B5 PCPM101 - MIDTERMS.docx (1).pdf

PCPM101 - MIDTERMS Aquino, Zuendie Pearl D. | BSP1E | Dr. Dean MODULE 1 Historical Development of Pharmacy Practice PHARMACY - defined as the Profession concerned with the art and science of preparing drugs from natural and syn...

PCPM101 - MIDTERMS Aquino, Zuendie Pearl D. | BSP1E | Dr. Dean MODULE 1 Historical Development of Pharmacy Practice PHARMACY - defined as the Profession concerned with the art and science of preparing drugs from natural and synthetic sources and suitable and convenient dosage forms for administering, treating, and preventing diseases both of man and animals. - It embraces the knowledge of the identification, selection, pharmacologic action, preservation, analysis, and standardization of drugs & medicine - From the Greek word “Pharmakon”– drug or medicine PHARMACIST - A person considered the expert on drugs or the medication expert. - He is legally responsible for handling drugs and knows all about them. FIVE HISTORICAL PERIODS OF PHARMACY 1. Ancient through Early Modern Era: Human Prehistory to AD 1500 2. Empiric Era: 1600 to 1940 3. Industrialization Era: 1940 to 1970 4. Patient Care Era: 1970 to present 5. Biotechnology and genetic engineering: The new horizon BEFORE THE DAWN OF HISTORY - Ancient man learned from instinct, from observation of birds and beasts. - His first soothing application was cool water, a leaf, dirt, or mud. Why people got sick before? ○ victim of evil forces ○ God’s anger ○ Disease as a punishment of God Use for treating ailment before ○ Supernatural ○ Natural resources Healer during the early days ○ Shaman ○ Priest PHARMACY IN ANCIENT BABYLONIA Babylon, the jewel of ancient Mesopotamia, often called the cradle of civilization, provides the earliest practice of the art of the apothecary. Practitioners of healing in this era were priests, pharmacists, and physicians, all in one. Medical texts on clay tablets record first the symptoms of illness, the prescription, and directions for compounding, then an invocation to the gods. 1  2 TYPES OF MEDICAL CARE IN BABYLONIA 1. ASHIPU 2. ASU - “Sorcerer” or exorcist. - “Physician” - Diagnose the ailment, this meant - Dealt with empirical applications of which god or demon was causing the medication. illness. - For example, when treating wounds, - Attempt to cure the patient the asu generally relied on washing, through charms and spells designed bandaging, and making plasters (a to drive out the spirit causing the mixture of medicinal ingredients disease. applied to a wound and held on by a bandage) PHARMACY IN ANCIENT CHINA Shen Nung was an emperor who investigated the medicinal value of several hundred herbs. He has tested many of them on himself and written the first Pen T’Sao, or native herbal, with 350 different drugs. Medicinal plants included are podophyllum, rhubarb, ginseng, stramonium, cinnamon bark, ephedra, and ma huang. PHARMACY IN ANCIENT EGYPT Discovered various dosage forms (enemas, infusions, inhalations, lotions, etc.) Plant drugs such as acacia, onions, aloe, castor oil, and opium. The best-known and most important pharmaceutical record is the "Papyrus Ebers" (1500 B.C.), a collection of 800 prescriptions, mentioning 700 drugs. PHARMACY IN ANCIENT GREECE - During the superstition era, Asclepius (god of the healing art) was believed to impact healing by touching one with his staff or serpent. - Rod of Asclepius is an ancient Greek symbol associated with medicine, consisting of a serpent coiled around a rod. - His daughter, Hygeia (the goddess of health, cleanliness, and sanitation), was also believed to have a healing potion - the international symbol of the pharmacy profession “BOWL OF HYGEIA” HIPPOCRATES - “FATHER OF MEDICINE” - A Greek physician who introduced scientific pharmacy and medicine. - He showed in his writing and practiced the fundamentals of the scientific research method. - Starts with clinical inspection and observation. - Classification of illnesses as acute, chronic, endemic, and epidemic. - Rejection of unsupported theories and superstitions. - Wrote the Hippocratic Oath or Oath of Hippocrates - Recommends that physicians always be neat and clean, honest, calm, understanding, and serious. 2 THEOPHRASTUS - “FATHER OF BOTANY” - He is a Greek philosopher and natural scientist - Deals with the medical qualities and peculiarities of herbs PEDANIUS DIOSCORIDES - Scientist Looks at Drugs - Greek Physician and Botanist who deals with botany as an applied science of pharmacy. - He published De Materia Medica, or "On Medicinal Substances," in five volumes. The books have recorded what he observed and promulgated excellent rules for collecting drugs, storing them, and using them. Mithridates VI, King of Pontus - The Royal Toxicologist - He made the art of poisoning (preventing and counteracting poisoning) - He used himself and his prisoners as "guinea pigs" to test poisons and antidotes. - He invented Mithridate, one of the best-known antidotes, which is believed to be a universal antidote in ancient times. CLAUDIUS GALEN - EXPERIMENTER IN DRUG COMPOUNDING - a Greek pharmacist–physician who practiced and taught both Pharmacy and Medicine - Galenical formulations or galenicals was named after him. - Galenic formulation deals with the principles of preparing and compounding medicines to optimize their absorption. - He invented the cold cream. Terra sigillata - an early “trademarked” drug - Advantage of trademarks as a means of identifying the source and gaining customers' confidence. - Terra Sigillata (Sealed Earth), a clay tablet originating in the Mediterranean island of Lemnos before 500 B.C. - One day each year, clay was dug from a pit on a Lemnian hillside in the presence of governmental and religious dignitaries. - Washed, refined, and rolled to a mass of proper thickness, the clay was formed into pastilles and impressed with an official seal by priestesses, then sundried. - The tablets were then widely distributed commercially DAMIAN AND COSMAS - Patron Saints - Arabian-born twin brothers who embraced Christianity and practiced medicine and surgery without a fee - Twinship of the health professions - Damian, the apothecary (Pharmacy) - Cosmas, the physician (Medicine) 3  MONASTIC PHARMACY - The monks gathered herbs and simples in the field, or raised them in their own herb gardens. - These they prepared according to the art of the apothecary to benefit the sick and injured. - Manuscripts from many islands were translated or copied for monastery libraries ARABIAN ERA THE FIRST APOTHECARY SHOPS - The Arabs separated the arts of apothecary and physician. - First privately owned drug stores. - They developed with their natural resources syrups, confections, conserves, distilled waters, and alcoholic liquids. AVICENNA - THE "PERSIAN GALEN" - Ibn Sina, also called Avicenna, is a Persian pharmacist, poet, physician, philosopher, and diplomat. - He contributed to the sciences of pharmacy and medicine by his pharmaceutical teachings. - His famous books are: The Book of Healing (intended to "cure" or "heal" ignorance of the soul) The Canon of Medicine (presents an overview of the contemporary medical knowledge of the medieval Islamic world) SEPARATION OF PHARMACY AND MEDICINE - In Sicily and southern Italy, Pharmacy was separated from Medicine. - Frederick II of Hohenstaufen, who was Emperor of Germany as well as King of Sicily, was in his palace in Palermo, he presented subject Pharmacists with the first European edict, which is known as the Magna Carta of Pharmacy. - The three decrees of the Magna Carta include: 1. The pharmaceutical profession was to be separated from the medical profession 2. The pharmaceutical profession should be supervised officially 3. Pharmacists should take an oath to prepare drugs reliably, according to skilled art and in a uniform suitable quality CARL WILHELM SCHEELE - “FATHER OF MODERN PLANT CHEMISTRY” - Greatest of the Pharmacists-Chemists - He discovered oxygen, chlorine, prussic acid, tartaric acid, tungsten, molybdenum, glycerin, nitroglycerin, & countless other organic compounds Philippus Aureolus Theophrastus Bombastus von Hohenheim - Paracelsus - A Swiss physician and chemist who influenced the transformation of pharmacy from a profession based primarily on botanical science to one based on chemical science. 4 - He believed preparing a specific medicinal agent to combat each specific disease was possible and introduced a host of chemical substances to internal therapy. EMPIRIC ERA THE FIRST OFFICIAL PHARMACOPOEIA - The idea of a pharmacopoeia with official status, to be followed by all apothecaries, originated in Florence. - The Nuovo Receptario, originally written in Italian, was published and became the legal standard for the city-state in 1498. It was the first officially recognized pharmaceutical compilation or pharmacopeia. - It resulted from the collaboration of the Guild of Apothecaries and the Medical Society - one of the earliest manifestations of constructive interprofessional relations. THE SOCIETY OF APOTHECARIES OF LONDON - In 1617, Francis Bacon (philosopher-politician) formed a separate company known as the "Master, Wardens and Society of the Art and Mystery of the Apothecaries of the City of London". - This was the first organization of pharmacists in the Anglo-Saxon world. THE GOVERNOR WHO HEALED THE SICK - John Winthrop is a politician-physician and first governor of Massachusetts Bay Colony with broad interests in chemistry, metallurgy, astronomy, botany, and Materia Medica. - He developed a “sovereigne remedy” called “rubila,” which he believed was effective in treating measles, colics, headaches, sciatica, and many other ailments. THE MARSHALL APOTHECARY - Christopher Marshall established his apothecary shop in Philadelphia in 1729 - During 96 years, this pioneer pharmaceutical enterprise became a leading retail store, the nucleus of large-scale chemical manufacturing; a "practical" training school for pharmacists; an important supply depot during the Revolution; - It was managed by granddaughter Elizabeth, (America's first woman pharmacist). - Christopher earned the title of "The fighting Quaker" during the Revolution. FIRST HOSPITAL IN COLONIAL AMERICA - Colonial America's first hospital (Pennsylvania) was established in Philadelphia in 1751. - The first Hospital Pharmacy began in 1752. - The first Hospital Pharmacist was Jonathan Roberts. - John Morgan’s (Roberts’ Successor) impact on Pharmacy and Medicine influenced changes that were to become important to the development of the pharmacy profession. - He advocated prescription writing and championed the independent practice of two professions. 5 ANDREW CRAIGIE - AMERICA'S FIRST APOTHECARY GENERAL - The first man to hold the rank of a commissioned pharmaceutical officer in an American army was the Bostonian apothecary, Andrew Craigie. - His duties included procuring, storing, manufacturing, and distributing the Army's drug requirements. - He also developed an early wholesaling and manufacturing business. Friedrich Wilhelm Adam Serturner - First of the Alkaloid Chemists - German apothecary who discovered morphine - He recognized and proved the importance of a new class of organic substances: alkaloids - The first alkaloid was isolated from the opium poppy. CAVENTOU, PELLETIER AND QUININE French pharmacists: Pierre-Joseph Pelletier and Joseph- Bienaimé Caventou, whose works are: - isolation of Emetine (induces vomiting) from Ipecacuanha in 1817; - isolation of Strychnine (pesticide) and Brucine (anti-inflammatory and analgesic) from Nux vomica - Peruvian barks that were so useful against malaria - Separation of quinine and cinchonine from the cinchona barks AMERICAN PHARMACY BUILDS ITS FOUNDATIONS - Due to two major threats; deterioration of the practice of pharmacy, and a discriminatory classification by the University of Pennsylvania medical faculty, the pharmacists of aPhiladelphia formed an association, which became The Philadelphia College of Pharmacy, a school of pharmacy, and a self-policing board. - Sixty-eight pharmacists signed the Constitution of the first pharmaceutical association in the United States. THE SHAKERS AND MEDICINAL HERBS - Shakers - First U.S. industry in medicinal herbs (in 1820). - The Shakers gathered/ cultivated 200 plant varieties; dried, chopped, and pressed them into "bricks"; wrapped, labeled, and sold them to pharmacists and physicians worldwide. - The Shaker label was recognized for reliability and quality for over a century. THE AMERICAN PHARMACEUTICAL ASSOCIATION - Under the leadership of its first President, Daniel B. Smith, and first Secretary, William Procter, Jr., twenty delegates launched The American Pharmaceutical Association and opened membership to "all pharmaceutists and druggists" 6  THE FATHER OF AMERICAN PHARMACY - William Procter, Jr., graduated from The Philadelphia College of Pharmacy in 1837. - He is the leader in founding The American Pharmaceutical Association and served that organization as its first secretary and, later, as its president. A REVOLUTION IN PHARMACEUTICAL EDUCATION - Dr. Albert B. Prescott launched the pharmacy course at the University of Michigan in 1868. - He abandoned the traditional requirement of pre-graduation apprenticeship. - At the 1871 convention of the American Pharmaceutical Association, he was denied credentials, and the Michigan course pioneered other major changes: laboratory pharmacy, a definite curriculum that included basic sciences, and a program that demanded students' full-time attention. - During the next thirty years, Dr. Prescott was satisfied with seeing his once-revolutionary innovations generally adopted by pharmaceutical faculties. THE PHARMACOPOEIA COMES OF AGE - The first "United States Pharmacopoeia" (1820) was the work of the medical profession. - It was the first book of drug standards from a professional source to have achieved a nation's acceptance. - In 1877, the "U.S.P." was in danger of dissolution due to the lack of interest in the medical profession. - Dr. Edward R. Squibb, a manufacturing pharmacist and physician, took the problem to The American Pharmaceutical Association convention. - Pharmacists formed a "Committee on Revision" chair manned by hospital pharmacist Charles Rice, assisted by pharmacist-educator Joseph P. Remington, and by Dr. Squibb, their indefatigable collaborator. The "U.S. Pharmacopoeia" surged to new importance. THE STANDARDIZATION OF PHARMACEUTICALS - Parke Davis & Company introduced the standardized "Liquor Ergotae Purificatus" in 1879. - Dr. Albert Brown Lyons, as the firm's Chief Chemist, further developed methods of alkaloidal assay. - Parke and Davis recognized the value of his work, and in 1883, announced a list of twenty standardized "normal liquids.” - Parke-Davis also pioneered in developing pharmacologic and physiologic standards for pharmaceuticals. STANISLAS LIMOUSIN - PHARMACAL INVENTOR - a French retail pharmacist who combines scientific knowledge with technical skills. - He introduced the following: ○ medicine dropper ○ the system of coloring poisons (such as corrosive sublimate) 7  ○ wafer cachets (which found favor before mass production of the gelatin capsule). - His greatest contributions, ○ apparatus for the inhalation and therapeutic administration of oxygen ○ glass ampules that could be sealed and sterilized for the preservation of solutions for hypodermic use. THE ERA OF BIOLOGICALS - 1894, Behring and Roux announced the effectiveness of diphtheria antitoxin. - Parke Davis & Company was among the pioneers. The serum became available in 1895, and lives of thousands of children were saved. - 1903, Parke-Davis received U.S. Biological License No. 1. - New, improved biological products have continued to become available, climaxed in 1955 by poliomyelitis vaccine. THE DEVELOPMENT OF CHEMOTHERAPY Ernest Francois Auguste Fourneau ○ Research in the development of new chemical compounds specifically created to fight disease-causing organisms in the body ○ Headed the chemical laboratories in the world-renowned Institute Pasteur in Paris. - His early work with bismuth and arsenic compounds advanced the treatment of syphilis. - He broke the German secret of sleeping sickness. He paved the way for the life-saving sulfonamide compounds, and the first group of chemicals having recognized antihistaminic properties came from his laboratories. His work led other investigators to broad fields of chemotherapeutic research. INDUSTRIALIZATION ERA - Large numbers of war-related injuries led to the growth of industrial manufacturing to meet the need for pharmaceutical products - Firms other than the pharmacies themselves began centralized manufacturing of medicinal preparations - The periods of development of manufacturing pharmacies began as follows. ○ Formative (1867) ○ Biological (1895) ○ Vitamins (1909) ○ Botanical (1875) ○ Organic Chemical ○ Antibiotics (1940) ○ Standardization Synthesis (1883) (1882) ○ Hormones (1901) Many retail pharmacists protested the industrialization of manufacturing. Industrialization brought about: a. Biologically prepared products c. Increased use of parenteral medications b. Complex chemical synthesis d. Standardized manufacturing 8  THE ERA OF ANTIBIOTICS - Antibiotics are not new. Their actions probably were first observed by Louis Pasteur in 1877 - Louis Pasteur discovered that microbes were responsible for souring alcohol. He came up with pasteurization, where bacteria are destroyed by heating beverages and allowing them to cool. - Fleming's discovery of penicillin in 1929 went undeveloped, and Florey and Chain studied it in 1940. - Under the pressure of World War II, the pharmaceutical manufacturers rapidly adapted mass production methods to penicillin; have reduced costs to 1/1000th the original. - Antibiotic discoveries came rapidly in the '40s. Intensive research continues to find antibiotics to conquer more of qwwrmen's microbial enemies. PATIENT CARE ERA - Increased concentration on rational, targeted research through the use of computers - Well-coordinated teams of scientists and other professionals such as statisticians and financial managers worked together - Multiple drug therapy led to adverse reactions, interactions, and therapeutic outcomes that were greater than or less than desired - Patient-focused drug therapy evolved, centered on drug control or drug monitoring - C.D. Hepler established the concept of pharmaceutical care in the late 1980s CLINICAL PHARMACY CONCEPT - Area of pharmacy concerned with science and practice of rational medication use. - Patient-centered services that promote the appropriate selection, utilization, and monitoring of medications. - Its objectives is to optimize individual and improve therapeutic outcome THE NEW HORIZON - Biotechnology is the use of microorganisms to produce drugs, hormones, and other products - Genetic engineering is the scientific alteration of the structure of genetic material in a living organism - Research into gene therapy and genetic defects has greatly increased - Genetic research is involved in the pursuit of cures for major diseases such as cancer THE PHILIPPINE PHARMACY - 1871, the University of Santo Tomas which was founded in 1611, offered a course in BS Pharmacy and licentiate in pharmacy. - First Filipino to study pharmacy was Don Leon Ma. Guerrero - “Father of Philippine Pharmacy” 9  First Drugstore In The Philippines - Botica Boie, the first drugstore in the Philippines, is an institution that served as a soda fountain and drug company at the old Escolta. It was founded by a young physician-pharmacist named Dr. Lorenzo Negrao. - BOIE Inc. is a distinguished pharmaceutical company with over a century of strong commitment to providing quality medicines to consumers. We are a pioneer in the manufacture and marketing of phytomedicines. We are now focused on promoting natural plant-based products from reputable European research-based manufacturers and supported by substantial scientific literature. Dosage Forms - Collective term for tablets, capsules, syrups, solutions, powders, ointments, and creams. Routes of Administration - Collective term for oral, swallable, parenteral, topical, inhalation, and insertion. Drugs - substances that one uses for prevention (vitamins, vaccines), diagnosis (radiopharmaceuticals), mitigation (anticancer), treatment (antiasthma), and cure (total eradication of disease). FUNCTIONS OF THE PRACTICING PHARMACIST Professional Function Technical Function Administrative, supervisory, and managerial functions Entrepreneurial functions PROFESIONAL FUNCTION - Practicing Pharmacists are, among others, ensuring the safe, effective and appropriate use of drugs by patients. Functions of PROFESSIONAL Pharmacy Practice - Selecting drug product source of supply - Participating in the practice of drug use decisions - Selecting the drug product dosage form - Determining the dose (500 mg) and dosage schedule (three times a day for 7 days) - Preparing the drug product for patient’s use - Dispensing the drug with proper instruction - Counseling patient on the appropriate utilization of medication - Providing drug information to the patient - Monitoring the patient to maximize compliance - record keeping of prescription (1 copy) (prescription book) and dangerous drug prescription (3 copies) (dangerous drugs book) – Physicians –S2 license; Pharmacy – S3 license - Monitoring the patient to detect adverse drug reactions and interactions - Monitoring the patient to enhance the outcomes of drug therapy 10 TECHNICAL FUNCTION - Essential to practice which may not be restricted to pharmacists include a large variety of manipulative or mechanical tasks that must be carried out during the course of practice. - Although these functions are often performed by practicing pharmacists, nonprofessional personnel (pharmacy technician, pharmacy assistant) can be involved under professional supervision. - Examples: Functions indirectly related to dispensing. Functions carried out as a prerequisite to dispensing. Functions directly involved with dispensing. ADMINISTRATIVE, SUPERVISORY, AND MANAGERIAL FUNCTIONS - Employed pharmacists, even with no managerial responsibility have administrative duties related to the practice of pharmacy such as; proper prescription interpretation, record keeping of prescription and dangerous drug prescription, maintaining patients’ drug histories sourcing of medicines purchase request pricing procedures inventory control compliance with government requirements, and management of staff (schedule, salary, leave) - With proper planning, such tasks including personnel scheduling and payroll may be delegated to clerks but supervisory responsibility remains. - In a relatively small pharmacy, the pharmacists usually manage the entire operation including administrative and supervisory functions. - In chain drugstores, the staff pharmacist are confined to the management of the prescription department. - They are under the supervision of the branch pharmacist. - A good manager, administrator, and supervisor must be able to perform well in the pharmacy without diverting pharmacists from mainline and professional functions. ENTREPRENEURIAL FUNCTIONS - Many pharmacists, especially those with business acumen, practice as independent professionals, establishing their nonpharmacy functions by investing personal and borrowed funds. - They are directly dependent on their own skills as professionals and as managers. - Practicing Pharmacists who become entrepreneurs must be able to resolve professionally the conflicts that may arise. OTHER FUNCTIONS OF A PHARMACIST Some pharmacists are not engaged in providing pharmaceutical services directly to patients. They are, however, engaged in important functions related indirectly to the practice. These include: ➔ Research and development ➔ Production 11  ➔ Quality control ➔ Sales and marketing ➔ Teaching and research in academic institutions, ➔ Legal and regulatory functions with regards to drugs and pharmaceutical practice. ➔ Public health functions ➔ Association world ➔ Pharmaceutical journalism Note: Each of these areas requires skills beyond those normally taught and learned in colleges of Pharmacy; thus, those pharmacists working in these areas must acquire skills through additional education or by experience and on-the-job training EMERGING FUNCTIONS OF PHARMACISTS Pharmacists play a vital role in health care system through medicine and information they provide. While responsibilities vary among the different areas of practice, The function includes patient care, dispensing of medication, monitoring patient health and progress to maximize their response to medication, disease state management through appropriate medication therapy management to improve patient outcomes and decrease overall health care costs. These roles may include, but are not limited to: Reviewing medication regimens Monitoring of treatment regimens General health monitoring General health advice Providing specific education to patients about disease states and medications Counseling and advice on optimal use of medicines Advice and treatment of common ailments Referrals to other health professionals if necessary Dosing drugs in renal and hepatic failure Pharmacokinetic evaluation Promoting public health by administering immunizations Educating patient and consumer on the use of prescription medication, over the counter medication, herbal supplement and the proper use of medical devices. Advising physicians, nurses and other health professionals on drug selection and use. Pharmacists also provide expertise on product composition, it’s physical, chemical and biological properties as to its use. They ensure products are manufactured safe and effective. The World Health Organization (WHO) - Report on “The Role of the Pharmacist in the Health Care System” states that the competence of the Pharmacists is already proven and evident: in the direction and administration of pharmaceutical services; in drug regulation and control; in the formulation and quality control of pharmaceutical products; in the inspection and assessment of drug manufacturing facilities; 12  in the assurance of product quality throughout the distribution chain; in drug procurement agencies; and in national and institutional formulary committees I am a Pharmacist ❤ I am a specialist in medications ♥ I supply medicines and pharmaceuticals to those who need them. ♥ I prepare and compound special dosage forms. ♥ I control the storage and preservation of all medications in my care. ❤ I am a custodian of medical information ♥ My library is a ready source of drug knowledge. ♥ My files contain thousands of specific drug names and tens of thousands of facts about them. ♥ My records include the medication and health history of entire families. ♥ My journals and meetings report advances in pharmacy from around the world. ❤ I am a companion of the physician ♥ I am a partner in the case of every patient who takes any kind of medication ♥ I am a consultant on the merits of different therapeutic agents. ♥ I am the connecting link between physician and patient and the final check on the safety of medicines ❤ I am a counselor to the patient ♥ I help the patient understand the proper use of prescription medication. ♥ I assist the patient’s choice of nonprescription drugs or in the decision to consult a physician. ♥ I advise the patient on matters of prescription storage and potency. ❤ I am a guardian of public health ♥ My pharmacy is a center for health-care information. ♥ I encourage and promote sound personal health. ♥ My services are available to all at all time 13  MODULE 2 Roles of Pharmacists PHARMACIST A pharmacist is a person who is professionally qualified to prepare and dispense medicinal agents. THE TEN-STAR PHARMACISTS In 2004, the World Pharmacy Educators Congress was held in New Orleans with the aim of preparing a standard Pharmacy curriculum. However, because of the diversity of the needs of different countries, the body agreed to come up with the 7-star pharmacists, which are enumerated below. Pharmacists are medication experts. This expertise includes the preparation, control, use, and assuring desired outcomes of medicines in patients, beginning with drug discovery and continuing through their benefit to society. Future pharmacists must possess specific knowledge, attributes, skills, and behaviors that support this expertise. 1. Care-giver - the pharmacist provides caring services. Whether these services are clinical, analytical, technological, or regulatory, the pharmacist must be comfortable interacting with individuals and populations. 2. Decision-maker - the appropriate, efficacious, and cost-effective use of resources (e.g., personnel, medicines, chemicals, equipment, procedures, and practices) should be at the foundation of the pharmacist’s work. 3. Communicator - the pharmacist is in an ideal position between physician and patient. As such, he or she must be knowledgeable and confident while interacting with other health professionals and the public. Communication involves verbal, nonverbal, listening, and writing skills. 4. Leader - whether the pharmacist finds him/herself in multidisciplinary (e.g., team) caring situations or in areas where other healthcare providers are in short supply or non-existent, he/she is obligated to assume a leadership position in the community's overall welfare. 5. Manager - the pharmacist must effectively manage resources (human, physical, and fiscal) and information; he or she must also be comfortable being managed by others, whether an employer or the manager/leader of a health care team. 6. Life-long-learner - The concepts, principles, and commitment to life-long learning must begin while attending pharmacy school and must be supported throughout the pharmacist’s career. Pharmacists should learn how to learn. 7. Teacher - the pharmacist has a responsibility to assist with the education and training of future generations of pharmacists. 14  8. Entrepreneur – the pharmacist must learn how to make market surveys in the chosen area and plan, direct, and manage a new pharmacy business. 9. Researcher – the pharmacist must conduct research that will investigate new molecules, design new models of practice, introduce new pharmacy services, share best practices in pharmacy, etc. 10. Agent for positive change - the pharmacist must be the lead in creating change in pharmacy practice to improve patient care, pharmacy services, and inter-professional collaboration. Note: Dr. Olivia M. Limuaco, Former Dean of CEU, School of Pharmacy, added the last 3 attributes which are: - Entrepreneur - Researcher - Agent for positive change EXCLUSIVE AND NON-EXCLUSIVE FUNCTIONS OF A PHARMACIST BASED ON RA 10918-2 FUNCTIONS OF A PHARMACIST Based on Philippine Pharmacy Act (RA 10918), the scope of the pharmacy practice/ functions of the pharmacists are divided into exclusive and non-exclusive. Exclusive functions: only the pharmacist can do it while. Non-exclusive functions: can be done also by other professionals. Exclusive Functions 1. Preparation, compounding or manufacturing, and even storage, distribution, procurement, sale, or dispensing of any pharmaceutical product or its raw material 2. Render services, such as clinical pharmacy services, drug information services, regulatory services, pharmaceutical marketing, medication management, or whenever the expertise and technical knowledge of the pharmacist is required. 3. Teaching scientific, technical, or professional pharmacy courses in a school or college of pharmacy. 4. Dispensing pharmaceutical products in situations where supervision is required. 5. Provide other services where pharmaceutical knowledge is required. There are two categories of establishments where the pharmacist can practice his/her profession. Category A - Pharmaceutical establishment/outlets where the direct and immediate control and supervision of a duly registered and licensed pharmacist are required per establishment, whether in-store or online. Category B - Pharmaceutical establishments/ outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provision of law. 15  CATEGORY A CATEGORY B 1. Pharmaceutical 1. Retail outlets selling household establishments/outlets selling or remedies and OTC drugs as otherwise making available to the differentiated from the consuming public prescription/ethical pharmacist-only OTC medicines medicines, combination products classified as drugs according to the (Examples: Supermarkets, grocery primary intended mode of action, stores) pharmacist-only OTC medicine, whether owned by the government or 2. Satellite institutional pharmacies by a private person or firm, whether providing medicines solely to sold at wholesale or retail employees of their respective (Examples: Community and hospital companies or the employees' pharmacy) qualified dependents, or both, or members of a duly registered 2. Establishments involved in the organization or institution manufacture, importation, exportation, distribution, and sale of (Examples: PLDT, Maynilad, San Miguel combination products(medical devices Corp.) and drugs) are classified as drugs according to the primary intended 3. Fourth, fifth, and sixth-class mode of action. municipal health units involved in the (Examples: Unilab, Pfizer, Hizon procurement, distribution, Laboratories, Euromed) dispensing, and storage of 3. Department/division/units of pharmaceutical products pharmaceutical laboratories, pharmaceutical manufacturing 4. Institution providing telepharmacy laboratories, or other establishments services with processes involving the *Telepharmacy is the delivery of preparation, manufacture, assay, pharmaceutical care via regulation, product research and telecommunications to patients in development, quality control, locations where they may not have repackaging, importation, exportation, direct contact with a pharmacist. It distribution, sale, or transfer of is an instance of the wider pharmaceutical products in quantities phenomenon of telemedicine, as greatly in excess of single implemented in the field of therapeutic doses pharmacy. (Examples: Unilab, Pfizer, Hizon 5. Non-traditional outlets of Laboratories, Euromed) pharmaceutical products, provided 4. Government units, including local that no prescription medicines and government city. First to third-class pharmacist-only OTC medicines are municipal health units, non-government sold. organizations, and/or associations involved in the procurement, distribution, dispensing, and storage of pharmaceutical products. 16  ➔ Pharmacists who are working full-time in Category A are allowed to handle only 4 Category B outlets outside of their full-time work. ➔ Pharmacists in Category B are allowed to handle a maximum of 15 Category B outlets. However, he is not allowed to handle any category A outlet. A pharmacist is required to visit and supervise Category B 2 hours a week. ➔ A duplicate copy of his license with the schedule of visits per outlet must be hung in each Category B outlet. The pharmacist is expected to be in the specific outlet based on the specified date and time to avoid any violation during the inspection. Pharmacist salaries in the Philippines range between 21,418 PHP/month to 80,449/month. The median salary is 54,329 PHP per month, which means that half (50%) of people working as Pharmacists are earning less than 54,329 PHP while the other half are earning more than 54,329. Non-Exclusive 1. Chemical, biological, or microbiological analysis and assay of pharmaceutical products, food/dietary supplements, health supplements, and cosmetics 2. Physicochemical analysis for medical devices used in aid of administration of pharmaceutical products 3. Administration of adult vaccines as approved by the Food and Drug Administration (FDA): Provided that (1) they shall undergo the training on the safe administration of adult vaccines and management of adverse events following immunization for pharmacists & hold a certificate of training issued by an institution duly accredited by the Professional Regulation Commission (PRC); provided, further, that the safe administration of vaccines be part of the higher education curriculum for pharmacists. 4. Conduct or undertake scientific research in all aspects involving pharmaceutical products & health care 17  MODULE 3 Pharmacy Education in the World and Philippines PHARMACY EDUCATION Pharmacy education and practice varies from country to country. It is based on the needs, resources, regulations, policy, challenges, culture and expectations of the concerned country. LESSON 1: EVOLUTION OF PHARMACY EDUCATION IN THE WORLD AND IN THE PHILIPPINES The following discussions will show the different pharmacy practice in some countries. This will show some similarities and differences in the practice of pharmacy in the Philippines. In the United States of America: 1932 Four (4) years BS Pharmacy 1966 Five (5) years BS Pharmacy 2000 Doctor of Pharmacy (Pharm D) Program was initiated In Canada: Bachelor of Science in Pharmacy (BScPharm) four years of undergraduate pharmacy education, plus a minimum prerequisite of one additional year of undergraduate pre-pharmacy education 2007 - Introduced Doctor of Pharmacy (PharmD) Program - Two (2) years of Pre-Pharmacy undergraduate education and Four (4) years of Pharmacy Education 2020 Most Canadian Pharmacy schools will changed their Entry-To-Practice programs with a Bachelor of Pharmaceutical Sciences to Entry-To-Practice Pharm D In Australia: Undergraduate degree (Bachelor of Pharmacy) for 4 years full-time Post-graduate degree (Master of Pharmacy) 2 years full-time In other countries have: Asian countries Japan BSPharmacy (4years) and PharmD(6 years) Korea BPharm (2+4 years) China (4+3years) Taiwan BPharm (4 years) and Pharm D (6 years) Hongkong BPharm (4 years) Thailand BS(5 years) and Pharm D (6 years) 18  Singapore BSPharm (4+1 years) Malaysia BPharm (4+1 years) In the Philippines: The first course offered was leading to the degree of Pharmaceutical Chemistry (3-year course) It was extended to 4 years, leading to the degree of Bachelor of Science in Pharmacy. 1965 the BS Pharmacy course could be finished after five years of study. 1984 the BS Pharmacy was reduced to four years. The different pharmacy programs offered in the Philippines are as follows: 4 4-year B.S. Pharmacy (BSP) 5 5-year B.S. Pharmacy in Clinical Pharmacy (CPS) 5-year B.S. Industrial Pharmacy (B.S. IP) 6-year Doctor of Pharmacy (Pharm.D) 2 year post-baccalaureate degree leading to Doctor of Pharmacy (Pharm.D.) 2-year Master of Science in Pharmacy (MS Pharm) 3-year Doctor of Philosophy in Pharmacy (Ph.D. in Pharm.) PHARMACY PROGRAM IN CEU LADDERIZED PHARMACY PROGRAM Four-year program leading to the degree Bachelor Of Science In Pharmacy Five-year Program leading to the degree Bachelor Of Science In Clinical Pharmacy Six-year Program leading to the degree of Doctor Of Science In Clinical Pharmacy Effective School Year 2020-2021 The Technical Committee on Pharmacy Education is composed of the following: 19  CHED TECHNICAL COMMITTEE FOR PHARMACY EDUCATION CHAIR - Dr. Aleth Therese L. Dacanay Representatives: ACADEME - Dr. Imelda G. Pena - Prof. COP UPM GOVERNMENT - Dr. Mildred B. Oliveros - OIC - PRBP (PRC) - Ms. Ma. Lourdes C. Santiago - Former Deputy Director FDA PHARMACEUTICAL INDUSTRY - Dr. Yolanda R. Robles - President FAPA; - Atty. Jose Maria A. Ochave - VP and ECM of UNILAB - Ms. Rosario C. Barangan - VP for Manufacturing E.L. Laboratories Ma. Gilda Saljay Mr. Anthony Aldrin C. Dr. Aleth Therese L. President of PPHA Santiago Dacanay PRC Board of Pharmacy President of PACOP Officer-in-Charge LESSON 2: PHARMACY CURRICULUM CHED MEMORANDUM ORDER 25 Series of 2021 SUBJECT: POLICIES, STANDARDS, AND GUIDELINES FOR THE BACHELOR OF SCIENCE IN PHARMACY PROGRAM The curriculum was enhanced due to the implementation of the K-12 program of the government. The enhanced curriculum started in the Academic Year (A.Y.) 2018-2019. The enhanced curriculum is based on the following: Republic Act (RA) No. 7722: “Higher Education Act of 1994" RA No. 10918: "Philippine Pharmacy Act" (latest Pharmacy Law) RA No. 7796: “Technical Educational and Skills Development Act of 1994” or "TESDA Act," which pertains to the establishment and administration of the National Trade Skills Standards and training regulations for NC III Pharmacy Services RA No. 10647: “Ladderized Education Act of 2014” in pursuance of an outcome-based quality assurance system as advocated under CMO No. 46 s. 2012, and by virtue of Commission en Banc Resolution No. 340-2017 dated May 2, 2017 20  ARTICLE I INTRODUCTION SECTION 1: RATIONALE ○ Based on the Guidelines for the Implementation of CM0 No. 46 series of 2012, this PSG implements the "shift to learning competency-based standards/ outcomes-based education." ○ It specifies the 'core competencies’ expected of BS Pharmacy graduates "regardless of the type of Higher Education Institution (HEI) they graduated from." ○ However, in recognition of the spirit of outcomes-based education and of the typology of HEls, this PSG also provides "flexibility and ample space for HEls to innovate in the curriculum in line with the assessment of how best to achieve learning outcomes in their particular contexts and their respective missions ARTICLE II AUTHORITY TO OPERATE SECTION 2. GOVERNMENT RECOGNITION All private higher education institutions (PHEIs) intending to offer BS Pharmacy must first secure proper authority from the Commission in accordance with the Policies, standards, and guidelines (PSGs). All HEIs with an existing BS Pharmacy program are required to shift to an outcomes-based approach as mandated by this PSG. Autonomous and deregulated institutions, state universities and colleges (SUCs), and local colleges and universities (LUCs) should strictly adhere to this PSG's provisions as stipulated in CMO No.40s. 2008 “Manual of Regulations for Private Higher Education.” ARTICLE III GENERAL PROVISIONS Per Section 13 of RA No. 7722, the higher education institutions shall exercise academic freedom in its curricular offerings but must comply with the minimum requirements for specific academic programs, the general education distribution requirements and the specific professional courses. ARTICLE IV PROGRAM SPECIFICATIONS SECTION 5. PROGRAM DESCRIPTION 5.1. DEGREE NAME: The degree program described herein shall be called Bachelor of Science in Pharmacy (BSP) 21  5.2. NATURE OF THE FIELD OF STUDY Program BSPHARMACY Years 4 years Total Units 185 credit units Total Hours 1415 Hours of internship 1,200 hours Licensure Exam Pharmacy Licensure Exam 5.3. PROGRAM GOALS The program aims to produce graduates who can portray the following roles: Professional pharmacist Pharmaceutical care provider Researcher Manager and entrepreneur Educator 5.4. SPECIFIC PROFESSIONS/CAREERS/OCCUPATIONS FOR GRADUATES ○ Graduates of the BS Pharmacy program may pursue a career in any of the following areas of pharmacy practice: Pharmaceutical manufacturing/production Production planning and inventory control Quality assurance Hospital pharmacy Research and development Clinical pharmacy Regulatory affairs Community pharmacy Academe Cosmetics industry Clinical research Veterinary industry ○ Phase I – Healthy patient – Safety ○ Phase II – Patient with the disease – Safety and Efficacy (effectiveness of the drug) ○ Phase III – Patient with the disease – Safety, Efficacy (effectiveness of the drug), and the Dose (amount) Government service (Department of Health, Food and Drug Administration, PhilHealth, Professional Regulation Commission, Philippine Drug Enforcement Agency, Dangerous Drugs Board, and others) Health publications Sales or marketing Institutional pharmacy (non-pharmaceutical establishments with pharmacy clinics, such as those in the Supreme Court, San Miguel Corp, GSIS, etc.) 22 SECTION 6. PROGRAM OUTCOMES 6.1 COMMON TO ALL PROGRAMS IN ALL TYPES OF SCHOOLS a) The ability to engage in lifelong learning and understanding of the need to keep abreast of the developments in the specific field of practice. b) The ability to effectively communicate orally and in writing using both English and Filipino c) The ability to work effectively and independently in multi-disciplinary and multi-cultural teams. d) A recognition of professional, social, and ethical responsibility e) An appreciation of “Filipino historical and cultural heritage” (based on RA No. 7722) 6.2 Based on HEI type (CHED implementation handbook for OBE and ISA, 2013) Graduates of professional institutions demonstrate a service orientation in one's profession Graduates of colleges participate in various type of employment, development activities, and public discourses, particularly in response to the needs of the communities one serves Graduates of universities participate in the generation of new knowledge or in research and development projects Graduates of State Universities and Colleges must, in addition, have the competencies to support "national, regional and local development plans" (RA No. 7722). 6.3 COMMON TO ALL HEALTH-RELATED PROFESSIONS Graduates of the BS Pharmacy program shall have the following attributes common to all health-related professions: a) Demonstrate competence in handling health problems of individuals, families, communities b) Demonstrate higher-order thinking skills, problem-solving, decision-making, logical and critical thinking skills c) Subscribe to professional, legal, and ethical practice d) Work collaboratively with inter- and multi-professional teams e) Communicate proficiently f) Engage in self-directed lifelong learning g) Promote the use of a health system approach in the delivery of service 23 SPECIFIC TO THE BS PHARMACY PROGRAM Program Outcomes Operational Definition of Program Outcomes Practice pharmacy Adhere to legal requirements, practice standards, and code in a professional of ethics for the pharmacy profession. and ethical manner Apply knowledge & skills of mathematics, health sciences, social sciences, psycho-social sciences, physical sciences, environmental sciences, natural sciences, information technology, and other advanced technologies to pharmacy practice. Apply suitable techniques and principles in compounding, storing, manufacturing, distributing, administering, and disposing of pharmaceutical (biological) products to ensure product quality, safety & efficacy of products. Provide Develop a drug therapy plan appropriate for the patient pharmaceutical based on evaluated patient's health and medication history care Provide relevant information in dispensing pharmaceutical products in accordance to practice standards. Monitor the patient's progress in achieving specific outcomes and optimize patient's health-related quality of life. Collaborate effectively with the patients and other members of the health care team in accordance with practice standards Conduct relevant Conduct or participate in research activities in accordance research and with scientific research guidelines and dissemination of disseminate findings for utilization. findings Apply managerial Demonstrate efficient and effective management skills in any and entrepreneurial organization. skills Demonstrate entrepreneurial skills while ensuring patient safety Communicate and Facilitate learning of selected learners for specific purposes facilitate (patients, students, peers, support staff, other health effectively professionals) Communicate effectively using culturally appropriate language SECTION 7. PERFORMANCE INDICATORS This section contains a list of competency standards or performance indicators that will measure the attainment of each of the identified program outcomes. These competency standards have been determined according to the roles expected to be performed by the graduates in their workplace. These performance indicators will serve as bases for the assessment of student achievement/performance in various courses in the curriculum. ARTICLE V 24  CURRICULUM Curriculum Description Program BSPHARMACY Years 4 years Total Units 169 credit units Total Hours 1415 Hours of internship 1,200 hours Licensure Exam Pharmacy Licensure Exam CURRICULUM DESIGN WAS BASED ON… ○ International Pharmaceutical Federation (FIP) (published in the 2012 FIP Global Pharmacy Workforce Report) ○ Philippine Pharmacy Act (RA 10918) ○ Philippine Qualifications Framework (PQF), ○ Philippine Practice Standards for Pharmacists (PhilPSP) ○ other international professional competency standards. CURRICULUM CONTENT ○ Pharmacy Practice Perspectives in Pharmacy Dispensing I & II Clinical Pharmacy & Pharmacotherapeutics Pharmacy Administration, Management and Leadership Pharmaceutical Marketing and Entrepreneurship Legal Pharmacy and Ethics Pharmaceutical Manufacturing & Quality Assurance Cosmetics Product Development Hospital Pharmacy Health Technology Assessment, Health Policy & Pharmacoeconomics Social & Administrative Pharmacy Public Health Pharmacy & Pharmacoepidemiology ○ Pharmacy Science Drug Discovery and Development Biological Sciences Pharmaceutical Microbiology & Parasitology Pharmaceutical Toxicology Pharmacology and Pharmaceutical Chemistry 25 TOPICS FOR INTEGRATION PROFESSIONAL PHARMACY COURSES Professionalism and Good x Practices (GxP) (Good Pharmacy Practices, Good Manufacturing Practices, Good Clinical Practices, Good Storage Practices, All professional pharmacy courses Good Distribution Practices, Good Compounding Practices, Good Regulatory Practices, Good Pharmacovigilance Practices) Patient Safety (Rational use of Introduction to the Health System medicines. Antimicrobial resistance Pharmaceutical Microbiology and Parasitology, and antimicrobial stowardship, Dispensing I & II; Public Health Pharmacy & Immunization Techniques and Safe Pharmacoepidemiology, Clinical Pharmacy and Administration of Vaccines, as well as Pharmacotherapeutics Pharmacology, Advorse Evonts Following immunization Pharmaceutical Manufacturing and Quality Safety Assessment of Cosmetics) and Assurance; Human Physiology & Pathophysiology, Quality Risk Managoment Cosmetics Product Development Disaster Risk Reduction and Introduction to the Health System; Management Pharmaceutical Microbiology and Parasitology; Dispensing I & Il; Public Health Pharmacy & Pharmacoepidemiology: Clinical Pharmacy and Pharmacotherapeutics Leadership and Management (including Introduction to Pharmacy Administration, development of nontechnical skills or Management and Leadership; Pharmaceutical soft skills) Administration and Management; Pharmaceutical Marketing and Entrepreneurship Interprofessional Education (PE) Hospital Pharmacy, Public Health Pharmacy as an effective approach in & Pharmacoepidemiology: Pharmaceutical collaboration Manufacturing and Quality Assurance; Social & Administrative Pharmacy: Clinical Pharmacy & Pharmacotherapeutics, Internsnip courses Counterfeit Medicines and SSFFC Public Health Pharmacy & Pharmacoepidemiology: (Substandard, Spurious, Falsely Dispensing I and II; Introduction to the Health labeled, Falsified and Counterfeit System; Clinical Pharmacy & medical products) Pharmacotherapeutics: Pharmaceutical Manufacturing and Quality Assurance Pharmaceutical Promotion & Ethics Pharmaceutical Marketing & Entrepreneurship Philippine Practice Standards for All professional pharmacy courses Pharmacists (PhiPSP) Pharmaceutical Supply Chain Public Health Pharmacy & Pharmacoepidemiology: Management Dispensing I & II; Introduction to the Health System; Clinical Pharmacy and Pharmacotherapeutics, Legal 26  Hospital Pharmacy; Health Technology Assessments, Health Policy & Pharmacoeconomics: Legal Pharmacy and Ethics: Pharmaceutical Manufacturing and Quality Assurance 8.5. THE CURRICULUM SHOULD INCLUDE 36 UNITS OF REVISED GE COURSES, IN ACCORDANCE WITH CHED CM0 NO. 20 SERIES OF 2013, 36 Units Revised GE ○ 24 units of core courses, ○ 9 units electives and ○ 3 units Life & Works of Rizal (mandatory), 14 units additional ○ 8 units of Physical Education (PE) and ○ 6 units of NSTP, ○ Total of 50 units of non-professional courses. SUMMARY OF GENERAL EDUCATION (G.E.) COURSES + MANDATED COURSES Total Number of Units (GE+ Mandated): 50 UNITS G.E Core: No. of Units Understanding the Self 3 Purposive Communication 3 Mathematics in the Modern World 3 Science, Technology & Society 3 Ethics 3 Art Appreciation 3 Readings in Philippine History 3 The Contemporary World 3 TOTAL 24 G.E. Electives: Math, Science & Technology 3 Social Sciences & Philosophy 3 Math, Science & Technology 3 TOTAL 9 G.E. Mandated Life & Works of Rizal 3 Physical Education 8 NSTP 6 TOTAL NUMBER OF UNITS FOR G.E. COURSES: 50 TOTAL NUMBER OF UNITS FOR PROFESSIONAL COURSES: 135 27 SUMMARY OF CREDIT UNITS IN THE BS PHARMACY PROGRAM Total Number of Units: 169 units YEAR LEVEL 1st SEMESTER 2nd SEMESTER TOTAL LEC LAB TOTAL LEC LAB First 24 21 3 24 21 3 Second 24 17 7 25 21 4 Third 24 20 4 24 20 4 Fourth (Internship) 12 12 TOTAL 84 58 14 85 62 11 BREAKDOWN SUMMARY UNITS HOURS Lecture courses (1 unit = 17 hrs) 120 2,040 Laboratory courses (1 unit = 51 hrs) 25 1,275 Internship courses (1 unit = 50 hrs) 24 1,200 Total Number of Units (4-yr BSP) 169 4515 ○ Pharmacy Practice/Internship Public Health and Regulatory Pharmacy Hospital Pharmacy Industrial Pharmacy Community Pharmacy Institutional Pharmacy PHILIPPINE QUALIFICATION FRAMEWORK 28 SECTION 11. THE PHILIPPINE QUALIFICATIONS FRAMEWORK (LEVEL 6) Domains Descriptors Knowledge, Skills Graduates at this level have broad and coherent knowledge and and Values skills in their field of study for professional work and lifelong learning Application Application in professional work or research in a specialized field of discipline and/or for further study Degree of Independent and/or in teams of related field with minimal Dependence supervision guided by set procedures that frequently require judgment. Qualification Type Baccalaureate Degree ARTICLE VI REQUIRED RESOURCES SECTION 14. PROGRAM ADMINISTRATION Dean/Program Head Faculty Licensed pharmacist Licensed pharmacist At least MS degree in Has at least a Master’s degree in Pharmacy (Clinical pharmacy Pharmacy, Social & Administrative Pharmacy, Pharmaceutical Sciences, Pharmaceutical 5years teaching experience Regulatory Science, Public Health Pharmacy, Pharmaceutical Supply Chain Management, Health 2 years of administrative Technologies Assessment & Pharmacoeconomics, experience and other related pharmacy courses SECTION 15. LIBRARY Library personnel, facilities and holdings should conform to existing CHED requirements for libraries which are embodied in a separate issuance. CEU Library personnel, facilities, and holdings conform to existing CHED requirements for libraries. SECTION 16. LABORATORY AND PHYSICAL FACILITIES Classroom requirements The school/college/department of pharmacy must provide lecture and laboratory rooms, facilities, materials, and equipment that are adequate for instruction, laboratory work, and research Laboratory requirements The school/college/department of pharmacy should have a laboratory coordinator/manager, who is a graduate of pharmacy, to oversee the operations of pharmacy laboratories. 29  Separate laboratory rooms for the animal, microbiology, and pharmaceutical sciences and research should be provided. Audio-visual equipment There should be separate multimedia facilities consisting of USB-enabled TVs, LCDs, computers with internet access, and other relevant equipment to enhance instruction of professional pharmacy courses. ARTICLE VII INTERNSHIP SECTION 17. GENERAL GUIDELINES Site Accredited sites Hours Institutional Airline, BSP, San Miguel Corp, PLDT, Meralco, Supreme Court (120 hours) 300 Public health and regulatory FDA, DOH, RITM, PDEA (180 hours) Hospital Hospitals (private/public) 300 Community Drugstore (chain drugstore) 300 Industry Manufacturing firm, distributor 300 TOTAL 1200 Memorandum of Agreement (MOA) between the school and the internship facility is required An affiliation fee will be paid by the school to the internship facility. The internship may be scheduled any day of the week, including holidays, during business hours for as long as the supervising licensed pharmacist permits. The intern should have one day off a week. ANNEX F: List of Laboratory Equipment/Facilities/Supplies List of basic glassware/supplies: II. List of Laboratory Equipment A. Beakers (50, 100, 250, 500 and 1. Balances: 1,000 ml) a. Analytical balances (at least four) B. Buret (acid and alkali) b. Top loading balance (at least two) C. Erlenmeyer flask (100, 250, c. Double beam balance (at least two) 500 ml) d. Weighing scales (at least three) D. Florence Flask (50, 100, 250, 2. HPLC 500 ml) 3. FTIR E. Graduated cylinder (50, 100, 4. pH meter (at least two) 250, 500 and 1,000 ml) 5. Refractometer F. Conical flask 6. Polarimeter 7. Melting point apparatus 30 G. Volumetric flask (10, 50, 100, 8. UV/Vis spectrometer 250, 500 and 1,000 ml) 9. Dissolution Apparatus (atleast 6 H. Evaporating dish baskets/paddles) I. Spot plate 10. Disintegration Apparatus J. Watch glass 11. Furnace K. Test tubes 12. Rotary evaporator L. Test tube rack 13. Microscopes, compound with LED light (at M. Test tube Holders least 1 for every 5 students) N. Test tube brush 14. Fume hood (at least 1 in the Pharmaceutical O. Stirring rod/glass rods Chemistry laboratory) P. Glass funnels 15. Lyophilizer/ freeze drier Q. Percolators 16. Vortex mixer (at least two) R. Porcelain crucibles 17. Autoclave / Sterilizer with pressure gauge S. Pipets (transfer and 18. Ovens measuring)/Micropipets a. Drying ovens (at least two) T. Separatory funnels b. Circulating oven U. Spatula, steel, and porcelain c. Stability oven (with temperature & RH V. Wire gauze gauge) W. Iron stand d. Microwave X. Clay triangle/crucible 19. Viscometer tong/holders 20. Moisture Analyzer / Moisture Y. Buret holder determination instrument Z. Distillation set up (simple, 21. Distilling apparatus steam and fractional) 22. Pump (suction/vacuum) AA. Mortar and pestle 23. Ultrasonic bath (porcelain and glass) 24. Waterbath BB. Petri dish (glass) 25. Oil bath 26. Refrigerator 27. Microplate reader 28. Filtration assembly with pump 29. Centrifuge a. Centrifuge, ordinary b. Refrigerated centrifuge 31  CENTRO ESCOLAR UNIVERSITY ***Manila ***Makati * Malolos SCHOOL OF PHARMACY LADDERIZED PHARMACY PROGRAM *FOUR-YEAR PROGRAM LEADING TO THE DEGREE BACHELOR OF SCIENCE IN PHARMACY **FIVE-YEAR PROGRAM LEADING TO THE DEGREE BACHELOR OF SCIENCE IN PHARMACY SPECIALIZED IN CLINICAL PHARMACY ***SIX-YEAR PROGRAM LEADING TO THE DEGREE DOCTOR OF PHARMACY Date of Approval by the University Council: March 19, 2018 Effective First Year School Year 2018 – 2019 May 8, 2018 32 FIRST YEAR LEARNING OUTCOMES: 1. Demonstrate appreciation of pharmacy as a health profession and the scope of practice. 2. Demonstrate understanding of chemical, physical, and biological processes relevant to pharmaceutical sciences. 3. Recognize the importance of the healthcare system and its components, including the importance of pharmacovigilance. 4. Perform pharmaceutical calculations and appropriate laboratory techniques 5. Demonstrate understanding of morphology, anatomy, physiology, taxonomy, and distinct features of plant species of pharmaceutical importance. 6. Relates ethical practices to administration, management and leadership in pharmacy 7. Identify the different elements or components in a pharmacy operation while practicing good management skills. 8. Demonstrate understanding of the relationship among different levels of body functions from molecular to systemic level in normal conditions and diseased states, including the impact of immunization in vaccine-preventable diseases. 9. Demonstrate proper adult vaccine administration techniques. 10. Practice good housekeeping in the laboratory and other working areas. 11. Manifest a sound understanding of oneself in relation to others and the society. 12. Communicate effectively to appropriate audience. 13. Demonstrate an appreciation of mathematics and its relevance to science. 33  LESSON 3: PHARMACY RESEARCH EDUCATION Research is necessary to drive pharmacy practice forward. Research on the quality, outcomes, and cost of pharmacy services is essential for pharmacy practice to evolve in response to changing healthcare needs and marketplace competition, says the Royal Pharmaceutical Society. The Canadian Pharmacists Association (CPhA) defines pharmacy practice research as a component of health services research that focuses on assessing and evaluating pharmacy practice. Pharmacy Research Education develops strategies, improves outcomes, and implements evaluation plans. Clinical pharmacy and pharmacy practice ➳ Clinical pharmacy research concerns the science and practice of rational medication use and medication management therapies. Pharmacy practice research deals with assessing and evaluating pharmacy practice while addressing the role(s) of the pharmacist, utilizing a system-based, patient-centered approach. Both areas are concerned with optimal patient outcomes. Pharmaceutical sciences ➳ The pharmaceutical sciences combine a broad range of scientific disciplines critical to discovering and development of new drugs and therapies. Research can involve aspects of chemistry, biology, statistics, mathematics, physics, and chemical engineering. Pharmacoepidemiology and pharmacoeconomics ➳ The field of pharmacoepidemiology applies methods and clinical pharmacology to investigate medications' use, effectiveness, and safety in human populations. ➳ Pharmacoeconomics seeks to identify, measure, and compare the costs and consequences of pharmaceutical products and services, often with the goal of optimizing the allocation of healthcare resources. 34  LESSON 4: POST-GRADUATE TRAINING Post graduate residency training and specialty is being practiced in the USA and other ASIAN countries. The American Society of Health-System Pharmacists (ASHP) accredits postgraduate residency training programs for pharmacists. Postgraduate training is elective, though this yearlong experience allows you to apply the knowledge and skills learned in pharmacy school to real patients, situations and settings In the Philippines, there is no post-graduate training yet named PGY-1 and PGY 2. It is only in other countries, such as the United States. In the US, post-graduate training is a 2-year training as follows: POST-GRADUATE TRAINING A postgraduate year one (PGY-1) residency prepares graduate pharmacists for clinical practice ○ advantage in the job market, networking contacts and professional mentors, and direction for future career opportunities. A postgraduate year two (PGY-2) is an additional yearlong training program that builds on the skills from a PGY-1 residency. The PGY-2 residency is often referred to as a "specialty" residency due to the training focus — such as critical care, oncology, or infectious diseases and may be offered in combination with other programs, such as a master's degree or a fellowship THE BOARD OF PHARMACY SPECIALTIES® ESTABLISHED IN 1976 The principal responsibilities of BPS include: To grant recognition of appropriate pharmacy practice specialties based on criteria established by BPS. To establish standards for certification and recertification of pharmacists in recognized pharmacy practice specialties. To grant qualified pharmacists certification and recertification in recognized pharmacy practice specialties. To serve as a coordinating agency and information clearinghouse for organizations and pharmacists in recognized pharmacy practice specialties. To enhance public/consumer protection by developing effective certification programs for specialty practices in pharmacy. 35 THE AREA OF SPECIALTY FOLLOWS: Specialty Council on ❧ Ambulatory Care Pharmacy ❧ Nuclear Pharmacy ❧ Cardiology Pharmacy ❧ Nutrition Support Pharmacy ❧ Critical Care Pharmacy ❧ Oncology Pharmacy ❧ Geriatric Pharmacy ❧ Pediatric Pharmacy ❧ Infectious Diseases Pharmacy ❧ Pharmacotherapy ❧ Psychiatric Pharmacy MINIMUM REQUIREMENTS FOR THIS SPECIALTY CERTIFICATION Graduation from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) or a program outside the U.S. that qualifies the individual to practice in the jurisdiction. A current, active license to practice pharmacy in the U.S. or another jurisdiction. Completion of four (4) years of practice experience** (post-pharmacist licensure) with at least 50% of time spent in specialty area Completion of a PGY-1 residency * plus one (1) additional year of practice experience** (post- pharmacist licensure) with at least 50% of time spent in specialty area Completion of a specialty (PGY-2) residency* in specialty area; and Achieving a passing score on the Specialty Certification Examination. LESSON 5: CONTINUING PROFESSIONAL DEVELOPMENT (CPD) CONTINUING PROFESSIONAL EDUCATION RA 10912 is known as the Continuing Professional Development Act of 2016”. An act mandating and strengthening the continuing professional development program for all regulated professions, creating the continuing professional development council, and appropriating funds for other related purposes. Continuing Professional Development or CPD - refers to the inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialization or an inter- or multidisciplinary field of study for assimilation into professional practice, self-directed research, and/or lifelong learning. ↦ Previously, the Pharmacy profession was required to have 45 credit units (cu) every three years to renew the PRC license. There were complaints about the number of units implemented. Resolution no. 1032 changed that to 15 credit units every three (3) years. At present, it is still implemented. 36  ↦ Every Professional Regulatory Board (PRB) shall create a CPD Council composed of a Chairperson and 2 members: The BOP Chair served as the chairperson. Dr. Mildred B. Oliveros (OIC) The members of the Pharmacy CPD council are the: ○ Presidents of the Philippine Pharmacists Association (PPhA) (Dr. Aleth ○ Therese Dacanay) ○ President of the Philippine Association of Colleges of Pharmacy, Inc. (PACOP) (Prof. Perlita Crucis) CPD COUNCIL ACCREDITS, the provider of CPD Local CPD Providers - Individual/ Sole Proprietor - Firm/Partnership/ Corporation - Government Institutions/ Agencies Foreign CPD Providers CPD PROGRAMS 1. Formal learning refers to educational arrangements such as curricular qualifications and teaching-learning requirements in education and training institutions recognized by relevant national authorities, leading to diplomas and qualifications 2. Non-formal learning refers to learning acquired in addition or alternatively to formal learning, which may be structured and made more flexible according to educational and training arrangements. 3. Informal learning is the recognition, validation, and accreditation process, which can contribute to a qualification. 4. Self-directed learning refers to learning activities such as online training, local/ international seminars, non-degree courses, institution/ company-sponsored training programs, and the like, which did not undergo CPD accreditation but may be applied for and awarded CPD units by the respective CPD Council. 5. Online learning activities refer to structured or unstructured learning initiatives that make use of the Internet and other web-based Information and Communications Technology solutions; 6. Professional work experience HOW TO EARN CPD PROGRAM/ACTIVITY CREDIT UNITS SUPPORTING DOCUMENTS 1. Professional Track (Training Offered By Accredited CPD Providers, Face To Face/ Online) 37  1.1 Participant APPROVED CREDIT UNITS Certificate of attendance with FOR THE PROGRAM number of hours, seminar program and list of participants 1.2 Resource Speaker 3 CU PER HOUR Photocopy of a certificate, copy of papers and program invitation 1.3 Panelist/Reactor 2 CU PER HOUR Certification from sponsoring organization copy of program 1.4 Facilator/ Moderator 1 CU PER HOUR Certification from sponsoring organization copy of program 1.5 Monitor twice the number of approved Monitoring report, certificate of credit units for the program appearance and the authority to monitor 1.6 In-Service Training maximum of 20 CU for a Certificate of training & 12-month period or a fraction training description thereof upon completion 2. Academic Track 2.1 Master’s degree or FULL CREDIT UNITS for University certification/diploma equivalent compliance period upon and transcript of records completion of degree (authenticated copy) FULL CREDIT UNITS for 2.2 Doctorate degree or compliance period upon University certification/diploma equivalent completion of candidacy and transcript of records additional full credit (authenticated copy) units for compliance period upon completion of degree 2.3 Professorial chair 15 CU PER YEAR Certification of grant or appointment paper 2.4 Residency/ Hospital certification externship/ specialty/ 10 CU PER YEAR certificate of completion sub- specialty program 2.5 Fellowship grant 2.5.1 Participant 2 CU PER GRANT Certification from the granting institution 2.5.2 Resource speaker 4 CU PER GRANT and/or certificate of 2.5.3 Researcher 5 CU PER GRANT fellowship MAXIMUM OF 30 CU for an 2.6 Post graduate 18- month period or a Diploma/ certification diploma/certificate fraction thereof upon from the institution completion 38 3. SELF-DIRECTED (TRAINING OFFERED BY NON-ACCREDITED CPD PROVIDERS, Face to Face/ Online) 3.1 Participant credit units for the Certificate of attendance program as evaluated by the with number of hours, seminar CPd council program, and list of participants 3.2 Resource speaker 3 CU PER HOUR Photocopy of certificate, copy of papers and program invitation 3.3 Panelist/reactor 2 CU PER HOUR Certification from sponsoring organization copy of program 3.4 Facilator/ 1 CU PER HOUR Certification from sponsoring moderator organization copy of program 3.5 In-service training maximum of 20 CU for a Certificate of training & 12-month period or a fraction training description thereof upon completion 3.6 Program/training 10 CU per module Copy of module and evaluation module development 3.7 Technical paper 5 CU per technical paper for Certification of completion and published paper, see 3.8 approval for published paper, see 3.8 3.8 Article published in a refereed i peer reviewed professional journal LOCAL 10 CU INTERNATIONAL 10 CU 3.8.1 Author/s Copy of published article and for multiple authors, divide table of contents CU equally among them 3.8.2 Peer reviewer 2 CU PER ARTICLE 3.9 Pamphlet / book or monograph 20 CU for single author for pamphlet (less than 100 3.9.1 Author/s pages) Copy of published book 40 CU for single author for book or monograph (more than 100 pages) 3.9.2 Editor MAXIMUM OF 20 CU 3.10 Article in MAXIMUM OF 5 CU per magazine/ newspaper article for multiple authors, Proof of publication of article divide cu equally among them. 3.11 Inventions FULL CREDIT UNITS for Certified copy of patent 39  compliance period certificate 3.12 Study tours/visits 2 CU/ DAY (maximum of 20 Certification from sponsoring CU/tour institution 3.13 Consultancy (e.g. technical meetings/ accreditation and other 1 CU PER HOUR Certificate of appearance and activities as per request invitation of an institution, etc.) 3.14 Socio-civic Project proposal, report and activities (e.g.medical 1 CU PER HOUR photos missions, outreach programs, etc.) 3.15 Recognition/title (e.g. fellows, hall of fame award outstanding FULL CREDIT UNITS for Copy of certification from the professional, lifetime compliance period awarding body (duly notarized) achievement awardee, etc.) 4. SUCH OTHER ACTIVITIES TO BE RECOMMENDED BY THE CPD COUNCIL AND APPROVED BY THE BOARD AND THE COMMISSION 40  MODULE 4 Pharmacy Regulations BOARD EXAMINATION - The purpose is to identify persons who possess the minimum knowledge necessary to perform tasks on the job safely and competently. LESSON 1: PHARMACIST LICENSURE EXAMINATION A pharmacist, before being able to practice the profession, must pass the licensure examination as required by the Republic Act 10918, otherwise known as the “Philippine Pharmacy Act”. The following are the requirements for applicants who will be taking the Pharmacists’ Licensure Examination: 1. A citizen of the Philippines or of a foreign country which has a law or policy on reciprocity for the practice of the pharmacy profession; 2. Of good moral character and reputation; 3. A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED; 4. Has completed an internship program approved by the Board, pursuant to such guidelines as may hereinafter be promulgated, in consultation with the duly recognized associations of pharmacy schools and the CHED. SCHEDULE OF EXAMINATIONS Upon completion of the requirements, the applicant may take the licensure examination, usually given two times a year in places and dates designated by the Professional Regulation Commission (PRC). Deadline of application 20 working days before the examination MODULE 1: Pharmaceutical Chemistry - 20% Inorganic Pharmaceutical and Medicinal Chemistry Organic Pharmaceutical and Medicinal Chemistry Qualitative Pharmaceutical Chemistry MODULE 2: Pharmacognosy - 15% Pharmacognosy Plant Chemistry Biochemistry MODULE 3: Practice of Pharmacy - 17.5% Compounding and Dispensing Pharmacy Clinical and Hospital Pharmacy Pharmaceutical Calculations MODULE 4: Pharmacology and Pharmacokinetics - 15% Pharmacology 41  Pharmacokinetics Toxicology Incompatibilities and Adverse Drug Reactions MODULE 5: Pharmaceutics - 17.5% Manufacturing Pharmacy Pharmaceutical Dosage Forms Physical Pharmacy Jurisprudence and Ethics MODULE 6: Quality Assurance & Quality Control - 15% Quality Assurance Quality Control Microbiology and Public Health Qualitative Pharmaceutical Chemistry Drug Testing with Instrumentation In order to be registered and licensed as a pharmacist, a candidate must: obtain a general weighted average of seventy-five percent (75%) with no rating lower than fifty percent (50%) in any of the subjects. An applicant who failed the licensure examination for the third (3rd) time shall not be allowed to take the next succeeding examinations without having undertaken a refresher program in a duly accredited institution. The Board shall issue guidelines on the refresher program requirement. All successful candidates in the licensure examination shall: take their oath of profession prior to entering the practice of the pharmacy profession, in which he or she will be issued a Certificate of Registration (COR) and a Professional Identification Card (PIC) RENEWAL OF LICENSE EVERY 3 YEARS AND THE REQUIREMENTS A PIC bearing the registration number and dates of its issuance and expiry, duly signed by the Chairperson of the PRC, shall likewise be issued to every registrant upon payment of the prescribed fees. The PIC shall be renewed every three (3) years upon presentation of the Certificate of Good Standing (COGS) from the accredited professional organization (APO) and proof of completion of the continuing professional development (CPD) requirements. LESSON 2: LAWS AFFECTING THE PHARMACY PRACTICE The practice of pharmacy profession is regulated by the following laws in the country: A. Republic Act 10918 – “Philippine Pharmacy Act” It is an act regulating and modernizing the practice of pharmacy in the Philippines. It provides for and shall govern the following: 1. Standardization and regulation of pharmacy education; 2. Administration of licensure examination, registration and licensing of pharmacists; 3. Supervision, control, and regulation of the practice of pharmacy in the Philippines; 42  4. Development and enhancement of professional competence of pharmacists through continuing professional development, research and other related activities; 5. Integration of the pharmacy profession. The Professional Regulatory Board of Pharmacy, under the administrative control and supervision of the PRC, shall be responsible for the full implementation of the law. B. Republic Act 3720 – “The Foods, Drugs, Devices and Cosmetics Act” It is an act to ensure the safety and purity of foods, drugs, and cosmetics being made available to the public by creating the Food an