L6 Prescribing, OBRA' 90, and DSHEA Flashcards
T or F:
authority to prescribe is defined by the federal gov
F, NOT defined, left to states to determine as established by the Durham-Humphrey Amendment
what are the big 4 prescribers with authority to prescribe in every jurisdiction
physicians
dentists
podiatrists
vets
T or F:
“Full Prescribers” scripts are honored only in the state of their jurisdiction
false, if they have a license in one place they can prescribe anywhere
what are some examples of mid-level prescribers
NP
PA
optometrist
pharmacists
naturopaths
chiropractors
psychologists
scope of practice:
Physicians
whole body authority for humans
scope of practice:
dentists
mouth and maxillofacial area for HUMANs
scope of practice:
podiatrists
feet
ankles
some places (hands) for humans
scope of practice:
vets
whole body authority for all animals
scope of practice:
mid-levels
depends upon their scope of training, the specialty of their supervisor, and/or formulary of drugs they are allowed to prescribe
T or F:
From a federal standpoint, there are no uniform standards for non-controlled prescriptions in the US
true
t or F:
federal law frequently addresses prescription expiration or refills
F, DOES NOT address. dont really know what this means
if the fed gov does not address prescriptions, refills, and expiration dates, what do they address?
prescription labels
what are the 4 prescription label requirements with no strings attached
-name and address of dispenser
- prescription number
- date of prescription OR its filling
- name of prescriber
what are the 3 prescription label requirements with strings attached (if’s)
- if stated on the prescription -> name of patient
- if contained on the prescription -> any directions for use
- if contained on the prescription -> any cautionary statements
why can the date on a script be either date written or date filled?
because nothing in fed law requires a prescription to be dated
INDIANA refill rules:
OTC, Non-Control
A. one year
B. six months
A
INDIANA refill rules:
Rx-only, Non-Control
A. one year
B. six months
A
INDIANA refill rules:
OTC or Rx-only, CIII, CIV, CV
A. one year
B. six months
B
INDIANA refill rules:
Rx-only, CII
A. one year
B. six months
A, surprisingly
INDIANA refill rules:
How many refills?
OTC, Non-Control
A. No rule
B. Five
C. Not refillable
A
INDIANA refill rules:
How many refills?
Rx-only, Non-Control
A. No rule
B. Five
C. Not refillable
A
INDIANA refill rules:
How many refills?
OTC or Rx-ONly, CIII, CIV, CV
A. No rule
B. Five
C. Not refillable
B
INDIANA refill rules:
How many refills?
Rx-only, CII
A. No rule
B. Five
C. Not refillable
C
Indiana refill rules:
when does the expiration clock start ticking for any med basically
when it is issued (in the hands of the patient)
What did the OBRA ‘90 aw target?
spending on medications by medicaid beneficiaries
OBRA ‘90
4 primary requirements related to pharmacy practice:
- Prospective Drug Utilization (DUR)
- Retrospective Drug Utilization Review
- Offer to Conduct Patient Counseling
- Maintaining Patient Records
T or F:
OBRA ‘90:
states were left to implement laws. many applied these laws to all patients, not just medicaid
true
what is meant by prospective DUR from OBRA ‘90?
pharmacist must review drug therapy before each prescription is filled for accuracy and appropriateness
6 things included in Prospective DUR
- therapeutic duplications
- drug-disease CI’s
- DDI
- Incorrect dosage or duration of treatment
- Drug allergies
- clinical abuse and/or misuse
OBRA ‘90
T or F:
states must review med use of drugs and compare how they are being used against accepted standards
true
OBRA ‘90 Patient Records:
pharmacist must make an effort to obtain, record, and maintain AT LEAST what 3 things? (kinda more than 3 but grouped up)
- name, address, phone #, DOB (or age), gender
- individual hx where significant (disease states, drug allergies, list of meds and devices)
- pharmacist comments relevant to individuals drug therapy
T or F:
most things related to patient counseling through OBRA ‘90 apply to all patients under law
FALSE, only to medicaid patients BUT most states have extended it to all pts
T or F:
the FDA has authority to classify supplements with a potency >150% of rec daily allowance as drugs
FALSE, stripped of this ability in 1976, could no longer regulate special dietary needs claims as a result
what is DSHEA?
dietary supplement health and education act
why was DSHEA passed?
to clarify the place in the law for dietary supplements
DSHEA def of dietary supplement
a product (other than tobacco) intended to supplement the diet that contains one or more of the following: (will make another card for this)
what are the 4 things that DSHEA defined a dietary supplement as? (“contains one or more of the following”)
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
5 things all dietary supplement labels MUST contain under DSHEA
- name of product and phrase “dietary supplement”
- quantity of contents
- manufacturers, packers, or distributors name and address
- directions for use
- a supplement facts panel containing serving size, list of dietary ingredients, amount per serving size, % daily value if established
what are the 3 types of claims manufacturers CAN make about dietary supplements?
- health claim
- nutrient content claim
- structure-function claim
DSHEA:
relationship between a product and it’s potential impact on an approved disease state or condition
A. health claim
B. nutrient content claim
C. structure-function claim
A
DHSEA:
relative description of the nutrient or dietary substance in the product
A. health claim
B. nutrient content claim
C. structure-function claim
B
DSHEA:
description of maintaining proper body function independent of specific disease states
A. health claim
B. nutrient content claim
C. structure-function claim
C
if a dietary supplement contains any of the 3 claims, what must accompany it?
FDA disclaimer:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease.”
