PPLE 4.1 Controlled Substance Recordkeeping

Introduction to Controlled Substance Recordkeeping

• Recordkeeping for controlled substances is legally mandated and crucial
• Proper recordkeeping ensures patient care and safety and is legally important.
• Negligence in recordkeeping may result in fines, Board of Pharmacy actions, and potential criminal penalties.

Types of Records

• Inventory records document of all controlled substances on hand at a specific time.
• Records of drugs received document controlled substances obtained by the registrant.
• Records of drugs dispersed documentation of how controlled substances leave the registrant's control.

General Recordkeeping Requirements

• All controlled substance records must be kept for two years.
• Keeping records longer is practical for reasons such as potential lawsuits, Board of Pharmacy audits, tax audits, and legal defense actions.
• Certain records can be kept at a central location if the DEA is notified (e.g., for a large chain).
• There is a 14-day waiting period after notifying the DEA before centralization can occur.
• Centrally stored records must be readily retrievable.
• Electronically, with easy differentiation for Schedule II substances.
• Non-electronically, capable of being delivered to the registered location within two business days of a DEA request.
• C-II order forms must be kept at the location where the drugs are received or dispersed.
• Inventory records must be kept on-site.

Maintenance of Records by Schedule:

• Schedule I and II records must be maintained separately from all other records.
• Schedule I records are less common outside of research environments
• Schedule III through V records do not need to be kept separately
• Schedule III through V records can be intermingled with other drug prescriptions and invoices, but they must be designated in a way that allows for easy identification and ready retrieval
• For paper prescriptions of Schedule III-V drugs kept with regular prescriptions, they must be marked with a red "C" at least one inch tall on the prescription itself.
• For invoices containing Schedule III-V drugs mixed with regular prescription drugs, the Schedule III-V drugs must be marked in some way (e.g., red asterisk, underlining) for easy identification

Inventory Recordkeeping

• Initial Inventory involves a complete and accurate inventory of all controlled substances on hand and must be taken before beginning business
• Wholesaler records can serve as the beginning inventory.
• Subsequent Inventories must be conducted at least every two years on or very close to the anniversary of the original inventory after the initial inventory
• More frequent inventories are recommended.
• Newly scheduled drugs must be inventoried on the date of scheduling.
• Inventories must be taken either at the beginning or the end of the business day to ensure accuracy.
• Inventory records must be written, typed, or printed, verbal records are not acceptable.
• The inventory must be a complete and accurate record of all controlled substances "on hand", those in the possession or control of the DEA registrant.
• An exact count is required for Schedule I and II drugs.
• An estimated count is permissible for Schedule III, IV, and V drugs unless the container holds more than 1,000 units, in which case an exact count is required.

Records of Drugs Received

• Acceptable records include invoices for Schedule III, IV, and V drugs and DEA Form 222 for any distribution of Schedule I or II drugs.
• The pharmacy must record the date of receipt on either the invoice or the Form 222 when the drugs are received.
• Invoices must contain all required information.
• If an invoice contains both controlled and non-controlled substances, the controlled substances must be readily retrievable by marking them with a red asterisk, underlining, or another clear method.
• DEA Form 222 is used for the distribution of Schedule I and II drugs
• Forms are requested in writing from the nearest DEA office
• Forms are issued in mailing envelopes, serially numbered and pre-printed with the registrant's information and schedules
• Registrants cannot correct or change any information or errors on the forms.
• Each form has 20 numbered lines, with only one item per line
• The number of the last line completed must be noted in the designated box to prevent additions.
• The form must contain all required information
• The form must be signed and dated by an authorized person.
• Upon receipt of the order, the purchaser must record the number of containers received for each item and the date received
• Partial orders filled by the supplier must be completed within 60 days.
• The purchaser sends the original completed form to the supplier after making and retaining a copy and the supplier sends the original completed form to the DEA after making and retaining a copy for the Process with Single Form
• Electronic Order System (CSOS) may be used instead of Form 222 for ordering controlled substances and allows the purchaser to order any drug.
• Each DEA-registered location must obtain a digital certificate for CSOS use for security.
• Electronic Order System offers advantages such as speed and reduced risk of lost forms compared to paper forms.

Power of Attorney (POA)

• A Power of Attorney form designates someone to act in place of the DEA registrant for activities related to controlled substances, such as signing Form 222 or using CSOS.
• The number of individuals with POA is not specified but should be limited for security and liability reasons.
• The individual granted POA does not have to be a pharmacist.
• POA can be revoked if necessary.
• Individuals with POA can also face penalties for actions inconsistent with the law, even if they are not licensed pharmacists.

Distributions from a Pharmacy to Another Practitioner

• Borrowing controlled substances from another pharmacy with a handshake agreement or writing a prescription to another pharmacy for "office use" are improper methods.
• The proper method is the pharmacy with the controlled substance (Pharmacy B) acts as a wholesaler to the pharmacy needing it (Pharmacy A), even for small quantities.
• Pharmacy A fills out a Form 222 (for Schedule II drugs) or provides an invoice (for Schedule III-V drugs) with Pharmacy B as the supplier and Pharmacy B then fulfills the role of the wholesaler.
• The total number of dosage units of controlled substances distributed to another registrant must not exceed 5% of the total units of controlled substances distributed and dispensed by the pharmacy in one year per the 5% Rule
• If this limit is regularly exceeded, the pharmacy may need to register as a distributor.

Records of Dispersal

• Acceptable records of how drugs go out include: prescriptions, Form 222 (for distributions to other registrants), record books (for non-prescription C-V sales), invoices, records of disposal (Form 41), and records of theft or loss (Form 106).
• If using paper prescriptions, they must be filed in one of two ways:
• Two-File System: One file for Schedule II prescriptions and another file for Schedule III-V prescriptions intermingled with non-controlled prescriptions. Schedule III-V prescriptions must have a red "C" stamp.
• Three-File System: Separate files for Schedule II prescriptions, Schedule III-V prescriptions, and non-controlled prescriptions.
• Electronic prescriptions do not have these specific filing requirements.
• In some states (including Florida), certain Schedule V products can be sold without a prescription under specific conditions:
• Dispensing must be done only by a pharmacist.
• Quantity limitations (e.g., no more than 8 ounces of an opium-containing product or 4 ounces of any other controlled substance to the same purchaser within 48 hours, though state laws may be stricter).
• Purchaser must be at least 18 years of age and provide suitable identification.
• A record of the sale must be made in a bound record book containing all required information.
• There must be no state or local law prohibiting such sales.
• The sale cannot occur at Central Fill Pharmacies; it must be at a pharmacy with a front-facing dispensing area.
• Medication or chart orders are distinct from prescriptions and require only the minimum information necessary for an acceptable dispersal record in hospitals
• These records must be readily retrievable, often through electronic systems.
• Discharge medications for patients leaving the hospital can only be dispensed pursuant to a prescription.

Disposal or Destruction

• For controlled substances that are no longer viable, a DEA Form 41 must be used.
• The Form 41 can be downloaded from the DEA website and must be completed to show what is being disposed of.
• The registrant must contact the DEA after completing the form and await their instructions for disposal.
• The DEA may instruct the registrant to deliver the drugs to another registrant, bring the drugs to the DEA, destroy the drugs with a witness from the DEA present, or follow other approved methods of destruction.
• If using a reverse distributor, the reverse distributor may request the drugs from the pharmacy using a Form 222 effectively making the initial pharmacy the wholesaler for that transaction.
• Form 41 does not apply to controlled substances collected from ultimate users or Long-Term Care Facilities (LTCFs).

Records of Theft or Loss

• A DEA registrant must notify the DEA within one day of discovery of any theft or significant loss of any controlled substance.
• the police and the state Board of Pharmacy should also be notified.
• "Significant loss" is determined by the DEA based on several factors, including the actual quantity lost, the relative potential for diversion, and whether the loss is a single incident or a pattern over time.
• Documentation of a theft or loss includes DEA Form 106.

Records Required of Individual Practitioners (Non-Pharmacists)

• Individual practitioners must keep records of the controlled substances they dispense but not those they prescribe
• Generally, they do not need to keep track of controlled substances they administer directly to patients.
• Records must be kept of controlled substances administered in the course of maintenance or detoxification treatment of addiction.
• Individual practitioners may administer or dispense controlled substances without a prescription.

Lost or Stolen DEA Form 222

• If unfilled forms are lost in transmission, the purchaser must execute a new Form 222.
• They must attach a statement containing the order form number and date of the lost form, stating that the goods were not received due to the loss.
• A copy of the second Form 222 and a copy of the statement must be retained with a copy of the first executed form.
• If the first Form 222 is subsequently received by the supplier, they must mark it "Not accepted" and return the original to the purchaser, who must then attach it to their statement.
• If unfilled forms are lost or stolen, the purchaser must immediately notify the DEA and provide the serial numbers of the missing forms.
• The DEA must be notified immediately if the lost or stolen forms are later found.
• Executed Forms must be maintained separately from all other records and retained for two years. Copies of the forms must be kept at each location involved.

Amendments to Florida Statute 456.44 (Controlled Substance Prescribing) – HB21

• Requires that a prescriber or dispenser must consult the PDMP database to review a patient's controlled substance dispensing history before prescribing or dispensing a controlled substance to a patient 16 years of age or older for the Florida Prescription Drug Monitoring Program (PDMP).

Prescribing for Acute Pain:

• Acute Pain is defined at the normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness.
• This definition does not include pain related to cancer, terminal condition, palliative care, or traumatic injury with a severity score ≥9.
• Limits on Prescribed Amounts: The base limit is a 3-day supply.
• A prescriber can prescribe up to a 7-day supply if their professional judgment determines it is medically necessary.
• To prescribe more than a 3-day supply for acute pain, the prescription must include the words "ACUTE PAIN EXCEPTION".
• The prescriber must also document in the patient's medical record the acute medical condition, the lack of alternative treatments that would provide adequate relief, and the justification for deviating from the 3-day limit.
• Prescriptions for chronic pain must have the designation "NONACUTE PAIN" on the prescription.
• When prescribing opioids for non-acute pain, the prescriber is also required to prescribe an emergency opioid antagonist at the same time.
• Discussion of Non-Opioid Alternatives is required with patients being prescribed opioids for chronic pain or for acute pain resulting from a traumatic injury with a severity score of greater than nine.
• A prescription for an emergency opioid antagonist is also required when prescribing for acute pain from traumatic injury with a severity score ≥9.