General Pharmacy Laws and Rules Pt 4 Flashcards
Pages 130-136
T/F: A prescriber must have an “X” DEA number to prescribe buprenorphine for opioid use disorder.
False - this was changed, anyone with a valid DEA number and training can prescribe it
T/F: There is a limit on the number of patients a prescriber may treat with buprenorphine.
False - this limit was removed
Who can a pharmacist sell syringes to?
Hint - 5 groups
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
What is the definition of a poison?
A substance that is deleterious to adult life in quantities of 4 grams or less
How old must you be to buy a poison?
16+ years old (or <16 years old with written permission)
How long must records regarding poisons be maintained?
5 years
What must be included in a poison record book?
Hint - 6 things
1) Name of purchaser
2) Address of purchaser
3) Poison
4) Quantity
5) Dispenser
6) PURPOSE
What are the criteria for a pt to qualify for the use of controlled substances for weight loss?
BMI 30+ OR BMI 27-29 with an existing comorbid factor (DM, heart disease, etc.)
What is the maximum days supply that a controlled weight loss drug can be prescribed for?
30 days
How much time must pass between the end of one weight reduction program with a controlled substance and the start of a new one?
6 months
T/F: PAs can prescribe short-term weight loss drugs.
False, but they can prescribe chronic therapy starting with the 4th visit (physician must see the pt 3 times before)
T/F: NPs can prescribe controlled substances for weight loss.
True
What schedule is Qsymia (phentermine / topiramate ER)?
CIV
What is the duration of use for short-term controlled weight reduction medications (phentermine)?
12 weeks, but they can be prescribed longer as long as the patient maintains a 5% weight loss (new 2/28/23)
What is the duration of use for Qsymia?
There is no duration limitation as long as the pt has met the weight loss goals in the FDA package insert
For Qysmia, how often must the physician meet with the patient?
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)
For Qysmia, after the initial visit + 2 follow up visits, how many refills can the physician authorize for the prescription?
5 refills within a 6 month period
T/F: A PA can prescribe Qsymia.
True, as long as it is on their formulary
When must a physician discontinue a controlled substance for chronic weight loss management (for safety)?
1) Pt has repeatedly failed to comply with physician’s treatment recommendations
2) Pt is pregnant
For short-term weight loss therapy, there cannot be more than a _________ interruption in therapy.
7 day
Define non-retrievable
A condition, state, or process, that permanently alters a controlled substance’s physical or chemical condition irreversibly to prevent drug diversion
How long must records of controlled substance destruction be kept for?
3 years
What is a reverse distributor?
A DEA registered location/company who handles the disposal of controlled substances
What is an authorized collector?
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
T/F: All oral drugs can be disposed of in a drug collection receptacle.
False, CI and illegal substances cannot be disposed of in a receptacle
When a new liner is placed in a drug collection receptacle, how many people must be present?
2 people (both must sign the records)
T/F: Unused and used receptacle liners must be inventoried like controlled substances, regardless of if controlled substances are accepted in the receptacle.
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
Who is allowed to operate a drug take-back event?
Only law enforcement agencies
How long can a removed receptacle liner be stored at a long term care facility?
Up to 3 business days
How often must a prescriber assess a patient on weight loss medication?
At least once every 3 months (new 2/28/23)
T/F: A patient can be switched to Qysmia after 12 weeks of phentermine therapy.
True, as long as there is no interruption in treatment
When must a prescriber discontinue Qysmia (for efficacy)?
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.
When transitioning from Qsymia to phentermine, when does the “12 week clock” start?
At the initiation of phentermine therapy
How often is Qsymia titrated up?
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
What 3 things are required for a Class I medical device?
1) Good manufacturing practices
2) Premarket safety review
3) Proper labeling and truthful advertising
ex. ice bags, crutches, blood pressure kits, etc.
What 4 things are required for a Class II medical device?
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.
What is required for a class III medical device?
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.
What must be listed on an OTC label?
Hint - 8 things
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
T/F: Tamper resistant prescription pads are required for all outpatient Medicaid prescriptions.
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)
What is a class I drug recall?
Drug will cause either serious adverse effects or death
What is a class II drug recall?
Drug may cause temporary or medically reversible adverse effects on health or where the probability of serious adverse events is remote
What is a class III drug recall?
Exposure to the drug is not likely to cause adverse events
T/F: An advanced NP can write prescriptions for a controlled substance under their collaborating physician’s DEA number.
False, the ANP must have their own DEA number to prescribe controlled substances (number starts with M)
T/F: An ANP must have a collaborating physician.
True
T/F: A PA can write prescriptions for a controlled substance under their collaborating physician’s DEA number.
False, they need their own DEA number
How much pseudoephedrine can be purchased per day?
3.6 grams
How much pseudoephedrine can be purchased per month?
9 grams
What drug is the S.T.E.P.S program used for?
Thalidomide
What drug is the iPLEDGE program used for?
Isotretinoin
What is the maximum days supply of isotretinoin that can be dispensed at a time?
30 days
What is the maximum days supply of thalidomide that can be dispensed at a time?
28 days
How many refills can a thalidomide prescription have?
Zero
