Opioids Part IV

By Frank G. Vice, DVM, BS Pharm

Opioids Part IVIt has been said “America is in a war against drugs”, a statement that seems especially true for the state of Kentucky. During a recent interview, President Trump stated, “A stronger law enforcement response is needed to combat the opioid crisis”. While speaking, Tom Price, Secretary of Health and Human Services, and the acting Director of National Drug Control Policy, Richard Baum, stood nearby.  President Trump continued in his interview by stating, “It’s a problem the likes of which we have never seen, meanwhile, the overall drug prosecutions have gone down in recent years.” The president’s statements concerning the current opioid crisis appear to focus on a narrow solution. The fact is, every president during the past 60 years has dedicated ambitious efforts, using a variety of methods, attempting to correct drug abuse, but the problem continues. The nation’s abusive drug problem has festered for years, with an escalation in the past 20 years in abusive opioids prescriptions. Prior to 1990, these controlled products were selectively used to medically manage pain. However, opinions directed toward pain control changed during the late 1990’s, placing an emphasis on controlling all types of pain, especially chronic pain or pain diagnosed as non-cancer pain. This attitude change was influenced by medical organizations who notified physicians they were not adequately treating pain and ultimately, not prescribing adequate pain medication to their patients. Doctors were advised to regard pain as a diagnostic vital sign along with heart rate, respiration rate and body temperature. Physicians were instructed to rate pain according to the current pain standards of that day, which would allow better pain control. Additional recommendations urged physicians to use more opioids to control pain which would allow patients to heal faster with a better quality of life. During this time, the availability and appropriate use of legal opioid prescription analgesics were being medically promoted with greater intensity. Florida physicians embraced this new philosophy and began evaluating each painful patient more closely, attempting to manage symptoms of pain, and ultimately writing more pain control prescriptions. During the 1990’s, and extending to 2014, there was a four-fold increase in physician generated opioid prescriptions.  The most commonly written opioid prescriptions were hydrocodone and oxycodone, which are DEA schedule ll medications with strong addictive and abuse potential.

The medical philosophy of the day suggested that legitimate opiate use, designed to control pain, was actually a safeguard against abuse and addiction.  It was believed painful people simply wanted their pain controlled and drug dependency would occur in only about 1% of these patients. Many physicians were told and considered prescription opioids to be safer, having fewer side effects than many of the over-the-counter products.  A new emphasis on pain management led to the growth of pain clinics throughout the nation, especially in Florida which ultimately became a legal “Pill Mill Industry”. Many states allowed ownership of storefront pain clinics, which offered quick physical examinations to evaluate patients for pain, then ending the examination with a narcotic prescription. Florida physicians, anxious to meet the pain demands, were ready to evaluate painful patients and write narcotic prescriptions by the thousands. During those days there were no legal restrictions.  Pain clinics could be owned by anybody and were opening all over Florida. Pain management was becoming a big business. Patients flocked to Florida, realizing they could obtain as many narcotic prescriptions as they wanted with little concern about drug abuse and dependency. For years, the Florida pain clinics were opioid drug distributors with a direct pipeline into Kentucky.

This became a way of life, traveling to Florida, doctor shopping for prescriptions, then returning to Kentucky with hundreds of OxyContin tablets ready to sell throughout eastern Kentucky, eventually spawning an illegal drug industry. Finally, the Florida pain clinic industry was exposed in a 2009 documentary titled “Vanguard, The OxyContin Express”.  The documentary revealed the extent of narcotic abuse, originating from storefront pain clinics throughout south Florida. It was reported that Florida was a “pill poppers paradise” with OxyContin, the drug of choice, being prescribed five times the national average by the top 50 prescribers in the nation. Eventually law enforcement, along with emergency room physicians, recognized an increase in opiate prescription drug abuse, dependency, overdose and death.  Many of the emergency room patients had opiate medication bottles with addresses from Florida. Kentucky was leading the nation in prescription narcotic abuse, dependency, overdose and death.

In light of Kentucky’s out-of-control opioid prescription drug abuse problem, medical authorities decided to reconsider pain control options. It was determined, based on research with painful patients, that a new pain management approach must be developed.  Therefore, non-cancer painful patients would be evaluated based on whether their symptom of pain was acute or chronic in duration. The new pain control management recommendations were different for each group. Basically stated, current studies by the Center for Disease Control, CDC, evaluated to main groups of non-cancer painful patients. One group was evaluated with acute non-cancer pain and one group with chronic non-cancer pain. It was determined, with strong evidence, that opioid use for acute short term pain management is appropriate when the pain is expected to last less than three months. However, when researchers considered chronic non-cancer pain lasting longer than three months, they found a lack of evidence supporting any benefit from chronic narcotic use non-cancer pain. The research indicated that opioid use to control chronic non-cancer painful patients is less likely to functionally restore these patients. Therefore, this new research offered no strong evidence that chronic narcotic use was appropriate, which was a complete opposite determination from research a decade earlier. However, the patient population that is the exception to this research is the hospice or palliative care patient that is experiencing debilitating cancer or other life ending illness which deserves special attention since their therapy goals have a different intention.

However, in the 1990’s, there were limited guidelines and essentially no laws in place to help monitor the escalating drug abuse problem. No one understood the magnitude of abuse until the urgency of the problem was recognized by community and social leaders. It was because of multiple opiate overdoses and increases in drug related deaths throughout the commonwealth, that legislators of Kentucky’s General Assembly were motivated to develop regulatory guidelines restricting prescription narcotic use. As a result of strong collaborative oversight, the 2012 Kentucky General Assembly passed House Bill 1 (Kentucky Controlled Substance Regulation) which focused on pain clinic regulation and prescription drug abuse. A part of this legislation involved strengthening the prescription drug monitoring program (PDMP). This is a state-run electronic database system used to identify the prescribing and dispensing histories of patients using controlled substances. This electronic data helps monitor narcotic prescription misuse along with patient doctor shopping attempting to collect additional opiate prescriptions.

The PDMP established in Kentucky is referred to as KASPER, Kentucky All Schedule Prescription Electronic Reporting, which is an electronic database collection system designed to be used by doctors and pharmacies in an effort to monitor narcotic prescriptions. This type of prescription monitoring database is operational in 49 of the 50 states.  Kentucky’s regulatory agencies developed opioid prescription guidelines, including KASPER, which helped to identify opioid prescription abuse. However, just as these goals were achieved, an unintentional consequence of these regulatory efforts helped to push drug abuse and dependency into the hands of street criminals.

Since legal narcotic prescription opioids were now more difficult to obtain, illegal street sources collected prescription opioids and sold them at inflated prices. This potent group of unregulated opioids created an epidemic of abuse with a population of young adults who would suffer the greatest harm. A further unexpected result was a shift from opioid prescription drugs to heroin and fentanyl, which offered more potency and danger of death with overdosing. Opioid abusers do not get their euphoria from orally popping pills. Their true euphoria is accomplished by crushing and mixing the powder for intravenous injection. Pharmaceutical companies understood the tablet crushing techniques used by abusers and began developing narcotic tablets that were insoluble and resisted crushing. Just as opioids were getting harder and more expensive to obtain, abusers were developing a tolerance to prescription opioids, driving a desire for more potent chemicals to deliver more euphoria. The desire for more potent abusive drugs created avenues for abuse from heroin and other synthetic opioids. Opiate tolerance and euphoric urges drove abusers to use heroin since it is more potent and cheaper than prescription opioids. Heroin’s abundant supply provided a rapid growth in its abuse in just a few of years, affecting not only larger cities but small rural communities throughout Kentucky. Heroin became the right abusive drug at the right time.

The author wishes to thank the following educational sources for their literary contributions; Christopher Stock Pharma D, August 2016” The Rx Consultant, “Opioid Prescriptions”, Christopher Stock Pharma D, October 2015, The Rx Consultant, “Opioid Overdoses and Naloxone Rescue Kits”, DrugRehab, “ Florida’s Opioid Crisis Fueled by Pill Mills,” US pharmacist March 2017, Managing Pain in the Opioid Tolerant Patient”, KASPER, Kentucky Cabinet for Health and Family Services, ky.gov

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