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CPJE > law stuff > Flashcards

law stuff Flashcards

1
Q

what must pharmacy staff name tags say

A

name & license status

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2
Q

when must licensees join the BOP’s email notification list?

A

within 60 days of being licensed

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3
Q

how many pharmacies can a PIC supervise

A

2 pharmacies as long as they’re within 50 driving miles away

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4
Q

when should the BOP be notified about a PIC change

A

old PIC must report within 30 days

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5
Q

when is the biennial Self-Assessment form due

A

before july 1st of each odd numbered year

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6
Q

when should additional Self-Assessment forms be done

A
  • within 30 days if a new permit was issued
  • if there’s a new PIC
  • when pharmacy moves to a new location
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7
Q

how long is the Self-Assessment form kept

A

3 years

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8
Q

what services can RPhs do

A
  • administer drugs & biologics
  • provide consultation, training & education
  • be in multidisciplinary reviews
  • furnish self-administered hormonal contraceptives
  • furnish travel meds
  • furnish prescription nicotine replacement products
  • independently initiate & administer immunizations to ≥3
  • order & interpret tests
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9
Q

what CE do RPhs have to do

A
  • 30 hours of CE during each 2 year license renewal
  • ≥2 hours of pharmacy law & ethics
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10
Q

what day do RPh licenses expire

A
  • on the last day of their birth month
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11
Q

how long do RPhs have to keep their certification for

A

4 years

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12
Q

how many interns per RPh

A

2 interns

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13
Q

how many techs per RPh in community setting?

A

1 tech with 1st RPh, 2 per additional RPh

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14
Q

how many techs per RPh in hospital setting

A

2 techs per RPh

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15
Q

how many tech trainees per RPh

A

1 per RPh for 120-140 hour training period; 340 hours if externship is between hospital & community

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16
Q

how many clerks per RPh

A

reasonable number per RPh’s discretion

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17
Q

what are advance practice pharmacists do

A

initiate, adjust & d/c drug therapy per protocol

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18
Q

criteria to be an advanced practice pharmacist

A
  • earn certification in relevant area of practice
  • complete residency
  • provide clinical services for 1 year [≥1500 hours] under CPA or protocol w/ physician, Collaborative Drug Therapy Management or within health system
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19
Q

requirements to be an intern pharmacist

A
  • be currently enrolled in ACPE-accredited or BOP-recognized pharmacy school
  • be graduate of a pharmacy school & has application pending to be a licensed CA RPh
  • be graduate of foreign pharmacy school w/ certification from NABP’s FPGEC
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20
Q

tech-check-tech

A
  • in hospital settings w/ clinical pharmacy programs & RPhs are in patient care areas
  • another tech can check after tech fills unit-dose distribution system, floor stock or ward stock
  • RPh must check compounded & repackaged drugs before tech fills unit-doses
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21
Q

what can pharmacy clerks do

A

put drugs on the shelf & give pts their prescriptions during transaction

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22
Q

what is the pharmacist recovery program for substance abuse & mental illness

A
  • evaluates drug abuse and/or mental illness, develops trx plan, monitors progress & provides suport
  • accepts referrals on voluntary basis
  • BOP may refer RPh to recovery program in lieu of discipline
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23
Q

when must a RPh report to the BOP about a licensed staff member who is chemically, mentally or physically impaired to the extent that it affects their ability to work OR found for theft, diversion or self-use of drugs

A

14 days

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24
Q

who can keep an extra key to the pharmacy

A

pharmacy owner, building owner or manager in tamper-evident container for purpose of delivering the key to a RPh

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25
Q

what’s the difference between a policy and a procedure

A

policy: course of action for a specific activity
procedure: steps that must be carried out by the staff [written in policy]

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26
Q

what are required policies & procedures?

A
  • action when staff is chemically, mentally, or physically impaired
  • action when staff is engaged in theft, diversion or self-use of prescription drugs belonging to the pharmacy
  • operation of pharmacy during RPh’s breaks/meal periods
  • assuring confidentiality of medical info
  • delivery of drugs/devices to storage facility when pharmacy is closed & no RPh present
  • compliance with Combat Methamphetamine Epidemic Act of 2005
  • reporting requirements to protect the public
  • how a pt will get their med when RPh has conscientious objection to dispensing it
  • preventing dispensing when RPh decides it would cause a harmful interaction
  • helping pts with limited/no English proficiency to understand their meds
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27
Q

how long must drug acquistion & disposition records be kept

A

at least 3 years

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28
Q

how long are hospital pharmacy chart orders for controls maintained for

A

7 years

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29
Q

how long are patient acknowledgements of HIPAA kept for

A

6 years

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30
Q

how long is transaction info, history and statement for most prescription drugs under Drug Supply Chain Security Act kept for

A

6 years

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31
Q

how long must a certificate for completion of CE be kept for

A

4 years

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32
Q

how long must community or clinic pharmacy prescriptions be kept for

A

3 years

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33
Q

how long must hospital pharmacy chart orders for non-controls be kept for

A

3 years

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34
Q

how long must be quarterly C-II inventory be kept for

A

3 years

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35
Q

how long must DEA forms 222, CSOS records, & power of attorney forms be kept for

A

3 years

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36
Q

how much purchase invoices for all prescription drugs be kept for

A

3 years

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37
Q

how long should self-assessment forms be kept for

A

3 years

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38
Q

how long should documentation of drug returns be kept for

A

3 years

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39
Q

how long should documentation of transfers be kept for

A

3 years

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40
Q

how long should theft/loss reports of controls be kept for

A

3 years

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41
Q

how long should biennial controlled substances inventory be kept for

A

2 years

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42
Q

how long should pseudoephedrine. ephedrine, phenylpropranolamine & norpseudoephedrine sales logs be kept for

A

2 years

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43
Q

how long should pt med profiles be kept for

A

1 year

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44
Q

how long should med error/quality assurance reports be kept for

A

1 year

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45
Q

when should a change of RPh address or name be reported

A

within 30 days

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46
Q

when should a change of PIC be reported

A

within 30 days

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47
Q

when should changes in the pharmacy permit be reported

A

within 30 days

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48
Q

when should theft by or impairment of a licensee be reported

A

within 14 days

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49
Q

when should loss/theft of controlled drugs be reported

A

report to DEA immediately [1 business day]
report to CA BOP within 30 days

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50
Q

when should bankruptcy, insolvency or receivership be reported

A

immediately

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51
Q

when should a completion of self-assessment form be done

A
  • every odd-number year before July 1
  • within 30 days if there’s a new pharmacy permit, change in PIC or change in pharmacy location
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52
Q

when should biennial controlled substance inventory be done

A

every 2 years

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53
Q

when should RPh CE [30 hours] be done

A

every 2 years, except first cycle

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54
Q

when should C-II inventory be done [CA requirement]

A

every 3 months

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55
Q

when should med error investigations be done

A

within 2 days of error

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56
Q

when should submitting dispensing data to CURES be done

A

within 1 business day of dispensing

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57
Q

what are options for filing controlled substances paper prescriptions

A
  1. 3 separate files → C II, C III-V, non-controlled
  2. 2 separate files → C II, all others [CIII-V need red C stamp]
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58
Q

when should a new PIC do a C II inventory

A

within 30 days of their appointment as PIC

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59
Q

when is inventory counted (time)

A

beginning or close of business → not during business hours

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60
Q

inventory counting - unopened containers

A

exact count needed → use number listed on bottle

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61
Q

inventory counting - opened containers

A
  • C I & II need exact count
  • C III-V with ≤1000 units can be estimated
  • C III-V with >1000 units need exact count
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62
Q

how can pharmacies have off-site storage of records

A
  • BOP has to approve waiver → signed copy goes to pharmacy within 30 days
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63
Q

when must pharmacies produce records if the BOP requests it

A

within 2 business days upon request

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64
Q

how long do you keep non-control Rxs

A
  • at least 1 year at the pharmacy
  • 2 years off-site after initial year
  • throw away after 3 years
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65
Q

how long do you keep control Rxs

A
  • at least 2 years
  • 1 year offsite after initial year
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66
Q

types of DME

A
  • blood glucose monitors, test strips, lancet devices & lancets
  • nebulizers & nebulized drugs
  • CPAP machines
  • prosthetics, orthotics & supplies
  • ostomy supplies
  • walkers, scooters, canes & commode seats
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67
Q

how can we bill Medicare for DME

A

with DWO → need prescriber’s signature & date + detailed description of item

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68
Q

drug supply chain security act of 2013

A

outlines steps to build system to track & tract drugs as they’re distributed in the US → prescription meds for human use

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69
Q

what must be maintained for each product received

A
  • transaction information
  • transaction history
  • transaction statement
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70
Q

transaction history

A

statement w/ transaction info for each prior transaction

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71
Q

transaction info

A
  • Proprietary or established name or names of the product
  • Strength & dosage form of the product
  • NDC of the product
  • Container size
  • Number of containers
  • Lot number
  • Date of transaction
  • Date of shipment, if more than 24 hours after date of transaction
  • Business name & address of person from whom ownership is being transferred
  • Business name & address of the person to whom ownership is being transferred
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72
Q

transaction statement

A

statement that entity transferring ownership in a transaction:
- is authorized
- received the product from a person that is authorized
- received transaction info & a transaction statement from the prior owner of the product
- didn’t knowingly ship a suspect or illegitimate product
- had systems & processes in place to comply with verification requirements
- didn’t knowingly provide false transaction info
- didn’t knowingly alter the transaction history

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73
Q

adulteration

A

involves the drug itself → quality
- filthy, putrid, decomposed
- prepared/store in unsanitary conditions
- contaminated
- lack of quality control
- recognized in official compendia but lower than official standards
- not recognized in official compendia but quality is different from label

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74
Q

misbranding

A

involves incorrect or missing info on the label
- lack of required info
- false/misleading ifno
- improper packaging
- ingredients differ from standard quality

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75
Q

when must the hospital drug supply be checked

A

every 30 days

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76
Q

how long are the records kept for the hospital drug supply checks kept

A

3 years

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77
Q

when must irregularities found during hospital durg supply check be reported

A

within 24 hours to PIC & director or chief executive officer

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78
Q

how are controlled drugs stored

A

locked cabinet or dispersed throughout the other drug stock

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79
Q

how are investigational new drugs stored

A

separate from other drug stock

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80
Q

how are repackaged/resold drugs stored

A

separate from other drug stock, assigned a BUD

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81
Q

how are recalled drugs stored

A

separate from other drug stock

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82
Q

how are expired drugs stored

A

separate from other drug stock

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83
Q

how are drug samples stored

A

separate from other drug stock, not allowed in retail pharmacies

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84
Q

how are drug supplies for medical emergencies supplied at nursing units or service areas

A

portable container sealed by RPhs → contents listed on outside cover & have earliest expiration date of any drugs within

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85
Q

drug recall

A

drug is removed from market bc its defected or potentially harmful

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86
Q

what is the RPh responsible for in a class I recall

A

determining which pt got the med & notifying their prescriber

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87
Q

who is the manufacturer responsible for notifying during drug recalls

A

customers → distributors & patients

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88
Q

class I drug recall

A

reasonable probability that use or exposure to the drug will cause serious adverse health consequences or death

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89
Q

class II drug recall

A

use or exposure to drug will cause temporary or reversible adverse health consequences

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90
Q

class III drug recall

A

use of or exposure to the drug isn’t likely to cause adverse health consequences

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91
Q

when can a pharmacy or outsourcing contact recipient about a recalled compounded drug?

A
  • use of or exposure can cause serious adverse effects or death AND
  • recalled products was dispensed or intended for use in CA
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92
Q

when should the recipient pharmacy, prescriber or pt be notified about a compounded drug recall

A

within 12 hours

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93
Q

when should the BOP be notified about a compounded drug recall

A

24 hours

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94
Q

when must a pharmacy report to FDA MedWatch about a compounded drug recall

A

within 72 hours

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95
Q

when must an outsourcing facility report to FDA MedWatch

A

within 15 calendar days

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96
Q

can drugs be donated in CA

A
  • SNFs, HHC & mail-order can donate drugs in single-use or sealed packages to repository and distribution programs
  • drugs must be unused & not expired → no controls!!
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97
Q

FDA flush list

A

Buprenorphine [Butrans, Belbuca, Brixadi, Buprenex, Sublocade]
Diazepam rectal gel [Diastat]
Fentanyl-containing products [Actiq, Fentora, Duragesic, Subsys]
Hydrocodone-containing products [Norco, Lortab, Vicodin]
Hydromorphone [Dilaudid, Exalgo]
Methadone [Dolophine, Methadose]
Methylphenidate transdermal system [Daytrana patch]
Morphine [MS COntin, Kadian]
Oxycodone-containing products [Ocycontin, Percocet]
Oxymorphone [Opana]
Tapentadol [Nucynta, Tapenta, Palexia, Yantil, Tapal, Aspadol]

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98
Q

pharmacy take-back program

A
  • pharmacies register with DEA to take back unwanted drugs
  • only reverse distributor can remove the liner with drugs → 2 pharmacy staff must witness
  • controls can be mixed with non-controls
  • cannot put sharps, needles & illicit drugs
  • pharmacies cannot use for their own expired/recalled drugs
  • can give pre-paid, pre-addressed envelopes to mail drugs to destruction location [waterproof, spill-proof, tamper evident, tear resistant & sealable]
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99
Q

when should establishment of the drug take-back service be reported to the BOP

A

within 30 days

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100
Q

when should discontinuation of the drug take-back service be reported to the BOP

A

within 30 days

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101
Q

when should any tampering with a collection bin be reported to the BOP

A

within 14 days

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102
Q

when should theft of deposited drug be reported to the BOP

A

within 14 days

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103
Q

when should disclosure of service & location of each receptacle be reported to the BOP

A

annually, at time of facility license renewal

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104
Q

when should a written report about child abuse, elder abuse and neglect by done

A

within 2 working days or 36 hours of receiving the info concerning the incident

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105
Q

type of prescribing/furnishing authority - physician

A

independent authority → controls & non-controls

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106
Q

type of prescribing/furnishing authority - dentist, podiatrist, veterinarian

A

independent authority, limited to scope of practice → controls & non-controls

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107
Q

type of prescribing/furnishing authority - optometrist

A

independent authority, limited to scope of practice → non-controls & C II-IV [no V!!]
- must be certified with board of optometry to prescribe → T at end of license number
- codeine or hydrocodone-containing meds: max 3 days

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108
Q

type of prescribing/furnishing authority - naturopathic doctors

A

independent authority → only epi, natural/synthetic hormones, vitamins, minerals. etc
- need furnishing number to prescribe → starts with NDF

dependent authority
- all non-controls & C III-V [no C II]

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109
Q

type of prescribing/furnishing authority - RPhs

A

independent authority, limited to:
- emergency contraception, self-administered hormonal contraception
- travel meds
- routine immunizations
- naloxone
- Rx NRT
- PrEP [max 60 days Q2 years]
- PEP

dependent authority:
- all other non-controlled & C II-V

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110
Q

type of prescribing/furnishing authority - CNM, NP, PA

A

dependent authority → non-controls & controls

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111
Q

what can prescribers self-prescribe

A

non-controls

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112
Q

what can prescribers prescribe for family members

A

non-control & controls if there’s a valid physician/pt relationship, legitimate medical purpose & good faith exam

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113
Q

how long is a prescription from a deceased prescriber valid for

A

until all refills are gone & NMT 6 months from date written [controls] or 1 year [non-controls]

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114
Q

can RPh fill out of state prescriptions

A

yes if prescriber has license equivalent to CA prescriber → may need to verify license

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115
Q

can RPh fill foreign prescriptions

A

no; only if from District of Columbia & US territories [Puerto Rico, Virgin Islands, Guam & American Samoa]

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116
Q

requirements for a valid prescription

A
  • patient name & address
  • drug name & quantity
  • directions for use
  • date of issue
  • prescriber info
  • condition/purpose if requested by patient
  • prescriber signature
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117
Q

how long must non-control chart orders be kept for

A

3 years

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118
Q

how long must control chart orders be kept for

A

7 years

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119
Q

medi-cal prescription form requirements

A
  • prevent unauthorized copying of a completed or blank prescription form → “void”, watermarks
  • prevent erasure/modification of info → quantity check-off boxes, preprinted text
  • prevent use of counterfeit prescriptions → serial number, thermochromic ink, microprint sig line
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120
Q

when can you dispense a 90 DS with an initial prescription that specified a shorter time period

A
  • Rx isn’t for a control or psych med
  • pt completed initial 30 DS with no negative effects or previously got 90 DS
  • total quantity dispensed doesn’t exceed amount authorized on prescription
  • RPh notified prescriber of larger quantity dispensed
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121
Q

when can you NOT dispense a 90 DS with an initial prescription that specified a shorter time period

A
  • prescriber indicates no change to quantity
  • prescriber indicates that dispensing prescribed amount is medically necessary
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122
Q

dispensing hormonal contraceptives

A
  • CA allows pts to get 12 month at one time → oral contraceptives, patch, ring & injection
  • health plans are required to cover
  • total quantity can’t exceed amount authorized on prescription
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123
Q

refill limits

A
  • no limit for non-controls but can’t dispense after 1 year from date of issue
  • all controls expire in 6 months
    • no limit for C V
    • restrictions for C II-IV
    • no refills for C II
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124
Q

PRN refills

A
  • allowed for non-controls → don’t refill after 1 year
  • not allowed for PRN controls
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125
Q

emergency refills

A
  • can do without authorization → judge if not filling will interrupt pt’s ongoing care or have significant & attempt to contact prescriber
  • no limit for non-controls
  • reasonable amount for C III-V
  • can’t give for C II → can get emergency verbal order
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126
Q

refill pharmacies

A
  • fill new prescriptions & refills → need contract or same owner to use common e-file
  • originating pharmacy is responsible for counseling pts, maintaining medication profiles & performing drug utilization review
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127
Q

prescription refills

A
  • must be between 2 RPhs or interns
  • no limit for non-controls as long as there’s refills
  • C III-V can be transferred once → unless there’s a shared database
  • cannot transfer C IIs
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128
Q

requirements for prescription labels

A
  • pt name
  • drug name, strength, quantity
  • directions
  • indication
  • prescriber name
  • physical description of drug
  • exp date
  • name & address of dispenser
  • serial/Rx number
  • date of issue
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129
Q

critical items on prescription

A
  • 12 pt font
  • pt name
  • drug name & strength
  • clear & simple directions for use
  • condition or purpose
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130
Q

less critical items on a prescription

A
  • less prominent location
  • pharmacy name, # & prescriber name
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131
Q

dispensing brand name vs generic name on label

A
  • brand name: no need for manufacturer
  • generic: must also say generic for ___ & drug manufacturer
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132
Q

expiration dates

A
  • manufacturer’s exp date or 1 year from date dispensed
  • no exp date = misbranded
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133
Q

labeling format

A

50% of label in 12 pt sans serif typeface
- pt name
- drug name & strength
- directions
- indication

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134
Q

translation on labels

A
  • must have translated directions at request
  • supplemental document
  • can use translations made by BOP
  • RPh isn’t required to provide translated direction for beyond the languages the BOP made available
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135
Q

poison prevention packaging act of 1970

A
  • requires use of child-resistant containers for many OTC products, most PO prescription drugs & dangerous household chemicals
    • can have one size of OTC in non C-R if same product is available as C-R
  • new plastic container & closure needed for each prescription dispensed
  • replace top closure only for glass containers
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136
Q

exceptions to C-R packaging

A
  • sublingual NTG
  • oral contraceptives
  • hormone replacement therapy
  • powdered unflavored aspirin
  • effervescent aspirin
  • powdered iron preparations
  • effervescent APAP
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137
Q

waiving C-R packaging

A
  • prescriber can waive C-R for single prescription
  • pt can give blanket waiver for all → must document
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138
Q

consumer medication information

A
  • useful written pt info is given to pts with each new prescription
  • CMI handouts have drug info & added with prescription bag
  • explain how to use the drug, receive benefit & avoid harm
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139
Q

patient package inserts

A
  • all oral contraceptives must be dispensed with FDA- approved PPI
    • outpatient/retail: each time its dispensed
    • institutional:; prior to first dose & every 30 days after
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140
Q

medication guides

A
  • FDA-approved pt handouts for meds that have serious & significant health concern
  • how to prevent SEs & adherence to special instructions
  • manufacturers must supply MedGuides so pharmacy can print them out
  • give when:
    • initial fills & refills in outpatient
    • first time dispensed to HCP to administer to pt
    • pt or caregiver asks
    • MedGuide has been revised
    • REMS drugs
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141
Q

drug classes where MedGuides should be given

A
  • antidepressants
  • NSAIDs
  • insomnia drugs
  • LABAs
  • ADHD drugs
  • diabetes drugs
  • antipsychotics
  • antiarrhythmics
  • retinoids
  • others: anticoagulants, bisphosphonates, mAbs, FQs, enbrel, ESAs, opioids, CNIs, controls, chantix
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142
Q

REMS

A
  • from FDA amendents act of 2007 → to ensure benefits > risks
  • communication plans, elements to assure safe use, implementation systems, MedGuides
  • for thalidomide, isotretinoin, clozapine, phentermine/topiramate [Qsymsia], opioid analgesics, flibanserin [Addyi]
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143
Q

REMS - thalidomide

A
  • risk: severe birth defects
  • negative pregnancy test required before dispensing each prescription
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144
Q

REMS - isotretinoin

A
  • risk: severe birth defects
  • iPledge
  • 2 negative pregnancy test before first fill & 1 negative test before each subsequent fill
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145
Q

REMS - clozapine

A
  • risk: neutropenia
  • monitor ANC
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146
Q

REMS- phentermine/topiramate [Qsymia]

A
  • severe birth defects
  • MedGuide required, healthcare training program, dispensed only through certified pharmacies
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147
Q

REMS - opioid analgesics

A
  • risk: high abuse potential, life-threatening respiratory depression
  • educate providers by completing REMS-compliant training & taking tests
  • dispense with MedGuide
  • educate on safe use, risks, storage & disposal
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148
Q

REMS - flibanserin [Addyi]

A
  • risk: hypotension & syncope due to an interaction w/ alcohol
  • no alcohol use while taking it
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149
Q

how long do you keep pt med profiles active

A

1 year

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150
Q

prospective DUR

A
  • evaluation of pt’s med profile prior to dispensing → done by dispensing RPh each fill
  • purpose to optimize pt’s therapy
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151
Q

retrospective DUR

A

review of drug therpy after drug is dispensed → done by state, medical institutions or insurance

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152
Q

concurrent DUR

A

ongoing monitoring during course of trx

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153
Q

when must pts be counseled

A
  • Rx drug hasn’t been previously dispensed to pt
  • refill is being dispensed in diff dosage form, strength or w/ new written prescription
  • if pt requires counseling
  • when RPh feels its necessary
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154
Q

what must counseling include

A
  • directions for use & storage
  • important of compliance w/ direction
  • precautions & relevant warnings
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155
Q

when must RPh be available for counseling

A

RPh must beat least 6 days of the week & at least 40 hours per week

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156
Q

notice to consumers

A
  • lets pts know they have certain rights → receiving counseling from RPh & pt’s right to ask questions
  • easy-to-read type, interpreter services & drug prices
  • in public view
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157
Q

HIPAA 1996

A
  • protects privacy of PHI → ensure pt info is secure regardless if electronic, verbal or written
  • PHI can be shared with HCPs, healthcare facilities & health insurance companies
  • need HIPAA
  • violations = fines & imprisonment
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158
Q

what’s included as PHI

A
  • pt’s past, current or future physical or mental health
  • healthcare provided to pt
  • past, present or future payment for providing healthcare to pt
  • when associated with health information: name, address, birthdate, SSN
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159
Q

who can you share PHI with

A
  • pt
  • HCPs
  • payment/operational purposes
  • limited data for research
  • law enforcement
  • DEA, FDA & BOP inspectors [for public health purpose]
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160
Q

incidental disclosures

A

unavoidable & acceptable under HIPAA
- oral coordination pt care at nursing station
- HCP discussing over phone with another HCP, pt or family member
- discussion between providers on rounds
- RPh discussing Rx w/ pt or HCP

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161
Q

privacy notice

A
  • in prominent location within pharmacy
  • give to pt on first day & any time requested
  • good faith to get written acknowledgement
  • distribute when there’s changes
  • can still provide services if pt refuses to sign
  • signed HIPAA privacy disclosure
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162
Q

how long must signed HIPAA privacy disclosure forms be kept for

A

6 years

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163
Q

CA rules for pt obtaining a copy of their records

A

must be able to inspect medical records within 5 business days & get copies within 15 business days

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164
Q

Orange Book

A

approved drug products w/ therapeutic equivalence evaluations

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165
Q

how to use the orange book

A

2 letter code system
- 1st letter: indicated if drug is therapeutically equivalent
- 2nd letter: additional info

first letter A: therapeutically equivalent
- AB: bioequivalence in vivo & in vitro
- AA, AN, AO, AP, AT = in vitro bioequivalence & no in vivo bioequivalence issues

3 character code
- when there’s more than 1 RLD of the same strength under the same heading

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166
Q

when can RPh substitute a diff formulation

A

to improve pt compliance → must have same active ingredients of equivalent strength & duration of therapy

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167
Q

which formulations can’t be switched

A
  • long-acting and short-acting
  • combo drugs and multiple single agents
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168
Q

biosimilar

A

highly similar to FDA-approved biologic [reference product]

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169
Q

substituting biologics

A
  • cannot automatically substitute bc not considered therapeutically equivalent
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170
Q

Purple Book

A

licensed biological products w/ reference product exclusivity & biosimilarity or interchangeability evaluations

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171
Q

formulary

A
  • preferred drug list w/ safest & most effective drugs while considering cost
  • determined by P&T
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172
Q

P&T committee

A
  • create & update formulary, conduct MUE/DUEs, monitor/report ADRs, conduct med error safety initiatives & develop clinical care plans/protocols
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173
Q

therapeutic interchange protocol

A
  • made by P&T to dispense therapeutically similar drugs to meds prescribed
  • cost-effective strategy
  • ex: PPIs, statins, antacids, H2RAs, hypnotics, ACE-Is, ARBs, potassium supplements, ABXs, insulins, topical steroids, laxatives & stool softeners
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174
Q

legitimate mail order pharmacies

A

dispense meds pursuant to Rx from prescriber who has performed a good faith medical exam

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175
Q

ryan haight online pharmacy consumer protection act of 2008

A

prevents illegal sales of controlled substances via the internet

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176
Q

requirements for telepharmacy

A
  • within 150 miles from supervising pharmacy
  • RPh isn’t on site → techs are but do non-discretionary tasks
    • techs can’t accept new prescriptions, compound meds or other discretionary tasks
    • single RPh [off-site] can supervise 2 techs
    • responsible tech has key
  • counseling required → remotely
  • drugs are stored at remote site → controls stored separately [management captured on video & keep for 120 days]
  • countersign for control deliveries
  • RPh must go on site at least once monthly
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177
Q

dispensing epi auto-injectors

A
  • can dispense to pre-hospital emergency medical care person, lay rescuer or authorized entity
  • physician must have written order to specify # dispensed
  • can dispense for school based on written order
  • dispense with product info sheet [name to who it was issued, Section 1797.197a responder””, “First Aid Purposes Only”, dosage, use & exp date
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178
Q

dispensing blood clotting products for home use

A
  • have 24 hour on-call service available every day
  • obtain all FDA-approved blood clotting products
  • supply all necessary infusion equipment & supplies
  • ship within 2 business days
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179
Q

dispensing during federal, state or local emergency

A
  • can dispense in reasonable quantities
  • keep record of date, pt’s name and address & drug/device name, strength and quantity dispensed
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180
Q

when does the mobile pharmacy have to cease activity after the emergency is over

A

48 hours

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181
Q

CA end of life option act of 2016

A

for mentally competent, terminally ill adults to self-administer drugs to end their life in peaceful, humane manner → death with dignity or physician-assisted
- ≥18 years
- CA resident
- mentally competent
- diagnosed with terminal illness that will lead to death within 6 months [confirmed by 2 physicians]

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182
Q

procedure for end of life seppuku

A
  • pt makes request to MD & discuss
  • after 15 days, pt makes second request
  • after 1st request, makes written request
  • after all 3 requests, furnish drugs directly to pt or send Rx to RPh
    • MD must notify RPh & hand-deliver, mail or e-send prescription
  • pt gets med
  • pt does final attestation form & give to attending within 48 hours before taking the med
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183
Q

meds for aid in seppuku

A

CII secobarbital [cap] & pentobarbital [sol]
- take anti-emetic 1 hour before

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184
Q

requirements for ADDS in SNFs

A
  • RPh reviews each med order & pt profile before drug is removed → override only in emergencies
  • RPh stocks ADDS if stocking directly in facility
  • RPH, intern or tech can restock if outside facility → tamper-evident
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185
Q

when must pharmacies that remotely operate ADDS register ADDS with the BOP

A

within 30 days of installing the device & then annually

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186
Q

requirements for repackage meds labeling

A

drug name, strength, dosage form, manufacturer’s name and lot #, exp date & quantity per repackaged unit

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187
Q

centralized hospital packaging

A
  • BOP has specialty license for hospital pharmacy that does centralized packaging & one or more general acute care hospitals under common ownership and within 75 miles
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188
Q

section 503A

A
  • traditional compounding
  • allows RPhs to prepare small batches of a compound in advances based on dispensing hx
  • pharmacies can sell compounds to prescribers for administration to pts in their office [needs to send purchase order]
  • vets can buy compounds to furnish/dispense a 120 hour supply
  • can compound pt-specific parenteral therapy for other pharmacies
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189
Q

section 503B

A
  • permits specially licensed compounding facilities to operate as an outsourcing facility → can make bulk meds w/o prescription
  • sterile drugs for humans
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190
Q

outsourcing facility requirements

A
  • compliance with CGMPs
  • listed as outsourcing by FDA & CA BOP
  • cannot be licensed as sterile compounding pharmacy at the same time
  • cannot perform functions of a pharmacy
  • subject to inspection
  • preparations are made/under supervision by licensed RPh
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191
Q

manufacturing characteristics

A
  • regulation: FDA
  • standards: FDA drug approval, USP, CGMPs
  • NO individual prescription required
  • interstate distribution: yes
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192
Q

traditional compounding characteristics

A
  • regulation: state board
  • standards: 503A, USP
  • individual prescription required
  • interstate distribution: up to 5% of total sales
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193
Q

outsourcing compounding characteristics

A
  • regulation: FDA, state board
  • standards: 503B, USP, CGMPs
  • NO individual prescription required
  • interstate distribution: yes
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194
Q

common HDs

A

antineoplastics, teratogenics, hormones, transplant drugs

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195
Q

minumum requirements for handing HDs

A
  • engineering controls: closed-system transfer devices & negative pressure ventilated cabinets [hood or BSCs] → negative air pressure
  • PPE: chemo gown, respiratory protection, goggles, 2 shoe covers, chemo gloves
  • safe work practice, spill kits & disposal requirements
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196
Q

nuclear pharmacy requirements

A

sterile compounding permit from BOP

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197
Q

when must all actions to test ordering, interpreting & management be documented

A

within 24 hours

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198
Q

SB 493

A

allows RPhs to administer drugs & biologics by other routes [not PO & TOP] → need adequate training

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199
Q

who can CA RPhs administer routine immunizations to

A

≥3 year olds

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200
Q

requirements to administer vaccines

A
  • complete CDC or ACIP-approved immunization training program
  • maintain BLS certification
  • complete 1 hour of CE every 2 years
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201
Q

immunization recordkeeping requirements

A
  • notify PCP & prenatal care provider within 14 days
  • report to CAIR
  • update pt vaccine administration record
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202
Q

emergency contraception drugs

A
  • levonorgestrel [Plan B One-Step] → OTC
  • ulipristal [Ella] → Rx
  • effective during first 72 hours → up to 120 hours [5 days]
  • can furnish high dose birth control pills as off-label EC
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203
Q

furnishing EC protocol

A
  • option if pt doesn’t have a prescription & wants to use insurance coverage
  • RPhs need to finish 1 hour of CE
  • ask about allergies, timing [up to 5 days], will not interfere with established/implanted pregnancy, & say to follow up with HCP
  • can furnish for future use
  • give fact sheet
  • keep inventory of EC meds & adjunct meds
  • can give up to 12 non-spermicidal condoms to each Medi-Cal & Family PACT beneficiary
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204
Q

naloxone

A

opioid antagonist that binds to & displaces opioid from receptor sites
- reverse action of opioid & overdose symptoms
- abrupt reversal can cause opioid withdrawal in chronic users

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205
Q

how to administer naloxone spray w/ assembly

A
  1. take off yellow caps
  2. put on white caps
  3. take purple cap off naloxone
  4. screw on naloxone capsule into syringe barrel
  5. insert white cone into nostril & give short strong push → ONE HALF OF CAPSULE INTO EACH NOSTRIL
  6. repeat in 2nd nostril if no reaction in 3 min
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206
Q

how to administer injectable naloxone

A
  1. remove cap from vial & uncover needle
  2. insert needle through rubber plug w/ vial upside down & draw 1mL
  3. inject into upper arm or thigh
  4. give 2nd dose if no reaction in 3 min
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207
Q

opioid overdose symptoms

A
  • extreme or unusual somnolence
  • respiratory difficulty
  • miosis
  • bradycardia
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208
Q

furnishing naloxone protocol

A
  • can furnish w/o Rx
  • must do 1 hour of CE
  • only offer to those who request it & those at highest risk of overdose
  • cannot waive pt counseling
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209
Q

how long must records of furnishing naloxone be kept

A

3 years

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210
Q

who are at highest risk of opioid overdose

A
  • hx of prior overdose
  • use of ≥50 MME/day
  • concurrent BZD use
  • recent period of opioid abstinence
  • chronic illness that affects lung, liver or kidney
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211
Q

where can RPhs furnish naloxone pursuant to prescriber’s Rx

A

school district, county office of education or charter school

212
Q

furnishing prescription nicotine replacement therapy

A
  • RPhs need minimum 2 hours of CE
  • have screening → pregnancy, heart palpitations, irregular heartbeats, arrhythmia, unstable angina, nasal allergies, TMJ dysfunction
213
Q

how long to keep nicotine furnishing records

A

3 years

214
Q

furnishing self-administered hormonal contraceptives

A
  • RPh must complete 1 hour of CE → specific to USMEC
  • have pt complete self-screening form [initial & annual] to determine eligibility
  • record BP if planning combined hormonal contraceptive
  • counsel pt & give 3 fact sheets [inc PPI]
  • refer to PCP for follow up
215
Q

how long to keep hormonal contraceptive furnishing records for

A

3 years

216
Q

sterilization surgery for women

A
  • <1 pregnancies/100 women
  • onetime procedure; permanent
  • SE: pain, bleeding, ifx/complication after surgery
217
Q

sterilization implant for women

A
  • <1 pregnancies/100 women
  • onetime procedure; permanent
  • SE: pain/cramping, pelvic/back discomfort, vaginal bleeding
218
Q

sterilization surgery for men

A
  • <1 pregnancies/100 women
  • onetime procedure; permanent
  • SE: pain, bleeding, ifx
219
Q

IUD copper

A
  • <1 pregnancies/100 women
  • inserted by HCP; lasts up to 10 years
  • SE: cramps, heavier, longer periods, spotting
220
Q

IUD with progestin

A
  • <1 pregnancies/100 women
  • inserted by HCP; lasts 3-5 years
  • SE: irregular bleeding, no periods, abd/pelvic pain
221
Q

implantable rod

A
  • <1 pregnancies/100 women
  • inserted by HCP; last 3 years
    – SE: menstrual changes, weight gain, acne, mood swings, HA
222
Q

shot/injection

A
  • 6 pregnancies/100 women
  • need 1 Q3months
  • SE: loss of bone density, irregular bleeding, HA, nervousness, abd discomfort, weight gain, dizziness
223
Q

oral contraceptives

A
  • 9 pregnancies/100 women
  • 1 pill QD
  • SE: spotting/bleeding, nausea, breast tenderness, HA
  • mini pill [progestin only]: must take at same time every day
224
Q

patch

A
  • 9 pregnancies/100 women
  • new patch Qweek x3 weeks, no patch on 4th week
  • SE: spotting, nausea, breast tenderness, skin irritation, stomach pain, HA
225
Q

vaginal contraceptive ring

A
  • 9 pregnancies/100 women
  • keep ring in for 3 weeks & take out for 1 week
  • SE: vaginal discharge, discomfort/irritation, HA, nausea, mood changes, breast tenderness
226
Q

diaphragm w/ spermicide

A
  • 12 pregnancies/100 women
  • must use every time you have sex
  • SE: irritation, allergic rxn, UTI
227
Q

sponge w/ spermicide

A
  • 12-24 pregnancies/100 women
  • must use every time you have sex
  • SE: irritation
228
Q

cervical cap w/ spermicide

A
  • 17-23 pregnancies/100 women
  • must use every time you have sex
  • SE: irritation, allergic rxn, abnormal pap tets
229
Q

male condom

A
  • 18 pregnancies/100 women
  • must use every time you have sex
  • provides protection against some STDs
  • SE: irritation, allergic rxn
230
Q

female condom

A
  • 21 pregnancies/100 women
  • must use every time you have sex
  • provides protection against some STDs
  • SE: discomfort or pain during sex, burning sensation, rash/itching
231
Q

spermicide alone

A
  • 28 pregnancies/100 women
  • must use every time you have sex
  • SE: irritation, allergic reactions, UTI
232
Q

levonorgestrel

A
  • plan B
  • 7/8 will not get pregnant
  • swallow ASAP within 3 days after unprotected sex
  • SE: menstrual changes, HA, dizziness, breast pain, lower stomach pain, N/V, tiredness
233
Q

ulipristal acetate

A
  • Ella
  • 6-7/10 will not get pregnant
  • swallow within 5 days after having unprotected sex
  • SE: HA, abd pain, tiredness, nausea, menstrual pain, dizziness
234
Q

furnishing travel meds

A
  • must be for condition that’s self-diagnosable & self-treatable or for ppx
  • complete immunization certificate program, travel med training program [10 hours], Yellow Fever Vaccine Course, BLS, 2 hours CE Q2 years
  • good faith evaluation
  • notify PCP within 14 days
  • provide pt written record of drugs provided
235
Q

selective self-diagnosable conditions & treatment options for travel med

A
  • motion sickness: prochlorperazine, scopolamine
  • traveler’s disease: azithromycin, cipro, rifaximin
  • UTI: nitrofurantoin, bactrim
  • vaginal conditions: fluconazole
236
Q

furnishing PrEP

A
  • for those at high risk for HIV exposure
  • can furnish 30 day supply of Truvada [TDF 300mg/emtricitabine 200mg] QD
    • pt must have negative HIV test within last 7 days, have no s/sx, & not on drugs CI with PrEP
  • provide counseling [cannot be waived]
  • all future prescriptions must be supplied by PCP
  • RPhs can only furnish PrEP 60mg max to single pt over 2 year period
237
Q

furnishing PEP

A
  • given after exposure to prevent transmission
  • start ASAP → ideally within 72 days
  • RPh must complete board-approved training program
  • can furnish 28 days to pt who reports exposure within 72 days
  • |Truvada + Isentress| OR |Truvada + Tivicay| OR |Truvada + Prezista + Norvir|
  • must offer HIV testing [pt can refuse]
  • must provide counseling [cannot be waived]
238
Q

PrEP regimen

A

Truvada [TDF 300mg/emtricitabine 200mg] QD

239
Q

PEP regimen

A

Truvada [TDF 300mg/emtricitabine 200mg] QD
AND 1 of the following:
Isentress [raltegravir 400mg] BID
Tivicay [dolutegravir 50mg] QD
Prezista [darunavir 800mg] QD + Norvir [ritonavir 100mg] QD

240
Q

clinical laboratory improvement amendments [CLIA]

A

waives BG, hemoglobin A1C, cholesterol & PT/INR test for RPh can perform them

241
Q

physical assessment

A
  • conduct pt interview
  • obtain health history w/ med use
  • measure vital signs: BP, HR, RR, temp
  • pain
  • physical exam
242
Q

conduct pt interview

A
  • in area to protect pt privacy
  • open-ended questions
  • active listening
243
Q

obtain health history w/ med use

A
  • CC, HPI, PMH, social history, family history, allergies, intolerances, reactions & med use
  • social hx: alcohol, tobacco & illicit drug use
  • tobacco cessation: 5 As → ask, advise, assess, assist, arrange
244
Q

measuring BP

A
  • ask about tobacco, alcohol & caffeine use
  • measure after pt used restroom & rested comfortably w/ back supported and feet resting
  • refrain from talking
  • arm same level as heart
  • initial visit: 2 readings 1-2 min apart & record average
  • elderly: measure for orthostatic HoTN → SBP decreases ≥20mmHg or DBP decrease ≥10mmHg
  • sphygmomanometer technqiue: listen to Korotkoff sounds
245
Q

measuring HR

A
  • normal HR: 60-100 BPM
  • tachycardia: hypoglycemia, ifx, dehydration, anxiety, pain, hyperthyroidism, anemia, arrhythmia, shock, excessive caffeine/drug use
  • bradycardia: exercise, arrhythmias, organophosphate poisoning, hyperK+, hypothyroidism or drug-induced
  • measure w/ index and middle fingers on radial artery & count to 30 seconds
246
Q

measuring RR

A
  • normal RR: 12-20 breaths per minute
  • watch & count # of times when pt’s chest rises and falls for 30 seconds
247
Q

measuring temp

A
  • normal temp: 97.8-99F [36.5-37.2C]
  • tympanic or oral measurement
248
Q

measuring pain

A
  • subjective
  • use pt’s own report + behavioral observation
249
Q

physical exam

A
  • inspection: visual observation for deformities/abnormalities
  • palpitation: examine body for masses/tenderness
  • percussion: tap fingers on body & listen to sound → dull sounds can mean solid mass
  • auscultation: listen to internal sounds of body
250
Q

BMI & waist circumference screening

A
  • normal BMI: 18.5-24.9 kg/m2
  • risk fi waist circumference >40 in [men] or >35 in [women]
251
Q

glucose screening

A
  • A1C, FPG or OGTT
  • offer to all adults ≥45 & any overweight/obese [BMI ≥25] with ≥1 risk factor
252
Q

cholesterol screening

A
  • use cardiocheck
253
Q

bone density screening

A
  • ultrasound densitometer: measures bone density in heel
  • DEXA scan: gold standard; emits radiation
254
Q

depression screening

A
  • PHQ-9 is commonly used
  • at risk: substance abuse, other mental health conditions, pain, cancer or heart disease, pregnancy/postpartum
255
Q

antimicrobial stewardship programs

A
  • ABX misuse = ABX resistance & MDROs
  • ensures pts get the right ABX at the right dose, right time & for right duration
256
Q

medication utilization evaluation

A
  • performance improvement method that focuses on evaluating & improving medication-use processes with goal of optimal pt outcomes
257
Q

med error reporting

A
  • ISMP requires all pharmacies to have QA program
  • investigation must begin within 2 business days
  • keep QA record for at least 1 year
  • RPh must inform pt about med error & inform of steps to take to avoid further injury
  • must also inform prescriber
258
Q

medicare

A
  • federal health insurance program for ≥65 or <65 w/ disability & pts with ESRD
259
Q

medicare part D

A

drug benefit for medicare enrollees

260
Q

medi-cal

A

state medicare for lower income children, pregnant women, families & low-income adults

261
Q

quality measures in medicare part D

A
  • annual comprehensive med review for those in MTM
  • adherence to diabetes meds, statins & RAAS antagonists
  • ensuring statin use in pts w/ diabetes 40-75 years
  • appropriate use or avoidance of high-risk meds in ≥65
262
Q

covered california

A
  • health insurance “marketplace” in CA
  • 4 levels of coverage: bronze, silver, gold & platinum
  • minimum coverage plan for <30 years
263
Q

patient assistance programs

A

help low-income, uninsured pts get free or low-cost brand-name meds

264
Q

tablet splitting

A
  • helps save money
  • not good candidates for tab splitting: manual dexterity problems, visual impairment or cognitive impairment
  • don’t split: very small tabs, asymmetrical shape, narrow therapeutic index drugs, EC/coated/XR
265
Q

are manufacturers allows to offer drug discounts to push most costly branded drugs to pts?

A
  • no
  • exception: can offer at discounted price that’s less than generic
266
Q

C-I drugs

A

no currently accepted medical use; high potential for abuse risk & lack of accepted safety under medical supervision

267
Q

C-II drugs

A

high potential abuse; abuse may cause severe psychological or physical dependence

268
Q

C-III drugs

A

lower abuse potential than C-I & C-II, abuse may cause moderate or low potential for physical dependence or high psychological dependence

269
Q

C-IV drugs

A

low potential for abuse relative to C-III, abuse may cause limited physical or psychological dependence relative to C-III

270
Q

C-V drugs

A

low potential for abuse relative to C-IV, abuse may cause limited physical or psychological dependence relative to C-IV

271
Q

Actiq

A

fentanyl [must know]
C-II opioids

272
Q

Duragesic

A

fentanyl [must know]
C-II opioids

273
Q

Fentora, Lazanda, Sublimaze, Subsys

A

fentanyl [additional names]
C-II opioids

274
Q

Hysingla ER

A

hydrocodone, single ingredient
C-II opioids

275
Q

Zohydro ER

A

hydrocodone, single ingredient
C-II opioids

276
Q

Lortab

A

hydrocodone/APAP
C-II opioids

277
Q

Norco

A

hydrocodone/APAP
C-II opioids

278
Q

TussiCaps

A

hydrocodone, combo products
C-II opioids

279
Q

Tussionex

A

hydrocodone/chlorpheniramine
C-II opioids

280
Q

Vicodin

A

hydrocodone, combo products
C-II opioids

281
Q

Vicoprofen

A

hydrocodone/ibuprofen
C-II opioid

282
Q

Dilaudid

A

hydromorphone
C-II opioids

283
Q

Demerol

A

meperidine
C-II opioids

284
Q

Methadone HCl Intensol

A

methadone
C-II opioids

285
Q

Methadose

A

methadone
C-II opioids

286
Q

Kadian

A

morphine
C-II opioids

287
Q

MS Contin

A

morphine
C-II opioids

288
Q

Duramorph, Infumorph, Mitigo

A

morphine [additional names]
C-II opioids

289
Q

OxyContin

A

oxycodone, single ingredient
C-II opioids

290
Q

Roxicodone

A

oxycodone, single ingredient
C-II opioids

291
Q

Oxaydo, Xtampza ER

A

oxycodone, single ingredient [additional names]
C-II opioids

292
Q

Endocet

A

oxycodone/APAP
C-II opioids

293
Q

Percocet

A

oxycodone/amphetamine
C-II opioids

294
Q

Percodan

A

oxycodone/aspirin
C-II opioids

295
Q

Opana

A

oxymorphone
C-II opioids
*tk on empty stomach

296
Q

Nucynta, Nucynta ER

A

tapentadol
C-II opioids

297
Q

Adzenyza ER

A

amphetamine
C-II ADHD stimulants

298
Q

Adzenys ER-ODT

A

amphetamine
C-II ADHD stimulants

299
Q

Dyanavel XR

A

amphetamine
C-II ADHD stimulants

300
Q

Evekeo, Evekeo ODT

A

amphetamine
C-II ADHD stimulants

301
Q

Adderall, Adderall XR

A

amphetamine/dextroamphetamine
C-II ADHD stimulants

302
Q

Mydayis

A

amphetamine/dextroamphetamine
C-II ADHD stimulants

303
Q

Focalin, Focalin XR

A

dexmethylphenidate
C-II ADHD stimulants

304
Q

Dexedrine

A

dextroamphetamine
C-II ADHD stimulants

305
Q

Vyvanse

A

lisdexamfetamine
C-II ADHD stimulants

306
Q

Desoxyn

A

methamphetamine
C-II ADHD stimulants

307
Q

Concerta

A

methylphenidate
C-II ADHD stimulants

308
Q

Daytrana

A

methylphenidate patch
C-II ADHD stimulants

309
Q

Ritalin, Ritalin LA

A

methylphenidate
C-II ADHD stimulants

310
Q

Adhansia XR

A

methylphenidate
C-II ADHD stimulants

311
Q

Aptensio XR

A

methylphenidate
C-II ADHD stimulants

312
Q

Cotempla XR-ODT

A

methylphenidate
C-II ADHD stimulants

313
Q

Jarnay PM

A

methylphenidate
C-II ADHD stimulants

314
Q

Metadate CD

A

methylphenidate
C-II ADHD stimulants

315
Q

Methylin

A

methylphenidate
C-II ADHD stimulants

316
Q

QuilliChew ER

A

methylphenidate ER chewable
C-II ADHD stimulants

317
Q

Quillivant XR

A

methylphenidate
C-II ADHD stimulants

318
Q

Syndros

A

dronabinol solution
C-II

319
Q

Nembutal

A

pentobarbital
C-II

320
Q

Seconal

A

secobarbital
C-II

321
Q

Butrans

A

buprenorphine, single ingredient
C-III

322
Q

Belbuca

A

buprenorphine, single ingredient
C-III

323
Q

Buprenex

A

buprenorphine, single ingredient
C-III

324
Q

Probuphine

A

buprenorphine, single ingredient
C-III

325
Q

Sublocade

A

buprenorphine, single ingredient
C-III

326
Q

Suboxone

A

buprenorphine/naloxone
C-III

327
Q

Zubsolv

A

buprenorphine/naloxone C-III

328
Q

Fioricet

A

butalbital/APAP/caffeine
C-III

329
Q

Fioricet w/ Codeine

A

APAP/butalbital/caffeine/codeine
C-III

330
Q

Fiorinal

A

butalbital-containing products
C-III

331
Q

Fiorinal w/ Codeine

A

butalbital/aspirin/caffeine + codeine
C-III

332
Q

Allzital

A

butalbital/APAP
C-III

333
Q

Bupap

A

butalbital/APAP

C-III

334
Q

Tylenol w/ Codeine #3

A

codeine/APAP
C-III

335
Q

Tylenol w/ Codeine #4

A

codeine/APAP
C-III

336
Q

Marionol

A

dronabinal capsules
C-III

337
Q

Ketalar

A

ketamine
C-III

338
Q

Fycompa

A

perampanel
C-III

339
Q

Xyrem

A

sodium oxybate
C-III

340
Q

Androderm

A

testosterone and all anabolic steroids
C-III

341
Q

AndroGel

A

testosterone and all anabolic steroids
C-III

342
Q

Aveed

A

testosterone and all anabolic steroids
C-III

343
Q

Depo-Testosterone

A

testosterone and all anabolic steroids
C-III

344
Q

Fortesta

A

testosterone and all anabolic steroids
C-III

345
Q

Jalenzo

A

testosterone and all anabolic steroids
C-III

346
Q

Natesto

A

testosterone and all anabolic steroids
C-III

347
Q

Testim

A

testosterone and all anabolic steroids
C-III

348
Q

Testopel

A

testosterone and all anabolic steroids
C-III

349
Q

Vagelxo

A

testosterone and all anabolic steroids
C-III

350
Q

Xyosted

A

testosterone and all anabolic steroids
C-III

351
Q

Alprazolam Intensol

A

alprazolam
C-IV BZD

352
Q

Xanax, Xanax XR

A

alprazolam
C-IV BZD

353
Q

Librium

A

chlordiazepoxide
C-IV BZD

354
Q

Onfi

A

clobazam
C-IV BZD

355
Q

Sympazan

A

clobazam
C-IV BZD

356
Q

Klonopin

A

clonazepam
C-IV BZD

357
Q

Tranxene-T

A

chlorazepate
C-IV BZD

358
Q

Diastat AcuDial

A

diazepam
C-IV BZD

359
Q

Diazepam Intensol

A

diazepam
C-IV BZD

360
Q

Valium

A

diazepam
C-IV BZD

361
Q

Ativan

A

lorazepam
C-IV BZD

362
Q

Lorazepam Intensol

A

lorazepam
C-IV BZD

363
Q

Versed

A

midazolam
C-IV BZD

364
Q

Mayzilam

A

midazolam
C-IV BZD

365
Q

Seizalam

A

midazolam
C-IV BZD

366
Q

Doral

A

quazepam
C-IV BZD

367
Q

Byfavo

A

remimazolam
C-IV BZD

368
Q

Restoril

A

temazepam
C-IV BZD

369
Q

Halcian

A

triazolam
C-IV BZD

370
Q

Lunesta

A

eszopiclone
C-IV hypnotic

371
Q

DayVigo

A

lemborexant
C-IV hypnotic

372
Q

Belsomra

A

suvorexant
C-IV hypnotic

373
Q

Sonata

A

Zaleplon
C-IV hypnotic

374
Q

Ambien, Ambien CR

A

zolpidem
C-IV hypnotic

375
Q

Edluar

A

zolpidem
C-IV hypnotic

376
Q

Zolpimist

A

zolpidem
C-IV hypnotic

377
Q

Adipex-P

A

phentermine
C-IV weight loss drugs

378
Q

Lomaira

A

phentermine
C-IV weight loss drugs

379
Q

Qsymia

A

phentermine/topiramate
C-IV weight loss drugs

380
Q

Nuvigil

A

armodafinil
C-IV

381
Q

Stadol

A

butorphanol
C-IV

382
Q

Soma

A

carisoprodol
C-IV

383
Q

Motofen

A

difenoxin/atropine
C-IV

384
Q

Viberzi

A

eluxadoline
C-IV

for IBS-D

385
Q

Provigil

A

modafinil
C-IV

386
Q

Ultram

A

tramadol
C-IV

387
Q

ConZip

A

tramadol
C-IV

388
Q

Ultracet

A

tramadol/APAP
C-IV

389
Q

Briviact

A

brivaracetam
C-V

390
Q

Cheratussin AC

A

codeine containing cough syrups
C-V

391
Q

G Tussin AC

A

guaifenesin/codeine
C-V

392
Q

Robitussin A-C

A

guaifenesin/codeine
C-V

393
Q

Virtussin A/C

A

guaifenesin/codeine
C-V

394
Q

Lomotil

A

diphenoxylate/atropine
C-V

395
Q

Vimpat

A

lacosamide
C-V

396
Q

Lyrica, Lyrica CR

A

pregabalin
C-V

397
Q

barbiturate schedules

A

C-II: single-entity oral pentobarbital or secobarbital
C-III: pentobarbital & secobarbital in suppository or combo with non-controlled substance
C-IV: phenobarbital

398
Q

codeine schedules

A

C-II: single-entity
C-III: combo tabs/caps
C-IV: combo cough syrups

399
Q

dronabinol schedules

A

C-II: PO sol [Syndros]
C-III: PO caps [Marinol]

400
Q

diff between CBD & THC

A
  • CBD: doesn’t cause high but has anxiolytic [relaxing] effect
  • THC: psychoactive effect
401
Q

Epidiolex

A

cannabidiol
non-controlled
CBD-derived

402
Q

Cesamet

A

nabilone
C-II for CINV

403
Q

regulation of cannabis products in CA

A
  • federal law states that CBD derived from other source cannot be used in dietary supplements → Farm Bill allows CBD from hemp for topical products
  • pharmacies aren’t permitted to sell marijuana → be aware of DDIs
  • CBD & THC are CNS depressants & CYP450 substrates
404
Q

DEA form #224

A

registration form for retail pharmacies, hospitals/clinics. teaching institutions, practitioners or mid-level practitioners

405
Q

DEA form #225

A

registration form for drug manufacturers, distributors & researchers

406
Q

DEA form #363

A

registration form for narcotic trx clinics

407
Q

DEA form #510

A

registration form for bulk chemical manufacturers & distributors

408
Q

DEA form #222

A

ordering form for C I-II drugs

409
Q

DEA form #106

A

reporting form for theft or significant loss of controlled substances

410
Q

DEA form #41

A

record of controlled substances destroyed

411
Q

who must register with the DEA to prescribed controls

A
  • individuals except for medical residents in HCF [use facility’s DEA]
  • facilities in manufacture, distribution, research, prescribing & dispensing of controls
412
Q

which facilities do HCPs not have to register with DEA to prescribe, administer or dispense controls

A
  • Federal Bureau of Prisons
  • Indian Health Service
  • US Armed Forces
  • US Public Health Service
413
Q

how to order C III-IV drugs

A
  • use purchase order or CSOS
  • need name, formulation, # dosage units & # of packages
414
Q

how to order C I & II drugs

A
  • PIC must register with DEA using Form 224
  • CSOS can be used to order C I-IV & DEA form 222 for C I-II
  • each pharmacy has 1 designated registrant to order CI-IIs but can give POA to another
  • need copy of form 222 during distribution, purchase or transfer
415
Q

provisions of the use of a POA

A
  • can be granted to licensed or unlicensed pharmacy personnel
  • registrant can grant multiple POAs
  • registrant can terminate POA w/ notice of revocation
  • need new POA if diff person signs renewal application
  • POA should be filed at pharmacy & readily retrievable [not submitted to DEA]
416
Q

DEA form 222 details

A
  • paper
  • limit 10 items [triplicate] or 20 items [single-sheet]
    • triplicate not used anymore
  • orders C-I & II
  • 2-5 business days
  • handwritten sig
  • can endorse order to another supplier
  • supplier must report transaction to DEA by the end of the month
417
Q

CSOS details

A
  • electronic
  • no limit on orders
  • orders C-I to IV
  • 1-2 business days
  • digital sig
  • CANNOT endorse order to another supplier
  • supplier must report within 2 business days of filling the order
418
Q

items preprinted on DEA form 222

A
  • serial number
  • pharmacy name & address
  • pharmacy DEA #
  • drug schedules that pharmacy is permitted to order
419
Q

CII drug transaction: pharmacy orders drugs from a supplier

A

copy 1 [brown]: supplier
copy 2 [green]: DEA
copy 3 [blue]: pharmacy

420
Q

CII drug transaction: pharmacy returns unused drugs back to a supplier

A

copy 1 [brown]: pharmacy
copy 2 [green]: DEA
copy 3 [blue]: supplier

421
Q

CII drug transaction: pharmacy sends unused drugs back to reverse distributor for disposal

A

copy 1 [brown]: pharmacy
copy 2 [green]: DEA
copy 3 [blue]: reverse distributor

422
Q

CII drug transaction: pharmacy sells or lends drugs to another pharmacy

A

copy 1 [brown]: supplying pharmacy
copy 2 [green]: DEA
copy 3 [blue]: receiving pharmacy

423
Q

CII drug transaction: pharmacy sells or lends drugs to a physician for administration or dispensing

A

copy 1 [brown]: pharmacy
copy 2 [green]: DEA
copy 3 [blue]: physician

424
Q

ordering w/ form 222 step 1 - purchaser

A

both forms:
- fil out name & address of supplier
- enter drugs & confirm # ordering
- sign/date

triplicate form diff:
- 10 lines → max 10 ordered
- keep copy 3 [blue] & send copies 1 & 2 to supplier

single-sheet diff:
- 20 lines → max 20 items ordered
- make a copy of form & keep for 3 years
- send form to supplier

425
Q

ordering w/ form 222 step 2 - supplier

A

both forms:
- return form is missing info, sloppy, illegible
- fill in NDA & number of containers shipped
- if unable to provide full quantity, provide partial & supply balance within 60 days or endorse to other supplier

triplicate form diff:
- keep copy 1 [brown] & send copy 2 [green] to DEA by end of the month

single-sheet diff:
- keep original copy for 3 years

426
Q

ordering with form 222 step 3 - purchaser

A

both forms:
- check order & record number of packages & date received

triplicate diff:
- record info on copy 3 [blue]
- keep copy 3 for 3 years

single-sheet diff:
- complete part 5 once drugs arrive

427
Q

ordering w/ CSOS

A
  • needs personal digital certificate to sign orders
  • uses DEA-approved software → sign in & submit order
  • supplier verifies certificate & fills it & must report transaction to DEA within 2 days
428
Q

advantages of CSOS

A
  • reduced ordering errors
  • decreased paperwork
  • reduced administrative costs
  • foster drug delivery
  • easy to use
429
Q

how to deal with completed lost/stolen DEA form 222

A
  • purchaser must resubmit order with a new form 222
  • provide statement about serial number, date of initial order, how order wasn’t received
430
Q

how to deal with unused lost/stolen DEA form 222

A
  • notify DEA immediately
  • provide serial number of each form → unless entire book is missing, then give approximate date
431
Q

how to deal with lost electronic control order

A
  • purchaser must give signed statement to supplier w/ unique tracking number & date of order
  • if replacement order is made, purchaser must e-link new order
432
Q

how to transfer controls to another pharmacy, supplier or manufacturer

A
  • use DEA form 222 or CSOS to transfer C I-IIs
  • use invoice or CSOS to transfer C III-Vs
  • keep records for 3 years
433
Q

distribution of controls when pharmacy is going out of business

A
  • pharmacy can transfer controls once DEA is confirmed
  • complete inventory is done → final for closing pharmacy & initial for new pharmacy
  • each pharmacy must keep records for ≥3 years
434
Q

how does a pharmacy sell controlled substances

A
  • both parties must be registered with DEA to dispense controls
  • total quantity sold cannot exceed 5% of total quantity dispensed each year
  • use form 222 to sell → forward copy 2 to DEA by end of the month
  • HCP cannot write Rx for office use or dispense directly to pts
435
Q

how to cancel/void control orders

A
  • notify supplier in writing & indicate cancellation
  • supplier can void order by notifying purchaser in writing
  • an endorse to another supplier to fulfill [only if paper form used]
436
Q

when must a pharmacy report significant loss/theft of a controlled substance

A

within 1 business day of discovery

437
Q

how to deal with loss/theft of controlled substances

A
  • report significant loss/theft to DEA within 1 business day
  • do investigation & submit form 206 to DEA w/ findings → don’t submit if it didn’t occur but notify DEA in writing
  • report to BOP within 14 days
438
Q

when must a pharmacy report to BOP about controlled substance losses

A

within 14 calendar days

439
Q

when must a pharmacy report to BOP about other losses

A

within 30 calendar days

440
Q

considerations to determine if loss of theft is significant

A
  • specific substances lost/stolen & likelihood for diversion
  • quantity lost in relation to type of business
  • individuals with access to lost or stolen drug
  • hx or pattern of losses or local diversion issues
  • unique circumstances surrounding the loss of theft
441
Q

reporting in-transit losses

A
  • report to DEA verbally immediately & in writing within 3 days
  • supplier is responsible for reporting loss to DEA
  • pharmacy is responsible for making the report if registrant already signed for the delivery
442
Q

registrants returning controlled substances to supplier

A
  • can return → RPh must maintain written record
  • new form 222 or e-version must accompany return
  • triplicate form: supplier will keep copy 3 & send copies 1-2 to pharmacy → pharmacy forward copy 2 to DEA
443
Q

registrants sending controls to reverse distributor

A
  • reverse distributor must register with DEA
  • must issue form 222 to pharmacy that’s transferring C-IIs for disposal
  • keep record for transferring III-V
  • DEA form 41 documents destruction of controls → reverse distributor submits to DEA
444
Q

NP control prescribing authority

A

C II-V

445
Q

PA control prescribing authority

A

C II-V

446
Q

RPh control prescribing authority

A

C II-V

447
Q

ND control prescribing authority

A

C III-V [no C II!!]

448
Q

valid DEA number

A
  • 1st letter: type of practitioner/institution
  • 2nd letter: first letter of prescriber’s last name
  • 7 numbers
449
Q

DEA number - first letter A/B/F/G

A

hospital, clinic, practitioner, teaching institution, pharmacy

450
Q

DEA number - first letter M

A

mid-level practitioner

451
Q

DEA number - first letter P/R

A

manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program

452
Q

DEA number - first letter X

A

DATA-waived practitioner

453
Q

how to determine the validity of a DEA number

A
  1. add 1st, 3rd & 5th digits
  2. add 2nd, 4th & 6th digits
  3. multiply step 2 by 2
  4. add step 1 & step 3 together → last digit should match last digit in DEA#
454
Q

NABP red flags

A
  • frequent requests for early fills
  • prescriber/pt location far
  • pt profile shows multiple prescribers for duplicate therapy
  • similar/identical prescriptions for multiple pts from same prescriber
  • prescription not within prescriber’s scope of practice
  • pts presenting in groups
  • unusual pt behavior
  • pt pays cash
  • use of street slang to refer to med
  • pt prescribed “drug cocktail”
  • pending federal or state action against prescriber
455
Q

CURES

A
  • CA’s PDMP → reviews all controls that have been prescribed & dispensed to a pt
  • must submit dispensing data to CURES within 1 working day
  • must register with CURES
  • prescribers must check before prescribing controls for the first time & at least every 6 months after → no earlier than 24 hours or on previous business day
456
Q

how long are controlled prescriptions valid for

A

6 months

457
Q

out of state prescriptions

A
  • if prescriber is out of state, prescription must meet controlled substance requirements of that state & prescriber must be registered with FDA
  • C II: CA pharmacy can fill but must be delivery only
  • C III-V: CA may dispense directly or deliver by mail
458
Q

requirements on CA security forms

A
  • void appears when photocopied/scanned
  • chemical void protection
  • watermark “California Security Prescription”
  • thermochromic ink
  • area w/ opaque writing
  • description of security features
  • quantity check off boxes
  • preprinted name of prescriber
  • refill check off boxes
  • check box for substitution
  • unique serial number
458
Q

11159.2 exemption

A

pt is terminally ill [life expectancy ≤1 year]

458
Q

11159.3 exemption

A
  • declared emergency when CA BOP has issued notice of exemption
  • NMT 7 day supply for controls
458
Q

faxed control prescriptions

A
  • can fax C III-V but needs prescriber’s manual signature on fax before sending
  • use regular prescription form
  • faxed C IIs are not original prescription → only faxed to let pharmacy prep while pt brings over actual prescription
458
Q

calling in control prescriptions

A
  • only for C III-V
  • not for C II → except for emergency situations
458
Q

EPCS for controls

A
  • use DEA approved software
  • credentials are validation of something you know, have or are → 2/3 needed
  • two-factor authentication
  • alt: digital certificate
458
Q

what can’t RPh make changes to on C II prescriptions

A
  • issue date
  • prescriber name
  • prescriber sig
  • pt name
  • drug name
459
Q

medicare part D opioid limits on initial prescription

A

7 days

459
Q

partial filling of C IIs circumstances

A
  1. pharmacy cannot supply full quantity & partial given until rest can be obtained [within 72 hours]
    - pursuant to written or emergency oral prescription
    - document quantity supplied
  2. 2016 CARA - RPhs can fill at request of pt or prescriber to prevent stockpiling of unused CIIs
    - additional partial fills can be dispensed up to 30 days from date issued
    - no limit on number of partial fills
  3. can give partial for LTCF or terminal illness pt
    - document “terminally ill” or “LTCF pt”
    - can dispensed for up to 60 days on date issued
459
Q

emergency filling of CIIs

A
  • can dispense oral prescription if drug is needed immediately to avoid pt harm & there’s no reasonable alternative
  • make good faith effort to decide that prescriber is DEA registered
  • dispense minimum necessary
  • prescribers must provide original prescriptin within 7 days → say Authorization for Emergency Dispensing & date of oral prescription
  • if original prescription isn’t received, must report to California Bureau of Narcotic Enforcement within 144 hours
459
Q

multiple prescriptions for C-IIs

A
  • cannot refill C IIs
  • can have multiple prescriptions at one time for C-IIs → fill sequentially but can’t exceed 90 day supply
  • cannot be post-dated → data written & earliest acceptable fill date
460
Q

C III & IV refills

A
  • refill up to 5 times within 6 months
  • total of refills cannot exceed 120 day supply
  • original fill doesn’t count as refill
460
Q

partial fills for C III-V

A
  • permitted if recorded in same manner as refill & total dispensed in all fills doesn’t total quantity prescribed
  • no dispensing beyond 6 months from issue date
  • partial fills aren’t refills
460
Q

C V refills

A
  • refilled up to 6 months of issue date
  • no refill or day supply limit as long as refills are authorized by prescriber
460
Q

california controlled substance label requirements

A
  • Opioid. Risk of overdose and addiction → required on outpatient containers
  • Impaired ability to operate a vehicle or vessel → label required
  • Substantial risk when drug is taken in combination with alcohol → label required
  • ⭐Required on C II-IV: CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed
460
Q

transferring controls

A
  • cannot transfer C IIs
  • C III-Vs can be transferred one time only by 2 licensed RPhs
  • keep records for 3 years
461
Q

methadone dose for opioid addiction trx

A

40mg soluble tab

461
Q

mailing controls

A
  • prescription in plain outer container or securely wrapped in plain paper
  • prescription label contains name & address of pharmacy, practitioner or other person dispensing the prescriptions
461
Q

methadone clinics for opioid addiction

A
  • practitioner needs approval & certification by CSAT
  • OTP can dispense & administer methadone for opioid dependence
  • OTP practitioner cannot prescribe
  • pts must visit every day to get supervised date → take-home dose when OTP is closed & longer if eligible
461
Q

methadone take-home supply dispensing restrictions

A
  • first 90 days: up to 1 take-home dose/week
  • second 90 days: up to 2 take-home doses/week
  • third 90 days: up to 3 take-home doses/week
  • > 720 days & less than 1 year: max 6-day suppl
  • after 1 year: max 2 week supply
  • after 2 years: max 1 month supply & must have monthly visits
462
Q

comprehensive addiction & recovery act [CARA] of 2016

A
  • expanded DATA-waived practitioners to NPs & PAs
  • only prescribe buprenorphine for 5 year period
462
Q

substance use-disorder prevention that promotes opioid recovery & treatment [SUPPORT] for patients and communities act of 2018

A
  • NPs & PAs have permanent prescribing authority of buprenorphine
  • expanded to include qualified clinical nurse specialists, certified registered nurse anesthetists & certified nurse midwives
  • up to 100 pts in first time as practitioner → 275 after
462
Q

drug addiction treatment act of 2000

A
  • physicians can treat opioid dependence w/ narcotics [buprenorphine] in office-based setting
  • need specific training
  • DATA 2000 waiver unique ID number
  • max 30 pts in first year & then 100 pts after
462
Q

what must a prescription for opioid dependence have

A

prescriber’s UIN & DEA

462
Q

buprenorphine for opioid addiction

A
  • prescriber must have DATA waiver
  • buprenorphine: Probuphine, Sublocade
  • buprenorphine/naloxone: Suboxone, Bunavail, Subsolv
463
Q

combat methamphetamine epidemic act of 2005

A
  • limits widespread availability of pseudoephedrine, ephedrine, phenylpropranololamine & norpseudosphedrine
463
Q

requirements for OTC sales of CMEA drugs

A
  • pseudoephedrine, ephedrine & logbook must be kept behind the counter or in locked cabinet
463
Q

restricted sale of dextromethorphan

A
  • OTC cough suppressant → abused in high doses
  • cannot sell to <18
  • need government-issued ID
463
Q

max limits for OTC sales

A

pseudoephedrine & ephedrine:
- 3.6g/day
- 9g/30 days
- 7.5g/30 days for each mail-order purchase
- 3 packages/transaction

463
Q

buprenorphine for pain management

A
  • prescriber must specify the prescription is for pain
  • buprenorphine: Butrans, Belbuca, Buprenex
464
Q

restricted sale of hypodermic needles & syringes

A
  • Rph knows pt has previous prescription or legitimate medical need
  • ≥18 as public health measure → no limit
  • use for animals
464
Q

CAUTION: Federal law PROHIBITS transfer of the drug to any person other than the pt for whom it was prescribed

A
  • federal law requires all C II-IVs have this
464
Q

CAUTION: OPIOID. risk of overdose and addiction

A
  • state law requires for drugs with single or combo opioids
  • addition to cautionary statement by federal law to C II, IIII & IV drugs
464
Q

epinephrine 1:1000 to mg/mL

A

1 mg/mL

464
Q

epinephrine 1:10,000 to mg/mL

A

0.1 mg/mL

464
Q

sedatives monitoring

A

RR & mental status

464
Q

may cause DROWSINESS. USE CARE when operating a car or dangerous machinery

A
  • state law requires for muscle relaxants, antipsychotics, antidepressants, AHs, motion sickness drugs, antipruritics, antiemetics, anticonvulsants & antihypertensives, controls, anticholinergics
464
Q

check for peanut or soy allergy

A

required for:
- progesterone [Prometrium only]
- clevidipine [Cleviprex]
- propofol

464
Q

anticoagulants monitoring

A
  • baseline labs [INR, aPTT, CBC]
  • lab goals [indications based]
  • symptoms of bleeding
  • reversal strategy
464
Q

do not take this drug if you become PREGNANT

A

for:
- ACE-Is, renin inhibitors
- Angiotensin II receptor blockers
- Statins
- Warfarin
- Hormones [most, including estradiol, progesterone, raloxifene, testosterone, contraceptives]
- Isotretinoin & topical retinoids
- Paroxetine
- VPA, CBZ, PHT, PHB
- Lithium, topiramate
- NSAIDs
- Ribavirin
- Misoprostol, methotrexate
- Leflunomide, lenalidomide, thalidomide
- Dutasteride, finasteride

465
Q

CAUTION: do not take with alcohol or nonprescribed drugs w/o consulting your doctor

A
  • state law requires for:
    • dilsulfiram & other drugs [chlorproamide, metronidazole, tinidazole]
    • MAOIs
    • nitrates
    • cyclosporine
    • antidiabetic agents
    • opioids, tramadol, BZDs, barbiturates, non-BZD hypnotics, AEDs, antipsychotics, some antidepressants, skeletal muscle relaxants
466
Q

high alert double check

A

ISMP requires for:
- adrenergic agonists → epi
- adrenergic antagonists → beta-blockers
- sedatives → midazolam [Versed], propofol [Diprivan]
- antiarrhythmics → amiodarone, sotalol
- anticoagulants → heparin, argatroban, warfarin
- insulin
- positive inotropes → dobutamine, milrinone
- opioids→ hydromorphone, fentanyl
- electrolytes → hypertonic saline, K+

467
Q

insulin monitoring

A
  • BG & K+
  • rate adjustment based on BG
467
Q

positive inotrope monitoring

A

BP, HR, hemodynamic parameters & urine output

467
Q

opioid monitoring

A

oversedation & respiratory depression

467
Q

HIGH ALERT. paralytic

A
  • required for neuromuscular blocking agents: cisatracurium, vecuronium, succinylcholine, rocuronium, pancuronium
  • only give to pt on BOTH analgesic and under deep sedation with pain & sedation assessed continuously
467
Q

IMPORTANT. finish all this medication unless otherwise directed by prescriber

A

required for ABXs, antifungals or antivirals

468
Q

avoid prolonged exposure to sunlight while taking this medication

A

d/t increased skin sensitivity
- sulfa ABX
- quinolones, tetracyclines
- flagyl, isoniazid
- topical retinoids, isotretinoin
- ritonavir
- NSAIDs → piroxicam, diclofenac, ibuprofen, naproxen
- diuretics

468
Q

when taking this medication the effectives of birth control pills are decreased. use additional and/or alternative methods of birth control

A

important to counsel pts
- barbiturates
- SJW
- ampicillin, tetracycline
- rifampin, rifapentaine, griseofulvin
- bosentan
- anticonvulsants → topiramate, lamotrigine, CBZ, primidone, PHT, oxcarbazepine
- some HIV drugs → PIs, NNRTIs

468
Q

may cause blurred vision

A

for meds that cause blurry vision:
- anticholinergics → scopolamine
- voriconazole [Vfend]
- telithromycin
- PDE-inhibitors → sildenafil
- digoxin → yellow/green halos if toxic
- others: hydroxychloroquine, tamoxifen, amiodarone, ethambutol, isotretinoin, isoniazid & ivabradine

468
Q

WARNING: if your stool become soft and water after using this antibiotic, contact your doctor immediately

A

persistent diarrhea d/t colitis may occur weeks after using this med
- clindamycin
- quinolones
- broad-spectrum ABX

468
Q

may cause discoloration of the urine or feces

A
  • entacapone, carbidopa/levodopa
  • metronidazole, rifampin
  • nitrofurantoin, phenazopyridine
  • sulfasalazine
  • doxorubicin, mitoxantrone
  • propofol
469
Q

take med on empty stomach 1 hour before or 2-3 hours after a meal unless otherwise directed by your doctor

A
  • ampicillin, voriconazole
  • efavirenz [Sustiva/Atripla], didanozine [Videx]
  • bisphosphonates
  • captopril
  • iron [if tolerated], PPIs
  • levothyroxine
  • oxymorphone [Opana]
  • mycophenolate [CellCept], tacrolimus extended release [Astragraf XL, Envarsus XR]
  • zafirlukast
469
Q

med should be taken with plenty of water

A
  • bactrim
  • bisphosphates
  • sulfasalazine [Azulfidine] → take w/ water & food
  • pancrelipase
469
Q

take with food

A
  • carvedilol, metoprolol tartrate
  • lovastatin [w/ dinner]
  • fenofibrate & derivatives [Lipofen, Fenoglide]
  • niacin, gemfibrozil [Lopid]
  • metformin [IR w/ breakfast and dinner, XR w/ dinner]
  • itraconazole caps
  • phosphate binders [when eating]
  • NSAIDs, steroids
  • opioids [except Opana]
470
Q

do not take dairy products, antacids or iron preparations within 1 hour of this med

A

can make med less effective
- tetracyclines
- quinolones
- levothyroxine

470
Q

avoid this med with grapefruit or grapefruit juice

A
  • lovastatin, simvastatin, atorvastatin
  • amiodarone, dofetilide
  • cyclosporine, tacrolimus
  • diazepam, triazolam
  • verapamil, nicardipine, felodipine, nisoldipine & nifedipine
470
Q

shake well

A

for meds that may not have equal distribution of drug unless shaken
- suspensions
- most asthma inhalters
- nasal steroid sprays
- lidocaine viscous topical liquid

471
Q

swallow whole, do not crush break or chew

A

can alter effects of med & be dangerous
- EC formulations
- XR< ER, LA, SR, CR, CRT, SA, TR, TD or has 24 in name

472
Q

epidural

A

label to decrease risk of administration via incorrect route

472
Q

chemotherapy drug - toxic. dispose of as bio-hazard

A

need special packaging & labeling for proper handling of the med & proper disposal of the bag and tubing

472
Q

protect from light

A

Protect Every Necessary Med from Daylight [PENMD]
- Phytonadione
- Epoprostenol
- Nitroprusside
- Micafungin
- Doxycycline

472
Q

for central line administration only

A

mainly d/t risk of phlebitis & for vesicant meds [risk of severe tissue damage if line extravasates]

risk of rhlebitis
- parenteral nutrition, most chemotherapeutics
- calcium chloride, hypertonic saline, mannitol, digoxin
- foscarnet, nafcillin, mitomycin
- quinupristin/dalfopristin [Synercid], KCl, amiodarone [concentrated]

vesicants
asopressors [e.g. norepinephrine, dopamine]
athracyclines [e.g. doxorubicin]
inca alkaloids [e.g. vincristine] → do not administer vincristine by intrathecal

472
Q

for irrigation only, not for IV use

A

for any type of irrigation
- peritoneal dialysis irrigation solution
- saline & sterile water irrigation solution

472
Q

administer by IM injection

A

label to decrease risk of administration via incorrect route
- preferred route of promethazine inj is IM → CI in <2

472
Q

do not refrigerate

A

Dear Sweet Pharmacist, Freezing Makes Me Edgy [DSPFMME]
- Dexmedetomidine
- Sulfamethoxazole/Trimethoprime
- Phenytoin
- Furosemide
- Metronidazole
- Moxifloxacin
- Enoxaparin

472
Q

refrigerate

A

36-46 F → not frozen or at room temp
- ABX suspensions [refrigerate after reconstitution]: amoxicillin/clavulanate [Augmentin], amoxicillin [refrigeration not required, but improves taste], cefpodoxime, cefproxil, cefuroxime [Ceftin], ceftibuten, cephalexin [Keflex], erythromycin/benzoyl peroxide gel [Benzamycin], penicillin V
- eyedrops: latanoprost [Xalatan - unopened], tafluprost [Zioptan - unopened]
- others: adalimumab [Humira], dronabinol [Marinol, Syndros], etanercept [Enbrel], calcitonin nasal [Miacalcin], ESAs [Epogen, Aranesp, Procrit], etoposide [VePesid], filgrastim [Neupogen], insulins [that pt isn’t using], interferons [all], lopinavir/ritonavir solution [Kaletra], alprostadil [Muse, Caverject], ritonavir soft gel capsule [Norvir], octreotide [Sandostatin], sirolimus solution [Rapamune], teriparatide [Forteo], thyrolar [Liotrix], lactobacillus [Visbiome], NuvaRing [prior to dispensing, pt can keep at room temp], promethazine supp, typhoid oral caps [Vivotif], formoterol [prior to dispensing, pt can keep at room temp], dornase alfa [Pulmozyme]

472
Q

for external use only

A

topical
- “For the Eye”
- “For the Ear”
- “For the Nose”
- “For Rectal Use Only”
- “For Vaginal Use Only”
- “Not to be Taken by Mouth”

473
Q

filter

A

That’s my GAL, PLAT
- Golimumab
- Amiodarone
- Lorazepam
- Phenytoin
- Lipids
- Amphotericin B
- Taxanes

CPJE (3 decks)

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