Transcript Dispensing Controlled Substances

Dispensing Controlled
Substances
Pharmacy 151
Introduction to Pharmacy Law
Chapter Objectives
 What are “legitimate medical purpose” and
“corresponding responsibility” doctrine and
how are they applied in practice?
 What are the dispensing requirements for
C-II through C-V?
 What are the function and execution
procedures for Form 222?
 What are the record keeping requirements?
Prescriptions
 Must be for an ultimate user
 Issued by an individual practitioner
authorized to prescribe controlled
substances and registered under the
Act
 Agent of prescriber may communicate
authorized Rx and refill information
 Agent may prepare the Rx for
prescriber’s signature
DEA Number
 Number is 9 characters
 First two are alphabet letters followed by 7
digits
 First letter assigned, started with A now at
B
 Second letter usually the first initial of last
name of registrant
 The next 6 are computer generated digits
that are unique to each registrant
 The final digit is a computer calculated
check digit
Validation of a DEA Registration
Number
 Check the second letter with the first
initial of the registrants last name
 Add the first, third, and fifth digits
 Add the sum of the second, fourth,
and sixth digits times two to the first
sum
 Determine whether the right-most
digit of the sum corresponds with the
ninth check digit
Example of Validation
William R Nash, M.D.
DEA# BN3672145
Add 1,3,& 5
3 + 7 + 1=
11
Add 2, 4, 6 X 2
(6 + 2 + 4) X 2=
12 X 2=
24
Add first sum to second= 25
Right must number is check number= 5
DEA number ends in 5 the check is correct
This is just one simple check
If we know this information, so do the “bad guys”
Issuance of Prescriptions
Date of issue (can’t be pre or post dated)
Full name of patient
Complete address of the patient
Drug name
Drug strength
Dosage form
Quantity prescribed
Directions for use
Name, address, and registration number of the
prescriber
 Signature of the prescriber if written or printed Rx
 Oral Rx must contain all of the above except
prescriber’s signature
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Rx Example 1
PRIMARY CARE ASSOCIATES
811 North Main St Our Town, MO 64111 (816) 555-1324
Name
Address
RX
Betty Burum
Date 10/26/04
8826 Dunbar Ave Our Town, MO 64112
Fentanyl Patch 25 mcg
Disp #10
Sig: Place on skin q 3 days for pain
__________________
Dispense as Written
Refills
_0_
Molly Morris, M.D.
Substitution Permitted
DEA# BM5313870
Rx Example 2
PRIMARY CARE ASSOCIATES
811 North Main St · Our Town, Missouri 64111 · (816) 555-1324
Name
Address
Priscilla White
Date 10/19/04
124 Over Street Our Town, MO 64123
RX
_______________
Dispense as Written
Refills
_5_
Ativan
Disp #60
Sig: 1 tab bid
Molly Morris, M.D.
Substitution Permitted
DEA# BM5313870
Purpose of Controlled Substance Rx
 Legitimate Medical Purpose
 Corresponding Responsibility Doctrine
C-II Rx
 Must receive written/printed, signed Rx
(there are some exceptions)
 Exceptions—emergency Rx and fax for
injectable compounded order, patient
enrolled in hospice, and patient in longterm care (terminally ill)
 May be partially filled if out of stock, but
completion needs to be done in 72 hours. If
not, can not fill rest of Rx
 Partially fill for long-term care or terminally
ill patient can be up to 60 days
 No C-II Rx may be refilled
Rx (order) or piece of paper?
 An order purporting to be an Rx
issued not in the usual course of
professional treatment is not a Rx
and the person knowingly filling such
a purported Rx, as well as the person
issuing it, will be subject to penalties
provided for violations of the law
C-III, C-IV, & C-V Rx
 Issued by written, oral, or fax.
 All information required—written and faxed
must have prescriber’s signature
 Oral all information must be promptly
reduced to writing
 C-III and C-IV may be refilled 5 times
within 6 months if authorized
 C-III, C-IV, & C-V may be partially filled,
however, not for more than originally
ordered and not more than 6 months
Records
 Records of inventory
 Records of drugs received
 Records of drugs dispensed
 CSA indicates that these records must
be maintained for 2 years, Missouri
requires Rx records to be maintained
for 5 years
Order Form 222
 Used for ordering C-II drugs. No
other use for this form
 Can use it to order C-II drugs from
manufacturer, wholesaler, hospital
pharmacy, or other pharmacy
 Registered prescriber’s may use it to
order drugs for the office. May not
write a prescription for office use