Part 2 Flashcards
Food and drug act of 1906
Prohibited interstate commerce of misbranded and adulterated drugs
MISBRANDED ADULTERATED
1938 Food Drug and Cosmetic Act
- New drugs must be safe prior to marketing
- Factory inspections allowed
- Safe tolerances for poisonous substances
Durham Humphrey Amendment of 1951
- Defines which medications can be used without medical supervision
- Requires a prescription from a practitioner
(OTC VS PRESCRIPTION)
Kefauver Harris act of 1962
- Ensures efficacy and safety prior to marketing
(Came after Thalidomide)
Poison prevention packaging act (PPPA) 1970
- Protects children from accidental ingesting
- Requires childproof caps on prescriptions
- Dangerous chemicals need safe packaging
Exceptions ntg, blister packs, no safety caps request
Medical Device Amendment 1976
Higher safety and efficacy standards started for medical devices
Enacted because of intrauterine device failures in women
Explain the classes of medical devices in the medical device amendment of 1976
- Class 1 - lower risk where significant injury or death is unlikely
- Class 2 - moderate risk
- Class 3 -high risk of significant injury or death
Tamper resistant packaging regulation of 1982
Became a crime to tamper with packaged consumer products
Orphan drug act of 1983
Enabled fda to promote research for rare diseases
How many people are affected to qualify as an orphan drug
200,000 or less
Another name for Hatch-Waxman Act 1984
Drug price competition and patent term restoration act
What did Hatch-Waxman Act do
- Generic drug system
- Abbreviated new drug application became easier
- Only need to prove bioequivalence
- Market exclusivity for a period of time
Prescription Drug Marketing Act 1987-1988
- Requires licensing of wholesalers
- Bans sale or trade of drug samples
- Bans diversion of prescription drugs from normal comercial channels - can’t sell your rx mds
Dietary Supplement Health and Education Act (DSHEA) 1994 (6 things)
- classified as food
- Good manufacturing process required
- Can’t be misbranded or adulterated
- Do not have to prove safety
- Cannot make specific claims for treating a specific illness
- Must be labeled as a dietary supplement(herbal, vitamin, etc)
Health Insurance portability and accountability act HIPAA -1996
1.Provides standards of handling PHI
2. Appropriate access for health care providers to do their jobs
2.no restrictions on use of disidentified PHI
FDA Modernization Act of 1997
Regulated advertising of off labeled uses of drugs
OFF LABEL
Medicare Prescription Drug Improvement and Modernization Act of 2003
Medicare part D started (implemented in 2006)
Affordable Care Act of 2010
Obamacare
Older children to remain in parents plan until age 26
Attempts to stop insurance companies from selecting patients without preexisting conditions
Established cms innovation center
Purpose of cms innovation center
Test healthcare delivery models to maximize cost and service (MTM included in this)
What does OSHA stand for
Occupational Safety and Health Administration
Who does OSHA PROTECT
Healthcare workers who could be exposed to hazardous drugs or blood Bourne pathogens - think chemo meds
What safety procedures are included in OSHA?
HASDT
1. Handling
2. Administration
3. Storage
4. Disposal
5. Transportation
What does MSDS stand for
Material Safety Data Sheets
What agency oversees MSDSs?
OSHA
Another name for MSDS
SDS (safety data sheets)
OSHA requires employers who use hazardous substances to have what for each
Safety DAta Sheets - HASDT
Ie chemo agents will have an SDS
What info is in an SDS?
- Name of chemical compound
- What to do if exposed
- Procedures for accidents
- Risks if exposed
- Protective equipment
Name, EXPOSURE, accident, RISKS, PE
What does NIOSH stand for
National Institute for Occupational Safety and Health
What is listed in NIOSH
Hazardous drugs that may impact the health and safety of healthcare professionals who administer, compound, or dispense them
Ie chemo or hormonal drugs
What type of equipment is often needed when working with medications that are on a NIOSH list
Personal Protective Equipment PPE
What is the EPA
Environmental Protection Agency
What is defined by the EPA
Hazardous waste and recommends how to dispose of it
Hazardous waste must meet one the following categories
TIRC
T - toxic - harmful if ingested
I- ignitability
R - Reactivity - causes a dangerous chemical reaction
C - Corrosive - high or low ph that can cause damage to skin
Which listed drugs require special disposal
P listed
Ie warfarin and nicotine
Where are patients encouraged to take p listed medications when disposing of them
Sheriffs office or a pharmacy
What is the EPAs method of disposal if there is no take back program?
1 remove from vial
2 combine with kitty litter or coffee grounds
3 put in a container that can be closed ie ziplock bag
4 remove phi
5 place in trash
What is DMEPA
Division of Medication Error Prevention and Analysis
What is DMEPA under the umbrella of?
CDER
What does DMEPA do
Reviews medication error reports on prescriptions and otcs
What institutes does DMEPA work closely with?
Institute of Safe Medicine Practices (ISMP) and United States Pharmacopia (USP)
What is MERp
ISMP Medications Errors Reporting Program
MERP is voluntary reporting where are the reports forwarded
To the FDA and possibly to the manufacturer if a change is needed (ie sound alike meds)
What is MERPs culture of safety called
Just Culture
MERPs just culture 3 goals
- Systems focused on patient safety
- Strive for continuous improvement
- Looks at work environment and processes improvement
What is VERP
ISMP Vaccine Errors Reporting Program
What’s reported in VERP
Voluntary
Vaccine errors and good catches
What is VAERS
Vaccine Adverse Event Reporting System
What is reported on VAERS
Non preventable adverse reactions
What does VAERS do with the info they receive in the voluntary reporting
Analyze the data
Publish data for the public
What department is VAERS under
Department of Health and Human Services
