Term
| Dispensing SIII, IV, V Controlled Substances |
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Definition
| May be dispensed pursuant to a written, faxed or oral prescription that contains appropriate information; no electronic prescribing allowed |
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Term
| Refills for CIII or IV prescriptions |
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Definition
refilled up to 5 times within 6 months of the date of issuance; Restrictions do not apply to CV drugs under DEA requirements BUT
(VA permits CV controlled substances to be refilled 5 times in six months) |
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Term
| VA Requirements for CVI Prescriptions |
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Definition
Prescribers must authorize refills either orally or on face of prescription; Pharmacists may refill CVI 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 AND
Document of quantity, date, prescriber unavailability, and rationale for refill must be recorded on back of rx drugs) |
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Term
| How long can CVI Rxs be refilled |
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Definition
| CVI prescriptions may only be refilled for one year after issue date unless prescriber indicates otherwise on face of prescription |
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Term
| Partial Filling of CIII, IV, V |
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Definition
| Partial filling permissible so long as it meets requirements of refills; No dispensing after six months of issuance |
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Term
| Nonprescription Schedule V Dispensing |
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Definition
| Must be dispensed by pharmacist only; 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 quantity of preparation, name and address of person to whom preparation is dispensed |
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Term
| Nonprescription Schedule V Requirements for dispensing |
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Definition
240 ml or 48 dosage units of any controlled substance containing opium; In VA, NMT 200 mg of opium
NMT 120 ml or 24 dosage units of other controlled substance |
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Term
| VA requirements for Nonprescription Schedule V |
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Definition
| 270 mg of codeine; 130 mg of dihydrocodeinone; 65 mg of ethylmorphine; 32 5/10 mg of diphenoxylate |
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Term
| Transferring Prescription Information for Refill Purposes |
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Definition
Pharmacies may transfer prescription information with other pharmacies for refill purposes for schedule III, IV, V prescriptions on a one-time basis
(DEA and VA 18 have same requirement) |
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Term
| Information Required on Transferred Prescriptions for transfering pharmacy |
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Definition
Write void on face of invalidated rx;
Record on the back of the invalidated rx the:
Name,
Address,
DEA registration number (for SIII-V only; not on SVI) of pharmacy where rx transferred,
Name of pharmacist receiving information,
Date of transfer and name of transferring pharmacist |
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Term
| Requirements for pharmacy receiving transfer |
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Definition
Write transfer on face of transferred rx;
Record all required information on SIII-VI rxes 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 pharmacist,
Pharmacy name, address, DEA number (for SIII-V not for SVI) an prescription number originally filled |
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Term
| How long should records be kept for pharmacy receiving transfer? |
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Definition
| Records must be kept for 2 years from date of last refill |
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Term
| Label Requirements for CII, III, IV, V, VI |
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Definition
CII 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, III, IV must include caution related to transfer others than the person prescribed |
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Term
| Automated Dispensing Systems (ADS) in LTC Facilities |
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Definition
ADS now permit stocks of controlled substances to be maintained at the LTCF with a computerized system directly linked to a pharmacy (to tract every dispensed controlled drug);
Unused dosage forms can be dispensed to another patient |
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Term
| Which form is used for the Disposal and Destruction of Unwanted or Outdated Controlled Substances? |
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Definition
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Term
| What must be included on DEA Form 41? |
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Definition
| name of drug, content of container and each drug that will be disposed or destroyed, date and method 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 (must be submitted at least two weeks in advance - VA and DEA reqs); Pharmacy may request destruction once each calendar year |
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Term
| What VA reqs on DEA Form 41 in addition to other reqs? |
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Definition
In VA must provide place of destruction; witnesses - In VA, must be 2 pharmacists, including pharmacist in charge and a non-employee pharmacist; Must be initiated by pharmacist in charge (PIC) through:
Transfer of drugs to another person or entity authorized to posses;
Destroy by burning in an incinerator in compliance with all applicable local, state, and federal laws and regulations |
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Term
| DEA will then inform registrant the proper procedure in disposal and destruction of controlled substances |
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Definition
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 |
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Term
| Opioid Treatment Programs |
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Definition
DEA does have authority over OTPs, you have to register with dea (pharmacist and practitioners)
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Practitioners and programs wishing to participate must apply for certification;
OTPs reaccredited and recertified every 3 years;
Applies to inpatient programs;
Use DEA Form 363;
Only use 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 |
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Term
| Pharmacy Dispensing of Methadone |
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Definition
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 (INPATIENT) |
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Term
| Drug Addiction Treatment Act expands outpatient options available for treatment of narcotic addiction; Qualifying physicians may prescribe and pharmacies dispense CIII, IV, and V opioids - must provide what info? |
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Definition
Do not have to regiser but 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;
Two drugs have been approved for this purpose Subutex and Suboxone |
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Term
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Definition
Pharmacies recognized by DEA and VA to package and deliver patient specific prescriptions to another pharmacy to help manage pharmacy’s volume;
Applicable to high volume pharmacies with a single owner or pursuant to a contract with pharmacies without common ownership; May fill both new and refill rxes |
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Term
| Central Fill Pharmacies must fill out what form? |
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Definition
| Must register with DEA to centrally fill controlled substances using Form 224 |
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Term
| DEA requirements for Central Fill Pharmacies |
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Definition
Retail pharmacy receives a prescription from a patient and sends the prescription to 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 |
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Term
| Transmitting prescription information from originating pharmacy to central fill pharmacy |
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Definition
| All prescriptions, even controlled substance prescriptions may be faxed from originating pharmacy to central fill pharmacy; Originating pharmacy maintains hard copy and central fill pharmacy maintains faxed copy |
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Term
| Electronic transmission permitted for Central Fill Pharmacies |
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Definition
| Only current situation allowing controlled substance prescriptions to be transmitted electronically!;Originating pharmacy must follow all other DEA rules involving initial prescriptions |
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Term
| VA Requirements for Central Fill Pharmacies |
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Definition
| 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 and regulations |
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Term
| VA Requirements for Central Fill Pharmacies - Delivery of prescriptions from a pharmacy to a physician’s office |
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Definition
| Must provide a written contract with procedures for the transaction |
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Term
| VA Requirements for Central Fill Pharmacies - Description of central or remote processing |
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Definition
| Originating pharmacy, not the secondary pharmacy considered dispensing pharmacy |
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Term
| Controlled Substance Recordkeeping Requirements |
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Definition
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 |
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Term
| Controlled Substance Inventory Requirements |
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Definition
Pharmacies need only record the controlled substances currently on hand in the pharmacy and not on order or returned;
In VA, when the pharmacist in charge (PIC) changes, the new PIC must conduct the inventory prior to business opening on first date as PIC; Pharmacies must take a biennial inventory on any date within 2 years of the initial inventory - In VA, if an inventory is taken because of a theft of controlled substances, then it is considered the opening inventory within the biennial period
(DOES NOT CHANGE THE BIENNIAL PERIOD, ONLY CHANGES THE AMOUNT ON HAND) |
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Term
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Definition
| DEA and VA require that inventory be taken either at beginning of the day or close of business; VA requires 24 hour pharmacies to document whether receipt or disposition of drugs on the inventory date occurred before or after time of inventory; PIC is in charge of insuring inventory is correct |
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Term
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Definition
| DEA and VA require that inventory be taken either at beginning of the day or close of business; VA requires 24 hour pharmacies to document whether receipt or disposition of drugs on the inventory date occurred before or after time of inventory; PIC is in charge of insuring inventory is correct |
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Term
| Newly scheduled drug inventory |
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Definition
DEA publishes information related to newly scheduled drugs in Federal Register;
Pharmacies must inventory those drugs effective on the date the scheduling became effective |
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Term
| Controlled Substance Recordkeeping Requirements must be maintained for how long? |
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Definition
In general, most controlled substances regulations must be maintained for a period of two years at the place of registration;
VA requires 2 years to begin from date of recorded transaction;
Chain pharmacies may maintain some records at a central location if they notify DEA (Must be able to produce all or part of records within 2 days of receipt of a written request by DEA) |
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Term
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Definition
| make an exact count or measure of each substance in inventory |
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Term
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Definition
| make an estimated count except if for containers holding more than 1000 tablets or capsules which require an exact count |
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Term
| VA requirements for maintaining records of controlled substance inventory |
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Definition
| in addition to all else also reqs Dates of production or removal from manufacture |
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Term
| VA requirements for inventory upon loss or theft of controlled substances |
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Definition
Must be immediately reported to Board of Pharmacy;
(Now DEA has same requirement);
If unable to determine amount of loss in SI-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 |
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Term
| DEA permits prescriptions for controlled substances to be filed in 3 one of three ways |
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Definition
3 files (One for SII, One for III, IV, V, One for all other non-controlled substances)
2 files (One for SII, One for III, IV, V and non-controlled substances)
2 files
(One for all II-V controlled substances,One for non-controlled drugs); VA requires that SIIs be maintained separately (does not allow option 3) |
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Term
| DEA requires that pharmacies NOT using an electronic filing system in addition to hard copies record the following information on controlled substance prescriptions |
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Definition
A stamp containing a red “C” no less than one inch high on the lower right hand corner of the prescription
(Only applies when non-controlled and controlled substances are filed together) |
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Term
| VA requirements for prescription information to be on file? |
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Definition
| for two years from date of initial dispensing |
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Term
| Chart orders in hospitals and long-term care facilities |
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Definition
Note 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 SIIs contain all elements of prescription including prescriber 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 met; VA allows exemptions if documents are readily retrievable in pharmacy records and policies and procedures in place to ensure compliance with regulations |
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Term
| Chart orders in hospitals and long-term care facilities |
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Definition
Chart orders for a SII and other controlled and SVI controlled substances permitted
; Original chart order must be on file for SII and then copy must be placed in files for all other prescriptions |
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Term
| Rx Records Stored in Automated Data Processing Systems |
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Definition
VA allows automated data processing systems (computerized prescription records) to be used instead of manual recordkeeping requirements subject to the following requirements: Must maintain hard copies of prescriptions for two years pursuant to rules for recordkeeping Schedules II-VI prescriptions;
However, if a pharmacy can produce a legible electronic exact image of a SVI prescription that can be made available within 48 hours 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 SVI prescriptions;
DEA does not permit electronic transmission of SII-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 |
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