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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?

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Dispensing Controlled Substances

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  1. Dispensing Controlled Substances Pharmacy 151 Introduction to Pharmacy Law

  2. 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?

  3. 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

  4. 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

  5. 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

  6. 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”

  7. 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

  8. Rx Example 1 PRIMARY CARE ASSOCIATES 811 North Main St Our Town, MO 64111 (816) 555-1324 NameBetty BurumDate10/26/04 Address 8826 Dunbar Ave Our Town, MO 64112 RX Fentanyl Patch 25 mcg Disp #10 Sig: Place on skin q 3 days for pain __________________Molly Morris, M.D. Dispense as WrittenSubstitution Permitted Refills     _0_ DEA# BM5313870

  9. Rx Example 2 PRIMARY CARE ASSOCIATES 811 North Main St · Our Town, Missouri 64111 · (816) 555-1324 NamePriscilla WhiteDate10/19/04 Address 124 Over Street Our Town, MO 64123 RX Ativan Disp #60 Sig: 1 tab bid _______________Molly Morris, M.D. Dispense as WrittenSubstitution Permitted Refills     _5_ DEA# BM5313870

  10. Purpose of Controlled Substance Rx • Legitimate Medical Purpose • Corresponding Responsibility Doctrine

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

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