PPLE ALS 3

Prescription vs. OTC Drugs, Generic Substitution, and Filling Prescriptions

• Paul Ackerman, a retired pharmacist with 43 years of experience, will be speaking
• The lecture will focus on state regulations.
• Covered topics include prescription vs OTC drugs, generic substitution, and filling prescriptions.

Brand Name Versus Generic Drugs

• Brand name drugs have a registered trademark
• Generic drugs should be equivalent to their brand name counterparts
• Generic drugs must be equivalent
• Substituting entities must be subject to legal processes in the US
• Both generic and brand name product must be listed in the formulary
• Brand name drugs possess a registered trademark, while generic drugs do not
• Legally, distributors of generic drugs must be subject to legal processes in the US

Generic Substitution Regulations in Florida

• Florida Administrative Code 465.025 concerns state regulations
• Board of Pharmacy rules support legislative actions.
• A pharmacist must substitute a brand name drug prescription with a less expensive generic equivalent, unless the purchaser requests otherwise.
• An exception exists if the prescriber indicates "medically necessary," either in writing or verbally for an oral prescription; brand name must be dispensed
• Patients can refuse generic substitution, but must be informed of the price difference
• Cost savings from substituting a less expensive drug must be passed on to the consumer
• Each community pharmacy needs a positive formulary of generic and brand name products from manufacturers or distributors with FDA approval (NDA or ANDA)

Negative Drug Formulary

• Boards of Pharmacy and Medicine establish a negative formulary of generic products
• The generics in the negative formulary demonstrate significant biological or therapeutic inequivalence and hence are a threat to the patient if substituted
• Florida is one of the few states to have a negative formulary
• Generic drugs are removed from the negative formulary if every equivalent is "A" rated therapeutically to a reference drug; listed in the FDA's "Orange Book"
• Current Negative Formulary medications include digitoxin (primarily hospital use), conjugated estrogens, dicumarol, chlorpromazine (solid dosage), theophylline (controlled release), and pancrelipase (oral dosage)
• Digoxin, phenytoin, levothyroxine and warfarin were removed from the Negative Formulary
• Phenytoin caused breakthrough seizures
• Levothyroxine had dosage problems making it hard to reestablish the proper thyroid condition

Community Pharmacy Signage

• Pharmacies must display a prominent sign (at least 1 inch tall) that states: "CONSULT YOUR PHARMACIST CONCERNING THE AVAILABILITY OF A LESS EXPENSIVE GENERICALLY EQUIVALENT DRUG AND THE REQUIREMENTS OF FLORIDA LAW."

Substitution of Interchangeable Biosimilar Products

• Biological, biosimilar, and interchangeable products have the same meaning as defined in statute 351 of the Public Health Service Act
• Biosimilar product can be substituted if the US FDA says it is biosimilar and interchangeable
• Notify the person with the prescription as for a generic drug
• Substitution records are kept for 2 years
• Class II institutional pharmacies must enter the substitution in the institution's written medical record system
• The board maintains a website with a current list of FDA-deemed biosimilar and interchangeable products

Duty of the Pharmacist to Inform

• Pharmacists must inform the person presenting a prescription about generic substitutions, price differences, and the right to refuse substitution
• Appropriate professional discretion and judgment should be used when communicating this information
• Technicians/cashiers can offer generic substitution

Expiration Dates

• Manufacturers must display the expiration date in a readable fashion
• Community pharmacies must show the expiration date on the dispensed container, or on documentation delivered by the manufacturer, repackager, or distributor
• An earlier beyond-use date (up to one year after dispensing) may be used
• Pharmacists must provide expiration date information upon request
• Pharmacists must provide appropriate instructions about proper drug use/storage
• Provide the actual date on the bottle if a patient asks for it

Filling of Certain Prescriptions (Transfers)

• Pharmacists can fill/refill valid prescriptions transferred electronically or otherwise from Florida or another state
• The patient must be advised that the prescription at the other store will be cancelled
• Verify the prescription is valid and can be filled/refilled per the prescriber’s directions
• Notify the transferring pharmacy that the prescription must be canceled
• Record prescription order, transferring pharmacy name/Rx number, drug name, original amount, dispensing date, and remaining refills

Receiving a Prescription Transfer Request

• Transfer the information accurately and completely
• Record requesting pharmacy/pharmacist details and date
• Cancel the prescription on file electronically or by writing "void"
• The transferring pharmacy must be notified to revalidate canceled prescriptions if a transferred prescription is not dispensed in a reasonable time (Walgreens' policy was around 7-10 days)
• For out-of-state transfers, a Florida pharmacist must verify the transferring entity is a licensed pharmacist or pharmacy; transfers in Florida must be between pharmacists only
• Electronic transfers are allowed regardless of whether the pharmacies are open
• Transfers of Schedule III, IV, and V refills are permitted subject to state and federal law

Centralized Prescription Filling

• A Florida-licensed pharmacy can perform centralized prescription filling for another pharmacy if they share ownership/contract
• Policies and procedures must comply with federal and state laws; include pharmacist identification, counseling procedures, Rx tracking, pharmacy identification, patient confidentiality, and a quality assurance program (CQI)
• Filling via centralized prescription filling is not a transferred prescription

Common Database

• Dispensing a prescription in a common database by a licensed pharmacist does not constitute a transfer if all involved pharmacies have common ownership and a common database
• Pharmacies/pharmacists involved must be properly licensed in their respective states
• The common database must record all pharmacists involved
• The owner of the common database needs a policy and procedure manual including: best practices, record maintenance, oversight, tracking, pharmacist identification, board request responses, confidentiality policies, and a quality assurance program

Exceptions

• The sale of home remedies/patent preparations in original, unbroken packages is permitted
• Businesses like gas stations and 7-Elevens can sell these items
• This chapter does not apply to agents holding an active permit under chapter 499 making/distributing dialysate drugs/devices for home renal dialysis, if FDA approved/cleared and delivered in original sealed packaging after a physician's order

Emergency Prescription Refill

• A one-time emergency refill of a 72-hour supply is permissible if refill authorization cannot be readily obtained
• A one-time emergency refill of one vial of insulin for diabetes can be provided
• During a declared state of emergency, a pharmacist may dispense up to a 30-day supply
• A Schedule II controlled substance cannot be refilled
• The medication must be essential for life maintenance or continuation of chronic therapy
• The interruption needs to cause health consequences or discomfort as determined by the pharmacist's judgement
• The dispensing pharmacist makes a written order with the information on the prescription and signs it
• The dispensing pharmacist must notify the prescriber within a reasonable time afterward