update
Federal Food and Drug Act
FDA
- Series of consumer protection laws
- led to creation of the FDA
- banned foreign and interstate traffic in adulterated or mislabeled food and drug products
- Products had to be inspected and offenders where prosecuted
- Active Ingredients had to be placed on labels of packaging
- drugs can not fall below purity levels set by United states pharmacopoeia or national Formulary
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Health Insurance Portability and Accountability Act
- HIPAA
- Provides the ability to transfer and continue health insurance coverage for millions of American
workers and families when they change or lose jobs
- reduces Health care fraud and abuse
- Mandatory Industry Wide standards for health care information and electronic billing processes
- requires the protections and confidential handling of protected health information
Omnibus Budget Reconciliation Act
OBRA
- Allowed Workers and Families to keep their group coverage in cases of volentary or involentary job
loss
- in case of reduced hours worked
- job transitions
- give workers who lost their health benifits right to choose to continue plans under certain
circumstances
- required under businesses with 20+ employees
- applies to both government and private sector
- set period of time, maybe influenced by circumstances
OBRA 90
- placed regulations on how to interact with patients
- record keeping mandates, prospective drug reviews
- counseling obligations
- must review medicaid participants enire drug profile before prescribing medications
Medicaid
- Social Health care program for families and individuals with low income + recources
- government insurance for people of all ages who can not afford sufficient health care
- varies from state to state --> joint funded between state and federal
- must be US citizens or legal permanent residents
-
Medicare
- National Social Insurance Program
- administered by US government
- provides health insuracne for Americans aged 65+
- members must have worked and payed for the system
- provides health insurance for younger people with disabilities
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Disability
- Form of Insurance that insures the beneficiaries income against the risk that disability creates a
barrier for a worker to complete the core functions of their work
- encompasses paid sick leave, short term disability benefits, and long term disability benifits
-
Ameriplan
U.S. Social Security Act
- Social Welfare Legislation Act
- provides federal assistance to those who can not wotk
-
Combat Methamphetamine Epidemic Act
- enacted to curb the growing problem of underground manufacture of illegal drugs
- regulates over the counter products that can be used to make drugs
- include daily sales limits and 30 day purchase limits
- places products out of easy reach
- sale logbooks
- customer ID verification
- training of employees and sellers
-
Sale of Ephedrin
- sale is limited to behind the counter
- must present photo ID
- stores require to keep personal information on buyers for at least 2 years
- sales allowed in drive through lanes
U.S. Merck + co
- An American pharmaceutical company
- one of the largest in the world
- publishes Merck Manuals --> a series of reference books for medical professionals
- Merck Index -->list of chemical compounds --> lost
Poison prevention Packaging Act
PPPA
- requires use of child resistant packaging for prescription drugs, OTC, household chemicals, and
hazerdous materials
- some drugs are exempt from child proof packaging --> OTC drugs with the proper labeling not for
children and in big enough packages
Kefauver - Harris Act
- requires drug manufacturers to provide proof of their effectivness and safety before approval
- requires drug advertisements to disclose side effects
- stopped cheap generic drugs from being marketed as more expensive drugs and taking credit as
breakthrough medications
,Controlled Substances Act
CSA
- federal US drug Policy
- manufacture, importation, possession, use and distribution of certain substances is regulated
- created 5 classifications of schedules
- all controlled substances need to be inventoried Biannually
Schedule I Drugs
- High Potential for abuse
- no potential medical use or treatment in US
- lack of accepted safety for use of drug under medical supervision
- No prescriptions may be written for drug
- Crimes involving drugs can be quite serious
Schedule II Drugs
- Drugs have high potential for abuse
- Drugs have currently accepted medical uses, although there may be serious restrictions
- Abuse of drug may lead to severe psychological or physical dependence
- may not be used unless directly dispensed by a practitioner
- refills not allowed --> must write multiple prescriptions at once
- must be stored in a safe, while other schedules can be stored throughout pharmacy
Schedule III Drugs
- has potential for abuse, but to a lesser degree than schedules I + II
- drug has an accepted medical treatment
- abuse of drug may lead to moderate or low physical dependency or high psychological dependence
- may not be dispensed without a prescription
- may not be dispensed six months after prescription written
- may not be refilled more than 5 times
- may be prescribed orally or over phone
Schedule IV Drugs
- low potential for abuse
- has currently accepted medical use
- abuse may lead to limited physical or psychological dependence
- can be refilled up to five times after 6 months written or orally
Schedule V Drugs
- low potential for abuse
- currently accepted medical use
- limited dependence
- may be dispensed without medical reason
- orally or written
DEA form 222 1 + 2 order form
- Order Forms for Schedule 1 and 2 drugs
- used to order from another registrant retail and hospital pharmacies
- wholesaler or retailers use this form
- forms need to be maintained for 2 years --> all forms
, Standard Invoice
DEA form 69
DEA Form 41 form of controlled substances
inventory and destruction
- registers inventory of controlled substances
- used to return drugs to DEA or acceptable recipients
- documents surrender or destruction of controlled substances
- forwarded to DEA for disposal
DEA 82 form of inspection
- Notice of Inspections of controlled premises
- informs registrant an inspection will be made
DEA form 104 surrender and close
- Voluntary surrender of controlled substance privileges
- used to surrender permit to the DEA on a voluntary basis
- used to close pharmacys
DEA 106/666
loss or theft
- report loss or theft of controlled substances
- Report discovered shortage of controlled substances
DEA 222a
- used to obtain DEA 222 form from DEA
DEA 224 license form - institutions
- new Application for registration of controlled substances act
- Form used by retail pharmacies, clinics, hospitals, practitioners, and teaching institutions,
- to get license to obtain or dispense controlled substances
DEA 225 license form sellers
New application for registration used by manufacturers, distributors , wholesalers, importers,
exporters, researchers
- to obtain and use controlled substances
DEA 226
application for re-registration of controlled substances
- privileged by retail pharmacies, hospitals, practitioners or teachers to obtain or dispense controlled
meds
DEA 363 narcotics for pharmacy programs
- Registration for narcotic rx programs