New Things To Know

Question 1

503A

Answer 1

503A facilities are pharmacies that perform traditional compounding based on patient specific prescriptions.

These are regulated by the BOP.

**Compounding in bulk for medical office use (i.e. Not patient specific) is PROHIBITED.

503A permits to preparation of small batches of compound medication in advance if the dispensing history of the store supports the need.

Question 2

503B

Answer 2

503B facilities allows compounding pharmacies that makes sterile products for humans to register with the FDA as an outsourcing facility.

These facilities can prepare medication in bulk and without a prescription written for an individual patient.

503B facilities can compound medications for office use.

Question 3

BUD for Aw >= 0.60

Answer 3

Aqueous Preparations

Non-preserved - 14 days refrigerated
Preserved - 35 days

Question 4

BUD for < 0.60

Answer 4

Non-aqueous Preparations

Oral Liquids - 90 days
Others - 180 days

Question 5

ISO Class and Sterile Compounding

Answer 5

The lower the ISO Class, the lower the particle count and the cleaner the air.

1. Critical Areas - ISO 5 (e.g. in hood or PEC)
2. SEC - ISO 7
3. Anteroom:
   - ISO 8 (if opens to a positive-pressure buffer area: Non-HD sterile compounding)
   - ISO 7 (if opens to a negative-pressure buffer area: HD sterile compounding)

Question 6

BUD of Sterile Compounds

Answer 6

Categories: 1,2,3

Category 1
-RT: 12 hours
-Refrigerated: 24 hours
-Freeze: n/a

Category 2
-RT: 45 days
-Refrigerated: 60 days
-Freeze: 90 days

Category 3
-RT: 90 days
-Refrigerated: 120 days
-Freeze: 180 days

Question 7

What are some things we can do to limit the exposure of HD in pharmacy?

Answer 7

1- Putting drugs in distinctive bins on the shelf to alert staff of its contents
2- Wearing ASTM D6978 (chemo) gloves when counting or packaging HDs
3- Dedicating a counting tray and spatula for counting HDs and decontaminating after each use.
4- Placing prepared HD containers into a sealed plastic bag

*Do not place HD into mechanical pill counters or robots.

Question 8

Disposal of Hazardous Drugs

Answer 8

Yellow Container - trace antineoplastic waste (empty vials, syringes, IV bags, gloves, gowns)

Black Container - bulk antineoplastic waste

Question 9

Repackaging vs Bulk Compounding vs Manufacturing vs Manipulation

Answer 9

Repackaging - This is taking a drug out of the container in which it was distributed by the manufacturer and placing it into a different container without manipulation (e.g. unit dose dispensing). BUD 6 months

Bulk Compounding - Done by 503B facilities

Manufacturing - This is the development and production of licensed drugs, which are mass-produced in bulk.

Manipulation - e.g. using powders to prepare a solution, cutting tablets, reconstituting.

Question 10

Drug Samples

Answer 10

Regulated by PDMA - Prescription Drug Marketing Act

Drug samples can only be distributed to prescribers at their written request!

*Written requests must be maintained by the manufacturers for 3 years.

Retail Pharmacies are NOT PERMITTED to stock or dispense drug samples.

Drug samples are different from starter packs, drugs provided free-of-charge, reduced price, provided through a patient-assistance program

Question 11

What medications are not safe to be delivered through Vacuum Tubes?

Answer 11

1- Hazardous Drugs
2- Combustable Products (sprays, gels)
3- Protein Products (insulin, immunoglobulins)

Question 12

Patient-prescriber Relationship

Answer 12

In order to fill a prescription, a VALID patient-prescriber relationship must exist:

1- A patient reports a medical issue or condition.
2- A medical history has been taken
3- A face-to-face physical exam or telemedicine adequate to establish the medical issue has been performed by the prescribing practitioner
4- A logical connection exists between medical issue, medical history, physical examination and drug prescribed

Question 13

Can pharmacists fill prescriptions for Off-Label Use?

Answer 13

YES

Question 14

Can pharmacists correct errors on prescriptions?

Answer 14

Minor errors (e.g. spelling) - yes; no need to contact prescriber

Otherwise, consult with prescriber and document the discussion.

After verification with the prescriber, the prescription can be re-written as an oral prescription. In some cases, the original prescription will be voided, and the prescriber will resend another prescription by fax or electronic transmission.

Question 15

BUD for a Multi-dose container and Unit-dose containers

Answer 15

Multi-dose: 1 year from DISPENSED Date
Unit-Dose: 6 months from REPACKAGED Date

Question 16

Can a patient request that a mediation be dispensed in “easy-open” or “non-Child resistant” packaging?

Answer 16

YES

-The prescriber can waive the use of CR containers for a single prescription.

-The patient can provide a blanket waiver for all prescriptions Needed: documentation waiver request and signature

Question 17

DUR

Answer 17

OBRA ‘90

Prospective DUR: Evaluation of patient’s drug therapy prior to dispensing - performed by the dispensing pharmacist - needed for Medicaid patients

Retrospective DUR:Evaluation of drug therapy after dispensing - performed by the state

OBRA ‘90 requires individual states to perform a system-wide retrospective DUR to analyze physician prescribing habits and assess the appropriate use of certain drugs

Question 18

When to provide a PPI vs a Med Guide?

Answer 18

PPI - Must with oral contraceptives and estrogen-containing products. Given every time it is dispensed! If it is not provided, this is considered misbranding!

Med Guide - meds that have serious and significant health concerns. There are over 300 meds which require this. This includes antidepressants, NSAIDs, retinoids

NB: PPI, Med Guides and Instructions-for-Use are all FDA approved information.

Question 19

REMS Program

Answer 19

2007 FDA Amendments Act gave the FDA the authority to require a REMS from manufacturers to ensure that the benefit outweighs the risks.

I-PLEDGE REMS: (Isotretinoin)
Primary Risk: Severe Birth Defects
-Prescribers, patients and pharmacies must enroll in iPLEDGE REMS
-Pharmacies can only obtain drugs from iPLEDGE registered wholesalers.
-Patients that can get pregnant require a negative pregnancy test before dispensing (two negative tests before first fill, one negative test for subsequent fills)
-No more than 30 day supply
-Must have MedGuide
-Educate provider and patient

Question 20

Emergency Contraception

Answer 20

-Levonorgestrel (PlanB One-Step, Take Action, My Choice, My Way) - approved for use within 72 hours
-Ulipristal (Ella) - approved for use within 120 hours

-Both male and females may purchase it
-No age restrictions
-Can be processed through insurance, but needs a valid prescription for a female patient only

Question 21

Drugs with Restricted Sales

Answer 21

2005 CMEA - Combat Methamphetamine Epidemic Act

These are “behind-the-counter” medications
1- Pseudoephedrine - decongestant
2- Ephedrine - decongestant
3- Phenylpropanolamine - Vet use only (with script)
4- Norpseudoephedrine - not available in US

Question 22

What is needed on an OTC-drug label?

Answer 22

1- Principle display panel
2- Name of drug with pharmacological category
3- “Drug Facts” panel
4- Directions for use
5- Quantity of contents
6- Expiration date
7- Name and address of manufacturer, packager or distributor

*NDC not required, but recommended

Question 23

Electrolyte threshold for OTC medications

Answer 23

1- Sodium, Potassium: 5 mg
2- Magnesium: 8 mg
3- Calcium: 20 mg

If the max-recommended dose contains more than or equal to the values above, the label must state the amount of electrolyte per dosage unit on the label.