Jurisprudence-Review 2.pdf

Pharmaceutical Jurisprudence RA 8203 SPECIAL LAW ON SEPTEMBER 4, Nilita Sirikit Villanueva COUNTERFEIT DRUGS 1996 RA 9711 FOOD AND DRUG AUGUST 1...

Pharmaceutical Jurisprudence RA 8203 SPECIAL LAW ON SEPTEMBER 4, Nilita Sirikit Villanueva COUNTERFEIT DRUGS 1996 RA 9711 FOOD AND DRUG AUGUST 18, 2009* INTRODUCTION TO PHARMACEUTICAL ADMINISTRATION ACT JURISPRUDENCE AND ETHICS OF 2009 RA 7581 PRICE ACT MAY 27, 1992 JURISPRUDENCE A system of laws RA 7394 CONSUMERS ACT OF APRIL 13, 1992 Science of philosophy of laws THE PHILIPPINES RA 6425 DANGEROUS DRUG MARCH 30, 1972 ETHICS ACT OF 1972 Science of morality RA 9165 COMPREHENSIVE JANUARY 23, 2002 Moral principle of practice DANGEROUS DRUG ACT OF 2002 PHARMACEUTICAL JURISPRUDENCE RA 7432 SENIOR CITIZENS ACT APRIL 23, 1992 Legal and ethical control governing pharmacy profession RA 9257 EXPANDED SENIOR FEBRUARY 26, CITIZENS ACT OF 2003 2004 PHARMACY LAWS RA 9994 EXPANDED SENIOR FEBRUARY 15, Define and regulate the pharmacy profession CITIZENS ACT OF 2010 2010 and delimit its practice RA 6675 GENERICS ACT OF SEPTEMBER 13, 1988 1988 LAWS GOVERNING PHARMACY PROFESSION R.A. 5921 - Pharmacy Law RA 9502 UNIVERSALLY JUNE 6, 2008 ACCESSIBLE CHEAPER R.A. 10918 - The Philippine Pharmacy Act (the new AND QUALITY pharmacy law) MEDICINES ACT OF 2008 R.A. 3720 - Food, Drug, and Cosmetic Act R.A. 8203 - Special Law on Counterfeit Drugs RA 9184 GOVERNMENT JANUARY 10, 2003 R.A. 9711 - FDA Act of 2009 PROCUREMENT REFORM ACT R.A. 7581 - Price Act R.A. 7394 - Consumer Act of the Philippines RA 9211 TOBACCO JUNE 23, 2003 REGULATION ACT OF R.A. 6425 - Dangerous Drugs Act of 1972 (old) 2003 R.A. 9165 - Comprehensive Dangerous Drugs Act of 2002 RA 10354 RESPONSIBLE DECEMBER 21, PARENTHOOD AND 2012 R.A. 7432 - The Senior Citizens Act of 1992 REPRODUCTIVE R.A. 9257 - Expanded Senior Citizens Act of 2003 HEALTH BILL R.A. 9994 - Expanded Senior Citizens Act of 2010 R.A. 6675 - Generics Act of 1988 RA 10912 CONTINUING JULY 21, 2016 PROFESSIONAL R.A. 9502 - Universally Accessible, Cheaper, and DEVELOPMENT OF Quality Medicines Act of 2008 2016 R.A. 8423 - Traditional and Alternative Medicine Act RA 8432 TAMA DECEMBER 9, (TAMA) of 1997 (TRADITIONAL AND 1997 R.A 8981 - PRC Modernization Act of 2000 ALTERNATIVE MEDICINE ACT OF 1997) STATUTORY LAWS AFFECTING PHARMACY PROFESSION RA 8981 PRC MODERNIZATION DECEMBER 5, REPUBLIC TITLE DATE APPROVED ACT 2000 ACT RA 10611 FOOD SAFETY ACT OF AUGUST 23,2013 RA 5921 PHARMACY LAW JUNE 23, 1969 2013 RA 10918 THE PHILIPPINE JUNE 21, 2016 RA 8172 ASIN LAW, SALT W/ DECEMBER 20, PHARMACY ACT IODINE 1995 RA 3720 FOOD DRUG DEVICES June 22, 1963 EO 51 MILK CODE OF THE OCTOBER 28,1986 AND COSMETICS ACT PHILIPPINES R.A. 5921 - THE PHARMACY LAW laboratories, and hospital pharmacies for ‘An Act regulating the practice of pharmacy and purposes of pharmacy internship. setting standards of pharmaceutical education in the Philippines and for other purposes’. THE BOARD OF PHARMACY June 23, 1969 COMPOSITION: Chairman and 2 members Shall hold office for three years OBJECTIVES: Appointed by the President of the Philippines 1. Standardization and regulation of Chairman - most senior member pharmaceutical education. 2. Examination for registration of graduates of QUALIFICATIONS Schools of Pharmacy A natural born citizen of the Philippines 3. Supervision, control, and regulation of the A duly registered pharmacist and has been in practice of Pharmacy in the Philippines. the practice of pharmacy for at least 10 years. Of good moral character and recognized IMPLEMENTING AGENCIES standing in the pharmaceutical profession. Council of Pharmaceutical Education Not a faculty member of any school offering Board of Pharmacy (responsible for giving the courses in pharmacy. board exam) A member of good standing of any bonafide national pharmaceutical organization. THE COUNCIL OF PHARMACEUTICAL EDUCATION Composition: REMOVAL OF THE BOARD MEMBERS: Secretary of Education May be removed by the President of the - Vice President Sara Duterte Philippines if found guilty of: Undersecretary of Health ○ Neglect of duty, incompetence, - Dr.Rosario Vergeire malpractice or unprofessional, unethical, BOP, Chairman immoral, or dishonorable conduct. - Hon. Anthony Aldrin C. Santiago (new) Members: THE POWERS AND DUTIES OF THE BOARD - Hon. Adelina C. Royo (OIC) To examine applicants for the practice of - Hon. Mildred B. Oliveros Pharmacy. To issue certificates of registration of pharmacists; To reprimand any pharmacists or to suspend or revoke his certificate of registration (Sec. 13) To promulgate the rules and regulations. To study the conditions affecting the practice of pharmacy in the Philippines. PACOP, President To check the employment of qualified personnel - Ma. Fay Cariaga, Dean (Univ. of Makati) in drugstore, hospital pharmacies, laboratories BFAD, Director and similar establishments for which the board - Dr. Samu el Zacate may designate inspectors from the Board of UP COP, Dean Pharmacy. - Bienvenido Balotro (Dean of UP Manila) To encourage the development of botanical PPHA, President gardens and their inspection particularly the - Ma. Gilda Saljay propagation of the Philippine medicinal plants. FUNCTIONS GROUNDS FOR REPRIMAND, SUSPENSION OR 1. To promulgate rules and regulations relative to REVOCATION OF REGISTRATION OF CERTIFICATES pharmaceutical education in the Philippines; OF A PHARMACIST 2. To recognize and accredit colleges of pharmacy Conviction by a court by any violation. in the different private colleges and universities Immoral and dishonorable conduct. 3. To approve the accreditation of community Fraud or deceit in the acquisition of the pharmacies, pharmaceutical manufacturing certificate of registration.  Gross negligence, ignorance or incompetence in 8. A pharmacist, in coordination with the the practice of his profession resulting in injury, government and other health professionals, damage or death of another helps in the formulation and implementation of Malpractice, including aiding or abetting the health care policies, standards and programs commision of criminal abortion or sex crimes designed for the benefit of society. through illegal compounding, dispensing or sale of abortive or sex drugs. CANDIDACY FOR BOARD EXAMINATION Acting as a dummy of an alien or a person who He shall be a citizen of the Philippines (as is not qualified to establish and operate a retail amended by P.D. 1363 on May 2, 1978) drugstore He shall be of good moral character Addiction to alcoholic beverages or any habit He shall have completed an internship forming drug rendering him incompetent to program (old:960 hrs.)(new: 1200 hrs) practice his profession. ○ Prescription/Community pharmacy Insanity ○ Pharmaceutical laboratory False or extravagant or unethical (manufacturing) advertisements wherein other things such as his ○ Hospital pharmacy anime, profession, limitation of his practice and He shall have graduated with the degree BS the like are mentioned. Pharmacy or with an equivalent degree from a Violation of any of the provisions of the Code of school, college or university duly accredited by Ethics. the CPE, completing a standard pharmacy course of not less than 4 academic years (as CODE OF ETHICS FOR PHARMACISTS amended by P.D. 1926 on May 30, 1984) PREAMBLE Pharmacists are health professionals who help RATINGS REQUIRED TO PASS individuals protect themselves against diseases, Schedule of examination - twice a year during maintain good health and make the best use of their the month of January and July medications. The pharmacists promote rational use of A general average of 75 percent or over with no drugs and ensure the provision of safe, effective and rating below 50 percent in more than 2 quality drugs for improved patient care and quality of life. subjects This Code, prepared and supported by pharmacists, is intended to state publicly the principles that form the PREREQUISITE FOR THE PRACTICE OF fundamental basis of their roles and responsibilities PHARMACY which are based on moral obligations and virtues and to Is at least 21 years of age; guide pharmacists in their relationship with patients, Has satisfactory passed the corresponding health professionals and society. examination given by the board of pharmacy; 1. A pharmacist places the well being of the patient Is a holder of a valid certificate of registration at the center of professional practice. duly issued to him by the said board 2. A pharmacist promotes the welfare of each individual in a caring and compassionate PRACTICE OF PHARMACY manner. Prepare of manufacture, analyze, assay, 3. A pharmacist serves the needs of the individual, preserve, store, distributed, or sell any medicine, community and society and provides health for drug chemicals, cosmetics pharmaceuticals, all. devices or contrivances; 4. A pharmacist respects the rights of patients and Render pharmaceutical service in any office or upholds confidentiality of patients’ records. drug and cosmetic establishment where 5. A pharmacist acts with honesty, integrity and scientific, technological or professional professionalism in relationship with the patients knowledge of pharmacy is applied; and other health professionals. Engage in teaching scientific, technological or 6. A pharmacist respects the abilities, values and professional pharmacy subject in college of contributions of colleagues and other health pharmacy; professionals and work with them closely to Conduct or undertake scientific pharmaceutical ensure better patient care. research for biological and bacteriological 7. A pharmacist is committed to continuously testings and examinations. enhance professional competence.  ○ NOTE: REQUIREMENTS FOR THE OPENING AND Persons performing executive OPERATIONS OF DRUGSTORES AND PHARMACIES managerial or administrative “The minimum requirements necessary for the opening functions & their subordinate and operation of drugstores and pharmacies shall be in personnel employed in the accordance with the rules and regulations prescribed by pharmaceutical laboratories shall the BFAD. No application for the opening of a retail NOT be considered, for purposes of this drugstore shall be approved unless it is signed by a definition, persons in the practice of Filipino registered pharmacist, either as owner or as a pharmacy supervising pharmacist. (as amended by P.D. 1363 on May 2, 1976) Sale of Medicine, Pharmaceuticals, Drugs and Device RA 5921 Markings and Inhibition to the Sale of Drug VIOLATIONS Samples Sale of medicines outside of Hospital pharmacy Pharmacist Required and Compensation (HP) and drugstores (DS) Display of Certificate Required Sale of samples Responsibility for Safety, Efficacy, Quality and Operation without a pharmacist Purity of Drugs Fillings and Refilling of Prescription PENALTY Labels of dispensed Medicine Fine of not less than P1000 but not more than P4000, or Record Books for Prescription imprisonment of 6 months and 1 day not to exceed 4 Inhibition Against Use of Cipher or Unusual years depending on the discretion of the court. terms in Rx & Rx Switching Provision Relative to Dispensing of Violent VIOLATIONS Poisons - Operating without a certificate Provisions relative to Dispensing of Less Violent - Filling of Rx without pharmacist Poisons - Using cipher in dispensing Receptacle for Poisonous Drugs - Improper dispensing of abortive, poisonous Provisions Relative to Dispensing of compounds, etc. Anti-Conceptional Substances & Devices - Continuing to practice even if the license is Provisions Relative to Dispensing of Potent already suspended. Drugs PENALTY VIOLENT POISONS: Not less than P100 but not more than P500 or Arsenical preparations, phosphorus, corrosive sublimate, imprisonment of 30 days but not more than 4 months. atropine, strychnine, or any of their salts, hydrocyanic acid or prussic acid, oil of mirbane (nitrobenzene) REVIEW QUESTIONS 1. RA 5921 was signed into law on: POISON BOOK: 5 years a. June 23, 1969 Date of each sale b. June 23, 1963 The name and address of the purchaser c. June 22, 1969 The name & quantity of poison sold d. June 22, 1963 The purpose of the purchase 2. RA 5921 provides for and shall govern: a. Standard’n & regulation of pharm ABORTIVES & ANTI-CONCEPTIONAL SUBSTANCES education OR DEVICES b. Examination for registration of Number and date of the Rx graduates of school of pharmacy Number and address of physician c. Supervision, control & regulation of the Name, quantity, and manufacturer of the drug practice of pharmacy in the Phil. Name and address of purchaser d. A and C only Date of filling the Rx e. AOTA Signature of pharmacist filling the Rx 3. For the purpose of implementing RA 5921 these c. Secret Keys were created: d. Any of the above a. Board of Pharmacy 12. Record for the sale of poisons must be kept for b. Council of Pharm’l Education a. 5 years c. PRC b. 1 year d. A & B only c. 3 years e. AOTA d. 2 years 4. For how many years shall the chairman & members of the board hold office? R.A. 5921 a. 3 PHARMACY LAW b. 4 An act regulating the practice of pharmacy and c. 5 setting standards of pharmaceutical education in d. 6 the Philippines and of other purposes 5. To be appointed member of the Board has been Consist of FOUR Articles: in the practice of Pharmacy for: I. Objective and Implementation a. 5 II. The council of Pharmaceutical b. 7 Education c. 8 III. The Board of Pharmacy and d. 10 Examination and Registration of 6. Any of the ff. Shall be a ground for reprimanding, Pharmacist suspending, or revolving the certificate of IV. Practice of Pharmacy registration: a. Immoral or dishonorable conduct RA 10918: PHILIPPINE PHARMACY ACT b. Fraud or deceit in the acquisition of cert NEW PHARMACY LAW c. Insanity AN ACT REGULATING AND MODERNIZING d. A & B only THE PRACTICE OF PHARMACY IN THE e. AOTA PHILIPPINES , REPEALING FOR THE 7. This is a requirement for the opening of d/s. PURPOSE REPUBLIC ACT NUMBERED FIVE a. Filipino registered pharmacist THOUSAND NINE HUNDRED TWENTY-ONE b. 7x5 drugstore space (R.A. NO. 5921), OTHERWISE KNOWN AS c. Drugstore label THE PHARMACY LAW d. Record books Consist of EIGHT articles: 8. Age requirement in order to practice pharmacy ○ General Provisions a. 18 ○ The professional regulatory Board of b. 25 Pharmacy c. 21 ○ Examination, Registration, Certifications d. 20 and Licensure 9. This is a proof that a person is a license ○ Regulation of Practice of Pharmacy pharmacist ○ Accredited integrated national a. Transcript of Record organization of Pharmacist b. Diploma ○ Violations, Administrative sanctions and c. Cert. of registration Procedures d. Certificate of Internship ○ Penal Provisions 10. To encourage the development of a botanical ○ Final Provisions garden is one function of: a. Board of pharmacy Note: For complete notes of this topic, kindly check the b. BFAD ppt “NEW PHARMACY LAW” uploaded. c. Council of pharmaceutical education d. AOTA 11. Method of secret writing which substitutes other letters or transposes the letter after arranging them in blocks a. Cipher b. Code  ○ To affect the structure or any function of RA 3720 the body of man or animals FOODS, DRUGS, DEVICES & COSMETICS ACT “An act to ensure the safety and purity of foods ADULTERATED FOOD and cosmetics, and the purity, safety, efficacy A food shall be deemed to be adulterated if: and quality of drugs and devices being made If it bears or contains any poisonous or available to the public, vesting the BFAD with deleterious substances: authority to administer and enforce the laws ○ May render it injurious to health pertaining thereto, and for other purposes.” ○ Other than one w/c is a pesticides June 22, 1963 - approved chemical in or on a raw agricultural E.O. 175 (May 22, 1987) - amendment commodity & with an established E.O. 851, Sec. 4 (December 2, 1982) - The tolerance Food and Drug Administration was abolished ○ In the container used - may affect the and created the BFAD. contents RA 9711 - Renamed BFAD to FDA If it has been prepared, packed, or held under unsanitary conditions “BUREAU” means the Bureau of Food & Drugs ○ May have been contaminated “SECRETARY” means the Secretary of Health ○ May have been injurious to health “DEPARTMENT” means the Department of If any substance or valuable constituents has Health been: “DIRECTOR” means Director of the BFAD ○ Omitted or abstracted “PERSON” includes individual, partnership, ○ Replaced or substituted by any corporation and association substance injurious to health “FOOD” means ○ Added or mixed or packed so as to ○ Articles used for food or drinks for man increase its bulk, or weight, or reduce its ○ Chewing gum quality or strength, or make it appear ○ Articles used for components of such better or greater value article If it bears or contains a coal-tar color other than “DRUG” means one which is permissible under existing ○ Articles recognized in the current official regulations USP-NF, official Homeopathic Drug Note: Any poisonous or deleterious substance added to Formulary, or any supplement to any of any food shall be deemed to be unsafe except when them such substance is required or cannot be avoided in its ○ Articles intended for use in the diagnosis production or manufacture. cure, mitigation, treatment, or prevention If it is a confectionery, and it bears or contains of disease in man or other animal any ○ Articles (other than food) intended to If it is an oleomargarine or margarine or butter affect the structure or any function of the and any of the raw material body of man or animals Unifit for food if in whole or in part consists of “COSMETICS” means any filthy, putrid or decomposed substance. ○ Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced MISBRANDED FOOD into, or otherwise applied to the human If its labeling is false or misleading body or any part thereof for cleansing, If it is offered for sale under the name of another beautifying, promoting attractiveness, or food altering the appearance If it is an imitation of another food ○ Articles intended for use as a ○ NOTE: Unless its labels bears in type of component of any such articles uniform size and prominence the word “DEVICE” means instrument, apparatus, or “IMITATION” and immediately thereafter contrivances, including their components, parts the name of the food imitated and accessories, intended: If its container is so made, formed, or filled as to ○ For use in the diagnosis, cure, be misleading mitigation, treatment or prevention of If it purports to be or is presented special dietary disease in man or animals uses  ○ Unless its label bears such information concerning its vitamins, minerals and *Adulterated - more on the components/ quality other dietary properties in order to fully *Misbranded - more on labelling inform purchasers as to its value for such uses. Factory Inspection If it bears or contains any artificial flavoring Officers or employed duly designated by the coloring, or chemical preservatives, unless it secretary, upon appropriate credentials to the bears labeling stating that fact. owner, operator, or agent in charge, are authorized: ADULTERATED DRUGS AND DEVICES ○ To inspect, in a reasonable manner, A drug or device shall be deemed to be adulterated: such factory, warehouse, establishment, If it consists in whole or in part of any filthy, or or vehicle and all pertinent equipment, decomposed substance: finished or unfinished materials, ○ May affect its safety, efficacy, or good containers, and labeling therein quality If it has been prepared, manufactured or held CERTIFICATE OF DRUGS CONTAINING under unsanitary conditions: ANTIBIOTICS ○ May have been contaminated with filth Antibiotic Drug - means any drugs intended for use by or dirt man containing any quantity of any chemical substance ○ May have been injurious to health which is produced by microorganism in dilute solution If its container is compared, in whole or in part, (including the chemically synthesized equivalent of any of any poisonous or deleterious substance: such substance) ○ May render the contents injurious to The Secretary shall provide for the certification health of batches of drugs composed wholly or partially If it is a drug and it bears or contains, for the of any kind of antibiotic purpose of coloring only, any color other than a Must meet or conform with the applicable permissible one taking into consideration standards of identity, strength, quality and purity standards of safety, efficacy or good quality. If the drug which is recognized in the official PROHIBITED ACTS compendium: The sale or offering for sale any drug or device If its strength differs from standards of, safety, beyond its expiration or expiry date efficacy, quality, or purity The release for sale or distribution of a batch of If it is a drug or device and any substance has drugs without batch certification been mixed or packed or has been substituted The manufacture, importation, exportation, sale wholly or in part offering for sale, distribution, or transfer of any ○ May reduce its safety, efficacy, quality, drug or device: strength or purity ○ Which is not registered If in the manufacture of drugs does not conform ○ Which is considered adulterated or with the CGMP standards misbranded ○ Without the license form the Bureau ADULTERATED COSMETICS ○ The refusal to permit entry or inspection A cosmetics shall be deemed to be adulterated: or to allow samples to be collected. If it bears or contains any poisonous or The adulteration or misbranding of any food, deleterious substance drug, device, or cosmetic ○ may render it injurious to users Forging, counterfeiting, stimulation, or falsely If it contains in whole or in part of any filthy, representing or without proper authority using putrid, or decomposed substance any mark, stamp, tag, label, or other If has been prepared, packed, or held under identification device unsanitary conditions The alteration, mutilation, destruction, ○ May have been contaminated with filth obliteration, or removal of the whole or any part ○ May have been injurious to health of the label of a food, drug, device or cosmetic, if If it is not a hair dye and it bears or contains a such article is held for sale. coal-tar color other than one which is The using by any person to his own advantage permissible or revealing, other than to the Secretary of  officers & employees of the Department any Laboratory Services Division information concerning any method or process Physico-Chemical Section which is a trade secret entitled to protection Microbiology Section Toxicology Section RA 3720 Research Section VIOLATIONS: Experimental Animal Section Provisions on Misbranded drugs and devices Legal, Information & Compliance Division Legal, Research and Investigation Section PENALTIES: Public Assistance, Information & Compliance Imprisonment of not less than 1 year and one Section day but not more than 5 years or a fine of Advertising & Promotion Section P5,000 and not more than P10,000 or both Administration Division imprisonment and fine Planning & Budget Section No person will be subject to penalties for having Personnel Section sold, offered for sale of the drugs were both in Cash, Collection and Disbursement Section good faith, unless he refers to furnish BFAD with Accounting Section information relating to the acquisition of the said Supply & Properly Section drug. Records & Communication Section Building & Facilities Maintenance Section ORGANIZATION OF THE BFAD Office of the Director The minimum mandatory information that shall be Director included in the labeling materials are: Drug Information Unit Labeling Requirements Regulation Division I Name of the product Inspection & Licensing Section Dosage form and strength Retail drugstores Pharmacologic category Hospital Pharmacies Rx symbol Retail outlets for non-Rx drugs Name and complete address of trader & Drug department manufacturer ○ General wholesale Net contents ○ Distributor/importer/exporter of finished Indication (s) products Formation Retailer of household hazardous substances C/I Precautions (s), Warnings (s) Mode of administration/Direction for use Regulation Division II Batch and lot number Inspection and Licensing Section Expiry date & date of manufacturer Drug manufacturer Registration number Drug assay laboratory Storage Conditions Drug producer (For Rx product) Foods, Drugs, Devices & Drug department Cosmetics Act prohibits dispensing w/o ○ importer/exporter in bulk prescription ○ distributor/importer/exporter/which at the same time a manufacturer or producer REVIEW QUESTIONS Food and food products manufacturer/processor 1. The division of BFAD which is in charge in the Cosmetic manufacturer inspection and licensing of the manufacturer of Household hazardous substance manufacturer food, drug, and cosmetics a. Regulation Division I Product Services Division b. Legal Division Food Product Section c. Product Service Div Drug & Medical Device Product Section d. Regulation Division II Cosmetic Product Section 2. Which Exec. Order abolished the Food & Drug Household Hazardous Substance Section Adm. a. EO 137 b. EO 851  c. EO 951 11. Any person who commits the following shall be d. EO 147 penalize for 6mon-5 yrs imprisonment & fine > 3. RA 3720 was signed into law on 1000 a. June 22, 1963 a. Sale of any dug beyond its expiration b. June 22, 1969 date c. June 23, 1969 b. Distribution of bathes of drugs w/o batch d. July 22, 1969 cert. 4. A food shall be deemed to be adulterated if: c. Forging, counterfeiting w/o proper a. Prepared, packed, held under authority unsanitary condition d. A & C only b. Damage or inferiority, concealed in any e. AOTA manner 12. In order to manufacture, sell, distribute any drug, c. Offered for sale under the name of a license to operate should be first secure from: another food a. BFAD d. A & B only b. DTI e. AOTA c. PRC 5. If the food is an imitation of another food: d. Dep of Commerce a. Fake b. Misbranded RA 8203 c. Misleading Special Law on Counterfeit Drugs d. Adulterated “An act prohibiting counterfeit drugs, providing 6. Drugs are considered adulterated if: penalties for violations and appropriating funds a. Label is misleading therefore” b. An imitation of a product Sept. 4, 1996 c. Differs from USP Std. d. NOTA Counterfeit Drug /Medicines refers to: 7. RA 3720 was amended by EO Medicinal products with the correct ingredients a. 881 but not in amount as provided b. 851 Wrong ingredients c. 175 Without active ingredients d. 170 With insufficient quantity of active ingredient 8. The Division of BFAD that certifies batches of Reduction of drugs “QEPSS” antibiotics: Deliberately & fraudulently mislabeled a. Product Services With fake packaging b. Laboratory Services Drug product refilled in containers by c. Legal Info & Compliance unauthorized persons if legitimate labels or d. Inspection Services Adulterated drug - reduction or loss of efficacy 9. Among the prohibited act under RA 3720 are: due to expiration a. Manufacture for sale, distribute declared as banned 4S: b. Adulteration or misbranding of any food, Segregate drug Seal c. Manufacture, sale, distribution of any Search warrant drug not registered with BFAD Seize d. B and C only e. AOTA MONITORING OF COUNTERFEIT DRUG 10. Shall provide for the certificate of batches of The said inspection shall be w/o prior notice drugs composed wholly or partially any kind of FDRO - inventory, segregate, seal, collect antibiotics samples for examination a. Secretary of health Owner - sales invoice, delivery receipts or b. PRC commissioner documents c. BFAD Director FDRO - submit to either LSD or PSD d. BFAD Administrator ADMINISTRATIVE SANCTIONS 2. Drug Trader Permanent closure of the establishment - Registered owner of the drug product concerned & revocation of its LTO - Procures the raw materials & packing A fine of NLT P 100,000 but NMT P500,000 components Forfeit, confiscation & destruction of products - Engage in distribution &/or marketing and/or equipment found to be counterfeit - sub-contractor Filling of an appropriate proceeding against the 3. Drug Distributor registered pharmacist involve at the PRC for - DD/ Importer cancellation of license - DD/ Exporter Permanent disqualification of the person - DD/ Wholesaler concerned from owning or opening an establishment Renewal of LTO Initial Period (Initial Application) - 1 year MINIMUM PENALTY Subsequent Period (Renewal Application) - 2 An administrative fine of NLT P100,000 but years NMT P500,000 MEDIUM PENALTY Grounds for non-renewal of LTO An administrative fine of establishment Failure to comply or rampant violation of existing Permanent closure of establishment laws, rules, and regulations Revocation of LTO Failure to assures the safety, efficacy & quality MAXIMUM PENALTY of its drug products An administrative fine of NLT P300,000 but NMT P500,000 ADMINISTRATIVE SANCTIONS Permanent closure establishment Grounds for Revocation of LTO Revocation of LTO Misrepresentation of any material fact For manufacturer’s & traders - any deficiency The following penalty shall be imposed: in GMP MINIMUM PENALTY ○ Lack of key technical & professional When the counterfeit drug products are not personnel life-saving drugs ○ Lack of key equipment in production or When the volume of the said products is worth QC more than P100,000 ○ Poor or inadequate or improper When the number of drug product involved is documentation of the production NMT 3 brands or generic products process MEDIUM PENALTY For distributors - distribution of: When the counterfeit drug products are not ○ Fake or counterfeit drugs life-saving drugs ○ Misbranded or adulterated When the volume of the said product is worth ○ Unsafe drug products more than P100,000 but not exceeding 1 Violations of BFAD standards of “QEPS” of drug million pesos products When the number of drug product involved is Sale or distribution of antibiotic products w/o more than 3 brands or generic products batch certification Failure to take adequate remedial or corrective MAXIMUM PENALTY measures for deficiencies identified When the counterfeit drug products are Failure to keep up-to-date, secure, orderly & life-saving regardless of the volume inspected record for compliance When the volume of the said product is worth more than 1,000,000 GROUNDS FOR SUSPENSION OF LTO Minor deficiencies in GMP: DRUG ESTABLISHMENT Poor housekeeping TYPES Inadequate storage facilities 1. Drug Manufacturer Lack of minor equipment - Engaged in operations Lack of minor requirements Other minor shortcomings Lapses in record-keeping of: A full-time validity registered pharmacist Invoices physically peasant while drugstore is open Receipts of distribution records business Invoices indicating the lot number or batch REAPPLICATION AFTER REVOCATION number of the manufacturer’s stock “No establishment whose LTO has been revoked may File or prescriptions filled, consequently apply for an LTO within 5 years after revocation of its numbered license” Dry seal or rubber stamp containing the name and address of drug outlet DRUG OUTLETS Red and white labels indicating the name and TYPES: address of the drugstore 1. Drugstore, Pharmacy or Botica, Hospital Pharmacy, Dispensary ADMINISTRATIVE SANCTIONS - Where registered drug, chemical Temporary Closure: products, active principles, proprietary Absence of pharmacist on three inspections by medicines, galenical, or veterinary BFAD inspector preparations are compounded and/or Suspension of LTO: dispensed. Failure to produce invoices and receipts 2. Retail outlet non-Rx drugs including together with lot no., expiry dates for the drugs non-traditional outlets such as supermarkets and in stock store Failure to properly record & keep a file of all Rx - Where registered non-Rx or OTC drugs filled in the last 2 years are sold in their original packages, bottle Refusal to allow entry of BFAD inspectors or containers or in small quantities not in their original containers Revocation of LTO: Sale or offer for sale of drugs that are: SPECIFIC REQUIREMENTS FOR OPENING A ○ Adulterated & misbranded DRUGSTORE ○ Substandard & unregistered Signboard in front of the place of business ○ Expired and unsafe bearing the registered name of the drugstore ○ Marked “not for sale” Well-ventilated for compounding prescription Failure to properly record dangerous drugs A suitable and proper place for the adequate Failure to take necessary remedial or corrective storage of the drugs and biological products measures within the prescribed period A suitable cabinet and adequate water supply Reference Books and documents REVIEW QUESTIONS: Philippine National Drug Formulary 1. Counterfeit drugs refer to medicinal products United States Pharmacopeia a. Recognized in USP/NF National Formulary b. Article intended for use in the diagnosis, RA 3720, RA 6675, RA 5921, RA 8203 cure, treatment or disease ,iRemington’s pharmaceutical sciences c. W/O active ingr w/c results in Goodman and Gilman pharmacological reduction of drug safety, efficacy, basis of therapeutics quality or strength Records books duly registered with d. A and C only BFAD e. AOTA Prescription book 2. RA 8203 was signed into law on: Dangerous prescription book a. Sept 4, 1996 Exempt preparation book b. Sept 14, 1988 Poison book c. Oct 4 1996 d. Sept 4, 1992 Record book for selected no-prescription drugs 3. Counterfeit drug may contain less than how subject to abuse as determined by BFAD or many % of the active ingredient DDB a. 80% b. 75% c. 60%  d. 85% R.A. 7581 4. Parties liable under RA 8203 PRICE ACT a. Pharmacist “An act providing protection to consumers by stabilizing b. Inspector the prices of basic necessities and prime commodities c. Manufacturer and by prescribing measures against undue price d. A and C only increase during emergency situations and like 5. Co involved in manufacture, distribution of drugs occasions.” a. Drug establishment b. Drug outlet Basic Necessities Includes: c. Drug manufacture Rice; corn; bread; dried and canned fish and d. Drug trader other marine products; fresh pork; beef and 6. Administrative sanctions for any violation of RA poultry meat; fresh vegetables; root crops; 8203 coffee; sugar; cooking oil; salt; laundry soap; a. Fine NLT 100,000 pesos & NMT detergents;firewood;charcoal;candles; & drugs 500,000 pesos classified as essential by the DOH b. Permanent closure of establishment & revocation of license to do business “Prime commodities” include: c. Confiscation & destruction of counterfeit fresh fruits; flour; dried processed and canned products pork; beef and poultry meat; dairy products not d. A and C only falling under basic necessities; noodles; onions; e. AOTA garlic; vinegar; patis; soy sauce; toilet soap; 7. Drugs as defined in RA 8203, refers to: fertilizer; pesticides; herbicides; poultry; swine a. Any article recognized in the official and cattle feeds; veterinary products for poultry, USP/NF swine and cattle; paper; school supplies; nipa b. Any article use in diagnosis, cure, shingles; sawali; cement; clinker; GI sheets; treatment or prevention of disease in hollow blocks; plywood; plyboard; construction man nails; batteries; electrical supplies; light bulbs; c. Herbal or traditional drugs used in folk steel wire; and all drugs not classified as medicine essential drugs by the Department of Health d. A and B only e. AOTA Implementing Agency 8. Upon finding that the drugs are counterfeit, the DOA- Department of Agriculture professional license of reg. Pharmacist will be: DENR- Department of Environment and Natural a. Revoke Resources b. Suspend DOH- Department of Health c. Cancel DTI- Department of Trade and Industry d. A and B 9. Commission of act prohibited in RA 8203, “Buffer fund” punished by a contingent fund in the budget of the a. Imprisonment of NLT 6 months & 1 day implementing agency which shall not be used in but NMT 1 year its normal or regular operations but only for b. Imprisonment of 6 years & 1 day but purposes provided under RA 7581 NMT 10 years c. Fine of NLT 100,000 pesos but NMT “Panic-buying” 500,000 is the abnormal phenomenon where d. B and C only consumers buy basic necessities and prime e. AOTA commodities grossly in excess of their normal requirement resulting in undue shortages of such goods to the prejudice of less privileged consumers  MANDATED PRICE CEILING AUTOMATIC PRICE CONTROL The impendency, existence, or effects of a Disaster area or under state of calamity calamity; State of emergency The threat, existence, or effect of an emergency; Suspension of the privilege of the writ of habeas The prevalence or widespread acts of illegal corpus price manipulation: State of Rebellion The impendency, existence, or effect of any State of War event that causes artificial and unreasonable State of Martial Law increase in the price of the basic necessity or prime commodity; and ILLEGAL ACTS OF PRICE MANIPULATION Whenever the prevailing price of any basic Hoarding necessity or prime commodity has risen to ○ undue accumulation by a person or unreasonable levels. combination of persons of any basic commodity beyond his or their normal DETERMINATION OF PRICE CEILINGS inventory levels or the unreasonable Supply available in the market limitation or refusal to dispose of, Average price in the last 3 months sell, or distribute the stocks of any Cost to the producer, distributor or seller basic necessity or prime commodity to the general public. PESO EXCHANGE RATE ○ PRIMA FACIE EVIDENCE CHANGE IN AMORTIZATION COST Has 50% stocks higher than CHANGE IN THE COST OF LABOR usual inventory INCREASE IN THE COST OF LABOR Refuses to sell to the general public PRICE COORDINATING COUNCIL Profiteering The Secretary of Trade and Industry, as ○ Selling of basic necessity or prime Chairman; commodity at a price grossly in The Secretary of Agriculture; excess of its true worth. The Secretary of Health; ○ PRIMA FACIE EVIDENCE The Secretary of Environment and Natural Has no price tag Resources; Misinterpreted as to its weight & The Secretary of Local Government; measure The Secretary of Transportation and Adulterate or diluted Communications; Raises the price by more than The Secretary of Justice; 10% The Director General of the National Economic Cartel and Development Authority (NEDA); ○ agreement between two (2) or more One (1) representative from the consumers’ persons unreasonably increase or sector; manipulate its price One (1) representative from the agricultural producers’ sector; ○ PRIMA FACIE EVIDENCE One (1) representative from the trading sector; 2 or more persons or business and enterprise competing for the One (1) representative from the manufacturers’ same market sector. Dealing in the same basic/prime commodity PRICE ACTION OFFICER Perform uniform complimentary Any member of the Price Coordinating Council acts Appointed by the President NATIONAL STATISTICS OFFICE Conduct independent periodic survey Studies the selling prices of basic & prime commodities.  b. Fine for NLT Php 5,000 and NMT 1 PENALTIES million ACTS OF ILLEGAL PRICE MANIPULATION c. Imprisonment for NLT 5 years and Imprisonment for 5 to 15 years NMT 15 years Fine of 5 thousand to 2 million d. Fine of NLT Php 500,000 and NMT 15 VIOLATION FOR PRICE CEILING years Imprisonment for 1 to 10 years 5. FF conditions may impose a price ceiling except: Fine of 5 thousand to 1 million a. Existence of calamity b. Existence of an emergency LAWS AND LETTER OF INSTRUCTIONS c. Widespread illegal price manipulation Republic Act No. 4164 d. NOTA “An act to Prevent the excessive increase in the 6. Factors in determining reasonable price ceiling: price of certain prime necessities of life on the a. Supply available in the market occasion of a public calamity, penalizing the b. Peso exchange rate violation thereof, and for the other purposes.” c. Change in the authorization cost Presidential Decree No. 1674 d. AOTA “Providing a mechanism for price regulation , creating a price stabilization council, prescribing R.A. 7394 its power and responsibilities and for other CONSUMER ACT OF THE PHILIPPINES purposes.” It is the policy of the state to protect the interest Letter Of Instruction No. 1305 of the consumer, promote his general welfare “Directing Measures to prevent cement and to establish standards of conduct for hoarding, price manipulation and profiteering.” business and industry. Letter Of Instruction No. 1342 Approved: April 13, 1992 “Ordering immediate measures to prevent price manipulation and to protect consumers;” 12 Areas of Concern in CGMP Letter Of Instruction No. 1359 1. Building “Directing measures to prevent hoarding, 2. Equipment profiteering and price manipulation.” 3. Personnel 4. Components (raw materials) REVIEW QUESTIONS: 5. Master formula & batch production records 1. Directing measures to prevent hoarding, 6. Production and control procedures profiteering and price manipulation 7. Product containers a. Letter of Instruction 1305 8. Packaging & labeling b. Letter of Instruction 1342 9. Laboratory controls c. Letter of Instruction 1359 10. Finished-goods warehouse control and d. Letter of Instruction 1349 distribution 2. A prevailing price be placed under automatic 11. Stability price control except: 12. Complaint files a. State of calamity b. Declared under an emergency R.A. 7432 c. Declare in a state of rebellion SENIOR CITIZENS ACT d. Privilege of the writ of habeas corpus “An act to maximize the contribution of senior e. NOTA citizens to nation building, grant benefits, and 3. Appoints the Sectoral representative of the Price special privileges and for other purposes” Coordinating Council: April 23, 1992 a. Secretary of Trade & Industry SENIOR CITIZEN - shall mean any resident b. President of the Philippines citizen of the Philippines at least 60 years old, c. Secretary of DA including those who have retired from both d. Secretary of DENR government & private enterprises, and has an 4. Penalty for acts of illegal price manipulation income of not more than P60,000 per subject to a. Imprisonment for 1 year and NMT 10 review by the NEDA every 3 years. years R.A. 9257 When the drug are for chronic condition requiring EXPANDED SENIOR CITIZENS ACT OF 2003 continuous use for more than a month, such as but not An act granting additional benefits and privileges limited to: to senior citizens, further amending Republic Act Anti-hypertensive No. 7432, as amended, otherwise known as “an Anti- diabetic act to maximize the contribution of senior Anti- parkinsonism citizens to nation building, grant benefits and Anti- arthritis special privileges and for other purposes” Anti-tb Approved: February 26, 2004 anti-neoplastic anti-psychotic hormonal drugs; SENIOR CITIZEN or ELDERLY For prolonged use and dietary supplements, a maximum Any resident citizen of the Philippines at least 60 of one month supply may be dispensed at a time years old The following should be recorded in a special record BENEFACTOR book for senior citizens discount provided under 7432: any person whether related to the senior citizens 1. Name and address or not who takes care of him/her as a dependent 2. National ID number of senior citizen 3. Generic name of the drug/medicine HEAD of the FAMILY 4. Number of units dispensed Any person so defined in the National Internal Revenue Code, as amended For partial filling: The drugstore pharmacist will indicate the GERIATRICS quantity partially filled in the special record book branch of medical science devoted to the study and the unfilled balance in the prescription. of the biological physical changes and the diseases of old age PRESCRIPTION A prescription is an order for medication issued by a SENIOR CITIZENS physician, dentist, veterinarian or other properly licensed What to ask the doctor/ pharmacist to avail of the 20% practitioner discount in the purchase of medicine for your personal Parts of Prescription: use and according to his personal needs. 1. Heading What are the requirements to purchase the 2. Patient’s information medicine and avail the 20% discount? 3. Date Present the National Identification Card and his 4. Superscription - Rx symbol purchase slip booklet duly approved by the 5. Inscription - medication prescribed OSCA chairman. 6. Subscription - direction to the pharmacist Doctor’s prescription pad should have the 7. Transcription - direction to the patient following information: 8. Special labeling and other instructions 1. Patient name, age, address, and date 9. Prescriber’s signature 2. Generic name of the medicine PRACTICES TO BE OBSERVED TO AVOID prescribed DISPENSING ERRORS 3. Name and address of the doctor, his 1. One should have adequate knowledge about PTR number and S2 license drugs to avoid dispensing errors. 2. Careful examination of prescription. Read For those who cannot afford the consultation accurately what is written on the prescription. fee of a private doctor: 3. Read the label of the bottle/container twice or Consult at their nearest Health Center or thrice and should not rely on the familiarity of its Government Hospital and get a prescription free location. of charge 4. Always label the products to be dispensed for proper identification. Any single dispensing should not be more 5. Allow other pharmacy assistants or pharmacists than one-week supply to recheck your work.  6. Do not hesitate to ask the help of the 9. Which of the ff should be presented by senior citizen: pharmacist-in charge in case there is any doubt a. Purchase slip booklet about the prescription b. Prescription c. Birth certificate REVIEW QUESTIONS: d. National ID CARD 1. RA 7432 was signed into law on: e. A, B, & D a. April 23, 1992 b. February 7, 1992 10. Violation of any provision of senior citizen act is c. February 13, 1992 punishable by: d. April 13, 1992 a. Fine not exceeding 2,000 pesos 2. The Expanded Senior Citizens Act of 2003 is also b. Imprisonment not exceeding 1 mon & fine known as: not exceeding 1,000 pesos a. RA 9265 c. Imprisonment not exceeding 2 months b. RA 9165 d. Both A and C c. RA 9275 d. RA 9257 RA 7432 3. The term “ senior citizen” shall mean any resident Seniors Citizens Act citizen at least ___ years old: An act to maximize the contribution of Senior Citizens to a. 50 nation building; grant benefits and special privileges and b. 55 for other purposes. c. 60 d. 65 Declaration of policies: To motivate and encourage the senior citizens to 4. The government agency w/c issues National ID card contribute to nation building and purchase slip booklet: To encourage families and communities they lie a. DSWD w/ to reaffirm the valued Filipino tradition of b. GSIS caring for the senior citizens. c. OSCA d. BFAD Objectives: Establish mechanisms where contributions of 5. The discount privileges of the senior citizen shall be: Senior Citizens are maximized a. Non transferable Adopt measures where senior citizens are b. Transferable but limited for senior citizen assisted by the community c. Limited and exclusive for senior citizen Establish programs beneficial to senior citizens. d. Both A and C Definition of Terms: - Benefactor 6.Any person maybe a relative or not who takes care of - Head of the Family senior citizen as dependent: - Senior Citizen a. Head of the family b. Relative Senior Citizen: c. Benefactor Any resident citizen of the Philippines d. Caregiver 60 years of age Retired from both government and private 7.Supplies of medicine to be given should not exceed: enterprise a. One day supply Income of not more than sixty thousand pesos b. One week supply per annum. c. One month supply Contribution to the Community d. One year supply Tutorial or Consultancy services Actual teaching and demonstration of hobbies 8. OSCA refers to: and income generating skills a. Office of senior citizen affiliate Lecture on Specialized field b. Office of senior citizen affairs Transfer of New skills c. Office of senior citizen’s academy Undertake other appropriate services d. NOTA Privilege for Senior Citizens BFAD Circular No. 123 S. 1994 20% discount from all establishment Amending Memo Circular No. 4 1994 20% discount on admission fees for culture, Compliance w/ the IRR of the SC Act leisure and amusement Purchase of medicines requirements Exemption from payment of individual taxes Dispensing of Medicines Exemption from training fees for socio-economic ○ Single dispensing programs ○ Chronic conditions Free medical and dental services in Govt Required Records Establishment ○ special Continuance of the same benefits & Privileges Partial Filling given by GSIS, SSS and PAG IBIG Special Discount Prices GOVERNMENT ASSISTANCE APPROVED BY: Treated as dependents Ramon V. Mitra Establish homes, residential communities Neptali Gonzales retirement villages Corazon Aquino RETIREMENT BENEFITS APRIL 23, 1992 From both private and government sectors shall be upgraded to be at PAR w/ the current scale enjoyed by DIFFERENCE & ADDITIONAL PROVISIONS those in actual service COMPARISON OSCA AKA “Office for Senior Citizens Affair” Establish in the office of the mayor Headed by a counselor Designated by the Sanggunian Bayan Assisted by the Community Development Officer In coordination w/ the DSWD Functions: Plan, Implement & monitor yearly work programs Draw up list of available & required services Maintain list of senior citizen and issue uniform national id cards Serve as general Information and liaison officer PENALTIES Imprisonment not exceeding 1 month Fine not exceeding P1000 Guidelines on the Issuance of ID Enlist at the Office of Senior Citizens Affair OSCA determines eligibility of senior citizen OSCA prepares list o SC to be certified by local BIR and local civil registrar Duplicate copy of certified list be submitted to DSWD field office DSWD field office shall release to ID to local OSCA OSCA shall issue ID cards to qualified senior citizens OSCA shall issue ID cards w/out cost to senior citizens  2. Any person who takes care of SC as a dependent: a. Head of the family b. Benefactor c. Beneficiary d. Protector 3. The discount privileges of the SC shall be: a. Transferable but limited use only for the SC. b. Non transferable c. Limited and exclusive for the benefit of SC d. B and C only e. NOTA 4. Who provides the National ID of SC a. DSWD field office b. OSCA c. FDA d. DOH 5. Gov’t agency who issues National ID card of SC: a. DSWD b. OSCA c. FDA d. DOH 6. The SC shall be entitled the grant of _____ discounts for consumption of electricity, water and telephone by SC center & residential care homes: a. 20% b. 50% c. 10% d. 5% 7. The SC shall be entitled the grant of _ discount from all establishments. a. 20% b. 50% c. 10% d. 5% 8. The violation of any provision of SC act is punishable by: a. A fine not exceeding Php 2000 b. Imprisonment of NLT 6 mon but NMT 2 yrs for the 1st offense c. Imprisonment not exceeding 2 months d. A fine of Php 5,000 not exceeding 2 months 1. Determining the eligibility of the Senior Citizen: a. DSWD b. OSCA c. Office of the Mayor d. Community Dev’t Officer GENERIC ACT OF 1988 (RA 6675) 3. The generic name of the drug ordered must “An act to promote, require, and ensure the production of be clearly written on the prescription adequate supply, distribution, use and acceptance of immediately after the Rx symbol, or on the drugs identified by their generic name” SEPTEMBER 13, order chart 1988 3.1 In addition to the generic name, a brand name may also be indicated. In such cases, the Generic Name following shall be observed: - is a simpler term for the scientifically 3.1.1 If written on a prescription pad, the recognized active ingredient of a drug brand name enclosed in parentheses shall be written below the generic name Brand Name 3.1.2 If written on a px’s chart, the brand - proprietary name given by the name enclosed in parentheses shall be written manufacturer to distinguish its after the generic name production from those of competitors 4. Only one drug shall be prescribed on one Essential Drug List/National Drug Formulary prescription form - Is a list of alternative drugs prepared & periodically updated by DOH on the basis of health conditions obtained in the Philippines, as well as on internationally accepted criteria. - Consist of a core list and a complementary list Core List - A list of drugs that meet the health care needs of the population Complementary List - A list of alternative drugs used when there is no response to the core essential drug, when there is hypersensitivity reaction or if it cannot be given. Generic Drugs - Drugs not covered by patent protection and which are labeled solely by their INN or generic name Additional Guidelines on Prescribing to Implement the Generics Act of 1988 1. Generic Names shall be used in all prescriptions 1.1 For drugs with a single active ing., the generic name of that active ing. shall be used in prescribing 1.2 From drugs with two or more active ing. the generic name as determined by BFAD shall be used in prescribing 2. The generic name must be written in full but the salt or chemical form may be abbreviated  Partial filling of prescription - means dispensing less than the total number of units prescribed. GUIDELINES ON DISPENSING TO IMPLEMENT THE GENERICS ACT OF 1988 I. All drug outlets are required to practice generic dispensing. II. Dispensing: products not in their original containers: Small bottles; tin cans; boxes; plastic or paper envelopes information required on drug outlet’s labels: Name of the patient Generic name of the drug Brand name, if any Manufacturer Dosage Strength Expiry Date Directions for use Name of the Pharmacist III. In partial filling of the Rx: GUIDELINES ON WHAT TO DO WITH VIOLATIVE, Information required to be written on the Rx: ERRONEOUS, IMPOSSIBLE PRESCRIPTIONS 1. Date of partial filling 2. Quantity served & balance of the Rx I. VIOLATIVE AND IMPOSSIBLE Rx 3. Name & address of the drugstore - Shall not be filled - Shall be kept & reported by the pharmacist to Additional Requirements: the nearest DOH office 1. The prescriber must have an S-2 license - Pharmacist shall advice the prescriber of the 2. The special DDB problem 3. A recording system following pertinent DDB - Instruct the customer to get proper Rx regulation must be covered II. ERRONEOUS Rx IV. In dispensing drugs in List A and List B: Shall be filled 1. Dispensing must be done by the pharmacist Shall be kept & reported to the nearest DOH office 2. Follow the order & instructions of the doctor on the Rx A.O. No. 63 s. 1989 3. Partial filling of Rx for drugs in List A: RULES AND REGULATIONS TO IMPLEMENT 3.1 Rx must be retained by the pharmacist DISPENSING, REQUIREMENTS UNDER THE 3.2 The patient must asked the prescriber for GENERIC ACT OF 1988 (R.A. 6675) another Rx to complete the total dose of the medication Dispensing - is the act by validly registered Pharmacist 4. After the Rx is filled the original copy of the Rx of filling a prescription or doctor’s order on the patient’s shall be retained & kept for a period of 1 year by chart the pharmacist for inspection. Generic Dispensing- means dispensing the patient’/ buyers’ choice among the generic equivalents, i.e finished pharmaceutical products having the same active ingredient(s) same dosage form and same strength as the prescribed drug. ADDITIONAL GUIDELINES ON DISPENSING TO PENALTIES: IMPLEMENT THE GENERIC ACT OF 1988 Fine of Php 5,000 to Php 10,000 and or suspension or DRUGSTORES, BOTICAS, AND OTHER DRUG revocation of license to operate such business OUTLETS establishment. Inorder to ensure the informed choice and use of drugs by the patient/buyer, the outlets are required to: Officers responsible for the violation shall suffer a - Inform the patient/buyer of all the available drug penalty of fine and suspension or revocation of license to products generically equivalent to the one practice and if applicable, imprisonment of not less than prescribed with their corresponding prices 6 months but not to exceed 1 year or both penalty and - Shall not favor or suggest any particular product fine. so that the patient/buyer may fully and adequately exercise his option to choose. REVIEW QUESTIONS (RA 6675) - Post in a conspicuous place in their 1. R.A. 6675 was signed into law on: establishment a list of drug products using a. Sept. 23, 1998 generic names with their corresponding brand b. Sept. 13, 1988 names, if any, and their corresponding current c. Sept. 4, 1988 prices d. Sept. 30, 1988 - Provide a handbook or directory containing the 2. When the drug product prescribed is not above-required information readily accessible to registered w/ BFAD, this is a case of: the patient/buyer. a. Violative Rx b. Impossible Rx VIOLATIONS ON THE PART OF THE DISPENSERS c. Erroneous Rx AND OUTLETS d. Coded Rx 1. Imposing a particular brand or product on the 3. If the brand name precedes the generic na,e, buyer the Rx 2. Inaccurate dispensing a. Violative 3. Failure to post or make accessible the required b. Impossible up-to-date information on the drug product c. Erroneous 4. Failure to adequately inform buyer on available d. Coded product that meet the Rx 4. Under the generics law, w/c of this Rx shall be 5. Failure to indicate the generic name/ official filled? name designated by the BFAD & other required a. Violative information on the drug outlet’s label of thr b. Impossible dispensing drug c. Erroneous 6. Failure to record and keep Rx filled d. NOTA 7. Failure to report to the nearest DOH office 5. Rules and regulations to implement dispensing incorrect Rx within 3 months after receipts odf requirement under the Generics Act of 1988: such Rx a. AO 63 b. AO 64 PENALTIES FOR VIOLATING THE RULES & c. AO 65 REGULATIONS OF THE GUIDELINES ON GENERIC d. AO 66 DISPENSING 6. The ff. Are the violations on the part of - Suspensions or revocation of the LTO of th drug dispensers and outlet outlet by the Secretary of Health a. Failure to record and keep Rx filled - Professional directly involved in the violation b. Imposing a particular brand or product shall be recommended by the Secretary for c. Failure to report to the nearest DOH appropriate administrative sanctions by the PRC office d. Both A and B R.A 6675 e. AOTA 7. Generic prescribing is also known as: VIOLATIONS: a. AO 61 Provisions related to the Practice of Pharmacy b. AO 62 c. AO 63 d. AO 64  8. What is to be done with violative prescription: ARTICLE a. Shall be filled and kept UNLAWFUL ACTS AND PENALTIES b. Not be filled and report to nearest DOH c. Shall be mark w/ red ink d. Torn 9. Which of the ff. Is an erroneous Rx. a. Generic name is not legible and brand name is legible b. Brand name is not in parenthesis c. Only generic name is written but not legible d. AOTA 10. Corelist means: a. List of drugs that meet health care needs b. List of drugs that meet the requirements established by pharmaceutical assn c. List of drugs with corresponding brand names d. AOTA R.A 9165 “COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002” An act instituting the Comprehensive Dangerous Drugs Act of 2002, repealing republic act no.6425, otherwise known as the dangerous drugs act of 1972, as amended, providing funds therefor, and for other purposes. DANGEROUS DRUG BOARD COMPOSITION: 17 members (3 of which are permanent members) 12 members in ex-officio capacity (2 shall be regular members) SECTION 4: IMPORTATION OF DANGEROUS DRUGS PERMANENT CONSULTANTS &/ OR CONTROLLED PRECURSORS & ESSENTIAL Director of the NBI CHEMICALS Chief of the PNP PENALTY: PHILIPPINE DRUG ENFORCEMENT AGENCY (PDEA) DANGEROUS DRUGS: Implementing arm of the Board - Life imprisonment to death and a fine ranging Shall be headed by a Director General (with the from Php 500,000 to Php 10M (regardless of rank of Undersecretary quantity and purity) including any and all species Shall be appointed by the President of the of opium, poppy or any part/substance even for Philippines floral,decorative and culinary use. Created on July 30, 2002 CONTROLLED PRECURSORS AND ESSENTIAL