Pharm Law lecture 6

Question 1

What did the durham humphrey amendment establish?

Answer 1

Authority to prescribe is not defined by federal govt, this is left to the states

Question 2

What are the big 4 prescribers

Answer 2

Physicians
Dentists
Podiatrists
Veterinarians

These are full prescribers, honored in any part in the united states

Question 3

Who are the mid level prescribers

Answer 3

All practitioners outside big four that have authority to prescribe.

Mid level prescribers do not necessarily have authority to prescribe across all states, and their prescriptions may not be honored in all jurisdictions

Question 4

What are the scopes of practice of physicians, Dentists, podiatrists, veterinarians, mid level practioners

Answer 4

Physicians- whole body authority for humans
Dentists- Mouth and maxillofacial (jaw and face area) for humans
Podiatrists- feet ankles and hands for humans
Veterinarians- Whole body authority for all animals
Mid level practitioners- Depends upon scope of training and specialty of supervising practitioner

Question 5

differentiate scope of practice vs specialty practice of dentist and dermatologist

Answer 5

Dentist can prescribe antibiotic for tooth infection, but not a respiratory infection (not in their scope)

Dermatologist can prescribe for a respiratory infection even though specialty is skin, hair and nails. Since they must have MD or DO and scope is whole body for humans

Question 6

What would it be called if a prescription is filled outside their scope of practice

Answer 6

Mislabeled

Question 7

Describe law of agency (agency law)

Answer 7

When a prescriber authorizes an “agent” ( another person without authority to prescribe) to deal with 3rd party (like a pharmacy)

Question 8

What can and cant an agent do according to the law of agency

Answer 8

Agent (nurse or medical assistant) can call in a prescription, clarify an order and complete tasks on behalf of prescriber, they can not make decisions on behalf of prescriber.

Question 9

From a federal POV, what are the standards for non controlled prescriptions?

Answer 9

From a federal POV, there are no uniform standards for non controlled substances in the US

Federal law does not address expiration or refills of prescriptions. SO there is a lot of difference between state to state

Question 10

Which of the following does the federal government address? Expiration dates, refills, prescription labels.

Answer 10

Only address prescription labels

Question 11

What do prescription labels do for a drug

Answer 11

allow prescription drugs to be exempted from many subsections of the misbranding law and still n compliance with the law, so long as they are dispensed pursuant to valid prescription.

Question 12

If a product is dispensed, regardless if it is in a manufacturer bottle or a pursuant of a prescruption, what subsections must it follow

Answer 12

(a), (g), (h), (i) (2), (i) (3), (k), (l), and (p)

Question 13

To be exempted from being misbranded, a prescription label must contain what things

Answer 13

1. Name and address of dispenser
2. serial number of prescription
3. Date of prescription OR its filling
4. Name of prescriber
5. IF STATED ON THE PRESCRIPTION, the name of patient (not always)
6. IF CONTAINED ON PRESCRIPTION, any directions of use (not always)
7. IF CONTAINED ON PRESCRIPTION, any cautionary statements (not always)

Question 14

What are some prescription quirks

Answer 14

1. Nothing requires a prescription label to be dated. Which is why the date on the label is either date written or date filled
2. The prescription label must have the name and address of the dispenser, not name and address of pharmacy that filled prescription. (consider a central fill pharmacy, the address listed shouldnt be the central fill pharmacy, but the dispensing pharmacy)

Question 15

In indiana law, any prescription that is not a controlled substance how long can prescription be refilled? Limit on number of refills

Answer 15

One year, no limit on number of refills

Question 16

For CIII, CIV, CV substances, how long can prescription be refilled? Limit on number of refills?

Answer 16

Prescription can be refilled for 6 months, up to 5 refills

Question 17

For CII substances, how long can prescription be refilled? Limit on number of refills?

Answer 17

One year and it is not refillable

Question 18

What are omnibus laws

Answer 18

Omnibus laws are passed regularly to adjust federal spending revenus and debt ceiling language

Question 19

Describe the OBRA 90 law

Answer 19

The OBRA 90 law targeted spending on medications by medicaid beneficiaries.

States were left to implement laws and many applied to all patients not just medicaid

Question 20

WHat are the 4 requirements related to pharmacy practice for OBRA 90

Answer 20

1. prospective drug utilization review (DUR)
2. Retrospective drug utilization review
3. Offer to conduct patient counseling
4. Maintaining patient records

Question 21

In OBRA 90, what does prospective DUR state

Answer 21

Pharmacists must review drug therapy before each prescription is filled for accuracy and appropriatness

Question 22

What should prospective DUR review include

Answer 22

Duplications
Drug- Drug, Drug- Disease contraindications
Incorrect dosage or duration of tx
Drug-allergy interactions
Clinical abuse and/or misuse

Question 23

What did retrospective DUR state in OBRA 90

Answer 23

States must review medication use of drugs and compare how they are being used against accepted standards

Question 24

What are state appointed DUR panels comprised of? What does this panel look for?

Answer 24

Usually state appointed DUR panels consist of 33% minimum physician, 33% minimum pharmacist and other healthcare professionals

Panel looks for adverse drug events and monitors for signs of potential drug abuse

Question 25

Accoridng to OBRA 90 patient counseling, What does it state? When should pharmacists counsel on matters

Answer 25

Law requires an offer to have a pharmacist counsel the patient be made. Pharmacists should counsel on matters which professional judgment is significant. Nothing in clause requires consultation when individual refuses consultation This ONLY APPLIES to medicaid patients

Question 26

According to OBRA 90, what does it state regarding patient records?

Answer 26

A reasonable effort must be made by pharmacist to obtain, record and maintain atleast the following info (name, address, phone, DOB, gender, allergies, meds, devices)

Question 27

Who MUST dpatient records and patient counseling?

Answer 27

medicaid pts, not all patients

Question 28

What did the dietary supplement health and education act (DSHEA) define a dietary supplement as? Why was it passed?

Answer 28

DSHEA was passed to clarify the place in law for dietary supplements. Defined a dietary supplement as a product other than tobacco intended to supplement the diet

Question 29

According to DSHEA, what must a dietary supplement contain

Answer 29

One or more of the following 1. vitamin 2. mineral 3. herb or botanical 4. amino acid

Question 30

What must all dietary supplement labels include?

Answer 30

1. Name of product and phrase "dietary supplement" 2. Quantity of content 3. Manufacturers packer, distributor name and address 4. directions for use 5. Supplement facts panel containing serving size, list of ingredients, amount per serving size and percent daily value established

Question 31

WHat are the three types of claims a manufacturer of dietary supplement can make

Answer 31

1. health claim- relationship between product and potential impact on an approved disease state or condition 2. Nutrient content claim- Relative description of nutrient or dietary substance in product 3. Structure-function claim- description of maintaining proper body function independent of specific disease states Health claims and nutrient claims must be FDA approved Structure function claims do not require prior approval (but do need to be evidence based)

Question 32

WHat is a disclaimer that must be on dietary supplements

Answer 32

This statement has not been evaluated by FDA. This product is not intended to diagnose, treat, cure or prevent disease