Federal Pharmacy Law and Regulation: Reading 4

Question 1

____________________ Act of 1970 was in response to the growing issues of child poisonings caused by common household substances.

Answer 1

Poison Prevention Packaging Act (PPPA) of 1970

Question 2

The Poison Preventing packaging Act of 1970 gave the Consumer Product Safety Commission (CPSC) the authority to require _____________ ____________ of hazardous substances.

Answer 2

special packaging

The goal is to prevent accidental poisoning in children under the age of 5, which means FOUR and under.

Question 3

The Poison Prevention Packaging Act of 1970 is only meant to prevent poisonings in children younger than

Answer 3

five; which means four and under.

Question 4

_____________ ____________ is “packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.”

Answer 4

Special packaging

more commonly known as child-resistant packaging or child-resistant containers (CRCs)

Question 5

T or F:

special packaging IS childproof.

Answer 5

FALSE;

it is commonly known as child-resistant packaging or child-resistant containers - all 3 terms used interchangeably; but NOT 100% childproof!

Question 6

Requirements that a package must meet to be considered child-resistant and qualify as special packaging:

1)
2)
3)

Answer 6

1) At least 90% of adults should be able to open the container without significant difficulty.

2) At least 85% of children under 5 who have never seen the kind of packaging undergoing testing and have not been given any instruction on opening the packaging, should not be able to open the container in 5 minutes.

3) At least 80% of children under 5 still cannot successfully open the package after an adult shows them how to open the container in five minutes.

Question 7

Which products require child-resistant packaging?

Answer 7

both controlled substances (controlled drugs) in a dosage form intended for oral administration and prescription drugs in a dosage form intended for oral administration require special packaging

Question 8

Which drugs MUST be dispensed in special. packaging?

Answer 8

NONE

Question 9

T or F?

drugs not in a dosage form intended for oral administration do NOT have to be in child-resistant packaging (nasal sprays, eye drops, and ointments as well as other non-ral dosage forms dont need to be disepnsed in special packaging)

Answer 9

True

Question 10

T or F?

Patients AND prescribers can provider a waiver for non-child-resistant packaging.

Answer 10

True

Question 11

___________ is an intentional and voluntary relinquishment of a right.

Answer 11

waiver

Question 12

T or F?

Prescribers can grant a waiver ONLY on a prescription-by-prescription basis, and that stays in place for all refills of that prescription.

Answer 12

True

**prescribers cannot issue a blanket waiver that applies to all rxs for a single patient or all rxs they write.

Question 13

Who CAN request a blanket waiver for all prescriptions to not be placed in special packaging?

Answer 13

patients and patient representatives

**does not legally need to be made in writing nor do these individuals need to sign anything to get non-child-resistant containers; however, it is a good idea to have documentation that the request was made and when.

Question 14

List of prescription drug exemptions from special packaging requirements (12)

Answer 14

1. sublingual dosage forms of nitroglycerin;
2. sublingual and chewable forms of isosorbide dinitrate,10mg or less;
3. erythromycin ethylsuccinate granules for oral suspension and oral suspensions containing
   8g or less of erythromycin, or tablets in packages containing no more than the equivalent
   of 16 grams erythromycin;
4. cyclically administered oral contraceptives in manufacturers’ mnemonic (memory-aid)
   dispenser packages that rely solely upon the activity of one or more progestin or estrogen
   substances;
5. anhydrous cholestyramine in powder form;
6. all unit dose forms of potassium, 50mEq or less;
7. betamethasone tablets packaged in manufacturers’ dispenser packages, containing 12.6mg
   or less;
8. prednisone tablets, when dispensed in packages containing no more than 105mg total;
9. medroxyprogesterone acetate tablets;
10. methylprednisolone tablets in packages containing not more than 84mg total;
11. colestipol powder in packages containing no more than 5g total;
12. mebendazole tablets in packages containing no more than 600mg total.

Question 15

Who can decide or request that a medication NOT be placed in child-resistant containers?

Answer 15

patient, patient representative, prescriber, and the Consumer Product Safety Commission (CPSC)

– a pharmacist cannot.

Question 16

If a patient brings the last rx bottle/child-resistant packaging to the pharmacy when they request a refill are you able to reuse it?

Answer 16

no; plastic wears down as we use it and this wear may compromise the mechanisms that make the package child-resistant.

the CPSC has stated that if the container is GLASS, it is acceptable to reuse the container as long as a NEW cap (or closure) is used.

Question 17

Who are package inserts intended to provide essential information to?

Answer 17

healthcare professionals

*it CAN be given to the patient.

info is both science-based and medical in nature and can assist practitioners in understanding the safe and effective use of a drug

Question 18

package inserts are based on data obtained in ____ studies

Answer 18

human

animal studies can be used as evidence for claims if the claims are necessary for the safe and effective use of the medication, but the information must be clearly identified as coming from animal studies.

Question 19

T or F?

Package inserts MUST be with a product both when shipped to your pharmacy and while sitting on your shelf in the pharmacy

Answer 19

TRUE

Question 20

Adulterated or misbranded:

if there is not a package insert with the drug while sitting on your shelf in the pharmacy, it is considered…

Answer 20

MISBRANDED

Question 21

____________ is FDA-approved labeling written in patient-friendly language and explains the uses, risks, and precautions related to a particular drug.

Answer 21

patient package insert (PPI)

*supplied by the manufacturer with the product and must be dispensed with the drug both on new prescriptions and refills

Question 22

T OR F:

failing to dispense a patient package insert is misbranding

Answer 22

TRUE

INCLUDES ALL WHO DISPENSE (pharmacists, institutions, practitioners in their office, LTC)

Question 23

Which drugs require patient package inserts?

Answer 23

estrogens

oral contraceptives

although other drugs may come with PPIs, if a manufacturer believes having one would benefit the patient

Question 24

________________ is FDA-approved labeling written in patient-friendly language that explains issues related to a specific drug or drug class

Answer 24

Medication guide

Question 25

T or F

Med guides MUST be provided on new AND refill prescriptions for patients who are outpatients and not under the direct supervision of a healthcare professional

Answer 25

True

*required for a long list of drugs, including NSAIDs, amphetamines, and some opioids

Question 26

Med guides are required when the “FDA determines that one or more of the following circumstances exists:

Answer 26

the drug product is one for which patient labeling could help prevent serious adverse effects; the drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product; or the drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.”

Question 27

____________ is a nonprofit organization that develops standards relating to different areas of practice relating to drug products.

Answer 27

USP

*some information from USP has the force of law, such as the drug monographs that establish the basic requirements for testing, labeling, and storage of drug products.

*more often USP chapters are considered standards for competent practice; so even tho they aren’t law, they can still cause issues.

Question 28

Not following the USP’s requirements for testing, labeling, and storage of drug products can leave the drug…

Answer 28

misbranded or adulterated.

<795> – nonsterile compounding, <797> – sterile compounding, and <800> – hazardous drugs.

Question 29

This chapter sets the standard for non-sterile compounding; the purpose of this chapter is to ensure products have appropriate potency and are without contamination preventing patient exposure to adverse events.

Answer 29

USP <795>

BUD dates to nonsterile products is in this chapter. which is most products in a retail pharmacy.

Question 30

This chapter sets the standards for sterile compounding; it describes many requirements for sterile compounding including personnel, training, facilities, environmental monitoring, and storage for testing of finished products.

Answer 30

USP <797>