Reading 16 Flashcards
What does the Indiana Legend Drug Act talk about?
IC 16-42-19
- Drug orders, prescriptions, labeling, and many other important things that impact pharmacies and pharmacist
What is the definition of Drug Order within the Legend Drug Act?
- For inpatient in institution
- I.e: hospital, LTCF, other inpatient places
What are some of the things that need to be on a drug order?
- Name/Bed # of patient
- Name/Strength of drug
- Amount
- Direction
- Name of Dr
What is the definition of Pracitioner within the Legend Drug Act?
Who?
- Those that can prescribe in Indiana [Physician, Vets, Dentists, Podiatrists, Optometrists, APNs, PAs]
What is the definition of Prescription within the Legend Drug Act?
What needs to be on it?
- Name/Address of Patient
- Name/Strength of Drug
- Amount
- Directions
- Name of Dr
- Signature [written or electronic]
Can be called in, electronically sent, written or faxed
What information MUST be on a prescription for it to be Legal?
- Name, Address, Number of Pharmacy
- Date filled
- Rx number
- Name of Dr
- Patients Name
- Directions
- Its a opioid
What information MUST be on a label when dispensed from a Pracitioners Office?
- Directions
- Name and Address of Dr
- Name of Patient
- Animal species [if animal]
What is the important thing to note about refilling prescriptions and drug orders within the Legend Drug Act section>
IC 16-42-19-12
- Prescriptions and Drug Orders CANNOT be refilled unless the Dr says so
What does the Legend Drug Act say are Unlwful Acts?
- Getting a legend drug [by: fraud, forgery, concealment, false name]
- Telling Dr false things to get meds
- Falsely titling self as whatever to get meds
- Utter false or forged Rx
- False or forged on Label
What does the Legend Drug Act say about the use of Anablic Steroids?
Can you get without Rx? What are the two reasons to NOT get filled?
- NO patient is able to get without an Rx
- CANNOT get them for the enhancment of preformence or hormonal manipulaiton
What does the Legend Drug Act say about the Validity of Prescriptions?
- Rx or Drug Orders are NOT VAILD unless for a legit medical purpose by Dr
What does the Legend Drug Act say about the use of Mechanical Storage Devices?
Where can they be used?
- Increase the availability of Drugs [Omincell or Pyxis]
- These can be used in institutions with pharmacy permits, if device is held in remote locations, or if device is in licenesed healthcare place
What does the Legend Drug Act say about the requirement of prescription for retail sale of insulin?
- Insulin can bow be purchased OTC by anyone as of 01/01/2021
What does the Chapter about Drugs: Enforcement of Pharmacy Law and Rules talk about?
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- Members of the board enforce it; they can carry guns, execute warrents, make arrests without warrents, sieze property, do other law enforcement duties that the board says
Basically dont mess around with the Board or else you get shot
What does the Chapter about Drugs: Drug Samples talk about?
About PAs? What can you NOT do?
- Practitioner doesnt list PAs; but they have the power through their physician (why they can do samples)
- CANNOT: remove from OG package and repackage it to resell or give when its expired
These apply to manufacturers, wholesalers, practitioners, pharmacist…
What does the Chapter about Drugs: Generic Drugs talk about?
- Orange Book is for generic substitution for which are pharmaceutical or therapeutic equal
- This chapter is ONLY for Brand –> Generic
- DOESNT cover biologics
What does the Practitioner section talk about within the Legend Drug Act?
Who? Whos not included and why?
- Includes Physicians, Dentists, Podiatrists, optometrists, APNs [NOT PAs & Vets]
- PAs: get their authority from Physicains
- Vets: we dont know how drugs work in animals [they write brand, we give brand]
Can give generic instead of brand for others tho
What does the Prescription Forms section of the Legend Drugs Acts chapter talk about?
- Two signature lines: “Dispense as Written” or “May Substitute”
- When “Dispense as Written” we MUST dispense as written, no if and or buts
- When “May Substitute” we CAN sub
“May Substitute” doesnt mean to another class
For an electronic prescription, are the “Dispense as Written” and “May Substitute” suppose to be there?
- NO
- Electronics must say instruction on dispense as written or substitute; what the Dr wants
What are some of the exceptions to the “Dispense as Written” and “May Substitute”?
- Patient enrolled in Medicaid, Childerns Health Insureance, Medicare = MUST sub to the lowest cost
- If Dr wants the Brand they MUST write Brand Medically Necessary in there handwritting [same for eletronic and orally]
What does the chapter over identification of product state within the Legend Drug Act?
- If substituting, labels must say ____ generic for ____
- Must also state the manufacturer, distribuotr or both for dispensed product
What does the chapter over Drugs: Biosimilar Biological Products state within the Legend Drug Act?
When can we substitute a biologic?
- Product deemed interchangeable by Purple Book
- Dr signed “May Substitute”
- Inform the patient
The FDA must maintain a link to the website of all current biologicals that are interchangable
What does the chapter over Drugs: Overdose Intervention Drugs state within the Legend Drug Act?
What must we do for it?
- Allows pharmacist to dispense overdose intervention [Naloxone] if at risk of opioid overdose
- Must educate on overdose; adminstering, when to call 911, info on drug programs