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Innov Pharm. 2021; 12(3): 10.24926/iip.v12i3.4222.
Published online 2021 Jun 10. doi: 10.24926/iip.v12i3.4222
PMCID: PMC9119992
PMID: 35601574


PHARMACIST ALLOWANCES FOR THE DISPENSING OF EMERGENCY OR CONTINUATION OF THERAPY
PRESCRIPTION REFILLS AND THE COVID-19 IMPACT: A MULTISTATE LEGAL REVIEW

Nicholas DeRosa, Candidate for Doctor of Pharmacy-Accelerated '21, Ka Leung,
Candidate for Doctor of Pharmacy-Accelerated '21, Julia Vlahopoulos, Candidate
for Doctor of Pharmacy-Accelerated '21, and Joseph Lavino, PharmD, JD


NICHOLAS DEROSA

Massachusetts College of Pharmacy and Health Sciences University

Find articles by Nicholas DeRosa


KA LEUNG

Massachusetts College of Pharmacy and Health Sciences University

Find articles by Ka Leung


JULIA VLAHOPOULOS

Massachusetts College of Pharmacy and Health Sciences University

Find articles by Julia Vlahopoulos


JOSEPH LAVINO

Massachusetts College of Pharmacy and Health Sciences University

Find articles by Joseph Lavino
Author information Copyright and License information PMC Disclaimer
Massachusetts College of Pharmacy and Health Sciences University
Corresponding author.
Corresponding author: Joseph Lavino, PharmD, JD Adjunct Professor, College of
Pharmacy Massachusetts College of Pharmacy and Health Sciences University 179
Longwood Ave, Boston, MA 02115 Email: ude.shpcm@onivaL.hpesoJ

Copyright © Individual authors
This is an open-access article distributed under the terms of the Creative
Commons Attribution-NonCommercial License, which permits noncommercial use,
distribution, and reproduction in any medium, provided the original work is
properly cited.


Go to:


ABSTRACT

The COVID-19 pandemic has taught Americans many lessons, including what can
happen when our healthcare system is strained. During the pandemic, certain
healthcare related activities such as seeing or contacting a practitioner to
receive a prescription refill may have been a challenge for some patients that
could have interfered in the patient’s medication adherence and continuity of
care. Given these circumstances, the pandemic also shed light on the necessity
for pharmacists to dispense emergency refills, which often is based on variable
state pharmacy laws and regulations. State pharmacy laws and regulations vary
from allowing pharmacists to dispense as much medication that is required for
the patient to receive a new prescription to emergency refills being allowed
only in the direst situations to save a patient’s life. State pharmacy laws and
regulations vary in the allowable quantities that may be dispensed, the federal
schedule of controlled substance medications, and the circumstances they can be
dispensed. In many cases, COVID-19 emergency regulations, governor executive
orders and board of pharmacy guidance have expanded the authority for a
pharmacist to dispense emergency refills. However, these allowances are often
finite in nature and would end when the pandemic state of emergency ends. This
paper seeks to analyze the laws and regulations in each state pertaining to the
ability of a pharmacist to dispense an emergency refill when a patient’s
prescription does not have refills and provide a recommendation to optimize the
state legal and regulatory landscape to expand current allowances.

Keywords: Pharmacy, Emergency Refill, COVID-19, Regulations
Go to:


BACKGROUND


IMPORTANCE OF CONTINUATION OF THERAPY

The Durham-Humphrey Amendment of 1951 allowed for refills of a prescription with
a prescriber’s authorization.1 Prescription refills play an important role in
allowing patients to get their medication without frequent office visits.
Refills also support patient adherence to chronic medications. Typical
pharmacotherapy requires a patient’s adherence to the regimen to achieve the
therapeutic outcome, especially in patients with chronic conditions. Abrupt
cessation or unplanned interruption of therapy may lead to undesirable outcomes.
Common examples include rebound tachycardia or rebound hypertension due to
abrupt discontinuation of antihypertensive medications such as beta blockers and
clonidine. Some patients with chronic respiratory disease require the use of
maintenance inhalers every day to control symptoms and breath normally2. Other
medications, such as oral contraceptives and antidepressants, require consistent
administration without interruption to be effective.3 An extreme case occurred
in Ohio, in which a patient died due to not being able to get his insulin
refilled over the New Year holiday.4 It is paramount for the pharmacist to
ensure the patient’s regimen is not disrupted and medications are dispensed in a
timely manner. When a prescription runs out of refills and the prescriber is not
available to authorize a new prescription, the pharmacist is brought to a
cross-roads; prioritize the patient’s continuity of care, which may or may not
be in full compliance with pharmacy laws and regulations, or potentially
compromise patient care.

While the federal law requires authorization for prescription refills, the law
is silent regarding emergency or continuity of therapy refills. The states have
their own statues and regulations regarding the pharmacist’s ability to dispense
an emergency refill. In some states, when a patient’s prescription is out of
refills and the pharmacist is unable to reach the prescriber to authorize the
refill, the pharmacist may dispense an emergency refill to the patient. Some
states allow emergency refills for a 72-hour, 30-day, or 90-day supply, while
other states do not allow for any emergency refills or leave the quantity to the
pharmacist’s discretion. Typically, emergency refills are allowed by law or
regulation in a shorter duration, which is typically 72 hours, while
continuation-of-therapy (“COT”) refills are allowed by law or regulation in a
longer duration, which is typically 30 to 90 days.71 Both emergency refills and
COT are often referred to as “prescription adaptation”.71


THE COVID-19 PANDEMIC’S IMPACT ON PHARMACY

The COVID-19 pandemic has created many challenges in pharmacy practice.5 Limited
provider office hours reduced the number of available office appointments. Some
practitioners may have chosen to retire or stop practicing in certain areas,
further reducing accessibility to check-ups and appointments. It may have been
difficult for patients to obtain refills from their providers as some patients
could not find a new primary care provider in time. With quarantine mandates in
place, some patients were forced to cancel existing appointments with their
providers, resulting in a gap period without medication. Due to the pandemic,
some states added or expanded emergency refill allowances to have longer
durations and fewer restrictions. The states are not unified in this effort and
vary on the quantities a pharmacist may dispense in an emergency scenario from
days to months’ worth of medication.

The COVID-19 pandemic has been an unprecedented situation that has provided an
opportunity for many laws and regulations to adapt to the ever-evolving nature
of the practice of pharmacy. Some states have met this challenge and have
expanded the scope of pharmacist’s practice. In this paper we specifically
discuss emergency/COT refill laws and regulations. Many states had existing laws
and regulations in place concerning pharmacist emergency/COT refill allowances
in cases where patients could not get a prescription refill from their provider.
During the pandemic, the risk of patient’s running out of refills without a
mechanism to obtain further refills came to light. This made it a necessity for
these laws and regulations to expand or run the risk of patients going without
essential medications. We posit in this paper that COVID-19 emergency
regulations, governor executive orders and board of pharmacy guidance pertaining
to the pharmacist’s ability to dispense emergency/COT refills have helped
patients with maintaining adherence and states would benefit in making these
expanded allowances permanent.


EXPANSION OF PHARMACIST EDUCATION

In 2000, it was mandated that all entry-level pharmacists complete a Doctor of
Pharmacy, or PharmD, degree which replaced the traditional bachelor’s degree
requirement. PharmD programs allow pharmacists to sharpen therapeutics skills
that can be used in the rapidly expanding clinical role of the pharmacist.
PharmD programs require 2-4 years of undergraduate work, 3 years of didactic
pharmacy study, and 1 year of on-site clinical experience. Post-graduate
training programs, such as residency and fellowship, are becoming increasingly
popular in pharmacy and offer 1-2 years of specialized training in various areas
of the field. These rigorous programs prepared pharmacists to expand their scope
of practice into the more clinical roles they hold today. Pharmacists conduct
full medication regimen reviews (MTM), immunize, work in collaborative practice
agreements with providers to alter medication regimens as needed, and see
patients in outpatient clinics to provide counseling and identify potential
problems with a treatment plan to maximize patient health outcomes.

With the expansion of pharmacist education, a logical next step in the evolution
of the practice of pharmacy is to update laws and regulations to allow for a
greater scope of practice. One of these expansions is an allowance for the
pharmacist to use their professional judgement to dispense emergency/COT
refills. While restrictive or nonexistent emergency/COT refill laws and
regulations were intended to protect the public, there is a potential for
patient harm when compliance with these laws and regulations may lead to patient
missed doses of their medication.

Go to:


RESEARCH RESULTS AND DISCUSSION

A complete state survey of the laws and regulations regarding emergency/COT
refill authorization by a pharmacist was completed. Key aspects of the research
were whether there is a law or regulation authorizing pharmacists to dispense an
emergency/COT supply, the day supply quantity, limitations to the types and
controlled substance schedule of medications authorized, and the conditions in
which these types of refills are allowed. Research was also conducted to compare
allowances surrounding emergency/COT refills given during the COVID-19 pandemic
via COVID-19 emergency regulations, governor executive orders and board of
pharmacy guidance.


STATE REGULATIONS FOR EMERGENCY/COT REFILL DAY SUPPLY OF
NON-SCHEDULED/NON-CONTROLLED SUBSTANCES PRIOR TO THE COVID-19 PANDEMIC AND
CHANGES DUE TO THE COVID-19 PANDEMIC.

Insulin, oral contraceptives, and inhalers are pre-packaged and cannot be broken
into smaller quantities and are some of the most dispensed medications filled in
the pharmacy. Some states allow for dispensing an emergency/COT refill up to a
30-day supply, which would likely accommodate the full dispensing of a single
package of insulin, oral contraceptives, or inhalers. Table 1 shows the day
supply allowances for states that had emergency/COT refill allowances in place
prior to the COVID-19 pandemic. For states with emergency/COT refill laws and
regulations with a limit of a 72-hour supply per emergency/COT dispensing, the
law or regulation conflicts with the dispensable size of many maintenance
medications, such as insulin, and those medications cannot be dispensed in full
compliance with said laws or regulations. Some states have addressed the
existence of this conflict, hence allowing the dispensing of the smallest
dispensable package size if this scenario were to occur. It would benefit
patients of those respective states if the laws and regulations were to allow
for the emergency/COT refill dispensing of pre-packaged medications utilizing a
pharmacist’s professional judgement.


TABLE 1:

Day supply allowances for emergency/COT refills of non-scheduled medications
prior to the COVID pandemic.

StatesDay supply allowedAlabama6 72 hoursAlaska7 120 daysArizona8 30
daysArkansas9 Day supply not addressedCalifornia10 Day supply not
addressedColorado11 Not exceeding the amount of most recent
prescriptionConnecticut12 72 hoursDelaware13 Day supply not addressedFlorida14
72 hours, 1 vial for insulinGeorgia15 72 hoursIdaho16 Day supply not
addressedIllinois17 30 daysIndiana18 30 daysIowa19 Day supply not
addressedKanas20 7 days or 1 packageKentucky21 72 hours, greater is allowed for
insulin/chronic respiratory diseaseLouisiana22 72 hoursMaryland23 14
daysMinnesota24 30 daysMississippi25 72 hoursMissouri26 7 days, 30 days if the
provider is dead or incapacitatedMontana27 Day supply not addressedNevada28
Sufficient amountNew Hampshire29 90 daysNew Jersey30 72 hoursNew Mexico31 72
hoursNew York32 Day supply not addressedNorth Carolina33 30 days, 90 days if the
prescriber is incapacitatedNorth Dakota34 30 daysOhio35 72 hoursOklahoma36 30
daysOregon37, 38 72 hours, smallest package unit of insulinPennsylvania39,40 72
hoursRhode Island41 72 hoursSouth Carolina42 14 daysTennessee43 72 hours, or the
smallest packaged unitTexas44 72 hoursUtah45,46 72 hours, 30 days for
prescription on file, 60 days for insulinVirginia47 Day supply not
addressedWashington48 30 daysWest Virginia49 30 daysWisconsin51 7 days or the
smallest packaged unitWyoming52 72 hours

Open in a separate window

*States that are silent on emergency/COT refill provisions in its entirety or do
not allow for emergency/COT refills are not included.

Due to the COVID-19 pandemic, some states that did not have previously existing
emergency/COT refill allowances created such allowances for emergency/COT
refills during the pandemic. Massachusetts and Vermont are some examples of this
new allowance. Some states that had previously existing emergency/COT refill
allowances loosened the day supply allowed to make it less restrictive. These
changes are shown in Table 2 below.


TABLE 2:

Changes to day supply for emergency/COT refills of non-scheduled medications
during the COVID pandemic.

StatesDay supply allowedAlabama53 72 hours → 30 daysArizona54 30 days → 90 days
+ additional 90 daysConnecticut55 72 hours → 30 daysDistrict of Columbia56 No
allowance → 90 daysFlorida57 72 hours, 1 vial for insulin → 90 daysIndiana58 30
days → 90 daysKentucky59 72 hours, greater is allowed for → 30 days
insulin/chronic respiratory diseaseMassachusetts60 No allowance → 30
daysMissouri61 7 days, 30 days if the provider is dead or incapacitated → 14
daysNevada62 Sufficient amount → 30 daysNew Mexico62 72 hours → 30 daysOhio63 72
hours → 90 daysPennsylvania65 72 hours → 30 daysRhode Island66 72 hours → 90
daysSouth Dakota67 No allowance → 30 daysTennessee68 72 hours, or the smallest
packaged unit → 90 daysVermont69 No allowance → Day supply not addressed

Open in a separate window

*Only states with an allowance specifically for the COVID-19 pandemic are
included.


STATE REGULATIONS REGARDING FREQUENCY OF AN EMERGENCY/COT REFILL ALLOWED AND
CHANGES DUE TO THE COVID-19 PANDEMIC.

While some laws and regulations allow for a “one time only” emergency/COT
supply, other states specified this as “one time in a certain period”. Due to
this variability in language used, the laws and regulations could be interpreted
differently. For example, a state may contain an allowance for an emergency/COT
refill “one time per lifetime”, while others may have an allowance for “one time
per prescription”. The different laws and regulations may cause confusion not
only for pharmacists, but also for patients and providers. Therefore, it is
important for the states to enact statutes or promulgate regulations that are
clear, concise and allow for a pharmacist to ensure a patient’s continuity of
care while practicing at the top of their education.


TABLE 3:

Emergency/COT supply frequency allowed among states before COVID-19.

StatesEmergency/COT supply frequencyAlabama5 One time onlyArizona8 One time
onlyArkansas9 One time onlyColorado11 Once in 12 monthsConnecticut12 One time
onlyDelaware13 One time onlyFlorida14 One time onlyIndiana18 Once in 6
monthsIowa19 One time onlyKentucky21 One time onlyLouisiana22 One time
onlyMaryland23 One time onlyMinnesota24 Once in 12 monthsMississippi25 One time
onlyMontana27 One time per prescriptionNorth Carolina33 One time onlyNorth
Dakota34 One time onlyOhio35 Once in 12 monthsOklahoma36 One time onlyOregon38
Only for Insulin: up to 3 times a yearPennsylvania40 One time onlyRhode Island41
One time onlySouth Carolina42 Once in 12 monthsTennessee43 2 consecutive
fillsUtah45 One time per exhausted prescriptionWashington48 Once in 6 monthsWest
Virginia50 Once in 12 monthsWisconsin51 One time only

Open in a separate window

*Only states allowing emergency/COT refills are included; states that are silent
on emergency/COT refills or not allowing emergency/COT refills are not included.

**Alaska, California, Georgia, Idaho, Illinois, Kanas, Missouri, Nevada, New
Hampshire, New Jersey, New Mexico, New York, Texas, Virginia, and Wyoming allow
emergency/COT refills, however the frequency limit is not addressed in the law.


TABLE 4:

Emergency/COT supply frequency allowance changes among states due to COVID-19.

States Emergency/COT supply frequency Arizona542 timesIndiana58One time
onlyKentucky59Not limited to a one-time refillOhio643 times in 12 months Note:
COVID allowance allows emergency fill 3 times in 12 months for all non-CII
substances, instead of insulin only.

Open in a separate window

*Only states with COVID allowance are included in this table.

**Alabama, Connecticut, District of Columbia, Florida, Massachusetts, Missouri,
Nevada, New Mexico, Pennsylvania, Rhode Island, South Dakota, Tennessee, and
Vermont allow for emergency refills during the COVID-19 pandemic, while the
frequency limits in those states are not addressed. The rationale behind the
silence in the allowance is potentially due to the uncertainty of the pandemic.
Patients may require more than one emergency refill for the maintaining the
patient’s health. The states mentioned in the tables are those that have had
their restriction loosened due to the pandemic.


SPECIFIC REGULATIONS AND GUIDANCE REGARDING THE EMERGENCY/COT REFILLING OF
FEDERALLY SCHEDULED CONTROLLED SUBSTANCE MEDICATIONS AND CHANGES DUE TO THE
COVID-19 PANDEMIC.

Many states have specific regulations surrounding the dispensing of an
emergency/COT refill for federally scheduled controlled substances. Table 5
presents the current laws and regulations regarding an emergency/COT refill of
controlled substance medications and changes, if any, due to the COVID-19
pandemic. Most states limit emergency/COT refill allowances to non-scheduled
drugs only. This may present a problem for those who are taking controlled
substance medications for chronic conditions. For example, diazepam is a
benzodiazepine commonly used for seizure control and a patient who misses a
single dose of this medication is at risk of having a seizure. Similarly,
patients who have regularly taken benzodiazepines for many years to treat a
variety of conditions often develop a dependence on the medication. If these
patients are without their medication, they are also at risk of having a
seizure, even if they have no prior seizure diagnosis. As it applies to Schedule
II controlled substances, Federal law states that a pharmacist may dispense a
Schedule II prescription drug only pursuant to a written prescription.72
However, in the case of an emergency, a pharmacist may dispense a Schedule II
prescription drug upon receiving oral authorization of a prescribing individual
practitioner, provided that certain conditions are followed. Due to these
requirements, state laws and regulations exclude Schedule II drugs from their
emergency/COT refill allowances if an allowance exists.72


TABLE 5:

Specific regulations regarding emergency/COT refills of scheduled medications
prior to the COVID-19 pandemic.

State Controlled Substance Specific Regulations COVID-19 Changes
Alabama6,53Allowed for schedules IV-VSchedules III-V allowedAlaska7Limited to
non-scheduled onlyN/AConnecticut12Limited to non-scheduled
onlyN/ADelaware13Limited to non-scheduled onlyN/ADistrict of Columbia56No
emergency fill allowance for any medicationsLimited to non-scheduled
onlyFlorida14Allowed for schedules III-VN/AGeorgia15Limited to non-scheduled
onlyN/AIdaho16Limited to non-scheduled onlyN/AIllinois17Limited to non-scheduled
onlyN/AIndiana18Limited to non-scheduled onlyN/AKansas20Limited to non-narcotics
onlyN/AKentucky21Limited to non-scheduled onlyN/AMaryland23Limited to
non-scheduled onlyN/AMinnesota24Scheduled medications allowed only if used as an
anti-epileptic and limited to a 72-hour supply *Non-scheduled can be filled for
a 30-day supplyN/AMississippi25Limited to non-scheduled
onlyN/AMissouri26,61Limited to non-scheduled onlySchedule III-V 14-day supply
allowed if original pharmacy that filled the RX is closedMontana27Allowed for
schedules III-VN/ANew Hampshire29Allowed for schedules III-VN/ANew
Mexico31,63SilentLimited to non-scheduled onlyNorth Carolina33Allowed for
schedules III-VN/ANorth Dakota34Allowed for schedules III-V(COVID allowance
adopted into law)Ohio35,6472-hour supply allowed for schedule III-V30-day supply
allowed for schedules III-V*Non-scheduled can be filled for a 30-day
supply90-day supply allowed for non-scheduledOklahoma36Limited to non-scheduled
onlyN/AOregon37,38Limited to non-scheduled onlyN/APennsylvania39,40,65Limited to
non-scheduled onlySchedule V allowedRhode Island41,66Allowed for schedules
III-VCOVID policies exclude scheduled medications from the expanded 90-day
allowanceSouth Carolina42Limited to non-scheduled onlyN/ASouth Dakota67Emergency
fill not allowed for any medicationsLimited to non-scheduled
onlyTennessee43Limited to non-scheduled onlyN/ATexas44Limited to non-scheduled
onlyN/AUtah45,46Limited to non-scheduled onlyN/AVermont69SilentLimited to
non-scheduled onlyVirginia47Limited to non-scheduled onlyN/AWashington487-day
supply allowed for schedule III-V only during emergency
proclamationN/A*Non-scheduled can be filled for a 30-day supply regardless of
emergency proclamationWest Virginia49,5072-hour supply allowed for schedule
III-VN/A*Non-scheduled can be filled for a 30-day supplyWisconsin51Limited to
non-scheduled onlyN/AWyoming52Limited to non-scheduled onlyN/A

Open in a separate window

*States in which scheduled controlled substance drugs are not addressed are not
included in the table.

**Schedule II medications are not addressed as they are not allowed to be
refilled per federal law.

Knowing the risks involved with not timely dispensing some of these controlled
substance medications, pharmacists may be positioned to give medication “loans”
or a few days’ supply not pursuant to a valid prescription. This presents many
problems, including changes to the controlled substance inventory that could
appear to be diversion and cause red flags that may lead to a board of pharmacy
investigation. Another problem is that this short, undocumented supply may not
be reported to the state’s prescription drug monitoring program (PMP), which
makes it difficult to track how many short supplies the patient has received
from various pharmacies. Legal allowances for pharmacists to dispense
emergency/COT supplies of controlled substances are necessary to take the legal
burden away from pharmacists and allow them to provide the most appropriate
patient care.


STATE REGULATIONS THAT REQUIRE A DECLARED STATE OF EMERGENCY TO ALLOW A
PHARMACIST TO DISPENSE AN EMERGENCY/COT REFILL.

Prior to the COVID-19 pandemic, some states had in place specific allowances for
emergency/COT refilling of medications during a declared emergency. These states
offered broader allowances for emergency/COT refilling during a declared state
of emergency and were prepared to handle the challenges that the lengthy
COVID-19 pandemic presented to pharmacists and patients when prescribers’
offices were closed, and patients were unable to go to appointments to obtain
prescription refill renewals of chronic medications. Many states have the
blanket condition that the refill can be dispensed if the pharmacist is unable
to obtain refill authorization after a good faith effort to contact the
prescriber, which covers a variety of situations. Only two states, Arizona and
Oklahoma, have very restrictive laws that only allow for an emergency/COT refill
when there is a declared state of emergency.

While it is beneficial to have expanded emergency/COT refill allowances during a
declared emergency, there are many other situations where extended refill
allowances would be appropriate. One example is in the case in which a
prescriber dies or retires unexpectedly. In this situation a patient would need
to identify a new provider and have an appointment to obtain refills. This
process is time consuming and allowances for upwards of a month supply to hold
these patients over would provide the patients with the necessary continuity of
care. The condition and days’ supply surrounding emergency/COT refills should be
left to the pharmacist’s professional discretion to ensure the best possible
patient care. Certain states allow for an emergency/COT refill only under
specific circumstance, such as a pharmacist being unable to obtain a refill from
a prescriber pursuant to an outreach to the prescriber. In another example, such
as Florida and Louisiana, a pharmacist may dispense a smaller emergency/COT
quantity if unable to reach the prescriber, but they may also dispense a larger
quantity during a declared state of emergency. Table 6 outlines the conditions
in which an emergency/COT refill can be dispensed and whether there is a
distinction in the allowance when there is a declared state of emergency.


TABLE 6:

Conditions in which an emergency/COT refill can be dispensed.

StateConditions for Emergency/COT Refill AllowanceAlabama6, Alaska7, Arkansas9,
California10, Colorado11, Connecticut12, Delaware13, Georgia15, Idaho16,
Illinois17, Indiana18, Iowa19, Kansas20, Kentucky21, Minnesota24, Mississippi25,
Missouri26, Montana27, Nevada28, New Hampshire29, New Jersey30, New Mexico31,
New York32, North Carolina33, North Dakota34, Ohio35, Pennsylvania39,40, Rhode
Island41, Tennessee43, Utah45,46, Virginia47, West Virginia49,50, Wisconsin51,
Wyoming52 Pharmacist is unable to obtain refillArizona8 Declared
emergencyFlorida14 Allowance varies based on whether it is a situation where the
pharmacist is unable to obtain refill vs. declared state of emergencyLouisiana22
Allowance varies based on whether it is a situation where the pharmacist is
unable to obtain refill vs. declared state of emergencyMaryland23 Allowance
varies based on whether it is a situation where the pharmacist is unable to
obtain refill vs. declared state of emergencyOklahoma36 Declared state of
emergency or disasterOregon37,38 Allowance varies based on whether it is a
situation where the pharmacist is unable to obtain refill vs. declared state of
emergencySouth Carolina42 Allowance varies based on whether it is a situation
where the pharmacist is unable to obtain a refill vs. declared state of
emergencyTexas44 Allowance varies based on whether it is a situation where the
pharmacist is unable to obtain a refill vs. declared state of
emergencyWashington48 Allowance varies based on whether it is a situation where
the pharmacist is unable to obtain a refill vs. declared state of emergency

Open in a separate window

*States that are silent on emergency/COT refill laws or do not allow for
emergency/COT refills are not included.


SPECIFIC STATES OF NOTE AND OUTLIERS.

The legal research revealed certain states that have statutory or regulatory
language that may have presented as outliers to language seen in other states,
which may benefit from some clarification from those states. Below are a few
examples.

Colorado: Colorado’s law on emergency prescription refills presents a scenario
in which there is specificity pertaining to the quantity of medication allowed
in an emergency through the following language: “the amount of the chronic
maintenance drug dispensed does not exceed the amount of the most recent
prescription of the standard quantity or unit of use package of the drug”.11
This language may place pharmacists in a position to choose dispensing a day
supply that is appropriate to ensure patient continuity of care or a quantity
that closely aligns with the applicable language, which may not mitigate gaps in
the patient’s pharmaceutical care.

Nevada: Nevada emergency/COT refill laws prior to the COVID-19 pandemic were
quite open ended and allowed for any “sufficient quantity” of medication,
including controlled substances, until the physician can be reached.28 When the
COVID-19 pandemic began the board of pharmacy released new guidance on the
issuance of emergency/COT refills that restricted the statutory allowance, by
limiting the supply to 30 days as opposed to the sufficient quantity needed
until the prescriber could be contacted.62

North Dakota: North Dakota is a case in which, prior to the COVID-19 pandemic,
the law was silent regarding dispensing of emergency refills, however pursuant
to the pandemic, the state enacted a new law to allow pharmacists to dispense
emergency refills, including controlled medications.34 North Dakota is a
noteworthy example of a state that realized the value a pharmacist may bring to
the public under these circumstances and adopted a law to make a COVID-19
allowance permanent.

Go to:


RECOMMENDATIONS AND CONCLUSION

The ability for a pharmacy to dispense an emergency/COT refill is an important
component in ensuring patient continuity of care. As this paper demonstrates,
there is great variability on the ability to dispense an emergency/COT refill,
the circumstances in which the dispensing may occur, and the day supply that may
be dispensed. Given the variability and inconsistency with the state laws and
regulations pertaining to pharmacist emergency/COT refill allowances, the public
would benefit from having those states amend their laws and regulations. This
action would allow the pharmacist to not be deterred to provide an emergency/COT
refill to the patient, with the concern over whether they are complying with
state laws and regulations, and the patient would be able to continue their
therapeutic regimen without interruption. These amendments would further provide
additional time for both the pharmacy and prescriber to react to a scenario in
which a patient needs their medications and do not have refills on their
prescription. Lastly, these amendments would avoid the possibility of not
dispensing a medication to a patient because the medication is in a unit of use
dosage form, such as an inhaler, or insulin.

When dispensing an emergency/COT refill, the quantity, day supply and frequency
dispensed should be predicated on the circumstances and the professional
judgment of the pharmacist, without the need for statutory or regulatory
restrictions. While the professional judgment of pharmacists may vary, the
alternative that includes stringent statutory or regulatory mandates, limiting
the amount of medication the patient may receive in an emergency, places the
patient in a position where the pharmacist is not afforded any opportunity to
leverage their professional judgement and ensure continuity of care. If a state
legislature or Board of Pharmacy has concerns over pharmacists utilizing
emergency/COT refills in perpetuity, a reasonable statutory or regulatory
guardrail such as a 90 to 180 day maximum day supply allowance would be
recommended.

Disclaimer: The views expressed in this manuscript are those of the authors
alone, and do not necessarily reflect those of their respective employers or
universities.

Go to:


REFERENCE

1. THE DURHAM-HUMPHREY AMENDMENT. JAMA. 1952;149(4):371. [Google Scholar]
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exacerbation in patients with asthma: A retrospective study of managed care
data. Ann. Allergy Asthma Immunol. 2006;97(3):402–408. [PubMed] [Google Scholar]
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treatment among patients with current depressive episode and their impact on
long-term outcome: A naturalistic study with 5-year follow-up. Patient
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11. Colorado CO ST 12-280-125.5.
12. Connecticut Conn. Gen. Stat. § 20-616.
13. Delaware Del. Code § 24-2550.
14. Florida Fla. Stat. § 465-0275.
15. Georgia Ga. Code § 26-4-80.
16. Idaho Idaho Admin. Code r. 27.01.01.402.
17. Illinois Ill. Comp. Stat. § 225-85/15.3.
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19. Iowa Iowa Code § 155A.29.
20. Kansas Kan. Stat. § 65-1637.
21. Kentucky Ky. Rev. Stat. § 315.500.
22. Louisiana La. Admin. Code tit. 46, § LIII:519.
23. Maryland Md. Code, HealthOcc Law § 12-506.
24. Minnesota MN ST 151.211.
25. Mississippi MS ST 73-21-115.
26. Missouri MO ST 338.200.
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28. Nevada Nev. Rev. Stat § 639.2394.
29. New Hampshire N.H. Admin. Rules 704.15.
30. New Jersey N.J. Admin. Code § 13:39-7.4.
31. New Mexico N.M. Stat. § 61-11-7.
32. New York N.Y. Comp. Codes R. & Regs. tit. x, § 8.29.1.
33. North Carolina N.C. Admin. Code 21-46.1815.
34. North Dakota N.D. Cent. Code § 43-15-01.
35. Ohio Ohio. Rev. Code § 4729.281.
36. Oklahoma Okla. Admin. Code § 535:13-1-4.
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41. Rhode Island R.I. Gen. Laws §5-19.1-24.
42. South Carolina S.C. Code. § 40-43-86.
43. Tennessee Tenn. Code § 63-10-207.
44. Texas Tex. [Emergency Refills] Code §562.054.
45. Utah Utah Code § 58-17b-608.
46. Utah Utah Admin. Code r.156-17b-612.
47. Virginia Va. Code § 54.1-3411.
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49. West Virginia W.Va. Code § 30-5-36.
50. West Virginia W.Va. Code R. § 15-1-22.
51. Wisconsin Wis. Stat. § 450.11.
52. Wyoming Wyo. Stat. § 33-24-136.
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56. District of Columbia DC. Mayor’s Order No. A23-247 (Apr. 10, 2020)
57. Georgia Ga. Exec. Order No. 03.20.20.02 (Mar. 20, 2020)
58. Indiana Ind. Exec. Order No. 20-12 (Mar. 6, 2020)
59. Kentucky Ky. Exec. Order No. 2021-137 (Mar. 4, 2021)
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Issue Emergency Refills in Response to COVID-19. Apr, 2020.
https://bop.nv.gov/uploadedFiles/bopnvgov/content/Resources/ALL/Guidance%20On%20the%20Authority%20of%20a%20Pharmacist%20to%20Issue%20Emergency%20Refills%20in%20Response%20to%20COVID-19%2004.01.2020.pdf
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64. State of Ohio Board of Pharmacy. Extension of emergency refill. Jun, 2020.
https://www.pharmacy.ohio.gov/Documents/Pubs/Special/COVID19Resources/Extension%20of%20Emergency%20Refills.pdf
Accessed April 10, 2021.
65. Pennsylvania Department of State. Pennsylvania Issues Additional
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10, 2021.
66. Rhode Island Code R.I. Rules 216-40-15-1.15.
67. South Dakota S.D. Admin R. 20:51:05:20.
68. Tennessee Tenn. Exec. Order No. 2020-15 (Mar. 19, 2020)
69. Vermont Vt. Stat. Ann. Pharmacists; Clinical Pharmacy; Extension of
Prescription for Maintenance Medication. § H-742.
70. Michigan Mich. Exec. Order No. 2020-25 (April 22, 2020)
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 * Abstract
 * Background
 * Research Results and Discussion
 * Recommendations and Conclusion
 * Reference

--------------------------------------------------------------------------------

Articles from Innovations in Pharmacy are provided here courtesy of University
of Minnesota Libraries Publishing

--------------------------------------------------------------------------------

1. THE DURHAM-HUMPHREY AMENDMENT. JAMA. 1952;149(4):371. [Google Scholar] [Ref
list]
2. Stern L, Berman J, Lumry W, et al. Medication compliance and disease
exacerbation in patients with asthma: A retrospective study of managed care
data. Ann. Allergy Asthma Immunol. 2006;97(3):402–408. [PubMed] [Google Scholar]
[Ref list]
3. Li K, Tao J, Li Y, et al. Patterns of persistence with pharmacological
treatment among patients with current depressive episode and their impact on
long-term outcome: A naturalistic study with 5-year follow-up. Patient
Preference Adherence. 2018;12:681–693. [PMC free article] [PubMed] [Google
Scholar] [Ref list]
4. Houser S. Ohio man’s death leads to law that gives access to lifesaving
prescription refills. Feb, 2020.
https://www.fox19.com/2020/02/06/ohio-mans-death-leads-law-that-gives-access-lifesaving-prescription-refills/
Fox19 news website. Accessed April 25, 2021. [Ref list]
71. Adams AJ. Prescription Adaptation Services: A Regulatory and Practice
Perspective. Ann Pharmacother. 2018 Jul;52(7):700–703. 10.1177/1060028018763883
Epub 2018 Mar 7. PMID: [PubMed] [Google Scholar] [Ref list]
5. Okoro RN. COVID-19 pandemic: The role of community pharmacists in chronic
kidney disease management supportive care. 2021;17(1):1925–1928. Res Social Adm
Pharm. [PMC free article] [PubMed] [Google Scholar] [Ref list]
6. Alabama Ala. Admin. Code r. 540-X-4-.07. [Ref list]
7. Alaska Alaska Admin . Code tit. 12, § 52.470. [Ref list]
8. Arizona Ariz. Admin. Code R4-23-412. [Ref list]
9. Arkansas AR ST 17-92-102. [Ref list]
10. California Cal.Bus. & Prof.Code § 4064. [Ref list]
11. Colorado CO ST 12-280-125.5. [Ref list]
12. Connecticut Conn. Gen. Stat. § 20-616. [Ref list]
13. Delaware Del. Code § 24-2550. [Ref list]
14. Florida Fla. Stat. § 465-0275. [Ref list]
15. Georgia Ga. Code § 26-4-80. [Ref list]
16. Idaho Idaho Admin. Code r. 27.01.01.402. [Ref list]
17. Illinois Ill. Comp. Stat. § 225-85/15.3. [Ref list]
18. Indiana Ind. Code § 25-26-13-25. [Ref list]
19. Iowa Iowa Code § 155A.29. [Ref list]
20. Kansas Kan. Stat. § 65-1637. [Ref list]
21. Kentucky Ky. Rev. Stat. § 315.500. [Ref list]
22. Louisiana La. Admin. Code tit. 46, § LIII:519. [Ref list]
23. Maryland Md. Code, HealthOcc Law § 12-506. [Ref list]
24. Minnesota MN ST 151.211. [Ref list]
25. Mississippi MS ST 73-21-115. [Ref list]
26. Missouri MO ST 338.200. [Ref list]
27. Montana Mont. Admin. R. 24.174.836. [Ref list]
28. Nevada Nev. Rev. Stat § 639.2394. [Ref list]
29. New Hampshire N.H. Admin. Rules 704.15. [Ref list]
30. New Jersey N.J. Admin. Code § 13:39-7.4. [Ref list]
31. New Mexico N.M. Stat. § 61-11-7. [Ref list]
32. New York N.Y. Comp. Codes R. & Regs. tit. x, § 8.29.1. [Ref list]
33. North Carolina N.C. Admin. Code 21-46.1815. [Ref list]
34. North Dakota N.D. Cent. Code § 43-15-01. [Ref list]
35. Ohio Ohio. Rev. Code § 4729.281. [Ref list]
36. Oklahoma Okla. Admin. Code § 535:13-1-4. [Ref list]
37. Oregon Or. Admin. R. 855-041-1120. [Ref list]
38. Oregon Or. Rev. Stat. § 689.696. [Ref list]
39. Pennsylvania 63 Pa. Cons. Stat. §390.2. [Ref list]
40. Pennsylvania 63 Pa. Cons. Stat. §390.8. [Ref list]
41. Rhode Island R.I. Gen. Laws §5-19.1-24. [Ref list]
42. South Carolina S.C. Code. § 40-43-86. [Ref list]
43. Tennessee Tenn. Code § 63-10-207. [Ref list]
44. Texas Tex. [Emergency Refills] Code §562.054. [Ref list]
45. Utah Utah Code § 58-17b-608. [Ref list]
46. Utah Utah Admin. Code r.156-17b-612. [Ref list]
47. Virginia Va. Code § 54.1-3411. [Ref list]
48. Washington Wash. Admin. Code § 246-945-330. [Ref list]
49. West Virginia W.Va. Code § 30-5-36. [Ref list]
51. Wisconsin Wis. Stat. § 450.11. [Ref list]
52. Wyoming Wyo. Stat. § 33-24-136. [Ref list]
53. Alabama Board of Pharmacy. Emergency Refills for Maintenance Medications.
Yeatman, DC.: Mar, 2020.
https://www.albop.com/PDF%20Files/2020/Coronavirus%20-%20Emergency%20refill%20-%20UPDATED.pdf
Accessed April 5, 2021. [Google Scholar] [Ref list]
54. Arizona Ariz. Exec. Order No. 2020-20 (Apr. 2, 2020) [Ref list]
55. Connecticut Conn. Exec. Order No. 71 (Mar. 12, 2020) [Ref list]
56. District of Columbia DC. Mayor’s Order No. A23-247 (Apr. 10, 2020) [Ref
list]
57. Georgia Ga. Exec. Order No. 03.20.20.02 (Mar. 20, 2020) [Ref list]
58. Indiana Ind. Exec. Order No. 20-12 (Mar. 6, 2020) [Ref list]
59. Kentucky Ky. Exec. Order No. 2021-137 (Mar. 4, 2021) [Ref list]
60. Executive Office of Health and Human Services. Order of the Commissioner of
Public Health Related to Pharmacy Practice. March; 2020.
https://www.mass.gov/doc/pharmacy-practice-order/download Accessed April 10,
2021. [Google Scholar] [Ref list]
61. Missouri Missouri Exec. Order No. 20-02 and 20-04 (March. 31, 2020) [Ref
list]
62. Nevada State Board of Pharmacy. Guidance on the Authority of a Pharmacist to
Issue Emergency Refills in Response to COVID-19. Apr, 2020.
https://bop.nv.gov/uploadedFiles/bopnvgov/content/Resources/ALL/Guidance%20On%20the%20Authority%20of%20a%20Pharmacist%20to%20Issue%20Emergency%20Refills%20in%20Response%20to%20COVID-19%2004.01.2020.pdf
Accessed April 10, 2021. [Ref list]
63. New Mexico Board of Pharmacy. DECLARATION – New Mexico Regulation and
Licensing Department Board of Pharmacy. Apr, 2020.
https://www.newmexico.gov/2020/04/11/emergency-dispensing-declaration-new-mexico-regulation-and-licensing-department-board-of-pharmacy/
Accessed April 10, 2021. [Ref list]
65. Pennsylvania Department of State. Pennsylvania Issues Additional
Pharmacy-Related Waivers During COVID-19 Emergency. Apr, 2020.
https://www.dos.pa.gov/Documents/2020-04-13-Pharmacy-Omnibus.pdf Accessed April
10, 2021. [Ref list]
66. Rhode Island Code R.I. Rules 216-40-15-1.15. [Ref list]
67. South Dakota S.D. Admin R. 20:51:05:20. [Ref list]
68. Tennessee Tenn. Exec. Order No. 2020-15 (Mar. 19, 2020) [Ref list]
69. Vermont Vt. Stat. Ann. Pharmacists; Clinical Pharmacy; Extension of
Prescription for Maintenance Medication. § H-742. [Ref list]
50. West Virginia W.Va. Code R. § 15-1-22. [Ref list]
64. State of Ohio Board of Pharmacy. Extension of emergency refill. Jun, 2020.
https://www.pharmacy.ohio.gov/Documents/Pubs/Special/COVID19Resources/Extension%20of%20Emergency%20Refills.pdf
Accessed April 10, 2021. [Ref list]
72. 21 C.F.R. § 1306.11. [Ref list]

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