Pharmacology Competency 2

Front 1

What is Pharmacology?

Back 1

Study of changes brought about in living organisms by chemically acting substances.

Front 2

Role of the Food and Drug Administration

Back 2

Protecting public health by monitoring:
Food supply, drugs, biological products, medical devices, cosmetics, radiation, and tobacco.

Hint 2

also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Front 3

1906 Pure Food and Drug Act

Back 3

Required drugs be free of adulterants

Hint 3

Said nothing about safety and effectiveness.

Front 4

1938 Food, Drug, and Cosmetic Act

Back 4

Said all drugs must undergo tests for toxicity and created the FDA.

Hint 4

First legislation to address drug safety.

Front 5

1952 Durham-Humphrey Amendment to the 1938 Act

Back 5

Distinguished between drugs that should be sold with or without a prescription and those that should not be refilled, such as narcotics. Must be labeled.

Front 6

1962 Kefauver-Harris Amendment to the 1938 Act

Back 6

From Thalidomide tragedy which caused babies to be born w/ extreme limb deformities. Said all drugs be proved effective.

Front 7

1970 Controlled Substance Act

Back 7

Scheduled I-V established. Abuse potential vs. Medical Acceptance.
designated categories for the controlled substances

Hint 7

1. promotion of drug education and research into prevention and treatment of drug dependance 2. strengthen enforcement 3. establish treatment and rehabilitation facilities, 4. designation of schedules or categories for controlled substances

Front 8

1992 Drug Relations Act

Back 8

To increase approval rate of drugs used to treat immunodeficiency syndromes and cancer.

Front 9

FDA Modernization Act of 1997

Back 9

required to give info on off label drugs, clinical testing data required for life threatening drugs, any discontinued drugs must be alerted to public at least 6 months prior

Front 10

2007 FDA Amendments

Back 10

expands FDA post market surveillance. phase IV clinical trials.

Front 11

C-I controlled substance

Back 11

High abuse potential, no accepted medical use, i.e. heroin, hallucinogenics, ecstacy

Front 12

C-II

Back 12

High potential for drug abuse with accepted medical use. i.e. hydrocodone, oxycodone, demerol, cocaine

Front 13

C-III

Back 13

Medically accepted drugs, potential for abuse is less than II but still prevalent. Codeine, anabolic steroids.

Front 14

C-IV

Back 14

Medically accepted drugs, may cause dependance. i.e. Phenobarbiital, benzodiazepines (lorazepam, diazepam) chloral hydrate, Xanax

Front 15

C-V

Back 15

Medically accepted, limited potential for abuse. i.e. – Opioid controlled substances for diarrhea and cough (codeine in cough preparations)

Front 16

C-VI

Back 16

non drugs with abuse potential i.e. spray paint, aeresol cans, glue

Front 17

Nurse Practice Acts & Nursing Responsibilities

Back 17

Perscriptive authority for NP's not RN's

A.D.P.I.E and delegation

Front 18

Autonomy

Back 18

respect for the individuals right to make their own decisions

Front 19

Beneficence

Back 19

to do good

Front 20

Malfeasance

Back 20

to never do harm

Front 21

Justice

Back 21

equality for all patients no matter what

Front 22

Fidelity

Back 22

Keeping a commitment. Responsibility to patient, employer, government. matters of privacy and confidentiality are under fidelity.

Front 23

Clinical trials Pre trials

Back 23

animal testing - In-vitro, In-situ, In-vivo

Front 24

Clinical trials phase 1

Back 24

Healthy volunteers to determine pharmacokinetics, metabolism, and biologic effects

Front 25

Phase II

Back 25

Patients with the disease, tests therepeautic utility and dosage range

Front 26

Phase III

Back 26

Large number of patients. Safety and effectiveness.

Front 27

Phase IV

Back 27

Post Market Surveillance

Front 28

FDA Preganancy Categories A

Back 28

Adequate evidence to show no risk to fetus

Front 29

Category B

Back 29

no human studies to show risk, animal studies show no risk to fetus

Front 30

Category C

Back 30

Caution advised. No adequate human studies. animal studies shown to be harmful..

Front 31

Category D

Back 31

Clear evidence of risk to human fetus but benefits could still outweight risk.

Front 32

Category X

Back 32

Clear evidence that medication causes risk to fetus.The risks outweigh any potential benefit.

Hint 32

Any drug where there would be no reason the benefits outweight the risks would be category X, even if the drug is not all the toxic. i.e. birth control

Front 33

Black box label

Back 33

Black label on medicine packages that is supposed to explain the risk for serious side effects. Means that medical studies conclude the drug contains serious risk for life-threatening adverse events.

Front 34

Off label use

Back 34

Use of a drug for a purpose outside the scope of the drug's approved use.

Front 35

Five Rights

Back 35

1. Right Patient
2. Right drug
3. Right dose
4. Right Route
5. Right time

Front 36

Requirements for advertising

Back 36

Must state:
One approved use, generic name, all the risks.
Does not need to state:
Cost, how the drug works, how quickly, if behavior changes change condition