RECORDKEEPING REQUIREMENTS Flashcards
Every pharmacy must maintain complete and accurate records on a current basis for?
each controlled substance received, sold, delivered, or otherwise disposed of.
Pharmacy records are required to provide
accountability of all controlled substances from the manufacturing process through the dispensing pharmacy and to the ultimate user.
In record keeping the closed system reduces the potential for
diversion of controlled substances.
All required records concerning controlled substances must be maintained for at least how many years for inspection and copying by duly authorized DEA officials.
two years
Records and inventories of schedule II controlled substances must be maintained _________ from all other records of the registrant.
separately
All records and inventories of schedules III, IV, and V controlled substances must be maintained either
must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records.
Recordkeeping requirements for prescriptions are
detailed in
Section VII, Valid Prescription Requirements.
For pharmacy record keeping readily retrievable is defined as:
- Records kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time, and/or
- Records kept in such a manner that certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the
records.
The records which must be maintained by a pharmacy are:
- Executed official order forms (DEA Form 222) or the electronic equivalent.
- Power of Attorney authorization to sign order forms.
- Receipts and/or invoices for schedules III, IV, and V controlled substances.
- All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business.
- Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors).
- The Suspicious Orders Report System (SORS) should be accessed on-line and only be used by DEA registrants that distribute controlled substances to other DEA registrants. Reporting a suspicious order to SORS Online constitutes compliance with the reporting requirement under 21 U.S.C. 832. Previously, only manufacturers and distributors were required to report suspicious orders. The SUPPORT Act requires that ALL DEA registrants that distribute controlled substances report suspicious orders to DEA. Reverse distributors and exporters are not affected by this SUPPORT Act requirement.
- Records of controlled substances dispensed, to include prescriptions or a logbook of controlled substances which may be lawfully dispensed without a prescription.
- Reports of Theft or Significant Loss (DEA Form 106), if applicable.
- Registrant Record of Controlled Substances Destroyed (DEA Form 41), if applicable.
- DEA registration certificate.
- The self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005.
The SUPPORT Act requires
ALL DEA registrants that distribute controlled substances report suspicious orders to DEA. Reverse distributors and exporters are not affected by this SUPPORT Act requirement.
A registrant desiring to maintain shipping and financial records (but not executed official order forms) at a central location rather than the registered location must
submit written notification of its intention by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the local DEA Diversion Field Office in which the registrant is located
Unless the registrant is informed by DEA that
permission to keep central records is denied, the registrant may begin maintaining central records ____ days after DEA receives this notification.
14
Central recordkeeping permits are no longer issued by DEA.
Central recordkeeping permits are no longer issued by DEA.
Pharmacies have how many options for filing paper prescription records and how many option for electronic prescription records.
two, one
Paper prescriptions for schedule II controlled substances shall be maintained at the registered location in a
separate prescription file.
Prescriptions for schedules III, IV, and V controlled substances shall be maintained at the registered location either in
a separate prescription file for schedules III, IV, and V, or in such form that they are readily retrievable from the other prescription records of the pharmacy
How many options are there for filing controlled substance paper prescriptions?
Two, option one and option two
What is Paper Prescriptions Records Option 1:
Paper Prescriptions Records Option 1:
- A file for schedule II controlled substances dispensed.
- A file for schedules III, IV and V controlled substances dispensed.
What is Paper Prescriptions Records Option 2:
Paper Prescriptions Records Option 2:
1. A file for all schedule II controlled substances dispensed.
2. A file for all other drugs dispensed (non-controlled and those in schedules III, IV and V). If this method is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red “C” stamp not less than one inch high.
If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed, and date filled, the requirement to mark the hard copy with a red “C” is waived
Remember: Federal requirements for filling prescriptions shall not be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other federal laws or obligations under international treaties, conventions or protocols, or under the law of the state in which he or she desires to do such act nor shall compliance with such parts be construed as compliance with other federal or state laws unless expressly provided in such other laws.
Remember: Federal requirements for filling prescriptions shall not be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other federal laws or obligations under international treaties, conventions or protocols, or under the law of the state in which he or she desires to do such act nor shall compliance with such parts be construed as compliance with other federal or state laws unless expressly provided in such other laws.
Electronic Prescription Records
1. If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained how?
electronically
Electronic Prescription Records
2. Electronic records must be maintained electronically for ______ from the date of their creation or receipt. However, this record retention requirement shall not
preempt
two years,
any longer period of retention which may be required now or in the future, by any other federal or state law or regulation, applicable to pharmacists or pharmacies.
Electronic Prescription Records
3. Records regarding controlled substances must be readily retrievable from all other records. Electronic records must be easily
readable or easily rendered into
a format that a person can read.
The computers on which the records are maintained may be located at another location, but
the records must be readily retrievable at the registered location if requested by a DEA or other law enforcement agent.
The electronic application must be
capable of printing out or transferring the records in a format that is readily understandable to a DEA or other law enforcement agent at the registered location.
Electronic copies of prescription records must be sortable by
prescriber name, patient name, drug dispensed, and date filled.
