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In the United States, the scope of practice of pharmacists is determined primarily at the state level. Not all state laws expressly permit or prohibit pharmacists from providing certain services; in between is a grey area of legal silence. Does legal silence permit pharmacists to perform a service that is not specifically permitted, but not expressly prohibited? Point-of-care testing provides a useful case study in legal silence: there are 1536 pharmacies currently holding a CLIA-waiver to administer tests in states reporting that pharmacists are not expressly permitted to administer tests. Legal silence may even provide a better framework for pharmacy based testing as it is naturally inclusive of any point-of-care test and no laws need updated when a new test comes to the market. Other health professions navigate this legal silence by governing according to a "standard of care." Rather than specifying a list of services a health professional can or cannot provide in law, it provides a flexible framework for the health professional to provide any service that other similarly situated health professionals would provide in the same or similar situation. A standard of care regulatory framework should thus be the target of the pharmacy profession in order to advance patient care., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

National pharmacy associations have increasingly explored regulation according to a "standard of care." In such a model, pharmacists can provide a wide range of clinical services aligned with their education and training. Based on Idaho's experience implementing this model, there are five critical steps states must take to enact a standard of care: 1) Adopt a broad definition of "practice of pharmacy;" 2) Allow elasticity for practice innovation over time; 3) Decide which limited instances still necessitate prescriptive regulation; 4) Eliminate all unnecessary regulations; and 5) Strengthen accountability for deviations from the standard of care. States wishing to adopt a standard of care approach can follow this five-step process to enhance patient care and mitigate the lag that is otherwise constant between laws and practice., Competing Interests: Disclosure The authors declare no relevant conflicts of interest or financial relationships., (Copyright © 2024 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: Pharmaceutical care has been implemented and regulated differently across Europe with no consensus among countries in relation with professional competencies and especially on nurse prescribing. Demophac Project funded by the European Commission aims to develop a Pan-European Pharmaceutical Care Model with collaboration of 14 partner teams across Europe including Spain where nurse prescribing is starting its implementation at regional level. The aim of the study was to increase understanding of the role of nurses in Pharmaceutical care in Spain after the Nurse Prescribing Regulation approved in 2018 throughout exploring the views and expectations of health professionals involved in the representative settings., Methods and Findings: In depth interviews were conducted in a structure previously agreed by the European Demophac partnership around four topics associated with the Nursing ideal role in pharmaceutical care and the ideal interaction with other healthcare professionals. A grounded-theory approach based on Corbin & Strauss was conducted to interpret collected data from the Spanish most representative settings (primary care, specialized care and residential care for older population). Participants were health professionals involved in pharmaceutical care that accepted to participate (nurses (n = 7), physicians (n = 8) and pharmacists (n = 9)). A pharmaceutical care comprehensive model for the Spanish context considering the recently approved Nurse Prescribing role and the interprofessional collaboration and communication was developed towards facilitating the understanding in such context and the contribution to the unified European Demophac Framework., Conclusions: Nurses are primarily responsible for population's Pharmaceutical Care while other professionals pivot on them to provide quality healthcare on a multidisciplinary level. Nurse prescribing may contribute efficiently to the Spanish Health System though more consensus in terms of nurses' training nationwide and enhancement in communication among different professionals within healthcare organizations is required to achieve adequate integrated care into practice., Competing Interests: The authors have declared that no competing interests exist.

Objective: To assess pharmacy participation in and accessibility of pharmacist-prescribed contraception after legislation effective in the state of Utah in 2019., Methods: A secret-shopper telephone survey was used to assess participation in pharmacist-prescribed contraception. Geospatial analysis was used to map the distribution of participating pharmacies by population characteristics., Results: Of all operating Class A retail pharmacies in Utah, 127 (27%) were providing pharmacist-prescribed contraception 1 year after implementation of the Utah standing order. Oral contraceptive pills were widely accessible (100%); however, other allowed methods were not (vaginal ring 14%; contraceptive patch 2%). Consultation fees and medication costs varied widely. Participating pharmacies were mainly concentrated in population centers. Assuming access to a personal vehicle, urban areas with a high percentage of Hispanic people (Utah's largest minority race or ethnicity group) have access to a participating pharmacy within a 20-minute driving distance. However, access in rural areas with a high percentage Hispanic or other minority were limited. We identified 235 (40%) census tracts with a high proportion of Utah's residents living below the poverty line or of minority race or ethnicity who also had low access to pharmacist-prescribed contraception., Conclusions: Although the pharmacy-based model is intended to increase access to contraception, practical availability 1 year after the authorization of pharmacist-prescribed contraception in Utah suggests that this service does not adequately serve rural areas, particularly rural areas with a high proportion of minorities and those living below the federal poverty line., Competing Interests: Financial Disclosure The authors did not report any potential conflicts of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Although prospective drug utilization review and patient counseling have long been recognized as professional and ethical responsibilities of pharmacists, the implementation of the Omnibus Budget Reconciliation Act of 1990 made them legal responsibilities. Ensuring the safety and effectiveness of prescription pharmaceutical care requires that all members of the prescriber-patient-pharmacist triad are equally informed about the therapeutic plan for which the pharmacist is professionally, ethically, and legally responsible for properly implementing. Providing pharmacists with the clinical indication or diagnosis is an important and long overdue first step. DISCLOSURES: No funding was received for the writing of this article. Warholak has received grant funding through the University of Arizona from Sinfonia Rx, Pharmacy Quality Alliance, and the Arizona Department of Health Services, unrelated to this work. The other authors have nothing to disclose.

To fully engage in the Pharmacists' Patient Care Process, pharmacists must be able to (1) participate in a Collaborative Practice Agreement, (2) order and interpret laboratory tests, (3) prescribe certain medications, (4) adapt medications, (5) administer medications, and (6) effectively delegate tasks to support staff. Each of these activities is dependent on state scope of practice laws, but these laws are not binary. Various state-level restrictions allow us to view these activities on a continuum from more restrictive to less restrictive. This continuum will allow pharmacy and public health stakeholders to identify priorities for action in their states.

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., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: Public and private payers have implemented benefit limitations to reduce high-risk opioid prescriptions. The effect of these policies on the increase of out-pocket payment is unclear. To understand this gap, we compared the discrepancies in trends between opioid prescription fills vs claims among Medicaid beneficiaries., Methods: Data from the Oregon Prescription Drug Monitoring Program (PDMP) and Oregon Medicaid administrative claims were used to identify Medicaid beneficiaries 18 years and older enrolled at least one full month from 2015 to 2017. Generalized linear models assessed the trends in the monthly rates of opioid PDMP prescription fills and pharmacy claims per 1000 eligible members. Rates by morphine equivalent dose (MED) tier (<50, 50-89, 90-120, >120 MED) and co-prescribed opioid and benzodiazepine were also assessed., Results: During the study period, an average of 495 355 Medicaid members had 2 797 054 opioid PDMP fills and 2 472 155 opioid Medicaid pharmacy claims. Study participants had 15.4 (95% confidence interval [CI] 13.6 to 17.0; P < .001) more prescriptions per 1000 member per month in the PDMP data (114.1 [SD 7.4]) compared with the Medicaid claims data (98.7 [SD 7.9]). Similarly, there were 1.9 more co-occurring opioid/benzodiazepine prescriptions per 1000 members per month observed in the PDMP data than the Medicaid claims data (95% CI 1.7 to 2.1; P < .001). At each MED tier, the PDMP fills were consistently higher than the claims (P < .001)., Conclusions: Higher rate of fills in the PDMP compared to pharmacy claims suggests that there may be an increasing trend of out-of-pocket payment among Medicaid beneficiaries., (© 2020 John Wiley & Sons Ltd.)

Disclosures: No funding supported the writing of this commentary. The authors have nothing to disclose.

On November 5th, 1808, D. João de Bragança issued a license about the practice of druggists and the price of drugs and ordered the creation of a regulation to tax the cost of medicines marketed in Brazil. First published on 1809, the Regimento dos preços dos medicamentos... gained new editions in the following years and became an indispensable working tool for those involved in the making and trading of drugs at this time. This paper situates historically and sheds light on a document briefly explored by the researchers of the history of the Brazilian pharmacy, taking into account that it was one of the first initiatives of the Luso-Brazilian government in line with the pharmaceutical activity in Brazil in the nineteenth century.

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.

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.

Background: Recently, the Executive Branch and Judiciary in Brazil increased spending due to larger numbers of lawsuits that forced the State to provide health goods and services. This phenomenon, known as health judicialization, has created challenges and required the Executive Branch and Judiciary to create institutional strategies such as technical chambers and departments to reduce the social, economic and political distortions caused by this phenomenon. This study aims to evaluate the effects of two institutional strategies deployed by a Brazilian municipality in order to cope with the economic, social and political distortions caused by the phenomenon of health judicialization regarding access to medicines., Methods: A longitudinal study was carried out in a capital in the Central-West Region of Brazil. A sample of 511 lawsuits was analyzed. The variables were placed into three groups: the sociodemographic characteristics and the plaintiffs' disease, the characteristics of the claimed medical products and the institutional strategies. To analyze the effect of the interventions on the total cost of the medicines in the lawsuits, bivariate and multivariate linear regressions with variance were performed. For the categorical outcomes, Poisson regressions were performed with robust variance, using a significance level of 5%., Results: A reduction in the costs of medicines in the lawsuits and of the requests for medicines within the SUS formulary was verified after the deployment of the Department of Assessment of Nonstandardized Medicines (DAMNP) and the Technical Chamber of Health Assessment (CATS); an increase in processed prescriptions from the Brazilian Universal Health System was observed after the deployment of the CATS; and an increase in medicines outside the SUS formulary without a therapeutic alternative was verified after the CATS., Conclusion: The institutional strategies deployed were important tools to reduce the high costs of the medicines in the lawsuits. In addition, they represented a step forward for the State, provided a benefit to society and indicated a potential path for the health and justice systems of other countries that also face problems caused by the judicialization of health.

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between health care payers and pharmaceutical manufacturers in which the price, quantity, or nature of reimbursement is tied to value-based outcomes. As value-based payment models have permeated through much of the health care payment landscape via reimbursement to payers and providers, VBPCs offer opportunities for manufacturers to similarly engage in performance-based models. This article compares 2 VBPC schemes: "pay-for-failure" schemes, in which manufacturers offer rebates or discounts to payers for treatment failure, and "pay-for-success" schemes, in which manufacturers offer rebates or discounts to payers for treatment success. Each method has its own short-term and long-term trade-offs, and both lead to some degree of misaligned incentives between payers and manufacturers. These incentive differences have important downstream effects, influencing patient selection, provision of wraparound services, and nature of reimbursements. This analysis contrasts potential benefits and disadvantages for each of these approaches and offers potential solutions to address misalignment. For example, although pay-for-success models may be more aligned between payers and manufacturers, pay-for-failure contracts can be innovative and effective in controlling costs and/or improving outcomes. To illustrate, VBPCs aimed to reduce costs could incorporate total cost of care reduction as a value-based outcome. The authors encourage payers and manufacturers to consider a blended alternative where pay-for-failure and pay-for-success outcomes could be incorporated as VBPC outcomes. Since little is known about the effect of each scheme on outcomes, further research on VBPCs is necessary to fully understand how differing incentives ultimately affect clinical outcomes and costs. DISCLOSURES: No outside funding supported the writing of this article. Good and Kelly are employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care, and Parekh was employed by the UPMC Centers for Value-Based Pharmacy Initiatives and High-Value Health Care at the time of this study. The authors have no other disclosures to report.

Recent discussions about the increasing prices of prescription drugs have focused on pharmacy benefit managers (PBMs), third-party intermediaries for various types of employers and government purchasers who negotiate drug prices in health plans and thus play a crucial role in determining the amount millions of Americans pay for medications. In this position paper, the American College of Physicians expands on its position paper from 2016 by offering additional recommendations to improve transparency in the PBM industry and highlighting the need for reliable, timely, and relevant information on prescription drug pricing for physicians and patients.

In 2016, The Professional Society for Health Economics and Outcomes Research (ISPOR) formed a special task force (STF) to review approaches and methods to support the definition and use of high-quality U.S. value frameworks. As the leadership group of that initiative, we present our perspective, focusing on implications for the managed care pharmacy community. Our reflections are organized by 9 key observations and conclude with a summary recommendation. We begin by emphasizing the importance of distinguishing among "perspectives" and "decision contexts." Possible perspectives include patient, payer, provider, health care sector, and societal. Decision contexts range from formulary inclusion to guideline development to clinical shared decision making, and multiple perspectives can be taken on each of these decisions. The STF focused on value in the context of including a new medicine in a formulary and, thus, health plan, using a health economics approach that compares marginal benefit (gross value) and marginal (opportunity) cost, yielding the net value. Health care is unique compared with other markets. While economists often use market purchases as indicators of value, they also recognize that this does not work well in health care, since most patent-protected drugs are covered by insurance. To assess the likely health and economic impact, health economists often employ cost-effectiveness analysis, using the quality-adjusted life-year (QALY), a metric that combines mortality and morbidity into a single preference-based index. We strongly endorse the STF's recommendation that payers should use the cost-per-QALY metric as a starting point. However, like the STF, and many of those stakeholders who provided input, we recognize that this metric has some limitations in theory and in practice. Nonetheless, the cost-per-QALY metric is a pragmatic tool that can be augmented to address some of its limitations by integrating other elements of value, particularly those related to uncertainty, such as financial risk protection, health risk protection, the value of hope, real option value, and the value of knowing. The resulting adjusted ratio can be compared with a willingness-to-pay threshold or combined in a measure of net monetary benefit. Alternatively, the array of elements can be valued using multi-criteria decision analysis. We end with the key recommendation that further development and testing of these promising approaches is needed to improve the deliberative process of health technology assessment. DISCLOSURES: No outside funding supported the writing of this article. The authors are leaders of the ISPOR Special Task Force on U.S. Value Frameworks. Willke is employed by ISPOR. Garrison and Neumann have nothing to disclose. The opinions expressed in this article should be considered as belonging only to the authors.

Background: The National Association of Boards of Pharmacy (NABP) recently established a task force to help states develop regulations based on "standards of care" rather than "prescriptive rule-based regulation." The NABP resolution signals a paradigm shift as the pharmacy profession has historically been governed by prescriptive rules at both the federal and state levels., Objective: To identify opportunities to make the transition to a "standard of care" regulatory model in pharmacy law as NABP has advanced, this manuscript attempts to quantify the regulatory burden for the medical, nursing, and pharmacy professions in the state of Idaho to facilitate a comparison., Method: The relevant statutes and regulations were gathered, and key measures were extracted, including word count and restrictions (e.g., the use of specific terms like "shall"), the composition and age of each profession's laws, how frequently the respective laws have been amended, and how the composition has changed from 1996 to 2017., Results: When compared to medicine and nursing, pharmacy laws have a larger overall word count, more restrictions, a younger overall age, and have been amended more frequently. In particular, pharmacy has 97.5% more words than nursing and 105.8% more words than medicine with respect to the regulation of professional practice standards. From 1996 to 2017 nursing and pharmacy took two diverging paths to professional practice standard regulation. Nursing decreased the net word count in this area (-3006 words; -28.7%), whereas pharmacy (5208 words; 36.6%) experienced gains., Conclusions: For pharmacy to continue to evolve, replicating the medical and nursing approach to the regulation of professional practice standards will be necessary to fully achieve patient and public health goals., (Copyright © 2018 Elsevier Inc. All rights reserved.)

In many countries with legal systems based on English common law, pharmacy regulators have a responsibility to protect, promote and maintain the health and safety of patients. Where there is a potential risk to patient safety, or where the public's confidence in pharmacy could be adversely affected by the actions of a pharmacist, these regulators have a statutory duty to investigate concerns. The legal provisions underpinning each jurisdiction's disciplinary processes depict distinctive outlooks from the different authorities, as each works towards the same goal. Legal statues, regulations, rules, and guidance affecting the disciplinary process in Great Britain, Australia, New York and New Brunswick were collated, and the processes they describe were attached to a common process flow diagram for step-by-step evaluation of their respective legal provisions. The initial stages of the respective investigation process are broadly similar in all the jurisdictions examined; however, each process has subtle differences that afford some level of advantage or disadvantage over its comparators. Factors including: how matters of discipline are framed; the existence of a separate process for minor and uncontested violations; the ability to effect an interim suspension of a practitioner's license; threshold criteria for escalation of complaints; the membership of disciplinary panels; and the perceived independence of these panels all philosophically affect the public safety remit of each regulator. This work constitutes the first comparison of international regulatory frameworks for the profession of pharmacy. Of the four jurisdictions examined, Great Britain most clearly acts in the interest of the public and the profession - rather than the respondent pharmacist - at every step of its process., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: In 2014, California signed into law AB1535 permitting pharmacists to dispense naloxone upon request and without physician or midlevel provider prescription., Objective: We sought to determine pharmacist knowledge of AB1535, participation, availability of naloxone, future plans for participation, and out-of-pocket charges to consumers amongst outpatient pharmacies in selected California counties., Methods: All pharmacies in Plumas, Lake, Lassen, Humboldt, Shasta, Fresno, and San Diego Counties were identified. Between January 30 and March 30, 2017, pharmacies meeting inclusion criteria were contacted and the pharmacist-on-duty were queried regarding knowledge, participation, availability, and cost of naloxone., Results: A total of 2296 pharmacies were identified in the 7 counties. Twenty-six were unwilling or unable to participate and an additional 1648 were excluded because of licensing or special pharmacy status. Six-hundred-twenty-two pharmacies completed the survey. There was variation in knowledge of AB1535, participation in, immediate availability of naloxone, charge, and expressed future interest in participation identified. Charge to consumers was similarly variable amongst surveyed pharmacies within counties., Conclusions: Despite considerable public health and political support, the passage of CA AB1535 has not resulted in broad current, future planned participation, or availability of naloxone in selected counties. Out-of-pocket costs to the consumer remain highly variable., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Approximately 25 million people in the United States are limited English proficient (LEP). Appropriate language services can improve care for LEP individuals, and health care facilities receiving federal funds are required to provide such services. Recognizing the risk of inadequate comprehension of prescription medication instructions, between 2008 and 2012, New York City and State passed a series of regulations that require chain pharmacies to provide translated prescription labels and other language services to LEP patients. We surveyed pharmacists before (2006) and after (2015) implementation of the regulations to assess their impact in chain pharmacies. Our findings demonstrate a significant improvement in capacity of chains to assist LEP patients. A higher proportion of chain pharmacies surveyed in 2015 reported printing translated labels, access and use of telephone interpreter services, multilingual signage, and documentation of language needs in patient records. These findings illustrate the potential impact of policy changes on institutional practices that impact large and vulnerable portions of the population.

Widespread liberalizing reform of the Swedish community pharmacy and primary care sectors took place in 2009-2010, including opening the market to private providers. One important rationale for the reforms was to increase diversity in the health-care system by providing more choices for individuals. The aim of this study was to increase the understanding how policy makers understood and defined diversity as a concept, and as a rationale for the reforms. The method used was document analysis of preparatory work and plenary parliament debate protocols. The results show that policy makers held vague and unclear definitions of diversity, which complicated its implementation. Diversity was sometimes seen as an effect of competition-a goal-while in other cases it was seen as a condition to be met in order to achieve competition-a means. Thus, policy makers viewed diversity both as a goal and as a means, making the underlying mechanisms unclear. The findings also revealed that policy makers failed to consistently demonstrate how the introduction of competition would lead to diversity., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Studies have found that expanded pharmacy technician roles can help "free up" pharmacist time, leading to role optimization. However, these studies and the positions taken by many are quite pharmacist-centric. We seem to have underestimated the importance of support staff in pharmacy operations. If research demonstrates that technicians can perform a function safely and effectively, that alone should compel the function's allowance in practice. Freeing up pharmacist time for higher-order care is a positive corollary to technician advancement, but it need not be a precondition for it.

Background: In 2016, Oregon became the first of eight states to allow pharmacists to directly prescribe hormonal contraception (HC), including the pill, patch, or ring, without a clinic visit. In the two years following this policy change, the majority of ZIP codes across the state of Oregon had a pharmacist certified to prescribe HC., Methods: We will utilize complementary methodologies to evaluate the effect of this policy change on convenient access to contraception (cost, supply dispensed), safety, contraceptive continuation and unintended pregnancy rates. We will conduct a prospective clinical cohort study to directly measure the impact of provider type on contraceptive continuation and to understand who is accessing hormonal contraception directly from pharmacists. We will concurrently conduct a retrospective analysis using medical claims data to evaluate the state-level effect of the policy. We will examine contraceptive continuation rates, incident pregnancy, and safety measures. The combination of these methodologies allows us to examine key woman-level factors, such as pregnancy intention and usual place of care, while also estimating the impact of the pharmacist prescription policy at the state level., Discussion: Pharmacist prescription of HC is emerging nationally as a strategy to reduce unintended pregnancy. This study will provide data on the effect of this practice on convenient access to care, contraceptive safety and continuation rates.

Objective: Nonprescription or over-the-counter (OTC) medications play a crucial role in a patient's ability to make choices to manage his or her own health care. Often these nonprescription choices are unknown to health care practitioners and thus are often not included as part of patients' health records. The exclusion of these therapies can pose risks to patient safety. There is a significant need to address the capture of OTC medication use in both the physician and pharmacy electronic health records (EHRs) and during the practitioner-patient medication history and reconciliation process., Data Sources: On October 26, 2016, the National Association of Chain Drug Stores Foundation hosted a forum for a select group of health care industry professionals to work on a series of recommendations to improve the documentation of OTC medication use by patients. This diverse group of more than a dozen stakeholders included community pharmacy leaders from multiple chain pharmacies, pharmacy system vendors, e-prescribing vendors, health information technology experts, and multiple industry representatives, including individuals from the public sector. This commentary is a summary of the insights and suggestions where the group was in general agreement., Summary: Successful OTC medication EHR integration will require system-level buy-in across multiple layers of the health care industry to improve patient safety. Forum participants suggested incremental steps that could be taken by multiple stakeholders to lay the foundation for integration within an appropriate regulatory structure., Conclusion: Based on the results of the stakeholder forum, an agreement formed around one approach that the group supported as feasible: the creation of a consistent and uniform identification method for OTC medications in cooperation with government regulatory authorities., (Copyright © 2019 The Author. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Advocacy has been defined as "the essential competence". Literature describes and assesses the impact of elective, extracurricular, and co-curricular advocacy experiences, but there is a deficiency of literature that describes and assesses core curricular advocacy experiences., Educational Activity and Setting: An electronic pre- and post-survey was administered to second-year student pharmacists who attended a didactic lecture on advocacy within a pharmacy law course. All responses were anonymous and matched via self-generated code. Wilcoxon signed rank tests analyzed matched data., Findings: Pharmacy students were generally unaware of their legislative representation and did not know what to expect when meeting with legislators. A small percentage (24%) had previously contacted their legislator regarding pharmacy topics. All three knowledge items and seven of eight attitudes showed statistically significant improvement after the lecture. Following the lecture, 85% of students agreed/strongly agreed they were more prepared to be an advocate for pharmacy, with 76% reporting increased commitment., Discussion: This study shows that a brief didactic educational intervention may improve student pharmacists' knowledge of and commitment to political advocacy, addressing previously noted limitations of models to prepare student pharmacists for advocacy efforts. The skill of advocating was not addressed by this intervention., Summary: A brief didactic lecture at one institution showed a short-term positive influence on pharmacy students' knowledge and attitudes towards legislative advocacy. Introduction of advocacy within the core didactic curricula may provide a method to increase the prevalence of advocates within the profession of pharmacy, but this requires further assessment and identification of best practices., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: The availability of suicide prevention training programs for pharmacists is unknown and may depend on state training requirements. This study's objectives were to: 1) report state training requirements for pharmacist suicide education; and 2) describe educational resources that are available to prepare pharmacists for interactions with patients at risk of suicide., Methods: Each state's board of pharmacy was contacted from July to November 2017 to determine whether that state required pharmacists to complete suicide prevention training. A scoping literature review completed in August 2017 identified suicide prevention resources for pharmacy professionals. A systematic search of 5 databases and Google yielded publications and online resources that were screened for full review. Two coders reviewed articles and resources that met inclusion criteria and extracted data on program format and length, intended audience (i.e., students, practicing pharmacists), learning methods, topics covered, and outcomes assessed., Results: Only Washington State requires pharmacists to obtain suicide prevention training. Sixteen suicide education programs and resources targeted pharmacists, including 8 in-person courses, 6 online courses, and 2 written resources. Five resources exclusively targeted pharmacists and 2 exclusively targeted student pharmacists. Most programs included information on suicide statistics, how to identify individuals at risk of suicide, how to communicate with someone who is suicidal, and how to refer patients to treatment resources. The long-term effectiveness of the programs at improving outcomes was not reported., Conclusion: Although only 1 state requires pharmacists to obtain training on suicide prevention, there are several resources available to help prepare pharmacists to interact with individuals at risk of suicide., (Copyright © 2018 American Pharmacists Association®. All rights reserved.)

Objective: To highlight how sourcing practices for lethal injections drugs are undermining state and federal regulatory structures established to preserve the security and integrity of the medicines supply chain in the United States., Summary: Unable to find sources for execution products approved by the U.S. Food and Drug Administration (FDA), some states have started sourcing the required drugs or active ingredients from unapproved foreign manufacturers or have contracted with small compounding pharmacists to compound them. Many states have passed legislation barring the disclosure of information regarding the origin and chain of custody for prisons' stocks of compounded lethal injection drugs. This creates a regulatory vacuum and prevents the responsible authorities (e.g., FDA, Drug Enforcement Agency, state boards of pharmacy) from performing their crucial roles to ensure quality and supply chain transparency for medicines in circulation., Conclusion: By purchasing medicines from non-FDA-approved suppliers and enacting lethal injection sourcing secrecy laws, states are undermining the robust enforcement of chain of custody and pharmaceutical supply chain transparency. The secrecy surrounding the execution drug procurement risks creating illicit supply channels. Once an illicit supply channel is established with a supplier, it creates risks that other drug products move through it, particularly in a context where the FDA, Drug Enforcement Agency, and state boards of pharmacy are prevented from performing their usual regulatory duties. Lawmakers have the obligation and authority to step in and close this regulatory gap to promote public health and safety., (Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Purpose Hemophilia Treatment Centers (HTCs) provide integrated and comprehensive services to individuals affected with rare bleeding disorders, such as hemophilia and Von Willebrand disease. Through the 340 Drug Pricing Program, HTCs may use pharmacy income to support clinical staff and patient services. The objective of this study was to describe the impact of the 340B program funding on services and support provided by HTCs to persons affected by rare bleeding disorders. Description Federally designated comprehensive HTCs with established 340B programs were invited to participate in a mailed survey in 2014. Participants were requested to report on 340B program-funded staff and services in the calendar year 2013. Assessment The 31 of 37 HTCs responding served over 10,000 individuals, or one-third of the national HTC patient population. The majority of responding HTCs reported that 340B program income supported over 90% of staff such as nurses, social workers, and physical therapists. Conclusion The results from this survey of 31 centers with established programs demonstrates the HTCs' reliance on 340B program support for vital comprehensive services, that are otherwise non-reimbursable, and highlights the importance of the 340B program in sustaining the high quality of care and in increasing access for a geographically dispersed, medically vulnerable population.

Objectives: To discuss the potential for improving access to early abortion care through pharmacies in the United States., Summary: Despite the growing use of medications to induce termination of early pregnancy, pharmacist involvement in abortion care is currently limited. The Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex® (mifepristone 200 mg), the principal drug used in early medication abortion, prohibits the dispensing of the drug by prescription at pharmacies. This commentary reviews the pharmacology of medication abortion with the use of mifepristone and misoprostol, as well as aspects of service delivery and data on safety, efficacy, and acceptability. Given its safety record, mifepristone no longer fits the profile of a drug that requires an REMS. The recent implementation of pharmacy dispensing of mifepristone in community pharmacies in Australia and some provinces of Canada has improved access to medication abortion by increasing the number of medication abortion providers, particularly in rural areas., Conclusion: Provision of mifepristone in pharmacies, which involves dispensing and patient counseling, would likely improve access to early abortion in the United States without increasing risks to women., (Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Medication compounding gained national attention in the fall of 2012 after contaminated compounded medications produced in the New England Compounding Center infected 800 people with fungal meningitis and led to several fatalities. This prompted Congress to pass regulations on compounding through the Drug Quality and Security Act (DQSA) in 2013. The act increased oversight of patient-specific drug compounding taking place in compounding pharmacies, created 503(b) outsourcing facilities to obtain compounded drugs, and added regulations for obtaining compounded drugs from traditional 503(a) pharmacies. These regulations also had a broader overall impact by triggering federal and state-specific policies, which have ultimately limited a physician's ability to perform low-risk, in-office compounding. This article provides an overview of the different types of compounding restrictions, reviews the current federal and state regulations and/or guidelines, discusses how newly proposed policies may affect the practice of dermatology, and presents an algorithm on how the practicing dermatologist should approach compounding. J Drugs Dermatol. 2018;17(7 Suppl):s17-22.

Four states have created advanced practice pharmacist designations in state law: advanced practice pharmacist (California), clinical pharmacist practitioner (Montana and North Carolina), and pharmacist clinician (New Mexico). To attain an advanced pharmacist designation, states typically require a fee and set a minimum education requirement either through continuing pharmacy education (CPE) or through attainment of a national certification or completion of a residency. Once attained, pharmacists may practice with additional scope of practice authorities, namely the ability to order and interpret drug therapy-related tests, and initiate or adjust/modify medications under a collaborative practice agreement (CPA). Uptake of advanced practice pharmacist designations has been light (range: 0.35%-9.8%). The additional scope of practice authority is on par with, and in some instances more restrictive than, other states with fewer barriers to entry. As such, the excitement surrounding advanced pharmacist designations may be disproportionate to the actual scope of practice gains when compared to other existing state laws., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: This study was carried out to: (1) explore the views of pharmacists in Nigeria on the extension of prescribing authority to them and determine their willingness to be prescribers and (2) identify the potential facilitators and barriers to introducing pharmacist prescribing in Nigeria., Method: An online cross-sectional survey was conducted from August to October 2014 among 775 pharmacists recruited from the Facebook group of the Pharmaceutical Society of Nigeria using a simple random technique. The questionnaire used for the survey was developed based on the review of the literature and previous qualitative studies conducted in Nigeria. The instrument was evaluated for content validity by two external pharmacy practice researchers and the reliability of items assessed using internal consistency tests. Data obtained from the survey were entered into SPSS v.22, and descriptive statistics were generated. Relationships between variables were evaluated using the chi-square test, and P < 0.05 was considered statistically significant., Key Findings: The response rate was 40.6% (315/775). Three hundred and six (97.1%) respondents agreed that pharmacists should be given prescribing authority. Of these 306, 295 (96.4%) were willing to be prescribers, and just over half of them (148/295; 50.2%) would prefer to prescribe in collaboration with medical doctors. Of those willing to be prescribers, 285 (96.6%) reported that they would need additional training. The most perceived areas of training needed were in the principles of differential diagnosis (81.4%), pathophysiology of diseases (74.0%) and interpretation of laboratory results (68.1%). Respondents identified increasing patients' access to care (308/315; 97.8%) and better utilisation of pharmacists' skills (307/315; 97.5%) as the most likely facilitators to pharmacist prescribing in Nigeria. On the other hand, resistance from the medical doctors (299/315; 94.9%) and pharmacists' inadequate skills in diagnosis (255/315; 81.0%) were perceived as the most likely barriers., Conclusion: Pharmacist prescribing represents an opportunity to promote patients' access to care and the utilisation of pharmacists' skills in Nigeria. The majority of pharmacists showed a positive attitude towards pharmacist prescribing and were willing to be prescribers. The findings of this study could potentially contribute to future medicine prescribing policy and pharmacy practice in Nigeria., (© 2017 Royal Pharmaceutical Society.)

The controversy surrounding the different interpretations on the integrality of therapeutic and pharmaceutical care has led to the delimitation of its scope by a law, but the issue has not been completely pacified. As a contribution to this debate, we aim to discuss the challenges to ensure the integrality of the therapeutic and pharmaceutical care, based on a conceptual approach on the meanings of integrality in the Brazilian Unified Health System (SUS). We identified important challenges to ensure the integrality of the therapeutic and pharmaceutical care in the SUS. These challenges are related to professional practices, the organization of actions and services, and the governmental response to health problems or to the treatment of specific population groups. For this end, governments need to carry out structuring actions and be efficient in using available resources so that existing problems can be overcome.

Disclosures: Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

Occasionally, residents actively or passively refuse to take medications. Residents may refuse medication for a number of reasons, including religious beliefs, dietary restrictions, misunderstandings, cognitive impairment, desire to self-harm, or simple inconvenience. This action creates a unique situation for pharmacists and long-term facility staff, especially if patients have dementia. Residents have the legal right to refuse medications, and long-term care facilities need to employ a process to resolve disagreement between the health care team that recommends the medication and the resident who refuses it. In some cases, simple interventions like selecting a different medication or scheduling medications in a different time can address and resolve the resident's objection. If the medical team and the resident cannot resolve their disagreement, often an ethics consultation is helpful. Documenting the resident's refusal to take any or all medications, the health care team's actions and any other outcomes are important. Residents' beliefs may change over time, and the health care team needs to be prepared to revisit the issue as necessary.

The history of capital punishment in the United States is long and controversial. In many cases, lethal injection has brought medical personnel, ethically and professionally charged with preserving life, into the arena of assisting the state in taking life. U.S. Supreme Court decisions, including Baze v. Rees (2008) and Glossip v. Gross (2015), have evaluated and condoned lethal injection protocols. Despite the judicial validation of some midazolam-containing protocols, controversy exists about the level of unconsciousness provided due to the ceiling effects of the drug. Drug shortages, induced in part by manufacturers under pressure by death penalty opponents and governments opposed to capital punishment, have forced states to sometimes use creative means to obtain medications for use in lethal injection, even proposing to allow inmates to supply their own drugs for use in execution. Others have resorted to using compounding pharmacies and enacting tougher execution secrecy laws to protect the identities of those involved in the process. Professional organizations representing health care team members, including nursing, medicine, and pharmacy, among others, have roundly denounced the medicalization of capital punishment. Legal challenges continue to mount at all levels, leading to an uncertain future for lethal injection., (© 2017 Pharmacotherapy Publications, Inc.)

Use of medications without doctor's prescription widely established in Georgia had negative impact on the health of the population and on the whole social situation. The use of home-made drugs "Krokodil", "Jeff" and "Vint" produced from the preparations bought without prescriptions (Codeine, Ephedrine), became a special matter of concern. Psychoactive substances became available for teenagers causing damage to their central nervous system and formation of drug-addiction in them. Due to the situation Georgian Government took a number of legislative measures, particularly, it set Criminal Liability for illegal circulation of pharmaceutical products containing Codeine and Ephedrine and Administrative Measures for issuing the psychoactive substances without prescription. Reviewing the clinical histories (2013-2016) of the hospitalized beneficiaries of the "Center for Mental Health and Prevention of Addiction", revealed that the number of the users of home-made drugs produced of Codeine and Ephedrine was reduced but the reform did not have significant influence on distribution of psychoactive substances, due to which administrative measures for breaking circulation rules on psychoactive substances was tightened. The situation is also being improved with the help of universal use of electronic prescriptions and the introduction of quotas on psychoactive substances.

Pharmaceutical services and the formulation of a medicines policy are SUS areas ensured by the organic health care law 8,080/90. Thus, after a widely participative process, involving stakeholders, the National Medicines Policy (NMP) was approved in 1998 by Ordinance 3,916.The NMP presents directives and priorities, aligned with organic health care law, which should guide the federal, states and municipals entities actions to achieve the policy goals. Considering almost 20 years of the NMP, this paper took stock discussed some of the directives in light of the SUS principles. It was not the objective to provide an exhaustive review of all the activities performed during this period. The authors tried to get close to those that have brought advances and dilemmas, with potential risk of regression. Efforts to implement an ambitious agenda applied to pharmaceutical services were identified. This agenda tried to deal with different challenges like the dynamics of the pharmaceutical market and the operation of pharmaceutical services to guarantee the supply of medicines aligned with principles and directives of SUS.

Purpose: Reducing global disease burden requires improving access to medicines, thus the need for efficient and effective supply chain management for medicines. The Nigerian government came up with new policies on Mega Drug Distribution Centres and National Drug Distribution Guidelines to improve access to quality medicines with pharmacists having a key role to play. However, pharmacists in Nigeria seem not to be aware and adequately equipped to handle the medicines supply chain. This article aimed at assessing the awareness and readiness of Nigerian pharmacists on supply chain management practices for improving access to medicines., Methods: Pharmacists in Nigeria's Capital were randomly sampled. Semi-structured questionnaires were administered. Descriptive statistics was used in data analysis. P values less than 0.05 were considered to be significant., Results: 29.3%, 20.7% and 53.7% were not aware of supply chain management, National Drug Distribution Guidelines and Mega Drug Distribution Centres, respectively. 85.46% do not have a copy of the National Drug Distribution Guidelines. 78% were not aware that Mega Drug Distribution Centres are already operational. 35.4% have never been involved in any supply chain management practice. 69.5% often experience stock out of vital and essential medicines, of which 85.2% were in hospitals. 15.9% were successful in managing their facility's supply chains. 84.1% opined that pharmacists in Nigeria are not yet ready to handle the medicines supply chain., Conclusions: Findings showed limited awareness and readiness on supply chain management of medicines. This may be due to inadequate supply chain management skills and infrastructure, poor financing, lack of accountability and poor management. Tackling these as well as pharmacists showing more interest in the country's health policies and obtaining necessary postgraduate certifications will lead to improvements. This will improve access to quality medicines and thus help in the fight to reduce disease burden both locally and globally., (Copyright © 2016 Elsevier Inc. All rights reserved.)