PharmLaw 3

smoore020390's version from 2015-09-07 11:45


Question Answer
Who can sign DEA form 222?Same person who signed DEA registration or designated by power of attorney
Where do copies of DEA form 222 go Copy 1 stays with supplier, copy 2 forwarded to DEA from supplier and copy 3 stays with purchaser
What must be recorded on DEA form 222, copy 3 when pharmacy receives meds? Record number of containers received and date
If DEA form 222 is stolen mustNotify special agent for DEA in division office and provide serial number for each missing form
What is the electronic equivalent to form 222?Controlled substance ordering system (CSOS)
What form must be submitted to DEA for destroying controlled substances? DEA form 41. Upon destruction, must submit signed copy to DEA
Who is authorized to witness CS destruction?Physican, RPh, mid-level practitioner, nurse, or state local law enformement officer
Letter requesting authorization to destruct CS must containDate and method of destruction and names of 2 people who will witness destruction


Question Answer
Initial inventory CFR requirementsDate and time, drug name, strength, and dsg form, number of units/volume and total quantity.
How often must a CS inventory be completed per NYS law?Every 2 years. For all CS. Exact count for CII, can estimate with CIII-CV unless container holds more that 1000 units and has been opened
What to do if notice theft or loss of CS?Notify nearest DEA office and local police. Fill out form 106 and forward 2 copies to DEA diversion field office


Question Answer
I-STOP Part APrescription monitoring program
What pt info must be included in PMP?Name, resi address, DOB, gender, date RX issued, date Rx dispensed, metric qty dispensed, days supply dispensed, name of prescriber and DEA number, NDC of drug dispensed and method of payment
When to practitioners have to consult the PMP?b4 prescribing or dispensing CS sced II-IV
I-STOP Part B: E-prescribing
Question Answer
Schedule of tapentadolNucynta is a CII in NYS
What schedule are anabolic steroids?In NYS schedule II
What schedule is carisoprodolol?Soma is schedule IV
What schedule is tramadol?NYS and fed now CIV
What schedule is ezogabineSched V


Question Answer
What is a class 3 institution?Hospital, vet hospital, mental hospitals etc. Nursing homes may also qualify if they have services of physician, RN, and RPh
What can class 3 institutions do with CS?May PURCHASE and STORE CS! For inpt and outpt use through registered pharmacy dispenser. When on floors etc. must also be accompanied by administration sheet
How can CSs be administered at class 3 institution?Written order or when an emergency situation
How long are PRN CS orders good for at a class 3 institutionmust be rewritten Q72hrs
How long are standing CS orders good for at a class 3 institution?Every 7 days EXCEPT with convulsive disorders/chronic spacicity, or ADD. OR if a class 3 RHCF in prisons orders are valid for 30 days
What is a class 3a institution?Nursing homes, convalescent homes, health related facilities, dispensaries, clincis.
When can class 3a institution administer a CS?Only admin to pts pursuant to an RX filled at an OSH. EXCEPTION - emergency medical kits. Or if 3a institution operated as integral and physical part of class 3, may be provided with bulk stocks of CS
When can CS from emergency kits at 3a institutions be administered?By order from authorized practitioner
What can an emergency medical kit at 3a institution contain?24 hr supply with a max of 10 different CS in unit dose packaging no more than 3 in injectable form
How must an emergency med kit at 3a be secured?Must be secured in a stationary double-locked system
When must pharmacy who supplied emerg med kit be notified?Within 24 hrs of kit being unsealed, opened, or tampered with
What must administration records for CS at institutions contain?Date and hr of admin, name of pt, name of prescriber, qty administered, balance on hand after administration, signature of administering RN


Question Answer
In institutions where must CI and CII main stocks be kept?A GSA class 5 rated steel cabinet or equiv safe. If weights <750lb needs to be bolted or cemented to floor. In a vault where walls, floors, and ceiling cannot be less than 8in of reinforced concrete. Doors need multi posit combo lock, relocking device, or equive, and steel plate at least 1.5" thick
In institutions where must CIII-CV main stocks be kept?Stationary, securely locked cabinet
Where should working stocks be kept in a registered pharmacy for CII-CV?Dispersed throughout stock of noncontrolled drugs or in a stationary and securely locked cabinet
Where should working stocks be kept if NO registered pharmacy for CII-CIV?Stationary, double locked cabinet each having separate keys
Where should working stocks be kept if NO registered pharmacy for CV?stationary, securely locked cabinet
Where can CSs be stored on pt care units?If <72hr supply, can be kept with other pt meds in securely locked med card or other approv storage unit. CANNOT keep CIIs in carts. If >72hrs supply then in stationary, double locked cabinet each having separate keys
Storage for 3a institutions who obtain CS for individ pts from outside pharmIf <72hr supply, can be kept with other pt meds in securely locked med card or other approv storage unit. CANNOT keep CIIs in carts. If >72hrs supply then in stationary, double locked cabinet each having separate keys
Requirements for med carts at institutionsDouble keyed locks, anchored to floor or wall when not in use, have locked drawer system, and have independent locking device. Access should be limited to identified individual at all times
Disposal of CSs in an institutionsingle unit doses or partial doses remaining may be destroyed by RPH or nurse if a notation is made on administration sheet and witnessed by 2nd RPh, nurse, or other resp person designated by admin
When can a CS be dispensed at institution for non inpt use?Emerg sitch where MD determines necessary to transfer critically ill pt to another medical facility. Can dispense SINGLE DOSE of CS to medical attendant accompanying pt if travel expected to be >3 hrs


Question Answer
STEPS ProgramThalidomide. Females undergo preg testing and take BC, males use condoms. Prescribers and pharmacies registered. Monitored with pt surveys. Rxs limited to 28 day supply with NO REFILLS! Must be filled within 7 days of last preg test if childbearing age or 30 days for all other pts. NO telephone Rxs
iPLEDGEFor isotretinoin. Prescribers, pharmacies, wholesalers must be registered. Rquires monthly MD visits for refills. RPhs must check database prior to filling everytime!! Women of child-bearing age have 7 day window to fill and pick up med (first time?). M and W non-child bearing age have 30 day window to fill and pick up. Can take phone and fax orders
How long are scripts for syringes valid?2 years from date issued
What should RPhs do when filling a Rx for syringes?1st fill - SIGN and record date on face of Rx, renewals recorded on reverse side with date, qty, and SIGNATURE of RPH
Are oral Rxs allowed for syringes?Only emergency! Need to record that it is a telephone order on script. Cannot exceed 100 syr! Need script within 72 hrs. If not, dont have to report but mark on oral script Rx not receive, sign, date. If get follow up script, on face of Rx document signature, date of filling ,Rx number and follow up. On back stamp as if CIII-CIV
Are oral refills for syringes allowed?NO!
ESAP definitionExpanded Syringe Access Demonstration Project
How to pharmacies participate in ESAP and what can they do?Must be registered with NYS DOH. Can sell up to 10 syr to pts 18yrs+. Also participate in safe disposal. SAFETY INSERT must be provided


Question Answer
After giving vaccine how soon must pharmacy let pts PCP knowWithin one month! Electronic ok. Must also report to DOH
Record keeping for vaccines at pharmacyFor all ppl immunized, their name, the date, address of location where administered, administering RPh, immunizing agent, and manufacturer and lot number. Can be pt profile or separate file.
Which barbituates are CIIs?amobarbital, secobarb, pentobarb
Phendimetrazine scheduleCIII
Phenteramine scheduleCIV
What schedule is dronabinol?CIII
Fospropofol (Lusedra) ScheduleCIV
Meprobamate scheduleCIV
What schedule is lisdexfetamine?CII
Tramadol scheduleCIV
Chlorphenteramine scheduleCIII
What schedule is ketamine?CIII
Carisoprodol (Soma) scheduleCIV
Benzphetamine scheduleCIII
Paraldehyde scheduleCIV
Max codeine in CIII combosNot >1.8 gm codeine/100mL or 90mg/dsg unit
HCG scheduleCIII
Pentazocine scheduleCIV