Term
|
Definition
-optimizing biochemical activity
-increasing specificity
-limiting negative effects |
|
|
Term
|
Definition
-Rx
-non Rx
-approved use
-unapproved use (21%) |
|
|
Term
| Source of OTC distribution |
|
Definition
-pharmacy 35%
-mass merchandisers 29%
-food stores 21%
-other 15% |
|
|
Term
| reasons for choosing a particular pharmacy |
|
Definition
|
|
Term
| factors influencing prescribers behavior |
|
Definition
-education
-colleagues
-control and regulatory mechanisms
-demands by consumers and society
-promotional activities by drug manufacturers |
|
|
Term
| % of patients know what they want |
|
Definition
|
|
Term
| concerns with foreign drug trials |
|
Definition
-informed consent
-data reliability
-biological differences (DNA)
-lack of regulatory oversight
-treatment after trial
-owe the country? |
|
|
Term
| % of clinical trials that take place outside US |
|
Definition
|
|
Term
| number of clinical trials conducted by the 20 largest pharm companies outside US |
|
Definition
|
|
Term
| % of off label prescribing |
|
Definition
|
|
Term
| required by VA system that all Rx include |
|
Definition
|
|
Term
|
Definition
-redefining or relabeling of a personal or social problem as a medical condition
-anxiety/depression
-ADD/ADHD
-obesity/eating disorders
-substance use |
|
|
Term
|
Definition
| pharmacy practice and professionals |
|
|
Term
|
Definition
-drug products
-medical devices
-food safety |
|
|
Term
| 3 acts that control pharmaceuticals |
|
Definition
-Food Drug Cosmetic Act
-Public Health Service Act
-Food Safety Modernization Act |
|
|
Term
| Food Drug Cosmetic Act controls |
|
Definition
| -small molecules and hormones |
|
|
Term
| Public Health Service Act controls |
|
Definition
|
|
Term
|
Definition
-premarketing clearance of all new products based on purity, safety, and effectiveness
-labeling and advertising
-good manufacturing and recalls |
|
|
Term
|
Definition
-bioequivalence
-postmarketing surveillance
-blood supply
-food safety |
|
|
Term
|
Definition
-Jan 2011
-shift from responding to contamination to preventing it
-July dietary supplement industry
-August Strategic Plan
-September Coordinated Outbreak Response and Evaluation (CORE) |
|
|
Term
|
Definition
-determines safe dosage range, preferred route of administration, mechanisms of absorption, distribution, elimination, and possible toxicities
-<100 volunteers
-1 year |
|
|
Term
|
Definition
-safety and efficacy in treating a disease or symptom
-volunteers with the disease or symptom (<300)
-2 years |
|
|
Term
|
Definition
-safety,efficacy, and dosage range under market conditions
-volunteers with disease or symptom (<3000)
-3 years |
|
|
Term
| number of days FDA has to decide to review NDA |
|
Definition
|
|
Term
| FDA's Center for Drug Evaluation and Research |
|
Definition
-10 review (6 for priority)
-inspects manufacturing facility
- |
|
|
Term
|
Definition
| -supplemental NDA if new indication, label change or new manufacturing process |
|
|
Term
| price is ultimately determined by |
|
Definition
| costs and profits (manufacturer, wholesaler, retailer) of supply chain plus any discounts and economic forces |
|
|
Term
| average cost of brand name Rx medications in upstate NY jumps |
|
Definition
|
|
Term
| generic drug use up to ____ from_____ |
|
Definition
|
|
Term
|
Definition
|
|
Term
| % total Rx spending increase that is not unusual |
|
Definition
|
|
Term
| rate(%) costs of branded drugs are increasing |
|
Definition
|
|
Term
| reasons for faster increases in costs of brand name drugs |
|
Definition
-lack of therapeutically equivalent drugs
-limited competition |
|
|
Term
| cost is typically a percentage discount off the |
|
Definition
|
|
Term
| plans that discount Rx drugs |
|
Definition
-Monroe County Discount card
-EPIC assistance for Medicare Part D
-Family Health Plus
-Child Health Plus |
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
Term
| personal importation of a 3 month supply is legal if |
|
Definition
-valid Rx from US
-intended us is unapproved and for a serious condition
-not much risk |
|
|
Term
| prevalence of counterfeiting in developing world |
|
Definition
|
|
Term
| % of NDAs approved by FDA including data from foreign trials |
|
Definition
|
|
Term
| reasons for foreign trials |
|
Definition
-cost
-Americans don't want placebo
-less red tape
-cleaner baseline who have never been treated |
|
|
Term
| common locations for foreign drug trials |
|
Definition
-India
-Thailand
-Eastern Europe |
|
|
Term
|
Definition
-1996
-Meningitis epidemmic
-200 children received Trovan
-11 died
-severe side effects
-sues Pfizer |
|
|
Term
|
Definition
-2009
-$175,000 per family
-$35 million fund
-first families received payment in 2011 |
|
|
Term
|
Definition
-international property rights
-laws to protect innovators of drugs |
|
|
Term
| IPR for small molecule drugs |
|
Definition
-Hatch-Waxmon Act
-patent protection
-copies considered generics |
|
|
Term
|
Definition
-Patent Protection and Affordable Care Act
-data exclusivity
-copies considered biosimilars |
|
|
