Lecture 3 part 4

Question 1

Poison Prevention Packaging Act of
1970: requires__________ (=80% of children <5 years old cannot open but 90% adults can), not child-proof packaging for all drugs and cosmetics (and various other hazardous household substances) unless the product is
-on a list of excepted products;
-a one size OTC product for ____________ or handicapped patients
-a prescription drug, and the _________ or patient request noncomplaint packaging (it is recommended to obtain such requests in writing)

Answer 1

child resistant

elderly

prescriber

Question 2

Poison Prevention Packaging Act of 1970 and this was in response to childhood poisonings occurring involving prescription medications and other medications but primarily they were concerned about children getting into medication, over the counter or prescription, and this impacts on both…

Question 3

on over the counter products they had to be put into tamper resistant or some sort of packaging that was difficult for children to get into and you would call them child resistant lids…there allowed in ibuprofen or motrin in one of their containers to not have a child resistant lid and its geared toward older people who may have difficulty getting the lids open they are allowed to have 1 but that one has to be specifically labeled and everything that its not child resistant

Question 4

Child resistant lids are definitely on prescription drugs and either the prescriber or the patient can ask for an easy open container

Question 5

The prescription drugs it comes down to the pharmacy on whose responsible for putting on child resistant lids!

Question 6

Many products you get nowadays are called a unit of use in other words its already packaged in a 30 or 60 and they have a child resistant on there..this gets a little more difficult if patient wants and easy open lid because those you cant alter and you have to put it in a bottle

Question 7

Medical Device Amendment of 1976

FDA has the responsibility of classifying all medical devices as

_________-general controls ex: sphygmomanometer

Answer 7

Class I

Question 8

Drugs can’t be on the market until they are proven safe and effective by the FDA

Question 9

If your product falls in Class III you have to go through a premarket approval process

Question 10

Class I and Class _____don’t have to go through premarket approval process

Answer 10

Class II

Question 11

Class II-_____________
ex: IV fluid pump

Answer 11

specific performance standards

Question 12

Class I, Class II, and Class III fall under medical devices

Question 13

Class ________:premarket approval since they are life-supporting or life sustaining ex=heart pacemaker

Answer 13

Class III

Question 14

Class I is the least potential for _________ex:blood pressure cuff

Answer 14

harm

Question 15

_________:more potential for harm, need to meet specific performance standards when its operating ex: IV fluid pump if you put in too much fluid too fast yes you can kill someone with that

Answer 15

Class II

Question 16

__________:life-supporting, life-sustaining or potential unreasonable risk of illness or injury; requires premarket approval of safety and efficacy

Answer 16

Class III

Question 17

FDA must establish standards of performance for all medical devices and they do that through __________

Answer 17

regulation

Question 18

FDA must establish a system of premarket testing and review for _______medical devices done through regulations

Answer 18

Class III

Question 19

FDA must develop a system of post-market surveillance of medical devices (now product is on the market it was approved…are we monitoring even though its now approved and on the marktet