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Intro to Pharm
Chapter 2
| To dispensed controlled substances | Form 224 |
| For retail pharmacies that want to engage in wholesale distribution of bulk quantities of drugs containing pseudoephedrine, phenylpropanolamine, or ephedrine | Form 510 |
| To manage a controlled substances treatment programs or compound controlled substances | Form 363 |
| To order or transfer schedule II substances | Form 225 |
| Authorization to destroy damaged, outdated, or unwanted controlled substances | Form 41 |
| For loss or theft of a controlled substance | Form 106 |
| The following are temper-proof prescription features except | Each sheet is non-sequentially numbered for internal and state mandated record keeping |
| Which of the following controlled substance schedule drugs can be obtained without a prescription in some states? | C-V |
| Recording keeping is being regulated by | Federal law |
| Invoices for C-II drugs must be kept for ______ years | 2 |
| Retail pharmacies disposing of bulk quantities of PSE, phenylephrine, or ephedrine must register with DEA form 510 | True |
| Encourages discovery and use of devices intended to benefit patients in treatment and diagnosis of diseases or conditions that affect fewer than 4000 individuals in the U.S. | 1990 Humanitarian Device Exemption - Safe Medical Devices Act |
| Covers food items and their labeling, vitamins, minerals, or other nutrients are on the label and in some cases highlighted | 1990 Nutritional Labeling and Education Act |
| Helps to avoid counterfeit drugs and ingredients in the supply chain and also helps limit diversion of pharmaceutical samples and prescription drugs | 1987 Prescription Drug Marketing Act |
| Encourages drug companies to develop drugs for rare diseases by providing research assistance, grants, and cost incentives | 1983 Orphan Drug Act |
| Gives FDA an accurate list of all drugs manufactured, prepared, propagated, compounded or processed by a drug establishment regulated under the FDA and amends the Federal Food, Drug, and Cosmetic Act prevents unfair or deceptive packaging and labeling | 1972 Drug Listing Act |
| Helps enforce regulations on the abuse of anabolic steroid | 1990 Anabolic Steroids Control Act |
| Better defines the term dietary supplements to include herbs such as ginseng, garlic, fish oil, psyllium, enzymes, glandulars, and mixtures of these | 1994 Dietary Supplement Health and Education Act |
| Congressional Act that changed reimbursement limits and mandated Drug Utilization Evaluation, pharmacy patient consultation, and educational outreach programs | 1990 Omnibus Budget Reconciliation Act |
| Requires a prescription for dispensing; the federal legend: "federal law prohibits the dispensing of this medication without a prescription" | Legend Drug |
| Any drug or other substance that is scheduled I through V and regulated by the Drug Enforcement Administration | Controlled Substances |
| Nonspecific term used to describe a drug that in moderate doses drills the senses relieves pain, and induces profound sleep but in excessive doses causes stupor, coma, or convulsions and may lead to addiction | Narcotic |
| A drug derived from barbituric acid; acts as a central nervous system depressant and often used in the treatment of seizures and as a sedative and hypnotic agents | Barbiturate |
| Describes medication that can be purchased without a prescription; non-legend medication | Over - the - counter (OTC) |
| There are no federal or state laws that require a prescription to dispense schedule V drugs, then dispensing without a prescription is permitted | True |
| When federal and state law affects the most lenient law is the one you should follow | False |
| A prescriber how has met all the conditions to prescribe suboxone and Subutex will be issued a special number with a Z by the DEA | True |
| A process that ensures that prescribed drugs are used appropriately; main desired outcome is an increase in medication related safety | Drug Utilization Evaluation |
| Comprehensive information on a medications actions within that class of drugs; lists brand/generic names, route of admin, side effects, adverse effects, ingredients, foods and other drugs to avoid | Monograph |
| A 10 digit number that indicates specifics the drug manufacturer, the drug product, the package, size of a package drug or an insulin product | National Drug Code |
| Compiles and publishes select manufacturer provided package inserts and prescribing info useful for health professionals | Physician's Desk Reference |
| Document providing chemical product information | Safety Data Sheet |
| System used by the FDA to describe 5 levels of assessment of fetal effects caused by a drug; a required section of current prescription drug labeling | Pregnancy Categories |
| Publication of the USP that contains standards for meds, dosage forms, drug substances, excipients, medical devices, and Dietary supplements | United States Pharmacopeia - National Formulary |
| Term used to describe a patients personal health data; protected from being shared or distributed without permission | Protected Health Information |
| DEA requires narcotic inventory to be taken every 5 years | False |
| VIPPS is a label that indicates to the public that the website from which they are ordering drugs from is both legitimate and licensed | True |
| To destroy controlled substances, which DEA form must be used | Form 41 |
| Adequate and well controlled studies have failed to demonstrate a risk to the fetus in the 1st trimester of pregnancy (no evidence of risk in later trimesters) | Pregnancy Category A |
| There is positive evidence of human fetal risk based on adverse reaction data from investigating or marketing experience or studies in humans, but potential benefits may warrant use of drug in pregnant women despite potential risks | Pregnancy Category D |
| Studies in animal/humans show fetal abnormalities, and/or positive evidence of human fetal risk based on adverse reactions from investigational/marketing experience, and risks involved outweigh potential benefits | Pregnancy Category X |
| Animal reproduction studies show adverse effect on fetus, and are no adequate well controlled studies in humans, but potential benefits may warrant use of drug during pregnancy despite potential risks | Pregnancy Category C |
| Animal reproduction studies failed to demonstrate risk to fetus and no adequate and well controlled studies in pregnant women | Pregnancy Category B |
| If a tech is asked a question about the pharmacy's policies and procedures by a representative of the TJC and does not know the answer, the tech should do the following | Give an honest answer |
| To obtain a schedule II substance from distributor, which DEA form must be filled out | Form 222 |
| In most states, a prescription for a C - IV drug expires after | 6 months or 5 refills |
| Practice of pharmacy is governed by a series of laws, regulations, and rules enforced by federal, state, and local governments | True |
| Highest level of a manufacturer recall, which indicates that products could cause serious harm or fatality, is a | Class 1 recall |
| Manufacturers need to prove the effectiveness of the drugs through methods such as scientific studies | True |
| Important concepts of this act were adulteration, misbranding, and providing legal status for the FDA | 1938 Food, Drug and Cosmetic Act |
| Adds more instructions for drug companies, required label "caution: federal law prohibits dispensing without a prescription" made distinction between legend and OTC and do not require a physicians order | 1951 Durham Humphrey Amendment |
| Label must show net contents; name, place of business of manufacturer, packer, or distributor; and net quantity of contents in terms of weight, measure, or numeric count | 1967 Fair Packaging and Labeling Act |
| Required practitioner registration, documentation regarding prescriptions and dispensing, and implementation of restrictions regarding the importation, sale, and distribution of opium, coca leaves, and any derivative products | 1914 Harrison Narcotic Act |
| Ensures the safety and effectiveness of all new drugs on the U.S. market | 1962 Kefauver Harrison Amendment |
| One of the first laws enacted to stop the sale of inaccurately labeled drugs | 1906 Federal Food Drug Act |
| Requires manufacturers and pharmacies to place all medications in containers with child-proof caps or packaging, including both OTC and legend drugs | 1970 Poison Prevention Packaging Act |
| Formed the DEA to enforce the laws concerning controlled substances and their distribution and introduced a stair step schedule of controlled substances | 1970 Comprehensive Drug Abuse Prevention and Control Act |
| Methadone is a C - II controlled substance that is commonly used for opioid addiction but is also prescribed for | Cancer patients to alleviate pain |
| Who has the authority to decide under what schedule a drug should be placed | Attorney General |
| States that allow the schedule V drugs to be sold OTC may dispense | To purchase at least 17 years of age or older |
| Federal and state managed insurance program that covers health care costs and prescription drugs for individuals older than 65, younger than 65 with disabilities, or ppl with end stage renal failure | Medicare |
| U.S. government managed agency that oversees safety in the workplace; created safety data sheets (SDS) requirement | Occupational Safety and Health Administration (OSHA) |
| Federal and state operated insurance program that covers health care costs and prescription drugs for low income children, adults, and elderly and those with disabilities | Medicaid |
| Federal agency within the U.S. department of justice that enforces U.S. laws and regulations related to controlled substances | Drug Enforcement Administration (DEA) |
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