FED #5 and up

Drug shortage list

Allows compounding pharmacists to compound the drug bc there’s a shortage

FDA Boxed Warning

•One of the strongest actions FDA can place on a product

The complete information is located in the manufacturers package insert, and additional info located on manufacturer’s label used to inform patients and clinicians about serious potential adverse reactions

• Called black box warning before

Orange book

typically referenced when the RPh Generically Substitutes drug products, to ensure no clinical issues with the substitution

• Enables Pharmacists to substitute with generics if '“therapeutically equivalent”

• •To ensure ability to substitute; it compares the generic drug bioequivalence to the reference drug (brand name drug), addressing difference potential by what code they are assigned

  •Ex:  AA and AB rated are typically “generic substitutable”  as to having no bioequivalence problems compared to brand name reference drug. 

Generic Substitution

Contains identical amount of identical active ingredients

Pharmacist may dispense generically equivalent drugs as long as

•Physician has not written DAW or Dispense as Written, (or other verbiage with this intent)

•Purchaser is informed that substitution will occur, and is informed that they may refuse

Biosimilars

•Molecules typically composed of living material, thus cannot be an exact copy of their reference product.

FDA requires biosimilars be “highly similar” to the existing biologic brand name reference product with no clinically meaningful differences in:

•Safety

•Purity

•Potency

• Must meet FDA’s interchangeable designation in order for a pharmacist to swap one biosimilar with another (not needed for generic swaps bc they are exactly the same)

Purple Book

Lists interchangeable biosimilar products

Controlled substance classes

C1- illegal drugs

C2- narcotics

C2N- NOT narcotics, stimulants

C3- Less than 90mg of codeine per dosage unit, Narcotic

C3N- NOT narcotics, steroids

C4- benzodiazepines

C5- cough preps with less than 200mg of codeine per 100mL/or 100g

Who requires a DEA license?

Businesses/individuals that write prescriptions for controlled substances

• STORE controlled substances must have a SITE DEA license

• WRITE cs scripts is individual DEA license

224 form

order form if opening a new pharmacy or attempting to get your personal DEA

• expires every 3 years

Verifying a valid DEA number

1. Start with A, B, F, or G for practitioners, start with M for mid-level practitioners

2. Second letter is first letter of last name, followed by a 7 digit number

• (1+3+5)+(2+4+6)x2 (last digit in the number should equal last number of license)

Form 41

used to report destruction of controlled substances (flood/tornado)

Form 106

used to report lost or stolen controlled substances, mail-back packages, and/or inner liners for controlled substance containers (theft/robbery)

Form 222

used to order/transfer C2 drugs, paper only

• must keep for 2 years federally (state requires 3 years)

• Must be signed/dated on day order submitted, signed only by the DEA registrant

• Must secure these forms like drugs!!! (people can cover their tracks by doctoring forms)

• “Power of attorney” is the one that can sign the 222, anyone part of the pharmacy can be given this title (a POA form must be kept on site) (fill out parts 2 and 3, fill out part 5 AFTER receiving drugs!!!)

Controlled Substance Ordering System (CSOS)

An electronic/digital system, approved by DEA, to order all schedules of controlled substances (CI-CV’s)

• Replaced 222 form, but for ALL controlled substances not just C1 and C2

• software systems must be audited so that system knows who you are

CSOS certificates

•Digital identity issued by DEA which allows for digital ordering of all controlled substances. 

•Essentially the digital equivalent of the identification information contained on a DEA 222 form

• Allows digital signature

• Must have an electronic record when receiving drugs to make sure you get correct amount of drugs

1) CSOS signing certificate: allows you to order controlled substances

2) CSOS Administrative certificate: These are only used by CSOS administrators and are NOT valid for electronic ordering

ARCOS

• Applies to only manufacturers and distributors, REQUIRED reporting into ARCOS

• Can put restrictions on manufacturing

an automated, drug reporting system which monitors the flow of DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level - hospitals, retail pharmacies, practitioners, mid-level practitioners, and teaching institutions

Drugs tracked: All Schedules I and II materials (manufacturers and distributors); Schedule III narcotic and gamma-hydroxybutyric acid (GHB) materials (manufacturers and distributors); and selected Schedule III and IV psychotropic drugs (manufacturers only)

HHS OIG Exclusion List

a Federal database of individuals and organizations that are prohibited from participating in federal health care programs due to convictions related to fraud committed against CMS and other federally funded programs (medicare/medicaid)

• can get on the list by committing fraud with insurance companies

• come up with a time frame you're on the list

What to do when theft/lost of controlled substance?

procedures must be implemented within one business day of the discovery of the theft or loss

1. Notify DEA directly and local police

2. Complete DEA form 106 if loss is significant

• How to know if a loss is significant: loss in relation to type of business (% of rx filled vs loss), pattern of losses, candidate for diversion, suspected its from individuals, is the drug a candidate for diversion (street value)

• In Ohio: same as federal, also must report on online portal within 30 DAYS (follow up report if you know what happened)

Who must you notify for thefts of drugs and/or drug documents? 

1.Board of Pharmacy

2.Local law enforcement

3.DEA (if controlled substance involved)

Submission of a second communication including a detailed report via online portal for theft/loss of drug documents is NOT REQUIRED

How often does DEA vs Ohio require controlled substances to be reported for inventory?

DEA: 2 yrs

Ohio: 1 yr

Requirements for a valid script

1. Medical purpose

2. Prescribing under usual course of practice

3. Bona fide (real) treatment of patient

Number of refills authorized for C2-C5

C2: No refills

C3/C4: Can’t be refilled 6 months after written date, max 5 refills

C5: may refill for life of rx (12 months after written)

Paper prescription

must be manually signed , “wet signature”

Legal requirements for electronic scripts

• Must pass 3rd party audit to pass DEA standards

Federal CMS Electronic Prescribing for Controlled Substances (EPCS)

Practitioners issuing electronic prescriptions for controlled substances (EPCS) must use a software application that meet all DEA requirements

• prescribers can apply for a waiver so they can write an pharms can fill C2 paper scripts

SUPPORT Act

enacted into law to address the opioid crisis

mandates that Schedule II-V controlled substance Rx’s must be done electronically for Medicare Part D prescription drug plans and Medicare Advantage prescription drug (MA-PD) plans

Expiration/quantity limit of C2 drugs

There is NO LIMIT federally, but script must be legit and pharm must use corresponding responsibility

• States usually have rules on filling timeframes/expiration/max fill amount

• NO REFILLS allowed on C2 drugs, can transfer to another pharmacy if it wasn’t filled yet

Can you fax C2 scripts?

May not use fax copy as original for CII prescriptions EXCEPT FOR hospice, long term care, or used in a compounded prescription

May dispense CIII, CIV or CV prescriptions via?

1. Paper script signed by practitioner

2. Fax of a signed paper script from practitioner (MUST BE WET SIGNATURE)

3. Electronic scripts

4. Over the phone scripts immediately written down by pharmacist

May dispense C2 via?

1. Electronic scripts

2. Phone in script for emergencies (must get hard copy from practitioner within a week)

3. Can be faxed in rarely (hospice, long term care, or compounder scripts ONLY)

C3 and C4 script life

6 months or 5 refills from date of issuance

C5 script life

No refill limits federally, states may have stricter regulations

PRN can only be on what type of scripts?

Only non controlled drugs can have PRN (1 year life)

• Controls CANNOT have PRN on it

What does it mean when a pharmacist dates and initials on the back of a prescription?

Means that they dispensed a refill for the FULL FACE amount of the prescription

Requirements to transfer UNFILLED INITIAL electronic scripts?

Federal law allows INITIAL transfer of an UNFILLED controlled substance received at a pharmacy (in schedules II-V), to another pharmacy, on a 1 time basis only

Requirements:

1. Must be between 2 pharmacists

2. No changes to the script

3. Must keep E-records for 2 yrs

After the first fill, how many times can you transfer C3/4/5?

•Once filled, any refills may only be transferred 1 time!!!-Then the Rx must stay at that pharmacy for the remainder of its life

• C2 are NOT refillable

• C2 CAN be transferred one time BEFORE they are filled

What to do if you get both a paper and electronic script?

1. Check records to make sure E-script wasn’t already dispensed

2. Mark one as void

Methods to dispose of controlled substances

1. Non-retrievable: used for expired/adulterated drugs- drug is chemically changed

2. Unusable/unavailable: used for wasting partial drug doses in clinical setting (this method is only ok when wasting partial dose, DONT USE for expired/adult drugs) ex: nurses dumping down sink, mixing with kitty litter at home

DEA regulations allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies to collect controlled and non-controlled pharmaceutical drugs from ultimate users by:

1. Mail back programs

2. Collection receptacles

(DONT just take drugs back!!!)

Central Fill Pharmacies

fills prescriptions for controlled substances on behalf of retail pharmacies with which it has a contractual agreement to provide such services or with pharmacies who share a common owner

• One retail pharm receives a script and another pharm prepares/delivers it to the first pharm

• ALSO central fill for non controls at the STATE level

Can retail pharmacies also do central fill?

Yes, can do it without a separate DEA license, have 2 functions

• Can both prepare and refill prescriptions

• C2-5 CAN be faxed from retail pharmacy to CF place (not directly from prescriber)

• MUST keep OG script for at least 2 yrs federally (3yrs for ohio) from date last refilled