Pharmacy Orientation Handout PDF
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Faculty of Pharmacy, Pharmaceutical Technology Department
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This handout covers pharmacy orientation, including definitions, scopes of work and careers, pharmaceutical ethics, prescription components, and introduction to dosage forms. It's targeted at undergraduate students in the pharmaceutical technology department.
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Faculty of Pharmacy Pharmaceutical Technology Department Pharmacy Orientation PHT 101 Handout (Pharm-D Clinical) List of contents: Introduction........................................................................................................ 1 Pharmacy education....................
Faculty of Pharmacy Pharmaceutical Technology Department Pharmacy Orientation PHT 101 Handout (Pharm-D Clinical) List of contents: Introduction........................................................................................................ 1 Pharmacy education......................................................................................... 13 Information Resources in Pharmacy................................................................ 20 Pharmaceutical Organizations......................................................................... 27 Scope of Work & Pharmacy Careers............................................................... 30 Pharmaceutical Ethics...................................................................................... 40 The Prescription............................................................................................... 44 Introduction to Dosage forms.......................................................................... 58 References:....................................................................................................... 70 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. Classification of drugs 1. Prescription-Only drugs: Drugs prescribed by the physician and dispensed through a prescription. 2 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. 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 3 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 toxicological specifications till the end of the stated dating, under defined storage conditions. 4 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 Drug nomenclature 1. Empirical formula, as C15H12N2O2 for phenytoin. 5 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 comparable brand-name drug, are as effective and of the same quality as the brand-name drug. 6 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. Around the world, nearly 14% of patients are harmed from the health care they receive during their hospital stay. 7 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. Governmental Faculties of pharmacy Alexandria, 1948 Assiut, 1961 13 El-Azhar (males), 1965 Beni-Suef, 1994 Mansoura, 1970 Helwan, 1995 Tanta, 1973 Ain Shams, 1996 Zagazig, 1975 ElAzhar (females) and El-Minya Suez Canal, 1993 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. 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. 14 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. 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 15 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 pro-fessional 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, Ther-apeutics 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. Clinical pharmacy 18 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 Information Resources in Pharmacy Pharmacists have a constant need for reliable and current information, and in the modern world information is everywhere. Challenge is sorting out the current information; reliable from the questionable. Practitioners and scientists must be able to find and identify different types of information in a variety of formats and media. Pharmacists must also be able to assist patients in their information needs regarding drugs, therapy, and diseases. Drug information should be: 1. Current i.e., uses the most recent, up-to-date sources possible. 2. Critically examined i.e., it should meet the following criteria: More than one source should be used when appropriate. The extent of agreement of sources should be determined; if sources do not agree, good judgment should be used. The validity of information, based on clinical circumstances, should be determined 3. Relevant i.e., it must be presented in a manner that applies directly to the circumstances under consideration. Drug information resources Primary literature Primary literature forms the base of the literature ranking. It is the source of information for the development of secondary and tertiary literature resources. Primary literature is 20 made up of original research that is written in the author(s) own words. It consists of original research articles published in scientific journals, case reports, editorials, and letters to the editor, as well as theses, conferences and lectures. Most primary literature contains a detailed description of the study design, methodology, and scientific results. The reader is able to analyze the study in order to develop a conclusion. Steps of publishing a research in a scientific journal: 1. Researchers conduct their study and finish it. 2. Researchers (authors) write the results in standard format manuscript. 3. Authors submit the finished article to the journal. 4. Journal editor sends the manuscript to referees to be reviewed (Blind vs. double blind). 5. Reviewers send their comments on the article to the journal editor. 6. Accepted manuscripts are published in the journal. First page pf a published manuscript must contain: 1. Journal volume, year and pages 5. Manuscript title 2. Publisher logo 6. Authors names and affiliation (where 3. Journal name they work) 4. Journal logo 21 2 1 4 3 5 6 Standard manuscript format: 1. Abstract: Summary of methods and results. 2. Introduction: Review of the past researches in the same area. The aim of the research must be stated at the end of the introduction. 3. Experimental section: Involves the materials used and their sources, methods applied with the condition of each experiment and the equipments used with specifications. 4. Results and discussion: Results of experiments is expressed as text, tables and figures. Discussion is the explanation of results. 5. Conclusion: Highlight the main results. 6. References: A list containing the reference sources of the information used. Examples of journals in pharmaceutical sciences: Journal of controlled release. Drug Delivery. 22 Journal of Liposome Research. European Journal of Pharmaceutics. Limitation of primary sources: Although publication of an article in a well-known, respected journal enhances the credibility of information contained in an article, this does not guarantee that the article is accurate. Secondary literature Secondary sources contain information from any or all of the primary sources previously mentioned, which has been modified, selected, rearranged or compacted, usually by someone other than the original author, possibly for a specific scientific audience or purpose. Indexing and abstracting services are valuable tools for quick and selective screening of the primary literature for specific information, data, citation, and articles. Secondary literature embraces review articles, including systematic reviews and meta- analyses and bibliographic databases, such as PubMed. Examples of secondary resources International Pharmaceutical Abstracts IPA Drugs in Use Drugdex Index Medicus Iowa Drug Information System 23 Pharmaceutical News Index Limitations of secondary sources They are generally interpretations of a study and therefore a misinterpretation of important information may occur. Pharmacists should obtain and evaluate the original article because abstracts might not tell the whole story. Another important fact to remember is the substantial difference in lag time (i.e., the interval between publication of an article and citation of the article in an index) among various services. Tertiary resources Tertiary sources of information are those which are derived from either or both of the previously mentioned groups (i.e. primary and secondary). They represent a composite of information from these sources; tertiary sources include specialized guides to the literature which point the user directly to primary or secondary sources. General reference textbooks can provide easy and convenient access to a broad spectrum of related topics. Background information on drugs and diseases is often available. Examples of tertiary resources Compendia, Monographs, Handbooks (e.g., Handbook of Pharmaceutical Excipients) Martindale, The extra Pharmacopeia Textbooks on Biopharmaceutics and Pharmacokinetics Merck Index 24 Examples of Online Tertiary Sources Access Pharmacy AccessMedicine APhA Library Micromedex DailyMed USPDI - Medline Plus Facts and Comparisons Online Drugs.com LexiComp Online Limitations of tertiary sources It could take several years to publish a text, so information available in textbooks might not include the most recent developments in the field. Other resources should be used to update or supplement information obtained from textbooks. The author of a textbook might not have done a thorough search of the literature, so relevant data could have been omitted. An author also might have misinterpreted the primary or secondary literature. Reference citations should be available to verify the validity and accuracy of the data. Pharmacopoeias Official publications issued by highly specialized persons in pharmacy & medicine. They must be authorized by governments or international agencies. Examples of pharmacopoeias: a. United State Pharmacopoeia/National Formulary (USP/NF). b. The British Pharmacopoeia (BP). c. Martindale, The Extra Pharmacopoeia. 25 Contents of the pharmacopoeia All information on drugs (drug monographs) including: 1. Physical & chemical properties. 4. Drug interactions. 2. Active & inactive ingredients. 5. Direction of use. 3. Therapeutic uses & side effects. Specifications needed for: 1. Raw materials. 4. Pharmaceutical processes. 2. Dosage forms. 5. Analytical techniques. 3. Medicinal accessories. Drug formularies List of drugs approved for use by special government or a hospital. Example of drug formularies is The Orange Book, annually produced book by the FDA. Drug compendia Short and clear information on the therapeutic use of drugs including: 1. Dose. 3. Adverse reactions. 2. Contraindications. 4. Pharmacokinetic parameters Examples: 1. Physician Desk Reference (PDR). 2. Handbook of Non- Prescription Products. 3. Handbook of Injectable Drugs. 26 Pharmaceutical Organizations Classification International organizations (working all over the world). National organizations (working inside specific countries yet collaborating with abroad organizations). Pharmacists should keep in touch with both. International Organizations: International Pharmaceutical Federation (FIP) The International Pharmaceutical Federation (or Fédération Internationale Pharmaceutique) abbreviated as FIP, is an international federation of national organizations that represent pharmacists and pharmaceutical scientists. It is founded in 1912. The mission of FIP is to "improve global health by advancing pharmacy practice and science to enable better discovery, development, access to and safe use of appropriate, cost-effective, quality medicines worldwide." It gathers 137 member organizations and represents three million practitioners and scientists around the world. It is a non-governmental organization in official relations with the World Health Organization. It covers the pharmaceutical sciences and pharmacy practice World Health Organization (WHO) 27 Its goal is to build a better, healthier future for people all over the world. It works through offices in more than 150 countries side by side with governments and other partners to ensure the highest attainable level of health for all people. Partners are with countries, United Nations system, international organizations, civil society, foundations, academia, research institutions, people and communities to improve their health and support their development. All countries which are members of the United Nations (UN) may become members of WHO by accepting its Constitution. WHO defines Health as “a state of complete physical, mental and social well-being and not only the absence of disease or infirmity” American National Organizations Food and Drug Administration (FDA) It is the organization responsible for the quality of food and drug in the USA. FDA is the middleman between the drug makers and the consumer because it regulates the safety and effectiveness of medicines. Drug Companies pay fees with each application. Due to public pressure, the FDA eliminated some restrictions to quicken approval rate (regularly 12 years from drug birth to approval). The American Association of Colleges of Pharmacy (AACP) It is the national organization representing the interests of pharmacy education in USA The American Pharmacists Association (APhA) 28 It is made up of practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. British National Organizations National pharmacy association It is a British industry trade association for community pharmacies formed in 1921. It represents virtually all owners of pharmacies including large chains and offers insurance and legal services. It keeps members up to date with recent developments and new drugs and offers training and education. Egyptian National Organizations Egyptian Syndicate of the Pharmacists It is the organization responsible for pharmacy profession in Egypt and welfare of enrolled pharmacists. Egyptian Pharmaceutical Society The main function of this society is educational. It issues a scientific journal in pharmacy and holds conferences for pharmacists. National Pharmacopeial Committee The committee is responsible for reviewing the pharmacopeia to cancel or add new drugs. Egyptian drug authority https://www.edaegypt.gov.eg/ 29 Scope of Work & Pharmacy Careers Market and job opportunities is continuously growing due to the increased pharmaceutical needs of a larger and older patient population, the increased likelihood of scientific advances that will provide more drug products for the prevention, diagnosis, and treatment of disease, new developments in administering medication and the presence of large number of well-informed consumers who are sophisticated about health care and eager for more detailed information about drugs and their effects. Why a pharmacy career is attractive? A personal relationship with a Media pharmacist Experience of illness within the Watching community pharmacists family College representatives visiting Salaries high schools Community pharmacists Work according to legal and ethical guidelines to ensure the correct and safe supply of medical products to the general public. Community pharmacists are involved in maintaining and improving people's health by providing advice and information, as well as supplying prescription medicines. Of all pharmacists now in practice, the majority are in community pharmacy practice. 30 Tasks 1. Dispensing prescription medicines to the public. 2. Ensuring that different treatments are compatible. 3. Checking dosage and ensuring that medicines are correctly and safely supplied and labeled (pharmacists are legally responsible for any dispensing errors). 4. Supervising the preparation of any extemporaneous medicines (not all are supplied ready made-up by the manufacturer). 5. Keeping a register of controlled drugs for legal and stock control purposes. 6. Consult with doctors about prescriptions. 7. Selling over-the-counter (OTC) medicines. 8. Counseling and advising the public about minor ailments. 9. Giving advice about stop-smoking, contraception, or weight-reduction. 10. Advising patients of any adverse side-effects of medicines or potential interactions with other medicines/treatments. 11. Preparing dosette and cassette boxes, usually for the elderly, but also for those with memory/learning difficulties or who have several combinations of tablets to take, where tablets are placed in compartments for specified days of the week. 12. Help patients understand how their medicines work and why they must take them. 13. Advising patients about all medical appliances. 14. Measuring blood pressure & sugar levels. 31 15. Managing, supervising, and training pharmacy support staff. 16. Financial management. 17. Keeping up to date with current pharmacy practice, new drugs and their uses. Required skills 1. Good communication skills as they must be able to listen carefully to what patients say, as well as be able to explain complex and sometimes sensitive information to the general public and other healthcare professionals. 2. The ability to work with others in a multidisciplinary team as well as lead others in a team. 3. Concern for the welfare of the general 6. A professional and confident manner. public. 7. Trustworthy behavior. 4. Accuracy and attention to details. 8. High level of responsibility. 5. An understanding of business 9. Competence and cultural competence. principles. 10. Loyalty and patience. Hospital pharmacists They work either in governmental or private hospitals. Their role can extend to health centers, nursing homes, and any other health institute. They work with regular patients on a daily basis. They also work in laboratories and small, sterile rooms called "clean rooms". 32 Tasks 1. Check prescriptions to make sure there are no errors and that they're appropriate and safe for the individual patient. 2. Provide advice on the dosage of medicines and the most appropriate form of medication, for example, tablet, injection, ointment or inhaler. 3. Participate in ward rounds to take patient drug histories. 4. Interact with other medical staff to discuss problems patients may experience when taking their medicines. 5. Discuss treatments with patients' relatives. 6. Make sure medicines are stored appropriately and securely. 7. Supervise the work of less experienced and less qualified staff. 8. Answer questions about medicines from within the hospital, other hospitals and the general public. 9. Keep up to date with, and contribute to, research and development. 10.Write guidelines for drug use within the hospital and implement hospital regulations. 11.Provide information on cost of drugs. 12.Prepare and quality-check sterile medications, for example, intravenous medications and intravenous admixture. 13.Set up and supervise clinical trials. 33 Governmental Management Employment Pharmacists can work as government employees in regulatory control and drug management e.g., working in the central administration of pharmaceutical affairs, the Ministry of Health and Population, institutes of health insurance or other administrative services. Tasks 1. Planning and implementing health and drug policy and rational use of drugs. 2. Registration, approval and quality control of drugs, cosmetics and medical devices. 3. Distribution of drug products to the governmental hospitals and pharmacies and their rational use. 4. Inspection (to follow the compliance of pharmacists to the pharmacy laws and regulations). 5. Custom department. 6. Attending tenders of MOHP (Ministry of Health & Population). Industrial Pharmacists Opportunities 1. Manufacture & Production. 5. Clinical trials and post-marketing 2. Sales & Marketing. surveillance. 3. Administration. 6. Quality-control (or quality-assurance). 4. Research and Development (R&D). 34 Family planning Tasks They inform and educate women about the use of contraceptive pills and other methods for contraception. They also advise and educate mothers especially in rural areas about the importance of childcare. Family planning does not mean restriction of pregnancy but includes also helping couples to have healthy children during appropriate intervals. Academic Pharmacists Pharmaceutical education offers opportunities to pharmacists with advanced degrees in any of the professional specialties. The need for college instructors is increasing by expanding enrollment and changes in the curricula at colleges to meet the employment needs of the future. Pharmaceutical Journalism and Media It offers rewarding experiences for a number of pharmacists with writing and editing skills as well as for those with communicative talents. Military Service They provide pharmaceutical services including: 1. Manufacturing of generic products. 2. Distributing drugs to different areas and hospitals in army. 3. Dispensing drugs to personnel working in the army and their families. 4. Other jobs related to their education e.g., Purification of water during emergency. 35 Pharmaceutical Sales Representatives (PSR) - Medical Representatives (Medical Rep.) Description Communication links between companies that produce drugs and professionals who prescribe and dispense them. Hence, they must possess selling skills and the ability to communicate product information to physicians with clarity and precision. The pharmacist is familiar with drugs and has this obvious advantage over degree holders in other disciplines competing for positions as representatives. Job objectives Inform the physician about the company's products and answer the physician's questions and increase the company's sales of the drug. If the representative impresses physicians with the advantages of the drug, physicians will prescribe it for their patients, and the sales objective will be achieved. Thus, both objectives are inter-twined, and one cannot be realized without the other. The efforts of the representatives are measured by the sales of prescription products generated in their areas. The geographic area of a representative may include hundred physicians, some of whom must be visited five or more times a year. As the representative must visit pharmacies, clinics, nursing homes, wholesalers, and hospitals, it is clear that his or her schedule is full and requires considerable travel. Hence, companies provide cars for this purpose. The 36 typical visit to a physician's office lasts between five and ten minutes and requires planning, speed and eagerness on the part of the PSR. Extra qualifications Master's degrees in business or additional degrees in law find additional opportunities in the pharmaceutical industry in the marketing, sales, and legal departments. Companies prepare sales personnel as representatives for their products by training. The training consists of: Seminars on communication and sales techniques. Self-instruction programs with texts and audiotapes. Observation field studies by accompanying older PSRs in their areas. Testing and evaluation to guarantee acceptable standards of excellence. Promotion of PSRs Medical representative (Med reps): to inform pharmacists, physicians and hospitals about the products of his company. Product Manager: to train medical representatives. Area Manager: to supervise medical representatives in an area. Marketing manager: to put the plan for marketing of a group of products or all products over 1-5 years. 37 Medical director: to afford research, brochures and post marketing surveillance. (Brochures are leaflets included in the drug product package, containing information about the drug). General Manager: to plan control and monitor all activities. Other opportunities in pharmacy job market Food Industries: Milk, water, jam, chocolates, etc. Self-employment: Pharmacists can establish their own industries or pharmacy store business. The advantages of self-employment include professional independence and personal satisfaction. It requires a degree of business skill in making correct quick decisions and judgments and involves responsibility for: accounting procedures; staff hiring and training; negotiating and influencing; and marketing. The cultivation of plants that are used as drugs. The synthesis of chemical compounds of medicinal value. The analysis of medicinal agents. Forensic Pharmacy due to their great knowledge about toxins and their symptoms. Drug Information Centers. Clinical pharmacist VS. pharmacist: Pharmacist is drug expert. Clinical pharmacists take this knowledge and apply it to clinical scenarios. Clinical pharmacists work directly with other health professionals and 38 patients to ensure the medication prescribed to patients contribute to the best possible health outcomes. Tasks: 1. Determine whether the prescribed medications are optimally meeting the patient's needs. 2. Evaluate the effectiveness of patient medications. 3. Follow the progress of patients to determine the effect of medications on his or her health. 4. Advise the patient on how to best take his or her medications. 5. Consult with the physicians and other health care providers in selecting the therapy which best meets the patient's need. 6. Apply specialized knowledge of medications (including medication action, dosing, adverse effects, drug interactions) in performing their patient care activities. 7. Refer the patient to his or her physician to address specific health, wellness, or social services concerns as they arise. Where do you find a clinical pharmacist? Clinical pharmacist practice in many health care environment including hospitals and their outpatient clinics, community pharmacies, emergency departments, ……. 39 Pharmaceutical Ethics Ethics: Moral principles that govern a person's behavior. Ethical codes: Provide health care professionals with codes and standards to guide their practice. They do not provide right or wrong answer to every question. They also offer a framework to use when faced with ethical questions. Hippocratic law: His direction that a physician should “not give a deadly drug to anyone” provides one moral view on the existing issue of assisted suicide. Code of ethics of the American pharmacists’ association (APhA) A pharmacist respects the relationship between the patient and pharmacist. A pharmacist promotes the good of every patient in a confidential manner. A pharmacist respects the autonomy of each patient. A pharmacist acts with honesty in professional relationships. A pharmacist maintains professional competence. A pharmacist respects the values and abilities of colleagues and other health professional. A pharmacist serves individual, community, and societal needs. A pharmacist seeks justice in the distribution of health resources. Ethical principles and moral rules Autonomy Non-maleficence Beneficence Distributive justice 40 Confidentiality Veracity Fidelity Values Definition: important part of ethics and the internal motivators for our actions. Developed in childhood and remain unchanged until we reach adulthood. They can be changed when they become apparent that an old value system doesn’t work. Values include: Compassion Patience Faithfulness Responsiveness Fairness Kindness Communication with patients The biomedical approach It neglects psychological factors that have a major role in explaining disease. The narrative communicative approach It allows the patient to discuss his/her perceptions (observations and impressions), concerns, attitudes, beliefs, and values regarding his/her health status. It also alerts healthcare providers to mistaken ideas held by patients and allows them to take corrective actions. It allows providers to: 1. Construct treatment plans based on patient-driven information concerning illness as opposed to stereotype. 41 2. Build a treatment regimen with patients rather than prescribe a treatment regimen to patients which leads to better patient compliance. The learn model 1. Listen 2. Explain 3. Acknowledge 4. Recommend 5. Negotiate Healthcare team relationship Pharmacist is just one component of the multi-profession team. The team should value and understand the contribution of all its members. The patient is the primary member and the focus of the activity. Other members include practitioners, physiotherapists, social workers, radiologists, nurses, and dieticians. “Role boundaries” should be set to clarify roles and responsibilities. Effective teams result from understanding people and the way they work, realizing and valuing their differences. Principles of effective communication Warm greetings Reassuring Good listening Ability to express fear and Clear explanations concerns 42 Respect Treating patients as a person, not Giving enough time just a case 43 The Prescription “The written order from the physician to the pharmacist for the preparation and dispensing of medicines to the patients“. The word "prescription" can be decomposed into "pre" and "script" and literally means, "to write before". It contains the names and quantities of the desired drugs. It transfers instructions to the pharmacist for dispensing the medicines as well as to patients on how to take the prescribed medicines. First Prescription The world’s first recorded prescriptions were engraved on a clay tablet in Mesopotamia around 2100 B.C. The first drugstores were established in the ancient city of Baghdad in the eighth century A.D. Parts of a prescription Patient's name, address and date Name, address, age and weight of the patient help to prevent the possibility of misuse and errors. Name and address are legally essential for certain drugs especially the narcotic drugs. Inclusion of address also enables the pharmacist to contact the patient, if need arises. Age and weight are desired to confirm the suitability of doses of prescribed drugs (Dose differ for infants and children). The date of prescription is important in medico- legal cases and to avoid misuse of prescription for an indefinite period (drug of abuse). Superscription It consists of the symbol Rx (read as R-X). 44 Inscription The main part of the prescription and so, it is called as ‘body of the prescription’ It contains the names and amounts of drugs. Drugs are written by their proprietary names followed by the dose in the metric system. The name of each drug is written on a separate line directly under the preceding one. The name of each drug is started with the capital letter. Subscription Subscription is the physician's directions to the pharmacist. It deals with the method of preparation of the medicine (mix and make a solution) and in case of solid preparations as to the number of pills or tablets to be dispensed. Transcription or Signature Signature is abbreviated as "Sig" or "s" derived from the Latin word signatura which means "let it be labelled". Directions for the patient or nurse which the pharmacist is required to put in specific manner on the label of the medicine container e.g., how to administer or apply the drug(s), its dose and time of administration. Physicians often write the directions in abbreviated Latin preceded by Sig to save time. The pharmacist expresses them in the ordinary common language when transcribing them on the label. Expressions like "take as directed or take as necessary" are not satisfactory and should be avoided. Directions for particular use of medicine should start with the particular word as: 45 For internal use "take" For suppositories "insert“ For ointment and lotion "apply“ For drops "place" or “instill” Prescriber Identity The prescription must be signed by the prescriber, be dated and should bear his address. This is required as per drugs act. This is the final guarantee of the genuineness of the order. The prescription must be written correctly and legibly for the correct supply of medicines. Prescriptions, when handwritten, are dangerous for being often unreadable. Contrary to popular belief, pharmacists do not have special decoding skills, to succeed in establishing what a word or piece of writing says when it is difficult or almost impossible to read. When in doubt, pharmacists should call the doctor. At other times, even though some of the individual letters are unreadable, the position of the readable letters and length of the word is sufficient to distinguish the medication based on the knowledge of the pharmacist. However, guessing is still dangerous because of look-alike or sound-alike drug names. For doctors that the pharmacist deals with regularly, they learn to read the doctor's handwriting. How to avoid illegible prescriptions? Patients are advised to ensure that the prescription is legible before leaving the doctor's office. Computer printed prescriptions are becoming increasingly common in some places 46 Classes of prescription order 1. Pre-compounded Prescriptions Dug or mixture of drugs supplied by the pharmaceutical company by its official or proprietary name in a form that pharmacist dispenses without pharmaceutical alteration. 2. Extemporaneous or Compounded Prescriptions The physician selects the drugs, doses and pharmaceutical form desired and the pharmacist prepares the medication for dispensing to the patient. 3. Narcotic Prescriptions They are prescriptions for drugs which have narcotic properties similar to those of morphine or of drugs expressly mentioned in the law. Components of a Narcotic Prescription 1. The name, the address and the registry number of the prescriber. 2. The name and the address of the patient. 3. The narcotic prescription should be written by ink or typewriter. 4. The quantities of the narcotic substance must be written in words and numbers. 5. In the pharmacy, the narcotic prescription must include the date on which the prescription was filled and the name, address and the registry number of the pharmacy. 6. Narcotic prescriptions must be kept in a separate file and may not be refilled. 47 The prescriber can put the symbol "N.R." which is an abbreviation of the Latin non- repetatur that means "not to repeat" or "not to be refilled". Refilling of prescription containing drug-depending drugs such as narcotics is prohibited by the law. For their refilling, the physician should write a new prescription. 48 Dose calculation Pediatric doses The dose of a drug to be administered to a child is calculated based on clinical studies relative to the adult dose. Dose adjustment methods include the use of age, body weight and body surface area. The age ranges are: Neonate (1 month of life) Infant (Up to 1 year old) Child (any person under the age of 12 years) Adult (>12 years old) 1. Based on age Fried's Rule (for infants younger than 1 year): ( )× Dose for infants = Young’s Rule: ( )× Dose = 2. Based on weight Better than age because it reflects more accurately the development of the child. Many children's doses are expressed as mg/kg. For obese children the dose prescribed would be greater than for a normal child of the same age. Hence, dose should be calculated using 49 the ideal body weight for the age, rather than the actual weight. The usual doses for drugs are considered generally suitable for 70 kg (150 pounds) individuals. Clark's Rule: ( )× ( )× Dose for child = = 3. Based on Body Surface Area (BSA) The use of body surface area is the most accurate basis for calculating the dose of a drug for a child. Many physiological factors e.g., blood volume, glomerular filtration as well as requirements for electrolytes fluids and calories are more closely related to BSA than they are to body weight. × × Child dose = = ( ). Checking the compatibility of the prescribed drugs Some drugs may affect the efficacy of others. They may decrease, increase or even totally alter the effect of the co-administered drugs. In extemporaneous compounding, some ingredients may-when added to other ingredients- result in change in the product physical form, color, stability or even pharmacological activity. These drugs which exhibit drug- drug interactions are known to be incompatible drugs. Drug incompatibility is categorized as being physical, chemical or therapeutic incompatibilities. 50 Physical incompatibility e.g., precipitation, complexation, liquefaction. Easily overcome by the pharmacists using his knowledge of compounding techniques. Chemical incompatibility e.g., Oxidation-reduction reactions, acid-base reactions, hydrolysis, polymerization, etc. These reactions render the product unsatisfactory as product deterioration, discoloration, precipitation. It can be solved by the pharmacists by using their knowledge of chemistry. Therapeutic Incompatibility The response of the patient to one drug is different in intensity or in nature -than that intended- when the drug is co-administered with another one. Therapeutic incompatibility includes: 1. Drug synergism (the response increases by the co-administration of the incompatible drug). 2. Drug antagonism (the response decreases by the co-administration of the incompatible drug). In many cases, antagonistic combinations are intentional. For example, in prescribing morphine as analgesic, a physician may use atropine (in partial doses) to prevent the excessive depressant effect of morphine on the respiratory center. Therapeutic unintentional incompatibilities can be classified as: 1. Dosage error: overdose can result from the administration of excessive single dose or frequent administration of usual doses. So, the pharmacist should consider how 51 much drug should be given in each dose, age of patient, duration of treatment and the drug activity (cumulative or non-cumulative). 2. Synergistic combinations: if drugs having the same pharmacological action are prescribed together near their full individual dose, usually produce undesirable effect. Drugs of such combinations should be prescribed in reduced amounts since the sum of their activity may be great. 3. Antagonistic combinations: if the drug actions cancel each other (e.g., stimulants with sedatives and acidifiers with alkalinizes), the resulting prescription will have no effect. A classical example of antagonism is prescribing Aspirin and Benemid together for treating gout. Both drugs are uricosuric agents separately but combination is reported ineffective. 4. Contraindicated drug: some combinations may increase the toxicity or decrease the action of drugs. For example, Santonin is more dangerous when administered with any fixed oil as oils increase the solubility of active principles and thus increasing their toxicity. Administration of Tetracycline antibiotic with drugs containing calcium ions or food containing calcium is contraindicated because calcium cause precipitation of antibiotic. When drug- drug interaction is recognized by the pharmacist in a prescription, he should first consider alternative drug or drug product (that is compatible with the prescription 52 components) and then consult with the prescriber to determine the best alternative to the patient. 53 Packaging Types of containers 1. Prescription bottles, used for dispensing liquids of low viscosity. 2. Wide-mouth bottles, used for bulk powders, large quantities of tablets or capsules, and viscous liquids that cannot be poured readily from the narrow-necked standard prescription bottles. 3. Round vials, used primarily for solid dosage forms as capsules. 4. Dropper bottles, used for dispensing ophthalmic (eye), nasal (nose), otic (ear), or oral liquids to be administered by drop. 5. Applicator bottles, used for applying liquid medication to a wound or skin surface. 6. Ribbed bottles, having a plain front surface and flutes down the back, may be used to warn the user- even if he cannot see the label- that the contents are not to be swallowed, as mouth washes, gargles, lotions and antiseptic solutions. 7. Ointment jars and collapsible tubes, used to dispense semisolid dosage forms, such as ointments and creams. 8. Sifter-top containers, used for powders to be applied by sprinkling. 9. Slide boxes, used for dispensing suppositories and powders prepared in packets. 10.Aerosol containers, used for pharmaceutical aerosol products. They are pressurized systems dispensed by the pharmacist in the original container. 54 Prescription containers usually are available in colorless of amber-colored glass or plastic. Amber-colored containers are widely used because they provide maximum protection of their light-sensitive contents against photochemical deterioration. The plastic containers have advantageous over plastic ones e.g., lightness of weight, resistance to breakage on impact and greater versatility in container design. Closures Closures are as important as the container itself. They should restrict entrance of moisture into the container. For example, aspirin tablets are hydrolyzed in the presence of moisture and broken down into acetic acid and salicylic acid. Safety closures which are too difficult to open by children (childproof) help in reducing the number of accidental poisonings. Labeling Labeling is important for prescriptions that need pharmaceutical compounding. It should be aesthetic, clean, tidy, professional-appearing and written in a way that is easy and clear for the patient to read. The label must include: 1. The name, address and telephone number of the pharmacy. 2. The prescriber's name. 3. The patient's name. 4. The date of dispensing. 55 5. The number of the prescription. 6. The directions for use. Patient counseling “The final educational checking process to ensure the correct medicine is supplied to the correct patient so that the patient gets the maximum benefit from his medication” Patients have the right to expect that the pharmacist will counsel them privately about their medicines, but the patient reserves the right not to be counseled. The pharmacist should make every effort to counsel, or to offer to counsel the patient whenever a medicine is supplied. Lack of counseling can be a significant contributor in dispensing errors and their detection. Effective communication and patient education increase patient motivation to comply leading to increased compliance or adherence. Counseling is especially important in some cases: 1. Medicines that cause sedation or 5. New medicine is prescribed. drowsiness. 6. The brand of medicine has 2. Medicines that have a narrow changed. therapeutic index. 7. The medicine is a "controlled" 3. Unusual dose forms (e.g., drug. nebulizers). 8. Teratogenic or cytotoxic drugs. 4. Unusual frequency of use (e.g., methotrexate). 56 9. Special patient needs (such as, 12.Pediatric medications vision, hearing or cognitive 13.Many medicines for multiple impairment. diseases (polypharmacy) 10.Cultural issues (e.g., Language 14.Acute illness (e.g., hospital preference). admission). 11.Medicines used for long-term therapy. In the case of patients taking repeat prescriptions, counseling provides the opportunity to inquire if: the patient is taking the medicine correctly, the medicine is having the desired outcome, and there are unwanted effects? It offers a further opportunity to detect any errors. Face-to-face counseling is the best way of communicating. If not possible, written information and/or a telephone call are recommended while making sure that the information is provided directly to the patient. 57 Introduction to Dosage forms Dosage forms or Drug Delivery Systems are the forms of drugs in which they are administered to the body. One drug may be formulated in different dosage forms to satisfy the personal preference of the physician and patients and to meet the particular needs, nature of drugs, product stability and convenience of the patient. Need for suitable dosage forms: 1. Protection of drug from atmospheric oxygen and/or moisture (coated sealed capsules or tablets). 2. Protection of drug from gastric juice on oral administration (enteric coated tablets). 3. Mask the bitter taste or foul smell (capsules, coated tablets or flavored syrup). 4. Provide liquid preparation of an insoluble and/or unstable drug in a desired vehicle (suspension). 5. Provide extended drug action (Retarded release tablets, spansules). 6. Provide optimum drug action on topical application (creams, ointments, ear/eye/nasal drops). 7. Provide drug for administration by insertion (rectal, vaginal suppository). 8. Provide drugs within body tissues (injection). 9. Provide drug action through inhalation. Components of a dosage form: 1. Drug component. 58 2. Non-drug components (adjuvants/excipients/additives/auxiliary/ secondary materials). They are used to alter the amount, duration of action and /or intensity of action of drug component. Characteristics of a dosage form: 1. Not deteriorate in temperature and humidity. 2. Stable from microbial contamination, oxidation or degradation. 3. Acceptable for patients have proper shape, taste, color, flavor and convenient in use. Oral dosage forms Solid oral dosage forms Advantages of solid dosage forms 1. Accurate dosage. 2. Easy shipping, handling and identification. 3. Less shelf space needed per dose than for liquid, smaller in bulk. 4. No preservation requirements. 5. No taste-masking problem. 6. More stable than liquids with longer expiration dates. Powders 59 It is a dry preparation consisting of finely divided particles. It is meant for oral administration or for inhalation. Simple powder contains only one active ingredient, e.g., digitalis powder. Compound powder contains several active ingredients, e.g., ORS (oral rehydration salts) powder. Powders are commonly dispensed in either bulk form or divided form. 1. Bulk powders 2. Divided Powders Granules Granules are solid, dry, agglomerate powder particles. They are irregularly shaped usually in 4-12 sieve size and used orally and are generally more stable than powders. Dissolve more easily and less likely to cake or harden on storage. Granules may be effervescent or soluble meant for the preparation of liquids for oral use. A number of unstable anti-biotics are available as granules so that these can be reconstituted into solution with water or other suitable solvent before use. Capsules Solid dosage forms in which one or more medicinal or inert substances are enclosed within a small gelatin shell (hard or soft). Most capsules are intended to be swallowed whole. Sometimes, the contents are removed from the gelatin shell and employed as a premeasured medicinal powder e.g., Theo-Dur Sprinkle, an anhydrous Theophylline preparation meant to be sprinkled on a small amount of soft food before ingestion. 60 1. Hard gelatin capsules 2. Soft gelatin capsules Spansules It is a capsule which contains coated granules of medicinal agent. The advantage of this preparation is the gradual and prolonged release of its medicament in intestine. Pills It is a small globular or ovoid mass, containing active drug and is meant for swallowing without chewing, e.g., contraceptive pills. They were once prepared by molding. However, they are prepared nowadays on tablet machines. Lozenges Lozenges are spherical or elongated medicinal preparation consisting of sugar, gum and medicament. They are placed in the mouth and allowed to dissolve in saliva for its local action on the oral and pharyngeal mucosa e.g., coughs lozenges. Tablets It is a unit dose of one or more active medicaments. Depending upon the intended use or their method of manufacture, the tablets may vary in weight, shape, size, thickness, hardness and disintegration characters. Tablets are sometimes coated with sugar, gelatin or other suitable specific coating materials. Excipients (Auxiliary substances) 1. Diluents (lactose, mannitol, calcium phosphate). 2. Binding agents (starch, CMC, gum or sucrose). 61 3. Disintegrating agents (starch, super-disintegrants: primojel). 4. Lubricants, Glidants and antiadherents (magnesium stearate, talc, stearic acid). 5. Colors and dye. 6. Flavoring agents (especially for chewable: menthol). 7. Sweetening agents (saccharin, cyclamate). 8. Adsorbents (magnesium oxide, bentonite, silicon dioxide). 9. Coating agents (sugar, salol). Types of tablets 1. Oral tablets (can be swallowed) 2. Sublingual tablets 3. Solution tablets 4. Vaginal tablets 5. Effervescent tablets: 6. Implants Liquid oral dosage forms Aqua (Water) Used as a vehicle. For parenterals, they should be pyrogen-free. In some special cases, CO2- and ammonia-free water is used. 62 Mixture (Mistura) Oral aqueous preparations can be in the form of either a solution or a suspension. These preparations contain one or more solid and/or liquid substances. They are manufactured on a small scale as required and allocated a shelf life of a few weeks before dispensing. Doses are usually given in multiples of 5 ml using a metric medicine spoon, e.g., carminative mixture. Draught (Haustus) is a term used to describe a mixture comprising of only one or two large doses of about 50 ml. Syrup Definition: A concentrated aqueous solution of sucrose or other sweetening agents (dextrose, non-sugars like sorbitol, glycerin and propylene glycol) with or without added flavoring agents. Used as vehicle to provide proper viscosity, sweetness and flavor to number of drugs such as antibiotics, antihistamines, antitussives and vitamins. The sucrose concentration of syrup plays an important role in the control of microbial growth. Dilute sucrose solutions are excellent media for microorganisms while concentrated ones tend to crystallize. Elixir Elixir is a sweet aromatic hydro-alcoholic solution used orally. It is less sweet and less viscous than syrup because of its alcoholic content. Used as a vehicle to keep water 63 soluble and alcohol soluble ingredients in solution. It is used also to mask the disagreeable odor and taste of many drugs. Infusion Infusion is a diluted liquid preparation which contains active principles of crude drugs obtained by soaking the crude drug in water with or without alcohol. Decoction Decoction is a liquid preparation of active principle(s) of crude drugs obtained by boiling crude drug(s) in water. Linctus A viscous, syrupy, mucilaginous liquid preparation contains sucrose and medicinal substances. Linctuses possess demulcent, expectorant or sedative properties. Hence, they are used for relief of cough in doses of small volumes (sipped and slowly swallowed without the addition of water, e.g. codeine linctus). The active ingredient of the linctus after absorption may act at other site(s) in the body to produce beneficial effect(s). Spirit Spirit is an alcoholic solution of volatile oil(s) or chloroform or ether used as flavoring and medicinal agents. Tincture Tincture is an alcoholic solution of active principle(s) of crude drugs (10-20%) 64 It is comparatively stable preparations, e.g., tincture belladonna, tincture cardamom Used orally (but may also be used externally, e.g., tincture iodine). External dosage forms Semi-solids Suppositories-Creams-Ointments-Plaster-Poultice Liquids Drops-Gargles and mouthwashes-Glycerins-Lotions-Liniments-Enemas-Paint Parenteral Dosage Forms Liquid solutions A sterile liquid preparation of soluble chemical substances drugs in a suitable solvent meant for administration by injection or infusion. They are prepared in such a way so that they are sterile pyrogen-free and prepared according to the route of administration, volume of injection, solvent, osmosis, pH of solution, specific gravity, stability and preservation. The most common solvent for injections is water. When the drug is insoluble in water or depot effect is desired, other non-aqueous solvents like fixed vegetable oils, dilute alcohol, propylene glycol, glycerin and some other liquids are used. Injections with non- aqueous solvents are given by intramuscular route only. Unstable drugs such as penicillin or streptomycin are available in dry form in their final containers and the solution of 65 these drugs is made with prescribed volume of water for injection or other appropriate sterile liquid just before use. When intravenous infusions are given in large volume, they are made isotonic to blood plasma. Single doses are packed in ampoules or vials. Multiple doses are packed in vials Uses of parenteral preparations 1. In emergency for rapid onset of the action of drug 2. For depot effect of drugs 3. For drugs not absorbed from gastro-intestinal route such as streptomycin 4. In patients who show inability or unwillingness to swallow the drug 5. To prevent the decomposition of drugs such as insulin 6. When areas are not accessible by other means, e.g., local anaesthetics 7. For replacing large volume of body fluids Routes of administration A successful therapeutic response will only be achieved if the drug reaches the appropriate site of action or receptor site in sufficient concentration to exert its pharmacological action. This is achieved by the drug being absorbed into the body tissues from the site of administration. The choice of administration site will be dependent on a 66 variety of factors; such as whether a local or systemic action is required and how quickly a response to the drug is needed. The Oral Route It is used to obtain either systemic or local effects. The drug, formulated in either a solid or a liquid form, is absorbed from the gastrointestinal tract (GIT). Oral route is the most commonly used route for drug administration. The Buccal Route Formulated as a mucoadhesive tablet and absorbed from the buccal cavity. The highly vascular nature of the tongue and buccal cavity, and the presence of saliva which facilitates the dissolution of the drug make this a highly effective and useful route for drug administration. It is used for both systemic and local actions. Buccal absorption occurs in the area between the lip and the gum. Absorption from the buccal cavity can occur in the area under the tongue called sublingual absorption. Buccal tablets give a quick onset of action and a reasonably long duration of action, compared to sublingual absorption that gives a very fast onset of action, but duration is usually short. The Rectal Route Can be liquids e.g., enemas or solid dosage forms, e.g., suppositories or semi-solids such as cream, ointment and foams. The chosen preparation is inserted into the rectum from 67 where the drug may be absorbed. The amount of fluids in the rectum is limited (about 4 ml only). It is also used for both systemic and local effects. The Vaginal Route Formulated as pessaries or as creams, ointments and foams. It is used for both local and systemic effects. Drugs absorbed from vagina are not subject to the first pass effect. Drug dissolution is more efficient in the vagina than in the rectum because of higher fluid content in the vagina. The Inhalation Route Drugs are inhaled through the nose or mouth (or both) to produce either local or systemic effects. It is used mainly to treat respiratory conditions as drugs are delivered directly to the site of action, namely the lungs. Because of the high blood flow to the lungs and their large surface area, drug absorption by this route is extremely rapid. A variety of dosage forms are used, from simple inhalations consisting of volatile ingredients such as menthol to sophisticated inhaler devices. The drug dose required to produce a systemic effect is much smaller than for the oral route, with a consequent reduction in the side effects. The Topical Route The skin is used as site of administration which is the largest and one of the most complex organs of the body. It is commonly used for local effects and the formulations used include ointments, creams and pastes. 68 Specialized dosage forms known as "transdermal" therapeutic systems which, when applied to the skin, allow the drug to pass through the skin layers to produce a systemic effect. The Parenteral Route In which drugs are given by injection and includes: 1. Intravenous Route Drugs are injected directly into the systemic circulation and produce a very fast onset of action. 2. Subcutaneous Route Drugs are injected into the subcutaneous layer of the skin. It is considered as the easiest and least painful type of injections. 3. Intramuscular Route Drugs are injected into muscle layers. This method can be used to produce a fairly fast onset of action when the drug is formulated as an aqueous solution. A slower and more prolonged action will occur when the drug is presented as a suspension or in an oily vehicle (depot). 69 References: Introduction to Pharmaceutics, Vol. I & II, 4th. Ed., Edited by Gupta,A.K. & Bajaj, S.S, CBS Publishers (2013). Pharmaceutical Practice, 5th Ed., Edited by Collett, D.M. & Aulton, M. E, Churchill Livingstone (2014). Mali, P.Y.; Wankhede, A.R. Glimpse of Some Abbreviations Used in Pharmacy, 2015. Universities’ regulation law (Arabic version) (2006) 23rd edition. Raj, G.M.; Raveendran, R. Introduction to basics of pharmacology and toxicology: Volume 1: General and molecular pharmacology: Principles of drug action, part III; Springer: (2019). Kassem, M.A.; ElMeshad, A.N.; Fares, A.R. Enhanced bioavailability of buspirone hydrochloride via cup and core buccal tablets: formulation and in vitro/in vivo evaluation. International journal of pharmaceutics 2014, 463, 68- 80. Qiu, Yihong, et al., eds. Developing solid oral dosage forms: pharmaceutical theory and practice. Academic press, (2016). 70 Augsburger, Larry L., and Stephen W. Hoag, eds. Pharmaceutical dosage forms: capsules. CRC Press, (2017). Remington, The Science and Practice of Pharmacy, 23th Edition, Academic Press, (2020). 71