Quiz #1 Flashcards
T/F
Out of state Pharmacists who is licensed out of states can prescribe for someone in Florida
False
They would first need to have a FL permit in order to do so
T/F
Pharmacists MUST counsel patients
False
must OFFER to counsel but not required to do so
What is considered a supplement based on the definition?
- a vitamin
- a mineral
- an herb or other botanical
- An amino acid
- dietary substance for use by humans to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, extract, or combination of the previous
Exception to PPPA
Colestipol in powder form up to 5g in a packet
What came from the Sulfamide Tragedy?
Food, Drug, and Cosmetic Act of 1938
Intended to cure, diagnose, prevent or treat diagnosis with changes to the body
drug; device; cosmetic; food
DRUG
Printed material on drug, it’s container or wrapping or any printed materials that comes with drugs.
label, not labeling; labeling, not label; both label and part of labeling; neither
both labeling and part of labeling
What did Durham-Humphrey amendment do?
- Rx & OTC category
- label w/ caution now Rx ONLY
Class 1 medical devices
least harm; least regulation; general controls sufficient for safety and effectiveness
- needles, scissors, examination gloves, enema kits, elastic bandages, and toothbrushes
Class II medical devices
intermediate class, general controls insufficient; specific performance standards required
- insulting syringes, infusion pumps, thermometers, diagnosis reagents, tampons, and electric heating pads, powdered wheelchairs, some pregnancy testing kits
Class III medical devices
most risk/injury - life-supporting, life-sustaining, or present a potential unreasonable risk of illness or injury; must have premarket approval
- pacemakers, soft contact lenses, replacement heart valves, silicone gel-filled breast implants and implanted cerebella stimulators
Which act placed more control on distribution of Rx meds and samples?
Prescription Drug Marketing Act
Class 1 recall
issued when there is a reasonable probability that the product will cause serious, adverse health consequences or death
Class II recall
issued when the product may cause temporary or medically reversible adverse health consequence, but the probability of serious adverse consequences is remote
Class III recall
applies to products that are not likely to cause adverse health consequences
Federal Authority to Regulate Drug Distribution
authority under the interstate commerce clause
10th amendment: State authority to regulate drugs & professions through tenth amendment and police powers
the powers not delegated to the US by the constitution, nor prohibited by it to the states, are reserved to the states respectively, or to the people
Notice and Comment
- agency propose a regulation
Probable Cause Committee
current or former board member but at least 1 must be current and at least 1 must be a licensed pharmacist
9 members; 7 pharmacists; 2 consumer members who have nothing to do with the practice of pharmacy
Pharmacist comes in drunk. What do you do?
report to the department or the consultant (PRN program)
duty to warn/notify when patient can cause…
severe harm
Who is covered under HIPAA?
- health plans
- clearinghouses
- health care providers including pharmacists
- business associates who assist covered entities with provision of health care
Consultant pharmacist needs what?
- currently be a licensed pharmacist
- 20 CE hrs
Nuclear pharmacist requires …
- 200 hours of nuclear certificate of didactic training from approved program
- 500hrs of on the job training
- must complete within 7 years or have practiced nuclear pharmacy in another state for at least 1080hrs in last 7 yrs
