PHARM 131 Chapter IV Pharmacy Regulations PDF

PHARM 131| PERSPECTIVES IN PHARMACY CHAPTER IV CHAPTER IV: PHARMACY REGULATIONS B. LAWS AFFECTING PHARMACY PRACTICE AND PHARMACY PROFESSIONAL ETHICS PHARMACY PRACTICE In the Philippines, pharmacy practice is governed by several laws and regulations designed to ensure the safe and...

PHARM 131| PERSPECTIVES IN PHARMACY CHAPTER IV CHAPTER IV: PHARMACY REGULATIONS B. LAWS AFFECTING PHARMACY PRACTICE AND PHARMACY PROFESSIONAL ETHICS PHARMACY PRACTICE In the Philippines, pharmacy practice is governed by several laws and regulations designed to ensure the safe and ethical delivery of pharmaceutical services. These laws cover various aspects of the profession, including licensure, professional ethics, the handling and distribution of medications, and patient care. PHARMACY PROFESSIONAL ETHICS In addition to legal regulations, pharmacists are expected to adhere to ethical standards to ensure they provide responsible and high-quality care. The Pharmacy Code of Ethics is a set of ethical guidelines that pharmacists must adhere to as part of their professional practice. While it is not a law itself, it is derived from various legal provisions and is enforced by the Professional Regulation Commission (PRC) and the Philippine Pharmacists Association (PPhA). Key principles include: Beneficence and Non-Maleficence: Pharmacists must always act in the best interests of patients and avoid actions that may cause harm. Autonomy and Respect for Patients: Pharmacists must respect the rights of patients to make informed decisions about their health, providing them with accurate information and options regarding medications. Justice and Fairness: Pharmacists must treat all patients equitably, without discrimination based on economic status, race, gender, or other factors. Integrity and Honesty: Ethical pharmacy practice requires pharmacists to maintain honesty in all professional interactions, including avoiding conflicts of interest or financial incentives that compromise patient care. PHARMACY PRACTICE PROFESSIONAL ETHICS 1. RA No. 10918 − is the primary law that regulates the practice of pharmacy in the country. Pharmacy Code of Ethics: The law mandates pharmacists to adhere to a code − It was enacted in 2016 to replace the outdated Republic Act No. 5921. of ethics, which is established by the Professional Regulatory Board of Licensure: Sets the requirements for pharmacy education, licensure, and Pharmacy. This code covers ethical obligations related to patient care, honesty, registration with the Professional Regulation Commission (PRC). and integrity in dispensing and counseling. Scope of Practice: Defines the roles of pharmacists in various settings, such as Professional Conduct: Pharmacists must always act with professionalism, community pharmacy, hospital pharmacy, industrial pharmacy, and regulatory putting patient health and safety above all else. Engaging in fraudulent practices work. or unethical behavior such as falsifying prescriptions, dispensing counterfeit or Continuing Professional Development (CPD): Mandates pharmacists to engage substandard drugs, or misleading patients is strictly prohibited. in ongoing education to maintain their competence and stay updated with new Continuing Professional Development (CPD): The law requires pharmacists to pharmaceutical knowledge. undergo continuous education to maintain competence and adhere to evolving Ownership of Pharmacies: Restricts ownership and management of pharmacies ethical standards. This ensures that pharmacists stay updated with medical to licensed pharmacists. advances and are well-informed when serving their patients. Expanded Scope: Allows pharmacists to provide patient care services, including Confidentiality: The act underlines the ethical obligation of pharmacists to immunization, medication therapy management, and drug information services. protect patient information and maintain confidentiality in all interactions, Dispensing and Prescribing: Specifies rules for dispensing prescription drugs except where disclosure is required by law. and giving medication advice.  PHARM 131| PERSPECTIVES IN PHARMACY CHAPTER IV 2. RA No. 3720 − aims to ensure the safety, efficacy, and quality of food, drugs, cosmetics, and The Food, Drugs, and Cosmetics Act provides a framework for ethical devices made available to the public. responsibilities in ensuring the safety, efficacy, and quality of pharmaceutical − Food and Drug Administration (FDA) regulates: products. Ethical implications for pharmacists include: Registration and Approval of Drugs: Pharmaceutical products must be Quality Assurance: Pharmacists are ethically and legally responsible for registered with the FDA before they can be distributed or sold. ensuring the drugs they provide are of the highest quality, meeting the standards Drug Distribution: The law outlines procedures for the manufacture, set by the Food and Drug Administration (FDA). Selling counterfeit or substandard importation, distribution, and retail of pharmaceutical products. products is a direct violation of both legal and ethical standards. Labeling Requirements: Ensures that drugs are properly labeled, including Professional Integrity: Pharmacists must not engage in practices that information about dosage, administration, warnings, and expiration dates. compromise the quality of drugs, such as improper storage or dispensing expired Adulterated or Misbranded Drugs: Prohibits the sale of products that are medications, which could harm patients. unsafe, adulterated, or misbranded. 3. RA No. 9165 − regulates the use, sale, and distribution of dangerous drugs in the Philippines. Key The Comprehensive Dangerous Drugs Act regulates the handling of dangerous provisions include: drugs and includes ethical provisions aimed at preventing abuse, misuse, and illicit Control of Dangerous Drugs: Classifies certain substances as dangerous drugs trade. Key ethical considerations include: (e.g., narcotics, stimulants, depressants), and their sale and use are strictly Responsible Dispensing: Pharmacists must strictly follow legal guidelines regulated. when dispensing controlled substances and ensure that dangerous drugs are Prescription Requirements: Pharmacists must ensure that prescriptions for only dispensed with valid prescriptions. This includes keeping accurate records dangerous drugs are in accordance with legal requirements, such as the use of and preventing misuse or diversion of such substances. special prescription forms and compliance with limits on dosages. Ethical Compliance: Engaging in illegal drug distribution, diversion of Record-Keeping: Requires pharmacies to maintain records of dangerous drug controlled substances, or collaborating with illegal drug networks constitutes a transactions for audit and inspection by authorities. severe violation of ethical and legal responsibilities. Penalties for Violations: Stiff penalties for illegal possession, sale, or manufacture of dangerous drugs. 4. RA No. 6675 − to promote the use of generic drugs in the Philippines, making affordable and The Generics Act promotes the use of generic medicines and mandates ethical effective medicines available to the public. practices in their promotion and dispensation. It includes provisions that affect Generic Labeling: All pharmaceutical products must indicate their generic professional ethics: names on packaging and in advertisements. Obligation to Inform: Pharmacists are ethically and legally obligated to inform Mandatory Generic Dispensing: Pharmacists are required to inform patients of patients of the availability of cheaper generic drug equivalents, ensuring they the availability of generic equivalents when dispensing prescription drugs. have the option to make cost-effective choices for their health. Education Campaigns: Both healthcare providers and the public are educated Truthful Advertising and Promotion: The law enforces ethical standards in on the benefits of using generic medicines. advertising and promotion, prohibiting the dissemination of false or misleading claims about generic drugs. Non-Discrimination: Pharmacists must not discriminate against patients who choose to buy generic alternatives, ensuring equal access to affordable medicine for all.  PHARM 131| PERSPECTIVES IN PHARMACY CHAPTER IV 5. RA No. 9502 − aims to lower the prices of essential drugs and ensure their availability, particularly The Cheaper Medicines Act promotes the availability of affordable quality for lower-income Filipinos. medicines, and it imposes ethical obligations on pharmacists: Parallel Importation: Allows the importation of more affordable generic versions Patient Welfare First: Pharmacists are ethically required to prioritize patient of patented drugs. welfare by recommending and providing the most cost-effective, safe, and Price Regulation: The government can impose price ceilings on essential drugs effective medications, regardless of potential financial incentives from through the Maximum Drug Retail Price (MDRP) system. pharmaceutical companies. Generic Promotion: Strengthens the promotion of generic drugs by requiring Non-Exploitation: Pharmacists are prohibited from taking advantage of their availability in government and private healthcare facilities. patients by overpricing drugs or promoting medicines that are not therapeutically necessary. 6. RA No. 7394 − focuses on protecting the rights of consumers, including those purchasing The Consumer Act enforces the ethical obligation of pharmacists to protect pharmaceutical products. It includes provisions on: consumers by ensuring that drugs and health products meet safety and quality Drug Quality and Safety: Ensures that drugs are safe, properly labeled, and standards. Ethical considerations include: effective. Truth in Labeling and Advertising: Pharmacists must ensure that the False Advertising: Prohibits deceptive advertising that misleads consumers medicines they dispense are properly labeled, contain accurate information, regarding the efficacy of medicines. and that any claims made in advertisements or recommendations are truthful Consumer Rights: Grants consumers the right to accurate information about the and not misleading. drugs they are purchasing. Adulterated or Misbranded Drugs: Dispensing adulterated or misbranded drugs is a severe ethical violation under the law. Pharmacists must ensure that only safe, quality products reach the hands of consumers 7. EO No. 174 − The PNF serves as a reference for healthcare professionals, including pharmacists, on the proper selection of essential medicines. It outlines the standard drugs for use in public healthcare and promotes rational drug use.