chapter 1 (UMPJE) - pharmacy practice, malpractice

What can't interns do? (3)

Make the final verification of a medication order prior to dispensing

Supervise technicians

Sign any documents that require a signature of a PharmD

Interns can generally perform most tasks that a pharmacist can but they must be done under ______ of a pharmacist or preceptor

SUPERVISION

Technicians must be licensed and _____

certified

Can optometrists or opthalmologists prescribe?

Optometrists (OD) can

Opthalmologists (MD/DO) can

What information is required on a prescription when issued? (7)

Patient name

Drug name

Dosage

Directions

Prescriber name

Date of issuance

Any cautionary statements

Emergency refills are typically limited to a ___ hr supply in most states

72

OBRA90 Meaning

Omnibus Budget Reconciliation Act of 1990

Mandated PROSPECTIVE DUR for all medicaid pts receiving new RX

Before OBRA PharmD could only just fill prescriptions

After OBRA PharmD can review therapy, counsel, catch problems, etc

Originally only applied to Medicaid patients but now we adopted these standards for all patients

T/F: OBRA 90 required PharmD's to OFFER counseling to Medicaid pts on new RXs

True - now most states expanded to ask everyone

The key is OFFER to counsel, they dont force the counseling if they dont want it

What is CPMP?

Customized Patient Medication Packages

EX: med packs, AM/PM blister packs

CPMP BUD

60 day max or earliest manufacturer expiration date

T/F: You must include a physical description of each medication in a CPMP

True

T/F: You can have controls in a CPMP

True! There is no restrictions on controls in the packs

Unit dose repackaging BUD (2)

EARLIEST OF:

1 year from repackaging

25% of time remaining until manufacturer expiration

T/F: CPMP can be returned to pharmacy and placed back to stock

NO - can't be returned and should not be used to fill a different patients prescription

What drugs can be returned to pharmacy? (2)

LTCF non-controls in unit dose or OG packaging

Inpatient unit dose meds

Requirements to give vaccines (5)

Initial training and certification (minimum 20 hrs)

BLS or BCLS

Continuing education

Protocols with collaborating physicians

Reporting administration to PCP

What is the PREP act?

Public Readiness and Emergency Preparedness Act

Allows pharmacists to give COVID & flu vaccines to >3 years until 12/31/2029

Where do you report vaccine adverse effects?

VAERS (Vaccine Adverse Effect Reporting System)

What is the primary purpose of state BOP?

Protect the public health, safety, and welfare

T/F: State BOP advocate for our profession

FALSE - they dont, thats what organizations like APhA are for

What is rulemaking with the BOP?

How pharmacy laws and rules get created or changed

Formal multistep process

What are the steps of BOP rulemaking? (6)

Notice of proposed action

Public comment period

Public hearing

Reviews/revisions

Final adoption

Publication/effective date

T/F: Pharmacies can refuse inspections from the BOP

False!

What is a malpractice claim?

Civil lawsuit agains pharmacist/pharmacy that is based on negligence

Most severe disciplinary action when a PharmD screws tf up and license is withdrawn and no longer in effect

A. Suspension

B. Revocation

C. Reprimand

D. Probation

B. Revocation

Least severe disciplinary action, doesnt restrict ability to practice

A. Suspension

B. Revocation

C. Reprimand

D. Probation

C. Reprimand

The most common method of adopting rules and regulations by the BOP is known as

A. Notice and comment rulemaking

B. Intent and action rulemaking

C. Emergency rulemaking

A. Notice and comment rulemaking

4 ELEMENTS OF MALPRACTICE

Duty owed - pharmacist has duty of care

Breach duty - pharmacist failed standard of care

Causation - breach caused harm

Damages - patient suffered injury/damages

T/F: Simply filling a prescription is an example of a duty owned

True - PharmDs have a duty to patients to fill a RX correctly

A malpractice claim is ____ in natrue

civil

Doing something wrong

A. Commission

B. Omission

A. Commission

you COMMIT an act

Failing to do something

A. Commission

B. Omission

B. Omission

OOPS i forgot

Person suing

A. Plaintiff

B. Defendant

A. Plaintiff

Person being sued

A. Plaintiff

B. Defendant

B. Defendant

Did the pharmD's action directly cause the harm? Would this have happened if the PharmD didnt do that?

A. Actual cause

B. Proximate cause

A. Actual cause

Ex: warfarin 10mg instead of 1mg causing bleed

Was the harm reasonably forseeable? Was the bad outcome predictable?

A. Actual cause

B. Proximate cause

B. Proximate cause

We dont want to blame people for totally random things

Ex: PharmD gives wrong BP med and the patient faints.

That is predictable and so the pharmacist is probably liable.

Money to help cover the pts losses: hospital bills, pain, lost wages

A. Actual damages

B. Punitive damages

A. Actual damages

Extra punishment money for reckless behavior, negligence, etc. This punishes the PharmD

A. Actual damages

B. Punitive damages

B. Punitive damages

Something that is not just a normal human mistake but reckless so paying patient more bc pharmD is dumb

Most states require ~ ___ CE hrs/year for pharmacist license renewal

15

1 hour of CE = ___ CEU

0.1 CEU

continuing education units

What are the common required CE topics? (5)

Pharmacy law

Medication error prevention

Opioids/pain management

Immunizations

Human trafficking awareness

Kroger sends the RX somewhere to be physically fills and then it gets shipped back to Krogers for patient to pick up

A. Central fill

B. Centralized processing

C. Remote order verification

A. Central fill

Data entry, DUR, clarifying RX at another facility, but the dispensing is still done at the local Krogers

A. Central fill

B. Centralized processing

C. Remote order verification

B. Centralized processing

allows for verifying from a remote location

A. Central fill

B. Centralized processing

C. Remote order verification

C. Remote order verification

What is one requirement that a drug kiosk must have?

Audio-visual connection to the pharmacy to allow a pharmD to counsel the pt if needed

A pharmD is moving to a new address, what is the required time frame for notifying the BOP?

A. Within 30 days

B. At the time of next license

C. Within 10 days

D. Within 60 days

C. Within 10 days

A pharmD is renewing their license and cannot find their CE certificates from 3 years ago. The BOP audit policy usually requires records to be kept for:

A. 2 years

B. 4 years or two full renewal cycles

C. 10 years

D. Indefinitely

B. 4 years or two full renewal cycles

A summary suspension of a pharmD license occurs:

A. After a full 3 day hearing

B. When the board determines that the public health & safety are in immediate danger

C. When a pharmD fails to pay their renewal fee

D. Every time a pharmD is charged with a misdemeanor

B. When the board determines that the public health and safety are in immediate danger

Ratio of pharmD to interns at a vaccination clinic

six

What is the maximum duration of techician trainee registration before it expires?

24 months