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.

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.

A comparison of trends in opioid dispensing patterns between Medicaid pharmacy claims and prescription drug monitoring program data.

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.

Institutional strategies as a mechanism to rationalize the negative effects of the judicialization of access to medicine in Brazil.

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.

Policy Recommendations for Pharmacy Benefit Managers to Stem the Escalating Costs of Prescription Drugs: A Position Paper From the American College of Physicians.

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.

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.

Assessing the Impact of Language Access Regulations on the Provision of Pharmacy Services.

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.

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.

Prescription and over-the-counter medication record integration: A holistic patient-centered approach.

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.

The Practice of Compounding, Associated Compounding Regulations, and the Impact on Dermatologists.

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.

Impact of the 340B Pharmacy Program on Services and Supports for Persons Served by Hemophilia Treatment Centers in the United States.

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.

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.

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.

Pathway to pharmacist medical provider status in Washington State.

OBJECTIVES: To describe Washington State's successful legal and legislative efforts to gain pharmacist medical provider status and major medical compensation and to compare those efforts with similar efforts in other states to identify key lessons learned. SUMMARY: Washington State Engrossed Substitute Senate Bill 5557 was enacted in 2015, securing pharmacists as medical providers and requiring compensation under major medical insurance for pharmacists providing health services (Revised Code of Washington 48.43.715). Other states have passed, or attempted to pass, pharmacist provider status bills, but none have achieved both pharmacist medical provider status and mandatory major medical compensation. CONCLUSION: Pharmacist medical provider status ideally should include recognition as a medical provider and compensation through major medical health insurance as a clinical decision maker rather than an "incident-to" provider. Both elements should be sought as part of a complete legislative package to ensure sustainable patient access to needed health care services.

State legal innovations to encourage naloxone dispensing.

OBJECTIVES: The opioid overdose epidemic continues to claim the lives of tens of thousands of Americans every year. Increased access to the opioid antagonist naloxone can reduce opioid-related morbidity and mortality. In this commentary, we describe several recent legal innovations designed to encourage pharmacists to ensure that naloxone is available when and where it is needed, and dispel some common misconceptions regarding potential legal risks associated with pharmacy naloxone dispensing. DATA SOURCES: Data are drawn from state laws and regulations, as catalogued by the Westlaw database. SUMMARY: States have rapidly modified law and policy to increase layperson access to naloxone. As of August 2016, 44 states permit naloxone to be prescribed for administration to a person with whom the prescriber does not have a prescriber-patient relationship. Forty-two states permit naloxone to be dispensed via a non-patient-specific mechanism such as a standing or protocol order, and 5 states permit some pharmacists to prescribe naloxone on their own authority. The liability risk associated with naloxone dispensing is no higher than any other medication, and may be lower than some. However, to encourage the prescription and dispensing of naloxone, 36 states provide additional protection from civil liability for pharmacy naloxone dispensing, and 32 states provide protection from potential criminal action. Naloxone access laws in 31 states explicitly provide that dispensing naloxone as permitted by law cannot be grounds for disciplinary action by the state board of pharmacy or similar entity. CONCLUSION: Pharmacists are key members of the health care team and are uniquely situated to reduce potential opioid overdose risk. Pharmacists should be aware of and utilize innovative state laws designed to increase access to naloxone.

Medication Refusal: Resident Rights, Administration Dilemma.

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.

IMPACT OF PHARMACY REFORM ON THE DYNAMICS OF THE USE OF DRUGS AND PSYCHOACTIVE SUBSTANCES ACCORDING TO THE 2013-2016 CLINICAL DATA FROM THE "CENTER FOR MENTAL HEALTH AND PREVENTION OF ADDICTION".

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.