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chapter 2

how the practice of pharmacy is regulated by federal and state law state pharmacy laws establish the legal requirements restrictions and prohibitions for the practice of pharmacy.laws are general so regulations or rules are needed. laws are enforced by the state legislative and the rules are adopted by the state agencies
practice of pharmacy laws are by the state legislative and regulations are through the board of pharmacy.
state pharmacy laws and regulations distinguish between the task and responsiblities that pharmacist perform and those that pharmacy technicians are permitted to perform.
state board of pharmacy have authority over licensing pharmacies and pharmacist;registering or licensing pharmacy technicians;inspecting;issuing laws and regulations;investigating complaints;and disciplinary actions against pharmacies,pharmacist and pharmacy technicians for violations of laws.
different licensure categories retail community institutional hospital nuclear mailorder and long term care. none residental pharmacies. must be licensed to mail ship dispense and deliver prescription
common requirements of PT background check high school diploma completion of the program and examination
pharmacy technician ratio limit the number of pharmacy techinicans who assist a pharmacist at one time. 3:1
controlled substances are subject to stricter controls through federal and state laws because of potential misue abuse and addiction
how the federal law regulate controlled substances establish controls over manufacture import export distribution ordering dispensing and prescribing
Pharmacies prescribers wholesale distributors drug manufacturers must be registered with DEA
other requirements for controlled substances reporting significant losses records of dispensing controlled substances and inventory records
pharmacies must comply with both state and federal laws dealing with controlled substances
pharmacies are required to keep complete accurate and up to date record of controlled substances that they purchase recieve distribute dispense or discard
scheduleII records must be kept seperatly from CIII IV and V records
scheduling of a drug is placed to determine the level of control
schedule I(CI) most restrictive not available at the pharmacy because they have no legally approved medical use. heroin and marijuana
schedule II(CII) high potential for abuse or misues high risk of dependence FDA approved Demerol morphine oxycodone methadone
schedule III(CIII) moderate potential abuse misues and dependence contains small quantities of controlled substances acetaminophen and codeine acetaminophen and hydrocodone(vicodin)
schedule IV(CIV) low potential of abuse and limited risk of depenedence valium ativan phenobarbital and other sedatives and hypnotics
schedule V(CV) lower potential of abuse and misuse cough meds that contain limited amount of codeine anti diarrheal meds containing an opiate such as lomotil
dispensing controlled substances must be valid must be prescribed by a licensed prescriber for medical purposes prescriber must be registered with the DEA and be licensed in that state
controlled substances prescriptions must contain date issued patient full name and address practioner name and address DEA registration number drug name strength form quantity directions number of refills signature of prescriber
federal law allows schedule III and IV prescriptions to be refilled up to five times within six months after prescripton date
federal law allows schedule V prescriptions may be refilled more than five times but with a six month time limit
federal law does not allow refill or transfer for schedule II
federal law allows the transfer of prescriptions of one refill for schedule III IV V
federal law requires the pharmacy to keep controlled substance records for 2 years and availble for DEA inspection
role of state prescription monitoring programs pharmacies must submit information on the controlled substance prescriptions that they dispens to the designated state authority electronicall on a periodic basis once or twice a month include patient info perscriber info pharmacy id and prescription info
federal law that restricts ephedrine or pseudoephedrine is Combat Methampheetamine Epidemic Act of 2005 (CMEA)
the restrictions of ephedrine or pseudoephedrine laws limit the amount of these products that a customer may purchase a single transaction in one day over a 30 day period. require customer to sign a logbook.
federal law limits sales on ephedrine to 3.6 grams daily and limits 9 grams within a 30day period. the federal 3.6 grams daily limits for pseudoephedrine hydrochloride 30 mg tabs
FDA approval process before a new drug is apporoved the drug manufacturer must submit a new drug application NDA to FDA. the FDA reviews the NDA to assess whether the drug is safe and effective for its proposed use if the benefits outweigh the risk if the fda reviews favor
brand name and generic drugs generic equivalents contains same active ingredients and have the same dosage form strength and formulations as their brand name counterparts. they must show bioequivalence to the brand name drug which means the drug must deliever the same amount of the d
generic drugs have a different apperance because the law do not allow a generic drug to copy the apperance of the brand name
generic drug substiution the fda approved generic equivalent pharmacists are premitted to substitute the generic equivalent. state laws instruct prescribers to indicate no substititutions through daw or dns
package inserts for patients called consumer medicine information CMI. PPI patient package insert.assit patients with avoiding serious adverse events to inform patients about known serious side effects
package inserts for physicians include indication of use dosage and administration adverse reactions warnings precaustions details about how to prepare the drug proper storage and the package size NDC numbers
patient privacy required by federal and state law to maintain the required privacy and confidentiality of pateint health. taking care to discard patient information in a secure manner and taking reasonable precautions to maintain privacy
hippa health insurance portability and accountability act
PHI protected health information
Created by: 2402sp



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