Pharmacy Laws, Regulations and Ethics

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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

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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

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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

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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 Signup and view all the answers

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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 Signup and view all the answers

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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 Signup and view all the answers

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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 Signup and view all the answers

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 Signup and view all the answers

Pharmacists were required to offer counseling to Medicaid patients by the

1990 Omnibus Budget Reconciliation Act (OBRA) Signup and view all the answers

Drugs that require prescriptions are _________ drugs

legend Signup and view all the answers

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

FDA Signup and view all the answers

The main purpose of phase 2 clinical trials is

effectiveness Signup and view all the answers

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

generic Signup and view all the answers

Drugs that do not require a prescription are ______ drugs

OTC Signup and view all the answers

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 Signup and view all the answers

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

18 Signup and view all the answers

The second set of digits in the NDC represents the

name of drug and strength Signup and view all the answers

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

MedWatch Signup and view all the answers

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

Class I Signup and view all the answers

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 Signup and view all the answers

The form for ordering Schedule II controlled substances is DEA Form

222 Signup and view all the answers

The error that led to Emily's Law involved

sodium chloride Signup and view all the answers

Which FDA recall classification is the most serious?

Class I Signup and view all the answers

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

The more strict law must be followed Signup and view all the answers

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

Chapter 795 Signup and view all the answers

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

The manufacturer Signup and view all the answers

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

Both B and C Signup and view all the answers

Which drug has a REMS?

Isotretinoin Signup and view all the answers

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

Location of pharmacy Signup and view all the answers

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

Phase 1 Signup and view all the answers

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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. Signup and view all the answers

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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 Signup and view all the answers

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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 Signup and view all the answers

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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 Signup and view all the answers

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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 Signup and view all the answers