Law Review Flashcards
1
Q
Pure Food and Drug Act of 1906
A
- Prohibited food/medication from being misbranded or adultered
- False/incorrect claims of efficacy weren’t prohibited, labeling wasn’t regulated, and safety didn’t have to be proven
- Only addresses contaminated and inappropriately labeled foods/medications
2
Q
Harrison Narcotics Tax Act of 1914
A
- Passed to regulate opium and narcotic use
- Required prescription for opium to be given to patients and for prescribers to be registered to prescribe opium
- Had to document scripts for opium
3
Q
Food, Drugs, Cosmetics Act of 1938
A
- Used to try and correct pitfalls from Pure Food and Drug Act of 1906
- Established the FDA and said that they had to approve all new medications being sold in US
- Not approved until they are proven safe
- Established that adulteration and misbranding were illegal and required adequate instructions and warnings be included on medication labels
- Required quantities of active ingredients, alcohol content, and name/location of manufacturer
4
Q
Durham-Humphrey Amendment of 1951
A
- Established two classes of medication, OTC and Rx
- Rx meds were allowed to have prescriber’s directions for use on the label if they had the following warning: “Caution: Federal law prohibits dispensing without a prescription”
- Allowed scripts to be called in over the phone and allowed for refills as well
5
Q
Kefauver-Harris Amendment of 1962
A
- Drugs must be proven to be effective in addition to being pure and safe
- Followed the thalomid tragedy
- Retroactively applied to drugs approved between 1938-1962
- Gave FDA authority to oversee med advertising and established good manufacturing practices (GMP) for drug manufacturers
- Also more control over clinical trials, participants were required to have informed consent
6
Q
Comprehensive Drug Abuse, Prevention, and Control Act of 1970
A
- AKA Controlled Substances Act
- Regulations on prescribing, dispensing, importation, possession, and use of controlled substances
- Required dispensing facilities to register with DEA with DEA form 224 every 3 years
- Established the five controlled substance classes that decrease in abuse potential/dependence as the classes increase
7
Q
Ordering Controlled Substances
A
- Complete DEA 222 form in writing
- Must retain a copy, send other two to wholesaler who then sends one to the DEA
- Must acknowledge that the medications were received on the DEA 222 kept at the pharmacy and retain those records for at least 2 years
8
Q
Maintaining DEA Records
A
- All kept for a minimum of two years, longer based on state law
- Defective and incorrectly filled out DEA 222 should be kept too
- Check record keeping requirements per state, varies widely
9
Q
Controlled Substance Inventories
A
- Must conduct controlled substance inventories on a regular basis
- One before pharmacy ever opens, then biennially thereafter
- Exact counts must be done for CII and estimated counts for CIII-V in packages <1000
- Keep records of these inventories for at least 2 years
- Perpetual inventory of CII must be utilized, all additions and subtractions from controlled substance inventory should be recorded as they occcur
10
Q
Returning Controlled Substances
A
- DEA 222 needs to accompany any transfer of CII
- Keep record in receiving and transferring pharmacy
- Send green copy to DEA within 60 days of transfer
11
Q
Destroying Controlled Substances
A
- Damaged or outdated controlled substances need permission to be destroyed be submitting a DEA 41
- Include date of destruction, name, concentration/quantity of controlled substance, method used for destruction, and names of witnesses
- Must be sent to DEA at least two weeks before destruction
- Hospitals can apply for “blanket authorization”
12
Q
Controlled Substance Theft
A
- Must inform closest DEA diversion office and submit a DEA 106
- Include DEA registration information, purchase value of products, name/dose/quantities
- Send original copy to DEA and keep a copy at pharmacy
13
Q
Emergency Filling Controls
A
- Faxes okay for terminally ill
- Some Schedule Vs can be bought without a script
- Requirements: only done by pharmacist, min 18 y.o., keep records of identification with details of transaction, no more than 240mL/48 dosage units of opiate based products and 120mL/24 dosage units of other controlled substances within 48 hours
14
Q
Poison Packaging Act of 1970
A
- Goal: Decrease accidental poisoning of children
- OTC and most Rx should have child resistant containers
- Exceptions include if patient requests EZ open, doctor requests EZ open, or if OTC warn “This package for households without young children” OR “Package not child resistant”
15
Q
OSHA of 1970
A
- Ensured employees had a right to a safe/healthy work environment
- Developed employee health and safety standards
- Reduced hazardous working environments and could audit workplaces to ensure they remained compliant
- Safety data sheets and guidelines for cytotoxic drugs
16
Q
Drug Listing Act of 1972
A
- Created NDCs
- First five: manufacturer, Next four: specific drug, Last 2: package size/type
- Used to differentiate products
17
Q
Orphan Drug Act of 1983
A
- Orphan drugs treat conditions that effect <200,000 people worldwide
- Tax incentives for companies to produce orphan drugs
- Also gave exclusive licensing rights for 7 years after approval
- Research assistance and grants also made available
18
Q
Drug Price Competition and Patent Term Restoration Act of 1984
A
- AKA Hatch-Waxman Amendment
- Streamlined a generic drug approval process to encourage their development
- Abbreviated new drug application made to decrease time to approval from FDA
- First generic to file ANDA got exclusive marketing rights for 180 days before other manufacturers
19
Q
Prescription Drug Marketing Act of 1987
A
- Solidify drug chain of Rx meds
- Reinforce standardized routes that drug products follow from wholesaler to pharmacies
- Help prevent counterfeit products from entering supply
- Prevented hospitals from reselling medications to outside businesses
- No dispensing samples unless you were licensed to prescribe the meds
20
Q
FDA Modernization Act of 1997
A
- Streamlined FDA’s regulatory process to more rapidly approve drugs
- Aimed to reduce backlog of medications in approval process
- Fast-tracked approval for meds for life-threatening conditions, database of clinical trial information, and expanded rights to give information on unlabeled uses of drugs
- Increased FDA oversight of OTCs and required inactive ingredients to be listed as well
21
Q
OBRA of 1987
A
- Addressed the quality of healthcare received by elderly under Medicare
- Standards of care for those living in nursing homes were established
- Prevented use of medications that were not necessary for the patients’ conditions and established requirements for antipsychotic use
- Nursing homes must be serviced by a consulting pharmacist
22
Q
Anabolic Steroid Control Act of 1990
A
- Regulations for anabolic steroids and punishments for abusing/misusing these products
- “Any medication chemically related to testosterone”
- Set aside money to educate about their harmful effects
- Moved them to CIII status
23
Q
OBRA-90
A
- Drug utilization evaluations must be completed before filling a drug
- Must check for CI, DDI, dosage accuracy, and treatment duration
- Established a need for patient counseling
- Right to refuse counseling, use professional judgement on what to include in counseling
24
Q
DSHEA of 1994
A
- Regulations for herbal products
- List ingredients and quantity of each ingredient as well as plant or part of plant used to make product
- Must also state that the product is a dietary supplement
- Meet standards for purity, quality, composition, and production to comply with standards
- Good manufacturing practices and prevent adulteration of products
25
Q
DATA of 2000
A
- Broaden rights of prescribers to prescribe controlled substances to treat opiate addiction (DEA registration)
- CIII-V use for patients undergoing detox or for maintenance of opiate addiction
- Buprenorphine included, not methadone
- Patients must enroll into a program with support services and counseling
26
Q
MPDIMA of 2003
A
- Modernized Medicare system
- Added prescription drug benefit to Medicare (Part D)
- Medicare Advantage program for low-income Medicare patients for additional cost savings
27
Q
Isotretinoin Safety and Risk Management Act of 2004
A
- Acne med that causes birth defects
- Established REMS program where patients and prescribers had to register and be approved for monthly refills
- Restricted to 30 day fills
- Pregnancy tests required monthly before getting additional medication
28
Q
Combat Meth Epidemic Act of 2005
A
- Limited meth ingredients to specific amounts
- 3.6 g per day and 9 g per 30 days
- Pseudoephedrine, ephedrine, and phenylpropanolamine
29
Q
Medicaid Tamper-Resistant Prescription Act
A
- Handwritten scripts for Medicaid patients must be on tamper resistant paper
- To stop modifying or erasing parts of prescriptions
- Fax is an option if tamper resistant paper isn’t available
30
Q
USP <797>
A
- Reinforced regulations for sterile products
- Created requirements for aseptic techniques and requirements for facilities that make, store, or dispense sterile products
- Required training/evaluation for all personal who involved in compounding
- Classifications for air cleanliness and construction of sterile compounding rooms as well
