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P JESSIE FPP CH# 2
PHARMACY LAW & ETHICS CH# 2
| Question | Answer |
|---|---|
| Five principles | beneficence, fidelity, veracity, justice, autonomy |
| beneficence | bringing about good |
| fidelity | promise keeping |
| veracity | telling the truth |
| justice | acting with fairness ar equity within the law |
| autonomy | acting with self reliance |
| ethical theories | consequentialism,nonconsequentialism, social contracts,ethics of care, rights-based ethics, pinciple-based ethics,virtue-based ethics, law,codes of ethics |
| consequentialism | bring out the greatest good to the greatest number |
| nonconsequentialism | study of actions themselves without regaurd to outcome |
| social contracts | pharmacists,technicians,and patients recognize certain expectations of each other and act accordingly |
| ethics of care | clearly focus on such basic moral skills as kindness,sensitivity,attentivness,tact, patience and reliability |
| right based ethics | individuals havecertain rights, legal as well as moral |
| principle based ethics | moral principles are general, universal guides to action |
| virtue based ethics | the use of virtues in establishing right reason in action |
| codes of ethics | sincere acceptance of the responsibility to maintain a standard of conduct beyond either an unthinking conformity to the law or the routine performance of technical skill |
| pharmacy tech code of ethics | 1996 |
| legislator passed the food,drug,and cosmetic act | 1938 (FDCA) |
| label of drugs | display of written, printed or graphic matter upon the immediate container of any article |
| labeling of a drud | all labels and other written, printed or graphic either upon or accompanying the drug |
| durham humphrey amendment (1951) | (precription drug amendment)require that prescription drugs bear a legend caution (later is says Rx only) |
| kefauver harris amendments (1962) | (drug efficacy amendment) accountabability from drug manufacturers for the efficacy or effectiveness of drugs. |
| drug abuse control amendments (1965) | proviided the first guidelines for determining the classification of drugs subject to abuse |
| comprehensive drug abuse prevention and control act (1970) | combine all of the federal laws dealing with narcotics,stimulants,depressants and abuse designer drugs |
| medical device amendment (1976) | safety and life supporting devices have pre market approval of the FDA |
| legend drugs may be prescribed only by | a practitioner licensed to administer and prescribe such drugs |
| labeling requiremens for prescription | pharmacy name & address,Rx #,date to fill,exp. date,prescribers name,patients name,directions of use,caution statement |
| OTC label of the drug requires | products name, name & address of the maufacturer & distributor ect., established name of all ingredients & quantities (active or inactive),net contents,cautions & warnings,name of habit forming drugs contained,directions for use |
| poison prevention packing act(PPPA) | legend and controlled drugs must be dispensed in child proof container. |
| exceptions to the PPPA | sublingul doses of nitroglycerin, contraceptives,drugs dispensed to inpatients in hospitals and certain emergency meds. |
| legend or prescription only drugs lable of drug | established name and quantity of active ingredients,quantity,usual dosage,federal legend,adminisstrtion,federal warning,all inactive ingredients(if other than oral),lot or control#, type of container to be used, name and place of manufacturer,exp. date |
| FDA additional info accompaning legend drugs on its labeling on the packet insert | description,clinical pharmacology,indication, contraindications,warnings,precautions,adverse reactions,drug abuse,dosage,how supplied,date of revision |
| adulterated drugs | packed or held in unsanitary condiions,manufactured not conform with the GMP,container made of poisonous substance, unsafe color additive, class 3 banned device, OTC not in tamper proff pack |
| misbrandfed drugs | misleading labels, labels fail to state the name and place of business or manufacturer ect.,no warning or cautions and so on |
| FDCA has 3 classes for devices | 1-low potential for harm,2-require specific performance standards by experts(thermometers,hearing aids,catheters),3-medical devices are life supporting systems whose failure could cause death |
| activties requires registration with the DEA | *manuf. controlled sub.,*dist. contr. sub., *disp contr sub,*conducting research w/ contr sub,*cond instructional activities w/ contr sub,*cond a narcotic treatment program, *cond chemical analysis w/ cont sub, *importing or exporting cont sub, *compoundi |
| register form 225 w/ DEA | to manufacturer or distribute |
| register form 224 w/ DEA | to dispense |
| register form 363 w/ DEA | to compound or conduct a narcotic treatment program |
| prescriptions for controlled substances are required to have | *full name & address of patient,*name address & registry # of prescriber,*date issued, *manual signature of prescriber |
| schedule 2 drugs CSA require | prescription be completed on a triplicate & only valid for 7 days |
| to order schedule 1 or 2 drugs | DEA form 222 |
| CSA | CONTROLLED SUBSTANCE ACT (1970) five classes oe schedules |
| Qmnibus budget reconciliation act (1990) | (OBRA) federal government funding of medicare and medicaid programs |
| health insurance & accountability act (1996) | (HIPAA) patient confidentiality & privacy |
| the moral principle focusing on acting with self reliance is? | autonomy |
| the FDCA is administered by the? | FDA |
| Which one of the following requires that perescription drugs bear?////////////// the ?//ledgend"Caution:Federal law prohhibits dispensing without a prescription"or "RX ONLY"? | Durham Humphrey amendment |
| thermometers are classified as? | class 2 devices |
| which of the following established good manufacturing practices for drug manufacturers? | Kefauver harris amendment |
| marijuana is classified as? | C1 |
| a drug that is in a condition contray to the intentions of the manufacturer is called? | adulterated |
| the CSA established _____ classes for controlled substances? | 5 |
| schedule 2 drugs are permitted to have ___ refills? | no |
| the form required to order C2 drugs is | DEA 22 |
Created by:
PAJJ21
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