chapter 1 pharm review

When writing a prescription for opioids or other controlled substances, what is advisable to ensure correct dosage?

Add the number of tablets written in Roman numerals or longhand. The prescriber of other controlled substances should add in parentheses the number of tablets or capsules written out in Roman numerals or in longhand after the Arabic number of tablets or capsules to reduce the possibility of prescription tampering.

All are required on a prescription labels except:

Age of the patient The age of the patient is required on the prescription, but not on the prescription label. The name of the medication and its strength; the name, address, and telephone number of the pharmacy; the patient's and dentist's names; the directions for use; the original date and the date filled; and the quantity of medication dispensed are all required to be on the prescription label.

All statements about generic drugs are true except:

All ingredients in the generic drug must be exactly the same as for the brand name. Although the active ingredient of the generic product must enter the bloodstream at the same rate as it does for the trade name product, some variation is allowed in the reformulation of the brand name product as long as the generic drug is biologically and therapeutically equivalent to the original trade name drug. Manufacturers who develop trade name drugs are allowed a 20-year patent with extensions to market their drug.

The __________ of the prescription contains the symbol Rx, name and dose size or concentration (liquids) of the drug, the amount to be dispensed, and the directions to the patient.

Body The body of the prescription contains the symbol Rx, name and dose size or concentration (liquids) of the drug, the amount to be dispensed, and the directions to the patient. The heading contains the name, address, and telephone number of the prescriber (printed on the prescription blank); the name, address, age, and telephone number of the patient (written); and the date of prescription (not a legal prescription unless filled in with date); this is often missing. The closing of the prescription contains the prescriber's signature, the DEA number (if required), and the refill instructions. There is no subscription in the current prescription format.

A drug may have more than one generic name, but only one trade or propriety name.

Both parts of the statements are false. Only one generic name is assigned for each drug, which is selected by the U.S. Adopted Name Council, and the name is not capitalized. Each company that manufacturers a drug is allowed to give the drug its own name; therefore, the same drug may have many trade names.

All off-label uses of drugs must contain a Black Box warning. The Black Box Warning must contain the FDA indications for the use of the drug, contraindications, warnings, adverse reactions, drug interactions, dose and administrtion, and how the drug is supplied.

Both statements are false. Both statements are false. Off-label uses of drugs are uses other than the specific FDA indication listed on the package insert of the drug. Prescribers are allowed to use a drug for off-label use if it is justified by good medical practice. The FDA required the manufacturer to prominently display a black box warning to ensure the prescriber and the patient understand that there may be serious safety concerns associated with the drug. The package insert, not black box warnings contain FDA indications for the use of the drug, contraindications, warnings, adverse reactions, drug interactions, dose and administration, and how the drug is supplied.

When a generic drug is prescribed, then the generic name of the drug and the company that manufactures it are not required on the label. If the trade drug is used, the trade name and the name of the company that manufactures the drug are required on the label.

Both statements are false. Both statements are false. When a generic drug is prescribed, the generic name of the drug and the name of the company that manufactures the drug are required on the label. If the trade drug is used, only the trade name is required on the label.

Which federal regulation requires manufacturers to demonstrate drug effectiveness through strict testing, and submit reports of adverse drug effects of drugs already on the market to the FDA?

Drug Amendments of 1962 The Drug Amendments of 1962 made major changes to the Food, Drug and Cosmetic Act, requiring manufacturers to demonstrate drug effectiveness through strict testing, and submit reports of adverse drug effects of drugs already on the market to the FDA.The Drug Abuse Control Amendment of 1965 required that drugs with a potential for abuse such as barbiturates and amphetamines be accounted for. The Controlled Substances Act of 1970 replaced the Harrison Narcotic Act and the Drug Abuse Control Amendment and regulates the manufacture and distribution of drugs with a potential for abuse, and set requirements for writing prescriptions for these drugs. The Food, Drug, and Cosmetic Act and its amendments prohibit interstate commerce of drugs that have not been proved to be safe and effective.

Which agency grants approval for drugs marketed in the United States after determining the safety and efficiency of the drugs? Federal Trade Commission

Food and Drug Administration The Food and Drug Administration of the U.S. Department of Health and Human Services grants approval for drugs marketed in the United States. The Federal Trade Commission regulates trade and advertising practices of drug companies, foods, nonprescription drugs, and cosmetics; the Drug Enforcement Administration (DEA) regulates controlled substances. The United States Adopted Name Council selects the official generic name for each drug.

Which name is considered the official name of a new drug?

Generic name The generic name is the only official name given to a drug before it is marketed. The trade, brand, or proprietary name is the property of the company that registers the patent for the new drug, and the chemical name is determined by the chemical structure. The code name is given to a drug if the chemical structure is unknown at the time of investigation and is often used even after the chemical structure is known because it is shorter and easier to pronounce.

The abbreviation that means "by mouth" is

PO PO means "per os," or to be taken orally (by mouth); pc means after meals, a means before, and q means every.

A black box warning is most likely to be issued for a drug during which Food and Drug Administration (FDA) clinical phase?

Phase 4 A black box warning is usually issued during the postmarketing surveillance phase (phase 4) to determine toxicity of a drug that occurs in patients after the drug has been released. If there are safety concerns about a drug, and the FDA doesn't remove the drug from the market, a black box warning may be issued to ensure that the prescriber and the patient understand about the safety concerns. Phase I trials administer small and then increasing doses to a limited number of healthy human volunteers, primarily to determine safety. Phase 2 trials' primary purpose is to test effectiveness by giving the drug to larger groups of humans, and adverse reactions are reported to the FDA. Larger numbers of patients who have the conditions for which the drug is indicated are used during Phase 3 trials, where both safety and efficacy must be demonstrated and dosage determined.

All are important reasons for a dental hygienist to have knowledge of pharmacology except:

Prescribing drugs to the dental patient Prescribing drugs is typically the responsibility of the supervising dentist and is not within the scope of practice for dental hygienists in most jurisdictions. Dental hygienists need to be knowledgeable of pharmacology for obtaining a medical history, administering certain drugs in the office, handling medical emergencies, planning appointments, and educating patients.

Which schedule of controlled substances has the highest potential for abuse?

Schedule I Schedule I drugs have the highest abuse potential and have no accepted medical use, except in research. Schedule II covers those that have a high abuse potential among drugs that have an accepted medical use, and schedule IV drugs have the least potential for abuse.

All are true of scheduled drugs except which of the following? a) Prescriptions for a controlled substance require a Drug Enforcement Administration number. b) All schedule II through IV drugs require a prescription. c) Prescriptions for schedule II drugs must be written in indelible ink or typed. d) Schedule II prescriptions can be telephoned to the pharmacist. e) Schedule II prescriptions cannot be refilled; the patient must obtain a new written prescription to obtain more medication.

Schedule II prescriptions can be telephoned to the pharmacist. Schedule II prescriptions cannot be telephoned to the pharmacist (except at the discretion of the pharmacist for an emergency supply, to be followed by a written prescription within 72 hours). Prescriptions for schedule II drugs must be written in indelible ink or typed and cannot be refilled; the patient must obtain a new written prescription to obtain more medication. Schedule drugs require the prescriber to have a Drug Enforcement Administration's number to dispense these drugs. All schedule II through IV drugs require a prescription.

Tylenol with added codeine is listed in what schedule of controlled substances?

Schedule III Codeine mixtures (e.g., Tylenol #3) are schedule III drugs. Schedule III drugs have moderate potential for abuse.

Which categories of drugs refer to those with the potential for abuse?

Schedule drugs Scheduled drugs are also called controlled substances because of their abuse potential. The Controlled Substance Act of 1970 divided these drugs into schedules according to their abuse potential. Drugs with the highest abuse potential are schedule I drugs, and those with the least abuse potential are schedule V drugs. Over-the counter drugs are drugs that have been deemed safe for use by the general public without physician supervision in the directed dose. Prescription drugs are drugs that require physician supervision due to possible adverse reactions. Orphan drugs are developed to treat rare medical conditions than occur in fewer than 200,000 persons in the United States.

Metric units are used in prescription writing. All statements are true concerning metric measurements except:

The basic metric unit for volume is the gram (g). The basic metric unit for volume is the liter (L), not the gram. Gram is a measure of weight.

Certain states require the use of triplicate or duplicate prescription blanks for schedule II drugs. Prescriptions for schedule III and IV drugs may be telephoned to the pharmacist and may not be refilled.

The first statement is true; the second statement is false .The first statement is true; the second statement is false.Certain states require the use of triplicate or duplicate prescription blanks for schedule II drugs. Prescriptions for schedule III and IV drugs may be telephoned to the pharmacist and may be refilled no more than five times in 6 months if so noted on the prescription.

Marijuana is a schedule I drug. This designation means that dentists may prescribe it if a dental indication exists.

The first statement is true; the second statement is false. The first statement is true; the second statement is false.Marijuana is a schedule I drug, which means that no accepted medical indication exists and that only research or experimental use is allowed. No dental indication exists.

The clinic dentist can write a prescription for all situations except...?

Xanax for fear of flying Dentists can only prescribe for dental-related conditions to patients of record. Dental-related anxiety, dental abscess, and temporomandibular joint-related muscle spasms are appropriate dental indications; fear of flying is not.

Which criteria must be met before a dentist can prescribe a medication?

a and c only Patient must be a patient of record. Condition for which the prescription is being prescribed is a dental-related condition. For a dentist to write a prescription for a patient legally, the following criteria must be met: the person must be a patient of record, and the condition for which the prescription is being prescribed is a dental-related condition.

For a drug to gain Food and Drug Administration approval, which is true concerning animal studies?

a, b, and d only The median effective dose is not determined during animal studies; however, the median lethal dose is determined for several species of animals. Additionally, for a drug to gain Food and Drug Administration approval, animal studies measure both acute and chronic toxicity, and long-term animal studies continue, including a search for teratogenic effects

Package Inserts (PIs) contain information aboaut the drug that has been negotiated between the manufacturer and the FDA. What information about the drug must be provided?

a, c, and d a. Chemical makeup of the drug c. FDA-approved indications for use, contraindications and warnings, and adverse reactions d. Drug interactions, dosage and administration The PI provides information about the chemical makeup of the drug, FDA-approved indications for use, contraindications, warnings, adverse reactions, drug interactions, dosage and administration. There are no FDA-approved "off-label" uses, which are uses ouside the labeled FDA-approved uses. Prescribers are allowed to use a drug for off-label use if good medical practice justifies it, use is well-documented in the literature, and the drug meets the current standard of medical care.

Preclinical testing by the Food and Drug Administration (FDA) is used to determine

a, c, and d only Acute and chronic toxicity in animals Toxicity and pharmcokinetic properties Median lethal dose for several species The FDA conducts a preclinical testing period of about 3 years on several species of animals. These tests measure acute and chronic toxicity to animals, the median lethal dose for several species of animals, and toxic and pharmcokinetic properties of these drugs. Acute and chronic toxicity in humans oddus only after the preclinical testing is completed, and and investigational new drug application has been submitted.

The abbreviation that means "before meals" is

ac The abbreviation ac means before meals; pc means after meals, a means before, PO means by mouth, and q means every.

Which conditions must be met for a drug to be approved as a generic substitution for the patented trade name drug?

b and c only Biologically equivalent Therapeutically equivalent

All are trade names of drugs except:

lidocaine Lidocaine is the generic name of a common local anesthetic. The generic name is not capitalized. Drugs have only one generic name. Septocaine, Octocaine, and Xylocaine are all trade or brand names for lidocaine. Trade names are registered as a trademark as property of the registering company and is specific for that company, so there may be many trade names for the same drug.

Which abbreviation stands for every?

q