Exploring LGBTQ+ cultural competency and DEI in continuing education: A cross-sectional review of U.S. pharmacy legislation.

BACKGROUND: Lesbian, gay, bisexual, transgender, queer or questioning, intersex, asexual, or other sexual orientations or gender identities (LGBTQ+) cultural competency training is offered in pharmacy curricula to variable extents. State legislation directly dictates pharmacist training through continuing pharmacy education (CPE) requirements. OBJECTIVES: This study aimed to identify the U.S. states and the District of Columbia (D.C.) that require CPE or training on topics related to LGBTQ+ cultural competency or topics related to diversity, equity, and inclusion (DEI) in general. In addition, this study quantified and compared each state's CPE hours required for each renewal period. METHODS: This cross-sectional study retrospectively examined pharmacy legislation on CPE requirements for each of the 50 U.S. states and D.C. Only state legislation that was signed into law and related to pharmacy practice was included. Official websites for each board of pharmacy were identified to locate lawbooks, laws, rules, regulations, and statutes specific to pharmacy practice. Search terms included "lgbt," "lgbtq," "cultural," "cultural competency," "equity," "health equity," "implicit," and "implicit bias." Two study investigators independently collected data from March 2023 to April 2023. Data were re-reviewed for accuracy in January 2024. Discrepancies were resolved through discussion until a consensus was reached. The total number of required CPE hours, years for each pharmacist license renewal, required LGBTQ+ cultural competency CPE hours, and required DEI-focused CPE hours were described using descriptive statistics. RESULTS: A total of 44 of 51 states and D.C. required 30 CPE hours for each 2-year renewal cycle or 15 CPE hours for each 1-year renewal cycle. California and D.C. had LGBTQ+ cultural competency CPE requirements of 1 CPE hour or 2 CPE hours per cycle, respectively. Five additional states, Illinois, Maryland, Michigan, Oregon, and Washington, required training or CPE on topics related to DEI as a whole. CONCLUSION: Few U.S. states require CPE on LGBTQ+ cultural competency. This study highlights the need for standardized pharmacist training in LGBTQ+ health care.

A Follow-Up Study on Delivery of Pharmacy Law Education Across Doctor of Pharmacy Programs.

OBJECTIVE: To present 2018-2019 data from an expanded investigation after an inaugural 2016 pilot survey, which previously reported on the delivery of pharmacy law education in doctor of pharmacy (PharmD) programs in the US. METHODS: Due to the limited scope of responses in the 2016 pilot study, the earlier survey was refined and readministered (Qualtrics, Provo, UT) utilizing branching logic to specifically identify characteristics of the pharmacy law content and its delivery in PharmD curricula. The follow-up study received an exempt status from the Institutional Review Board of Keck Graduate Institute. RESULTS: Of the 142 American Association of Colleges of Pharmacy member institutions in 2018, 97 provided complete responses to the survey, yielding a response rate of 68.3%. The survey results from this 2018-2019 further investigation examining the delivery of pharmacy law education in US PharmD programs indicate significant variations across respondent programs with respect to professional background of pharmacy law educators and assessment strategies used in pharmacy law courses, as well as variations in the structure and timing of the core pharmacy law course within the PharmD curriculum. CONCLUSION: The current data show PharmD curricula at surveyed institutions lack uniformity in pharmacy law content and sequencing of pharmacy law courses, supporting further investigation to identify the best practices in the delivery of pharmacy law education. Another deliberate focus should aim to more specifically determine how, if, and which specific modifications to delivery of pharmacy law education might ensure achievement of student learning outcomes and optimize PharmD graduates' performance on standardized jurisprudence exams.

Investigation of the boxed warnings in package inserts of prescription medicines for medical professionals in Japan

Objective: In the Japanese Pharmacists Act, article 25-2, revised in 2013, it states that pharmacists shall provide the necessary information and guidance to the patient based on pharmaceutical knowledge and experience for ensuring the proper use of the medicine dispensed. The package insert is one of the documents to be referred to when providing the information and guidance. The boxed warnings in package inserts that include the precautions and responses are the most significant parts, however, the suitability of boxed warnings for pharmaceutical practice has not been evaluated. The aim of this study was to investigate the boxed warning descriptions in package inserts of prescription medicines for medical professionals in Japan. Methods: Package inserts of prescription medicines listed in the Japanese National Health Insurance drug price list on March 1st 2015 were collected one by one by hand from the website of the Japanese Pharmaceuticals and Medical Devices Agency (https://www.pmda.go.jp/english/). Package inserts with boxed warnings were classified according to the Standard Commodity Classification Number of Japan based on the pharmacological activity of each medicine. They were also compiled according to their formulations. The boxed warnings were divided into the precautions and responses parts, and their characteristics were compared among medicines. (AU)

Protocolo del servicio para la realización, trazabilidad y seguimiento de los resultados obtenidos de test de diagnóstico y autodiagnóstico de antígenos de SA R S- CoV-2 / Protocol for the performance, traceability and monitoring of the results obtained from the SARS-CoV-2 antigen diagnostic and self-diagnostic test

Introducción: A través de un acuerdo de colabora-ción entre el Departamento de Sanidad del Gobier-no de Aragón y el Consejo de Colegios Oficiales de Farmacéuticos de Aragón, las oficinas de farmacia de Aragón tienen la posibilidad de adherirse volun-tariamente para su colaboración en la vigilancia epidemiológica, mediante la realización de test de antígenos, comunicación de los resultados y emi-sión de certificados.Método: Previamente a la adhesión, las farmacias han de cumplir una serie de requisitos, incluyen-do una declaración de responsabilidad. Ante la solicitud de un paciente asintomático que desea realizarse un test, el farmacéutico debe seguir un algoritmo de decisión.Resultados: A fecha 3 de octubre de 2021,303 far-macias en Aragón han participado. Se han emitido 6.021 Certificados COVID Digitales de la UE, tras la realización de un test de diagnóstico de antíge-nos en la oficina de farmacia, con 92 resultados positivos. Conclusiones: Las oficinas de farmacia han resul-tado esenciales en la realización de test de antí-genos, comunicación de resultados y emisión de Certificados COVID Digitales de la UE. (AU)

Introduction: Through a collaboration agreement between the Department of Health of the Govern-ment of Aragon and the Council of Official Associa-tions of Pharmacists of Aragon, those pharmacies that voluntarily wanted to register were incorporat-ed into the epidemiological surveillance system. In this way, they can carry out diagnostic and self-diagnosis tests on patients, issue certificates and communicate positive results directly to the Department of Health.Method: In order to accede to this agreement, some requirements must be met by the pharma-cies, including a statement of responsibility. At the request of an asymptomatic patient who wishes to undergo a test, the pharmacist must follow a decision algorithm.Results: As of October 3, 2021, 303 pharmacies in Aragón participated in this collaboration. 6.021 EU Digital COVID Certificates were issued, after having carried out an antigen diagnostic test at the phar-macy. 92 positive results were reported.Conclusions: Pharmacies have been essential in carrying out antigen tests, communicating results and issuing EU Digital COVID Certificates. (AU)

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.

Medicamentos órfãos em Portugal no contexto internacional (séculos XX-XXI) / Orphan drugs in Portugal in the international context (XX-XXI centuries)

A consciência científica, clínica e pública da existência das doenças raras tem aumentado nos últimos anos. Os medicamentos denominados de “medicamentos órfãos” são aqueles que são apropriados para o tratamento de doenças raras. As doenças raras, comparadas com outras doenças, apresentam uma baixa incidência demográfica. Por esta razão, e em virtude das condições vigentes de comercialização, as indústrias farmacêuticas não apostam fortemente nos medicamentos órfãos. Os produtores não teriam oportunidade de recuperar o capital investido na investigação e desenvolvimento do medicamento. Neste estudo os autores fazem um historial dos medicamentos órfãos em Portugal tendo como fontes a legislação e regulamentação portuguesas no quadro da legislação e diretivas europeias, o papel das indústrias farmacêuticas em Portugal, a regulamentação e fiscalização realizada pelo INFARMED, IP, bem como o acesso dos doentes aos medicamentos órfãos e o papel fulcral das associações de doentes (AU)

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.

COVID-19 related regulatory change for pharmacists - The case for its retention post the pandemic.

The delivery of healthcare including the provision of pharmacy services globally is highly regulated internationally in order to protect public health and welfare. However, the onset of the COVID-19 pandemic has precipitated the need internationally to amend the model of regulation in order to ensure that people were able to continue to access a range of healthcare services in a timely and effective manner. Many of the changes introduced to the regulation of pharmacy services in Ireland have been replicated in other countries. These include the introduction of electronic means to transmit prescriptions and other orders for medications, relaxing the legal restrictions in place controlling the emergency supply of prescription only medicines and more fully utilizing the professional competency of pharmacists by empowering them to use their expertise and judgment to support their patients accessing the healthcare services that they need. Many of the regulatory changes that have been introduced to support the COVID-19 public health emergency effort are ones that pharmacists have previously sought to enable them provide a more effective and expanded model of pharmaceutical care to their patients. Accordingly, many pharmacists will want these regulatory changes to be retained and further expanded in the aftermath of the COVID-19 public health emergency in order to extend their scope of practice and support them in the care of their patients.

The legal extension of the role of pharmacists in light of the COVID-19 global pandemic.

BACKGROUND: The COVID-19 epidemic has affected every area of life. The greatest challenge has been to adapt the functioning of the health service to prevent the spread of the epidemic and to help infected patients. This has required the involvement of not only doctors and nurses, but also pharmacists. In the face of this pandemic, governments in many countries have granted pharmacists greater authority. OBJECTIVES: The purpose of this paper is to review the legal extension of the role of pharmacists in light of the COVID-19 pandemic. The review considers recent changes in European countries, Canada, and the United States. METHODS: A literature review was performed to summarise knowledge about the extension of the role of pharmacists during the pandemic period. Key articles were retrieved mainly from PubMed and Google Scholar, using the terms "COVID-19", "2019-nCoV", "coronavirus", and "pandemic" in combination with "pharmacist" as keywords for our search. We included scientific publications from February 1, 2019 to May 15, 2020. RESULTS: Pharmacists have been given numerous opportunities so that they can actively join in the fight against the virus. Some of the novel legal extensions aimed at aiding overloaded healthcare systems are as follows: authorisation to prepare hand and surface disinfectants, eligibility to renew chronic treatment prescriptions, as well as filling pro auctore and pro familia prescriptions by pharmacists, performing COVID-19, influenza, and Group A Streptococcus screening tests, and vaccine administration. Moreover, many countries have facilitated Internet services, such as virtual medical consultations, e-prescriptions, and home drug delivery - to promote social distancing among patients. To mitigate drug shortages, the following strategies have been implemented: alternative sourcing, strength, generic, or therapeutic substitution, and preparing compounded formulations at the pharmacy. CONCLUSIONS: Novel legal extensions have allowed exploitation of the full potential ofpharmacists worldwide, aiding the limited resources of overloaded healthcare systems.

[Design of Teaching Materials for Pharmaceutical Law Education].

A questionnaire survey was conducted with pharmacy students to obtain useful information for preparing teaching materials in the field of pharmaceutical laws. We conducted a customer satisfaction (CS) analysis by asking pharmacy students to evaluate whether the teaching materials used in the Pharmaceutical Laws class at Kitasato University were effective in promoting learning and understanding. In addition, we asked them about their impressions of attending the Pharmaceutical Laws class and analyzed their freely described answers. The CS analysis suggested teaching materials that included case studies of pharmaceutical law judgments and violations may have been useful for learning this subject. Furthermore, the text analysis showed many of the participants believed the contents of the teaching materials were difficult. Therefore, it is necessary to redesign the contents so that learning can progress step by step from the basic items. In addition, since some students recognized that the subject could be memorized, it is possible they can convey only what they remember and not what they had learned or what knowledge they could use in other contexts and situations. Therefore, it is necessary to clearly present the learning objectives for each item in lesson's teaching materials.

Do disasters predict international pharmacy legislation?

Objective The aim of this study was to explore whether a relationship exists between the number of disasters a jurisdiction has experienced and the presence of disaster-specific pharmacy legislation. Methods Pharmacy legislation specific to disasters was reviewed for five countries: Australia, Canada, UK, US and New Zealand. A binary logistic regression test using a generalised estimating equation was used to examine the association between the number of disasters experienced by a state, province, territory or country and whether they had disaster-specific pharmacy legislation. Results Three of six models were statistically significant, suggesting that the odds of a jurisdiction having disaster-specific pharmacy legislation increased as the number of disasters increased for the period 2007-17 and 2013-17. There was an association between the everyday emergency supply legislation and the presence of the extended disaster-specific emergency supply legislation . Conclusions It is evident from this review that there are inconsistencies as to the level of assistance pharmacists can provide during times of crisis depending on their jurisdiction and location of practice. It is not a question of whether pharmacists have the skills and capabilities to assist, but rather what legislative barriers are preventing them from being able to contribute further to the disaster healthcare team. What is known about the topic? The contributing factors to disaster-specific pharmacy legislation has not previously been explored in Australia. It can be postulated that the number of disasters experienced by a jurisdiction increases the likelihood of governments introducing disaster-specific pharmacy legislation based on other countries. What does this paper add? This study compared five countries and their pharmacy legislation specific to disasters. It identified that as the number of disasters increases, the odds of a jurisdiction having disaster-specific emergency supply or disaster relocation or mobile pharmacy legislation increases. However, this is likely to be only one of many factors affecting the political decisions of when and what legislation is passed in relation to pharmacists' roles in disasters. What are the implications for practitioners? Pharmacists are well situated in the community to be of assistance during disasters. However, their ability to help patients with chronic disease management or providing necessary vaccinations in disasters is limited by the legislation in their jurisdiction. Releasing pharmacists' full potential in disasters could alleviate the burden of low-acuity patients on other healthcare services. This could subsequently free up other healthcare professionals to treat high-acuity patients and emergencies.

A Pilot Study Regarding Pharmacy Law Education Across Doctor of Pharmacy Programs.

Objective. To describe the features of pharmacy law education in Doctor of Pharmacy (PharmD) programs in the United States. Methods. A review of the literature found no prior published data describing the delivery of pharmacy law education across PharmD programs in the United States. Members of the Pharmacy Law Educators Subcommittee of the American Society for Pharmacy Law (ASPL) developed questions for a survey. The survey was administered electronically to all 139 American Association of Colleges of Pharmacy (AACP) member institutions in the summer of 2016. A link to complete the 32-item online survey was distributed via email to the pharmacy law educator or associate dean at each AACP member institution. Results. Of the 139 PharmD programs surveyed, 49 completed the survey instrument, yielding a response rate of 35.2%. Variations between programs were found in the professional background of pharmacy law instructors and assessment strategies for pharmacy law courses, as well as in the structure and placement of the main pharmacy law course within the various curricula. Conclusion. This pilot study represents the first and only known attempt to examine delivery of pharmacy law education across colleges of pharmacy. The variations between programs found in this study highlight the need for further investigation into this area of pharmacy education.

Using MyDispense to simulate validation of controlled substance prescriptions in a pharmacy law course.

BACKGROUND AND PURPOSE: MyDispense is an innovative, web-based program which simulates a community pharmacy. Use of this software may assist students' comprehension of validating controlled substance prescriptions by determining if prescriptions contain errors or omissions. EDUCATIONAL ACTIVITY AND SETTING: Fourteen MyDispense practice exercises were created and implemented into a required second-year pharmacy law course. Completion of the MyDispense exercises and performance on the pharmacy law midterm exam were recorded. A questionnaire was administered to students to receive feedback on the exercises. FINDINGS: There were complete data on all 94 student pharmacists enrolled in the didactic course. Thirty-five students (37%) completed all MyDispense exercises, 15 students (16%) completed some of the exercises, and 44 (47%) did not complete any of the exercises. Linear regression results indicate that students who completed more MyDispense exercises were significantly more likely to score higher on the midterm than those who completed fewer exercises (ß = 0.28, p = 0.02). Students reported moderate to high exercise value and a willingness to use the software in preparation for future pharmacy law examinations. SUMMARY: MyDispense provided a platform for students to apply controlled substance laws to the prescription validation process in the community pharmacy setting. Completion of practice exercises in MyDispense was shown to positively impact student performance on a pharmacy law midterm. Students valued the innovative simulation tool and were willing to access the tool again to prepare for future examinations.