Dr. C's Chp. 2 MPJE

High abuse potential, high addiction potential, no medical use

CI

High abuse potential, high addiction potential, accepted medical use

CII

High psychological dependence potential or low/med physical dependence potential, accepted medical use

CIII

limited physical and psychological dependence, accepted medical use

CIV

Each CS Schedule has a _________ potential for abuse compared to the one above it. Ex: CII—> CIII

a. higher

b. lower

b.

To be considered a CV, diphenoxylate/atropine limit is <____mg/___mcg per dosage unit.

< 2.5mg/25mcg

FEDERALLY, what drug is exempt from being labeled a CS.

How does PA handle that?

FEDERALLY—> Fioricet (butalbital, APAP, caffeine) is exempt as a CS

PA —> Fioricet is a CIII

“Listed Chemicals” according to the FDA includes what?

Under federal law how are ephedrine, pseudoephedrine, and propanolamine

FEDERALLY, is pseudoephedrine a CS?

NO—> but there are sales restrictions

Pharmacies are allowed to compound with CS as long as the concentration does not exceed _____%

20

True or False: I am allowed to mix oxycodone tablets in simple syrup and sell it.

False—> if compounding a CS… must mix with another drug

True or False: A compounded narcotic prescription will never be a CIV or V drug.

true (only ever CII or CIII if <0.05%)

True or False: There are some exceptions where dispensers do NOT have to register with the DEA

false—> all manufacturers, distributors, or dispensers of any CS must register with the DEA

What is the frequency for DEA registration?

every 3 years

What form is used for DEA registration of DISPENSERS?

Form 224 for new, 224a for renewals

Formula for verifying a DEA #:

1. 1+3+5

2. (2+4+6) X 2

3. Add step 1 + 2

Last digit of total should be identical to last digit of DEA #

If I am a manufacturer and distributor of CS, do I have to register twice with the DEA or can I do it under 1 form?

must register separately (note: each activity requires separate registration)

If Martin owns 3 independent pharmacies in the area is he allowed to register 1 DEA number for all 3 pharmacies or does each pharmacy require its own DEA registration?

SEPARATE registrations are required (think: separate locations= separate registrations)

Which of the following would have to register with the DEA?

a. patient picking up oxycodone

b. pharmacist that works at CVS

c. Shipping manager at a drug manufacturer

d. Narcotic treatment facility

d.

What is required for each transfer of a CII?

DEA Form 222 (THINK: C2 REQUIRES FORM 222)

Examples of when a pharmacist would use a Form 222:

• order CII

• sell/lend CII to other pharmacies/prescribers

• borrow CII from other pharmacies

• transfer CII back to wholesaler or reverse distributor

REVIEW: What are each of the following forms used for:

• Form 222

• Form 224

• Form 41

• Form 106

• Form 107

• Form 222= transfer of CII

• Form 224= DEA dispenser registration

• Form 41= destroying CS

• Form 106= Theft or significant loss of CS

• Form 107= Theft of significant loss of “listed chemicals” (sudafed)

REVIEW: What are the time frames associated with each of the following forms (exp dates, deadlines to fill out, etc.):

• Form 222

• Form 224/224a

• Form 41

• Form 106

• Form 107

• Form 222= expires after 60 days

• Form 224= done initially for registration, then Form 224a every 3 years

• Form 41= filled out with each CS destroyed

• Form 106= 45 days

• Form 107= 15 days

Who can sign a 222 form?

DEA registrant or POA

A 222 form is good for ____ days after it was executed.

60

Who keeps the hard copy of the Form 222?

The supplier/ the one providing the CS (usually manufacturers/distributors but could be a pharmacy if transferring a CS to another pharmacy or doctor)

Suppliers are required to report the acquisition and disposition of CII’s.

What are the 2 ways to do this?

1. ARCOS (electronic reporting system)

2. submit a copy of the 222 form directly to the DEA

The DEA allows e-ordering of CII’s through what?

CSOS (Controlled Substances Ordering System)

How long are CSOS certificates valid for?

3 yrs (same as DEA registration)

What are the 2 types of CSOS certificates?

1. CSOS admin cert —> for CSOS coordinators to communicate with the DEA (NOT FOR E-SIGNING)

   1. sidenote: must have a least 1 CSOS coordinator appointed

2. CSOS signing cert—> needed for e-signing CII orders

How are CIII-CV substances ordered electronically?

• normally aka no CSOS bs required

• must have invoice (drug name, form, strength, # received, quantity, date, DEA info)

If a e-order for a CS is deemed invalid, how long must the order be kept for records?

2 years

Is an invalid CS order allowed to be modified/corrected and sent back?

NO—> MUST SEND NEW ORDER

Pharmacies do NOT have to be registered as a distributor for CS as long as what is followed?

total distributed is <5% of all total CS dispensed AND distributed

What reporting system is used for suspicious CS ORDERS?

SORS (note: DOES NOT APPLY TO DISPENSING ONLY ORDERING)

FEDERALLY—> what is really the only thing you can’t do when storing CS?

store them all together on one unsecured shelf (note: may be locked or dispersed)

For any theft or significant loss of CS what are the steps and times?

1. report to the DEA within 1 day

2. fill out Form 106 within 45 days

For any theft or significant loss of “listed chemicals” what are the steps and times?

1. report to the DEA prompty (no exact time frame)

2. fill out Form 107 within 15 days

What additional label requirement is required for CS when being dispensed to a patient? How does Federal Law differ from PA law?

• must include federal transfer warning statement

  • federal law: CII-CIV

  • PA law: CII-CV

On-site destruction for a CS requires the use of what form?

Form 41

What are the 2 primary methods a pharmacy can use to get rid of CS?

1. Form 41- onsite disposal/destruction

2. Transfer via reverse distributor

   1. If CII —> Form 222 (REVERSE DISTRIBUTER KEEPS ORIGINAL COPY)

   2. If CIII-CV —> Invoice

Describe what being an authorized collector means:

• optional program DEA registrants can be apart of

• basically is for secure collection/take backs of CS that can then be destroyed on site or transferred out

• key points: inside the “receptacle” aka the bin for collecting the CS is a bag with an inner liner. This inner liner has a unique #. AS SOON as the liner is removed from the bin, seal it immediately. Do not look/investigate the contents at ALL!

Does “waste” of a CS require Form 41?

NO! (happens when the dr. orders for admin to a patient and the CS isn’t entirely administered—> waste is created during the normal process of patient care)

When to fill out Form 41 for a break or spill?

if the CS is NON-recoverable—> like a liquid spilling (recoverable would be something like a tablet falls on the floor and gets crushed)

Federal Law states that inventory for CS must be done when?

before the 1st day of business and every 2 years after

When does inventory for CS when is an exact vs. estimated count needed?

Exact: CIIs

Estimated: CIII-CVs unless the bottle >1000 then an exact count is needed

Federal law states records for CS must be kept for ____ years.

2

How must records for CS be kept?

• CII ALWAYS SEPERATE

• CIII-V can be separate or together with other NS as long as they are readily available

  • stamped with the letter C in red ink

Central record keeping is allowed ______ days after notifying the DEA.

14

Central record keeping includes and excludes what?

includes: shipping records (ex: packing slips) and financial records (invoices)

excludes: DEA Form 222, inventory records, prescriptions

If there is an unresolvable red flag with a CS prescription, should the pharmacist dispense the medication?

NOOOOO (Even though it may be different in real life—> for exam purposes do not)

Who can prescribe is determined _________.

a. by the federal government

b. by the state government

b.

Can a pharmacist fill a CS from an out-of-state prescriber?

YES (but must verify/use judgement)

Can a pharmacist fill a CS for an out-of-country prescriber

NO

What can/can’t a designated agent do?

Can:

• communicate CIII-V rx (*key word is “communicate” NO PRESCRIBING/NO AUTHORIZING)

• prepare a written rx for the prescriber to sign

• transmit a written CS rx by a prescriber by fax to a pharmacy

Can’t:

• communicate CII rx —> INCLUDING EMERGENCY CII RX

There are exceptions to this rule, however in PA all CS prescriptions must be _____________.

a. written

b. faxed

c. verbal

d. electronic

d.

Exceptions to when an electronic prescription is not needed for a controlled substance:

(7 total)

1. Vets

2. Technology related issues/failure (includes prescribers not being set up electronically or could be an electrical outage)

3. ER prescribers and delaying the rx would harm the patient

4. LTCF

5. Hospice

6. PDMP is not required for the medication

7. Emergency in accordance w/ state or federal laws (ex: verbal emergency CII)

Written CS prescription requirements:

• NO PRE/POST DATING

• What does the prescriptions need:

  • Name, address of patient

  • Name, address, and DEA registration # of the practitioner

  • Drug name, strength, dosage form

  • Quantity

  • Directions for use

  • Others:

    • Prescriber's signature

    • Before filling--> pharmacist name, dispense date, quantity dispensed

When are verbal, faxed, or written prescriptions allowed for CIIs?

• verbal: emergency only

• fax: 3 exceptions

  • home-health care

  • LTCF

  • hospice

• written: 7 exceptions (listed prior)

  • Vets

  • Technology related issues/failure (includes prescribers not being set up electronically or could be an electrical outage)

  • ER prescribers and delaying the rx would harm the patient

  • LTCF

  • Hospice

  • PDMP is not required for the medication

  • Emergency in accordance w/ state or federal laws (ex: verbal emergency CII)

When are verbal or faxed prescriptions allowed for CIII-CV?

BOTH ALLOWED!!!!!!!!! For faxes ensure prescribers original signature is there. no e-sig allowed.

How are INITIAL transfers for CS handled?

• allowed? how many times?

• which CS does it apply to? (CII? CIII? CIV? CV?)

• what form if allowed? (written, verbal, oral, fax)

• who can communicate the transfer if allowed?

• YES allowed only for CIII-CV on a 1 time basis

• only can be electronic

• must be between two pharmacists

How are REFILL transfers for CS handled?

• allowed? how many times?

• which CS does it apply to? (CII? CIII? CIV? CV?)

• what form if allowed? (written, verbal, oral, fax)

• who can communicate the transfer if allowed?

• YES allowed only for CIII-CV on a 1 time basis

• can be any form—>fax, oral, written, electronic

• must be between two pharmacists

In general is the transfer of a CII allowed at all?

NO

What is the primary difference between initial transfers and refill transfers?

for initial transfers the prescription can only be electronic, for refill transfers it can be any form

Transfer records for CS prescriptions must be kept for ___ years.

2

What is the expiration date for CS rx?

• CII

• CIII-CV

• CII: 6 months from date written

• CIII-CV: may be refilled up to 5 times for up to 6 months from date written

Are there quantity limits on CII prescriptions? exception?

no quantity limits —> 1 exception is for multiple rx written on the same day for the same patient 90 day max

There is no federal guidance on what a RPh can/can’t change on a rx.

What does PA say as far as guidance?

PA only has guidance on electronic CII rx

• no changes to a CII rx

• for CIII-CV can make changes with prescriber okay as long as the following is not missing:

  • patient name

  • drug name or quantity

  • prescriber signature

  • date

To get around the whole no refills on CII prescriptions, what can prescribers do?

write multiple rx on the same day

If a prescriber writes multiple CII prescriptions for the same patient on the same date what 2 rules MUST be followed?

1. 90 day max

2. must have a “do not fill until XYZ date”

CII prescriptions are allowed to be faxed in what 3 situations?

1. home-infusion

2. LTCF

3. hospice

Verbal CII prescriptions are only allowed in emergencies.

Answer the following:

• what are the quantity limits?

• what info is required vs. missing?

• what must the prescriber do after calling this in?

• quantity limited to the duration to treat acute period

• must have all necessary info - prescriber signature

• the prescriber must provide the pharmacy with a valid prescription within 3 days

What are 3 situations in which a partial fill would be done for a CII?

1. pharmacy out of stock (72 hr rule)

2. patient or prescriber request (30 day rule)

3. LTCF or hospice request (60 day rule)

How do partial fills work with the 72 hour rule?

if a pharmacy is out of stock —> can partial and must have rest of prescription ready within 72 hours

How do partial fills work with the 30 day rule?

if a patient or prescriber requests a partial fill —> patients have 30 days to pick up all remaining portions of the prescription aka the prescription is only good for 30 days from THE DATE IT WAS WRITTEN

Example of 30 day rule and partial fills:

if a doctor writes a prescription on August 1st, and you pick up a 15-day supply on August 5th, you have until August 31st (30 days from August 1st) to pick up the remaining balance. If the remaining balance is not picked up by that date, the prescription for the remaining quantity becomes void, and a new prescription from the prescriber would be required.

Partial fills for emergency verbal prescriptions do not follow the 30 day rule, but have what time limitation?

72 hours

True or False: A household member that is dropping off an rx for a patient can request that it is partially filled.

FALSE—> patient wise the only people that can make a request are…

(1. the patient themself 2. a POA 3. if a minor, their guardian can)

When can a prescriber request a partial fill for a patient?

before OR after issuing the prescription

CIII-CV medications may be refilled up to ___ times in a ___ month period.

5 times in a 6 month period

Does PA require a prescription for CV cough products? If so what products?

YES YES YES —> includes any products with codeine, dilaudid, or any narcotic

(ex: Guaifenesin AC)

Is methadone allowed to be dispensed in a community pharmacy?

YES—> but only if prescribed for pain (NOT ALLOWED TO PRESCRIBE FOR OUD)

Traditional vs. Non-traditional OTPs

Traditional OTP

• traditional “rehab” “detox”

• drugs that can be utilized: methadone, bup, bup/combo products

Non-traditional OTP

• allows prescriber to treat OUD outpatient

• drugs that can be utilized: bup, bup/combo products only. no

Dispensing naloxone in PA:

• there is a statewise standing order —> aka functions like a “blanket prescription” and anyone that wants it can get it

• now naloxone is available OTC

Pseudoephedrine limits:

• per day

• per 30 days

• mail order

• 3.6 g/day

• 9 g/30 days

• 7.5 g/30 days mail order

Where must pseudoephedrine be kept?

• behind a counter (any counter)

• if located on the selling floor—> locked in a cabinet

Pseudoephedrine quantity limits apply to otc, rx, or both?

ONLY OTC. ONLY OTC. —> DOES NOT APPLY TO RX

Record keeping requirements for pseudoephedrine purchases:

1. logbook (exception if <60mg pseudo)

2. Photo ID

3. NPLEx system PRIOR to sale

   1. NPLEx = statewide, real-time pseudoephedrine monitoring program

What are considerations for Dextromethrophan sales in PA?

CAN ONLY SELL TO ≥18 YOs —> MUST PRESENT PHOTO ID IF THEY LOOK UNDER 25

Who must register with the state’s PDMP?

ALL DISPENSERS

In certain situations, you are and aren’t required to look at the PDMP before dispensing a CS.

When MUST you check the PDMP?

1. new patient

2. paying cash

3. >1 prescriber and prescriptions for opioids + benzo

4. early refill request (per insurance or >15% left)

When must all CS dispensing info be submitted to the PDMP by?

by the end of the subsequent business day

To apply for licensure, ___ hours of education consisting of pain management and the practice of prescribing or dispensing opioids is required.

4 hours (2 of each)

For licensure renewal, ___ hours of CE in pain management and the practice of prescribing or dispensing opioids are required.

2

Do the hours of CE done for pain management/opioids count towards the total CE requirements necessary for licensure renewal?

yes