RX422 - Advanced Dosage Forms; DQSA

Dr. Drake's lecture on DQSA, quality control, and your role.

What major event happened in 2012 that was linked to the NECC?

NECC had been acting as a drug manufacturer and sent out contaminated methylprednisolone injections with a fungi that caused meningitis and resulted in 64 deaths.

What is the NECC?

New England Compounding Center

What type of behavior correlates to inadvertent action (Slip, lapse, mistake)

Human error

What type of behavior correlates to a choice or action that increased risks (Shortcuts or workarounds)

At-risk behavior

What type of behavior correlates to a conscious disregard of a substantial and unjustifiable risk; willful decision to disregard safety procedures

Reckless behavior

What should to do if one of your employees makes a human error?

Console them

What should to do if one of your employees is doing at-risk behaviors?

Coach them

What should to do if one of your employees is doing reckless behaviors?

Discipline them

What 6 things were factors in sterile compounding that were faulty in NECC that led to the 2012 incident?

Environmental control

• Air

• Surfaces

Equipment maintenance

Sterilization procedures

Cleaning

Personnel training

What does DQSA stand for?

Federal Drug Quality and Security Act

When was the DQSA signed into effect?

2013 by Obama

What two categories does the DQSA split pharmacies into?

503A

503B

What type of pharmacy does 503A apply to?

Traditional pharmacy

What type of pharmacy does 503B apply to?

Outsourcing facilities

What is the primary responsibility of the state board of pharmacy?

Day-today oversight of state-licensed pharmacies

What does cGMP stand for?

Current good manufacturing practices

What 3 rules must 503A compounding pharmacies follow?

Compounding must be done by or under the supervision of a licensed pharmacist

Compounding must be done in a state-licensed pharmacy

Compounding is done only in receipt of a prescription from a practitioner

• Only compound for a given prescription

What type of compounding pharmacy must follow cGMP?

503B (Outsourcing facilities)

What are the 5 important notes about 503B pharmacies

Compounding must be done by or supervised by a licensed pharmacist

Permitted to manufacture large batches of a product

Does not require specific prescriptions

Does not have to be state-licensed pharmacy

• Regulated by FDA

Require testing every batch of compounded medications prior to release

When compounding in a 503A pharmacy, what can the pharmacist not do?

Can not compound regularly or inordinate amounts of products that are commercially available

When can a 503A compound a copy of a commercially available drug?

Is on the FDA drug shortage list

Is not commercially available during the period of shortage

What does it mean to compound “FOR OFFICE USE ONLY?”

Compounding without a patient-specific prescription

For a practitioner to administer or dispense to patients later

What 2 things must be confirmed for a 503A to compound?

A valid prescription

For an identified patient

What is anticipatory compounding?

Limited quantities based on historical prescription patterns before the receipt of the prescription.

When can a 503A pharmacy anticipatory compound?

Established relationship between pharmacist and prescriber

Prescription is for a specific patient

What is batch compounding in hospitals?

IV bags that are commonly used

When resourcing compounded products from another pharmacy, what happens when something is wrong with it? Who takes the blame?

The pharmacy that gave the patient the medicine, not the compounder.

Who regulates 503B outsourcing facilities?

FDA (cGMP)

What type of compounding can be done in outsourcing facilities?

Sterile

Which type of pharmacy (503A or 503B) must label compounded products beyond normal Rx labels.

503B

Can a technician compound without pharmacist supervision in a 503A facility?

Yes with specific training and if the state allows (Most don’t)

Can a technician compound without pharmacist supervision in a 503B facility?

No