Legal requirements for pharmacists to destroy unused medications in skilled nursing facilities. - A 50 state review and insights based on the Covid-19 pandemic.

A novel challenge presents itself when the law requires a pharmacist be on site to perform their required duties, such as destroying unused medications, however a skilled nursing facility is not allowing them to enter the property due to a pandemic. Current laws regarding drug destruction are unclear and vastly differ among the states. At times, there is even conflict between skilled nursing facility laws and regulations with pharmacy laws and regulations. This legal analysis reveals that the states are divided into 4 general groupings. 1) Where a pharmacist is physically required on site to destroy medications, 2) a pharmacist is not needed on site to destroy medications, 3) a pharmacist is likely not needed on site to destroy medications; however, the terms "witness" and "presence" are not defined and 4) it is unknown based on the states laws whether a pharmacist is required on site to destroy medications. States would benefit from amending their laws and regulations to explicitly allow pharmacists to either destroy medications themselves when onsite or delegate the drug destruction to a trusted, responsible member of the healthcare field so long as the pharmacist is able to virtually witness said destruction.

Pharmacist-led Smoking-Cessation Services in the United States - A Multijurisdictional Legal Analysis.

A challenge presents itself when pharmacy students and pharmacists have the knowledge, skills, and abilities to provide optimal patient care, which can prevent the healthcare industry from incurring expenditures reaching billions of dollars annually from chronic and acute disease state management, yet due to the lack of statutory or regulatory authority to independently prescribe and dispense smoking cessation products they are unable to tap into this potential. Prescriptive authority of pharmacists is not a novel concept; however, State Legislatures and Boards of Pharmacy have been slow to expand upon the pharmacist's scope of practice to include this authority. As a consequence, this inaction hinders the opportunity of almost 21.5 million patients, who attempt to quit smoking annually, the ability to access a U.S. Food and Drug Administration approved, evidence-based medication-assisted or nicotine replacement therapy prescribed by a pharmacist.2 Current legislative efforts, laws, and regulations regarding a pharmacist's prescriptive authority for tobacco cessation therapy vary greatly amongst the states and do not include reference to e-cigarettes or electronic nicotine delivery systems (e.g., e-cigs, vape pens, vapes, mods, etc.). Additionally, pharmacists are often required to practice under a statewide protocol or enter into a collaborative practice agreement ("CPA") with a designated physician, which are often complex and create significant barriers for the pharmacist to practice at the top of their license and for the benefit of the patient. This legal and regulatory study reveals the following: 1) Those States that have addressed or attempted to address the pharmacist's prescriptive authority for tobacco cessation therapy, 2) the authority to independently prescribe vs. practice under a statewide protocol, 3) the products able to be prescriber or dispensed under the pharmacist's prescriptive authority or statewide protocol, and 4) the guidelines and/or protocols referenced within their respective State laws and regulations. States and their residents would benefit greatly from amending their laws and regulations to expand upon the pharmacist's prescriptive authority, granting them the ability to help their communities by performing services they are highly trained to perform.

Ability of community pharmacists to independently perform CLIA-waived testing - A multistate legal review.

The scope of practice of community pharmacy has continued in its evolution into a clinically focused profession. A critical component to pharmacist clinical offerings in the United States is the performance of Clinical Laboratory Improvement Amendments ("CLIA") waived tests. However, state laws and regulations greatly influence a pharmacist's ability to perform a CLIA-waived test. Based on this variability and lack of clarity in state laws and regulations, a legal review was performed, which focused on the following themes: 1) states which currently allow a pharmacist to independently perform CLIA-waived testing; 2) of those states, which states impose restrictions on the scope of CLIA-waived tests that may be independently performed by a pharmacist; and 3) states that impose restrictions on the ability of a pharmacist to independently perform CLIA-waived testing. Federal laws already exist that allow individuals, pursuant to certification, to perform CLIA-waived testing. This allowance presumably includes pharmacists if they follow federal law. However, some states regulate and restrict this area for pharmacists, contrary to these federal laws. States may see an improvement in patient care and further expand the practice of pharmacy by limiting restrictions on pharmacists to perform CLIA-waived tests and following federal allowances.

Applicability of pharmacist to technician ratio laws and regulations on non-resident pharmacies - A multistate legal review.

A challenge presents itself when a pharmacy obtains multiple non-resident pharmacy licenses and is mandated to comply with the laws and regulations of those states, including pharmacist to technician ratios. Current laws and regulations regarding ratios vary greatly amongst the states. Additionally, non-resident licensees, are at times required to comply with several different state pharmacy laws and regulations simultaneously, which often are in conflict and create a significant barrier for the pharmacy to comply. This legal analysis reveals the following. 1) Those states that have a ratio in law or regulation, and 2) of those states, which states mandate compliance with their ratio on a non-resident pharmacy. States would benefit from amending their laws and regulations to both eliminate ratios and allow pharmacies to solely follow the laws and rules of their resident state to avoid confusion and to mitigate conflict of law issues.

Pharmacist Allowances for the Dispensing of Emergency or Continuation of Therapy Prescription Refills and the COVID-19 Impact: A Multistate Legal Review.

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.