WITH ANSWERS RATED A+
✔✔Primary wholesale distributors - ✔✔Buy most of their drugs directly from
manufacturers. Legally considered authorized distributors within the meaning of the
PDMA because they usually have ongoing relationships with manufacturers
✔✔Secondary wholesale distributors - ✔✔Buy from a primary and other secondary
wholesalers as well as manufacturers but are not considered authorized distributors of
the manufacturers within the meaning of the PDMA
✔✔Distribution Terminology - ✔✔Pg 60-61
✔✔Average wholesale price (AWP) - ✔✔Published wholesale price of list price
suggested by the manufacturer.
✔✔Chain drug store - ✔✔Company that owns and operates four or more pharmacies
✔✔Drop shipment - ✔✔Drug manufacturer directly delivers the drugs to a dispenser,
but order and payments are made through a wholesaler
✔✔Group purchasing organization (GPO) - ✔✔An entity consisting of two or more
hospitals or other healthcare entities that is formed to offer its members access to
purchasing contracts for health supplies
✔✔Upcharge - ✔✔Percentage fee that is paid by the dispenser to the wholesaler for the
cost of distribution
✔✔Package Insert Info - ✔✔Pg 63
✔✔Drug Patents - ✔✔Pg 65
Terms pg 67
✔✔Orange Book ratings - ✔✔A
AA
AN
AO
AP
AT
B
✔✔Hatch-Waxman Act - ✔✔aka Drug Price Competition and Patent Term Restoration
Act of 1984. Considered the most significant drug-related legislation affecting pharma
and healthcare. H-W made it easier to bring generics to the marker by requiring FDA to
,only look at bioavailability studies in order to approve. Also gave protection to the
research based manu's by providing a 30 months automatic cooling off period
✔✔It is important not to change the order of a sample closet - ✔✔True
✔✔Manufacturers and distributors are required to have systems to monitor and audit
the distribution of their drug samples - ✔✔True
✔✔Meticulous records must be kept of sample inventories and reps are required to
account for their samples periodically. - ✔✔True
✔✔Representatives are required to store samples in a secure area where people
cannot access them without permission and where they will not be subjected to
extremes of temperature, moisture, and contamination - ✔✔True
✔✔A sample closet or cabinet is essentially similar to a grocery store shelf. The more
visibility you can give your drug, the more likely it will be used. - ✔✔True
✔✔In some situations, a physician may sign the paperwork before the number of
samples has been recorded - ✔✔True
✔✔Section 503 - ✔✔Prohibits sale, purchase, or trade of drug samples
✔✔E-sampling - ✔✔Pg 72
✔✔Many pharmaceutical manufacturers set expiration dates every six months (June,
December) - ✔✔True
✔✔DEA regulates the distribution and use of narcotics and other controlled substances
- ✔✔True
✔✔FTC - ✔✔Regulates general business practices to protect consumers against
misleading claims and anticompetitive behavior
✔✔AMA - ✔✔provides ethical guidelines to physicians about appropriate interactions
with pharmaceutical companies
✔✔Benefits of Government-Industry Partnerhsips - ✔✔Pg 79
✔✔Preclinical studies - ✔✔pg 81
✔✔Pinocytosis - ✔✔Involves the engulfing of fluids by a cell.
, ✔✔Transport Mechanisms - ✔✔Passive diffusion, facilitated diffusion, active transport,
pinocytosis
✔✔Absorption methods - ✔✔Oral, Buccal, sublingual, rectal, subcutaneous,
intramuscular, transdermal, topical, inhalation, intravenous
✔✔The liver is the major organ for metabolizing drugs. Secondary is kidney - ✔✔True
✔✔CL= rate of drug elimination/drug concentration in blood - ✔✔True
✔✔In vitro assays are increasingly being see because they are usually less expensive,
offer more rapid results, and are not as prone to negative publicity. - ✔✔True
✔✔Clinical Trials - ✔✔pg 89
✔✔Subjects should be informed about the aims, methods, risks, and benefits of the trial
- ✔✔True
✔✔Four phases of clinical trials - ✔✔Pg 90
✔✔Regulatory Requirement terms - ✔✔Pg 92
✔✔Investigator - ✔✔The person who conducts the trial. This person is normally an
expert in the field. They should not be employed by the sponsor
✔✔Sponsor - ✔✔The organization or individual that initiates the trial and finances the
study,
✔✔Protocol - ✔✔This document sets out how a trial is to be conducted
✔✔Epidemiology - ✔✔The study of how factors influence disease and health in human
populations.
✔✔Therapeutic - ✔✔Antibodies
✔✔Vaccines - ✔✔Pg 108
✔✔Toxoids - ✔✔Derived from toxins secreted by a pathogen.Examples are diphtheria
and tetnus vaccines.
✔✔Vector-based vaccines - ✔✔Viruses and bacteria are detoxified and used as
vehicles to carry vaccines. Example is the use of canary pox (a virus that infects birds
but not humans) to carry envelope proteins for HIV treatment.