Module 1

• Laws are promulgated by specific bodies to define and regulate the profession and delimit its practice.
• Statutory Laws are enacted by a legislative body and composed of the Congress and the Senate and approved by the President of the country.
• Statutory Laws dictate the conduct of persons or organizations subject to the law and enable Regulatory Agencies to regulate a field pursuant to the mandate of the legislative body.
• The President of the Philippines approves the consolidation of the Senate and Lower House versions of the law.
• The preparation of the implementing rules and regulations (IRR) involves changes to certain provisions of the law.
• A public hearing is conducted for the consolidation of the Senate and Lower House versions of the law.
• Examples of Statutory Laws include RA 10918 - The Philippine Pharmacy Act, RA 3720 - Food, Drugs, and Cosmetics Act, RA 8203 - Special Law on Counterfeit Drugs, RA 6675 - The Generics Act of 1988, RA 9165 - Comprehensive Dangerous Drug Act of 2002, RA 9994 - The Price Act, RA 7394 - Consumer Act of the Philippines, RA9502 - Universally Accessible Cheaper and Quality Medicines Acts, RA 9711 - Food and Drug Administration Act of 2009, RA 10912 - Continuing Professional Development (CPD) Act of 2016, RA 11223 - Universal Health Care Act.
• Regulatory Laws are rules and regulations promulgated by government agencies at the local, state, and federal levels to enhance enforcement and understanding of the law.
• Examples of Regulatory Laws include A.O No. 62, s. 1989; rules and regulations to implement Prescribing Requirements under the Generic Act of 1988, M.C (Memorandum Circular) No. 1, s. 1991; Registration of Medical Devices and Diagnostic Reagents, B.C (Bureau Circular) No. 2, s. 1997; Accreditation of Drug Liaison Officer to BFAD, IRR (Implementing Rules and Regulation) RA 10918 Professional Regulatory Board of Pharmacy Resolution no 52 series of 2017.
• Judicial Laws are the law that results from court decisions.
• Civil Law gains its name from the Latin term “civis” meaning “citizen” and governs the relationship between individuals within society and deals with lawsuits brought by individuals.
• Criminal Law governs the relationship between individuals to society as a whole and state or federal prosecutors bring a case against a person charged with a major crime, called a felony.
• The importance of bioethics is to provide awareness to the health team or workers of the do’s and don'ts of medical practice and to enrich one’s competence by understanding that the patient is a person and a holistic individual.
• The objectives of ethics are to make clear to us why one act is better than another, to live an orderly social life, to appraise and criticize intelligently the moral conduct and ethical system, and to seek the value of life.
• The elements of negligence include existence of duty, failure to perform the duty, and injury resulting from failure.
• Negligence is doing or failing to do that action which a reasonably prudent person would have done or would have not done in like or similar circumstances.
• Bioethics involves human beings and is the term used to describe the application of ethics to biological sciences, medicines, and related fields.
• Norms of human acts are directives or guidelines in making decisions on what we ought to do or to be.
• Professional ethics is a branch of moral science that treats the obligations that a member of a profession owes to the public, to his profession, and to his clients.
• Ethics is the science of morality, referring to the moral principles of practice and the discipline is concerned with what is morally good and bad and morally right or wrong.
• The term ethics is also applied to any system or theory of values or principles.
• Universal principles of biomedical ethics include autonomy, veracity, beneficence, nonmaleficence, and confidentiality.
• Malpractice is any professional misconduct or any unreasonable lack of skill or fidelity in the performance of professional or fiduciary duties.
• Quasi-Legal Standard refers to standards accepted professional practice standards, standards set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and U.S Pharmacopeia (USP) guidelines.
• Parts of the Law include RA No. 2, Title 3, Declaration of Policy and Purpose, Government agency created to implement the Law, Composition of the Body, Qualification of the body, Appointment and Removal, Terms of Office, Functions of the body, Standards of Practice, Prohibited Acts and Penalties, Appropriations, Final Provisions, Effectivity date of the Law, Signatures of the Legislative bodies and the President of the Country.
• Types of Penalty include Counseling, Reprimand, Suspensions, Confiscation of product/equipment, Cancellation of LTO, Cancellation of LTP.
• A pharmacist exercises professionalism, diplomacy, and tact at all times and recognizes the individual contributions and differences of the members of the team in the patient’s continuum of care.
• A pharmacist takes part in the formulation and development of health policies and standards relevant to the practice of the profession and its proper implementation.
• A pharmacist advocates equitable distribution of health resources, health promotion, disease prevention, and wellness.
• A pharmacist takes leadership roles and involvement in initiatives and programs that are critical to the demands of the profession as it continuously evolves.
• A pharmacist provides pharmaceutical care and assists patients and clients with compassion.
• A pharmacist demonstrates a commitment to the development and enhancement of the profession.
• A pharmacist conducts the business of pharmacy in an ethical and professional manner.
• A pharmacist respects and collaborates with other healthcare professionals and colleagues to achieve optimal treatment outcomes for their patients and ensures a continuum of care.
• A pharmacist, in coordination with the government and non-government organizations, actively participates in the formulation and implementation of healthcare policies, standards, and programs designed for the benefit of society.
• A pharmacist conducts business practices in the best interest of the patients and clients, respects confidentiality and exercises propriety in communicating information; respects his competitors and their products and services while using her/his time and resources for legitimate business purposes.
• A pharmacist cares for each individual with competence and compassion.
• A pharmacist establishes a therapeutic relationship to gain the trust and confidence of the clients.
• A pharmacist acts with honesty, integrity, and professionalism in her/his relationship with patients, carers, and other stakeholders in healthcare.
• A pharmacist is responsible for her/his actions and faces consequences when regulatory and scientific standards are not met.