PT101 Pharmacy Orientation - Lecture 2 PDF

Pharmacy Orientation PT101 Presented by: Dr. Doaa M. Elsegaie Prepared by the department of Pharmaceutics. Lecture Two  Summarize the role of different national and international pharmaceutical organizations Lecture CL...

Pharmacy Orientation PT101 Presented by: Dr. Doaa M. Elsegaie Prepared by the department of Pharmaceutics. Lecture Two  Summarize the role of different national and international pharmaceutical organizations Lecture CLOS Identify different types of drug information sources  Pharmaceutical organizations a) International organizations b) National organizations  a) International organizations World Health Food and Drug United Organization Administration Nations (WHO) (FDA) Commission of ‫منظمه الصحه‬ Narcotic ‫لجنة العقاقير‬ ‫العالميه‬ Responsible for Drugs ‫المخدره التابعة‬ the quality of ‫لألمم المتحدة‬ Responsible for the food and drug in Responsible for health care USA the regulations all over the ‫اداره الغذاء والدواء‬ concerning the world use and abuse of narcotic drugs  Role of international organization Development of protocols & methodologies (intercountry studies) for the trading, formulation and exporting of drugs Development of materials as magazines and brochures. Exchange of information and experiences. For example, FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs, veterinary drugs and biological products.  b) National organizations 2. Egyptian ‫ الجمعية المصرية‬4. Egyptian 1. Egyptian Pharmaceutical Syndicate of the ‫ لصيادلة المستشفيات‬Society of Society pharmacists Hospital Pharmacists A group of pharmacists in Egypt Responsible for responsible for concerned with all pharmacy educating aspects of profession in pharmacists hospital and Egypt through: clinical 3. National pharmacists Issuing a journal Pharmacopeial Holding Committee conferences Responsible for reviewing the ‫اللجنة الوطنية لدستور‬ ‫الجمعية الصيدالنية المصرية‬ pharmacopeia to ‫األدوية‬ cancel or add new drugs  5. Egyptian Drug Authority (EDA) The Egyptian Drug Authority is a public service body with a legal personality affiliated with the Prime Minister. It was established by Law No. 151 of 2019 to replace the National Authority for Drug Control and Research, and the National Authority for Research and Control of Biopharmaceuticals, as well as to replace a number of ‫دمج للهيئة القومية‬ ‫للرقابة والبحوث‬ other administrative bodies and entities. ‫ والهيئة‬،‫الدوائية‬ Specialized in the field of control over medical ‫القومية للبحوث‬ ‫والرقابة على‬ preparations and supplies. ‫المستحضرات‬ ‫الحيوية‬ https://www.edaegypt.gov.eg  Role of National Organizations Educating the public about self-medication. Participation in curriculum development for training of pharmacists & other health professionals (regular updating of pharmacists information) ➔ Self-medication is the use of medicines by individuals to treat self- recognized illnesses or symptoms without any medical supervision. ➔ Such practices may cause antimicrobial resistance, which causes treatment failure.  Drug Information (Three types) 1. Primary 2. Secondary 3.Tertiary 1. Primary: Journal Original materials presented by the authors articles Patent Primary Conference applications proceedings Dissertation, thesis and technical reports Examples of primary sources American journal of pharmaceutical science International journal of pharmaceutics. Journal of Pharmacy and Pharmacology.  2. Secondary sources: Contain information derived from 1ry sources which has been modified, selected, rearranged or compacted by someone other than the original author. Examples: Index medicus (full journal list) International pharmaceutical abstracts (IPA)  3. Special (Tertiary) Sources: Derived from the secondary or primary sources. They represent a collection of information from the above sources. Examples: Tertiary sources Handbooks Textbook on drug stability Secondary sources Textbook on dosage forms index 1ry sources  The difference between a Review paper and Research Paper is that  A Review paper is a secondary source and research on an already existing report  Research paper is a primary source and gives an original report on a topic done by an individual.  Drug Compendia OFFICIAL NON- OFFICIAL OFFICIAL NON- OFFICIAL Contain groups of drugs and devices which Are not limited to drugs which are approved have been recognized as legal standards of for use by legally constituted committee of purity, quality, and strength by that country. a governmental agency of the country origin The books other than official drug compendia are used as secondary source of reference for drugs and related substances. e.g Remington’s pharmaceutical sciences Pharmacopeias and Formularies Books of standards for drugs and devices, known as pharmacopeias and formularies, are collectively referred to as the drug compendia. A pharmacopoeia is a legal and official book containing list of medicinal substances (drugs) and their related substance, tests for its identification, official standards for purity, analysis of the drugs and use. Published by the authority of the government. They differ from formularies in that they are far more complete. The world’s best-known pharmacopoeias: United States Pharmacopoeia/National Formulary (USP/NF) British Pharmacopoeia (BP) Egyptian Pharmacopoeia (EP)  Formulary A book containing a list of pharmaceutical substances along with their formulas, methods of preparation, uses and therapeutic action. e.g. British National Formulary (BNF) Egyptian national formulary (ENF) Resources on the internet Data bases: Medline (searchable by Pubmed www.pubmed.gov). EMBASE. International Pharmaceutical Abstract (IPA). PubMed has some newer information that Embase does not have (yet). PubMed is freely available to the world. Embase is a propriety database from Elsevier Embase is a biomedical and pharmacological bibliographic database of published literature designed to support information managers and pharmacovigilance in complying with the regulatory requirements of a licensed drug. Embase, produced by Elsevier, contains over 32 million records from over 8,500 currently published journals from 1947 Assignment 1: - Go and Search internet for EDA functions. - Describe one function in detail and provide an illustrative photo(s).