EXAM 3 Lecture 17

Question 1

If a prescription for a drug does not indicate how many times the prescription may be refilled, if any…

Answer 1

the prescription may not be refilled unless the pharmacist is subsequently authorized to do so by the practitioner

Question 2

Drug order

Answer 2

Written order for a drug or device for a patient in an inpatient institution

Question 3

Prescription

Answer 3

Written order for a drug or device for an outpatient

Question 4

Drug order requirements

Answer 4

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

Question 5

Prescription Requirements

Answer 5

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

Question 6

Prescription label requirements

Answer 6

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

Question 7

Prescription validity

Answer 7

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

Question 8

Mechanical storage devices (Pyxis or Omnicell) can only be utilized within…

Answer 8

• 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

Question 9

Enforcement of the law falls to members of the Indiana BoP, designated employees, and all law enforcement officers in Indiana. These individuals may:

Answer 9

• 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

Question 10

Prescription Drug Marketing Act (PDMA) - Samples and coupons

Answer 10

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

Question 11

Two things Indiana specifies in addition to the PDMA

Answer 11

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

Question 12

Generic substitution practitioners

Answer 12

Physicians
Dentists
Podiatrist
Optometrist
APRNs
PAs

Veterinarians: we cannot generic substitute

Question 13

Generic substitution: prescription forms

Answer 13

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

Question 14

Generic substitution: Medicaid and CHIP

Answer 14

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

Question 15

Biosimilar Products

Answer 15

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

Question 16

Naloxone entity requirements

Answer 16

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