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# BN Add 1,3,& = 11 Add 2, 4, 6 X 2 ( ) 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

Rx Example 1 PRIMARY CARE ASSOCIATES 811 North Main St Our Town, MO (816) NameBetty BurumDate10/26/04 Address8826 Dunbar Ave Our Town, MO RXFentanyl Patch 25 mcg Disp #10 Sig: Place on skin q 3 days for pain __________________ Molly Morris, M.D. Dispense as Written Substitution Permitted Refills _0_ DEA# BM

Rx Example 2 PRIMARY CARE ASSOCIATES 811 North Main St · Our Town, Missouri · (816) NamePriscilla WhiteDate10/19/04 Address124 Over Street Our Town, MO RXAtivan Disp #60 Sig: 1 tab bid _______________ Molly Morris, M.D. Dispense as Written Substitution Permitted Refills _5_ DEA# BM

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 long- term 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