opioids.
9.) Take great precautions in prescribing opioids to patients with coexisting anxiety and depression, particularly due to heightened professional liability risks. In certain states it has been established that the medicolegal standard of care in these patients is to seek formal consultation from a board-certified pain specialist and/or psychiatrist. Avoid prescribing anxiolytics and opioids together, and consider utilizing validated instruments such as the Opioid Risk Tool and Pain Catastrophizing Scale to evaluate the relative risks and benefits of initiating chronic opioid therapy for a particular patient.
10.) If a patient’s urine drug screen monitoring reveals any non-prescribed controlled substance, including cannabinoids, I strongly recommend consideration of discontinuing opioid therapy with referral to an addictionologist. Patients who are engaged in the unauthorized acquisition of any controlled substance are likely to consider diverting their prescribed opioid supply to their contacts.
11.) Do not prescribe muscle relaxants round-the-clock or for extended periods of time due to upregulation of junctional receptors. True paraspinal muscle spasm requiring more than 2 to 6 weeks of muscle relaxant therapy is an indication for referral to a board-certified pain specialist to consider RF ablation to treat facet-mediated pain.
12.) Consider NSAID therapy when appropriate, keeping in mind to monitor regularly for cardiovascular, gastrointestinal, and renal effects. A recent landmark article in Lancet funded by the UK Medical Research Council identified naproxen as the "safest" NSAID with lowest cardiovascular risk. I personally recommend adding esomeprazole therapy to any NSAID to further reduce GI risks.
By Advanced Pain Solutions - V.K. Puppala, M.D.ABOUT THE AUTHOR: V.K. Puppala, M.D.
Anesthesiologist & Pain Physician Expert Witness
Anesthesiologist & Pain Physician Expert Witness
Dr. Puppala is double board-certified in anesthesiology and pain medicine with expertise involving major catastrophic claims.
Copyright Advanced Pain Solutions - V.K. Puppala, M.D.
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer.For specific technical or legal advice on the information provided and related topics, please contact the author.