key: cord-1021506-d98z31fb
authors: DeRosa, Nicholas; Leung, Ka; Vlahopoulos, Julia; Lavino, Joseph
title: Pharmacist Allowances for the Dispensing of Emergency or Continuation of Therapy Prescription Refills and the COVID-19 Impact: A Multistate Legal Review
date: 2021-06-10
journal: Innov Pharm
DOI: 10.24926/iip.v12i3.4222
sha: 4b0f6ad1d70943d02f3d75d668538b5a5f55d932
doc_id: 1021506
cord_uid: d98z31fb

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.

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 normally 2 . 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.

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.

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 nonscheduled/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 30day 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. 9 Day supply not addressed California 10 Day supply not addressed Colorado 11 Not exceeding the amount of most recent prescription Connecticut 12 72 hours Delaware 13 Day supply not addressed Florida 14 72 hours, 1 vial for insulin Georgia 15 72 hours Idaho 16 Day supply not addressed Illinois 17 30 days Indiana 18 30 days Iowa 19 Day supply not addressed Kanas 20 7 days or 1 package Kentucky 21 72 hours, greater is allowed for insulin/chronic respiratory disease Louisiana 22 72 hours Maryland 23 14 days Minnesota 24 30 days Mississippi 25 72 hours Missouri 26 7 days, 30 days if the provider is dead or incapacitated Montana 27 Day supply not addressed Nevada 28 Sufficient amount New Hampshire 29 90 days New Jersey 30 72 hours New Mexico 31 72 hours New York 32 Day supply not addressed North Carolina 33 30 days, 90 days if the prescriber is incapacitated North Dakota 34 30 days Ohio 35 72 hours Oklahoma 36 30 days Oregon 37, 38 72 hours, smallest package unit of insulin Pennsylvania 39,40 72 hours Rhode Island 41 72 hours South Carolina 42 14 days Tennessee 43 72 hours, or the smallest packaged unit Texas 44 72 hours Utah 45, 46 72 hours, 30 days for prescription on file, 60 days for insulin Virginia 47 Day supply not addressed Washington 48 30 days West Virginia 49 30 days Wisconsin 51 7 days or the smallest packaged unit Wyoming 52 72 hours *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. No allowance 30 days Tennessee 68 72 hours, or the smallest packaged unit 90 days Vermont 69 No allowance Day supply not addressed *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. One time only Arizona 8 One time only Arkansas 9 One time only Colorado 11 Once in 12 months Connecticut 12 One time only Delaware 13 One time only Florida 14 One time only Indiana 18 Once in 6 months Iowa 19 One time only Kentucky 21 One time only Louisiana 22 One time only Maryland 23 One time only Minnesota 24 Once in 12 months Mississippi 25 One time only Montana 27 One time per prescription North Carolina 33 One time only North Dakota 34 One time only Ohio 35 Once in 12 months Oklahoma 36 One time only Oregon 38 Only for Insulin: up to 3 times a year Pennsylvania 40 One time only Rhode Island 41 One time only South Carolina 42 Once in 12 months Tennessee 43 2 consecutive fills Utah 45 One time per exhausted prescription Washington 48 Once in 6 months West Virginia 50 Once in 12 months Wisconsin 51 One time only *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. Not limited to a one-time refill Ohio 64 3 times in 12 months Note: COVID allowance allows emergency fill 3 times in 12 months for all non-CII substances, instead of insulin only. *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.

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

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. Allowed for schedules IV-V Schedules III-V allowed Alaska 7 Limited to non-scheduled only N/A Connecticut 12 Limited to non-scheduled only N/A Delaware 13 Limited to non-scheduled only N/A District of Columbia 56

No emergency fill allowance for any medications Limited to non-scheduled only Florida 14 Allowed for schedules III-V N/A Georgia 15 Limited to non-scheduled only N/A Idaho 16 Limited to non-scheduled only N/A Illinois 17 Limited to non-scheduled only N/A Indiana 18 Limited to non-scheduled only N/A Kansas 20 Limited to non-narcotics only N/A Kentucky 21 Limited to non-scheduled only N/A Maryland 23 Limited to non-scheduled only N/A Minnesota 24 Scheduled 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 supply N/A Mississippi 25 Limited to non-scheduled only N/A Missouri 26, 61 Limited to non-scheduled only Schedule III-V 14-day supply allowed if original pharmacy that filled the RX is closed Montana 27 Allowed for schedules III-V N/A New Hampshire 29 Allowed for schedules III-V N/A New Mexico 31, 63 Silent Limited to non-scheduled only North Carolina 33 Allowed for schedules III-V N/A North Dakota 34 Allowed for schedules III-V (COVID allowance adopted into law) Ohio 35, 64 72-hour supply allowed for schedule III-V *Non-scheduled can be filled for a 30-day supply 30-day supply allowed for schedules III-V 90-day supply allowed for non-scheduled Oklahoma 36 Limited to non-scheduled only N/A Oregon 37, 38 Limited to non-scheduled only N/A Pennsylvania 39,40, 65 Limited to non-scheduled only Schedule V allowed Rhode Island 41, 66 Allowed for schedules III-V COVID policies exclude scheduled medications from the expanded 90-day allowance South Carolina 42 Limited to non-scheduled only N/A South Dakota 67 Emergency fill not allowed for any medications Limited to non-scheduled only Tennessee 43 Limited to non-scheduled only N/A Texas 44 Limited to non-scheduled only N/A Utah 45, 46 Limited to non-scheduled only N/A Vermont 69 Silent Limited to non-scheduled only Virginia 47 Limited to non-scheduled only N/A Washington 48 7-day supply allowed for schedule III-V only during emergency proclamation *Non-scheduled can be filled for a 30-day supply regardless of emergency proclamation 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.

Pharmacist is unable to obtain refill Arizona 8 Declared emergency Florida 14 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain refill vs. declared state of emergency Louisiana 22 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain refill vs. declared state of emergency Maryland 23 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain refill vs. declared state of emergency Oklahoma 36 Declared state of emergency or disaster Oregon 37, 38 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain refill vs. declared state of emergency South Carolina 42 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain a refill vs. declared state of emergency Texas 44 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain a refill vs. declared state of emergency Washington 48 Allowance varies based on whether it is a situation where the pharmacist is unable to obtain a refill vs. declared state of emergency *States that are silent on emergency/COT refill laws or do not allow for emergency/COT refills are not included.

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.

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.

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

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