law stuff Flashcards
what must pharmacy staff name tags say
name & license status
when must licensees join the BOP’s email notification list?
within 60 days of being licensed
how many pharmacies can a PIC supervise
2 pharmacies as long as they’re within 50 driving miles away
when should the BOP be notified about a PIC change
old PIC must report within 30 days
when is the biennial Self-Assessment form due
before july 1st of each odd numbered year
when should additional Self-Assessment forms be done
- within 30 days if a new permit was issued
- if there’s a new PIC
- when pharmacy moves to a new location
how long is the Self-Assessment form kept
3 years
what services can RPhs do
- 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
what CE do RPhs have to do
- 30 hours of CE during each 2 year license renewal
- ≥2 hours of pharmacy law & ethics
what day do RPh licenses expire
- on the last day of their birth month
how long do RPhs have to keep their certification for
4 years
how many interns per RPh
2 interns
how many techs per RPh in community setting?
1 tech with 1st RPh, 2 per additional RPh
how many techs per RPh in hospital setting
2 techs per RPh
how many tech trainees per RPh
1 per RPh for 120-140 hour training period; 340 hours if externship is between hospital & community
how many clerks per RPh
reasonable number per RPh’s discretion
what are advance practice pharmacists do
initiate, adjust & d/c drug therapy per protocol
criteria to be an advanced practice pharmacist
- 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
requirements to be an intern pharmacist
- 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
tech-check-tech
- 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
what can pharmacy clerks do
put drugs on the shelf & give pts their prescriptions during transaction
what is the pharmacist recovery program for substance abuse & mental illness
- 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
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
14 days
who can keep an extra key to the pharmacy
pharmacy owner, building owner or manager in tamper-evident container for purpose of delivering the key to a RPh
what’s the difference between a policy and a procedure
policy: course of action for a specific activity
procedure: steps that must be carried out by the staff [written in policy]
what are required policies & procedures?
- 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
how long must drug acquistion & disposition records be kept
at least 3 years
how long are hospital pharmacy chart orders for controls maintained for
7 years
how long are patient acknowledgements of HIPAA kept for
6 years
how long is transaction info, history and statement for most prescription drugs under Drug Supply Chain Security Act kept for
6 years
how long must a certificate for completion of CE be kept for
4 years
how long must community or clinic pharmacy prescriptions be kept for
3 years
how long must hospital pharmacy chart orders for non-controls be kept for
3 years
how long must be quarterly C-II inventory be kept for
3 years
how long must DEA forms 222, CSOS records, & power of attorney forms be kept for
3 years
how much purchase invoices for all prescription drugs be kept for
3 years
how long should self-assessment forms be kept for
3 years
how long should documentation of drug returns be kept for
3 years
how long should documentation of transfers be kept for
3 years
how long should theft/loss reports of controls be kept for
3 years
how long should biennial controlled substances inventory be kept for
2 years
how long should pseudoephedrine. ephedrine, phenylpropranolamine & norpseudoephedrine sales logs be kept for
2 years
how long should pt med profiles be kept for
1 year
how long should med error/quality assurance reports be kept for
1 year
when should a change of RPh address or name be reported
within 30 days
when should a change of PIC be reported
within 30 days
when should changes in the pharmacy permit be reported
within 30 days
when should theft by or impairment of a licensee be reported
within 14 days
when should loss/theft of controlled drugs be reported
report to DEA immediately [1 business day]
report to CA BOP within 30 days
when should bankruptcy, insolvency or receivership be reported
immediately
when should a completion of self-assessment form be done
- 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
when should biennial controlled substance inventory be done
every 2 years
when should RPh CE [30 hours] be done
every 2 years, except first cycle
when should C-II inventory be done [CA requirement]
every 3 months
when should med error investigations be done
within 2 days of error
when should submitting dispensing data to CURES be done
within 1 business day of dispensing
what are options for filing controlled substances paper prescriptions
- 3 separate files → C II, C III-V, non-controlled
- 2 separate files → C II, all others [CIII-V need red C stamp]
when should a new PIC do a C II inventory
within 30 days of their appointment as PIC
when is inventory counted (time)
beginning or close of business → not during business hours
inventory counting - unopened containers
exact count needed → use number listed on bottle
inventory counting - opened containers
- C I & II need exact count
- C III-V with ≤1000 units can be estimated
- C III-V with >1000 units need exact count
how can pharmacies have off-site storage of records
- BOP has to approve waiver → signed copy goes to pharmacy within 30 days
when must pharmacies produce records if the BOP requests it
within 2 business days upon request
how long do you keep non-control Rxs
- at least 1 year at the pharmacy
- 2 years off-site after initial year
- throw away after 3 years
how long do you keep control Rxs
- at least 2 years
- 1 year offsite after initial year
types of DME
- blood glucose monitors, test strips, lancet devices & lancets
- nebulizers & nebulized drugs
- CPAP machines
- prosthetics, orthotics & supplies
- ostomy supplies
- walkers, scooters, canes & commode seats
how can we bill Medicare for DME
with DWO → need prescriber’s signature & date + detailed description of item
drug supply chain security act of 2013
outlines steps to build system to track & tract drugs as they’re distributed in the US → prescription meds for human use
what must be maintained for each product received
- transaction information
- transaction history
- transaction statement
transaction history
statement w/ transaction info for each prior transaction
transaction info
- 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
transaction statement
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
adulteration
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
misbranding
involves incorrect or missing info on the label
- lack of required info
- false/misleading ifno
- improper packaging
- ingredients differ from standard quality
when must the hospital drug supply be checked
every 30 days
how long are the records kept for the hospital drug supply checks kept
3 years
when must irregularities found during hospital durg supply check be reported
within 24 hours to PIC & director or chief executive officer
how are controlled drugs stored
locked cabinet or dispersed throughout the other drug stock
how are investigational new drugs stored
separate from other drug stock
how are repackaged/resold drugs stored
separate from other drug stock, assigned a BUD
how are recalled drugs stored
separate from other drug stock
how are expired drugs stored
separate from other drug stock
how are drug samples stored
separate from other drug stock, not allowed in retail pharmacies
how are drug supplies for medical emergencies supplied at nursing units or service areas
portable container sealed by RPhs → contents listed on outside cover & have earliest expiration date of any drugs within
drug recall
drug is removed from market bc its defected or potentially harmful
what is the RPh responsible for in a class I recall
determining which pt got the med & notifying their prescriber
who is the manufacturer responsible for notifying during drug recalls
customers → distributors & patients
class I drug recall
reasonable probability that use or exposure to the drug will cause serious adverse health consequences or death
class II drug recall
use or exposure to drug will cause temporary or reversible adverse health consequences
class III drug recall
use of or exposure to the drug isn’t likely to cause adverse health consequences
when can a pharmacy or outsourcing contact recipient about a recalled compounded drug?
- use of or exposure can cause serious adverse effects or death AND
- recalled products was dispensed or intended for use in CA
when should the recipient pharmacy, prescriber or pt be notified about a compounded drug recall
within 12 hours
when should the BOP be notified about a compounded drug recall
24 hours
when must a pharmacy report to FDA MedWatch about a compounded drug recall
within 72 hours
when must an outsourcing facility report to FDA MedWatch
within 15 calendar days
can drugs be donated in CA
- 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!!
FDA flush list
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]
pharmacy take-back program
- 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]
when should establishment of the drug take-back service be reported to the BOP
within 30 days
when should discontinuation of the drug take-back service be reported to the BOP
within 30 days
when should any tampering with a collection bin be reported to the BOP
within 14 days
when should theft of deposited drug be reported to the BOP
within 14 days
when should disclosure of service & location of each receptacle be reported to the BOP
annually, at time of facility license renewal
when should a written report about child abuse, elder abuse and neglect by done
within 2 working days or 36 hours of receiving the info concerning the incident
type of prescribing/furnishing authority - physician
independent authority → controls & non-controls
type of prescribing/furnishing authority - dentist, podiatrist, veterinarian
independent authority, limited to scope of practice → controls & non-controls
type of prescribing/furnishing authority - optometrist
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
type of prescribing/furnishing authority - naturopathic doctors
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]
type of prescribing/furnishing authority - RPhs
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
type of prescribing/furnishing authority - CNM, NP, PA
dependent authority → non-controls & controls
what can prescribers self-prescribe
non-controls
what can prescribers prescribe for family members
non-control & controls if there’s a valid physician/pt relationship, legitimate medical purpose & good faith exam
how long is a prescription from a deceased prescriber valid for
until all refills are gone & NMT 6 months from date written [controls] or 1 year [non-controls]
can RPh fill out of state prescriptions
yes if prescriber has license equivalent to CA prescriber → may need to verify license
can RPh fill foreign prescriptions
no; only if from District of Columbia & US territories [Puerto Rico, Virgin Islands, Guam & American Samoa]
requirements for a valid prescription
- patient name & address
- drug name & quantity
- directions for use
- date of issue
- prescriber info
- condition/purpose if requested by patient
- prescriber signature
how long must non-control chart orders be kept for
3 years
how long must control chart orders be kept for
7 years
medi-cal prescription form requirements
- 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
when can you dispense a 90 DS with an initial prescription that specified a shorter time period
- 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
when can you NOT dispense a 90 DS with an initial prescription that specified a shorter time period
- prescriber indicates no change to quantity
- prescriber indicates that dispensing prescribed amount is medically necessary
dispensing hormonal contraceptives
- 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
refill limits
- 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
PRN refills
- allowed for non-controls → don’t refill after 1 year
- not allowed for PRN controls
emergency refills
- 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
refill pharmacies
- 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
prescription refills
- 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
requirements for prescription labels
- 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
critical items on prescription
- 12 pt font
- pt name
- drug name & strength
- clear & simple directions for use
- condition or purpose
less critical items on a prescription
- less prominent location
- pharmacy name, # & prescriber name
dispensing brand name vs generic name on label
- brand name: no need for manufacturer
- generic: must also say generic for ___ & drug manufacturer
expiration dates
- manufacturer’s exp date or 1 year from date dispensed
- no exp date = misbranded
labeling format
50% of label in 12 pt sans serif typeface
- pt name
- drug name & strength
- directions
- indication
translation on labels
- 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
poison prevention packaging act of 1970
- 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
exceptions to C-R packaging
- sublingual NTG
- oral contraceptives
- hormone replacement therapy
- powdered unflavored aspirin
- effervescent aspirin
- powdered iron preparations
- effervescent APAP
waiving C-R packaging
- prescriber can waive C-R for single prescription
- pt can give blanket waiver for all → must document
consumer medication information
- 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
patient package inserts
- 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
medication guides
- 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
drug classes where MedGuides should be given
- antidepressants
- NSAIDs
- insomnia drugs
- LABAs
- ADHD drugs
- diabetes drugs
- antipsychotics
- antiarrhythmics
- retinoids
- others: anticoagulants, bisphosphonates, mAbs, FQs, enbrel, ESAs, opioids, CNIs, controls, chantix
REMS
- 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]
REMS - thalidomide
- risk: severe birth defects
- negative pregnancy test required before dispensing each prescription
REMS - isotretinoin
- risk: severe birth defects
- iPledge
- 2 negative pregnancy test before first fill & 1 negative test before each subsequent fill
REMS - clozapine
- risk: neutropenia
- monitor ANC
REMS- phentermine/topiramate [Qsymia]
- severe birth defects
- MedGuide required, healthcare training program, dispensed only through certified pharmacies
REMS - opioid analgesics
- 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
REMS - flibanserin [Addyi]
- risk: hypotension & syncope due to an interaction w/ alcohol
- no alcohol use while taking it
how long do you keep pt med profiles active
1 year
prospective DUR
- evaluation of pt’s med profile prior to dispensing → done by dispensing RPh each fill
- purpose to optimize pt’s therapy
retrospective DUR
review of drug therpy after drug is dispensed → done by state, medical institutions or insurance
concurrent DUR
ongoing monitoring during course of trx
when must pts be counseled
- 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
what must counseling include
- directions for use & storage
- important of compliance w/ direction
- precautions & relevant warnings
when must RPh be available for counseling
RPh must beat least 6 days of the week & at least 40 hours per week
notice to consumers
- 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
HIPAA 1996
- 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
what’s included as PHI
- 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
who can you share PHI with
- pt
- HCPs
- payment/operational purposes
- limited data for research
- law enforcement
- DEA, FDA & BOP inspectors [for public health purpose]
incidental disclosures
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
privacy notice
- 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
how long must signed HIPAA privacy disclosure forms be kept for
6 years
CA rules for pt obtaining a copy of their records
must be able to inspect medical records within 5 business days & get copies within 15 business days
Orange Book
approved drug products w/ therapeutic equivalence evaluations
how to use the orange book
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
when can RPh substitute a diff formulation
to improve pt compliance → must have same active ingredients of equivalent strength & duration of therapy
which formulations can’t be switched
- long-acting and short-acting
- combo drugs and multiple single agents
biosimilar
highly similar to FDA-approved biologic [reference product]
substituting biologics
- cannot automatically substitute bc not considered therapeutically equivalent
Purple Book
licensed biological products w/ reference product exclusivity & biosimilarity or interchangeability evaluations
formulary
- preferred drug list w/ safest & most effective drugs while considering cost
- determined by P&T
P&T committee
- create & update formulary, conduct MUE/DUEs, monitor/report ADRs, conduct med error safety initiatives & develop clinical care plans/protocols
therapeutic interchange protocol
- 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
legitimate mail order pharmacies
dispense meds pursuant to Rx from prescriber who has performed a good faith medical exam
ryan haight online pharmacy consumer protection act of 2008
prevents illegal sales of controlled substances via the internet
requirements for telepharmacy
- 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
dispensing epi auto-injectors
- 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
dispensing blood clotting products for home use
- 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
dispensing during federal, state or local emergency
- can dispense in reasonable quantities
- keep record of date, pt’s name and address & drug/device name, strength and quantity dispensed
when does the mobile pharmacy have to cease activity after the emergency is over
48 hours
CA end of life option act of 2016
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]
procedure for end of life seppuku
- 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
meds for aid in seppuku
CII secobarbital [cap] & pentobarbital [sol]
- take anti-emetic 1 hour before
requirements for ADDS in SNFs
- 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
when must pharmacies that remotely operate ADDS register ADDS with the BOP
within 30 days of installing the device & then annually
requirements for repackage meds labeling
drug name, strength, dosage form, manufacturer’s name and lot #, exp date & quantity per repackaged unit
centralized hospital packaging
- 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
section 503A
- 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
section 503B
- permits specially licensed compounding facilities to operate as an outsourcing facility → can make bulk meds w/o prescription
- sterile drugs for humans
outsourcing facility requirements
- 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
manufacturing characteristics
- regulation: FDA
- standards: FDA drug approval, USP, CGMPs
- NO individual prescription required
- interstate distribution: yes
traditional compounding characteristics
- regulation: state board
- standards: 503A, USP
- individual prescription required
- interstate distribution: up to 5% of total sales
outsourcing compounding characteristics
- regulation: FDA, state board
- standards: 503B, USP, CGMPs
- NO individual prescription required
- interstate distribution: yes
common HDs
antineoplastics, teratogenics, hormones, transplant drugs
minumum requirements for handing HDs
- 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
nuclear pharmacy requirements
sterile compounding permit from BOP
when must all actions to test ordering, interpreting & management be documented
within 24 hours
SB 493
allows RPhs to administer drugs & biologics by other routes [not PO & TOP] → need adequate training
who can CA RPhs administer routine immunizations to
≥3 year olds
requirements to administer vaccines
- complete CDC or ACIP-approved immunization training program
- maintain BLS certification
- complete 1 hour of CE every 2 years
immunization recordkeeping requirements
- notify PCP & prenatal care provider within 14 days
- report to CAIR
- update pt vaccine administration record
emergency contraception drugs
- 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
furnishing EC protocol
- 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
naloxone
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
how to administer naloxone spray w/ assembly
- take off yellow caps
- put on white caps
- take purple cap off naloxone
- screw on naloxone capsule into syringe barrel
- insert white cone into nostril & give short strong push → ONE HALF OF CAPSULE INTO EACH NOSTRIL
- repeat in 2nd nostril if no reaction in 3 min
how to administer injectable naloxone
- remove cap from vial & uncover needle
- insert needle through rubber plug w/ vial upside down & draw 1mL
- inject into upper arm or thigh
- give 2nd dose if no reaction in 3 min
opioid overdose symptoms
- extreme or unusual somnolence
- respiratory difficulty
- miosis
- bradycardia
furnishing naloxone protocol
- 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
how long must records of furnishing naloxone be kept
3 years
who are at highest risk of opioid overdose
- 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
where can RPhs furnish naloxone pursuant to prescriber’s Rx
school district, county office of education or charter school
furnishing prescription nicotine replacement therapy
- RPhs need minimum 2 hours of CE
- have screening → pregnancy, heart palpitations, irregular heartbeats, arrhythmia, unstable angina, nasal allergies, TMJ dysfunction
how long to keep nicotine furnishing records
3 years
furnishing self-administered hormonal contraceptives
- 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
how long to keep hormonal contraceptive furnishing records for
3 years
sterilization surgery for women
- <1 pregnancies/100 women
- onetime procedure; permanent
- SE: pain, bleeding, ifx/complication after surgery
sterilization implant for women
- <1 pregnancies/100 women
- onetime procedure; permanent
- SE: pain/cramping, pelvic/back discomfort, vaginal bleeding
sterilization surgery for men
- <1 pregnancies/100 women
- onetime procedure; permanent
- SE: pain, bleeding, ifx
IUD copper
- <1 pregnancies/100 women
- inserted by HCP; lasts up to 10 years
- SE: cramps, heavier, longer periods, spotting
IUD with progestin
- <1 pregnancies/100 women
- inserted by HCP; lasts 3-5 years
- SE: irregular bleeding, no periods, abd/pelvic pain
implantable rod
- <1 pregnancies/100 women
- inserted by HCP; last 3 years
– SE: menstrual changes, weight gain, acne, mood swings, HA
shot/injection
- 6 pregnancies/100 women
- need 1 Q3months
- SE: loss of bone density, irregular bleeding, HA, nervousness, abd discomfort, weight gain, dizziness
oral contraceptives
- 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
patch
- 9 pregnancies/100 women
- new patch Qweek x3 weeks, no patch on 4th week
- SE: spotting, nausea, breast tenderness, skin irritation, stomach pain, HA
vaginal contraceptive ring
- 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
diaphragm w/ spermicide
- 12 pregnancies/100 women
- must use every time you have sex
- SE: irritation, allergic rxn, UTI
sponge w/ spermicide
- 12-24 pregnancies/100 women
- must use every time you have sex
- SE: irritation
cervical cap w/ spermicide
- 17-23 pregnancies/100 women
- must use every time you have sex
- SE: irritation, allergic rxn, abnormal pap tets
male condom
- 18 pregnancies/100 women
- must use every time you have sex
- provides protection against some STDs
- SE: irritation, allergic rxn
female condom
- 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
spermicide alone
- 28 pregnancies/100 women
- must use every time you have sex
- SE: irritation, allergic reactions, UTI
levonorgestrel
- 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
ulipristal acetate
- 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
furnishing travel meds
- 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
selective self-diagnosable conditions & treatment options for travel med
- motion sickness: prochlorperazine, scopolamine
- traveler’s disease: azithromycin, cipro, rifaximin
- UTI: nitrofurantoin, bactrim
- vaginal conditions: fluconazole
furnishing PrEP
- 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
furnishing PEP
- 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]
PrEP regimen
Truvada [TDF 300mg/emtricitabine 200mg] QD
PEP regimen
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
clinical laboratory improvement amendments [CLIA]
waives BG, hemoglobin A1C, cholesterol & PT/INR test for RPh can perform them
physical assessment
- conduct pt interview
- obtain health history w/ med use
- measure vital signs: BP, HR, RR, temp
- pain
- physical exam
conduct pt interview
- in area to protect pt privacy
- open-ended questions
- active listening
obtain health history w/ med use
- 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
measuring BP
- 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
measuring HR
- 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
measuring RR
- normal RR: 12-20 breaths per minute
- watch & count # of times when pt’s chest rises and falls for 30 seconds
measuring temp
- normal temp: 97.8-99F [36.5-37.2C]
- tympanic or oral measurement
measuring pain
- subjective
- use pt’s own report + behavioral observation
physical exam
- 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
BMI & waist circumference screening
- normal BMI: 18.5-24.9 kg/m2
- risk fi waist circumference >40 in [men] or >35 in [women]
glucose screening
- A1C, FPG or OGTT
- offer to all adults ≥45 & any overweight/obese [BMI ≥25] with ≥1 risk factor
cholesterol screening
- use cardiocheck
bone density screening
- ultrasound densitometer: measures bone density in heel
- DEXA scan: gold standard; emits radiation
depression screening
- PHQ-9 is commonly used
- at risk: substance abuse, other mental health conditions, pain, cancer or heart disease, pregnancy/postpartum
antimicrobial stewardship programs
- ABX misuse = ABX resistance & MDROs
- ensures pts get the right ABX at the right dose, right time & for right duration
medication utilization evaluation
- performance improvement method that focuses on evaluating & improving medication-use processes with goal of optimal pt outcomes
med error reporting
- 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
medicare
- federal health insurance program for ≥65 or <65 w/ disability & pts with ESRD
medicare part D
drug benefit for medicare enrollees
medi-cal
state medicare for lower income children, pregnant women, families & low-income adults
quality measures in medicare part D
- 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
covered california
- health insurance “marketplace” in CA
- 4 levels of coverage: bronze, silver, gold & platinum
- minimum coverage plan for <30 years
patient assistance programs
help low-income, uninsured pts get free or low-cost brand-name meds
tablet splitting
- 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
are manufacturers allows to offer drug discounts to push most costly branded drugs to pts?
- no
- exception: can offer at discounted price that’s less than generic
C-I drugs
no currently accepted medical use; high potential for abuse risk & lack of accepted safety under medical supervision
C-II drugs
high potential abuse; abuse may cause severe psychological or physical dependence
C-III drugs
lower abuse potential than C-I & C-II, abuse may cause moderate or low potential for physical dependence or high psychological dependence
C-IV drugs
low potential for abuse relative to C-III, abuse may cause limited physical or psychological dependence relative to C-III
C-V drugs
low potential for abuse relative to C-IV, abuse may cause limited physical or psychological dependence relative to C-IV
Actiq
fentanyl [must know]
C-II opioids
Duragesic
fentanyl [must know]
C-II opioids
Fentora, Lazanda, Sublimaze, Subsys
fentanyl [additional names]
C-II opioids
Hysingla ER
hydrocodone, single ingredient
C-II opioids
Zohydro ER
hydrocodone, single ingredient
C-II opioids
Lortab
hydrocodone/APAP
C-II opioids
Norco
hydrocodone/APAP
C-II opioids
TussiCaps
hydrocodone, combo products
C-II opioids
Tussionex
hydrocodone/chlorpheniramine
C-II opioids
Vicodin
hydrocodone, combo products
C-II opioids
Vicoprofen
hydrocodone/ibuprofen
C-II opioid
Dilaudid
hydromorphone
C-II opioids
Demerol
meperidine
C-II opioids
Methadone HCl Intensol
methadone
C-II opioids
Methadose
methadone
C-II opioids
Kadian
morphine
C-II opioids
MS Contin
morphine
C-II opioids
Duramorph, Infumorph, Mitigo
morphine [additional names]
C-II opioids
OxyContin
oxycodone, single ingredient
C-II opioids
Roxicodone
oxycodone, single ingredient
C-II opioids
Oxaydo, Xtampza ER
oxycodone, single ingredient [additional names]
C-II opioids
Endocet
oxycodone/APAP
C-II opioids
Percocet
oxycodone/amphetamine
C-II opioids
Percodan
oxycodone/aspirin
C-II opioids
Opana
oxymorphone
C-II opioids
*tk on empty stomach
Nucynta, Nucynta ER
tapentadol
C-II opioids
Adzenyza ER
amphetamine
C-II ADHD stimulants
Adzenys ER-ODT
amphetamine
C-II ADHD stimulants
Dyanavel XR
amphetamine
C-II ADHD stimulants
Evekeo, Evekeo ODT
amphetamine
C-II ADHD stimulants
Adderall, Adderall XR
amphetamine/dextroamphetamine
C-II ADHD stimulants
Mydayis
amphetamine/dextroamphetamine
C-II ADHD stimulants
Focalin, Focalin XR
dexmethylphenidate
C-II ADHD stimulants
Dexedrine
dextroamphetamine
C-II ADHD stimulants
Vyvanse
lisdexamfetamine
C-II ADHD stimulants
Desoxyn
methamphetamine
C-II ADHD stimulants
Concerta
methylphenidate
C-II ADHD stimulants
Daytrana
methylphenidate patch
C-II ADHD stimulants
Ritalin, Ritalin LA
methylphenidate
C-II ADHD stimulants
Adhansia XR
methylphenidate
C-II ADHD stimulants
Aptensio XR
methylphenidate
C-II ADHD stimulants
Cotempla XR-ODT
methylphenidate
C-II ADHD stimulants
Jarnay PM
methylphenidate
C-II ADHD stimulants
Metadate CD
methylphenidate
C-II ADHD stimulants
Methylin
methylphenidate
C-II ADHD stimulants
QuilliChew ER
methylphenidate ER chewable
C-II ADHD stimulants
Quillivant XR
methylphenidate
C-II ADHD stimulants
Syndros
dronabinol solution
C-II
Nembutal
pentobarbital
C-II
Seconal
secobarbital
C-II
Butrans
buprenorphine, single ingredient
C-III
Belbuca
buprenorphine, single ingredient
C-III
Buprenex
buprenorphine, single ingredient
C-III
Probuphine
buprenorphine, single ingredient
C-III
Sublocade
buprenorphine, single ingredient
C-III
Suboxone
buprenorphine/naloxone
C-III
Zubsolv
buprenorphine/naloxone C-III
Fioricet
butalbital/APAP/caffeine
C-III
Fioricet w/ Codeine
APAP/butalbital/caffeine/codeine
C-III
Fiorinal
butalbital-containing products
C-III
Fiorinal w/ Codeine
butalbital/aspirin/caffeine + codeine
C-III
Allzital
butalbital/APAP
C-III
Bupap
butalbital/APAP
C-III
Tylenol w/ Codeine #3
codeine/APAP
C-III
Tylenol w/ Codeine #4
codeine/APAP
C-III
Marionol
dronabinal capsules
C-III
Ketalar
ketamine
C-III
Fycompa
perampanel
C-III
Xyrem
sodium oxybate
C-III
Androderm
testosterone and all anabolic steroids
C-III
AndroGel
testosterone and all anabolic steroids
C-III
Aveed
testosterone and all anabolic steroids
C-III
Depo-Testosterone
testosterone and all anabolic steroids
C-III
Fortesta
testosterone and all anabolic steroids
C-III
Jalenzo
testosterone and all anabolic steroids
C-III
Natesto
testosterone and all anabolic steroids
C-III
Testim
testosterone and all anabolic steroids
C-III
Testopel
testosterone and all anabolic steroids
C-III
Vagelxo
testosterone and all anabolic steroids
C-III
Xyosted
testosterone and all anabolic steroids
C-III
Alprazolam Intensol
alprazolam
C-IV BZD
Xanax, Xanax XR
alprazolam
C-IV BZD
Librium
chlordiazepoxide
C-IV BZD
Onfi
clobazam
C-IV BZD
Sympazan
clobazam
C-IV BZD
Klonopin
clonazepam
C-IV BZD
Tranxene-T
chlorazepate
C-IV BZD
Diastat AcuDial
diazepam
C-IV BZD
Diazepam Intensol
diazepam
C-IV BZD
Valium
diazepam
C-IV BZD
Ativan
lorazepam
C-IV BZD
Lorazepam Intensol
lorazepam
C-IV BZD
Versed
midazolam
C-IV BZD
Mayzilam
midazolam
C-IV BZD
Seizalam
midazolam
C-IV BZD
Doral
quazepam
C-IV BZD
Byfavo
remimazolam
C-IV BZD
Restoril
temazepam
C-IV BZD
Halcian
triazolam
C-IV BZD
Lunesta
eszopiclone
C-IV hypnotic
DayVigo
lemborexant
C-IV hypnotic
Belsomra
suvorexant
C-IV hypnotic
Sonata
Zaleplon
C-IV hypnotic
Ambien, Ambien CR
zolpidem
C-IV hypnotic
Edluar
zolpidem
C-IV hypnotic
Zolpimist
zolpidem
C-IV hypnotic
Adipex-P
phentermine
C-IV weight loss drugs
Lomaira
phentermine
C-IV weight loss drugs
Qsymia
phentermine/topiramate
C-IV weight loss drugs
Nuvigil
armodafinil
C-IV
Stadol
butorphanol
C-IV
Soma
carisoprodol
C-IV
Motofen
difenoxin/atropine
C-IV
Viberzi
eluxadoline
C-IV
for IBS-D
Provigil
modafinil
C-IV
Ultram
tramadol
C-IV
ConZip
tramadol
C-IV
Ultracet
tramadol/APAP
C-IV
Briviact
brivaracetam
C-V
Cheratussin AC
codeine containing cough syrups
C-V
G Tussin AC
guaifenesin/codeine
C-V
Robitussin A-C
guaifenesin/codeine
C-V
Virtussin A/C
guaifenesin/codeine
C-V
Lomotil
diphenoxylate/atropine
C-V
Vimpat
lacosamide
C-V
Lyrica, Lyrica CR
pregabalin
C-V
barbiturate schedules
C-II: single-entity oral pentobarbital or secobarbital
C-III: pentobarbital & secobarbital in suppository or combo with non-controlled substance
C-IV: phenobarbital
codeine schedules
C-II: single-entity
C-III: combo tabs/caps
C-IV: combo cough syrups
dronabinol schedules
C-II: PO sol [Syndros]
C-III: PO caps [Marinol]
diff between CBD & THC
- CBD: doesn’t cause high but has anxiolytic [relaxing] effect
- THC: psychoactive effect
Epidiolex
cannabidiol
non-controlled
CBD-derived
Cesamet
nabilone
C-II for CINV
regulation of cannabis products in CA
- 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
DEA form #224
registration form for retail pharmacies, hospitals/clinics. teaching institutions, practitioners or mid-level practitioners
DEA form #225
registration form for drug manufacturers, distributors & researchers
DEA form #363
registration form for narcotic trx clinics
DEA form #510
registration form for bulk chemical manufacturers & distributors
DEA form #222
ordering form for C I-II drugs
DEA form #106
reporting form for theft or significant loss of controlled substances
DEA form #41
record of controlled substances destroyed
who must register with the DEA to prescribed controls
- individuals except for medical residents in HCF [use facility’s DEA]
- facilities in manufacture, distribution, research, prescribing & dispensing of controls
which facilities do HCPs not have to register with DEA to prescribe, administer or dispense controls
- Federal Bureau of Prisons
- Indian Health Service
- US Armed Forces
- US Public Health Service
how to order C III-IV drugs
- use purchase order or CSOS
- need name, formulation, # dosage units & # of packages
how to order C I & II drugs
- 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
provisions of the use of a POA
- 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]
DEA form 222 details
- 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
CSOS details
- 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
items preprinted on DEA form 222
- serial number
- pharmacy name & address
- pharmacy DEA #
- drug schedules that pharmacy is permitted to order
CII drug transaction: pharmacy orders drugs from a supplier
copy 1 [brown]: supplier
copy 2 [green]: DEA
copy 3 [blue]: pharmacy
CII drug transaction: pharmacy returns unused drugs back to a supplier
copy 1 [brown]: pharmacy
copy 2 [green]: DEA
copy 3 [blue]: supplier
CII drug transaction: pharmacy sends unused drugs back to reverse distributor for disposal
copy 1 [brown]: pharmacy
copy 2 [green]: DEA
copy 3 [blue]: reverse distributor
CII drug transaction: pharmacy sells or lends drugs to another pharmacy
copy 1 [brown]: supplying pharmacy
copy 2 [green]: DEA
copy 3 [blue]: receiving pharmacy
CII drug transaction: pharmacy sells or lends drugs to a physician for administration or dispensing
copy 1 [brown]: pharmacy
copy 2 [green]: DEA
copy 3 [blue]: physician
ordering w/ form 222 step 1 - purchaser
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
ordering w/ form 222 step 2 - supplier
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
ordering with form 222 step 3 - purchaser
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
ordering w/ CSOS
- 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
advantages of CSOS
- reduced ordering errors
- decreased paperwork
- reduced administrative costs
- foster drug delivery
- easy to use
how to deal with completed lost/stolen DEA form 222
- purchaser must resubmit order with a new form 222
- provide statement about serial number, date of initial order, how order wasn’t received
how to deal with unused lost/stolen DEA form 222
- notify DEA immediately
- provide serial number of each form → unless entire book is missing, then give approximate date
how to deal with lost electronic control order
- 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
how to transfer controls to another pharmacy, supplier or manufacturer
- 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
distribution of controls when pharmacy is going out of business
- 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
how does a pharmacy sell controlled substances
- 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
how to cancel/void control orders
- 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]
when must a pharmacy report significant loss/theft of a controlled substance
within 1 business day of discovery
how to deal with loss/theft of controlled substances
- 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
when must a pharmacy report to BOP about controlled substance losses
within 14 calendar days
when must a pharmacy report to BOP about other losses
within 30 calendar days
considerations to determine if loss of theft is significant
- 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
reporting in-transit losses
- 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
registrants returning controlled substances to supplier
- 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
registrants sending controls to reverse distributor
- 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
NP control prescribing authority
C II-V
PA control prescribing authority
C II-V
RPh control prescribing authority
C II-V
ND control prescribing authority
C III-V [no C II!!]
valid DEA number
- 1st letter: type of practitioner/institution
- 2nd letter: first letter of prescriber’s last name
- 7 numbers
DEA number - first letter A/B/F/G
hospital, clinic, practitioner, teaching institution, pharmacy
DEA number - first letter M
mid-level practitioner
DEA number - first letter P/R
manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program
DEA number - first letter X
DATA-waived practitioner
how to determine the validity of a DEA number
- add 1st, 3rd & 5th digits
- add 2nd, 4th & 6th digits
- multiply step 2 by 2
- add step 1 & step 3 together → last digit should match last digit in DEA#
NABP red flags
- 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
CURES
- 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
how long are controlled prescriptions valid for
6 months
out of state prescriptions
- 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
requirements on CA security forms
- 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
11159.2 exemption
pt is terminally ill [life expectancy ≤1 year]
11159.3 exemption
- declared emergency when CA BOP has issued notice of exemption
- NMT 7 day supply for controls
faxed control prescriptions
- 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
calling in control prescriptions
- only for C III-V
- not for C II → except for emergency situations
EPCS for controls
- use DEA approved software
- credentials are validation of something you know, have or are → 2/3 needed
- two-factor authentication
- alt: digital certificate
what can’t RPh make changes to on C II prescriptions
- issue date
- prescriber name
- prescriber sig
- pt name
- drug name
medicare part D opioid limits on initial prescription
7 days
partial filling of C IIs circumstances
- 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 - 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 - 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
emergency filling of CIIs
- 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
multiple prescriptions for C-IIs
- 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
C III & IV refills
- refill up to 5 times within 6 months
- total of refills cannot exceed 120 day supply
- original fill doesn’t count as refill
partial fills for C III-V
- 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
C V refills
- refilled up to 6 months of issue date
- no refill or day supply limit as long as refills are authorized by prescriber
california controlled substance label requirements
- 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
transferring controls
- cannot transfer C IIs
- C III-Vs can be transferred one time only by 2 licensed RPhs
- keep records for 3 years
methadone dose for opioid addiction trx
40mg soluble tab
mailing controls
- 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
methadone clinics for opioid addiction
- 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
methadone take-home supply dispensing restrictions
- 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
comprehensive addiction & recovery act [CARA] of 2016
- expanded DATA-waived practitioners to NPs & PAs
- only prescribe buprenorphine for 5 year period
substance use-disorder prevention that promotes opioid recovery & treatment [SUPPORT] for patients and communities act of 2018
- 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
drug addiction treatment act of 2000
- 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
what must a prescription for opioid dependence have
prescriber’s UIN & DEA
buprenorphine for opioid addiction
- prescriber must have DATA waiver
- buprenorphine: Probuphine, Sublocade
- buprenorphine/naloxone: Suboxone, Bunavail, Subsolv
combat methamphetamine epidemic act of 2005
- limits widespread availability of pseudoephedrine, ephedrine, phenylpropranololamine & norpseudosphedrine
requirements for OTC sales of CMEA drugs
- pseudoephedrine, ephedrine & logbook must be kept behind the counter or in locked cabinet
restricted sale of dextromethorphan
- OTC cough suppressant → abused in high doses
- cannot sell to <18
- need government-issued ID
max limits for OTC sales
pseudoephedrine & ephedrine:
- 3.6g/day
- 9g/30 days
- 7.5g/30 days for each mail-order purchase
- 3 packages/transaction
buprenorphine for pain management
- prescriber must specify the prescription is for pain
- buprenorphine: Butrans, Belbuca, Buprenex
restricted sale of hypodermic needles & syringes
- Rph knows pt has previous prescription or legitimate medical need
- ≥18 as public health measure → no limit
- use for animals
CAUTION: Federal law PROHIBITS transfer of the drug to any person other than the pt for whom it was prescribed
- federal law requires all C II-IVs have this
CAUTION: OPIOID. risk of overdose and addiction
- state law requires for drugs with single or combo opioids
- addition to cautionary statement by federal law to C II, IIII & IV drugs
epinephrine 1:1000 to mg/mL
1 mg/mL
epinephrine 1:10,000 to mg/mL
0.1 mg/mL
sedatives monitoring
RR & mental status
may cause DROWSINESS. USE CARE when operating a car or dangerous machinery
- state law requires for muscle relaxants, antipsychotics, antidepressants, AHs, motion sickness drugs, antipruritics, antiemetics, anticonvulsants & antihypertensives, controls, anticholinergics
check for peanut or soy allergy
required for:
- progesterone [Prometrium only]
- clevidipine [Cleviprex]
- propofol
anticoagulants monitoring
- baseline labs [INR, aPTT, CBC]
- lab goals [indications based]
- symptoms of bleeding
- reversal strategy
do not take this drug if you become PREGNANT
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
CAUTION: do not take with alcohol or nonprescribed drugs w/o consulting your doctor
- 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
high alert double check
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+
insulin monitoring
- BG & K+
- rate adjustment based on BG
positive inotrope monitoring
BP, HR, hemodynamic parameters & urine output
opioid monitoring
oversedation & respiratory depression
HIGH ALERT. paralytic
- 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
IMPORTANT. finish all this medication unless otherwise directed by prescriber
required for ABXs, antifungals or antivirals
avoid prolonged exposure to sunlight while taking this medication
d/t increased skin sensitivity
- sulfa ABX
- quinolones, tetracyclines
- flagyl, isoniazid
- topical retinoids, isotretinoin
- ritonavir
- NSAIDs → piroxicam, diclofenac, ibuprofen, naproxen
- diuretics
when taking this medication the effectives of birth control pills are decreased. use additional and/or alternative methods of birth control
important to counsel pts
- barbiturates
- SJW
- ampicillin, tetracycline
- rifampin, rifapentaine, griseofulvin
- bosentan
- anticonvulsants → topiramate, lamotrigine, CBZ, primidone, PHT, oxcarbazepine
- some HIV drugs → PIs, NNRTIs
may cause blurred vision
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
WARNING: if your stool become soft and water after using this antibiotic, contact your doctor immediately
persistent diarrhea d/t colitis may occur weeks after using this med
- clindamycin
- quinolones
- broad-spectrum ABX
may cause discoloration of the urine or feces
- entacapone, carbidopa/levodopa
- metronidazole, rifampin
- nitrofurantoin, phenazopyridine
- sulfasalazine
- doxorubicin, mitoxantrone
- propofol
take med on empty stomach 1 hour before or 2-3 hours after a meal unless otherwise directed by your doctor
- 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
med should be taken with plenty of water
- bactrim
- bisphosphates
- sulfasalazine [Azulfidine] → take w/ water & food
- pancrelipase
take with food
- 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]
do not take dairy products, antacids or iron preparations within 1 hour of this med
can make med less effective
- tetracyclines
- quinolones
- levothyroxine
avoid this med with grapefruit or grapefruit juice
- lovastatin, simvastatin, atorvastatin
- amiodarone, dofetilide
- cyclosporine, tacrolimus
- diazepam, triazolam
- verapamil, nicardipine, felodipine, nisoldipine & nifedipine
shake well
for meds that may not have equal distribution of drug unless shaken
- suspensions
- most asthma inhalters
- nasal steroid sprays
- lidocaine viscous topical liquid
swallow whole, do not crush break or chew
can alter effects of med & be dangerous
- EC formulations
- XR< ER, LA, SR, CR, CRT, SA, TR, TD or has 24 in name
epidural
label to decrease risk of administration via incorrect route
chemotherapy drug - toxic. dispose of as bio-hazard
need special packaging & labeling for proper handling of the med & proper disposal of the bag and tubing
protect from light
Protect Every Necessary Med from Daylight [PENMD]
- Phytonadione
- Epoprostenol
- Nitroprusside
- Micafungin
- Doxycycline
for central line administration only
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
for irrigation only, not for IV use
for any type of irrigation
- peritoneal dialysis irrigation solution
- saline & sterile water irrigation solution
administer by IM injection
label to decrease risk of administration via incorrect route
- preferred route of promethazine inj is IM → CI in <2
do not refrigerate
Dear Sweet Pharmacist, Freezing Makes Me Edgy [DSPFMME]
- Dexmedetomidine
- Sulfamethoxazole/Trimethoprime
- Phenytoin
- Furosemide
- Metronidazole
- Moxifloxacin
- Enoxaparin
refrigerate
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]
for external use only
topical
- “For the Eye”
- “For the Ear”
- “For the Nose”
- “For Rectal Use Only”
- “For Vaginal Use Only”
- “Not to be Taken by Mouth”
filter
That’s my GAL, PLAT
- Golimumab
- Amiodarone
- Lorazepam
- Phenytoin
- Lipids
- Amphotericin B
- Taxanes
