PHA-035-SAS-3.pdf

Course Code: PHA 035 (Perspectives in Pharmacy)...

Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ Lesson title: Republic Act 10918 and Laws affecting Pharmacy Materials: pen, SAS Practice in the Philippines Lesson Objective: Reference: At the end of the module, you should be able to: 1. Identify terms used in the Republic Act https://www.officialgazette. 2. Describe the regulation of pharmacy practice in the Philippines gov.ph/downloads/2016/07j 3. Identify other laws that affect Pharmacy Practice in the ul/20160721-RA-10918- BSA.pdf Philippines 4. Describe each law and its importance to Pharmacy Practice https://www.lawphil.net/stat utes/repacts/ra2016/ra_10 918_2016.html Productivity Tip: After finishing this module, explain quickly what you`ve learned to your parents or friend and share your reaction here. A. LESSON PREVIEW/REVIEW Introduction (2 mins) Law is the principles and regulations established in a community by some authority and applicable to its people, whether in the form of legislation or of custom and policies recognized and enforced by judicial decision. Republic Act 10918 is An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five Thousand Nine Hundred Twenty-One (R.A. No. 5921), Otherwise Known as the Pharmacy Law. Recognize the vital role of pharmacists in the delivery of quality healthcare services through the provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counselling, and health promotion. The pharmacists’ professional services shall, therefore, be promoted as an indispensable component of the total healthcare system to ensure the physical well-being of the Filipinos. Hence, the State shall develop and nurture competent, productive, morally upright, and well-rounded pharmacists whose standards of professional practice and service shall be excellent and globally competitive through regulatory measures, programs, and activities that promote and sustain their continuing professional development. 1  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ Activity 1: What I Know Chart, part 1 (5 mins) Instruction: in this chart reflect on what you know now. Do not worry if you are sure or not sure of your answers. This activity simply serves to get you started on thinking about our topic. Answer only the first column, “What I know”. Leave the third column “What I Learned” blank at this time. What I Know Questions: What I Learned (Activity 4) 1. Why we need to know the law governing pharmacy? 2. What is a generic name? What is the importance of using a generic name over a brand name? B.MAIN LESSON Activity 2: (13mins) Instruction: Please take note, highlight or outline some important and striking information about how pharmacy is being described and the differentiation of a drug and a medicine. Republic Act No. 10918 Section I. Title: This Act shall be known as “Philippine Pharmacy Act” Section 2. Statement of Policy The State recognizes the vital role of pharmacists in the delivery of quality health care services through the provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counselling, and health promotion. The pharmacists’ professional services shall, therefore, be promoted as an indispensable component of the total health care system to ensure the physical well-being of the Filipinos. Hence, the State shall develop and nurture competent, productive, morally upright, and well-rounded pharmacists whose standards of professional practice and service shall be excellent and globally 2  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ competitive through regulatory measures, programs, and activities that promote and sustain their continuing professional development. Please read, take note and highlight the following sections of the Republic Act 10918: ARTICLE I: a. section 1 – title b. section 2 – statement of policy c. section 3 – objectives d. section 4 – scope of the practice of pharmacy e. section 5 – definition of terms ARTICLE III: a. section 14 – qualifications for the licensure examination b. section 15 – scope of examination c. section 16 – holding of examination d. section 17 – ratings in the licensure examination e. section 19 – oath of profession ARTICLE III: a. section 30 – dispensing/sale of pharmaceutical products b. section 31 – pharmacist requirement c. section 33 – filling and partial filling of prescription d. section 34 – physician’s sample Laws affecting Pharmacy Practice in the Philippines A Republic Act is a piece of legislation used to create policy in order to carry out the principles of the Constitution. It is crafted and passed by the Congress of the Philippines and approved by the President of Philippines. The following Republic Acts are important in the regulation, monitoring, safeguarding the country and ensure the well-being of every Filipino. The following Republic Acts are in relation to RA 10918, the Philippine Pharmacy Act, regulates, protect, safeguard and promote the right to health of the people. 3  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ 1. RA 9165 This Act shall be known as the “Comprehensive Dangerous Drugs Act of 2002” to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the same against acts or omissions detrimental to their development and preservation. In view of the foregoing, the State needs to enhance further the efficacy of the law against dangerous drugs, it being one of today’s more serious social ills. The government shall however aim to achieve a balance in the national drug control program so that people with legitimate medical needs are not prevented from being treated with adequate amounts of appropriate medications, which include the use of dangerous drugs. Examples of dangerous drugs include, opium, morphine, heroin, cocaine or cocaine hydrochloride, marijuana resin or marijuana resin oil, methamphetamine hydrochloride or “shabu”, or other dangerous drugs such as, but not limited to, MDMA or “ecstasy”, paramethoxyamphetamine (PMA), trimethoxyamphetamine (TMA), lysergic acid diethylamide (LSD), gamma-hydroxybutyric acid (GHB) 2. RA 9257 This Act shall be known as the “Expanded Senior Citizens Act of 2003” An act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges. It is the duty of the family to take care of its elderly members while the State may design programs of social security for them. In addition, the State shall adopt an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health and other social services available to all the people at affordable cost. There shall be priority for the needs of the underprivileged, sick, elderly, disabled, women and children. Privileges for the Senior Citizens: (a) the grant of twenty percent (20%) discount from all establishments relative to the utilization of services in hotels and similar lodging establishments, restaurants and recreation centers, and purchase of medicines in all establishments for the exclusive use or enjoyment of senior citizens, including funeral and burial services for the death of senior citizens; (b) exemption from the payment of individual income taxes; Provided, That their annual taxable income does not exceed the poverty level as determined by the National Economic and Development Authority (NEDA) for that year; (c) exemption from training fees for socio-economic programs; 4  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ (d) free medical and dental services, diagnostic and laboratory fees such as, but not limited to, x-rays, computerized tomography scans and blood tests, in all government facilities, subject to the guidelines to be issued by the Department of Health in coordination with the Philippine Health Insurance Corporation (PHILHEALTH); (e) the grant of twenty percent (20%) discount on medical and dental services, and diagnostic and laboratory fees, including professional fees of attending doctors in all private hospitals and medical facilities, in accordance with the rules and regulations to be issued by the Department of Health, in coordination with the Philippine Health Insurance Corporation; (f) the grant of twenty percent (20%) discount in fare for domestic air and sea travel for the exclusive use or enjoyment of senior citizens; (g) the grant of twenty percent (20%) discount in public railways, skyways and bus fare for the exclusive use and enjoyment of senior citizens; (h) educational assistance to senior citizens to pursue post-secondary, tertiary, post tertiary, as well as vocational or technical education in both public and private schools through provision of scholarship, grants, financial aid, subsidies and other incentives to qualified senior citizens, including support for books, learning materials, and uniform allowance, to the extent feasible: Provided, That senior citizens shall meet minimum admission requirements; (i) to the extent practicable and feasible, the continuance of the same benefits and privileges given by the Government Service Insurance System (GSIS), Social Security System (SSS) and PAG-IBIG, as the case may be, as are enjoyed by those in actual service. (j) retirement benefits of retirees from both the government and private sector shall be regularly reviewed to ensure their continuing responsiveness and sustainability, and to the extent practicable and feasible, shall be upgraded to be at par with the current scale enjoyed by those in actual service. (k) to the extent possible, the government may grant special discounts in special programs for senior citizens on purchase of basic commodities, subject to the guidelines to be issued for the purpose by the Department of Trade and Industry (DTI) and the Department of Agriculture (DA); and (l) provision of express lanes for senior citizens in all commercial and government establishments; in the absence thereof, priority shall be given to them. 5  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ 3. RA 9502 This Act shall be known as the “Universally Accessible Cheaper and Quality Medicines Act of 2008”. The State to protect public health and, when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to promote and ensure access to affordable quality drugs and medicines for all. 4. RA 8203 This Act shall be known as the "Special Law on Counterfeit Drugs." It is the policy of the State to protect and promote the right to health of the people and instill health consciousness among them. It is also further declared the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs. Prohibited Acts: a) The manufacture, sale, offering for sale, donation, distribution, trafficking, brokering, exportation, or importation or possession of counterfeit drugs b) Possession of any such counterfeit drugs c) Forging, counterfeiting, simulating or falsely representing, or without proper authority, using any mark, stamp, tag, label or other identification mark or device. d) Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label or any part thereof, lawfully belonging to another person, for the purpose of using such label or a part thereof on any counterfeit drug: e) Making, selling, or concealing any punch, dye, plate or any other equipment or instrument designed to print, imprint or reproduce the trademark, trade name or other identifying mark of another registered producer or any likeness thereof, upon any drug product or device or its container or label without authority from the legitimate owners of the trademark or trade name. 5. RA 6675 This Act shall be known as the “Generics Act of 1988”. An act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names. Importance of this Act: a. To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs; b. To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients; 6  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ c. To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution; d. To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their therapeutic effectiveness; and e. To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions. 6. RA 3720 This Act shall be known as the "Food, Drug, and Cosmetic Act." is to ensure the safety and purity of foods, drugs, and cosmetics being made available to the public by creating the Food and Drug Administration which shall administer and enforce the laws pertaining thereto. Prohibited Acts: f. The manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded. g. The adulteration or misbranding of any food, drug, device, or cosmetic. h. The refusal to permit entry or inspection or to allow samples to be collected. i. The giving of a guaranty or undertaking which is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or undertaking referred to is false. j. Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other identification device authorized or required by regulations promulgated under the provisions of this Act. k. The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department or to the courts when relevant in any judicial proceeding under this Act. l. The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labelling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale and results in such article being adulterated or misbranded. 7. RA 11223 This Act shall be known as the Universal Health Care Act. An Act Instituting Universal Health Care for All Filipinos, Prescribing Reforms in the Health Care System, and Appropriating Funds Therefor. It is the policy of the State to protect and promote the right to health of all Filipinos and instill health consciousness among them. Towards this end, the State shall adopt: 7  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ (a) An integrated and comprehensive approach to ensure that all Filipinos are health literate, provided with healthy living conditions, and protected from hazards and risks that could affect their health; (b) A health care model that provides all Filipinos access to a comprehensive set of quality and cost- effective, promotive, preventive, curative, rehabilitative and palliative health services without causing financial hardship, and prioritizes the needs of the population who cannot afford such services; (c) A framework that fosters a whole-of-system, whole-of-government, and whole-of-society approach in the development, implementation, monitoring, and evaluation of health policies, programs and plans; and (d) A people-oriented approach for the delivery of health services that is centered on people’s needs and well-being, and cognizant of the differences in culture, values, and beliefs. PHILIPPINE PHARMACISTS ASSOCIATION, Inc. (PPhA) - The PPhA is an association that advances the nobility of pharmacy profession, ensuring its integrity of relevance. - was founded on 29 August 1920 and is the only Professional Regulation Commission (PRC) - accredited, integrated national organization of licensed Filipino pharmacists with 83 regional and local chapters, 10 affiliate organizations and about 15,000 individual members. - Its mission is to empower the Filipino pharmacist to be professionally competent and globally competitive for quality health care through: o Upholding and enhancing the nobility of the profession; o Advocating for the recognition of the pharmacist as an equal yet distinct partner among health care providers; o Actively participating in the formulation and Implementation of health care policies, standards and programs at the national and international levels; o Uniting the local chapters and affiliates and networking with local and international organizations; o Protecting the rights and promoting the well-being of its members; and o Providing opportunities for continuing professional growth and development of ots members. 10 affiliate Organizations under PPhA: 1. PAPPI. Philippine Association of Pharmacists in Pharmaceutical Industry 2. PSHP. Philippine Society of Hospital Pharmacists. 3. PACOP. Philippine Association of Colleges of Pharmacy. 4. DOHLP. Department of Heath - League of Pharmacists. 8  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ 5. CPAP. Community Pharmacists Association of the Philippines. 6. IPAP. Industrial Pharmacists Association of the Philippines, Inc. 7. FJC-PPhA. Federation of Junior Chapters PPhA 8. YPG. Young Pharmacists Group-Philippines 9. COSHWELL. Cosmetics, Health and Wellness Pharmacists Association, Inc. 10. PAPVI. Philippine Association of Pharmacists in the Veterinary Industry Activity 3: Skill-building Activities (15 mins + 2 mins checking) A. What are the 5 objectives of RA 10918? 1. 2. 3. 4. 5. B. Enumerate at least 10 subjects included in the Pharmacists Licensure Examination 1. 6. 2. 7. 3. 8. 4. 9. 5. 10. 9  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ C. Differentiate Category A and Category B establishments, and List all the establishments under Category A and Category B. CATEGORY A CATEGORY B 1. 1. 2. 2. 3. 3. 4. 4. 5. 5. 10  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ D. A patient came into your drugstore with a prescription from her doctor for a brand name medication and with a note. “Dispense as written” meaning you should not fill in the prescription with a generic. But you still told the patient about what a generic drug is and that there is a generic equivalent of the drug available. Questions: 1. Differentiate a generic name from a brand name ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ 2. Enumerate 5 importance of the Generics Act of 1988. ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ ____________________________________________________________________________________________________________ Activity 4: What I Know Chart, part 2 (4 mins) Instruction: To review your answers and what was learned from the session today. Please go back to activity 1 and answer the “what I learned” column of the chart. Notice and reflect on any changes in your answers. 11  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ Activity 5: Check for Understanding (6 mins) Instruction: Now it`s time for you to figure this one out on your own! Take time to read, analyse, and understand the following scenarios. I. Matching type: Match column A to column B. Write your answers on the space provided before the number. NO ERASURES ALLOWED. COLUMN A COLUMN B ____ 1. refer to drugs in their appropriate dosage forms a. Brand name with assured quality, safety and efficacy for b. OTC medicines humans and animals c. Generic name d. Dispensing ____ 2. refers to a display of written, printed or graphic e. Label matter on the immediate container f. Medicines g. Compounding ____ 3. refers to the process wherein a pharmacist provides h. Referral consultative services and conducts preliminary i. Prescription/ethical assessment of symptoms medicines ____ 4. refers to the proprietary name given by manufacturer to j. Cipher, code or secret key distinguish its product from other competitors ____ 5. a method of secret writing or use of characteristic style or symbol for the purpose of misleading the consumer ____ 6. the sum of processes performed by a pharmacist in drug preparation including calculations, mixing, packaging of a drug ____ 7. the sum of processes performed by a pharmacist from reading, validating, interpreting prescriptions in relation to the sale or transfer of pharmaceutical products ____ 8. the scientifically and internationally recognized name of the active ingredients as approved by the FDA. ____ 9. medicines used for symptomatic relief of minor ailments and which may be dispensed without a prescription ____ 10. medicines which can only be dispensed by a pharmacist to a patient upon the presentation of a valid prescription from a physician 12  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ B. TRUE or FALSE: Write the word TRUE is the statement is true and FALSE if the statement is false. NO ERASURES ALLOWED. ___________1. RA 9502 is an act known as the Universally Accessible Cheaper and Quality Medicines Act of 2008 which protect public health and to promote and ensure access to affordable quality drugs and medicines for all. ___________2. RA 3720 is an act to maximize the contribution of senior citizens to nation building, grant benefits and special privileges. ___________3. RA 9502 is an act to promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions. ___________4. RA 3720 is an act to ensure the safety and purity of foods, drugs, and cosmetics being made available to the public by creating the Food and Drug Administration. ___________5. A privileges for the senior citizens is the grant of thirty percent (30%) discount from all establishments relative to the utilization of services in hotels and similar lodging establishments and purchase of medicines in all establishments for the exclusive use or enjoyment of senior citizens. ___________6. RA 3720 is to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on their physical and mental well-being. ___________7. Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other identification device authorized or required by regulations promulgated under the provisions of RA 5921. ___________8. RA 8203 is the policy of the state to protect and promote the right to health of the people and instill health consciousness among them. ___________9. Examples of prohibited drugs include opium, morphine, heroin, cocaine or marijuana. ___________10. RA 6675 to encourage the extensive use of drugs with generic names through a rational system of procurement and distribution. 13  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ C. LESSON WRAP-UP Activity 6: Thinking about Learning (5 mins) A. Work Tracker: You are done with this session! Let’s track your progress. Shade the session number you just completed. SAS 1 2 3 4 5 6 7 8 9 10 B. Think About your Learning: Tell me about your thoughts on today`s topic. What surprised you about the lesson today? Please explain why. FAQs 1. Do generic drugs work the same way as brand name drugs? - Yes, generics are made to work the same way as brand name drugs. Below are similarities and differences of generic and brand name drugs. 14  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ 2. What does it mean when a product has a label of “no approved therapeutic claim”? - No approved therapeutic claim means that the product is not validated by the Food and Drug Administration (FDA) for safety and effectiveness as claimed before they are marketed. Because these products are supplements, these are not considered drugs, they are not put through the same strict safety and effectiveness requirements that drugs are. So all the drugs you can buy, even without a prescription, must be proven safe and effective – but dietary supplements do not. 3. How Food supplements differ from Health supplements and give examples for each. Food 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. Health supplements refers to any product that is used to maintain, enhance and improve the healthy function of the human body and contains one (1) or more or a combination of the following: (1) herbal fatty adds, enzymes, probiotics, and other bioactive substances; and (2) substances derived from natural sources, including animal, plant, mineral, and botanical materials in the form of extracts, isolates, concentrates, metabolites, synthetic sources of substances mentioned in (1) and (2). KEY TO CORRECTIONS: Activity 3 A: What are the 5 objectives of RA 10918? (a) Standardization and regulation of pharmacy education (b) Administration of licensure examination, registration, and licensing of pharmacists (c) Supervision, control, and regulation of the practice of pharmacy in the Philippines (d) Development and enhancement of professional competence of pharmacists through continuing professional development, research, and other related activities and (e) Integration of the pharmacy profession 15  Course Code: PHA 035 (Perspectives in Pharmacy) STUDENT ACTIVITY SHEET #3 Name: ___________________________________________________ Class number: _____ Section: ____________ Schedule: ____________________________ Date: ____________ B: Enumerate at least 10 subjects included in the Pharmacists Licensure Examination 1. Pharmacy Science and Practice 11. Inorganic Pharmaceutical Chemistry 2. Organic Pharmaceutical Chemistry 12. Qualitative and Quantitative Pharmaceutical Chemistry 3. Pharmacognosy and Plant Chemistry 13. Pharmaceutical Biochemistry 4. Microbiology and Parasitology 14. Physical Pharmacy 5. Biopharmaceutics 15. Pharmacology and Toxicology 6. Manufacturing 16. Quality Assurance and Instrumentation 7. Pharmaceutical Calculations 17. Drug Delivery Systems 8. Hospital Pharmacy 18. Clinical Pharmacy 9. Dispensing and Medication Counseling 19. Pharmaceutical Administration and Management 10. Public Health 20. Legal Pharmacy, and Ethics. C. Differentiate Category A and Category B establishments, and List all the establishments under Category A and Category B. 16