Pharmacology

1.

ACTIVITY 1 Orientation, Organizational Set-Up and Policies MEMBERS OF STAFF or PHARMACY PERSONNEL of MERCURY DRUGSTORE The qualifications in applying to Mercury Drug must be at least a college graduate depending on what position he/she is applying for, but except for Pharmacist which must be a graduate of Bachelor of Science in Pharmacy and must be a board passer and has a license, must be 21yrs old and above, can be married or single, has experience in working under pressure, and has a pleasing personality.  District Manager: Sherwin Trinidad -The district manager ensures the monitoring of every branch that he/she handles in his district. Branch Manager: Gelin P. Cayago -The branch manager handles the whole branch and monitors properly every situation that happens in his/her branch. Assistant Branch Manager (ABM): Shirley Cabinto Robert Auditor Joan Marie Celeste Michelle Pengla Gladys Mae Galera -The assistant branch managers are the one who looks after the branch, when the branch manager is not around, they are the ones who sends and files the reporting. They also handle the auditing of money in the branch. Pharmacist: Marjorie C. Palaganas Winnielyn C. Cardenas Madonna Q. Magno Marian M. Dayasen Gina P. Kibad -The Pharmacist is the one who checks the prescriptions and ensure that the drugs that are dispense are correct. They also monitor their stocks through an inventory. Stock Analyst: Shirley Garcia -The stock analyst is the one who also do the reporting and the one who returns the stocks that are about to expire. He/she ensure that the no drug must be dispensed from their expiration date. General Clerk: Aiza Alban -The general clerk types and finished some of the reports that are needed to be send in their head office. Cashier: Haydie Quirion Rose Basa Juliet Nicolas Myra Campos -The cashier ensures that every change and receipt must be correct. Pharmacist Assistant: Geoffrey Gonzales Shierra Mae Mandapat Roderick Jose Catherine Mauri Diana Rose Dulatre Jovelyn Cabangon Joel Paragas Joffrey Viray -The pharmacist assistant is the one who take the orders from the customers and gets the drug to be punched.

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ORGANIZATIONAL SET_UP OF THE PHARMACY through FLOW CHART

District Manager

Branch Manager

Assistant Branch Manager

Branch Pharmacist

Stock Analyst

General Clerk

Staff Reliever

Cashiers

Pharmacist Assistants

Utility

3.

MERCURY DRUGSTORE’S POLICIES We were instructed that the company policies of Mercury Porta Vaga should be for private use only. We decided to enumerate the company policies that most of us interns know.  Bags are not allowed inside the drugstore  Should always know the lines of authorities  Always wear your complete uniform and nameplate  Employees must always be on time  Before starting for work, money must be log in and be check by the assistant branch manager or the manager itself.  Before starting for work, gadgets such as cellphones, tablets, etc. must be surrender.  When going to the comfort room employees or even interns must sign in their log book.  All employees have at least 1 day off a week.  Every 7am and 7pm employees must do their opening and closing prayer  Every 3pm employees must do the Oratio  Before leaving the drugstore’s premises, employees must have a body search first. Comments: 1. We think that their company policies are effectively being abide by their employees. 2. We also think that they should have a duplicate key for their restroom, since it has always been a problem inside that the key of the restroom is missing.

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Following information from Mercury drugstore: a. Name of Establishment : Northern Luzon Drug Corporation (Mercury Drug) b. Address: Porta Vaga Mall, Session Road, Baguio City c. Date if Established: June 2004 d. Name of Manager/ or Proprietor: Gelin P. Cayago e. Name of Pharmacist/s: 1. Marjorie C.Palaganas  License Number :0058321 -Date Issued: August 3, 2010 -Date of Expiry: May 24, 2013  PTR Number:1337749 -Date Issued: January 7, 2013 2. Winnielyn C. Cardenas  License Number :0058330 -Date Issued: August 3, 2010 -Date of Expiry: January 23, 2013  PTR Number:1337143 -Date Issued: January 4, 2013 Marian Dayasen  License Number :0060619 -Date Issued: July 18, 2012 -Date of Expiry: March 19, 2015  PTR Number:1336471 -Date Issued: January 4, 2013

3.

ACTIVITY 2 Pharmacy Law (RA 5921) 1. Provisions of the Pharmacy Law (RA 5921) (a) Objectives (Art. I, Sec. 1) This act provides for and shall govern (a) the standardization and regulation of pharmaceutical education; (b) the examination for registration of graduates of school of pharmacy and (c) the supervision, control and regulation of the practice of pharmacy in the Philippines. (b) Practice of Pharmacy (Art. IV) SECTION 23. Definition of practice of pharmacy. - A person shall be deemed to be practicing pharmacy within the meaning of this Article, who shall, for a fee, salary, percentage or other reward paid or giv en directly to himself or indirectly through another, prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drug chemicals, cosmetics, pharmaceuticals, devices or contrivances; or render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional knowledge of pharmacy is applied; or engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or conduct or undertake scientific pharmaceutical research for biological and bacteriological testings and examinations. However, persons performing executive manager or administrative functions and their subordinate personnel employed in the pharmaceutical laboratories shall not be considered for purposes of this definition. SECTION 24. Prerequisite for the practice of pharmacy.- No person shall engage in the practice of pharmacy unless he is at least twenty-one years of age, has satisfactorily passed the examination given by the Board of Pharmacy, and is a holder of a valid certificate of registration duly issued by said Board. SECTION 25. Sales of medicine, pharmaceuticals, drugs, devices. - No medicine, pharmaceutical or drug whatever nature and kind or device shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public except through a prescription drug store or hospital pharmacy. Pharmaceutical, drug or biological manufacturing establishments, importers & wholesalers of drugs medicines, or biological products are authorized to sell their products only at wholesale to duly established retail drugstore or hospital pharmacies. SECTION 26. Markings and inhibition to the sale of drug samples.- No sample of any drug, biologic product, proprietary medicine, given or intended to be given for free to the physician and other qualified person by any manufacturer or distributor or its representative or detailman as part of its program of promotion, may be sold. SECTION 27. Pharmacist required & compensation. - Every pharmacy, drugstore or hospital pharmacy whether owned by the government or a private person or firm shall at all times when open for business be under the personal

and immediate supervision of a registered pharmacist: Provided, that no pharmacist shall have personal supervision of more than one such establishment. In case where a drug establishment operates in more than one shift, each shift must be under the supervision and control of a registered pharmacist. Drug or pharmaceutical laboratories engaged in the repacking, manufacture or sale drugs, biologic products and pharmaceutical products of quantities greatly in excess of the therapeutic doses of such substance, such processes involving the preparation, quality control or repacking of said products shall for each respective operation be under the direct and immediate supervision of a registered pharmacist, or, in the sale of pharmaceuticals, medicines and drugs, at wholesale, such business shall be conducted under the immediate supervision of a registered pharmacist practicing only in such establishment. Every pharmacist employed as such in any of the establishment whose capitalization is not less than ten thousand pesos shall receive notwithstanding any provision of law contrary, a minimum of similar to that of government pharmacists. SECTION 28. Display of certificate required. - It shall be the duty of every pharmacist engaged in the practice of pharmacy either on his own account or under the employ of another to display his certificate of registration in a prominent and conspicuous place in pharmacy, drugstore, hospital pharmacy or drug establishment which he operates or in which he is employed. No pharmacist shall with his knowledge allow his certificate of registration to be displayed in such establishments when he is not actually employed or operating therein in his professional capacity. SECTION 29. Responsibility for quality of drugs. - In case of drugs, pharmaceuticals or poisons sold in their original packings, the seal of which has not been broken or tampered with, the liability that may arise because of their quality and purity, rests upon the manufacturer or in his absence, upon the importer, the distributor, representative or dealer who was responsible for their distribution or sale. It shall be unlawful for any person to manufacture, prepare, sell or administer any prescription, drug, pharmaceutical or poison under any fraudulent name, direction or pretense or to adulterate any drug, pharmaceutical, medicine or poison so used, sold or offered for sale. Any drug, pharmaceutical, medicine or poison shall be held to be adulterated or deteriorated within the meaning of this section if it differs from the standard or quality or purity given in the United States Pharmacopoeaia or National Formulary, both in their latest edition, or, in lieu thereof, in any standard reference for drugs and medicines given official recognition; and those which fall within the meaning as provided for in the Food, Drug and Cosmetic Act (R.A.3720) SECTION 30. Filling and refilling of prescription. - No prescription shall be filled or compounded except by a registered pharmacist. It shall be incumbent upon the pharmacist so compounding or filling the prescription to see to it that every component of the prescription called for meets the standard of purity and quality given in the standard references. Student undergoing pharmaceutical internship may assist said pharmacist in the compounding & dispensing of the prescription called for. No prescription shall be refilled except upon express order of the person prescribing. SECTION 31. Label of dispensed medicine. - Upon every box, bottle or package containing medicine sold or dispensed by a pharmacist based on prescription, there shall be pasted, affixed or imprinted a seal or label bearing, the name of the prescriber, date and the number of prescription; and direction for use. Every prescription which in its preparation, contains any quantity of a drug which is habitforming, or a derivative of such drug, shall have in the label attached to the container added statement, "Warning- may be habit forming." Every prescription for external use filled in the drugstore shall bear a red label showing in black ink the components for s uch prescription and the words "For external use only " at the bottom of the label. SECTION 32. Record books of prescription.- All prescriptions dispensed shall be recorded in the books kept for the purpose indicating the name of the manufacturer, the original stock, lot and control numbers of the main ingredients of the prescriptions, which book shall be open to inspection by the proper authorities at any of the day when the pharmacy is open to the public and must be preserved for a period of not less than two years after the last entry in it has been made. All prescription shall be attached to said book for prescriptions and numbered consecutively and shall be preserved for the same length of time as the prescription book. SECTION 33. Inhibition against use of cipher or unusual terms in prescription and prescription switching. - No pharmacist shall compound or dispense, prescriptions, recipes, or formulas which are written in ciphers, codes or secret keys or in which there are employed unusual name of drugs which differ from the names ordinarily used for such drugs in standard pharmacopoeia as or formularies. No pharmacist dispensing or compounding prescription shall substitute the drug or drugs called for in the prescription with any other drug or substance or ingredient without prior consultation with, and with a written consent of the person prescribing. SECTION 34. Provisions relative to dispensing of violent poisons. - Every pharmacist who dispenses, sells or otherwise delivers any of the violent poisons intended for medicinal use, to wit: Arsenical preparations, phosphorus, corrosive sublimate, atropine, strychnine, or any of their salts, hydrocyanic acid or prussic acid, oil mirbane (nitrobenzene), and such other poisonous substances which may from time to time be classified under this category by the Food and Drug Administration, shall do so only upon prescription of a duly licensed physician, dentist or veterinarian. He shall make or cause to be made in the separate book, kept for the purpose, an entry stating the date of each sale and the name and address of the purchaser, the name and quantity of the poison sold and the purpose for which it was claimed to be purchased, before delivering it to the purchase.

No prescription, the prescribed dose of which contains a dangerous quantity of poison, shall be filled without first consulting the prescribing authority and verifying the prescription. The pharmacist before delivery of such poison to the purchaser shall acquaint the latter of its poisonous character. The pharmacist shall also affix to every box, bottle or other package containing any dangerous or poisonous drug, another label of red paper upon which shall be printed in large letter the word "Poison" and a vignette representing a skull and bones before delivering it to the purchaser. No poison specified in this section shall be sold or otherwise delivered to any person less than eighteen years of age or who is mentally deranged or under the influence of liquor or one who is apparently addicted to opiates and other habitforming drugs. The books kept for the purpose of recording the sale of poisons shall be open at all times to the inspection of the proper authorities, and every such book shall be preserved for at least five years after the last entry in it has been made. Should any of the poisons above-stated be intended for purposes other than medicinal, the same may be sold without a prescription by the pharmacist but the other requirements of this section must be complied with. SECTION 35. Provisions relative to dispensing of less violent poisons. Every pharmacist who dispenses, sell or delivers any poison which is less violent in category as classified by the Food and Drug Administration may do so even without the prescription of a physician & its sale may be recorded in the poison book. The other requirements as provided for in Section thirty-four hereof, however, shall be complied with. SECTION 36. Receptacle for poisonous drugs. – The poisonous drugs specified in Section thirty-four and thirty-five hereof shall be kept in a cabinet to be provided in every pharmacy carrying such drugs in stock and the same shall be kept in a cabinet to be provided in every pharmacy carrying such drugs in stock and the shall be kept securely locked when not in use. SECTION 37. Provisions relative to dispensing of anti-conceptional substances and devices. No drug or chemical product or device capable of provoking abortion or preventing conception as classified by the Food and Drug Administration shall be delivered or sold to any person without a proper description by a duly licensed physician. The pharmacist in charge of a drugstore or pharmacy after filling a prescription containing abortive or anticonceptional substances or devices shall record in a separate register book for abortives and anti-conceptionals the following data. a. Number and date of prescription; b. Name and address of the physician; c. Name, quantity and manufacture of the drug; d. Name and address of the purchaser; e. Date of filling the prescri ption; and f. Signature of the pharmacist filling the prescription SECTION 38. Provisions relative to dispensing of potent drugs.- Every pharmacist who dispenses, sells or delivers any drug which falls under the classification of the Food and Drug Administration as potent drugs shall do so only upon prescription of a duly licensed physician, dentist or veterinarian. SECTION 39.- Requirements for the opening & operations of drugstores and pharmacies. – The minimum requirements necessary for the opening and operation of drugstores and pharmacies shall be in accordance with the rules and regulations to be prescribed by the Food and Drug Administration in accordance with the provisions of this Act. Only natural born-Filipino citizens who are registered pharmacists can apply for the opening of a retail drugstore. SECTION 40. Penal provisions. Any person who shall violate any provisions of Section twelve, twenty-four, twentyfive, twenty-six, twenty-seven and twenty-nine, of this Act or any person who shall make false representation to procure a registration certificate as pharmacist for himself of for another; or any person shall allow anyone to his employ who is not a registered pharmacist to engage in the practice of pharmacy; or any person who shall freely display within the establishment the certificate of registration of a pharmacist who is not actually and regularly employed therein as such or to act as a dummy for an alien or an unqualified person for the purpose of opening and operating a retail drugstore; shall upon conviction thereof, be sentenced to a fine of not less than one thousand pesos but not exceeding four thousand pesos or to an imprisonment of not less than six months and one day but not more than four years, in the discretion of the court. SECTION 41 Other penalties..– Any pharmacist who shall violate any of the provisions of Sections twenty-eight, thirty-one, thirty-three, thirty-four, thirty-seven, and thirty-eight of this Act or any pharmacist, after his certificate of registration has been lawfully suspended or revoked, who continues to engage in the practice of pharmacy, pended or revoked, who continues to engage in the practice of pharmacy, shall upon conviction thereof, be sentenced to a fine of not less than thirty days but not more than four months, in the discretion of the court. Any person other than the citizens of the Philippines having been found guilty of any violation as provided for in this and the preceding section shall after having paid the fine or having served his sentence or both when so required be also subject to deportation. SECTION 42. Definition of terms. - For purposes of this Act, the term a "Pharmacy" or "Drug Store" means a place of establishment where drugs, chemical products, active principles of drugs, pharmaceuticals, proprietary medicines or pharmaceutical specialties, devices, and poisons are sold at retail and where medical, dental and veterinary prescriptions are compounded and dispensed. b. "Drug or Pharmaceutical Laboratory" or "Pharmaceutical Manufacturing Laboratory" means an establishment where pharmaceuticals, propriety medicines or pharmaceutical specialties are prepared, compounded, standardized and distributed or sold. c. "Wholesaler" means and includes every person who acts as merchant, broker or agent, who sells or distributes for resale pharmaceuticals, propriety medicines or pharmaceutical specialties.

e. "Drug" means (1) article recognized in the official United States Pharmacopoeia or the United States Official National Formulary, or any of their supplements; (2) articles intended for use in the diagnosis, cure, mitigation, treatmen t, or prevention of disease in man or animals; (3) articles (other than food) intended to affect the structure or function of the body of man or animals; and articles intended for use as a component of any articles specified in clauses (1), (2) or (3), but do not include devices or their components, parts or accessories. f. "Pharmaceuticals", "Proprietary Medicines" or "Pharmaceutical Specialties" means any drug, preparation or mixture of drugs marked under a trade name and intended for the cure, mitigation, treatment, or prevention of disease in man or animals. g. "Device" means instrument, apparatus, or contrivances including their components, parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or (2) to affect the structure or any function of the body in man or animals. h. "Biological Products" are viruses, sera, toxins and analogous products used for the prevention or cure of human diseases. i. "Poison" is any drug, active principle or preparation of the same, capable of destroying life or seriously endangering health when applied externally to the body or introduced internally in moderate doses. j. "Cipher" means a method of secret writing that substitutes other letters or characters for the letter intended or transposes the letter after arranging them in blocks or squares. k. "Code" means a system of words or other systems arbitrarily used to represent words. l. "Secret Keys" means characteristics styles or symbols kept from the knowledge of others or disclosed confidentially to but one or few. SECTION 43. Final Provisions. – To carry out the provisions of this Act, there is hereby authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, the sum of thirty thousand pesos within the fiscal year of the approval hereof. Thereafter, such funds as are necessary for the maintenance and operation of the Board of Pharmacy and of the Council of Pharmaceutical Education shall be include in the annual General Appropriation Act. SECTION 44. Repealing Clause. – the following are hereby repealed: Selections Seven hundred seventeen to seven hundred fifty-seven inclusive, Selections two thousand six hundred seventy-five to two thousand six hundred seventyseven inclusive the Revised Administrative Code, as amended: and such other laws or part of law, executive orders, circulars, regulations and memoranda inconsistent or incompatible with this Act. SECTION 45. Separability of provisions. If any part, section or provisions of this Act shall be held invalid or unconstitutional, no other part, section or provision thereof shall be affected thereby. SECTION 46. Effectivity. – This Act shall take effect upon its approval. (c) Registration of Pharmacists (Art. III, Sec. 13 and 18-20) SECTION 13. Grounds for reprimand, suspension or revocation of registration certificate.- Any of the following shall be sufficient ground for reprimanding s pharmacist, or for suspending or revoking his certificate of registration: a. Conviction by a court of competent jurisdiction of any violation as penalized in sections 40-41; b. Immoral or dishonorable conduct which includes conviction by a competent court of any criminal offense involving moral turpitude; c. Fraud or deceit in the acquisition of the certificate of registration; d. Gross negligence, ignorance or incompetence in the practice of this profession resulting in the injury, damage or death of another; e. Malpractice, including aiding or abetting the commission of criminal abortion or sex crimes through illegal compounding, dispensing or sale of abortive or sex drugs; f. Acting as a dummy of an alien or a person who is not qualified to establish and operate a retail drugstore; g. Addiction to alcoholic beverage or to any habit- forming drug rendering him incompetent to practice his profession; h. Insanity; i. False or extravagant or unethical advertisements wherein other things than his name, profession, limitation of practice, office and same address and the like are mentioned; and j. Violations of any provision of the Code of Ethics which may be adopted as part of the Rules and Regulations of the Board. SECTION 18. Candidate for board examination.- qualifications: a. He shall be a natural-born citizen of the Philippines. b. He shall be of good moral character; c. He shall have completed an Internship Program which shall be spent equally distributed in a prescription pharmacy, a pharmaceutical manufacturing laboratory and a hospital pharmacy duly accredited by the Council of Pharmacy, the rest of the hours of internship shall be spent in any or all the said establishments at the choice of the candidate. For this purpose, the above-mentioned prescription pharmacy, pharmaceutical manufacturing laboratory and hospital pharmacy shall keep a separate record of pharmacy students who have undergone said internship program directly under their control and as a result thereof shall issue the proper certificate of said hours of internship. It shall also be the duty of said establishments to submit annually a complete report of the names of those who have undergone training under their supervision and the corresponding number of hours of internship credit of each of the pharmacy students to their respective colleges or schools and to the Board of Pharmacy for proper accreditation; and

d. He shall have graduated with a degree of Bachelor of Science in Pharmacy or with an equivalent degree from a school, college or university duly accredited by the Council of Pharmaceutical Education after satisfactory completing a standard pharmacy course of not less than five academic years. SECTION 19. Scope of examination.- The pharmacist examination shall consist of both theoretical and practical examinations. The theoretical examination shall include subjects in Chemistry, Biological Science and Pharmacy. The Chemistry subjects shall include (1) General Inorganic Pharmaceutical and Physical Chemistry, (2) Organic and Medical or Pharmaceutical Chemistry, (3) Qualitative, Quantitative and Drug Assaying. The Biological Science subjects shall include (4) Physiology Biochemistry, (5) Microbiology and Public Health, (6) Pharmacology and Toxicology. The pharmacy subjects shall include (7) Botany and Pharmacognosy, (8) General Pharmacy, (9) Compounding and Dispensing, (10) Physical and Manufacturing Pharmacy, (11) Pharmacy Administration, and (12) Pharmaceutical Jurisprudence and Ethics. The subjects shall be weighed as follows: Chemistry, thirty per cent; Biological Science, twenty per cent; Pharmacy, fifty per cent. The practical examination shall consist of (1) Identification and Analysis of Drugs, (2) Preparation of Official Pharmaceuticals, (3) Compounding and Dispensing of Prescriptions and fixing of Prices of Prescriptions, and (4) Manufacturing Pharmacy and Quality Control. The practical examination shall be weighed as follows: Identification and Analysis of Drugs, thirty per cent; Compounding of Official Pharmaceutical Preparations, Dispensing and Fixing of Price of Prescription and Manufacturing Pharmacy and Quality Control, seventy per cent. It shall be the duty of the Board of Pharmacy to prepare the schedules of the theoretical and practical examinations and the syllabus of each subject to be given two months before the dates of the examination wherein they are to be used. SECTION 20. Ratings required.- In order to pass the examination, a candidate must obtain on the basis of hundred per cent a general average of seventy-five per cent or over in both the theoretical and practical examinations, with no ratings below fifty percent in more than 2 subjects in the theoretical examinations: Provided, that any candidate who passed in the theoretical, may, upon taking a re- examination, repeat only the practical examination and vice-versa: Provided, further, that any candidate who fails to pass the theoretical and practical examination in three successive attempts shall not be admitted in the fourth examination unless he could present to the Board a certification that he had enrolled and undergone within the year preceding, a pre-board review course from a duly accredited college of Pharmacy. (d) Detailmen Requirements and Qualifications (Art. III, Sec. 12). SECTION 12. Detailmen requirements, qualifications and fees.- Any person who shall be employed as detailman by any pharmaceutical or drug laboratory or other manufacturers of medical, dental pharmaceutical, biological and veterinary products and by distributors, dealers or wholesalers of said product, doing business directly in the Philippines, shall be required at the beginning of each year, to register with the Board of pharmacy that he is employed as such: a. An applicant for registration shall be, preferably, a graduate of a college of pharmacy. There shall be an initial fee of twenty pesos upon registration and thereafter fifteen pesos shall be charged annually for renewal. Upon payment of said fees, the proper credential shall be issued to the applicant. b. It shall be incumbent upon the drug establishment referred to in this section to require that detailmen employed or to be employed by them possess the necessary credentials issued by the Board of Pharmacy as provided for herein. For purposes of this section, a detailman is one who represents any duly authorized manufacturer, dealer, distributor, representative or wholesaler of drugs, pharmaceuticals, biological products and devices, whose primary duty is to introduce or reacquaint a product or products prepared, distributed or made by said manufacturer, dealer, distributor, representative or wholesaler to the physician, dentist, pharmacist, veterinarian or any other qualified person and which form part of their program for promotion by describing its use, composition, action, dosage, administration, contraindication, advantages and other salient information relative to said drug, pharmaceutical, biological product or device. 2. Interviews of (a) pharmacist, (b) manager, and (c) pharmacy assistant / sales clerk regarding their knowledge as well as their role in the implementation of the following provisions: (a) Reprimand, Suspension or Revocation of pharmacist’s registration certificate a. Pharmacist: • Board certificate must be displayed, if not, there will be a penalty • If the pharmacy is open, there must also be a pharmacist on duty. If the pharmacist's board certificate is displayed but there are actually no pharmacist on duty there will be sanctions given. • Any person who will make up false representation to procure a registration certificate as a pharmacist for exchange for another. • There are pharmacist who get paid even if they are not present in the drugstore and if caught by BFAD there will be a revocation of their license because this branch regulates their licenses. • If the certification was displayed with in the establishment and the pharmacist is not present then there will also be a penalty • Any person who acts as a dummy for the alien pharmacist for the purpose of opening a new drugstore can be imprisoned for 4-6 months but not more than 4 years. • The pharmacist should renew their license, health certificate and working permit yearly.

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Board certificated does not expire but if your license expires, you are not allowed to work with corresponding there are also special provisions for pharmacist working abroad. The license must be renewed 2 months before it expires. The pharmacist can be sued if the patient or customer did not recieve the right medication require. b. Manager: The manager wasn’t able to give an opinion because of her busy schedule. c. Pharmacy assistant/sales clerk: Of course we acknowledge and value the pharmacist's registration certification that's why we let the pharmacist check the drug before dispensing to make sure that the patient or customer will recieve the correct medication and also of the customer has any question the pharmacist will be the one to counsel the patient especially if the drug concerned is classified under the dangerous drugs. (b) Practice of Pharmacy a. Pharmacist: • Licensed pharmacist are the ones who are allowed to practice their profession • A pharmacist under the age of 21 are not yet allowed to practice their profession even though they already passed the board exams because the license are only issues once you turn 21. • You'll be able to get your lisence first before the board certificate depending on the place where you had register b. Manager: The manager wasn’t able to give an opinion because of her busy schedule. c. Pharmacy assistant/sales clerk: Our work in the drugstore is already an evidence that we practice pharmacy. Example of this is knowing the use of drugs in order to give even just a simple counseling to the patient or customer regarding on how to take the medication. (c) Pharmacist Requirement in a drugstore a. Pharmacist: • Has satisfactory passed the board exam (75%) rate. • A pharmacist is a holder of the valid certificate for registration by the board of pharmacy. • The grade in the board exam or the computed grade of the 5 modules given should be 75% in total. b. Manager: The manager wasn’t able to give an opinion because of her busy schedule. c. Pharmacy assistant/sales clerk:  We know that in order to be a pharmacist you should be:  a board passer  must have the board certificate  must have a prc license (d) Filling and Refilling of Prescription a. Pharmacist: As a pharmacist we are strict about the filling and refilling of the presciption because we are monitored by PDEA. Any discrepancy in the prescription will be acted upon immediately. We make sure that the prescription is legal and real we also do not tolerate any fake or false presciption. b. Manager: The manager wasn’t able to give an opinion because of her busy schedule. c. Pharmacy assistant/sales clerk: To avoid any errors, you must read the prescription carefully and correctly. In case that you are doubtful, don't hesitate to ask the pharmacist. In refilling for example, the required amount or quantity of drug is 20 pcs and the patient only bought 10 pcs but they want another set if 20 pcs, we are not allowed to dispense because the patient went beyond the limited dispensing for the drug. (e) Sale of Drug Samples a. Pharmacist: We do not sell any drug samples. These drug sample comes from the med rep to the doctor and the doctor personally gives it to the patient not us pharmacist here in the drugstore. b. Manager: The manager wasn’t able to give an opinion because of her busy schedule. c. Pharmacy assistant/sales clerk: We don't have any drug samples because these should come or to be given by the doctor. (f) Use of cipher or unusual terms in prescriptions and Prescription switching a. Pharmacist: • If ever we have cases like these we double check it. We immediately consult the doctor who gave the prescription to ask about the drugs given and if it not available in our branch we suggest any alternate drugs but with the same generic name b. Manager: The manager wasn’t able to give an opinion because of her busy schedule. c. Pharmacy assistant/sales clerk: If ever we encounter cipher or any unusual terms in the prescription, we forward it immediately to the pharmacist especially if the prescription is an impossible one. If the generic name did not match the brand name or vice versa we are not to dispense. In cases that we can't understand the prescription we ask for the help of the pharmacist.

3. Discuss with the pharmacist his compensation vis-à-vis the provision on Art. IV, Sec. 27 of RA 5921. For drugstore thats open for 24hrs should provide a pharmacist on duty all the time having the shifts of 7am3pm, 3pm-11pm, 11pm-7am and mid-day shift to ensure that there is always a pharmacist in the drugstore. 4. Ask the assistance of the pharmacist and/or head of the pharmacy with detail men. Obtain the name of the detail men, together with regarding the nature of his/her work. Discuss with him/her his Pharmacy Law covering his/her work. Unfortunately, we weren’t able to conduct an interview with the the drugstore. ACTIVITY 3 Drugs 1. OFFICIAL DEFINITIONS OF DRUGS A. The World Health Organization notes that drug is a "term of varied usage," and that: (1) "in medicine, it refers to any substance with the potential to prevent or cure disease or enhance physical or mental welfare"; (2) "in pharmacology to any chemical agent that alters the biochemical physiological processes of tissues or organisms"; and (3) "in common usage, the term often refers specifically to psychoactive drugs, and often, even more specifically, to illicit drugs, of which there is non-medical use in addition to any medical use." In the United States, the Federal Food, Drug, and Cosmetic Act definition of "drug" includes: (1) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (A), (B), or (C). establishment in conducting an interview the company he/she represents. Inquire knowledge regarding provisions of the detail men because he/she wasn’t there on

B.

2. (a)

LEGAL CLASSIFICATIONS OF DRUGS As seen in the CSA of 1970, the new act includes five legal drug classifications. The drugs are ranked based on their usefulness in medical treatment, and their potential for abuse. Schedule I High Abuse, No recognized Medical use, Lack of Safety Examples:  Marijuana  Heroin  LSD Sentences, for non-violent, first time offenders convicted of trafficking Schedule I drugs, can be turned into life sentences when multiple sales are prosecuted in one hearing. Schedule II High Abuse, Medical Utility, High Dependency Risk Examples:  Cocaine  Opium  Morphine Substance II drugs may not be dispensed without written prescription from a doctor. Prescriptions of substance II drugs are in a "closed system". This means, the prescription may not be refilled, unless medically required. Schedule III Lower Abuse, Medical Utility, Moderate Dependency Risk Examples:  Anabolic Steroids  Buprenorphine  Amphetamine Schedule III drugs may not be used without prescription from a doctor. Prescriptions may not be refilled after six months of the date they were issued for use. Schedule IV Low Potential for Abuse, High Medical Utility, Limited Dependency Risk Examples:  Benzodiazepines  Temazepam

(b)

(c)

(d)

 Barbiturates (Long acting) Prescriptions for Schedule IV drugs may be refilled up to five times within six months. (e) Schedule V Low Abuse, High Medical Utility, Little Dependency Risk Examples:  Cough syrups containing small amounts of codeine  Preparations containing small amounts of opium  Pyrovalerone No drug found in schedule V may be dispensed or distributed for anything other than medicinal use. THERAPEUTIC CLASSIFICATIONS OF DRUGS (a) Analgesic – suppresses pain perception without including loss of consciousness. Ex. Aspirin (Disprin), Aspirin and Codeine (Aspalgin), Ibuprofen(Advil) (b) Anesthetic – eliminates pain perception. Ex. Halothane (Fluothane), Hyoscyamine (Femidol), Isoflurane (Isorane) (c) Antiasthma – drugs used to dilate bronchioles. Ex. Zafirlukast (Accolate), Salbutamol SO4 (Activent), Terbutaline SO4 (Alloxygen) (d) Anti-emetic – suppresses nausea and vomiting. Ex. Metoclopramide (Plasil), Meclizine HCL (Bonamine), Astellas (Nasea) (e) Antipyretic – restores the normal body temperature in the presence of fever. Ex.Paracatamol-ibubrofen (Alaxan FR), Paracetamol (Biogesic), Paracetamol (Tempra syrup) (f) Anti-psychotic – suppresses symptoms of psychoses of various diagnostic types. Ex. Risperidone (Ridonex), Olanzapine (Zapinex), Chlorpromazine (Thorazine) (g) Anxiolytics – suppresses symptoms of anxiety. Ex. Clorazepate diK (Tranxene), Diazepam (Valium), Bromzepam (Lexotan) (h) Anti-convulsant – induces convulsion by inducing general CNS depression. Ex. Gabapentin (Neurontin), Levetiracetam (Levit), Phenytoin Na (Lantidin) (i) Antibacterial – kill or inhibit pathogenic bacteria. Ex. Clindamycin HCl (Cliz), Metronidazole (Flagyl), Daptomycin (Cubicin) (j) Vaccine – antigen-containing drug used to induce active immunity against an infection. Ex. Tetanus toxoid absorbed (Imatet), Hepatitis B vaccine (Hepliv), Influenza virus vaccine (Influvac) (k) Anti-coagulant – administered to slow the rate of blood clotting. Ex. Dalteparin (Fragmin), Enoxaparin (Lovenox), Tinzaparin (Innohep) (l) Anti-angina – a coronary vasodilator useful in preventing or treating attacks of angina pectoris. Ex. Amilodipine besylate (Amlocor), Trimetazidine HCl (Angimax), Niledipine (Altapres) (m) Laxative – promotes defecaton. Ex. Lactulose (Duphalac), Bisacodyl (Dulcolax), Glycerin (Rhea Glycerin Supp.) (n) Antacids – neutralizes excess gastric acid. Ex. Eupatilin (Stilen), Omeprazole (Tansinel), Lansoprazole (Propilan) (o) Diuretics – agents that promote renal excretion of electrolytes. Ex. Furosemide (Lansix), Losartan (Losacar-H), HCTZ (Urilzid) (p) Immunosuppressants – inhibits immune response to foreign materials. Ex. Tacrolimus (Vingraf), Mycophenolic acid (Myfortic), Ciclosporin (Osporin) (q) Cholinergics – drugs that mimic the neurotransmitter acetylcholine. Ex. Pilocarpine (Fotil), Nicotine (Nicorette), Carbachol (Miostat) (r) Anticholinergics – drugs that block the neurotransmitter acetylcholine. Ex. Atropine (Anespin), Ipatropium (Atrovent), Homatropine (Lesopen) (s) Sympathomimetics – drugs used for cardiovascular, respiratory, and other conditions by mimicking the stimulation of the sympathetic ANS. Ex. Epinephrine (Adrenin), Terbutaline (Alloxygen), Ephedrine (Ephedra) (t) Adrenoceptor blockers – drugs that block the stimulation of the Sympathetic ANS. Ex. Metoprolol (Alltrex), Enalapril (Vasotec), Atenolol (Tenormin) (u) Antifungal – drugs used to kill or inhibit fungal growth. Ex.Nystatin (Afunginal), Amphotericin B (Ampholip), Fluconazole (Diflucan) (v) Antiviral – drugs used to kill or inhibit viral growth. Ex. Aciclovir (Aciherpin), Entecavir (Baraclude), Acyclovir (Cyclostad) (w) Antineoplastics – drugs used to kill or inhibit cancer cells. Ex. Anagrelide HCL (Agrylin), Vincristine SO4 (Alcavixin), Methotrexate (Alltrex) (x) Antirheumatics – an anti-inlammatory drug used to treat arthritis and rheumatoid disorders. Ex. Ciclosporin (Arpimune), Methotrexate (Emthexate), Ciclosporin (Osporin) (y) Vitamins – organic chemicals essential in small amounts for normal metabolism. Ex. B Com Nerve, Beetab, Benutrex C (z) Minerals – inorganic chemicals occuring naturally which plays a vital role in regulating many bodily functions. Ex. Chilcee, Flexivit, Enervon syrup TOP TEN LEADING DRUGS IN THE MARKET

3.

4.

i. Top 10 in 10 pharmacies 1. Biogesic (Paracetamol) 2. Neozep (Phenylephrine HCl, Clorphenamine maleate, Paracetamol) 3. Alaxan FR (Paracetamol, Ibuprofen) 4. Bioflu (Same as number 2) 5. Decolgen (Same as number 2) 6. Diatabs (Loperamide HCl) 7. Ascorbic Acid 8. Mefenamic Acid 9. Advil (Ibuprofen) 10. Solmux (Carbocisteine) ii. Top 10 in the Internet 1. Lipitor (Atorvastatin) 2. Plavix (Clopidogrel) 3. Nexium (Esomeprazole) 4. Seretide/Advair (fluticasone+ salmeterol) 5. Enbrel (etanercept) 6. Zyprexa (olanzapine) 7. Risperdal (risperidone) 8. Seroquel (quetiapine) 9. Singulair (montelukast sodium) 10. Aranesp (darbepoetin alfa) CONCLUSION/COMMENTS: As observed in the first set of information, almost all of the leading drugs bought in the Philippines according to 10 pharmacies are generally cough and cold preparations and for the treatment of fever and pains. Factors that may contribute to this is the fact that these drugs can be obtained without a prescription and that they are the ones frequently advertised. In contrast with the list obtained in the Internet, the leading drug is a cholesterol-lowering drug, and the second leading drug is an anti-atherosclerotic agent, both for the treatment of cardiovascular diseases. This may be because it has been shown in statistics that the number one cause of mortality in most countries is heart disease. One in 5 adults in developed countries have high cholesterol and only about 20% of it comes from the foods we eat whereas the rest 80% is produced by our body. 5. UPDATES ON NEW DRUGS Pegloticase (Krystexxa - Savient) Agent for GOUT Indication: Administered intravenously for the treatment of chronic gout in adult patients refractory to conventional therapy; is not recommended for the treatment of asymptomatic hyperuricemia. Comparable Drugs: Allopurinol (Zylopprim), Febuxostat (Uloric) Comments: Advantages: It is effective in some patients with chronic gout that is refractory to conventional therapy. It has a unique mechanism of action (reduces serum uric acid concentration by catalysing the oxidation of uric acid.) it is less likely to interact with other medications. Disadvantage: It must be administered intravenously, risks of anaphylaxis and infusion reactions may get in the way, and it may cause exacerbation of Congestive Heart Failure. Belimumab (Benlysta – Human Genome Sciences; GlaxoSmithKline) Agent for Systematic Lupus Erythematosus Indication: Administered intravenously for the treatment of adult patients with active autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Comparable Drugs: Corticosteroids (Prednisone) Comments: Advantage: The drug is undoubtedly beneficial in the sense that it increases the effectiveness of treatment in some patients when used with standard therapy. It also has unique mechanism of action (inhibits binding of B-lymphocyte stimulator protein to its receptors on B-Cells). Disadvantage: On the other hand, the effectiveness in Black African American patients has not been demonstrated, which might bring up problems in the future when a patient from this group will take the drug. Also, it has not been evaluated in patients with severe active lupus nephritis or severe active Central Nervous System Lupus.

ACTIVITY 4 Prescription 1. DEFINITION OF PRESCRIPTION  A prescription is an order for medication issued by a physician, dentist, or other properly liscensed medical practitioner.

  2.

A prescription designates a specific medication and dosage to be prepared by a pharmacist and administered to a particular patient. A written prescription may be presented at the pharmacy by the patient or caregiver, or it may be transmitted from the prescriber by telephone or by other electronic means.

DIFFERENT PARTS OF THE PRESCRIPTION a. Prescriber information and Signature b. Patient Information c. Date Prescription was written d. Superscription e. Medication Prescribed (Inscription) f. Dispensing instructions to the Pharmacist (Subscription) g. Directions to the Patient (Signa) h. Special Instructions *A typical complete prescription is atttched on the next page. STEPS IN PROCESSING A PRESCRIPTION  Pharmacy Asst. receives the prescription  Pharmacist transcribes the prescription  Pharmacist – Filling of Prescription i. Partial Filling – Deduct the drugs being dispensed ii. Countersign (Pharmacist)  Provide the necessary information (Name of Client, Pharmacist who partially dispensed, Number of remaining balance and expiration of prescription, Counselling)  Dispense drugs needed. Receive payments and give back change.  Prescription is back to client DIFFERENT PHARMACEUTICAL AND MEDICAL ABBREVIATIONS *The abbreviations are shown on the following pages. COMMENTS ON THE ACTUAL PHILIPPINE PRACTICE OF PROCESSING THE PRESCRIPTION In a pharmacy setting, many people do not have enough patience to line up to purchase the medications they need. Most of the time, people who work in a pharmacy need to work quickly to immediately address the needs of the clients. Sometimes, when things need to be done too fast, some pharmacists and pharmacy assistants overlook some steps. Also, some pharmacies fail to follow the correct way of processing prescriptions. Some pharmacies do not even look for prescriptions to dispense drugs that supposedly should be dispensed with prescriptions. This is what we aim to change with proper training and supervision. Luckily, the pharmacy establishment and the people in it are helping us to do so.

3.

4. 5.

1.

ACTIVITY 5 Pharmaceutical Dosage Forms, Drug Delivery Systems and Medication Administration Techniques DEFINITION OF PHARMACEUTICAL DOSAGE FORMS Dosage forms are provided for most of the Pharmacopeial drug substances, but the processes for the preparation of many of them are, in general, beyond the scope of the Pharmacopeia. In addition to defining the dosage forms, this section presents the general principles involved in the manufacture of some of them, particularly on a small scale. Other information that is given bears on the use of the Pharmacopeial substances in extemporaneous compounding of dosage forms. BIOAVAILABILITY Bioavailability, or the extent to which the therapeutic constituent of a pharmaceutical dosage form intended for oral or topical use is available for absorption, is influenced by a variety of factors. Among the inherent factors known to affect absorption are the method of manufacture or method of compounding; the particle size and crystal form or polymorph of the drug substance; and the diluents and excipients used in formulating the dosage form, including fillers, binders, disintegrating agents, lubricants, coatings, solvents, suspending agents, and dyes. Lubricants and coatings are foremost among these. The maintenance of a

demonstrably high degree of bioavailability requires particular attention to all aspects of production and quality control that may affect the nature of the finished dosage form. TERMINOLOGY Occasionally it is necessary to add solvent to the contents of a container just prior to use, usually because of instability of some drugs in the diluted form. Thus, a solid diluted to yield a suspension is called [DRUG] for Suspension; a solid dissolved and diluted to yield a solution is called [DRUG] for Solution; and a solution or suspension diluted to yield a more dilute form of the drug is called [DRUG] Oral Concentrate. After dilution, it is important that the drug be homogeneously dispersed before administration. 2. DIFFERENT TYPES OF DOSAGE FORMS ACCORDING TO ROUTE OF ADMINISTRATION ORAL Tablets, Capsules, Solutions, Syrups, Elixirs, Suspensions, Magmas, Gels, Powders SUBLINGUAL Tablets, Troches, lozenges Drops (solutions) PARENTERAL TRANSDERMAL, EPICUTANEOUS Solutions Suspensions Ointments, Gels, Creams, Infusion Pumps, Pastes, Plasters, Powders, Aerosols, Lotions Transdermal Patches, Discs, Solutions Contact Lens Inserts Ointments Solutions Suspensions Solutions, Sprays Inhalants, Ointments Aerosols Solutions, Ointments Suppositories, Gels Solutions, Ointments, Emulsion Foams Gels, Tablets Inserts, suppositories, Sponge Solutions Suppositories

CONJUNCTIVAL INTRAOCULAR, INTRA-AURAL INTRANASAL INTRARESPIRATORY RECTAL VAGINAL

URETHRAL

ORAL ROUTE Drugs are most frequently taken by oral administration. Although a few drugs taken orally are intended to be dissolved in the mouth, nearly all drugs taken orally are swallowed. Of these, most are taken for the systemic drug effects that result after absorption from the various surfaces along the gastrointestinal tract. A few drugs, such as antacids, are swallowed for their local action in the gastrointestinal tract. Compared with alternative routes, the oral route is considered the most natural, uncomplicated, convenient, and safe means of administering drugs. Disadvantages of the oral route include slow drug response (compared with parenterally administered drugs); chance of irregular absorption of drugs, depending upon such factors as constitutional makeup and the amount or type of food in the gastrointestinal tract; and the destruction of certain drugs by the acid reaction of the stomach or by gastrointestinal enzymes. RECTAL ROUTE Some drugs are administered rectally for their local effects and others for their systemic effects. Drugs given rectally may be administered as solutions, suppositories, or ointments. Suppositories are solid bodies of various weights and shapes intended for introduction into a body orifice (usually rectal, vaginal, or urethral) where they soften, melt, or dissolve, release their medication, and exert their drug effects. These effects simply may be the promotion of laxation (as with glycerin suppositories), the soothing of inflamed tissues (as with various commercial suppositories used to relieve the discomfort of hemorrhoids), or the promotion of systemic effects (as antinausea or anti–motion sickness). The composition of the suppository base, or carrier, can greatly influence the degree and rate of drug release and should be selected on an individual basis for each drug. The use of rectal ointments is generally limited to the treatment of local conditions. Rectal solutions are usually employed as enemas or cleansing solutions. PARENTERAL ROUTE The term parenteral is derived from the Greek words para, meaning beside, and enteron, meaning intestine, which together indicate something done outside of the intestine and not by way of the alimentary tract. A drug administered parenterally is one injected through the hollow of a fine needle into the body at various sites and to various depths. The three primary routes of parenteral administration are subcutaneous, intramuscular, and intravenous, although there are others, such as intracardiac and intraspinal. EPICUTANEOUS ROUTE Drugs are administered topically, or applied to the skin, for their action at the site of application or for systemic drug effects. Drug absorption via the skin is enhanced if the drug substance is in solution, if it has a favorable lipid–water partition coefficient, and if it is not an electrolyte. Drugs that are absorbed enter the skin by way

of the pores, sweat glands, hair follicles, sebaceous glands, and other anatomic structures of the skin’s surface. Because blood capillaries lie just below the epidermal cells, a drug that pen etrates the skin and is able to traverse the capillary wall finds ready access to the general circulation OCULAR, ORAL, OTIC AND NASAL ROUTES Drugs are frequently applied topically to the eye, ear, and mucous membranes of the nose, usually as ointments, suspensions, and solutions. Ophthalmic solutions and suspensions are sterile aqueous preparations with other ingredients essential to the safety and comfort of the patient. Ophthalmic ointments must be sterile and free of grit. Innovative new delivery systems for ophthalmic drugs continue to be investigated. One dosage form, the Ocusert, is an elliptical unit designed for continuous release of pilocarpine following placement in the cul-de-sac of the eye. Also, case reports of the ability of soft contact lenses to absorb drug from the eye have spawned research on soft contact lenses impregnated with drug. Most nasal preparations are solutions or suspensions administered by drops or as a fine mist. Research is directed toward the feasibility of nasal administration of insulin for diabetes mellitus. Ear preparations are usually viscid so that they have prolonged contact with the affected area. They may be employed simply to soften ear wax, to relieve an earache, or to combat an ear infection. Eye, ear, and nose preparations usually are not used for systemic effects, and although ophthalmic and otic preparations are not usually absorbed to any great extent, nasal preparationsmay be absorbed, and systemic effects after the intranasal application of solution are fairly common. OTHER ROUTES The lungs provide an excellent absorbing surface for the administration of gases and for aerosol mists of very minute particles of liquids or solids. The gas is usually oxygen, and the drugs are the common general anesthetics administered to patients entering surgery. The rich capillary area of the alveoli of the lungs, which in a man covers nearly a thousand square feet, provides rapid absorption and drug effects comparable in speed with those following an intravenous injection. In the case of drug particles, their size largely determines the depth to which they penetrate the alveolar regions; their solubility, the extent to which they are absorbed. After contact with the inner surface of the lungs, an insoluble drug particle is caught in the mucus and is moved up the pulmonary tree by ciliary action. Soluble drug particles that are approximately 0.5 to 1.0 µm in size reach the minute alveolar sacs and are most prompt and efficient in providing systemic effects. Particles smaller than 0.5 µm are expired to some extent and thus, their absorption is not total but variable. Particles 1 to 10 µm effectively reach the terminal bronchioles and to some extent the alveolar ducts and are favored for local therapy. Therefore, in the pharmaceutical manufacture of aerosol sprays for inhalation therapy, the manufacturers not only must attain the proper drug particle size but also must ensure their uniformity for consistent penetration of the pulmonary tree and uniform effects. In certain instances and for local effects, drugs are inserted into the vagina or the urethra. Drugs are usually presented to the vagina in tablet or other form, such as a suppository, ointment, emulsion foam, gel or solution, and to the urethra as a suppository or solution. Systemic drug effects may result after vaginal or urethral application of drugs following absorption of the drug from the mucous membranes of these sites. 3. COMMON PHARMACEUTICAL DOSAGE FORMS (a) TABLETS Tablets are solid dosage forms containing medicinal substances with or without suitable diluents. They may be classed, according to the method of manufacture, as compressed tablets or molded tablets. The vast majority of all tablets manufactured are made by compression, and compressed tablets are the most widely used dosage form in this country. Compressed tablets are prepared by the application of high pressures, utilizing steel punches and dies, to powders or granulations. Tablets can be produced in a wide variety of sizes, shapes, and surface markings, depending upon the design of the punches and dies. Capsule-shaped tablets are commonly referred to as caplets. Boluses are large tablets intended for veterinary use, usually for large animals. (b) CAPSULES Capsules are solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or ‘‘shell.’’ The shells are usually formed from gelatin; however, they also may be made from starch or other suitable substances. Hard-shell capsule sizes range from No. 5, the smallest, to No. 000, which is the largest, except for veterinary sizes. However, size No. 00 generally is the largest size acceptable to patients. Size 0 hard gelatin capsules having an elongated body (known as size OE) also are available, which provide greater fill capacity without an increase in diameter. Hard gelatin capsules consist of two, telescoping cap and body pieces. (c) PILLS Pills are API (active pharmaceutical ingredient)-containing small round solid bodies intended for oral administration. At one time pills were the most extensively used oral dosage form, but they have been replaced by compressed tablets and capsules. Pills are distinguished from tablets because pills are manufactured by a wet massing and molding technique, while tablets are formed by compression. (d) LOZENGES Lozenges are solid preparations that are intended to dissolve or disintegrate slowly in the mouth. They contain one or more medicaments, usually in a flavored, sweetened base. They can be prepared by molding (gelatin and/or fused sucrose or sorbitol base) or by compression of sugar-based tablets. Molded lozenges are sometimes referred to as pastilles while compressed lozenges are often referred to as troches. They are usually intended for treatment of local irritation or infections of the mouth or throat but may contain active ingredients intended for systemic absorption after swallowing. (e) SYRUP

Oral Solutions containing high concentrations of sucrose or other sugars traditionally have been designated as Syrups. A near-saturated solution of sucrose in purified water, for example, is known as Syrup or ‘‘Simple Syrup.’’ Through common usage the term, syrup, also has been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions. In addition to sucrose and other sugars, certain polyols such as sorbitol or glycerin may be present in Oral Solutions to inhibit crystallization and to modify solubility, taste, mouth-feel, and other vehicle properties. Antimicrobial agents to prevent the growth of bacteria, yeasts, and molds are generally also present. Some sugarless Oral Solutions contain sweetening agents such as sorbitol or aspartame, as well as thickening agents such as the cellulose gums. Such viscid sweetened solutions, containing no sugars, are occasionally prepared as vehicles for administration of drugs to diabetic patients. (f) ELIXIR Many oral solutions, that contain alcohol as a cosolvent, have been traditionally designated as Elixirs. However, many others designated as Oral Solutions also contain significant amounts of alcohol. Since high concentrations of alcohol can produce a pharmacologic effect when administered orally, other cosolvents, such as glycerin and propylene glycol, should be used to minimize the amount of alcohol required. To be designated as an Elixir, however, the solution must contain alcohol. (g) SUSPENSION Suspensions are liquid preparations that consist of solid particles dispersed throughout a liquid phase in which the particles are not soluble. Dosage forms officially categorized as ‘‘Suspensions’’ are designated as such if they are not included in other more specific categories of suspensions, such as Oral Suspensions, Topical Suspensions, etc. Some suspensions are prepared and ready for use, while others are prepared as solid mixtures intended for constitution just before use with an appropriate vehicle. Such products are designated ‘‘for Oral Suspension’’, etc. (h) EMULSION Emulsions are two-phase systems in which one liquid is dispersed throughout another liquid in the form of small droplets. Where oil is the dispersed phase and an aqueous solution is the continuous phase, the system is designated as an oil-in-water emulsion. Conversely, where water or an aqueous solution is the dispersed phase and oil or oleaginous material is the continuous phase, the system is designated as a waterin-oil emulsion. Emulsions are stabilized by emulsifying agents that prevent coalescence, the merging of small droplets into larger droplets and, ultimately, into a single separated phase. Emulsifying agents (surfactants) do this by concentrating in the interface between the droplet and external phase and by providing a physical barrier around the particle to coalescence. Surfactants also reduce the interfacial tension between the phases, thus increasing the ease of emulsification upon mixing. (i) PARENTERALS An Injection is a preparation intended for parenteral administration or for constituting or diluting a parenteral article prior to administration. Each container of an Injection is filled with a volume in slight excess of the labeled ‘‘size’’ or that volume that is to be withdrawn. The excess volumes recommended in the accompanying table are usually sufficient to permit withdrawal and administration of the labeled volumes. (j) OINTMENTS Ointments are semisolid preparations intended for external application to the skin or mucous membranes. Ointment bases recognized for use as vehicles fall into four general classes: the hydrocarbon bases, the absorption bases, the water-removable bases, and the water-soluble bases. Each therapeutic ointment possesses as its base a representative of one of these four general classes. (k) CREAMS Creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base. This term has traditionally been applied to semisolids that possess a relatively fluid consistency formulated as either water-in-oil (e.g., Cold Cream) or oil-in-water (e.g., Fluocinolone Acetonide Cream) emulsions. However, more recently the term has been restricted to products consisting of oil-in-water emulsions or aqueous microcrystalline dispersions of long-chain fatty acids or alcohols that are water washable and more cosmetically and aesthetically acceptable. Creams can be used for administering drugs via the vaginal route (e.g., Triple Sulfa Vaginal Cream). (l) PASTES Pastes are semisolid dosage forms that contain one or more drug substances intended for topical application. One class is made from a single-phase aqueous gel (e.g., Carboxymethylcellulose Sodium Paste). The other class, the fatty pastes (e.g., Zinc Oxide Paste), consists of thick, stiff ointments that do not ordinarily flow at body temperature, and therefore serve as protective coatings over the areas to which they are applied. The fatty pastes appear less greasy and more absorptive than ointments by reason of a high proportion of drug substance(s) having an affinity for water. These pastes tend to absorb serous secretions, and are less penetrating and less macerating than ointments, so that they are preferred for acute lesions that have a tendency towards crusting, vesiculation, or oozing. (m) SUPPOSITORIES Suppositories are solid bodies of various weights and shapes, adapted for introduction into the rectal, vaginal, or urethral orifice of the human body. They usually melt, soften, or dissolve at body temperature. A suppository may act as a protectant or palliative to the local tissues at the point of introduction or as a carrier of therapeutic agents for systemic or local action. Suppository bases usually employed are cocoa butter, glycerinated gelatin, hydrogenated vegetable oils, mixtures of polyethylene glycols of various molecular weights, and fatty acid esters of polyethylene glycol.

4.

STEPS OR TECHNIQUES IN ADMINISTERING THE FOLLOWING DOSAGE FORMS THAT THE PHARMACIST MAY GIVE TO THE CLIENT: (a) EAR DROPS Step 1: Wash your hands thoroughly with soap and water. Step 2: Gently clean your ear with a damp facecloth and then dry your ear. Step 3: Warm the drops to near body temperature by holding the container in the palm of your hand for a few minutes. Steps 4: If the drops are a cloudy suspension, shake the bottle well for 10 seconds. Step 5: Check the dropper tip to make sure that it is not chipped or cracked. Step 6: Draw the medication into the dropper, or hold the dropper-top bottle with the dropper tip down. Step 7: Tilt the affected ear up or lie on your side. Pull the ear backward and upward (or if giving to a child younger than 3 years of age, pull backward and downward) to open the ear canal. Step 8: Place the correct number of drops in your ear. Gently press on the small skin flap over the ear to help the drops to run into the ear canal. Step 9: Keep your ear tilted up for a few minutes or insert a soft cotton plug in your ear, whichever method has been recommended by your pharmacist or doctor. Step 10: Replace and tighten the cap or dropper right away. Step 11: Wash your hands to remove any medication. (b) EYE DROPS Step 1: Wash your hands thoroughly with soap and water. Step 2: Check the dropper tip to make sure that it is not chipped or cracked. Step 3: Avoid touching the dropper tip against your eye or anything else – eye drops and droppers must be kept clean. Step 4: While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket. Step 5: Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it. Step 6: Brace the remaining fingers of that hand against your face. Step 7: While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid. Step 8: Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids. Step 9: Place a finger on the tear duct and apply gentle pressure. Step 10: Wipe any excess liquid from your face with a tissue. Step 11: If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop. Step 12: Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip. Step 13: Wash your hands to remove any medication. (c) EYE OINTMENTS Step 1: Wash your hands thoroughly with soap and water. Step 2: Avoid touching the tip of the tube against your eye or anything else – the medication and its container must be kept clean. Step 3: Holding the tube between your thumb and forefinger, place it as near to your eyelid as possible without touching it. Step 4: Brace the remaining fingers of that hand against your face. Step 5: Tilt your head forward slightly. Step 6: While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket. Step 7: Squeeze ribbon of ointment into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid. Step 8: Blink your eye gently; then close your eye for 1 to 2 minutes. Step 9: With a tissue, wipe any excess ointment from the eyelids and lashes. With another clean tissue, wipe the tip of the tube clean. Step 10: Replace and tighten the cap right away. Step 11: Wash your hands to remove any medication. (d) INHALATION OR NASAL SPRAY Step 1: Remove cap. Step 2: Hold inhaler upright and shake well. Step 3: Breathe out gently. Step 4: Put mouthpiece between teeth without biting and close lips to form good seal. Step 5: Start to breathe in slowly through mouth and press down firmly on canister. Step 6: Continue to breathe in slowly and deeply. Step 7: Hold breathe for about 10 seconds or as long as comfortable. Step 8: While holding breath, remove inhaler from mouth. Step 9: Breathe out gently away from mouthpiece. Step 10: If an extra dose is needed, wait 1 minute and then repeat steps 2 to 9. Step 11: Replace cap.

(e) AEROSOLS Step 1: Reassemble the inhaler and remove the cap from the mouthpiece. Step 2: Vigorously shake the inhaler (failure to do this can result in unreliable delivery of the medication). Step 3: Hold the inhaler upright with your index finger on top and your thumb on the bottom. Posit ion the mouthpiece about 1½ - 2 inches away from your mouth. Tilt your head back slightly and breathe out through your mouth. Step 4: Opening your mouth wide, simultaneously press down on the top of the canister while you slowly and deeply breathe in the medicine (3-5 seconds). Step 5: Close your mouth and hold your breath for 10 seconds, or as long as you comfortably can, to allow the medicine to travel deeply into your lungs. Resume normal breathing after exhaling. Step 6: Repeat steps 3-5 as many times as directed by the health care provider. Allow 1 minute between puffs to permit deeper penetration of the medicine with each remaining puff. (f) NEBULIZER Step 1: Wash hands. Step 2: Position the patient in a comfortably seated position. Step 3: Place nebulizer on table or counter and plug into electrical outlet with ON/OFF switch in the OFF position. Step 4: Attach a mouthpiece or facemask to the medicine chamber with an adapter. Step 5: Connect one end of the tubing to the medicine chamber and the other end to the nipple on the nebulizer compressor. Step 6: Turn on the compressor switch and watch for the medication mist to flow from the mouthpiece or mask. Step 7: If a mask is used, place the mask over the student’s mouth and nose, securing it comfortably with the elastic strap that is attached. Step 8: If a mouthpiece is used, have the student place the lips around the mouthpiece to make a seal. Step 9: Instruct the student to breathe in and out through the mouth slowly and completely. Step 10: Monitor the student for changes in respiratory rate or effort. Initiate emergency procedures if indicated. Step 11: Continue to have the nebulizer dispense the medication until all the medication has disappeared from the chamber. (g) NOSE DROPS Step 1: Blow your nose gently. Step 2: Wash your hands thoroughly with soap and water. Step 3: Check the dropper tip to make sure that it is not chipped or cracked. Step 4: Avoid touching the dropper tip against your clean nose. Step 5: Tilt your head as far back as possible, or lie down on your back on a flat surface (such as a bed) and hang your head over the edge. Step 6: Place the correct number of drops into your nose. Step 7: Bend your head forward toward your knees and gently move it left and right. Step 8: Remain in this position for a few minutes. Step 9: Clean the dropper tip with warm water. Cap the bottle right away. Step 10: Wash your hands to remove any medication. (h) RECTAL SUPPOSITORIES Step 1: Wash your hands thoroughly with soap and water. Step 2: If the suppository is soft, hold it under cool water or place it in a refrigerator for a few minutes to harden it before removing the wrapper. Step 3: Remove the wrapper, if present. Step 4: If you were told to use half of the suppository, cut it lengthwise with a clean, single-edge razor blade. Step 5: Put on a finger cot or disposable glove, if desired. Step 6: Lubricate the suppository tip with a water-soluble lubricant such as K-Y Jelly, not petroleum jelly. If you do not have this lubricant, moisten your rectal area with cool tap water. Step 7: Lie on your side with your lower leg straightened out and your upper leg bent forward toward your stomach. Step 8: Lift upper buttock to expose the rectal area. Step 9: Insert the suppository, pointed end first, with your finger until it passes the muscular sphincter of the rectum, about 1/2 to 1 inch in infants and 1 inch in adults. (If not inserted past this sphincter, the suppository may pop out.) Step 10: Hold buttocks together for a few seconds. Step 11: Remain lying down for about 5 minutes to avoid having the suppository come out. Step 12: Discard used materials and wash your hands thoroughly. 5. SPECIAL INSTRUCTIONS THAT A PHARMACIST CAN GIVE TO A CLIENT FOR THE USE OF EACH OF THE FOLLOWING SPECIAL DOSAGE FORMS: a. CHEWTAB – Never swallow the tablet as a whole, since it is a chewable tablet, chew it first before swallowing. You may also hew or dissolve it in the mouth.

b. c. d. e. f. 6.

EFFERVESCENT TABLET – Never swallow it with water or chew it like a candy and always remember to dissolve it first in water before taking it in. LOZENGE – Take 1 lozenge only every 2-3 hours. When a sore throat persists for more than two days, consult your doctor. Also, remember that young children can choke on lozenges. ORAL SUSPENSIONS – Shake first the bottle before adding in the mineral water to avoid the settling in of the powder. Shake well before use. Always finish your medication even if your condition is already getting better. SUBLINGUAL TABLET – Tablet must be placed under the tongue. Do not swallow whole. RECTAL SUPPOSITORIES – Keep out of reach of children. Do not ingest. Store in a cool dry place, preferably on a refrigerator.

UPDATES ON EXISTING OR NEW DOSAGE FORMS IN THE MARKET Afinitor (everolimus) Tablets Date of Approval: March 30, 2009 Afinitor (everolimus) is an oral once-daily inhibitor of mTOR indicated for the treatment of patients with advanced kidney cancer, subependymal giant cell astrocytoma (SEGA) and renal angiomyolipomas associated with tuberous sclerosis, pancreatic neuroendocrine tumors and advanced breast cancer. New Dosage Form Approved: August 29, 2012 Exalgo (hydromorphone) Extended Release Tablets Date of Approval: March 1, 2010 Exalgo (hydromorphone) is a once-a-day extended release opioid formulation for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. New Dosage Form Approved: August 27, 2012 ACTIVITY 7 GENERICS ACT of 1988 ADMINISTRATIVE ORDER No. 63 And PHILIPPINE NATIONAL DRUG POLICY Read and understand the provisions of the following: a. Generics Act (RA 6675) b. Philippine National Drug Policy c. Administrative No. 63 Conduct a survey among ten (10) community pharmacies in Baguio City regarding the top ten (10) generic drugs sold, Make a presentation of the results of the survey. Top 10 Generic Drugs Sold DRUGSTORES GENERIK Maxene Watson A Pharma s cy

1.

2.

Drug Mercur y Drug Porta Vaga Amlodipine Diclofenac Losartan Mefenamic Acid Vitamin BComplex Amoxicillin Metformin Co-amoxiclav Atorvastatin Cefuroxime Mefenamic Acid Amoxicillin Metformin HCL Simvastatin Paracetamol Celecoxib Cefalexin Vit. B1+B6+B12 St. Joseph Bonifaci o St. Josep h Mabin i

St. Josep h MS

Circle Drug

BHD

Mabisa Pharma cy

TOTA L

4 1 3 2 1 1 1 2 1 1 6 2 6 4 8 2 1 3

Cetrizine Ambroxol HCL Clopidogrel Clindamycin Ibuprofen + Paracetamol Carbocisteine Phenylephrine HCl + Chlorphenamin e Maleate + Paracetamol Multivitamins Hyoscine Nbutylbromide Losartan Potassium + hydrochlorothi azide Furosemide Loperamide Diclofenac Sodium Paracetamol + Phenyleprine HCl +Chlorphenami ne Maleate Chlorpheniram ine Maleate+ Paracetamol +Phenylpropan olamie Ascorbic Acid Oral Rehydration Salts Dextromethrop han HBr + Phenylephrine, Paracetamol Cloxacillin Lagundi Leaf Mebendazole Metronidazole Meclizine HCL Ibuprofen Dichlorobenzyl Alcohol Amymetacresol 3. Interview (a) a medical doctor/physician, and (b) a community pharmacist regarding their insights on RA 6675, then make a conclusion/remarks regarding the actual scenario on the implementation of the Generics Act. a. Medical Doctor - Dr. Philip Manuel M. Oliva -“The Generic Drug Law was passed to ensure that you receive the savings from using a lower cost generic drug selected by a pharmacist in place of the brand name drug prescribed. Your pharmacist is required to make this selection when he or she has a lower cost generic drug in stock unless you or your doctor prefer a brand name and choose not to have a substitution. By using generic drugs, your savings can be substantial.” b. A community pharmacist – Ma’am Madonna Magno -“Dispensing of drugs which are identified by their generic names is clearly practiced nowadays. Most of the physicians prescribe medicines indicating the generic name, and sometimes accompanied by a specific brand. Generic names of drugs written on physicians pad allows consumers to choose at least what brand of medicine are they going to purchase. They may be branded or the generic counterpart of

1 2 1 1 3 4 4

4 1 2

1 3 1 3

4

4 1 1

1 1 1 1 1 1 1

the drug. Since the GENERICS ACT identifies the dispensing and distribution of generic drugs, we try to recommend first the generic counterpart of drugs before the branded one.” CONCLUSION: We therefore conclude that the Generics Act was especially made for the people of our country. Since many of us Filipinos are not financially and medically well supported, the Generics Act enable us to save more money and it allows us to choose from branded drugs which are more expensive than to the generic ones which is much more cheaper and has still has the same level of efficacy. 4. State the significance of the Generics Act to thed. Pharmacy profession – For the pharmacy profession, the significance of having the Generics Act is that it makes the pharmacy profession even wider because as Health Care providers it give us more knowledge and help us to become competitive enough in the different drugs that are available in our community. e. Community health – The significance with regards to the community health is that the Generics Act gives the patient a lot more options to choose from and it helps them to save more money without them having to buy a lesser efficacy of the product. It helps them both socially and economically. Illustrate an ideal label for drug products in unit doses or those transferred to small bottles, tin cans, boxes, plastics &/or paper envelopes pursuant to the requirements of AO 63. -Illustration at the back. Briefly discus the pillars of the Philippine National Drug Policy. a. A Quality Assurance of Drugs – The quality assurance of safe and effective pharmaceutical products through control is a basic need -The pillar requires the regulation of the importation, manufacturer, marketing, consumer, utilization of all pharmaceutical products. This is task of the BFAD b. Rational Use of Drugs by Health Care Professionals and Consumers -The promotion of the rational use of drugs by health professionals and consumers c. National Self-Sufficiency in Pharmaceuticals -Development in self-sufficiency in manufacturing of drugs d. Rationalization of the DOH’s Procurement Program -Designed to achieve economies of bulk purchasing and enhance the DOH resources e. People Empowerment -To cut across the 4 pillars -Aims to assist people in exercising an informed choice in the purchase of cost-effective medicines.

5.

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ACTIVITY 8 Generic Dispensing Define generic dispensing. Differentiate it from generic prescribing. Generic Prescribing is prescribing of drugs or medicines using their generic name(s) or generic terminology while Generic Dispensing means dispensing the patient's/buyer's choice from among generic equivalents, i.e., finished pharmaceutical products having the same active ingredient(s), same dosage form and same strength as the prescribed drug. Trace the flow of generic dispensing through a chart.

2.

3.

Give the kinds of incorrect prescriptions and state the provisions making prescriptions incorrect pursuant to RA 6675 Section 2 Guidelines On Dispensing Based on Prior Laws Prior to the Generic Act of 1988, the following general guidelines on dispensing have been operative. In order to have an integrated implementation of all relevant guidelines on dispensing, these guidelines based on prior laws are restated hereunder: 2.1. Prescription or Ethical Drugs These drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian. 2.2 Non-Prescription or Over-the-Counter (OTC) Drugs

These drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing OTC drugs without a doctor’s prescription, the pharmacist shall give the necessary information and direction for use of the drug. 2.3. All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a prescription book duly-registered by BFAD which shall be open for inspection to Food and Drug Inspectors at any time during business hours of the outlet. This prescription book shall be kept for two years after the last entry. Section 3. Additional Guidelines on Dispensing to Implement the Generics Act of 1988 In addition to the guidelines contained in Section 2, the following shall specifically guide dispensing under the Generics Act of 1988: 3.1. All drug outlets are required to practice generic dispensing as defined in Section 1.2 of these Rules and Regulations, with some exceptions, modifications or qualifications in certain cases or circumstances, as described in Section 3.2 and 3.4. 3.1.1. Drug Stores, Boticas, and other Drug Outlets In order to ensure the informed choice and use of drugs by the patient/buyer, the drug outlet is required to: 3.1.1.1. Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose. 3.1.1.2. For this purpose, all drug outlets shall post in a conspicuous place in their establishment a list of drug products using generic names with their corresponding current prices. A hand-book or directory containing the above required information, readily accessible to the patient/buyer shall be considered substantial compliance. 3.1.2. Hospital Pharmacies Recognizing the special needs and circumstances of hospitals, the following modified rules and regulations shall govern generic dispensing in hospital pharmacies, in the case of in-patients only: 3.1.2.1. Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug policies or reserve the option to buy drugs and medicines outside of the hospital pharmacy. 3.1.2.2. Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health (DOH), and using generic terminology in procurement, prescribing, dispensing, and recording of drugs, shall be exempted from the following: 3.1.2.3. Recording of prescriptions filled in the prescription book, provided such prescription book, provided such prescriptions shall be kept in file for two years. 3.1.2.4. Individually informing the in-patient/buyer on the available generic equivalents and their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the wards for patients, responsible relatives of patients, and professional staff. 3.2. In dispensing to the buyer, drug products in unit dose or products which are not in their original containers but transferred to small bottles, tin cans, boxes, plastic and/or paper envelopes and the like, the pharmacist shall place legibly on the required drug outlet's label the following information: 1. Name of the patient; 5. Dosage strength; 2. Generic name of the drug; 6. Expiry date; 3. Brand name, if any; 7. Directions for use; and 4. Manufacture; 8. Name of pharmacist 3.3. In partial filling of the prescription, the following shall be written on the face of the prescription: 1. the date of partial filling. 2. the quantity served and balance of the prescription unserved; and 3. name and address of the drugstore The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file. 3.4. Dispensing drugs in List A and List B In dispensing drugs included in List A (Prohibited and Regulated Drugs) and List B (Drugs Requiring Strict Precautions in their Use), attached as Annex and B respectively, the followingshall be observed: 3.4.1. Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled. 3.4.2. The order and instructions of the doctor as written on the prescription, must be precisely followed. 3.4.3. Partial filling of prescription for drugs belonging to List A shall not be allowed. Section 4 Guidelines on what to do with violative, erroneous,and impossible prescriptions 4.1. Violative and impossible prescriptions as defined in A.O. 62 (Generic Prescribing) shall not be filled. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. These violative and wrong prescriptions shall be kept and reported by the pharmacist or other interested parties to the nearest DOH office for appropriate action. 4.2. Erroneous prescriptions shall be filled, but they shall also be kept and reported to the nearest DOH office for appropriate action.

SECTION 5 Violations on the part of dispensers and outlets The following acts or omissions are considered violations of these rules and regulations: 5.1. Imposing a particular brand or product on the buyer. 5.2. Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as to any or all of the following: active ingredient, dosage form and strength. 5.3. failure to post or make accessible the required up-to-date information on drug products. 5.4. failure to adequately inform the buyer on available products that meet the prescription. 5.5. failure to indicate the generic name/official name designated by BFAD and other required information on the drug outlet's label of the dispensed drug. 5.6. failure to record and keep prescriptions filled. 5.7. failure to report to the nearest DOH office cases of violative, erroneous, and/or wrong prescriptions within three months after receipt of such prescriptions. SECTION 6 Reporting and Monitoring of Non-Compliance Any interested party may report any verifiable violation of these Rules and Regulations to the nearest DOH office. the local DOH office is responsible for giving notice to erring pharmacists/outlets and for transmitting the report on violations to the Secretary of Health or the fiscal's office for appropriate action. SECTION 7 Administrative Sanctions For violation of these Rules and Regulations, the following sanctions, after due notice and summary hearing, may be imposed: 7.1. Suspension, or revocation of the license to operate the drug outlet by the Secretary of Health. 7.2. Professionals directly involved in the violations shall be recommended by Secretary of Health for appropriate administrative sanctions by the PRC. SECTION 8 Criminal Liability The imposition of the above sanctions does not preclude the institution of appropriate criminal proceedings pursuant to Section 12 of RA 6675 known as the Generics Act of 1988, RA 3720 known as"Foods, Drugs and Devices and Cosmetics Act" as amended and R.A. 5921 known as "Pharmacy Law" as amended, R.A. 6425 known as the Dangerous Drugs Act of 1972 as amended and other relevant laws, by the regional health office concerned, upon receipt of complaints or reports of violations. 4. 5. 6. Identify whether the prescriptions (to be given by the instructor) are correct or incorrect. If incorrect, identify the kind/type and what makes it incorrect Photocopy at least (5) incorrect prescriptions received in your pharmacy. Identify the errors. Define/Describe the following: (a) Poster/s - Eye-catching printed paper announcement or advertisement that is exhibited to promote a product, event, or idea. (b) Handbook/ Directory Drug List - is a comprehensive database for drugs, and active ingredients with a full profile including:  Pharmacology  Indications and doses  Contraindications  Side and Adverse Effects  Using with pregnancy and lactation  Known and unknown allergy cases  Drug-drug Interactions  Drug-food Interactions  Drug-laboratory Interferences  Drug Storage  Patient Advising  Drug Alternatives Rx-Care Drug Directory enables the user searching by trade name, active ingredient, ATC code, anatomical group, therapeutic group, pharmacological group, and chemical group. (c) Menu Card – list of drugs which can be suggested to consumers. It contains gift certificates in which cash can be converted to. How are prescriptions filed? FILING PRESCRIPTIONS Prescriptions that have been filled must be maintained in one of several separate files:  Schedule II and III narcotics—Prescriptions containing narcotics are numbered consecutively, preceded by the letter “N,” and filed separately.  Alcohol—These prescriptions are numbered consecutively, preceded by the letter “A,” and filed separately.  Schedule III (nonnarcotic), IV, and V drugs—these prescriptions are part of and are numbered in the same manner as the general files; however, they are maintained separately.  General files—All other prescriptions are numbered consecutively and filed together. Currently, prescriptions are required to be kept on file for at least 2 years after the date of issue. What is referred to as “right of informed choice”?

7.

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Informed choice is a voluntary, well-considered decision that an individual makes on the basis of options, information, and understanding. The decision-making process should result in a voluntary and informed decision by the individual about whether or not he or she wishes to obtain health services and, if so, what method or procedure the individual will choose and consent to receive. Briefly discuss the substitution for bioequivalent drugs. When a company develops a generic version of a trade-name drug, the company's experts in drug formulation must figure out how to make it. It is not enough for them to simply reproduce the trade-name drug's chemical structure or to buy the active ingredient from a chemical manufacturer. Although 250 milligrams (mg) of a trade-name chemical is identical to 250 mg of the same generic chemical, a 250-mg generic pill containing that chemical may or may not have the same effect in the body as a 250-mg tradename pill. That is because everything that is used in a particular product formulation affects how it is absorbed into the bloodstream. Inactive ingredients such as coatings, stabilizers, fillers, binders, flavorings, diluents, and others are necessary to turn a chemical into a usable drug product. These ingredients may be used to provide bulk so that a tablet is large enough to handle, to keep a tablet from crumbling between the time it is manufactured and the time it is used, to help a tablet dissolve in the stomach or intestine, or to provide a pleasant taste and color. Inactive ingredients are usually harmless substances that do not affect the body. However, because inactive ingredients can cause unusual and sometimes severe allergic reactions in a few people, one version, or brand, of a drug may be preferable to another. For example, chemicals called bisulfites (such as sodium metabisulfite), which are used as preservatives in many products, cause asthmatic allergic reactions in many people. Consequently, drug products containing bisulfites are prominently labeled as such. Although people generally think of oral dosage forms, such as tablets, capsules, and liquids, when they think about generic prescription drugs, generic versions of other drug dosage forms, such as injections, patches, inhalers, and others, must also meet a bioequivalence standard. The FDA sets bioequivalence standards for different drug dosage forms. The manufacturer of the trade-name drug also must prove bioequivalence before a new form of an approved drug can be sold. New forms include new dosage forms or strengths of an existing trade -name drug product and any other modified form that is developed, as well as new generic drugs. Sometimes the form that was originally tested is modified for commercial reasons. For example, tablets may need to be made sturdier, flavoring or coloring may be added or changed, or inactive ingredients may be changed to increase consumer acceptance.

10. Design a way to or strategy to promote generic dispensing or to inform the public to exercise the right of informed choices. a. No treatment shall be given without the client's informed consent, except in accordance with the law. b. Consent must be for that particular treatment or plan of treatment. c. Consent can be withdrawn at any time. d. Information about the treatment must be provided in writing on request. e. Every effort must be made to promote understanding and access to information about proposed treatments. f. Every client is presumed to have decision-making capacity unless found to be incapable. g. Consent must be voluntary and not obtained by coercion or misrepresentation. h. If a client is legally found to be incapable of making decisions, her/his substitute decision-maker has the same rights as the client to informed consent. i. Every client: 1) has the right to have her/his prior capable wishes respected to the fullest extent that the law allows. 2) has the right to be fully involved in treatment decisions (including location, duration and type of treatment). 3) including those considered incapable of making treatment decisions, has the right to be involved in the development of her/his treatment goals, plan of care and discharge planning.

1. 2.

ACTIVITY 9 Food, Drugs, Devices, and Cosmetics Act (RA 3720) Read and understand RA 3720 and be familiar with its provisions When are drugs and devices deemed to be misbranded? According in the RA 3720 Chapter VIII Section 19. A drug or device shall be deemed to be misbranded: a) If its labeling is false or misleading in any particular. b) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary. c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, cabromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulfonmethane; or any chemical derivative of such substance, which derivative has been recommended by the Secretary, after investigation, and by regulations, designated as, habit forming; unless its label bears the name, and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement "Warning May be habit forming." e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not, the name and quantity of proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides mercury, ouabain, strophantin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided, That where compliance with this paragraph in impracticable, exemptions shall, upon recommendation of the Food and Drug Administrator, be established by regulations promulgated by the Secretary. f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as necessary for the protection of users: Provided, That where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations exempting such drug or device from such requirement. g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein: Provided, That the method of packing may be modified with the consent of the Secretary. h) If it has been found by the Secretary to be a drug liable to determination, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health. i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug. j) If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof. k) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other anti-biotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate of release has been issued pursuant to Section twenty-two (a), and (2) such certificate of release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under Section twenty-one (a), (b) and (c).

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When are drugs and devices deemed to be adulterated? According in the RA 3720 Chapter VIII Section 18, A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions contaminated with filth or whereby it may have been rendered injurious to health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than a permissible one. (b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium, except that whenever tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination the Secretary, shall promulgate, upon recommendation of the Food and Drug Administrator, regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality or purity in strength, quality, or purity from such standards is plainly stated on its label. (c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity of quality falls below, that which it purports or its represented to possess. (d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefore. Make a literature or internet search about misbranded or adulterated products in the Philippines. Cite examples by showing pictures or related articles about these products, if available. First Posted 09:06am (Mla time) 10/21/2007 MANILA , Philippines – There was a time when drugstores sold mainly medicine. Now, they have evolved into mini department stores, cosmetic bars and groceries selling anything from diabetic medication to chocolates and umbrellas. A parallel evolution in the production of health-related products has led to an enormous consumption of food supplements, herbal concoctions and energy boosters. The health product market has grown so diverse and huge that Filipino consumers have fallen prey to slick marketing campaigns. With movie stars, celebrities and broadcast journalists swearing by the latest dietary supplements, who’s to tell what’s safe and effective, what’s real and what’s just hype? The recent recall of several food products and toys from China also begs the question: when it comes to health, who’s looking out for the welfare of ordinary consumers? In the Philippines, the task of monitoring drugs, diagnostic reagents, medical devices, cosmetics and household hazardous substances falls squarely on the Bureau of Food and Drugs (BFAD), the watchdog agency in the country. In an e-mail interview, Pharmacist VI Virginia Francia C. Laboy, OIC of BFAD’s Policy, Planning and Advocacy Division, states that the agency traces its mandate to two laws: Republic Act No. 3720 and Republic Act No. 7394. RA 3720 is also known as the Foods, Drugs and Devices, Cosmetics Act as amended by EO 175, which created the BFAD, while RA 7394 is otherwise described as the Consumer Act of the Philippines. Among BFAD’s many tasks are the evaluation and registration of products, their analysis and testing, the issuance of health advisories, and the monitoring of advertisements and promotions to make sure that the product information given is true and accurate. Laboy reveals that all food products, including imported ones, must be registered with the BFAD, which checks if they contain only safe

4.

A beauty product, earlier found by the Bureau of Food and Drugs (BFAD) to have deviated from its indicated formulation, has been allowed to be sold to the public despite the possible public health risk involved. A BFAD report said the RDL Babyface Astringent, was "not only adulterated but also misbranded" and that its factory in Davao City did not comply with the bureau’s "good manufacturing practice (GMP) policy" to make sure products are clean and of high quality to protect public health. The findings were on top of the product not having BFAD registration, which is required before any product of that nature could be sold. BFAD regulation officer Rhoda Laine Manaloto said in a report dated January 2000 that RDL Babyface Astringent "did not conform to its label claim and to a BFAD approved label, rendering the product not only adulterated but misbranded. Manaloto had recommended legal action against RDL. Months later, BFAD rejected the registration application of the product for "non-conformity to product specification" and yet allowed it to be sold anew. Last August, acting on a complaint, BFAD seized more than 60,000 bottles of RDL Babyface in the company’s premises in Davao City. But again a BFAD official allegedly released them "for reasons of financial burden" and because RDL had filed a new application to register. The astringent was finally registered last Dec. 27. In her report, Manaloto said the samples showed varying potency, meaning the formulation of one batch of the product differed from another. "The factory also failed to conform with GMP due to unreadable lot and number and expiry date," she said. A different kind of drug watch By Marian C. Martin Inquirer

ingredients and have passed the standards in food preparation. The agency also analyzes food products based on their microbiological specifications and allowable limits of additives. Product samples collected from the market are tested continuously in the agency’s laboratories to make sure they are not adulterated and conform to safety standards. ”We do not consider food as ‘fake’ but ‘adulterated’ or ‘misbranded’,” says the BFAD official. Products which are the subject of complaints or disputes are also tested here, with the testing period usually extending from two to four weeks. Laboy cites the case of the drug Cytotec as one instance when consumer reports decided its fate. Originally approved for the treatment and prevention of gastritis induced by nonsteroidal anti-inflammatory drugs, Cytotec came under fire after reports that it was being used as an abortifacent. The reports prompted the BFAD to issue in 1994 a memorandum circular limiting the sale and dispensing of the drug to tertiary hospital pharmacies and big drugstore chains. In 1998, Cytotec’s manufacturer, GD Searle Philippines. Inc., voluntarily withdrew the product from the market, although reports reached BFAD that the drug was still being sold by sidewalk vendors. Says Laboy: “In August 2002, BFAD warned the public against dispensing/selling and using the drug product because it was no longer registered with BFAD. If a drug is not registered with us, we cannot assure its safety, efficacy and quality.” The episode illustrates the limitations of the agency’s powers, points out Laboy. “We have been receiving reports that this product is still available in the market but the establishments where it is being sold (sidewalks, etc.) are no longer within BFAD jurisdiction. They fall under the Local Government Units.” Nonetheless, violators of RA 3720 face a jail term of from six months and one day to more than five years, or a fine of not less than a thousand pesos. Another challenge that BFAD faces, adds Laboy, is its limited resources, particularly in terms of personnel needed to monitor erring products. It is still up to an alert public to keep itself informed and updated on which products promote health or otherwise endanger it, she adds.

5.

Research about Bureau of Food and Drugs, its organization, functions, powers and duties. Republic Act No. 9711. AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled: Section 1. The Bureau of Food and Drugs (BFAD) is hereby renamed the Food and Drug Administration (FDA). Section 2. This Act shall be known as the "Food and Drug Administration (FDA) Act of 2009". Section 3. It is hereby declared a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish and maintain an effective health products regulatory system and undertake appropriate health manpower development and research, responsive to the country's health needs and problems. Pursuant to this policy, the State must enhance its regulatory capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments and the registration and monitoring of health products. Section 4. This Act has the following objectives: (a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction; (b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction; and (c) To provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction. Section 5. Section 4 of Republic Act No. 3720, as amended, is hereby further amended to read as follows: "SEC. 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration (FDA) in the Department of Health (DOH). Said Administration shall be under the Office of the Secretary and shall have the following functions, powers and duties: (a) To administer the effective implementation of this Act and of the rules and regulations issued pursuant to the same; (b) To assume primary jurisdiction in the collection of samples of health products; (c) To analyze and inspect health products in connection with the implementation of this Act; (d) To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container; (e) To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA; (f) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate authorizations to ensure safety, efficacy, purity, and quality; (g) To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person; (h) To issue cease and desist orders motu propio or upon verified complaint for health products, whether or not registered with the FDA Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed; (i) After due process, to order the ban, recall, and/or withdrawal of any health product found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization; (j) To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products; (k) To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products; (l) To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA; (m) To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act;

To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and (o) To exercise such other powers and perform such other functions a8 may be necessary to carry out its duties and responsibilities under this Act." Section 6. Section 5 of Republic Act No. 3720, as amended, is hereby further amended and new subsections are added to read as follows: "SEC. 5. The FDA shall have the following centers and offices: "(a) The Centers shall be established per major product category that is regulated, namely: "(1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biological); "(2) Center for Food Regulation and Research; "(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances); and "(4) Center for Device Regulation, Radiation Health, and Research. "These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products. The Centers shall likewise conduct research on the safety, efficacy, and quality of health products, and to institute standards for the same. "(b) Each Center shall be headed by a director. The Centers shall be so organized such that each will have, at least, the following divisions: "(1) Licensing and Registration Division, which shall be responsible for evaluating health products and establishments as covered by this Act for the purpose of issuance of authorizations and conditions to be observed; "(2) Product Research and Standards Development Division, which shall be responsible for the conduct of research, development of standards and regulations, compliance monitoring, and the oversight and audit of related researches that would ensure safety, quality, purity and efficacy of health products, as covered in this Act; and "(3) Laboratory Support Division, which shall be responsible for the conduct of research and appropriate tests and calibration, analyses and trials of products including, but not limited to, assays, and the conduct of oversight and/or audit of centers conducting bioavailability and bioequivalence tests and other tests as covered by this Act. It shall likewise provide direct line support to the centers which shall be separate and distinct per major product category that is regulated. "(c) The Administration and Finance Office headed by the deputy director-general for administration and finance shall have, at least, the following divisions: the Human Resource Development Division; Property and Logistics Management Division; Human Resource Management Division; Assets and Financial Management Division; and the Information and Communication Technology Management Division. "(d) The Policy and Planning Office which shall be under the Office of the Director-General shall have, at least, a training, advocacy and communications division and shall monitor the performance of the centers for product research and evaluation and standards development. "(e) The Field Regulatory Operations Office headed by the deputy director-general for field regulatory operations shall include, among others, all the field offices, field or satellite laboratories and the regulator y enforcement units. "(f) The Legal Services Support Center shall provide legal services to the entire FDA and shall be directly under the Office of the Director-General." Section 7. Section 6 of Republic Act No. 3720, as amended, is hereby further amended, to read as follows: "(a) The FDA shall be headed by a director-general, with the rank of undersecretary, who shall be tasked, among others, to determine the needed personnel and to appoint personnel, below the assistant director level in coordination with the Secretary of Health. "(b) The director-general shall be assisted by two (2) deputy directors-general, one for administration and finance and another for field regulatory operations. "(c) The director-general and deputy directors-general shall be appointed by the President of the Republic of the Philippines. "(d) The director-general shall, preferably, possess either a university degree in medicine or at least the relevant master's degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management. In addition, he/she shall have management experience in his/her field of discipline or profession and in any development, manufacturing, regulatory work or quality assurance of products as covered in this Act. "(e) The Deputy Director-General for Field Regulatory Operations of the FDA shall, preferably, possess the relevant master's degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management. In addition, he/she shall have management experience in his/her field of discipline or profession and in any development, manufacturing, regulatory work or quality assurance of products as covered in this Act. "(f) The Deputy Director-General for Administration and Finance of the FDA shall he a certified public accountant or shall possess a master's degree in accounting, management, economics or any business course, and must have management experience in a position related to his/her field of discipline or profession.

(n)

"(g) A person who was previously employed in a regular full-time capacity regardless of its consultative designation at higher management supervisory levels in regulated establishments, including related foundations shall be disqualified from appointment as director-general and deputy director-general within three (3) years from termination of employment with the said establishment or foundation. All persons who are candidates for appointment as director-general and deputy director-general must disclose all their incomes for the past three (3) years from all establishments regulated by this Act. The director-general and the two (2) deputy directors-general shall, upon assumption into office, declare any conflict of interest with any establishment covered by the FDA, including their foundations. "(h) Each center and field office shall be headed by a director who shall be assisted by an assistant director. These directors shall be appointed by the Secretary of Health. "(i) The existing directors of the Bureau of Health Devices and Technology (BHDT) and division chiefs of the BFAD shall be given preference for appointment as directors and assistant directors of their respective centers: Provided, That if the current officers of the BFAD and the BHDT applying for the above positions lack the required third level civil service eligibility, they will have to comply with the said requirement within three (3) yearn from their appointment, otherwise their appointment shall be revoked immediately." ACTIVITY 10 COMPREHENSIVE DANGEROUS DRUGS ACT (RA 9165) 1. Read and understand the Comprehensive Dangerous Drugs Act and be familiar with its provisions. 2. Give the descriptions of the following terms based on RA 9165: a. Dangerous Drugs – include those listed in the Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol, and in the Schedules annexed to the 1971 Single Convention on Psychotropic Substances and made as an integral part of RA 9165, as well as those classified as such by the Dangerous Drugs Board pursuant to Section 93, Article XI of RA 9165. Such drugs are those that when ingested by or administered to a person for reasons other than for medical purposes cause physical, emotional and/or behavioral changes to the person concerned. b. Controlled Precursors and Essential Chemicals – include those listed in Tables I and II of the 1988 UN Convention Against Illicit Traffic InNarcotic Drugs and Psychotropic Substances and made as an integral part of RA 9165, as well as those classified as such by the DangerousDrugs Board pursuant to Section 93, Article XI of RA 9165. Controlled precursors are those that are used in the manufacture of a narcotic drug or psychotropic substance, which in the process of manufacture becomes part of the molecular structure of the narcotic drug or psychotropic substance. Essential chemicals, such as reagents and catalysts, are those that are essentially used in the manufacture of a controlled substance, but do not become part of the molecular structure of the drug. c. Narcotic Drugs The 1961 Convention, which was expanded and strengthened by the 1972 Protocol, is considered a major achievement in international drug control because it consolidated all previous conventions and streamlined the international drug control machinery. The 1961 Convention establishes strict controls on the cultivation of opium poppy, coca bush, cannabis plant and their products, which, in the Convention, are described as "narcotic drugs" (although cocaine is a stimulant drug rather than one that induces sleep). Control is exercised over 119 narcotic drugs, mainly natural products, such as opium and its derivatives, morphine, codeine and heroin, but also synthetic drugs, such as methadone and pethidine, as well as cannabis and coca leaf. Parties to the 1961 Convention undertake to limit the production, manufacture, export, import, distribution and stocks of, trade in and use and possession of the con trolled drugs so that they are used exclusively for medical and scientific purposes. The production and distribution of controlled substances must be licensed and supervised, and Governments must provide estimates and statistical returns to INCB on the forms supplied for that purpose, on the quantities of drugs required, manufactured and utilized and the quantities seized by police and customs officers. The control system established under the 1961 Convention functions well, and the system of estimates first introduced by the 1931 Convention is considered to be the key to that success. The system of estimates covers all States, regardless of whether or not they are parties to the 1961 Convention. Each year, INCB publishes in technical publication information about the licit movement of the internationally controlled narcotic drugs. d. Psychotic Drugs The 1971 Convention was adopted to curtail the diversion and abuse of certain psychotropic substances, such as central nervous stimulants, sedative-hypnotics and hallucinogens, which had resulted in public health and social problems in some countries. By implementing the provisions of the Convention, parties to the 1971 Convention should comply with the dual aim of (i) limiting the use of psychotropic substances to medical and scientific purposes and (ii) ensuring their availability for those purposes. Currently one hundred sixteen psychotropic substances are controlled under the 1971 Convention. Governments must provide statistical returns on manufacture, imports and exports of psychotropic substances to INCB on the forms supplied for that purpose. In addition, they should provide complementary information on psychotropic substances, based on recommendations of the Economic and Social Council. The controls foreseen under the 1971 Convention together with the additional controls required by the Economic and Social Council have significantly reduced the diversion of psychotropic substances. INCB publishes each year information on the licit movement of psychotropic substances in a technical publication .

3. Attach a copy of the list of Controlled Precursors and Essential Drugs and of dangerous Drugs and be familiar with the enlisted drugs. LIST OF SUBSTANCES IN TABLE I 1. ACETIC ANHYDRIDE 8. 3, 4-METHYLENEDIOXYPHENYL-2 PROPANONE 2. N-ACETYLANTHRANILIC ACID 9. NOREPHEDRINE 3. EPHEDRINE 10. 1-PHENYL-2-PROPANONE 4. ERGOMETRINE 11. PIPERONAL 5. ERGOTAMINE 12. POTASSIUM PERMANGANATE 6. ISOSAFROLE 13. PSEUDOEPHEDRINE 7. LYSERGIC ACID 14. SAFROLE LIST OF SUBSTANCES IN TABLE II 1. ACETONE 6. PHENYLACETIC ACID 2. ANTHRANILIC ACID 7. PIPERIDINE 3. ETHYL ETHER 8. SULPHURIC ACID 4. HYDROCHLORIC ACID 9. TOLUENE 5. METHYL ETHYL KETONE LIST OF DRUGS INCLUDED IN SCHEDULE I 1. Acetorphine 6. Alphacetylmethadol 11. Alphaprodine 2. Acetyl-alpha-methylfentanyl 7. Alphameprodine 12. Anileridine 3. Acetylmethadol 8. Alphamethadol 13. Benzethidine 4. Alfentanil 9. Alpha-methylfentanyl 5. Allylprodine 10. Alpha-methylthiofentanyl 14. Benzylmorphine 17. Beta-hydroxy-319. Betamethadol 15. Betacetylmethadol methylfentanyl 20. Betaprodine 16. Beta-hydroxyfentanyl 18. Betameprodine 21. Bezitramide 22. Cannabis and Cannabis 50. Heroin 80. Normorphine resin and extracts and 51. Hydrocodone 81. Norpipanone tinctures of cannabis 52. Hydromorphinol 82. Opium 23. Clonitazene 53. Hydromorphone 83. Oxycodone 24. Coca leaf 54. Hydroxypethidine 84. Oxymorphone 25. Cocaine 55. Isomethadone 85. Para-fluorofentanyl 26. Codoxime 56. Ketobemidone 86. PEPAP 27. Concentrate of poppy straw 57. Levomethorphan 87. Pethidine 28. Desomorphine 58. Levomoramide 88. Pethidine intermediate A 29. Dextromoramide 59. Levophenacylmorphan 89. Pethidine intermediate B 30. Diampromide 60. Levorphanol 90. Pethidine intermediate C 31. Diethylthiambutene 61. Metazocine 91. Phenadoxone 32. Difenoxin 62. Methadone 92. Phenampromide 33. Dihydroetorphine 63. Methadone Intermediate 93. Phenazocine 34. Dihydromorphine 64. Methyldesorphine 94. Phenomorphan 35. Dihydromorphine* 65. Methyldihydromorphine 95. Phenoperidine 36. Dimenoxadol 66. 3-methylfentanyl 96. Piminodine 37. Dimepheptanol 67. 3-methylthiofentanyl 97. Piritramide 38. Dimethylthiambutene 68. Metopon 98. Proheptazine 39. Dioxaphetyl butyrate 69. Moramide intermediate 99. Properidine 40. Diphenoxylate 70. Morpheridine 100. Racemethorphan 41. Dipipanone 71. Morphine 101. Racemoramide 42. Drotebanol 72. Morphine methobromide 102. Racemorphan 43. Ecgonine 73. Morphine-N-oxide 103. Remifentanil 44. Ethylmethylthiambutene 74. MPPP 104. Sufentanil 45. Etonitazene 75. Myrophine 105. Thebacon 46. Etorphine 76. Nicomorphine 106. Thebaine 47. Etoxeridine 77. Noracymethadol 107. Thiofentanyl 48. Fentanyl 78. Norlevorphanol 108. Tilidine 49. Furethidine 79. Normethadone 109. Trimeperidine LIST OF DRUGS INCLUDED IN SCHEDULE II 1. Acetyldihydrocodeine 6. Nicocodine 2. Codeine 7. Nicodicodine 3. Dextropropoxyphene 8. Norcodeine 4. Dihydrocodeine 9. Pholcodine 5. Ethylmorphine 10. Propiram LIST OF DRUGS INCLUDED IN SCHEDULE III 1. Preparations of : Acetyldihydrocodeine, Nicocodine, Codeine, Nicodicodine, Dihydrocodeine, Norcodeine and Ethylmorphine, Pholcodine LIST OF DRUGS INCLUDED IN SCHEDULE IV 1. Acetorphine 2. Acetyl-alpha-methylfentanyl

3. Alpha-methylfentanyl 4. Alpha-methylthiofentanyl 5. Beta-hydroxy-3-methylfentanyl 6. Beta-hydroxyfentanyl 7. Cannabis and Cannabis resin 8. Desomorphine 9. Etorphine 10. Heroin LIST OF SUBSTANCES IN SCHEDULE II 1. AMFETAMINE (AMPHETAMINE) 2. DEXAMFETAMINE (DEXAMPHETAMINE) 3. FENETYLLINE 4. LEVAMFETAMINE (LEVAMPHETAMINE) 5. LEVOMETHAMPHETAMINE 6. MECLOQUALONE 7. METAMFETAMINE (METHAMPHETAMINE) 8. METHAMPHETAMINE RACEMATE 9. METHAQUALONE

11. 12. 13. 14. 15. 16. 17.

Ketobemidone 3-methylfentanyl 3-methylthiofentanyl MPPP Para-fluorofentanyl PEPAP Thiofentanyl

10. METHYLPHENIDATE 11. PHENCYCLIDINE (PCP) 12. PHENMETRAZINE 13. SECOBARBITAL 14. DRONABINOL (delta-9-tetrahydro-cannabinol and its stereochemical variants) 15. ZIPEPROL 16. 2C-B(4-bromo-2,5-dimethoxyphenethylamine

LIST OF SUBSTANCES IN SCHEDULE III 1. AMOBARBITAL 2. BUPRENORPHINE 3. BUTALBITAL 4. CATHINE (+)-norpseudo-ephedrine 5. CYCLOBARBITAL 6. FLUNITRAZEPAM 7. GLUTETHIMIDE 8. PENTAZOCINE 9. PENTOBARBITAL Substances in Schedule IV 1. ALLOBARBITAL 2. ALPRAZOLAM 3. AMFEPRAMONE 4. AMINOREX 5. BARBITAL 6. BENZFETAMINE(benzphetamine) 7. BROMAZEPAM 8. Butobarbital 9. BROTIZOLAM 10. CAMAZEPAM 11. CHLORDIAZEPOXIDE 12. CLOBAZAM 13. CLONAZEPAM 14. CLORAZEPATE 15. CLOTIAZEPAM 16. CLOXAZOLAM 17. DELORAZEPAM 18. DIAZEPAM 19. ESTAZOLAM 20. ETHCHLORVYNOL 21. ETHINAMATE 22. ETHYL LOFLAZEPATE 23. ETILAMFETAMINE(N-ethylampetamine) 24. FENCAMFAMIN 25. FENPROPOREX 26. FLUDIAZEPAM 27. FLURAZEPAM 28. HALAZEPAM 29. HALOXAZOLAM 30. KETAZOLAM 31. LEFETAMINE(SPA) 32. LOPRAZOLAM 33. LORAZEPAM 34. LORMETAZEPAM 35. MAZINDOL 36. MEDAZEPAM 37. MEFENOREX

38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61.

MEPROBAMATE MESOCARB METHYLPHENOBARBITAL METHYPRYLON MIDAZOLAM NIMETAZEPAM NITRAZEPAM NORDAZEPAM OXAZEPAM OXAZOLAM PEMOLINE PHENDIMETRAZINE PHENOBARBITAL PHENTERMINE PINAZEPAM PIPRADROL PRAZEPAM PYROVALERONE SECBUTABARBITAL TEMAZEPAM TETRAZEPAM TRIAZOLAM VINYLBITAL GHB (Gamma-Hydroxyburic acid) Zolpidem

4. Outline the procedures to be served in dispensing dangerous drugs pursuant to RA 9165. The prescribing and dispensing of controlled substances receives extensive treatment in Chapter 453 of the Nevada Revised Statutes. Nonetheless, this subject is largely governed by federal regulations, and the practitioner must be aware of both federal and state law when prescribing or dispensing controlled substances. Definitions Specific to Controlled Substances Narcotic Drug includes, but is not limited to, any opium derivative, synthetic opiate, cocaine, ecgonine, poppy straw, and any compound, mixture, or preparation containing any quantity of the above and other listed substances. NRS 453.101. Opiate means any substance having, or capable of conversion into a substance having, an addiction-forming or addiction-sustaining liability, similar to morphine. NRS 453.106. Steroid means any of the compounds that contain a hydrogenated cyclopentophenanthrene-ring system, including the sterols. Controlled substances are listed in five schedules, depending on their potential for abuse, degree of physical or psychological abuse caused, and whether the substances have been accepted for medical use in the United States. NRS 453.166 to 453.206. The exact substances that make up Schedule I through V are listed in the Nevada Administrative Code sections 453.510 to 453.550 (reproduced in the appendix, below). Registration Requirements Nevada law grants the Board of Pharmacy broad powers to regulate and enforce laws and regulations related to the prescription and dispensing of controlled substances. The board may grant or deny registration to a practitioner, set regulations for the storage, inspection, and dispensing of controlled substances and records of controlled substances, and control the classification of the substances. Every practitioner who dispenses any controlled substance in Nevada must obtain a registration from the Board of Pharmacy. A separate registration is required at each principal place of business or professional practice where the applicant dispenses controlled substances. NRS 453.226. Dispensing controlled substances without being registered with the board is a category D felony in Nevada. NRS 453.232. Any person who is exempt from federal registration by federal laws and regulations for activities involving controlled substances is also exempted from registration in Nevada. NAC 453.100. The Board of Pharmacy charges a $50.00 fee for each registration and biennial reregistration. NAC 453.180. Prescription Requirements A practitioner who is registered with the board to possess and dispense controlled substances may dispense dangerous drugs or controlled substances only after he has issued a written prescription that authorizes the patient to have the prescription filled by the dispensing practitioner or at another location of the patients choosing. NRS 453.410. A practitioner may prescribe or administer controlled substances only for a legitimate medical purpose and in the usual course of his professional practice. NRS 453.381. Each Schedule II prescription must be written on a separate prescription blank or as an order on a patients chart. The prescription must contain the name of the practitioner, his signature if the prescription was not transmitted orally, his address if not immediately available to the pharmacist, the classification of his license, and his registration number from the Drug Enforcement Administration if it is not immediately available to the pharmacist. The name, strength, and quantity of the drugs must be included, as well as directions for use and the date of issue. Schedule II prescriptions must generally be written and signed entirely by hand, except that standard practitioner information, such as address and registration number may be preprinted, and the address of the patient and the practitioner may be added by the pharmacist. NRS 453.385. No Schedule II substance may be prescribed without a practitioners written prescription, unless stringent rules are followed. In an emergency a Schedule II substance may be dispensed without a written prescription, if it is reduced to writing promptly, and in all cases within 72 hours, signed by the practitioner, and filed by the pharmacy. In cases of direct administration to a patient or use in certain facilities, a facsimile machine transmission is authorized, if the transmission is printed on paper that is capable of being retained for two years. Refills are not authorized for Schedule II drugs. NRS 453.256. Generally, Schedule III, IV, or V substances cannot be dispensed unless a practitioner signs a prescription for the substance. NRS 453.385. Schedule III and IV substances that are dangerous drugs must not be dispensed without a written or oral prescription by a practitioner, unless administered directly by the practitioner to a patient. Prescriptions may not be refilled more than five times or more than six months after the original prescription, unless renewed by the physician. NRS 453.256. No practitioner may dispense a Schedule II, III, or IV substance for his own personal use except in a medical emergency. A violation of any of the above laws related to the prescription of dispensing of controlled substances constitutes a category E felony. NRS 453.256. Further, a physician may not prescribe, administer, or dispense a Schedule II controlled substance for himself, his spouse, or his children except in an emergency. NRS 453.381. All prescriptions for controlled substances must specifically indicate the portion of the body to which the medication is to be applied, or, if the medication is to be taken by means other than orally, the orifice or canal of the body into which the medication is to be inserted or injected must be specified. NRS 453.385. According to the board of medical examiners, a physician engages in prohibited professional conduct if he writes a prescription for a controlled substance for any person without making an appropriate examination that confirms the medical necessity for the controlled substance, or engages in the practice of writing prescriptions for controlled substances in amounts excessive enough to constitute a departure from the prevailing medical standards. A physician also engages in unprofessional conduct if he prescribes anabolic steroids to increase muscle mass for competitive or athletic purposes, or prescribes certain controlled substances for weight control (specifically, schedule II

or III controlled substances, controlled substance analogs, chorionic gonadotrophic hormones, thyroid preparations, or thyroid synthetics). NAC 630.230. Recording and Storage Requirements There are numerous requirements related to recording the dispensing of controlled substances and ensuring that controlled substances dispensed are done so in an accurate manner. In general, practitioners must keep complete, accurate, and readily retrievable records. Prescriptions must be serially numbered and kept in numerical order. Each record of a controlled substance dispensed must contain the patients name, and the patients address if it is not readily available from the practitioners records, as well as the name of the prescribing practitioner, his license classification, the practitioners DEA registration number. The signature of the prescribing practitioner, and the initials of the dispensing practitioner, if the dispensing practitioner did not prescribe the controlled substance, must be included. The name, strength, and quantity of the controlled substance must be recorded as must the date of the prescription. The record must also include directions for use of the controlled substance. NAC 453.410 A practitioner who is registered to possess controlled substances is required to establish and maintain effective controls and procedures to guard against theft and misuse of controlled substances. A dispensing practitioner must maintain a separate file for his schedule II controlled substances purchases as well as a separate file for the dispensing of each controlled substance. Prescriptions for controlled substances must be kept in a separate file according to the requirements set out by NAC 453.80. All controlled substances and dangerous drugs must be kept in a locked storage area, with access restricted to authorized persons. NAC 453.375. Practitioners dispensing dangerous drugs are responsible for ensuring that each package or container in which a controlled substance or dangerous drug is dispensed complies with all state and federal packaging requirements. Further, each package in which a controlled substance is dispensed must be clearly labeled according to the requirements of NRS 639.2801. NAC 453.410. As a condition of registration to dispense controlled substances, the Board of Pharmacy may inspect the establishment of a practitioner who dispenses controlled substances. NRS 453.226. With an administrative warrant, officers or employees of the Board of Pharmacy may enter the premises of a practitioner, inspect and copy records, and inventory the stock of any controlled substance and related equipment. No warrant is required to inspect books and records. NRS 453.261. Appetite Suppressants A physician who is authorized to prescribe controlled substances may prescribe appetite suppressants under certain specific conditions. Appetite suppressants are defined as drugs or other substances listed in schedule IV which are used to suppress the appetite of a natural person. Before prescribing an appetite suppressant, a physician must obtain a medical history and conduct a physical exam and appropriate studies to determine if the use of appetite stimulants is contraindicated in a patient. Appetite suppressants may be prescribed if used in the treatment of exogenous obesity as part of a program which includes dietary restrictions, modification of behavior, and exercise. The physician must determine that the patients obesity represents a threat to the patients health or the patients weight exceeds by twenty percent the upper limits of the patients healthy weight set forth by the U.S. Department of Health and Human Services. Appetite suppressants may not be prescribed for more than three months, unless the patient is losing at least two pounds a month or is maintaining a weight established by the physician, and the patient is weighed at the beginning and end of each month during the time the patient is taking the appetite suppressant. NAC 630.205.

5. Make a schematic diagram on the recording and filling procedures following pertinent DDB provision stated in RA 9165.

REQUIREMENTS FOR FILLING OF PRESCRIPTION

YELLOW PRESCRIPTION (IN TRIPLICATE COPIES) THAT IS GIVEN TO THE PHARMACY UPON RECIEVEING REQUIREMENTS NEEDED DISPENSING OF DANGEROUS DRUG

S-2 LICENSE OF A PHYSICIAN, VETERINARIAN OR ANY LICENSED MEDICAL PRACTITIONER

COUNSELING ABOUT THE DRUG AND ITS POSSIBLE HARMFUL EFFECTS WHEN MISUSED

RECORDING OF PATIENT INFORMATION, PURCHASED DRUG, QUANTITY, DATE OF TRANSACTION, TYPE OF FILLING DONE AND SIGNATURE OF THE CUSTOMER IN THE DAGENGEROUS DRUG RECORD BOOK

TAKING AND FILLING OF THE PRESCRIPTION IN THE PHARMACY (FOR ONE YEAR) WHEN DRUG HAS BEEN FULLY SERVED AND RECORING IF ONLY PARTIALLY

1.

ACTIVITY 11 Pharmacy Physical Set-up What is the minimum size or floor area for a community pharmacy? Substantiate your answer with a law providing such requirement. According to Administrative Order no. 56, s. 1989, a community pharmacy should be a well-ventilated area not less than 15 sq. m. in floor area with concrete, tile or wooden flooring. What is the equal floor area of your community pharmacy? Is it pursuant to the requirements? The actual floor area of our pharmacy, Mercury Drugstore-Porta Vaga, is approximately 96 sq. m. It is pursuant to the requirements having more than 15 sq.m in area. A. What is a prescription area? Describe the area. State its importance in the pharmacy. Prescription area is an area of the pharmacy used for compounding, legend drug storage and other activities necessary to the practice of pharmacy. The term does not include waiting counters or display space attached to the waiting counters. The minimum size of the prescription area must be at least 250 square feet, and must be large enough, considering the level of activity, to carry on the practice of pharmacy in a manner that protects the health and safety of professionals, employees and the public. Within the prescription area, there must be a prescription working counter of at least 10 linear feet in length and 2 linear feet in width. If more than two pharmacists are on duty simultaneously, the minimum counter length shall be increased by 5 linear feet for an additional pharmacist. Institutions with special considerations may apply to the Board for a waiver. B. Does your pharmacy have a prescription area? If yes, give an estimated floor size. If no, why? (Ask your pharmacist/manager) Our pharmacy has a prescription area. The estimated floor size of the prescription area is 2.5 m by 1.5 m having an area of 3.75 sq. m. Give at least 5 guidelines for proper placement/arrangement of cabinets in a pharmacy. The cabinets should be clean, sanitary and free from insects. The cabinets should be placed in a cool and dry place. The cabinets should be arrange wherein authorized personnel can pass by and look at the drugs. The refrigerator should be closed to the prescription area. The cabinets of dangerous drugs should be locked are carefully monitored by the pharmacist. How are stocks arranged in a community pharmacy? In our pharmacy, stocks are arranged according to manufacturer. Dangerous and prescription drugs are separated and are stocked in a different cabinet wherein they are monitored by the pharmacist. Enumerate and give the use/s of the different apparatus or equipment ideally present in a pharmacy. Identify those found in your drugstore. According to AO 56, these are the following apparatus ideally present in a pharmacy:  For all drugstores including hospital pharmacies, refrigerator for biologicals and other drug products needing refrigeration.  Prescription balance of one centigram sensitivity and a set of weights.  Glass volumetric measures a set of not less than six pieces from 15 ml to 1000 ml capacity.  Mortar and pestle — a set of not less than three in assorted sizes. Other Additional Requirements:  File of prescription filled, consecutively number  Dry Seal or Rubber Stamp containing the name and address of the drug outlet.  Red and White labels indicating name and address of drugstore. In Mercury Drugstore Porta Vaga, these apparatus or equipment are present except one mortar and pestle with a different size. What are the different storage and sanitary facilities in a pharmacy? Are these present in your pharmacy?

2.

3.

4.

5.

6.

7.

There should be a suitable and proper place for the adequate storage of drugs and biological products as specified on the label. There should also be a suitable cabinet for keeping poisons and/or dangerous drugs and lastly, there should be an adequate water supply. Except for pharmacies operating as central processing centers, pharmacies shall be equipped with a sink within the prescription area to be used solely for pharmaceutical purposes. The sink must be connected properly to supply hot and cold water. Restroom facilities for employees of the pharmacy shall be provided reasonably close to, but outside of the prescription area. These are present in our pharmacy.

ACTIVITY 12 Licenses

1. What are the licenses found in a pharmacy need for its operation? State the relevance of each license in community pharmacy practice. Professional Regulation Commission (PRC) of Board of Pharmacy license • To assure the community that the pharmacist residing in the drugstore is a registered pharmacist License to Operate as a Drugstore Granted to person who have the premises for the business and who engage the services of a qualified person to supervise the sale of drug store • The licenses should be displayed in prominent place in a part of premises open to the public and should comply with the provisions of FDA & C acts and rules there under in force Restricted licenses The licenses for the restricted sale of drug • The licenses must have adequate premises equipped with facilities for the proper storage of drugs to which the licenses applies and only can deal in such drug as can be sold without the supervision of qualified person 2. Are these licenses found in your pharmacy? If not, why? - All the licenses stated above are found in the pharmacy. 3. Obtain a copy (photocopy) of these licenses. - We were not allowed to photocopy the licenses but we were allowed to take pictures instead.

4. Enumerate and describe the licenses obtained from the Dangerous Drugs Board (DDB)

S1 LICENSE Retailer of Drug Preparations exempted from special prescription requirement or drug preparations containing Table 1 controlled chemical as the only active medicinal ingredient or contains Table 1 controlled chemical and therapeutically insignificant quantities of another active medicinal ingredient that require a prescription with a doctor’s S2 license. S3 LICENSE Retailer of (a) Dangerous Drug Preparations and/or (b) drug preparations containing Table 1 controlled chemical as the only active medicinal ingredient or contains Table 1 controlled chemical and therapeutically insignificant quantities of another active medicinal ingredient. S4 LICENSE Wholesale Distributor/ Trader of specified (a) Dangerous Drugs and their preparations, (b) drug preparations containing Table 1 controlled chemical,(c) Table 1 controlled chemicals used in the manufacture of drugs S5C LICENSE Manufacturer/ Distributor of named (a) Dangerous Drugs and their preparations, (b) drug preparations containing Table 1 controlled chemical, (c) Table 1 controlled chemicals used in the manufacture of drugs. S5D LICENSE S4 and S5 license holders whose bulk depot/ storage facilities of the specified controlled substance is separate and district from its office address. S5E LICENSE Exporter of specified (a) Dangerous Drugs and their preparations, (b) drug preparations containing Table 1 controlled chemical, (c) Table 1 controlled chemicals used in the manufacture of drugs S5I LICENSE Importer of specified (a) Dangerous Drugs and their preparations, (b) drug preparations containing Table 1 controlled chemical, (c) Table 1 controlled chemicals used in the manufacture of drugs and (d) diagnostic test kits 5. (a) Outline the steps on how to apply for the License to Operate (LTO) from BFAD. How to Apply for License to Operate (LTO) to BFAD Before applying for a License to Operate in BFAD, a registration to the Client Management should be made to acquire your account number which will enable you to access the web portal of BFAD. The web portal serves as a way of transacting to BFAD. Once the registration has been made, application for the initial LTO is now possible through the Client Management Console. The following are the steps in the application: 1) Classification of Products- BFAD created a classification of product that they regulate. It is called Product Classes. The classes includes:  Drugs  Diagnostic reagents  Medical devices  Cosmetics  Household hazardous substances  Food 2) Classification of establishments- classification of establishments depends on the activities it is engaged with. BFAD has also categorized them according to the following: Category of Establishment Activities  Raw materials and packaging materials are purchased by the manufacturer  It produces the product may it be in own plant or subcontracted to other manufacturer  Packing finished products  Keeps records of input materials, finished products and goods-process  Finished product distribution  Finished product purchasing  Outlet of Retail for drug outlets only o private and government drugstore o private and government pharmacies o non-prescription drugs retail outlet  finished products or compounds purchasing and dispensing both prescription and non-prescription drugs Establishments may fall under any or all of the following establishment types depending on the additional activities. Further classification is then made. Additional Activities of Establishment Type Importer- Both raw materials as well as packaging materials and finished products are purchased from suppliers outside the country. Exporter- distributes or sells products to other countries called the country of destination or where the purchasing party operates. Wholesaler- finished products acquired from suppliers within the country are distributed or sold to local buyers 3) Decision on what LTO Type is required on your establishment- depending on the product class, the establishment category and type of establishment, the LTO type required is determined. Your LTO may be food distributor/importer, food manufacture/exporter or others. 4) Decision on the type of application- the application type to be applied for is determined after determining on the LTO type. The different transaction types are:  Initial issuance of LTO- the first LTO acquired prior to the commencement of operations.  Renewal of LTO- this is done after the inspection and approval of BFAD to extend the legitimacy of the LTO.

5)

Amendment of LTO- a request to re-issue LTO indicating the changes in conditions upon the approval of BFAD.  Change in ownership or the name of the establishment or the name and address of sources  Transfer of facilities’ location  Addition or deletion of products, sources or activities  Lost LTO replacement Online submission of application and payment of processing fees- through the Client Management Console, application can be made online. With several payment options, payments can be done through the most convenient way to the applicants.



(b) Show a filled-up application form/document.

6. Where should these licenses be posted? Is this evident in your pharmacy? Have a documentation to prove your answer.

- The licenses are posted in a prominent place in a part of premises open to the public. ACTIVITY 13 Community Pharmacy References 1. Enumerate all the references present in a community pharmacy. Give a brief description of each. REQUIRED PHARMACY REFERENCES All community pharmacies at a minimum must have one of the following authorized library references in each of the categories listed: CATEGORY VERSION TEXT ELECTRONIC FORMATS COMPENDIUM Current year 1. Compendium of 1. www.pharmacists.ca - e-CPS Pharmaceuticals and Specialties COMPLEMENTARY / Within the 1. Stockle’s Herbal 1. www.MedicinesComplete.com ALTERNATIVE last 4 years Medicine Interaction 2. www.naturaldatabase.com 2. Natural Medicines 3. www.lexi.com - Lexi-Naturals Comprehensive Database 4. www.ipharmacist.com 3. Herbal Medicines – 5. www.Micromedex.com - AltMedDex Pharmaceutical Press MedicinesComplete.com DISPENSATORY Within last 9 1. Martindale - The 1. www.MedicinesComplete.com years Complete Drug 2. www.lexi.com Lexi-drugs Reference. 3. www.ipharmacist.com (Published every 3 years) DRUG INTERACTIONS In its entirety 1. Stockley’s Drug 1. www.MedicinesComplete.com every 2 Interactions 2. www.factsandcomparisons.com years, or 2. Hansten and Horn’s 3. www.lexi.com - Lexi-Interact continual Drug Interactions 4. www.ipharmacist.com updates Analysis 5. www.Micromedex.com – Drug-Reax and Management. St. Louis: Facts and Comparisons; continual updates 3. Drug Interaction Facts (Tatro). St. Louis: Facts and Comparisons NONPRESCRIPTION Most current 1. Patient Self-Care. 1. www.pharmacists.ca - e-Therapeutics MEDICATION issue (PSC). Ottawa: Canadian (suite) * Both references Pharmacists Association required 2. Compendium of SelfCare Products. (CSCP). Ottawa: Canadian Pharmacists Association MEDICAL Within the 1. Dorland’s Illustrated 1. www.dorlands.com DICTIONARY last 15 years Medical Dictionary 2. www.ipharmacist.com * Those listed or any 2. Dorland’s Pocket equivalent Medical Dictionary professional 3. Stedman’s Medical medical dictionary Dictionary 4. Stedman’s Medical Dictionary-Health Professions and Nursing 5. Tabor’s Medical Dictionary PREGNANCY AND Within the 1. Drugs in Pregnancy 1. www.lexi.com - Lexi-Pregnancy and LACTATION last 3 years and Lactation by Briggs Lactation 2. Drugs during 2. www.ipharmacist.com Pregnancy and Lactation by Christof Schaefer 3. Medications and Mother’s Milk by Thomas Hale PEDIATRICS Within the 1. Pediatric Dosage 1. www.lexi.com - Lexi-Pediatric Drugs last 4 years Handbook. (Taketomo) 2. Hudson: http://edreg.cw.bc.ca/BookStore/public/book Lexi-Comp Inc. store/

THERAPEUTICS

Within last 4 years

2. British Columbia's Children's Hospital Pediatric Drug Dosage Guidelines. (Vancouver 1. Therapeutic Choices. Ottawa: Canadian Pharmacists Association

3. www.ipharmacist.com

1. www.pharmacists.ca – e-Therapeutics

Comoendium of Pharmaceuticals and Specialties is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately. Stockley's Herbal Medicines Interactions brings together available data on over 190 of the most commonly used herbal medicines, dietary supplements and nutraceuticals in highly structured, rigorously researched, and fully referenced monographs. Martindale: The Complete Drug Reference is a reference book published by Pharmaceutical Press listing some 6,000 drugs and medicines used throughout the world, including details of over 161,000 proprietary preparations. It also includes 675 disease treatment reviews. Stockley's Drug Interactions is still the most indispensible and authoritative international source of drug interaction information. Based upon the many thousands of published clinical papers and reports, it provides a series of detailed, yet concise, monographs designed for quick and easy reference. Each monograph contains a summary, clinical evidence for the interaction under discussion, its probable mechanism, clinical importance, and management. Therapeutic Choices for Minor Ailments provides the best available evidence to help you deliver expanded services expertly and efficiently. It helps you manage the continuum of care from nonpharmacologic to pharmacologic therapy and addresses patient assessment, goals of therapy and lifestyle management. It also includes outcomes monitoring, prevention, pregnancy and breastfeeding. Products for Minor Ailmentsmakes a great companion resource. Dorland’s Illustrated Medical Dictionary this user-friendly reference, trusted for more than a century by healthcare personnel at every professional level, allows you to grasp the meanings of all medical terms in current usage. Understand and correctly use all the latest terminology in todays ever-evolving medical field with the 32nd Edition of the comprehensive, highly respected Dorlands Illustrated Medical Dictionary. Drugs in Pregnancy and Lactation by Briggs an A-Z listing of drugs by generic name. Each monograph summarizes the known and/or possible effects of the drug on the fetus. It also summarizes the known/possible passage of the drug into the human breast milk.an A-Z listing of drugs by generic name. Each monograph summarizes the known and/or possible effects of the drug on the fetus. It also summarizes the known/possible passage of the drug into the human breast milk. The pediatric population is a dynamic group, with major changes in pharmacokinetics and pharmacodynamics taking place throughout infancy and childhood. Because of these changes, the need for the evaluation and establishment of medication dosing regimens in children of different ages is great. The Pediatric & Neonatal Dosage Handbook continues to be the trusted resource for all medical professionals managing pediatric patients. 2. Give the latest edition or copy of these references. Dorland's Illustrated Medical Dictionary, 32nd Edition Compendium of Pharmaceuticals and Specialties 2013 edition Stockley's Drug Interactions, Tenth edition Martindale: The Complete Drug References, 37th edition Stocley’s Drug Interaction, 10th edition Compendium of Self-Care Products. (CSCP). Ottawa: Canadian Pharmacists Association, Current year (2013) Drugs in Pregnancy and Lactation by Briggs, 8th edition Pediatric Dosage Handbook. (Taketomo) Hudson: Edition year 2012-2013 Therapeutic Choices. Ottawa: Canadian Pharmacists Association, 5 th edition 3. What are the references found in your pharmacy? Give the edition.  Goodman and Gilman’s Pharmacological Basis of Therapeutics 9 th Edition 2006  Philippine National Drug Formulary Volume I 7th Edition 2008  PPD Better Pharmacy 11th Edition 2011-2012  Monthly Index of Medical Specialties (MIMS) 2010 Make a compilation of a front covers/title pages (photo copy, scanned image or download image) of the latest edition of the reference.

4.

5.

Make a search on updates on community pharmacy practice from pharmacy journal. Assessment of community pharmacists’ counseling skills on headache management by using the simulated patient approach: a pilot study

Abstract Background: Headache, or cephalalgia, is one of the 20 most disabling diseases in the world and affects a large portion of the world’s population. People generally use over-the-counter medications to treat headaches and other minor symptoms. A pharmacist should help patients choose the most effective, safe, and convenient pharmacotherapeutic option. Objective: To assess the counselling skills of community pharmacists for headache management by using the simulated patient approach. Methods: A cross-sectional study was conducted from March 2010 to July 2010. Data were obtained from a convenience sample consisting of one pharmacist from each of the 24 participating community pharmacies. In order to evaluate the pharmacists’ counselling skills, a simulated patient role played a standardized headache case requesting self-medication. The interactions of the simulated patient with the pharmacists were audiovisually recorded using a hidden micro camera, and these recordings were analysed using a validated questionnaire. Results: Of the 24 evaluated pharmacists, 19 (79.1%) were women. Information was spontaneously provided by 15 (62.5%) pharmacists. At least one question was asked by the pharmacist to assess the signs and symptoms. Most pharmacists (n=17, 70.8%) recommended sodium dipyrone, either alone or in combination with other drugs. The most discussed items in the simulation visits were contraindications (n=17, 70.8%), indications (n=10, 41.6%), and drug administration times (n=8, 33.3%). None of the pharmacists recommended any non-pharmacological therapeutic alternatives. The overall impressions of the pharmacists’ professional counselling skills ranged from poor to fair. Conclusion: This study showed that the pharmacists’ counselling skills and the guidance provided by the pharmacists to the simulated patient were insufficient for the satisfactory management of headache

ACTIVITY 14 Expanded Senior Citizen Act of 2003 (RA 9257) 2. Enumerate the requirements to be presented to avail of the privilege of a senior citizen in the purchase of his/her medicines.     ID of the senior citizen Purchased booklet Prescription Authorization letter- only if the senior citizen is not around

3. Present through a flow chart the steps on how to avail the senior citizen’s privilege in a community pharmacy. Senior Citizen

Prescription

Senior Citizen’s ID

Senior Citizen’s Booklet

*if the Senior Citizen is not present

*the customer must present an authorization letter for the senior.

“PRIVILEGES”

4. The law affects the drugstore positively in a way that the number of customer is directly proportional to the growth of the establishment. The RA 9257 that concerns with the provision ensuring to provide full 32% discount to the goods availed by the senior citizen. The law influences the drugstore in many aspects. 1. 2. 3. 4. Patronage of the senior citizen customer because of the full implementation of the law in the drugstore Full implementation of law happy customers Good image of the establishment due to the positive feedback given by the customers This gives more clients to the establishment by means of the affiliates of the other customer

5.

Add more sales and income to the drugstore due to the demands of the SC’s ACTIVITY 15 Pricing of Prescription Make a literature search on the factors affecting the prices of drugs and prescription.  prices of patented drugs  prices of non-patented drugs  prices of generic drugs  retail and wholesale mark-ups  pharmacists' professional fees  changes in the composition of total population, e.g. proportion of older persons  changes in prescribing habits of physicians  changes in the utilization of drugs, i.e. number of drugs used per patient  trends towards using newer drug therapy instead of other treatments List the prices or price-range if common drugs (at least 10 Branded &/or Generic Drugs).  Biogesic® - ₱3.00  Bioflu® - ₱6.50  Neozep®-₱4.35  Kremil-S ® -₱5.00  Advil®- ₱8.00  Diatabs®- ₱6.75  Alaxan FR®- ₱7.65  Centrum®- ₱9.75  Buscopan®-₱21.50  Poten-cee®-6.00 State the specific part of code of ethics influencing the pricing of the prescription. - 52.203-2 Certificate of Independent Price Determination. As prescribed in 3.103-1, insert the following provision. If the solicitation is a Request for Quotations, the terms “Quotation” and “Quoter” may be substituted for “Offer” and “Offeror.” Certificate of Independent Price Determination (Apr 1985) A. The offeror certifies that— 1. The prices in this offer have been arrived at independently, without, for the purpose of restricting competition, any consultation, communication, or agreement with any other offeror or competitor relating to— (i) Those prices; (ii) The intention to submit an offer; or (iii) The methods or factors used to calculate the prices offered. 2. The prices in this offer have not been and will not be knowingly disclosed by the offeror, directly or indirectly, to any other offeror or competitor before bid opening (in the case of a sealed bid solicitation) or contract award (in the case of a negotiated solicitation) unless otherwise required by law; and 3. No attempt has been made or will be made by the offeror to induce any other concern to submit or not to submit an offer for the purpose of restricting competition. B. 1. Each signature on the offer is considered to be a certification by the signatory that the signatory— Is the person in the offeror’s organization responsible for determining the prices being offered in this bid or proposal, and that the signatory has not participated and will not participate in any action contrary to paragraphs (a)(1) through (a)(3) of this provision; or 2. (i) Has been authorized, in writing, to act as agent for the following principals in certifying that those principals have not participated, and will not participate in any action contrary to paragraphs (a)(1) through (a)(3) of this provision ____________________ [insert full name of person(s) in the offeror’s organization responsible for determining the prices offered in this bid or proposal, and the title of his or her position in the offeror’s organization]; (ii) As an authorized agent, does certify that the principals named in subdivision (b)(2)(i) of this provision have not participated, and will not participate, in any action contrary to paragraphs (a)(1) through (a)(3) of this provision; and (iii) As an agent, has not personally participated, and will not participate, in any action contrary to paragraphs (a)(1) through (a)(3) of this provision.

1.

2.

3.

C.

If the offeror deletes or modifies paragraph (a)(2) of this provision, the offeror must furnish with its offer a signed statement setting forth in detail the circumstances of the disclosure.

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Comment on the following situation: A mother is buying a prescribed medicine but cannot afford its price. The said mother is badly needed. As a pharmacist, how would you deal with this customer? -As a Pharmacist I would feel bad for the mother and if only I could just buy the medicine for her, I will surely do it. But as an employee and at the same time Pharmacist of the drugstore, I would first try to recommend and apply the generic dispensing and I would try to ask her if how much money she has, and maybe we could just dispense a few piece of that drug, or I would simply just refer her to the other drugstores since she can’t afford to buy the drug. Another thing that I could do is that maybe I could refer her to other medical representatives so she could asks if they have samples of the drug that she needs.  ACTIVITY 16 Recording of Prescription What are the different official record books present in a pharmacy? Enumerate their respective contents. Prescription Record Book According to Section 32 of R.A 5921, all prescriptions dispersed in the drugstore shall be recorded in the book kept for the purpose indicating therein, among others, the name of the manufacturer, the original stock, lot and control numbers of the main ingredients of the prescriptions, which book shall be open to inspection by the proper authorities at any time of the day when the pharmacy is open to the public and must be preserved for a period of not less than two years the last entry in it has been ma de. All prescription shall be attached to said book for prescriptions and numbered consecutively and shall be preserved for the same length of time as the prescription book. Poison Book Section 34. Provisions relative to dispensing of violent poisons. Every pharmacist who dispenses, sells or otherwise delivers any of the violent poisons intended for medicinal use, to wit: arsenical preparations, phosphorus; corrosive sublimate; atropine, strychnine, or any of their salts, hycocyanic acid or any of its salts; oil of bitter almonds containing hydrocyanic acid or prassic acid; oil of mirbane (Nitro-benzene); and such other poisonous substances which may from time to time be classified under this category by the Food and Drug Administration; shall do so only upon prescription of a duly licensed physician, dentist or veterinarian. He shall make or cause to be made in a separate book, kept for the purpose, an entry stating the date of each sale and the name and address of the purchaser, the name and quantity of the poison sold and the purpose for which it was claimed to be purchased, before delivering it to the purchaser. Dangerous Drugs Record Book Narcotics & Psychotropics Senior Citizen’s Maintenance Drugs Record Book A record of Senior Citizens’ information together with their physicians’ information PWD Record Book Give at least three (3) specific prescribed drugs for each record book. A. OTC Ex. Ibuprofen (Advil®) Paracetamol (Biogesic®) Hyoscine N-butylbromide (Buscopan®) B. Ethical drugs Ex. Atorvastatin (Lipitor®) Esomeprazole (Nexium®) Clopidogrel (Plavix®

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C. Dangerous Drugs C.1. Narcotics Ex.

Methylphenidate (Concerta ER®) Oxycodone HCl (Oxycontin®) Fentanyl (Durogesic D-TRANS®)

C.2. Psychotropics Ex. Midazolam (Dormicum®) Alprazolam (Altrox®) Diazepam (Valium®) D. Senior Citizen’s Maintenance Drugs Ex. Donepezil HCl (Aricept®)

Digoxin (Lanoxin®) Aripiprazole (Abilify®) E. PWD – may vary according to the disability 3. 4. 5. Illustrate a sample entry on a record book. -Illustration is found on the next page How long are these books to be retained in the pharmacy? The books are retained for two (2) years in the pharmacy. Enumerate the record books found in your pharmacy.  Prescription Record Book  Dangerous Drugs Record Book  Senior Citizen’s Maintenance Drugs Record Book  PWD Record Book

ACTIVITY 17 Drug Procurement and Inventory Control 2. Describe the drug inventory in a community pharmacy. Drug Inventory is a stock of drugs owned by a company and held for sale or for processing before being sold. It is an itemized list of current assets and a list of drugs on hand. It is considered as a survey and summary of drugs. It is a form of registration of drugs arranged systematically with descriptive details. 3. Define / describe the following terms: (a) MAXIMUM STOCK LEVEL The amount of inventory which should not be exceeded. The limit is normally determined after considering storage space of the facilities, how quickly inventory is sold or used, cost of insurance on inventory, and the risk of inventory becoming outdated before it is used. Some businesses use a formula to calculate the maximum stock level: Maximum limit or level = Re-order level or ordering point - Minimum usage * Minimum re-order period + Economic order quantity (b) REORDER LEVEL A minimum amount of an item which a company holds in stock, such that, when stock falls to this amount, the item must be reordered (c) TURNOVER 1. Accounting: (1) The annual sales volume net of all discounts and sales taxes. (2) The number of times an asset (such as cash, inventory, raw materials) is replaced or revolves during an accounting period. 2. Human resource management: The number of employees hired to replace those who left or were fired during a 12 month period. 3. Finance: The volume or value of shares traded on a stock exchange during a day, month, or year. 4. How is drug inventory conducted in your pharmacy? Interview your pharmacist &/or manager. According to Ms. Gina Kibad, one of the pharmacists in Mercury Drugstore Porta Vaga, the inventory of the pharmacy is conducted every week specifically between Sunday to Tuesday only. Both the pharmacists and the pharmacists’ assistants have an assigned area for which they will be counting. In our pharmacy, we have 10 books that are divided into two except book 7 and 10 that are stocked and are written in the inventory. There are three primary steps to complete the inventory: (1) Count the drugs, (2) Record in the Inv entory Book, and (3) Order of the Drugs. In the pharmacy, there are two major drug inventory, the mid-year inventory and the year-end inventory. In the inventory book, stocks counted weekly are written in pencil. Before the mid-year inventory, the stocks counted are written in Blue ink. The results of the inventory during the mid-year are written in Red ink. The year-end inventory is written Black Ink. 5. What is the role of the pharmacist in drug inventory? During the drug inventory, the pharmacists are in-charge of the inventory of the Prescription Drugs, Dangerous Drugs, and even the Refrigerator in the pharmacy. ACTIVITY 18 Community Pharmacy Problems/ Malpractices Interview your pharmacist &/or manager regarding a problem that they have encountered in the community pharmacy. -The parents of the patient before was trying to return some drug products that were not even consumed nor opened in less than 24 hours. They were trying to return the medicines since the patient already died after they have bought his medicines. Present a brief discussion of this problem and include the solution/s that they have performed.

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-Since the parents of the patients would like to get a refund and the cost of the return products were quite high, the establishment didn’t permit them easily. Instead the parents left their contact number and the medicine to the establishment. The parents didn’t come back and visit the establishment for updates since they were so busy trying to fix the burial of their son. So the establishment had enough time to prepare and had a meeting with the manager. The Assistant Branch Manager (ABM) thought that they should allow to give a refund to the parents since the medicine were not used and was returned to them in less than 24hrs. The patient also was a regular customer to the establishment said one of the PA’s. Solution/s: -The manager of the establishment agreed that they would refund the said amount to parents of the patient. But before doing that they first try to ask the parents of the patient if there are willing to replace the amount into other products such as diapers if they have a baby, or even milk products as long as it can cover the said amount of the return medicines. 3. Make an investigation on the actual community pharmacy (in your pharmacy, in other drug stores, or through literature or internet search), and present a community pharmacy malpractice observed or researched. - No Punitive Damages for Ordinary Negligence Jesse C. Vivian, RPh, JD Professor, Department of Pharmacy Practice College of Pharmacy and Health Sciences Wayne State University Detroit, Michigan 2/18/2011 US Pharm. 2011;36(2):62-65. A pharmacist makes a mistake when filling a prescription. This mistake causes the patient harm that can be measured in monetary and emotional terms. The pharmacist is sued. There is no question that each of the elements of ordinary negligence is present here. There is a duty to fill the prescription accurately; there has been a breach of that duty, the breach caused the patient harm, and that harm is measurable in monetary damages. The pharmacist will likely be held liable to pay a judgment in favor of the injured patient. What liabilities does the pharmacist face? The only questions are how much the pharmacist will have to pay and for what kind of damages. In cases of ordinary negligence, often also referred to as malpractice when the negligence is caused by a licensed professional (the words are used interchangeably without any other meaningful distinction), courts have most uniformly held that the defendant, in this case the pharmacist, will be liable to the plaintiff, the patient here, for an amount designed to compensate the plaintiff for ordinary loss of income or value of life and, if appropriate, an amount calculated to pay the plaintiff for emotional damages. The goal of the courts, in a jurisprudence sense, is to make the plaintiff “whole” in monetary terms as if the malpractice never happened. Often it is up to a jury to decide the exact amount of liability damages and, if approved by the judge, that amount will become the judgment the defendant has to pay. In more recent years, however, plaintiffs in pharmacy malpractice cases have begun with increasing frequency to ask for extra amounts of money in the form of punitive damages that, in addition to the ordinary compensatory damages, are designed to punish the defendants for such egregious conduct as to correct whatever problem lead to the mistake in the first place. Punitive damages can be double, triple, or sometimes even exponentially higher than compensatory damages and are awarded together with compensable damages. This could be disastrous for organizations that do not typically have insurance coverage for the increased punitive damage amounts. Typically, punitive damages are sought from corporate defendants, such as the owner of the pharmacy where the mistake was made, for “system failures,” or for procedures that are not designed sufficiently to prevent the error from occurring. Herein lies the problem: What is the difference between simple human error and system failure? Lawsuits -A recent case sheds light on the question and provides some guidance for pharmacists to know what kinds of problems they might face when a mistake is made. 1 The opinion issued by the federal Sixth Circuit Court of Appeals involves two different cases that were consolidated because the legal issues were the same. Both cases originated in a Tennessee court against the same defendant and required the court to interpret Tennessee’s law on whether punitive damages were properly allowed under that state’s laws. As a procedural matter, both cases were transferred to a federal district court. Case 1: In 2001, a 75-year-old woman presented a handwritten prescription from her urologist for imipramine (an antidepressant) to a pharmacist employed in a national chainstore pharmacy. The pharmacist mistakenly read the drug name as Imuran (azathioprine) and dispensed this powerful immunosuppressant. There is no dispute that the patient did not receive counseling at the time she picked up her prescription. Upon returning home and over a period of several weeks, she took the entire prescribed dose and part of one refill before she

went to the emergency room complaining of symptoms of swelling in her legs, feet, and abdomen; weight gain; and shortness of breath. According to the records, the emergency room physician recognized that Imuran was not a drug prescribed for bladder problems, and the patient immediately stopped taking the erroneously dispensed medication. In the complaint, she alleges that her health improved after she stopped taking Imuran and began taking imipramine, but she never fully recovered from the congestive heart failure complications that Imuran caused. The patient died in 2003. Case 2: A 93-year-old patient, through his son-in-law, presented a prescription for a manufacturer-created Uro-Pac dosage of Floxin (ofloxacin) to a different pharmacist employed by the same chainstore in 2001. The Uro-Pac was unavailable at that location but the pharmacist offered to create a simulated dose pack. The patient’s son-in-law accepted this option. Unfortunately, the pharmacist miscalculated the number of tablets necessary to simulate Uro-Pac and created a dose pack with dosage directions greater than prescribed. The patient took the medication as directed until another son-in-law recognized that she was taking too large of a dosage after she complained of nausea and vomiting. In her lawsuit, she claims that she never fully recovered prior to her death in 2002. District Court -After much legal rambling, the two cases ended up together in front of a federal district court judge sitting in Tennessee. Both of the plaintiffs had asked for compensatory and punitive damages. Germane to this discussion, the federal district judge granted a summary judgment motion on behalf of the defendant pharmacy, holding that neither plaintiff will be able to seek punitive damages once the cases are set for trial. Both plaintiffs appealed that ruling to the Court of Appeals, claiming the district court erred in interpreting Tennessee law on the availability of punitive damages. Court of Appeals: The primary issue under review is whether Tennessee law, specifically the Tennessee Medical Malpractice Act,permits punitive damages to be sought under the circumstances of these two cases. The Tennessee law, according to this court, “codifies the common law elements of negligence—duty, breach of duty, causation, proximate cause, and damages,” and that “no claim for negligence can succeed in the absence of any one of these elements.” To obtain punitive damages, the plaintiffs would have to offer additional proof, in the form of clear and convincing evidence, of a required mental state of the defendant under Tennessee law. The Court of Appeals started its analysis, stating that: “Punitive damages are not available under Tennessee law unless a plaintiff can prove by clear and convincing evidence that the defendant acted intentionally, fraudulently, maliciously, or recklessly.” Clear and convincing evidence “leaves no serious or substantial doubt about the correctness of the conclusions drawn.” This means that “in contrast to the preponderance of the evidence standard [for ordinary negligence] clear and convincing evidence should demonstrate that the truth of the facts asserted is highly probable as opposed to merely more probable than not.” Punitive damages are “intended to punish a defendant, to deter him from committing acts of a similar nature, and to make a public example of him”—they are “appropriate only in the most egregious cases.” Further, “to prevail on a claim for punitive damages in a negligence case, the plaintiff must show that the defendant’s negligence that proximately caused his or her injury reached a substantially higher level than ordinary negligence” and “was so reprehensible that it must be both punished and deterred.” In addition, “a submissible punitive damages claim has been made if the evidence and the inferences reasonably drawn from the evidence are sufficient to permit a reasonable juror to conclude that the plaintiff established with convincing clarity that the defendant’s conduct that caused the plaintiff’s injury was intentional, fraudulent, malicious, or reckless.” On appeal, the plaintiffs limited their claims, alleging only that the pharmacy had acted either intentionally or recklessly. Intent: Insofar as the “intentional” part of the standard goes, the plaintiffs urged “that a person can be subject to punitive damages if she intentionally engages in conduct regardless of whether that conduct is meant to be hurtful, benign, or helpful.” Under state law, “a person acts intentionally when it is the person’s conscious objective or desire to engage in the conduct or cause the result.” Trying to claim that their punitive damages allegations meet this standard, the plaintiffs argued that the “or” prior to “cause the result” in this definition negates the need to prove any connection between the required mental state and the result. They argued that the pharmacy’s intentional action in filling the prescriptions is sufficient to satisfy the “intentional” standard for punitive damages. Furthermore, the plaintiffs asserted, the defendant pharmacy acted intentionally because it was the pharmacy’s “conscious objective or desire to engage in the conduct” of filling the prescriptions, knowing that improperly filled prescriptions could be harmful even though the pharmacy had no intent to make mistakes in filling the prescriptions or to cause any resulting injury to the plaintiffs. Thus, they argued that “negligent conduct is reprehensible enough to demand an award of punitive damages.” The district court judge rejected this argument, stating: “Such an interpretation would lead to freakish results where almost every act of mere negligence becomes an intentional act subject to punitive damages.” The Appellate Court agreed, stating that the plaintiffs did not offer any case law in support of this interpretation. On the contrary, the court found a case decided under Tennessee law holding that “the issue is not whether

[the defendants] intentionally or consciously [engaged in the conduct], but rather the motive for the [conduct].” From this the court concluded, “Intentional refers to a person who acts intentionally with respect to the nature of the conduct or to a result of the conduct when it is the person’s conscious objective or desire to engage in the conduct or cause the result.” The court then concluded that while a pharmacy is generally cognizant of the fact that an error in filling a prescription could happen, “this is not s ufficient to meet the clear-and-convincing-evidence standard” required under state law. Reckless: The plaintiffs also claimed that punitive damages should be available because the pharmacy’s conduct satisfies the “reckless” standard. Tennessee law states, “A person acts recklessly when the person is aware of, but consciously disregards, a substantial and unjustifiable risk of such a nature that its disregard constitutes a gross deviation from the standard of care that an ordinary person would exercise under all the circumstances.” The court explained that “reckless” can refer to the circumstances surrounding the defendant’s conduct or the result of the defendant’s conduct. The pharmacy admitted that its pharmacists were negligent in violation of the standard of care requiring the accurate filling of prescriptions but denied that “preventable errors” are the equivalent to the “gross deviation” of the standard of care to constitute recklessness. Tennessee courts have defined “recklessly to require” as disregarding a substantial risk such that the person gave no thought to or paid no attention to the known risk. The state courts have gone on to explain, “Although the reckless actor intends to act or not to act, the reckless actor lacks the ‘conscious objective or desire’ to engage in harmful conduct or to cause a harmful result…[R]ecklessness contains an awareness component similar to intentional conduct which is not demanded of negligence.” This court concluded that none of the pharmacy’s or pharmacists’ acts rose to this level of recklessness. Analysis -This case adequately demonstrates the difference in the standards that must be met to prove ordinary negligence (or malpractice) and the extra burden of proving sufficient evidence that the defendant acted so recklessly or intentionally as to have the mental intent that harm be caused to the plaintiff. It’s bad enough to get sued for making a simple mistake, but when punitive damages allegations are made, vigilance is important to make sure the judgment is reasonable and not excessive. 4. With such community pharmacy malpractice, present the following: a. Law/ regulation violated. Cite specific provision of law or regulation  REPUBLIC ACT No. 5921 - An Act Regulating the Practice of Pharmacy and Setting Standard of Pharmaceutical Education in the Philippines and for Other Purposes - Specifically mandated by law the creation of the Council of Pharmaceutical Education in the Philippines . Its primary responsibility is to formulate the rules and regulations in all aspects related to pharmaceutical education: pass rules and regulations for the implementation of the respective agencies such as the Department of Education and the pharmacist organizations; recognize and accredit the college of pharmacy of various colleges and universities, and to accredit the pharmacist, laboratory and hospital pharmacy for the internship program. -The law also stipulates the conduct of board exam for pharmacist. The main requirements for obtaining a bachelor degree examination is in Pharmacy and comprehensive internship program. The examination will be made twice a year and administered by the Board of Pharmacy.Besides the administration of the exams, also the responsibility of the Board to issue the certificate of registration of pharmacists and passed suspend or withdraw it from the pharmacist found the crab made in accordance with acceptable standards of law. -The law also applies the rules to the sale of drugs and medical devices. Specifically it stated that the non-prescription drug is inappropriate sold without prescription: the drug sample is forbidden to sell; should instruct the certificate of registration of the pharmacist to pharmacist, hospital pharmacy, drugstore and similar establishments, and the toxic substances will not be sold without a corresponding prescription from a doctor, dentist, or veterinarian. b. A goal to solve such problem or malpractice -Since the problem occurs so frequently that a special committee of the United States Pharmacopeia (USP) has been formed to look at the selection of new drug names. There is an evolving science in understanding and preventing this error of fine distinction. Physicians’ handwriting is another cause of pharmacist error. Often the subject of jokes, the typical physician’s scrawl presents the most dangerous type of pharmacist error. There is increased interest in electronic prescribing, which would help obviate such interpretative errors between physician and pharmacist. c. Three to five (3-5) objectives • Lessen the risk of pharmacy malpractice litigation where possible; • Act in a manner to defend against litigation, should litigation occur • Indemnify against malpractice litigation. • Protect the patient and pharmacy employees from malpractice litigation. • The supervision, control and regulation of the practice of pharmacy in the Philippines.

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Resources needed -The BFAD was asked to monitor such practices that happen in our country.

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-Any complain from the customer that is considered to be a malpractice under the law will be a good resource for the BFAD. ACTIVITY 19 Ghost Pharmacist: A Reaction Cite the specific provision pertaining to the legal matters of the “Ghost pharmacist” malpractice. RA 5921 (Pharmacy Law) Section 27. Pharmacist required and compensation. Every pharmacy, drugstore or hospital pharmacy whether owned by the government or a private person or firm shall at all times when open for business be under the personal and immediate supervision of a registered pharmacist: Provided, That no pharmacist shall have personal supervision of more than one such establishment. In cases where a drug establishment operates in more than one shift, each shift must be under the supervision and control of a registered pharmacists. Drug or pharmaceutical laboratories or similar establishments engaged in the repackaging, manufacture or sale of drugs, biologic products and pharmaceutical products in quantities greatly in excess of the therapeutic doses of each substance; such processes involving the preparation, quality control or repackaging of said products shall for each respective operation be under the direct and immediate supervision of a registered pharmacist, or, in the sale of pharmaceuticals, medicines and drugs at wholesale, such business shall be conducted under the immediate supervision of a registered pharmacist practicing only in such establishment. Every pharmacist employed as such in any of the establishments mentioned in this section whose capitalization is not less than ten thousand pesos shall receive, notwithstanding any provisions of law to the contrary, a minimum compensation similar to that of government pharmacists. State the specific section on the Code of Ethics pertaining to the professional matters of the said malpractice. SECTION IV. A pharmacist acts with honesty and integrity in professional relationships. A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients. Interview the following people regarding their insights of the “ghost pharmacist” malpractice: (a) PHARMACY STUDENT: Brian Joseph Felipe As a pharmacy student I learned that as mandated and implemented in our law every pharmacy must have a licensed pharmacist in order for that pharmacy to operate, and this is a malpractice of pharmacy profession. There will be no patient counseling is being rendered to the patient how would the substitute will go over to the queries and questions regarding the medication there will be a low quality of service provided hence a negative implication to the establishment and to the pharmacy practice . It’s unfair in our part because we study 4 years in college to practice pharmacy. This may occupy the job vacancy for the registered pharmacist who is suited for the work. (b) COMMUNITY PHARMACIST: Madonna Q. Magno, RPh “Ghost pharmacist”, a term used to identify a pharmacist who’s license and certificate is present in the dispensing area, but totally absent in the scene of his practice. For me, engaging in such act is on a crucial and negative side. It can degrade the dignity of a pharmacist. The license of the pharmacist is even at risk especially that they worked hard for it. This would be a big lie to one’s self and to the customers, since you made a pledge to follow the laws governing the pharmacy practice. Moreover, it can even cause trouble to the customers, especially when there is information and queries that they need to know and understand. As a pharmacist, it is our calling to properly dispense, counsel and monitor a patient’s drug medication. It is not just a job that we’ve accepted, but a passion to make, and not just a mere money-making scene. (c) ORDINARY PERSON: Mylene Lopez I am not aware of the scenario that someone replaces the role of the pharmacist in the pharmacy. This might cause a big problem due to lack of knowledge of the person who replaces the work of the pharmacist. And I cannot avail the proper information needed, the trust and credibility of the pharmacist in charge. Then I will change the pharmacy in order for me to get necessary services I need. State the effects of “ghost pharmacy” practice on (a) COMMUNITY HEALTH In a news article of the Philippine Inquirer, it is said that the absence of pharmacists could endanger the health of consumers because no one is present to advise members of the public about the medicines they buy. We should remember that medicines are not candies. If you use it incorrectly—there is not enough dosage or there is too much–it could have a negative effect on the health of the patient. (b) PHARMACY PROFESSION Having ghost pharmacists can affect the image of the pharmacy profession. Pharmacists should not play around with the health of the people so they should be present in the pharmacy at all times for patient counseling and monitoring prescriptions. Having ghost pharmacists means taking a life-anddeath issue because medicines can kill if misused or the right dosage as prescribed by doctors is not followed. Those so-called ghost pharmacists may just make ghosts of our ailing countrymen by being absent in the pharmacies they man only on paper.

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