Chapters 1-3 main points

Question 1

Pharmacology

Answer 1

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

Question 2

Materia Medica

Answer 2

Generally pharmacology, but also refers to the drugs in use

Question 3

Pharmaceutics

Answer 3

Of or about drugs; also, a drug product

Question 4

Omnibus Budget Reconciliation Act (OBRA)

Answer 4

Requires pharmacists to provide counseling services to Medicaid patients.

Question 5

Pharmacogniosi

Answer 5

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

Question 6

How often is certification renewed

Answer 6

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

Question 7

PTCE

Answer 7

Pharmacy Technician Certification Exam

Question 8

PTCB

Answer 8

Pharmacy Technician Certification Board

Question 9

ExCPT

Answer 9

Exam for the Certification of Pharmacy Technicians

Question 10

NHA

Answer 10

National Healthcare Association

Question 11

1938 Food, Drug and Cosmetic (FDC) Act

Answer 11

Requires new drugs be shown to be safe before marketing

Question 12

1951 Durham-Humphrey Amendment

Answer 12

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

Question 13

1962 Kefauver-Harris Amendment

Answer 13

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

Question 14

1970 Poison Prevention Packaging Act

Answer 14

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

Question 15

1970 Controlled Substances Act (CSA)

Answer 15

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

Question 16

1990 Omnibus Budget Reconciliation Act (OBRA)

Answer 16

Requires the pharmacists to offer counseling to Medicaid patients regarding medications

Question 17

1996 Health Insurance Portability and Accountability Act

Answer 17

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.

Question 18

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

Answer 18

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

Question 19

What happens in the different phases of clinical Testing?

Answer 19

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.

Question 20

How long does a patent last past the date of filing

Answer 20

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

Question 21

1984 Hatch-Waxman Act

Answer 21

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

Question 22

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

Answer 22

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

Question 23

Exempt Narcotics

Answer 23

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

Question 24

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

Answer 24

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

Question 25

What do the number in the NDC stand for

Answer 25

``` 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 ```

Question 26

What is a schedule I control substance?

Answer 26

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

Question 27

What is a schedule II control substance?

Answer 27

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

Question 28

What is a schedule III control substance?

Answer 28

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

Question 29

What is a schedule IV control substance?

Answer 29

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

Question 30

What is a schedule V control substance?

Answer 30

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

Question 31

DEA Form-224

Answer 31

Application for New Registration

Question 32

DEA Form-224a

Answer 32

Application for Renewal Application for registration

Question 33

DEA Form-224b

Answer 33

Retail Pharmacy Registration Affidavit for Chain Renewal

Question 34

DEA Form-222

Answer 34

US Official order form for Schedule I & II

Question 35

DEA Form-41

Answer 35

Registrants Inventory of Drugs Surrendered

Question 36

DEA Form-106

Answer 36

Report of theft or loss of Controlled Substances

Question 37

DEA Form-363

Answer 37

New Application Narcotic Treatment Program

Question 38

DEA Form-363a

Answer 38

Application for DEA Registration for NTP renewal registration

Question 39

DEA Form-510

Answer 39

Chemical Registration

Question 40

MedWatch

Answer 40

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

Question 41

What is the ASHP

Answer 41

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

Question 42

What is the USP?

Answer 42

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

Question 43

What is TJC?

Answer 43

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

Question 44

What is the ASCP

Answer 44

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

Question 45

Pharmaceutically Equivalent

Answer 45

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

Question 46

Therapeutic Equivalent

Answer 46

Pharmaceutical equivalents that produces the same effects in patients

Question 47

What is the class 1 recall

Answer 47

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

Question 48

What is a class 2 recall

Answer 48

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

Question 49

What is a class 3 recall

Answer 49

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