Pharmacy Orientation PHT 101 Handout (Pharm-D) PDF

Faculty of Pharmacy Pharmaceutical Technology Department Pharmacy Orientation PHT 101 Handout (Pharm-D) List of contents: Introduction........................................................................................................ 1 Pharmacy education............................

Faculty of Pharmacy Pharmaceutical Technology Department Pharmacy Orientation PHT 101 Handout (Pharm-D) List of contents: Introduction........................................................................................................ 1 Pharmacy education......................................................................................... 13 Information Resources in Pharmacy................................................................ 20 Pharmaceutical Organizations......................................................................... 27 Scope of Work & Pharmacy Careers............................................................... 30 Pharmaceutical Ethics...................................................................................... 39 The Prescription............................................................................................... 43 Introduction to Dosage forms.......................................................................... 56 References:....................................................................................................... 72  Pharmacy Orientation (PHT101) Introduction Pharmacy Definition: The art and science of preparing and dispensing medications and the provision of drug-related information to the public. It involves: 1. The interpretation of prescription orders; 2. The compounding, labeling, and dispensing of drugs and devices; 3. Drug product selection and drug utilization reviews; 4. Patient monitoring and intervention; and 5. The provision of cognitive services related to use of medications and devices. It is also defined as every store or shop licensed by authority where drugs, controlled substances, poisons, medicines or chemicals are stored, possessed, dispensed, sold, displayed for sale, or where prescriptions are compounded or dispensed. Types: Outpatient hospital, community, nuclear, institutional and internet pharmacies. Pharmacist Pharmacist is educated and licensed to dispense drugs and to provide drug information. Pharmacist should be graduated from an accredited School of Pharmacy. 1 Pharmaceutical care The term holds that the important role of the pharmacist is "the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life". No one can imagine how many words of wisdom from pharmacists to patients each day may have prevented unnecessary visits to doctors' offices and gratified countless recipients with precious, professional health counseling. Nature and sources of drugs 1. Plant sources: Parts of plants e.g., castor oil (laxative). 2. Animal sources: Insulin and heparin. 3. Mineral sources: Magnesium sulphate and iodine. 4. Microorganisms: Fungi and bacteria isolated from soil are important sources of antibiotics e.g., penicillin. 5. Synthetic drugs: Produced in the laboratory by synthetic chemist e.g., aspirin, sulphonamide, barbiturate. 6. Biotechnology (Recombinant DNA): Preparation of many complex chemical structure drugs e.g., Human insulin, Vaccines, Antibiotics, Interferon. 2 Classification of drugs 1. Prescription-Only drugs: Drugs prescribed by the physician and dispensed through a prescription. 2. OTC drugs: Drugs which the patient can have without prescription i.e., according to his choice or according to the pharmacist advice; such drugs may be referred to as over the counter drugs (OTC drugs). Drug versus medicine: A substance or material, other than food, intended for use in the diagnosis, cure, alleviation, treatment or prevention of disease in humans or other animals, intended to affect the structure or any function of the body of humans or other animals. The “drug” is the active material or the substance having a pharmacological or therapeutic activity. The “medicine” is a drug on a pharmacy store shelf after being mixed with excipients (inactive materials), formulated, packed and labeled. Drugs processed on large scale by pharmaceutical manufacturers are known as "pharmaceutical products", when again dispensed to the patient they are referred to as medicines. Other terms: Drug Product: A dosage form containing one or more active ingredients along with other substances included during the manufacturing process. Excipient: Anything other than the drug substance in the dosage form. 3 Strength: The concentration of the drug in a dosage form Dose: The amount of the drug which is taken each time Dose regimen: The frequency of use of the drug Placebo: A fake treatment that in some cases can produce a very real response. It can also be defined as a substance with no known medical effects, such as sterile water or a sugar, starch or talc pill. Placebo is prescribed for the psychological benefit to the patient rather than for any physiological effect. It is originated when physicians discovered that giving sugar pills to patients could have surprisingly good results. The doctor knows the patient wants treatment, so he gives the patient a pill containing no medication. In some cases, it relieves the symptoms. Today, the use of a placebo would be considered dishonest and unethical. It is commonly used in blind clinical studies that test the effectiveness of new medicines in which one group is given the medicine or treatment being tested, and the other group is not. Participants are not aware of which group they are belonging to. Double blind trials are preferred as they eliminate bias. Quality control Physical or chemical tests used to ensure the required specification of a raw material or a dosage form. Specifications are those given by pharmacopoeia or those of the factory. Stability of a Pharmaceutical product Definition: The ability of the formulation, in a specific container closure system, to remain within the defined physical, chemical, microbiological, therapeutic, and 4 toxicological specifications till the end of the stated dating, under defined storage conditions. Expiration date The date (placed on the container) through which the product is expected to remain within specifications under appropriate storage conditions. It is the time at which 90% of the material remains. Storage Storage describes the safe keeping of starting materials, packaging materials and drug products. Storage conditions The conditions specified for storing the product and include temperature, humidity, container and light. Temperature for storing the product 1. Cold place: Less than 8°C 2. Refrigerator: Between 2°C & 8°C 3. Deep freezer: Less than -10°C 4. Cool place: Between 8°C & 15°C 5. Warm place: Between 30°C & 40°C 6. Room temperature: Between 15°C & 30°C 5 Drug nomenclature 1. Empirical formula, as C15H12N2O2 for phenytoin. 2. Chemical name, which is usually a lengthy name as: sodium 5,5-diphenyl-2, 4- imidazolidinedione. It is named according to its chemical structure following IUPAC (International Union of Pure and Applied Chemistry) rules. 3. Code numbers before the assignment of a non-proprietary name. 4. Generic (official, non-proprietary) name when approved: Phenytoin used in the Pharmacopoeia and is called official name. 5. Brand (proprietary or trademark or trade) name: Dilantin. Brand and Generic names When a drug is under patent protection, the company markets it under its brand name. Other companies that file for approval to market the off-patent drug must use the same generic name but create their own brand name. As a result, the same generic drug may be sold under either the generic name or one of many brand names. Generic and brand names must be unique to prevent one drug from being mistaken for another when drugs are prescribed, and prescriptions are dispensed. The medical authorities must agree to every proposed brand name. The term generic, when applied to such items as foods and household products, is used to describe a less expensive, sometimes less effective or lower-quality imitated version of a brand-name product. However, most generic drugs, although less expensive than the 6 comparable brand-name drug, are as effective and of the same quality as the brand-name drug. Name choice: Be short and distinctive in sound and spelling and not easily confused with existing names. It should indicate the general pharmacologic or therapeutic class into which the substance falls. It should also embody the syllable or syllables characteristic of a related group of compounds. e.g., Lopressor lowers blood pressure, Glucotrol controls high blood sugar (glucose) levels, Disflatyl relieves flatulence, etc. General mission for health care “All health care organizations, professional groups, and private and public purchasers should adopt a clear purpose to continually reduce the burden of illness, injury, and disability and to improve the health and functioning of the public”. Aims of health care system quality 1. Effective: Quality health care is effective: this means you will be accurately diagnosed and treated. In some countries, only 35% of patients get the correct diagnosis. 2. Safe: Quality health care is safe: this means that the care you receive does not harm you. 7 Around the world, nearly 14% of patients are harmed from the health care they receive during their hospital stay. 3. Patient-centered: This means that decisions about your care are tailored to your needs and preferences and you are treated with respect and compassion. 4. Timely: Quality health care is timely: this means you can see your doctor when you need to, without waiting too long. In some countries: 74% of patients have to wait between 60- 120 minutes to be seen by a doctor. 5. Equitable: This means that all people, regardless to their gender, race, ethnicity, geographical location, socioeconomic status, receive the good quality health care they need. 6. Integrated: If you have multiple chronic diseases, your medicinal care is coordinated across all the doctors and specialists who take care of you. 7. Efficient: This means that your laboratory tests will not be repeated unnecessarily. You will not undergo needless imaging tests. Antibiotics will be prescribed only in the case of confirmed infection. 8 Pharmacist role in the society Pharmacy does not lie just in dispensing medication but in the provision of relevant drug information and drug therapy recommendation to the people in the society. No longer a fixed and rigid profession but has been continuously changing and redefining its meaning and significance and that’s why the bond between a pharmacist and society is becoming stronger day by day and acquiring new dimensions. Consumerism versus Paternalism Paternalism is ‟the belief that the health care professional knew best”. It was accepted as standard practice by most health care professionals and their patients. The medical rights of patients were not as widely recognized as other rights (food, shelter, voting...). Today, patients have become true consumers of medical care. Patients have a right to be informed and ask for their consent. For a health care professional to do otherwise would not only be unprofessional and unethical, but also illegal. Health professionals who fail to meet the demands of medical consumers for care will quickly find themselves without customers and, sometimes, with legal problems. Patient’s rights 1. Pharmacists will employ their knowledge and experience in caring for them. 2. Pharmacists will respond to their wishes about their treatment. 3. Choose their own physician, pharmacy, and hospital. 9 4. Give their approval, through the process of informed consent, prior to the initiation of care. 5. Choose from multiple options of treatment when they exist. 6. Treatment is both safe and effective within given parameters. Pharmaceutical Symbols The serpent of Epidaurus on the staff (rod) of Aesculapius. The bowl of Hygeia with the serpent of Epidaurus. The Caduceus (Satff of Hermes) 10 Rx: Universally accepted as an abbreviation of “recipe” (Latin for ‘take thou’). It has been suggested that it is the astronomical sign of the planet Jupiter or evolved from the Eye of Horus, an ancient Egyptian symbol associated with healing powers Drug patents Patent allow firms to be the only company to market the drug in the country issuing the patent. During the life of the patent, the patented drug will have no direct market competition. This allows the pharmaceutical company to charge higher prices for the product so that it can recover the cost of developing the drug. After the patent has expired, other companies may market the drug under its generic name or under another brand name. The price of the patented drug usually decreases when a patent expires because of competition from other companies that begin marketing a generic version of the drug. The cost of developing a generic version of a drug for market is significantly less than the cost of developing the patented drug, since many of the studies required for first regulatory approval of a drug are not required for marketing approval for subsequent generic versions. 11 Essentially, the only requirement is to demonstrate that the new version is biologically equivalent to the already approved drug. Bioequivalent drug products have the same rate and extent of absorption and produce the same blood concentration of drug when the two drugs are given in the same dose and in the same dosage form. 12  Pharmacy education The apprenticeship system Until the beginning of 19th century, there were no educational requirements for practicing pharmacy. An apprentice learns a trade or profession by working for a person who has mastered the field (to gain credentials). Sole dependence upon on-the-job training for pharmacists was eliminated when the first school of pharmacy was founded. Schools of pharmacy in Egypt: the beginning The first school of Pharmacy in modern history of Egypt was founded by the ruler of Egypt Mohamed Ali Pasha, in 1824 AD, as a part of a hospital established in Abu Zaabal (Cairo). The dean of the school was the French Doctor, Klute Bey, who invited several professors from Europe to join the newly born schools of medicine and pharmacy. The pharmacy school was later transferred to El-Kalaa (the citadel area) in 1829, then to Kasr El-Aini in 1837, the place of residence until today. First Faculty of Pharmacy in Egypt After establishment of Cairo University in 1908, the first pharmacists were graduated in 1929; they were only three. The Faculty of Pharmacy, Cairo University was announced as separate entity in 1955. 13 Governmental Faculties of pharmacy Alexandria, 1948 Suez Canal, 1993 Assiut, 1961 Beni-Suef, 1994 El-Azhar (males), 1965 Helwan, 1995 Mansoura, 1970 Ain Shams, 1996 Tanta, 1973 ElAzhar (females) and El-Minya Zagazig, 1975 in the late 90s Private Faculties of pharmacy In 1996, for the first time in Egyptian modern educational history, four “private” universities started their pharmacy programs after the approval of the ministry of higher education. The four colleges were located in Cairo, and like other new schools took their syllabi from Cairo University with minor modifications. Some of them established connections with external European universities. The four universities, 6th of October, Misr University for Science and Technology, Misr International University, and Modern Science and Arts followed the same regulations as Egyptian governmental Universities with few exceptions – notably student acceptance criteria. 14 Number of students and accreditation Number of accepted students per year in each faculty is defined by the National Supreme Council of Universities who assigns the number of Egyptian students to each university, after taking the suggestions from faculties and universities’ boards. The national agencies responsible for accreditation of professional degree programs in pharmacy and surveillance of pharmaceutical curricula are: The Supreme Council of Universities Ministry of higher Education The National Authority for Quality Assurance and Accreditation of Education “NAQAAE” Awarded pharmaceutical degrees in Egypt Bachelor degree (Bachelor in pharmaceutical science)  A minimum standard of a five-year course (10 semesters).  Recently, regulations called for 6 –years course (Pharm D). Master’s degree (Master in pharmaceutical science)  A minimum of two years including one-year study and a pre-master exam and a practical thesis in the specialized field. PhD degree (Doctor in philosophy in pharmaceutical science)  A minimum of two years after which the student should defend a practical thesis. 15 Diploma Requires a minimum study of one year during which the graduate is completely devoted. There are many diplomas in the field of pharmacy: e.g.,  Diploma in Industrial pharmacy  Diploma in Hospital pharmacy  Diploma in Cosmetics Departments of faculty of pharmacy  Department of Pharmaceutics &  Department of Pharmacology and Industrial Pharmacy Toxicology  Department of Clinical Pharmacy  Department of Biochemistry  Department of Pharmacognosy  Department of Pharmaceutical Chemistry  Department of Microbiology and Immunology 16 Types of courses General Courses Include social sciences, humanities, arts, history, and literature. They provide the broad general education required of a professional in today's society. Prerequisite Courses Mathematics and the physical and biological sciences teach the principles, the application of which find their way into many of the upper level pro­fessional pharmacy courses Professional Courses Basic to most pharmacy curricula are courses in pharmacology, medicinal chemistry, pharmaceutics, etc. Courses in social and administrative pharmacy as well as pharmacy law also are found in this sequence. Curriculum content Course titles, contents, and sequences may vary from one faculty to another. But all curricula include courses that may be grouped under several principal areas of study. Chemistry General chemistry and organic chemistry prepare the student for advanced chemistry courses. Biochemistry deals with the chemistry of living matter, enzymes and drug metabolism, and diseases caused by malfunctions of metabolic activities and biochemical systems. 17 Medicinal chemistry is concerned with relationships of chemical structures of drugs and their biological activities in the body. The medicinal chemist synthesizes drugs with the knowledge that specific chemical structures will produce anticipated actions in the body. Students are taught to relate drug structure to drug action (SAR) and to understand molecular mechanisms on drug action. Pharmaceutics and Biopharmaceutics Pharmaceutics Science concerned with formulation of drugs’ dosage forms or drug delivery systems (DDS) e.g., capsule, tablet, injection, suspension, etc. Biopharmaceutics and pharmacokinetics Sciences concerned with physicochemical properties of drugs and the significance of these properties on drug's absorption, distribution, metabolism, and excretion (ADME) within and from the body. Pharmacology Pharmacology is a medical science dealing with drug action on living systems and their constituent parts. Some courses originating from pharmacology include Pharmacodynamics, Pharmacotherapy, Ther­apeutics and Toxicology among others. Prior to studying pharmacology, students master two basic sciences; Anatomy concerned with structure and Physiology concerned with functions of body organs. 18 Clinical pharmacy It concerned with actual observation and treatment of disease in patients rather than artificial experimentation or simulation of reality. It also embraces observation and communication with patients in community and institutional pharmacy settings. Pharmacy practice has always been clinical because the pharmacist is the member of the health-care delivery team who communicates with the greatest number of people in any single day. Social and Administrative Sciences Practicing pharmacists must deal with the management requirements of their responsibilities. Pharmacy administration courses prepare the student by providing information about legal, business, economic, managerial, and social/behavioral aspects of pharmacy practice. 19