Philippine Pharmacy Practice Regulations PDF

PHAPERSP (WEEK 8-9) Regulations of Pharmacy Practice RA 10918 (Philippine Pharmacy Act): Modernizes the practice of pharmacy in the Philippines repealing R.A. 5921, otherwise known as the Pharmacy Law. RA 6675 (Generics Act of 1988): Promotes the use of generic names in drug...

PHAPERSP (WEEK 8-9) Regulations of Pharmacy Practice RA 10918 (Philippine Pharmacy Act): Modernizes the practice of pharmacy in the Philippines repealing R.A. 5921, otherwise known as the Pharmacy Law. RA 6675 (Generics Act of 1988): Promotes the use of generic names in drug prescriptions. RA 8203 (Special Law on Counterfeit Drugs): Defines counterfeit drugs and addresses their regulation. - refer to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with insufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or purity. RA 9165 (Comprehensive Dangerous Drugs Act of 2002): Regulates the use and handling of dangerous drugs. RA 9994 (Expanded Senior Citizens Act of 2010): Provides additional benefits to senior citizens. - R.A. 7432, as amended, otherwise known as “an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges and for other purposes”. RA 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008): Focuses on making medicines more affordable. - SEC. 17. Drugs and Medicines Price Regulation Authority of the President of the Philippines. - SEC. 23. List of Drugs and Medicines that are Subject to Price Regulation - The list of drugs and medicines that are subject to price regulation RA 10699 (National Athletes and Coaches Benefits and Incentives Act): Provides benefits and incentives for athletes and coaches. - SEC 4. Benefits and Privileges for National Athletes and Coaches - Twenty percent (20%) discount from all establishments Dispensing and related Terminologies Based on R.A. 10918 Refers to the process of preparing and giving medicine to a named person based on a prescription Vital elements of rational medication use Involves the: - Correct interpretation of wishes of the prescriber - Accurate preparation and labeling of the medicines  - Refers to the sum of processes performed by a pharmacist from Reading Validating, and interpreting prescriptions Preparing Packaging Labeling record keeping dose calculations counseling or giving information In relation to the sale or transfer of pharmaceutical products, with or without a prescription or medication order Rational Medication Use Patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time and the lowest cost to them and their community PATIENT MEDICATION COUNSELLING Providing medication information orally or in written form to the patients or their representatives on directions of use, advice on side effects, precautions, storage, diet and life style modifications Drugs refer to pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals (1) Any article recognized in the official United States Pharmacopeia/National Formulary, Homeopathic Pharmacopeia of the United States of America, Philippine Pharmacopeia, Philippine National Drug Formulary, British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and any official compendium or any supplement to them (2) Any article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease of man or animals (3) Any article, other than food, intended to affect the structure or any function of the human body or animals. (4) Any article intended for use, as a component of articles, specified in clauses (1), (2) and (3), not including devices or their components, parts and accessories. (5) Herbal or traditional drugs as defined in Republic Act No. 9502 Over-the-Counter (OTC) medicines refer to medicines used for symptomatic relief of minor ailments and which may be dispensed without a prescription Pharmacist Only OTC Drugs refer to over-the-counter medicines classified by appropriate government agencies to be obtained only from a licensed pharmacist, with mandatory pharmacist’s advice on their selection and proper use Household Remedies refer to any preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments and which may be dispensed without a medical prescription in original packages, bottles or containers, of which the nomenclature has been duly approved by the FDA Food/ Dietary supplements refer to processed food products intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. Cosmetics refer to a substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition, as defined under Republic Act No. 9711 Generic name refers to the scientifically and internationally recognized name of the active ingredients, as approved by the FDA pursuant to Republic Act No. 6675, otherwise known as the "Generics Act of 1988" Brand name refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors Compounding refers to the sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug Filling refers to the act of dispensing or providing medicines in accordance with a prescription or medication order Refilling of a Prescription refers to the act of dispensing the remaining balance of medicines ordered in the prescription Prescription a written order by medical practitioner that authorizes a patient to be provided a medicine and treatment. "pre" and "script" and literally means, "to write before" a drug can be prepared. Types of Prescription - Pre-compounded Prescription - Prescription for already prepared drug - Extemporaneous prescription - Impromptu Rx and Magistral prescription  Prescription Writing - The most important requirement for a prescription is that it should be clear. - It should be legible and indicate precisely what should be given - All prescriptions should be containing the following information: Patient’s name, age, and gender Prescriber’s information Date of prescription Under section 3 of the Generics Act lists the following specific guidelines to prescribing: Generic name shall be used in all prescriptions Generic name must be written in full, but the salt or chemical form may be abbreviated Generic name must be clearly written immediately after the Rx symbol A brand name may also be included. It must be enclosed in parenthesis and written below the generic name The pharmaceutical form should also be stated Three types of incorrect prescriptions may be identified: ERRONEOUS - Where the BN precedes the GN - Where the GN is the one in parenthesis - Where the BN is not in the parenthesis VIOLATIVE - Where the GN is not written - Where the GN is not legible, and a BN which is legible is written - Where the BN is indicated and instructions added such as “no substitution” IMPOSSIBLE - When only GN is written, but not legible - When the GN does not correspond to the BN - When both the GN and BN are not legible - When the drug product prescribed is not registered with the Philippine FDA Common Medical Abbreviations Common Medical Abbreviations Common Medical Abbreviations  Common Medical Abbreviations PPhA - Code of Ethics for Pharmacists PREAMBLE Pharmacists are health professionals who help individuals protect themselves against diseases, maintain good health and make the best use of their medications. The pharmacists promote rational use of drugs and ensure the provision of safe, effective and quality drugs for improved patient care and quality of life. This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the fundamental basis of their roles and responsibilities which are based on moral obligations and virtues and to guide pharmacists in their relationship with patients, health professionals and society. PPhA - Code of Ethics for Pharmacists 1. A pharmacist places the well-being of the patient at the center of professional practice. 2. A pharmacist promotes the welfare of each individual in a caring and compassionate manner. 3. A pharmacist serves the needs of the individual, community and society and provides health for all. 4. A pharmacist respects the rights of patients and upholds confidentiality of patients’ records. 5. A pharmacist acts with honesty, integrity and professionalism in relationship with the patients and other health professionals. 6. A pharmacist respects the abilities, values and contributions of colleagues and other health professionals and work with them closely to ensure better patient care. 7. A pharmacist is committed to continuously enhance professional competence. 8. A pharmacist, in coordination with the government and other health professionals helps in the formulation and implementation of health care policies, standards and programs designed for the benefit of society Professional Organizations Philippine Pharmacy and International Pharmacy Philippine Pharmacists Organization (PPhA): PSHP (Philippine Society of Hospital Pharmacists) CPAP (Community Pharmacists Association of the) PACOP (Philippine Association of Colleges of Pharmacy) PAPPI (Philippine Association of Pharmacists in the Pharmaceutical Industry) IPAP (Industrial Pharmacists Association of the Philippines) PAPVI (Philippine Association of Pharmacists in the Veterinary Industry) DOHLP (Department of Health League of Pharmacists) YPG (Young Pharmacists Group) FJCPPhA (Federation of Junior Chapters of the Philippine Pharmacists Association) - NU