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.

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.

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.

[Direct-to-consumer genetic testing: a regulation by the market, or a medical regulation?] / Les tests génétiques en libre accès - Régulation par le marché, ou régulation médicale ?

The direct-to-consumer genetic testing (DTC-GT) market has been developing for about twenty years now, raising various debates, even controversies. But what about the regulation of these so-called "innovative" devices, but whose medical status is ambiguous? A first regulatory aspect is depending on the market itself, since the latter is currently subjected to a strong structuring process. A second regulatory aspect, more classical, is the legal one. While the DTC-GT status has long been unclear on European scale, a new text (a Regulation, not a Directive) is modifying the situation. It encourages regulation "by the market" rather than "by the medical profession", which does not imply that the latter will have no (indirect) impact on the DTC-GT market.

TITLE: Les tests génétiques en libre accès - Régulation par le marché, ou régulation médicale ? ABSTRACT: Le marché des auto-tests génétiques se développe depuis une vingtaine d'années, non sans soulever des débats, voire des controverses. Qu'en est-il de la régulation de ces dispositifs dits « innovants ¼, mais dont le statut médical est ambigu ? Un premier aspect régulatoire vient du marché lui-même, puisqu'il est en cours de forte structuration. Un second aspect régulatoire relève plus classiquement du juridique. Alors que le statut des auto-tests a longtemps manqué de clarté à l'échelle européenne, un nouveau texte (un Règlement, et non une Directive) change la situation. Il encourage une régulation « par le marché ¼, plutôt que « par la profession médicale ¼, ce qui n'implique pas que cette dernière n'aura aucun impact (indirect) sur le marché des auto-tests.

The Reemergence of Specialty Pharmacy.

Twenty years ago, the Journal of Managed Care & Specialty Pharmacy published an article titled "The Emergence of Specialty Pharmacy." While the industry was in its relative infancy at the time, the specialty pharmacy model has since grown, expanded, and matured, largely following some of the trends outlined at the time. Now, with changes in legislation, a progressive approach within the FDA, a second coming of novel therapies and supplemental indications, along with an involvement in cell and gene therapy, a reemergence of the specialty model is taking place, and the market must adapt to the new challenges associated with this era of modern medicine. DISCLOSURES: No funding contributed to the writing of this article. Ogurchak reports speaker fees from MJH Live Events and WellSky, unrelated to this work. The other authors have nothing to disclose with respect to research, authorship, and/or publication of this article.

Implementing California Senate Bill 493 in an Outpatient Pharmacy Within an Integrated Health System: Evaluation of the Operational and Clinical Effect of Pharmacist-Ordered Laboratory Tests.

BACKGROUND: Under California Senate Bill 493, pharmacists can order patient laboratory tests (labs). Currently, it is unknown if this service affects patient outcomes or pharmacy operations. Does lab ordering by pharmacists improve access to care, improve quality outcomes, and/or affect pharmacy operational functions? PROGRAM DESCRIPTION: A 13-month pilot study was conducted at 2 Kaiser Permanente (KP) outpatient pharmacies where pharmacists provided extended adherence consultations and ordered hemoglobin A1c (HbA1c) labs for patients nonadherent to their oral diabetic medications with an HbA1c ≥ 8% or missing annual labs. Clinical outcomes of the pilot study were compared with a similar patient population at KP who concurrently received lab orders from their primary providers, defined here as the "usual care model." OBSERVATION: Of the 793 HbA1c lab orders, 87 (11.0%) were generated by a pharmacist, and 706 (89.0%) were generated by the usual care group. Forty-three (49.4%) patients in the pharmacist group completed their labs compared with 279 (39.5%) patients in the usual care group (P = 0.10). A significantly greater proportion of patients in the pharmacist group achieved an HbA1c < 8% within the follow-up period of 30-180 days (34.9%), compared with the usual care group (12.2%, P < 0.01). Of the patients who completed labs during the evaluation period, 38 (43.7%) patients in the pharmacist group and 111 (15.7%) patients in the usual care group had prelaboratory values ≥ 8% within the previous 12 months. The average pre-HbA1c value was 9.47% in the pharmacist group, and the average post-HbA1c value was 8.68% (P < 0.01). For the usual care group, the average pre-HbA1c value was 9.70%, and the average post-HbA1c value was 9.43% (P = 0.06). When comparing the difference in HbA1c reduction between the 2 groups, there was a larger decrease in HbA1c in the pharmacist group, but this difference was not significantly different (P = 0.06). The pilot study added an average of 5 minutes per patient encounter to the pharmacy workflow but did not affect overall patient wait times for receiving outpatient prescriptions. IMPLICATIONS: Laboratory ordering by pharmacists in the outpatient setting improved access to care, improved quality outcomes, and did not adversely affect pharmacy operations. DISCLOSURES: No outside funding supported this project. The authors have nothing to disclose.

Review of HIPAA, Part 2: Limitations, Rights, Violations, and Role for the Imaging Technologist.

This article is the second part of a continuing education series reviewing the Health Insurance Portability and Accountability Act (HIPAA) of 1996. The term HIPAA should be familiar to those who work in the medical profession, but this article includes details on its rules, patients' rights, violations, breaches, and penalties. To help administer these safeguards, HIPAA requires that every organization designate a HIPAA privacy and security officer. HIPAA violations can have serious repercussions when rules are not followed; these violations can be either negligent or willful. If breaches of unsecured protected health information occur, HIPAA requires covered entities to notify affected individuals, the Secretary of Health and Human Services, and in some cases the media. Violations in which the covered entity did not know of the violation are now punishable under the first tier of penalties. Unintended violations carry a minimum penalty of $100 per violation and a maximum of $50,000 per violation. All patients have a right to privacy and a right to confidential use of their medical records. The role of medical professionals includes understanding how and when to apply these HIPAA rules verbally and electronically.