Controlled Substances Flashcards
What drugs are federal CIII or CIV products but treated like CIIs in NYS?
Anabolic steroids, BZDs
Corresponding responsibility of pharmacists for a controlled substance
Making sure it’s used for a legit medical purpose by an individual practitioner acting in the usual course of their professional practice
Rules for CIIs and drugs treated like CIIs in NYS: how does the Rx have to be issued?
Electronically
Rules for CIIs and drugs treated like CIIs in NYS: how many refills are allowed?
NONE
Rules for CIIs and drugs treated like CIIs in NYS: how many days supply at a time can you fill?
30 days, there are exceptions though
Rules for CIIs and drugs treated like CIIs in NYS: how soon can you fill them?
7 days early (AKA they can have up to 7 days of a supply before their next fill)
Rules for CIIs and drugs treated like CIIs in NYS: what can prescribers not do?
Issue 3 scripts in a single setting
YOU CAN DO THIS FEDERALLY BUT THIS IS STRICTER
Rules for CIIs and drugs treated like CIIs in NYS: are pharmacists required to check the PDMP before dispensing?
No, it’s the responsibility of prescribers to check this but it’s the pharmacist’s call at the end of the day
When do controls have to be filled?
Within 30 days of the issue date
In some circumstances, a 3-month supply of a controlled substance can be filled depending on the indication. What are these indications?
Panic disorders
ADHD
Chronic, debilitating neurological conditions like a movement disorder, seizures
Relief of chronic pain
Narcolepsy
Hormone deficiency states in males, metastatic breast cancer in women, anemia and angioedema
Code for panic disorders
A
Code for ADHD
B
Code for neurological conditions
C
Code for relief of chronic pain
D
Code for narcolepsy
E
Code for hormone deficiency states
F
What can a pharmacy dispense up to a 6-MONTH supply of?
Anabolic steroids if used in accordance with the directions for use
Verbals for CIIs, BZDs, steroids: emergency situations may require a verbal. What’s a criteria for an emergency?
Immediate administration is necessary
No appropriate alternative treatment available
Not possible to provide a written or electronic prescription before dispensing
Permitted for immediate need situations
Verbals for CIIs, BZDs, steroids: what do you do when you get an emergency verbal?
Verify the emergency situation for the drug
Take the verbal
Limit the quantity to the emergency period for CIIs
Verbal script follow-up requirements for CIIs (actual CIIs)
Obtain a cover script in 72 hours
Ensure the cover script is marked “authorization for emergency dispensing”
Attach the follow-up script to the verbal script record
Verbal script follow-up requirements for CIIs- what if you don’t get a cover script in 72 hours?
Notify the NYS BNE AND the DEA within 7 days
Verbal script follow-up requirements for BZDs and anabolic steroids
Obtain a cover script within 72 hours
Attach the follow-up prescription to the verbal script record
Verbal script follow-up for BZDs and anabolic steroids: what if you don’t get a cover script in 72 hours?
Notify the NYS BNE within 7 days
You DO NOT need to notify the DEA because it’s not a federal CII!
When can you fax a CII, BZD, or steroid script?
Patients are in hospice or residing in a LTCF
Conditions for CII, BZD, and steroid faxed script acceptance
Hospice program or LTCF must be licensed/approved by the department
Dispensing pharmacy must have a written agreement or contract with the hospice program or RCHF
Follow-up requirements for faxed CIIs, BZDs, and steroid scripts
Original paper script must be delivered to the pharmacist within 72 hours
What happens if you don’t get the original copy of a faxed script within 72 hours for a CII, BZD, or steroid?
Notify the BNE IN WRITING OR ELECTRONICALLY WITHIN 7 DAYS
Faxed scripts for a CIII-CV: can you do it?
Yes, they’re allowed
Faxed scripts for CIIIs-CVs: pharmacist actions
Ensure the faxed script is legible and complete
Verify the prescriber’s info and DEA registration
Faxed scripts for CIIIs-CVs: documentation
Maintain the faxed script as part of the patient’s permanent record
No follow-up written or electronic script needed
Rules for CIIIs-CVs: 3 things
You can dispense what the physician writes for if the script is faxed or you take a verbal for it
Up to 5 refills in 6 months
A nurse can phone in the script
Purpose of the PDMP
Enhances patient care by providing comprehensive script information. This reduces misuse, abuse, and diversion of controls, and helps support clinical decision-making and identifying potential drug interactions
Key components of the PDMP
I-STOP, PMP registry
What’s the purpose of I-STOP?
Integrates the PDMP into EHRs
What’s the purpose of the PMP registry?
Accessible database that tracks dispensed controls
Prescriber requirements for the PDMP: what to do before prescribing controls
They have to consult the PMP registry before prescribing or dispensing CII-CIVs and check the patient’s control substance script history to ensure appropriate therapy
Prescriber requirements for the PDMP: documentation
Document in the patient’s medical record that the PMP was consulted and include relevant info from the PMP in the patient’s medical record
Prescriber requirements for the PDMP: what are exceptions to it being checked?
Scripts for hospice patients
Situations where the PMP Registry is temporarily unavailable
Scripts for a maximum of 5 days in an emergency situation
Pharmacist requirements for the PDMP: dispensing controls
Pharmacists don’t HAVE to check the PMP, but they’re encouraged to before dispensing CII-CIVs.
Also have to verify the legitimacy of the script and ensure it’s consistent with the patient’s controlled substance history (duh)
Pharmacist requirements for the PDMP: documentation
Document the dispensing of the controlled substance in the system and maintain the records in accordance with state and federal regulations
Pharmacist requirements for the PDMP: reporting
Report dispensed controlled substances to the PMP registry within 24 hours of dispensing and ensure accurate and timely submission of prescription information
Canceling or voiding controlled substance orders: how does it work?
Purchaser has to notify the supplier in writing that they want to cancel part or all of an order and the supplier has to indicate the cancellation on the original 222 form and drawing a line through the canceled item and writing “CANCELED” in the space for the number of items shipped
A supplier can void part or all of an order by notifying the purchaser in writing and must draw a line through the canceled items on the original 222 form and print “VOID” in the space for the number of items shipped. They can also endorse the order to another supplier that can fulfill it
Canceling or voiding a controlled substance order: what if it’s illegible, incomplete, or altered?
The supplier returns the original 222 form to the purchaser with the reason they didn’t fill the order
Invalid electronic orders: what can the supplier do?
They can refuse to fill an order for any reason and must provide the purchaser with a statement of the occurrence and indicate nothing was shipped with each part of a voided order (if they choose to do so)
Invalid electronic orders: what can the purchaser do?
Submit a new order and keep an electronic copy of the voided order
What can a pharmacy do with their controlled substances if they go out of business?
They can transfer them to the new pharmacy once the DEA number is confirmed
What’s required for a controlled substance transfer? (Moving it to another place, not a phone transfer)
Complete inventory, it serves as the transferring registrant’s final inventory and as the initial inventory for the acquiring registrant
When transferring controlled substances to another pharmacy, does the DEA need to know about the inventory?
No
How long should a pharmacy maintain a copy of the inventory records for?
5 years (NYS)
(2 years for federal)
When should inventory be taken?
Before dispensing for the day has started or at the end of the day
Can pharmacies sell controls? If so, to who?
They can sell them to other pharmacies or prescribers without registering as a distributor as long as both parties involves are registered with the DEA
What form is needed for a pharmacy selling CIIs?
222
The total quantity of controls sold by a pharmacy cannot exceed what?
5% of the total quantity dispensed each year by the pharmacy
Returning controls to a supplier: what does the pharmacy need to do?
Maintain a written record of the return showing the date of transaction, name, strength, dosage form, and quantity of the controlled substance, and the supplier or manufacturer’s name, address, and registration number
Form 222 or electronic equivalent needs to accompany the return of the CIIs
Send a photocopy of 222 to the DEA
Returning controls to the supplier: what does the supplier/manufacturer have to do?
Initiate the order, keep a photocopy of 222 and send the original 222 form to the pharmacy
Returning controls to a reverse distributor: what does the pharmacy need to do?
Can send controls to a reverse distributor as long as they’re registered with the DEA
If they’re transferring CIII-CVs, they need to keep a record with the drug name, dosage form, strength, quantity, and date transferred
Returning controls to a reverse distributor: what does the reverse distributor have to do?
Issue Form 222 or the electronic equivalent to the pharmacy that’s transferring the CIIs
Keep a photocopy of 222 and send the original copy to the DEA
Send Form 41 to the DEA once the drugs have been destroyed
Disposal of control wastage in an institutional setting: controlled substances
It remains under the control of that institution at all times
Disposal of control wastage in an institutional setting: single-dose vials and syringes that are partially used
These are referred to as “drug wastage” or “pharmaceutical wastage” and isn’t reported with Form 41; just record it in a logbook or electronic record keeping system
What should be recorded for controlled substances when it comes to record keeping? (9 things)
- Completed and blank DEA Form 222 or CSOS equivalents
- Power of attorney forms
- Receipts and/or invoices for Schedule III-V drugs
- Initial and biennial inventory records for controlled substances
- Records of transfers of controlled substances between pharmacies
- Records of distribution
- Records of dispensing
- Reports of theft or significant loss
- Inventory of drugs surrendered for disposal
Recordkeeping of controls: what records should also be kept by a pharmacy?
DEA registration certificate
Self-certification certificate and paper/electronic logbook for PSE sales
Paper script recordkeeping: there’s 2 ways to do it, what are they?
Option A:
CIIs together, CIII-CVs together, and non-controls together
Option B:
CIIs together, CIII-CVs together if they have a red “C”, and “C” is waived if the pharmacy has an electronic prescription recordkeeping system that can identify the controlled drugs by script number
If a script was received electronically, must it be kept electronically?
Yes
Partials for CIIs for terminally ill or hospice patients: what does the prescription need to have?
The practitioner has to write “terminally ill” or “hospice patient” on the script
Partial Fill Guidelines in NYS
Permissable to provide adequate pain management while minimizing the potential for drug diversion/damage
Documentation requirements for pharmacists: what to record for a partial fill
Date of the partial
Quantity dispensed
Remaining quantity authorized to be dispensed
Identification of dispensing pharmacist
Corresponding responsibility and red flags to prevent diversion: what to look for
The script has to be issued in the usual course of professional treatment for a legit medical purpose
Condition being treated has to be one that the prescriber would be expected to treat (aka within scope of practice)
Making sure the script is valid, and if it’s not or if there’s other issues, the pharmacist isn’t obligated to fill it
If a controlled substance was suspected to be issued for an illegitimate purpose, the pharmacist and the prescriber can be prosecuted
Red flags to watch out for
Frequent visits for early refills
Prescriber and/or patient located an unusual distance from the pharmacy
Patient profile has multiple prescribers for duplicate therapy
Similiar or identical prescriptions for multiple patients from the same prescriber
Script isn’t within scope of practice of the prescriber
Patients presenting to the pharmacy in groups
Unusual patient behavior
Patient pays OOP
Street slang to refer to a med
Patient is prescribed a drug cocktail
Pending federal or state action against the prescriber
Prescribing controls for oneself or for immediate family members
Doesn’t recommend self-prescribing or treating immediate family members
