Substitutions And Interchangeable Flashcards
Define Generic Equivalent
A drug that is pharmaceutically equivalent and therapeutically equivalent
Define Pharmaceutically Equivalent
Drug products have identical amounts of the same active ingredient in the same dosage form
Define Therapeutically Equivalent
Pharmaceutically equivalent drugs that when administered in the same amounts will provide the same therapeutic effect, identical duration and intensity
Define Interchangeable
Means a biological product that is designated as biosimilar and therapeutically equivalent to another product approved by the FDA
Orange Book
Dangerous drug equivalences
Purple Book
Biological interchangeability
Define Permissive Substitution
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
Physician can prohibit substitution on a written prescription by:
Writing in the Practitioners own handwriting on the face of the prescription “brand medically necessary”
May NOT be pre-printed
Physician can prohibit substitution on a verbal prescription by:
Must specify “brand medically necessary”
For Medicaid: physician must also fax or mail a written copy stating brand medically necessary within 30 days
Physician can prohibit substitution on a electronic prescription by:
Physician must note “brand medically necessary”
For Medicaid: physician must also fax or mail a written copy stating brand medically necessary within 30 days
Out of State, Mexican, Canadian Substitution
They MUST authorize substitution, rather than prohibit it
Pharmacist Responsibility for Substitutions
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”
Substituting Dosage Forma
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
Pharmacy Displays
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
Can I make a copy of my original license or renewal certificate?
No but you can make a copy of your pocket license
Emergency Refills
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
What drugs are allowed a 72 Hour Emergency Refill?
All Dangerous Drugs and C3, C4, C5
Not C2!!
90 Day Supply and Accelerated Refills
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
Administration of Epinephrine
- 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
Physician Administration and Dispensing
Texas does not generally permit physician Dispensing
Exceptions: 72 hour supply of Dangerous Drugs to meet immediate needs, physicians in rural area, veterinarians
Impaired Pharmacists/Students
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
Peer Review Program
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
Reporting Professional Liability Claims
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)
