Dispensing Controlled Substances: Pharmacy Practice Law Notes
Dispensing Controlled Substances: Pharmacy Practice Law
Controlled Substance (CS) Prescriptions
Definition: An order for medication dispensed to or for an ultimate user.
Exclusions: Does not include orders for medication dispensed for immediate administration (e.g., hospital chart orders).
Prohibition: Prescriptions for office use are prohibited.
Individuals Allowed to Prescribe CSs
Individual Practitioners (IPs):
Must be authorized to prescribe (or issue medication orders) in their state.
Must be registered by the Drug Enforcement Administration (DEA) or exempt from registration.
Employees or Agents of IPs: May communicate prescriptions to a pharmacist or prepare the prescription (Rx) for the IP's signature.
Delegation of Prescriptive Authority: Not legal unless the agent also possesses their own prescriptive authority.
Validity Check: When suspicious, pharmacists should verify the validity of a DEA number using calculations or by searching a national database.
Individuals Allowed to Dispense Controlled Substances
Pharmacists: Must be acting in the usual course of professional practice and either be individually registered or employed by a registered pharmacy or institutional practitioner.
Ancillary Personnel: May engage in CS dispensing activities if permitted by state law.
Individual Practitioners (IPs): May dispense if permitted by state law.
Verifying DEA Numbers
Requirements: A CS prescription can only be issued by an IP who is authorized to prescribe in their licensed state and is registered or exempt under .
Structure: Nine digits long, consisting of two alphabet letters followed by seven numbers.
First Letter: Historically started with 'A'. All 'A' numbers have been assigned. New registrations now start with 'B' or 'F'.
Mid-level Practitioners: Begin with 'M'.
Distributors: Begin with 'P' or 'R'.
Second Letter: Usually the first letter of the registrant's last name, but not always.
Next Six Positions: A unique computer-generated number.
Last (9th) Position: A computer-calculated check digit.
Validity Check Calculation: To check the validity of a DEA registration number (e.g., ):
Add the first, third, and fifth digits:
Add the second, fourth, and sixth digits, then multiply the sum by :
Add the results from steps 1 and 2:
Determine if the rightmost digit of this sum (\ from ) corresponds with the ninth (check) digit of the DEA number (\ in ). If they match, the number could be valid.
Disclaimer: Forgers are often familiar with this procedure, so pharmacists cannot rely solely on this calculation for validity. Other verification methods and professional judgment are essential.
Information Requirements of CS Prescriptions
Date of Issuance: Required; no predating or postdating is allowed.
Patient Information: Full name and address.
Drug Information: Drug name, strength, dosage form, and quantity prescribed.
Directions for Use.
Prescriber Information: Name, address, and registration number of the practitioner.
Pharmacist Documentation: Before filing, the prescription must contain the written or typed name or initials of the dispensing pharmacist, the date dispensed, and the units or volume dispensed.
Other Requirements of Written CS Prescriptions
Signature: Must be signed on the day of issuance.
Format: Must be written in ink, indelible pencil, or typed and manually signed.
Corresponding Responsibility: Both the pharmacist and the prescriber share a corresponding responsibility to ensure that a CS Rx complies with all legal requirements.
Individual Practitioners (IPs) Exempt from Registration
For IPs exempt from individual DEA registration (e.g., institutional practitioners):
The prescription must include the institution's registration number and a special internal code number.
The name of the prescriber must be stamped, typed, or hand-printed, along with their signature.
IPs in the armed services or public health must include their service ID number in place of a registration number.
Correcting Errors and Omissions on CS Prescriptions
Current Status: Awaiting a new DEA Rule on this topic.
Past Practice (C-III, C-IV, C-V Rxs): Pharmacists could add or change any information after consulting with the practitioner and documenting the change, except for the patient's name, the name of the controlled substance (generic substitution was an exception), or the prescriber's signature. A new verbal Rx could be taken if permitted.
Past Practice (C-II Rxs): The DEA's position has fluctuated. Previously, additions/changes were allowed similar to other CS Rxs. Currently, corrections may be made based on state law/policy until a proposed/passed DEA Rule establishes a federal standard.
Purpose of CS Prescriptions
Legitimate Medical Purpose: A CS Rx must be issued for a legitimate medical purpose in the usual course of professional practice.
Corresponding Responsibility: This places a corresponding responsibility on the pharmacist to ensure legitimacy.
Violation: Knowingly prescribing or dispensing a CS Rx not for a legitimate medical purpose violates the law.
"Knowingly" Standard: Implies a conscious disregard for obvious signs of illegitimacy.
Pharmacist's Expectation: When suspicions arise, a pharmacist is expected to exercise professional judgment and investigate further.
Accepted Standards: A legitimate medical purpose in the usual course of professional practice generally means acting in accordance with accepted standards of medical practice.
Examples of Invalid Prescriptions: Include, but are not limited to, narcotic Rxs used for maintaining or detoxifying an addict, Rxs for fictitious patients, Rxs written without a good-faith medical examination, or Rxs issued when no medical reason exists.
Facial Validity: An Rx that appears valid on its face is not necessarily a legally valid prescription.
Enforcement: Pharmacists are more likely to face enforcement action for blatant or glaring misconduct rather than isolated incidents.
DEA Guidance: The DEA has published examples of situations that might raise suspicion.
Exercise of Clinical Judgment and Pain Treatment
Legitimate Purpose: Treatment of pain is a legitimate medical purpose.
Normal Consequences: Drug tolerance and physical dependence are normal and natural consequences of opioid use.
Quantity/Frequency: The quantity of drugs prescribed and the frequency of Rxs alone are not indicators of improper prescribing.
Pharmacist's Role: Under the Controlled Substances Act (CSA), the pharmacist's role is to determine the legitimacy of a prescription for pain, rather than the therapeutic appropriateness of using opioids.
Differentiating Treatment of Pain from Treatment of Addiction
Crucial Distinction: It is important to determine if opioid treatment is legally for pain or illegally for addiction.
Detoxification vs. Withdrawal: Important to ascertain whether taper-down dosages are for detoxification of addiction or withdrawal resulting from physical dependence.
Addiction vs. Dependence: Critical to distinguish between addiction and dependence.
Exceptions: There are exceptions allowing for the treatment of addicts outside of licensed addiction programs or a Drug Abuse Treatment Act (DATA)-licensed facility.
Ascertaining the Legitimacy of Opioid Prescriptions in Pain Treatment
Pain Clinics: Alleged pain clinics often raise special concerns for pharmacists.
Familiarization: Pharmacists should familiarize themselves with the medical standards of practice for diagnosing and treating pain.
Collaboration: Should seek a collaborative practice relationship with pain physicians.
Patient/Prescriber Interview: When necessary and appropriate, pharmacists should interview both the patient and the prescriber regarding the pain and the chosen treatment.
Federal/State Efforts to Balance Pain Treatment with the Opioid Epidemic
Rising Overdose Deaths: Overdose deaths in the U.S. continue to rise.
Comprehensive Efforts: Various federal and state efforts have been implemented, encompassing prevention, treatment, and enforcement.
Examples: Prescribing guidances and laws, prescription drug monitoring programs (PDMPs), naloxone access initiatives, Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS), medication disposal programs, expansion of partial fills, and mandated electronic prescribing.
Dispensing C-II Drugs
General Rule: C-II prescriptions must generally be written and physically signed by a prescriber.
CMS Requirement: The Centers for Medicare & Medicaid Services (CMS) requires electronic prescriptions (eRx) for Medicare Part D prescriptions.
State-Specific Laws: Some states have stricter laws, such as quantity limits, time limits for dispensing, or security prescription forms.
Exceptions to Written Requirement:
Emergency Situations.
Narcotic Compounded Drugs for Direct Infusion: A faxed prescription serves as the original.
Long-Term Care Facility (LTCF) Patients: A faxed prescription serves as the original.
Hospice Patients (Narcotic C-II Drugs): A faxed prescription serves as the original.
Electronic Prescriptions: Permitted when certain requirements are met.
Emergency Situations for Oral C-II Prescriptions
Definition of "Emergency Situation": A situation where a practitioner determines that:
Immediate administration of the controlled substance is necessary for the proper treatment of the intended ultimate user.
No appropriate alternative treatment is available, including a controlled substance not in Schedule II.
It is not reasonably possible for the prescribing practitioner to provide a written prescription before dispensing.
Pharmacist's Responsibilities in an Emergency: A pharmacist may dispense a C-II upon oral authorization, provided:
Quantity Limit: The quantity dispensed is limited to the amount adequate to treat the patient during the emergency period.
Documentation: The prescription contains all state-required information (except the prescriber's signature) and is immediately reduced to writing by the dispensing pharmacist.
Verification: The dispensing pharmacist makes a reasonable good faith effort to determine that the orally or electronically transmitted authorization was issued by an authorized practitioner (e.g., callback, other good faith efforts).
Partial Filling of C-II Drugs
2016 Comprehensive Addiction and Recovery Act (CARA):
Allows partial fills of C-II medications if requested by the patient or prescriber.
The remainder must be provided within days from the date of the prescription, provided state law does not prohibit it.
Also allows partial fills for verbal emergency C-II prescriptions, with any remainder provided within hours.
LTCFs or Terminally Ill Patients: May partially fill for up to days from the date of issuance, given that recordkeeping requirements are met.
"Unable to Supply" Rule: The long-standing -hour partial fill is still permitted if the pharmacy is unable to supply the full quantity. This includes situations like verifying information with the prescriber.
The remaining quantity must be obtained within hours, or no more is permitted, and the pharmacist must contact the prescriber to inform them.
The DEA clarified that the pharmacy must obtain the remainder within hours, but the patient can pick it up after this timeframe if it was filled by the pharmacy within hours.
The pharmacist must document the details of the partial fill.
Multiple C-II Prescriptions for the Same Drug and Patient on the Same Day
Conditions for Permissibility:
Each prescription must be on a separate blank.
The total quantity prescribed must not exceed a -day supply.
The practitioner must determine there is a legitimate medical purpose for doing so.
The practitioner must write instructions on each prescription (other than the first) indicating the earliest date on which each Rx may be dispensed.
The multiple prescriptions must not create an undue risk of diversion.
Must be permissible under state law.
Dispensing C-III, C-IV, and C-V Drugs
Permitted Forms: May be dispensed pursuant to a written, faxed, electronic, or oral order.
Oral orders must be promptly reduced to writing.
IPs: Individual practitioners may administer or dispense these schedules without a prescription.
Refilling C-III and C-IV Prescriptions
Limits: Limited to months after the date of issuance or five refills, whichever comes first.
Additional Refills: The practitioner may orally authorize additional refills if the original prescription was written for less than five, and this authorization is recorded on the hard copy or in an automated system.
Quantity: The refill quantity cannot exceed the quantity originally authorized.
Recording Refills of C-III and C-IV Prescriptions
Nonautomated System: Required information must be recorded on the back of the prescription or another readily retrievable document.
Automated System: Must provide online retrieval (display or hard copy printout) of the original prescription information and an up-to-date refill history.
Hard copy printout requirements exist.
As an alternative to printouts, a bound logbook or separate refill file may be maintained.
Record Retention: Records must be maintained for years.
Auxiliary System: Pharmacies must have an auxiliary system for documenting refills in case of computerized system downtime.
Partial Filling of C-III, C-IV, and C-V Prescriptions
Permitted Conditions:
Must be recorded in the same manner as a refill.
The total quantity dispensed must not exceed the total quantity prescribed.
No dispensing is allowed after months from the date of issuance.
Differentiation: It is important to differentiate partial fills from refills.
Labeling Requirements for Controlled Substances
Date of Filling: The label must include the date of filling for a C-II drug and the date of initial filling for drugs in other schedules.
Refills: Should be labeled with both the date of initial filling and the date of dispensing.
Required Information: Labels must include all federally mandated information plus a cautionary statement prohibiting the ultimate user from transferring the drug to any other person.
Exemption: Labeling requirements are not applicable if the drug is prescribed for administration to an institutionalized patient, provided specific restrictions and requirements are met.
Electronic Transmission Prescriptions (ERx)
Prescriber Requirements:
Must undergo identity proofing.
Must digitally sign using two of three possible factors for authentication.
An agent can enter prescription information but cannot have access to the authentication factors or sign the prescription.
Pharmacy Requirements:
The pharmacy or Application Service Provider (ASP) must digitally sign the prescription, and the pharmacy must archive it.
If transmission of a prescription fails, specific regulatory requirements must be followed.
May make changes to the prescription after receipt.
Must back up data daily and keep records for years.
System Approval: All application systems used for ERx must be approved by a third-party audit or certified by a DEA-approved entity.
Transferring Prescription Information
Non-C-II CS Rxs: May be transferred one time between pharmacies if state law allows and requirements are followed by both the transferring and receiving pharmacies.
Common-Electronic Record Systems: Prescription information sharing among pharmacies participating in common-electronic record systems is not subject to the one-time transfer requirements. CS Rxs can be transferred up to the maximum number of refills allowed.
Electronic Transfers of C-II-V ERx: The DEA permits a retail pharmacy, upon request, to electronically transfer a Schedule II-V electronic prescription to another pharmacy for initial dispensing on a one-time basis.
Return of Controlled Substances to Pharmacy for Disposal
Historical Prohibition: Historically, the DEA forbade patients or LTCFs from returning CSs to a pharmacy for disposal.
Secure and Responsible Drug Disposal Act of 2010: Allows an ultimate user to deliver CSs to another person for disposal.
DEA Regulations (2014): Allow authorized entities, including pharmacies, to collect CSs from ultimate users, provided they register as a "collector."
Central Filling of Prescriptions
Definition: Pharmacies that fill prescriptions for other retail pharmacies pursuant to a contractual arrangement.
Scope: May fill both new and refill prescriptions.
Delivery: Any prescription dispensed for another pharmacy must be transported to that pharmacy for furnishing to the patient.
Labeling: The label of the dispensed drug must indicate at which pharmacy the drug was dispensed.
Direct Interaction: Central fill pharmacies cannot accept prescriptions directly from a patient or practitioner or deliver prescriptions directly to a patient or practitioner.
Corresponding Responsibility: The corresponding responsibility doctrine applies to pharmacists at both the central fill facility and the retail pharmacy.
Internet Prescriptions
Rogue Internet Pharmacies: Businesses that sell prescription medications without requiring prescriptions or by issuing prescriptions based solely on online surveys.
Ryan Haight Act (Valid Rx Definition): Defines a valid prescription as one issued for a legitimate medical purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient.
Telemedicine Exceptions: The DEA permits limited exceptions for telemedicine CS prescriptions without an in-person evaluation in specific circumstances.
State Law Implications: Although the Ryan Haight Act primarily applies to CS Rxs, most states consider any prescription not dispensed pursuant to a legitimate physician-patient relationship as invalid.
State Electronic Drug Prescription Monitoring Programs (PDMPs)
Prevalence: All states in the U.S. have a PDMP.
Reporting Requirement: Requires a pharmacy to electronically transmit to the state a record of the controlled substance prescription dispensed.
Purpose: Enables states to determine possible diversion and abuse situations.
Practitioner Access: Most PDMPs allow or mandate practitioners to request patient-specific information.
Data Sharing: Many states share data between their PDMPs to enhance monitoring efforts.
Long-Term Care (LTC) Pharmacy
DEA Registration: LTC facilities (LTCFs) are not registered with the DEA.
DEA Concerns: The DEA is concerned about excess supplies of controlled substances in LTCFs.
Solutions: To address these concerns, the DEA permits automated dispensing systems (ADS), partial filling of prescriptions, and voluntary collection receptacles by registered "collectors" within LTCFs.
Automated Dispensing Systems (ADS) in LTCFs
Definition: A mechanical system that stores, packages, counts, labels, and dispenses medications while maintaining transaction information.
Purpose: To reduce stocks of excess controlled substances in LTCFs.
DEA Registration: A pharmacy that installs an ADS in an LTCF must maintain a separate DEA registration for the LTCF location.
Distribution Limit: Distributions that a pharmacy makes to ADSs do not count toward the pharmacy's limit, which would otherwise require a separate registration as a distributor.
LTCF Nurses as Agents of the Prescriber
DEA Position Change: The DEA has changed its position over time on whether LTCF nurses can act as agents of the prescriber.
Current Federal Register Notice: Permits an agency relationship provided there is a formal written, witnessed agreement between the nurse and prescriber.
Limitations: An agent may only perform certain specific acts (e.g., communicating a prescription, not physically signing).
Dispensing from LTCF Emergency Kits
Permissibility: LTCF emergency kits are permitted.
Responsibility: The pharmacy is responsible for the kits.
Nurse as Agent: The DEA does not consider a nurse as an agent of the prescriber for the purpose of authorizing dispensing from an emergency kit.
Procedure: The prescriber must issue the prescription to the pharmacy, and the pharmacist must then authorize the nurse to dispense the controlled substance from the kit.
Recordkeeping for Controlled Substances
General Requirement: Every registrant must keep a complete and accurate record of all controlled substances.
Types of Records:
Inventory records.
Records of drugs received.
Records of drugs dispersed.
Violation: Negligent recordkeeping is a violation of the Controlled Substances Act (CSA).
General Recordkeeping Requirements
Retention Period: Records generally must be kept for years.
Centralized Records: Certain records may be kept at a central location with notification to the DEA.
The DEA must be notified about centralized records.
Records must be deliverable to a registered location within two business days upon DEA request.
C-I and C-II Records: Must be maintained separately or be readily retrievable from other records.
Inventory Records
Timing: Prior to beginning business and subsequently every years, a complete and accurate inventory of all CSs "on hand" must be conducted.
"On Hand": Means in the possession of or under the control of the registrant.
Inventory Day: May be taken at the beginning or end of the business day.
Format: Records must be written, typed, or printed.
Newly Scheduled Drugs: Must be inventoried on the date they are scheduled.
Counting Requirements:
C-I or C-II Drugs: An exact count must be made.
Other Schedules: An estimated count is permissible unless the container holds more than units, in which case an exact count is required.
Records of Receipt
Acceptable Records: Include invoices and DEA Form .
Documentation: A pharmacy must record the date of receipt on the invoice or Form .
Mixed Invoices: If an invoice contains both controlled substances and non-controlled substances, the controlled substances must be identified in a manner that makes them readily retrievable.
Content: Records of receipt must contain all required information.
Records of Dispersal
Acceptable Records: Include prescriptions, record books, DEA Form , invoices, records of disposal, theft or loss reports, etc.
Prescription Filing: Prescriptions may be filed in one of two ways, and each prescription must contain all required information.
Nonprescription Schedule V Sales
State-Dependent: Permitted in some states without a prescription, provided:
Dispensing Person: Dispensing is done only by a pharmacist.
Quantity Limits: No more than ounces ( mL) of an opium-containing product or ounces ( mL) of any other controlled substance may be dispensed to the same purchaser within a -hour period (some states have stricter requirements).
Age: The purchaser must be at least years of age.
Identification: The purchaser must furnish suitable identification.
Recordkeeping: The sale must be recorded in a bound record book containing all required information.
Distributions from a Pharmacy to Another Practitioner
C-III, C-IV, and C-V Products: An invoice containing all required information is necessary.
C-II Products: DEA Form is required.
Rule: The total number of dosage units of controlled substances distributed to another registrant must not exceed of the total units of controlled substances distributed and dispensed by the pharmacy in year. Exceeding this limit requires the pharmacy to register as a distributor.
Institutional Medication Records
Distinction: Medication or chart orders for institutionalized patients are distinguished from prescriptions.
Content: Need only contain the minimum information necessary to provide an acceptable dispersal record.
Retrieval: Must be readily retrievable.
Discharge Orders: Discharge medication orders for controlled substances may only be dispensed pursuant to a prescription.
Disposal or Destruction of Controlled Substances
Documentation: Must be requested and documented via DEA Form (available online), completed with all required information.
Options: The DEA allows destruction pursuant to various options.
"Blanket Authorization": May be allowed for hospitals, permitting destruction under specific conditions.
Reverse Distributor: A registrant may transfer controlled substances to a reverse distributor for destruction.
The reverse distributor is responsible for using DEA Form for the destruction.
Records of Theft or Loss
Notification: A registrant must notify the DEA within business day of discovering any "theft or significant loss" of any controlled substance.
Local police and the state board of pharmacy should also typically be notified.
"Significant Loss": The DEA has listed several factors to consider when determining if a loss is significant.
Documentation: A registrant must complete DEA Form , which is available online.
Records Required of Individual Practitioners (IPs)
Dispensing Records: IPs must keep records of controlled substances they dispense.
Prescribing Records: IPs are not required to keep records of controlled substances they prescribe.
Administering Records: IPs generally do not need to keep records of controlled substances they administer, unless the IP regularly engages in dispensing or administering and charges patients for the controlled substances, or if the substances are administered in the course of maintenance or detoxification treatment of addiction.
Administration/Dispensing Without Rx: IPs may administer or dispense controlled substances to an ultimate user without a prescription.
DEA Form 222
Purpose: Required for any distribution of Schedule I or Schedule II controlled substances.
Obtaining Forms: Requested in writing from the nearest DEA office.
Format Change: Triplicate forms have been phased out; a single-sheet form is now used.
Form Details: Forms are serially numbered and pre-printed with the name, address, and registration number of the registrant, authorized activity, and schedules the registrant is authorized to handle.
Corrections: A registrant may not correct or change any information or errors on the forms.
Execution of Form 222
Line Count: The number of the last line completed must be noted on each form.
Content: The form must contain all required information. The National Drug Code (NDC) number is optional for the purchaser to enter (the supplier must enter it).
Signature and Date: Must be signed and dated by an authorized person.
Purchaser's Receipt: Upon receipt of the order, the purchaser must record the number of containers received for each item and the date received.
Partial Order Fills: If a supplier partially fills an order, the remainder must be completed within days.
Alterations: Errors, alterations, or erasures are generally not permitted on the form.
Single-Sheet DEA Form 222 Procedure
Purchaser's Action: The purchaser sends the original completed form to the supplier after making and retaining a copy for their records.
Supplier's Action: The supplier keeps the original form and must inform the DEA of the purchase via the Automation of Reports and Consolidated Orders System (ARCOS) or by sending a copy of Form to the DEA.
Electronic Order System (CSOS)
Alternative: The Controlled Substance Ordering System (CSOS) may be used instead of paper Form .
Scope: The purchaser can order any controlled substance (C-I to C-V) using CSOS.
Digital Certificate: The registrant must obtain a digital certificate for each DEA-registered location to use CSOS.
Power of Attorney (POA)
Requirement: A Power of Attorney (POA) is required to allow a person other than the one who signed the registration to execute DEA Form .
Distributions of C-I and C-II Drugs Between Registrants
Form 222: Whenever registrants distribute C-I or C-II drugs among themselves, they must execute a DEA Form following the proper procedure.
Lost or Stolen Unfilled Order Forms
Procedure for Lost Unfilled Order: If an unfilled order form is lost, the purchaser must execute another form, along with a statement. This statement must note the serial number of the lost form, the date of the lost form, and state that the controlled substances were not received.
Record Retention: The purchaser must maintain a copy of the second order form and the lost order form with the accompanying statement.
Submission to Supplier: The copy of the statement must be sent to the supplier along with the second original order form.
Stolen/Lost Forms (Other than in Transmission): If order forms are stolen or lost (not in transmission), the registrant must immediately notify the DEA and provide the serial numbers of the missing forms. If the forms are subsequently found, the DEA must be notified immediately.
Preservation of Forms
Storage: Executed DEA Form s must be maintained separately from all other records.
Retention Period: Must be retained for years.
Copies: A copy of the single-sheet DEA Form must be kept at the registered location by the purchaser.
Supplier's Copy: The supplier always keeps the original DEA Form .