Law Help

dinosaur1234's version from 2015-05-05 23:35

Schedule of substances

Question Answer
Hydromorphone (Dilaudid)2
Amphetamine (Adderall)2
Methylphenidate (Ritalin)2
Pentobarbital 2
Combo products containing less than 15 mg hydrocodone per dosage unit and not more than 90 mg per unit of codeine3
Tylenol with codeine3
Buprenorphine products (suboxone and subtex)3
Anabolic steroids (i.e. oxandrolone)3
Benzodiazepines (i.e. lorazepam, midazolam, teamzapam, alprazolam, etc)4
Propoxyphene (Darvon)4
Cough preparations containing not more than 200 mg codeine per 100 ml or per 100 g (i.e. robitussin, Phenergan with codeine)5

Law module 10

Question Answer
How long to keep CPP records5 years
Central fill records shall be retrievable in48 hours
Central fill CS Rx for a retail pharmacy shall do what on Rxon the FACE of the original write “central fill”; DEA # of central fill pharmacy
NPI useused by HIPPA-covered entities (health plans, certain providers, etc) to identify HCP in HIPAA transactions; vets do NOT need a NPI
Controlled substance advisory committee13 members appointed by governor; meet at least once every 3 months; monitor indicators of CS abuse and diversion and make recommendations
What is ARCOSautomation of reports and consolidated orders system; is a sclosed system for controlled substance dictribution; monitors flow of DEA CS from point of manufacture to point of sale/distribution
Form to fill out to register with DEADEA form 224
DEA registration is required formanufacturing, distributing, dispensing (practitioner and pharmacies), physicians, research, list 1 chemicals
Exemptions to DEA registrationpublic health, armed forces, bureau of prisoners, federal and state employees enforcing laws relating to CS, individual practioner who is an agent or employee of a hospital or other institution
How long is pharmacy DEA registration good for3 years
DEA numbers begin with the letterA, B, F, G, or M; the second letter is the first letter of the last name (usually)
No primary (professional) CS license required forconduct research, animal euthanasia, animal sedation
When to notify DEA of pharmacy change of addressbefore the effective date of move
How soon to notify DEA of transfer of pharmacy business14 days before transfer
How long is an emergency rule good for6 months after its date of filing and may be extended for 6 more months with proper paperwork; an identical or similar rule is promulgated; identical or similar bill is enacted into law; administrator determines emergency rule is no longer necessary
How to tell if DEA number is legitstarts with proper letter; add 1+3+5 spots; add 2+4+6 spots and multiply by 2; add these two numbers together and the last digit should match the last digit in the DEA number
How are drugs scheduledby the administrator through the rule process
Tramadol schedule4
Pregabalin schedule5
MD or DO and delegatingMD/DO shall not delegate the dispensing fo more than a 72-hour supply of a Rx drug
X DEA numberneeded to prescribe buprenorphine products for opioid dependence

Module 11

Question Answer
DEA 222 form useorder schedule 1 and schedule 2 drugs ; also use it any time you move a C2 other than dispense
How long does supplier have to fill DEA 222 form60 days
Controlled substances ordering system (CSOS)keep records electronically; recordkeeping for 2 years and al linked records
How soon must a registrant notify DEA of change of POAwithin 6 hours of the person leaving employement or having priveliges revoked
Where is POA forms keptat the pharmacy with executed official order forms as a readily retrievable record
What to do if lost/stolen DEA 222 formsimmediately report the lost to nearest DEA diversion field office; notify DEA if forms are recovered or found
Who does the DEA 41 formreverse distributor does (they also do a 222 form [C2] or invoice [3-5] to the pharmacy); DEA 41 form is used for destruction
How soon to notify DEA of losswithin one business day if significant loss
DEA 106 form usereport significant loss/theft of CS to the DEA; don’t need to file the form if loss is not significant
Reporting loss to BOPreport any loss of any CS to BOP within 10 days following discovery using a DEA 106 form or equivalent
Readily retrievablerecord that can be separated from all others within 48 hours
How long must CS records be kept for2 years minimum, but often kept longer
Records that MUST be maintained on siteexecuted order forms (DEA 222), prescriptions, inventories, CS signature logs, POA forms
Beginning inventory in brand new store vs transferwhen opening a brand new store, beginning inventory shall be ZERO; if it is a transfer of business then beginning inventory would have drugs listed
How often are you required to take inventory in MIannual for MI; take between April 1 and June 30
How often are you required to do inventory for DEAbiennial
Max amount of CS you can bring into the states with you50 dosage units; must declare it
Ryan Haight Actapplies to all CS; amends the CSA and is designed to combat the proliferation of so-called “rogue internet sites”

Module 12

Question Answer
To sign and submit electronic CS Rx, prescriber must sign and transmit 2 out of 3something they know, something you have, biometric
What is the pharmacy application for CSto accept electronic CS Rx, the pharmacy application must be completed and approved by third party auditor or certifying organization; pharmacy must have a copy of this report
How long are C2 Rx valid for90 days from the date written; CAN’T HAVE REFILLS!
Is there a quantity restriction for C2No! no quantity restriction UNLESS there are multiples on same day
Partial fill of C2must supply remainder within 72 hours
Partial fill on a C2 for patient in LTC or terminal illnessvalid for a period of not more than 60 days from the issue date
Info on emergency dispensing of C2only 4 instances in which this can happen; within 7 days, prescribed must furnish a written, signed Rx for the CS prescribed; Rx must have written on its face “authorization for emergency dispensing”. Pharmacist must notify DEA if physician does not provide a written Rx
3 situations where fax C2 may serve as originalcompounded for direct administration; LTCF; patient in hospice
Things pharmacist may change/add on C2 Rxpatient address, dosage form, dosage strength, drug quantity, directions for use, issue date of Rx
Things pharmacist can NOT change on C2 Rxpatients name, CS prescribed unless generic equivalent; prescribers signature, do not fill until date
Multiple C2 prescriptionsallows practitioners to issue multiple Rx on same day for up to 90 day supply;
How long are C3-4 Rx valid for6 months from date written! Can refill up to 5 times or 6 months
How long are C5 Rx good forno date limit unless partially filled than it is only good for 6 months
How long is partial fill of C3/4 good for6 months
How many times can you transfer ORIGINAL C3-5 RxONE TIME
How many times can you transfer Rx with refillspharmacies sharing a real time online electronic database may transfer up to the maximum refills permitted by law
Info on transferring PAPER CSwrite void on the face of invalidates Rx; communicated directly between two licensed pharmacists; on the reverse on invalidated Rx, must write the address and DEA registration number of the pharmacy to which is was transferred and the name of the RPh receiving transfer
Schedules that OD can write for3, 4, 5 and hydrocodone with APAP (2)
Schedules that PA can write forALL schedules if delegated
Schedules that NP or NM can write for3, 4, and 5 no limit; for C2, not more than a 7 day period of therapy upon discharge of a patient
Caution statement is required on what schedules2, 3, 4
How long to keep orders (patient chart ) for5 years

Module 13

Question Answer
“trinity” cocktailopioid + alprazolam + cyclobenzaprine or carisoprodol
Drugs FDA approved for detoxification or maintenancemethadone (only from OTP), buprenorphine/naloxone, naltrexone
Exempt C5 can have not more than…240 cc (8 oz) or 48 solid doses of a substance containing opium; not more than 120 cc (4 oz) or 24 solid dosage forms of any other substances listed in C5 (codeine/guaifenesin 10/100 per 5 ml)
Exempt C5 infomust be at least 18y to purchase; has to furnish suitable ID if not known by pharmacist; must affix label to container; maintain immediately retrievable record; must keep bound record book; only a pharmacist (or intern) can dispense
What to report to MAPSall CS prescriptions from pharmacy are to be reported
What to do if CS is for animalmust have positive ID of owner and use drivers license # of animals owner
Patient identifiers to include in MAPSfull name, address and zip code, DOB, DL # or state-issued ID number or number 0 if pt under 16
Exemptions to reporting to MAPSCS administered directly to patient; dispensed from a health facility in treatment quantity of less than 48 hours
What is used to capture sales of PSE and EPHNPLEx; DEA requires bound logbook; no log required for a single sale of less than 60 mg PSE
How often do you have to self certify with DEA to sell PSE/EPHannually!
When to report loss of PSE/EPH to DEAorally to DEA at earliest opportunity; in writing within 15 days
Who can you show logbook toONLY to local, state, and federal law enforcement
Max amount of PSE and EPH you can givemax of 3.6 g in a day; max of 9 g in 30-day period
How soon to report to MAPSnext business day
Things that you have to be 18 to buyPSE, nicotine patches/gum, robitussin AC