Pharm One Final - 1 Flashcards
What is a medication?
A drug used to prevent, diagnose, treat, or cure a disease.
antihistamines, beta blockers, antibiotics, chemotherapy
3 core ethical principles in drug studies
Justice, respect, and beneficence
Justice
Fair selection of subjects.
Enough subjects in the study.
Testing on the right people.
Distribution of benefits and burdens equitable.
Treating people equally.
Allocation resources to all individuals equally.
Reflects all social classes racial and ethnic groups
Respect
Subjects are treated as a person capable of making their own decisions
Subjects have the right to self-determination
Autonomy of the subject
Informed consent
Beneficence
Protecs subjects from harm.
Risk/Benefit ratio
Beneficence= Benefit
What are the 2 types of Trials in pharmaceutical research?
Pre- Clinical Trials -invivo and invitro animal
Clinical Phases -humans - 4 phases
Name the 4 phases of Clinical Trials
Phase 1 -Healthy Patients - small groups
SAFETY/SIDE EFFECTS/DOSAGE
Phase 2 -Have disease or condition - larger group
SAFETY/EFFECTIVENESS
Phase 3 -Have disease or condition - larger group SAFETY/EFFECTIVENESS/ *SIDE EFFECTS/ *COMPARE TO OTHER DRUGS/ *TREATMENT BENEFITS
Phase 4 -Have disease or condition
- Aftermarket- drug being sold
DIFFERENT POPULATIONS/
LONG TERM EFFECTS
WHAT PHASE OF CLINICAL TRIALS CAN A DRUG BE DISCONTINUED?
Any of the 4 phases
LIST the 5 scheduled categories
1 - NO ACCEPTED Medical Use - HIGH POTENTIAL FOR ABUSE
Heroin, MDMA, LSD, Peyote
2 - High POTENTIAL FOR ABUSE That may lead to dependence
Used post-surgical for pain.
3 - Potential for ABUSE Not as high as 1 and 2
4. Lower potential for abuse than 3
5. Lower potential for abuse than 4
Remember if a drug addict is in a car accident (or sickle cell crisis) and is in pain, cannot deny them pain medication, even if it is a scheduled drug.
Where are narcotics kept?
LOCKED AREA.
PPTX also says double locked cabinet.
When and by who are NARCOTICS counted?
Count end of each shift (7 am and 7 pm)
Oncoming nurse counting and outgoing nurse verifying.
What needs to be documented with NARCOTICS?
- The PURPOSE
- The RESPONSE (description and degree of pain/using same pain scale)
What are the THREE types names for a DRUG?
Chemical Name = ie C8H9NO2
Generic Name = non-proprietary assigned by FDA - acetaminophen
Generics mus onain the bioequivalent amount as their brand name.
Brand Name = proprietary, trademarked - Tylenol
Name Guidelines for Dietary Supplements
What can they declare with supporting data?
-Health claims
-Structure and Function Claims
-Nutrient content claims
-They DO NOT TREAT OR CURE
cannot claim it cures or treats
Regulated by FTC - truth in advertising
Manufacturing Guidelines Good Manufacturing Practices require: - quality -strength -free of impurities
Do HERBAL REMEDIES need to be reported to the provider?
Why?
YES
Side effects and drug interactions
AVOID CAMS if PG, nursing, trying to get PG, infants and iyoung children
Ingredients may not reflect all the ingredients in the remedy
What is Pharmacotherapeutics?
PHARMACO - THERAPEUTICS
Use of of drugs to prevent, treat, and diagnose disease as well as to alter normal function (birth control)
Pharmaco-KINETICS
WHAT does ADME stand for?
Absorption
Distribution
Metabolism/Biotransformation
Excretion/Elimination
What is Pharmacokinetics?
PHARMACO -KINETICS
The process of the drug moving (kinetics) through the body that results in drug action.
- Absorption
- Distribution
- Metabolism (Biotransformation)
- Excretion (Elimination)
ADME
What is ABSORPTION?
How the medication gets into the body.
List Ways Body Absorbs Medications?
- Oral meds absorbed by GI tract, with help of LOW GI pH (acidic)
- Local Effect -Eye drops, ear drops, and inhalers
- Enteric-coated drugs - dissolve in small intestine, more alkaline, prevent damage to gastric mucosa
- EXCIPIENTS /fillers/inert. Give drug its shape and helps drug to dissolve (ie suppositories, Na+ and K+ In penicillin sodium. With an MI - Do NOT give enteric coated, 325 mg of regular aspirin
SubQ, Rectal, Oral/PO, IV
Name 3 ways ABSORPTION OCCURS IN THE SMALL INTESTINE
- Active Transport
- Passive Transport
- Pinocytosis - cell drinking
List 7 factors that influence ABSORPTION
- Blood flow (inc blood flow, inc absorption)
- Pain
- Stress
- Hunger
- Fasting
- Food (can make it slower OR faster)
- pH (acidic or alkaline)