Notes on controlled substances through disposal (Sec 1307.21)
The Closed System of Controlled Substance Distribution
Controlled Substances Act 1970Administered by DEA part of Justice Department
Classified
drugs according to schedules
establishes
closed system of drug distribution
Part 1301
Definitions-
Pages 8-10 supplement
(11) Dispenser
(17) Individual practitioner
(18) Institutional practitioner
(28) Midlevel practitioner
(33) Pharmacist
(35) Prescription
Persons Required to register
Practitioners -
MDs. DDSs
-Pharmacies, Wholesalers
(1301.11) Page 13
-Individual
pharmacists exempt
(1301.22) Page 20
-Note
exemptions for hospital or individual practitioners (1301.22) Page 20
Page
107
Separate registration for independent activities. 21USC Sec.822
Separate registrations for separate locations.(1301.12)
Exemption of agents and employees; affiliated practitioners.(1301.22)
Exemption of certain military and other personnel.(1301.23) Page 21
1301.71 Adequate Security Page 25
1301.75 for
pharmacies -
review requirements Page 27
Authority for Scheduling
Federal Level - DEA
State Level- Each state has
to have controlled substance schedules. Either by statute or regulation (Some
states simply adopt federal schedules).
In Ohio Both the Pharmacy Board &
the Legislature can modify schedules
Controlled Substance Schedules
Pages 109-127
Schedule I - Illegal drugs
No known medical use
Schedule II
high potential for abuse
currently accepted medical use
severe physical or psychological dependence
Schedule III
high abuse potential but less than I or II
accepted medical use
moderate or low physical dependence or high psychological dependence
know limits on certain schedule III drugs
Schedule IV
low potential for abuse relative to schedule III
accepted medical use
limited phys. and psyc. dependence compared to schedule III
Schedule V
low abuse potential
accepted medical use
limited phys. or psyc. dependence relative to schedule IV
know limits on certain substances
Review study
tips
Excluded
(Exempt) Substances
Manufacturers
may apply to the DEA for exemption of a product from controlled substance
status. The exemption may be granted if it appears unlikely that the product
can be abused.
Certain
non-narcotic substances (products) are excluded from all schedules even though
they contain a controlled substance. See Page 128
Use
of DEA Form 222
Required
for each sale or transfer of a schedule I, or II controlled substance.
Cannot be used for Schedule III, IV or V drugs.
Can
only be obtained from DEA by authorized registrants.
Triplicate
form.
Forms
are serially numbered. A registrant must keep track of all forms and report
lost forms.Page 129-140 Blue Book & Page 84 Supplement
Completing
DEA Form 222
Must complete all three copies
Use typewriter,
pen, or indelible pencil.
Only
one item may be entered on each numbered line of the order form
Must contain name
and address of the supplier
must
be signed and dated by a person authorized to sign an application for
registration
(or an authorized agent)
Creating a
Power of Attorney
Any
purchaser may authorize one or more individuals to obtain and execute order
forms on his/her behalf by creating a Power of Attorney
must
be filed
must
be retained
must
be available for inspection
may
be revoked at any time by executing a Notice of Revocation Page 133
Filling
Orders Written on DEA Form 222
Usually only a person registered as a manufacturer or distributor of
controlled substances listed in Schedule I or II may fill an order form
But see
exceptions page 134 of Blue Book
Ordering
Controlled Substances Using DEA Form 222
Pharmacy
Submits Copy I and Copy 2 of the form to the supplier
Retains Copy 3
If
an order cannot be completely filled, it may be partially filled and the
balance supplied by additional shipments within 60 days (Order form is no
longer valid after 60 days)
The
supplier must retain Copy 1 of the order form for his/her own files and forward
Copy 2, to the DEA
The
purchaser (i.e. the pharmacist, physician, etc.) must record on Copy 3 of the
order form the number of commercial or bulk containers received on each item
and the dates on which such containers are received.
Unaccepted or
Defective Order Forms
An
order form must not be filled if it:
-is
not complete, legible, or properly prepared, executed, or endorsed; or
-shows
any: alteration, erasure, or change of any description.
Lost or
Stolen Order Forms
Must immediately
report the loss to the DEA
Must immediately
report the loss to the Ohio Board of Pharmacy
Storage of
Order Forms
The
PURCHASER must retain Copy 3 of each order form that has been filled
The
SUPPLIER must retain Copy 1 of each order form that he/she has filled
Order
forms and other related documents must be kept available for inspection for a
period of 2 years
(Three
years by Ohio Law)
Summary of Form 222
.Can only be used for Sch II drugs
.Execution details
.Name & address of Supplier
.Can only be signed by person who signed for CS
registration or person w Power of Attorney
(1305.07)
Dont forget to complete Copy 3 and keep
Part 1302
Manufacturer Labeling
Identification Symbols
C-II or C with schedule designation inside. (1302.03)
Page 29-30 Supp
Part 1306
Page 49-57 Supp
Pages 140-162 Blue Book
Sec. 1306.03
Persons entitled to issue prescriptions.
(1) Authorized to prescribe
controlled substances by the jurisdiction in which he is licensed to practice
his profession and
(2) Either registered or exempted from registration pursuant to Secs.
1301.24(c) and 1301.25 of this chapter.
Check Validity of DEA Number
Add first, third and fifth digits
Adds the sum of the second, fourth, and sixth digits multiplied by 2
and adds to first sum
Determines if the right most digit corresponds with the ninth check
digit.
AN 1257218
1 + 5 +2 = 8
(2 + 7 + 1) x 2 = 20
then 20 plus 8 = 28
The 8 of 28 is the same as the ninth digit of the DEA number
Special Ohio Issues Concerning Persons entitled to
prescribe
Advanced Practice Nurses (APN) and Prescriptive Authority (4723-19-07)
Conditions allowing an APN to prescribe
Ohio State Medical Board - Self and Family Prescribing (Medical Board
Position Paper)See material in Supplement Pages. 73-83
Sec. 1306.04 Purpose of issue
of prescription Page 49
1. Legitimate
medical purpose by an individual practitioner acting in the usual course of his
professional practice
2. A
prescription may not be issued in order for an individual practitioner to
obtain controlled substances for supplying the individual practitioner for the
purpose of general dispensing to patients
Purpose of Prescription
3.A
prescription may not be issued for the dispensing of narcotic drugs listed in
any schedule for ``detoxification treatment'' or ``maintenance treatment''
Sec. 1306.05 Manner of
issuance of prescription Page 50
1. Dated as of,
and signed on, the day when issued
2. Bear the
full name and address of the patient
3. Drug name,
strength, dosage form, quantity prescribed
4. Directions
for use
5. The name, address and registration number of the
practitioner
6. Sign a prescription in the same manner as he
would sign a check or legal document
7. If an oral order is not permitted, prescriptions
shall be written with ink or indelible pencil or typewriter and shall be
manually signed by the practitioner
An
individual practitioner exempted from registration 1306.05(b)
An individual practitioner exempted from
registration 1306.05(c)
Member of military service
MUST Have DEA # or equivalent
DEA # am1234567
Internal code # am1234567-A01
Military - use branch of
service & SSN
USAF 999-99-9999
Sec. 1306.06 Persons entitled
to fill prescriptions. Page 50
A pharmacist acting in the usual course of his professional practice
and either registered individually or employed in a registered pharmacy
Methadone Treatment Programs
Prescriptions cannot be issued for methadone maintenance purposes.
Pharmacists cannot dispense methadone for maintenance.
Methadone must be administered at a treatment center.
Exception - hospitalized patient.
DISPENSING PRESCRIPTIONS
Sec 1306.11
Schedule II Substances Page 51
Usually only written prescriptions are allowed
Exceptions are:
Emergency situations (Oral rx's permitted) see division (d) to follow
Schedule II Substances
1. IV administrations (Faxes permitted) see division (e) of
1306.11
2. Long Term Care Facility (Faxes permitted) see division (f)
3. Patient residing in a hospice
certified by Medicare (Faxes permitted)
see division (g)
EMERGENCY SITUATION
1306.11(d)
DEFINITION
Immediate
administration necessary
No
appropriate alternative treatment available
Not possible for
prescriber to provide written Rx
Conditions for dispensing(Emergencies)
1. Quantity prescribed and dispensed is limited to the amount adequate
to treat the patient during the emergency period
2. The prescription shall be immediately reduced to writing by the
pharmacist
3. Must make a reasonable effort to determine that the oral
authorization came from a registered individual practitioner
4. Within 7 days the prescribing individual practitioner shall cause a
written prescription to be delivered to the dispensing pharmacist
Sec. 1306.12 Refilling
prescriptions.
The refilling of a prescription for a controlled substance listed
in Schedule II is prohibited
Page 52
Sec. 1306.13 Partial filling
of prescription Page 52
1.Permitted
2.If the
pharmacist is unable to supply the full quantity (Only reason)
3.The remaining
portion of the prescription may be filled within 72 hours of the first partial
filling; however, if the remaining portion is not or cannot be filled within
the 72-hour period, the pharmacist shall so notify the prescribing individual
practitioner. No further quantity may be supplied beyond 72 hours without a new
prescription.
Partial
Filling For patients of a long tem care facility (LTCF) or a terminally ill
patient:
1. M.D. must
certify patient terminally ill
2. Notation
must be made on the prescription
3. Partial
fillings allowed for up to 60 days
4. Total
quantity cannot exceed amount RX written
for
5. Computerized
recordkeeping allowed
Sec.
1306.14 Labeling of substances in
Schedule II
Affix to the package a label showing
.date of filling,
.the pharmacy name and address,
.the serial number of the prescription,
.the name of the patient,
.the name of the prescribing practitioner,
directions for use
cautionary statements.
Labeling regulation does not apply to following
When a controlled substance listed in Schedule II is prescribed for
administration to an ultimate user who is institutionalized: Provided, That:
(1) Not more
than 7-day supply of the controlled substance listed in Schedule II is
dispensed at one time;
(2) The
controlled substance listed in Schedule II is not in the possession of the
ultimate user prior to the administration;
(3) The
institution maintains appropriate safeguards and records regarding the proper
administration, control, dispensing, and storage of the controlled substance
listed in Schedule II; and
(4) The system
employed by the pharmacist in filling a prescription is adequate to identify
the supplier, the product, and the patient
Controlled Substances Listed in Schedules III, IV and V
Sec. 1306.21
Requirement of prescription
Page 53
written
prescription signed by a practitioner
a facsimile
of a written, signed prescription transmitted by the practitioner or the
practitioner's agent to the pharmacy
an oral
prescription
Sec. 1306.22 Refilling of
prescriptions Page 54
1.Can be
refilled for up to six months from date of issuance or
2.Up to 5
refills whichever comes first
Prescriber may
authorize additional refills as long as the refills do not exceed the 6 month
or 5 refill limitation(Does not apply to Sch V drugs)
Recordkeeping of refills
1.Recordkeeping
of refills
2.Note refills
on back
3.Computerized
records allowed
4.Must printout
list of controlled substance Rx's and sign or
5.Maintain
logbook
Refills continued
If computer goes down, have auxiliary procedure available. Enter in
computer as soon as it comes back up.
Sec. 1306.23 Partial filling
of prescriptions
The total quantity dispensed
in all partial fillings does not exceed the total quantity prescribed
No dispensing occurs after 6
months
Page 56
Sec. 1306.24
Labeling of substances.
Page 56
1.Pharmacist
shall affix to the package a label showing
2.the pharmacy
name and address,
3.the serial
number
4.date of
initial filling,
*** (Federal
law for all rx's requires date of current filling)
Labeling of substances.
5. Name of the
patient,
6. Name of the
practitioner issuing the prescription,
7. Directions
for use
8. Cautionary
statements,
Labeling Rules for Institutional Pharmacies
Above
requirements do not apply provided that
the patient is institutionalized and
see 4 requirements listed in notes and rule
1306.24
Sec 1306.25 Transfer between pharmacies of
prescription information for Schedules III, IV, and V
1. One time
basis only (Except for pharmacies sharing a real-time on-line database)
2. Communicated
directly between two licensed pharmacists
Page 75
Sec 1306.25
Responsibilities
of the
1. Transferring
pharmacist
2. Receiving
pharmacist
Sec 1306.26 Dispensing without prescription Page 57
1.Dispensing is made only by a
pharmacist
2.Prescription not required by
federal law
3.Note limits (See Sec 1306.26)
that may be dispensed at retail to the same purchaser in any given 48-hour
period;
Requirements for dispensing
The
purchaser is at least 18 years of age;
The
pharmacist requires every purchaser of a controlled substance under this
section not known to him to furnish suitable identification (including proof of
age where appropriate);
A bound record book for dispensing of
controlled substances under this section is maintained by the pharmacist.
The book shall contain
the name and
address of the purchaser,
the name and
quantity of
controlled
substance purchased,
the date of
each purchase, and
the name or initials of the pharmacist
Disposal or Destruction of Controlled Substances
Request DEA for
permission to destroy - DEA will give 4 options
1. Two Parties - Keep records
2. State agency will destroy or forward to state agency
3. Hold for DEA
4. Forward to DEA