Mpje Flashcards
(96 cards)
1
Q
Federal CSA - enforced by
A
DEA, unit of US Dept of Justice
2
Q
Schedule I drugs have…
A
- HIGH potential for abuse
- NO accepted medical use
- Lack of accepted safety
3
Q
Schedule II drugs have…
A
- HIGH potential for abuse
- Accepted medical use
- physical: SEVERE
- psych: SEVERE
4
Q
Amendment 64
A
21+ years old can:
- consume/possess up to 1 oz.
- grow up to 6 plants
5
Q
What can u change/add on a C2?
A
- Dosage form
- Strength
- Quantity
- Directions
- Issue date
6
Q
What can u NOT change/add on a C2?
A
- Patient Name
- Drug prescribed
- Signature
7
Q
Schedule III drugs have…
A
- Lower abuse potential than C1 or C2
- Accepted medical use
- physical: MODERATE OR LOW
- psych: HIGH
8
Q
Schedule IV drugs have…
A
- Lower abuse potential than C3
- Accepted medical use
- physical: LOW
- psych: LOW
9
Q
Schedule V drugs have…
A
- Low potential for abuse v. C4
- Accepted medical use
- physical: LIMITED
- psych: LIMITED
(usually limited qty of narcotics)
10
Q
Activities requiring DEA registration (8)
A
- Manufacturing
- Dispensing
- Distributing/reverse distributing
- Importing and exporting
- Prescribing by individual practitioners
- Conducting research
- Conducting narcotic treatment program
- Conducting chemical analysis
11
Q
DEA registration renewed how often?
A
Every 3 years. Online or paper, but no more than 60 days prior to expiration date. Use Form 224a
12
Q
DEA registration expired???
A
Can reinstate expired registration for 1 month after expiration date. If past that new registration is required.
13
Q
New pharmacy registration
A
- state license must be obtained (fed agencies are exempt)
- complete Form 224
- Form 223: Certificate of Registration - must be kept on site
14
Q
Retail Chain Renewal
A
Form 224b + list of corporation’s registrations
15
Q
Notify DEA prior to changing… (3)?
A
- Address
- Termination of business
- Transfer of business/change in ownership
16
Q
Termination of Registration/business:
A
- return registration certificate
- return unused order forms (like 222)
17
Q
Transfer of business/change in owner:
A
- 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
18
Q
DEA can deny, suspend, or revoke registration if:
A
- 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.)
19
Q
If Military exempt from DEA registration:
A
- 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
20
Q
CS hardcopy requirements:
A
- Patient Full Name
- Patient Address
- Drug
- Strength
- Dosage form
- Quantity
- Directions
- Doctor name
- Doctor Address
- Doctor DEA
(11. Refills if applicable)
21
Q
CS Rx label requirements:
A
- 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#)
22
Q
Cautionary Statements for CS label:
A
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”
23
Q
C2 partial fill exceptions:
A
LTCF or “terminally ill” (documented with dx). Partial fills allowed for max of 60 days. Must document:
- pharmacist
- date of fill
- # dispensed
- # remaining
24
Q
DEA 222 forms have…
A
- order form # Registrant's: - Name - Address - DEA# - Authorized activity - Authorized schedules
25
DEA 222 form Copy 1 goes to....
Supplier
26
DEA 222 form Copy 2 goes to...
DEA
27
DEA 222 form Copy 3 goes to...
kept by Purchaser
28
222 Form partial shipments must be completed by
60 days
29
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
```
30
Drug Regimen review includes (8):
1. Allergies
2. Rational therapy & contraindications
3. Dose, duration, ROA
4. Directions
5. ADEs, interactions, CIs
6. Therapeutic duplication
7. Proper utilization & optimum outcomes
8. Abuse/misuse
31
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
32
If license inactive/expired = 24 months:
- 24 hours of CE, in past 24 months
| - application & fee
33
If license inactive/expired > 24 months:
- 1 hour of CE for each month inactive/expired
- Pass MPJE
- application & fee
34
if pharmacy manager terminates employment:
- OWNER must transfer state board registration to new manager within 30 days
- MANAGER must notify board IMMEDIATELY
35
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
36
Reinstatement of PDO registration (non-resident PDO):
- application/fee
- current pharmacy registration
- inspection report from resident BOP
37
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
38
CS inventory within ___ hours of manager change
72 hours
39
Pharmacy business hours
- 2 days per week
- 4 continuous hours each day
- submit hours to board in writing if open less than 32 hours per week
40
Pharmacist can supervise up to...
```
6 people
(max 2 interns)
```
41
Notify board of any criminal problems within...
30 days
42
Notify board of any legal proceeding alleging a drug/device law or rule violation, including civil malpractice...
within 72 hours of service of process or knowledge, and 30 days of disposition
43
Emergency kits may be provided to state-licensed or certified facilities, by PDOs or hospital other outlets...
- Long Term Care Facilities (LTCF)
- Acute Treatment Units (ATU)
- Hospices (inpatient & outpatient)
- Home Health Agencies (HHA)
one PDO/hospital other outlet per facility
pharmacy manager responsible for accuracy of contents
44
Emergency kits: LTCF, ATU, inpatient hospices
- contents determined by medical director & RPh
- limited to 60 drugs, 12 may be CS
- up to 30 doses of any dosage form or strength
- oral dosage forms OK
45
Emergency kits: outpatient hospice, HHA
- contents determined by nursing director & RPh
- limited to 60 drugs, NO CS
- up to 30 doses of any dosage form or strength
- NO oral forms... only injectables!
46
Emergency kit requirements:
- must be sealed with tamper-evident or electronic seal
- Expiration: earliest of any drug in kit, OR 1 year from sealing
- Written kit contents attached to kit
- Pharmacist/designee inspect contents annually or within 72 hours of kit being opened
- Kit drugs only for facility patients pursuant to practitioner order
47
The following may register as an "other outlet"
- hospitals without a registered PDO
- Federal Qualified Health Centers
- Family planning, Community, or Rural Health Clinics
- Colleges, universities, schools
- County/district public health agencies
- Ambulatory surgical centers
- Med clinics operated by a hospital that administer meds to patients while being treated in the facility
- Jails, hospices, Acute Treatment Units, Telepharmacies, Convalescent Centers
48
Other Outlet's Consultant pharmacist is responsible for:
- Registration & overall operation
- Developing protocols and review annually
- Developing inspection form & documenting visits
- Recordkeeping of procurement, compounding, dispensing and/or distribution of drugs
- Initial interpretation of prescription orders or have a protocol for unlicensed persons
- Be available for professional consultation
49
2 types of Collaborative Practice Agreements:
1. CDTM (Collaborative Drug Therapy Management)
| 2. Statewide Protocols (Contraception)
50
CDTM: 2 components
1. Protocol for disease management
| 2. Agreement between pharmacist(s) & provider(s) that is reviewed annually
51
Pharmacist requirements for Collaborative Pharmacy Practices:
1. PharmD or 5 years experience
2. Current CO license & actively practicing
3. MUST carry liability insurance
* *Additional qualifications for CDTM:*
4. Completion of residency, OR
5. Completion of 1 year training + 40 hours supervised clinical training, OR
6. ACPE certificate program (or 50 hours CE) + 40 hours supervised training, OR
7. BPS certification
52
CDTM: Agreement
1. names of participating pharmacists/prescribers (physicians or APNs)
2. lists the protocol
3. method & frequency of communication
4. effective date & signatures of participants
53
CDTM: Protocol
1. Required patient information
2. Specific drugs/dosages
3. Specific labs
4. Pharmacist Training
5. Treatment plan based on evidence
6. Referral criteria
7. effective date & signatures of participants
54
CDTM: records
- copy of written Agreement & Protocol
- Evidence/literature the protocols are based on
- Documentation of pharmacist training requirements
- keep for 3 years from last date of service
55
Training required for immunizations:
- Didactive & live hands-on training, accredited by ACPE (20 hours for RPh/intern, 4 hours for techs)
- CPR certification
56
For board inspection (for immunizations):
- proof of completion of ACPE training
- CPR certification
- Immunization records x 3 years
- Written policy - contaminated supplies
57
Immunization records must contain:
- pt name, address, Dob
- pt responses to indication/CI questions
- date & site of injection
- name, dose, manufacturer, lot#, expiration
- name & address of PCP
- name/initials of pharmacist (& intern)
- pt's signed informed consent
- VIS version & date provided
58
may outsource portions of dispensing to other pharmacies if (Central Prescription Processing):
- same owner or entered into a central prescription processing contract
- share electronic file or have appropriate technology or interface
- registered with board as prescription drug outlets or non-resident prescription drug outlet
59
Central Prescription Processing: Policy and Procedure Manual
- must be reviewed annually by pharmacy manager
- outline responsibilities of each involved pharmacy
- include list of involved pharmacies (name, address, number and license/registration
- delineate which pharmacy name and address appears on the Rx label
60
Manufacturer or Wholesaler can sell to:
- another wholesaler
- hospital
- PDO
- practitioner
61
Casual sale:
Rx drug outlet, or hospital, selling to:
- Rx drug outlet
- Wholesaler
- Prescribing practitioner
no more than 10% of sales!
62
Pharmacy can REGISTER as compounding PDO if:
- Accredited (can then compound more than 10% of total sales for practitioners or PDO with same owner)
- PDO must be owned solely by pharmacist
63
REGISTERED compounding PDO may dispense compounded drugs..
without 10% limitation to practitioners and other PDO's with same owner
64
Registered compounding PDO CANNOT:
```
commercially available drug, except:
- if significantly different, OR
- best medical interest of patient (dye allergy)
AND
- must notify patient
```
65
Hospital employee may dispense 24 hour drug supply to registered ER patient if:
- ordered by practitioner
| - employee is authorized to administer or dispense meds
66
Compounding overview:
- up to 90 day supply (based on prior 6 month history)
- only distributed to a practitioner's Rx (or chart) order
- Formulation & compounding records must be kept ** except if compounded per manufacturer's labeling instructions**
- "Casual Sales" distributions allowed only by in-state PDOs to practitioners and hospitals located and licensed/registered in Colorado
67
Compounding: labeling
- sterilenon-sterile
- Rx*/chart orders/for practitioners*/within hospitals as floor stock... includes:
(* except radiopharmaceuticals prepared from FDA approved, commercially available kits and/or drug products)*
- BUD
- Batch (lot) number
- Storage directions if appropriate
- Statement: compounded by the pharmacy
68
Policy & Procedure Manual for non-sterile (Non-CSP):
- required of all PDOs
- annually reviewed & signed by manager
- new manager... sign within 30 days of starting
69
Policy & Procedure manual for Sterile (CSP)
- required if sterile compounding performed
| - follows USP 797
70
CSP: Immediate Use
1. where low-risk would add risk due to delays
2. NO storage or batch compounding
3. continuous compounding process lasts NO MORE THAN 1 HOUR
4. administer less than 1 hour after preparation begins
5. simple transfer of sterile, non-hazardous drugs
71
CSP: Low-Risk
1. using only sterile ingredients/components
2. simple volume transfers of sterile dosage forms (ampules, bottles, bags, and vials using sterile syringes and needles)
3. Simple aseptic measuring & transferring with NO MORE THAN 3 PACKAGES of manufactured sterile products
72
CSP: Low-Risk with < 12 hour BUD
1. usually in rural sites
| 2. used in facilities that don't need longer BUD (infusion centers, operating room pharmacies)
73
CSP: Medium Risk
1. uses only sterile ingredients
2. batch preparations
3. complex manipulations (TPN)
4. preparation over several days
5. making or using PRESERVATIVE FREE components
74
CSP: difference between Low & Medium Risk
- NO batch compounding v. batch compounding
- multi-dose vials vs. single use vials
- using = 3 drugs vs. > 3 drugs in a product
75
CSP: High Risk
examples. ..
- using non-sterile (bulk powders) ingredients
- open system transfers
- sterile products must be terminally sterilized (filtered, autoclaved)
76
Pure Food & Drug Act
**ADULTERATION & MISBRANDING**
prohibited adulteration/misbranding of foods & drugs in interstate commerce.
it did NOT require listing ingredients, be safe/effective, directions, or provide warnings.
77
FDCA (Food Drug and Cosmetic Act)
required drugs to be SAFE for intended use & approved by FDA before they could be marketed
required labels to have directions & warnings about habit-forming properties of some drugs.
First law to apply to both cosmetics/devices AS WELL AS food/drugs
78
Durham Humphrey Amendments
established 2 classes: Rx and OTC
authorized ORAL prescriptions and refills
79
Kefauver Harris Amendment
required drugs to be not only safe, but EFFECTIVE
established GMP (Good Manufacturing Practices)
required "informed consent" of subjects in trials
80
Medical Device (Regulation) Act
requires medical devices to be SAFE and EFFECTIVE
established 3 classes based on impact on health:
Class I: minor potential impact
Classs II: moderate...
Class III: major potential - requires premarketing approval
81
Orphan Drug Act
incentivize companies to make meds for rare diseases (< 200,000 occurrences in USA)
82
Drug Price Competition and Patent Term Restoration Act
sped up approval of GENERIC DRUGS by extending the ANDA (Abbreviated New Drug Application) process to all generics
extended patent life for new BRAND DRUGS: 5 additional years of patent protection
83
Prescription Drug Marketing Act
- requires STATE licensing of wholesalers
- bans sale, trade, or purchase of Rx samples
- bans community pharmacies from receiving samples
- specified storage, handling, recordkeeping requirements for drug samples
- bans resale of Rx drugs purchased by hospitals or healthcare facilities
- bans re-importation of Rx drugs produced in the US
84
Food and Drug Modernization Act
- prescription labels must contain "Rx Only"
- clarified compounding by pharmacists
- manufacturer has to do only 1 clinical trial to supplement their NDA
- fast track approval for drugs for serious or life-threatening diseases
85
Priority Review
- used for BLA (Biologics License Application) or NDA submission
- reduces FDA review period from 10 months to 6
- drugs qualifying for Breakthrough Therapy, Accelerated Approval, and Fast Track.. can also be eligible for Priority Review
86
Fast Track
- may be requested for IND application and prior to BLA or NDA submission
- for drugs that address unmet medical need (no tx exists, or substantial benefit over existing tx)
- sponsors get extra opportunities to meet with FDA to discuss study design & how to best expedite development
- sponsors may have early reviews of their product marketing before complete application has been submitted
87
Breakthrough Therapy
- may be requested as early as IND application... preferably prior to end of Phase 2 meeting
- similar to Fast Track, but Breakthrough drugs must show early clinical evidence of substantial improvement over existing txs
88
Accelerated Approval
- for drugs with long term endpoints, such as increased survival/decreased morbidity, that are difficult to measure efficiently in trials
- allows approval based on easily measured outcomes that are reasonably likely to predict clinical benefit, like shrinking tumor
- sponsors required to confirm dug efficacy in post market clinical trials
89
ANDA (Abbreviated New Drug Application)
- for generics
- must prove PK properties, bioavailability, and clinical activity similar to innovator product
- first generic to market gets 6 months exclusivity
90
SNDA (Supplemental New Drug Application)
- after marketing new dug, manufacturer might want to change the synthesis, production procedures, manufacturing locations, packaging, labeling etc.
91
PPPA (Poison Prevention Packaging Act)
child-resistant packaging
92
HITECH (Health Info Portability & Accountability Act)
EHR implementation
93
Dental Hygienist: prescriptive authority?
```
CO License needed
IN COLLABORATION WITH LICENSED DENTIST:
- fluoride
- antimicrobial solutions for mouth rinsing
- non-systemic antimicrobial agents
```
94
Direct Entry Midwife (CPM)
CO Registration AND Designated Authority needed.
- no Rx drugs or CS. (OTCs ok)
- they can procure shit
95
Naturopathic Doctor (ND)
CO Registration needed
| only: epi, barrier contraception
96
Optometrist (OD)
CO license, ** certified as Therapeutic Optometrist (TPA)
- any Rx drug
- C2: ONLY hydrocodone combos
- C3-5 any
- NO INJECTABLES EXCEPT EPI!!!
