General Pharmacy Laws and Rules Pt 4

Question 1

T/F: A prescriber must have an “X” DEA number to prescribe buprenorphine for opioid use disorder.

Answer 1

False - this was changed, anyone with a valid DEA number and training can prescribe it

Question 2

T/F: There is a limit on the number of patients a prescriber may treat with buprenorphine.

Answer 2

False - this limit was removed

Question 3

Who can a pharmacist sell syringes to?
Hint - 5 groups

Answer 3

1) A person authorized to administer injections in the regular course of the person’s profession/employment
2) A person using it for the purpose of self-administration of insulin or other prescribed drug
3) A person who is using them for legal research, clinical, educational, or medicinal purposes
4) A farmer for administration of a drug to an animal
5) A person who is using them for lawful professional, mechanical, trade, or craft purposes

Question 4

What is the definition of a poison?

Answer 4

A substance that is deleterious to adult life in quantities of 4 grams or less

Question 5

How old must you be to buy a poison?

Answer 5

16+ years old (or <16 years old with written permission)

Question 6

How long must records regarding poisons be maintained?

Answer 6

5 years

Question 7

What must be included in a poison record book?
Hint - 6 things

Answer 7

1) Name of purchaser
2) Address of purchaser
3) Poison
4) Quantity
5) Dispenser
6) PURPOSE

Question 8

What are the criteria for a pt to qualify for the use of controlled substances for weight loss?

Answer 8

BMI 30+ OR BMI 27-29 with an existing comorbid factor (DM, heart disease, etc.)

Question 9

What is the maximum days supply that a controlled weight loss drug can be prescribed for?

Answer 9

30 days

Question 10

How much time must pass between the end of one weight reduction program with a controlled substance and the start of a new one?

Answer 10

6 months

Question 11

T/F: PAs can prescribe short-term weight loss drugs.

Answer 11

False, but they can prescribe chronic therapy starting with the 4th visit (physician must see the pt 3 times before)

Question 12

T/F: NPs can prescribe controlled substances for weight loss.

Answer 12

True

Question 13

What schedule is Qsymia (phentermine / topiramate ER)?

Answer 13

CIV

Question 14

What is the duration of use for short-term controlled weight reduction medications (phentermine)?

Answer 14

12 weeks, but they can be prescribed longer as long as the patient maintains a 5% weight loss (new 2/28/23)

Question 15

What is the duration of use for Qsymia?

Answer 15

There is no duration limitation as long as the pt has met the weight loss goals in the FDA package insert

Question 16

For Qysmia, how often must the physician meet with the patient?

Answer 16

Initial visit = face to face
First 3 months of treatment = face to face visits at least every 30 days (can do once every 3 months after)

Question 17

For Qysmia, after the initial visit + 2 follow up visits, how many refills can the physician authorize for the prescription?

Answer 17

5 refills within a 6 month period

Question 18

T/F: A PA can prescribe Qsymia.

Answer 18

True, as long as it is on their formulary

Question 19

When must a physician discontinue a controlled substance for chronic weight loss management (for safety)?

Answer 19

1) Pt has repeatedly failed to comply with physician’s treatment recommendations
2) Pt is pregnant

Question 20

For short-term weight loss therapy, there cannot be more than a _________ interruption in therapy.

Answer 20

7 day

Question 21

Define non-retrievable

Answer 21

A condition, state, or process, that permanently alters a controlled substance’s physical or chemical condition irreversibly to prevent drug diversion

Question 22

How long must records of controlled substance destruction be kept for?

Answer 22

3 years

Question 23

What is a reverse distributor?

Answer 23

A DEA registered location/company who handles the disposal of controlled substances

Question 24

What is an authorized collector?

Answer 24

A registered manufacturer, distributor, reverse distributor, narcotic treatment program, hospital, clinic w/ a pharmacy, or retail pharmacy that is authorized by the DEA to receive controlled substances for the purpose of destruction

Question 25

T/F: All oral drugs can be disposed of in a drug collection receptacle.

Answer 25

False, CI and illegal substances cannot be disposed of in a receptacle

Question 26

When a new liner is placed in a drug collection receptacle, how many people must be present?

Answer 26

2 people (both must sign the records)

Question 27

T/F: Unused and used receptacle liners must be inventoried like controlled substances, regardless of if controlled substances are accepted in the receptacle.

Answer 27

True, per Ohio law they must be inventoried annually (Federal law, every 2 years) Just the liners are counted, not the contents of the liners

Question 28

Who is allowed to operate a drug take-back event?

Answer 28

Only law enforcement agencies

Question 29

How long can a removed receptacle liner be stored at a long term care facility?

Answer 29

Up to 3 business days

Question 30

How often must a prescriber assess a patient on weight loss medication?

Answer 30

At least once every 3 months (new 2/28/23)

Question 31

T/F: A patient can be switched to Qysmia after 12 weeks of phentermine therapy.

Answer 31

True, as long as there is no interruption in treatment

Question 32

When must a prescriber discontinue Qysmia (for efficacy)?

Answer 32

After 12 weeks at the 15/92 mg dosage, if the patient has not lost at least 5% of baseline body weight, the medication is required by FDA labeling to be discontinued. If the patient has lost at least 5% of baseline body weight, the medication may be continued.

Question 33

When transitioning from Qsymia to phentermine, when does the "12 week clock" start?

Answer 33

At the initiation of phentermine therapy

Question 34

How often is Qsymia titrated up?

Answer 34

Every 14 days to a max dose of 15/92 mg - it is recommended (but not required) that the prescriber sees the patient prior to each dose increase

Question 35

What 3 things are required for a Class I medical device?

Answer 35

1) Good manufacturing practices 2) Premarket safety review 3) Proper labeling and truthful advertising ex. ice bags, crutches, blood pressure kits, etc.

Question 36

What 4 things are required for a Class II medical device?

Answer 36

1) Good manufacturing practices 2) Premarket safety review 3) Proper labeling and truthful advertising 4) Performance standards ex. tampons, contact lens solution, heating pads, syringes, etc.

Question 37

What is required for a class III medical device?

Answer 37

1) Good manufacturing practices 2) Premarket safety review 3) Proper labeling and truthful advertising 4) Performance standards 5) Premarket approval - manufacturers must demonstrate safety and efficacy ex. IUDs, pacemakers, heart valves, artificial joints, etc.

Question 38

What must be listed on an OTC label? Hint - 8 things

Answer 38

1) Name of product 2) Name and address of manufacturer/repacker 3) Net contents of the package 4) Established name and amount of all active ingredients 5) Name of any habit-forming drugs in the preparation 6) Cautions and warnings 7) Adequate directions for safe and effective use 8) " ... side effects occur. You may report side effects to the FDA at 1-800-FDA-1088." IF ANY OF THESE ARE MISSING, THE OTC IS CONSIDERED MISBRANDED

Question 39

T/F: Tamper resistant prescription pads are required for all outpatient Medicaid prescriptions.

Answer 39

True - if the Rx does not comply, the pharmacist has 72 hours to receive confirmation the Rx is legitimate (policed by Ohio Medicaid, not the board)

Question 40

What is a class I drug recall?

Answer 40

Drug will cause either serious adverse effects or death

Question 41

What is a class II drug recall?

Answer 41

Drug may cause temporary or medically reversible adverse effects on health or where the probability of serious adverse events is remote

Question 42

What is a class III drug recall?

Answer 42

Exposure to the drug is not likely to cause adverse events

Question 43

T/F: An advanced NP can write prescriptions for a controlled substance under their collaborating physician's DEA number.

Answer 43

False, the ANP must have their own DEA number to prescribe controlled substances (number starts with M)

Question 44

T/F: An ANP must have a collaborating physician.

Answer 44

True

Question 45

T/F: A PA can write prescriptions for a controlled substance under their collaborating physician's DEA number.

Answer 45

False, they need their own DEA number

Question 46

How much pseudoephedrine can be purchased per day?

Answer 46

3.6 grams

Question 47

How much pseudoephedrine can be purchased per month?

Answer 47

9 grams

Question 48

What drug is the S.T.E.P.S program used for?

Answer 48

Thalidomide

Question 49

What drug is the iPLEDGE program used for?

Answer 49

Isotretinoin

Question 50

What is the maximum days supply of isotretinoin that can be dispensed at a time?

Answer 50

30 days

Question 51

What is the maximum days supply of thalidomide that can be dispensed at a time?

Answer 51

28 days

Question 52

How many refills can a thalidomide prescription have?

Answer 52

Zero