Opioids and the Law




© American Academy of Pain Medicine 2015
Timothy R. Deer, Michael S. Leong and Vitaly Gordin (eds.)Treatment of Chronic Pain by Medical Approaches10.1007/978-1-4939-1818-8_13


13. Opioids and the Law



Selina Read  and Jill Eckert2, 3  


(1)
Department of Anesthesiology, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, 500 University Drive, H187, Hershey, PA 17033, USA

(2)
Pennsylvania State University College of Medicine, Hershey, PA, USA

(3)
Department of Anesthesiology, Pennsylvania State Milton S. Hershey Medical Center, 850, Hershey, PA 17033, USA

 



 

Selina Read (Corresponding author)



 

Jill Eckert





Key Points



  • Opioids have been used for medicinal purposes since as early as 3000 B.C.; problems such as abuse and addiction have also been reported alongside.


  • Understanding the definitions, incidence, and cost of chronic pain is important for anyone who will be prescribing these medications.


  • The clinician must become familiar with both state and federal laws pertaining to opioid prescribing. Not adhering to both state and federal laws can put the prescriber at risk.


  • Clinicians who prescribe opioids must be well versed in detecting abuse and be able to find avenues for treatment of both the abuse alongside with the chronic pain issue.


  • Prescription monitoring programs have become a valuable tool in preventing diversion of controlled substances.


Introduction


As physicians, one of the most important aspects of our job is the alleviation of pain, both acute and chronic. Opioids have been an integral part of easing pain for thousands of years and continue to play an important role in the medical landscape today. The downside of these often powerful medications is the possibility of those taking them to become addicted and divert them away from the intended use.


History of Opioids and the Law


The earliest use of opioids dates back several thousand years, where in 3000 B.C. residents of Sumer, what is modern-day Iraq, used opium for both its medicinal and recreational characteristics. Hippocrates, one of the most important Greek physicians of his time, used opium to cure several ailments ranging from headache to depression. Other ancient Greeks and Romans used opium to relieve aches and pains. They also used opium for entertainment, enjoying the euphoric effects. Opium made its way to Europe and China sometime in the tenth century when Arab traders brought it from the Middle East. This efflux into Europe brought with it many of the problems we face today, namely, addiction. As early as the sixteenth century, manuscripts can be found discussing addiction and tolerance. It may be China that experienced the most problems with abuse in the seventeenth century when tobacco was outlawed, and the population began smoking opium as an alternative. There are no records of any of these ancient civilizations trying to pass laws to decrease or ban the use of opioids; however, many records indicate that abuse was prevalent and caused problems in society.

It wasn’t until the nineteenth century when chemist Friedrich Sertürner isolated the active ingredient in opium that this plant found its birth in modern medicine. Sertürner named this isolated chemical morphine, after the Greek god of dreams, Morpheus. The safety of morphine was marginal as evidenced by untreatable respiratory depression which caused several deaths. Many companies began the search for a “safer, nonaddictive” opioid. Chemical modification of morphine began at the end of the nineteenth century when German chemists added two acetyl groups to the drug, forming heroin. This modification allowed the opioid to dissolve faster through the blood-brain barrier, making it twice as potent. Interestingly, this German company, known as Bayer, marketed heroin as a cough suppressant. Unfortunately, heroin had the same addictive properties and dangers as morphine, and the search continued into the twentieth century where meperidine and methadone were added to the physician’s arsenal. An important discovery by Wejilard and Erikson in the middle of the twentieth century was nalorphine, the first opioid antagonist, providing clinicians the ability to reverse the dangerous effects of opioids [1].

As opioid use became more widespread, the United States government started placing heavy taxes on the medications, in an attempt to prevent unintended usage. The International Opium Convention of 1912 committed governments to restrict trade of these substances to medical and scientific purposes only. In 1924, the US banned all nonmedical use of opioids along with creating the Permanent Central Opium Board, which became the agency in charge of determining whether there was too much or too little opioid production around the world. The US government passed the federal Controlled Substance Act in 1970 which scheduled opioids according to their abuse potential. This act prohibited the use of opioids by any individuals not under a physician’s care and assured the safety of the medications being prescribed. Then, in 1990, the International Narcotics Control Board, which was initially formed in 1961 to unite all the international agencies under one umbrella, determined that opioids are not sufficiently available for legitimate medical purposes and called for governments to take corrective actions to repair the problem [2].


Important Definitions


When discussing opioids, certain terminology must be understood to apply the prescribing laws, treating pain in patients with addiction/dependence and understanding a clinician’s practice. Furthermore, not understanding or mislabeling definitions may actually hinder effective pain treatment, leading to unnecessary suffering.

In 1999, the American Academy of Pain Medicine, the American Pain Society, and the American Society of Addiction Medicine formed the Liaison Committee on Pain and Addiction (LCPA), allowing collaboration between these groups to develop consensus definitions regarding terminology. Prior to this, most clinicians would use the World Health Organization’s definitions along with the DSM and ICD-10 classifications; however, consensus was needed because practitioners need a way to communicate in the same language, along with easily understood definitions to implement into their practice [3].

Addiction is defined as a primary, chronic, neurobiologic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, or continued use despite harm and craving.

Physical dependence is defined as a state of adaptation that is manifested by a drug class that causes specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of antagonist.

Tolerance is defined as a state of adaptation in which exposure to a drug induces change that results in a diminution of one or more of the drug’s effects over time.

Clearly, both addiction and physical dependence can occur in the same patient; however, it is important to realize that physical dependence does not equal addiction. It is essential to understand that even though these are universally understood definitions, often state and federal governments have their own defined terminology. Whenever prescribing opioids, the prescriber should review not only the above definitions but also those set forth by their respective governing agencies they are prescribing under.


Incidence of Pain and Its Cost


It is expected that a patient will have pain following acute injury such as trauma or surgery; this pain is generally easily treated with current therapies, including opioids for short periods of time. Chronic pain presents a different set of problems due to the length of time needed for treatment, and the increasing dosage of medications that occurs with tolerance.

Chronic pain is defined as pain that persists beyond the usual course of an acute disease or pain that is not amenable to routine pain control methods. The prevalence of chronic pain ranges from 2 to 40 % in the adult population [4]. A survey in 1999 found that almost half of American households had at least one family member who suffers from chronic pain. The same survey found that one third of chronic pain sufferers did not feel they could function in society due to their pain; a majority of them felt that the pain was so horrible that they sometimes wanted to die [5]. More recently, a study from 2011 found that at least 116 million American adults suffer from pain, more than those affected by heart disease, cancer, and diabetes combined [6].

All of this adds up to billions of dollars in costs each year, $635 billion to be exact [6]. It is projected that the health-care costs of patients with chronic pain may exceed the cost for treating patients with coronary artery disease, cancer, and AIDS combined [4].


How Common Is Abuse?


The statistics regarding abuse of prescription drugs is startling. In 2004, an estimated 19 million Americans, or 8 % of the population, admitted to abusing illicit drugs in the past year, and more than half of the public has tried an illicit drug during their lifetime [4]. The National Co-morbidity Study suggests that up to 14 % of Americans will develop alcohol addiction, and up to 7.5 % will develop addiction to illicit drugs over their lifetime [3]. According to the DEA, more than 6 million Americans are abusing prescription drugs – more than the number abusing cocaine, heroin, hallucinogens, and inhalants, combined. In the past 20 years, more people began abusing prescription pain medications (2.4 million) compared with marijuana (2.1 million) or cocaine (1.0 million) [4].

There are many types of prescription drugs abused, including opioid analgesics, tranquilizers, stimulants, and sedatives. About 75 % of the abuse is in the opioid analgesic class, with OxyContin, hydrocodone, Vicodin, morphine, and Dilaudid being the most commonly abused [4].

Although the true extent of prescription drug abuse is unknown, 10 % of patients receiving treatment for illicit drugs abuse prescription drugs only. The number abusing prescription medications is staggering, and the figures are climbing each year. Between 1992 and 2003, the United States population increased by 14 %; however, prescription drug abuse increased 94 %. During this time, the abuse rate for 12–17-year-olds increased 212 %, and it is known that those teens who abuse prescription drugs are more likely to abuse other illicit drugs such as alcohol, marijuana, cocaine, and heroin [4].

Demographics regarding abuse are varied, with the two extremes of age appearing to be the most susceptible. In 2004, the number of adolescents abusing tobacco, alcohol, marijuana, cocaine, and heroin appeared to be decreasing; however; this may be linked to an increase in the rate of prescription drug use. Monitoring the future, which is an epidemiological and etiological research project based at the University of Michigan, reported that OxyContin use among 12th graders increased almost 40 % over the previous 3 years. At the other extreme of age is the elderly who often are taking multiple prescriptions, which may lead to abuse or unintentional misuse [4].

Abuse is frequent in patients being treated for a chronic pain conditions, 15 % are concomitantly abusing prescription drugs, while 35 % are abusing illicit drugs. The direct cost of medical care is staggering in a pain clinic for those who abuse opioids, costing approximately $15,000 a year, compared with $1,800 for those on opioid therapy not abusing the prescriptions [4].


Possible Causes for Increased Abuse


It’s not completely clear why there is such a significant rise in abuse rates. Some postulate it’s due to increased supply, rising street values, and perceived safety of prescription medications in the general public [4].

Increased supply and demand can certainly play a large role in the ability of abusers to obtain controlled substances due to the simple fact that more medications being prescribed lend to more being available. The estimated number of prescriptions filled for controlled substances has been increasing dramatically since the early 1990s. Approximately 222 million controlled substance prescriptions were filled in 1994, compared with 354 million in 2003. This represents a 154 % increase in prescription filled for controlled substances contrasted with only a 57 % increase in all other prescription medications [4].

The street value for controlled substances is staggering; these medications sell for much more than most illicit drugs. Just a few examples will help the reader understand. The cost of 100 OxyContin 80-mg tablets to insurance is $1,081; the estimated street value for this same amount is $8,000. The pharmacy cost for 100 4-mg Dilaudid tablets is $88 where the street value is $10,000 [4]. Drug dealers will do almost anything to obtain prescriptions for these controlled substances because there is a large profit margin to be made.

The public may believe that prescribed medications are safer than the similar illicit drugs that may be found on the street. Most feel that if a doctor prescribes the medication, it must be safe. Furthermore, the acquisition of licit drugs poses much less of a threat, compared with purchasing a similar drug on the street.


Sequelae of Abuse


The increased incidence of prescription drug abuse has led to many socioeconomic problems. One of the most serious is an increase in the number of deaths due to unintentional overdose. According to the Centers for Disease Control and Prevention, the number of fatal poisonings due to prescription drugs increased 25 % from 1985 to 1995. The number of overdoses due to prescription opioids now surpasses both cocaine and heroin overdoses combined. Paulozzi et al. [5] hypothesized that this increase in fatal poisonings was linked to an increase in opioid prescriptions by physicians. They found that at the end of the 1980s, pain specialists began to argue that the risk of addiction should not prevent opioid analgesics from being prescribed for nonmalignant pain. This increased utilization of opioids for pain was linked to an increase in the sales of opioids and, not surprisingly, the number of deaths due to prescription opioids [5]. However, it is not completely clear that there is a cause and effect relationship. More information and further studies will need to be completed before definitive conclusions can be formed.

Abuse puts a significant strain on society, costing nearly $200 billion dollars a year. This cost comes from medical costs from misuse, crime involved supporting diversion/addiction, loss of productivity and wages, and cost of law enforcement. The illicit drug market was estimated at $322 billion dollars a year [5].


How Will This Affect Your Practice?


In the United States and around the world, pain goes untreated and undertreated every day. This inadequate treatment has been attributed to a lack of knowledge of pain management options, inadequate understanding of addiction, or fears of investigation and sanction by federal, state, and local regulatory agencies [4].

In response to this, multiple advocacy groups and professional organizations have been formed, with the goal of improving pain management. The Joint Committee on Accreditation of Healthcare Organizations labeled pain as the fifth vital sign and suggested hospitals use some form of pain assessment in all patients, allowing for more prompt and thorough treatment [3].

Nearly 90 % of patients being treated in a pain management setting are receiving opioid therapy, with many actually being treated with more than one type of opioid [4]. In order to protect yourself and your patient’s well-being, it is vital to understand the laws governing prescribing of these medications. It’s also essential to understand addiction, or have a specialist’s advice, to help diagnose and adequately treat patients.


Federal Law


In 1973, the DEA was established to serve as the primary federal agency responsible for the enforcement of the Controlled Substances Act, which sets forth the federal law regarding both licit and illicit controlled substances. The Practitioner’s Manual is designed to explain the basic federal requirements for prescribing, administering, and dispensing controlled substances to professionals, including physicians, mid-level providers, dentists, and veterinarians. The authors are explicit in explaining that the manual and the laws that guided its writing are not intended to hinder the practitioner’s ability to treat pain, but to safeguard society against diversion [7].

In the United States, the Controlled Substances Act (CSA) placed controlled substances into five schedules. Substances are placed into their respective category based on whether they have an accepted medical use and the probability of causing dependence when abused. Schedule I drugs have no accepted medical use, with a very high potential for abuse. Some examples from this class are heroin, lysergic acid diethylamide, marijuana, and peyote. Schedule II substances have a high potential for abuse with severe psychological or physical dependence. Some examples include morphine, codeine, hydromorphone, fentanyl, and meperidine. Schedule III substances have a potential for abuse that is less than schedule II, including narcotics which contain less than 15 mg of hydrocodone and products that contain less than 90 mg of codeine per unit dosage. Schedule IV substances have a lower potential for abuse compared with schedule III and include partial agonist opioids, benzodiazepines, and long-acting barbiturates. Schedule V substances have the lowest potential for abuse and include most of the antitussive, antidiarrheal, and less potent analgesic medications.

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Oct 21, 2016 | Posted by in PAIN MEDICINE | Comments Off on Opioids and the Law

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