Pharmacy Laws, Regulations and Ethics - CH 3

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Match the term

adverse effects = an unintended side effect of a medication that is negative or in some way injurious to a patient's health. civil law = laws pertaining to wrongs to an individual Combat Methamphetamine Epidemic Act (CMEA) = federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine compliance = doing what is required

Match the term

contracts = legal agreements that have duties associated with them controlled substance mark = the mark (CII-CV) that indicates the control category of a drug with a potential for abuse controlled substances = 5 groups of drugs identified by the 1970 Controlled Substances Act (CSA) as having the potential for abuse and who distribution is therefore strictly controlled by five control schedules set fourth in the CSA criminal law = laws pertaining to a wrong to society

Match the term

dual marketing = status of medication like plan B that are classified as both prescription and OTC drugs ethics = a branch of philosophy that helps determine what should be done in a principled sense exempt narcotics = medications with habit-forming ingredients that can be dispensed without a prescription by a pharmacist to persons at least 18 years of age Health Information Technology for Economic and Clinical Health Act (HITECH) = a federal act that strengthens HIPAA and promotes electronic prescribing and electronic medical records

Match the term

injunction = a court order preventing a specific action, such as the distribution of a potentially dangerous drug legend drug = any drug that requires a prescription and this legend on the label: Rx only liability = legal responsibility for costs or damages arising from misconduct or negligence malpractice = a type of negligence lawsuit brought against a person with a professional license

Match the term

negligence = a tort arising from the breach of the duty of care pediatric = having to do with the treatment of children pharmaceutical equivalent = drug products that contain identical amounts of the same active ingredients in the same dosage form placebo = an inactive substance given in place of a medication

Match the term

product labeling = important associated information that is not on the label of a drug product itself protocol = specific guideline for practice recall = the action taken to remove a drug from the market and have it returned to the manufacturer Risk Evaluation and Mitigation Strategies (REMs) = information and procedures that are required of manufacturers by the FDA for drugs with known risks

Match the term

therapeutic equivalent = pharmaceutical equivalents that produce the same effects in patients torts = civil wrongs that have duties associated with them n/a = n/a N/A = N/A

Because of fatal poisoning from liquid sulfanilamide, the _______ required new drugs to be shown to be safe before marketing

1938 Food, Drug, and Cosmetic Act

Pharmacists were required to offer counseling to Medicaid patients by the

1990 Omnibus Budget Reconciliation Act (OBRA)

Drugs that require prescriptions are _________ drugs

legend

Both domestic and imported drugs require approval by (a/the) __________ before they can be marketed in the US.

FDA

The main purpose of phase 2 clinical trials is

effectiveness

After a patent has expired for a medication, other manufacturers may copy the drug and release it under the _______ name.

generic

Drugs that do not require a prescription are ______ drugs

OTC

The Combat Methamphetamine Epidemic Act requires that OTC cold allergy medications containing which of the following drugs be kept behind the counter?

Ephedrine and pseudoephedrine

Purchasers of exempt narcotics must be at least ____ years of age.

18

The second set of digits in the NDC represents the

name of drug and strength

The FDA reporting system for adverse effects that occur from use of approved drugs is called

MedWatch

____________ drug recalls are issued by manufacturers when there is a strong likelihood that the product will cause serious adverse effects or death

Class I

Amphetamines, opium, cocaine, and methadone are in the DEA schedule _____ because they have accepted medical use, but have a high potential for abuse and may lead to physical or psychological dependence.

II

The form for ordering Schedule II controlled substances is DEA Form

222

The error that led to Emily's Law involved

sodium chloride

Which FDA recall classification is the most serious?

Class I

What law should be followed when federal and state laws don't agree?

The more strict law must be followed

Which USP chapter sets the legal standard for non-sterile compound preparations.

Chapter 795

What does the first set of numbers in the national drug code indicate?

The manufacturer

According to the Poison Prevention Packaging Act, who can request containers that are not child-proofed?

Both B and C

Which drug has a REMS?

Isotretinoin

Which is not an example of protected health information (PHI)?

Location of pharmacy

Which phase of clinical trials involves healthy patients without the disease or condition?

Phase 1

Match the terms

DEA number = This number all prescribers of controlled substances are assigned and that must be used on all controlled drug prescriptions Beneficence = The actions of the health care provider should be in the best interest of the patient Placebo = an inactive substance given in place of a medication adverse effects = an unintended side effect of a medication that is negative or in some way injurious to a patient's health.

Match the terms

legend drug = any drug that requires a prescription and this "legend" on the label: Rx only negligence = failing to do something you should have done autonomy = patients have the right to choose their treatment PHI = any personal information that could be used to identify an individual or their health history

Match the terms

Liability = means you can be prosecuted for misconduct Controlled Substance Act = 1970 law that established schedules of controlled substances NDC (national drug ode) = the number on a manufacturer's label indicating the manufacturer and product information OTC = drugs that do not require a prescription

Match the terms

Schedule II Drugs = Amphetamines, opium, cocaine, methadone, and various opiates are included on this schedule Schedule III Drugs = Anabolic steroids and various compounds containing limited quantities of narcotic substances such as codeine are included on this schedule Class III recall = When a product is not likely to cause adverse effects Schedule V Drugs = compounds containing limited amounts of narcotic such as codeine are included in this group

Match the terms

Class II recall = when a product may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects Schedule I Drugs = Heroin, various opium derivatives, and hallucinogenic substances are included on this schedule Schedule IV Drugs = Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital are included in this group. Class I recall = when there is a strong likelihood that the product will cause serious effects or death

Childproof packaging was required by the Drug Enforcement Administration

False

The CMEA sets daily and monthly restrictions on the sale of pseudoephedrine

True

Only about 25% of drugs tested on humans are approved for use by the FDA

True

OTC medications do not require a prescription but sometimes prescriptions are written for them

True

The prescriber's name must appear on the label of a dispensed prescription container

True

A class III recall is most likely to cause harm or death

False

HITECH effectively amends HIPAA

True

Schedule III, IV, and V drugs may be stored openly on shelves in retail and hospital settings

True

All controlled schedule substances must be ordered using a DEA controlled substance order form

False

Justice means fairness and equality should be applied when providing care to all patients

True

The ______ defined what drugs require a prescription

1951 Durham-Humphrey Amendment

Legend drugs should have the legend _______ on the manufacturer's label

"Rx only"

A need for tighter drug regulations from the thalidomide lesson led to the

Kefauver-Harris Amendment

In clinical trials, the testing is done

on people

The main purpose of phase II clinical trials is

efficacy

The monthly sales limit of the pseudoephedrine base is

7.5 g per purchaser

The National Drug Code (NDC) is assigned by the

manufacturer

Legal agreements that have duties associated with them

Contracts

A branch of philosophy that helps determine what should be done in a principled sense

Ethics

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