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law, regulations etc
module 3
| Question | Answer |
|---|---|
| The number all prescribers of controlled substances are assigned and that must be used on all controlled drug prescriptions. | DEA number |
| When there is a strong likelihood that the product will cause serious adverse effects or death. | Class I Recall |
| Heroin, various opium derivatives, and hallucinogenic substances are included on this schedule. | Schedule I Drugs |
| Legal agreements that have duties associated with them. | Contracts |
| A Class III recall is most likely to cause harm or death. | False |
| An unintended side affect of a medication that is negative or in some way injurious to a patient's health. | Adverse Effect |
| All controlled substances must be ordered using a DEA controlled substance order form. | False |
| Schedule III, IV, and V drugs may be stored openly on shelves in retail and hospital settings. | True |
| The ______ defined what drugs require a prescription. | Sherley Amendment |
| The main purpose of phase II clinical trials is | Efficacy |
| The actions of the health-care provider should be in the best interest of the patient. | Beneficence |
| Childproof packaging was required by the Drug Enforcement Administration. | False |
| Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group. | Schedule IV Drugs |
| 1970 law that established schedules of controlled substances. | Controlled Substance Act |
| In clinical trials, the testing is done | on people |
| The national drug code (NDC) is assigned by the | CDER |
| When a product is not likely to cause adverse effects. | Class III Recall |
| Means you can be prosecuted for misconduct. | Liability |
| Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule. | Schedule II Drugs |
| The monthly sales limit of pseudoephed-rine base is | 7.5 g per transaction |
| Any drug that requires a prescription and this "legend" on the label: Rx only. | Legend Drug |
| When a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects. | Class II Recall |
| Legend drugs should have the legend __________ on the manufacturer's label. | "For external use only" |
| The CMEA sets daily and monthly restrictions on the sale of pseudoephedrine | True |
| The prescriber's name must appear on the label of a dispensed prescription container. | True |
| Over-the-counter medication do not require a prescription but sometimes prescriptions are written for them. | True |
| Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on this schedule. | Schedule III Drugs |
| A branch of philosophy that helps determine what should be done in a principled sense. | Ethics |
| The number on a manufacturer's label indicating the manufacturer and product information. | NDC (national drug code) |
| The action taken to remove a drug from the market and have it returned to the manufacturer. | Recall |
| Drugs that do not require a prescription. | OTC drugs |
| A need for tighter drug regulations from the thalidomide lesson led to the | Kefauver-Harris Amendment |
| Justice means fairness and equality should be applied when providing care to all patients. | True |
| Any personal information that could be used to identify an individual or their health history. | Protected health Information (PHI) |
| Patients have the right to choose their treatment. | Autonomy |
| Failing to do something you should have done. | Negligence |
| HITECH effectively amends HIPAA. | True |
| Compounds containing limited amounts of a narcotic such as codeine are included in this group. | Schedule V drugs |
| DEA form ______ is used to order Schedule II controlled substances. | 222 |
| An inactive substance given in place of a medication. | Placebo |
| The second set of digits in an NDC represents the | Name of drug and strength |
| A court order preventing a specific action, such as the distribution of a potentially dangerous drug. | injunction |
| An unintended side effect of a medication that is negative or in some way injurious to a patient's health. | Adverse Effect |
| The error that led to Emily's Law involved | Sodium Chloride |
| Purchasers of exempt narcotics must be at least ____________ years of age. | 18 |
| Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine | combat Methamphetmine Epidemic Act (CMEA) |
| According to the Poison Prevention Packaging Act, who can request containers that are not child-proofed? | Physician and Patient |
| Which USP chapter sets the legal standard for non-sterile compounded preparations? | chapter <795> |
| Five groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and whose distribution is therefore strictly controlled by five control schedules set forth in the CSA. | controlled substances |
| The Combat Methamphetamine Epidemic Act requires that OTC cold and allergy medications containing which of the following drugs be kept behind the counter? | ephedrine & pseudoephedrine |
| __________ drug recalls are issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death. | Class I |
| Information and procedures that are required of manufacturers by the FDA for drugs with known risks. | Risk Evaluation and Mitigation Strategies (REMS) |
| The mark (CII-CV) that indicates the control category of a drug with a potential for abuse. | Controlled substance mark |
| The action taken to remove a drug from the market and have it returned to the manufacturer. | recall |
| A tort arising from the breach of the duty of care. | Negligence |
| A branch of philosophy that helps determine what should be done in a principled sense. | Ethics |
| Laws pertaining to a wrong to society. | Criminal law |
| Pharmacists were required to offer counseling to Medicaid patients by the | 1990 Omnibus Budget Reconciliation Act (OBRA) |
| A federal act that strengthens HIPAA and promotes electronic prescribing and electronic medical records. | health information technology for economic and clinical health act (HITECH) |
| Drug products that contain identical amounts of the same active ingredients in the same dosage form. | pharmaceutical equivalent |
| Amphetamines, opium, cocaine, and methadone are in DEA Schedule ____________ because they have accepted medial use, but have a high potential for abuse and may lead to physical or psychological dependence. | II |
| Which FDA recall classification is the most serious? | Class I |
| Important associated information that is not on the label of a drug product itself. | Product Labeling |
| Civil wrongs that have duties associated with them. | Torts |
| Medications with habit-forming ingredients that can be dispensed without a prescription by a Pharmacist to persons at least 18 years of age. | Exempt narcotics |
| .The FDA reporting system for adverse effects that occur from use of approved drugs is called. | MedWatch |
| Laws pertaining to wrongs to an INDIVIDUAL | civil law |
| Doing what is required | compliance |
| Specific guideline for practice | Protocol |
| Pharmaceutical equivalents that produce the same effects in patients. | Therapeutic Equivalent |
| Because of fatal poisoning from liquid sulfanilamide, the ____________ required new drugs be shown to be safe before marketing. | 1938 Food, drug and Cosmetic Act |
| After a patent has expired for a medication, other manufacturers may copy the drug and release it under the ____________ name | generic |
| Drugs that require prescriptions are ____________ drugs. | Legend |
| Which phase of clinical trials involves healthy patients without the disease or condition? | phase I |
| Drugs that do not require a prescription are ____________ drugs. | OTC |
| What does the first set of numbers in the national drug code indicate? | manufacturer |
| Both domestic and imported drugs require approval by (a/the) ____________ before they can be marketed in the United States | FDA |
| Which drugs has a REMS? | Isotretinoin |
| What law should be followed when federal and state laws don't agree? | The MORE STRICT law must be followed |
| Legal agreements that have duties associated with them | Contracts |
| A type of negligence lawsuit brought against a person with a professional license | Malpractice |
| Legal responsibility for costs or damages arising from misconduct or negligence. | Liability |
| Status of medications like Plan B® that are classified as both prescription and OTC drugs. | Dual marketing status |
| What is not an example of protected health information (PHI)? | location of pharmacy |
Created by:
abdomin