Many are potent meds with significant side effects. Orphan Drug Act***- provided $$ incentive to drug companies to adopt and develop a drug.ĩ0% of illness initially tx by OTC. Not financially viable, so not attractive to manufacture. Useful in treating a rare disease or maybe as potentially dangerous adverse effect. Drug stores must fill prescription with drug, not generic Less expensive than original Drug must meet USP guidelines, but can have different filers- can alter absorption** Frequently required to be dispensed due to costĭrugs with narrow safety margin. Use contraception if on drug to avoid pregnancy.Īfter patent expires- about 7 years. Females of child bearing age should avoid risk with drugs.Ī- 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. General rule: do not use any drug during pregnancy. Malfeasance: Wrong route, death with right drug.įederal guidelines, state laws, Ohio board of Nursing rules, policies of agency.ĭescribe potential or actual teratogenic effects. Misfeasance: negligence, wrong drug or dose. Requires Nurse to be accountable for drugs given. No prescription by nurses, unless APN and with prescriptive authority.

Opioid- controlled substances for diarrhea and cough. Less risk for dependenceīenzodiazepines, chloral hydrate. Accepted medical use but can cause physical dependenceĬodeine preparations, nonnarcotic drugs. Narcotics (morphine, methadone, hydromorphone), amphetamines. High potential for abuse, NO accepted medical use Some drugs may fall into different classification, depending on dosage and medical use** Outlined those that should not be refilled without a new Rx such as narcotics, tranquillizers.Īttempted 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** Not considered nutritional supplements and are NOT regulated by FDA**ĭetermined which drugs were OTC. Ensures that drugs are tested for harmful effects, labels contain accurate information, drug packaging explains adverse effects.

Drugs with USP following name have met standards and are included in formulary.įDA formed to monitor and regulate the manufacture and marketing of drugs. Identifies standards for drugs in US related to: safety, purity, quality, packaging safety, dosage form***. The authoritative source for set of drug standards. This can occur months or even years after a drug has been approved and widely available. Problems can be identified at any time and drug must be recalled. Given trade name.ĭrug marketed to public. Application submitted to FDA for approval. Wider subject base including those with the disease intended for treatment. Common to see placebo effect in this phase. Given to persons that have the condition for which the drug is intended to determine if effective for treatment. Given to healthy volunteers: to assess safety, determine dose range, study pharmokineticsĭetermine safety and efficacy. Human testing phases vary depending on drug Beneficence-no harm Justice- social benefit & burden can be allocated objectively, equal treatment/circumstances Truth telling-tell truth & whole truthīefore human trials, must be tested in animals to determine effects on living tissue and evaluate adverse effectsĭrugs given to human volunteers. Respect for person-autonomy, informed consent, voluntary inclusion, & exclusion from research. Must be reviewed by IRB's to assure quality & integrity of research.ĭrug research must follow ethical principles When patent expires- 7 years, generic available. Only 5 in 100,000 potential drugs make it to market. $800 million-2 billion to develop new drug. Genetic engineering to use bacteria produce drugs. Plants, animal products, inorganic compounds 1950's antipsychotics, antihypertensives, oral contraceptives, polio vaccine developed. Arabic doctors formulated first set of drug standards.Īspirin, phenobarbital, insulin, and sulfonamides developed. Egyptians started documenting particular usages. Body's response to the drugĮarly drugs evolved from observing effects of substances derived from plants, animals, or minerals. Using drugs to: treat, prevent and diagnose disease.

Study of how chemicals (drugs) interact with living organisms to produce biological effectsĬlinical pharmacology. Pharmacology Introduction to Basic Pharm Question

Study stack pharmacology