Chapter 1: Historical and Legal Issues

Did you ever wonder how drugs and medicines came into existence? How did rules and regulations governing the formation and distribution of drugs develop? Drugs and medicines were created or developed to heal the sick and injured and protect people who are at risk of sickness or disease. They have been used by the human race for thousands of years.

As an athletic trainer, you need to understand the origins of medicines and how the laws that govern them protect patients, including your athletes. In addition, it is imperative to learn and understand the differences among classifications of drugs: which medications can be prescribed only by a physician and which can be bought at the local pharmacy or store. Most importantly, you need to know whom to contact for drug information and drug emergencies. This chapter will focus on the origins of drugs and medicines, their current classifications, and basic laws that surround the usage and distribution of drugs in the athletic setting.

The origins of drugs and medicines and the development of pharmacy can be traced back to the ancient civilizations of the Tigris and Euphrates river basin region⁶ (Figs. 1–1 and 1–2). Around 2100 BC, physicians and priests began to record references to drug therapy on clay tablets. This collection of works left by ancient healers contained formulas and directions for compounding medicines, which, when translated into modern language, resulted in the identification of 250 vegetable and 120 mineral drugs.⁶

According to these tablets, common foodstuffs, such as alcoholic beverages, fats and oils, parts of animals, honey, waxes, and milks were used as vehicles (substances used to carry drugs to their site of action) for medicines. Thus, these tablets from ancient civilizations mark the true beginning of pharmacy.

Over time, the Mesopotamian influence spilled into Egypt. In 1500 BC, the Egyptians developed a collection of writings, now commonly referred to as the Ebers Papyrus. The Ebers Papyrus was a 22-yard-long document that described 811 prescriptions and 700 drugs.⁶ During this period, the Egyptians also quantitatively defined specific recipes with weights and measures to produce exact formulations of medications. It was at this time that the practice of pharmacy was integrated into daily life.

Between 600 and 330 BC, the Greeks took pharmacy another step forward. True pharmacopeias were written. These writings, the forerunners of today's pharmacopeias (treatises documenting the standards for preparation and dispensation of drugs), described how botanicals (extracts derived from plants) were used to make medicines. The pharmacopeias specifically listed the drugs' botanical habitats, physical properties, type of actions, medicinal usage, side effects, quantities, and dosages, as well as instructions for harvesting, preparation, and storage of medicinal plants.⁷

Greek physicians eventually became overwhelmed by the responsibilities involved in diagnosing diseases and preparing drug products to treat them. Therefore they found it desirable to rely on the expertise of specialists in the preparation of remedies. It was during this time that the role of the pharmacist—a specialist who creates and dispenses medicines for sick people—evolved.

Throughout the Middle Ages and into the Renaissance period, pharmacy continued to grow as a profession. Pharmacy shops appeared and local guilds of pharmacists were formed. The guilds were created to maintain a monopoly within the town, protect the quality and integrity of pharmacists' products, control the training and length of service for apprentices, and recognize the status of "master" within the guild.⁸

During the Middle Ages, the practice of pharmacy further improved when it was officially separated from medicine. Emperor Frederick II wrote laws that legally recognized pharmacy as a separate profession. At this time, official schools of pharmacy were created. Students in Montpellier, France studied at the first university program dedicated to the science of pharmacy, with courses taught by prominent physicians. Overall, the Middle Ages gave rise to the most prominent developments in the history of pharmacy.

The settlement of North America brought a new dimension to the pharmacist's profession. The discovery of new plants and the export of knowledge from the indigenous peoples of the Americas fueled a new interest in medicine. As in previous times, most early medical practitioners in North America had no formal training and often dispensed their own types of medicines from their homes. The earliest practicing pharmacy in the North American colonies was thought to be that of William Davis of Boston, opened in the year 1646. However, the first written record of day-to-day pharmacy operations in the colonies was created in 1698 by Bartholomew Browne of Salem, Massachusetts.¹¹

During the Revolutionary War, the practice of pharmacy became more standardized. Pharmaceutical activity increased and became a separate but equally important branch of the medical community. The first known mass production of pharmaceutical products began during this period. The Revolutionary War also marked the first attempt to develop a formulary—a book that provides standards and specifications for drugs.

As the United States expanded, so did the development of pharmacy. The movement westward produced scores of "pharmacists," both real and fake. Drugstores opened to supply the needs of the migrating population (Fig. 1–3). Charlatans sold "medications" in many forms to cure a variety of ailments. These products often had no therapeutic value. As a result, rules and regulations were adopted in 1804 to govern pharmacy practice and protect the people from unscrupulous practitioners. On the whole, these rules were ineffective. It was not until around 1870 that the American Pharmaceutical Association developed draft regulations for pharmacy practices and sales of pharmaceuticals. Rhode Island was the first state to adopt the rules. One by one, each state followed suit.

The 20th century brought new laws and regulations to the pharmacy profession. The United States Food and Drug Administration (FDA) was established to ensure the safety of drug production, consumption, and distribution. Prescription and over-the-counter (OTC) medication classifications were also developed during this time. Pharmacies opened in almost every community. The pharmacist's scope of practice became highly regulated, and specialized schools similar to those in Europe were opened in the United States.

The current profession of pharmacy still has links to ancient civilizations (Fig. 1–4). New drugs are being still being developed; time-tested compounds are still being manufactured; and laws continue to be enacted to ensure the safety and efficacy of pharmaceutical products. The modern-day pharmacist continues to work in environments similar to the traditional pharmacies of the Renaissance period and, since the 19th century, has also worked in hospitals and industry. As in previous periods, the profession of pharmacy continues to evolve to provide patients with the essential drug therapies and quality drug information they need to treat illnesses and injuries.

In the early 20th century, virtually no laws existed to control the sale of medicines, the purity of drug preparations, or the efficacy of medical devices. People could purchase Coca-Cola, a tonic that contained cocaine, an extract of the coca shrub, to help with digestion and respiration. Teething babies were given special soothing syrups (e.g., paregoric) that contained opium. Menstruating women took elixirs of morphine to help with dysmenorrhea.¹² The use of these "medications" was a common practice, and patients sometimes became physically and psychologically dependent on them.

Because of the lack of regulations in this area, the federal government enacted the Pure Food and Drug Act in 1906. This act prohibited the adulteration and misbranding of foods and drugs that moved in interstate commerce.¹ However, pharmacists were still able to make products containing ingredients of any quality, whether they were efficacious or not. For example, in 1937 sulfanilamide elixir, an oral antibiotic containing deadly diethylene glycol (the main ingredient in automobile antifreeze) was manufactured without safety data for the user. As a consequence, over 100 people died, prompting the federal government to pass the Food, Drug, and Cosmetic Act of 1938. This act stated that all drugs must be safe for human use and be approved before marketing.¹ The act also stated that labels had to contain adequate directions for use and warn users of the habit-forming properties of certain drugs. Drug sellers and manufacturers were forced to comply with the new standards. They had to identify the specific strength and purity of the drug and list on the label any narcotic agents contained in the product. Even so, many drug manufacturers did not differentiate between prescription and nonprescription medicines. Drugs were often mislabeled. As a result, individuals sometimes took prescription drugs without proper medical supervision. In 1952, the passage of the Durham-Humphrey Amendment further enhanced the Food, Drug, and Cosmetic Act of 1938. This amendment codified the distinction between prescription and nonprescription drugs, although, at the time, the legislation was primarily focused on limiting the nonwritten transmission of prescriptions and requests for refills of prescription drugs. The Durham-Humphrey amendment also required that every prescription drug have the following statement on its label: "Caution: Federal law prohibits dispensing without a prescription".

During the 1950s, a popular sleeping pill, thalidomide, was marketed to pregnant women in Europe (the FDA refused to give approval for its use in pregnant women in the United States until it had gathered adequate safety information). After a decade of use in Europe, a positive correlation was established between mothers who ingested thalidomide and the risk of a birth defect called phocomelia (the development of seal-like extremities) in children.¹ This birth defect, which affected hundreds of children, resulted in the passage of the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act in 1962. The Kefauver-Harris Amendment required manufacturers to test their new drugs for safety and efficacy. The amendment also required that drugs manufactured between 1938 and 1962 be evaluated for safety and efficacy. As a result, many drugs were withdrawn from the market.

In 1970, the Poison Prevention Packaging Act was passed. This act was intended to protect children from accidental poisoning by household substances and drugs. The Poison Prevention Packaging Act requires that drugs dispensed pursuant to a prescription be dispensed in child-resistant containers. The containers must be manufactured so that 80 percent of children under the age of 5 cannot open them, whereas at least 90 percent of adults can.

The Anti-Tampering Act was passed by Congress in 1984 after a number of deaths were caused in the early 1980s by ingestion of OTC medicines that had been contaminated with cyanide. The Anti-Tampering Act requires all OTC products to have tamper-resistant packaging. Packaging can be made tamper resistant by various techniques, including placing a plastic wrapper around the neck of a bottle or gluing an aluminum seal over a container's opening.

Although many laws have been enacted to further public safety, certain drugs warrant even stricter regulation and control. Rigorous regulations have been developed for manufacturing and distribution of specific medications identified by the government as "controlled substances" or "scheduled drugs" because of their potential for addiction and abuse. The Comprehensive Drug Abuse Prevention and Control Act of 1970, otherwise known as the Controlled Substances Act (CSA),² governed the use and distribution of these drugs. This law includes regulations for drug abuse rehabilitation programs, a system of registration of manufacturers and distributors of controlled substances, and rules for distribution of these substances.

The CSA also sets forth a five-level scheme or schedules for classifying controlled substances. It is still being used today (Table 1–1). This scheme separates drugs based on their medicinal use and their potential for physical dependence and abuse.

Schedule I drugs are drugs or substances that have a high potential for abuse and are not acceptable for medical use in the United States. Examples of schedule I drugs are heroin and lysergic acid diethylamide (LSD).

Schedule II drugs are drugs or substances that have a high affinity for abuse but are also used medically. Morphine, hydromorphone (Dilaudid), and codeine are examples of schedule II drugs. These drugs may produce severe psychological or physical dependence but are effective in the treatment of pain.

Schedule III drugs are considered to have a lower abuse potential than schedule I and II substances. Some examples of schedule III drugs include acetaminophen with codeine (popularly called Tylenol No. 3) and various hydrocodone combinations such as Lortab and Vicodin.

Schedule IV drugs have an even lower potential for abuse compared to those on schedule III. Common agents in this class are the benzodiazepines, including diazepam (Valium), alprazolam (Xanax), and lorazepam (Ativan).

Schedule V drugs are drugs that have the lowest potential for abuse of all scheduled substances. A common schedule V drug is Robitussin A-C.

The FDA was created in 1938 to enforce the Food, Drug, and Cosmetic Act of 1938. This agency is responsible for protecting the public's health by ensuring the safety, efficacy, and monitoring of products on the market. This includes making sure that foods are sanitary, safe, and properly labeled; recalling improperly manufactured goods; and inspecting facilities where foods, drugs, or cosmetics are produced. One of the main functions of the FDA is to regulate the drug manufacturing and labeling processes (Fig. 1–5).

It has been estimated that for every 5000 new compounds that enter testing, only one becomes a new product. The drug approval process may take several years. It costs millions of dollars for a pharmaceutical company to manufacture and market a drug. Conversely, in other countries, the approval process may last only 1 year and does not follow the strict regulations of the FDA. Therefore some drugs are available in other countries that are not available in the United States.

Some critics argue that the FDA's stringent and lengthy process limits the public's and the medical community's access to new drugs that address life-threatening and serious illnesses such as AIDS, Alzheimer's disease, and multiple sclerosis. In response to these critiques, in 1992 the FDA established a "fast-track" approval process to decrease the approval time for important therapeutic drugs. This process allows marketing of a drug before the last phase of clinical trials, provided that follow-up studies will be performed. The FDA's rationale was that, in certain cases, the unknown risks are balanced by the urgent need for these new drugs.

Another major responsibility of the FDA is to monitor adverse drug reactions. Adverse reactions are unintended effects of drugs. An example of an adverse reaction would be a rash or itch that develops in a patient after he or she takes an antibiotic. The FDA requires that pharmaceutical firms report at regularly scheduled intervals all adverse effects associated with the drugs they sell. The FDA has a reporting system called MedWatch in which health-care professionals can post any occurrences of adverse reactions associated with a drug, its formulation, or its packaging. The MedWatch reporting system documents can be found at www.fda.gov.

Drugs considered safe for self-administration by consumers without medical guidance are called over-the-counter (OTC) drugs. OTC drugs can be found almost anywhere, from drug stores and pharmacies to supermarkets and gas stations. It has been estimated that over 300,000 OTC products are available to the public to treat minor illnesses, injuries, and other problems. The FDA must approve both the ingredients and the information printed on the label of every OTC drug. The drug must also show a low incidence of severe side effects and a low potential for harm when the patient follows all directions for use. Although OTC products are considered relatively safe for general use, they can still produce severe adverse effects if taken incorrectly or if mixed with other OTC or prescription drugs.

A patient who takes an OTC product must read the label carefully. Each OTC label (Fig. 1–6) should contain the following information:¹

• The name of the product

• The name and address of the manufacturer, packer, or distributor

• A list of ingredients, both active and inactive (inert)

• The quantity of contents

• The name of any habit-forming components contained in the drug

• All warnings and precautions for the user, including whether it is habit forming or is contraindicated for use by pregnant or nursing women

• Adequate directions for use.

Consumers who have questions regarding any of the information found on the label should consult their physician or pharmacist.

One of the most confusing aspects of pharmacology is the naming of each drug. Drugs are typically identified by their chemical, generic, or brand name (Table 1–2).

drug is first developed, it is given a chemical name. Chemical names are derived from chemical composition and molecular structure. A chemical name is usually long and complex and difficult for everyday use. For example, N-acetyl-para-aminophenol is a complex name to pronounce or remember. It is much easier to use its generic name (acetaminophen) or its brand name (Tylenol) instead.

A generic name, also known as a nonproprietary name, is a shorter name that is assigned to a drug by the United States Adopted Names (USAN) Council. It may have relatively little in common with the drug's chemical or brand name. A generic name is usually given for general recognition and, once assigned, cannot be used for any other drug. The generic name is the preferred name listed in the United States Pharmacopeia (USP).¹⁵ After a drug is given its generic name, the manufacturer assigns the name by which that generic drug will be traded, called a brand (trade) or proprietary name. This name must be approved by the FDA before the drug is marketed. However, several brand names can exist for drugs of the same generic name. For example, Advil, Motrin, and Nuprin are all brand names for the drug whose generic name is ibuprofen. Because of the various brand names that identify the same product, most healthcare professionals choose to use the generic name when describing a drug. Brand names usually have the symbol (®) after the name and are capitalized (in this text, we will only capitalize the brand name drug), whereas generic names are not capitalized. Any drug on the market, whether prescription or OTC, can be identified by its brand or generic name, or by both.

Historically, physicians and patients have been reluctant to substitute equivalent generic drugs for brand-name drugs. Manufacturers of brand-name drugs have argued that their drugs are superior in quality and effectiveness to their generic equivalents. However, the products must have the same active ingredient(s) and must be identical in strength and dosage form. Theoretically, generic drugs produce the same desired effects as brand-name drugs.

Brand-name drugs and their ingredients are usually patented for 17 years. After the patent expires, other companies can use the same chemical ingredients to produce a generic equivalent. In order for a generic company to produce a similar-brand-name product, it must submit an abbreviated new drug application (ANDA) to the FDA. This document includes proof of the drug's bioavailability and bioequivalence, as well as information about the manufacturing methods and control of the product the company wishes to manufacture. In other words, the manufacturer must show proof that the generic drug is as clinically effective as the brand-name drug. After it receives FDA approval, the company can release the product to the public.

The FDA recommends that physicians consider prescribing generic drugs when appropriate because they are less expensive to the consumer (most generic drugs cost about one-half to one-fourth the price of brand-name drugs). In fact, all states permit the pharmacist to dispense the generic equivalent of brand-name drugs, if applicable, unless specifically requested by the physician to do otherwise. To determine the equivalency of a generic product to a brand-name product, please refer to an FDA publication entitled "Approved Drug Products with Therapeutic Equivalence Evaluations."¹⁰

Most health-care professionals use a written code system consisting of symbols, codes, and abbreviations. This abbreviation system is used to quickly denote commonly used words, phrases, and conditions of medical terminology. Abbreviations are usually standard across professions, and every health-care professional must memorize them for use in medical documentation. In prescribing drugs and medicines, abbreviations are used to denote concepts including frequency, amount, and weight. Table 1–3 provides a common list of drug abbreviations used in the medical and pharmacy professions.

Throughout this text, drugs and their actions will be covered in detail. When questions arise about what course of action or procedure to take regarding a drug, it is imperative that you contact the proper individuals or locate the correct drug information. The references discussed in the next section will help guide you, the athletic trainer, in answering questions about drugs and medicines.

Pharmacists

Pharmacists are integral to the medical profession. As health-care professionals, they are trained in the concepts of defining, monitoring, and modifying drug therapy. As a part of a patient's health-care team, pharmacists assess therapeutic needs, prevent adverse drug reactions, develop patient-specific therapy, manage chronic diseases, and monitor follow-up care.³ The pharmacist understands the actions of drugs: uses, doses, drug and food interactions, contraindications, and many other aspects of each drug agent. Pharmacists are typically educated at the postsecondary level for 6 years, at the end of which they receive a Doctor of Pharmacy (PharmD) degree, and are required to successfully pass a national certification examination. Like many other professionals, pharmacists are also required to pass a state licensure exam. Their scope of practice is therefore geographically defined.

Pharmacists work in a variety of settings, from local drugstores to hospitals, long-term care facilities, managed care, government, and industrial settings. A pharmacist may be part of an interdisciplinary team of physicians, dietitians, social workers, physical therapists, and many other professionals working together in a university or hospital atmosphere. In the athletic training setting, one particular pharmacy is usually used for all prescription and OTC medications. The pharmacist associated with the athletic training setting should be the first choice for soliciting information. If your work setting does not have a designated pharmacist, please contact a pharmacist in your community.

Poison Control Centers

Poison control centers (PCSs) are located in all 50 states; are accessible by phone 24 hours a day, 7 days a week; and are free. They provide rapid access to information for assessing and treating poisonings and assist with poisoning prevention. They can answer questions about any potential poison, including medications, chemicals, household products, and biologically produced natural toxins.⁵ PCSs handle all calls concerning humans and animals for all different types of poisonings. A PCS can handle emergencies related to insect and snake bites; ingestion of substances such as household products or poisonous plants; identification of different types of drug tablets and capsules; and hazardous material spills. PCSs usually employ specially trained, certified specialists who are nurses, pharmacists, or physicians.

The PCS should be called if you or someone you know has ingested, touched, or been bitten by something you think is poisonous or toxic. Poison control specialists will ask a series of questions and inform the caller on how to solve the problem. For example, they may instruct the caller to seek medical attention, administer ipecac to induce vomiting, or call emergency personnel to the home. When calling a PCS, callers should provide as much detail as possible regarding the description of the product ingested or the source of venom, the amount ingested, and the amount of time that has gone by since ingestion. In most cases, the PCS will ask identifying questions of the caller to assist with follow-up, but the caller can also remain anonymous if desired (Box 1–1). To find the phone number of the nearest PCS, you can call the national hotline at 800-222-1222, check your local phone directory, or call directory assistance. You may also locate a PCS by visiting the American Association of Poison Control Centers at http://www.aapcc.org.

Reference Books

Depending on the scope of their practice, most allied health-care facilities have a variety of written information concerning drugs and medicines. However, it is very important that credible sources be used for gathering drug information. The sources described in the following paragraphs are the texts and guides most commonly used by physicians and pharmacists for information on drugs and other chemicals.

Drug Facts and Comparisons⁹ is a very comprehensive and user-friendly reference. It contains comparative drug information and relative costs, and indicates which products are sugar and alcohol free. Basic drug information found in this reference includes drug actions, indications and contraindications, precautions and warnings, administration, and dosage. The text also contains manufacturers' addresses and phone numbers and standard pharmaceutical abbreviations, plus various other reference materials. This reference is updated monthly.

The Physician's Desk Reference (PDR)¹³ is produced by the pharmaceutical industry and provides detailed descriptions of drugs. This content is identical to the information found in drug package inserts. The PDR also has color photos of over 1000 drug products to assist with identification, and is updated annually. The PDR is easily accessible but sometimes difficult to comprehend because of the complexity of the information it contains.

American Hospital Formulary Service (AHFS) Drug Information ⁴ is produced by the American Society of Health-System Pharmacists. This reference has detailed monographs on all drugs and general summaries of the drug categories. It provides both FDA-approved and nonlabeled indications. This reference is also updated annually.

United States Pharmacopeia Drug Information (USP DI) is a three-volume set published annually with monthly updates. Volume I, Drug Information for the Health Care Provider,¹⁵ provides comprehensive monographs and includes information on veterinary drugs and OTC diagnostic agents. Volume II, Advice for the Patient,¹⁶ provides drug information in lay language. Volume III, Approved Drug Products and Legal Requirements,¹⁷ provides equivalence information and legal issues.

What are the rules and regulations for athletic trainers regarding dispensing, acquiring, and storing drugs in the athletic setting? To answer these questions, each athletic trainer must first contact his or her state attorney general or state licensing board to determine what, if any, laws regulate medications in the athletic training setting. In addition, the athletic trainer should be aware of federal laws and regulations (promulgated primarily by the United States Drug Enforcement Agency [DEA] and the FDA) that govern controlled substances that may be found in the athletic training room.

There are literally hundreds of federal laws governing the prescription, storage, distribution, and administration of medications. However, athletic trainers should be particularly aware of specific laws that may be applicable in the athletic training setting. For example, any controlled substance in schedules II through V must be securely locked in a structurally sound location to avert theft. All controlled substances found in the athletic training setting must have a complete and accurate written inventory, including the date. If controlled substances are kept in multiple locations, a separate inventory must be on file at each location. Inventory of all controlled substances must be taken at least every 2 years.

If controlled substances are stored in the athletic training setting and dispensed to athletes, it is suggested the athletic trainer contact the state attorney general (for state law guidance) and the DEA (for federal law information) to determine whether special procedures, registrations, or certificates are required. Usually, the team physician solicits this information, because he or she is ultimately responsible for dispensing controlled substances.

To avoid legal liability, the athletic trainer should follow some simple procedures. The athletic trainer should document the following information about each drug administered, whether prescription or OTC, in a logbook (Fig. 1–7):

• Name of the athlete/patient

• Sport

• Age of athlete/patient

• Name of drug

• Dose given

• Quantity prescribed

• Indication (why the drug was given)

• Manufacturer

• Lot number

• Drug expiration date

• Name of person who dispensed the drug

• Date drug was given

In order to properly monitor drug therapy, all drugs should be in single-dose packages with expiration dates stamped on them. If drugs are purchased in bulk, only a 1-day supply should be dispensed. Drugs so dispensed should be placed in a small, secured envelope labeled with the athlete's name and appropriate directions for use.

Many athletes self-administer their medications. They may need assistance with this process. To properly assist the athlete in the drug administration process, the athletic trainer should read all package inserts with the athlete and make sure that the athlete understands the directions for use. OTC and prescription medications should never be made freely available for use or distribution without proper supervision. All medications should be kept in locked offices or storage cabinets and should only be dispensed with physician approval and supervision. Failure to follow these guidelines can predispose athletic trainers to undue legal liability.

In the foregoing scenario, an athletic training student was given the task of delivering the medication to the athlete without:

• Determining if the athlete had medical allergies.

• Instructing the athlete on the proper administration of the prescription.

• Determining if the athlete was currently taking other medications.

• Providing information about possible complications from the prescription.

1. The origins of pharmacy began approximately 4000 years ago within this ancient civilization:

   1. Europe

   2. Mesopotamia

   3. Greece

   4. Egypt

2. The earliest pharmacy practice was thought to be established in the United States in the year:

   1. 1646

   2. 1776

   3. 1804

   4. 1870

3. The Pure Food and Drug Act of 1906 was enacted to:

   1. Prohibit misbranding of foods and drugs.

   2. Regulate drug distribution.

   3. Regulate compounding pharmacies.

   4. Ensure drug safety.

4. The Durham-Humphrey Amendment of 1952:

   1. Codified the OTC and prescription drug classifications.

   2. Mandated drug efficacy.

   3. Set forth testing procedures for new drugs.

   4. Required anti-tampering precautions.

5. Drugs that produce the highest affinity for abuse but also can be used medically are called:

   1. Schedule I drugs.

   2. Schedule II drugs.

   3. Schedule III drugs.

   4. Schedule IV drugs.

6. Which of the following disclosures is NOT required but can be found on an OTC label?

   1. Name of the product

   2. Inert and active ingredients

   3. Habituation warnings

   4. Expiration date

7. A generic drug name:

   1. Is shorter than the chemical name.

   2. Is used for general recognition.

   3. Is also called the "nonproprietary" name.

   4. All of the above.

8. Generic equivalent drugs can be substituted for brand-name drugs if:

   1. The drug is similar in dose and strength to the brand-name drug.

   2. The drug has dosage, strength, and active ingredients that are identical to those of the brand-name drug.

   3. The generic drug is similar in color and size to the brand-name drug.

   4. The patient requests the brand-name drug.

9. When calling the poison control center, it is imperative that you provide the following information:

   1. Name, type of poison, and amount ingested

   2. Type of poison, amount ingested, and address

   3. Name, closest living relative, types of poison, and amount ingested

   4. Only what you think is appropriate

10. This reference guide provides a detailed description of a drug similar to the information found within the drug package insert:

    1. Drug Facts and Comparisons

    2. American Hospital Formulary Service Drug Information

    3. U.S. Pharmacopeia Drug Information

    4. Physician's Desk Reference