Ch 2: Controlled Substances Flashcards
1
Q
C1 Drugs
A
- Heroin
- Dihydromorphine
- Hallucinogens: Marijuana, LSD, peyote, mescaline
- Depressants like methaqualone
2
Q
C2 Drugs
A
Severe levels of physical/psychological dependence:
-Phenmetrazine
-Amobarbital/Pentobarbital/Secobarbital
-Glutethimide
-Phencyclidine
(Plus opioids, stimulants, barbitals, etc.)
3
Q
C3 Drugs
A
Mod-low physical dependence or high psychologic dependence:
- Codeine + APAP
- Suppository forms of barbitals
- Chlorphentermine, phendimetrazine, benzphetamine
- Anabolic steroids: testosterone
- Ketamine
- Paregoric
4
Q
C4 Drugs
A
Limited physical/psychological dependence:
- Dextropropoxyphene
- Max 1 mg of difenoxin
- Min 25 mcg of atropine sulfate/dosage unit
- Benzos
- Chloral hydrate
- Phenobarbital
- Diethylpropion/phentermine
- Carisoprodol, tramadol, pentazocine, butorphanol
5
Q
C5 Drugs
A
Limited physical/psychological dependence:
- Pregabalin
- Antitussives with codeine
- Antidiarrheal with opium
- Brivaracetam (Brivact) and Lacosamide (Vimpat)
6
Q
Epidiolex
A
- Cannabidiol drug used for seizures in children
- Contains max of 0.3% THC
- Removed from controlled substance list in Texas and by DEA in 2020
7
Q
DEA Exempt Product List
A
- Meds exempt from Controlled Substance Act due to being unlikely to abuse
- Ex: Fioricet (Butalbital/APAP/Cafffeine)
- May still be considered controlled substances for certain crimes even if exempt from list
- Small amounts of phenobarbital, butalbital, chlordiazepoxide, or meprobamate are also included
- Full list on DEA website
8
Q
Listed Chemicals
A
- Chemicals with legitimate uses that are used to manufacture controlled substances
- Ephedrine, pseudoephedrine, and phenylpropanolamine are included (only PSE still on market)
- Not controlled substances but have sales limitations/other restrictions
9
Q
Scheduling Authorities
A
- U.S. Attorney General (head of Justice Department, DEA under them) can add/delete/reschedule substances but needs a scientific/medical recommendation from FDA
- Texas: Commissioner of State Health Services can add/delete/reschedule substances but can’t override actions by legislature
10
Q
Compounding Narcotics
A
- Even with prescription, limit to “aq. or oleaginous soln or solid dosage forms with no more than [20%]”
- > 20% considered manufacturing, even if Rx provided
- Must be compounded with 1+ nonnarcotic therapeutic ingredients
11
Q
Codeine Compounding Limits
A
- CV: 200 mg/100 mL
- CIII: 1.8 g/100 mL and 90 mg/dosage unit
12
Q
Dihydrocodeine Compounding Limits
A
- CV: 100 mg/100 mL
- CIII: 1.8 g/100 mL and 90 mg/dosage unit
- *Anything above this limit = CII**
13
Q
Opium Compounding Limits
A
- FEDERAL CV: 100 mg/100mL
- TEXAS CV: 50 mg/100 mL (most commercial products need Rx in Texas, CIII here)
- CIII: 500 mg/100 mL and 25 mg/dosage unit
14
Q
Morphine Compounding Limits
A
- CV: None (either CIII or CII)
- CIII: 50 mg/100 mL
- *Compounded narcotics will NEVER be CV**
15
Q
Registration
A
- Any person/firm engaging with controlled substances must register with DEA
- No state controlled substance registration in Texas
- Dispensers must register Q3y (pharmacies/practitioners)
- A/B/F means they have registered
- G if through the Department of Defense
- 2nd letter if practitioners last name or pharmacy/hospital’s name if under entity
16
Q
Mid-Level Practitioners
A
- Practitioners other than physicians/dentists/vets/podiatrists who are licensed/registered/authorized to dispense in course of professional practice
- Registration begins with M
- May include advanced practitioners like nurses/PAs if state allows them to prescribe controlled substances
17
Q
Examples of Mid-Level Practitioners
A
- Advanced practitioners like nurses/PAs if state allows them to prescribe controlled substances
- Ambulance services
- Animal shelters
- Vet euthanasia techs
18
Q
Activities Requiring Separate Registrations
A
- CI-CV: Manufacturing, (reverse) distributing, chemical analysis, importing, exporting
- CII-CV: dispensing, conducting research, conducting narcotic tx program
- CI: conducting research
19
Q
Separate Location Registration
A
- Don’t need to register secondary sites if they only PRESCRIBE controlled substances at site
- DO have to register if they keep supply of controlled substances or if other site(s) is in another state
- Each pharmacy needs a separate DEA registration
- Campus registration can occur for multiple buildings; case-by-case basis
20
Q
Application for Registration
A
- DEA 224 for dispensers (practitioners/pharmacies)
- Must be signed by applicant, partner, or officer if for individual, partnership, or corporation respectively
- Can sign for other individuals if POA present and POA if filed with DEA Registration Unit
21
Q
Registration Exemptions
A
- Agent/employee of registered manufacturer/distributor/dispenser if acting in usual course of business/employment
- Carrier/warehouseman/employee whose possession of controlled substances is within usual course of business
- Ultimate user (patient) who possess substance for lawful purpose
- Officials of Armed Services, Public Health Service, or Bureau of Prisons acting in course of official duties (Texas: can only be electronic CII that are filled on base/out of facilities…. CIII-CV can be written and filled off base)
22
Q
Practitioner Use of Hospital DEA
A
- Interns, residents, staff physicians, and mid-level practitioners who are employees of institution may administer/dispense/prescribe controlled substances under hospital’s registration
- Specific internal code must be assigned to each practitioners authorized to use DEA code (suffix to hospital DEA number ___-10 or -A12)
- Internal code must be available to other registrants and law enforcement agencies
- Controlled substance scripts can be filled at any pharmacy
23
Q
Temporary Use of Registration
A
New owner of pharmacy can continue previous course of business under old owner’s registration IF:
- New owner expeditiously applies for DEA registration/state licensure
- Previous owner grants POA that allows controlled substance activities carried under registration including ordering, acknowledges that they will be held accountable, can only be in effect for 45 days post-purchase
24
Q
Ordering CII
A
- DEA 222
- Required for each sale/transfer of CII
- Only one item ordered per line
- Orders for etorphine HCl and diprenorphine must contain orders for ONLY these substances
- Name/address of supplier order being placed with must be included
- Signed by registrant and person authorized to execute Form 222
- Registrant can allow individuals to execute forms by creating POA (need to maintain copy in pharmacy, not send to DEA)
- Forms not complete/legible/filled properly not accepted
- Alterations/erasure/changes will not be accepted
25
Single-Copy DEA 222
- As of Oct. 2021, only single-copy DEA 222 can be used (NO MORE TRIPLICATE)
- 20 order lines per form (10 lines on triplicate)
- Need to make copy of form for pharmacy's record and submit original; copy doesn't need to be on premises but readily retrievable
- Supplier should only fill order if on an original; they can enter their DEA number information if left blank by purchaser (include number of containers for item shipped and date they shipped)
- Most suppliers are required to report acquisition/disposition of CII to DEA's ARCOS... if done no need to send DEA 222... if not done, MUST send DEA 222
- When received purchaser records number of containers and date received on DEA 222 copy
- TEXAS: Pharmacist must verify products on invoice were received by initialing invoice and signing date of receipt
26
Misc DEA 222 Info
- If completed form lost/stolen, purchaser must complete another with serial number/date of lost form and stating that goods covered by first order weren't received due to lost/stolen form
- If not filled in entirety, supplier has 60 days to supply balance
- DEA 222 can be faxed to supplier to start order preparation but can't be SHIPPED until original received
27
Digital CS Ordering
- Pharmacy must appoint CSOS coordinator who will serve as pharmacy's agent for issuance/revocation/changes to digital certificates
- CSOS allows electronic orders based on digital certificate issued by DEA Certification Authority which is valid through DEA's registration of facility (Q3y)
- Certificates are for INDIVIDUALS and should only be used by them
- All CSOS applications must be audited prior to use and whenever system software changes to ensure compliance
28
Types of CSOS Certificates
- Administrative Certificates: used to digitally sign communications with DEA and other participants in CSOS - only for CSOS Coordinators and not used for electronic ordering
- Signing Certificates: used to digitally sign controlled substance orders, issued to approved registrants/POA applicants => will only be issues if they hold POA for controlled substance ordering and request Signing Certificate on CSOS Certificate Application
29
Electronic Order will NOT be filled if...
- Required data fields aren’t completed
- Order not signed using digital certificate issued by DEA
- Digital certificate expired/revoked
- Purchaser's public key won't validate digital certificate
- Validation of order shows invalid order in any way
- Order cannot be filled => supplier must notify purchaser with reason and may refuse to accept any order (Order not accepted = valid reason)
- Unaccepted orders must have statement of unacceptance linked to original order and retain original statement for 2 years
- Defective orders may not be corrected, issue new order to get it filled
30
Ordering CIII-CV
- Can be ordered through normal ordering processes from a wholesaler/manufacturer, but must be documented by pharmacy by invoice provided
- Texas: All invoices for controlled substances must be initialed by receiving pharmacist (unless Class-ASC or F pharmacies, initialed by receiver (not necessarily pharmacist))
31
CIII-CV Invoice MUST Contain
- Name of substance
- Dose form/strength
- Number of units/container
- Quantity of containers received
- Date of receipt
- Name/address/DEA number of registrant from where the substances were received from
32
5% Rule
- Does not have to register with DEA as distributor as long as max controlled substances (not just CII) dispensed/distributed is 5% over 12-month period
- IF transferring CII, DEA 222 required
- Transfers can only be made to address listed on DEA registration, ALL controlled substances
33
Storage/Security of CS
- May go in locked secure cabinet
- May be stored by dispersal throughout noncontrolled stock to deter theft
- May NOT store all CS on one shelf
* *Only required to keep all CII in locked storage in Class C/F pharmacies in Texas**
34
Theft/Significant Loss of CS
- Must be reported to DEA within 24 hours of discovery, also contact local police is recommended
- TSBP is also required to be informed immediately upon discovery
- Complete DEA 106, can be done online, doesn't need to be immediately if additional investigation needed... BUT initial notification must be provided in writing to DEA within 1 business day
35
Losses of Listed Chemicals
- Any unusual/excessive loss/disappearance be reported to DEA at earliest practicable opportunity
- Written report provided within 15 days and must include description of circumstances of loss
- DEA 107 used to report
36
Convicted Felon Rule
- Pharmacy cannot employee someone who has access to controlled substances if they have convicted felony involving controlled substances
- Exception: waived by DEA
37
Employee Screening Procedures
DEA requires pharmacies to screen potential employees with specific questions regarding criminal history and use of CS
38
Employee Responsibility to Report Drug Diversion
Individuals are required to report any diversion by other employees to a responsible security official of employer
39
Patients Bringing CS from Home
Per DEA Pharmacist's Manual, if admitted to hospital by ambulance/EMS and no family present and patient has meds....
- Treating practitioner can deem it appropriate for patient to continue home meds and they are secured within patient's room (safe/lockbox) and thus not considered possessed/unlawfully distributed
- Treating practitioner deems inappropriate to continue home meds, they can be turned over to patient's family to return home or dispose of via hospital collection receptacle (if registered) or empty mail-back packages
- OTHERWISE, contact local DEA Diversion Field Office for proper disposal procedures
40
Federal Transfer Warning
- "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" required to be on any CII-CIV label
- Exception: "Blinded" clinical study
41
DEA 41
```
-Onsite destruction of CS
Form requires:
-NDC
-Strength/dosage form/package size
-Quantity of substance destroyed
-Method of how drug was destroyed
-Two signatures of employees who witnessed destruction
**Not used often due to difficulty complying with other regulations, like EPA**
```
42
Transfer to Authorized Reverse Distributor
- Preferred method of destruction
| - Transfer documented with DEA 222 for CII and invoice for CIII-CV
43
Disposals of CS from Ultimate Users/Non-Registrants
- DEA allows pharmacies to modify DEA registration to serve as collector of CS from ultimate users (pts, representations, LTCF)
- NOT required to serve as a collector, optional
- Meet specific requirements for collection receptacles and may provide mail-back program
- Drugs collected in receptacles can be destroyed on site (DEA 41 used, collected substances section that requires unique ID of inner liner from receptacle)
- DEA also conducts Drug Take Back Days to collect meds from ultimate users (CS or not)
44
Disposal of Hospice Pt Meds by Hospice Employees
- SUPPORT Act from 2018 authorized employee of qualified hospice program to handle CS for purpose of destruction that were lawfully dispensed to hospice patient
- DEA hasn't adopted regulations to implement this law into practice
45
Inventories of CS
- Initial inventory required on first day pharmacy is open for business
- Newly scheduled drugs or drugs that moved schedules must be inventoried on day scheduled or moved
- Biennial (Q2y) inventory must be maintained in the pharmacy for 2 years; HOWEVER, TSBP requires annual inventories
- Exact counts for CIIs, estimates for CIII-V accepted UNLESS container holds >1000 tabs/caps
46
Perpetual Inventories
Required in Texas for:
- CII in Class C pharmacies (institutional)
- All CS stored at remote location under remote pharmacy rules
- All CS in Class C ambulatory surgical centers (ASC)
- All CS in Class F (freestanding emergency medical facility) pharmacies
47
TSBP Rules for Inventories
- Signed by person taking inventory and PIC
| - PIC signature be notarized within 3 business days of inventory being completed
48
CS Records
- Records of CS kept for 2 years under federal and Texas law
- Records/inventories of CII kept separate from other CIII-CV records (readily retrievable!)
- Readily retrievable meaning it can be separated from other records in a timely manner/identified by asterisk, redline, or other manner
49
Records of Disbursement of CS
-DEA 106, 41, and DEA 222/invoices made under the 5% rule are also counted in disbursement records
-Most maintain electronic dispensing records
TSBP has specific rules for hard copies (3-file system):
-File 1: CII
-File 2: CIII-CV
-File 3: Non-scheduled drugs
50
Central Recordkeeping
- Must notify DEA Diversion Field Office if want to keep shipping/financial records at location other than central location registered
- Unless given notice that this request is denied, can start storing information at secondary location 14 days after notifying DEA
- Cannot keep executed DEA forms (scripts, inventories, order forms) there, must be kept at pharmacy
