MPJE Flashcards
Exceptions for faxed CIIs
CII can actually be faxed a filled and can be given to pt if they bring in the original
-if the CII is used for compounding for direct admin by IV,IM, sub-q or intranspinal infusion
-resident of long term care facility
-hospice pt., must be noted on the fax
These faxes serve as the original and no further documention is required
When can a CII be written for a 90 day supply?
- each RX must be seperate (one fro each month)
each month must have a corresponding date to fill and can’t be filled before that date and there must be no known cause for abuse
who may write a controlled RX?
Physicians dentists podiatrists vets residents animal shelters mid-level practitioners (all must have supervisors w/ DEAs) nurse practitioners, nurse midwives, ambulance services,nurse anesthetists, PA's optometrists, homeopathic physicians, nursing homes, euthenasia techs *all must be registered w/ the DEA, prescribe within parameters- varies by state
Requirements for an RX
6- drug name, strength,dosage form, quantity,directions and number of refills
* if controlled must have 6: date, signature, DEA, full name of pt, address of pt, address and name of MD
DEA form 224
Registration form for the DEA, a renewal must be done every 3 years with the 224a form for an independant, for a coorporation it’s done with the 224b form. Can be renewed no more than 60 days prior to expiration
How many days to let the board know about transfer of business?
14 days before the date of the proposed transfer
DEA form 222
CI & CII order form and can be used as a transfer form that lets stores transfer CII’s back to the distributor, a company to destroy or to another pharmacy. Can be ordered www.DEAdiversion.ursdoj.gov. Must use DEA number, name and phone #. or can order by calling DEA office. Each book has 7 forms and a max of 6 books can be ordered at a time
closed-door pharmacy
pharmacies that distribute to institutions such as long term care or jails and not open to the public
DEA form 41
form that allows disposing of controlled substances for instances such as expiration or broken meds. This is usually filled out by the company who is doing the destroying and the pharmacy must fill out a 222form to give them the medication
How many days do you have to let the DEA know if there has been a theft or a significant loss?
1 business day of discovery. you must:
1- notify DEA and/or police in writing
2- complete the DEA for 106 that documents the entire experience
DEA form 106
makes them aware of a theft or significant loss
Who fills out the DEA 106 form?
In-transit loss- the supplier fills out
Central fill to pt- central fill pharmacy
Central fill to pharmacy- receiving pharmacy
The fed will get involved w/ a theft in these instances:
1- the replacement for meds in at least $500
2-interstate or foreign commerce was involved
3-a person was killed or suffered harm as a result of the crime
Recordkeeping. What must be kept?
These all must be kept for at least 2 years
1-DEA 222 forms
2-power of attorney forms
3-invoices for CIII-CVs
4-all inventory records for all controlled substances
5-record of all controlled substances distributed
6-records of RX dispensed & CV logbook
7-reports of theft DEA 106 form
8-records of drugs for disposal- DEA form 41
9-records of drugs trasnferred between pharmacies
10-DEA registration certificate
11-CMEA 2005 certificate
Paper RX recordkeeping
Option 1- 3 separate files (one for CII’s, one for controlled, one for non-controller)
Option2- 2 separate files (one for CIIs and one for non-controlled and CIII-CV (controlled designates with a red “c” on them)
Electronic RX records must be kept for?
Must be kept electronically and must be available at the registered pharmacy for 2 years from the date of creation
Inventory requirements
CII-actual count
other controlled- estimated count (unless the bottle holds more than 1000 pills, must be hand counted)
Inventory must be kept for at least 2 years, and CII inventory mist be kept separate. There is a recommendation to put name, address, DEA registration number and the person doing the on the forms
Required inventories for controled substances
Initial inventory-done when first opens
Biennial inventory- once every 2 years on any date . Doesn’t need to be submitted to DEA, just kept on record
DEA form 222-filling it out
Number of packages, the size of the package and the name of the item, Must be signed and dated by the authorized person that is granted power of attorney. When they are received, the Rph must document on the purchasers copy the number of packages received and date. Must keep copy for 3years
When a DEA 222 form is not accepted
a supplier may refuse to accept an order and they must return copies 1 and 2 of the 222 form and a statement explaining the refusal
DEA 222 form colors
Copy1 (Brown) goes to supplier
Copy2 (Green) goes to supplier then goes to DEA
Copy3 (Blue) purchaser keeps -us
Lost or stolen DEA form- a shipment was never received
Contact supplier and ask if they got form, if it was lost, fill out another one and attach a sheet w/ reference the old form with serial number and date and write that it was lost or stolen and never received and send that with new order to the supplier
Unacceptable DEA forms
(1) The order is not complete, legible, or properly prepared, executed, or endorsed.
(2) The order shows any alteration, erasure, or change of any description.
Receiving controlled III-V
Invoice that is dated and has a confirmation that the total amount was received
DEA registration numbers
Issued before 1985, DEA starts with A
After that, starts w/ B or F-dispenser of controlled substances
Midlevel practioners start w/ M
The next letter is usually the first letter of their last name then followed by 7 numbers
Refills for CIII-V
5 refills (original fill + 5) within 6 months after the date of issue. After whichever one occurs first a new RX is required
Manually keeping records of CIII-CV fills
If refilling a controlled med, each fill must be indicated on the back of the original script with initials of Rph, date filled and quantity filled on that date
Transferring a controlled RX between pharmacies
May only be done ONCE between pharmacies. Transferring between stores of the same company doesn’t count. Transferring rph must:
- write “void” on the face of the invalid RX
- record the name of the pharmacy, name of rph
- record the date and name of pharmacist transferring RX
Incoming transfer requirements
The word “transfer” must be written on the top of RX
1) date of original RX
2) original # of refills authorized
3) date of original dispense
4) Number of refill remaining
5) Transferring pharmacy name, address, DEA, original RX number
6) name of Rph transferring
7) if different the name, DEA & address of the original pharmacy
RX label requirements
Date of fill
Pharmacy name and address
RX number
Name of pt
Name of prescriber
RX units
Drug and strength
Directions for use
Expiration date (if less than a year put that, if more than a year can just put 1yr from dispensing
If MD specifies-the symptom or purpose for RX
* every controlled label must say not to share meds and no ETOH
Emergency prescriptions for a CII
When a prescriber can’t give an RX at that time. This is telephoned in and MD must send the original within 72 hours in NV.
- RX must only be written for the amount of days that emergency occurs
- Must have all info for RX but sig not needed
- The RX received in 3 days must have “Authorization for Emergency Dispensing” on it + the date of the oral order. Attach RX to verbal order RX
- if MD doesn’t send , Rph must contact DEA (no specified time
Partial fills for CIIs
An RX may be partially dispensed if full amount is not in stock.Must write date and partial fill # on RX. The original RX may be dispensed in the next 72 hours, if not MD must be contacted
RX for LTC pts
RX must have “terminally ill” or “LTCF patient” on RX. If partial fills done, the fill must be written on back of RX w/ date, initials and qty including qty remaining. CII rx for these pts can be up to 60 days supply
Dispensing a controlled substance without an RX (robitussin)-AKA exempt narcotic
Dispensing is only done by the Rph, the purchaser is at least 21 yo, purchase must be recorded in bound record book, qty may not exceed 60ml and cannot give to same purchaser any sooner than 48hrs. (federal-240 ml of any substance containing opium is sold to the purchaser in any 48 hour period.24 dosage units of any other controlled substance (other than opium) is sold to the purchaser in a 48 hours period
Can controlled subsrances be shipped out of the country?
No unless the person sending it has a registered DEA as an “exporter” and has a permit to do so
Ryan Haight Online Pharmacy Consumer Protection Act of 2008
Used to combat any “rogue internet sites” making it illegal to deliver, distribute, or dispense a controlled substance by means of internet use if they don’t have a DEA to do so
Online pharmacy rules
Must notify the DEA within 30 days of dispensing, delivering or distributing of a controlled substance and must inform each state board within each state where they will be sending meds to. They must also abide by the rules of each state. Each month they must send to the DEA a total qty of each controlled med over 100 RXs filled of more than 5,000units sold-reports are done by NDC due before or on the 15th of each month
Central fill pharmacy
When one pharmacy received the prescription and another pharmacy fills it. Records must be maintained by both pharmacies, they have the authority to fill CII’s
Long Term Care Facilities
Nursing home, retirement home, mental care or other facility that provides extended healthcare to residents. They are hot registered with the DEA
Narcotics Treatment Programs
MDs who are involved in prescribing and dispensing have to have a separate DEA to do so and must also get approval from SAMHSA
Five Percent Rule
A pharmacy can distribute controlled substances to a practitioner for general dispensing if the total number dispensed to them does not exceed 5% of all controlled substances dispensed by the pharmacy in a calendar year. If it exceeds that 5% they must register as a distributor
Combat Methamphetamine Epidemic Act of 2005 (CMEA)
Sellers of ephedrine, PSE and phenylpropanolamine must abide by these rules and register every year. Must be behind counter, check ID and maintain a log (name,address,date,time and amount sold) and keep it for 2 years. Max 3.6 grams/day and 9grams per 30 days
Pt record must include
Full names, address, phone number, DOB, gender, medical condition, allergies, and Rph comments related to drug therapy…retain records for ???
Pharmacy Practice experience hour requirements for Nevada
1500 hours, can be an intern upon enrollment in pharmacy school
Foreign licenses in NV
Accepts degrees and must do 1500 hours of practical experiance
RPh renewal schedule in NV
Every 2 years-on odd years. Fee of $180 on Oct 31st, renewal sent out Sept 15th
CE requirements NV
30 hours within 2 years. 15 credits in accredited programs and either: 1hr in jurisprudence program (a-set up by board b-approved by board or c- earned by attending one), or1 full day of a board meeting (3hrs of CPE + 1 NV jurisprudence)
License disciplining in NV
Done by NV state board of pharmacy
Technician license in NV
NV doesn’t license or certify techs, they register them. Register every 2 years $40
Tech to pharmacist ratio
3:1. This includes 2 techs and 1 tech in training if those are the circumstances. Data input can only be done by licensed tech and the only thing a clerk can do is enter demographic info and insurance info on a new RX
Tech responsibilities
Can accept refills from Drs office, can prepare,package and compound medication for dispensing, stock supplies in the pharmacy, maintain inventories of drugs, maintain pharmacy records, transfer an rx through a computer network,but can’t transfer prescription orders (can initiate though)
Two types of Rph license catergories
Institutional and retail, $500 renewal fee due every 2 years
Wholesaler destirbuter liscense requirements
The NV BOP is responsible for licensure, they have authority of medical device distributors, must be renewed every 2 years
NV Board of PHarmacy controls these laws and regulations
Dangerous Drug Law, Controlled Substances Act. They also come up w/ laws/reg on dispensing RX medical devices, and medical O2
Preventing substitution on NV state drug formulary
MD must write “Dispense as Written” on the RX
Taking a non-controlled & controlled RX from out-of-state
Yes, but Rph must verify pt has seen the MD in the 6 months since date on RX and document it as “face to face” for a CII and record, name of the person who you spoke with, date and time and date of examination
Time limit on RX refills
1 year from the date written and 6 months for CIII-IV
Requirements for formatting on RX in NV
Electronically generated and signed RXs must be printed on security paper
Faxed RX rules
Can accept faxes for non-controlled and CIII-V and the fax has to state “Faxed Copy”. Prescriber’s info is required with a signature
Electronic RX info
Can receive from in state or out of state and ca only be seen by pharmacy or practitioner. Controlled RXs can be sent
Counseling requirements
For medicaid pts, new rxs and professional judgement used for refills. If pt is not there in person to counsel it may be done in writing
Prescribing authority in NV
PA-dependant prescribing authority
Advanced nurse practioner-dependant prescribing authority
Clinical nurse specialist- no authority
Nurse midwife or midwife-no authority
Nurse practitioner-no authority
Nurse anesthetist-no authority
Dr. of homeopathy-independant authority
Optometrist- independat authority but limited
EMT-no authority
Naturopathic MD-not licensed in this state
MD prescribing authority
Dr. of osteopathic med-yes MD-yes Dentist-yes Podiatrist-yes Vet-yes Dr. of homeopathy-yes
Who can possess non-controlled drugs in their practice?
MD-yes DO-yes Dentist-yes Podiatrist-yes vet-yes Dr. of homeopathy-no PA-yes Advanced nurse practitioner-yes nurse specialist-no midwife-no nurse practitioner-no optometrist- may dispense a med at no charge to pt if in scope of practice
Dr of optometry
OD
Dr of osteopathy
DO
Who can possess controlled legend drugs?
MD-yes DO-yes Dentist-yes podiatrist-yes vet-yes Dr of homeopathy-yes but at homeopathic doses PA-yes Advanced registered nurse-yes nurse specialist-no midwife-no nurse practitioner-no optometrist-no*** RPh-no
May RPh’s initiate,modify or D/C drug therapy?
Yes, in the hospital setting only
Can a prescriber own a pharmacy?
Yes but it can’t be more than 10% of the total interest of the pharmacy
Can RPh’s administer meds?
Yes but only when written approval, and we can do immunizations under protocol
Does NV allow the return and reuse of medications?
Yes???
Members of the board of pharmacy
6 members who are registered RPhs (have been for at least 5 years) and 1 person from the general public and are given terms of 3 years and cannot serve on the board for more than 3 consecutive terms all appointed by the governer. They meet every 6 months
Jobs of pharm techs
1)removal of drug from stock 2)counting,pouring or mixing of drugs 3)placing of drugs in containers 4)affixing labels on containers 5)packaging and repackaging of drugs
License display
Must be displayed where public can see in the pharmacy. If employeed in more than 1 pharmacy, the main license should be displayed in the main pharmacy and the a 8’’ by 10’ color photocopy of registration and a copy of the renewal receipt in the other pharmacy
Notice of new place of practice
If changing employers, the BOP must know within 10 days after changing jobs.
How many pharmacies may a manager be?
Only one pharmacy per pharmacy manager
Institutional pharmacy rules
A hospital with more than 100 beds requires a pharmacist on staff at all times. In less than 100, a pharmacist can work part of the day and designate to nurse practitioners authority to fill. same thing for corrections in pt <1500
How long does a DR have to sign an RX in a ot’s chart?
48 hrs from time the order was given
Requirements for mail order RXs
1) pt name 2) prescriber name 3)RX number 4)date of RX 5)the name of the drug 6)strength quantity and dose
Canadian Mail Order rules
CANNOT sell controlled substances, has to send meds approved by the FDA, cannot dispense meds stopped by the FDA and max 3 months supply at a given time
What the MD must do before writing an RX for a controlled substance
Must verify in a patient utilization report from the past 12 months through the Investigation Division of the Dept. of public Safety to make sure pt is not abusing controlled substances.
A written prescription must contain
1) name and signature of the practitioner
2) classification of license
3) name of pt and address if not available to RPh
4) name, strength and qty of drug
5) symptom or purpose for the RX, if included by MD
6) directions for RX
7) date of issue
Numbering and filling an RX
All RX’s must be numbered. CIIs must be filed alone and all filed RXs must be available for 2 years. Each RX must have the date it was originally filled & must be signed by the RPh who filled it
People who have access to filed RXs
*these are not public record
a)pt RX was issued to
b)practitioner who prescribed RX
c)a new practitioner treating the pt
d)member of the board of FDA
e)an agency of the govn. responsible for the health of the pt
f)an insurance carrier w/ authorization from pt
g)any person from the district court
h)an inspector or investigator of any professional licensing board who licenses a practitioner
I)other BOPs if pertaining to misusing RXs
j)peace officer from the local govn
k)a county coroner to help id someone or determine cause of death
Copy of an RX
If someone needs a copy of an RX, it should be clearly marked “COPY, Not refillable-for reference purposes only” and RPh must sign or initial
Controlled substances records
A record for each refill of any prescription must either be kept on the back of the original RX or in a bound book and the record must include the date of each refill, the number of dosage units the signature of initial of RPH who filled it
A controlled med needs to be refilled for a chronic condition and are unable to get a hold of the MD an RPh may
If the RPh feels that the pt needs the medication, can give the pt a sufficient supply of the med until there is a time where an MD can be found
Mental or physical examination
If the Board believes that a license holder has become incompetent, they may designate a physician or psychiatrist to conduct an exam at the Board’s cost. The RPh may hire their own physician and must have that report in 10 after original psych report and a suspension may be put on the RPh until deemed competent. RPh can be placed on probation if they voluntarily enter a drug rehab program
Notice of hearing
If someone has received a report for a crime, the Board has 30 days to have a hearing after RPh receives a report
Hearing
Must be presided by a board member and 3 others. Any decision about hearing must be made by at least 3 members of the board and must be recorded
Counseling in the hospital
Not required to inpatients where they are being administered their meds
Reusing medications in a home and correctional institute
In the instance of a skilled nursing facility, if unit doses are not used or d/c’s for a pt, ins will be reimbursed and the meds will go back to the med stock for reissuance.
laetrile
amygdalin
Gerovital H3
procaine hcl w/ preservatives and stabilizers. Can be sold without an RX but name and address of person sold to needs to be kept, the amount sold, the signature of the pt and the signature of the RPh (only person who can sell it)
May sell parenteral meds for personal in a medical facility
The pharmacy is selling it or a licensed practitioner, if there is an expiration date on the label and if someone is available at all times for immediate assistance
It is illegal to resale or sell knowing
the med left the control of an RPh, has been damaged or subject to damage in heat,smoke,fire or water, has been obtained through bankruptcy or foreclosure, is no longer safe or effective for use, or has not been properly stored or refrigerated
Can RPh’s or inteens sell contact lenses
No, cannot sell or fit lenses. Can sell prepackaged ones but not special order ones
Products that are precursors to meth
pseudophedrine, ephedrine or phenylpropalamine
If meth precursons are missing from the pharmacy
Make and oral report to the Dept of Safety, submit a written report within 15 days of finding out and a loss report filled out
Things that can be changed on a controlled II RX
1) The strength of the med
2) the quantity of the drug prescribed
3) the directions for use
4) the date the RX was issued
* any change should be initialed, w/ date and time w/ reason for change
Things that can’t be changed on a CII RX
1) The name of the pt (can add a last name-no changing)
2) the name of the controlled substance
3) The signature of the practitioner
What to do if there is a CII and a non-controlled on the same RX
Make a copy of the RX and retain the original for the CII records and on each RX make a reference for the RX number for each
How long does a new RPh manager have to do an inventory of controlled substances?
48hrs after first reporting to duty with the pharmacist who preceeded him. Both must sign the inventory
CII’s
codeine powder, hydrocodone, ethylmorphine, powdered opium, concentrate of opium,piminodine, tapentadol, amphetamine salts, phenmetrazine, methylphenidate, pentobarbital, amobarbital, d. Tuinal pulvule, Amytal sodium, Seconal pulvule, Nembutal capsule
CIII’s
benzphetamine, chlorphentermine, clortermine, phendimetrazine, chlorhexadol, any combo or mixture w/ pentobarbital, nalorphine, <300mg hydrocodone, testosterone, anabolic steroid, Ketamine, synthetic dronabinol, any combo w/ buprenorphine
CIV’s
benzos, carisoprodol, chlorazepate, phenobarbital, triazolam,zaleplon, zolpidem, any combo w/ fenfluramine, any combo with phentermine
CV’s
<100mg opium, pregabalin, lacosamide
How long must a manufaturer maintain samples and records for their lots?
Those samples used to detect sterility must be kept for 2 years after distribution of the last lot or 1 year after the expiration date of the last drug lot
What to do when there are controlled meds that need to be destroyed?
Must be kept separate from other returns and destruction is done by the board. A form 41 should be filled out and the destruction is done on a yearly basis.
How soon does an RPh need to let the board know of an address change?
Within 10 days after changing residence or place of practice
How soon does a pharmacy need to let the board know if there has been a change in ownership?
No less than 15 business days before a change of 50% or more of the beneficial interest of the pharmacy has been paid
Requirements for a tech
Must be at least 18, must have graduated from high school or equiv, never been convicted of a felony or misdemeanor involving drugs, no history of drug abuse, or completed a tech program or trained 1,500 hrs of experience (within 3yrs of app) in NV and 350hrs of employment in a pharmacy, written statement from the managing RPh
Schedule records must be kept for how long?
2 years
A pharmacy tech may not
perform an action requiring judgment decision regarding a drug or interpretation of a RX, take new orders on the phone, dispence an RX unless the RPh has verified,
What must be kept on file for each tech?
documentation of completion of orientation and training, evidence that the techs are familiar w/ state and federal laws. These must be available for at least 2 years
Role of a pharmacy intern
1) selling controlled substances
2) compounding of meds
3) filling Rxs and dispensing them
4) preparing and maintaining records and reports
5) counseling pts
6) administer immunizations
How long must CE providers keep a list of attendees?
4 years since CE class
Remote sites
The telepharmacy attached must be located within NV, the RPh or practitioner must be in the telepharmacy at all times, if communication is lost, the remote site should NOT continue filling, the tech must have license for at least 1yr, can’t supervise more than 3 techs at once, RPh or practitioner must visit site once monthly
Minimum age for immunization
14 years old (retail chains allow 11 yo)
Admixture label requirements for institutional pharmacy
1) name of pt and ID number
2) name and amount of drugs added
3) name of the basic solution (NS)
4) Name, initials or ID code for RPh
5) expiration date of the solution
Prepackaging label requirements
1) generic or tradename of the med
2) lot number
3) expiration date of the drug
4) qty of the drug
If a drug is withdrawn from an institution w/ out an RPh present how long does the RPh have to verify?
Medical facility- 72 hrs
Correctional institute- 96 hours
Part-time pharmacist absent-90 days
If a controlled medication is not fully used in a intermediate care facility what is done with it?
It is to be delivered to the director of nurses for destruction. This must be recorded and filed under pts name for 2 yrs. Destroying occurs from director or consulting RPh and is done once monthly
How are controlled meds to be destroyed in facilities?
1) flushed down the toilet
2) place in H20 then in a waste container
3) break ampule or container and contents to be placed in waste container
Ownership of a pharmacy-choosing someone in charge
Has done 6,000 hrs in a pharmacy, has passed the law exam, is at least 21 years old, must be emplyeed full time, must be present in the pharmacy during work hours
Annual inspections from the board
A self inspection form needs to be done by the manager and will go through it with a member of the board. Any reports of inspection must be kept for 2 years
What pharmacies must carry as far as law and references
1) must carry current state statutes and regulations for controlled drugs
2) Reference materials- prep. and compounding, biologic or therapeutic equivalencies, pharmacology and PK, indications and usage of drugs, CI or SE, dosage and administration of drugs and overdosage of drugs
Class A & B packaging expiration date compared to class C
Class A and B- expire 12 months from packaging
Class C- 60 days from packaging
Required temp in fridge and freezer
Fridge- 3-46 F
Freezer- -32 F
Requirements for bathrooms
A pharmacy or remodeled built after Nov, 1 1996 must have a bathroom within the pharmacy.
How long does a pharmacy need to let the board know when their is a termination of employment?
Must let the board know if an RPh, intern, tech, tech in training has been terminated within 10 days
How long does a pharmacy have once it has voluntarily closed to deal with controlled substances?
A licensee has 60 days after date of closure to make arrangements for the lawful sale or disposition of controlled substances
Voluntary closure
Whenever a pharmacy is not open longer than 5 days the board must be notified no more than 5 days after closure and state the reasons for the temp closure. If the licensee of the pharmacy dies or becomes disabled, the board will take custody of all controlled drugs
Permanent closure of the pharmacy
1) Must place a sign in the front door stating the pharmacy and address where records have been transfered and be placed there for 30 days
2) Return the pharmacy license
3) Inventory controlled meds
4) transfer rxs and make sure they have sufficient info about refills
Nuclear RPh requirements
1) be certified by the Board of Pharmaceutical Specialties
2) meet the min standards of training for radioactive material & licensed by the Nuclear Regulatory Commission
3) Min 200 contact hrs of instruction in nuclear pharmacy and safety
4) MIn 500 hrs clinical or practical training
RX for nuclear pharmacy must contain
1) Name if the institution & the prescriber
2) date of dispensation and the calibration time
3) Name of the procedure
4) name of the radiopharmaceutical
5) dose or qty of radiopharmaceutical
6) rx number
7) instructions from the prescriber
8) initial of person who received the order
9) initial of the person who dispensed the order
10) name of the pt if necessary
Label for a radiopharmaceutical container
1) Name and address of pharmacy
2) name of the prescriber
3) date of dispensation
4) RX number
5) radiation symbol
6) “CAUTION RADIOACTIVE MATERIAL”
7) name of the procedure
8) the radionucleotide and chemical form
9) the amount and date of calibration
10) volume, weight or # of ampules
11) the molybdenum
12) name of pt
Requirements for the representative of a wholesaler
1) must have 6000hrs in a pharmacy or wholesaler that has dispensed drugs
2) has received a score of at least 75 fromthe board
3) at least 21 yo
4) must work full time and be actively involved in daily practices
5) may only serve one wholesaler at a time
* notify board in 48hrs if this person is gone
Cessation of operation of a warehouse
Board must be told 30 days before the intend on ceasing operation
CHanging ownership of a facility
The board must know within 5 days of changing ownership
Storage of RX drugs within a warehouse
Must follow temp and storage rules adopted by United States Pharmacopeia-National Formulary
Compounding pharmacy and requirements for records
1) name of the compounded med
2) a list of components & quantities (including lot and expiration date of each ing.)
3) the internal control number assigned by the RPh
4) beyond use date
5) date of prep
6) initials of RPh or tech that compounded med
7) qty of the final product
Expiration date for compounded meds
non-aqueous liquid and solid formulations- 6months
non-sterile H20-14 days after it was made
other compounds-30 days after the date
Environment for compounding sterile products
Compounding sterile products should be in an ISO class 5 environment. If a laminar flow hood is to be maintained in an ISO 5, the room it is located in that has an ISO 7, and an ante-area close to entrance of the room should maintain ISO-8
Cleaning an ISO 5 environment
Done at the beginning of each work shift, before the compounding of each batch, at least every 30min after each compounding activity. The floors and counters around the hood are cleaned daily. The walls, ceiling, storage and shelves are to be cleaned once monthly
Tests for competency and proficiency in personnel
Retest at least once a year in low-risk sterile compounding
Retest at least twice each year if compounding high-risk products
Records for compounding pharmacies
The record must be maintained for at least 6 months after the date the product was compounded
Re-writting expiration date if a vial is opened in sterile environment
Time and date must be marked & container used:
- within 1 hr in a worse than ISO 5 environment or stored in a worse than ISO 7environment
- within 6hrs if opened in an ISO 5 environment or stored in an ISO 7environment
- within 24hrs if opened in better than ISO 5 and stored in better than ISO 5 environment
The period of storage before admin of a low-risk compounded product
- 48hrs in a room temp at least 20- 25 C
- 14 days at 2-8C (fridge)
- 45 days in solid frozen state -10 C or colder
The period of storage before admin of med-risk compounded products
- 30hrs at room temp 20-25 C
- 9 days at 2-8C
- 45 days in solid frozen state -10 C or colder
The period of storage before admin of high-risk compounded products
- 24hrs at room temp 20-25 C
- 3 days at 2-8C
- 45 days in solid frozen state -10 C or colder
Drugs usually compounded in ISO 5 environment
1) antineoplastics
2) radiopharmaceutical drug
3) a drug whose manufacturer recommends it
Medical products administrator
Must have a high school diploma, 1500 hr work experience relating to medical products, must work 40hr/week, board must know within 3 days after cessation of employment and within 3 days of new hire and wholesaler may not operate if no administrator for 10 days
Maintenance of records for medical supply RXs
Kept in a file in reference to pt name,retained for at least 5 years from date order was made
These are the things that can only be done by an RPh or intern
1) take new orders over the telephone
2) identify and interpret an RX
3) interpret medical data on a chart
4) consult with a nurse or MD
5) take responsibility of techs
6) counsel a pt or giving advise
7) determine efficacy of a drug or drug substitution
8) professional judgement in the pharmacy
Jobs a clerk can do
- Enter info into the system other than info contained on a new RX
- processing sales
- stocking shelves
- delivering meds
Topics to discuss during consultation
name and description of med, form of dosage, dose, route, intended uses of drug and expected responses, and special directions, common SE, CI or interactions, techniques for use, proper storage, info about refills
DUR includes determining
1) over utilization of a med
2) under-utilization of a med
3) therapeutic duplications
4) interactions between drugs & other drugs, diseases and allergies
5) incorrect dosage and treatment
Records for counseling
Must be maintained for at least 2 years, list all rxs dispensed to pt
An RX submitted electronically must include
DEA of MD if controlled, phone # of MD, time and date of transmission, name of pharmacy sent to and all other requirements for an RX
What is on the label of every cell in a counting machine?
1) generic name of trade name of device
2) lot number
3) expiration date
4) name of the manufacturer
5) strength of the medication
6) initials of the RPh who filled the device or oversaw a tech do so
When an RX doesn’t need a safety cap
1) when the pt is at least 18yrs old
2) specific request an easy open container
3) signs a document saying they don’t want safety cap
Dispensing tech
Someone under the observation of a prescriber that is allowed to dispense meds. This person may be certified if worked over 500hrs w/ practitioner and verification from practitioner that they work to satisfaction. They will not have access to meds unless they have completed those hrs. If locations have been changed 200 more hrs need to be done under that new practitioner
Reasons for an RPh to deny an RX
1) reason to believe it would be unlawful to fill
2) the filling of the rx would be harmful
3) the rx is fraudulent
4) the RX is not for a legitimate medical purpose
* must discuss with prescribed before denying
A prescription for a controlled substance shall be written with
Ink, indelible pencil, typewriter, non-erasable ball-point pen
The DEA is a component of the
Dept. of Justice. DEA also controls to Controlled Substance Act
“Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” This statement is required as part of the prescription label for
CII-CIV - not required for CV
Controlled drugs definitions
C-II-Drugs which have a currently accepted medical use in the US and have a high abuse potential with severe psychic or physical dependence liability
C-III-Drugs which have a currently accepted medical use in the US and have a potential for abuse which may lead to moderate or low physical and psychological dependence
C-IV- Drugs which have a currently accepted medical use in the US and have an abuse potential which may lead to limited physical or psychological dependence
CV-Drugs which have a currently accepted medical use in the US and have a low abuse potential and limited physical or psychological dependence
The person having authority to reschedule a controlled substance or remove controls
Attorney general
Federal regulations permit the partial filling of a C-II substance. The balance of the Rx may be supplied to a patient in a nursing home within
60 days
Manufacturers and distributors of controlled substances are required to register with the DEA:
Every 3 years
Which of the following among other things, must be recorded on the retained copy of the federal order form when a C-II substance is received by the purchaser (pharmacist)?
Number of packages received and date on which received
According to federal regulations, if a vendor cannot supply the entire order for a C-II drug product, within what period of time may the balance of said order be shipped to the purchaser?
60 days from date order was issued by the purchaser
You make a mistake on a DEA 222 form by indicating the right quantity but the wrong medication on one line. Everything else on the form is filled out correctly. How does the DEA law advise you to handle this situation?
Void the entire form and retain copies 1, 2, and 3
Which of the following DEA authorized registrants is permitted to purchase reasonable quantities of either etorphine HCl or diprenorphine using the DEA 222 form?
Veterinarian engaged in exotic animal practice
If an order for a C-II substance cannot be filled for any reason, the supplier shall
Return copies 1 and 2 to purchaser and explain why the order was not filled
Copy 2 of the DEA 222 form for C-I drug shall be forwarded by the supplier to the DEA
At the close of the month in which shipment was made to the purchaser
The DEA 222 form is not valid beyond ____ after its execution by the purchaser
60 days
A purchaser may cancel part or all of an order for a C-II drug by
Notify the supplier in writing
Which of the following controlled substances must be ordered by themselves when a DEA form 222 is used?
Carfentanil, Diprenorphine HCl, Etorphine HCl, Marijuana
What is the supplier required to do if part or all of the C-II drug order is cancelled by the purchaser?
Indicate the cancellation of the order on the original and copy 2
Unless the registrant is informed by the DEA that the permission to keep central records is denied, the registrant may begin to maintain such central records of controlled substances ____ after notifying the DEA:
14 days
A DEA registrant who elects to maintain central records of controlled substances is required to deliver all or any part of such records to the registered location within ____ business days after a written request by the DEA
2 days
Which of the following amendments to the FD&C Act required that a drug be safe and effective before it could be marketed in the US?
Kefauver-Harris
The reporting to FDA of any developments that may affect the safety and effectiveness of a drug product is known as:
Drug Experience Reports
Which amendments to the FD&C Act established the legal difference between prescription and nonprescription drugs?
Durham-Humphrey
The advertising of OTC drug products is regulated by
FTC-Federal Trade Commission
The advertising of Rx drugs is regulated by the
FDA
Certain types of Rx drug advertising are exempt by the FDA from fully disclosing prescribing info about the advertised RX drug product. Such ads are referred to as:
Reminder Ads
When a drug’s patent expires
A generic drug manufacturer may file an ANDA
The Drug Price Competition and Patent Term Restoration Act is also known as the
Waxman-Hatch Amendments-Permits marketing of off-patent post 1962 drugs in the US. Includes patent extension for innovator drug companies
The amendments to the FD&C Act that granted authority to the FDA to issue regulations with the force and effect of law are known by the name of:
Wheeler-Lea
The established name of a drug is its
Generic name
A notice of adverse finding letter to a pharmaceutical manufacturer generally requests the firm to respond to the FDA within:
30 calendar days
A regulatory letter from the FDA to a manufacturer of a drug generally requests that the firm respond within
10 days
The organization responsible for setting standards in human antibiotics is:
USP-United States Pharmacopeia
Which federal government agency compiles the National Drug Code Directory?
FDA
Which federal government agency is responsible for implementing the Poison Prevention Packaging Act of 1970?
NABP-National Association of Boards of Pharmacy
Can a CII RX be written for more than a 1 month supply
There is no limit on how much drug can prescribed for a CII
Can a prescribing practitioner prescribe medication for a family member?
A prescribing practitioner cannot prescribe a CII (except in cases of emergency) for: Himself;
His spouse; OR His children
A prescribing practitioner can prescribe any other controlled substance or dangerous drug for the practitioner or the practitioner’s family.
