Download Chapter 27 Controlled Dangerous Substances

Chapter 27 Controlled
Dangerous Substances
Jeffery D. Evans, Pharm.D,
Associate Professor of Pharmacy
Practice
Objectives
• At the end of this presentation the student
will be able to:
– Apply various aspects of controlled substance
law to practice
– Understand the interaction between the
Federal CSA and the board rules for LA
– Know which agents are in which class
Chapter 27
• Purpose
– Regulate multiple aspects of Controlled
Dangerous Substances
– Impose penalties for failing to comply with
them.
• Impact on pharmacy practice
– In most areas significant. Nuclear for
example is zero.
Definitions (2701)
• Important ones (I think)
– Central Fill Pharmacy
• A pharmacy that fills other pharmacies medications
– Controlled Dangerous Substance or Controlled
Substance
• Any substance deemed an CDS by the Federal or State CSA
– Dispense or Dispensing
• Deals with controlled substances here, but says the same
thing.
• <note must be labeled for use by the patient or caregiver>
Definitions (2701)
• Dispenser
– Notice that the word ‘pharmacist’ does not
appear here
• Persons
– Not just humans. Any Entity is considered a
person
• Practitioner
– Allowed to ‘prescribe and administer’ CDSs
Definitions (2701)
• Prescription or Prescription Drug Order
– Must be patient specific.
• Sales Representatives or Professional
Medical Representatives
– Employed by a manufacturer to transfer CDSs
to other CDS registrants.
What is a schedule? (2703)
• This section is verbatim from the LA CSA
and the US CSA
– Defines what makes a substance get
scheduled
– Defines what schedule a substance will fall
into
What words mean inside the
scheduling (2703)
• ‘Stimulant effect’
– Extended wakefulness, Elation, Alleviation of
fatigue, irritability, flight of ideas, loquacity
• ‘Depressant effect’
– Calming Effect, sedation, mood depression,
increase pain threshold, disorientation
• ‘Habit-Forming’
– Compulsive use, Chronic brain syndrome,
personailty changes, dependence
What words mean inside the
scheduling (2703)
• ‘Hallucinogenic effect’ – Alteration of
– Orientation in time or place, motor
coordination, ideation (flight of ideas)
• ‘Potential for abuse’
– People take a substance in amounts that may
be harmful
– Diversion of the drug from proper channels
– Patients want to take it without medical
advice.
– Drug contains or is related to a known CDS
CDS Licensure (2705)
• Every person who
any
controlled substance
–
–
–
–
Manufactures
Distributes
Prescribes
Dispenses
• Every person who
proposes to engage
in the
any
controlled substance
–
–
–
–
Manufacture
Distribution
Prescribing
Dispensing
CDS Licensure (2705)
• Who is exempt from registration?
– Workmen for the company
• Not sales reps*
• Contract carriers
• Warehouseman
– Person who possesses a CDS pursuant to a
valid prescription
– People located on the site of a licensed entity
• researchers
CDS Licensure (2705)
• Practitioners who must register
– Must have another license before the CDS
– May have one CDS for their prescribing, but
must have individual licenses for each of
their sites.
• If only one site, only need one license for
practitioner and site
– Physicians in possession of a medical license
and a CDS license may prescribe marijuana
for authorized therapeutic reasons.
CDS Licensure (2705)
• Pharmacies
– Must be licensed by
the board of pharmacy
– CDS license only valid
at the address on the
license
– Different location =
Different license
• Manufacturers and
distributors
– Must be credentialed
by the appropriate LA
licensing body
– Outside folks need a
CDS if transporting
inside the State
CDS Licensure (2705)
• Researchers
– Must have Institutional
Review Board
Approval for a trial
– Reviewed by board to
determine if elgible
• Drug Reps
– Must show proof of
employment if carrying
and delivering CDSs
I would like a license, how do I
get one? (2707)
• Application to BOP
• ONE CDS license per
applicant per location
• Can not fax in or
submit non-complete
applications
• If not licensed by
other board, must
submit to a
background check
• CDS license is good
for one year
• If you have a
temporary license,
you get a temporary
CDS license
I have a CDS license, how do I
keep it (2707)
• Complete the form and pay the fees
• Must be renewed prior to the expiration
date.
• May not fax
• If expiration date is past, the licensee may
not act as if they have a CDS license
• If expired for 30 days, the license dies
You took my license, may I
have it back (2707)
• If late renewal
– Pay late fees + registration
• If expired for
– < 1year an administrative assistant may renew
– 1 – 5 years the board member in charge of CDS may
renew
– >5 years full board hearing required
• If taken due to loss of other license, other license must
be reinstated
• Application for reinstatement secondary to board
punishment, must occur to the full board
What if circumstances change?
(2707)
• CDS license is only good for the person
who it was issued to
– All changes of location must be provided
within 10 days
– If you need a new license (printed), you will
pay for it
– A CDS license is not transferable
• New ownership needs a new CDS license
Do they have to approve my
application? (2709)
• Short answer, no
– Must be denied ‘for cause’
• Any CDS issues is cause
• Even if you surrender and plead not guilty, they still
have cause
So I messed up, what can
happen? (2711)
• This is rehash of Chapter 3, thus will cover
there
– However, full range of punishments may
occur including permanent licensure
revokement
What will the board inspector be
looking for when he stops by? (2713)
•
•
•
•
•
•
•
•
•
•
Type of activity conducted
What CDSs are handled
Quantity of CDS handled
Location of licensee
Type of building and characteristics of building
Type of storage area (vault)
Adequacy of security systems
Who enters the premises (public)
Local police protection
Documentation
Stuff not so interesting to us
(2715)
• This section deals with storage
requirements not of a pharmacy.
• Interesting to read, but not directed at
Pharmacy
How do I store controls in a
pharmacy? (2717)
• Schedule I
– Always in a locked, substantial cabinet
• Schedules II, III, IV, and V
– Store in a securely locked, substantial cabinet
– May disperse such substances throughout the stock
of non-controlled substances … as to obstruct theft or
diversion of the CDS
• People with felonies related to CDSs are not allowed
near CDSs in a pharmacy
• Significant loss or theft must be reported
within 1 day
– How is a significant loss determined
significant?
•
•
•
•
•
•
Actual quantity
Agents lost/stolen
Is the loss tied to an individual
A pattern of loss over a time period
Are the drugs candidates for diversion
Local trends and other indicators for diversion
DEA Form 106 must be used to report loss
What if some stuff is missing?
(2717)
What if a central fill pharmacy
loses it? (2717)
• Rule is
– Whoever is contracted with the carrier, is
responsible for filing the loss/theft paperwork
• Example
– JoeBob contracts with JimBob trucking to pick
up scripts from LarryBob’s Central fill
pharmacy. A truck done went and got
hijacked on the way from LarryBob’s to
JoeBob’s. Who reports the loss?
No, not important (2719)
• Deals with freight forwarding facilities
– I assume life FedEx or UPS
Are there questions you should
ask of new employees? (2721)
• Yep!
Within the past five years, have you been convicted of a felony, or
within the past two years, of any misdemeanor or are you presently
formally charged with committing a criminal offense? (Do not include
any traffic violations, juvenile offenses or military convictions, except
by general court-martial.) If the answer is yes, furnish details of
conviction, offense, location, date and sentence.
In the past three years, have you ever knowingly used any narcotics,
amphetamines or barbiturates, other than those prescribed to you by
a physician or other authorized prescriber? If the answer is yes,
furnish details.
Symbol required on all controlled stock
bottles (2723,2725,2727)
CI or C-I
CII or C-II
CI or C-III
CI or C-IV
CI or C-V
* If bottle too small, it does not need to appear
Bottles must be tamper
evident
Schedule I Schedule II Schedule III Schedule IV Schedule V -
Must appear large enough to
notice when walking by.
• If controlled, the commercial bottle must
have the schedule symbol on it*
Exporting and importing (2729)
• Not really important to pharmacy
• Deals with manufacturers
What records should I keep for
CDSs? (2731)
• Practitioners are required to keep records
for all CDSs which are dispensed
– Not if they are prescribed or administered
– They are required if prescribed for detox or
maintenance of addiction.
– If they charge for administered or dispensed meds,
they must document.
– Midlevels must keep documentation of what they may
prescribe
– Records must be kept in English, or a translator must
translate within 72 hours if requested.
How should I store my CDS
records? (2731)
• All records should be kept for at least two
years
• Records can be kept at a central location
– If financial or shipping
– Executed order form can not be kept at a
central location
– If you use special equipment, you must
provide the investigator with that equipment
• Prescriptions and prescription records are
special
How do I store my prescription
records? (2731)
• Records
– Dealing with CI or CII must be stored in a different
place than other records
– CIII, CIV, or CV must be stored in a different location
than other records
• Prescriptions must be stored in one of the
three following ways?
– A ‘C’ in red ink of at least 1 inch in height stamped in
the lower right corner
– Have a CII, CIII – CV, and a non-controlled file
What about records dealing with
central fill pharmacies? (2731)
• Pharmacy must have information about each
central fill pharmacy (CFP) it uses including
– Name
– Address
– DEA Number
• Pharmacy must also document that it verifies
the registration of the CFP
• The CFP must do the same for the
pharmacies it serves
Should I complete an inventory?
(2733)
• Inventories must be in hard copy
– If electronic, then print
– If oral, then transcribe it
• Initial Inventory date
– Occurs when the business first handles CDSs
• Biennial Inventory
– Every one, but PHARMACY, must do an
inventory every OTHER year
• Pharmacies must do them yearly!
Any other times to do a CDS
inventory? (2733)
• YES!
– Change in Pharmacist in Charge
• When old one leaves AND
• When new one starts.
– Substantial Loss of CDS
• Theft
• Lost
– Closure of the Pharmacy (Permanent)
What should I count? (2733)
• Schedule I or II
– Exact counts
• Schedule III – V
– If container has less than 1k doses in it
• Guesstimate
– If container has 1k or more doses in it
• EXACT COUNT ONLY!
What must be recorded? (2733)
• All of the following data must be kept in
the official, written inventory
– Name of substance
• Not specified if Brand or Generic is expected
– Finished form of the substance
• e.g 10 mg tablets, 4 mg capsule
– The number of units in each bottle
• 100 count bottle with 30 tablets in it
– The number of commercial containers
• 3 100 count bottles
Continuing Records (2735)
• An odd little section
– Copies verbatim from Federal CSA
– But, most of the material was covered in 2733
– Adds section dealing with Compounders for
Narcotic Treatment Programs
• Requires few extra requirements
• Few pharmacists fall into this regulation
– GHB dispensers
• Again limited people do this
• Adds a requirement that you have proof the prescriber
may prescribe GHB
Is there anything else I should
know about reports? (2737)
• Yes, most of this deals with manufacturers
• Provides exception to ‘institutional
practitioners’ who repackage
– Meaning?
• Most likely hospitals to allow them to not have to
do all the paperwork required
How do I know if I have had a
significant loss of a CDS? (2737)
• Consider these
– Actual quantity lost in relation to type of business
– The specific agent lost
– Can the loss be tied to a specific activity or
person
– A pattern of losses over a time period
• Random patterns?
• Results of trying to stem losses
– Is the drug likely gonna be diverted
– Local trends for diversion
What do I do if I decide the loss
is significant? (2737)
• Notify
– New Orleans Field Division Office of the DEA
– Board of Pharmacy
– WITHIN ONE BUSINESS DAY!
• Also submit to the NOFDO DEA
– A 106 form
• Loss should be reported even if they are
recovered.
Manufacturing of CDSs (2739)
• This section does not apply to pharmacy
practice
– Strange that the Board of Pharmacy regulates
industry
• Be careful when compounding not to be
classified as a manufacturer (more on that
elsewhere!)
Distributing CDSs (2741)
• Note dispensing is not distributing
– So most pharmacies do not need to comply
• However, the ‘five percent rule’ may
change that
– If you sale (trade, or give) 5% or more of your
annual amount of any CDS. You are a
distributor and must register as one
I would like to buy some CDSs,
how do I make this happen? (2743)
• Schedule I or II
– Require 222
– Duplicate copies must be retained at least
two years
– Central fill to retail pharmacy is exempt
– Electronic 222 is cool
• Unique number assigned by purchaser (9 digits)
• First two are year, then X, then six unique
characters
– 11X928S29
What about ordering CIII – CV
• Requires recordkeeping
– But no specific form
– BUT, whatever you order from must include
•
•
•
•
•
Name, Address and DEA license of supplier
Name of CDS
Dosage form and strength
Amount
When recieved
Who can prescribe controlled
substances? (2745)
• Duly registered, licensed
– Physicians
– Dentist
– Veterinarian
– Physician Assistant (no CII, only per protocol)
– Advanced Pract Reg Nurse (only per protocol)
– Optometrist (no C-IIs)
– Medical psychologist
What can a controlled substance
be prescribed for? (2745 B)
– A prescription for a controlled substance shall
be issued for a legitimate medical purpose
ny an individual practitioner acting in the
usual course of his professional practice.
– The responsibility for the proper prescribing of
controlled substances rests upon the
prescribing practitioner; however, a
corresponding responsibility rests with the
pharmacist who dispenses the prescription
Emphasis from Dr. J. Evans, not BOP
What can a controlled substance
be prescribed for? (2745 B)
• If it is not for a legitimate medical purpose
AND
• A pharmacist knowingly fills the
medication
– Bad things can happen
• Can not be written for ‘office supply’ or
‘office use.’
What about detoxification
programs?
• Only FDA approved CIII – CV can be used
for outpatient detox supplied by a
pharmacy
– Only Suboxone/subutex meets this
requirement
– Methadone written for detox can not be filled
by a retail pharmacy
What needs to be on a CDS
Rx? (2745 C)
•
•
•
•
•
•
Must be dated (for date written)
Full name AND address of patient
Drug name, strength, and dosage form
Quantity of drug prescribed
Directions for use
Name, address, telephone number and
DEA number of prescriber
– If for suboxone must have suboxone DEA
number
What about prescribers without
a DEA number? (2745 C)
• Hospital interns/residents
– Use hospital DEA PLUS unique ID for
prescriber
• Military Personnel
– Use his service ID number
Is there a format that must be
used for CDS RXs? (2745 C)
• Written Rxs
– Must be on a slip no smaller than 4 x 5 inches
– Must be in ink or indelible pencil
– Must clearly indicate who prescribed the
medication
– May have a max of four rxs on one script
– There needs to be a pre-printed ‘Dispense as
Written’ or DAW box
– Refill information must be present
– Printed signature line with manually signed by
prescriber
What if it is an oral prescription?
(2745)
• Not for CIIs (well not here at least)
• Must be communicated to the pharmacist
by an agent or employees of the
prescriber.
• Pharmacist will write the order down as
soon possible
• All requirements for information of a
written Rx must be present
Who can dispense CDS
prescriptions? (2745 D)
• A pharmacist at a pharmacy (not any
where else)
• Physician, dentist or veterinarian
– If they do, the CDS must be procured
correctly
Administering Narcotic Drugs
(2745 E)
• Not really directed at Pharmacists
– But impacts the validity of a script
• Practitioners may administer or provide
directly, but may not prescribe a narcotic
drug for detox or maintainance
– Except as noted before
Can you fax a CII? (2745 F)
• A prescription may be faxed if a written rx
is turned in for the fax. However
– If the patient is in a long term care facility, the
fax serves as the original
– If the medication will be compounded and
administered directly to the patient by the
prescriber
– If the patient is in hospice, the pharmacist
must right on the fax that the patient is a
‘hospice patient’
Can you phone in a CII? (2745)
• Yes, if it is an emergency and meets the
following
– Quaintly is limited to the emergency period
– Is immediately reduced to writing
– Physician ID is verified (to best of ability)
– Within 7 days, the physician must provide a
written Rx for the emergency
• If not received by the pharmacist, DEA must be
notified
• Pharmacist will attach written rx to oral/written rx
Electronic Prescribing of CIIs
(2745)
• More later
• Being implemented by the DEA, board just
says ‘whatever they say, we are cool with.’
Is there a maximum day supply
for a CII? (2745)
• Um, no, but, well sort of
– Generally recognized as 90 days
• Fed CSA does not have a limit
• In LA, a practitioner may write 3 rxs for a
total of 90 days
– Must all be dated with the correct written date
– Two of them must have do not fill before dates
• All CII scripts die after 6 months
Can I refill a CII? (2745)
• No
• You may partial fill them (More on this
later)
How can C-III – CV be provided
to a pharmacy? (2745 G)
• Written
• Phone
– Must be communicated to a pharmacist
• Fax
– As long as the fax is of the completed written
prescription
– Must originate from practitioner’s office
– Counts as an original
• Electronic
– Once DEA provides and implements rule set
Can a CIII – CV be refilled?
(2745)
• Yes
– For up to a total of 6 fills (5 refills)
• DEA has clarified ‘partial fills’ don’t count
– No longer than 6 months after original date
• Prescriber can put other limits.
– If no refills noted, then 0 refills authorized
Are there special rules for faxed
in CDSs? (2747)
• Yes
– Fax must be located in pharmacy
– Must be on non-fading paper with non-fading
ink
– ID of prescriber must be clear on fax
Can a pharmacist alter a CII?
(2745)
• Pharmacist may record on RX
– Patient’s address
– Drug strength
– Quantity prescribed and directions for use
• Pharmacist may add (without prescriber)
– Patient’s address
– Drug Dosage form
– Prescriber’s DEA registration number
Can a pharmacist alter a CII?
(2745)
• A pharmacist may NEVER add/record
– Patient’s name
– Date of issue
– Drug name (generic replacement ok)
– Prescriber Signature
When is a partial fill of a CII ok?
(2745)
• Partial fills are ok when
– Normal patients pick up all of the medication
with 72 hours of initial fill
• Or lose remainder
– Long-term care facility patient or ‘terminally ill’
patients.
•
•
•
•
Notation must be on script
Must fill entire amount within 60 days
Can not dispense more than what was written for
Each partial fill must be noted on the original script
Do all records of CII partial fills
have to be written? (2745)
• No, they may be kept by computer if
– If the computer can keep all required
information and is queryable
– If computer under goes realtime updates
•
•
•
•
•
•
•
•
•
Name, address, and telephone of pharmacy
Prescription number
Date of dispensing
Prescribing practitioner’s name
Patient’s name
Drug name and strength
Directions for use
Pharmacist’s name or initials
Federal warning
These also apply to CIII - CV
What information must be on a
dispensed CII label? (2745)
Do I have to cancel a CII
prescription? (2745)
• Yes
– On the front of the RX ‘deface’ the script
– Place name or initials on the front of RX
How do I document a CII if a
central fill pharmacy fills it? (2745)
Prescription info may be sent electronically to the central fill pharmacy
• Pharmacy must
– Write CENTRAL FILL on
the Rx
– Record Name, address,
and DEA number of the
pharmacy. Date of
transmittal
– Maintain original for at least
2 years
– Document receiving the
filled Rx
• Central Pharmacy must
– Keep copy of Rx (electronic
or whatever)
– Keep record of date
received, pharmacist
dispensed, and date
dispensed
– Keep date delivered and
how sent.
How do I document refills for a
CIII – CV (2745)
• Depends
– If you don’t have a computer
• You must write each refill on the back of the
original Rx
– If you do have a computer
• You must be able to query the computer for refills
– The pharmacy must print out all control refills
daily
• And have all pharmacists sign it
• If not, they must keep a log book and log EACH
CDS dispensed
Are there any special requirements for
institutionalized patients (2745)
• Yes
– May not dispense more than a 34 day supply
or 100 dosage units (whichever is less)
– End user can not possess medication
Do CIII – CV prescriptions have
to be cancelled? (2745)
• Yes and no
– No they don’t need to have a line drawn
through them
– Yes they MUST have the dispensing
pharmacist’s name or initial
Can a CIII-CV be transferred?
(2745)
Yes, one time and the following must be documented
• Transferring pharmacist
must record
– Invalidation of script
– On the back of the script,
name, address DEA
number of other pharmacy.
Name of pharmacist
– Date of transfer, name of
pharmacist giving transfer
Both pharmacies must maintain
script for at least two years after
last refill
• Receiving pharmacist
must record
– That RX was a transfer
– All information required to fill
rx (Drug name etc)
– Name, address, telephone,
DEA number of other
pharmacy
– Date of original RX
– Original number of refills and
number left
– Date of original fill
– Names of pharmacist
transferring RX
Can a pharmacist dispense a CDS
without a prescription? (2745)
• Certain C-Vs are available for OTC
dispensing
– Can only be sold by a pharmacist
– Must be recorded in a bound record book that
includes
•
•
•
•
Name and address of purchaser
Quantity and name of CDS
Date of purchase
Name ore initials of pharmacist
– Central fill pharmacies may not do this
What are the responsibilities of a pharmacist
when dealing with CDSs? (2745)
• Primary Responsibility
– Drug diversion
– Possession
• Any deviation in CDSs will be blamed on the PIC,
owner, and/or other parties
• Corresponding Responsibility
– Medical purpose
– Authenticity
• Forged prescriptions
• Altered prescriptions
How do I dispose of a CDS?
(2749)
• Complete a DEA 41 and submit it to the Special
Agent in Charge in his area
• Special agent in Charge will advise to do one of
four things
–
–
–
–
Transfer to a licensed person for disposal
Deliver to a DEA agent or to a DEA office
Destruct the CDS in the presence of an agent
Whatever the DEA agent says
• If disposal occurs regularly, the agent may issue
an umbrella approval.
May I loan some CDSs to
another pharmacy (2751)
• Yes
– If CII a DEA 222 must be filled out with you as
the distributor
– Remember the five percent clause
– CIII – CV can be done without a DEA 222
• Some record of transfer should be kept
• All controls must be accounted for
What actions can the board take to enforce
the CDSs rules? (2753 – 2757)
• Inspections
• Seizures
• Hearings
Conclusions