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Pharmacy > Chapters 1-3 main points > Flashcards

Chapters 1-3 main points Flashcards

1
Q

Pharmacology

A

The study of drugs-their properties, uses, application, and effects.

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2
Q

Materia Medica

A

Generally pharmacology, but also refers to the drugs in use

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3
Q

Pharmaceutics

A

Of or about drugs; also, a drug product

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4
Q

Omnibus Budget Reconciliation Act (OBRA)

A

Requires pharmacists to provide counseling services to Medicaid patients.

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5
Q

Pharmacogniosi

A

The study of physical, chemical, biochemcial and biological properties of drugs as well as the search for new drugs from natural sources

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6
Q

How often is certification renewed

A

Certification must be renewed every two years; contains 20 contact hours of pharmacy related training continuing education, which includes at least one hour in law

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7
Q

PTCE

A

Pharmacy Technician Certification Exam

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8
Q

PTCB

A

Pharmacy Technician Certification Board

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9
Q

ExCPT

A

Exam for the Certification of Pharmacy Technicians

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10
Q

NHA

A

National Healthcare Association

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11
Q

1938 Food, Drug and Cosmetic (FDC) Act

A

Requires new drugs be shown to be safe before marketing

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12
Q

1951 Durham-Humphrey Amendment

A

Defines which drugs require a prescription; including a legend on the label

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13
Q

1962 Kefauver-Harris Amendment

A

Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug

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14
Q

1970 Poison Prevention Packaging Act

A

Requires childproof packaging on all controlled and most prescriptions drugs dispense by pharmacies

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15
Q

1970 Controlled Substances Act (CSA)

A

Classifies 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution

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16
Q

1990 Omnibus Budget Reconciliation Act (OBRA)

A

Requires the pharmacists to offer counseling to Medicaid patients regarding medications

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17
Q

1996 Health Insurance Portability and Accountability Act

A

This law defined the scope of health information that may and may not be shared among health-care providers without patient consent and provided for broad and stringent regulations to protect patients’ right to privacy.

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18
Q

Whose job is to prove safety and effectiveness of a new drug and to whom must they show proof to?

A

It is the responsibility of the drug manufacture to provide proof of safety and effectiveness to the FDA’s Center for Drug Evaluation and Research

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19
Q

What happens in the different phases of clinical Testing?

A

There are 3 phases of clinical testing; Phase 1: 20-100 patients and lasts several months, the purpose is mainly safety. In phase 2 there are up to several hundred patients, lasts several months to two years, the purpose of phase 2 is some safety but mainly effectiveness. Phase 3 contains several hundred to several thousand patients, will last between 1 to 4 years, the purpose of safety is safety, effectiveness, and dosage.

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20
Q

How long does a patent last past the date of filing

A

A patent will expire 20 years past the date of filing.

21
Q

1984 Hatch-Waxman Act

A

Allows for both the extension of drug patent terms and quicker introduction of lower0cost generic drugs

22
Q

What are the limits on ephedrine that can be sold per day/per month

A

A person can purchase 3.6 grams of pseudoephedrine per day and 7.6 per month

23
Q

Exempt Narcotics

A

Medications with habit forming ingredients that could be dispensed by a pharmacist without a prescription by persons at least 18 yrs old

24
Q

What are the minimum requirements on prescription labels for most drugs?

A 
Name and address of pharmacy
Prescription serial number
date written
expiration date
name of prescriber
25
Q

What do the number in the NDC stand for

A 
1st set (5 numbers) indicate the manufacturer
2nd set (4 numbers) indicates the medication, strength, and dosage form
3rd set (2 numbers) indicate the package size
26
Q

What is a schedule I control substance?

A

These are drugs with a high potential for abuse and have no accepted medical use in the US; Heroin, various opiums, and various Hallucinogenic substances

27
Q

What is a schedule II control substance?

A

These are drugs that have a high potential for abuse, which can lead to physical or psychological dependence but that also have currently accepted medical uses in the US; Amphetamines, opium, cocaine, methadone, and various opiates

28
Q

What is a schedule III control substance?

A

These are drugs with a potential for abuse less than those in Schedules I and II. Their abuse may lead to moderate or low physical dependence or high psychological dependences; anabolic steroids and various compounds containing limited quantities of narcotic substances such as codine

29
Q

What is a schedule IV control substance?

A

These are drugs have a low potential for abuse relative to schedule III. Their abuse can lead to low physical or psychological dependence. Phenobarbital, chloral hydrate, anesthetic methohexital

30
Q

What is a schedule V control substance?

A

These are drugs that have a low potential for abuse. Their abuse could lead to limited physical and psychological dependence

31
Q

DEA Form-224

A

Application for New Registration

32
Q

DEA Form-224a

A

Application for Renewal Application for registration

33
Q

DEA Form-224b

A

Retail Pharmacy Registration Affidavit for Chain Renewal

34
Q

DEA Form-222

A

US Official order form for Schedule I & II

35
Q

DEA Form-41

A

Registrants Inventory of Drugs Surrendered

36
Q

DEA Form-106

A

Report of theft or loss of Controlled Substances

37
Q

DEA Form-363

A

New Application Narcotic Treatment Program

38
Q

DEA Form-363a

A

Application for DEA Registration for NTP renewal registration

39
Q

DEA Form-510

A

Chemical Registration

40
Q

MedWatch

A

FDA reporting program for health-care professionals to report adverse effects that occur from the use of an approval drug or other medical product

41
Q

What is the ASHP

A

The American Society of Health-System Pharmacists is an association for pharmacists practicing in hospitals, HMSOs, long-term care facilities, home care agencies, and some other health-care systems

42
Q

What is the USP?

A

The United States Pharmacopeial Convention is a voluntary not-for-profit organization that sets standards for the manufacture and distribution of drugs and related products in the US

43
Q

What is TJC?

A

The Joint Commission is an independent non-profit organization that establishes standards and monitors compliance for hospitals, health-care networks, HMOs, and nursing homes.

44
Q

What is the ASCP

A

The American Society for Consultant Pharmacists sets standards for practice for pharmacists who provide medication distribution and consultant services to nursing homes

45
Q

Pharmaceutically Equivalent

A

Drug products that contain identical amounts of the same active ingredients in the same dosage form

46
Q

Therapeutic Equivalent

A

Pharmaceutical equivalents that produces the same effects in patients

47
Q

What is the class 1 recall

A

In a class 1 recall there is a strong likelihood that the product will cause serious adverse effects or death

48
Q

What is a class 2 recall

A

A class 2 recall is where a products may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects

49
Q

What is a class 3 recall

A

In a class 3 recall a product is not likely to cause adverse effects.

Pharmacy (14 decks)

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