Chapter 2 Drug Approval and Regulation
2.6 Controlled Substances, Drug Schedules, and Teratogenic Risks
Some drugs are frequently abused or have a high potential for addiction.
Technically, addiction refers to the overwhelming feeling that drives someone to use a drug repeatedly.
Dependence is a related term, often defined as a physiological or
psychological need for a substance. Physical dependence refers to an altered physical condition caused by the adaptation of the nervous system to
repeated drug use. In this case, when the drug is no longer available, the individual expresses physical signs of discomfort known as withdrawal . In contrast, when an individual is psychologically dependent, there are few signs of physical discomfort
Table 2.1 U.S. Drug Schedules and Examples
when the drug is withdrawn; however, the individual feels an intense compelling desire to continue drug use. These concepts are discussed in detail in chapter 22 .
In the United States, a controlled substance is a drug whose use is restricted by the Controlled Substances Act of 1970 and later revisions.
According to this law, drugs that have a significant potential for abuse are
Drug Schedule
Abuse Potential
Potential for Physical Dependency
Potential for Psychological Dependency
Examples Therapeutic
Use
I Highest High High heroin, lysergic acid diethylamide
(LSD), marijuana (cannabis), peyote, methaqualone, and 3,4- methylenedioxymethamphetamine (“ecstasy”)
Limited or no therapeutic use
II High High High hydromorphone, methadone,
meperidine, oxycodone, and fentanyl; amphetamine, methamphetamine, methylphenidate, cocaine, amobarbital, glutethimide, and pentobarbital
III Moderate Moderate High combination products containing
less than 15 mg of hydrocodone per dosage unit, products containing not more than 90 mg of codeine per dosage unit, buprenorphine products,
benzphetamine, phendimetrazine, ketamine, and anabolic steroids
Used therapeutically with
prescription;
some drugs no longer used (Schedules II, III and IV)
IV Lower Lower Lower alprazolam, clonazepam,
clorazepate, diazepam, lorazepam, midazolam, temazepam, and triazolam
V Lowest Lowest Lowest cough preparations containing not
more than 200 mg of codeine per 100 mL or per 100 g
Used therapeutically without prescription
placed into five categories called schedules. These scheduled drugs are classified according to their potential for abuse: Schedule I drugs have the highest potential for abuse, and Schedule V drugs have the lowest potential for abuse. Schedule I drugs are restricted for use in situations of medical necessity, if at all allowed. They have little or no therapeutic value or are only intended for research purposes. Drugs in the other four schedules may be dispensed only in cases in which therapeutic value has been determined.
Schedule V is the only category in which some drugs may be dispensed without a prescription because the quantities of the controlled drug are so low that the possibility of causing dependence is extremely remote.
Table 2.1 gives the five drug schedules with examples. Not all drugs with an abuse potential are regulated or placed into schedules; tobacco, alcohol, and caffeine are significant examples.
The Controlled Substances Act is also called the Comprehensive Drug Abuse Prevention and Control Act. Hospitals and pharmacies must register with the Drug Enforcement Administration (DEA) and use their assigned registration numbers to purchase scheduled drugs.
PharmFacts Extent of Drug Abuse
In 2012, 23.9 percent of 18- to 20-year-olds reported using an illicit drug in the past month. There were 18.9 million users of
marijuana, about 7.3 percent of people age 12 or older. Trends in drug use other than marijuana have not changed appreciably over the past decade.
About 6.8 million Americans or 2.6 percent of people age 12 or older have reported taking psychotherapeutic drugs. More than one million Americans, (0.4 percent) have used hallucinogenic drugs (including Ecstasy and LSD).
In 2008, over 29.8% of the U.S. population age 12 and older (70.8
million people) had smoked cigarettes during the past month. In 2012, the rate of past-month cigarette smoking among 12- to 17- year-olds had gone down by 6.6 percent. Although it is illegal in the United States to sell tobacco to under-age youths, in most cases they are still able to purchase tobacco products personally.
From 1996 to 2009, emergency departments recorded increased use of abused substances such as gamma hydroxybutyric acid (GHB; street name Fantasy), ketamine (street names jet, super acid, Special K, among others), and MDMA (chemical name 3,4- methylenedioxymethamphetamine; street name Ecstasy). Use of many of these illicit drugs except for Ecstasy leveled off after 2009.
The trend was not changed through 2012.
Cocaine use has declined in recent years. From 2007 to 2012, the number of users age 12 or older dropped from 2.1 million to 1.7 million. Methamphetamine use has slightly declined from 530,000 current users in 2007 to 440,000 in 2012.
In 2009, an estimated 30.2 million people (12% age 12 or older), reported driving under the influence of alcohol at least once in the past year. Alcohol use by the same age group showed a general decline from 28.8 percent to 24.3 percent between the years 2002 and 2012. Although reflecting a downward trend, alcohol abuse remains a national health concern. (National Institute of Drug Abuse, 2014)
Hospitals and pharmacies must maintain complete records of all quantities purchased and sold. Health care providers, nurse practitioners, and others with prescriptive authority must also register with the DEA and receive an assigned number before prescribing these drugs. Drugs with higher abuse potential have more restrictions. For example, in many states, a special order form must be used to obtain Schedule II drugs, and orders must be written and signed by the health care provider. Telephone orders to a pharmacy are
not permitted. Refills for Schedule II drugs are not permitted: patients must visit their health care provider first. Those convicted of unlawful
manufacturing, distributing, or dispensing controlled substances face severe penalties.
A teratogen is a substance that has the potential to cause a defect in an unborn child during pregnancy. A small number of drugs have been shown to be teratogenic, either in humans or in laboratory animals. Classification of teratogenic risk places drugs into categories A, B, C, D, and X. Category A is the safest group of drugs while Category X poses the most danger to the fetus. Birth defects are most probable in the first trimester; thus, nurses must be mindful of the various drug risks during this time. Table 2.2 outlines drug risk classification in pregnancy. Additional details on the teratogenic risk posed by medications are included in chapter 8 .
Table 2.2 FDA Drug Risk Classification in Pregnancy
Category A
Controlled studies in women fail to show a risk to the fetus and the possibility of fetal harm appears unlikely.
Category B
Animal-reproduction studies have not shown a fetal risk or adverse effect. Risks have not been confirmed in controlled studies in women.
Category C
Either studies in animals have revealed adverse effects on the fetus and there are no controlled studies in women or studies in women and animals are not available.
Category D
There is confirmation of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used).
Category X
Animal and human studies have shown fetal abnormalities. The drug is contraindicated in women who are or may become pregnant.
Chapter Review
Key Concepts
The numbered key concepts provide a succinct summary of the important points from the corresponding numbered section within the chapter. If any of these points are not clear, refer to the numbered section within the chapter for review.
2.1 Drug regulations were created to protect the public from drug misuse and to ensure continuous evaluation of safety and
effectiveness.
2.2 The regulatory agency responsible for ensuring that drugs are safe and effective is the U.S. Food and Drug Administration (FDA).
2.3 There are four phases of approval for therapeutic and biologic drugs. The phases progress from cellular and animal testing to use of the experimental drug in patients with the disease.
2.4 Once criticized for being too slow, the FDA has streamlined the process to get new drugs to market more quickly.
2.5 Nurses may participate in several phases of the drug approval process. They will have the most frequent opportunities during Phase 4, postmarketing surveillance. Medication safety is a matter of
paramount importance in health care.
2.6 Drugs with a potential for abuse are restricted by the Controlled Substances Act and are categorized into schedules. Schedule I drugs are the most tightly controlled; Schedule V drugs have less potential for addiction and are less tightly controlled. Drugs are also categorized according to their teratogenic risk. Category A drugs are the safest to
take during pregnancy. Category X drugs are the most dangerous to the fetus.
Critical Thinking Questions
1. How does the FDA ensure the safety and effectiveness of drugs? What types of drugs does the FDA regulate or control?
2. What is a “black box warning”? Why is it important for nurses to consider these when reading drug information materials?
3. Identify opportunities the nurse has in educating about, administering, and monitoring the proper use of drugs.
4. Why are certain drugs placed in schedules? What does the nurse need to know when a scheduled drug is ordered?
5. A nurse is preparing to give a patient a medication and notes that a drug to be given is marked as a Schedule III drug. What does this information tell the nurse about this medication?
See appendix C for answers and rationales for all activities.
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