Brinkley review Flashcards
recall classifications
Class I – worst, reasonable likelihood of serious AEs
Class II – temporary or reversible AEs
Class III – least concerning, not likely to cause AEs
patient package inserts (PPIs)
- required for estrogen- and progestin-containing products
- must be given to inpatient at first administration and q30 days thereafter
Med guides
- required for many different products that FDA deems necessart
- no requirement for inpatient distribution
major exclusions from Poison Prevention Packaging Act
- bulk containers not intended for household use
- drugs for institutionalized patients
- several products intended for emergency/rapid use
- several products commonly dispensed in unit dose forms
A medication regimen review must be performed for LTC patients every _______
-every 30 days
This is a CMS requirement
mailing prescriptions by USPS
- allowed provided contents are not alcoholic beverages, poisonous, or flammable
- controlled drug outer packaging cannot contain any words/symbols indicating its contents
- UPS and FedEx can deliver any Rx drugs and are not subject to above restrictions
For what purposes can a pharmacy use/disclose PHI without authorization from the patient?
- for treatment
- for payment
- for healthcare operations
- gov’t functions: LEOs, PMPs, adverse event reporting
How long do pharmacies have to respond to patient requests for their own PHI?
-within 30 days, but can request an extension for another 30 days
How long do pharmacies have to respond to patient requests to amend their PHI or obtain record of disclosures?
within 60 days, but can request extension for another 30 days
Notification requirements when there is a breach of patients’ PHI
- notify patient within 60 days of discovery
- for breaches < 500 individuals, maintain log and reports to HHS annually
- for breaches > 500, notify HHS and local media within 60 days
DEA form for applying for a DEA number
Form 224 (for prescribers and dispensers)
Can federal/military prescribers write CII’s in Texas?
- only if on official TSBP prescription pad, which requires DEA registration in Texas
- otherwise can be filled only at federal facility/base
A new owner can use the previous owner’s DEA for up to how long after the purchase?
- up to 45 days
- previous owner must grant POA to purchaser
What’s the highest concentration a pharmacy can compound narcotics?
- up to 20%
- any more and the pharmacy would need to be registered with DEA as a manufacturer
scheduling concentrations of codeine
- CIII 18 mg/ml
- CV 2 mg/mL or 90 mg per dosage unit
scheduling concentrations of opium
- CIII 5 mg/ml
- CV 0.5mg/mL (less than that of federal limit)
where do triplicate forms of 222 go?
- Purchaser keeps copy 3, sends copies 1 and 2 to supplier
- supplier keeps copy 1, sends copy 2 to DEA
If a C-II order cannot be completed in its entirety, the supplier has ____ days to do so
60 days
What items must the C-II purchaser record on their copy of the 222 form after receiving the shipment?
- number of containers received
- date received
Invoices for controlled substances must be initialed/dated by that pharmacist, except in what cases?
Class C-ASC and Class F pharmacies
5% rule
- a pharmacy can distribute of up to 5% of the total controlled substances dispensed during a 12-month period
- any more requires registering with DEA as a distributor
storage of controlled substances
- can be in a secure locked cabinet or unsecured scattered throughout – but not together on an unsecured shelf
- C-II’s must be securely locked in Class C and Class F pharmacies
how long to report CS theft or significant loss
- 1 business day
- can take time to investigate before submitting form 106, but keep DEA updated, esp. if taking longer than 2 mos
form for theft/loss of controlled substances
DEA form 106
“Federal law prohibits transfer of this drug to any person other than…” is required for which drugs
CII through CIV only, although post pharmacy systems will include this on CV as well
form for disposal and destruction of controlled substances
DEA form 41
-must be submitted at least 2 weeks prior to proposed destruction date
how many must witness destruction of controlled substances
at least 2 witnesses
how often does DEA require an inventory of CSs
every 2 years (biennial)
how often does TSBP require inventory of CSs
annually
exact vs estimated count during inventory
- exact for all CII’s
- exact for all containers holding > 1000 tablets
- estimates allowed for the rest
when is a perpetual inventory required?
- CII’s in class C pharmacies
- all controls at remote locations
- all controls at class C-ASCs
- all controls at class F
which CS inventories do NOT require notarization
initial and change of PIC
how long after conducting CS inventory must the inventory be notarized?
within 3 days, excluding Sat/Sun and federal holidays
how must CS hard copies be stored?
TSBP mandates three separate files: non-controls, C-III through C-V, and C-II
what controlled substance records cannot be kept centrally, but must stay on site at the pharmacy?
- inventories
- executed 222s
- hard copy scripts
how can a pharmacy request central record keeping of records related to CSs?
- notify nearest DEA field office of intention
- if DEA does not deny request, it is ok to start central storage 14 days after giving notifcation
what prescriptions can a Designated Agents communicate for a prescriber
- CIII through CV and noncontrols
- cannot authorize emergency fills of C-IIs…only the prescriber themself can do this
T/F: quantity must be written numerically for all controlled rx’s
True – only exception is for e-Rx. If the quantity is not spelled out, the pharmacist should call prescriber to verify qty
what elements CANNOT be changed on a C-II rx?
- name of patient
- name of drug
- name of prescriber
- date of rx
what are quantity limits for C-IIs?
- no quantity limit for a CII rx
- when a prescriber issues multiple CII rx’s at once, they are collectively not to exceed a 90 DS
when can a faxed C-II serve as the original rx?
- CII narcotics for patients using home infusion/IV pain tx
- CII’s for patients in LTCFs
- CII narcotics for patients in hospice care
T/F: faxed CII’s can be valid emergency CII’s
True, but the same rules apply for receiving a valid rx in a timely manner. ie the fax is NOT the original rx
what is the quantity limit for emergency CII fills?
No specific quantity limit. Amount must be limited to the qty necessary to treat patient during the emergency period
how long does the prescriber have to send in a valid rx following a CII emergency fill?
- must be sent within 7 days of authorizing emergency fill
- rx should be marked “authorization for emergency dispensing”
partial filling of CII’s
- per 2016 federal law, can be partial filled for up to 30 days BUT the stricter TX law of completion within 72 hrs still stands
- terminal and LTCF patients can get partials as many times as needed as long as they are completed within 60 days
CII dispensing upon discharge from hospital
- discharged pts can receive up to a 7 day supply without having to get it on an official TX CII rx
- must be dispensed from hospital pharmacy
transferring controlled rx’s
- can be done only once per rx
- only refills can be txr’d, meaning you cannot transfer on hold prescriptions
what schedules does the PMP collect/report rx data for?
CII through CV
how long does the pharmacy have to transmit data to PMP?
-no later than the next business day after the date the rx was completely filled
restrictions on methadone
- can only be dispensed at retail level for analgesia (not detoxification)
- methadone 40mg cannot be purchased by retail pharmacies, only by hospitals and detox centers
short vs long term detox
- short term means weaning over no more than 30 days
- long term means weaning over 30 to 180 days
patients not enrolled in a drug detox program can receive narcotics for detox/maintenance under what circumstances?
- a physician can administer (not prescribe) up to 3 day supply until individual is enrolled in detox
- hospital can administer narcs if pt is in hospital for a condition other than their addiciton
DATA-waived practitioner
- prescribers authorized to prescribe certain CIII-V narcotics for detox purposes – mainly subutex and suboxone
- have “X” code along with DEA
how many patients can a DATA-waived prescriber treat
- physicians can treat 30, 100, or 275 patients depending on their authorization
- midlevels are limited to 30 pts
PSE limits
- 9 grams per month, 3.6 grams/day
- if mail order, 7.5 grams/month
minimum age to purchase PSE products
16 yrs, shown my state or federal photo ID
restrictions on auto-refills for CSs
- not allowed for CIII
- ok for CIV and CV
storage of PSE products
behind secure counter, or in locked cabinet within 30 ft of and in direct eye line of pharmacy counter
restrictions on out-of-state prescribers
- no restrictions on independent practitioners…same as if in state
- out of state midlevels have no restrictions on non-controls, but cannot prescribe controls
restrictions on Canadian/Mexican prescribers
- written rx’s only…no electronic or verbals
- no controlled rxs
can you transfer rx’s written by Mexican/Canadian prescribers
- ok to transfer between two TX pharmacies
- cannot transfer from a pharmacy in another state
can midlevels prescribe controls?
- yes, if they are based in Texas
- rx and any refills are valid for only 90 days
what happens to refills on an rx if the prescriber dies?
- no set in stone rules/laws
- TX Medical Board has stated it is ok to fill a single 30 ds while patient finds another provider
how many midlevels can a physician supervise?
- no more than 7 PAs/APRNs
- more allowed for underserved areas, LTCFs, or facility-based practices
T/F: rx label must have name of supervising physician for rx’s written by midlevels
False – is okay if label has only prescribing midlevel
when can midlevels write C-IIs?
- in hospital-based practices
- for terminally ill patients receiving hospice care
requirements for scripts written by midlevels
- name/address/phone # of both prescriber and their supervising physician
- DEAs of both practitioners, if controlled
T/F: an out of state APRN can write for tylenol #3
False — no controls can be filled if written by out of state midlevel
list the classes of pharmacy
- class A: community
- class B: nuclear
- class C: institutional
- class D: clinic
- class E: nonresident
A, C, and E can have S-designations if producing sterile products
TSBP members
11 total members
- 7 pharmacists
- 1 tech
- 3 public members
requirements for pharmacist TSBP members
- resident of TX
- currently practicing pharmacy
- licensed in TX for preceding 5 yrs
- CANNOT be a lobbyist, employee/consultant of Texas healthcare trade company (applies to spouse too)
terms of TSBP members
- 6 year terms
- cannot serve more than 2 consecutive full terms
how does one become a TSBP member?
-appointment by governor, with advice/consent of senate
how many times can a pharmacist candidate take the NAPLEX/MPJE
up to 5 times
what is an intern trainee
- a type of pharmacist intern
- for individuals in their first professional year at a Texas pharmacy school
what is a student intern
- a type of pharmacist intern
- must have completed at least 30 credit hours of a professional program (doesn’t specify a Texas program)
How does a student intern lose their intern status?
- leaving (i assume without graduating??) the pharmacy school
- failing the MPJE and/or NAPLEX
- not taking the MPJE and NAPLEX within 6 mos of graduation
how many intern hours must a pharmacist have to be licensed?
-1500 hours
what restrictions do intern trainees have compared to other types of pharmacist interns?
- can do any role other interns can (ie an do anything a pharmacist can do as long as they are supervised)
- however, they can ONLY do this at sites that are assigned to them by their pharmacy school
