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.

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.

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.

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.

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.

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.

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.

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.

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.

Professional practice following regulatory change: An evaluation using principles of "Better Regulation".

BACKGROUND: The provisions in place internationally to regulate the practice of healthcare professionals have undergone significant change. However, this changing regulatory environment as experienced by healthcare professionals in the practice setting has not to date been widely researched. OBJECTIVE: To describe the "lived experience" of pharmacists in community practice in Ireland of the model of regulation introduced by the Pharmacy Act 2007 and their perception of it as fulfilling the seven principles of "better regulation": Necessity; Effectiveness/Targeted; Proportionality; Transparency; Accountability; Consistency and Agility. METHOD: 20 community pharmacists purposively selected, shared their lived experiences of the Act, as implemented in a semi-structured interview. A qualitative content analysis incorporating a framework analysis based on the seven principles of better regulation was used to analyze the data. RESULTS: The Act and its implementation by the Pharmaceutical Society of Ireland (PSI) was not perceived by community pharmacists overall as fulfilling the principles of better regulation. While there was agreement that the Act was necessary, its implementation by the PSI was not viewed as being effective, targeted, proportional and consistent. The PSI was considered to act as a deterrence regulator that is not adequately transparent or accountable. The Act is not sufficiently agile to respond to changes in pharmacy practice. CONCLUSION: Community pharmacists acknowledge the need for the Pharmacy Act but perceive that the PSI needs to adopt a more responsive approach to implementation if the Act is to be considered a model of better regulation. The study findings are of interest as there is little published research on how regulation is experienced by healthcare professionals who are subject to its provisions. The principles of better regulation provide an effective qualitative methodology to examine models of professional regulation based on the "lived experience" of regulatees.

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.

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.

Regulating pharmacists as contraception providers: A qualitative study from Coastal Kenya on injectable contraception provision to youth.

INTRODUCTION: Young people worldwide are often reticent to access family planning services from public health facilities: instead, they choose to get contraception from private, retail pharmacies. In Kenya, certain contraceptives are available in pharmacies: these include injectables, which can be dispensed but not administered, according national guidelines. However, Kenya struggles with enforcement of its pharmacy regulations and addressing illegal activity. Therefore, in this qualitative study, we assessed private pharmacies as an existing source of injectable contraception for young Kenyans (age 18-24), and investigated the perceived quality of service provision. METHODS: This study used: focus group discussions (6) with young community members; in-depth interviews (18) with youth who had purchased contraception from pharmacies; key informant interviews with pharmacy personnel and pharmacy stakeholders (25); and a mystery shopper (visiting 45 pharmacies). RESULTS: The study found that for injectable contraception, private pharmacies had expanded to service provision, and pharmacy personnel's roles had transcended formal or informal training previously received-young people could both purchase and be injected in many pharmacies. Pharmacies were perceived to lack consistent quality or strong regulation, resulting in young clients, pharmacy personnel, and regulators being concerned about illegal activity. Participants' suggestions to improve pharmacy service quality and regulation compliance focused on empowering consumers to demand quality service; strengthening regulatory mechanisms; expanding training opportunities to personnel in private pharmacies; and establishing a quality-based 'brand' for pharmacies. DISCUSSION: Kenya's recent commitments to universal health coverage and interest in revising pharmacy policy provide an opportunity to improve pharmacy quality. Multi-pronged initiatives with both public and private partners are needed to improve pharmacy practice, update and enforce regulations, and educate the public. Additionally, the advent of self-administrable injectables present a new possible role for pharmacies, and could offer young clients a clean, discreet place to self-inject, with pharmacy personnel serving as educators and dispensers.

Supply of codeine combination analgesics from Australian pharmacies in the context of voluntary real-time recording and regulatory change: A simulated patient study.

BACKGROUND: In recent years there have been growing concerns regarding non-prescription codeine use in Australia. Efforts to mitigate risks associated with non-prescription codeine, such as addiction and toxicity, have been primarily through two initiatives; regulatory changes restricting their availability, and voluntary live-recording supply of non-prescription codeine combination analgesics (CCAs). This study sought to explore the supply of CCAs in the climate of regulatory change. METHODS: Eighty University of Sydney pharmacy students mystery-shopped 34 community pharmacies across metropolitan Sydney, Australia from August 2016 to November 2017, with scripted symptom-based (SBR) or direct product requests (DPR) for a CCA. Questions asked, staff involvement, regulatory compliance, voluntary recording, and product(s) supplied were recorded. RESULTS: Of 158 total visits, a non-prescription CCA was supplied in 101 instances. Sixty-one (60%) of these supplies complied with the legislative requirement for a pharmacist to supply the medicine. Voluntary recording was surmised to have been utilised 13 times (13% CCA supplies). CCAs were supplied less frequently in 2017 DPR scenarios compared to 2016 DPR scenarios (64% vs 86%; p = 0.024), and a greater proportion of 2017 DPR supplies were compliant with the legislative requirement of pharmacist supply (72% vs 46%; p = 0.041). No difference in proportion of sales surmised to have been voluntarily recorded was observed between the years. Interactions involving pharmacists resulted in less frequent supply of codeine than those without (58% vs 82%; p = 0.012). CONCLUSION: Mandatory legislative regulation of pharmacist supply of non-prescription codeine was more likely to be complied with than voluntary recording. Compliance with pharmacist supply for DPRs appeared to improve following the announcement of regulatory change to prescription-only, whereas voluntary recording of supply did not appear to change.

[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.