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119 Cards in this Set

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What does 21 CFR allow the DEA to do?
Enter premises of registrants where controlled substances or records are maintained
What may the DEA do when entering the premises of registrants where controlled substances or records are maintained?
Examine and copy all records related to controlled substance distribution, prescribing, or dispensing (not financial records)

Inspect the premises

Inventory controlled substances

Inspector must state the purpose for the inspection along with a written notice to which the owner or the pharmacist in charge must consent
How may a DEA inspector enter the premise of a registrant where controlled substances or records are maintained?
Must state the purpose for the inspection along with a written notice to which the owner or the pharmacist in charge must consent
How must Schedule I drugs be stored?
Stored and securely locked in a "substantially constructed cabinet"
How may Schedule II-V controlled substances be stored/ kept?
May be dispersed throughout inventory to prevent diversion or theft

Most states have extensive requirements for controlled substance security
How must Schedule II controlled substances be stored?
May either be dispersed with other schedules or shall be maintained within a securely locked cabinet, drawer, or safe

Cabinet, drawer, or safe may remain unlocked during hours that the prescription department is open and a pharmacist is on duty
Who does losses/ theft of controlled substances get reported to?
21 CFR requires registrants to report significant losses in writing of controlled substances to the Field Office of the Administration

Immediately upon discovery

Registrant must also complete Form 106 to document this loss
When and what form must be submitten when controlled substances are lost/ stolen?
Immediately upon discovery

Form 106
What factors are considered when "significant loss" of controlled substances occurs?
Types and amounts of controlled substances lost or stolen

Activities and/ or individuals involved in the loss or theft of the controlled substances

Pattern of loss or whether certain types of substances appear to be lost or stolen

Local trends in the area of lost or stolen controlled substances
What must be reported when controlled substances are lost/ stolen?
Must report los to Board of Pharmacy immediately upon discovery

If unable to determine the exact quantity and type of the loss of inventory of drugs in CI-V, then must immediately take an inventory of these products

Within 30 days of discovery of loss of drugs, must submit report to the Board listing the kind, quantity, and strength of drugs lost

Must also comply with reporting requirements for the DEA

All records must be maintained for a period of 2 years after the transaction date
Who must loss of controlled substances be reported to, and when must this occur?
Must report loss to the Board of Pharmacy immediately upon discovery

Within 30 days of discovery of loss of drugs
How long must records be maintained after reporting controlled substance loss/ theft?
A period of 2 years after the transaction date
Inspections of DEA Registered Entities extends to what?
Permitted as a power and duty under 54.1 and extends to all drugs, cosmetics, and devices stored, maunfactured or dispensed in the state of VA

May enter during business hours

Report of violations must be provided to the Board of Pharmacy and it must take action within 30 days

Board may have access to and copy records at reasonable times
Who may conduct DEA inspections?
Agent of the Department of State Police may conduct diversion investigations and be permitted access

Cannot copy or remove patient specific records unless pertinet to the investigation

Must provide receipts for removal of original records and provide a copy within a reasonable time

May take samples of drugs, etc., and provide a receipt
What is the DEA's definition of a controlled substance prescription?
21 CFR

Order for medications

Dispensed to or for an ultimate user - does not include order for medication dispensed for immediate administration to ultimate user

Individuals in hospitals receive controlled substances pursuant to medication orders
- Individuals in long-term care facilities receive prescriptions
How must a controlled substance prescription be communicated?
By an employee or agent of prescriber to the pharmacy for dispensing

DEA indicated recently that the agent must be individual under the direct control or supervision of the prescriber
- cannot be a nurse or other individual at an offsite location such as a long-term care facility unless that individual reports directly to the prescriber

Secretary or agent may prepare the prescription for the prescriber's signature

Pharmacists must verify legality of controlled substance prescription information
How must a controlled substance prescription be verified?
Check DEA number

2 letters followed by 7 numbers

Physicians and other "traditional" prescribers begin with letters "A" or "B" followed by first letter of prescribers last name
- Second field for businesses could be number or letter depending on the company name (i.e. 3 Physicians, Inc coulg be A3 or B3)

Mid-level practitioners registration numbers begin with "M"

Distributor numbers begin with "P" or "R"
How do you verify that a DEA number is correct?
DEA generates random 7-digin numbers to each prescriber and other registrant

Add the 1st, 3rd, and 5th digits
Add the sum of the 2nd, 4th, 6th digits and multiply by 2

Add the equation (1 + 3 + 5) + (4 + 6)*2

The last number in the full equation should correspond to the last digit in the DEA number
What is a National Provider Identifier, NPI?
Each practitioner, institution, and other health care setting will be issued unique identifying numbers over the next year

Does not replace DEA registration for controlled substances

Replaces DEA numbers and other randomly assigned numbers for insurance claim processing and other purposes

Pharmacies scheduled to receive NPIs
Pharmacists may receive NPIs in the future
What does the DEA allow technicians or other ancilliary pharmacy personnel to do in terms of controlled substances?
Assist pharmacist in dispensing prescriptions for controlled substances pursuant to state law

In VA, technicians may assist pharmacists in preparing a prescription for dispensing
- Pharmacist must review and approve the dispensing
- Technician must be under supervision of pharmacist on duty

In VA, pharamcy interns registered with the state may also assist in preparing controlled substance prescriptions under the supervision of a pharmacist
- Pharmacy interns can perform more duties in comparison to technicians
In what situations may a controlled substance prescription be written in Virginia?
Prescription by authorized prescriber must be issued for amedicinal or therapeutic purpose and only issued to persons or animals with whom the practitioner has a bona fide practitioner-patient relationship
- in good faith
- in the course of professional practice
- must ensure medical history; provide pt with risks and benefits of drugs; perform an appropraite pt exam and initiated additional interventions and follow-up care if necessary
- prescribers face criminal penalties for writing controlled substance prescriptions that will knowingly be used for illegal purposes

54.1 Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only

Correlates to federal DEA law and regulations requiring a legitimate medical purpose in the course of professional practice
How must a pharmacist verify a controlled substance prescription in Virginia?
Pharmacist shall contact prescriber or agent to verify whether a questionable prescription is written in the course of the practitioner's professional practice
- Verify name of patient and quantity of the drug prescribed
- Prescriptions filled outside the course of a bona fide pharmacist relationship not in the usual course of treatment invalid
- Pharmacists who knowingly fill invalid prescriptions shall be subject to criminal penalties
- In VA, controlled substances include C-VI products not considered controlled by federal DEA standards
What is "knowingly"?
High legal standard to prove, but also carries a high risk of penalties
- Prosecutors must prove awareness of actions

Pharmacists must use professional judgment using all the facts surrounding the presentation of the prescription

In some cases, even verification will not ensure legitimacy of prescription

Must balance good care with suspicion
- Pharmacists should presume legitimacy of prescriptions
How must pharmacists verify out-of-state controlled prescriptions?
Pharmacists may fill prescriptions from out-of-state prescribers authorized in VA to prescribe

Prescriptions must fulfill all requirements of VA laws and regulations for prescriptions
How must a pharmacist decline a prescription?
Pharmacists may decline prescriptions found to be written outside the scope of a prescriber's usual course of practice or for illegal purposes

In VA, a pharmacist that declines to fill a prescription for reasons other than unavailability of drug shall record on the back of the prescription:
the word "declined"
the name, address, and telephone number of the pharmacy
the date filling was declined, and the signature of the pharmacist
What must be on the prescription when a pharmacist declines a controlled substance?
"Declined"

Name, address, and telephone number of the pharmacy

Date filing was declined, and signature of the pharmacist
What are some factors to consider for appropriate prescribing of controlled substances?
Office use of controlled substances by practitioners should not be by Rx

Pharmacist can transfer pursuat to DEA regulations
- Transfers should only occur in limited circumstances

Physicians should purchase controlled substances from warehouses or distributors
How must a prescription for treatment for narcotic addiction be written?
Must be prescribed through a treatment program with some exceptions

Pharmacist should not judge all Rxs for extraordinary doses of controlled substances as fraudulent

Should determine medical purpose and condition of patient

VA 54.1-3408.1 provides immunity to pharmacists for certain prescriptions dispensed and prescribed in good faith for excess quantities

C-II Methadone - very specific for in-patient use

Must be documented on the front "for chronic pain"
How must a prescription for methadone be written in order for it to be filled in a pharmacy?
"For chronic pain"

Can't be used for narcotic withdrawal at pharmacy - must be filled at a methadone clinic

Always document high doses!
May controlled substances be purchesed from internet pharmacies?
Some internet pharmacies are legitimate entities that dispense legitimate prescriptions

Individuals may receive controlled substances and other prescriptions from legitimate internet and mail order pharmacies pursuant to a prescription from a prescriber

Individuals in the US may not purchase controlled substances or other medications from internet pharmacies not located in the United States

Internet pharmacies legitimately registered in the US will display its DEA number
How do you know an internet pharmacy in the US is legitimate?
It will display its DEA number
How must a controlled substance prescription be purchased/ dispensed from an internet pharmacy?
National Association of Boards of Pharmacy established a voluntary certification program called Verified Internet Pharmacy Practice Sites (VIPPS) that meet both DEA and state board of pharmacy requirements

Prescription information may not yet be transmitted via the internet

To receive a controlled substance prescription, information must be transmitted via phone, hard copy prescription, or fax pursuant to DEA regulations
How must inappropriate prescribing and controlled substance abuse be handled?
Pharmacist should report inappropriate prescribing to local law enforcement

Pharmacist may report individuals with fraudulent prescriptions to local law enformcement

Pharmacists and others may report instances of illegal sales of controlled substances to 877-RxAbuse (a hotline extablished by the DEA)
How often must pharmacies, manufacturers, and wholesalers register with the DEA?
Pharmacies, hospitals, teaching institutions must register every 3 years using Form 224

Manufacturers/ wholesalers register every year using Form 225

Must register each location

Common carriers, including mail service, UPS, and FedEx do not register with DEA
How may pharmacies distribute controlled substances to other DEA registrants?
So long as distributions do not total more than 5% of all controlled substance inventory in one year

If C-II, must use DEA form 222

For drugs in all other schedules, must record transfer information
What form is used to order and transfer CI-II controlled substances?
Form 222

Initial order forms provided by the Washington, DC headquarters office of DEA as part of registration process
- Subsequent order forms obtained from assigned DEA field office

Request must include name, address, registration number of each registrant and the number of envelopes requested with each order form

Requests must be signed and dated by the same person who signed the most recent application for registration or re-registration
- Usually in VA, is pharmacist in charge
Power of attorney allows another individual to sign order forms
- Must be kept in the pharmacy records
Does not have to be provided to the DEA
How must a Form 222 be filled out?
Copy 1 - original
Copy 2 - duplicate
Copy 3 - triplicate
Each form is numbered by the DEA
DEA pre-prints forms with name, address, DEA number and schedules of controlled substances that may be ordered or handled

Purhcaser must complete all 3 copies simultaneously
- Must be typewritten, ink pen, or indelible pencil
- Each line contains a space for ordering one substance with a total of 10 lines
- Must order the quantity of each container ordered
- Full name of product and quanty included
- Pharmacy may enter NDC but wholesaler must enter NDC if not provided by the pharmacy
- Must enter name and address of supplier of order
- Purchaser must sign and date the order form
- Substantive errors may NOT be corrected -- Wholesaler may make corrections if address or contact information of wholesaler is incorrect
Who gets each copy of the Form 222?
Purchaser submits Copy 1 and 2 to the supplier and retains Copy 3 for files

Supplier records on the 1st and 2nd copies the number of containers furnished on each item and date of shipment
- If supplier cannot provide the entire quanty, can provide a partial shipment and supply the balance within 60 days
- Supplier maintains Copy 1 for its files
- Supplier provides DEA with Copy 2
- Upon receipt of items, purchaser records date and quantity ot times purchased on Copy 3

Suppliers that cannot fulfill the orders or if the order form is illegible, incomplete, altered, or erased, then it returns Copy 1 and 2 to the purchaser with a rationale for not filling the order
- Purchaser must maintain Copy 1 and 2 with its Copy in its files

All executed order forms must be maintained by all entities for 2 years
Who does Copy 1 of the DEA Form 222 go to?
Purchaser submits Copy 1 and 2 to the supplier

Supplier maintains Copy 1 for its files

Must be maintained for 2 years
Who does Copy 2 of the DEA Form 222 go to?
Purchaser submits Copy 1 and 2 to the supplier

Supplier provides the DEA with Copy 2

Must be maintained for 2 years
Who does Copy 3 of the DEA Form 222 go to?
Purchaser retains Copy 3 for files

Upon receipt of items, purchaser records date and quantity of times purchased on Copy 3

Must be maintained for 2 years
What does the Electronic DEA Order Form 222 allow?
Part of DEA's Controlled Substances Ordering System (CSOS) initiative

Allows electronic transmission of Form 222 from manufacturers to distributors and distributors to pharmacies

Simplifies the process and sets the framework for electronic transmission of controlled substance prescription information

Uses the highest form of secure electronic transmission infrastructure by requiring signatures in public key infrastructure format
- A certification authority ensures that each transaction is verified (similar to credit card processing)
- Certification authority verifies order and then issues a digital certificate to the entity receiving the order form
- Entities apply for a digital certificate for each location where it conducts business
- Each individual with authority or power of attorney to execute DEA order forms must be issued a password protected digital signature
How may pharmacies return CI or CII drugs to manufacturers or distributors?
Pharmacy returns to manufacture or distributor considered pharmacy as supplier

Pharmacy notifies manufacturer or distributor of intent to return items and then thte distributor sends the Form 222 with the quantity and amounts recorded

Distributor retains Copy 3 for its records
- Pharmacy maintains Copy 1 and submits Copy 2 to the DEA
What form must be executed in the event of lost or stolen Form 222?
Purchaser must execute new Form 222 if lost or stolen in transmission
- Must record on new order form the serial number of the lost form, date of loss, and the fact that the controlled substances were not received
- Purchaser maintains Copy 3 of new form and lost form together
- Purchaser must send a copy of the statement to the supplier with Copy 1 and Copy 2 of the second order form
- If the supplier receives the original order form, then it must mark it as "not accepted" and return Copy 1 and Copy 2 to the purchaser who retains these copies with Copy 3

Other occasions where Form 222 is stolen must be reported to the DEA with serial numbers of stolen forms
How must a C-II prescription be dispensed?
Must be dispensed pursuant to an original, written prescription signed by prescriber
When may a C-II prescription be dispensed without a written prescription?
In emergency situations

Via facsimile for home infusion, residents of long-term care facilities or hospice patients

Partial filling in situations where a pharmacy cannot supply the entire prescription amount
How long is a C-II prescription valid in Virginia?
6 months after date written

C-II prescriptions may not be refilled
Under what conditions does VA allow emergency dispensing of C-II drugs?
DEA permits emergency dispensing of oral C-II prescriptions in retail pharmacies under the following conditions:

Quanty prescribed and dispensed limited to amount necessary to treat patient for emergency period

Prescription must be reduced to writing immediately by a pharmacist

Must contain all the necessary information except prescriber signature

If prescriber is unknown to pharmacist, must make reasonable efforts to determine that the prescription is valid
When must a prescribe provide the pharmacy with the original signed written prescription after calling in an emergency prescription?
Must provide the pharmacy with the original signed written prescription within 7 days after authorizing the emergency prescription

- Must be postmarked within 7 days
- Prescription must include statement "Authorization for Emergency Dispensing" and date of oral order

Pharmacist must attach the prescription to the oral emergency prescription

If prescriber fails to deliver written prescription within the 7 day period, pharmacist must notify the nearest DEA office

VA adopts the same standard
What definies an "emergency situation" when writing a C-II prescription for emergency fill?
Quantity limits not necessary or definitive, but mist ensure that quantites consistent with emergency period
When may pharmacies receive a facsimile prescription for a C-II drug?
In retail settings, pharmacies may receivew a facsimilie prescription for a C-II but must receive the original written signed prescription prior to dispensing

Facsimiles as original prescriptions for C-IIs
- narcotic substance compounded by pharmacy for direct administration to patient by parenteral, IV, IM, SQ, or in intraspinal infusion
- Residents of long-term care facilities
- Hospice setting certified by the Medicare program or licensed by state
-- Individual may be in a home hospice setting, does not have to be institutional
- Facsimile copies must contain all required information on face of Rx, including prescriber signature
When is a facsimile allowed as the original prescription for C-IIs?
Narcotic substance compounded by pharmacy for direct administration to patient by parenteral, IV, IM, SQ, or in intraspinal infusion

Residents of long-term care faciliteis

Hospice setting certified by the Medicare program or licensed by state
- Individual may be in a hope hospice setting, does not have to be institutional

Facsimile copies must contain all required information on face of Rx, including prescriber signature
What are the provisions for partially filling a C-II drug?
C-IIs can never be refilled

Pharmacies may provide a partial quantity of a C-II prescription if it is unable to provide the entire quantity

Pharmacist must make a note of face of prescription and fill the balance of the prescription within 72 hours after the partial fill

If pharmacist unable to fill remaining quantity, must contact the prescriber

exception interpreted by DEA to permit parital filling for a large quantity of controlled substance while pharmacy receives verification of Rx
- Also applies to situations where a patient cannot pay for the entire quantity of the controlled substance
What provisions are allowed for the partial filling of C-II drugs for residents of LTCFs/ Terminally Ill
To reduce waste associated with unused medications for residents of LTCFs or patients classified as terminally ill, pharmacies can partially fill quantities of controlled substances

Applies for dosages filled up to 60 days from date of issuance of prescription or until the prescription terminated by prescriber
How may a C-II prescription be partially filled for residents of LTCFs/ Terminally Ill?
Information regarding the patient's residents in LTCF or as terminally ill must be recorded on the prescription

Information related to the filling must be recorded each time on the face of the prescription
- Date
- Quantity dispensed
- Remaining quantity authorized to be dispensed
- Identification of the dispensing pharmacist
What are the recordkeeping requirements of C-II partial fills for LTCFs/ Terminally Ill patients?
Information regarding partial fill may be recorded on back of prescription or in a computer system if

The computer can indicate the original prescription number
- Date of issue
- ID of prescirber
- Patient
- Name of LTCF
- Medication including dosage form, strenth, and quantity
- Listing of partial fills
- Immediate, real-time updating of prescription record each time prescription partially filled
How may a CIII-V prescription be written?
Pursuant to a written, faxed, or oral prescription that contains appropriate information
- For oral or fax prescriptions, no follow-up hard copy necessary
- Faxed Rx considered oral Rxs must indicate on the face of the Rx the agent's name and record of oral Rx
How may a CIII-V prescription be dispensed?
CIII or IV prescriptions may be refilled up to 5 times within 6 months of the date of issuance

Restrictions do not apply to C-V drugs under DEA requirements - but Virginia permits C-V controlled substnaces to be refilled 5 times in 6 months
What are Virginia's requirements for C-VI prescriptions?
Prescribers must authorize refills either orally or on face of the prescription

Pharmacists may refill C-VI prescriptions without prescriber authorization if reasonable efforts made to communicate with prescriber and is unavailable
- Pharmacist must notify patient and prescriber of refill without authorization
- Document of quantity, date, prescriber unavailability, and rationale for refill must be recorded on back of Rx drugs

C-VI prescriptions may only be refilled for 1 year after issue date unless prescriber indicates otherwise on face of prescription
How may CIII, IV, and V prescriptions be partially filled?
Partial filling permissible so long as it meets requirements for refills

Total quantity dispensed does not exceed total quantity prescribed

No dispensing after 6 months of issuance
How must a nonprescription Schedule V drug be dispensed?
By pharmacist only
- Nonpharmacists may not dispense even under supervision of pharmacist
- Pharmacy interns may dispense
- Technicians may assist

- Must be at least 18 years old
- Must present proof of age if unknown to pharmacist

In VA, must record date of dispensing, name and quanityt of preparation, name and address of person to whom prepearation is dispensed
What are the requirements for dispensing a controlled, nonprescription Schedule V substance?
240mL or 48 dosage units of any controlled substance containing opium

In Virginia, NMT 200mg of opium

NMT 120mL or 24 dosage units of other controlled substance

Virginia requirements:
- 270mg of codeine
- 130mg of dihydrocodeinone
- 65mg of ehtylmorphine
- 32 5/1mg of diphenoxylate
How may prescription information for refill purposes be transferred?
Pharmacies may transfer prescription information between themselves for refill purposes for schedule III, IV, and V prescriptions on a one-time basis

Pharmacies that share electronic information in real-time online databases may transfer refill information for the maximum amount of times permitted by law

DEA and VA 18 VAC have same requirements
What information is required on a transferred prescription for the tranferring pharmacy?
Write void on face of invalidated Rx

Record on the back of the invalidated Rx the:
- Name, address, DEA registration number for CIII-V; not on C-VI of pharmacy where Rx is transferred
- Name of pharmacist receiving information
- Date of transfer and name of transferring pharmacist
What information is required on a transferred prescription for the receiving pharmacy?
Write transfer on face of transferred Rx

Record all required information on CIII-VI Rx including:

Date of issuance of original Rx; original number of refills authorized; date of original dispensing; number of refills remaining and dates and locations of previous refills; transferring pharmacy's name, address, DEA number, Rx number, and name of transferor pharmaicst; pharmacy name, address, DEA number (for CIII-V, not for C-VI), and prescription number originally filled

Records must be kept for 2 years from date of last refill
What are the label requirements for CII-VI?
C-II drugs must contain date of filling

Refills of CIII-VI should include date of initial filling and date of refill

VA requires label to show
- Rx number or name of drug
- Date of initial filling
- Pharmacist or pharmacy name and address
- Name of patient or name of animal and owner
- Name of prescriber
- Directions for use

CII-IV must include caution related to transfer
Are long-term care facilities with Automated Dispensing Systems (ADS) registered by the DEA?
No

Prescriptions considered dispensed to residents

Must comply with all dispensing requirmenets

Waste occurs because of unused dosage forms

Until May 2005, no easy way to return medications for re-use to other patients

ADS now permit stocks of controlled substances to be maintained at the LTCF

Unused dosage forms can be dispensed to another patient
How may unwanted or outdated controlled substances be disposed/ destroyed?
Must use DEA Form 41 and list the name of the drug, content of container, and each drug that will be disposed or destroyed
What must the Form 41 include?
Name of drugs, content of container, and each controlled drug that will be disposed or destroyed

Form must include information related to date and method of destruction

In Virginia, must provide place of destruction
- If destruction date does not occur, new notice must be provided to the Board

Need to provide list of witnesses
- Physicians, pharmacists, mid-level practitioners, nurses, or law enforcement officers
- In VA, must be 2 pharmacists, including pharmacist in charge and a non-employee pharmacist
Who is allowed to witness the disposal and destruction of controlled substances?
Physicians, pharmacists, mid-level practitioners, nurses, or law enforcement officers

In VA, must be 2 pharmacists, inlcuding pharmacist incharge and a non-employee pharmacist
What occurs after the DEA receives Form 41?
DEA will inform registrant the proper procedure
- Transfer to registrant authorized to possess the substance
- Delivery to DEA agent or nearest field office
- Destroy in presence of DEA agent or other authorized person
- Other means authorized by DEA, including registered distributor
When must Form 41 be submitted?
At least 2 weeks in advance to the disposal/ distruction of controlled substnaces

In VA, must also notify the Board of Pharmacy 14 days in advance

Forms must be forwarded to the DEA and in VA retained at the pharmacy

Pharmacy may request destruction once each calendar year
How often may a pharmacy dispose of/ destroy controlled substances?
Pharmacy may request destruction once each calendar year
Who is able to destroy/ dispose of controlled substances?
Must be initiated by pharmacist in charge through
- Transfer of drugs to another person or entity authorized to possess
- Destroy by burning in an incinerator in compliance with all applicable local, state, and federal laws and regulation

For CII-V, must provide written notice to Board of Pharmacy at least 14 days in advance

Provide names of pharmacists
How may controlled substances be destroyed/ disposed of?
Burning in an incinerator in compliance with all applicable local, state, and federal laws and regulations

Transfer to another person or entity authorized to possess
What is an Opioid Treatment Program?
Special program recognized by the Substance Abuse and Mental Health Services Administration (SAMHSA under HHS) and the DEA for maintenance and detoxification of addiction

Practitioners and programs wishing to participate must apply for certification
How often must Opioid Treatment Programs be reaccredited and recertified?
Every 3 years

Applies to inpatient programs

Used DEA Form 363
What form is used for reaccreditation and recertificaiton for Opioid Treatment Programs?
Form 363
What substances may be used in an opioid treatment program?
ONLY methadone and levo-alpha-acetyl-methadol (LAAM) may be used for the purposes of alleviating the adverse physiological or psychological effects incident to withdrawal

maintenance treatment refers to dosages levels in excess of 21 days
How long is maintenance treatment for an opioid treatment program?
Dosage levels in excess of 21 days
How may a pharmacy dispense methadone?
Any pharmacy may dispense for analgesic use

Only pharmacies involved with OTPs may dispense for detoxification or maintenance of addiction

Physicians may administer a one-day supply outside of the treatment program
- may not prescribe these substances outside the treatment program
What supply of methadone may a physician administer outside of an OPT?
A one-day supply
What does the Drug Addiction Treatment Act refer to?
2000, Expands outpatient options available for the treatment of narcotic addiction

Qualifying physicians may prescribe and pharmacies dispense CIII-V opioids
- Must provide the appropriate information to HHS including DEA registration number, drugs to be dispensed or prescribed
- Must ensure that patients will be referred to appropriate counseling
- Practices may only treat 30 patients at any one time

HHS notifies DEA of decision within 45 days

2 drugs have been approved for this purpose (Subutex and Suboxone)
What are central fill pharmacies?
Pharmacies recognized by the DEA and VA to package and deliver patient specific prescriptions to another pharmacy to help manage the pharmacy's volume

Applicable to high volume pharmacies with a single owner

Must register with DEA to centrally fill controlled substances using Form 224

May fill both new and refill Rxs
What form is used to register to become a central fill pharmacy?
Form 224
What are the DEA requirements to become a Central Fill Pharmacy?
Retail pharmacy receives a prescription form a patient and sends the prescription to a second pharmacy for filling
- Pharmacies must be under contractual arrangement
- Central fill pharmacy fills prescription and sends it back to originating pharmacy - cannot provide directly to patient or practitioner
- Both pharmacies must maintain records of pharmacies involved with receiving or dispensing under a central fill arrangement
- Both pharmacies responsible for validity of prescriptions
- May contract with out-of-state pharmacies if both states allow central filling
What are the DEA requirements for tranferring a prescription to a central fill pharmacy?
Transmitting prescription information from originating pharmacy to central fill pharmacy
- All prescriptions, even controlled substance prescriptions may be faced form originating pharmacy to central fill pharmacy
- Originating pharmacy maintains hard copy and central fill pharmacy maintains faxed copy

Electronic transmission is permitted
- Only current situation allowing controlled substance prescriptions to be transmitted electronically
What is the only current situation that allows controlled substance prescriptions to be transmitted electornically?
Via a central fill pharmacy
What are Virginia's requirements for a central fill pharmacy?
Both retail pharmacy and central fill pharmacy must have the same owner OR have a written agreement specifying services and responsibilities of each pharmacy as well as a plan for compliance with federal and state laws an dregulations

Document must include:
- Prodedures for maintaining original copy and active prescription record
- Manner in which each pharma carries out responsibilities
- Procedures for tracking prescription at each phase
- Identification of all pharmacies involved on label of prescription
- Procedures fo rsecurity and confidentiality of patient information
- Procedures for accuracy and accountability of delivery
- Procedures for recording any unfilled prescriptions to original pharmacy
- Procedures for requesting patient consent for delivery and dispensing (if required by law)
What are Virginia's requirements for delivery of a prescription from a central fill pharmacy to a physician's office?
- Must provide a written contract with procedures for the transaction
- Must track accountability for the prescriptions
- Must ensure that patients receive the appropriate offer to counsel as defined by federal and state laws and regulations
What is the description of central or remote processing as part of Virginia's requirements for central fill pharmacies?
Originating pharmacy, not the secondary pharmacy considered dispensing pharmacy

Secondary pharmacy provides dispensing functions
- Receive, analyze, interpret, or clarify prescription information
- Enter prescription and patient data into computer system
- Transfer prescription information
- Perform prospective drug review (for potential drug interactions with existing drug regimen/ disease state)
- Obtain refill or substitution authorization
- Perform therapeutic interventions
- Provide patient counseling

Both pharmacists must ensure accuracy of prescription prior to dispensing
What are Virginia's record keeping requirements for a central fill pharmacy?
Paper files must be maintained individually by each pharmacy

If computer records used, then may maintain in a common electronic file shared by both pharmacies

Must be readily retrievable for at least 2 years through the dispensing pharmacy and available for Board inspection
What are the controlled substance recordkeeping requirements?
Inventory
Drugs received
Drugs dispersed
- Inadequate recordkeeping penalties include $10,000 per offense or 1 year inprisonment
- CII controlled substance records MUST be maintained separately from all other records
- VA allows CIII, IV, V to be maintained with CVI drugs but separate from all other records of the pharmacy

In VA, all records must be filed chronologically
What are the controlled substance inventory requirements?
Prior to opening a new pharmacy, must take a complete inventory of all controlled substances
- All subsequent controlled substances records will be recorded from the date of the initial inventory
- Pharmacies need only record the controlled substances currently on hand in the pharmayc and not on order or returned

In VA, when the pharmacis tin charge changes, the new PIC must conduct the inventory prior to business opening on first date as PIC
What are the controlled substance inventory recordkeeping requiremnts?
Pharmacies must maintain inventory at each location

Pharmacies must take a bieenial inventory on any date within 2 years of the initial inventory
- In VA, if an inventory is taken because of a theft of controlled substnaces, then it is considered the opening inventory within the biennial period
- Does NOT change the biennial period, only changes the amount on hand
What are the timing of inventory requiremnts for controlled substances?
DEA and VA require that inventory be taken either at the beginning of the day or close of business
- Must maintain records in written, typewritten, or printed format
- May take inventory using a recording device if promply reduced to writing
- VA requires that inventory records must be signed and dated by individual taking inventory and indicate whether inventory taken at opening or close of business
- VA requires 24hr pharmacies to document whether receipt of disposition of drugs on the inventory date occurred before or after time of inventory
What are the inventory requirements for newly scheduled controlled drug inventory?
DEA publishes information related to newly scheduled drugs in Federal Register
- Pharmacies must inventory those drugs effective on the date the scheduling becomes effective
How long must controlled substance records be maintained?
A period of 2 years at the place of registration
- VA requires 2 years to begin from date of recorded transaction
Where may chain pharmacies maintain controlled records?
At a central location if they notify the DEA
- This can include packing records, invoices, shipping records
- Individual patient Rxs, executed order forms, and pharmacy-specific inventory must remain onsite at a pharmacy
- Must notify DEA of the type of records maintained off-site, exact location where records are stored, registrant's name, address, DEA number, and registration type
- Method of storing records - computer or manual form
- Must be able to produce all or part of records within 2 days of receipt of a written request by the DEA
What type of records are chain pharmacies allowed to keep offsite (controlled substance records)?
Packing records, invoices, shipping records

Individual patient Rxs, executed order forms, and pharmacy-specific inventory can NOT be stored off-site
How must controlled substance inventory be counted?
CI or CII must make an exact count or measure of each substance in inventory

CIII-V may make an estimated count except for containers holding more than 1000 tablets or capsules - these require an exact count
What does the DEA require to be kept in controlled substances inventory records?
Name of substance
Dosage form and strength
Number of units or volume in each container and number of containers
Date of receipt
Name, address, and registration number of supplier
What does Virginia require to be kept for controlled substance inventory requirements?
Date of receipt
Name and address of person or entity drugs received
King and quantity of drugs received
Kind and quantity of drugs removed or produced from process of manufacture
Dates of production or removal from manufacture
What are Virginia's requirements for inventory upon loss or theft of controlled substances?
Must be immediately reported to the Board of Pharmacy
- DEA now has the same requirement

If unable to determine the amount of loss in CI-V, then must take an immediate inventory

Must provide the Board of Pharmacy information regarding the kind, quantity, and strength of drugs lost within 30 days
When must loss or theft of controlled substances be reported to the Board of Pharmacy and the DEA?
Within 30 days

Must provide information regarding the kind, quanity, and strength of drugs lost
What are the controlled substance prescription recordkeeping requirements?
DEA permits prescriptions for controlled substances to be filed in 1 of three ways

3 files:
- 1 for CII
- 1 for CIII, IV, and V
- 1 for all other non-controlled substances

2 files:
- 1 for CII
1 for II, IV, V, and non-controlled substances

2 files:
- 1 for all II-V controlled substances
- 1 for non-controlled drugs
What does the DEA require of pharmacies who don't use an electronic filing system in addition to hard copies for controlled substance prescription recordkeeping?
Must record information on controlled substance prescriptions:
- A stamp containing a red "C" no less than 1 inch high on the lower right hand corner of the prescription
- Only applies hwne non-controlled and controlled substances are filed together

Pharmacies that use an electronic prescription record are exempt from requirements above if:
- Prescriptions can be identified by serial number, prescriber, name, patient name, drug dispensed, and date filled
What must a prescription for a controlled substance include?
Full name and address of the patient
Name, address, and DEA registration number of practitioner
Date of issuance of prescription
Date of dispensing
Drug name, strength, and dosage form
Directions for use
Number or units of volume dispensed
Written or typewritten name or initials of individual dispensing prescription

VA requires prescription information to be on file for 2 years from date of initial dispensing
How long must a prescription for a controlled substance be kept on file?
2 years from date of initial dispensing
What must chart orders in hospitals and long-term care facilities contain for controlled substances?
DEA distinguishes between hospital chart orders and controlled substance prescriptions for residents of long-term care facilities and others

VA defines chart orders to include orders for patients in hospitals, long-term care facilities, hospice patients, and patients receiving home infusion services

VA exempts chart orders from some requirements of prescription BUT DEA requires that chart orders for CIIs contain all elements of prescription including presciber signature for non-hospital patients

VA allows chart order to serve as original prescription for individuals listed above
- DEA also permits so long as Rx requirements are met
- VA allows exemptions if documents are readily retrievable in pharmacy records and policies and procedures are in place to ensure compliance with regulations
How must a chart order for a CII substance be written/ stored?
Original chart order must be on file for CII and then copy must be placed in files for all other prescriptions
Under what conditions may automated data processing systems be used instead of manual recordkeeping?
VA allows automated data processing systems (computerized prescription records) to be used instead of manual recordkeeping requirements:
- Must maintain hard copies of prescriptions for 2 years pursuant to rules for recordkeping CII-VI Rxs
- However, if a pharmacy can produce a legible electronic exact image of a CVI prescription that can be made available within 48hrs, then this can be used in lieu of a hard copy
- VA allows electronic transmission of prescription information to serve in lieu of a hard copy for CVI prescriptions
- DEA does not permit electronic transmission of CII-V
- Must be able to print a hard copy and retrieve all historical information for at least 2 years
- Pharmacist must place initials on prescription and in the data processing system
How are Rx records stored when an automated data processing system is used?
Pharmacy may make a daily printout summarizing all transactions that occurred during the day and sign the printout
- Pharmacy may choose a log book in lieu of a printout signed by each pharmacist who dispensed prescriptions that day

Any printout must be made available to the Board of Pharmacy and others within 48hrs of request
What is the Combat Meth Epidemic Act of 2005 (CMEA)?
Established a new category of controlled drugs called schedule listed chemical products

Regulates retail distributors of products - not only phramcies - but everyone who sells the product
What is included in schedule listed chemical products?
PSE
Ephedrine
PPA
Other OTC drugs deemed as precursors to methampthetamine by the DEA
What are CMEA's requirements for sales?
Limits sales to 3.6g per day per purchaser or 9g per month at retail

Permits mail-order entities to ship products to consumers after confirming identity
- Limits total mailorder sales to 7.5g per month

All non-liquid forms of affected substances, including gel caps, must be in 2-unit blister packs

Limits do not apply to products written pursuant to a valid Rx
- Rx orders are permitted in any quantity
What are CMEA's requirements for product placement?
Must be behind a counter without ability of public to access
- Does NOT mean a pharmacy counter

Seller must deliver product to consumer
- Sales and delivery not restricted to pharmacy personnel
What are CMEA's requirements for the logbook?
Electronic or written and includes the following:
- Product name
- Quantity sold
- Name and address of purchaser
- Time and date of sale
- Notice to purchasers regarding the max penalties for providing false info - $250,000 fine and/or 5 years imprisonment
- Signature of purchaser

Sales of less than 60mg of PSE are exempt from logbook requirements

Must be maintained for a minimum of 2 years after date of entry

DEA may access logbooks
What are CMEA's requirements for employee training?
Seller must provide training program and self-certification must be on file

Program must include education on the need for purchaser to present ID, daily limits on sales, placement of affected products in store, and logbook requirements

DEA and state and local law enforcement may access training information