• 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 - MD’s. DDS’s
-Pharmacies, Wholesalers
(1301.11) Page 13

Page 107 Blue Book

– Separate registration for independent activities. 21USC Sec.822

– Separate registrations for separate locations.(1301.12)

– Exemption of agents and employees; affiliated practitioners.(1301.22) Page 20

– 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 & Pages 123-146

• Schedule I - Illegal drugs

– No known medical use

• Schedule II

– high potential for abuse

– currently accepted medical use

– severe physical or psychological dependence

Controlled Substance Schedules

• 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

Controlled Substance Schedules

• 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 Pages 109-127

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

Completing DEA Form 222 (More)

• 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)

Ordering Controlled Substances Using DEA Form 222 (More)

• 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 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. Page 68 or Page 140

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 or page 141

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 or page 142

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

Sec. 1306.05 Manner of issuance of prescription

• 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 or page 143

• 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 & 169-191

• 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 144

• 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 145

• 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

Schedule II Substances
More Exceptions Page 146

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 147

Sec. 1306.13 Partial filling of prescription Page 52 or page 147

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 148

• 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 149

• 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 151- 162

• Pages 53-57

Sec. 1306.21 Requirement of prescription
Page 53 or page 151

• 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 152

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

Refills continued

• 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 156)

Sec. 1306.24 Labeling of substances.
Page 56 (page 157)

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) MORE

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 (page 158)

Sec 1306.25
Page 158 or page 75

Responsibilities of the

1. Transferring pharmacist

2. Receiving pharmacist

Sec 1306.26 Dispensing without prescription Page 57 or page 160

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