Exam 2- Dr. McDowell

Who can compound?

Licensed Pharmacist

Licensed Physician

Person Under Licensed Pharmacist's Supervision

What is 503A?

-Medications prepared for a specific patient according to orders from a licensed prescriber

-"Traditional compounds"

-Prepared once a prescription is received

What is 503B?

-Outsourcing facilities

-May manufacture large batches with or without prescriptions to be sold to healthcare facilities or office use only

What are the 530B requirements?

-Register with the ALBOP

-Register with the FDA as a outsourcing facility and pay a annual establishment fee

-Register with the DEA

-Report product list to FDA biannually

Can technicians compound?

Yes -

-When a written procedure for a compound is not on file at the pharmacy, a pharmacist must direct the preparation of the compound.

-At all times, a pharmacist shall verify the weight or volume of all active ingredients of a compound

What are the requirements for the compounding area?

-Maintained in a good state of repair

-Cleanable surfaces to include walls, ceilings, and floors

-Adequate lighting and ventilation

-Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any compounded drug product

-Maintained in a clean and sanitary condition

When a component is transferred from the original container to another container, the new container shall be identified with the what information?

Component name and supplier

Strength and concentration

Lot number and expiration

How should compounded products be labeled?

-Ingredient list or preparation name

-Preparation date

-Beyond use date

-Storage information

-Batch or lot number

Can a compounded product be sold OTC?

Yes

-May be prepared in advance

Can a pharmacy prepare a compounded prescription for a prescriber's office use?

Yes,

-Prescriber's order with the formula and quantity dispensed should be stored at the pharmacy

-Record of compounded drug product = prescription record in the pharmacy's computer system

-Label and prescription number can be generated for the compounded product

What are the label requirements for compounding for prescriber's office use?

1. Designated name and strength of finished product

2. Quantity dispensed

3. Date when the product was compounded

4. Beyond use date

5. Lot or batch number

6. Any other information the pharmacist deems

necessary

7. Pharmacy's name and address

8. Phrase "For Office Use"

What are the record requirements of compounding for prescriber's office use?

1. Prescriber's name and address

2. Date of sale

3. Description and amount of product sold

The compounded product's sale to the prescriber should remain on file at the pharmacy for how long?

Not less then 1 year

What is USP 795?

Nonsterile compounding

What is USP 797?

Sterile compounding

What is USP 800?

Hazardous drug compounding

What is a class I recall?

Reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death

What is a class II recall?

Use of, or exposure to, a violative product may

cause temporary or medically reversible

adverse health consequences or where the probability of serious adverse health consequences is remote

What is a class III recall?

Use of, or exposure to, a violative product is not likely to cause adverse health consequences

What is the Red Book?

**red tag sale

Drug pricing

What is the Orange Book?

Therapeutic equivalents

What is the Yellow Book?

**phone book is yellow- call various people everywhere

Internationally travelers

What is the Green Book?

Animal drug products

What is the Purple Book?

**vIOlet, bIOlogic

Biological products

What is the Pink Book?

**pink and polio

Vaccines

What is Acute, Uncomplicated Illness/Injury?

Recent or short-term condition

Low risk of morbidity

Full recovery expected

Examples:

• Influenza

• Streptococcus

• Other JC-approved conditions

What is Patient Care Services?

Services provided by:

• Collaborating Physician

• Collaborating Pharmacist

Must:

• Benefit of the patient

• Be within training and experience

• Be explicitly covered by the CPA

What is the Joint Commission?

Joint body between:

• Board of Medical Examiners

• Board of Pharmacy

Responsibilities:

• Recommend conditions

• Approve expansions

• Oversee collaboration rules

Physicians and pharmacists may only engage in Collaborate Drug Therapy Management (CDTM) if:

An agreement has been appropriately executed and a written attestation has been filed with and approved by the Board of Pharmacy and Board of Medical Examiners +

The patient (or the patient's authorized representative) has signed an agreement-specific consent that the patient is to receive services from a healthcare team, including a Collaborating Pharmacist

When does the written agreement have to be reported to Board of Pharmacy and Board of Medical Examiners by?

10 days

What are the eligibiity requirements for a CDMT?

-Active unrestricted license to practice medicine or pharmacy in Alabama

-Pay all collaborative practice fees due to the Board of Medical Examiners and the Board of Pharmacy

-Pharmacists: Pharmacy must maintain an active unrestricted pharmacy permit and DEA registration

-Physicians: Practiced medicine for >3 years or >1 year if certified by a specialty board

-Active unrestricted Alabama Controlled Substances Certificate issued by the Board of Medical Examiners or Board of Pharmacy

Collaborating Physician and Collaborating Pharmacist shall communicate any changes initiated to a patient's drug therapy that is subject to an Agreement within _______ hours

24 hours

The collaaborating physician shall maintain documentation records for?

At least 6 years from the date of the last patient contact

If patient is a minor: at least 8 years from the date of the last patient contact

The collaborating pharmacist shall maintain documentation records for?

At least 2 years from the date of the last patient contact

All agreements must be reviewed, updated when applicable, and renewed by __________________ at least every _____ years

December 31st

2 years

Amendments involving substantive additions or reductions to the scope of patient care services provided must be provided to the Board of Pharmacy and Board of Medical Examiners no later than _____ days from the date the amendment is signed

10 days

Collaborating Physician and Collaborating Pharmacist are to perform a quality assurance review of the care provided to patients pursuant to the Agreement on a _____________ basis

Quarterly

How many patients under the CPA should have a quality assurance review?

No less than 25% of the patients pursuant to the Agreement for the first 2 years of the Agreement

No less than 10% of the patients pursuant to the Agreement after the Agreement has been in effect for 2 years

How many years should quality assurance review documentation be kept by the Board of Medical Examiners?

5 years

How many years should quality assurance review documentation be kept by the Board of Pharmacy?

2 years

What is the Board of Medical Examiners fee?

$300

What is the Board of Pharmacy fee?

$100

What does the scope of the agreement not include?

Patients who have not seen the Collaborating Physician within 12 months

Prescribing controlled substances

A Collaborating Physician may collaborate with a maximum of ________ Collaborating Pharmacists

3

A Collaborating Pharmacist may collaborate with a maximum of ________ Collaborating Physicians

3

Physicians must follow up with each patient receiving treatment by a pharmacist for an acute, uncomplicated illness/injury within ______ days following first day of treatment

5

If the Collaborating Physician becomes permanently absent, the Covering Physician may be designated temporary Collaborating Physician for up to _______ days

60 days

If the Collaborating Pharmacist becomes permanently absent, the Covering Pharmacist may be designated temporary Collaborating Pharmacist for up to _______ days

60 day

Agreement shall be renewed by December 31 every ______ years

2

What is the Board of Medical Examiners renewal fee?

$200

What is the Board of Pharmacy renewal fee?

$50

How many members are in the Joint Committee?

4

Joint Committee members?

Board of Medical Examiners Voting Member

Board of Medical Examiners Voting Member

ALBOP President

ALBOP Vice President

How often does the Joint Committee meet?

At least quarterly