1chpharm

Which is a Schedule IV drug according to the Canadian Controlled Drugs and Substances Act, 1997?

Butorphanol Butorphanol belongs to Schedule IV of the Controlled Drugs and Substances Act, 1997. Methadone falls under Schedule I; methaqualone and propylhexedrine belong to Schedules III and V, respectively.

Which drug is categorized as "unscheduled" according to Canadian drug legislation?

Nicotine patch Drugs that are not categorized in Schedule I, II, or III are considered unscheduled according to Canadian Drug Legislation. Unscheduled drugs include nicotine patches, some lower-dosage "cough and cold" preparations, and lower-dose ibuprofen. Loperamide and pseudoephedrine are Schedule II drugs. Diphenhydramine is a Schedule III drug.

The nurse finds pills in a patient room with an unidentifiable label and without an accompanying prescription. To which drug information resource would the nurse refer to determine the name of the drug?

Physicians' Desk Reference Referring to the Physician's Desk Reference is recommended because it contains a separate section on product identification. The American Drug Index consists of an index of medicines that are available in the United States; the index is used to compare brand names with generic names. Drug Facts and Comparisons consists of drug monographs and is used when similar products or cost indices are to be compared. Martindale: The Complete Drug Reference provides information regarding the international names, pharmacological activity, and side effects of drugs.

Which source of drug information includes a tear-out form for use by healthcare professionals to voluntarily report a drug's adverse effects?

Physicians' Desk Reference The Physicians' Desk Reference (PDR) includes a tear-out form for the MedWatch program that healthcare professionals can use to voluntarily report the adverse effects of drugs. Drug Interaction Facts is a comprehensive book that includes drug interactions. The LactMed Database contains information on drugs and other chemicals to which breastfeeding mothers may be exposed. Drug Facts and Comparisons contains drug monographs that describe all drugs in a therapeutic class.

Which source of drug information discusses more than 3000 therapeutic agents?

Physicians' Desk Reference The Physicians' Desk Reference contains information regarding more than 3000 therapeutic agents. Information on drugs and other chemicals that breastfeeding mothers may be exposed to is described in LactMed. Martindale: The Complete Drug Reference is a comprehensive text that contains information about more than 5500 drugs in current use throughout the world. The Natural Medicines Comprehensive Database is a scientific gold standard for evidence-based information about herbal medicines and combination products involving herbal medicines.

Which drug development process would need a correction in terms of the timeline? New Drug Application Review by FDA 24 mos Clinical research phase 5 years preclinical research 4 mos FDA's decision to allow human study 30 days

Preclinical research is a data collection process that can be 1 to 3 years, but usually requires an average of 18 months. New drug application review by the Food and Drug Administration (FDA) requires an average of 24 months. The clinical research phase of new drug development requires an average of 5 years. The FDA's decision to allow human study takes 30 days.

In which clinical phase of new drug development studies are a drug's pharmacological properties determined?

1 Phase 1 clinical studies of new drugs determine a drug's pharmacological properties. Phase 2 studies determine the drug's success rate and safety. Phase 3 studies determine the statistical significance of the study results. Phase 4 studies determine the drug's adverse reactions after marketing.

Which drug possesses a high risk for abuse according to the Controlled Substance Drug Schedules?

Acetaminophen and hydrocodone (Norco) Acetaminophen and hydrocodone (Norco) is listed under Schedule III of the Controlled Substances Act because of a high potential for abuse. Diazepam (Valium) is listed under Schedule IV because it has a low potential for abuse compared with Schedule III drugs. The combination of diphenoxylate and atropine (Lomotil) and guaifenesin and codeine (Robitussin AC) are classified as Schedule V drugs, which have low potential for abuse.

During the new drug development process, at which time is an investigational new drug application submitted to the Food and Drug Administration (FDA)?

After the preclinical phase of drug development An investigational new drug application is submitted to the FDA after the preclinical phase of drug development to begin the clinical phase of drug development.

Which source of drug information would the nurse refer to while educating the nursing student about comparing drug brand names with generic names?

American Drug Index The American Drug Index is used to quickly compare brand names with generic names. The Pharmaceutical Codex is recognized as an authoritative source of drug standards by the Canadian Food and Drugs Act. The Compendium of Pharmaceuticals and Specialties (CPS) is a source of Canadian drug information that contains a comprehensive list of pharmaceutical products distributed in Canada as well as other practical information. The USP Dictionary of United States Adopted Names (USAN) and International Drug Names is a source of United States drug information that describes the criteria by which drugs are named.

Which drugs have the highest potential for abuse? Select all that apply.

Amphetamine (Evekeo) Aspirin and oxycodone (Percodan) Amphetamine, aspirin and oxycodone are Schedule II drugs; they have a high potential for abuse and may lead to severe psychological or physical dependence. Acetaminophen, aspirin, butalbital, caffeine, hydrocodone, and acetaminophen also have a high potential for drug abuse, but it is less than that of Schedule II drugs.

A patient with acquired immunodeficiency syndrome (AIDS) does not qualify for the study protocol for a new antiviral drug and has no alternative therapy. Which action would the Food and Drug Administration take to expedite treatment for AIDS in this patient? Select all that apply.

Approve treatment with an investigational new drug (IND) Provide fast-tracking of an investigational new drug (IND) Allow parallel tracking of an investigational new drug (IND) The treatment of AIDS in a patient who does not fit the study protocol for the drug and has no alternative therapy is expedited by approving treatment with an investigational new drug (IND). Treatment with an IND refers to the availability of a new drug to a patient who is desperately ill as early as possible in the drug development process. Fast-tracking an IND refers to accelerating the drug's development and approval. Parallel tracking is another process that makes an IND available when there is no standard therapeutic alternative. Extending the clinical trial phase is not done because the patient requires immediate treatment with the IND. Approval for postmarketing surveillance of an IND is required after the IND has undergone preclinical and clinical trials.

Which nursing student's information indicates a need for further teaching regarding the Canadian Controlled Drugs and Substances Act, 1997? Student A I methadone (dolophine) Student B II Mescaline (mescalito) Student C 1V Propylexdrine (benzedrex) Student D V1 Pseudophedrine (sudafed PE

B Mescaline is a Schedule III drug according to the Canadian Controlled Drugs and Substances Act, 1997. Therefore nursing student B's information indicates a need for further teaching. Methadone and propylhexedrine are Schedule I and V drugs, respectively. Pseudoephedrine is a Schedule VI drug.

Which online source of drug information provides a database for new package inserts?

DailyMed DailyMed is an online source of information that provides a database for new package inserts and is searchable by any characteristic of a drug. Drug Interaction Facts, Physicians' Desk Reference (PDR), and Martindale: The Complete Drug Reference are offline sources of drug information.

The Durham Humphrey Amendment serves which function?

Division of medicines into prescription and nonprescription drugs based on safety Passed in 1951, the Durham Humphrey Amendment is an amendment of the Federal Food, Drug, and Cosmetic Act of 1938. It divides medicines into prescription and nonprescription drugs based on safety. The FDA's Office of Orphan Products Development provides incentives for sponsors to develop products for rare diseases. The Canadian Food and Drugs Act and Regulations protect the public from foreseeable risks of the manufacture and sale of drugs. The Kefauver-Harris Drug Amendment provides greater control and surveillance of the distribution of investigational drugs.

Which governmental body was organized to conduct research in the area of dangerous drugs, drug abuse, and enforcement of the Controlled Substances Act?

Drug Enforcement Administration (DEA) The DEA was organized to enforce the Controlled Substances Act, gather intelligence, train its officers, and conduct research in the area of dangerous drugs and drug abuse. The DEA is a bureau of the Department of Justice, and the director of the DEA reports to the Attorney General of the United States. The US Attorney General, after public hearings, has the authority to reschedule a drug, to bring an unscheduled drug under control, or to remove controls on scheduled drugs. The FDA was designed to monitor medications, not to enforce the Controlled Substances Act. The FBI and CIA were not specifically set up to enforce the Controlled Substances Act.

Which description best defines a medication?

Drug used for a therapeutic effect to prevent and treat disease Medications are drugs used for their therapeutic effects. A therapeutic effect can be the prevention or treatment of disease. All medications do not require a prescription. Specifying a certain action is not the best definition of a medication because it is incomplete.

Which schedule drugs have a very high potential for abuse?

I Schedule I drugs such as lysergic acid diethylamide (LSD), hashish, peyote, and heroin have a very high potential for abuse. Schedule III drugs have a high potential for abuse but less than Schedule I. Schedule IV drugs have a lower potential for drug abuse than Schedule III drugs. Schedule V drugs have a low potential for abuse.

Which drug schedule includes restricted-access nonprescription drugs according to the National Association of Pharmacy Regulatory Authorities (NAPRA) of Canada?

II The National Association of Pharmacy Regulatory Authorities (NAPRA) of Canada proposed a drug scheduling model consisting of four schedules. Schedule II includes restricted-access nonprescription drugs. Schedule I includes all prescription drugs, including narcotics. Schedule III includes pharmacy-only nonprescription drugs. Drugs that are not categorized in Schedules I, II, or III are considered unscheduled.

Which drug schedule would the nurse review before administering phenobarbital?

IV Schedule IV drugs include phenobarbital and chlordiazepoxide. Morphine, Vicodin, methadone, and methylphenidate are examples of Schedule II drugs. Schedule III drugs include Norco and acetaminophen. Schedule V drugs include Lomotil and Robitussin AC.

A new drug approved by the Food and Drug Administration (FDA) has acquired a black box warning. Which aspect of the drug would be included in the warning?

Its potentially life-threatening complications A black box warning indicates that the drug is associated with very serious or potentially life-threatening problems. Orphan drugs are used to treat rare diseases. A drug that has passed a phase 3 clinical study is ready for postmarketing surveillance. A drug passes phase 1 of development after its pharmacokinetic and pharmacological properties are determined in humans.

Which medication is included in Schedule I of the United States Controlled Substance Drug Schedules?

Lysergic acid diethylamide In the US Controlled Substance Drug Schedules, Schedule I drugs have the highest potential for abuse. Lysergic acid diethylamide is a hallucinatory agent that has a very high potential for abuse and is therefore included in Schedule I. Codeine is included in Schedule III because it has a moderate potential for physical dependence. Flurazepam is included in Schedule IV because it has a limited potential for physical dependence. Methadone is included in Schedule II because it has a high potential for abuse.

Which legislation was written to require companies to determine the safety of medications before marketing?

The Federal Food, Drug, and Cosmetic Act of 1938 The Federal Food, Drug, and Cosmetic Act of 1938 (passed on June 25, 1938 and amended in 1952 and 1962) requires the FDA to determine the safety of drugs before marketing and to ensure that certain labeling specifications and standards in advertising are met in the marketing of products. Manufacturers are required to submit new drug applications to the FDA for review of safety studies before products can be released. The Durham Humphrey Amendment of 1952 was passed to divides medications into prescription and non-prescription (OTC) categories based on safety. The Kefauver Harris Drug Amendment of 1962 was brought about by the thalidomide tragedy. The amendment provides greater control and surveillance of the distribution and clinical testing of investigational drugs and requires that a product be proven safe and effective before release for sale. The Controlled Substance Act of 1970 was passed by Congress to improve the administration and regulation of manufacturing, distributing, and dispensing of drugs that have a high incidence of abuse.

Which statement by the nursing student indicates understanding of the Canadian drug names?

The brand name of a drug in Canada may be different from that in the United States. The brand name is the name assigned to a drug by its manufacturer; a drug's brand name may be different in Canada and the United States. The term "official drug" pertains to a drug for which a standard is described specifically in the Food and Drug Regulations. The chemical name is not the proprietary name of a drug. The proper name of a drug is same in both Canada and the United States.

Which statement is true regarding Canadian drug names?

The chemical name is most meaningful to the chemist. The chemical name is most meaningful to the chemist because he or she can understand the exact chemical constitution of the drug and the exact placement of its atoms and molecules. The generic name is the nonproprietary name. The brand name distinguishes the drug for advertisement and sale; the brand name is assigned by the drug's manufacturer.

Place in the correct order the steps involved in the process of new drug development.

The drug is discovered, synthesized, and purified. The drug's therapeutic value is determined in animals. The drug's pharmacologic properties are determined in humans, including toxicity. The drug's safety and success rate at various dosages is determined in humans. The statistical significance of the results is ensured in a large human population. The drug's safety is monitored after releasing the drug in the market. The preclinical phase of new drug development begins with the discovery, synthesis, and purification of a drug. After extracting the drug, its therapeutic value is determined in animals. In the first phase of clinical study, the drug's pharmacologic properties are determined in humans. In phase 2, the drug's safety at various dosages is determined in humans. In phase 3, the statistical significance of the study results is ensured in a large human population. Finally, in phase 4, the drug's safety is monitored after it has been released in the market.

Which statement provides a definition of the trade name of a drug?

The proprietary name of the drug given by a manufacturer The trade or brand name is the proprietary name given to the drug by its manufacturer. The same drug produced by different companies has one generic name but may have many trade names. The trade name is trademark protected and can be used only by its manufacturer. The drug may be listed under more than one name in the US Pharmacopeia. The book is used to provide standards for identity, quality, strength, and purity of substances used in healthcare practice. The trade name is not given to a drug by the FDA. The chemical name is the exact chemical constitution of the drug and the exact placing of its atoms or molecular groupings.

Which method of classification is followed in classifying these drugs? diuretics antacids laxatives antibiotics

Therapeutic effect Diuretics, antacids, laxatives, and antibiotics describe the therapeutic effects they provide; therefore the therapeutic effect is the method used to classify these classes of drugs. Chemical action classification is used to classify chemicals that provide the same action. Physiological action classification is when the drugs are classified according to their site of action. If the drugs are classified, for example, as drugs for the cardiovascular system or the gastrointestinal system, it is a classification based on the body systems affected.

A patient reports taking an antacid routinely. The patient's reference to the drug in this way characterizes which method of drug classification?

Therapeutic use By stating he or she is taking an antacid, the patient is referring to the clinical indication or therapeutic use of the drug. Classification by body system would refer to the part of the body system that the drugs affect. Chemical and physiologic actions would describe the drug by its chemical or physiologic actions.

Which statement provides the rationale for parallel tracking done in the clinical research and development stage?

To make Investigational New Drugs (INDs) available to patients with life-threatening illnesses Parallel tracking is a mechanism that makes Investigational New Drugs (INDs) available to patients with life-threatening illnesses and patients who cannot participate in controlled clinical trials. Phase 3 clinical trials determine the success rate and safety of drugs for intended use. Phase 2 clinical trials provide additional information about proper dosing and safety of drugs. Fast-tracking is a mechanism that expedites the development and approval of drugs for the treatment of life-threatening illnesses.