Lecture 6 Flashcards
Objectives
-Distinguish the differences between full and mid-level prescribers, and determine whether a prescriber has prescribing authority given information about the prescriber
-Interpret a prescription and ensure the prescription and the subsequent prescription label contain all the required components
-Describe the impact of OBRA ‘90, MedWatch, and the Drug Supply Chain Security Act on pharmacy practices
Prescribing Authority
The big four
Physicians (MD/DO)
Dentists (DDS/DMD)
Podiatrists (DPM)
Veterinarians (DVM)
also known as full prescribers - theses prescriptions are honored in any part of the united states so long as they are licensed in at least one jurisdiction of the united states
Mid-level Prescribers
Can include advance practice nurses, physician assistants, optometrists, pharmacists, naturopaths, chiropractors, psychologists, etc.
Not necessarily have authority to prescribe across all states and their prescriptions may not be honored in all jurisdictions
essentially Big four can prescribe everywhere and mid level prescribers cannot
Scope of Practice
helps us know what they can prescribe
Physicians: whole body authority for humans
Dentists: mouth and maxillofacial (jaw and face) area for humans
Podiatrists: feet, ankles, and (in some places) hands for humans
Veterinarians: whole body authority for all animals
Mid-level Practitioners: depends upon their scope of training, the specialty of their supervising practitioner, and/or the formulary of drugs they are allowed to prescribe.
Scope of Practice vs. Specialty Practice
A dentist can prescribe an antibiotic for a tooth infection, but not a respiratory infection (not in her scope)
A dermatologist can prescribe for a respiratory infection, even though their specialty is the skin, hair and nails (dermatologists must have an MD or DO, and their scope of practice is the whole body for humans)
Agency Law/Law of Agency
When a prescriber authorizes an agent to deal with a third party
a nurse can call in a prescription, clarify an order, and complete tasts on behalf of the prescriber - THEY CANNOT MAKE DECISIONS FOR THE PRESCRIBER ONLY BE THE VOICE
Prescription Label Requirements
To be exempted from misbranding, a prescription label must contain:
-The name and address of the dispenser
-The serial number of the prescription (prescription number)
-The date of the prescription or its filling
-The name of the prescriber
Only required if STATED ON PRESCRIPTION
-If stated on the prescription, the name of the patient
-If contained on the prescription, any directions for use
-If contained on the prescription, any cautionary statements
Most of the time the script will have patients name, direction of use, and any cautionary statements
Prescription Label Quirks
No requirment on dating the prescription thats why it will usually have the date it was written or the date filled
Must have the name and address of the dispenser not the pharmacy that filled it
Indiana refill rule
OTC, non-controlled
How long can a prescription be refilled: one year
How many full refills are allowed: no rule
When does the expiration clock start ticking: date issured
Indiana refill rule
rx only, non-controlled
How long can a prescription be refilled: one year
How many full refills are allowed: no rule
When does the expiration clock start ticking: date issued
Indiana refill rule
OTC or RX only , CII, CIV, CV
How long can a prescription be refilled: six months
How many full refills are allowed: five
When does the expiration clock start ticking: date issued
Indiana refill rule
Rx-only CII
How long can a prescription be refilled: one year
How many full refills are allowed: not refillable
When does the expiration clock start ticking: date issued
1990: Omnibus Budget Reconciliation Act (OBRA ’90)
There were four primary requirements related to pharmacy practice:
Prospective Drug Utilization Review (DUR)
Retrospective Drug Utilization Review
Offer to Conduct Patient Counseling
Maintaining Patient Records
May apply these laws to all patients not just medicaid - For first exam this only applies for MEDICAID
OBRA ’90: Prospective DUR
Pharmacist must review drug therapy before each prescription is filled for accuracy and appropriateness. Review should include:
Therapeutic duplications
Drug-disease contraindications
Drug-drug interactions
Incorrect dosage or duration of treatment
Drug-allergy interactions
Clinical abuse and/or misuse
OBRA ’90: Retrospective DUR
States must review medication use of drugs and compare how they are being used against accepted standards.
Usually state appointed DUR panel, compiled of physicians (33% minimum), pharmacists (33% minimum), and other health care professionals.
Panel looks for adverse drug events and monitors for signs of potential drug abuse.
Based upon review, panel can recommend changes to prescribing habits and/or educational programs for health care providers.
OBRA ’90: Patient Counseling
This only applies to Medicaid patients under OBRA ’90, though many state legislatures have extended this to all patients.
Pharmacist should counsel on matters which, in the pharmacist’s professional judgement, are significant, including:
The name and description of the medication
Route, dosage form, dosage, administration, and duration of therapy
Special directions on preparation, administration, or use by the patient
Common severe side or adverse effects
Techniques for self-monitoring drug therapy
Proper storage
Prescription refills
Action to be taken in the event of a missed dose
Nothing in this clause requires consultation when an individual refuses such consultation
OBRA ’90: Patient Records
A reasonable effort must be made by the pharmacist to obtain, record, and maintain at least the following information:
Name, address, telephone number, date of birth (or age) and gender
Individual history where significant, including disease state(s), known allergies and drug reactions, and a comprehensive list of medications and relevant devices
Pharmacist comments relevant to the individuals drug therapy
Like patient counseling requirement, this only applies to Medicaid patients under OBRA ’90, though many state legislatures have extended this to all patients.
1994: Dietary Supplement Health and Education Act (DSHEA)
DSHEA was passed to clarify the place in the law for dietary supplements
Defined a dietary supplement as a product (other than tobacco) intended to supplement the diet that contains one or more of the following:
a vitamin,
a mineral,
an herb or other botanical,
an amino acid,
or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.
Dietary Supplement Labeling
All Dietary Supplement labels must contain:
The name of the product and the phrase “dietary supplement”
The quantity of the contents
The manufacturer’s, packer’s, or distributor’s name and address
Directions for use
A supplement facts panel containing serving size, list of dietary ingredients, amount per serving size, and percent daily value if established.
Dietary Supplement Claims
Health claims
Health Claim – relationship between a product and it’s potential impact on an approved disease state or condition
Dietary supplement claims
Nutrient content claim
Nutrient Content Claim – relative description of the nutrient or dietary substance in the product
Dietary supplement claims
Structure-Function Claim
Structure-Function Claim – description of maintaining proper body function independent of specific disease states
Dietary Supplement Claims
summary
Health claims and nutrient content claims must be FDA approved
A product containing any of these claims must carry the following disclaimer:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent disease.”
