How to implement a "standard of care" regulatory model for pharmacists.

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.

Toward Multistate Pharmacy Practice: Enhancing Mobility and Portability of Pharmacist Licensure.

Pharmacists are licensed in all 50 states. As society becomes increasingly mobile and interconnected, several models of cross-state pharmacy practice have emerged, straining the current state-based system of licensure. The nursing profession has provided a model for license portability that offers 3 primary advantages over the current pharmacist licensure model while still protecting safety: (1) faster speed, (2) lower cost, and (3) reduced administrative burden. A hybrid approach for the pharmacy profession that builds off of the expedited license transfer model and adds a mutual recognition model is ideal.

Pharmacists' Patient Care Process: State "Scope of Practice" Priorities for Action.

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.

Prescriber and pharmacist understanding of revised Rhode Island pain management regulations.

INTRODUCTION: Federal agencies and national associations have implemented action plans in response to the opioid crisis. Furthermore, over 30 states have enacted legislation with opioid-related restrictions, guidance, or requirements. Following recommendations from the governor-appointed Overdose Prevention and Intervention Task Force, the Rhode Island Department of Health developed an original and updated version of Pain Management Regulations in March 2017 and July 2018, respectively. Our study aimed to identify disparities in interpretation and misconceptions of the updated Rhode Island Department of Health new Pain Management Regulations. METHODS: Our 29-question survey evaluated pharmacist and prescriber knowledge of regulations, with special attention given to pain management in patients with cancer. RESULTS: Thirty-two prescribers and 33 pharmacists completed the survey. The survey identified significant variance in regulation knowledge. Pharmacists correctly identified diagnosis exclusions 13-84% of the time, with a much greater understanding when diagnosis language was used instead of ICD-10 codes. Prescribers correctly identified exclusions 24-46% of the time, with little difference noted when using diagnosis language versus ICD-10 codes. The majority (59.3%) of pharmacists misclassified patients with no prescription dispensed in 30 days as patients who would be considered opioid-naïve. Both prescribers and pharmacists commonly misidentified the frequency with which the prescription drug monitoring program needs to be checked, although in both scenarios were stricter than the regulations themselves. In addition, there were significant differences in interpretation regarding naloxone co-prescribing requirements and patient awareness of naloxone co-prescribing between prescribers and pharmacists. CONCLUSION: Our findings outline several misinterpretations that affect access to chronic and cancer-related pain opioid prescriptions, despite several Rhode Island Department of Health-initiated interventions. When adopting regulations, states should proactively develop educational initiatives to avoid access challenges for patients with diagnoses of exclusion.

Facilitating ethical, legal, and professional deliberations to resolve dilemmas in daily healthcare practice: A case of driver with breakthrough seizures.

OBJECTIVE: The present study was conducted among pharmacy students to use an 8-step systematic approach to facilitate discussions, deliberations, and decision-making on what to do when facing a dilemma of a patient with epilepsy who drives while having breakthrough seizures. METHODS: A hypothetical case was developed using the 12-tips for developing dilemma case-based assessments in health education. A mixed method was used in this study. A serial group discussions based on the nominal group technique (NGT) method were applied. A thorough review of the literature and interviews with key experts in the domain (n = 12) were conducted to obtain pertinent data to inform discussions, deliberations, and decision-making. The analytic hierarchy process (AHP) was used to pairwise compare countervailing arguments and alternative courses of action. RESULTS: In this study, 3 nominal groups were held, and for each 3, discussion rounds were conducted. A total of 27 panelists took part in the nominal groups. Compared with other alternative courses of action, significantly higher weight scores (p-value < 0.001) were given to the course action, "the pharmacist could counsel/educate the patient on the dangers/risks of driving while experiencing breakthrough seizures, inform the patient to refrain from driving in this period, and make a shared decision with the patient to refrain from driving in this period and inform the state authorities". CONCLUSION: This study demonstrates that the 8-step approach when combined with the AHP can be a handy method in facilitating decision-making while addressing and resolving ethical/legal/professional dilemmas in daily healthcare practice.

Impact of regulatory changes on pharmacist-delivered telehealth during the COVID-19 pandemic.

The 2020 coronavirus disease pandemic in the United States has created a dramatic need for the rapid implementation of telehealth services in areas of the country where telehealth is limited in scope. This implementation would not be possible without changes in how the Centers for Medicare and Medicaid Services provide reimbursement for these services. Reimbursement options remain open to pharmacists, but depend on local regulation or the ability to alter practice at the site. Though pharmacists provide high-quality direct patient care, they are excluded from seeking compensation for providing this care, even as the nation expands the telehealth model. This overview shows that despite changes in telehealth service compensation for health care providers, pharmacists remain unable to seek appropriate compensation for their direct patient care services.

Facilitators and barriers to implementing pharmacist-prescribed hormonal contraception in California independent pharmacies.

In 2013, California passed legislation to expand the scope of pharmacist practice, including authorizing pharmacists to prescribe hormonal contraception. Pharmacist-prescribed contraception was largely unavailable across the state in 2017. This study aimed to identify barriers and facilitators to offering this service in California independent pharmacies. To do so, we thematically analyzed qualitative data from structured interviews with 36 pharmacists working in independent pharmacies in 2016-17. We found that pharmacists anticipated general benefits from expanding their roles to prescribe contraception, including increasing health care access and decreasing costs. In contrast, described barriers were concrete, including lack of financial incentives and business risks for independent pharmacies. Specific barriers to prescribing hormonal contraception included time required to screen and counsel women about contraception and concerns that pharmacist-prescribed contraception would increase liability and lead to patients seeking health care less frequently. This study suggests that incentives and barriers identified by the respondents are likely to have varied and unequal impacts, with immediate barriers being potentially prohibitive for pharmacists to prescribe contraception. For independent pharmacies, perceived business risks and lack of insurance reimbursement may outweigh professional support for prescribing contraception, limiting the public health impact of legislation that should increase contraceptive access.

Pharmacy Technicians Are People, Too! Let's Consider Their Personal Outcomes Along With Other Pharmacy Outcomes.

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.

Pharmacists expand access to reproductive heaLthcare: PEARL study protocol.

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.

Unlawful dispensing practice of diazepam: a simulated client approach in community pharmacies in the north-west of Dar-es-Salaam region, Tanzania.

BACKGROUND: The use of psychotropic substances is controlled in most parts of the world due to their potential of abuse and addiction. Diazepam is one of the psychotropic substances which can be dispensed in community pharmacies in Tanzania. As per good dispensing practices and pharmacy laws, diazepam in the community pharmacies should strictly be stored in a controlled box and dispensed only by prescription. However, to our understanding little had been reported on availability and dispensing practices of diazepam in Tanzania. METHODS: A descriptive cross-sectional study which involved 178 randomly selected registered community pharmacies in Kinondoni district was conducted from January to March 2018. Simulated client approach was used to assess the availability and dispensers practice about dispensing of diazepam. Location of pharmacies was categorized as being at the centre or periphery of the Kinondoni district. Chi-squared test was used for the analysis of categorical data using SPSS version 23. The p-value of < 0.05 was considered significant. RESULT: The total of 178 community pharmacies were visited, the majority of the dispensers (89.1%) encountered were female. Most (69.1%) of the studied pharmacies were located at the centre of Kinondoni district. Diazepam was available in 91% of community pharmacies and 70% of dispensers issued diazepam without prescription. CONCLUSION: Diazepam was available in most of the community pharmacies in Kinondoni district, and the majority of the dispensers dispensed diazepam without prescription. This calls for the regulatory authorities to be more vigilant on the availability of diazepam and enhance the provision of ethical pharmacy practice in the community pharmacies.

[Evolution of the legal and normative framework surrounding the practice of hospital pharmacy and the correct use of drugs in Quebec]. / Évolution du cadre juridique et normatif entourant l'exercice de la pharmacie hospitalière et le bon usage des médicaments au Québec.

OBJECTIVES: The objective was to identify the main texts applicable to the practice of pharmacy in Quebec, then count the specific number of recommendations and criteria and describe the evolution of the legal and normative framework. METHODS: This is a descriptive and retrospective study of the main texts applicable to the legal and normative framework for the practice of pharmacy on January 1st, 2019. RESULTS: A total of 107 texts relating to the practice of pharmacy in Quebec were identified. They come from the legislator (53.1 %), the Order of pharmacists (26.1 %) or other organizations (20.8 %). These were laws/regulations (n=59), contributing to the optimal use of drugs (n=18), relating to hospital pharmacy management (n=18), the provision of pharmaceutical care (n=11), drug preparation (n=3), oncology practice (n=2) or health and safety at work (n=1). Thirty-three texts were considered for enumeration of recommendations and explicit criteria, for a total of 235 recommendations and 3703 explicit criteria applicable to the practice of hospital pharmacy in Quebec. CONCLUSION: There is a significant increase in the number of texts, recommendations and criteria applicable to the practice of hospital pharmacy in Quebec. Compliance with this legal and normative framework appears to be a considerable challenge for hospital pharmacists. It seems worthwhile to further promote discussion with text-issuing agencies in order to keep the search for compliance realistic.

Bills as Band-Aids: Hopes and Challenges of Expanding Pharmacists' Prescriptive Authority to Include Contraceptives.

This paper critically examines the implications of state efforts to expand prescriptive authority of pharmacists, which will allow them to prescribe various types of hormonal contraceptives. With this expansion, women no longer need to see a physician before being prescribed such contraceptives, but instead, they must answer self-assessment questionnaires at the pharmacy to ensure that their chosen method is safe and appropriate. This paper argues that while these measures to expand pharmacists' prescriptive authority will surely meet the stated goal to increase access to hormonal contraceptives, the measures may have detrimental consequences that have largely been downplayed. Studies consistently show that the OB-GYN is a significant primary care provider identified by young female patients, and some of the main reasons provided by these young women for going to the OB-GYN is to discuss, or obtain a prescription for, contraceptives. Through the expansion of pharmacists' prescriptive authority, a likely consequence is that some women will relinquish going to the OB-GYN. However, the OB-GYN provides important services beyond contraceptives, such as preventive screenings for hypertension, cardiovascular diseases, alcohol abuse, mental health, etc., and there is evidence supporting both the effectiveness and cost-benefits of these interventions. By increasing access to contraceptives, the likely result is that many women will have less interaction with a physician and will receive fewer preventive screenings. I do not wish to suggest that these bills should not pass, nor that OB-GYNs should hold contraceptives hostage, only that there are consequences to expanded prescriptive authority that must be anticipated. Further, expanding prescriptive authority obscures the real problem: some individuals have trouble accessing the health care system, not merely trouble accessing hormonal contraceptives. The expansion of prescriptive authority to include contraceptives applies a Band-Aid to treat one aspect of this problem. What is needed is not merely expanded access to hormonal contraceptives, but better access to health care in general.

Pharmacist prescriptive authority for smoking cessation medications in the United States.

OBJECTIVES: To characterize the status of state laws regarding the expansion of pharmacists' prescriptive authority for smoking cessation medications and to summarize frequently asked questions and answers that arose during the associated legislative debates. DATA SOURCES: Legislative language was reviewed and summarized for all states with expanded authority, and literature supporting the pharmacist's capacity for an expanded role in smoking cessation is described. SUMMARY: The core elements of autonomous tobacco cessation prescribing models for pharmacists vary across states. Of 7 states that currently have fully or partially delineated protocols, 4 states (Colorado, Idaho, Indiana, New Mexico) include all medications approved by the U.S. Food and Drug Administration for smoking cessation, and 3 (Arizona, California, Maine) include nicotine replacement therapy products only. The state protocol in Oregon is under development. Most states specify minimum cessation education requirements and define specific elements (e.g., patient screening, cessation intervention components, and documentation requirements) for the autonomous prescribing models. CONCLUSION: Through expanded authority and national efforts to advance the tobacco cessation knowledge and skills of pharmacy students and licensed pharmacists, the profession's role in tobacco cessation has evolved substantially in recent years. Eight states have created, or are in the process of creating, pathways for autonomous pharmacist prescriptive authority. States aiming to advance tobacco control strategies to help patients quit smoking might consider approaches like those undertaken in 8 states.

A review of suicide prevention programs and training policies for pharmacists.

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.

When government agencies turn to unregulated drug sources: Implications for the drug supply chain and public health are grave.

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.

The 2017 American College of Cardiology/American Heart Association hypertension guideline and opportunities for community pharmacists.

OBJECTIVES: To initiate a call to action for community pharmacists to maximize the opportunities to improve the management of hypertension (HTN) in light of the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) HTN guideline. SUMMARY: In November 2017, the ACC and the AHA, along with 9 other professional organizations, released a comprehensive guideline on the prevention, detection, evaluation, and management of high blood pressure (BP). Major changes included the reclassification of BP and redefinition of HTN to 130/80 mm Hg or above, significantly increasing the number of individuals with HTN. The 2017 ACC/AHA HTN guideline also emphasized out-of-office BP readings and recommended team-based care models that include pharmacists and other health professionals as one strategy to improve BP control rates and provide appropriate follow-up and monitoring. Community pharmacists are highly accessible health professionals that now have an even greater opportunity to improve the monitoring and management of patients with HTN. Monitoring of BP in pharmacies could be greatly improved if BP kiosks were replaced by automated BP monitors operated by appropriately trained personnel that would initiate a face-to-face consultation with a community pharmacist. Physicians and other prescribers should also refer patients directly to their community pharmacists to receive assistance in selecting a home BP monitor. Given recent expansion of collaborative practice legislation and prescriptive authority, health information exchanges, and reimbursement models, community pharmacists have a renewed opportunity to collaborate with medical practices and health systems to improve BP control. In addition, greater collaboration among pharmacists practicing in primary care and community pharmacy could improve care coordination. CONCLUSION: Community pharmacists have a significant opportunity to collaborate with patients, physicians, and the health care community at large to improve the monitoring and management of HTN and ensure that the 2017 ACC/AHA HTN guideline is successfully implemented.

Medication abortion: Potential for improved patient access through pharmacies.

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.

Encouraging comprehensive and consistent pharmacist education for provision of contraception.

OBJECTIVES: To initiate a call to action for community pharmacists and key stakeholders to encourage comprehensive and consistent education and certification for contraception services, especially in states where laws have been enacted for pharmacist prescribing of hormonal contraceptives. DATE SOURCES: Websites for several boards of pharmacy that have implemented pharmacist training for contraceptive prescribing. SUMMARY: From the authors' perspective of helping to implement laws that allow pharmacist prescribing of contraception in Oregon and Colorado, lessons learned have shown that it is better to have 1 consistent resource for pharmacist certification for the following reasons: 1) Boards of pharmacy are able to ensure patient safety because all pharmacists are providing the same level of care to every patient; 2) retail chain pharmacies and pharmacy managers are assured that all their pharmacists, regardless of state, are trained in a similar and appropriate manner; and 3) pharmacists can be reimbursed through medical insurance for the patient encounter because payers are able to identify and credential pharmacists who pass an approved and accredited certification program. CONCLUSION: New laws allowing pharmacists to prescribe contraception are expanding to other states, and the implementation of these laws provides an important increase in pharmacists' scope of practice. This exciting new prospect allows the pharmacy community of each state an opportunity to coordinate and learn from each other on best practices for implementation. Having a consistent training program was identified as being one key aspect of successful implementation.

Getting Paid for Clinical Services.

Increasingly, pharmacists are providing advanced, patient-centered clinical services. However, pharmacists are not currently included in key sections of the Social Security Act, which determines eligibility to bill and be reimbursed by Medicare. Many state and private health plans also cite the omission from Medicare as the rationale for excluding reimbursement of pharmacists for clinical services. This has prompted forward-thinking pharmacists to seek opportunities for reimbursement in other ways, allowing them to provide value to the health care system, while carving out unique niches for pharmacists to care for patients.

Impact of pharmacist administration of influenza vaccines on uptake in Canada.

BACKGROUND: Uptake of influenza vaccination in Canada remains suboptimal despite widespread public funding. To increase access, several provinces have implemented policies permitting pharmacists to administer influenza vaccines in community pharmacies. We examined the impact of such policies on the uptake of seasonal influenza vaccination in Canada. METHODS: We pooled data from the 2007-2014 cycles of the Canadian Community Health Survey (n = 481 526). To determine the impact of influenza vaccine administration by pharmacists, we estimated the prevalence ratio for the association between the presence of a pharmacist policy and individual-level vaccine uptake using a modified Poisson regression model (dependent variable: vaccine uptake) with normalized weights while controlling for numerous health and sociodemographic factors. RESULTS: Across all survey cycles combined, 28.8% of respondents reported receiving a seasonal influenza vaccine during the 12 months before survey participation. Introduction of a policy for pharmacist administration of influenza vaccine was associated with a modest increase in coverage (2.2%) and an individual's likelihood of uptake (adjusted prevalence ratio 1.05, 95% confidence interval 1.02-1.08). INTERPRETATION: Uptake of influenza immunization was modestly increased in Canadian jurisdictions that allowed pharmacists to administer influenza vaccines.