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Hi Jeanetta and Everyone,

This is little bit long but bear with me.

New Jersey Board of Pharmacy Statute 13:39-6.9

Restriction on Sale of Schedule V Over-The-Counter Controlled Substances

(a) It shall be considered unprofessional conduct for a pharmacist to dispense

a Schedule V over-the-counter controlled substance when:

1. The pharmacist, in his or her professional judgment, knows or reasonably

should know that the requested substance will be used for unauthorized or

illicit consumption or distribution; or

2. The pharmacist, in his or her professional judgment, knows or reasonably

should know that the person requesting the substance previously used it for

unauthorized or illicit consumption or distribution.

(B) The standard of professional judgment and care that attends the sale of

Schedule V over-the-counter controlled substance shall conform to the following;

1. All pharmacists shall comply with N.J.A.C. 8.65-7.19, which requires that

the sale of specified controlled substances be limited in quantity during any

48-hour period, that the purchaser be a least 18 years of age, and that the

pharmacist obtain suitable identification (including proof of age where

appropriate) from every purchaser not known to the pharmacist.

2. In all instances, any doubts regarding the propriety of a sale of a Schedule

V substance shall be resolved against making the sale.

3. The pharmacist shall enter every sale of a Schedule V substance in the

Over-The-Counter Schedule V Record Book pursuant to N.J.A.C. 8.65-7.19. The

information to be recorded shall include the purchaser's first and last name,

street address, city and state, the name and quantity of the Schedule V

substance sold, the date of each sale, and the name or initials of the

pharmacist making the sale.

4. Upon an individual's second request for a Schedule V substance within a

short period of time ( two to four days), the pharmacist shall determine,

through direct communication with the purchaser , whether the substance is being

used correctly. In that regard, the pharmacist shall ascertain how many people

are using the substance and whether the condition which the substance is being

used to treat is improving.

5. Upon an individual's third request for a Schedule V substance within a short

period of time relative to the number of persons using it (two to four days

subsequent to the second purchase), the pharmacist shall advise the purchaser of

the substance's abuse potential and shall caution the purchaser to consult a

physician if the condition for which the substance is being used does not

improve.

6. Upon an individual's fourth request for a Schedule V substance within a

short period of time (two to four days subsequent to the third purchase), the

pharmacist shall determine, through direct communication with the purchaser, how

many people are using the substance, whether continued use will be therapeutic,

whether the purchaser is treating a condition which requires a physician's

consultation, whether the purchaser is exhibiting signs of drug abuse and

whether the purchaser is making similar requests of other local pharmacies.

7. If a pharmacist determines that an individual's request for a Schedule V

substance within a short period of time (two to four days) subsequent to his or

her fourth purchase is warranted, the pharmacist shall document in the

Over-The-Counter Schedule V Record Book the justification for such a sale. In

addition, the pharmacist shall recommend that the purchaser consult with a

physician for medical evaluation due to the substance's abuse potential as well

as the potential hazard by the substance's continued use.

8. If any Schedule V substance is dispensed to one individual more than 5 times

within any 12-month period, the pharmacist shall obtain oral or written

confirmation from the purchaser's physician as to the continued need for the

substance and shall document such confirmation in the Over-The-Counter Schedule

V Record Book.

Thanks for taking the time to read this. I realize it's long. Now you can have

fun picking at all the holes in it. I'm not sure where to start with that

subject. But I'm sure someone here will.

Have fun!

Prescription...

> > >

> > > How long is a prescription good for from the date the doctor

> > writes

> > > it? How long is a CII prescription good for?

> > >

> > >

> > >

> > >

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Hi Jeanetta,

I was reading Scenario 1 (below) and I came up with a few

questions/observations. With the Sig: i tab q4-6 prn mild to moderate pain #30

refill 5 if the patient took the maximum dose (q4 or 6 tablets a day) the rx

would be refillable in 5 days. Some insurance companies will fill in the days

supply for the pharmacy while most leave that up the pharmacy. Personally, on

all controlled substances we err on the side of caution so in the case of a days

supply not being an even number (ie 7.5 days) we would round up to 8 days. As

for the validity of the prescription, the prescription itself is valid for all

the refills up to 6 months from the date of first fill regardless of when the

patient chooses to get the refills if they choose to refill it at all. In other

words, it can be filled for the first time today 11/01/02 and would be expired

on 05/01/03. It can be refilled any time between now and then so long as it is

not filled at less than 5 day intervals. and BTW - Tylenol #3 is codeine and

apap.

Sincerely,

Scenario 1

Let us say this was a narcotic such as Tylenol # 3 (hydrocodone +

APAP)

Sig: i tab q 4-6 hr prn mild to mod pain # 30, Refill 5

Theoretically the patient could get the first # 30 on Day 1

If this Rx lasted 7.5 days, 1 tab q6 hr prn == 4 doses in a day, if

pt used all of the 4 doses only, because it was necessary or needed,

he or she could return to get a refill on day 7 or 8 {30/4=7.5 )

Which day? Day seven or day 8 ? This would be up to pharmacists

discretion or up to the adjudication process of a particular health

plan or a specific state law).

So this could be a refilled for another 30 tabs at that time.

If the patient continued to use this pain med as if it were an ATC

order, ALL THE TIME AS IF IT WERE SCHEDULED AS Q 6 HR, because he/she

was in constant pain, then the pt would be returning every 7 or 8

days, for 5 refills. At every 7.5 days the Rx drug is used up.

7.5 days x 6 fills ( one original fill + 5 refills) this prescription

would only be good for 45 days. Even though the paper it is written

on is valid for 6 months =1 original plus 5 refills max ( unless the

Dr orders less refills) This means that at the rate that the patient

is using this drug and if the patient continues to use it at this

rate, this particular Rx would only be valid for 45 days min or 8

times 6 fills (1 original plus 5 refills, because of the 0.5 day)

for 56 days max.

Whew that was a hard one!

Re: Prescription...

Dear All,

Read carfully! You may wish to discuss with your pharmacist the

following scenarios for your state:

To my knowledge there is a Federal law that applies to every state

except those states that have a law that is MORE STRINGENT (strict):

Class III, IV and V Prescriptions ( the paper it is written on! Not

the med) are valid for 6 months from the time written with a max of 5

refills, for a total of 6 fills in a six month period. That is the

maximum that the doctor may write for a Class III, IV or V.

O fcourse a doctor may write for less refills or no refills!

States may be more strict than the above. And some health insurances

do not allow certain drugs to be written with that much leeway. As

you retail techs know this can " hang up " the adjudication process!

Examples :

Scenario 2

If the patient used the drug q4 hr ATC instead of prn because it was

needed this would be used at 6 doses per day . 30 /6 = 5 days. 5

times 6 fills = 30 days. That means the Rx would not be valid after

30 days if the patient used all of the Rx at the rate of 6 doses in a

day.

Let's try it another way: Scenario 3

Same Prescription: Sig: i tab q 4-6 hr prn mild to mod pain # 30,

Refill 5

Patient is using 1 tablet at night for nocturnal pain, instead of

the 6 max a day that he/she could be using. In other words her/his

pain is not as great as

the doctor had anticipated. After 30 days the patient wants another

refill. Can he/she get one? Yes because the doctor wrote for a max of

5 refills . If the patient continues to use this drug at this rate,

the patient would return (to pick up) to the Rx every 30th day. 30

days times 6 fills (1 original + 5 refills) = 180 days or 6 months.

So by Federal Law the patient could in fact use all of this med and

all of the refills at this rate in 6 months or less. Technically the

Rx would not have any refills left on it on day 150. So it would not

be valid after 150 days ( the last refill) even thought the patient

would have the meds to last a total of 180 days.

Scenario 4

Same Rx!

If the pt gets a Rx filled on Day 1 and returns on day 160 about 5.33

months or 5 months and 10 days later for a refill, this too would be

legal because he or she wants the second refill with in the 6 month

period. She /he is using this drug sporadically, or possibly the

original pain has returned full blast, or they just realized they

have some time left an just want to have some drug on hand ( or some

other reason that I am not thinking clearly about right now & #61514;) .

Adjunct Information - A good pharmacist would wonder (in fact a good

tech would `wonder' and show this to the pharmacist before computer

generating a label etc), what is going on with the pt. The pharmacist

has the right to ask the pt some questions, to ascertain what is

going on and to make a judgement call as to whether or not to fill

the med, or if this patient should see the doctor again. Here

the `good' pharmacist (depending upon the patient's " story " ) may call

the physician to discuss what is going on. Re-injury is one of the

most common complaints and reasons for this type of `behavior " and

most pharmacists would fill if the patient discusses `re-injury'

reasons.

About YOUR STATE!

If your state only allows 3 refills or if it says that the Class III,

IV or V (paper) Rx is good for only 3 months and 2 refills, then your

state would have a more stringent law than the Federal Law. ( I am

not aware of such a state, but you all would know that one better

than I, and will inform me I am sure!):) .

What now????

Okay Let us move on to Class II Rx's , AKA Triplicates in

some states, California being one of them.

In the state of California the law was identical the original Federal

law which stated that a Class II Rx could be valid for up to 7 days

and NO ABSOLUTELY NO Refills. Now if your state had a more stringent

law then that would apply such as the case that someone (sorry I

forgot who) mentioned older scripts were valid for only 2 days.)

Now only recently (last 2 or 3 yrs) in the State of California, the

law changed. Now Class II – Triplicate scripts are valid for a

maximum of 14 days – NO REFILLS. This means that the Federal law has

changed or else Ca could not have made a `looser' law than the

Federal Law.

Okay so what does this mean? It means that each state may mandate

anything more stringent than the Federal Law. But exactly what the

new Federal Law is, I do not know. I believe it is 30 days max. Does

any one know? Ask your " practicing " pharmacist about these Federal

laws. Let us know what they say. But fair warning! RPh's sometimes

can not quote it unless it is the more stringent law compared to the

state law.

The change?? Why?? It came about when more and more states went to

paperless Triplicate prescribing and more electronic Class II

prescribing. Supposedly California is to do away with paper Trips in

about 2 more years. Many other states already have. Since the

government `felt' that electronic prescribing would help the DOJ

keep `tabs' on the prescribing habits, use and or abuse of the

patients, and dispensing habits/practices of CII drugs etc., they

changed the tolerance or if you will the `strictness' of the Fed

laws. This in turn allowed for states to change their laws. The

Triplicate is not valid in California longer than 14 days. After

which the patient must get a new paper Rx triplicate. A phone call

will not do.

Okay I hope that I have not confused any one.

Simply put what ever the Federal law is your specific state may have

a stricter or more stringent law or an identical one.

If you are studying for the PTCB exam, the question is seeking the

Federal Law only. In addition, be careful with questions that

ask " how long is the prescription good for?: What are they talking

about? The stability factors in expiration dates, or beyond use dates

or shelf-life or the paper it is written on?

To all Retail Techs feel free to comment on this stuff. But remember

no debating except for actual Federal law since we are from various

states. Therefore please include your state. Now if we get two techs

from the same state say different things we will have a problem! :0

Oh no!

Okay I am waiting for someone to research the CURRENT federal law on

Class II Rx's and Class III, IV and V.

Respectfully,

Jeanetta Mastron CPhT BSChemistry

Founder/Owner

> I thought CII were only good from the written date for 6 months but

I will

> check on that. Char

>

> Charleen A. CphT

> Technician Representative

> Spokane Pharmacy Association

> &

> Pharmacy Technician/Trainer

> Sixth Avenue Pharmacy

> W. 508 6th Avenue

> Spokane, WA 99204

> (509) 455-9345 wk.

> (509) 953-9308 cell.

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  • 2 weeks later...

Dear Donna,

You might want to let your instructor know that we were studying the

Federal Law, and I found out that there is No Validity for Class II

prescriptions ( paper not med). AS our members prepare for PTCB the

exam asks Federal Law not state law. States do have validity laws.

Just thought I would let you know so that you can update your

instructor.

Respectfully,

Jeanetta

> I asked my instructor(Don Ballington at Midlands College) and he

said that a

> prescription for a CII drug is only good for 30 days.Now he did not

tell me

> if that was just in the state of S.C. or not but I wanted to just

let you

> know I e-mailed and asked the instructor and that was what he

said :-)

>

>

> Take care!

> Donna in SC

>

>

>

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