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142 Cards in this Set
- Front
- Back
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Predecessor to CSA |
Harrison Narcotic Act
only regulates narcotics |
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Harrison Narcotic Act
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before 1971
only regulates narcotics regulated by imposition of tax |
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CSA
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regulates manufacturing, distribution, dispensing, and delivery of drugs that are subjects to or have the potential for abuse or physical/psychological depnednece
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TITLE I
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of comprehensive drug abuse and prevention and control act
established rehab for drug abusers |
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TITILE II
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CSA
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TITLE III
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regulates export and import of controlled substances
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CSA
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replaced harrison in 1971
unlike harrison it also regulates narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in illicit mgf/products/controlled substances |
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DEA
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enforces CSA
unit of FBI w/ DOJ regulations found at 21 CFR Section 1300 et seq |
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Change a schedule of a drug
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21 U.S.C 811b
not easy but can be done by DEA considers the potnetial for abuse, pharmacological effect, scientific knowledge of drug's characteristics, scope, duration, and significance of abuse, risk to the public, psychic or physiologic dependence liability, and whether the substance is a precursor of existing CS |
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Scheduels
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CSA has 5
Mass has 6 - all drugs are controlled substances |
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Schedule I
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high abuse potential
no currently accepted medical use in US lack of accepted safety for use under medical supervision illegal |
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Schedule I Drugs
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heroin - psilocybin
propiram-tetrahydrocannabinl marjuana- benzyl mrophine LSD - dihyromorphine peyote - nicocodeine mescaline - nicomorphine MDMA/exctacy - methcathinone |
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Schedule I
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cannot be legally prescribed
need research registration to use US vs. Oakland Cannabis Buyers Cooperative 532 US 483 |
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Schedule II
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drug has currently accepted medical use in US
has high potential for abuse w/potential for severe psychological or physical depnedence |
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Schedule II Drugs
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opium morphine codeine hyromorphone
methadone meperidine cocaine and its salts oxycodone oxymorphone amphetamine methamphetamine mehtlyphenidate amobarbital pentobartial secobartial detropropoxyphene |
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drugs may be in different schedules depending on the dosage form
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tyenol w/codeine = CIII
davocent-N(propoxyphene and APAP) = CIII |
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Schedule III
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21 CFR 1308.13
drugs have abuse potential but iti is less than those of CII accepted medical use in US abuse of drug is dangerous and/lead to dependence |
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Schedule IV
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potential for abuse but less than other Cs
accepted medical use in US may result in dependence |
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Schedule IV drugs
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depressants (chloral hydrate)
PB meprobamates various benzodiazepine diethproprion (diet pill) phentermine |
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Schedule V
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low abuse potential
limited dependence codeine cough syrups/ lomotil accepted medical use in US |
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Schedule VI
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only Mass
all legend Rx ie amoxicillin, ibuprofen, sulfasazine |
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Registration
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individuals do not have to register w/DEA
residents/interns need DEA# each enitity needs to be registered separately |
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DEA 224
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whoever signs is liable if violation is prosecuted
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Dotterwich
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held laible for acts of underlings
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Entities exempt fro CSA registration requirements /DEA
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US military and public health service officials unless during private practice
service ID# instead of DEA# Rxs must conform w/ 21 CFR 1306.01-1306.32 certain law enforcement officials when procuring CS for possession during official duties CFR 1301.26 Civil defense or diaster relief agency officials during times of diaster or emergency proclaimed by president/congress |
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Labeling of CS
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commerical containers must be labeled to afford easy identification of the schedule of the CS w/o removal from dispensers shelf
substances rescheduled must be relabeled within 180 days from effective date of scheduling |
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Labeling of CS Federal Requirments
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name and address of pharmacy
patient's name Rx number date of dispensing name of prescriber directions for use cautionary statemnts CII/III/IV must also contain transfer warning |
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Labeling of CS State Requirments
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name of drug
quantity, strength expiration date pet rx must have owner's name and animal species RI law-label cannot be hand written & new NS cap executed w/every filling |
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CSA record keeping Federal
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sale
receipt dispensing deliveries other dispostion of CS |
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Inventory
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w/ initial registration and biennial inventory there after
have to count sealed unopened packages daily inventory not required maintain records of inflow and outflow of CS between inventories |
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Record Keeping
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if MD dispences must keep same records as Rx
intial and subsequent biennial inventories records of CS recipt/invoices records of dispensing and disposal of outdated CSs |
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Rx Records Must Contain
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name of CS
dosage form of CS strength/concentration/dosage unit amount of dosage units/container |
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Receipt Record must contain:
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# containers received
date of receipt name/address/DEA# of supplier commercial invoice ok |
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Dispensed Record must contain:
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# of unit or volume dispensed
name/address of person to whom drug is dispensed date of dispensing name/initials of Rph dispensing |
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Disposal of expired CS must contain
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# of unit disposed
# of containers disposed date method of disposal |
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DEA 41
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disposal form
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DEA 222c
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triplicate order form for purchase of C2s and official form and suffices as record of receipt for CII
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DEA 106
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lost/stolen Rx
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DEA 41
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expired drugs
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Inventory Records
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when 1st engage in practice
then every 2 years retain inventory documents for at least 2 years |
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Inventory for CI/CII
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exact count
All CS on hand which includes patient returns, in bins waiting for pickup, and expired units |
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Inventory for CIII/IV/V
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estimate count unless container holds 1000 tab/caps then exact count is required
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Inventory Formate
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name address, DEA # of pharmacy
date and time of inventory(opening/close of business) signature of person doing inventory statement original inventory is kept for 2 years statement that records for CII drugs are kept separately |
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Inventory
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forms must preserved for DEA review upon request
Name of CS, dosage form and unit strength, number of units/container, number of containers |
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Inventory Records for CS in Compounding
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name of CS in compound
total quantity Reason CS is maintained and if capable of being manufactured |
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Central Recordkeeping
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Even if use central record keeping executed order forms, Rxs, and inventories must be kept at the pharmacy
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Central Recording Keeping Invoice Requirment
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written notice in triplicate
sent to DEA w/ return receipt requested ID records to kept centrally w/exact location name/address/DEA#/type of DEA registration whether they will be computerized |
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Central Records
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14 days after receipt of notification by DEA, can begin to maintain central records unless it has been denied by DEA
Registrant must agree to provide central records within 2 days of requent or allow inspection @ central location without a warrent |
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Computerized Records
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readily retrievable
record every fill contain orginal Rx, Rx#,name,strenght, quanitity, dosage form, date, full name, address of patient, address/name/DEA# of MD, Rph initials, quanitity dispensed, total # of refills |
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Backup Documentation
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verified, dated, and signed by Rph
must be kept in separate fil for 2 years from dispensing date |
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DEA 106
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loss/ theft
executed in triplicate original kept in pharmacies copies to DEA name/address of pharmacy,DEA#,date of theft/loss, indicate if notified police, type of theft, list of symbols/cost code, list of CS missing |
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Substantial loss/theft of CS
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notify police
notify nearest DEA Diversion Office |
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Recording keeping
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CI/CII records must be kept spearately
readily retrievable |
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DEA 222
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legal distribution of CI and CIIs
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DEA 222d
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original order request form w/DEA registration form
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DEA 222b
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refill request
use after 222d(when you start a business) |
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DEA 222
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do not use out of sequence
forms must be accounted for keep voided forms signed by registrant/POA 1 item per line no erases/cross outs partial fill ok as long as balance is filled within 60 days no Rx of prn/for MDs offices transfer of CIII/IV/V as long as proper documentation |
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Partial Refills w/DEA 222
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partial refills as long as rest of Rx is obtained in 60 days
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Purpose of Issuance of Rx for CS
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legitimate Rx for CS must be for legitimate medical purpose by MD acting in course of professional practice
responsibility of proper prescribing and dispensing of CS is upon MD and RpH (document consulting MD about sketchy scripts) |
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Manner of Issuing Rx for CS
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agent may prepare but not sign Rx for MD
provision for emergency CII and MD does not need to sign agent cannot authorize approval but can communicate order Rx date and signed on date of issuance Rx has to have full name and address of patient name/strenght/dosage/form/qty/directions of drug and directions, name/address/DEA# of MD Completeness of Rx responsiblity w/MD and RpH |
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Electronic Rxs
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E sign law doe snot apply to CSA but does apply to recording keeping provisions
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Partial Filling of CII
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only if CII stock is insufficnet
note amount filled on Rx balance delivered in 72 hours( if can't then prescribed balance voided and must contacted for new Rx) written Rx unless emergency |
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Partial Filling of CII in LTCF
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only for terminally ill (ensured by RpH)
refilled within 60 days |
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Emergency PO Rx for CII
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amount limted to qty need to cover emergency period
need written Rx in 7 days or notify DEA Rx cannot be refilled!! |
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Refilling CS
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CIII/IV may be refilled up to 5-6 times in 6 months of the date of issuance
refilled authorized by MD NR = no refills some states limit to 34 day supply/120 (which ever is lower) |
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Sale of CS
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cannot be Rx drug
sale only by Rph limited qty been 48 hr. from last purchase 18 or older |
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Store Transfer CS Rx
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by state regulations
usually allowed once can do within same chain up to max by law no transfer of CII because NR! In state can fill 100 unites/5 refills |
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Methadone
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dispensed for pain at pharmacy
dispensed for detox at authorized facility can use CIII/IV/V for detox under linited conditions without registering w/DEA no more than 30 patients special DEA# Buprenorphine |
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DEA enforces CSA by
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inspection
seizure arrest powers |
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Recordkeeping violations
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max reduced from 25,000 to 10,000 per violation
up to 1 year in jail and 25,000 fine subsequent violation 2yr. in jail and 50,000 fine |
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Facsimile RX for CS
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hardcopy for CIII/IV/V authorized by state
CII can be faxed but not dispensed until hard copy unless CII is for IV,IM,IC,IS or home infusion pharmacy for LTCF |
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pharmacy inspections
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constitutional protection from unreasonable search and seizure
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Camara dn city of seattle
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expanded warrant requirement to include administrative actions
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Barlow
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expanded protection further to search warrent required when search of private property is conducted in commercial building
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Pharmacy inspections
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need warrant and for warrant need probable cause
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probable Cause
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specific articulable facts which lead to a reasonable person to believe that a crime has been committed or that the place to be searched will produce evidence of a criminal act
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Administrative Warrent
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easier to get buy limited in scope
issued only for use during business hours no forced entry |
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Traditional search warrent
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issue for day/night use
must announce presence before entering force entry allowed in exigent circumstances particularity requirement (say what your looking for) |
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US v. Enserro
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exclusionary rule: fruits of poisonous tree
search Rph's home evidence suppressed due to coerced consent |
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Inspections w/o warrants
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incident to lawful arrests
emergency exigent circumstances (need to preserve evidence) search limtied to public areas in plain view need consent |
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warrent exceptions
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congress can authorize inspection that are limited in time, place, and scope
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US vs. Biswell
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pharmacists have no expectation of privacy
state can review records |
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Stone v. City of Stow
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licensing exception in heavily regulated industry
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Marshall v. Barlow's
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businesses that are liscenced and extensively regulated
warrant less searches must be limited in time, scope, and place |
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Medicaid and Board of pharmacy
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implied consent for inspection
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FDA inspection
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rare
can be w/o warrant but must be limited in time, scope, and place |
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DEA inspection
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drug accountability audit
DEA notice w/ voluntary consent administrative warrant |
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OSHA inspection
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Administration warrent or consent (BARLOW)
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FDA inspection
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notice of inspection that is limited in time, scope, and place
cannot refuse FD 483 citation is serious can seize durgs |
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DEA inspections
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consent
notice of inspection DEA 82 can refuse and get a warrant adminstrative warrant chech credentials of inspector read document |
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DEA 82 forms
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right to refuse inspection w/owarrant
can withold consent w/o penalty anything found can and will be used against you present copy of form! consent can be withdrawn at anytime!!! |
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DEA issued warrent
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triggers miranda
silence not held agaisnt you statement can be suppressed if miranda not issued |
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Accountablility Audits
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at state and federal level
DEA is worst can result in criminal charges look for discreepancies w/CS State Board of Rx can do it too |
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Arrest
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taking into custody
reasonable belief not free to leave can arrest can search w/o a warrant |
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Detained
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temoporary restraint on liberty for questioning but person is free to go
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FDA Notice Inspection 482
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must allow access and challenge later
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DEA Notice Inspection 82
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can refuse access and mandate warrant obtained
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State board of RX
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administrative agency has power of all 3 branches of gov
powers specified by enabling statues civil and criminal powers suspend/revoke/withhold liscence criminal w/ state prosecuteros |
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Due process
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notice counsel
opportunity to be heard |
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Civil action
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no double jeopardy
can result in criminal charges |
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challenge administrative action
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get a lawyer
see if action exceeds authority by enabling statute, abuse of discretion, if action is arbitrarty or capricious, erroneous, violated due process |
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due process
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right to notice and opportunity to be heard
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Count can overturn administrative only if
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all administrative remedies have been exhausted, action exceed scope of enabling statue, erroneous, due process violation, arbitrary and caprious
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enabling statue
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agency's statutory authority
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declaratory judgment
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seek instructions relative to the right of the parties involved in judicial review
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Collateral Attack
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used to test authority or constitutionality of one ation in another action in judicial review
very risky |
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Equity
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nonmonatery relief such as inunctions, restraining orders, attachments
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judicial or governmental immunity
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protection of judicial officers from civil suit when acting within the scope of their authority
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pharmacy licence
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property right
cannot be taken away w/o due process |
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Civil law goal
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make whole
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Criminal law goal
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punish
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administrative law goal
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to protect public
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Civil liability
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can have criminal and administrative too
no double jeopardy |
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double jeopardy
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cannot be tried more than once for criminal charge
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Tort
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caused of action between people who have no formal relationship w/those who caused harm/injury
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Types of torts
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intentional
nelgigent strict liability |
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Intentional torts
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act to intent w/o consent
assault (civil) battery (civil and criminal) deformation (slander/libel) |
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Intentional Torts
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false imprisonment
invasion of privacy malicious prosecution breach of confidentiality intentional infliction of emotional distress trespass trespass to chattel/conversion |
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Negligent Torts
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most lawsuits based on negligence/malpractice
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malpractice
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professional negligence
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Need 4 elements for cause of action for negligence/malpractice
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duty
breach proximate causation harm/damages |
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duty and breach =
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negligence but w/o causation and harm no liability
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duty
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under obligation for the benefit of another person
established by common law statutes:FDCA, CSA, OBRA, HIPAA, POISON PREVENTION ACT |
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pharmacy
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held to error free standard
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Duty Standard of Care
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black letter rules
Rph must employ capable individuals, know purposed of drugs, properties, of drugs, not bound to fill at Rxs, have to do more than dispense correct drug |
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Harco v. Holloway
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RpH must take all necessary means to identity correct drug on Rx before dispensing
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Happel v. Walamart Stores
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Rbl prudent person standard does not apply RpH
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Riff v. Morgan
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duty to counsel expands RpH liability
duty to his brother's keepers |
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liability for product selection
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follow state law
labeling documentation beware subsituting OTC if harm occurs over Rx |
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Baker v. Arbor
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RpH standard of care raised by business
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recommendations
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not actionable
mistake in judgment does no = malpractice fine line |
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Nelgigence
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not refraining from what a prudent Rph would not do
refraining from what a prudent Rph would do do it incorrectly |
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ownership of RX
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patient until filled than federal and state law mandate it be retained by pharmacy
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Mechanical Errors
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wrong drug
correct drug but wrong strength wrong directions labeling errors |
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Baker vs. Arbor
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intellectual errors
failure to identity KDA interaction w/ Parnate and Tavist-D |
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Comparative Negligence
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if patient contributes to harm award reduced %
majority rule |
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Contributory Negligancy
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minority rule
patient contributed to harm than barred from recovery (seat belt) |
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Defenses to Nelgigence
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comparative and contributory nelgigence
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Malpractice Damages
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compensatory
punitive wrongful death wrongful birth |
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Malpractice defences
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independent intervening cause
comparative and contributory negligence statue of limitations assumption of risk improper parties sealed container doctrine |
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Strict liability
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liablilty w/o fault
intent is irrelevant product is dangerous |
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warranty
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involves sale of good
can occur w/strict liability |
