Mpje Flashcards
Federal CSA - enforced by
DEA, unit of US Dept of Justice
Schedule I drugs have…
- HIGH potential for abuse
- NO accepted medical use
- Lack of accepted safety
Schedule II drugs have…
- HIGH potential for abuse
- Accepted medical use
- physical: SEVERE
- psych: SEVERE
Amendment 64
21+ years old can:
- consume/possess up to 1 oz.
- grow up to 6 plants
What can u change/add on a C2?
- Dosage form
- Strength
- Quantity
- Directions
- Issue date
What can u NOT change/add on a C2?
- Patient Name
- Drug prescribed
- Signature
Schedule III drugs have…
- Lower abuse potential than C1 or C2
- Accepted medical use
- physical: MODERATE OR LOW
- psych: HIGH
Schedule IV drugs have…
- Lower abuse potential than C3
- Accepted medical use
- physical: LOW
- psych: LOW
Schedule V drugs have…
- Low potential for abuse v. C4
- Accepted medical use
- physical: LIMITED
- psych: LIMITED
(usually limited qty of narcotics)
Activities requiring DEA registration (8)
- Manufacturing
- Dispensing
- Distributing/reverse distributing
- Importing and exporting
- Prescribing by individual practitioners
- Conducting research
- Conducting narcotic treatment program
- Conducting chemical analysis
DEA registration renewed how often?
Every 3 years. Online or paper, but no more than 60 days prior to expiration date. Use Form 224a
DEA registration expired???
Can reinstate expired registration for 1 month after expiration date. If past that new registration is required.
New pharmacy registration
- state license must be obtained (fed agencies are exempt)
- complete Form 224
- Form 223: Certificate of Registration - must be kept on site
Retail Chain Renewal
Form 224b + list of corporation’s registrations
Notify DEA prior to changing… (3)?
- Address
- Termination of business
- Transfer of business/change in ownership
Termination of Registration/business:
- return registration certificate
- return unused order forms (like 222)
Transfer of business/change in owner:
- submit in person or by registered/certified mail with return receipt requested
- send to Special Agent in Charge in area
- at least 14 days in advance of proposed transfer
1. name/address/#/authorized activity of old and new
2. whether business activities will be continued at old location or moved to new location - if so, list
3. date on which transfer of CS will occur - on day of transfer: complete CS inventory. keep copy of inventory at both pharmacies. don’t need to send to DEA unless requested by Special Agent in Charge.
- acquiring pharmacy keeps records for 2 years
DEA can deny, suspend, or revoke registration if:
- Falsified application
- Felony conviction related to CS
- State license denied/suspended/revoked
- Excluded from participating in Medicaid/Medicare programs
- Committed act inconsistent w/ public interest (recommendation of the board, conduct threatening public health/safety, etc.)
If Military exempt from DEA registration:
- must state branch of service or agency on rx
- must state service ID # (PHS is SSN)
- for course of official duties..
if they want to practice privately, they need to register
CS hardcopy requirements:
- Patient Full Name
- Patient Address
- Drug
- Strength
- Dosage form
- Quantity
- Directions
- Doctor name
- Doctor Address
- Doctor DEA
(11. Refills if applicable)
CS Rx label requirements:
- Pharmacy Name
- Pharmacy Address
- Patient Name
- Rx#
- Doctor Name
- Directions
- Cautionary Statements
* *(if filled at central fill pharmacy… must add Retail Pharmacy Name, Address, and the Central Fill’s DEA#)
Cautionary Statements for CS label:
for C2, C3, C4 * NOT C5!!*
“Caution: Federal law prohibits the transfer of this dug to any person other than the patient for whom it was prescribed”
C2 partial fill exceptions:
LTCF or “terminally ill” (documented with dx). Partial fills allowed for max of 60 days. Must document:
- pharmacist
- date of fill
- # dispensed
- # remaining
DEA 222 forms have…
- order form # Registrant's: - Name - Address - DEA# - Authorized activity - Authorized schedules
DEA 222 form Copy 1 goes to….
Supplier
DEA 222 form Copy 2 goes to…
DEA
DEA 222 form Copy 3 goes to…
kept by Purchaser
222 Form partial shipments must be completed by
60 days
CO Board of Pharmacy members
5 pharmacists (5+ years experience in CO) 2 non-pharmacists with no financial interest in pharmac 4-year overlapping terms (max 2 terms) Balanced by political party, urban/rural, type of practice
Drug Regimen review includes (8):
- Allergies
- Rational therapy & contraindications
- Dose, duration, ROA
- Directions
- ADEs, interactions, CIs
- Therapeutic duplication
- Proper utilization & optimum outcomes
- Abuse/misuse
written II/FE Notice:
- signed & dated by manager
- manner of documenting II/FE, how it’s recorded & maintened. includes statement that all pharmacy personnel can print II/FE records
- posted next to current board registration
- keep for 3 years from date last used
- new manager must sign & date II/FE Notice within 72 hours of starting
If license inactive/expired = 24 months:
- 24 hours of CE, in past 24 months
- application & fee
If license inactive/expired > 24 months:
- 1 hour of CE for each month inactive/expired
- Pass MPJE
- application & fee
if pharmacy manager terminates employment:
- OWNER must transfer state board registration to new manager within 30 days
- MANAGER must notify board IMMEDIATELY
Reinstatement of PDO registration ( in-state PDO):
- application/fee
- Articles of Incorporation or Certificate of Good Standing
- list of shareholders (all if private, >/=5% if public)
- accurate, to-scale floor plan
- self inspection form
- whether prescribers own > 10% of PDO
Reinstatement of PDO registration (non-resident PDO):
- application/fee
- current pharmacy registration
- inspection report from resident BOP
Closure of outlet
- manager must relocate Rxs to another PDO within 72 hours
- manager must make reasonable efforts to inform patients were records were relocated
CS inventory within ___ hours of manager change
72 hours
