IPP Exam 3- Burns and Nottingham

What are the 3 types of potential legal concerns facing pharmacy providers?

• civil

• administrative

• criminal

when a private party (plaintiff) sues another party (pharmacy/cist), which of the following does that describe?

a. administrative

b. criminal

c. civil

c-civil

when action is taken by an agency like the DEA or FDA to enforce it’s regulations, which of the following does that describe?

a. administrative

b. criminal

c. civil

a-administrative

investigates crimes, prosecute those that commit crimes, and hold them accountable, which of the following does that describe?

a. administrative

b. criminal

c. civil

b-criminal

What is the most common type of legal claim involving pharmacist?

malpractice (negligence)

What is the most common medication error? (81% of errors)

misfilling prescriptions (mechanical error)

What is the difference between a mechanical and intellectual error?

mechanical- dispensing errors

• wrong drug, wrong strength, wrong directions

intellectual- scenarios where pharmacists don’t detect things

• pt counseling, miss interactions, miss allergies, non-bodily injury (breach HIPPA), compounding errors

Why are compounding claims more expensive than others?

can effect more people

What is the “Duty to Warn” theory?

pts injured by prescription drugs claim that pharmacist had duty to warn about the potential ADRs

A HIPPA violation falls under which of the following?

a. civil

b. administrative

c. criminal

a

In addition to civil, medication errors can also be an administrative legal concern.

What is the difference between med errors that are classified as civil and those that are administrative?

Unlike malpractice actions that require the plaintiff to prove harm, administration actions do NOT require actual patient harm to proceed

Which of the following has a possible consequence of jail time?

a. civil

b. administrative

c. criminal

c

Noncompliance leads to…

legal consequences

Which of the following is the LEAST regulated by the FDA?

a. prescription drugs

b. OTC

c. controlled substances

d. dietary supplements

d

What is the poison prevention packaging act?

• special packaging

  • like childproof/ adult-friendly

Should pharmacy interns counsel?

NO!

What is the State pharmacy practice act?

• passed by legislature to regulate pharmacy in the state

• this act creates a “board” of pharmacy that passes rules/regulations for pharmacy and enforces the act

• act gives broad authority to BOARD

• in general: BOARD ENFORCES PHARMACY ACT

Claims are primarily divided into what 2 categories?

• mechanical errors

• intellectual errors

What are the 4 steps to the risk management process?

1. identify risk

2. select technique

3. implement the technique

4. monitor and make necessary changes

What does the phrase “triple check plus two” mean?

• used to reduce med errors

  • triple check the medication

  • Plus 1: check NDC numbers

  • Plus 2: show & tell counseling

What are 3 benefits of patient counseling?

1. better informed patient= increased likelihood of positive outcome

2. allows more opportunity to detect mechanical error

3. fulfills the pharmacist’s legal duty

Can a pharmacist be sued if the prescription is filled correctly?

YES

Pharmacy professional liability is generally available in 2 layers. What are those 2 layers?

1. primary layer- policy that pays 1st in the event of a claim

2. excess layer- 2nd layer of protection

The _____________________ is the MOST the policy will pay for any ONE incident or loss.

The per occurrence limit is the MOST the policy will pay for any ONE incident or loss.

The ____________________ is the MOST the policy will pay during any one policy year.

The aggregate limit is the MOST the policy will pay during any one policy year.

What provides coverage cost of hiring an attorney to defend claims against a member’s license?

pharmacy license defense

Naloxone or Narcan is for everyone who overdoses with __________.

opiods

Is naloxone FDA approved?

yes

How is naloxone used?

• spray into nose

• works quickly

  • person usually wake up within 1-3 minutes

• repeat as necessary

• call 911

• stay with the person

• lay the person on their side to prevent choking

Will naloxone harm someone who doesn’t have opioids in their system?

NO!!!!

What are the PA laws on access to naloxone?

PA has statewide standing order access to naloxone

If I was parading around the streets of Erie and stumbled upon a man overdosing on oxy, and I administered naloxone, should I still call 911 or just go back to doing what I was doing?

call 911- naloxone is TEMPORARY tx