Substitutions And Interchangeable

Question 1

Define Generic Equivalent

Answer 1

A drug that is pharmaceutically equivalent and therapeutically equivalent

Question 2

Define Pharmaceutically Equivalent

Answer 2

Drug products have identical amounts of the same active ingredient in the same dosage form

Question 3

Define Therapeutically Equivalent

Answer 3

Pharmaceutically equivalent drugs that when administered in the same amounts will provide the same therapeutic effect, identical duration and intensity

Question 4

Define Interchangeable

Answer 4

Means a biological product that is designated as biosimilar and therapeutically equivalent to another product approved by the FDA

Question 5

Orange Book

Answer 5

Dangerous drug equivalences

Question 6

Purple Book

Answer 6

Biological interchangeability

Question 7

Define Permissive Substitution

Answer 7

A pharmacist may dispense a generic equivalent drug or interchangeable biological product if the generic product cost less, patient doesn’t refuse the substitution, or the prescriber has not prohibited substitution

Question 8

Physician can prohibit substitution on a written prescription by:

Answer 8

Writing in the Practitioners own handwriting on the face of the prescription “brand medically necessary”
May NOT be pre-printed

Question 9

Physician can prohibit substitution on a verbal prescription by:

Answer 9

Must specify “brand medically necessary”

For Medicaid: physician must also fax or mail a written copy stating brand medically necessary within 30 days

Question 10

Physician can prohibit substitution on a electronic prescription by:

Answer 10

Physician must note “brand medically necessary”

For Medicaid: physician must also fax or mail a written copy stating brand medically necessary within 30 days

Question 11

Out of State, Mexican, Canadian Substitution

Answer 11

They MUST authorize substitution, rather than prohibit it

Question 12

Pharmacist Responsibility for Substitutions

Answer 12

1) Patient notification of a less expensive generic or interchangeable biological AND must ask the patient to choose
2) Not later than 3 days after dispensing a biological product it must be communicated to the prescribing practitioners what was dispensed and the NDC (only if substituted)
3) Selection of drug products - is the professional responsibility of the pharmacist
4) Labeling must state “substituted for brand prescribed”

Question 13

Substituting Dosage Forma

Answer 13

Pharmacist may substitute dosage forms with patient approval but must be the identical amount of active ingredient as prescribed, is not enteric coated or time release, does not alter outcomes

Question 14

Pharmacy Displays

Answer 14

Pharmacist and technicians are not longer required to display licenses and renewals
Class A and C pharmacies must have the word “pharmacy” somewhere
Public can request proof that all pharmacist and technicians are licensed or registered

Question 15

Can I make a copy of my original license or renewal certificate?

Answer 15

No but you can make a copy of your pocket license

Question 16

Emergency Refills

Answer 16

Pharmacist may exercise professional judgement in refilling a prescription for a drug without authorization if:

• will interrupt therapeutic regimen or create patient suffering
• a natural disaster occurred or pharmacist is unable to contact prescriber after reasonable effort
• does not exceed 72 hours supply
• governor declares a disaster and if notified by TBSP, the pharmacist may dispense a 30 day supply
• TSBP permits dispensing of the entire unit-of-use product
• notify the patient you are doing an emergency fill

Question 17

What drugs are allowed a 72 Hour Emergency Refill?

Answer 17

All Dangerous Drugs and C3, C4, C5

Not C2!!

Question 18

90 Day Supply and Accelerated Refills

Answer 18

Allowed if: total quantity dispensed doesn’t exceed the total prescription, patient consents, physician is notified electronically or by phone, drug is not a psychotropic, patient is at least 18 years old

Question 19

Administration of Epinephrine

Answer 19

• May administer epinephrine through an autoinjector in emergency
• law provides lability protection for a pharmacist who acts in good faith
• Immediately call 911 after administration
• Must report to primary physician within 72 hours

Question 20

Physician Administration and Dispensing

Answer 20

Texas does not generally permit physician Dispensing

Exceptions: 72 hour supply of Dangerous Drugs to meet immediate needs, physicians in rural area, veterinarians

Question 21

Impaired Pharmacists/Students

Answer 21

Alcohol or drug impairment pharmacist or students can enter into treatment and monitoring through Professional Recovery Network (PRN)
Individuals who enter into the program voluntarily are NOT reported to TSBP
May also be placed in PRN as a disciplinary action
Partial funding on surcharge on all Pharmacy and pharmacist licenses but does not cover cost of treatment

Question 22

Peer Review Program

Answer 22

May be set up by pharmacy owners or pharmacy associations to evaluate the quality of care in pharmacies by reviewing errors or near errors or other quality issues
The statute provides legal protection in civil litigation to peer review documents
Voluntary to set up

Question 23

Reporting Professional Liability Claims

Answer 23

An insurer must report to TSBP any claim filed against a pharmacist, pharmacy technician, or pharmacy related to care that results in death or injury
If they do not have insurance, they must report to TSBP
Initial report is required within 30 days and a follow up report is required within 105 days after disposition (settlement, dismissal, judgement, etc)