Controlled Substances Flashcards
Who established a “closed” system for manufacturing, distributing, and dispensing controlled substances?
CSA- controlled Substances Act
Criteria used for determining schedule/class of a drug product: (8)
- Actual/relative potential for abuse
- Scientific evidence of it pharmacological effect
- State of current scientific knowledge
- History and current pattern of abuse
- Scope, duration, and significance of abuse
- Risk to the public health
- Physiological or psychic dependence liability
- Whether the substance is an immediate precursor of a substance already controlled
How many control classes/schedules are provided by the CSA?
5
Class/Schedule I (3)
- High potential for abuse
- No currently accepted medical use in treatment in the US
- Lack of accepted information on safety of their use, even under medical supervision
Class/Schedule II (4)
- High potential for abuse
- accepted medical use in treatment in the US
- currently accepted medical use with severe restrictions
- Abuse may lead to severe physical or psychological dependence
Class/Schedule III (4)
- Potential for abuse but LESS than that of drugs listed in Schedules I or II
- Current ACCEPTED MEDICAL use in treatment in the US
- Abuse may lead to moderate or low physical dependence o
- HIGH psychological dependence
Class/Schedule IV (3)
- Potential for abuse but less than Schedule III
- Current ACCEPTED MEDICAL USE in treatment in the US
- Abuse may lead to LIMITED physical or psychological dependence
Class/Schedule V (3)
- Potential for abuse but less than Schedule IV
- Current ACCEPTED MEDICAL USE in US
- Abuse may lead to LIMITED physical or psychological dependence
How can Manufacturers, distributors, and dispensers legally posses and dispense controlled substances in the scope of your profession?
must register with the DEA
T/F? Practitioners and mid-level practitioners CAN prescribe controlled substances WITHOUT registering with the DEA.
-false - CAN NOT - - they must register with DEA
How many DEA forms are there?
4
What type of DEA form is needed for dispensing controlled substances?
DEA Form 224
What type of DEA form is needed for Manufacturer, Distributor, Importer, Exporter or Researcher?
DEA Form 225
What type of DEA for is needed Narcotic Treatment Programs? (i.e. Methadone clinic)
DEA Form 363
When must the DEA have notice of change? (3)
- Modification: name or address change
- Transfer: registrant dies, legal existence ceases, professional practice discontinues, or business is sold -Termination:registrant dies, legal existence ceases, or professional practice discontinues
DEA number is a?
9-character code consisting of 2 letters and 7 digits
Physician DEA number:
First character for physicians is “A”, “B” or “F”
Mid-level practitioners DEA number:
First character for mid-level practitioners is “M”
Distributors DEA number:
First character for distributors is “P” or “R”
T/F? The second character of the DEA # is usually, ALWAYS, the first letter of the registrant’s last name.
false -NOT always
How to verify DEA numbers? (3)
- Step 1: Add 1st, 3rd, and 5th digits
- Step 2: Add 2nd, 4th, and 6th digits and multiply times 2
- Step 3: Add Step 1 and Step 2…the right most digit of this step MATCHES the 9th character
Which digit of Step 3 must match the 9th charter of the registrants DEA number?
right most digit
Exemptions to DEA Registration? (3)
- Agent or employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment
- Common or contract carrier or employee of, whose possession of the controlled substance is in the usual course of business or employment
- Ultimate user (PATIENT) who possesses the controlled substances for a lawful purpose
T/F? Pharmacists employed by a registered pharmacy or institution DO NOT have to register individually?
-false - DO have to
What form must be used in order to purchase controls?
DEA 222
“Paper” DEA Form 222 is a _________ form.
triplicate
What must be signed and dated by the authorized registrant or Power of Attorney?
“Paper” DEA Form 222
Which triplicate copy of the “paper” DEA 222 Form must be submitted to the “supplier”
Attorney Copy 1 (Brown) and 2 (Green)
The Supplier keeps ______ and forwards ______ to the DEA?
-copy 1 -copy 2
T/F? Any modifications made on the DEA 222 form makes in VALID if corrected?
-false - ANY modifications/write overs make the form VOID
Which copy of the “paper” DEA 222 Form is kept by the “purchaser”?
-Copy 3 (Blue)
The number of containers received and the date(s) received are recorded on which copy?
Copy 3 (Blue)
T/F? Transfer of Schedule I or II drugs from one registrant to another requires the use of DEA Form 222
-true - i.e.- sale of controls between two pharmacies
Exceptions to filling Orders using DEA 222? (5)
- Pharmacist discontinuing a pharmacy
- Registrant’s registration is expiring and they are not re-registering
- Registrant is returning product to the supplier
- Registrant authorized to conduct chemical analysis or research and is distributing the product to another authorized analyst or researcher
- Registered compounder of narcotic substances for use at an off-site narcotic treatment program
When can a DEA Form 222 NOT be filled? (3)
- Incomplete, illegible, or not properly prepared, executed or endorsed
- Altered (erasure or changed in any manner)
- An order form that is incorrect may NOT be corrected → A new order form must replace it
If an order is NOT filled for any reason, the supplier must do what?
return Copies 1 and 2 to the purchaser with explanation
Who may legally engage in these activities concerning the Contolled Substance Act?
Only those registered with the Drug Enforcement Agency (DEA)
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 AKA
AKA “Controlled Substance Act” (CSA)
What was created in 1973 replacing several different federal agencies?
Drug Enforcement Agency (DEA)
Who is charged with administering all parts of the CSA (control substance act)?
DEA
Who must coordinate activities with the FDA since controlled substances are drugs and subject to the FDCA?
DEA
Who does the DEA work closely with?
state boards of pharmacy
What if controlled substance violations are found during a routine pharmacy investigation?
the state board informs the DEA
Two types of controlled substances are?
Narcotic and Non-narcotic
T/F? NON-NARCOTIC drugs are natural or synthetic OPIUM OR OPIATE AND ANY DERIVATIVE
-false -NARCOTIC
Who may administer, dispense, and prescribe controlled substances under the registration of the hospital or institution?
Individuals acting in the normal course of business or employment
The criteria the hospital/institution must meet for individuals administering, dispensing, and prescribing controlled substances under the registration of the hospital or institution? (4)
- verification of the practitioner is permitted to dispense, administer, or prescribe within the jurisdiction
- authorization for the practitioner to dispense, administer, or prescribe under the hospital registration
- designates a specific internal code for each practitioner
- current list of internal codes and corresponding practitioners made available at all times to other registrants and law enforcement agencies for verification of prescribing authority
When must a certificate of registration be returned to the DEA with any unexecuted order forms, inventory disposed of in accordance with DEA requirements?
When TERMINATION occurs
T/F? The second character of the DEA # is ALWAYS, the first letter of the registrant’s last name.
-false -usually, BUT NOT ALWAYS
What is required for each sale or transfer of a Schedule I or II controlled substance?
A DEA Form 222 or its electronic equivalent
What does the Supplier do as it pertains to the DEA 222 Form? (3)
- completes the order
- records the number of containers furnished and the date shipped
- keeps Copy 1 and forwards Copy 2 to the DEA
What does the Purchaser do as it pertains to the DEA 222 Form? (2)
-records on Copy 3 the number of containers received -records the date(s) received
T/F? Fulfillment of DEA 222 orders is allowed by registered manufacturers ONLY.
-false -manufacturers or distributors only
T/F? IF an order CANNOT be completely filled by the supplier, it MAY NOT be partially filled.
-false; it MAY be partially filled and the balance supplied by additional shipment within 60 days of the order form
T/F? The balance of a CII partial DEA 222 order must be shipped within 30 days?
-false -60 days
Exceptions to the rule that Fulfillment of DEA 222 orders is allowed by registered manufacturers or distributors ONLY: (5)
- Pharmacist discontinuing a pharmacy
- Registrant’s registration is expiring and they are not re-registering
- Registrant is returning product to the supplier
- Registrant authorized to conduct chemical analysis or research and is distributing the product to another authorized analyst or researcher
- Registered compounder of narcotic substances for use at an off-site narcotic treatment program
What does the purchaser do once they receive DEA Copies 1 and 2 back from a supplier that could not fill request? (2)
-Copies 1 and 2, along with the explanatory statement must be attached to Copy 3 and retained in the purchaser’s files -“VOID” is written on the incorrect/returned form when filed
What must happen when an item is CANCELED by the supplier on the DEA 222 Form? (2)
- the cancellation must be noted on Copies 1 and 2 by drawing a line through the item
- “Canceled” is written in the space provided for the number of items shipped
What must be reported immediately to the DEA?
Loss of any used or unused order forms by any purchaser or supplier
T/F? If an order goes unfilled because the DEA 222 form is lost, the purchaser must complete another form
true
T/F? Purchaser must prepare a statement with DATE of the lost form that indicates the good covered by the first order form were not received because the order form was lost.
-false -SERIAL NUMBER and DATE
When a DEA 222 Form is lost what happens with Copy 3 of the “second” order.
It along with the “lost” statement must be kept with Copy 3 of the “first” order form
What happens if the “first” order form (of a lost order form) is subsequently received?
the supplier must write “Not accepted” on the face of the form and return Copies 1 and 2 to the purchaser who must attach it to Copy 3
T/F? Suppliers retain Copy 3
false -Copy 1
T/F? Purchasers retain Copy 3
-true
T/F? All DEA 222 forms must be KEPT TOGETHER with all other records of the Registrant?
maintained separately from
T/F? Records must be kept for a minimum of 2 years?
-true
Who keeps copy 2 of the DEA 222 Form?
the DEA
CSOS - Controlled Substance Ordering System (2)
-Provides an electronic equivalent to DEA Form 222 -Permits but does NOT requires, registrants to order electronically and maintain electronic records
Advantages of using CSOS: (4)
- Greater Ordering Freedom: no maximum number of line items
- Faster Transactions:electronic “certificate” contains same identification information as DEA Form 22 which allows timely and accurate validation by the supplier
- Accurate Orders:reduces the number of ordering errors
- Decreased Cost:greater accuracy + decreased paperwork = lower transaction costs
T/F? Registrants who purchase controlled substances for the purpose of repackaging for the sale within the pharmacy or to other registrants, DO NOT HAVE TO register as a manufacturer.
false - MUST
Pharmacy may compound a controlled substance for “office use” so long as the product: (3)
- is an aqueous, oleaginous, or solid dosage form
- Final product does not contain >20% controlled substance
- is only distributed to a practitioner authorized to dispense
T/F? An individual practitioner registered with the DEA acting in the normal course of professional practice MAY NOT issue a prescription for a controlled substance for a legitimate medical purpose?
-false -MAY
Responsibility for proper prescribing and dispensing lies where?
upon the prescribing practitioner with corresponding responsibility rests with the pharmacist who fills the prescription
What is NOT a prescription?
A prescription that is NOT issued in the usual course of professional treatment or part of legitimate and authorized research
Knowingly filling an unauthorized RX is violation of what?
Controlled Substance Act
When must practitioners be separately registered with the DEA?
In order to administer or dispense narcotic drugs in any schedule to a narcotic drug-dependent person for “detoxification treatment” or “maintenance treatment”
Physicians who are not registered with the DEA may do what? (3)
- administer narcotics for relief of acute withdrawal while arrangements are made for treatment
- MAY NOT administer more than a one day supply
- Emergency treatment may not extend for more than three days
