Pharmacy Law

• Requirements for prescriptions

  Federal law

  • Date of rx origination (date written or date of issue), CANNOT be post-dated
  • Patient name
  • Drug name
  • Drug strength
  • Directions for use

  General

  • Quantity, Refills, Prescriber name and signature (if written or faxed)
• Conditions under which PAs can prescribe in MI

  • PAs are required to work with a “participating physician” according to terms outlined in a “practice agreement”
  • Practice agreement generally defines the communication and decision making process by which the PA and the participating physician provide medical care to their patients
• How long rx are valid

  • Schedule II valid for 90 days, 0 refills
  • Schedule III and IV valid for 6 months and max 5 refills (does not include partial refills)
  • Schedule V/Legend valid for 1 year, no refills
• Different modes of transmitting prescriptions

  • Written: “hand written”, can be prepared electronically but must be signed manually
  • Phone
  • Facsimile: essentially a “written” prescription via fax
  • Electronic
• Requirements of CII prescriptions

  • Schedule II controlled substances are typically only valid if transmitted by written prescription or electronically once the pharmacy’s software has been certified to accept them AND the prescribing system has also been certified by a DEA-approved vendor
  • Limited circumstances where C II may be faxed = hospice program, long term care facilities
  • In emergency situations, C II rx may be called in w/ written rx received by pharmacy within 7 days of verbal authorization
• Methods for issuing multiple CII prescriptions

  Prescribers (except APRN) may issue multiple rx for the same C II med under the following conditions

  • Up to 90 day supply
  • Legitimate medical purpose
  • Do NOT post-date, instead indicate earliest day each rx may be filled “Do not fill until…”
• Requirements for prescribing controlled substances

  • Need controlled substance license → DEA # has to appear on prescription
  • State requirements (MI) → register through Dept of Licensing and regulatory affairs (LARA)
  • National requirements → register with the DEA
  • Provider needs to have a bona fide prescriber patient relationship w/ the patient for whom the controlled substance is being prescribed
• Schedules of controlled substances

  • I: High potential for abuse, no accepted medical use
  • II: high potential, accepted medical use w/ severe restrictions, abuse may lead to severe psychological or physical dependence
  • III: Potential less than I and II, accepted medical use, abuse may lead to moderate or low physical dependence or high psychological dependence
  • IV: potential less than III, accepted medical use, abuse may lead to limited physical or psychological dependence
  • V: potential less than IV, accepted medical use, abuse may lead to limited physical or psychological dependence
• Common controlled substances

  • I → cannabis, heroin, mescaline
  • II → Hydrocodone, Amphetamine salts (Adderall, Ritalin), Morphine, Oxycodone
  • III → Acetaminophen w/ codeine (Tylenol 3), Buprenorphine
  • IV → Benzos, Zolpidem, Tramadol
  • V → Guaifenesin w/ codeine, Pregabalin
• Define partial fill

  When only a portion of a prescription is filled (Example: A prescription is written for 30 tablets, but pharmacy is out of stock and can only provide 7 tablets and then the patient will have to obtain the rest once in stock.)
• Define refill

  Providing a subsequent fill of a prescription

  • Example: If prescription lists quantity 30 with 1 refill. Filling 30 tablets and then issuing a second set of 30 tablets
• What can a pharmacist change vs what they can't

  CAN change

  • Patient's address
  • Dosage form
  • Drug strength
  • Drug quantity
  • Directions for use
  • Issue date

  CANNOT change

  • Pt name
  • Drug prescribed (unless for lower cost equivalent)
  • Prescriber signature
  • Fo CS II, "Do not fill until"
• Purpose and requirements of MAPS

  • Purpose to to log all controlled substances dispensed to Michigan patients
  • Before prescribing or dispensing to patient a controlled substance (quantity > 3 days), a limited prescriber shall obtain and review a report concerning the patient (MAPS)
  • Check MAPS if any of the following
  • If dispensing occurs in a hospital or freestanding surgical outpatient facility
  • If patient is an animal
  • If the controlled substance is prescribed by a veterinarian