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Pure Food and Drug Act
- assurance of pharmaceutical safety
- labeling law
- written materials must be truthful and not misleading
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Federal Food and Drug Cosmetic Act
- test for safety before drug enters market
- direct regulation
- catalyst for law was sulfanilamide
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Durham Humphrey Amendment
- Distinguished Rx and OTC drugs
- legalized verbal transmiision of Rx
- Legalized refill authorizations
- Rx drugs had to state dispensing prohibited w/o Rx
- Proper OTC use labeling
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Kefauver Harris Amendment
- brought about by thalidomide
- requires drugs to be proven safe and effective
- retroactive to 1938
- established GMP requirements
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Medical Device Amendments
- classification of devices according to function
- premarket approval
- est. performance standards
- confomance with GMP
- record and reporting requirements
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Class 1 devices
- general controls
- least control
- minimum potential harm
- bandages, gloves, surgical instruments
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Class 2 devices
- special controls
- special labeling requirements
- mandatory performance standards
- post market surveillance
- powered wheelchairs, infusion pumps, surgical drapes
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Class 3 devices
- most stringent regulation
- devices that support human life
- require pre-market approval
- replacement heart valves, breast implants, pacemakers
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Prescription Drug Marketing Act
- States liscense wholesale distriutors of rx drugs
- bans re-importation
- bans sale, trade or purchase of samples
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Federal Food and Drug Administration
- under deparment of health and human services
- authority for FDCA
- secretary appointed by president
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Structure of FDA
- Five centers
- Biologics Evaluation & Research
- Food Safety and Applied Nutrition
- Drug Evaluation and Research
- Veterinary Medicine
- Devices & Radiological Health
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Functions of FDA
- Rulemaking
- Issue guidance documents
- incorporate advice from advisory committees of outside experts
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FDA makes rules about
- interstate commerce
- adulteration
- misbranding
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Food and Drug Administration Amendments Act
enhances FDAs responsibilies to regulate drug safety
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FDA's responsibilties reguarding drug safety
- labeling related to safety
- clinical trial data reporting and registries
- postmarket clinical trials to asses risk
- requirement of REMS when necessary
- website reguarding safety
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Post market clinical trials to asses risks
- phase 4 trials
- FDA can require more testing from manufacturer if problems arrise in the market
- FDA can mandate a black box warning
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REMS
Risk evaluation and mitigation strategies
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Goal of REMS
- minimize known risks of a product while maximizing its benefits
- drugs are misbranded if they do not have the correct labeling
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Penalty for violation of REMS
- $250,000
- penalty increases if the violation continues more than 30 days after notification by the FDA
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REMS is developed by ____ and approved by ___.
developed by manufacturers and approved by FDA
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Most frequent requirement of REMS
Patient directed information
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Patient directed instructional document
- medication guide
- patient package insert
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MedGuides are required if the FDA determines that one or more of the following exist
- patient directed labeling for the drug may help prevent serious ADEs
- drug has serious risks relative to benefits
- drug product is important for health and pt's adherance to instructions is crucial to effectiveness
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Communication that the FDA can require as part of REMS
- sending letters to health care professionals
- explain safey protocols/monitoring required
- info about serious risks associated with the drug
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Elements to assure safe use (ETASU)
guidelines intended to provide patients with safe acces to drugs taht are associated with a serious risk and would be removed from the market if not for REMS
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ETASU guidelines may be required by REMS to include the following
- special training for HC providers
- specially certified pharmacies/practitioners
- only dispense drug in a hospital
- restrictions on dispensing only if pt has labs
- pt is subject to certain monitoring
- pt must be enrolled in a registry
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Health care provider certification is completed by
- the manufacturer
- optional training from FDA
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In order to be certified, the health care provider may be required to show the ability to:
- diagnose the condition indicated for the drug
- understand risk/benefits of the product
- diagnose and treat potential ADRs from the drug
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Pharmacies certified to dispense a certain product may be required to demonstrate that they
- understand risk/benefits of the product
- agree to refill only with authorization
- agree to check labs or stickers
- agree to fill rx within an alloted time of writing
- agree to fill only from certified providers
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Evidence or other documentation demonstrating safe use conditions may include the following
- pt have been counseled about risk/benefit & signed
- pt provided educational materials & demonstrate understanding
- pt receives drug only after special authroization and verification from the pharmacy
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Patient Registries may collect information on enrolled patients that includes
- information about clinical outcomes
- clinical and lab data
- safety information
- data about compliance w/ management and rx protocols
- data about the impact of tools to ensure compliance and good outcomes
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What is a drug?
- recognized by the USP or Homeopathic pharmacopeia
- used in diagnosis, cure, mitigation, treatment or prevention of disease
- effect structure and function of body (not food)
- almost anything with an intended therapeutic purpouse
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Food vs drug
- foods found to be drugs can be removed from the market
- structure/function claims are acceptable for food
- treatment, diagnosis, mitigation, & cure claims are not acceptable
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Nutrition Labeling and education act allows food to
contain helath claims if approved by the FDA or significant scientific agreement
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Dietary Supplement Health and Education Act defines a dietary supplement as a product that is
- intended for ingestion
- intended to supplement the diet
- contains: vitamin, mineral, herb/botanical, amino acid, supplements to the diet, any combo of the previous
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Device vs drug
- device does not achieve its intended purpous through chemical action
- in not dependent on being metabolized
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Cosmetic vs. drug
cosmetic becomes a drug if mfg promotes it for a therapeutic perpose, despite chemistry
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Definition of a Label
- written, printed or graphic matter upon the immediate container
- includes container or wrapper
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Labeling
- labels
- written matterials or wrappers accompanying the drug
- information not sent directly with the drug if part of an integrated distribution process
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Rx labeling is directed to
- health care professionals
- must contain adequate information for use (pkg insert)
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OTC labeling
- for consumer
- must contain adequate directions for use
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Most prohibited acts involve
misbranding or adulteration
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Misbranding and adulteration become applicable to pharmacies when
- receipt and delivery of a/m drug
- causing a drug to be counterfeit
- alteration, mutilation of labeling
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Class I recall
issued when product will cause serious ADRs or death
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Class II recalls
- product may cause temporary or medically reversible ADRs
- serious consequences are remote
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Class III recalls
product is not likely to cause ADEs
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Initiation of product recalls
FDA can request mfg to recall or mandate a recall
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