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43 Cards in this Set
- Front
- Back
Controlled substances can only be prescribed by individual practitioner who is both:
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-authorized in the state in which licensed to practice (state law)
-either registered or exempt from registration under the CSA (fed law) |
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Controlled substances can only be dispensed by a pharmacist who is both:
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-licensed by a state in which practicing of controlled substances
-registered individually or employed by registered pharmacy or registered institutional practitioner |
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Corresponding responsibility doctrine can be violated by the:
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-issuer
-person knowingly (pharmacist had to know that there was a problem) filling improper prescription are both subject to penalty |
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Corresponding responsibility doctrine:
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-verification is not enough; consider other factors
-treatment of pain -treatment of addiction |
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Dispensing sched II controlled substances
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-must have written prescription signed by an individual practitioner
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Types of per se violations
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-Price fixing
-Boycotting -Tying Arrangements |
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An unnecessary drug is any drug when used:
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-in excessive dose (inc duplicative therapy)
-for excessive duration -W/o adequate monitoring -W/o adequate indications -In the presence of adverse consequences that indicate the dose should be reduced or d/c -Any combination of these reasons |
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Schedule I:
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-High potential for abuse
-No currently accepted medical use in treatment -Lack of accepted info on safety of use -The medical marijuana dilemma (illegal fed treatment preempts legal state treatment) |
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Schedule II:
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-High potential for abuse
-Currently accepted med use in treatment or currently accepted med use with severe restrictions -Abuse may lead to severe physical or psychological dependence |
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Schedule III:
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-Potential for abuse is less than I or II
-Currently accepted medical use in treatment -Abuse may result in moderate or low physical dependence or high psychological dependence |
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Schedule IV:
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-Low potential for abuse relative to III
-Currently accepted medical use in treatment -Abuse may lead to limited physical or psychological dependence relative to III |
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Schedule V:
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-Low potential for abuse relative to IV drugs
-Currently accepted medical use in treatment -Abuse may lead to limited physical or psychological dependence relative to IV |
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The Controlled Substances Act consists of three titles:
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I- establishes rehabilitation programs for drug abusers
II-provides for the registration and distribution of controlled substances (applies to pharm practice) III- addresses the importation and exportation of controlled substances |
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The secretary and attorney general must base the ultimate decision on these factors:
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-Actual or relative potential for abuse
-Scientific evidence of its pharm effect, if known -The state of current scientific knowledge regarding the drug or other substance -Hx 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 |
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Registration for manufacturers and dispensers:
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-1 year
-3 years |
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The CSA specifically allows the following persons to possess controlled substances without registration:
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-An agent or employee of any registered manufacturer, distributor, or dispenser of any controlled substance if such agent or employee is acting in the usual course of business or employment
-A common or contract carrier or warehouseman, or an employee thereof, whose possession of the controlled substance is in the usual course of his business or employment -An ultimate user who possesses such substance for a lawful purpose |
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Activities that require registration:
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-Manufacturing sched I-V
-Distributing sched I-V Reverse distributing of controlled substances -Dispensing sched II-V controls or instructing -Conducting research with sched I-V -Conducting a narcotic treatment program (inc a compounder) using any narcotic drug listed in sched II-V -Conducting chemical analyses with controlled substances -Importing or exporting controls |
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Dispense means:
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to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, inc the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery
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Practitioner means:
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A physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed...
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Registration for chain stores:
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Need a separate registration for each store even though they are part of a chain.
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Dispensers need to fill out:
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DEA form 224
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Manufacturers, distributors, and narcotic treatment programs must fill out:
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DEA form 225
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The following info must be included if the registrant wants to D/C the business by transferring it to another person:
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-The name, address, registration number, and authorized business activity of the registrant D/C business and that of the person acquiring the business
-Whether the business activities currently registered will be continued at the present address or at another specified address -Whether the transferor has a quota to manufacture or procure any controlled substance in sched I or II -The date on which the transfer of controlled substances will occur |
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The attorney general may deny a practitioner-applicant a registration to dispense controlled substances if it is determined that the registration would not be in the public interest. Attorney general must consider:
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-The recommendation of the appropriate state licensing board
-The applicant's experience -The applicant's conviction record with respect to controlled substances -The applicant's compliance with applicable state, fed, or local laws -Any other conduct by the applicant that may threaten the public health and safety |
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A registration to manufacture, distribute, or dispense controlled substances may be suspended or revoked by the attorney general on the finding that the applicant:
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-Has materially falsified any application
-Has been convicted of a felony relative to controlled substances -Has had a state license or registration suspended, revoked, or denied |
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When evaluating whether the overall security system of a registrant or applicant is adequate, the DEA may consider any of the following:
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-They type of activity conducted
-They type and form of controlled substances handled -The qty of CS handled -The location of the premises -The type of building construction and its general characteristics -They type of vault, safe, and secure enclosures or other storage system -The type of closures on vaults, safes, and secure enclosures -The adequacy of key control systems or combo lock control systems -The adequacy of electronic detection and alarm systems |
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Security system evaluation by the DEA (con'd)
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-The extent of unsupervised public access to the facility, inc the presence and characteristics of perimeter fencing, if any
-The adequacy of supervision over employees having access to manufacturing and storage areas -The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel -The availability of local police protection or security personnel -The adequacy of the system used for monitoring the receipt, manufacture, distribution, and disposition of CS. |
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Storing of Sched I CS
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Must be securely locked in a cabinet
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Storing of Sched II-V CS
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-Individual practitioners must handle in the same manner as I
-Pharmacies and institutional practitioners may disperse throughout stock in manner that will obstruct theft and diversion -Persons whose registration has been denied or revoked may not be employed in position that allows access to CS |
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Nonpractitioners must store CS:
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-Sched I and II in safe
-Sched III, IV, V in stingently secured area |
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Theft or loss of CS:
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Must be reported to the DEA
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Penalties from Distributing or dispensing in violation of CSA:
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- If with knowledge or intent, criminal penalty of up to 1 year in prison, up to $25,000 fine, or both
-If negligent, civil penalty of up to $10,000 |
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Order form 222 violation:
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-For Sched I and II
-If with knowledge and intent, criminal penalty of up to 4 years in prison, up to $30,000 fine, or both |
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Drug trafficking offenses:
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-Practitioners are not immune from being prosecuted as drug traffickers.
-It shall be unlawful for any person knowingly or intentionally- 1. To manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense a CS 2. To create, distribute, or dispense, or possess with intent to distribute or dispense, a counterfeit substance |
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Criminal vs Civil penalty
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Criminal- knowing or intentional
Civil- negligent |
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Illegal possession:
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Section 844. Applies to everyone while the others apply to RPhs. Prohibits any person form knowingly or intentionally possessing a CS, except persuant to a valid Rx. Penalty for first time violators: 1 year in prison and/or a fine up to $1000. Possession of cocaine carries a much higher risk.
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State Board Discipline:
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RPhs prosecuted under the CSA are also subject to disciplinary proceedings by the state board of pharmacy. Licenses could be revoked or suspended, but also could be subject to a fine, depending on state law.
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4th amendment protects individuals from unreasonable search and seizure and thus requires a warrant:
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-Requires a probable cause
-Failure to obtain a warrant can result in exclusionary rule, barring evidence from being used in court against defendant |
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DEA inspections under CSA:
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-DEA may enter and inspect places where persons are registered under CSA or where controlled substances records are kept
-Inspector is first req to state purpose of inspection ans present credentials and written notice of inspection to owner or PIC -Informed consent in writing from owner or PIC |
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Consent requirement. Inspector must obtain and owner or PIC must sign. The statement must include:
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-There is a constitutional right to refuse the inspection until an admin inspection warrant has been obtained
-Any incriminating evidence found may be seized and used against the owner or PIC in a criminal prosecution -A notice of inspection has been presented -The consent is voluntary and not coerced -The consent may be w/drawn at any time during the course of inspection |
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An administrative inspection warrant (AIW) must contain:
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-The name and address of the premises to be inspected
-A statement of the statutory authority for the warrant -A statement as to the nature and extent of the inspection inc, when necessary, a request to seize specific items -A statement that the premises either have not been previously inspected or were last inspected on a particular date |
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Exceptions to an Administrative Inspection Warrant:
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-The inspection is an initial inspection of a new pharmacy for licensure purposes
-The records are ordered pursuant to an administrative subpoena -The owner has given informed consent -The situation presents an imminent danger to the public health and safety -It is an exceptional or emergency situation where obtaining a warrant would be impractical bc of lack of time or opportunity to obtain one -It is a situation where a warrant is not constitutionally required |
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It is a situation where a warrant is not constitutionally required. Examples include:
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-When the search is made incident to a lawful arrest
-When the inspection is limited to areas of the commercial premises open to the public -When the evidence is in plain view- providing that the officer is legally in a place the officer should be and inadvertently sees the evidence |