Lecture #6 Flashcards
What is prescribing authority?
Authority to prescribe is not defined by the federal government, this is left to states to determine as established by the Durham-Humphrey Amendment.
* As a result, there are many differences in who can prescribe between different states/territories.
* We will highlight the similarities amongst all states and talk in generalities a bit for now, but we will be addressing this topic again once we start talking about Indiana Law.
What are the big four?
Four prescribers are recognized as having the authority to prescribe in every jurisdiction:
* Physicians (MD/DO)
* Dentists (DDS/DMD)
* Podiatrists (DPM)
* Veterinarians (DVM)
These prescribers are also known as “full prescribers.” Full prescribers’ 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.
Who are mid-level prescribers?
All practitioners outside of the big four that have authority to prescribe.
* Can include advance practice nurses, physician assistants, optometrists, pharmacists, naturopaths, chiropractors, psychologists, etc.
* Mid-level prescribers do not necessarily have authority to prescribe across all states, and their prescriptions may not be honored in all jurisdictions.
* We will cover Indiana later, for now, know that the big four can prescribe everywhere and mid-level prescribers cannot
What is scope of practice?
Scope of Practice answers the question “What can they prescribe for?”
* 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
Be sure to differentiate between Scope of Practice and 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)
* If you aren’t sure whether a prescriber is writing a prescription within their scope, gather more information from the patient or prescriber
What is law of agency?
This is utilized when a prescriber authorizes an “agent” (another person without independent authority to prescribe) to deal with a third party (a pharmacy, in this context).
* Through this, a nurse or medical assistant can call in a prescription, clarify an order, and complete other tasks on behalf of the prescriber.
* An agent cannot make decisions on behalf of the prescriber, they may only be their voice. If a decision is required, the prescriber must be directly involved, or have provided direct guidance to the agent.
What are prescription requirements?
From a federal standpoint, there are no uniform standards for non- controlled prescriptions in the United States
* Additionally, federal law does not address prescription expiration or refills.
* Because of this lack of federal guidance, you will see wide differences from state to state on prescription requirements and refill/expiration limitations.
What are prescription labels?
While the federal government does not address prescriptions, refills, and expiration dates, they do address prescription labels. These requirements will be expanded upon as we discuss controlled substances and Indiana state law, but serve as a good starting point.
* Prescription labels allow prescription drugs to be exempted from many of the subsections of the misbranding law, and still in compliance with the law so long as they are dispensed pursuant to a valid prescription.
* All products, whether dispensed pursuant to a prescription, or in a manufacturer bottle, must follow subsections (a), (g), (h), (i)(2), (i)(3), (k), (l), and (p)
What are prescription label requirements?
To be exempted from misbranding, a prescription label must contain:
1. The name and address of the dispenser
2. The serial number of the prescription (prescription number)
3. The date of the prescription or its filling
4. The name of the prescriber
5. If stated on the prescription, the name of the patient
6. If contained on the prescription, any directions for use
7. If contained on the prescription, any cautionary statements
What are prescription label quirks?
Some of the things on the previous list aren’t always on the prescription, so they are not always required to be on the prescription label
* Nothing in federal law requires a prescription to be dated, which is why the date on the label is either the date written or the date filled
* The prescription label must have the name an address of the dispenser, not the name and address of the pharmacy that filled the prescription. Consider a central fill pharmacy – it would list the final pharmacy address, not its own address, on the prescription label.
Indiana refill rules: how long can a prescription be refilled?
OTC, non-control: one year
Rx-only, non-control: one year
OTC or Rx-only, CIII, CIV, CV: 6 months
Rx-only, CII: one year
Indiana refill rules: how many full refills are allowed?
OTC, non-control: no rule
Rx-only, non-control: no rule
OTC or Rx-only, CIII, CIV, CV: 5
Rx-only, CII: not refillable
Indiana refill rules: when does the expiration clock start ticking?
OTC, non-control: date issued
Rx-only, non-control: date issued
OTC or Rx-only, CIII, CIV, CII: date issued
Rx-only, CII: date issued
1990: Omnibus budget reconciliation act (OBRA’90)
Omnibus laws are passed regularly, and are utilized to adjust federal spending, revenues, and debt ceiling language
* The OBRA ’90 law targeted spending on medications by Medicaid beneficiaries. There were four primary requirements related to pharmacy practice:
1. Prospective Drug Utilization Review (DUR)
2. Retrospective Drug Utilization Review
3. Offer to Conduct Patient Counseling
4. Maintaining Patient Records
* States were left to implement laws. Many applied these laws to all patients, not just 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
Law requires an offer to have a pharmacist counsel the patient be made
* 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.
Dietary supplements as drugs
Dietary supplements skirt the line between food and drug product, and the FDA tried to better clarify how they were regulated, with a focus on limiting those products making unfounded health claims.
* First attempted to classify them as drugs under the Federal Food, Drug and Cosmetic Act (FDCA) of 1938, but could not implement many labeling restrictions due to United States v. Sterling Vinegar and Honey ruling.
* In 1976, FDA was stripped of the authority to classify supplements with a potency greater than 150% of the Recommended Daily Allowance as drugs and could not regulate special dietary needs claims as a result.
Dietary supplements as food additives
After 1976, the FDA classified dietary supplements as food additives to ensure pre-market approval, with the opportunity to classify products as “unsafe food additives” under the FDCA.
* Manufacturers challenged that dietary supplement ingredients should be considered foods and be generally recognized as safe.
* Courts agreed with manufacturers, stating that the food additive definition “is so broad, however, that it would . . . classify every component of food—even single active ingredients—as food additives.”
* Manufacturers also attempted to persuade the general public
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:
1. The name of the product and the phrase “dietary supplement”
2. The quantity of the contents
3. The manufacturer’s, packer’s, or distributor’s name and address
4. Directions for use
5. A supplement facts panel containing serving size, list of dietary ingredients, amount per serving size, and percent daily value if established.
What are the 3 types of claims manufacturers can make?
- Health Claim – relationship between a product and it’s potential impact on an
approved disease state or condition - Nutrient Content Claim–relative description of the nutrient or dietary substancein the product
- Structure-Function Claim – description of maintaining proper body function independent of specific disease states
Dietary supplement claims
Health claims and nutrient content claims must be FDA approved, structure- function claims do not require prior approval
* 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.”
