Lecture 17 Flashcards
(21 cards)
IC 16-42. Regulation of Food, Drugs and Cosmetics
Similar to federal
Idk if we need to know??
Adulteration and Misbranding
“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
Practitioners able to prescribe
physicians
veterinarians
dentists
podiatrists
optometrists licensed in Indiana
APRNs
PAs
Drug order requirements
name and bed # of patient
name and strength/size
amount to be dispensed
adequate directions for use
name of prescriber
Prescription requirements
name and address of patient
name and strength/size
amount to be dispensed
adequate directions for use
name of prescriber
written or electronic signature
What must a prescription label contain?
name, address, and phone # of dispensing pharmacy
date on which prescription was filled
prescription #
name of prescriber
patient name or animal species
directions for use
if opium derived, statement
What must a prescription label from practitioner office contain?
patient name or animal species
name & address of practitioner
directions for use
Unlawful Acts
- Obtain or attempt to obtain a legend drug in a fraudulent manner
- Communicate information to a physician to unlawfully receive a legend drug
- Intentionally make a false statement in a health record
- Falsely represent oneself to be a person who could legally obtain a legend drug
- Falsify or forge a prescription or drug order
- Falsify or forge a label and affix it to a receptacle containing legend drugs
- Dispense a legend drug outside of the bounds of IC
Prescription Validity and Anabolic Steroids
Prescriptions and drug orders are only
valid if they are issued for a legitimate medical purpose.
If someone knowingly issues or fills an invalid prescription, they have broken the law
Enhancing performance in an exercise, sport or game, and hormonal manipulation intended to increase muscle mass, strength, or weight not
related to a medical necessity are prohibited indications
Mechanical Storage Devices
Pyxis or Omnicell machines commonly seen in institutional settings which can only be utilized in:
Pharmacy that holds a permit issued by Indiana BoP
Remote location under the jurisdiction of Indiana BoP
Licensed health care facility
Drugs: Enforcement of Pharmacy Laws and Rules
Indiana BoP, designated BoP employees, and all law enforcement in Indiana 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
They also audit controlled substance inventory and supply. It behooves you to comply with these individuals whenever possible.
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
A drug sample is “a unit of a prescription drug that is not intended to be sold…and intended to promote the sale of a drug.” This definition omits OTC drugs and starter packs, which are both intended for sale
Drug Samples: Indiana Quirks
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 date
What prescriber type can we not substitute generic products for a brand?
Veterinarians
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, the practitioner must state either dispense as written or may substitute
If the prescriber signs on Dispense as Written, we must dispense the brand-name product. If the prescriber signs on May Substitute, we may dispense a generic
equivalent.
Generic Substitutions: Medicaid and CHIP
The pharmacist must substitute the product that results in the lowest price unless:
- The words “Brand Medically Necessary” are written or electronically transmitted on the prescription in the practitioner’s own handwriting; or
- Orally stating that a generic equivalent may not be substituted, and subsequently forwarding a covering prescription that has “Brand Medically Necessary” included
Biosimilar Products
A biologic can be substituted if:
Purple book approved
“may substitute” by prescriber
inform patient of substitution
inform prescriber of name and manufacturer of biologic dispensed within 10 days
Overdose Intervention: Naloxone Entity Requirements
A pharmacist or naloxone entity who dispenses the naloxone must:
1. Register annually with the state department or local health department (https://optin.in.gov/)
2. Instruct the individual receiving the product to summon emergency services immediately
3. Provide education and training on drug overdose response and treatment
4. Provide drug addiction treatment and referral information
Overdose Intervention: Advocate protections
If that individual remains at the scene, cooperates with, and provides relevant information to law enforcement, they are immune from criminal prosecution related to any potential drug possession
