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filled, it may be partially filled and the balance supplied by additional shipments within 60 days (Order form is no longer valid after 60 days)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)

Don’t 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 153-182 Purple Book

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  or page 154

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

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 or page 155

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

1306.06   Persons entitled to fill prescriptions. Page 50 or page 156

A pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy

Methadone Treatment Programs Page 95-99 & 157, &183-206

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 or page 157

Usually only written original prescriptions are allowed

Exceptions are:

Emergency situations (Oral rx's permitted) see division (d) to follow

EMERGENCY SITUATION
1306.11(d) Page 158-159

DEFINITION

1.Immediate administration necessary

2.No appropriate alternative treatment available

3.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

Schedule II Substances  More Exceptions Page 160

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)

Sec. 1306.12   Refilling prescriptions.

The refilling of a prescription for a controlled substance listed in  Schedule II is prohibited

Page 52 or page 160

Sec. 1306.13   Partial filling of prescription for Schedule II Page 52 or page 160

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:
Page 161

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 page 163

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

Pages 161-181

Pages 53-57

Sec. 1306.21   Requirement of prescription
Page 53 or page 164

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 or page 165

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 print out list of controlled substance Rx's and sign or

5.Maintain logbook

If computer goes down, have auxiliary procedure available. Enter in computer as soon as it comes back up.

Computer maintained records

For refills

See Page 54 supplement

Section 1306.22(b) computer requirements
Must sign print-out
Enter information into bound log book that is signed by RPh. However 4729-5-28

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 (page 170)

Sec. 1306.24   Labeling of substances. Page 56 (page 170)

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)

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 (page 172)

Sec 1306.25 Page 172 or page 75
Copies (Transfers):

Responsibilities of the:
1. Transferring pharmacist See Regulation
2. Receiving pharmacist See Regulation

Sec 1306.26 Dispensing without prescription Page 57 or page 174

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  page 59

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

Part 1304 (page 175)

RECORDKEEPING (1304.03)

RECORDS OF DRUGS:
            1.DISPERSED
            2.RECEIVED
            3.INVENTORIES
KEEP FOR TWO YEARS(1304.04)

Records of distributions to other dispensers  Same records as purchases from wholesalers

Records of Receipt

1. Schedule II drugs - Use third copy of DEA form 222.

2. Sch III, IV & V drugs. Invoices from wholesaler are acceptable. Invoices containing both controlled and non-controlled drugs must be identified in some notable manner.

Records of dispersal /Removal of any drugs from pharmacy
1. Prescriptions,
2. record books,
3. Form 222,
4.  invoices,
5.  med orders,
6.  records of destruction & theft and loss

Prescription files - three options 
Section 1304.04(H) (page 176) or page 34

1. Three files:(This is the mandatory option for Ohio)
            -Sch II
            -Sch III, IV & V
            -Non controlled drugs
2. Two files:
            -Sch II
            -Sch III, IV & V & non controlled drugs w controlled drugs marked w Red C
3. Two files:
            All controlled drugs - III, IV & V with RED C
            Non controlled drugs in separate file
Red C not required if computer can retrieve information

Filled Prescriptions - 1304.22(c)

1. Dated when written (issued)
2. Name & address of patient
3. Name & address & DEA # of practitioner
5. Date dispensed and number dispensed
6. Written or typewritten name  or initials of dispenser
(Ohio requires written initials)

Inventory Requirement (1304.11)  (page 178)Page 34-35

1. All Controlled substances
2. Initial inventory then every two years
3. At beginning or end of business
4. Sch II exact count
5. Others estimate except for bottles >1000
6. Remember newly scheduled drugs When to inventory?

Records of Theft or Loss
Must notify DEA and State agency - Section 1301.76 (Use form 106)
1. Thefts must be reported to local law enforcement
2. Note Ohio board to be notified by phone immediately of any theft or significant loss of CS and dangerous drugs (4729-9-15)

1307.11 Five Percent Rule

Note difference between DEA rule & Ohio Board of Pharmacy rule

Pharmacies cannot distribute (different from dispensing) more than 5% of the total dosage units of all controlled substances they DISPENSE  in one year.
Example
Dispense total of 100,000 tablets of CS per year.
Then the pharmacy cannot distribute more than 5000 tablets of CS to other pharmacies

Malpractice     

Confidentiality &Insurance