Chapter 7.2: Valid RXs

what does a control Rx need to be valid?

• date of issue

• pt info: name and address (D.O.B?)

• practitioner info: full name, address, and DEA registration number

• drug info: name, strength, dose form, quantity prescribed, and directions

• signature: manual for paper rx

what info can a pharmacist add if it’s missing from an rx?

• for C-II - C-V, a pharmacist is permitted to add/correct factual info (ex: pt address) after verification from the prescriber

• cannot add prescriber’s signature

can practitioners fax C-III-C-V rxs to pharmacy?

• they can fax a signed, written rx to pharmacy and this fax serves as original hard copy

can practitioners fax C-II rxs to pharmacy?

• a doctor can fax a C-II to pharmacy to speed up filling process

• pharmacy CANNOT dispense drug until pt arrives and presents original manually signed RX

• fax is a placeholder, paper is legal document (electronic Rxs are different from faxed Rxs)

what are some crucial exceptions when C-II faxes are the valid original document?

• compounded injectables: a narcotic compounded for direct administration to a pt by parenteral (a general category where drug admin. bypasses stomach), IV, IM, SQ, or intraspinal infusion

• long-term care facilities (LTCF)

• hospice pts (enrolled in medicare certified hospice programs)

what is the first and second letter of a DEA number?

• first letter (A,B, F): are assigned to practitioners (Dr.), Pharmacists

  • A, B are old

  • F are for new registrants

  • M is for mid-level practitioners like nurse practitioners, physician assistants, and optometrists

• 2nd letter is the 1st initial of the prescriber’s last name

how do you calculate a DEA number?

• the 7th digit (last one) is the check digit

• the other 6 digits are used to calc the 7th

  • 1. add all odd position digits (1, 3, 5th position)

  • 2. add all even position digits, then x2 (2, 4, 6th position)

  • 3. add sum of step 1 and 2 together

what is the x-waiver?

• historically, prescribers needed a DEA w/ an X to prescribe buprenorphine (suboxone) for opioid addiction treatments

  • eliminated bc of MAT act of 2023

  • any prescriber w/ standard DEA can prescribe it

what is the federal law on C-II refills?

• NO REFILLS ALLOWED

• must get a new Rx to get another refill

• Exception: fed law permits issuance of multiple RXs at one time (3 separate Rxs = 90 day supply)

  • each Rx having specific earliest fill date (“do not fill before…”)

what happens if the pharmacy does not have enough medicine to fill a C-II rx?

• out of stock: if a pharmacy doesn’t have enough, dispense partial amount. Remaining amount MUST BE FILLED W/I 72 HOURS.

  • If pharmacy cannot fill the rest within 72 hours, the Rx is void → notify prescriber

• one of the reasons for a partial refill

what happens if a pt/prescriber requests a partial fill on a C-II?

• pt / prescriber request (30-day rule): under Comprehensive Addiction and Recovery Act (CARA), if a pt/dr. requests a partial fill (ex: to lower costs or to reduce the numb er of opioids at home), pharmacy may dispense the Rx in multiple fills for up to 30 days from the date the rx was written

how does the C-II partial refill rule apply to LTCF or terminally ill pt?

• C-II rxs may be partially filled multiple times for a period up to 60 days

what happens if there is an emergency verbal order for C-II?

• typically, verbal orders for C-IIs are prohibited but emergency situations where immediate administration is needed are exceptions

• prescriber is legally required to provide a written, signed hard copy (or valid electronic Rx) to pharmacy within 7 days

  • must be marked “authorization for emergency dispensing”

  • if the rx does not arrive within 7 days, the pharmacy is federally mandated to notify local DEA office

    • failure to notify DEA → illegal dispensing

what is the Five and Six rule and what does it apply to?

• applies to C-III - C-V (in some states)

• Five and Six rule = 5 refills in 6 months

• rx will expire when it has been more than 6 months or alr used all 5 refills

• for C-V: some states may apply the same rules although federally, they don’t have strict refill regulations

what are as needed (prn) refills?

• for non-ctrl = 11 refills

• for C-III to C-V (some states) = 5 refills in 6 months

how to calculate total quantity?

total quantity = original fill + (quantity x max refills)

• ex: tramadol 50mg w/ quantity of 30 tablets; directions: take 1 tab qd w/ prn refills

  • total quantity = 30 + (30 × 5) = 180 tablets (pt is legally entitled to a max of 180 tablets over 6 months)

what is the rule regarding C-II transfers?

• C-II Rxs CANNOT be transferred; applies to all forms including electronic Rxs

• if pt requires rx at a different location, original order must be voided and prescriber must issue a new rx to the correct pharmacy

what is the rule regarding C-III to C-V transfers?

• “one time rule”

• transfers are permitted but restricted; can one time

• ex: if xanax is transferred from pharmacy A to B, it cannot be moved again to pharmacy C nor can it go back to pharmacy A. It stays at B until it exp.

what is the “shared database exception”?

• exception to the “one-time” rule for pharmacies that share real-time, online electronic data base

  • applies to different locations within same pharmacy chain

• b/c shared database updates instantly, it prevents pt from filling Rx at multiple locations simultaneously

  • federal law permits transfers up to max # of refills authorized by prescriber

what are the mechanics of a transfer?

• transferring pharm must invalidate the rx in their system → voiding it

• receiving pharm must record word “transfer” on face of Rx

• required data: receiving pharm must document the original date of issuance, dates, location of previous refills + record DEA registration number of transferring pharmacy