scholarly journals Regulating Pharmacy Practice: Analysis of Pharmacy Laws in Ten States

2020 ◽  
Vol 11 (4) ◽  
pp. 20
Author(s):  
Alex J. Adams
Keyword(s):  
Professional Practice ◽  
Task Force ◽  
Pharmacy Practice ◽  
Standard Of Care ◽  
Standards Of Care ◽  
Word Count ◽  
Legislative Action ◽  
Regulatory Burden ◽  
Practice Standards ◽  
Regulatory Model

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.” This signals a shift in orthodoxy as pharmacy has traditionally been a highly regulated profession. A benchmark report on the pharmacy, nursing, and medical statutes and regulations in Idaho found that pharmacy had a higher overall word count, more overall restrictions, and had to be amended more frequently to keep pace with change. Objective: To identify opportunities to make the transition to a “standard of care” regulatory model in pharmacy law, this manuscript attempts to quantify the regulatory burden for 10 Western U.S. states. Method: The relevant statutes and regulations were gathered from each of the 10 states, and key measures were extracted, including word count, restrictions, exemptions, and the composition. Results: States exhibited wide variation in overall regulatory burden as measured by word count (average of 65,882 words, SD=35,057). The top categories of pharmacy law are: 1) professional practice standards (25,249 ± 16,077 words); 2) facility standards (15,230 ± 10,240 words); and 3) licensing (11,412 ± 6,191 words). More than 65% of all pharmacy regulations are in rule adopted by board of pharmacy rather than in statutes passed by the legislature. Conclusions: States exhibited major variation in total regulatory burden, with the largest contributors to cross-state variation being regulations related to professional practice standards and facility standards. This analysis suggests these two areas should be the primary targets of states looking to decrease regulatory burdens and that regulatory boards have a significant opportunity to remove regulatory burdens even in the absence of legislative action.

scholarly journals Use of professional practice guidance resources in pharmacy: a cross-sectional nationwide survey of pharmacists, intern pharmacists, and pharmacy students

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Deanna Mill ◽  
Jacinta L. Johnson ◽  
Kenneth Lee ◽  
Sandra M. Salter ◽  
Danielle D’Lima ◽  
...  
Keyword(s):  
Professional Practice ◽  
Practice Guidelines ◽  
Code Of Ethics ◽  
Pharmacy Practice ◽  
Nationwide Survey ◽  
Pharmacy Students ◽  
Cross Sectional ◽  
Practice Standards ◽  
Pharmaceutical Society ◽  
Resource Group

Abstract Background Variations in practice are commonplace in healthcare where health professionals, such as pharmacists act as autonomous practitioners. This is evident in simulated patient studies, where pharmacists practice does not meet widely accepted standards for medicines supply or treatment of an ailment. To promote best pharmacy practice a myriad of guidance resources including practice guidelines, codes and standards are produced by professional organisations. These resources provide a framework for pharmacy practice and endeavour to facilitate consistency in provision of pharmacy-based services to consumers. Despite their role in specifying essential pharmacist behaviours, there is limited research exploring if and how these resources are used in practice. Objective To characterise Australian pharmacists’ use of the Pharmaceutical Society of Australia’s Code of Ethics, Professional Practice Guidelines and Professional Practice Standards. Methods A cross-sectional, self-administered, electronic survey of registered pharmacists, intern pharmacists and pharmacy students living in Australia was conducted in July 2020. Questions considered use of professional practice resources (by resource group) in the preceding 12 months. Data were analysed descriptively. Results Of 601 responses included in the analysis 462 (76.9%) of respondents were registered pharmacists, 88 (14.6%) pharmacy students and 51 (8.5%) intern pharmacists. Interns and students accessed overarching practice resources, such as the Professional Practice Standards, Code of Ethics and Dispensing Practice Guidelines more frequently than practising pharmacists. Pharmacists accessed professional practice guidelines, such as Practice Guidelines for the Provision of Immunisation Services Within Pharmacy, more often than students. More pharmacists than interns and students indicated that they would access guidelines to resolve practice and patient care issues. All resources except the Professional Practice Standards for Pharmacists (67.4%) were accessed by less than 50% of respondents in the preceding 12-month period. Reasons for not accessing resources varied between participant and resource groups, and generally were due to a lack of awareness of the resource or not considering them necessary for the individual’s practice. Conclusion(s) Access and use patterns for professional practice guidance resources change with experience. Professional organisations responsible for developing resources should consider these patterns when designing and reviewing resources and related policies. To ensure resources are meeting the needs of the profession, students, interns, and pharmacists should be involved in the review of and design of further resources.

scholarly journals Do pharmacy practice standards effectively describe behaviour? Reviewing practice standards using a behavioural specificity framework

2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Deanna Mill ◽  
Amy Page ◽  
Jacinta Johnson ◽  
Kenneth Lee ◽  
Sandra M. Salter ◽  
...  
Keyword(s):  
Professional Practice ◽  
Health Care Professionals ◽  
Iterative Process ◽  
Pharmacy Practice ◽  
Directed Content Analysis ◽  
Pharmacy Profession ◽  
Practice Standards ◽  
Action Context ◽  
Behavioural Specificity

Abstract Background Guidelines and practice standards exist to communicate the conduct and behaviour expected of health care professionals and ensure consistent quality practice. It is important that they describe behaviours explicitly so they can be interpreted, enacted and measured with ease. The AACTT framework specifies behaviour in terms of the: Action to be performed, Actor who performs the action, Context where the action occurs, Target who the action is performed with/for and Time when the action is performed (AACTT). It provides the most up to date framework for specifying behaviours and is particularly relevant to complex behavioural problems that involve sequences of behaviours performed by different people. Behavioural specificity within pharmacy practice standards has not been explored. Aim To determine if behaviours described in the Professional Practice Standards for Australian Pharmacists specify Action, Actor, Context, Target and Time. Methods Two researchers independently reviewed the scope and structure of the practice standards and one extracted action statements (behaviours) verbatim. Through an iterative process, the researchers modified and developed the existing AACTT definitions to operationalise them for application to review of the action statements in the practice standards. The operational definitions, decision criteria and curated examples were combined in a codebook. The definitions were consistently applied through a directed content analysis approach to evaluate all extracted action statements by one researcher. For consistency 20% was independently checked for agreement by a second researcher. Results A novel codebook to apply AACTT criteria to evaluate practice standards was developed. Application of this codebook identified 768 independent behaviours. Of these, 300 (39%) described at least one discrete observable action, none specified an actor, 25 (3%) specified context, 131 (17%) specified target and 88 (11%) specified time. Conclusion(s) The behaviours detailed in practice standards for Australian pharmacists do not consistently specify behaviours in terms of Action, Actor, Context, Target and Time. Developers in the pharmacy profession, and beyond, should consider the behavioural specificity of their documents to improve interpretability, usability and adherence to the behaviours detailed. This also has implications for the development and evaluation of interventions to change such behaviours and improve quality of care.

scholarly journals Avoiding Common Legal Issues Confronted in Pharmacy Practice: Evaluating Prescriptions with PRN Wording and Calling for Refills

2020 ◽  
Vol 66 (4) ◽  
pp. 18-21
Author(s):  
Fred Weissman ◽  
Ettie Rosenberg
Keyword(s):  
Best Practices ◽  
Professional Practice ◽  
Attorney General ◽  
Pharmacy Practice ◽  
Community Pharmacists ◽  
Legal Issues ◽  
Pharmacy Technician ◽  
Concise Review ◽  
Practice Standards ◽  
Controlled Substance

Community pharmacists are cited and/or fined at an alarming rate. Pharmacists can also be charged by the California (CA) Attorney General (AG) or the Board of Pharmacy (BOP) for more severe violations of law and/or professional practice standards, in the form of an Accusation, the administrative equivalent of a civil “complaint.” This article presents a concise review of two pharmacy practice scenarios involving adjudication of refills with implications for practice violations and attempts to clarify best practices in order to meet the expectations of the BOP and avoid problems with a BOP inspection. The scenarios discussed here cover: 1) Use of “as needed” (prn) wording in a prescription (whether in the directions for use or refill context); and 2) Refills of routine and controlled substance prescriptions called in by a pharmacy technician or pharmacy clerk. The authors' identification of best practices in these refill contexts aims to enhance pharmacists' understanding of pharmacy law in order to ensure maximum compliance.

scholarly journals Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043370
Author(s):  
Ainsley Matthewson ◽  
Olena Bereznyakova ◽  
Brian Dewar ◽  
Alexandra Davis ◽  
Mark Fedyk ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Randomised Controlled Trials ◽  
Standard Of Care ◽  
Standards Of Care ◽  
Controlled Trials ◽  
Theory Approach ◽  
Reference Centre ◽  
Cochrane Database ◽  
Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

Electronic Fetal Monitoring: Physician Liability and Informed Consent

1984 ◽  
Vol 10 (1) ◽  
pp. 31-91
Author(s):  
Myra Gerson Gilfix
Keyword(s):  
Informed Consent ◽  
Fetal Monitoring ◽  
Standard Of Care ◽  
Legal Issues ◽  
Standards Of Care ◽  
Monitoring Technique ◽  
Electronic Fetal Monitoring ◽  
Monitoring Procedure ◽  
Practice Standard ◽  
Physician Liability

AbstractElectronic fetal monitoring (EFM) has been criticized as ineffective, unsafe and costly. Despite existing controversy regarding the risks involved in using EFM, this monitoring procedure continues to be widely employed. In many jurisdictions, in fact, the use of EFM during labor may be considered the customary practice. This Article analyzes the medical and legal issues arising from a physician's use of or failure to use EFM. The Author argues that EFM subjects the mother and the fetus to risks which may be avoided if auscultation, a less intrusive monitoring technique, is employed. The ‘customary practice’ standard of care, the ordinary negligence standard of care, and the ‘best judgment’ and ‘duty to keep abreast’ standards of care are compared and applied to the physician's decision to use EFM. The Author contends that physicians who employ auscultation may not be liable for failing to use EFM; however, physicians who use EFM despite the evidence of its risks may be liable for failing to ‘keep abreast’ or to use their ‘best judgment’ or for negligence. Finally, the Author contends that both physicians and their patients are best protected when the physician elicits the mother's informed consent to employ a particular monitoring technique during labor.

Defining the role of pharmacists in medication-related genetic counseling

2021 ◽  
Author(s):  
Nova A Chart ◽  
David F Kisor ◽  
Christopher L Farrell
Keyword(s):  
Genetic Risk ◽  
Pharmacy Practice ◽  
Interdisciplinary Team ◽  
Standard Of Care ◽  
Treatment Team ◽  
Multiple Cancer ◽  
Cancer Treatments ◽  
Disease States ◽  
Practice Approach

There is little question that precision medicine will eventually be the standard of care in treatment with algorithms designed for therapy selection and is already being used in some specialties such as cystic fibrosis and multiple cancer treatments. Genetic counselors are the heart of the treatment team in relation to counseling regarding genetic risk factors and disease states. A framework for treatment within the interdisciplinary team with more defined roles and areas of specialty will need to be in place as this practice approach expands with new data and treatments. Pharmacists are poised to be of great assistance in this matrix as many of these roles are merely an extension of current tasks and responsibilities of pharmacy practice.

Abstract 6270: How Many Guidelines Does it Take to Send an Asymptomatic Man to Invasive Angiography?

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Miguel A Leal ◽  
Jon G Keevil
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Medical Practice ◽  
Health Care Cost ◽  
Task Force ◽  
Calcium Score ◽  
Standards Of Care ◽  
Adult Males ◽  
Stress Tests ◽  
Artery Disease

Modern medical practice utilizes peer-reviewed published guidelines in order to establish if a diagnostic test or therapeutic intervention is appropriate and will likely promote better outcomes in patient care. However, some evidence-based recommendations may lead to incremental health care cost and potential patient harm if applied blindly, without the guidance of clinical judgment. To analyze the epidemiologic impact of applying the diagnostic algorithm for coronary artery disease (CAD) management suggested by the Screening for Heart Attack Prevention and Education (SHAPE) task force. Using data from the National Health and Nutrition Examination Survey (NHANES) and the Multi-Ethnic Study of Atherosclerosis (MESA), we assessed the hypothesis that proceeding with further diagnostic evaluation via stress testing in patients who have a coronary calcium score greater than 400 on CT scanning would lead to a remarkable number of invasive procedures performed in an asymptomatic population who is deemed to have low risk for cardiovascular events according to other published guidelines. According to the MESA database and the NHANES data collected up to 2002, 4.6 million American men between ages 45 and 79-years-old have a calcium score greater than 400 on coronary CT imaging, which corresponds to approximately 12 % of the population in that group. Potentially 10 to 12 % of those asymptomatic individuals could have false positive stress tests, leading to almost half a million cardiac catheterizations performed in asymptomatic adult males, with a sizable absolute number of procedure-related cost and complications. The decision to follow diagnostic algorithms in the care of patients with risk factors for coronary artery disease should focus great attention to the type of population being studied, the pre-test probability of disease, the cost-benefit relationship and the risk-benefit ratio. If these epidemiologic and health policy parameters are ignored or underestimated, the feasibility of medical practice (using coronary artery disease management as an example) could be compromised in the long-term, despite minimal or no deviation from established standards of care.

Adapting Standards of Care Under Extreme Conditions

2009 ◽  
Vol 3 (2) ◽  
pp. 111-116 ◽  
Author(s):  
Kristine M. Gebbie ◽  
Cheryl A. Peterson ◽  
Italo Subbarao ◽  
Kathleen M. White
Keyword(s):  
Public Health ◽  
Health Professionals ◽  
Control Policy ◽  
Standard Of Care ◽  
White Paper ◽  
Ethical Framework ◽  
Standards Of Care ◽  
State Legislation ◽  
Routine Tasks ◽  
Criminal Charges

ABSTRACTThe filing of criminal charges against a group of clinicians in New Orleans for failure to meet expected standards of care following the hurricanes of 2005 made the growing concern among health professionals about care provided during extreme emergencies or disasters all too real. Questions about what may lead to censure, penalties from licensing boards, or lawsuits have come from nurses, physicians, and many other licensed health professionals. A panel convened by the American Nurses Association that included representatives of medical, public health, hospital, and government agencies considered the ethical, professional, and practical aspects of meeting standards of care in such circumstances. Clinicians are reminded that in emergencies, it is only the circumstances that change (perhaps radically); neither the individual’s professional competency nor the basic professional standard of care is different. In making prioritized decisions under such circumstances, the individual’s ethical framework is utilitarian, and there are 3 areas for action, even when some routine tasks are set aside: maintain worker and patient safety; maintain airway, breathing, and circulation; and establish or maintain infection control. Policy recommendations such as state legislation for the adoption of comprehensive immunity for volunteer health care workers, and the establishment of a medical review panel as arbitration board are also suggested. The resulting white paper summarizes the issues and provides guidance to individual professionals, institutions in which they work, and emergency planners. (Disaster Med Public Health Preparedness. 2009;3:111–116)

scholarly journals How a Nutritional Deficiency Became Treated with Fluoride

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4361
Author(s):  
Philippe P. Hujoel
Keyword(s):  
Public Health ◽  
Vitamin D ◽  
Medical Profession ◽  
Standard Of Care ◽  
Professional Organizations ◽  
Standards Of Care ◽  
National Academy Of Sciences ◽  
Causes Of Disease ◽  
Academy Of Sciences ◽  
Health Experts

Ignoring evidence on causes of disease such as smoking can harm public health. This report explores how public health experts started to ignore evidence that pediatric vitamin D deficiencies are associated with dental caries. Historical analyses show that an organization of clinical specialists, the American Dental Association (ADA), initiated this view. The ADA was a world-leading organization and its governing bodies worked through political channels to make fluoride a global standard of care for a disease which at the time was viewed as an indicator of vitamin D deficiencies. The ADA scientific council was enlisted in this endeavor and authorized the statement saying that “claims for vitamin D as a factor in tooth decay are not acceptable”. This statement was ghost-written, the opposite of what the ADA scientific council had endorsed for 15 years, and the opposite of what the National Academy of Sciences concluded. Internal ADA documents are informative on the origin of this scientific conundrum; the ADA scientific council had ignored their scientific rules and was assisting ADA governing bodies in conflicts with the medical profession on advertising policies. The evidence presented here suggests that professional organizations of clinical specialists have the power to create standards of care which ignore key evidence and consequently can harm public health.

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