Federal Requirements Flashcards
FDA
Food and Drug Administration
what is the FDA responsible for?
managing the safe production and manufacture of drug substances in the US
the laws we review are governed by?
the FDA
Pure Food and Drug Act of 1906
was the first piece of legislation that regulated drugs
what did the Pure Food and Drug Act do?
outlawed interstate distribution and sale of compromised or misbranded foods and drugs
what does “compromised” mean when it comes to compromised drugs
manufacturing food or drugs that are unsafe and unhygienic environments
- their quality is poor standard
Food, Drug, and Cosmetic Act, 1938
was passed due to what tragedy?
sulfanilamide tragedy - where 100 patients lost their lives when the Massengill company used antifreeze (diethylene glycol) as a sweetening agent in an elixir
what does the Food, Drug, and Cosmetic Act mandate?
manufactures who wish to release new drugs to the market must file an NDA first (New Drug Application) - with the FDA
Durham-Humphrey Amendment, 1951
Senator Hubert Humphrey and Carl Dunham established clear cut criteria separating prescription drugs. Patients could not get meds without a prescription
- rxs could be taken over the phone as well as refills
“Caution: Federal law prohibits dispensing this medication without a prescription”
this was generated by what?
the Durham-Humphrey Amendment
what was the Durham-Humphrey Amendment added to?
Food, Drug, and Cosmetic Act
Kefauver-Harris Amendment, 1963
guaranteed the safety, purity, and efficacy of both prescription and non-prescription drugs
what did the Kefauver-Harris Amendment eliminate?
harmful/control meds being released into the public
what tragedy relates to the Kefauver-Harris Amendment?
thalidomide tragedy:
tens of thousands of birth defect were caused by thalidomide
what drug is thalidomide ?
a teratogenic drug:
drug that causes birth defects
Controlled Substances Act, 1970
(CSA)
introduced measures for safe organization of controlled substances
what is the Controlled Substances Act also known as?
Comprehensive Drug Abuse Prevention and Control Act
what are Schedules?
how the CSA categorized controlled substances
how many Schedules are there?
5
what schedule has the highest abusive potential?
Schedule 1
can drugs change Schedules?
yes, if evidence changed, according to the DEA only
what is DEA?
Drug Enforcement Administration
- organ that deals with every aspect of controlled substances, from their documentation to regulation and safe disposal
Poison Prevention Packaging Act, 1970
ensures that medicines were child resistant
what does child-resistant mean?
80% of children under the age of 5 cannot open it, and its resistant enough that at least 90% of adults can open it
what drugs did not have to be child-resistant?
- birth controls
- sublingual nitroglycerin tablets
- potassium effervescent tablets
- specific corticosteroid tablets
Occupational Health and Safety Act, 1970
prevents workplace illness and injury
- mandated employers through the country to ensure that their employees were working in a safe environment, free of risk
Safety data sheets (SDS)
any drug or chemical produced must come with a safety data sheet that has info on the hazards of the drug or chemical poses and what the worker can do to manage them.
(disposal info included)
Drug Listing Act, 1972
aid the safe identification of meds
identifies:
- drug manufacturer
- drug product and strength
- type or size of packaging (NDC)
Federal Hazardous Substances Act, 1960
ensures that hazardous drugs were managed and disposed of in the safe and correct manner
Orphan Drug Act, 1963
offered financial incentives to encourage drug manufacturers to develop drugs
what are orphan drugs
orphan drugs are drugs used to treat a rare disease
an example of orphan drug ?
penicillamine - treats Wilson’s disease ( a disease where copper is accumulated into the body)
Drug Price Competition and Patent Term Restoration Act, 1984
2 primary functions:
- extended patent licenses
- improving generic drug approval process
Prescription Drug Marketing Act, 1987
-prevented the sale or distribution of drug samples
- prevents reimportation of a drug
Omnibus Budget Reconciliation Act, 1990
required pharmacies that filled prescriptions for Medicaid patients to keep a database of basic patient information (an important function for the tech)
what does the OBRA mandate?
pharmacists conduct a drug utilization review and counsel the patients
Anabolic Steroids Control Act, 1990
allowed CSA to regulate anabolic steroids (substances that are invariably used by bodybuilders and athletes)
what Schedule are Anabolic Steroids?
schedule 3
Health Insurance Portability and Accountability Act, 1996
HIPAA:
- rights over patients over information
- confidentiality of PHI protected healthcare information
- patients giving consent that they have no questions regarding confidentiality of their personal data
FDA Modernization Act, 1997
sought to improve the standard of how medical products food, and cosmetics were produced, including the safe and effective production methods of pharmacy compounding, as well as the operation of medical devices
which act catalyzed the drug approval process that required “Rx Only” to be written on every legend medication?
FDA Modernization Act
Medicare Prescription Drug, Improvement, and Modernization Act, 2003
provides financial benefits for patients eligible for Medicare, specifically Part D
Combat Methamphetamine Epidemic Act, 2005
prevent the use and manufacture of methamphetamine
- means that drugs were locked up, such as ephedrine and pseudoephedrine
- also limited amount of pseudoephedrdine to 3.6g in one purchase, along with 9g in one month
how many regulatory bodies of pharmacy are there?
six
FDA (Food and Drug Administration)
widely known regulatory body in pharmacy
responsible for:
- food
- medicines
- biological products
- radioactive products
- cosmetics
what system does the FDA use to inform any adverse effects that patients experience?
MedWatch
who can report through MedWatch?
pharmacist, technician, or any other healthcare professional
DEA
Drug Enforcement Administration
why was DEA formed
because of the Controlled Substances Act
function of DEA?
to oversee and enforce legislation related to controlled meds
what form must be sent to the DEA in case controlled med gets lost or missing?
Form 106
Schedule 1 drugs are the most ______
potent and addictive
what do Schedule II drugs require?
special ordering requirements by the pharmacy
which schedules do not have special ordering requirements?
Schedules III to V
2 functions of the DEA?
- prosecute offenders who breach legislation
- reduce the use of illicit drugs in the United States
the Joint Commission (TJC)
an independent organization in the US that accredits and certifies healthcare organizations
function of TJC (the joint commission)
ensure the best possible treatment outcomes for patients
State Boards of Pharmacy
pharmacy boards that cater to the needs of their own state
responsible for certifying and licensing pharmacy personnel (some states, techs included)
National Association of the Boards of Pharmacy
(does not have law behind it)
regulatory body of pharmacy
an association that assists boards of pharmacy by ensuring there are consistent standards among each state board
United States Pharmacopoeia (USP)
sets the standards in
- otc meds
- prescriptions
- dietary supplements
what are the three chapters of USP
USP <795>
USP <797>
USP <800>
USP <795>
sets standards in non-sterile compounding formulations (i.e, cough meds)
USP <797>
sets standards in sterile compounding, making sure that no contaminants enter the meds
- strict controls of clean rooms, ventilation, quality assurance, and microbial levels are detailed here
USP <800>
sets standards for handling hazardous drugs for healthcare professional, patients, and the environment.
REMS
risk evaluation and mitigation strategies
what does REMS come under?
the FDA Amendments Act (FDAAA)
what do meds with special requirements include?
- drugs with potentially very harmful adverse effects
- drugs that increase the risk of fetal harm (teratogenic drugs)
- drugs with high risk of abuse potential
what drugs require REMS?
- Clozapine
- Fentanyl
- Buprenorphine
- Thalidomide
- Isotretinoin
- Pseudoephedrine containing products
some drugs have their own REMS
what is the REMS of isotretinoin?
iPledge
what are the functions of iPledge?
- ensure communication release of the drug is consistent across all healthcare professionals
- ensure effective communication on the teratogenic effects of isotretinoin and its risk of severe psychiatric effects
- promote the safe and effective prescribing and use of isotretinoin
are patient required to sign a consent form accepting the known risks of isotretinoin?
yes
how many pregnancy tests are to be negative before patient is prescribed isotretinoin?
2
two forms of birth control must be taken before they are prescribed isotretinoin. true or false?
true
why does fentanyl have its own REMS
because it is an opioid analgesic with a high risk of abuse potential
why does clozapine have its own REMS
because it is an antipsychotic drug that increases the risk of agranulocytosis
why does buprenorphine have its own REMS
because it is an opioid that carries abuse potential
why does thalidomide have its REMS
because it is a drug that contains high risk of deformed babies
reason for isotretinoin to have REMS
it is a teratogen that carries a risk of psychiatric disorders
the DEA was a federal agency formed and signed into existence in 1973 by President ______
Richard Nixon
what form registers the pharmacy with the DEA
Form 224
authorized controlled dispensing pharmacies must carry the license for how many years?
3 years
how can pharmacies renew the license for controlled dispensing?
by filling out the DEA Form 224a
how prior must the pharmacies renew the license for controlled?
at least 60 days prior to expiration
pharmacies that require duplicate authorization certification must fill out _________
DEA Form 223
inventory records must be kept within the pharmacy for how long?
2 years
damaged controlled substances must be destroyed and recorded using what form?
Form 41
how is hazardous waste unsafe?
- it can be absorbed through the skin into the bloodstream
- be inhaled as fine particles into the lungs
- burn the skin
- cause harm to the fetus (teratogenic substances)
non-hazardous waste is removed by —
using a reverse distributor
Environmental Protection Agency (EPA)
disposal of hazardous waste must comply with EPA
four classifications: P, U, K, F
pharmaceutical wastes are classified under which two EPA?
P-list and U-list
P-list pharmaceutical waste drugs
- Warfarin
- Nicotine patches, gum, or lozenges
-Physostigmine - Arsenic trioxide
- Nitroglycerin
- Epinephrine
U-list pharmaceutical waste drugs
- Lindane
- Selenium sulfide
- chloral hydrate
- mitomycin C
- Formaldehyde
- Benzene
Resource Conservation and Recovery Act
contains four characteristic waste categories
- ignitability
- toxicity
- corrosivity
- reactivity
Initial Incident Report, IIR
any inadvertent exposure to hazardous substances need to be first documented here
