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547 Cards in this Set

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When and What is the FD & C Act?
1938 after sulfanilamide tragedy (ethylene glycol).
Drugs must be proven safe to the FDA.
Involves the marketing of drugs.
What and When was Pure Food and Drug Act?
1906 to regulate how much mercury or arsenic can be in drugs or makeup
Durham-Humphrey Act

All Rx drugs must have what on label?
1951, Distinguished Rx drugs from OTC drugs.
prohibits unauthorized refills of legend (script) drugs, etc.

All Rx must have "fed law prohibits dispensing w/o prescription" or "Rx only".
Kefauver-Harris Amendment

When and What?
1962, Thalidomide tragedy

Drug must prove both safe and effective to FDA.
Required info on Label of commercial container:
1.
2.
3.
4.
5.
6.
7.
1. name and address of manufact.
2. ingredients
3. identity (generic and trade name)
4. Quantity (Net quantity of package)
5. Dosage statement
6. Expiration date
7. Lot number
(not required = NDC number)
What do the NDC numbers stand for?
M
N
S
1st 3 numbers are the id of the manufacturer
2nd set = drug name
3rd set= package site
Do hospitals have to provide PPI?
No they are exempt each time drug dispensed.
What info must be on Unit Dose Label? (5 things)
1. Name of drug
2. Quantity of active ingredient
3. Expiration date
4. Lot or control #
5. Name and place of business of manufacturer
Describe rules for Expiration Dating on Repackaged Drugs
If drug from manufact bottle exp >2 years then the repackaged drugs exp is 6 months from repackage date.

If manufact. expires in 1 year then the date is 3 months because of the 25% rule. (must be given 25% of exp time on manufact bottle)
can u dispense 2 or more different drugs in the same package?

Who must consent?
Yes, you may repackage like in blister or pill box w/ consent of either:
Patient
Caregiver
Provider
What is definition of Drug?

__/__/__/___ in ____ or ______ AND _______intended to ____ the _____/__ of body.
something that is intended to be used in:

diagnosis, cure, tx or prevention of disease in man or animals
AND
something other than food that is intended to affect structure/fx of body (vitamins)
What and When was PDMA Act?
(Prescription Drug Marketing Act)

Also it amended what.....

it is AKA as: (DDA)
1987, to reduce drugs being sold to different countries and then them sell them back to US. (Reimportation of human drugs)

Also it amended the FD&C to prohibit sale of drugs from hospitals to pharmacies and Ban the sale of drug samples. (except OTCs)
aka: Drug diversion Act
Describe "Misbranding"

It is also when a........... or.......................
Drug doesn't meet labeling requirements. (many things)

when a pharmacist sells a script drug w/o a Rx
or the refill w/o authorization.
Describe "Adulterated" drugs

______,_____ and ______

Think of a ___________.
drugs that contain filthy, putrid and decomposed substances;
drugs packed and held under unsanitary conditions.

Not conforming to Good Manufacturing Practice.

Think of meth lab in a barn.
Can you give Emergency refills when no refill left?

How much?

Do you need to tell provider?
Law allows a pharmacist to give up to a 30 day supply of any drug EXCEPT Schedule II under these circumstances.

You must contact the prescriber or the prescriber's office within 72 hours to notify them of what you have done.
What information is required to be on the prescription label? (13 things)
1. Name and address of the dispensing pharmacy.

2. Prescription number

3. Date of the prescription.

4. Name of the prescriber.

5. Name of the patient.

6. Name and strength of the drug.

7. The generic name of the drug,

(even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized.)

8. Directions for use.

9. Appropriate cautionary statements.

10. “Filled by” or “dispensed by” with the name of the dispensing pharmacist.

(The name must include, at a minimum, the first initial and full last name of the dispensing pharmacist.)

11. If the dispensed drug is a “tranquilizer or sedative,” it should bear the warning “The consumption of alcoholic beverages while on this medication can be harmful to your health” unless the prescriber directs otherwise.

12. If the prescription is dispensed in a container other than the manufacturer’s original container, a DISCARD DATE, which shall be the earlier of one year from the date dispensed or the manufacturer’s expiration date, whichever is earlier.

13. If dispensed in manufacturer’s original container, the label must not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container.
What does Controlled Substances Act require of a prescriber?
1. ____________ AND 2.____________
The Authority to Prescribe requires precriber to be:

1. Licensed under state to prescribe (state says who can legally prescribe);

and

2. They must register w/ DEA
On what grounds may a pharmacist refuse to fill a script?
If.....
or if....
or if....
Pharmacists can refuse to fill or refill prescriptions if :

they believe it would be harmful to the patient,

or

if there's a question as to its validity

or
they believe it is not in the patient's best interest.
What is the Orange Book?

Is it used in NC?
Therapeutic Equivalency info

In NC the pharmacist doesn't need to use book, NC says pharm is expert.
If script refills expire for Ex. Prilosec, may pharm sell OTC as an OTC transaction?
Yes, but can't if going to bill 3rd party or Medicaid. Then must get a script.
If call for refill authorization, can pharm take it from nurse or office assistant?
Yes but get persons name you talk to.
As of April 08 does NCBOP allow compounding of OTC's?
No
HIPAA stands for:

Who can you release info to?

_______AND______.
Health Insurance Portability and
Accountability Act

other health professionals and for payment purposes.
What is a Class I Federal Drug Recall?

Give 2 examples:
ex. like for Fentanyl patch or Digitek

Class I is the strictest and the patients must be notified and mandatory return of inventory.
Describe Class II and Class III drug recalls.
Class II = drug causes temporary or reversible AEs and so drug inventory should be returned.

Class III = drug not likely to cause AEs
How often does a pharmacist have to review Long Term Care Facility?

And what is it called?
DUR must be done by pharmacist MONTHLY for each patient to eliminate errors.
Describe FDA Pregnancy ratings:
A = safe, studies show no increased risk
B = no evidence of harm but no studies
C = animal stud show risk but no human studies
D = benefits may outweigh risk, studies show risk
X = don't even think about it
Healthcare Fraud, Waste and Abuse.

How often and Who must be trained?

What government body requires this?
YEARLY training of ALL employees.

Medicare Part D requires it.
Generally Describe Scheduled Drugs
Schedule I :
Schedule II:
Schedule III:
Schedule IV:
I: no legitimate use in US & high potential for abuse

II: accepted med use but still high abuse potential

III: med use and abuse potential less< than I & II

IV: med use and lower abuse potential
example of Sched II drugs:
methadone, morphine, cocaine, oxycodeine, amphet and methamphetamine, methylphenidate.
Ex of Sched III drugs:

ex of Sched IV:

Ex of Sched V:
III: certian levels of codeine or hydrocodone, testosterone

IV: -zepams, zolpidem, modafinil

V: Lyrica, other dosages of codeine and hydrocodone
what is required to purchase Schedule V drug as OTC?

How much can be sold?

can interns sell it?
DEA says:

must be over 18 yr old
and
give ID
sale must be recorded in book.

No more than 120 ml or 24 dosage units of any other controlled subs. may be sold in 48 hr period.

Yes
Who must have a DEA number?
(7 of them)
M
W
D
D
I
E
R
manufacturer, wholesaler, distributor, dispenser(practitioner or pharmacy), exporters, importers, researchers

Basically every location where controlled subst are.
How long is registration valid?

This is different for who?
for pharmacies = 36 months

manufact and distributors = 1 year
Describe how to verify valid DEA number: (2 then 7)
4 steps
2 letters at front are and followed by 7 digits

A,B,F are prescriber (M is midlevel prescriber)

1. add digits in places 1, 3, & 5
2. add digits in places 2, 4, & 6
3. Add sums of step 1 & 2
4. Last digit of the sum of 1 & 2 should match the 7th number (the "check digit")
DEA form 222 is for what:

which copy does pharmacy keep?
purchasing Schedule I and II drugs
(you should never need to purchase Sched I drug - DEA will visit you)

Copy 3 (blue copy)
What if a DEA form 222 is lost or stolen?
must inform DEA immediately

must give the serial # of the form missing
Can you sell or buy Sched II's from other DEA registrants?

what must be done?
Yes

Must use form 222
Do you need to use a DEA form for C III-V drugs?

What do you record?

What is limit to selling?
No

date
drug
strength
quantity
name of purchaser
their DEA number

Limit is no more than 5% of your annual purchases w/o registering as a distributor.
Can you accept a RX for " office use" or "medical bag"?

Can you fill it?
No

Yes, you can fill it as a non prescript just sale w/ DEA 222 if C II.
How often do you need to do initial and other inventory need to be done?
Must do initial inventory of Controlled drugs within 10 days of becoming pharmacist manager in NC.

Then inventory must be Biennial.
In NC, how long must inventory records be kept?

Inventory of what schedule drug must have an exact count?
NC requires keep records 3 years.


Exact count of schedule II drugs required.
Do you need an exact count of other scheduled drugs?
Other schedule drugs can be estimated unless there is an open bottle that holds more than 1000 count.
Destruction of Controlled substances requires what form?

Do you need DEA permission to destroy?

What must be included on form?
1.
2.
DEA form 41

Yes

1. Signature of 2 witnesses:

(pharm, dr, nurse or law officer.)

2. date of destruction.
Destruction of Controlled Substances.

Can a retail pharmacy request authorization for continual destruction of drugs?
How often?
Can a health care facility?
Yes, may request it yearly.

Yes.
Destruction of Controlled Substances.

Can a retail store transfer Scheduled drugs to distributor for destruction? What must be given?
What is difference between C II and other C drugs?
Yes, the distributor must give pharmacy the 222 form for C II drugs.

For other schedule drugs (III-IV), the pharmacy must document the name, strength, quantity and date of destruction.
How must controlled drugs be stored in pharmacy?

Can you store C II's in locked drawer?
2 options.

1. In locked cabinet
2. Dispersed throughout regular stock

Technically not allowed to store C II's in locked drawer.
what is DEA form 106 for?

How long do you have?
Theft or loss of controlled substances.

24 hours to report it as soon as you notice theft/loss.
What providers are exempt from registering with the DEA to prescribe controlled substances?

can a dentist prescribe for diabetic meds? or vet for human meds?
military docs

No, they must have a legitimate purpose for the prescription.
Controlled substances

What are the limits on PA's and NP's for scheduled drugs?
For C II and C III they are limited to 30 day supply with NO refill. (in NC) (the fed law is less strict)

They may prescribe all other C's in all settings.
What mid level practitioners must have supervising physician in order to prescribe controlled substances?
(3 of them)
PA's, NP's and CPP.
Can an agent of a prescriber issue an oral order for C III - IV to pharmacist ?

Can prescriber give oral or fax an Rx for a C III-IV drug?
Yes and it is not required to record the agent's name.

Yes, pharmacist will put in writing and file.
What are the limitations on refilling C III - IV drugs?
ie Refill limits.
1.
2.
1. can't be refilled more than 5 times

2. can't be refilled more than 6 months after the date the prescriber issued the Rx (not date of original fill)
Can Faxed Rx serve as original for C III-IV?

How long must you keep it ?
Yes

3 years

(must be kept for at least 2 yrs from date of LAST filling)
What is required on bottle label of C II - IV drugs given to patient?
Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
How often may C drugs be transferred?

Who is allowed to take or give transferred Rx?

How long must records be kept?
One time

Only Pharmacists.

3 yrs in NC.
Are partial fills of Controlled drugs allowed? Which C's?

They are not allowed to dispense past the ___ month from date of issuance.
Yes, of only C III and C IV.

You can not dispense past 6 months from date of Rx given.
If an doc exempt from DEA registration writes for a C III- IV, what must they include on the Rx?
1.
2.
The registration number of the institution they work with
and the internal control number or suffix assigned to them by the institution.
What is the quantity limit for prescriber on C III and C IV drugs ?
No quantity limit, except for NP or PA on CII or III.
What are the ways a pharmacy can File Scheduled Drugs:

1.
2.
3.

All scripts in files must be filed ________ ly and ________ly.
1. 3 separate files: one for non controlled Rx; one for C II and one for C III-V
2. 2 files: one for C II and One for all others. ( all C's must have red C stamp)
3. 2 files: Non controls and one for all C's ( must have red C stamped on them)

All Rx 's in files must be filed chronologically and consecutively.
What can NOT be changed on a C II Script?
1.
2.
3.

Can you add a last name if the person had a maiden name?
1. Patient's name
2. controlled substance's name (you may allow generic substitution as permitted by state law)
3. Prescriber's Signature

Yes, because it is still the same person.
What can you change on a C II Script? (DPSDQD)
1.
2.
3.
4.
5.

Do you need to speak to prescriber themselves?
* date of issue – may be added but not changed;
* patient’s address;
* strength;
* dosage form;
* quantity – may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed;
* directions for use.

Yes.
C II scripts:

You have Rx for meperidine 50 mg BID and you only have 25 mg.

Can you change script to 25 mg 2 tab BID?
Yes you can change it.
Emergency dispensing of C II drugs:

Can a prescriber call in a emergency C II?
Yes, the prescriber themselves must call. (not an agent)
Emergency Dispensing of C II drugs:

What is the quantity limited to?

What is the time limit to get a written Rx?

What must the written order have on it?
1.
2.

What happens if a written order is not sent?
Quantity is only the amount needed to tx patient during the emergency period.

Must get paper Rx w/ in 7 days

Must have "Authorization for Emergency Dispensing"
and
date of the order.

If Dr doesn't send a written Rx then you call the DEA.
Are you allowed to partially fill C II drugs?

What is the time limit?

What if you are unable to fill in this time limit?
One exception to that:
Yes, must write on Rx how much you gave.

Balance must be filled w/ in 72 hrs.

If unable to fill rest then must notify prscriber and the have to write new Rx.

One exception is LTCF for documented terminally ill patient.
Can you refill a C II Rx?

What is the DEA's exception?
What must be written on it.
Never

One exception is for the same C II (like ritalin) to be 90 day supply written on 3 scripts.
Dr must indicate the earliest that script can be filled. (The date on the Rx will be date Rx was written and signed.)
Can a Dr Fax a Rx for C II?
For who or what groups?
1.
2.
3.

Why do they do this?
yes for:

IV, IM, Parenteral or SC or intraspinal.

LTCF

Hospice patients

Why?

bc there will be frequent adjustments of doses.
Computer records for controlled drugs:

How long must these records be kept?
must keep records for 2 yrs and must be signed by each pharmacist who filled scripts that day

OR

they keep a log book or file where pharms sign.....must be signed w/in 72 hrs.
Can you transfer a C II Rx?
Never
How much Pseudoephedrine can be sold in NC at a time?

How much can be sold in a month?
No more than 3.6 gm per purchase with no more than 3 gm/package.

No more than 9 gm per 30 day period.
How much pseudoephedrine can be purchased under federal law?

In a month?
3.6 gm/purchase.

9 gm per 30 day period.
For what reason can dr prescribe Methadone?

Which C is it?
For analgesia only.

(not for addiction maintenaince.)

C II
What is Subutex and Suboxone?

Which C?
Generic name is buprenorphine 2 & w/o naloxone.

Used for chronic pain or opiod dependence.

C III

Dr must have waiver ID to tx for addiction
Can Scheduled drugs be mailed?
Yes ALL classes.

Don't put on package that it is from a pharmacy bc it will get stolen...
What is a VIPPS?
A Verified Internet Pharmacy Practice Site which NC law requires for internet pharmacies.
What does federal law require for internet purchase of Rx of controlled substance?
2 things
Valid Rx

and

IN-PERSON medical evaluation.
What is OBRA 90 for?

What does it require of Pharmacist?
1.
2.
3. Record a. b. c. d.
Guidelines for reimbursement by Government for Medicaid services.

It requires Pharm to:

1. Make OFFER to counsel.
2. To make a prospective DUR-----
(which means to review therapy before dispensing like if pt is pregnant, disease issues, allergies.)
3. Reasonable effort to obtain and record: patients info of address,
phone #,
DOB
allergies
and
list of prescriptions and OTC drugs.
MUST Know----What is Required Counseling?
1.
2.
3.
4.
5.
6.
7.
8.
1. Name, description & purpose of Rx
2. Route, dosage, administration, continuity of therapy
3. Special Directions for use
4. Common severe side effects or interactions, how to avoid, what to do if they occur.
5. Techniques for self-monitoring. Like BP, etc.
6. Proper storage
7. Refill info.
8. Action to be taken in the event of missed dose.
What is a good way to offer counseling?
1.
2.
3.
1. Our pharmacist will talk to you about this Rx if you like
2. Counseling is available from our pharmacist.
3. Our pharmacist would like (is available) to talk to you about this Rx.

Best thing is to just go ahead and tell them @ thier medications.
How many techs can be with 1 pharmacist?

What can allow for more? (2 things)
2 techs per 1 pharm.

Unless,
Approval from BOP

All additional techs must be nationally certified.
What is a "Legend" drug?
Prescription Drug
What defines an Emancipated Minor?

4 things
Under 18 yr of age AND
2. Is or has been married
3. Is or has been a parent
4. Parent surrendered rights (child stars)
5. Emancipated by court orders
What does Dispense mean?
acts of processing a drug for delivery or for administration:
making label, selection of drug, counting pill, that sorts of stuff.

ex. giving a shot to dr to give = dispense
(Pharm giving the shot themselves=administration.)
What defines the Practice of Pharmacy?
1. I & E
2. C
3. D & L
4. Stor
5. R
6. Control
The responsibility for:
1. Interpreting and evaluating drug orders
2. Compounding
3. Dispensing and labeling prescription drugs
4. Storing drugs properly and safely
5. Maintaining Records
6. Control pharmacy goods and services.
What is involved in a retrospective DUR?
(CDFR)

Where should it be done?
Review:
Choice of medication for appropriateness
Dose
Frequency
Route

It should be done on site.
How long does NC Medicaid require you to keep records?
5 years
How much of OTC controlled substances can be sold?

And what Schedule?
> No more than 8 oz or 48 dosage units of an opium-containing controlled substance within 48 hours

● No more than 4 oz or 24 dosage units of any other controlled substance may be distributed at retail to the same purchaser within 48 hours without a valid prescription.

Schedule V
What is allowed of pharmacy intern under the Pharmacy Practice Act?
They may perform all acts constituting the practice of pharmacy while under supervision of pharmacist.
Generic substitution of a drug is allowed only if it has same:
1. N
2. AI
3. S
4. Q

What if the drug is for tablet and pt can't keep anything down?
1. established name
2. Active ingredients
3. Strength
4. Quantity

Must call MD to get Rx changed to some other dosage form.
Dispensing of Drugs with Narrow Therapeutic Index is special, they must be what?

That is unless:
1.
2.
Of the same manufacturer.

Unless:
1. Prescriber is notified and gives documented consent.
2. Patient gives documented consent.
What are some drugs with NTI in NC?
(11 of them)
CCDELL PPTTW
Carbamazepine
Cyclosporine
Digoxin
Ethosuximide
Levothyroxine
Lithium
Phenytoin
Procainamide
Tacrolimus
Theophylline
Warfarin
What must dr write on Rx if they don't want generics dispensed?

What does Medicaid require? (strict)
Dispense as Written (or similar abbrev)

Medicaid requires "Medically necessary"
must not be abbrev and must be in prescriber's own handwriting. (no verbal intructions)
If a dr calls in a Rx, can you substitute generic for the brand drug?
Yes, they must specifically say they want Brand only.
When do Pharmacist licenses expire in NC?
December 31st of each year.
What things must you report to the BOP within 30 days (concerning your license, employment, etc)?
1.
2.
3.
4.
5.

Can you do this online?
1. Employment change
2. Address of new employer
3. Type of practice
4. Your name change
5. Your address change

Yes, you can do online.
What is required of Pharmacists for CE credit?
Total?

How many live hours (contact hours) do you need?

How many CE hours may be carried over from previous year?
30 hr over 2 year period

And 15 hr must be done in the previous year preceding license expiration.

Need 8 contact hours.

You may carry 5 CE's over from previous years.
How many members and Who makes up the NC BOP?

How long are the terms?
Six members.

5 are licensed pharmacists residing in NC.

1 is a governor appointed member of the public (not a pharmacist)

Terms are for 5 years. They may not serve more than 2 consecutive 5 yr terms.
What is the job of the Executive Director of BOP?

What are the jobs they do?
Hired by board and is a pharmacist that acts as a secretary to the board and acts as a prosecuting attorney (but not required to be an attorney).

They investigate and may file complaints.
Can Pharmacy in NC sell DME w/ out a DME permit?
Yes, pharmacy can sell DME from their pharmacy because it is under their license.
They don't need a separate registration.
What DME's require a Rx?
Give examples:
(one must specify L/min)

Why these devices?
Medicinal Oxygen, Nebulizers, Feeding pumps, CPAP and BiPap.

These are devices that could be misused or could cause harm.
What are some of the types of violations that the BOP may bring for review?
Physically unable to practice: ex. blindness.
Drug abuse that renders unfit to practice.

Make false statements in connection with practice of pharmacy that could endanger or defraud someone.

Negligence.
What is the Pharmacy Recovery Network (PRN)?
The NC BOP has a relationship w/ the PRN to help tx pharmacists, pharm students and techs w/ recovery.
Do BOP inspectors aid in emergencies?
Yes

they also investigate complaints.
Are scripts public records?
NO
What things can you NOT tell parents about their child's prescriptions:
1.
2.
3.
4.
(BASE)
For tx, dx or prevention of:
1. Birth control pills
2. Alcohol or drug abuse
3. STD
4. Emotional disturbances
Can people other than the patient pick up that patient's medications?
Yes, you can assume they know something about it but you don't need to divulge everything about it.
You can just say that you need the pt to call you and talk to you about it.
What health care providers or persons can you talk to about a patient's prescription?
1.
2.
3.
4.
5.
6.
7.
8.
9.
1. Licensed practiti. who wrote the Rx
2. licensed pract. who is treating the patient
3. A pharmacist who is providing pharmacy services to the patient
4. Anyone who presents a written authorization for the release of pharmacy info signed by the patient or his legal representative. (this is usually an attorney)
5. Any person authorized by court order (this is by statue which is usally law enforcement possibly to do w/ kidnapping or DEA)
6. Any firm, business trust charged by law responsib of providing for or paying for medical care for the patient. (Insurance Comp)
7. A member or designated employee of BOP
8. Executor or spouse of a DECEASED patient
9. Person owning the pharmacy
10. Researchers who have approval from BOP
Does a discard date need to be put on Rx bottle?

What should the discard date be?
Yes.

Needs to be a year from the date dispensed or the manufacturers exp. date whichever is first.
Who is allowed to transfer info of prescriptions?

What about C III-V?
Pharm or techs can transfer.

Only between 2 pharmacists unless the locations are under the same ownership.
What must be written on the script by the transferring pharmacist?
1.
2.
3.
The must mark with "void" on the script
and record the name and address of the pharmacy it was transferred to
and then their name and date of transfer.
What does the Receiving pharmacist need to write down upon receiving a transferred script?
1.
2.
3.
4.
5.
6.
1. "Transfer" on script
2. date and TIME of transfer
3. No# of valid refills and date of last refill
4. Pharmacy name, address and original Rx number from transferring pharmacy
5. name of transferring pharmacist or certified tech.
6. manufacturer or brand of drug dispensed.
For the transfer of controlled substances, what do the pharmacists need to include?
The DEA numbers of the pharmacies involved.
Can transfer of controlled substance prescriptions be faxed?

Who is allowed?
Yes, but usually between nursing homes only.

Transfers btw stores of same ownership, with same computer system can have the max # of refills allowed on the Rx.
What must be contained in a faxed prescription?
1. ___&___
2. ___&___
3.
4.
1. Date and time
2.. Telephone # and location of transmitting machine
3. name of operator of the transmitting machine.
4. signature of the prescriber
Can a Faxed script be taken for controlled drugs?
as long as what:
1
2
3
Yes, for Schedule III and IV the fax can serve as original as long as:
1. It is written
2. Signed
3. Transmitted directly by the presciber, it can't be from their house or from Kinko's
Can Schedule II prescriptions be faxed?

What must be done?
Yes and No.
The fax does NOT count as the original, it just acts to speed up the filling process. (3 exceptions)
The original must be presented at time of dispensing.
Describe Emergency Refills:
aka Hurricane Hugo & Sept 11 rule.
What may be filled and provided what:
1.
2.
3.
4.

When do you need to notify the prescriber?
You may dispense a one-time emergency refill of up to 30 day supply (in the event that a pt requests a refill and the pharm cannot obtain refill authorization from the prescriber provided that:
1. It is NOT for C II drug
2. It is essential to maintenance of life or chronic condition
3. In the Pharmacists professional judgment, that interruption of tx would be bad
4. Dispensing Pharm makes a written order w/ all Rx info and signs the order

You need to notify the prescriber w/in 72 hours of the prescibers office opening. (you don't need to get their permission, just notify)
What happens if the Dr is unable to provide service to the patient
(dies, moves, HMO doesn't allow)?

What can you do about Emergency refill with this?
You are allowed to dispense a one time emergency refill of up to 90 days supply.
Pharmacist Manager Responsibilities:

What do they need to notify the BOP of in their pharmacy?

What is the time limit?

How long do the need to maintain script records?
Need to notify BOP with in 30 days of change in pharmacist personnel.

3 years.
Pharmacist Manager Responsibilities:

Who is the pharmacy permit issued to and what happens when pharmacist leaves job?
It is issued to the pharmacist manager, must be signed by the pharmacist manager and when they leave or quit they must send permit back to BOP.
Pharmacist Manager Responsibilities:

Who must go get the pharmacy permit?
The pharmacist manager must appear in person at the Boards office to obtain a permit.
Pharmacist Manager Responsibilities:

In health Departments, when must managers verify scripts?
They must verify accuracy of records either weekly or daily --it depends on prescription volume.
Pharmacist Manager Responsibilities:

How many hours must the pharm manager be present in pharmacy?

When does the controlled substance inventory need to be done when there is a change in pharmacist manager?
They must be present at least half the time the pharmacy is open
OR 32 hrs per week (whichever is less).

Controlled substance inventory must be done within
10 days of change in pharmacist manager.

(it can be perpetual inventory ie computer.)
Pharmacist Manager Responsibilities:

What is the time limit that the pharmacy can be open without a pharmacist?
If pharmacy is without pharmacist for 90 minutes or more; the pharmacy must be secured.
Pharmacist Manager Responsibilities:

May a pharmacy manager be manager at two different pharmacies?
No, only one full service permit at one time.
Pharmacist Manager Responsibilities:

When and Who must be notified if the pharmacy is closed down or sold?
BOP and DEA well before you close your pharmacy (ie. 30 days).

This is the only time when a prescription transfer is mandatory and it is to the pharmacy of patient's choice.
Pharmacist Manager Responsibilities:

Must deaths be reported to BOP?

Is there a time limit?
Yes, deaths due to drugs dispensed must be reported to the BOP within 14 days.
What must you do if there is a dispensing error? (what must be included)
1.
2.
3.
4.
5. must there be a plan?
6. must they be made public?
1. Document
2. Report it to pharmacist manager
3. Include all chronological info including who made the error
4. Be open to the BOP
5. Tell what actions they have done as part of a QA plan
6. Not released unless required by law.
Must actions of QA programs be performed by the pharmacist manager?
No they can appoint someone else to do them.
What must be included in a QA program?
1. Q
2. C AND I
3. O
4. I
5. P
1. QUALITY of the pharmacy practice
2. CAUSE of medication errors and their INCIDENTS
3. OUTCOMES Pharmaceutical care
4. IMPROVEMENTS that can get u to outcomes
5. PLAN Methods to reduce medication errors and incidents
If the BOP inquires about a dispensing error or incident
who must provide the information
and
under what circumstances would you need to report?

who =

what
1.
2.
3.
OR
Who = Pharmacist-manager or an agent must provide documentation if it:

Resulted in:

1. visit to ER or MD
2. Hospitalization >24 hrs
3. Fatality

OR

a disciplinary proceeding has occurred.
Who (and WHEN would you) need to notify if there is a Fire/Flood?
You should notify the BOP within 10 days if the drugs strength, labeling or purity is affected.
Do pharmacies need to notify the BOP if they have been robbed?
No, just the DEA and police but Hospital pharmacies do need to notify the BOP.
Can CPP's have their initials on their ID badges?
No they must spell out all of name.

Other pharms can have initials on badge.
For what reason(s) can you refuse to fill a Rx?
1.
2. unless what:
a.
b.
c.
d.
e.
1. If, in your professional judgment, it is not in the patients best interest.
2. If you know that a physical exam was not performed unless:
a. psychiatrist order
b. flu vaccines
c. prophylactic purpose like strep, lice, worm meds for entire family
d. pregnancy prevention
e. trips outside the country
When would you NOT dispense more than face amount of the prescription?

(suppose you could dispense more if pt wanted to pay for themselves)

1.
2.
3.
4.
OR if you do what?
1. medicaid or insurance
2. Your professional judgment deems appropriate
3. controlled substance
4. psych drug (overdose)

OR you can contact the Dr and ask them if it's ok to dispense more than stated.

Ex. HCTZ 12.5 for 30day x 5 refills w/ copay of $30 but you can sell them 180 tabs for $30.
Can an out of state Dr write a script IN nc?
No
Can an Out of State Dr write a script for controlled substance and an antibiotic?
Yes, as long as they didn't write it in NC. You can fill both.
What is the 150 Rx per Day rule?

The 3 If's.

Why is it done?
IF a mistake occurs
and IF a Board hearing results
and IF the pharmacy filled more than 150 prescriptions per pharmacist that day ,

THEN the pharmacy will suffer the same penalty as the pharmacist.

(Why---so that the owner of the pharmacy will understand the problem.)
Can you require a person to show their ID before filling the script?

Can you refuse to fill because of that reason?
Yes and Yes,
If you don't feel comfortable with the person or script then you can refuse to fill it and you must not on the back of the script your reasons for the refusal. ie NO Valid ID.
What does the BOP require for a pharmacy to have on their computer software?
1.
2.
They need to have
1. drug interaction software
and
2. a procedure established to respond and override the prompts.
How often does the BOP require a pharmacy to back up their computer records?
Must back up weekly.
What are the requirements for dispensing veterinary prescriptions?
ie may be dispensed only to
1.
2.
1. May be dispensed to a veterinarian
Or
2. on the prescription of a veternarian
What vaccines may not be administered until a Rx (prescription) is given?
1.
2.
1. Zoster
2. Pneumococcal

All others may be administered w/out script.
What must be recorded for giving vaccines?
1. a, b, c
2.
3.
4.
5.
6. a, b, c, d,
7.
8.
1. Name, Address, and DOB
2. Date of administration
3. Site of admin
4. Route
5. Name, Manufacturer, Lot #, Exp. Date of vaccine
6. Dose
7. Name of Primary health care practitioner
8. Name or initials of pharmacist that gave it
Under what conditions are PA's, NP's and CPP's allowed to prescribe drugs?
Must have ______ and this should be on the ___.
Must have a __________in place.
What if they themselves want to compound or dispense drugs?
They must have a license number assigned by the Medical Board and should be on the Rx.

They must have an agreement with the Dr to prescribe the certain drugs they will prescribe.

If they want to compound or dispense they must obtain approval from the BOP.
Prescriptive authority of PA's and NP's:

What are the restrictions on Scheduled drugs?
1.
2.
What about the other scheduled drugs?
Schedule II and III drugs
1. shall not exceed a legitimate 30 day supply and
2. NO refills.
Other scheduled drugs can have refills and have no limit.
Prescriptive authority of PA's and NP's:

What must they put on the Rx?

What else must they have on the Rx's? ____ & _____
They must have their own DEA number on the Rx.

They must also have the NAME and TELE # of the responsible Dr.
What are the new rules (2007) for how many hours a pharmacist can work a day?
what if working more than 6 hour?
No more than 12 hours per day.

If working at least 6 hours, they get a 30 min meal break and one 15 min break.
Central Fill Pharmacies

Requirements of computer system are:

What must be on the label:
1.
2.
3.
Computer system must share access.

Label:
1, must ID the pharmacy and PharmD that filled and the pharmacy and PharmD that dispensed

2. Both pharmacies maintain records of Rx

3. who to call if there are questions.
What is required of Internet Pharmacies if they are going to provide drugs in NC?
1. Must be a _ _ _ _ _
2. Must _________.
3. All Rx must _________.
1. Must be a VIPPS
2. Must comply with NC laws
3. All scripts have to have had a physical exam.
Rules on Hospitals

All places that provide pharmacy service shall register with the exception of:
ie. ________


What if they have a Pyxis???
Exception: Facility where drugs are only administered

ie. long term care facility

if they have a Pyxis then they need a limited permit
Rules on Hospitals

When Would they need a separate registration for separate locations.
1. (bc bought at charity price)
2.
3.
They need them if:
1. the drugs dispensed at that location are obtained
from outside the facility
2. the pharmacist-manager is controlled and supervised from
a source other than the facility.
3. The location mostly is dispensing to outpatients.
Rules on Hospitals

does the pharmacist-manager need to be an employee of the facility?

Do technicians need to be certified?

And who needs to watch over tech activities?
Yes.

Yes.

The supervising pharmacist must watch over the techs,
there is no Tech check Tech thing.
Rules on Hospitals

Can pharmacist manager responsibility be delegated?

How often do they need to check patient care areas where meds are dispensed and stored?
No, only the duties of pharmacist manager.

Monthly
Rules on Hospitals

Off Hours:
When pharmacy is not open 24 hours what must be done?

Are ancillary drug cabinets allowed?
Must have "on call" pharmacist during ALL off times.

Yes, ancillary drug cabinets are allowed.
Hospital Rules

Who may enter the pharmacy after hours?

What must pharmacist manager do to make this possible?
1.
2.
3.


May clerical duties be done after hours?
Nurse authorized by the pharmacist manager

1. They must maintain a list of the authorized persons.
2. Do initial orientation and CE.
3. QC also.

Yes, just on approval by pharmacist manager.
Hospital Rules

In absence of a pharmacist, can a person authorized to enter pharmacy take any medication they need?

When can they take certain meds?
No, the pharmacist- manager must keep a list of restricted meds.

The restricted meds can be taken after consultation with the on-call pharmacist.
Hospital Rules

How long do records for ancillary drug cabinets need to be kept?

How often do the records need to be reviewed and by whom?
3 years

Pharmacist manager needs to review them quarterly.
Hospital Rules

Can controlled substances be stocked in the ancillary drug cabinets?

Can scheduled drugs be taken from the pharmacy after hours?
Yes.

No, not in absence of pharmacist.
Hospital Rules

Do they need a written order or can it be verbal?
It can be oral or verbal but there needs to be a signed order in whatever time frame established by that facility.
Hospital Rules

What must be contained on the med orders?
1. a, b, c, d
2. a, b, c
3.
4.
1. a. Pt Name
b. Location
c. Medical Record #
d. Account #

2. a. Medication name
b. strength
c. dosage form and
d. Route of administration

3. Date order written

4. Prescribers signature
Hospital Rules

Are Electronic signatures allowed in hospital?
NO
Hospital Rules

Medication orders must be entered on a patient profile. What must be contained on the patient profile?
1.a.b.c.

2.a.b.c.

3.

4.
1. a. Patient name
b. location
c. Important clinical data
(age, sex, allergies)
2. a. medication name
b. strength
c. route of administration

3. start date and discontinuation date
4. Indication of pharmacist or pharm tech responsible for entering order.
Hospital Rules

What must be on parental admixtures besides the drug name?
1.
2.
3.
1. amount of drugs added
2. date
3. time made
Hospital Rules

Does patient care unit inventories apply to nursing homes?

Who else?
No, it also does NOT apply to assisted living and adult care homes.
Hospital Rules

When a controlled substance from a dispensing unit for a patient is not used, what must be done with it?

If it is from a Pyxis or something like that then what?
It may be destroyed right there at the unit with a witness such as another pharmacist, RN or LPN only. Not CNA, clerk, etc.

It must be documented HOW it was destroyed. ie. down the sink

If from pyxis then can return it to pyxis or however that machine works.
Hospital Rules

What is a disposition form used for?

What must be on this form?
1. a,b,c,d
2.
3. a,b
4. a,b,c
5. a,b


when does this not need to be done?
It is for all controlled substances not located in the pharmacy but like in patient care unit inventories.

1. a. product name
b. strength
c. dosage form
d. quantity

2. Date transferred to care unit

3. a. name of pharmacy representative supplying drug
b. name of care unit rep. receiving

4. a. date
b. time
c. amount of drug removed from stock for administration.

5. a. patient name
b. ID of person acquiring product.

Does not need to be done like this when have an automated machine.
Hospital Rules

Are routinely prescribed meds (like prilosec) be stocked in ancillary drug cabinets?

When do they get used?

Do they keep records of use?
Yes, they can be stocked in limited quantities.

They can be used ONLY when the pharmacy is closed.

Yes, keep records of date and time, who took for what patient and what drugs.
Hospital Rules

May LTC facility use a pyxis?

What must they do?
Yes, they must get a limited permit for use.
Hospital Rules - Emergency Kits

How many drugs may be in kit?

What is the expiration date of kit?

How often must kit be checked?

Are controlled substances allowed in kit?
75 item limit in kit.

Exp. date of kit is the earliest item to go out of date, if it is in-house dating then it is 6 months.

Kit must be checked monthly.

Controlled substances must be in Separate emergency kit.
Hospital Rules

How long do records of compounding need to be kept?
Records need to be kept for 30 days.
Hospital Rules

Medication errors:

Who are they reported to?

How long are they kept?
Pharmacist Manager

Need to be kept for 3 years
Hospital Rules

Death reporting:

When must this be reported?
Report when there is a probability a prescription drug or device caused or contributed to death of a patient.

These documents must be kept (vials, substances, investigative reports) and be readily available to BOP.
Medications in the ED:

Who can dispense drugs in facility w/ 24 hr pharmacy?

What about w/out 24 hr pharmacy?

Who can get the drugs for their use?
Only pharmacist in 24 hr pharmacy

Without 24 hour service, they may be dispensed from the ED by:
1. MD
2. RN under MD supervision

They can only be for registered patients of the ED (not for patient's family).
Medications in the ED:

Must there be a procedure or policy in place for dispensing drugs w/out a pharmacist?
Yes, must be made with the pharmacist manager.
Medications in the ED:

What must be on the label of drugs dispensed when dispensed without pharmacist.
1.
2.
3.
1. Name of patient
2. Directions
3. Notation of the authorized personnel dispensing.
Medications in the ED:

What must be on the label of prepackaged drugs?
1. a,b,c
2.
3. a, b
4.
1. a. Generic or trade name
b. Strength
c. Quantity
2. Manufacturer
3. Lot number and expiration date
4. Expiration date of repackaged product
tx records of practitioners: (alcohol,drugs)

can you give them to anyone?
No

can only give for:

a disciplinary hearing of health board
to license or hospital committees deciding
or by order of a court
how long to reinstate after license revoked?
minimum 3 years
mandatory suspension or revocation

when can board do this without hearing??
suspend if:

suspended in another jurisdiction

convicted of felony

judged incapacitated
when can u apply to the board for reinstatement of license, (how long to wait)?
must wait 60 days after board receipt of your applic. to reinstate
what must occur to transfer pt records with closure,sale:

what must be posted,etc
must first attempt to notify pt by:

Mail
and
publish in newspaper

and must specify that will be sent to provider of choice
prohibited referrals and payments:
can't refer if you or immediate family is an investor in that group

except board may grant if it deems that community needs that service and:
can't refer to generate business

must offer same to other investors

contract can't include a clause limiting the practitioners investment in other entities
When is an exception to patient referral ok??
disclose practitioners investment in said company to patient at time of referral

provide list of alternative entities and that choosing someone else won't affect their care

must do an internal utilization review

give info about referral relationship if requested
what is the practitioners monitoring program?

how many members?

must dr enter in contract with the program and what if they can't pay?

can the program give out info on the person in the program?
program for helping practitioners who have impairments (mental or drugs)

7 members at least 1 an active RN

must enter contract and don't have to pay.

no unless they allow it
OR
it is essential to needs of practitioner
OR
ordered by court to protect public
OR
to a health board within the Dof HP
what is the Prescription Monitoring Program?
electronic system to monitor dispensing of controlled substances II-IV.
what is reported in the Rx monitoring program?
Once cont. subst. is dispensed:

pt name and address

pt DOB

drug that was dispensed

date of dispensing

quantity

prescribers and dispensers identifying number
what is exempt from reporting in the Rx monitoring program?
drug samples for indigent pt program

dispensing by dr in emergency or if pharmaceut services are not available

administering covered substances

dispensing withing a licensed narcotic tx program

dispensing to inpatients or nursing facilities or inpatients of hospices

dispensing by DVM
confidentiality in Rx monitoring program:

when can director after a request disclose info?
for an investigation or inspection of misconduct

for proceedings of grand jury

to DEA for drug diversion investigations
Rx monitoring program:

director at their discretion disclose what?
info concerning a pt who is over 18 to that pt

info about a specific pt to a dr for tx history who is tx that pt *(must notify pt that info may be requested by the dr from the Rx monitoring program.)

info to a dispenser for getting a Rx history to help determine validity of a Rx when the pt is getting a covered subst.

info for investigation or proceeding about licenses to practice.

info for investigation of pt participating in the Medicaid program

info to the chief ME for a death of a pt

info for research but eliminate pt and dr and dispenser
can info in Rx monitoring program be used as evidence in a malpractice or damages suit?
No
what defines misuse of rx monitoring program?
director decides with advisory panel
who can access info in database of rx monitoring program?
any dr authorized to access and they can delegate authority to up to 2 licensed health care profess. that are employed under that dr.
who is not liable for damages (civil) of inaccuracies in the rx monitoring program?
dirctor and employees of the dept of H Prof.

drs. ( in the absence of misconduct and negligence)
what happens for unlawful disclosure?
Class 1 misdemeanor.

and if receiver discloses again then same punishment
who can sale controlled substances?
only practitioner under their scope of practice
what is reported in the Rx monitoring program?
Once cont. subst. is dispensed:

pt name and address

pt DOB

drug that was dispensed

date of dispensing

quantity

prescribers and dispensers identifying number
what is exempt from reporting in the Rx monitoring program?
drug samples for indigent pt program

dispensing by dr in emergency or if pharmaceut services are not available

administering covered substances

dispensing withing a licensed narcotic tx program

dispensing to inpatients or nursing facilities or inpatients of hospices

dispensing by DVM
confidentiality in Rx monitoring program:

when can director after a request disclose info?
for an investigation or inspection of misconduct

for proceedings of grand jury

to DEA for drug diversion investigations
Rx monitoring program:

director at their discretion disclose what?
info concerning a pt who is over 18 to that pt

info about a specific pt to a dr for tx history who is tx that pt *(must notify pt that info may be requested by the dr from the Rx monitoring program.)

info to a dispenser for getting a Rx history to help determine validity of a Rx when the pt is getting a covered subst.

info for investigation or proceeding about licenses to practice.

info for investigation of pt participating in the Medicaid program

info to the chief ME for a death of a pt

info for research but eliminate pt and dr and dispenser
can info in Rx monitoring program be used as evidence in a malpractice or damages suit?
No
what defines misuse of rx monitoring program?
director decides with advisory panel
who can access info in database of rx monitoring program?
any dr authorized to access and they can delegate authority to up to 2 licensed health care profess. that are employed under that dr.
who is not liable for damages (civil) of inaccuracies in the rx monitoring program?
dirctor and employees of the dept of H Prof.

drs. ( in the absence of misconduct and negligence)
what happens for unlawful disclosure?
Class 1 misdemeanor.

and if receiver discloses again then same punishment
who can sale controlled substances?
only practitioner under their scope of practice
May pharm partially fill control II drug?
yes
partial dispensing:

How much time does the Pharm have to fill rest of partial fill?

What if it will take longer?

May the drug be filled after that time period?
they have 72 hrs

they must notify prescriber

no they cannot finish fill after 72 hrs without new script
can sched II for long term care pt be given partial fills?

How long are the scripts valid?
yes

valid for 60 days from the script issue date
who else can get partial fill for 60 days from issue date?

must pharm verify that pt is terminal
terminally ill

yes
Schedule VI drug filling:

how long do they have to fill script or refill ?

can dr allow dispensing or refill for longer than the 1 yr?
no longer than one year after date of script issue

Yes, not to exceed 2 yrs.
Schedule III-V refills:

How long do you have to fill?
and
How many refills?
6 mths from issue date

no more than 5 refills
Partial fills for Schedule III-V should be recorded as what?
Must record as a refill, so takes away from refill #
can u dispense a refill of schedule drug early?
Yes just document valid reason for early refill
when is compliance packing ok to use?

1.
2.
3
Requested by pt

hospitals

long-term care
how long must pharmacy keep records of repackaging drugs?
1 year or until the expiration of drug
What must be kept in records of repacked drugs?
1
2
3
4
5
6
7
name of drug
strength
date of repacking
quantity repacked
initials of pharm verifying
assigned lot no#
manufacturer name AND their lot #
an expiration date
What must be on label of repacked drugs?
1
2
3 OR
4
drug name
strength
assigned lot # OR the manufacturers name and lot number
expiration date
How long must pharm keep bin filling record if drugs kept in big bin?

What info do you need to keep?

1
2
3
4
5
6
7
8
1 yr from date of filling.

Info you need:
drug name
strength
manufacturer name
manufacturer lot number and expiration date
assigned lot number
date of filling
pharm initials who verified filling
What if more than one lot is added to a bulk bin?

what lot is used first?

should the bin be allowed to do what? and this is at least once every ____ days?

Must you record these dates?
must use lot that expires first

must allow bin to run dry

at least once every 60 days and must keep record of rung dry dates
transferring of Schedule III-VI

May be done by
1
2
3
May be done by
telephone btw 2 pharms

fax

electronic transmission
what must the pharm receiving a transferred script write?
1
2
3
4
5 AND
6 AND
7
8
1 TRANSFER
2 date of issue of original script
3 original # of refills
4 date of original dispensing (if applicable)
5 # of valid refills remaining AND date of last dispensing
6 Pharmacy name,/ address,/ DEA if controlled
7 original script #
8 name of transferring pharmacist
How long must the original script be kept if transferred?
2 years from date of last refill
how long must the transferred script be kept?
2 years from date of last refill
Can a pharmacist solicit prescription from a prescriber for kickbacks or feesplitting?
No
Can pharm give script blanks to drs?
Yes all advertising must be on back
can drugs be returned to pharmacy for redispensing?

in long term care too?

What must be present for this with long term care?
Only drugs still in manufactureres original sealed package

Can get drugs returned from long term care but must have a written agreement with the nursing home and procedure manual describing it.
What procedures must be in place for returns from long term care?
method of delivery

tracking of meds

procedure for determining suitability and integrity of drugs

procedure for assigning beyond use date for redispensed drugs
unit dose drug dispensing system can be used where?
long term care AND hospitals
can unit dose dispensing be used whether licensed or unlicensed persons administer drugs?
Yes
How many back up doses can be kept in the pt's drawer?
only one dose
How long must records be kept for cart fills?

what 4 things must be kept in records.
1 year

must contain:

date of filling
location of drug cart
initials of person who filled cart
initials of pharmacist checking cart
May an LPN prescribe controlled substances?
Only with a written agreement w/dr.
can a LPN have their own office?
No
can a LPN administer controlled substances?
Yes
can an LPN dispense med samples of controlled substances?
Yes
Who is able to compound, purchase and possess drugs on behalf of the health dept. of Virginia?

1.
2.
3.
Dentist, vets, drs.
what practitioners can purchase, administer and possess controlled subs?
1
2.
3.
4.
5.
6.

and what types of conditions or types of meds do they need to be?
1.
2.
MDs, DOs, and podiatry.
and optometrists, PAs and LPNs

Must be a medical emergency or providing manufacturers samples to his own patients.
indigent pt programs

who can dispense meds without a license to dispense
an MD or DO in indegent program can send a script to manufacturer for free meds

and they don't need a license to dispense from BOP
who is able to give free controlled subs at a free clinic?
MDs and DOs
How would an MD or DO be able to give free controlled subs meds to patients?

1.
2.
3.
4.

5. MUST they label the meds?
1. the controlled subs must be DONATED by another authority (NOT manufacturer)

2. must be their OWN patients

3. and a FREE CLINIC.

4. and they must get a controlled substances REGISTRATION from the BOP

5. and must follow label and packaging requirements
what must be met for a PharmD to give free health care in Virg?
1.
2.
3.
4.
5.
6
1 must be an UNDERSERVED pop.

2 May or may not regularly practice in virginia

3 Have to hold a valid and current license to practice pharmacy in another state

4 file a copy of license with the board

5 notify the board at least 5 business days prior as to the dates and location of the service

6. acknowledge in writing that this is for a limited time and as a volunteer, nonprofit org.
may the BOP deny a pharmD the right to practice in virginia?

What reasons?
1.
2.
3.
Yes if their license has been suspended or revoked
or

convicted of a felony

or

found to be in violation of laws or regulations
Can a Pharmd provide free health care to indegent without notifying the BOP?

1.
2.
yes for up to 3 days provided the pharmD meet criteria (no felony etc)

and nonprofit org verifies that the practitioner has a valid and unrestricted license in another state
can a pharmd dispense a controlled subs written by an out of state practitioner?
Yes
a TPA certified optometrist who is authorized to prescribe controlled substances may give what controlled subs?

1.
2.
3.
4.
Whatever is in the TPA formulary which is limited to

1 oral analgesics (III - VI) to relieve ocular pain

2 other oral VI meds needed to tx the eye and its adnexa

3 topical VI

4 IM epinephrine for tx of anaphylactic shock
can anyone give a flu vaccine and Pneumo vaccine in hospital?
Pretty much

a member or committee of a hopitals medical staff shall be deemed a bona fide dr/pt relationship (it must be protocol of the hospital or a standing order)
can a MDor DO dispense drugs legally granted by the BOP?

when?

can it be renewed?
yes, if the pharmaceutical service is not reasonably available.

yes, BOP may be renewed yearly
can the BOP regulate the dispensing of controlled subs by practioners?
yes
how many members are in the BOP?

break it down
10
8 pharm
2 citizens
how many years per term
4 yrs
who elects the chairman BOP?
members elect annually
How many hr of CE each year?
15 hrs
How long do you need to keep certificates?
2 years after renewal of license
Can a Pharm get an exemption from the CE from the board?
Yes for circumstances beyond control
Can you get an extension from the BOP for CE credits?

for how long?
Yes

1 year
can the BOP revoke, suspend or deny a license?

for what things?

Can the BOP suspend or revoke a license without a hearing? When?

How long must you wait to get reinstatement after revocation?
Yes for doing bad things,

1. drugs, alc, neglect

2. Conviction of a felony

3. or any misdemeanor involving moral turpitude.

Yes, they don't need to have hearing in there is substantial danger to public.

MUST wait 3 years
when BOP revokes license what do you need to do?
turn in your license.
Offer to counsel for script:

How may you offer?
1.
2.
3.
4
5..
1. face to face

2. posted sign

3. notation on bag

4. notation on script container

5. by telephone
How many pharm techs may a pharmacist supervise at one time?
4
Can the BOP waive registration and exam fee for a pharm tech?

what circumstances?
Yes if they work for free clinic only.

They may not work in any other setting.
When should Pharm take inventory of controlled subs in a newly opened business?
On the date he first engages in business.
How often do you need to take controlled subs inventory?
biennially

taken on any date winthin 2 years of the previous inventory.
After a theft or loss what must the pharmacist provide the BOP?

in what time frame
A list of what was taken

If you don't know what is stolen then do inventory and provide a list of the drugs lost within 30 days.
How long in VA do you need to keep records of controlled subsances?
2 yrs
What drug may an EMS tech possess and administer in emergency?
epinephrine
what drugs may an LPN or RN carry as standing protocol?
heparin or epinephrine and normal saline for emergency
Can an employee of a school board who is trained to give insulin and glucagon do so?

what conditions?
Yes

only if there is not an LPN,NP DR or PA around to give it.
Can a dentist allow someone to give topical drugs to pt?

what drugs?

1.
2.
3. ____ and ____

to patients how old?
Yes,

1.. schedule VI
2.oral anesthetics
3. NO and O2

pt >18 yo.

can be a dental hygienist or another agent
what types of vaccines can a Pharm give a minor?
flu vaccines
Can a dr let anyone administer controlled subs to a patient?
NOT sure, says anyone properly trained to assist a docotr or DO
what info of the dr must be on the prescriptions?
name
address
tele no#

if controlled then the DEA
How many orders can be on one script?

except for who?

1.
2.
3.
4.
5.
one

except for:

hospitals
LTCF
hospice
DOC
DofHealth
May drs fax over orders?

for who?
Yes for

LTCF
home infusion pharmacy
Are faxed and electronically transmitted orders valid?
Yes they are to be treated as valid original scripts.
Drug substitution

when can a pharm NOT substitute a generic for a trade drug?
1. dr says no substitution
2. pt wants brand
3.. not if it costs more
vet scripts

what must be on the script for the animal?
1,2
3
owner's name and address
species
May a drugs that has NO more refills be filled?


__________ and _______________
Yes if the pharm believes the pt's health would be in imminent danger w/o drug AND after a reasonable effort to contact the dr.
can a pharm sell and dispense radiopharmaceuticals?
Yes if the are for a dr who is authorized by state or fed law to administer them for tx or diagnosis.
Under what conditions can a pharm compound drugs?

1
pursuant to valid script for a SPECIFIC patient
can a pharm compound a drug in anticipations of script?
Yes based on a routine, regularly observed prescribing pattern.
What must be on the label of a compounded drug (besides pt name, dr name, etc)
1. ____________ AND ___________
2.
3.
4.
1. names and strengths of drugs

2. number that goes in compounding record book

3. beyond use date according to USP

4. quantity of product (grams, ,etc)
Can a pharm distribute compounded drugs for distribution or sale?
No
Can a pharm deliver compounded drugs for SPECIFIC patients to alternate delivery locations?
Yes
Can a pharm give compounded drugs to practitioners for them to administer to patients?

who can administer it?
Yes, and either they or someone under their direct and immediate supervision shall administer it.
What should be on the label of compounded drugs that are given to practitioners for administration to their patients?
1."_________" this is a big one
2
3
4
5
1. "For Administering in Prescriber Practice Location Only"

2. Name and strength of meds in product

3. facility's control number

4. beyond-use date

5. quantity
Can a pharm compound drugs that are commercially available?
Yes under certain circumstances.
When can drugs commercially available be compounded?
1.
2.
3.
1. when the dr changes the strength for a specific patient

2. the drug is unavailable from the supplier

3. mixing of 2 or more commercially available products regardless of whether the end product is a commercially available product.
How long do records of compounded meds be kept?
dat on
Do you need a QA plan?
Not sure, doesn't say.

Yes
Refills on Scheduled drugs III-V;

What are the restrictions for filling and refilling ?
May not be filled or refilled more than 6 months after the date on script

May not be refilled more than 5 times
Can a non scheduled drug (VI) be refilled if no refills remain?
Yes, same as earlier and just notify the pt than the dr didn't authorize bc they couldn't be reached and then notify the dr that you gave the pt.
When can drugs dispensed from a pharmacy be returned?

1.
2._________ or ___________ or_________
3.
1. Hospital with in house pharmacy

2. manufacturers original sealed container
or
sealed individual dose
or
unit dose packing that meets official compendium class A or B container requirements

3. When the drug has not been out of the possession of a delivery agent of the pharmacy
Can drugs be re-dispensed for the indigent?
Yes
under what conditions can drugs be gifted (re dispensed) to the indigent?

1.
2.
3.
4.
5.
6.
1. the physical transfer must be by someone authorized by pharmacy

2. person gives written consent for the donation

3. old pts name must be taken off

4. leave all other info about drug

5. an inventory list of the drugs given must be kept

6. out of date drugs will be destroyed
On redispensed drugs:

can the beyond-use date be extended past the one on the label at first dispensing?

Can the product be re-dispensed more than one time?
No, the beyond use date on the 1st label must be used

The product should NOT be re-dispensed more than ONCE.
Can the manufacturer be held liable for injury from donated drugs?
No when it has to do with the storage, transfer or dispensing of the drug.
When can a person manufacture or practitioner administer a Schedule I drug?
Only when authorized by Att General or pursuant to the federal Food, Drug and Cosmetic Act
What drs can order Scheduled drugs?

Six of them
PharmD
DO
MD
Podiatry
Dentist
Vet
What other peoples can order controlled substances?
1.
2.
3.
1. person issued a controlled substance certificate

2. special written order to govt or state employee

3. Master of ship or aircraft where no dr is regularly employed BUT the drugs must be sold to by a special order form fro a commissioned med officer or acting assist. surgeon of the US Public HS
When can a Schedule V be dispensed w/o a script?
1.
2.
3. ___who can sell?
4.
5. LONG
1. at least 18 yo

2. furnish suitable ID

3. by a pharmacist directly to the person requesting the preparation

4. No more than 270 mg of codeine

OR

more than 200 mg of opium

OR

more than 130 mg of dihydrocodeinone

OR

more than 65 mg of ethylmorphine

OR

more than 32 5/10 mg of diphenoxylate
Does the pharm need to keep a book of the OTC controlled sub sales?

for How Long?
Yes for 2 years
Disposing of Scheduled II-Vs:

Can a owner (Dr or pharmacy) of stocks of controlled sub dispose of them and HOW?
Yes they can only on an official written order as follows:

may dispose of them to a permitted manufacturer or wholesaler; or practitioner or pharmacy
May a pharmacist sell controlled sub in solution to practitioner?

To whom? (3 of them)

How much?
Yes, only on an official written order

to dr, dentist or vet

Not to exceed 1 ounce at a time AND not to exceed more than 20% narcotic drug
Can anyone sell insulin over the counter?
No must be dispensed only by OR under the supervision of a pharmacist
Can a pharm ask for ID before dispensing a controlled med?

Before refilling a controlled med?
yes and yes
Delivery of drug order by mail or delivery:

What must be done when the drug is not personally hand delivered to pt or agent of patient?
1.
2.
1. written notice that chemical degredation of drug may occur
2. written notice for toll free number for consumer questions of degred of drug
When is a controlled sub registration certificate needed?

What entity gives it out?
By peoples who want to manufacture, distribute or dispense controlled sub who are not already authorized to do so,,,,, ie pharm, dr, vet, dentist

The BOP
Can the same controlled sub certificate be used for each place of business?
No need separate registration for each place they manufacture, distribute or dispense
When can the BOP not issue a controlled sub registration certificate?
1.
2.
3.
4.
5.

and other obvious ones
1. they don't effectively control against diversion

2. they don;t follow state and local law

3. Any convictions with controlled substances

4. past exper. in manuf/dis or controlled sub diversion

5. giving false info on application
For controlled sub registration certificates, when a change of owner or location happens:

what must be done and in what time frame?
must give back the registration and within 14 days file a new application.
When can the BOP revoke a controlled sub registration?
1.
2.
3
1. federal registration for cont. sub has been revoked
2. filed false application
3. convicted of felony regarding controlled sub
Special packaging:

Who can request the a med be put in container without special packaging?
prescriber or purchaser
Is a pharmacist liable for delivering drugs in a non safety cap?

what are the circumstances?

1.

2. and
Not

1. if the recipient signs a release covering a period of time or a single delivery that releases the pharm from liability

2. unless the pharm acted with willful and wanton disregard of safety.
Can a historic building that is not a current pharmacy be granted to call themselves a pharmacy?
Yes, by the BOP if they were formerly a drugstore or pharmacy

The building must be deemed a historic landmark
Permits to conduct Pharmacy

Who must sign the permit on their application?

____ must be in _____&_______ ; and fully ___________.

can anyone else sign application for permit?
the pharmacist who will be in full and actual charge of the pharmacy

and who will be fully engaged in the practice of pharmacy at that location

no but if owner is not pharmacist in charge they can list their name on the permit, but can't act as pharmacist
How long after pharm in charge leaves job or ANY change in partnership OR selling pharmacy must the permit be turned in?

who must turn it in?
immediately

The pharm in charge it was issued to or their legal representative
If an owner has not designated a new pharmacist in charge within the time period what will happen?

In what time frame?
The director of the BOP will send written notice that the pharmacy no longer holds a valid permit.

Owner must get rid of controlled substances with in 15 days
What if the owner doesn't dispose of controlled sub within the 15 days?
The director will seize drugs and secure them.
What happens after 6 month of seizure of controlled sub?
Director of BOP can dispose the drugs or make owner pay a fee for storage when owner reclaims them.
When does the pharmacist in charge need to do inventory of scheduled drugs when becoming pharmacist in charge?
As of the date they become pharm in charge AND prior to opening for business on that date.
Notice of pharmacy closing:

What must happen if the pharmacy is going to close for a period of time?

ie what length of time before they have to do this

What do they need to do?

1.
2.


What is that time frame that they have to do this?
If the pharmacy will close for MORE than 1 week they should put out:

1. conspicuous notice ---at lest 30 days prior

2. mail notice ------- at least 15 days prior
Pharmacy closing:

What shall the notice indicate and who should it be given to?

Indicates:

1,
2,
It indicates what pharmacy the patients scripts will be given to UNLESS they specify otherwise

it also indicates date of closing

and should be given to every customer having refill authority
Change of ownership:

What records need to go to new
owner? Dating back how long?

1.

2.


When should the records be sent?
dispensing records and patient records dating back 2 years

Prior to closing.
Automated dispensing systems:

Who can have them?
Hospitals
automated dispensing system:

What are the conditions that must be met before hospital gets a license to have this?
1.
2.
3.
1. it is under the control of a pharmacy that provides services to the hospital
(does not have to be in house pharmacy)

2. procedure guides ensure accountability and security

3. drugs taken are only on a valid script or order of prescriber
Describe the packaging drugs must be in to be put in the automated dispenser.

Can it be multi-dose packs? AND what conditions if it is?
(ie who approves)
must be in manufacturers packaging or in unit dose containers packed by the pharmacy

If it is multi dose packaging then MUST be approved by the pharmacist in charge along with the hospital committee.
Who makes the procedures for inspecting, auditing and monitoring the automated dispensing machines?
Pharm in charge

and a pharmacist can monitor it while on the premises of the hospital
How often do the automated dispensing machines need to be audited?
Monthly
Pharmacies outside VA (nonresident pharmacies)

What does a nonresident pharmacy need to have in order to mail drugs to VA.
A PIC (pharmacist in charge) who is licensed in VA
non resident pharmacies:

What info must be sent to the BOP?
1.
2.

How often must a report on 1 and 2 be sent to the BOP? ____AND_____

3.
4.
5. If BOP or Police want records how soon do they need to provide them?
1. Name, location, titles of all principal officers of company

2. Name and VA license of pharm in charge

Report must be sent annually and within 30 days of any change.

3. A copy of most recent inspection ( within past 5 years)

4. For >50% of sells go out to internet sells, must be registered as VIPPS or has received certification from a similar program approved of by the BOP. (?)

5. 7 days within receipt of request.
When does a nonresident pharmacy not need to have a pharm in charge?
When they provide services as a
pharmacy benefits administrator.
nonresident pharmacy:

What do they need to provide to patients and for what hours do these need to operate?
Must provide toll free telephone service to a pharmacist who has access to their records

during regular hours of operation
Not less than 6 days/week and minimum of 40 hrs per week
Do non resident pharmacies need to pay extra registration fee?
no just the fee for pharmacies in VA.
Can nonresident pharmacy deliver controlled substances?

Where can they send them?
Yes, can send to consumer or agent or another pharmacy in VA.
nonresident pharmacies permits:

how often do they need to be renewed and what do they need to provide?
Annually and provide documentation of current unrestricted licensure.
Nonresident pharmacies:

Can the BOP immediately suspend without a hearing?
1.
2.
3.
Yes

1. if their license has been revoked

2. is expired

3. they endanger public
non resident pharmacy:

when can they apply for hearing after permit is revoked?

when can they get a hearing?
FIRST Must have reinstatement of registration in the jurisdiction where it is located

Then 30 days after their application for new permit is received by the BOP.
Wholesalers:

How often do they need to renew license/permit?
annually
Wholesalers:

If substantial change occurs in the company, what time frame do they need to notify the BOP?
within 30 days.
Nonresident wholesalers:

How often to renew permit

How long to notify of any substantial change?

How long to retrieve records if requested?
Annually

30 days

7 days
Wholesalers:

Do the need to be registered with VA BOP if they distribute drugs directly to a licensed wholesale distributor located within VA???
NO
Can a pharmacy act as a wholesaler?
Yes under certain circumstances?
Under what circumstances can pharmacy engage in wholesale distribution?

1.
2.
1. No more than 5% of gross annual sales

2. No more than 5% of total dosage units of controlled drugs dispensed annually
Can a pharmacy sale anything else besides drugs as a wholesaler?

What and how much?
Yes,

Oxygen not to exceed 5% of gross annual sale of oxygen.
Under what reasons can the BOP revoke or suspend permit of wholesaler?

1.

2.
3.
4.
1. conviction of controlled substances

2. violations of license

3. failure to produce records

4. not following Prescript Drug marketing Act
Do agents of the BOP need to show ID to inspect records or premises of wholesaler?
Yes, prior to inspection
Must one register as a medical equipment supplier?
Yes
What types of prescription drugs may they carry?

1

2
Only those Schedule VI with no medicinal properties that are used for cleaning and operation of equipment

OR

Peritoneal dialysis
Who can a medical supplier deliver drug or device to?
To direct recipient on order by prescriber.
Can medical device supplier sale needles?

Syringes?
Yes and yes
Do you need a permit to be a warehouser?
Yes

renew annually
Can a person get a non-restricted permit to manufacture meds?

Who?
Yes granted by the BOP

good moral character and properly safeguarded against diversion
Can the BOP change the schedules of drugs?
Yes, given the research and evidence and finds the substance has potential for abuse.
Can a drug that is deemed the immediate precursor of a controlled drug be automatically labeled as a controlled substance?
No
adulterated drugs are:

1. F____, P_____ or D____
2. or if
3.
4.
5.
1. filthy, putrid or decomposed

2. not conforming to good manufacturing practice

3. unsafe color additive

4. strength differs from what is represented

5. if it is mixed with something to reduce its strength
What does USPNF stand for?
US Pharrmacopoeia National Formulary
Misbranded drugs:

it is misbranded if:

1.
2.
3.
4.
5.
6.
and some other crap
1. false or misleading label

2. name and place of manufacturer, quantity and dosage form

3. must be able to read (conspicuous)

4. contains habit forming substance and doesn't say "Warning may be habit forming"

5. name and quantity of each active ingredients

6, directions for use
Do pharmacies that fill scripts need to put all this info on labels?

are they considered misbranding them?

what if the drug is recognized by the homeopathic pharmacopoeia of the US but not the USPNF?
No

they are exempt except for the insulin and antibiotic and if they put false or misleading info on it.

then it is must only be offered as a homeopathic drug
Can a pharmacist or anyone distribute hypodermic needles?
Yes and any other person who has received a license or permit from the BOP
What other drug and drug thing may be distributed by pharmacist and at what quantity?

1

2
1. Quinine and its salts

2. Gelatin capsules

In excess of 1/4 ounce should only be distributed by pharmacist or those with permit from the board.
What are the conditions of dispensing things like needles:

1.
2.
3.
1. required suitable ID

2. require written legit purpose of thing

3. make and keep a record of dispensing, etc
hypodermic needles or syringes can be distributed to what age?

Unless what two things?
Must be over 16 yrs old

Unless upon prescription

or

given by a doctor
What is the penalty for violating conditions of dispensing??
Class 1 misdemeanor
who can you give health records to?? (HIPAA)

1.
2.
3.
4.
5.
6. I think.....
1. patient
2. subpoena for records
3. person authorized by patient
4. doctor taking care of patient
5. insurer
6. emergency cases or situations when the person can give oral consent to discuss their health records
What other reasons can health info be given out?

1.
2.
3.
1. virginia workers compensation act

2. health records of minors

3. juvenile health records to a secure facility or shelter
More cases of when can health info be given out?

7.
8.
9.
10.
7. court
8. cases of neglect, abuse
9. safety of public
10. investigations
Is it lawful for someone to give a minor a drug containing combo of caffeine and ephedrine?
No unless they have a prescription for it.
Ephedrine or pseudo ephedrine OTC sales:

How much may be sold?
No more than 3.6 grams total daily to a individual customer.
Ephedrine or pseudo ephedrine OTC sales:

Do they need to provide anything before purchase?
Yes, ID with photo. ( either by government or a educational institution) ie not credit card
Ephedrine or pseudo ephedrine OTC sales:

When can a purchaser not need to sign the log book?
Isolated sale and the package contains 60 mg or less of pseudoephedrine.
Ephedrine or pseudo ephedrine OTC sales:

How long do log books need to be kept?
2 years from date of last entry
is medical marijuana legal in VA?

for what?
Yes

glaucoma and cancer
What is "controlled room temp"?
20 - 25 C but can go 15 - 30

68 - 77 F but can go 59 - 86
What is "cold"?
Not to exceed 8 C or 46 F

Fridge temp is 36 - 46 F
What is Freezer temp?
(-20) - (-10) C

(-4) - (14) F
What is "cool" temp>?
8 - 15 C

46 - 59 F
What does a pharmacist need to do to practice on a voluntary basis for the underserved?

1.
2.
3.
4.
5.
1. Must register w/ BOP at least 5 days before volunteering.

2 pay $10

3. List every state that they have had a pharm license in and copies of the licenses.

4.name of nonprofit org and dates and locations

5 notarized statement from the nonprofit group
What happens if you don't renew your license?
you have 1 yr to submit renewal fee and late fee and statement of compliance with CEs.
1 year after registration expires what must you do?

1.
2. pay what fees?
3.
after the passage on 1 year following expiration the pharm must submit:

1. application for reinstatement

2. pay renewal fee and reinstatement fee

3. submit documentation of CEs
What must a pharm who has an:
inactive license revoked/suspended/ or has had lapse in license do?

Not to exceed what?

MORE THAN 5 YEARS ?

1.
or
2.

3.
4.
Submit evidence of CEs for the number of years which license was not active

Not to exceed 60 hr of CEs

>5 yrs then must :

1. show they have been license in the past 5 yrs in another state

2. get practical experience as pharmacy intern of at least 160 hrs within 6 months

3. 60 hr of CE

4. pass law exam
What must a pharm do if license has been inactive for more than 5 years?

1.
2.
3 OR
Take law exam again

60 hr of CE credits

Get practical experience of at least 160 hr w/in 6 months of reinstatement
or copy of active license in another state
How many CEUs are needed annually?

How many contact hours?
1.5 CEUs

15 contact hours
Can CEUs or contact hours be credited to another year?
No
What are approved continuing pharmacy education in VA?

1.
2.
3.
ACPE (accreditation council for pharmacy education)

CME course (continuing medical education)
-focus on pharmacy, pharmacology or drug therapy

one approved by the BOP
How long after renewal of your license do you need to keep original certificates of CEs?
3 yrs after renewal

bc you may be audited
Pharm techs must submit what to bop?

1.
2.
1. complete approved training program

2. pass board-approved exam
Pharmacy tech trainees may do tasks for no more than ______ months before becoming registered as ______?
No more than 9 months w/o being registered as pharmacy tech.
can a pharm tech accept refill authorization from a dr?
Yes as long as there are no changes to the script
Pharmacy tech training programs:

Must they get approval from the BOP?

How long is the approval good for?
Yes

for 2 years then must apply for renewal
How soon do you need to notify BOP with change in address?
14 days of any change
How many contact hours and CEUs do pharmacy Techs need?
5 contact hours

0.5 CEUs
How long does pharmacy tech need to hold on to their original CE certificates?
3 years
Pharmacy permits:

Can a pharmacist be in charge of more than 2 pharmacies?
No
Does the PIC need to take inventory of Scheduled drugs before they quit?
No but they can unless the owner submits a written reason to the BOP as to why they shouldn't be able to.
How long can a PIC be absent from job before they will no longer be deemed PIC?
30 consecutive days
What must the PIC do if they know they will be gone longer than 30 consecutive days?
Notify the BOP and return their pharmacy permit
What is the day limit for unanticipated absences by the PIC?

What must the owner do?
Exceeding 15 days with no return date

The owner must notify the BOP and get another PIC
What is the time limit for a new PIC to file for permit?

Can the pharmacy operate in those days?

Can the BOP give an extension?
14 days from original date of termination/resignation of the last PIC

Yes they can operate until the 14 days just not after.

Yes for just cause
Can a pharmacy permit be given to a person to operate from a private dwelling or residence?
No not after sept 2 2009
Does there need to be documentation on On site training of pharm techs?

How long do you need to keep the documentation after the pharm tech terminates employment?
Yes

2 yrs from date of termination
How long can a pharm tech practice before becoming registered by the BOP as a pharm tech?
no more than 9 months
Does a pharm tech intern need to be enrolled in a training program ?
Yes and working up to becoming a pharm tech.
Can pharmacies apply for special or limited use pharmacy permits?

What are some requirements?
Yes

they must say why and detail what they are going to do.
For access in a special use pharmacy that provides free clinic that uses volunteer pharmacists on a part time basis in which the pharmacy is open <20 hr per week---who may be allowed in?

1.
2 or
3. If then they must do what
1. Access is only for pharmacist

2. restricted access may be granted for REPAIRS or securing a DELIVERED drug order.

3. If not a pharmD then 2 people must enter together
one an employee (RN, PA or DR only)
Both must remain in the pharmacy the entire time that access is required
Must the PIC of the special pharmacy be notified for other people to enter?
Yes and they must give permission
Where should the key for a special-use pharmacy be ?

What must be written?
In a secure location within the facility in a Sealed envelope or container

Pharmacist must sign on the seal.
What if an RN,PA or Dr enters the special use pharmacy?

And what must happen within 48 hrs.
They must resign their name across the seal

The PIC must ensure the alarm access code is changed with in 48 hrs
What type of records need to be kept for entry (not sure if off hrs) into the SPECIAL PERMIT pharmacy?

1.
2.
3.

How long must the log be kept and where kept?
Log book of each non pharmacist

1. Names of the 2 persons entering

2. purpose for entry

3. notation that permission was granted by PIC and date

Log must be kept on premises for 1 year.
Pharmacy closing/ Change of ownership:

How many days prior to closing does the owner need to notify BOP?
14 days prior
Pharmacy closing/ Change of ownership:

What does the owner need to tell the BOP?
1. what is going to happen to the controlled and VI drugs

2. Name and address the pt info records and all other records will be sent

3. Date of tranfser of records
Pharmacy closing/ Change of ownership:

What are exceptions to reporting the closing to the BOP?
Sudden closings

fire, natural disaster, death, eviction, bankruptcy, emergencies.
Pharmacy change of ownership:

What is the time frame that BOP must be notified?

How many years worth of dispensing records need to be transferred?
at least 14 days

2 yrs preceding the transfer of ownership
What must a pharmacy do if they want to change their hours of operation?

To whom: within how many days?

Unless it is what?
1.
2.
Must provide notice of change to public and BOP WIthin 14 days

Unless it is:

expansion of hrs

emergency and can't help it
Acquisition of Pharmacy:

How do you need to notify customers?

How soon prior?
In Writing

14 days prior to acquisition.
Under what circumstances do you need to file an application to the BOP?

(ie what changes to be made to pharmacy)

1.
2.
3.
1. move location/ change location

2. make changes to security system

3. make structural changes
Can drugs be stocked at a new pharmacy location pending approval by the BOP?
No they must have permit first.
How soon may a moved pharmacy stock drugs once they have the permit?

Any special requirements?
2 weeks prior to opening date

Pharmacist must be present on a daily basis to ensure safety of the drugs.
Physical standards for pharmacy:

How big does the pharmacy Prescription department need to be?
not less than 240 sq feet
Required pharmacy equipment:

What must the balances be sensitive to ?

can you have an electronic scale?
15 mg

yes
Can a pharmacy intern enter the pharmacy with their key?
Yes only when their is a pharmacist on duty.
What are the circumstances in which a pharmacy tech enter the pharmacy if a pharmacist isn't there?

1.
2.
3.
4.
1. only to get an already checked filled prescription

2. when pharm can't get there due to unforseen absence

3. no other pharmacist can be immediately obtained

4. tech must be accompanied by a member of pharmacy management or administration.
Emergency access into the pharmacy:

When should the alarm code be changed?
with in 48 hrs
Emergency access into the pharmacy:

What needs to be documented on a record?
1.
2,
3.
4
1. Name date and time of entry of pharm tech and administrative person entering

2. Pharm that ok'd it tele # where they were reached

3. pt name that needed med and what med and what was emergency

4. time of exit
How long do records of emergency access into the pharmacy need to be kept?
1 year on premises
Can ready prescriptions be put outside the prescription department?

What needs to be kept for this to occur?

How long do you need to keep this?
Yes, access is restricted to persons designated by the pharmacist.

Need to keep a log
Need to counsel pts'

Need to keep log for 1 year
How may a PIC dispose of drugs?

1.
2.

How far ahead do they need to notify BOP?

If they want to do #2 what must they do?

1. _____,______ &and;_______
2.

Who can witness?
1. transfer to another authorized entity

2. incinerate or use another BOP approved method

They must notify the BOP at least 14 days prior of the :

1 date time and manner of destruction

2. names of pharmacists who will witness

Another pharmD that is not employeed at the pharmacy
Drug Inventory &amp; Records:

How does inventory need to be kept for sched II drugs and how often?
Need perpetual inventory

RECONCILIATION At least monthly
Drug Inventory & Records:

How can you keep the Sched III - V drugs?
May keep separate or with the Sched VI drugs
Drug Inventory & Records:

Do the records and order and scripts need to be kept at the pharmacy?

What is the exception?

How soon do they have to be retrieved?
Yes they need to be at the same address at the stock of drugs that filled them.

Sched II - V INVOICES may be kept offsite if authorized be DEA

Must be retrievable within 48 hrs.
When do inventories of pharmacy drugs need to be done?

Scheduled drugs?

Who needs to sign them?
Prior to opening of business or after close of business

On the date they first engage in business.

The person doing the inventory.
Can invoices of Sched VI drugs be kept off site?

How soon do they need to be retrieved if asked for?
Yes

retrievable within 48 hrs
How long do you need to keep hard copy of script ?
2 years from date of last refill
Where can Sched II scripts be filed?
Separated file from other scripts
Where can Sched III - V scripts be filed?
Either separate or with the other scripts (VI) if they can be readily retrievable like have big red C on them
How big does the red C need to be and where on the script

When can the red C requirement be waived?
No less than1 inch high and lower right corner

Can be waived if the pharmacy has electronic record keeping system.
If the hospital has script on computer image, do they need to keep the hard copY?
No
Can you store Sched II - V scripts as electronic image instead of a hard copy?
Not sure

VA says only if fed law allows.
How far back does a computerized system need to display scripts dispensed?
2 years
Does a pharmD need to personally supervise compounding by pharm techs?
Yes
How many pharmacy tech may a pharmD supervise at one time?
No more than 4 persons acting as pharm techs at one time.
If a pharmD declines to fill a script for any other reason than unavailability of drug....What do they need to do?

1,
2,
3,
4,
1. write declined
2. name address and tele # of pharmacy
3. date filling was declined
4. signature of pharmD
What if pharmd determines that a script is a forgery?

What should they do?
Keep it

you can give it to the law or keep it for at least 30 days before destroying it to see if if is needed for investigation.
Delivery of prescriptions;

Where can filled scripts be delivered if not hand delivered at the pharmacy?

1.
2.
3.
4.
1. to patients residence
2. Another pharmacy --------special conditions
3. practitioner of the healing arts LICENSED to practice pharmacy or to SELL controlled substances
4. Authorized persons holding a CONTROLLED SUBSTANCE REGISTRATIONS issued for this purpose
Delivery of filled script:

Can it be delivered to any other pharmacy?

What must they have?
No

They must either be owned by the same owner

or

Have an agreement or contract specifying the services.
What must the contract between pharmacies for delivery specify:

1. Retrievable what...
2.
3. What must be on label?
4. All ____ involved
5. Re___
6.
7. Con and Pri
1. retrievable dispensing records

2. Procedure for tracking script during each stage of filling, dispensing and delivery

3. Must ID all pharmacies involved on label

4. All pharmDs involved

5. records for Returns of scripts not delivered

6. procedure for informing pt and consent of using this delivery system

7. procedure for providing confidentiality and privacy
Delivery of filled script:

What must occur for a script to be delivered to a practitioner of the healing arts?

1.
2.
3.
4.
5.
6.
1. written agreement

2. Policies & procedures for tracking, accountability

3. providing counseling

4. procedure for Recordkeeping of returns

5. informing pt and consent

6. procedure for assuring cofidentiality
delivery of filled script:

Where should contracts or procedures for delivery to different site be kept?
At Both the originating pharmacy and the alternate delivery site.
When can a controlled substances registration (site) be listed as an alternate delivery site??

Only when there is not ______ And there is a _______ And if ______ can be assured.
Only if there is not a prescriber or pharmD present at all times

And there is a valid reason not to deliver dispensed scripts

And compliance with safety procedures can be assured.
Central or Remote processing:

Do you have to find out about the patients other drugs?

Do you have to do therapeutic interventions?

Do you have to provide drug counseling?
Yes

yes

yes
Central or Remote processing:

can a pharmacy outsource to pharmacies outside of the state?


Do they need to have a VA license?

Do they need to abide by Va law?
Yes


No, but a VA permit and pharm techs and PharmD must be VA licensed.

yes
Remote processing:

Do you need to inform your patients that drugs are processed remotely?

How do you need to inform them?
yes

posted sign or by mail
Remote processing:

What type of procedures do you need do have in place?

1.
2.
3.
4.
5. how often do policies need to be reviewed?
pretty much everything!

protecting confidentiality

ensuring pharmDs have access to
drug info

maintaining records

complying with laws

QA

annual review of policies and procedures
Central or Remote processing:

Can the records be kept on computer system shared by each location?

How long do records need to be kept>
yes

2 yrs
Central or Remote processing:

can a employee pharmD of the remote place access the employers database from another remote location?
yes for the purpose of performing script processing

provided there is security for info
faxed scripts;

What type of sched drugs may be faxed?
Sched III - VI
Faxed scripts:

must they be signed?
yes or no

not sure
Faxed scripts:

May an oral script be sent by fax?

what must be on the script?
yes

and record on fax:

agents full name

with wording that clearly indicates that it is an oral script
Faxed scripts:

Where can the fax be sent from?

1. unless
a.
b.
c. AND
from the prescribers office

unless
a. from hospice or long-term care facility

b. oral script from authorized agent

c. forwarding a script from authorized agent from a LTCF AND the pharmacy must get original script w in 7 days.
Faxed orders:

Can sched II's be faxed?

Unless what:?

must they be signed?
No they are for info only


unless from hospice, LTCF or home infusion.

Yes they must be signed
May authorizations for refills be faxed?

What must be on them:

1.
2.
3.
4.
5,
6.
7 or
8.
yES

they must have

pt name

address

drug name and strength

quantity

directions for use

prescibers name

prescribers signature OR agent's name

date of authorization
what sched drugs can be electronically sent?
all
can chart orders be filled at an outpatient pharmacy?
yes

must be a lot like a regular script

# of refills, directions etc.
Dispensing of Sched II:

How long can a sched II be filled after written?
6 months
Dispensing of Sched II:

can an emergency sched II be called in?

Under what conditions?

1.
2.
3.
4.
yes

1. must be enough only for tx during emergency period

2. reduced to writing

3. pharmD must make a reasonable effort to see that it is from a real dr

4. must get script with in 7 days
Dispensing of Sched II:

What is the time period to get a written script?

who do you notify if you don't get?

1 AND 2
7 days (must be postmarked within 7 days)


Nearest office of the DEA

and

BOP
Partial dispensing of Sched II:

When do you you need to supply rest?


What if you cant get it to them, what do you need to do?

1

2
72 hrs

need to notify dr

and

get another script
Partial dispensing of Sched II:

What are the rules for LTCFs?

What about for terminally ill?
must get rest within 60 days

60 day
Partial dispensing of Sched II:

can info be kept in computer system?
yes for both partial fills and filling
refills for sched III - VI:

do partial fills count as a refill?
yes I think
How long can a Sched VI be refilled for?

Unless what?
1 year

Unless dr specifically authorizes dispensing OR refilling for longer time

then it can't exceed 2 yrs
May you refill early for a Sched VI?

what condition?
yes

if there is a valid reason for early refill
What is compliance packaging?
Unit dose packing or multi dose pack

labeled with specific day and time to take

(It better helps with pt compliance)
What do you not have to put on the label for LTCF or hospital where all drugs are administered by ppl licensed to administer?
Generic name of drug

and

generic name followed by (generic for) brand name of drug
who can compliance packing be used for?

1.
2.
3.
1. pt when they request

2. LTCF

3. hospital
what must be put on multi-dose packaging label ?

1. all elements for _____

2.
1. all elements for any outpatient script label

2. a physical description IDing each solid dosage form
what is special packaging?

When can it not be used?

1.
2.
3.
Child resistant

1. dr requests

2. pt requests

3. not in Poison Prevention Act
Bulk repacking (like in hospital):

How long do you keep records of repacking?

what do the records need to show?

1.
2.
3.
4.
5.
6.
7.
1 yr

1. name of drug

2. date repacked

3. quantity prepared

4. initials of pharmD verifying

5 assigned lot number

6. manufacturers name and lot number

7. expiration date
Automated counting devices or dispensers:

what type of records need to be maintained?

How long do you need to keep records?
records for what drugs were in the bin and all the info of repacked drugs

1 yr
Can more than one lot be added to a automated bin at one time?
yes
what has to happen if two lot numbers of drug is added at one time to bin?

what time frame?
must be allowed to "run dry" prior to refilling

every 60 days at least once
Can a pharmacy return a drug that has been dispensed back to stock for redispensing?

When?

1.
2. a. b.

What if there is no lot number on the drug returned?
yes

1. if it has never left the pharmacy

2. if it never left control of pharmacy agent under certain conditions:

a. put expiration date on it and if one wasn't already on there then put date not to exceed 1 yr from date drug originally dipsensed.

b. used next time drug that drugs script comes through

IF no lot # then must be disposed of
Transfer of scripts:

What must be done to transfer a script?

what schedules?

between who? or can be done how?

a. b.

Provided what from the transferring pharmacy?

1.
2.
3.
pharmD to PharmD

OR by fax OR electronic transmission

pt gives permission and there are valid fills or refills

Provided that:
1. VOID on invalid script face
2. Back of script write name of pharmacy, address and DEA number of pharmacy if Scheduled III-VI drug

3. date of transfer and name of pharmd who took it
What must the receiving pharmacy write on a transferred script?

1.
2.
3
4.
5. if transferred orally
1. TRANSFERED

2. all stuff on original script

3. number of valid refills and date of last refill

4. DEA number of transferring pharmacy if scheduled drug

5. name of transferred pharmacist if transferred orally
How long do you keep records of transferred script?
Keep 2 years from date of last refill
Can a pharmD get kickbacks from prescriber?

can they do fee-splitting or special charges in exchange for script order?
no

UNLESS they fully disclose in writing to patient and 3rd party payor.
What may be advertised on prescription blank?
Can advertise on back and put coupons on back

Nothing but essential info required by law on face
Unit does dispensing system:

What facilities can use them?

Do they need to have licensed persons administering meds?
Hospitals or LTCFs

No----unit dose dispensing may be used regardless of licensed employees administering meds
Unit does dispensing system:

What requirements must they have?

1.

2. what must happen 72 hrs after
1. must be locked

2. must get written order for Sched II ;
if verbal order then get written in 72 hrs
Unit does dispensing system:

What must the drug drawer be labeled with?

1.
2.
1. pt name

2. pt location

(says nothing about MR of patient)
Unit does dispensing system:

can pt's drugs be stored at the bedside?
Only some that are for external use only

Internal use must be inside drawer
Unit does dispensing system:

Can back up doses be kept in the pt drawer?
Not more than ONE dose
Unit does dispensing system:

How long must records be kept?

what do the records need to show?

1.
2.
3.
4.

What can be kept in place of this record?

How long must these records be kept?
Must keep 1 yr unless sched II-V then keep for 2 yrs.

1. date of filling of drug cart

2. location of cart

3. initials of who filled cart

4. initials of pharmD checking and filling cart

May keep a patient profile record

OR a fill list
Unit does dispensing system:

Places where only persons licensed to administer drugs do so:

How many days supply of drugs can be given
not more than a 7 day supply of solid dosage form
Unit dose dispensing system:

Places where unlicensed persons administer drugs:

How many days supply of drugs can be kept?

Who provides training to administer meds?

What type of med administration record do they need to have and who supplies this?

what also needs to be specific or unusual about the unit dose dispenser?
72 hrs (3 days) of solid oral dosage

pharmacy trains them for the specific unit dose system

Need to have full dosage directions with NO abbreviations supplied by pharmacy.

slots within the drawer to Indicate time of administration
Robotic systems:

How long do you keep records for drugs used by robotic system?
1 yr
Robotic systems:

How often do random checks need to be performed and by who?

____% of meds picked by robot

AND ___% of all first dose

OR for ______
Daily random checks by PharmD

of 5% of pts bins

AND 5% of all first doses

Or cart updates
Robotic systems:

what happens if the robot picks an incorrect med?

AND
do 100% check of all patients bins

immediately report it to BOP
Robotic systems:

How often do QA reports need to be done?

How long do QA records need to be kept for the robotic system?

Do you need to keep the records onsite?
Quarterly

Keep 2 yrs

No just need to get them within 48 hrs
Robotic systems:

what do you need to do for unanticipated downtime?
immediately report to BOP
Hospital pharmacies:

When can drugs be stocked in a satellite pharmacy ?
Only AFTER inspection by BOP and approval for opening
Hospital pharmacies:

Can drugs VI be stored outside of the pharmacy?

What safeguard must be in place?

How often must they be checked?
Yes, must be within the hospital

Locked when staff not present

Must check Monthly
Hospital pharmacies:

What things may be kept outside the pharmacy in a non-locked area?

1,
2,
3,
4
5,
6
1. large volume parenteral solutions

2. irrigation solutions

3. contrast media

4. medical gases

5. sterile sealed surgical trays

6. blood components or products
Hospital pharmacies After hours access:

Does it need to be alarmed?
yes if in area that has departments that close daily
Hospital pharmacies:

do you need to get signature for who you deliver drugs to?

When do records of administration need to be returned to pharmacy?

How often do records of administration of Sched II-V drugs need to be audited?

How long do records of this need to be kept? and can you store them offsite?
yes

within 3 months

randomly

Keep 2 years,

offsite store ---- VI yes

II-V no
Hospital pharmacies:

How long do you need to keep records of pyxis drugs used in ER?
2 yrs
Hospital pharmacies:

How often does pyxis need to be checked and by who?

What are you checking for ?

How often do they need to be inspected?

How long do these records need to be kept?

Do these records need to be kept at pharmacy?
AUDIT monthly the Sched II - V

by PIC or their designee

Checking for drug diversion

Need to inspect monthly

2 yrs

Yes II-V but VI's may be stored offsite.
EMS program:

How long do you keep records of drug box exchange?

How long do you keep records of drugs administered by EMS?
1 yr

2 yrs
What do medical interns or residents need to put on scripts?

Describe it
An ID number assigned by the hospital

It is the DEA number of hospital pharmacy PLUS a suffix assigned by the institution.
Remote script processing for hospitals:

Who can do this?
Either owned by same owner or have a written contract.
Remote script processing for hospitals

Does pharmD need to have a VA license?

Do they need to have procedures and who needs to keep them?
Yes

Yes and both pharmacies must have them
Remote script processing for hospitals:

How long do these records need to be kept?
2 yrs
LTCFs:

Can drugs be floor stocked?

Explain: What may be kept?

1.
2.
3.
4.
5.
only those for stat drug box or emergency drug box

Only in LTCF where persons licensed to administer drugs are administering drugs they may keep:

irrigation fluids

heparin flush kits

sterile water and saline

medicinal gases

prescription devices
May drugs be kept as first aid for companies in Va that do NOT have a pharmacy permit?
Yes under lock and to be in possession of practitioner or RN

Must be emergency (life threatening) situation.
LTCFs:

What are some of the responsibilities of the pharmacy that services a LTCF?

1.
2.
3. (what about external use only)
4.
1. make sure people are properly trained with automated system

2. ensure locked cabinet/ cart

3. external use only should be kept away from other meds

4. discontinued drugs are returned to pharmacy or disposed of properly
LTCFs:

How may discontinued drugs be disposed of?

1,
2,
Who should witness this?

3. Can LTCFs destroy drugs?

How long do records need to be kept of this?

Where do these records need to be Kept?
1. may be returned to pharmacy for resale or give to indigent

2. destroyed at the pharmacy

witnessed by PIC and another pharmacy employee


3. Yes must do this (or return them to pharmacy) within 30 days of date drug was discontinued

keep records 2 yrs

keep at provider pharmacy
LTCFs:

how often does pharmD need to review patient records?
monthly
LTCFs:

Can they repackage drugs for their residents?
Yes but not at their facility must do so at the pharmacy that provides the drugs.
LTCFs:

what kinds of drug boxes may be kept?
Emergency drug kit

Stat-drug box
Production of superoxide from O2
NADPH oxidase with NADPH cofactor; produces respiratory burst
Emergency drug kit:

What drugs can be in this kit?
Limited to injection or inhalation only

except Nitro SL may be included
Stat drug box:

Who may get drugs out of this?

1,
2.
3.
1. licensed nurse

2. PharmD

3. prescriber
Which kit do you need an order prior to getting the drugs out?
Stat drug box
What are the limits to scheduled drugs contained in the stat-drug box?

1.
2.

Can a liquid unit that is multi dose be used for more than one patient?
1. No more than 20 solid dosage units per schedule

2. one unit of liquid -- not to exceed 30 ml may be substituted for a solid dosage unit


NO
Nursing homes:

Use of automated drug dispensing devices:

What do they need to get before being able to have controlled drugs in the system?
A controlled sub registration
Nursing homes:

What do they need besides a dr order for them to be able to give (administer) a drug to a patient?

_______ and ____________
PharmD must review script

And

electronically authorize the access of that drug
Nursing homes:

Do you need to get the restocking sheet of controlled drugs signed?

What does the pharm tech doing the reloading/restocking of the automated thing need to do when filling ?
yes

must do count of controlled substances
Nursing homes:

How often does an audit need to be done on the automated drug dispensing device?

How long must records of audits be kept ?

Where do scheduled drug records need to be kept?

What about Sched VI?
monthly at least

keep records 2 yrs

keep at pharmacy

schedule VI may be kept offsite
Nursing homes:

May delivery and distribution records of sched II-V be stored offsite from the pharmacy?
No unless authorized by DEA

which means no
LTCFs:

what type of LTCF may keep IV fluids, heparin flushes etc, on the floor? ie as floor stock
Only those in which persons licensed to administer drugs are administering them.
Humane society or animal shelter:

May the have controlled substances and if so what do they need?
Yes, they need a permit and a DVM must make sure the people are trained and certified.
Humane society or animal shelter:

How long must certificates for administering drugs be maintained after the person stops working at the facility?
2 years
Humane society or animal shelter:

What happens when the person in charge stops working there?

________ and ____________

What is the time frame that a new person in charge must file for a new permit?

What must they do once they get permit?
The permit must be turned in immediately

and

do complete and accurate inventory of all drugs

Within 14 days to get new registration

at that time they shall do a complete and accurate inventory of drugs in stock
Humane society or animal shelter:

How long do you need to keep records of administration of drugs or inventories?
2 yrs
Correctional facility:

How long do records need to be dept for drugs administered?

Where do they need to be kept?
1 year

keep at the facility or at the provider pharmacy
Correctional facility:

May they keep stat box or emergency boxes?

If what?
yes

if they employ a dr, RN LPN or PA
Correctional facility:

May drugs be floor-stocked ?

what are the requirements?

1.
2.
3.
yes

1 they must have a controlled substance registration

2. must be staffed by at least one prescriber

3. must be in a medical clinic or surgery center in the correctional facility
Medical equipment supplier:

Do they need to have a permit?

Where may they practice?
Yes

Not from a private residence and place of practice must be inspected by the BOP before opening.
Medical equipment supplier:

How long do they need to keep records of devices dispensed ie orders from drs?
2 years
Who can get a Controlled Substance Registration?

1.
2.
3.
4.
5.
6.
7.
others can also but are not stated
1. hospitals with out in house pharmacy

2. nursing home that use automated drug dispensing systems

3. ambulatory surgery center

4. outpatient clinics

5. alternateive delivery sites

6. EMS agencies

7. MD or DO that uses donated controlled subs
When can the BOP require someone to get a controlled sub registration?

1.
2.
3.
4.
1. someone reported that they make large purchases of controlled subs

2. they have experienced a diversion or theft

3. they have failed to comply with record-keeping requirements for controlled subs

4. they have violated any provision of laws relating to controlled subs
Requirements for supervision for controlled Sub registrants:

Who supervises hospital or nursing home that doesn't have an in house pharmacy?

Who supervises EMS agency?

What about other facilities?
PharmD

Operational medical director

others will have pharmD supervise as long as it is in their scope of practice
controlled substances registrants:

Who has access to the controlled substances?

or in emergency situations
supervising practitioner or those authorized by law to administer drugs in VA

others authorized if emergency situation
Are alarm systems required for animal control or humane societies or alternate delivery sites?
no
How long do records need to be kept for controlled subs registrants?

What about sched II drugs?

Where should records be kept?
2 years

Must be kept separately

can keep on site or off site
Who can donate drugs to a free clinic?
They must have a current active license, permit or registration issued by the BOP for dispensing or distribution of drugs