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90 Cards in this Set

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Biotechnology
Process that may involve manipulating DNA (deoxyribonucleic acid) & RNA, and RECOMBINING genes into hybrid molecules that can be inserted into living organisms (Often E.Coli bacteria) and repeatedly produced (the hybrid molecules)
Controlled Substances definition and how are they classified (2) AKA

Drugs that are categorized by FEDERAL law according to


1) Therapeutic Usefulness


2) Potential for Abuse




(AKA Scheduled Drugs)

Drug classifications classified according to (3)

GROUPS of medications that are classified according to




1) Chemical Characteristics


2) Their effects on particular body systems


3) Therapeutic Uses


Generic Name AKA

OFFICIAL name/Chemical name of the drug that is INDEPENDENT of the manufacturer and often indicates (the drug group)




ONLY ONE GENERIC NAME FOR DRUG, BUT CAN HAVE MULTIPLE TRADE NAMES




lowercase


Ex: penicillin



Generic Names are indicative of?
DRUG GROUPS

OTC Drugs
Over the counter drugs: Medications available for purchase without a prescription

Pharmacoeconomics

COSTS OF DRUG THERAPY




(purchasing, dispensing, (salaries of pharm techs/pharmacists), storage, administration (salaries of nurses, cost of supplies) and laboratory+ other tests used to monitor patient responses/consider losses due to expiration.)

Brand (trade)/proprietary name:

Manufacturer's chosen name for the drug, often protected by a patent


-Individual to each drug company, trademarked




-CAPITALIZED



Pharmacotherapy
Use of drugs to prevent, diagnose, treat signs/symptoms, and disease processes
Placebo
Inert substance containing no medication and given to reinforce a person's expectation to improve
Prescription Drugs
Medications that are ordered in writing by a licensed HCP
Prototype

Often the FIRST drug of a particular drug class to be developed; usually the standard against which newer similar drugs are compared




(Ex: Morphine for the opioid analgesics)


(Penicillin for Beta-Lactam antibacterial drugs)




-Some groups lack a universal prototype, some replaced by newer/more common ones.)

Pharmacology
The study of drugs (chemicals) that ALTER FUNCTIONS of living organisms
Drugs can help improve quality of life/ADL's when ____ is not an option
Prevention
Medications:
Drugs that are given for THERAPETUIC purposes
Drugs may have ________ or _______ effects
Local; Systemic

Local+ Example:
Act mainly at SITE of application (Ex: Sunscreen, local anesthetic)
Systemic+ Example:

Taken into the body, CIRCULATED throughout the bloodstream to their sites of action (various body tissues)




-Eventually are eliminated by body

Most drugs are given for their ______ effects
SYSTEMIC
Historically, where did drugs come from?
Plants, animals, and minerals
Now what and where are most drugs made of?
In labs, most are SYNTHETIC COMPOUNDS (MAN MADE THROUGH BIOTECHNOLOGY)
Synthetic Drug Benefits (3)
More standard in their chemical characteristics, more consistent with their effects, and are LESS LIKELY TO PRODUCE ALLERGIC REACTIONS

Semisynethics:




Includes many ______

Naturally occurring substances that have been "modified"




ANTIBIOTICS

3 Importance's of Cloning for drug testing to make drugs:

Each hybrid molecule will produce a GENETICALLY IDENTICAL CLONE (molecule)




1) Cloning allows for IDENTIFICATION of DNA gene sequence




2) Allows for PRODUCTION OF PROTIEN ENCODED by a gene (Ex: Insulin)




3) Allows for ADEQUATE production/AMOUNTS of a drug, so we can see the therapeutic effects+ for research

Names of therapeutic classifications usually reflect the conditions they treat. Example:
Antidepressants
Drugs can be PRESCRIBED and DISPENSED by _____ or _____ name
Generic, Trade

Generic equivalents are available for a majority of the drugs and can be substituted for trade names UNLESS the prescriber writes?
"DO NOT SUBSTITUTE"
Generics are REQUIRED to be (2)

1) Therapeutically Equivalent


2) Less expensive



What works to protect drugs?
Patents and they protect for several years
Only the Pharm Manufacturer who developed the drug can ____ the drug

MARKET




(Other pharm companies can't manufacture or market until the patent expires)

What is the goal of pharmacoeconomics?
To provide the desired health benefits at the lowest cost
What are the 2 ways Americans can legally purchase drugs?

1) OTC


2) Prescription

Using prescription drugs for NONTHERAPETUIC purposes or if not authorized/without prescription=
ILLEGAL
FDA GOALS want to protect the public by ensuring that drugs made for THERAPETUIC PURPOSES ARE (2)
SAFE AND EFFECTIVE
FDA= + Define
Food and Drug Administration; Enforce the laws

DEA
Drug Enforcement Administration helps enforce the Controlled Substances Act

What types of laws help to regulate the sale and distribution of controlled drugs?

Federal, + State laws (State laws may be more strict)
Examples of Drug Standard Organizations=

USP-NF (United States Pharmacopeia National Formulary) and the IP (International Pharmacopeia) Published by World Health Organization




USP-NF: A book standard reflecting standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements.




IP: Quality Standards

Federal LEGISLATION. (Don't need to know dates) Who created the Food, Drug, and Cosmetic Act?

The FDA


(Regulate the manufacture, distribution, advertising, and labeling of drugs. Also requires that official drugs (listed in the US Pharmacopeia) meet standards for purity and strength, determined by chemical analysts




-Require proof of safety by man. before a new drug could be marketed


-Established penalties for fraudulent claims and misleading labels

Which act distinguished which medications need a prescription vs. those that CANT be refilled without a new prescription, who could write a prescription?



Durham-Humphrey Amendment






(Ex: With controlled substances)

Kefauver-Harris Amendment:

After thalidomide induced birth defects were found): Added regulations, experimental meds, drug testing, and labels EXPLAINING adverse reactions/side effects




-Man. needs to provide EVIDENCE that a drug was effective for its claims /conditions in labeling

Controlled Substances:
ANY substance that has potential for addiction
The Controlled Substances Act of 1970 involves (3)+ consists of?

Drug education, PREVENTION, and treatment


Designation of CATEGORIES of CONTROLLED SUBSTANCES



Schedule what through what?
I-5

Which schedule is not approved for medical use? Which schedules are approved for medical use?
1; 2-5
Schedule 1 Drugs + Examples (3)

Drugs that have NO accepted medical use, lack of accepted safety, and have HIGH abuse potentials.




(Heroin, MDMA/Ecstasy, Marijuana, LSD)

Schedule 2 Drugs +Examples (2)

Drugs that are used medically, but have HIGH abuse potentials




Opioid Analgesics (Codeine), CNS stimulants (Cocaine)



Schedule 3 Drugs +Examples (3)
Drugs with less potential for abuse than 1 and 2 but abuse may lead to psychological or physical dependence (Ex: Androgens/Anabolic Steroids, some depressants + CNS stimulants)
Schedule IV (4)
Drugs with an accepted medical use in US but with some potential for abuse (Ex: Benzodiazepines(antianxiety), Sedative Hypnotics, appetite suppressants
Schedule 5

Products containing moderate amounts of controlled substances. May be dispensed by pharmacist without a physician's prescription but with some restrictions regarding amount, recordkeeping, and other safeguards




(Ex: Cough suppressants (have some codeine), antidiarrheal drugs)


Limited Abuse

The Controlled Substances Act Mandates certain nursing interventions. Examples include (5)
Documentation, narcotic counts, countersignature/witness of all wasted or discarded narcotics, locked storage of narcotics, limited access to narcotics
HIPAA stands for?+ Explain

Health Insurance Portability and Accountability Act




-Confidentiality and protection with health insurance

Pediatric Research Equity Act
-We can't treat children like "small adults", we need to actually test children separately and carefully with drugs
Medicare Prescription Drug Improvement and Modemization Act (MMA)
Assistance to the elderly to pay for medications
With clinical trials we are generally testing males (30-50). With children we will usually get subjects with (2)
Benign issues or those that are dying
Nurse Practice Act

Specifies what a nurse can DO, nurses can't give medications without a prescription order


-Many nurses also can't prescribe

Pregnancy Categories. How many categories?



A, B, C, D, X

Pregnancy categories related to?
Effects of drugs on the fetus

Categories A+ B
Generally considered safe
C
Animal studies indicate a risk to the fetus
D
A risk has been PROVEN
X
AVOID DURING PREGNANCY
Basic Ethical Principles Involve:
Respect for person, beneficence, justice, truth telling (reporting near misses)
Define Drug:
ANY substance that has a PHSYIOLOGIC effect when introduced to the body

Examples of drugs
Alcohol, Echinacea (Herbs to boost immune system), Coffee, Cocaine, IV Fluids, Oxygen, Aspirin, Pain Pills, Chocolate

Ways drugs can be introduced to the body
Optic, Otic, oral, sublingual, nasal, IM, subcutaneous, IO (Intraoseous), Topical (rubbed in), Transdermal (patch), inhale, intradermal (PPD), rectal, vaginal
Which way is the fastest?
IV, taking less than 30 seconds to get to the heart. This is why these are the most dangerous
Why is IM faster?
More blood supply. Sublingual also fast, as it is close to the blood supply

What do we want to ask a patient before we give a medicine?


Allergies, Vitals, baseline, prior surgeries, medications, drug/alcohol use, pregnancy, herbs, OTC
Before giving a drug, objective data related to the drug includes:
Normal dose range, side effects, contraindications, route, how it should be given, interactions
Information about the patient that we need to get before giving a drug:
Pregnancy, LMP, Allergies, breastfeeding, vitals, alert and oriented, pain level, need to know baseline, level of orientation

Before med is given, use the nursing process to determine:

Diagnose (Is there a NEED for medicine)


Plan (What information does the patient need need to know before med administration- what does the nurse need to know prior to giving the med, so they can do so safetly


Implement Educate and give the med


Evaluate What needs to be evaluated? PAIN, using pain scale



Planning. What do we need to teach? Assess the patients needs including?
HOH (heard of hearing), visually/mentally impaired, should support person be present, knowledge level, ability to learn at that moment, knowledge needed that moment and later on, what should the patient know about the drug, plan an effective means of teaching+evaluate
If heard of hearing we can?
Use pictures, words, interpreter
What teaching needs to take place for drug therapy?

Drug+ Health History,


Reason for medication therapy


Expected results


side effects/reactions


when to notify HCO+ Pharmacist


Drug-drug, food-drug, drug-lab, and drug environment interactions




-Drugs can affect lab values (Ex: Having a lot of tums increases calcium, drinking lots of water will change electrolytes)


-Changes in ADL's


-Demonstration


-Med Schedule


-Record System


-Discussion/Monitoring of access to financial resources, medications, + associated equipment


-Development of back up system


-Community Resources



Basic Ethic Principles involve informed consent, which include?
Protecting individual autonomy, protecting them from harm, avoid fraud/duress in health care, encourage professionals to be through and clear in communicating information, promote client-educated decision making, promote self-determination of client

GCP=
Good Clinical Practice
We need GCP, as it is a standard for?
Design, conduct, performance, monitoring, auditory, recording, analysis, reporting
Testing proceeds through several phases if drug has evidence of being safe/effective. How many phases are there? (main)
4

Trials are usually?
RANDOMIZED, EXPERIMENTAL, and CONTROLLED
Phase 1
A few doses given to healthy individuals to determine safe dosages (range), and identify pharmacokinetics (routes of ADM, absorption, metabolism, excretion, toxicity)
Phase 2
To demonstrate safety and efficacy of drug in subjects with disease to be treated (response compared to healthy subjects)
Phase 3 + 4
Drug given to more representative population, to determine whether health benefits outweigh risks.
Nursing responsibilities ensure safety of the participants by?
recruit and accessing study subjects, thorough understanding of protocols, including (inclusion/exclusion criteria), validity and reliability of measurement instruments, communication and teamwork with other HCP'S., Knowledge of HIPAA, budget negotiations, informed consent, staff education, resource for subjects and families, documentation, examining research questions (clinically significant? Do we have valid conclusions based on data?)
Who approves the drugs?
FDA
What are the 6 rights of medication?

Right drug, dose, documentation, route, patient, time, + reason


(also should consider right education and right to refuse medication)

Joint Commission also affiliated with Medication Administration Safety, like QSEN. What are the 6 areas focused on in QSEN
Patient Centered Care, Teamwork and collaboration, EBP, Quality and Improvement, Safety, and Informatics
Affiliated with 3 main needs= KSA
Knowledge, Skills, & Attitudes
Joint Commission focuses on 2 areas of particular interest, related to safety. Name these categories.

1)"Do Not Use" List of abbreviations




2) High Alert Medications



Beers Criteria
List of medications that are considered inappropriate to give to eledery