Pharm Law Final Exam (Pennsylvania)

What are the members that make up the State Board of Pharmacy (9)

1. Commissioner of Professional and Occupational Affair

2. Director of Bureau of Consumer Protection

3. Public Representative

4. Public Representative

5. Independent Retail Pharmacist

6. Independent Retail Pharmacist

7. Retail Chain Pharmacist

8. Retail Chain Pharmacist

9. Acute Care Institutional Pharmacist

The executive secretary of the State Board of pharmacy must be a __________________ __________________, and the board counsel must be an ________________.

Licensed pharmacist, attorney

How long is a term on the State Board of Pharmacy?

6 years

Who is responsible for writing the laws and regulations for the practice of pharmacy?

The State Board of Pharmacy

True or False: the DEA issues pharmacist licenses and renewals

False: the State Board of Pharmacy does this

After the SBOP conducts an inspection, how long must the report be maintained on the pharmacy premises?

For 2 years

A license ______________ means that the pharmacist will not get their license back

Revocation

A license ______________ means that the pharmacist has the opportunity to gain their license back as long as they complete all requirements

suspension

True or False: felony in connection with the practice with the practice of pharmacy or any offense involving moral turpitude will NOT cause someone to have some form of license penalty

False: this will cause suspension or revocation

In what way would someone be able to maintain their license if they are found to have impaired professional duties due to alcohol or drugs?

They would have to self-report, and prove that they are in the efforts to rehab themselves

True or False: there is nothing wrong with a pharmacy advertising controlled substances

False: this is not allowed, and if this is done they will face penalties (suspension/revocation)

What are stark laws?

This says you cannot recommend the services of another for compensation

If a pharmacy is telling their patients to go to a specific doctor, and the doctor is telling their patients to go that specific pharmacy, what law is this violating?

Stark laws

Are drugs marked "sample" allowed to be resold?

No, you cannot resell a sample drug to patients

What condition must a drug be in in order for a pharmacy to take it as a return, and redistributed it?

It must be in the original, sealed container with the name, LOT number, and expiration date on the original manufacturer's label

If atenolol tablets have been placed into an amber vial and distributed to a patient, may the pharmacy take this medication back and redistribute it?

No, because it is not in the original sealed container

How must a person be to apply for a pharmacist license?

21 years

What are all of the criteria that must be met in order to apply for a pharmacist license in PA?

-Be at least 21 years old

-Be of good moral/professional character

-Graduate from an accredited school of pharmacy

-Complete a board-approved internship

-Pass a licensure exam

-Not be in the possession of a felony conviction related to controlled substances

How often does a pharmacist renew their license?

Every 2 years

The period for pharmacist license renewal runs from ________________ to _________________.

October 1 - September 30

How many CE credits must be earned during every renewal period for a pharmacist to be eligible for license renewal?

30 CE Credits

If someone is changing their name or address how soon must the SBOP be notified?

Within 10 days

True or False: pharmacist CE credits must be completed in person

False: they do not have to be live

If a pharmacist obtains 32 CE credits in one renewal period, will the extra 2 CE credits roll over to the next renewal period/

No, these will not carry over to the next period

How long must CE certificates be maintained?

For 2 years after renewal

What are the CE credits that are required every renewal period?

2 in child abuse recognition

2 in pain management/opioid dispensing

2 in patient safety

Explain how CE credits are different for new graduates:

Newly licensed graduates are exempt from obtaining all 30 CE credits during their first period.

However, they must still obtain 2 in child abuse and 2 in pain management/opioid dispensing

True or False: newly licensed graduates are exempt from all CE credits during their first renewal period

False: they must still obtain 2 in child abuse and 1 in pain management/opioid dispensing

What is the rule regarding CE credits and pharmacist who chose to administer injectables?

If a pharmacist is choosing to administer injectables (vaccinate), 2 of their CE credits must be relative to this topic

________________ is the process whereby a pharmacist license is transferred from one state to another

Reciprocation

If an Ohio pharmacist becomes a Pennsylvania pharmacist in the middle of the renewal period (October 2025), how many CE credits will they need to obtain?

They will only need 15 for that renewal period since they came into the State halfway through the period

If an Ohio pharmacist becomes a Pennsylvania pharmacist in the beginning of the renewal period (October 2024), how many CE credits will they need to obtain?

They will still need to obtain all 30 CE credits

In an institutional setting, what all must be contained on the badge that the employee wears?

-A recent photo

-Name

-Title

-Name of the employee's health care facility or employment agency

A pharmacy _______________ is the supervised practical experience required for licensure as a registered pharmacist

internship

What is the criteria for applying for a PA intern license?

-Must be enrolled in a School of Pharmacy

-Possess good moral character

-Have completed 2 years of college study

How long is an intern license valid for?

6 years

How many internship hours are required for licensure?

1500

An intern may not claim more than __________ hours per week

50

(they can work more than 50, but can not take credited for more than 50)

How many interns may be registered under a single preceptor at a time?

2 interns

(unless otherwise approved by the SBOP)

If a pharmacist is not employed at the same place as you, are they eligible to be your preeptor?

No

True or False: every pharmacy must obtain an individual permit, even if they are owned by the same person

True

The _____________ ________________ accredits institutional pharmacies

Joint commission

True or False: a pharmacist is permitted to be the pharmacist-manager of more than one pharmacy at a time

False

If a pharmacist-manager stops working at a pharmacy, it is very important that they do what?

Remove their name from the permit

What information must be contained on a pharmacy permit?

The name and address of the pharmacy, the name of the owner, the name of the pharmacist manager

True or False: it is ok for the pharmacy to remain open while the pharmacist has left the premises

False: they must remain in the physical structure of the building

What are all of the documents (registrations) that a pharmacy must have displayed at all times

1. Federal DEA registration

2. PA Pharmacy permit

3. Pharmacist AND intern licenses

In order to ship medications into the Commonwealth, what must non-resident pharmacies first do?

They must register for a non-resident license with the PA SBOP

How often are pharmacy permits renewable?

Every 2 years

Pharmacy permits are renewable during __________ numbered years, and pharmacist licenses are renewable during ______________ numbered years.

Odd, even

What is the renewal period for pharmacies?

September 1 - August 31

Where does the pharmacy permit go if it decides to close?

Back to the SBOP

When must a pharmacy notify the SBOP if they are deciding to close?

30 days before closing

If a pharmacy is changing their name, ownership, or controlling interest, when must the SBOP be notifed?

30 days before the change

If a pharmacy is changing their pharmacist-manager, how soon must the SBOP be notified?

!5 days before the pharmacist-manager leaves

If a pharmacy is having trouble finding a new pharmacist manager, how long of an extension do they have?

30 days

If a pharmacy has to appoint a pharmacist-manager that is also serving as pharmacist-manager of another pharmacy, how long can this occur for?

60 days

In what case would someone be able to regain a revoked license?

The license may be reinstated via a court order

They would have to apply for a new license

How soon may a person reapply for a license after it has been revoked?

After 5 years of revocation

(after 10 years if the revocation included a felony conviction)

If someone waits for the whole 5 years period, then reapplies for a license after theirs has been revoked, are they guaranteed to receive it back?

No

When will a suspended license be reinstated?

After the period of suspension is complete and all CE requirements are met

How long does a pharmacist have to report discipline in one jurisdiction to the other jurisdictions that they are licensed in?

90 days

How long does a pharmacy have to report discipline in one jurisdiction to the other jurisdictions that they are licensed in?

30 days

If a pharmacist is convicted of a felony, will they be allowed to stay in practice?

No

If a new pharmacy is being built, how soon must the SBOP be notified of the plans?

90 days in advance

If a pharmacy has decided to do some sort of remodeling, how soon must they notify the board of their plans?

30 days in advance

What is the minimum size requirement for the prescription area?

250 square feet

(needs to be large enough to meet the needs of the particular pharmacy and their daily tasks)

In the prescription area, there must be a working counter of _____________ linear feet in length, and ________ linear feet in width

10, 2

If more than two pharmacists are on duty at the same time, the counter length must be increased by __________ feet for each additional pharmacist

5

True or False: a central processing center must conform to the minimum pharmacy size requirements

False

What Schedule drugs MUST be stored in a locked area?

Schedule 1

True or False: the phone number on the prescription label does NOT need to be the same as the number of the telephone in the prescription area

False: these do need to match

The bathroom should be _____________ (outside or inside) the prescription area

Outside (within reasonable distance)

A pharmacy must have a minimum cost inventory of _____________.

$5000

True or False: outdates and adultered products can remain in the active stock

False: these need to be removed

What are the references that are required to be in the pharmacy?

1. Pharmacy Act and Board Regulations

2. Federal and State Statutes and Regulations Pertaining to pharmacy

3. Adequate and updated reference library

True or False: a pharmacy, such as Giant Eagle, would be allowed to store merchandise from the outside, general store

False

What is a self-contained pharmacy?

This is a pharmacy that operates inside a general store, that closes earlier than the general store

A self-contained pharmacy must be able to be securely sealed from the remainder of the store using a _____________ to ________________ barrier

Floor to ceiling

The _________ of a self-contained pharmacy must be posted at all points of access

Hours

If a self-contained pharmacy has already closed, but a patient asks the store-manager (manager of Giant Eagle) to open the pharmacy and provided them their prescription, is this permissible?

No, the store-manager would need to contact the pharmacy manager and have them open the pharmacy

It what case would a store-manager be able to have access to the pharmacy after it has already closed?

In the case of an emergency (fire), there has to be a protocol for emergency access by non-pharmacist staff

In a ______________ and ______________ pharmacies , controlled substance must be stored in a separate locked space

hospital, LTCF

What was the main effect of Act 102 and Act 29?

These expanded the scope of the pharmacist

(also expanded liability)

How did Act 102 expand pharmacist scope?

-Allowed for the managing of drug therapy in an institutional setting

-Allowed for the administration of injectables, biologicals, and immunizations

Act 102 expanded liability, meaning that a pharmacist must obtain professional liability in the minimum amount of ___________________ per occurence

$1,000,000

What was the significance of Act 29?

Act 29 expanded managing drug therapy to community settings by providing collaborative drug therapy managements (CDTMs)

The ___________ committee determines the products that are on the institutional formulary

P&T Committee

A _________________ DUR is completed prior to dispensing a prescription

prospective

A prospective DUR is mandated by ______________ for all new prescriptions

OBRA

A _________________ DUR is completed after dispensing a prescription

retrospective

According to PA law, how often does a DUR review need to be done for the residents of a skilled nursing facility?

Monthly

According to state law, how often does drug disposal need to be conducted in a LTCF?

On a quarterly basis

In over-the-counter and self-care counseling, the ___________________ is usually the first health care professional that the patient will come in contact with.

pharmacist

True or False: A pharmacist can NOT object to fill/refill a prescription based on their religious beliefs

False: they can do this

If a pharmacist decides that they are not going to fill/refill based on religious, moral, or ethical beliefs, what should they do?

They must adequately explain their objection to their employer, and they cannot be the reason that a patient does not have access to the medication

A pharmacist can not delegate any task that requires ___________________ ________________ to a technician.

Professional judgement

True or False: a technician is not permitted to carry or fill controlled substance prescriptions

False: they can perform both of these functions

True or False: a technician is permitted to transcribe an oral or telephone prescription order from a pharmacist

False

(this is including refills authorizations and prescription transfers)

Once a technician has been trained in a specific task, it must be outlined in a written _______________.

protocol