INTEGRATED PHARMACY APPLICATIONS I

Pharmacy Law Applications

Dr. Erika Zwachte Dr. Melissa Milfort

ez116@nova.edu mmilfort@nova.edu

October 28, 2020

 OBJECTIVES
1. Review the requirements needed to transfer prescriptions
between different databases or same database

2. Identify temporary expansion in the pharmacist scope of practice

with regards to vaccinations

3. Detail circumstances when it is permissible to fill an emergency

supply of non-controlled substances in a community pharmacy
setting

4. Explain the exceptions to accessing and consulting E-FORSCE

(PDMP) for a Schedule II through V controlled substance
 CASE #1
Which of the following elements are missing in order to fill this prescription?
 CASE #1 - Answer
Meeting legal requirements:
Florida Controlled Substances Act (FLCSA) and Applicable rules
● Full name and address of patient
● Drug name, strength, and dosage form
● Quantity prescribed
○ Written numerically (i.e. 30) and texturally (i.e. thirty)
● Directions for use
● Number of refills, if any
● Name, address, and DEA number of practitioner
● If written for an opioid, indicate on the prescription if for Acute
pain, Acute pain exception, or Non-acute pain
● Written on a standardized counterfeit proof prescription
approved by the Department of Health
 CASE #1 - Answer
(continued)
Acute pain vs. Acute pain exception vs. Non-acute pain
● Acute pain: day supply must be for less than 3 days

● Acute pain exception: if the prescriber determines in their

professional judgment that more than a 3–day supply is
medically necessary; it can be written for no more than a 7–day
supply

● Non-acute pain: more than 7–day supply if the prescription is

being used for the treatment of pain other than acute pain
Electronic-Florida Online Reporting of Controlled Substance Evaluation Program
(E-FORCSE®)

● FL Prescription Drug Monitoring Program created by 2009 FL Legislature

● Safer prescribing of controlled substances, reduction of drug abuse & diversion in FL
● Pharmacists & MDs required to access/consult E-FORCSE each time a controlled
substance is prescribed or dispensed

● Not required for:

○ <16 years old

○ Hospice patients

○ Department of corrections

○ FL department of health deems system non-operational

 CASE #2
While finishing restocking your shelves, you notice an individual
approaching the counter asking for help as his friend Charlie
might have overdosed on cocaine. He briefly explains that Charlie
passed out next to the allergy section in your pharmacy and he’s
not breathing. He doesn’t carry Naloxone (opioid reversal agent)
with him nor a prescription for it. He’s asking you to give him
Naloxone without a prescription to save his friend.

Can you (pharmacist) dispense Naloxone without a prescription?

 CASE #2 - Answer
● Dispensing pharmacists, acting in good faith and exercising
reasonable care, is not subject to discipline after dispensing an
emergency opioid antagonist (Naloxone) according to section
381.887-6(b)
● Statewide Standing Order for Naloxone (opioid reversal agent)
○ Section 381.887 of Florida Statutes since February 25th, 2019

○ Allows pharmacists to dispense naloxone to emergency responders for

administration to persons exhibiting signs of overdose

■ Naloxone intranasal (syringe or spray)

■ Auto-injector
 CASE #3
John Shark calls the NSU Pharmacy and states that he is out of
his metformin ER and requests that it is transferred to a location
closer to his home. The pharmacist notices that the prescription
is now out of refills.

What should the pharmacist do? Select all that apply.

 CASE #3 - Answer
Emergency supply: FS 465.0275
● May dispense a one–time emergency refill of up to a 72–hour
supply
● Has practiced professional judgment
● The dispensing pharmacist creates a written order
containing all the information required on a
prescription/signs the order and notifies the prescribing
physician of the emergency supply
 CASE #4

You are a pharmacist in a community pharmacy. For the past

week, you have been trying to get your patient’s propranolol
refill request approved by his doctor without any response. He
has enough tablets to cover him for two more days. Just three
hours ago, the Governor issued a State of Emergency due to the
current pandemic situation.

What quantity can a pharmacist dispense during a State of

Emergency?
 CASE #4 - Answer
● Emergency prescription refills (465.0275)
○ If the Governor issues an emergency order or proclamation
of a state emergency, pharmacists may dispense up to a 30-
day supply for chronic medications in areas or counties
affected by the order
■ Not for schedule II substances
■ Medication is essential to maintenance of life
■ Interruption might cause physical/mental discomfort
■ Pharmacist notifies prescriber of emergency dispensing
 CASE #5
NS has been a paramedic for the past 15 years. He exercises three
to four times a week and takes no medications. Despite his healthy
lifestyle, he recently found out that he has hypertension. His doctor
prescribed Clonidine patch 0.1 mg/24-hour patch applied once
every seven days and sent the prescription to Shark pharmacy. Per
the patient’s request, Shark pharmacy calls NSU pharmacy to
transfer the Clonidine prescription. The NSU Pharmacy technician
completes the transfer.

Is this appropriate?
 CASE #5 - Answer

● Delegable tasks
○ Tasks performed pursuant to a pharmacist’s direction,
without the exercise of the pharmacy technician’s own
judgment and discretion
○ Do not require the pharmacy technician to exercise
independent professional judgment (foundation of the
practice of the profession of pharmacy)
 CASE #5 - Answer
(continued)
Non-Delegable Tasks
● Receive new non-written prescriptions
● Receive any change in the medication, strength, or directions
of an existing prescription
● Interpret a prescription or medication order for therapeutic
acceptability and appropriateness
● Conduct final verification of dosage and directions
● Engage in prospective drug review
● Transfer a prescription
● Engage in patient counseling
 CASE #6

Mike, your 17- year-old nephew is about to start college and needs
to have all his vaccines up to date in order to complete his
application. He is only missing this season’s flu shot. Due to the
current pandemic, he can’t find a face-to-face doctor’s
appointments to get it. He is asking you, a community pharmacist,
to please give him the flu shot this afternoon as the application for
his top 1 school is due tomorrow.

Are you able to help Mike since he is not 18 years old yet?
 CASE #6 - Answer
● Before Aug. 2020
○ ≥ 18 years old

● Change in practice
○ U.S. Department of Health and Human Services (HHS)
expanded access to childhood vaccines during COVID-19
Pandemic
○ Third amendment passed Aug. 2020
■ Pharmacists able to immunize patients ≥ 3 years old
 CASE #7
MM is a 30-year-old new patient that presents to the pharmacy
where you work. She’s interested in getting all her prescriptions
filled at the NSU Pharmacy. New prescriptions are as follows:
● levothyroxine 125 mcg by mouth at bedtime every day
● ferrous sulfate 325 mg 1 – 2 tablets by mouth every day
● pantoprazole 40 mg tablet 1 tablet by mouth once a day
She is interested in switching her levothyroxine to Synthroid.

Can the pharmacist do this?

 CASE #7 - Answer

● Yes
○ The patient has the right to request brand medications
○ The prescriber may also write on the prescription (in own
handwriting) “Medically Necessary” for a brand
medication
 CASE #7 - Answer
(continued)
Dispense As Written (DAW)

● DAW 0: No product selection indicated ● DAW 5: Substitution allowed - brand

● DAW 1: Substitution not allowed by
prescriber
● DAW 2: Substitution allowed - patient
requested product dispensed
● DAW 3: Substitution allowed -
pharmacy requested product dispensed
● DAW 4: Substitution allowed - generic
drug not in stock
drug dispensed as generic
● DAW 6: Undefined
● DAW 7: Substitution not allowed -
brand drug mandated by
law/regulation
● DAW 8: Substitution not allowed -
generic drug not available in
marketplace
● DAW 9: Undefined
 CASE #8

Bob was recently diagnosed with asthma. His doctor prescribed

ProAir HFA (albuterol sulfate) and instructed him to inhale 2 puffs
by mouth every 6 hours as needed for shortness of breath. Today,
Bob is in the pharmacy filling his inhaler for the first time.

How many days is Bob’s inhaler going to last if used as

instructed?
Note: albuterol sulfate = 200 inhalations/canister
CASE #8 - Answer

Instructions:
2 inhalations every 6 hours (4 times/day)
2 x 4 = 8 inhalations/day

200 inhalations/canister ÷
8 inhalations/day = 25 days/canister
QUESTIONS?
INTEGRATED PHARMACY APPLICATIONS I
Pharmacy Law Applications

Dr. Erika Zwachte Dr. Melissa Milfort

ez116@nova.edu mmilfort@nova.edu

October 28, 2020