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Introduction to Basic Pharm

Pharmacology Study of how chemicals (drugs) interact with living organisms to produce biological effects
Pharmacotherapeutics Clinical pharmacology. Using drugs to: treat, prevent and diagnose disease. Focus on: drug's effect on the body. Body's response to the drug
Drug development Early drugs evolved from observing effects of substances derived from plants, animals, or minerals. Egyptians started documenting particular usages. Arabic doctors formulated first set of drug standards.
Early 20th century Aspirin, phenobarbital, insulin, and sulfonamides developed. 1950's antipsychotics, antihypertensives, oral contraceptives, polio vaccine developed.
Natural source of drugs Plants, animal products, inorganic compounds
Synthetic sources of drugs Genetic engineering to use bacteria produce drugs. Alterations of chemical structure.
Drug research $800 million-2 billion to develop new drug. Usually takes 5-6 years. Only 5 in 100,000 potential drugs make it to market. When patent expires- 7 years, generic available.
Role of research nurse Inform & educate subjects, staff. Ensure informed consent above all else. Ensure awareness of risk/benefit ratio. Screen subjects, follow protocols. Data collection. Analysis of results. Must be reviewed by IRB's to assure quality & integrity of research.
Drug research must follow ethical principles Respect for person-autonomy, informed consent, voluntary inclusion, & exclusion from research. Beneficence-no harm Justice- social benefit & burden can be allocated objectively, equal treatment/circumstances Truth telling-tell truth & whole truth
Preclinical testing Before human trials, must be tested in animals to determine effects on living tissue and evaluate adverse effects
Clinical trials drugs given to human volunteers. Human testing phases vary depending on drug
Phase 1 Clinical Trial Given to healthy volunteers: to assess safety, determine dose range, study pharmokinetics
Phase II Clinical Trial Determine safety and efficacy. Given to persons that have the condition for which the drug is intended to determine if effective for treatment. Common to see placebo effect in this phase.
Phase III clinical trial Wider subject base including those with the disease intended for treatment. Application submitted to FDA for approval. Given trade name.
Phase IV Clinical trial Drug marketed to public. Continued surveillance. Problems can be identified at any time and drug must be recalled. This can occur months or even years after a drug has been approved and widely available.
United States Pharmacopia (U.S.P.) The authoritative source for set of drug standards. Identifies standards for drugs in US related to: safety, purity, quality, packaging safety, dosage form***. Drugs with USP following name have met standards and are included in formulary.
1938 Food Drug Cosmetic Act FDA formed to monitor and regulate the manufacture and marketing of drugs. Ensures that drugs are tested for harmful effects, labels contain accurate information, drug packaging explains adverse effects.
Herbal products Not considered nutritional supplements and are NOT regulated by FDA**
1951 Dunham Humphrey Amendment Determined which drugs were OTC. Mandated prescription use. Outlined those that should not be refilled without a new Rx such as narcotics, tranquillizers.
1970 Controlled substance Act Attempted to decrease drug abuse by promoting education & research into prevention & tx of drug dependence Provided strict controls over distribution, storage & use Established treatment & rehab facilities Designated categories for controlled substances**
Drugs classification Some drugs may fall into different classification, depending on dosage and medical use**
Controlled Substances Category I Heroin, marijuana, LSD. High potential for abuse, NO accepted medical use
Controlled Substances Category II narcotics (morphine, methadone, hydromorphone), amphetamines. Accepted medical use but can cause physical dependence
Controlled Substances Category III Codeine preparations, nonnarcotic drugs. Less risk for dependence
Controlled Substances Category IV Benzodiazepines, chloral hydrate. May cause dependence.
Controlled Substances Category V Opioid- controlled substances for diarrhea and cough. Very limited potential for dependence.
Nurse Practice Act- OH No prescription by nurses, unless APN and with prescriptive authority. No administration without order. No dispensing of drugs. Requires Nurse to be accountable for drugs given.
Civil court prosecution for: Misfeasance: negligence, wrong drug or dose. Nonfeasance: omission of drug. Malfeasance: Wrong route, death with right drug.
Criminal court prosecution for Misuse, abuse, sale, possession of drug.
Nurses are obligated to follow Federal guidelines, state laws, Ohio board of Nursing rules, policies of agency.
FDA pregnancy category details Describe potential or actual teratogenic effects. General rule: do not use any drug during pregnancy. Risk Vs Benefit always considered. Females of child bearing age should avoid risk with drugs.
FDA Pregnancy Categories A- no risk to fetus B- Inadequate studies of women, probably safe C- animal studies show adverse effect on fetus Inadequate human studies D- evidence of fetal risk. X- proven fetal risk. Use contraception if on drug to avoid pregnancy.
Generic Drugs After patent expires- about 7 years. Less expensive than original Drug must meet USP guidelines, but can have different filers- can alter absorption** Frequently required to be dispensed due to cost
DAW- dispense as written** Drugs with narrow safety margin. Drug stores must fill prescription with drug, not generic
Orphan Drugs Useful in treating a rare disease or maybe as potentially dangerous adverse effect. Not financially viable, so not attractive to manufacture. Orphan Drug Act***- provided $$ incentive to drug companies to adopt and develop a drug.
Over the counter Drugs OTC 90% of illness initially tx by OTC. Many are potent meds with significant side effects. Cause drug interactions, may MASK serious illness.
Major types of OTC drugs used Analgesics (aspirin, ibuprofen), allergy treatment, cold flu remedies, cough remedies, skin/wound care, hemorrhoidal, sleep aids, weight control drugs
Problem with OTC drugs Fixed doses. Can't adjust for specific needs/symptoms**
OTC Cold and Cough remedies Contain sympathomimetics and/or anticholinergics which can increase danger for cardiac, DM, or thyroid diseases b/c stimulates HR, BP
OTC Sleep aids Usually antihistamine which increase/decrease analgesics
OTC Weight-control drugs May have stimulants-- danger for CV or thyroid disease
The five steps to Nursing Process Assessment, nursing diagnosis, planning, implementation, evaluation.
Nursing Process-- Assessment Subjective data Allergies***, current health history, client symptoms, current meds, past health history, client's environment, primary language and communication needs
Nursing process--Assessment Objective Data Physical assessment, laboratory tests, diagnostic studies (drugs given or need to be given)
Common nursing diagnoses related to drug therapy Deficient knowledge about drug action, administration, and side effects r/t cultural barrier. Pain r/t hesitancy in taking prescribed pain meds secondary to fear of addiction
Planning Goal setting for: safe administration, safe monitoring, report side effects.
Implementation Nursing actions to complete goals: Client teaching about med- general info, self-administration, diet, side effects
Evaluation Ongoing. R/t progress and achievement of goals; if not met, reassess and continue. Determine need for follow-up, refer to community resources.
Challenges to Effective therapy Consumer awareness: media influence, internet. OTC drugs. Alternative therapies and herbal meds. Off-label use. Costs of health care. Emergency preparedness. Cultural and health belief system.
Drug Abuse May initially be legitimate, prescribed drug. Street drugs. Behavioral changes. Many interactions. Develop tolerance. Legal consequences. Nurses and other health care providers at high risk.
Dietary Supplement Health and Education act of 1994 Herbals classified as dietary supplements May have pharmacological effect that interact with prescribed drugs. Marketing regulations: physiologic effects to be noted, no claims of preventing or curing specific condition
Potential Hazards of Herbs No preparations are safe in all situations. Contamination. Interaction with prescription drugs and OTC drugs.
Cultural Considerations Heredity and genetic factors influence how drugs are metabolized, how side effects are tolerated. Efficacy and compliance affected by environment and culture. Socioeconomic status.
Nutrition All cultures have prescriptions of a diet that will treat illness "feed a cold, starve a fever". Must be aware of diets role in illness and wellness. Dietary practices that include fasting- work with these clients for compliance with medication
High risk behaviors Safe sex practices, recreational drugs, Tobacco: causes more rapid elimination of some medications, less oxygenation, constricts vessels and decreases tissue perfusion.
ETOH use and Drugs Always screen for regular use, typical use or abuse in pts. Interferes with metabolism of most drugs. Potentiates effects of psyche and narcotics. Document how many units of ETOH per day or per week.
Transcultural considerations Ethno-cultural and racial background. Time away from country of origin. Travel history and language ability. Nonverbal communication practices. Preferred foods.
Client teaching Involve family in teaching about pharmacotherapeutics to increase compliance. Provide explanations of all Rx and OTC products at level appropriate to client. Provide written instructions in clients preferred language.
Created by: senmark



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