OFFICIAL NAMES: Dilaudid, Dilaudid-Hp, Hydrostat
STREET NAMES: Drug store heroin, dillies, little d, lords, big d, d's, delats, delaud, delantz, delida
DRUG CLASSIFICATIONS: Schedule II, narcotic analgesic
Hydromorphone is a semi-synthetic prescription drug that has similar pain-relieving properties to that of morphine and codeine. It is classified as an opioid or narcotic analgesic. It is an effective treatment for moderate-to-severe pain and is sometimes used in patients with a non-productive cough. It is used to treat several types of pain, including headache, cancer pain, and back pain.
Hydromorphone is formed by making a slight alteration to the morphine molecule. The primary active ingredient in hydromorphone is thebaine. Thebaine is one of several compounds called alkaloids that are found in all narcotic analgesics. Thebaine is a word based on the name of the ancient Egyptian city of Thebes. The residents of Thebes are known to have harvested significant amounts of opium from the poppy plant variety known as Papaver somniferum. Hydromorphone provides pain relief by bonding with specific pain receptors in the body. The pain-relieving effects of hydromorphone are very similar to those provided by morphine, but hydromorphone is actually more potent.
Hydromorphone is in the opiate family of drugs. The opiates and their semi-synthetic and synthetic descendants are big business for legal and illegal entities. Some 30 million prescriptions and orders are written annually in the United States alone for controlled substances, many of these for narcotic analgesics. A large part of the international illicit drug trade involves the sale of drugs in the opiate family. A substantial amount of crime committed in the world is linked with this drug trade and with illicit drug use.
Hydromorphone and its natural opioid relatives have been used to relieve pain, treat a variety of ailments, and create euphoric feelings at least as far back as the time of the ancient Greeks. In early Greek history, the priests controlled the use of opium and ascribed to it supernatural powers. In the fifth century BC, Hippocrates, the "father of medicine," dismissed the super-natural attributes of opium. Hippocrates believed opium had cathartic, narcotic, hypnotic, and styptic properties. He believed that all diseases had a natural origin and could be cured by natural therapies. All of the natural opiates historically were derived from opium poppy plants. The liquid extracted from the poppy seeds was typically dried to create a concentrated powder. These extracts were then smoked, eaten, or drunk.
From the world of the ancient Greeks, word of the powerful properties of opium spread quickly to the Romans. The Romans not only used opium as a painkiller and for religious rites, but also considered it an excellent poison. In the case of suicide, it was considered a pleasant means to exit this world. Somnus, the Roman god of sleep, was often depicted as a small boy who carried around poppy flowers and an opium horn. After the collapse of the Roman Empire, the use and knowledge of opium spread to the Islamic world, where considerable study of the drug was performed.
After many centuries of declining use, opium began to reappear in Europe around the beginning of the Renaissance. Opiate use steadily increased over the next few centuries, reaching a new high in the nineteenth century. It was widely used by artists and writers during the Romantic Era.
Opium was first cultivated and processed in England during the ninteenth century. It was commonly used as a sedative and painkiller. However, it was also used to treat fever and diarrhea. At this time in history, diarrhea was a major killer. Opium, with its constipating effects, proved to be effective in treating various types of serious diarrhea, especially that associated with cholera. The problem of addiction to opiates, long recognized even at this time, was largely ignored.
The active components of opium were not isolated until the first half of the nineteenth century. The first of these components to be isolated was morphine, named for Morpheus, the Greek god of dreams. Soon after, other alkaloids in the poppy were isolated, such as codeine in 1832, narceine in 1832, thebaine in 1835, and papaverine in 1848. The later invention of the hypodermic needle allowed opium to be delivered in greater concentrations and with greater rapidity to patients in severe pain. Morphine injections were used to treat a variety of complaints, including menstrual pain, eye inflammation, and rheumatism. Unfortunately, it also led to greater abuse of the drug for non-medicinal uses.
Heroin was first created in 1874 by boiling a solution of morphine and acetic anhydride. Heroin is an extremely concentrated form of opiate that was initially hailed as a miracle drug. Heroin acts quickly in the body, where it is immediately converted into morphine. Heroin is more fat-soluble and, because of this, can enter the central nervous system much more readily than morphine. It has five to eight times the analgesic power of morphine, but it was originally sold as a cough suppressant and treatment for respiratory ailments. Heroin was widely used in the United States and Europe in small quantities in cough lozenges and elixirs.
All of the opiates were legal and freely-available drugs in the United States and most other countries until the early part of the twentieth century. It was at this point that opiates began to be taxed and regulated not only in the United States but also throughout the world. The twentieth century was characterized by a division of the opiate family into the legal production of compounds, such as morphine, codeine, and hydromorphone for legitimate medical purposes and, on the other hand, the illegal production and distribution of heroin and other illicit narcotics for recreational purposes. The legitimate production of narcotic analgesics has led to innovative and effective means to alleviate pain as well as to ensure the purity and safety of the given drug. The legitimate pharmaceutical industry has also developed drugs to help treat various types of opiate addiction.
Most of the illegal opiates, especially heroin, enter the United States through the Mexican border. According to some law enforcement officials, heroin use may be supplanted in future years by increased use of prescription narcotics, provided that they continue to be available. As a result, the distribution and use of prescription narcotics is closely monitored by state and federal law enforcement agencies. Illicit hydromorphone abuse has not reached the same epidemic levels as OxyContin but remains a problem and a concern for drug enforcement authorities.
Structurally, hydromorphone is similar to morphine and has similar painkilling and other effects in the body. Hydromorphone by weight is actually a stronger painkiller than morphine. Hydromorphone is combined with a substance called guaifenesin in cough syrup formulations.
Hydromorphone is available through injections, tablets, oral solution, and suppositories. The usual route of administration is by way of swallowing tablets. For patients who have difficulty swallowing tablets, a flavored oral solution is available. This liquid form of the drug can be poured into a medicine dropper for measurement by the patient or a nurse. The liquid can also be added to soft foods to make it easier for the patient to ingest. Some of these liquid formulations may contain alcohol.
Hydromorphone is primarily used to treat patients who are experiencing moderate-to-severe back pain, cancer pain, and headache. In addition, hydromorphone is used before and during a variety of surgical dental procedures. Hydromorphone is also available as a cough syrup for the control of dry, non-productive cough or persistent, exhausting cough.
Chronic pain, especially back pain, is one of the most common maladies treated with hydromorphone and other narcotic analgesics. This type of pain can often be alleviated to the point where the person can function to some degree. Hydromorphone is also effectively used to treat cancer pain. Much of the pain associated with cancer involves what is called neuropathic pain. This is pain caused by interference or disruption of nerve cells and nerve transmission in the body.
Hydromorphone is also used to treat chronic pain syndromes. These pain syndromes can develop from a variety of injuries and can affect muscles, joints, and other parts of the body. In such cases, patients often take the drug on an "as needed" basis. Hydromorphone is frequently prescribed to treat pain associated with moderate-to-severe osteoarthritis. Narcotic analgesics are generally prescribed for these patients when other painkilling drugs are not effective.
Patients who have neuropathic pain also use hydromorphone. This includes AIDS and diabetes patients who often develop peripheral neuropathy as their conditions progress. This complication produces a tingling or burning sensation in the hands or feet. If untreated, the pain can progress to the point where normal activities, such as walking, can be severely impaired.
Hydromorphone is also indicated for use during surgical procedures, and pain associated with trauma to bone and tissue, biliary colic, myocardial infarction, severe burns, and renal colic.
Hydromorphone is more potent than morphine by weight and is believed to produce analgesic effects four to eight times greater than morphine. Side effects are comparable to morphine with the exception of vomiting, which tends to be less frequent with hydromorphone use.
Scope and severity
Despite worry over the potential for addiction, opioid use for medical purposes has been increasing in recent years for most narcotic analgesics. However, despite the overall increase in the use of opioids for legitimate medical reasons, drug abuse among legitimate users has fallen during this period of time.
Evidence gathered from surveys in the United States suggest prescription drug abuse is increasing. In these surveys, prescription drug abuse in the 1980s was compared with trends in the 1990s. During the 1980s, researchers estimated that less than one-half million persons abused prescription drugs. However, this number increased by 181% between 1990 and 1998 among pain-relieving drugs.
Evidence collected by the National Institute on Drug Abuse (NIDA) during 1999 suggests more than four million persons in the United States over the age of 12 years were using a variety of prescription drugs for nonmedical purposes. Many of these individuals were first-time users of these drugs. Most of the first-time users were between 12 and 25 years of age.
Statistics gathered by NIDA indicate that prescription drug abuse among girls is significantly increasing. Overall, girls are using illicit drugs at a higher rate than boys in the same age groups. The prescription drugs most likely to be abused by young people of both sexes are opioids. Tranquilizers and stimulants are also highly abused by many young people.
Women are more likely than men to receive prescribed drugs that are abused among adult populations. These prescribed drugs are most often antidepressants and pain relievers. Evidence indicates that men and women are at similar risk for becoming addicted to opioids. However, women are far more likely to become addicted to other types of prescription drugs than men.
The use of pain relievers is also significant in the elderly; it is well-known that pain is a widespread problem in this age group. Up to one-half of the elderly not living in nursing homes are affected by pain on a regular basis. The American Geriatrics Society also reports that as many as 20% of those over the age of 65 years use prescription pain relievers at least once per week. Furthermore, about 60% of the elderly have taken some type of prescription pain reliever for a minimum of six months. In nursing homes, these rates are even higher.
The elderly need greater attention when they receive strong pain-relieving drugs, such as opioids. This is based on the fact that elderly patients are more likely to accidentally misuse prescription drugs than the general population. They are more likely to inaccurately read drug labels and to not follow health-care provider instructions. Generally, the elderly need lower doses of drugs, especially potent drugs, than the general population.
Another area of concern in prescription drug abuse is with health-care providers, such as nurses, doctors, pharmacists, dentists, and others. These persons have ready access to highly addictive drugs, such as the opioids, and are more vulnerable to such abuse. In addition, these professions are more stressful than average, and this may be a factor in the higher-than-normal rates of abuse in this group.
Many drug abusers have developed elaborate schemes for obtaining prescription drugs for nonmedical purposes. They are often able to successfully dupe physicians into prescribing drugs, such as opioids, for recreational drug use. Many physicians believe these individuals are in pain and need relief. Organizations such as the Substance Abuse and Mental Health Services Administration are attempting to educate physicians about the warning sign behaviors associated with these abusers.
Age, ethnic, and gender trends
According to a report commissioned by the Texas Commission on Alcohol and Drug Abuse, adult clients who were admitted to a heroin inhalation addiction treatment program in 1998 tended to be male (65%), African-American (36%), and low-income (average yearly income $6,784). This fits with data collected from opiate addicts from other parts of the country. Researchers also know that hydromorphone, when available on the street, is commonly substituted for heroin. However, it is also known that women are much more likely to abuse prescription drugs than men, but men are much more likely to abuse the illicit forms of drugs, including opiates. Abuse of opiates, like abuse of most all other drugs, is mostly carried out by younger persons, but this is not always the case.
Hydromorphone, as with other narcotic analgesics, should be used with great caution when performing acts that require alertness, such as driving or operating heavy machinery. The most common side effects on the brain from taking hydromorphone are sedation and drowsiness. Dizziness and agitation also are known to occur when taking this drug. Like many drugs, hydromorphone should not be discontinued suddenly. Doses should be gradually tapered and then stopped.
Hydromorphone is highly addictive. Its use needs to be carefully monitored by the treating physician. Long-term use of the drug can lead to physical and psychological dependency. Mood can also be affected by hydromorphone and other narcotic analgesics. Infrequently, hallucinations and disorientation can develop. Insomnia develops in a minority of cases.
Hydromorphone and other narcotic analgesics have specific effects on the central nervous system in the body. These effects are produced through the binding of opioid-specific receptors in the brain. Hydromorphone also produces similar effects in organs in the body that contain smooth muscle. The primary therapeutic effects of hydromorphone are analgesia and sedation. One of the most important aspects of narcotic analgesics, such as hydromorphone, is that they produce significant analgesia without causing a loss of consciousness.
Hydromorphone affects the respiratory center in the brain, and this is why it suppresses the cough reflex. Hydromorphone is partially broken down, or metabolized, by the liver and is absorbed by a variety of tissues and organs, including the gastrointestinal tract, smooth muscle, skeletal muscle, pancreas, lungs, cardiovascular system, and central nervous system. Once metabolized by the liver, hydromorphone moves out of the body by way of the kidneys and into the urine. The precise mechanisms by which hydromorphone and the other narcotic analgesics work are not entirely known.
The levels of hydromorphone usually peak in the body about 45 minutes after oral administration of the drug. Injections into muscle produce effects within 15 to 30 minutes and reach peak levels between one-half to one and one-half hours later. The duration of effect usually lasts four to five hours. The actual amount of hydromorphone prescribed or administered depends on a variety of factors, including age, the degree of pain, the amount of opioid tolerance, and the body mass of the patient.
Hydromorphone produces pain-relieving qualities in the central nervous system. It also tends to produce a euphoric feeling in the user. Negative effects by way of the central nervous system include decreased blood pressure and slowed breathing. Hydromorphone slows down the processes of the gastrointestinal tract and commonly causes constipation. Patients taking hydromorphone need to increase water and fiber intake to prevent and treat constipation.
The most common side effects associated with the use of hydromorphone are increased sweating, light-headedness, dizziness, sedation, mental depression, nausea, and vomiting. Less commonly seen side effects include weakness, headache, muscle rigidity, decreased feeling in the extremities, double vision, hallucinations, disorientation, muscle coordination problems, muscle tremor, hearing loss, agitation, euphoric feelings, blurred vision, and insomnia. Additional side effects can include changes in heart rhythm, chills, decreased blood pressure, increased blood pressure, diarrhea, cramps, itching, dry mouth, skin flushing, breathing alterations, constipation, anorexia, cramps, alterations in taste, skin rashes, and urinary difficulties.
Patients with a history of cardiovascular, respiratory, or intestinal problems should use hydromorphone with great caution. One of the most serious and over-looked side effects that develops from the long-term use of opioids is the potential for serious dehydration.
Hydromorphone has comparable side effects to those produced by morphine use. This is true for sedation, respiratory depression, and constipation, but hydromorphone is associated with less vomiting than morphine. Nausea caused by hydromorphone and other opioids can be minimized by administering the drug along with food and having the patient lie down following administration.
Extra caution should be taken when hydromorphone is prescribed to the elderly, those with significant physical impairment, and those with a history of liver, lung, or kidney disease. In addition, those with thyroid problems, Addison's disease, central nervous system depression, coma, psychosis caused by toxic agents, and those with a history of gallbladder disease should receive hydromorphone only with great caution. The same is true for persons with a history of prostate enlargement, a narrowing of the urethra, severe alcoholism, delirium tremens, recent gastrointestinal surgery, or severe scoliosis.
Harmful side effects
Using more than the recommended dose of hydromorphone can cause a variety of serious health complications, such as convulsions, coma, and death. Early symptoms of overdose include confusion, nervousness, dizziness, low blood pressure, severe weakness, decreased pupil size, drowsiness, and slowed breathing. Later manifestations of serious overdose include significant changes in heart rate, low blood pressure, coma, and cardiac arrest. Persons who overdose on hydromorphone are usually treated with narcotic antagonists, such as naloxone. It is vital for the attending emergency physician to maintain respiratory function in these patients. Naloxone not only helps reduce the effects of hydromorphone throughout the body but also has specific respiratory-protecting effects.
Individuals who have developed tolerance to opioids and who have overdosed on hydromorphone are not likely to develop the serious depression of the respiratory system that occurs in individuals with no such tolerance who have overdosed on hydromorphone. The typical treatment of narcotic overdoses with narcotic antagonists can lead to a severe withdrawal reaction in those who have developed tolerance to opioids.
The Food and Health Administration has placed hydromorphone in the pregnancy category C. This means that pregnant women should receive hydromorphone only with great caution and should receive a high-potency formulation only when it is absolutely necessary. This classification is based on animal studies that suggest birth defects are more likely in animals receiving high doses of the drug. There have been no strictly controlled scientific studies in humans.
Women who are breastfeeding should likewise use caution before taking hydromorphone. This caution is based on the fact that low levels of narcotic drugs have been found in the milk of mothers who use these drugs. Therefore, Mosby's Medical Drug Reference recommends that nursing mothers not use hydromorphone. Women who are breastfeeding should inform their doctor or dentist that they are nursing if they require a strong prescription pain medication.
Persons with a history of acute bronchial asthma should not receive hydromorphone. Persons with a history of head injury, increased pressure within the brain, seizures, serious abdominal problems, liver disease, kidney disease, thyroid disease, prostate disease, and low blood pressure should use hydromorphone with great caution. Also, the elderly should receive hydromorphone with great caution.
Long-term health effects
The primary long-term concern of those who use hydromorphone is the risk of addiction. The National Institute on Drug Abuse has determined that persons who become addicted to hydromorphone and other narcotic analgesics are at increased risk of convulsion, overdose, and death.
Persons with a history of drug abuse of any kind should not receive hydromorphone unless absolutely necessary because of the great potential for addiction. Hydromorphone can become addictive for anyone who has received doses higher than those prescribed by a doctor and in those who use the drug for recreational purposes. In addition, those who receive the drug at prescribed levels for a lengthy period are at a relatively slight increased risk of addiction.
REACTIONS WITH OTHER DRUGS OR SUBSTANCES
Hydromorphone should never be combined with other drugs that depress the central nervous system. Such drugs include sedatives, tranquilizers, alcohol, and anesthetics. In addition, other types of drugs, such as antidepressants, antihistamines, anticonvulsants, and muscle relaxants should not be combined with hydromorphone. All of these combinations can produce excessive drowsiness. Patients should inform their doctor or dentist if they are currently taking any of these medications or have taken them in the last two weeks.
Hydromorphone should not be combined with other pain medications. This includes over-the-counter medications that are commonly used to treat pain, such as Nuprin or Tylenol. If the prescribed dose of hydromorphone does not sufficiently alleviate the pain, then the treating doctor can adjust the dose. The patient should not make adjustments of hydromorphone dose on his or her own or add pain medications to the regimen.
Patients who have received hydromorphone for long periods of time or those with confirmed opioid dependency should not receive the so-called agonist/antagonist analgesics, such as nalbuphine, pentazocine, butorphanol, dezocine, and buprenorphine. The use of these drugs in these patients can intensify withdrawal symptoms.
TREATMENT AND REHABILITATION
Addiction to hydromorphone and other prescription painkillers is one of the major reasons behind admittance to drug rehabilitation clinics. Treatment for opiate addiction has been occurring in the United States since the early part of the twentieth century. In these early days of treatment, doctors in private practice prescribed narcotics to those addicted to opiate drugs. Later, governments outlawed this practice and began operating clinics where morphine could be obtained by addicts. Eventually, these clinics were also closed. At that point in time, addicts began to be treated in public health hospitals or placed in jail.
The problem of opiate drug abuse both with illegal and prescription narcotics increased during the 1960s. In the years that followed, researchers and clinicians looked to new methods to treat the growing problem. Genetic factors have gained importance as one of the major underlying factors in narcotic and other types of dependence. The idea is that addicts have a stronger vulnerability to substance-abuse behaviors than those with no such inclination. Mental illness, previous history of substance abuse, and other environmental factors are undoubtedly important in the development of narcotic addiction.
It is important that patients who use hydromorphone and other narcotic analgesics not stop taking these drugs suddenly. Doses should be gradually tapered down with the help of the prescribing physician. Rapid cessation of these drugs can produce withdrawal symptoms. Although these withdrawal symptoms are not life threatening, they can cause significant discomfort. These symptoms begin with insomnia, restlessness, anxiety, and yawning and progress to more serious symptoms, such as vomiting, fever, sweating, abdominal pain, nausea, diarrhea, muscle aches, and other body pain.
Symptoms begin about 72 hours after the last dose and include anxiety, weakness, increased irritability, muscle twitching, kicking movements, significant backache, hot and cold flashes, anorexia, insomnia, muscle spasm, and intestinal spasm. Additional symptoms can include repetitive sneezing, increased body temperature, increased blood pressure, diarrhea, vomiting, increased respiratory rate, and increased heart rate.
If withdrawal symptoms do develop, some medical approaches can be used to treat symptoms. One approach uses the drug clonidine, which is typically used to treat patients with high blood pressure. Clonidine has been found to lessen some of the withdrawal symptoms. Tranquilizers can be used to treat symptoms such as insomnia and anxiety. Ibuprofen or naproxen can treat symptoms such as muscle ache, headache, or joint pain. Another approach is to replace hydromorphone, or any other narcotic analgesic, with methadone, a narcotic that has long been used to help treat heroin addicts.
The Drug Addiction Treatment Act of 2000 allows opioids to be distributed to physicians for the treatment of opioid dependence. This allows physicians to treat opioid-addicted patients on an individual basis and eliminates the need for the patient to attend a methadone clinic. Patients receiving this treatment should have been opioid-dependent for more than one year, had at least two previously unsuccessful opioid treatment episodes during a calendar year, and had a relapse to opioid dependence after previous opioid treatment. The only currently approved drugs under this act are methadone and levo-alpha-acetylmethadol. The treatment program not only involves drug therapy with these agents but also provides a combination of counseling and rehabilitation activities.
PERSONAL AND SOCIAL CONSEQUENCES
The opiates and their semi-synthetic and synthetic relatives have long been among the most important drugs in the world because of their ability to alleviate the most severe forms of pain. Often, this pain is derived from invasive surgical procedures or from advanced cancer pain that is virtually untreatable without this family of drugs. A clear majority of persons who use opiates and their relatives never develop an addiction problem. However, addiction can develop quickly in those with a propensity for these drugs. This can occur in those who are using them for medical reasons as well as in those who use them recreationally.
A drawback to physicians' increased caution for prescription drug abuse has been the reluctance by some medical providers to prescribe opioids for persons having a legitimate medical need for the drugs. This has led to the under-prescribing of opioids and the under-treatment of patients with significant pain. Many in the medical community have held the view that increased opioid prescription rates would necessarily increase the rate of opioid abuse. This is not the case, according to a study published in the April 2000 issue of the Journal of the American Medical Association. This study showed that even though the rate of oxycodone use had increased by 23% in a recent period of time, the reported rate of abuse did not significantly change.
The increased vigilance of legal authorities to crack down on prescription drug abuse has led to situations where patients are afraid to ask for sufficient pain medication for fear of being seen as an "addict" or someone with a low pain threshold. Many physicians are afraid to prescribe opioids because they are required by law to record and justify all narcotic analgesic prescriptions. This fear of prescribing opioids even when the patient is obviously suffering has been labeled opiophobia. They face potential criminal prosecution if these records do not conform to federal law. Many physicians are also wary of getting their patients "hooked" on these narcotics.
Those patients who do become addicted to opioids as well as those who become addicted for nonmedical reasons typically have a difficult time getting off the drugs. These individuals usually face a variety of problems along the way. They often have a difficult time holding a job, and their family life tends to be unstable. If untreated for addiction, many of these individuals eventually resort to living off welfare programs.
Opiate addiction has also helped spread diseases, such as the human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and tuberculosis among addicts who inject the opiate drugs and share dirty needles. The rate of opiate-associated emergency hospital visits in recent years has significantly increased. Furthermore, the number of deaths related to those opiate overdoses has almost doubled in this period. All of these trends point to the significant social costs associated with opiate abuse in the United States.
Researchers long ago found an association between narcotics addiction and increased levels of crime. Significant numbers of prisoners incarcerated in the United States have been imprisoned because of crimes involving drugs and drug abuse. A report by a conference at the National Institutes of Health found that more than one-fourth of all prisoners at all state and federal prisons were convicted of drug-related crimes.
Researchers have found strong associations between opiate addiction and theft. Opiate addicts steal to obtain greater amounts and quality of drug. The goal of many researchers and drug treatment programs is to not only to treat the opiate addiction problem of the individual but also to reduce the amount of theft and other crimes associated with this problem.
Until 1914, it was legal to put opiates into patent medicines, for example, that were sold over-the-counter. A 1914 law was the first to regulate the sale and distribution of controlled substances. At the time, this law was not enacted to benefit public health, but rather to generate tax revenue.
Federal guidelines, regulations, and penalties
Hydromorphone is classified as a Schedule II controlled substance under the Controlled Substances Act (CSA) of 1970. This act of the United States Congress placed enforcement of the CSA on the shoulders of the Drug Enforcement Administration (DEA). The CSA was created as a means to regulate the distribution and use of prescription drugs that are highly addictive, such as codeine, oxycodone, morphine, and hydromorphone. The CSA was not enacted to limit or disrupt the practice of medicine and the legitimate use of narcotic analgesics in patients with significant pain.
Under the CSA, a Schedule II drug is one that has a high potential for abuse and whose use may lead to significant psychological or physical dependence. Prescriptions for these drugs must be typewritten or written in ink and signed by the practitioner, or verbal prescriptions must be confirmed in writing within 72 hours and may be given only in a genuine emergency. No renewals are allowed without a new prescription.
Despite the significant power bestowed by Congress on the DEA to enforce the CSA, the actual power of the DEA to regulate and control physician practice is not unlimited. This provision allows physicians some leeway when treating terminal cancer patients with intractable pain, for instance. Such patients often receive significant amounts of opioids, and this could raise the eyebrows of the DEA. All physicians who prescribe drugs classified under the CSA are registered with the DEA for monitoring reasons. Likewise, other components of the health care system, such as hospitals and pharmacies, must also register with the DEA. All of the individuals and entities that dispense drugs covered under the CSA receive a number issued by the DEA. This number can be tracked every time one of these controlled substances is prescribed. All of these entities must also keep very accurate records that document all of the information associated with the prescription.
The primary aim of the CSA and the DEA's implementation of the law is to find those physicians who are prescribing opioids and other controlled substances for nonmedical purposes. All of the entities included in the chain of the production and distribution of the controlled substance are carefully watched by the DEA for signs of irregularities. Violators of the CSA can be charged with a felony and are subject to fines and imprisonment.
In addition to federal laws enforced by the DEA, many states have supplemental laws that cover controlled substances. These state laws have even more detailed guidelines on dosage limits and the total number of pills that can be prescribed. One of the oddities present in the CSA and the DEA guidelines is that there are no limitations on the amount of drug prescribed at one time or on the length of treatment for the patient. This is surprising because the guidelines for dispensing Schedule II drugs are so precise in some areas, such as the inability to renew prescriptions. The laws generated by some states attempt to eliminate some of the loopholes created by the CSA and the DEA guidelines.
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Mark Mitchell, MD