Transcript Food Drug and Cosmetic Act (Federal)

Controlled SubstancesGeneral Overview
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Harrison Narcotic Act
Marijuana Tax Act
Narcotics Manufacturing Act of 1960
Drug Abuse Control Amendments of
1965
• Comprehensive Drug Abuse
Prevention & Control Act of 1970
(current law)
Harrison Narcotic Act of 1914
• A law for the orderly marketing of opium, morphine,
heroin
• Small quantities OTC, large quantities Rx
• Stated that manufacturers, importers,
pharmacists, and physicians prescribing narcotics
should be licensed to do so
• Made opioids difficult to obtain and users flocked
to physicians and hospitals for drugs
Marijuana Tax Act of 1937
• Goal was to eradicate marijuana use
• Cultivation or transfer of marijuana
was legal
• Tax = $1 per ounce
• Penalty for unauthorized transfer
was $100 per ounce
1965 Drug Abuse Control Amendments
• Enacted to deal with problems caused
by abuse of three dangerous drugs:
depressants, stimulants, and
hallucinogens.
• There was rampant recreational drug
use in the 1960’s.
Controlled SubstancesGeneral Overview
• Drugs that are subject to abuse
• “Controlled substances” or “scheduled
drugs”
• Federal Comprehensive Drug Abuse
Prevention & Control Act of 1970 (current
law)
• Also called the “Controlled Substance Act”
• Establishes a “closed system” for
manufacturing, distributing, and dispensing
Controlled Substance Act
• Administered by the Drug Enforcement
Administration (DEA)
• DEA replaced the Bureau of Narcotics and
Dangerous Drugs (BNDD)
• Medical use of controlled substances
regulated primarily by Board of Pharmacy
• DEA more concerned with criminal use
CSA Addresses
• Rehabilitation under community mental
health programs
• Research in medical treatment of drug
abuse & addiction
• Import and export of controlled
substances
• Title II-The Controlled Substances Act
administered by DEA/US Dept. of Justice
Authority for Scheduling
• Given to Federal Gvt by CSA
• State Gvt, BofP, can make a drug more
restrictive than Federal law
(i.e. ephedrine, carisoprodol,
pseudoephedrine)
• Fed and State Gvt must publish intent to
schedule (i.e..., Fed Register, Oregon
Bulletin, BOP mailings to licensees)
Schedules of Controlled Substances
• See 21 CFR 812 and OAR 855-080
• Schedule I-high potential for abuse or no
medical use or lack of information on use
• Schedule II-high potential for abuse, has
medical use, abuse may lead to dependence
• Schedule III-less abuse potential than I or
II, has medical use, lower potential for
dependence
Schedules of Controlled Substances
• Schedule III may not contain more than
certain amounts of narcotics (Abood p 149)
• Schedule IV - Low potential for abuse
relative to I, II or III., has accepted
medical use, abuse may lead to limited
problems
• Schedule V-Cough medicines, anti-diarrhea
preps containing codeine or diphenoxylate
Medical Marijuana in Oregon
• Must be an Oregon resident to be a registered patient in
the Oregon Medical Marijuana Program (OMMP).
• Must have a qualifying debilitating medical condition as
listed on the Attending Physician's Statement.
• Physician must be a Medical Doctor (MD) or Doctor of
Osteopathy (DO) licensed to practice medicine in Oregon.
• Must have an established patient/physician relationship with
your "attending physician." Naturopaths, chiropractors, and
nurse practitioners cannot sign the documentation.
• OMMP cannot refer you to a physician. The OMMP does not
have a physician referral list.
Medical Marijuana in Oregon
• Must list a grow site address on application. You, or your
designated primary caregiver, may grow your own medication.
There is no place in the State of Oregon to legally purchase
medical marijuana.
• The OMMP cannot find a designated primary caregiver for
you. The OMMP does not keep a referral list of persons who
want to be caregivers for patients. (You are not required to
list a caregiver, unless you are less than 18 years old.) Your
caregiver cannot be your physician.
• The OMMP cannot supply you with seeds or starter plants,
or give you advice on how to grow medical marijuana.
• The application fee cannot be waived. Partial payments
cannot be accepted.
Treatment Programs
• The term detoxification treatment means the
dispensing, for a period of time as specified below, of a
narcotic drug or narcotic drugs in decreasing doses to
an individual to alleviate adverse physiological or
psychological effects incident to withdrawal from the
continuous or sustained use of a narcotic drug and as a
method of bringing the individual to a narcotic drugfree state within such period of time.
• The term maintenance treatment means the dispensing
for a period in excess of twenty-one days, of a narcotic
drug or narcotic drugs in the treatment of an individual
for dependence upon heroin or other morphine-like
drug.
Controlled Substance
Registrant Protection Act of
1984
• Requires a Federal investigation if:
– theft of CS > $500 in value
– death or injury occurs
– Interstate of foreign commerce involved
in crime
• Increased penalties for robbing a
pharmacy
Chemical Diversion and Trafficking
Act of 1988
• To decrease manufacture of controlled
substances
• 20 chemicals and tablet/capsule machines
placed under Federal control
• Manufacturers must verify legitimacy of
their customers
• Must maintain records of transactions and
report to DEA
Anabolic Steroids Control Act
of 1990
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Lots of abuse of anabolic steroids
Placed into C-III
“Performance enhancing”
Severe health hazards to athletes
who use them
• Penalties for distribution, possession
• The law hasn’t slowed abuse…
– See: Barry Bonds, Balco, etc.
Comprehensive Methamphetamine
Control Act of 1996
• Regulates the OTC sale of ephedrine,
pseudoephedrine, and phenylpropanolamine
• These are handy “precursor” chemicals for
cooking methamphetamine
Ephedrine
Pseudoephedrine
Methamphetamine
Registration
• Those who manufacture, distribute or
dispense a controlled substance must
register with DEA and Oregon Board
of Pharmacy
• Exemption: Employee of registrant,
common carrier or employee of
wholesaler, patient
Registration-Individual
Practitioners
• Physician (MD/DO), DDS, DVM, NP,
ND, PA, pharmacies, not pharmacists
• Physicians employed by a hospital
that do not have their own DEA
number may use the hospital’s DEA
number.
Activities that Require
Registration
• Manufacturing, distribution, dispensing, research,
instruction, narcotic treatment, chemical analysis,
import, export, compounding related to narcotic
treatment programs.
• Pharmacies may distribute CS to other
practitioners (i.e. another pharmacy) without
registering as a “distributor”.
• Amount of CS may not exceed 5 % of all CS
dosage units purchased that same year.
Application for Registration
• Must register with DEA and Oregon
Board of Pharmacy
Record Keeping
• Conduct physical inventory every year in Oregonmust keep records for 3 yrs.
• Perpetual inventory of C-II required in
institutional drug outlets (hospitals, LTCF)
• Separate inventory required for each drug outlet
(i.e., a chain like Fred Meyer)
• Inventory date-any time within the time period
• Drugs Received-invoices and 222 DEA Order form
(C-II)
– C-III-V use invoices to document purchases
– C-II-Use DEA Form 222-can’t transfer C-II using a Rx
from a prescriber
222 Order Forms
1. Prepared by purchaser in triplicate.
2. One item on each numbered line
3. No. of items ordered noted in space
provided
4. For each item show: drug name;
dosage form (tab…), strength,
quantity in container, no. of
containers
222 Order Forms
5. Name and address of supplier
6. Signature of Purchaser
7. Date
8. Submit copies 1 and 2 to supplier,
file copy #3 in pharmacy
222 Order form
• may be obtained and executed only by
person whose authorized signature appears
on original DEA registration form
• If forms are lost, notify DEA and Board.
• Power of Attorney. Authorized person can
legally delegate authority to sign DEA C-II
forms
• New for 2005 – online CS ordering!
222 Order Forms-Misc..
a. no corrections allowed
b. no cancellations
c. no NDC numbers
d. fill in all information legibly
e. valid for only 60 days
222 Order Forms-Misc..
f. supplier must deliver merchandise to
address on order form
g. maintain third copy for 3 years
h. indicate quantity and date received
on 3rd copy
i. supplier sends 2nd copy to PDX
Office of DEA at end of each month
Dispensing Controlled
Substances
• Drugs Dispensed
– Prescription records
– Invoices if you sold controlled drugs to
another registrant (MD or pharmacy)
– DEA 222 order forms if you sold a C-II
drug to another registrant
– Keep all records for three years
Filing Prescriptions
Filing Systems - two options
1. 3 separate files
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one for C-II, one for C-III-V, one for
non-CS drugs
2. 2 files
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one for C-II, one for all others
CS Files: From CFR
• Each registered manufacturer, distributor,
importer, exporter, narcotic treatment
program and compounder for narcotic
treatment program shall maintain
inventories and records of controlled
substances as follows:
• (1) Inventories and records of controlled
substances listed in Schedules I and II
shall be maintained separately from all of
the records of the registrant; and
CS Rx Files: From CFR
• (2) Inventories and records of
controlled substances listed in
Schedules III, IV, and V shall be
maintained either separately from all
other records of the registrant or in
such form that the information
required is readily retrievable from
the ordinary business records of the
registrant.
Hospitals and Institutions
• Record of Drug disposition is the
Medication Administration Record
(MAR)
• Daily profile with administration time
– indicates medication dispensed, when it
was administered, and who administered
it
Disposal or Destruction of
Controlled Substances
• Retail and Hospital pharmacies must
return outdated, adulterated,
misbranded, controlled substances
(“Reverse Distributor”)
Prescriptions-Definition
• An order for medication which is dispensed
to or for an ultimate user but does not
include an order for medication which is
dispensed for immediate administration to
the ultimate user.
• MAR in a hospital, LTCF is not a Rx
• Practitioner can’t write a Rx for Controlled
Substances for office use
Who Can Prescribe
Controlled Substances?
• Practitioners who are registered with
the State and DEA
• MD, DO, DVM, DDS, NP, PA, ND
• Office staff can call in a Rx C-III-V.
Does not have to be the Doc.
• Doc can call in a C-II in emergency
only - must have copy of original to
pharmacy in 7 days
CS Rxs- Requirements
• Must be dated when issued - can’t pre or post date
– (see BofP Newsletter August 2003 - #348)
• All CS Rxs must have: Date written, Date
dispensed, Pt name, Pt address, Drug name, Drug
strength, Dosage form, Quantity prescribed,
Quantity Dispensed (if different), SIG, Prescriber
name-address-DEA Number and if C-II the
Prescriber signature.
• RPh initials if C-III-V, “VOID” if C-II, initials of
Person taking Rx over the phone if different than
dispenser, initials of person counseling patient-on
separate log
CS Rx-Purpose of:
Found in: 21 CFR 1206.04
1. Legitimate medical purpose
2. By a qualified practitioner
3. Acting in usual course of practice
• Rxs for narcotic detox takes a separate
DEA registration
• Oregon Death with Dignity Act
– (We will discuss Oregon Death with Dignity Act later in
the quarter!)
C-II Rxs-Emergency Definition
• Immediate Administration of the drug is
needed
• No alternative drug will work, including a
non C-II drug
• Practitioner can’t reasonably get Rx to the
patient
• Under these conditions, some prescriber’s
phone in C-II Rxs for cancer pts, other
unusual situations
Example of Emergency
Dispensing
• Patient with terminal cancer runs out
of morphine liquid on Friday evening.
MD is out of town, but calls pharmacy
with a prescription.
– Is this an “emergency” dispensing?
– When must the pharmacy receive
written Rx?
– How much would you dispense?
Emergency C-II Dispensing
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Only in an emergency situation, as defined by
the Food and Drug Administration, may a C-II
prescription be transmitted verbally by the
practitioner, and it must be transmitted
directly to the pharmacist.
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The practitioner must identify the situation
as an emergency, and the pharmacist must
document the emergency on the prescription
with the phrase, “Authorization for
Emergency Dispensing.”
Emergency C-II Dispensing
• The quantity dispensed is limited to an
adequate amount to cover the emergency
period.
• Within seven days, the prescribing
practitioner must provide a written
prescription, signed by the practitioner, to
the pharmacy to cover this emergency
dispensing. File them together.
FAXing C-II Prescriptions
• A faxed C-II prescription signed by
the practitioner is acceptable in
LTCF, hospice, or home infusion
settings.
• Do not need original – FAX serves as
original Rx
Partial Filling of C-II
• You can partially fill a C-II if you are
unable to fill the entire Rx (i.e....,
don’t have enough medication)
• Must fill balance within 72 hours
• Can partial fill on patient request, but
remaining quantity is voided
C-II Rxs Partial Filling
• You can partially fill C-II Rxs for LTCF,
terminally-ill, or hospice patients
• Must contact prescriber first
• Prescription is valid for up to 60 days
• You must record the date, quantity
dispensed, quantity remaining, and initials
for each dispensing
• Must note “LTCF” or “terminally-ill” on Rx.
Dispensing Limits
• C-III-V Drugs are limited to 5 refills or 6
months, whichever occurs first
• Rx starts to age the day it is written
• No time limits on filling C-II Rxs in CFR
– RPh must judge validity/”context”
• C-II Rxs can’t be refilled, except as noted
• Non-CS Rxs are good for one year
Transfer of C-III-V Refills
Between Pharmacies
• Pharmacies with real time-on line systems
• Can transfer CS Rxs as long as valid refills
remain
• Must transfer all refill information each
time
• Rx must be voided from transferring
pharmacy
C-II - Changes to Rx
• Only after contacting prescriber:
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dosage form (tablet/capsule/suspension, etc)
patient address
drug strength
drug quantity
directions for use
• See Board of Pharmacy Newsletter
11/2000 (No. 302) … no longer online!
RPh Signature on CS Rx
• Full signature of filling RPh required
on face of C-II Rx
• RPh must “cancel” C-II Rx
– usually with a diagonal line through face
of Rx
• Initials on C-III-V (same as non-CS)
How to Validate a DEA
Number-AS1234563
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1+3+5=9
(2 + 4 + 6) x 2 = 24
9 + 24 = 33
Last numbers must match
Last name of practitioner is second
letter
Mailing of Drugs
• Can mail any drug (including C-II-V)
via US Postal Service, UPS, Fed Ex,
or other common carrier.
• Package generally not identified as
from a pharmacy!