EXAM 3 Lecture 17 Flashcards
If a prescription for a drug does not indicate how many times the prescription may be refilled, if any…
the prescription may not be refilled unless the pharmacist is subsequently authorized to do so by the practitioner
Drug order
Written order for a drug or device for a patient in an inpatient institution
Prescription
Written order for a drug or device for an outpatient
Drug order requirements
Name and bed number of patient
Name and strength/size of drug
Amount to be dispensed in quantity or days
Adequate directions for the proper use of the drug
Name of the prescriber
Prescription Requirements
Name and address of the patient
Name and strength/size of the drug or device
Amount to be dispensed
Adequate directions. for use
Name of the practitioner
Written or electronic signature of practitioner
Prescription label requirements
Name, address, phone # of dispensing pharmacy
Date of prescription fill
Prescription number
Name of prescribing practitioner
Name of patient
Directions for use
If the drug contains or derived from opium, a statement that the drug is an opioid
Name of drug
If for an animal, owner’s name
Prescription validity
prescriptions and drug orders are only valid if they are issued for a legitimate medical purpose
In relation to testosterone: enhancing excercise/sport or muscle mass not related to medical necessity are prohibited
Mechanical storage devices (Pyxis or Omnicell) can only be utilized within…
A pharmacy that holds a permit issued by the Indiana BoP
Remote location under the jurisdiction of the Indiana BoP
Or a licensed health care facility
Enforcement of the law falls to members of the Indiana BoP, designated employees, and all law enforcement officers in Indiana. These individuals may:
Carry a firearm when performing official duties
Execute and serve warrants and subpoenas
Make arrests without a warrant for suspected controlled substance felony
Seize property
Perform other enforcement duties as designated by the BoP
Prescription Drug Marketing Act (PDMA) - Samples and coupons
Bans the sale, purchase, or trade of a drug sample or drug coupon, and bans counterfeiting of drug coupons.
Practitioners must ask for drug samples in writing
Community pharmacies cannot have drug samples at anytime
Established record-keeping, storage, and handling requirements for drug samples
Two things Indiana specifies in addition to the PDMA
You cannot remove a sample from its original packaging, repackage it, and then sell it/exchange it
You cannot deliver a drug sample to someone after its expiration
Generic substitution practitioners
Physicians
Dentists
Podiatrist
Optometrist
APRNs
PAs
Veterinarians: we cannot generic substitute
Generic substitution: prescription forms
Written prescriptions must have two signature lines
These lines are not required on electronic or verbal prescriptions
- on phone orders, practitioners must indicate whether substitution is permitted
- on electronic submissions, practitioners must state either dispense as written (DAW) or may substitute
Generic substitution: Medicaid and CHIP
The pharmacist must substitute the product that results in the lowest price unless:
It states “Brand Medically Necessary” written or electronically transmitted in the practitioner’s own handwriting
Orally stating generic equivalent may not be substituted, and forwarding a covering prescription that has “Brand Medically Necessary” included
Biosimilar Products
Treated somewhat similarly in Indiana law as brand-generic
Can be substituted if:
The product has been determined to be interchangeable by the FDA
The prescribing practitioner has indicated “may substitute”
The pharmacist has informed the customer of the substitution
After completing the substitution, the prescriber is informed of the name and manufacturer of the biologic
Naloxone entity requirements
RPh or naloxone entity who dispenses naloxone must:
Register annually with the state department or local health department
Instruct the individual receiving the product to summon emergency services immediately
Provide education and training on drug overdose response and treatment
Provide drug addiction treatment and referral information
