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

What if some stuff is missing? (2717)

• 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 D

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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)

• If controlled, the commercial bottle must have the schedule symbol on it*Schedule I - CI or C-I Schedule II - CII or C-IISchedule III - CI or C-IIISchedule IV - CI or C-IVSchedule V - CI or C-V

* If bottle too small, it does not need to appear

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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

What information must be on a dispensed CII label? (2745)

• 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 Th

ese

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CIII

- C

V

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

• 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

Both pharmacies must maintain script for at least two years after last refill

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