PPLE Module 4

What are the three types of records involved with controlled substances?

Inventory

Drugs received

Drugs dispensed

Records of controlled substances must be kept for how many years?

2 years

Centralized records require that the ___ be notified.

DEA

Schedule __ and __ records need to maintained separately unless readily retrievable

1 and 2

Which schedule of controlled substances need an exact count and which only need an estimated count?

Schedule 1 and 2 need exact count

3,4,5 have estimated counts

This form is required for any Schedule 1 or 2 drug.

DEA Form 222

The DEA Form 222 has ___ lines per form, with only ___ items per line.

20 lines per form, with only 1 item per line

How do you process a single form?

The purchaser sends the original completed form to the supplier once they have made a copy and retained it. The supplier will do the same thing before sending the original completed form to the DEA.

This can be used instead of the DEA Form 222, and the purchaser can order any drug with this.

Electronic Order System (CSOS)

Is it possible to have more than 1 power of attorney recognized by the DEA?

Yes, but take into account of how secure your files are if you have more people.

Acceptable records of receipts include _____ and ______

invoices and Form 222

Pharmacies must record the date of receipts on the ______ or _____

invoices and Form 222

The total number of dosage units distributed to another registrant must not exceed ____% of the total units of CSs distributed and dispensed in one year

5%

Rxs may be filled in one of two ways and each Rx must obtain all required information. What are the two ways?

1. two file system - one file contains the C2, one has other schedules stamped with a big red C

2. three file system - one file contains C2, one file contains C3-5, one file has all other Rxs

T/F In some states, Schedule 5 products may be sold without Rx provided.

True, that is if the dispensing is done by the pharmacist, no more than 8 oz of an opium-containing product may be dispensed to same purchaser within 48 hours, the purchaser is 18, purchaser has good ID, sales recorded in record books, there isn't a law that prohibits this, if it is not at a central fill pharmacy

T/F Medication or chart orders are distinguished from prescriptions and need only contain minimum info necessary to provide an acceptable dispersal record

True

For the disposal or destruction of controlled substances, you must request it via what DEA form? Where is this form available?

DEA Form 41, found online

How and when should registrants notify the DEA about records of theft or loss of controlled substances?

What form do they fill out for this and where is it found

within one day of discovery of any theft or significant loss of CS

DEA Form 106 (found online)

What are the implications of lost or stolen 222 forms?

Think identity theft. All your info is on that form and if it falls in the wrong hands, it traces back to you

If an unfilled DEA form 222 has been lost, who must execute another and attach a statement containing the order form number and date of lost form?

The purchaser should do this, stating that the goods covered by the first DEA form 222 were not received through loss of that form.

If the original 222 form that was lost is received by the supplier, what do they do with it?

Put "Not accepted" and send it back to the purchaser

Executed Form 222s must be maintained separately from all other records for how long?

2 years

Under the Florida Prescription Drug Monitoring Program, who must consult the database to review patient's CS dispensing history before prescribing or dispensing a Schedule 2-5 CS except for non-opioid containing C5 for a patient who is 16 years or older?

Prescriber or dispenser

Under 456.44 Controlled Substance Prescribing, what limit was set on the amount of CSs that can be prescribed for acute pain?

3 day supply, or 7 days when judgment of prescriber notes more than 3 days

What designation should be on acute pain CSs Rxs?

"ACUTE PAIN EXCEPTION"

A prescription of what is needed when a patient is prescribed for acute pain from traumatic injury with a SS of greater than 9?

emergency opioid antagonist

Since 2017, what two professions are authorized to prescribe controlled substances?

PAs and ARNPs

PAs have a formulary of what they can't prescribe. What are two things that must be included?

anesthetics

radiographic contrast materials

T/F PAs and ARNPs can prescribe C2s to a 7 day supply

True

Can PAs and ARNPs prescribe psychiatric mental health CSs for minors under 18?

NO

What is the scope of authority for PAs?

Physician supervising can delegate prescribing and dispensing authority. They have to tell patients they are a PA and if they wanted to see a doctor too they can.

PAs must file a minimum ____ hours of CME with ___ of that 10 being on safe and effective use of CSs

10

3

ARNPs can prescribe or dispense a CS only if...

graduated from a Master's or Doctoral degree in a clinical nursing specialty area with training in specialized practitioner skills

Of the 30 required CE hours, ARNPs certified under 464.012 must complete at least ___

hours of CE on safe and effective prescribing of CS medications

3

PAs and ARNPs who prescribe any Schedule 2-4 for chronic non-malignant pain are required to designate themselves as a

CS prescribing practitioner

Can ARNPs and PAs prescribe CSs in pain management clinics?

No, only licensed physicians

Expedited Partner Therapy

Clinical practice of treating the sex partners of patients diagnosed with chlamydia or gonorrhea by providing prescriptions or medications to the patient to take to his/her partner without the health care provider first examining the partner

T/F Any pharmacist who knowingly fills a prescription in order for an individual practitioner to obtain CSs would be filling an invalid prescription and would be in violation of the law.

True

How to check validity of DEA number

1. Add digits 1, 3, 5

2. Add digits 2, 4, 6 and multiply by 2.

3. Add both sums together, the last digit should be the 7th numerical digit of the DEA number

DEA number's second letter corresponds to

the person's last initial

If my DEA number starts with A, B, F, or G, what is my profession?

Physician

If my DEA number starts with M, what is my profession?

Mid-level practitioner (nurse, PA)

If my DEA number starts with P or R, what is my profession?

Distributor

Who can legally dispense CSs?

Pharmacists (some state laws will allow techs with supervision)

All controlled substance prescription issues must have what? (6)

1. date of issuance

2. full name and address of pt

3. name, address, and registration number of practitioner

4. drug name, strength, dosage form

5. quantity prescribed

6. directions for use

The prescriber did not sign on the written CS prescription. Can you dispense it?

No

Can a pharmacist add or correct the patient's address if is not on the prescription or is incorrect on the Rx?

Yes

You discuss with the prescriber about changing the dosage form and strength of a CS for your patient. Is this possible?

Yes

Can the pharmacist make changes to the patient's name, the drug prescribed, or the prescriber's signature?

No

What is the guidance from the FDA on changing C2s?

Up to pharmacist's professional judgment if the state allows it

Is calling the prescriber's office enough to dispense an improper prescription?

No, bffr. Be smarter than that. You should know when something fishy is going on.

What are examples of invalid CS prescriptions? (5)

1. fraudulent or forged prescriptions

2. prescriptions written by individual practitioners for office use

3. prescriptions written by individual practitioners for fake pts, pts not named on script, no medical reason for it, faulty medical exam

4. narcotic scripts to maintain an addiction or to detoxify an addict

5. exceeds usual course of their professional practice (ex. a dentist getting narcotics)

Red flags for drug abuse or diversion

Multiple customers filling prescriptions written by the same prescriber for the same drugs in the same quantities

Customers with the same last name and street address presenting similar prescriptions on the same day or within a short time span

Two short-acting opiates prescribed together

Patients traveling long distances to fill opioid prescriptions

Drug cocktails

Payment by cash

Unusually large quantity of controlled substance

Pattern prescribing

Irregular dosing instructions

Lack of individualized therapy or dosing

Early fills/refills

Other pharmacies' refusals to fill the prescriptions

T/F Just because the dosage for a certain medication that is a CS is high, doesn't mean that it's a suspicious script.

True, we want to use our clinical judgments when needed, and some pts need to have higher dosages for their therapy. The DEA doesn't have the medical judgment to say if something is weird, so use your best professional judgment when fit.

All C2s must be ______ or _______

written or e-scribed

What are the exceptions to escribe and written C2 scripts, i.e., they can be faxed? (2)

1. compounded C2s

2. LTCF - long-term care is any C2 but hospices only narcotic C2s

Can C2s be dispensed during emergency situations?

Yes, only if the quantity tracks with the emergency period, is written, "authorization for emergency dispensing"

Who requests partial filling of C2s during emergencies?

patients or prescribers

The remainder of the prescription if partially filled must be provided to the pt within how many days?

3 days (72 hours)

After how many hours is no further dispensing of the emergency prescription allowed?

72

For multiple C2 prescriptions written on the same day, the total quantity prescribed cannot exceed how many day supply?

90 day supply

How can C3, 4, 5s be dispensed?

through a written, faxed, electronic, or oral prescription

C3 and C4s cannot be filled or refilled more than ___ months after the date of issuance or more than ____ times, whichever comes first

6 months

5 times

Electronic refill records of CSs must be maintained for at least how many years?

2

Precautionary label for C2/3/4 drugs

Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed

T/F Prescribers must use a two-factor authentication method to use escribe

True

Which controlled substances can be transferred? How many times?

C3/4/5 only once if state laws allow it

Transfers of C3/4/5s can only occur between

two licensed pharmacists in direct communication

_____ is written on the invalidated script for a transferred CS

VOID

The receiving pharmacist of a transferred CS must write what on the incoming script in addition to all necessary information?

TRANSFER

State PDMPs have been implemented in every state but are they all connected?

No

Are LTCF required to register with DEA?

No