Federal CS Act Flashcards
Schedule 1
no accepted med use in US, high potential for abuse, lack of accepted safety of substance
Schedule 2
accepted med use, high abuse potential, severe psych or physical dependence
Schedule 3
accepted med use and abuse potential < than C1 and C2, mod or low physical dependent and high psych dependence
Schedule 4
accepted med use and abuse potential < than C3, limited physical or psych dependence
Schedule 5
Accepted med use, abuse potential < than C4, NC allows OTC sales (robitussin AC, guafenesin AC, cheratussin AC), purchaser must be 18+ YO, rph must make determination to sell only, tech can complete transaction after, sale must be recorded and contain 1) name + address of purchase 2) name + quantity of drug 3) date of sale (+ time) 4) name or initials of rph involved, not more than 120 ml may be sold to person within 48 h period
DEA number
AKA federal registration #, valid for 3 yrs for pharmacies, manus and distributors must renew annually, 2 letter and 7 digits, required for manu/ dist/ wholesaler/ dispenser (practitioner or pharmacy location)/ researcher/ exporter/ importer of CS, employees of registered location do not need to be registered.
DEA number check
1) add digits in place 1,3,5. 2) add digits in 2,4,6 then double. 3) add the sum of step 1 and 2. 4) the last digit of step 3 should match the 7th digit. 2nd letter is usually 1st letter of last name (on app so gets confusing with maiden name)
DEA registration may be denied if
app info falsified, felony conviction relating to substance regulated, registrant has had state licensure or registration suspended or revoked
DEA Form 222
used to purchase C2 and C1 drugs, for transfer of these (like when pharmacy is sold), POA can be given to 1+ people and kept with executed order forms, name/add/reg# already on form, 1 item per line with name (or NDC) /dosage form/strength and bottle size, needs name/add of supplier, needs sig and date of rph manager or POA
DEA Form 224
practitioner must fill out for registration as a dispenser
DEA Form 41
broken pills/containers or destruction of CS requires letter requesting permission to destroy drugs with proposed date, method, and 2 witnesses (MD, rph, mid-level, RN or law enforcement). 2 signed copies for DEA, multiple other copies for accountant, pharmacy, etc. healthcare facilities can request blanket auth for continual destruction (sink or toilet). retail can request blanket auth annually.
Inventory
required initial and biennial, should include name/add/DEA, date and time, sig of person doing inventory, name/dosage form/strength of CS, number of units or volume + total qty, C2s require exact count, CS 3-5 can be est unless open bottle >1000 pills
Methods of Destruction
incineration, flushing into sewers (not septic tank), patches opened, mixed with litter disposed, or reverse distributors can be used
Reverse Distributor
fill DEA 41 and dispose of meds, they send DEA 222 to pharmacy for C2. for C3-5, document name, strength, and dosage form of drug and qty and date of destruction.
Theft of CS
notify regional office of DEA immediately (within 1 day), all local police, complete DEA Form 106 (send 2 copies to DEA, keep 3rd copy + others for insurance, etc)
Corresponding Responsibility
responsibility of proper prescribing/dispensing of CS is upon prescribing practitioner, but corresponding responsibility to rph who fills it. prescriber needs to be registered with DEA and authorized to prescribe, and within the usual course of pro practice for legit med purpose. rph needs to contact prescriber and ask if they wrote it, verify dosage and qty, #refills, med appropriate for condition being treated, prescriber’s response documented
Authority to Prescribe CS
DO (osteopath), DDS or DMD (dentist), DPM (podiatry), DVM (vet), OD (optometrist), PA, NP, certified nurse mid-wife, CPP. this is determined by states.
PAs and NPs prescribing CS
CS 2 and 3 limited to 30 day supply with no refill on 2, normal on 3 (5 refills in 6 mo and 1 mo at time). PA, NP, and CPP must have supervising physician
Rx Requirements for C3-5 drugs
name + add of pt, name + strength + dosage form + qty drug prescribed, directions for use, name + add of prescribing practitioner, DEA #practitioner, sig of prescriber at time of order (no stamp, no pre-printed)). oral orders can be communicated to pharmacist or CPhTs by agent of prescriber (not acting independently, not required to list name), then reduced to writing and filed, cannot be pre or post dated.
Practitioners exempt from DEA registration
must include on all rxs issued by them the registration# of the institution and the internal control number or suffix assigned to him or her by the institution
Refill History for CS
Name + address of patient, full name + address + DEA# of practitioner, name/strenght/dosage form of drug dispensed, date of refill, qty dispensed, date rx first dispensed, original number of fx, name/initials of dispensing rph for each refill, total # refills
Labeling Requirements for C2-5
name + add of pharmacy, name of patient, name of prescriber, directions for use, rx#, date of fill/refill (not on C5), on C2-4 - caution statement required or mislabeled
Transfer Requirements
fact that rx is transferred, name of transferring RPh and name + add + DEA# of transferring pharmacy, date of rx + original rx#, date of first fill, #refills authorized + complete refill record for rx as of date of transfer, #refills remaining, transfers date + time
Partial Fill
must record each partial fill as you would a refill, must not dispense more than the total qty prescribed, may not dispense past 6 mo from date of issuance
Info that can be changed on C2
after consulting with prescriber and documenting: patient’s add, drug strength, drug qty, directions for use, dosage form
Info that canNOT be changed on C2
patient name, CS prescribed (except for generic sub), prescriber sig. these would require new rx.
PSE
may purchase no more than 2 packages at a time with total <3.6 g PSE; <9 g/mo; required sig/date/etc on log/ sign must be posted stating aboxe; fed requires all to be blister packed unless liquid; all employees must be trained in the proper sale of PSE and transaction must be transmitted before sale
Methadone
practitioner may prescribe for analgesia - not for tx of narcotic addiction (has to be admin in a narcotic tx program), may be admin daily 3 days only while arranging for tx program (not allowed for rx), hospitals without tx program may admin while treating pt for something else pain related
Subutex/Suboxone
buprenorphine +/- naloxone, C3, 30 pt limit/MD unless certified to treat opioid dependence for 1 yr then 275 pt limit (CARA), drug may be used for off label indications such as chronic pain without pt limits
On label buprenorphine use
ask MD if treating chronic pain (off-label), if not look up X# (DATA 2000 Waiver ID from DEA) to see if MD agreed to be listed for ON-label use (required of rx), if so and are asked to stock - must have it immed avail to prevent pt going into withdrawal and possible relapse
Ryan Haight Online Pharmacy Consumer Protection Act
Requires valid rxs and in-person med eval (no telehealth). Applies to CS via fed, non-CS via NC. Pharmacy must be a Verified Internet Pharmacy Practice Site (VIPPS) for NC.
LTC/Hospice RNs as MD’s Agent
MD designates an agent to act on behalf, must be in writing, rph may request copy of designation, allows faxing and phoning rx orders, agent keeps copy and MD keeps copy
Partial Filling of C2s
Permissable, balance filled <72 h. If LTC or documented terminal illness, <60 d.
