Pages 91-end DS book Flashcards
What one place can a technician work where they are not required to obtain registration?
Federal facility
When do registered pharmacy technician registrations expire? Even or odd years?
March 31st, even years
When do certified technician licenses expire? Even or odd years?
September 30th, even years
How long is a technician trainee license good for?
Valid for one year
How many CE hours do registered techs need to do?
Ten hours total, 2 in law and 2 in med safety
What 5 things can a certified tech do that a trainee/registered tech cannot?
1.) Accept new verbal Rx’s for non-controlled drugs
2.) Accept verbal refill authorizations as long as no change to OG script
3.) Send/receive transfers for non-controlled drugs
4.) Contact prescriber/agent for clarification as long as no professional judgement nec.
5.) Perform diagnostic lab testing
What two things can a pharmacy technician trainee not do that a registered tech can?
1.) Stock automated drug dispensing cabinets, crash carts, floor stock
2.) Request refill authorizations with no change from OG script
If a pharmacist/intern license is revoked, suspended or refused how soon shall they return their ID card/license to the Board?
Within 10 days
At what age can retailers sell dextromethorphan products to customers?
18 or older
What 3 criteria must be met that prohibits pharmacists from dispensing certain non-self injectable cancer drugs directly to a patient?
1.) Drug is indicated for treatment of cancer or cancer related illness
2.) Must be administered IV or subQ
3.) Cannot reasonably be self-administered by patient or caregiver
4 requirements associated with a request to BOP for off-site record keeping
1.) Terminal distributor number of the pharmacy
2.) License # of the requestor
3.) Name and address of the alternative location
4.) The time frame of the records to be moved off-site
Which 2 situations is it reasonable to dispense naloxone without a prescription?
1.) To an individual who there is reason to believe is experiencing or at risk of experiencing an overdose
2.) A family member, friend, or other person in a position to assist an individual who they believe is at risk of experiencing an overdose
There must be a physician approved protocol in place for dispensing naloxone without a prescription. What 6 items must this protocol include?
1.) Description of clinical pharmacology of naloxone
2.) Indications for use of naloxone as rescue therapy, including eligible candidates
3.) Precautions and CIs concerning dispensing naloxone
4.) Assessment/follow-up actions by the pharmacist or intern
5.) Naloxone products authorized to be dispensed including name of product, dose, route of admin, required delivery device and directions for use
6.) Any patient instructions in addition to counseling requirements
What counseling is required when dispensing naloxone without a prescription? (8 items)
1.) Risk factors for overdose
2.) Strategies to prevent overdose
3.) Signs of overdose
4.) Steps in responding to overdose
5.) Info on naloxone
6.) Procedures for administering naloxone
7.) Proper storage and exp. of naloxone product dispensed
8.) Info on where to obtain referral for substance abuse treatment
When dispensing naloxone occasionally to state/local law enforcement agencies, does the pharmacy making the occasional sales have to count these towards the 5% rule?
No, does not apply to these types of sales
What are the 5 types of injections that pharmacists can administer to patients as long as a physician approved protocol is in place?
1.) LAI opioid antagonist used for treatment of drug addiction/alcohol dependence (could be initial or subsequent doses)
2.) LAI antipsychotic drug
3.) Hydroxyprogesterone caproate for PREGNANT women
4.) Medroxyprogesterone acetate for NON-PREGNANT women
5.) Vit B12 injections
Must renew protocol every 2 years FYI
T/F: The pharmacist that administered a non-immunization injection to a patient has 5 days to notify the physician
False, 7 days
Record keeping required for all injections given by pharmacist (11 items). How long must these be kept?
1.) Full name/address of pt
2.) DOB or age
3.) Gender
4.) Allergies
5.) Date of admin.
6.) Name, strength, and dose of drug admin.
7.) Lot # and exp. date of drug
8.) Route
9.) location of injection site
10.) Positive ID of pharmacist administering drug
11.) ID of person who provided permission to administer the drug
Records must be kept for 3 years
How much time of live or home study coursework must be completed to administer one of the five injections a pharmacist could hypothetically give?
1.5 hours of live or home study (7.5 hrs for all 5) with 30 minutes including review of sterile technique in injectable dosage preparation and administration
MTM main objectives (5 things)
1.) Enhance appropriate medication use
2.) Improve medication adherence
3.) Increase detection of adverse drug events
4.) Improving collaboration between prescriber and pharmacist
5.) Improving outcomes
How soon must suspicious wholesaler orders be submitted to the BOP electronically?
Within 5 days of the order being identified as suspicious
If there are no suspicious orders found during a month of review, when does a zero report have to be filed by?
The 15th of the next month
When dispensing naltrexone without a prescription how soon must you notify the prescriber and is there a limit to the number of times a pharmacist can dispense it without a prescription?
Within 5 days of dispensing; Unlimited amount (up to RPH discretion)
How long must records of naltrexone dispenses be kept?
At least one year
T/F: Naltrexone when dispensed without a prescription must be reported to OARRS
True; Write new prescription document for each dispense and assign a number as well
Define an “elder adult”
60 years or older and handicapped by age-related conditions or mental impairments
When starting to use an automated pharmacy system, how long must a pharmacist verify the accuracy of all drugs dispensed by the system for and what must the accuracy be?
A continuous 45-day period; Accuracy must be 99.985%
What % of all dispensed Rx’s need reviewed by a quality assurance program to make sure the automated dispensing system is working appropriately?
5%
What is the license called when an outpatient remote pharmacy does no dispensing, but enters orders, etc.?
Limited Category II terminal distributor; No dispensing, but sole purpose is to enter, review, and/or verify prescriptions
What two smoking cessation medications do not fall under the dispensing nicotine replacement therapy by pharmacists without a prescription law?
Zyban and Chantix
What 6 requirements must be in a physician-signed protocol in order to dispense NRT without a prescription?
1.) Treatment guidelines and location where this will occur
2.) Types of NRT to be dispensed
3.) Screening procedure to determine if patient is good candidate
4.) Provision for pharmacists to refer high-risk individuals or individuals with complications to a PCP
5.) Requirement that pharmacists must provide a follow-up care plan
6.) Proper documentation of all care
How soon after identifying a potential NRT candidate should the RPH notify the PCP?
Within 72 hours
What is the max days supply a pharmacist can dispense of an opioid analgesic?
90 days; NOTE: does not stop prescriber from writing for >90 days, falls on pharmacist to ensure this is followed
T/F: Opioid analgesics that are CIII-CV must follow the within 14 days of date written law to be refilled
False, does not apply to refills of these medications
How long does a pharmacy have to fill a “do not fill until ____” prescription?
Up to 14 days from the do not fill until date written
In regards to partial filling of C-II prescriptions, as long as an initial fill was dispensed within 14 days of written, how long does the patient have to pick up the remaining amount of the script?
Within 30 days of the date the RX was issued NOT when the first fill was
T/F: The issue date of a prescription for an opioid can be adjusted after pharmacist/prescriber consultation
True
Days supply limit for opioids in acute pain situations; adults then minors
7 days for adults
5 days for minors with parent consent
What is the average daily MME that cannot be exceeded for acute pain opioid prescriptions?
No more than 30 MME/MED per day
T/F: Medicare Part D/Advantage Plan patients must get their controlled substance prescriptions sent electronically.
True as of 1/1/23
How soon does a pharmacy have to fulfill a C-ii prescription they did not have enough in stock for?
72 hours
What are the three things that a pharmacist cannot change or clarify on a C-ii script?
1.) Patient name
2.) Prescriber signature
3.) Drug prescribed
If a patient brought in a script for Adderall 10mg BID written on 3/12/23 and they came in 8/12/23 to fill it would you be able to do so? Why or why not?
Yes, non-opioid C-II scripts have same rules on 1st fill timing as non-controlled substances, so patient has 6 months from written date.
If a pharmacist takes an emergency verbal C-II order, how long does the prescriber have to send in a written prescription?
Within 7 days; Written script has to be attached to the oral script that was transcribed on the phone call with the prescriber by the RPH (This can be sent electronically as well and must be marked by RPH for “Emergency Dispensing”)
How long can a prescriber indicate a “Do not fill until” for C-II scripts?
Up to 90 days
T/F: Controlled substances are eligible for simultaneous refills
False, only non-controlled maintenance medication can be filled this way.
Ex: Ativan 1mg #30 QHS x 5 RF
Pt would need to do #30 at a time
Ativan 1mg #90 QHS x 1 RF
Pt could do #90 at a time and would only be allowed 1 RF of 90
What ways can a prescriber write a non-opioid C-II for 90 day supply?
1.) Script with full 90 days supply quantity on it (Ex: Adderall 10mg #90)
2.) 3 separate scripts where 1 is filled now and the others have markings indicating to fill later, but cannot exceed 90 days from written date (6/22/23, DNF 7/20/23, DNF 8/18/23)
T/F: A prescriber can write a prescription for Oxycodone 5mg #100 with directions of “for office use” since he gives each patient one before a procedure
False, must fill out DEA 222 form and be invoiced by the pharmacy just like a wholesaler would. 5% rule applies
You accidentally write #1000 rather than #100 of Percocet 5-325 on the DEA 222 form. You erase the extra 0 and complete the rest of the form. Was that legal?
No, cannot erase/scribble out any information on DEA 222. Must void form and restart
How long does the wholesaler have to fulfill a C-II order off of a DEA 222 form? If this time period passes, what is the next step?
Up to 60 days to fulfill; If not fulfilled within 60 days, must write new form
Are LTC nurses considered “agents of the prescriber”?
Yes, they can fax prescriptions/call-in oral scripts for C-III to C-V drugs on behalf of the prescriber (DOES NOT APPLY TO ASSISTED LIVING)
If a patient has been given a prescription for a codeine cough syrup on 6/22/23, can they buy it OTC on 10/1/23?
No, cannot sell it OTC if a script was filled in the last 6 months
How much codeine (in mg) can a patient pick up in a 48hr period?
Up to 250mg or 125m
How often can a patient pick up OTC C-V’s?
One preparation every 48 hours
What documentation is required for dispensing OTC C-V’s? (7 things)
1.) Date of transaction
2.) Name of patient
3.) Address of patient
4.) Drug name
5.) Strength
6.) Quantity
7.) Pharmacist who dispensed it
How old does a patient need to be in order to buy C-V OTC?
18 y/o or older
In what 7 products is ephedrine NOT considered a C-V?
1.) Any pseudoephedrine containing product
2.) Breathe Easy Herb Tea
3.) Bronkaid Dual action caplets
4.) Hydrosal Hemorrhoidal Ointment
5.) Primatene Dual Action Formula tablets
6.) Primatene tablets
7.) SnoreStop tablets
How often must a pharmacy in Ohio complete a controlled substance inventory?
Within 13 months of the previous inventory
What must the controlled substance inventory include? (7 requirements)
1.) Inventory date
2.) Time of day it was taken (open or close)
3.) Drug name
4.) Drug strength
5.) Drug dosage form (tab, cap, etc.)
6.) Number of units or volume
7.) Total quantity
FYI: SHOULD also include signature of person who did it and name, address, DEA # of the registrant BUT not required to do these two things per the DEA
If a pharmacy sends a request to the DEA to store records off-site and does not hear from them in 60 days can they proceed with this plan or have to terminate the plan?
Can proceed; IF you do not hear within 60 days you can assume the request was approved (S T U P I D)
If gabapentin became a controlled substance in Ohio on 7/30/23, when would a pharmacy need to do an exact count of their inventory?
On 7/30/23
If Tramadol went from a C-IV to a C-II on 8/10/23, when would a pharmacy need to do an inventory/exact count of their current stock of tramadol?
On 8/10/23
What are the only two situations in which a pharmacist could partial fill C-II’s for up to 60 days vs. 30 for the normal population?
1.) Terminally ill (hospice)
2.) Long-term care facility or nursing home patients
For patients that are NOT terminally ill/in a LTC facility, what are the requirements that must be met in order to partially fill a C-II prescription? (4)
1.) Must be requested by patient OR prescriber
2.) Total quantity dispensed cannot exceed total quantity prescribed
3.) Remaining portion MUST be dispensed within 30 days of written date
4.) Documentation on back of script or in computer (Date, quantity dispensed, remaining quantity, “new” prescription # of each partial dispense if different from OG prescription #, and written initials of dispensing RPH
Do prescribers still need an X in their DEA # to dispense buprenorphine?
No
What is the limit of patients a prescriber can dispense buprenorphine on?
There is no longer a limit
What is the definition of a poison?
An item that is able to cause harm or damage to adult life in quantities of 4g or less (Does NOT apply to items with “external use only” on them)
What must be in the poison record book? (6 items)
1.) Name of purchaser
2.) Address of purchaser
3.) Poison name
4.) Quantity
5.) RPH who dispensed the poison
6.) Use for the poison
What is the cutoff for BMI when using controlled substance weight-loss drugs?
Anything above BMI of 30 OR 27 with comorbidities (DM, HF, ASCVD, etc.)
What is the max treatment length at a time for controlled substance weight loss drugs?
12 weeks; Must wait 6 months before restarting 12 week program
When is a PA allowed to prescribe controlled substances for weight loss?
Must be after the 3rd visit with the physician, then PA can start seeing patient and prescribe
How long can a patient use Qsymia?
Indefinitely as long as patient met weight loss goals described in package insert; Must meet with physician initially and monthly x 2 additional months before standard C-IV refill process can be initiated (30 DS x 5 RF)
Can a PA provide treatment with Qsymia?
Yes as long as it is on their formulary and the physician reviews the medical records of each patient following the visit
What is the maximum amount of time there can be a break in therapy for the short-term weight loss meds 12 week program?
7 days
Is Contrave a controlled substance weight loss med?
No, so the 12 week rule, etc. does not apply to this or Saxenda/Wegovy
What schedule II med can currently be used for binge-eating disorder?
Vyvanse
What is considered the appropriate means of destruction?
Reverse distributors NOT flushing down the sink, toilet, etc.
How long must records be kept of destruction of controlled substances?
3 years
What is required of a reverse distributor to send to you when transferring schedule II’s?
A DEA 222 form or electronic equivalent
When using a reverse distributor for controlled substances, who is required to fill out the DEA form 41?
The reverse distributor is responsible only
Who is the only entity that can offer a drug-takeback day?
Law enforcement agency
If using a collection receptacle for dangerous drugs, what inventory requirements must be followed? (4 things)
1.) Must be done every 13 months
2.) Record date of inventory of unused liners/liners that are in storage
3.) Number and size of the liners
4.) ID number of EACH liner
How long can collection receptacle liners that are removed from their respective container be stored in an LTC facility?
only 3 business days upon removal for LTC facility
What is considered an institutional facility?
Medical care provided on-site and a medical record that documents episodes of care including medications order/administered
What 5 things require positive ID in an inpatient facility?
1.) Dispensing
2.) Compounding
3.) Repackaging
4.) Removal and possession of a controlled substance to administer to a patient
5.) Wasting of a controlled substance
What 5 things need to be documented/established within an institutional facility regarding accessing the pharmacy when it is closed?
1.) Written policy/procedure
2.) Who has access/what circumstances allow them entry
3.) Written record: Names, time, date, what was taken, patient name and doctor name
4.) Filed within 24 hours and kept for 3 years
5.) Two employees where one is either prescriber or nurse
What must all inpatient orders have to be valid? (7 things)
1.) Name of patient
2.) Name, strength, dosage form of drug
3.) Directions for use
4.) Route of admin
5.) Date
6.) Prescriber’s positive ID
7.) Positive ID of person transmitting order on behalf of prescriber
What must compounded/repackaged items contain for recordkeeping? (8 things)
1.) Drug, strength, and dosage form
2.) NDC or bar code
3.) Manufacturer lot #
4.) Generic manufacturer (if needed)
5.) Pharmacy control #
6.) Manufacturer exp. date
7.) Positive ID of RPH
8.) Pharmacy exp. date/BUD
How often should training/assessment of staff be done for sterile compounding of low/medium risk compounds? High risk?
Every 6 months for low/medium; every 4 months for high
Can there be pre-printed C-II’s on a script for hospice patients?
No, prescriber can write them manually to a preprinted form, however. C-III to C-V can be preprinted on there along with non-controls
T/F: A product having an NDC means it has been approved by the FDA
False
How long must transaction history/information from either a wholesaler or manufacturer be maintained on file for after being given to pharmacies?
6 years
What drug and dosage form does the poison prevention act not require childproof caps for?
Nitroglycerin and any externally applied drugs
Standards for Class I devices (3 things)
1.) Good manufacturing practices
2.) Premarketing review; safety
3.) Proper labeling truthful advertising
Ex: Ice pack, BP cuff, crutches
Standards for Class II medical devices (2 things)
1.) Same 3 as class I devices
2.) Performance standards (have to work well)
Ex: Heating pad, condoms, syringes, etc.
Standards for Class III medical devices (3 things)
1.) Same 4 as Class II devices
2.) Premarketing approval required
3.) Manufacturers must demonstrate safety & effectiveness (Clinical trial)
Ex: IUD, heart valve, etc.
Who are the 3 groups of people that hospitals can sell to from its inpatient inventory?
1.) ER patients
2.) Patients being discharged from hospital (1st fill only)
3.) Staff at the hospital
If a drug leaves the US can it be returned into the US?
No, cannot be re-imported
What are the 6 regulation for samples via the Prescription Drug Marketing Act?
1.) RPH cannot possess Rx samples
2.) MD’s must request samples in writing
3.) Sales reps must store samples under proper conditions
4.) Sales rep must keep samples locked up
5.) Sales reps must keep records for 3 years
6.) Must do annual inventory of samples
What are the 8 labeling requirements for OTC drugs?
1.) Name of product
2.) Name and address of manufacturer or repackager
3.) Net contents of the package
4.) Established name and amount of all active ingredients
5.) Name of any habit-forming drug contained in preparation
6.) Cautions and warnings needed for protection of the user
7.) Adequate directions for safe and effective use
8.) Toll-free # to report complaints to manufacturer or distributor (1-800-FDA-1088)
If anything in this is missing it is considered to be misbranded and now a prescription drug
What 3 security features must be met for all outpatient Medicaid prescriptions?
1.) One or more industry recognized features designed to prevent unauthorized copying of completed/blank prescription forms
(Ex: High security watermark on reverse side of blank, thermochromic ink)
2.) One or more industry recognized features to prevent the erasure or modification of info written on prescription by prescriber
(Ex: Tamper-resistant background ink that shows erasures or attempts to change written info)
3.) One or more industry recognized features to prevent the use of counterfeit prescription forms (Ex: Sequentially numbered blanks, Duplicate/triplicate blanks)
If an outpatient Medicaid prescription does not comply with the 3 required security features, how long does the pharmacist have to confirm the prescription’s authenticity?
72 hours to receive verbal, faxed, or electronic confirmation of authenticity (If not authenticated, then the prescription will not be reimbursed by Medicaid)
List the drug recalls in order of least serious to most serious
(not likely to cause ADE) Class III –> (temporary ADEs possible) Class II –> Class I (serious ADEs)
T/F: Advanced Practice Nurses (APNs) have the right to prescribe since they are APNs
False, must have certificate to prescribe as well which is an additional license issued
What additional writing must APNs list on each prescription written after their license # per the Board of Nursing?
the letters “Rx”
T/F: APNs can use their collaborating physician’s DEA # to write controlled substance prescriptions
False, must have their own DEA # and use that
What must an APN’s DEA # begin with?
M for mid-level practitioner
If a supervising physician for a PA sees patients at two different offices, but has a third office that he does not see patients at is a PA allowed to see his patients at the third office?
No, supervising physician has to actively see patients at that location at some point. Does not have to be present in the office at the same time the PA is seeing patients, however.
What two letters are at the end of a PA’s license #?
“RX”; Actually in their license # not just required to write it like APNs
What 6 classes of drugs can optometrists prescribe since they relate to the visual system of the body?
1.) Anti-infectives
2.) Anti-allergy drugs
3.) Anti-glaucoma agents
4.) Analgesics that are NOT controls
5.) Epinephrine for emergency situations
6.) Anti-inflammatory drugs, excluding all oral steroids except methylprednisolone
What 4 conditions must be met in order for an optometrist to be able to prescribe methylprednisolone for a patient?
1.) Patient is 18 y/o
2.) Used to treat an allergy
3.) Being prescribed on basis of an individual’s particular episode of illness
4.) Amount does not exceed the amount packaged for a single course of therapy
What two active ingredients of controlled substances would an optometrist be able to prescribe?
Any controls with Hydrocodone or Codeine only
Max amount of codeine per dosage unit or hydrocodone per dosage unit an optometrist can legally prescribe
60mg codeine per unit
7.5mg hydrocodone per unit
Max days supply of controlled substances for an FDA-approved pain indication when prescribed by an optometrist
4 day supply limit (pain more than this amount of time should be managed by physician)
T/F: Only pharmacies can sell pseudoephedrine products
False, just have to follow same rules (Behind counter, locked case accessible only by staff, etc)
What 7 items must be kept in an electronic log of pseudoephedrine sales?
1.) Date
2.) Time
3.) Drug (Could be combo product)
4.) Quantity
5.) Purchaser signature
6.) Printed name
7.) Address
Do the OTC pseudoephedrine laws apply to prescriptions for pseudoephedrine?
No, Rx does not require same regulations as OTC
