Regulatory Issues

CHAPTER 36 REGULATORY ISSUES



Ellen Cooper, MS




1. Do patients with painful medical conditions generally receive adequate treatment for pain?


No. Both acute pain and chronic pain caused by cancer are generally undertreated. This is particularly true of treatment with opioid drugs. Surveys of patients in the postoperative period demonstrate that up to 75% suffer pain of moderate or severe intensity. Because virtually all postoperative pain can be controlled with proper medication, an alarmingly high number of patients suffer from unnecessary pain. Similarly, in patients with advanced cancer, simple drug regimens can provide relief for more than 70%. However, 70% of patients with advanced cancer still report significant pain! On a global scale, the statistics are even more alarming. More than 3.5 million people suffer from cancer pain, but only a small fraction receives adequate treatment. This is particularly striking in view of the fact that pain can be controlled with appropriate drug regimens in approximately 90% of these patients.



2. What factors stand in the way of adequate pain treatment?


Barriers to good analgesic therapy exist on the professional, societal, and governmental levels. From a professional point of view, physicians and nurses often have the misconception that the prescription of opioid medications will lead inexorably to tolerance, dependence, and addiction. Even physicians who understand that this is not true tend to underprescribe medications, possibly because of fear of other side effects. Furthermore, worry about regulation by outside agencies also tends to impede a physician’s prescribing practices. Many physicians do not understand government regulations on opioid prescribing, and their concerns are often unjustified. Certain government regulations, however, do limit prescribing practices. For example, in states that require a triplicate prescription for opioid medications, opioid prescribing decreases by about 50%.


Patients also have many misconceptions about opioids. Their fear that the opioids represent a “last-ditch effort” makes them reluctant to take these drugs early in their disease. They also may be afraid of addiction, other side effects, or the societal stigma that goes along with taking opioid medications.



3. Are patients with medical illness and no history of substance abuse at significant risk of addiction if opioids are administered?


Studies in patients with cancer have demonstrated that the main reason for escalating drug intake is progression of disease rather than aberrant behavior. This same pattern has been demonstrated in patients with pain caused by noncancer conditions. Although tolerance and physical dependence may occur, addiction is a rather rare phenomenon in patients treated appropriately with opioid medications for their pain. (See Chapter 35, Addiction and Pain Management.)



4. What are the differences among opiates, opioids, and narcotics?


“Opioid” is a generic term used to refer to codeine, morphine, and other natural and synthetic drugs whose effects are mediated by specific receptors in the central and peripheral nervous systems. The original term, “opiate,” was taken to mean any derivative of Papaver somniferum, the poppy plant that produces opium. Opioid also includes the endogenous opioids, such as endorphins and enkephalins.


The term “narcotic” was initially used to denote a drug capable of producing sleep (narcosis). It was mainly applied to the opioids. However, narcotic is now more of a legal term, used in reference to all substances covered by the 1961 Single Convention on Narcotic Drugs, including opiates as well as synthetic substances such as meperidine and fentanyl. The term covers not only the opioids but also cocaine and many other drugs of abuse.



5. At what governing levels do drug regulations exist? How do they pertain to individual practitioners?


There are three tiers of drug regulations: international, federal, and state. The regulation of professional practice in medicine, nursing, pharmacy, social work, and other professions occurs at the state, and not the federal, level. There have been a number of recent changes in state laws, because of concerns about inappropriate discipline of physicians for prescribing opioid analgesics.



6. What is the historical background that led the federal government to become involved in monitoring opioids?


Twentieth-century governments recognized the dangers of abuse and trafficking of opioids, including opium, morphine, and heroin. Concerns, particularly about the opium trade in China and the Philippines, prompted governments throughout the world to join together and set controls on the ever-increasing diversion of illegal substances.


Studies of addicts in the 1950s and 1960s seemed to show that many addicts had their first exposure to opioids from prescriptions during a painful illness. The finding was incorrectly extrapolated to suggest that medical treatment was a common cause of addiction.



7. What is the International Narcotics Control Board?


The International Narcotics Control Board (INCB) is a Vienna-based arm of the United Nations International Drug Control Program. It monitors the implementation of the Single Convention on Narcotic Drugs, an international treaty. The INCB recommends steps that governments and health professionals should take to address this problem.



8. What do governments perceive as the major impediments to the medical use of opioids?


In a survey of 65 governments performed by the INCB, concern about addiction was the most frequently stated impediment to the medical use of opioids; this concern appeared in 72% of statements. The next most frequently stated issue was insufficient training of health care practitioners. Sixty-five percent of the governments surveyed reported that they had national policies to improve the use of opioids.



9. Are legal restrictions on opioid prescriptions prevalent throughout the world?


The following is a quotation from literature produced by the World Health Organization (WHO) that addresses cancer pain:


The WHO has observed that physicians and pharmacists may become reluctant to prescribe or stock opioid analgesics due to strict requirements and fear of punishment. In the survey, many governments reported they required special government-issued prescription forms and other special permissions. The maximum sentence for a physician who fails to comply with prescriber requirements is 22 years in prison; the maximum fine afforded is up to 1 million dollars. Some governments reported having mandatory minimum penalties as high as 10 years in prison for such offenses. Forty-three percent of the governments required health professionals to report patients who receive opioid prescriptions.


None of the regulations in the United States are as stringent as this statement indicates. The majority of U.S. legislation is aimed at avoiding diversion of drugs rather than regulating appropriate prescribing practices.



10. Which federal legislation regulates the prescribing practices of opioid analgesics?


The Harrison Narcotic Act of 1914 is the hallmark legislation that marked the federal government’s interest in the prescribing and controlling of opioids. In 1961, the INCB was established to receive reports from governments about the movement of opioids and to ensure that supply and demand for opioids were in balance, hoping to prevent undersupply for legitimate purposes. All governments involved are required to furnish the INCB with statistics on an annual basis. In 1971, the Federal Comprehensive Drug Abuse Prevention and Control Act repealed all previous laws and took over the control of prescription drugs. Opioids and drugs with potential for abuse were placed into five schedules.


Hill (see Bibliography) summarized the source of the government’s authority to regulate as follows:

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Jun 14, 2016 | Posted by in PAIN MEDICINE | Comments Off on Regulatory Issues

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