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Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04208 Law and Ethics in Pharmacy Practice

Historical Background of Pharmacy Practice – PST04208 Law and Ethics in Pharmacy Practice

NTA Level 4 • Semester 2 • PST04208 Historical Background of Pharmacy Practice Law and Ethics in Pharmacy Practice • Source Session/Topic 4 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. 4. Historical Background of Pharmacy Practice Students Learning Tasks By the end of this session students are expected to be able to: Define pharmacy practice Explain historical background of pharmacy practice Importance of pharmacy practice Introduction/background of pharmacy practice The number of medicines on the market has increased dramatically over the last few decades, bringing some real innovations but also considerable challenges in controlling the quality and rational use of medicines. In developing and industrialized countries alike, efforts to provide health care, including pharmaceutical care, are facing new challenges. These include the rising costs of health care, limited financial resources, a shortage of human resources in the health care sector, inefficient health systems, the huge burden of disease, and the changing social, technological, economic and political environment which most countries face. While globalization has brought countries closer together in trade of products and services and in recognition of academic degrees and diplomas, for example, it has led to rapid changes in the health care environment and to new complexities due to increased travel and migration The mission of the profession of pharmacy is to improve public health through ensuring safe, effective, and appropriate use of medications. Contemporary pharmacy practice reflects an evolving paradigm from one in which the pharmacist primarily supervises medication distribution and counsels patients, to a more expanded and team-based clinical role providing patient centered medication therapy management, health improvement, and disease prevention services. The role of the pharmacist is developing rapidly to meet the needs of modern health care systems. Ensuring accurate dispensing of prescribed medicines against prescriptions and providing sound advice on responsible self-medication remain vitally important parts of the service provided by pharmacists. Pharmacists have, however, recognized for some years that equally important roles are to advise other healthcare professionals on safe and rational use of medicines and to accept responsibility for seeking to ensure that medicines are used safely and effectively by those to whom they are supplied so that maximum therapeutic benefit is derived from treatment. This activity contributes both to the welfare of the individual and the overall improvement of public health Definition of pharmacy practice The “ Pharmacy Practice” means the interpretation, evaluation, and implementation of Medical Orders; the Dispensing of Prescription Drug Orders; participation in Drug and Device selection; Drug Administration; Drug Regimen Review; the Practice of Telepharmacy within and across state lines; Drug or Drug-related research; the provision of Patient Counseling; the provision of those acts or services necessary to provide Pharmacist Care in all areas of patient care, including Primary Care and Collaborative Pharmacy Practice; and the responsibility for Compounding and Labeling of Drugs and Devices (except Labeling by a Manufacturer, Repackager, or Distributor of Non-Prescription Drugs and commercially packaged Legend Drugs and Devices), proper and safe storage of Drugs and Devices, And maintenance Of required records. The practice of pharmacy also includes continually optimizing patient safety and quality of services through effective use of emerging technologies and competency-based training. Importance of Pharmacy Practice (20 minutes) Having seen the background, definition and highlights of pharmacy practice, let’s now look unto the importance of pharmacy practice In geriatric pharmacy practice: pharmacy practice is important because, Elderly patients are unique in that they possess an altered metabolic capacity for medications due to, for example, increased body fat and water, decreased muscle mass, decreased cardiac output and perfusion, decreased protein binding, reduced liver function, and reduced physiologic reserve—all of which lead to unique medication selection and dosing requirements compared to younger adults. As a result of concomitant disease states, multiple medications are often prescribed for elderly patients by a variety of providers. They also often require additional assistance to understand how to take their medications to avoid possible adverse drug effects. Lack of mobility, vision/hearing difficulties, and possible altered mental status may further hamper proper use of medications by the elderly. There is a shortage of healthcare professionals trained in geriatric pharmacotherapy and seniors older than 75 years of age are under-represented in clinical trials, resulting in a poor evidence base on which to make individualized therapeutic decisions. As the number of elderly patients continues to increase, the contribution of the pharmacist to quality, long-term medication management will require dramatic expansion. Pediatric pharmacy practice: The pediatric patient population spans the years from birth through adolescence, presenting a unique challenge with regard to drug therapy administration and monitoring. Unlike adults, dosing is most commonly based on body weight, and pharmacokinetic variables are standardized relative to weight and/or body surface area. Since physical growth and organ system maturation are dynamic processes throughout the aging continuum, frequent individual dosing calculations and adjustments are necessary, particularly in infants. Pediatric disease states, such as cystic fibrosis can further impact pharmacotherapy due to differences in pharmacokinetics seen in this particular subset of patients. Pediatric patients are under-represented in clinical trials, resulting in an inadequate evidence base on which to make individualized therapeutic decisions. Most commercially available drugs are not formulated for use in infants and children. In addition, the pediatric patient population poses a higher risk for medication errors. Pediatric patients are three times more likely to suffer from a medication error; and a relatively small magnitude of error, as compared to adults, may result in more serious consequences, especially in the youngest, most vulnerable patients. Pediatric patients frequently experience adverse drug reactions similar to adults, but adverse reactions in the pediatric population may be harder to recognize or be of greater or lesser intensity The practice of pharmacy may include but is not limited to: The selection and provision of non-prescription medicine therapies and therapeutic aids; products; The selection and provision of non-prescription medicine therapies and therapeutic aids; Health promotion, including health screening; Administration of

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04208 Law and Ethics in Pharmacy Practice

Standards and Values of Pharmacy Profession – PST04208 Law and Ethics in Pharmacy Practice

NTA Level 4 • Semester 2 • PST04208 Standards and Values of Pharmacy Profession Law and Ethics in Pharmacy Practice • Source Session/Topic 5 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. 5. Standards and Values of Pharmacy Profession Students Learning Tasks By the end of this session students are expected to be able to: Define profession Explain standards of pharmacy profession Explain core values of pharmacy profession Definition of Profession Professions are dynamic; a definition is static. This makes any definition of a profession temporary from the very start. A generally recognized definition can, however, serve as a basis for a description of professionalism which takes into account the permanent factors whilst at the same time looking ahead to the development of the profession. A frequently used definition of (the medical) ‘profession’ is that of Cruess and Cruess (2004): Profession: an occupation whose core element is work based upon the mastery of a complex body of knowledge and skills. It is a vocation in which knowledge of some department of Science or learning or the practice of an art founded upon it is used in the service of others. Its members are governed by codes of ethics and profess a commitment to competence, Integrity and morality, altruism, and the promotion of the public good within their domain. These commitments form the basis of a social contract between a profession and society, which in return grants the profession a monopoly over the use of its knowledge base, the right to considerable autonomy in practice and the privilege of self-regulation. Professions and their members are accountable to those served and to society. The above definition emphasizes autonomy in practice. The practice of every professional, and therefore also that of the pharmacist, comprises four components Meet a social need or necessity within the practice; A clear stance regarding the responsibility of the individual professional for meeting the social needs The expectation to work in the patient’s interest A requirement to work within the healthcare paradigm. Standards of Pharmacy Profession Purpose of standards: Ensure that a learner possesses relevant competencies to undertake the roles and services described in his/ her scope of practice Assist in the development of education and training and development e.g. inform development of initial curriculum; assist providers in identifying learning outcomes; use as a self- assessment tool to evaluate their own level of competency; assist employers and learners to identify ongoing training and development needs Assist the individuals to facilitate their continuing professional development (CPD) e.g. a tool for all to use to assess their own practice. The Competence Standards for the Pharmacy Profession consist of seven standards. Supported by professional codes of ethics, competence standards describe the skills, attitudes and other attributes (including values and beliefs) attained by an individual based on knowledge and experience. They specify the application of that knowledge and skills to the standards of performance required in a practice setting. Together they enable the individual to practice effectively as pharmaceutical personnel. The value of competence standards rests with their capacity to support and facilitate professional practice and growth, in the interests of public safety. The seven broad areas of competency are: Practice Pharmacy in a Professional and Culturally Competent Manner Contribute to the Quality Use of Medicines Provide Primary Health Care Apply Management and Organization Skills Research and Provide Information Dispense Medicines Prepare Pharmaceutical Product STANDARD 1 Practice Pharmacy in a Professional and Culturally Competent Manner The Pharmacy Council recognizes that cultural competence, clinical competence and ethical Conducts are integral to professional pharmacy practice. Professionalism is encompassed by a set of attitudes, knowledge and skills based on clinical competence, communication skills, ethics, societal and legal requirements resulting in the application of behaviors that demonstrate a commitment to excellence, respect, integrity, empathy and accountability. This standard outlines these responsibilities which apply to all pharmacists, regardless of their pharmacy practice. Cultural competence is the ability to interact respectfully and effectively with persons from a background that is different from one’s own. It goes beyond an awareness of or sensitivity to another culture to include the ability to use that knowledge in cross-cultural situations, and includes the development and implementation of processes, procedures and practices that support the delivery of culturally competent (appropriate) services. Clinical competence, as expected of a pharmacist, is the application of knowledge and skills to ensure the safe and quality use of medicines to optimize health outcomes. Ethical conduct, as described in the Pharmacy Council Code of Ethics, is the expression of those principles and values that underpin the pharmacy profession STANDARD 2: Contribute to the Quality use of Medicines This competence standard covers the role of the pharmacist in promoting the quality use of medicines within an environment of professional pharmaceutical care. The Pharmacist’s role includes selecting, recommending, monitoring and evaluating medicine therapy as part of a health care team. Rational medicine use refers to the evidence-based selection, monitoring and evaluation of medicine therapy in order to optimize health outcomes. STANDARD 3: Provide Primary Health Care This competence standard concerns the role of the pharmacist in encouraging and assisting people to take responsibility for their own health. Primary health incorporates holistic care of patients including attention to lifestyle, diet, health promotion, illness prevention, referral and the supply of non-prescription medicines, therapies, diagnostic and therapeutic aids. This involves the pharmacist in treatment, referral and education STANDARD 4: Apply Management and Organization Skills This competence standard covers the organization and management skills common to all pharmacists. It encompasses the ability to deal with contingencies in the workplace as well as routine work. STANDARD 5: Research and Provide information This competence standard covers the role of the pharmacist in providing health-related information to other health professionals, patients and the public. The pharmacist’s role includes finding, interpreting, and evaluating, compiling, summarizing, generating and disseminating information, for the purpose of optimizing medicine related health outcomes. STANDARD 6:

Pharmaceutical Sciences Notes, PST Level 4 Semester 2, PST NTA Level 4, PST04208 Law and Ethics in Pharmacy Practice

Code of Ethics and Professional Conduct for Pharmaceutical Practitioners – PST04208 Law and Ethics in Pharmacy Practice

NTA Level 4 • Semester 2 • PST04208 Code of Ethics and Professional Conduct for Pharmaceutical Practitioners Law and Ethics in Pharmacy Practice • Source Session/Topic 6 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. 6. Code of Ethics and Professional Conduct for Pharmaceutical Practitioners Students Learning Tasks By the end of this session students are expected to be able to: Define important terms used in Code of Ethics Understand the Background of codes of ethics Explain codes of ethics Definition of important Terms used in Code of Ethics Pharmaceutical personnel pharmacist pharmaceutical technician pharmaceutical assistant intern pharmacist professional misconduct pharmacy practice professionalism pharmacy council breaches Definition of Terms: Pharmaceutical personnel: As per this code of ethics and professional conduct means registered pharmacist, enrolled pharmaceutical technician, enlisted pharmaceutical assistant and intern pharmacist. Pharmacist: Means a person registered under section 16 as per Pharmacy Act 2011, Cap 311 Pharmaceutical technician: Means a person enrolled under section 24 as per Pharmacy Act 2011, Cap 311 Pharmaceutical assistant: : Means a person enlisted under section 28 of Pharmacy Council Act 2011, Cap 311 Intern Pharmacist: Means any person registered as such under section 17 of Pharmacy Council Act 2011, Cap 311 Professional misconduct: Means any conduct which is in breach of the code of conduct, prescribed under the Pharmacy Council Act 2011, Cap 311 Pharmacy Practice: Means any act pertaining to the scope of practice of a Pharmacist, Pharmaceutical Technician and Pharmaceutical Assistant as approved by the council Professionalism: Means active demonstration of the following traits, Knowledge and skills of a profession, Commitment to self-improvement of skills and knowledge Service orientation, Pride in the profession, Collaborative relationship with the patient Creativity and innovation, Conscience and trustworthiness, Accountability for his/her work, Ethically sound decision making, and Leadership. Pharmacy Council: Means a council established under Section 3 of Pharmacy Council Act 2011, Cap 311. Breaches: Means an act of breaking, violating or disregarding any obligation of code of ethics and professional conduct. Background of Codes of Ethics A profession is distinguished by the willingness of individual practitioners to comply with ethical and professional standards, which exceed minimum legal requirements. The role of pharmaceutical personnel is developing and recognized as the expert on medicines within the overall health system, to ensure people maintain good health, through responsible use of medicines. To practice as pharmaceutical personnel means undertaking any role, whether remunerated or not, in which an individual uses his professional skills and knowledge. Pharmaceutical practices are not restricted to the provision of direct clinical care, but also include working in a non-clinical relationship with consumers, patients or care takers, in the discovery, development, and manufacture of medicines, in maintaining the supply chain or in procurement. Besides this, pharmaceutical management or administrations, in education, research, advisory, regulatory, or policy development roles are considered to be important role to this cadre. The code of ethics will therefore apply to pharmaceutical personnel in all pharmacy practice settings. At all times, Codes should strive to provide the best possible care for consumers, patients and care takers, with due regard for the limitations of available resources and the principles of equity and justice. These codes of ethics and Professional Conduct for pharmaceutical personnel therefore intend to reaffirm and state publicly the obligations that form the basis of the roles and responsibilities of pharmaceutical personnel. These obligations, based on established ethical principles, are provided to enable and guide pharmaceutical personnel in their daily practice of the profession. Explanation of Codes of Ethics The principles of the Code of Ethics are intended to capture the philosophical foundation of Pharmacy practice and to express the responsibilities and professional values that are fundamental and inherent to the pharmacy profession. They reflect and support developments in the profession, patient-centered practice and take into consideration patients’ rights and responsibilities. Pharmaceutical personnel are professionally accountable for their practice, which means being responsible for what they do or do not do, no matter what advice or direction a manager or another professional gives them. They may be faced with conflicting professional or legal responsibilities; therefore they must use their professional judgment when deciding on a course of action and should use their professional and ethical principles as a basis for making those decisions. The principles of the Code of ethics form the basis for the provision of a consistent high quality professional service which safeguards and promotes the well-being of patients and society and maintains public confidence in the profession. The principles are equally important and are listed in no particular order. AS PHARMACEUTICAL PERSONNEL YOU MUST: Make the health and well-being of the patient your first priority. Promote patient self-determination, respect patients’ rights, autonomy and freedom of choice. Use your professional judgment in the interests of patients and the public and promote family, and community health. Show respect for others and exercise your duties with professionalism. Actively seek and apply contemporary pharmacy knowledge and skills to ensure a high standard of professional competence. Act in a manner that promotes public trust and confidence in pharmacists and enhances the reputation of the profession. Practice in a manner that does not compromise your professional independence, judgment or integrity, or that of other pharmacists The principles or codes and their supporting explanations are given here under: Code 01: Make the health and well-being of the patient your first priority. The care, well-being and safety of patients are at the centre of everyday professional pharmacy practice. Irrespective of your field of work, your decisions or behavior can still affect their care or safety. For example: Ensure that your duty of care to a patient (or patients) is not compromised by a commercial interest or interest of any other kind, including any loyalty to or interests of an employer or other healthcare provider Where you have reasonable grounds to suspect the misuse or abuse of prescribed medicines consult with the prescriber. When medicines

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