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Ohio Law Time > General Pharmacy Laws and Rules Pt 4 > Flashcards

General Pharmacy Laws and Rules Pt 4 Flashcards

Pages 130-136

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1
Q

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

A

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

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2
Q

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

A

False - this limit was removed

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3
Q

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

A

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

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4
Q

What is the definition of a poison?

A

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

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5
Q

How old must you be to buy a poison?

A

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

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6
Q

How long must records regarding poisons be maintained?

A

5 years

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7
Q

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

A

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

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8
Q

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

A

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

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9
Q

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

A

30 days

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10
Q

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

A

6 months

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11
Q

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

A

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

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12
Q

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

A

True

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13
Q

What schedule is Qsymia (phentermine / topiramate ER)?

A

CIV

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14
Q

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

A

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

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15
Q

What is the duration of use for Qsymia?

A

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

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16
Q

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

A

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)

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17
Q

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

A

5 refills within a 6 month period

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18
Q

T/F: A PA can prescribe Qsymia.

A

True, as long as it is on their formulary

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19
Q

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

A

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

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20
Q

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

A

7 day

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21
Q

Define non-retrievable

A

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

22
Q

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

A

3 years

23
Q

What is a reverse distributor?

A

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

24
Q

What is an authorized collector?

A

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

25
Q

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

A

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

26
Q

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

A

2 people (both must sign the records)

27
Q

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

A

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

28
Q

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

A

Only law enforcement agencies

29
Q

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

A

Up to 3 business days

30
Q

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

A

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

31
Q

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

A

True, as long as there is no interruption in treatment

32
Q

When must a prescriber discontinue Qysmia (for efficacy)?

A

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.

33
Q

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

A

At the initiation of phentermine therapy

34
Q

How often is Qsymia titrated up?

A

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

35
Q

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

A

1) Good manufacturing practices
2) Premarket safety review
3) Proper labeling and truthful advertising

ex. ice bags, crutches, blood pressure kits, etc.

36
Q

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

A

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.

37
Q

What is required for a class III medical device?

A

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.

38
Q

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

A

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

39
Q

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

A

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)

40
Q

What is a class I drug recall?

A

Drug will cause either serious adverse effects or death

41
Q

What is a class II drug recall?

A

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

42
Q

What is a class III drug recall?

A

Exposure to the drug is not likely to cause adverse events

43
Q

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

A

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

44
Q

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

A

True

45
Q

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

A

False, they need their own DEA number

46
Q

How much pseudoephedrine can be purchased per day?

A

3.6 grams

47
Q

How much pseudoephedrine can be purchased per month?

A

9 grams

48
Q

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

A

Thalidomide

49
Q

What drug is the iPLEDGE program used for?

A

Isotretinoin

50
Q

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

A

30 days

51
Q

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

A

28 days

52
Q

How many refills can a thalidomide prescription have?

A

Zero

Ohio Law Time (8 decks)

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