In what schedule did DEA list carisoprodol products?
IV
What changes can be made to Schedule II Prescriptions?
date of issue - may be added but
... [Show More] not changed;
patient's address;
drug strength;
drug dosage form;
drug quantity - may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed; and
directions for use.
What changes may not be made to Schedule II Prescriptions?
name of the drug (except to generic when appropriate)
name of the patient
signature of the practitioner.
Can a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen?
Yes
after speaking directly with the prescriber and documenting the clarification on the prescription
Are there any exemptions to Controlled Substance Reporting System requirements regarding distribution of controlled substance samples?
Yes
"A dispenser shall not be required to report instances in which a Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for
the purpose of assessing a therapeutic response
when prescribed according to indications approved by the United States Food and Drug Administration."
How must controlled substances maintained in a practitioner's office (as opposed to a pharmacy) for dispensing or administration be stored?
Locked cabinet or other secure storage container with limited access by the office staff. FCSA
What is the NC Medical Board's position on the use of opiates to treat pain?
Basically there are no regulations but prescribers need to be careful.
http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/Policy_for_the_use_of_opiates_for_the_treatment_of_pain.
Is it "legal" for a pharmacist to add a DEA number to a controlled substance prescription when the prescriber omits that information?
yes
Are pharmacists required to hand sign and date controlled substance prescriptions?
no
May a prescribing practitioner prescribe other medications on a prescription that already includes a Schedule II medication?
yes
Can I fill Schedule II prescriptions bearing a "do not fill until" date?
yes
What are the rules around issuance of multiple prescriptions for CIIs?
(a) No CII refills
(b) Prescriber may issue multiple Rx's to provide (no more than a) 90 day supply
Common Sense Stuff:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.
What information must be reported under the controlled substance reporting act?
(1) Dispenser's AND Prescriber DEA number.
(2) Pt Name
Full address
Telephone number
Date of birth.
(3) Date writen
(4) Date filled.
(5) Rx number.
(6) Whether the prescription is new or a refill.
(7) Dispense quantity
(8) Days supply
(9) National Drug Code of dispensed drug.
Who is a dispenser under the controlled substance act?
Who is NOT a dispenser
"a person who delivers a Schedule II through V controlled substance to an ultimate user in North" ACCEPT:
a. Hospital or long term care pharmacy that dispenses for inpatient administration.
b. A person authorized to administer such a substance pursuant to Chapter 90 of the General Statutes.
c. A wholesale distributor of a Schedule II through V controlled substance.
What is my responsibility as a pharmacist in case of drug loss or theft?
1. Notify DEA within ONE BUSINESS DAY of discovery of such loss or theft.
2. complete a DEA 106 regarding the loss or theft.
3. If loss is "SIGNIFICANT" A Drug Disaster & Loss Report should also be completed and filed with the NC Board of Pharmacy office within 10 days of the drug loss/theft.
May a technician, certified technician, or pharmacy student transfer or receive transfers of prescriptions for controlled substances?
No, only pharmacists
Can prescription blanks for controlled substances be pre-printed?
No preprints
No stamped or electronic prescriber signatures
Note: A computer-generated controlled substance prescription is not considered "pre-printed" so long as the prescription was generated for an individual patient, and not "mass printed."
Are pharmacists required to "cancel" a prescription for a controlled substance by drawing a line from one corner to the other of the prescription document?
No, this is not a federal or state requirement
What collection methods of pharmaceutical controlled substances does the DEA authorize?
a. Collection receptacles
b. Mail-back programs
c. Take back events conducted by law enforcement only
Who may modify their DEA registration in order to become an authorized collector?
a. Manufacturers
b. Distributors
c. Reverse distributors
d. Narcotic treatment programs
e. Hospital or Clinic with an on-site pharmacy
f. Retail pharmacies
How does a DEA registrant modify their registration to become an authorized collector?
a. Submit an online request
b. The request shall contain:
registrant's name
address
registration number as printed on the certificate of
registration,
signature of registrant
type of collection (mail-back and / or collection
receptacle)
c. No fee will be collected for the modification of the registration to become an authorized collector.
d. Modification to a registration to become an authorized collector is voluntary. The new rule does not require any registrant to become a collector
Who can return controlled substances to an authorized collector?
a. Ultimate users
b. Individuals lawfully entitled to dispose of an ultimate user decedent's property
How does collection receptacle-based program work?
a. The DEA registrant must be an authorized collector
b. Schedule II-V controlled substances that are lawfully possessed by an ultimate user
Non-controlled substances may be comingled with controlled substances in collection receptacles.
c. Collection receptacles shall be
placed securely
maintained inside a collector's registered location
inside law enforcement's physical location
at an authorized long term care facility.§1317.75(d)
d. Physical requirements for the inner liner of the collection receptacle:
i. Water-proof; spill-proof; tamper-evident, tear-
resistant
ii. Removable and sealable
iii. Opaque so that contents of liner is not viewable
when sealed
iv. Size of liner clearly marked on bag
v. Bear a unique and permanent identification
number for tracking of the liner
Record keeping requirements for inner liners
i. Date each unused liner was acquired, unique identification number of each bag and size of unused liner (eg. 5-gallon, 10-gallon etc)
ii. Date and location address of installation of liner
iii. Date and location address of removal and sealing of liner, name of two (2) employees of the collector who oversaw the removal and sealing of the liner, unique identification number, size of liner removed and registration number of the collector
iv. Date of transfer to storage or for destruction of liner, unique identification number, size of liner removed, name of two (2) employees of the collector who oversaw the transfer for storage or destruction and the registration number of the collector
f. The removed and sealed inner liner must not be opened, x-rayed, analyzed or penetrated. §1317.70(f)
g. Sealed inner liners shall only be kept at the registered location in a securely locked, substantially constructed cabinet or securely locked room with controlled access except as authorized by §1317.80(d). §1301.75 (c )
h. The authorized collector must have and utilize an on-site method of destruction at its registered location or ensure safe transfer and transport for destruction by another authorized collector (e.g., reverse distributor). §1317.95
i. Must keep complete and accurate records of destruction (DEA Form 41) with names and signatures of 2 employees who witnessed the destruction. These records must be kept for 2 years. §1304.21(e)
How does a mail-back program work?
a. The DEA registrant must become an authorized collector.
b. The authorized collector must provide mailing envelopes that satisfy the following requirements
i. Nondescript without markings to identify the contents
ii. Water-proof; spill-proof; tamper-evident, tear-resistant and sealable
iii. Preaddressed to collector's registered address or law enforcement's physical address
iv. Postage paid
v. Unique identification number for tracking
vi. Instructions to user how to mail back package, who can send the package and what can be sent
c. For registrants authorized to collect through a mail-back program, the record of inventory shall include the following information about each mail-back package:
i. The date of inventory
ii. Number of mail-back packages
iii. Unique identification number of each package
d. The authorized collector must only accept controlled substances from ultimate users contained in appropriate packages provided by the collector.
i. NOTE: if collector receives controlled substances from an ultimate user in a package not provided by the collector then the collector must notify DEA Field Division of Administration within three (3) business days of receipt of package and store in a secure manner until given further instruction by DEA. §1317.70(e)(2)
e. Upon receipt of mail-back packages, the authorized collector must not x-ray, open, analyze or penetrate the package. §1317.70(f)
f. Sealed mail-back packages shall only kept at the registered location in a securely locked, substantially constructed cabinet or securely locked room with controlled access except as authorized by §1317.80(d). §1301.75(c )
g. The authorized collector must have and utilize an on-site method of destruction at its registered location or ensure safe transport and transfer for destruction by another authorized collector registrant (e.g., reverse distributor). §1317.95
h. Must keep complete and accurate records of destruction (DEA Form 41) with names and signatures of 2 employees who witnessed the destruction. These records must be kept for 2 years. §1304.21(e )
How can controlled substances be destroyed ?
a. Shall be rendered non-retrievable in order to prevent diversion and to protect the public health and safety.
b. Two (2) employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable.
c. Must keep complete and accurate records of destruction
(DEA Form 41) with names and signatures of two (2) employees who witnessed the destruction.
These records must be kept for 2 years. [Show Less]