Medication Regulation, Naming, Classifications and Schedules PDF

Medication Regulation, Naming, Classifications and Schedules PN 1077 Unit 1 COURSE LEARNING OUTCOMES Identify how drugs are developed, named and regulated within a Canadian context Recognize the importance of legislation, agency policy and drug standards in the a...

Medication Regulation, Naming, Classifications and Schedules PN 1077 Unit 1 COURSE LEARNING OUTCOMES Identify how drugs are developed, named and regulated within a Canadian context Recognize the importance of legislation, agency policy and drug standards in the administration and management of drugs in Canada Examine classifications of medications used to treat illness using a body systems approach, utilizing pharmacological references and resources Compare the roles of various healthcare professionals in prescribing, dispensing, delivering, educating and managing medication administration  Unit Topics Pharmacology terminology and principles o Chemical vs generic vs trade names Medication classifications based on a body systems approach Terminology related to drug classifications Legislation, standards and regulation Canadian drug approval process Purpose and regulation of clinical drug trials Regulation under the Canada Food and Drug Act Canadian Controlled Drugs and Substances Act Institute of Safe Medication Practices Schedule I, II, III and unscheduled medications Pharmacological references and resources Using a drug guide Creating medication research cards Legal and ethical responsibilities of the PN in medication administration including reporting medication errors Professional and legal responsibilities of varied health care professionals Interdisciplinary roles Professional and legal responsibilities of varied health care professionals  What is Pharmacology? The study of medicine or drugs work and how they affect our bodies Pharmacology knowledge is integral to all nursing specialties. There are over 10,000 available medications encompassing brand names, generic forms, and combinations accessible to the public.  Drug Names Chemical Generic Trade The chemical name refers to the This is the non-proprietary name Also known as the brand precise molecular structure of the given to a drug, usually based on its name, this is the name active ingredient. chemical structure. It's the official given to a drug by the name for the active ingredient and is pharmaceutical not owned by any specific company that pharmaceutical company. manufactures it. 1. Chemical Name: (RS)-2-(4-(2-methylpropyl)phenyl)propanoic acid. 2. Generic Name: Ibuprofen 3. Brand Name: Advil - The trademarked name given by the manufacturer. CREDITS: This presentation template was created by Slidesgo, and includes icons by Flaticon Slidesgo Flaticon, and Freepik infographics & images by Freepik Please keep this slide for attribution Categorizing Drugs: Class, Names, Schedule  Classification System Used by Health Canada (NAPRA, 2024) National Drug Schedules Schedule I Schedule II Require prescription No prescription is required, available only from pharmacist Schedule III Unscheduled No prescription Can be sold anywhere required but are shelved near pharmacist (NAPRA, 2024) Case Study  Mr. Smith, 77 years old, has developed a sore elbow from playing pickleball with his local club. Mr. Smith cannot decide if he should go to the pharmacy and pick up an over-the-counter medication or go to the walk-in clinic. 1. What are the advantages/disadvantages of using OTC medication? 2. What are the advantages/disadvantages of seeing a doctor for a prescription? 3. What are some age-related changes or challenges that Mr. Smith might be facing that could have an impact on the use of medications? Please list and discuss two considerations (can be related to body system changes or otherwise).  Canadian Drug Regulations There are many federal and provincial laws, as well as national guidelines, that have been established to protect public health and safety. Canadian Food and Drugs Act Controlled Drugs and Substances Act  Food & Drugs Act and Health Canada Regulations Health Canada Health Product & Food Branch Natural & Non- Therapeutic Products Biologic & Genetic Prescription Health Directorate Therapeutic Directorate Products Directorate  The Health Products & Food Branch (HPFB) of Health Canada Responsible for regulating, evaluating and monitoring the safety, efficacy, and quality of therapeutic and diagnostic products in Canada Drugs, medical devices, disinfectants and sanitizers Involved in official drug approval process Issuing Safety Warnings Regulation of Over-the-Counter medications  The Health Products Food Branch of Health Canada Regulate 3 branches The Therapeutic Products Directorate (TPD): pharmaceutical drugs or medical devices. The Biologics and Genetic Therapies Directorate (BGTD): biological drugs and radiopharmaceuticals (blood products, vaccines, tissues, organs, gene therapy products, etc.) The Natural and Non-prescription Health Products Directorate (NNHPD): natural health products.  Drug Approval Process in Canada HPFB assesses new drugs thoroughly, weighing benefits against risks for intended users. Evaluation covers manufacturing, labeling, therapeutic claims, and side effects. Monographs and information for doctors and clients are reviewed. All drugs must meet legal requirements of the Food and Drugs Act and its Regulations. Upon compliance confirmation, drug developers receive a Notice of Compliance. (DIN)  The Controlled Drug and Substance Act Passed in 1997, replacing the Narcotic Control Act (1952) and parts III and IV of the Food and Drugs Act Provides requirements for the control and sale of narcotics, controlled drugs, and substances of misuse that can only be obtained legally with a prescription from a licensed medical practitioner  The Controlled Drug and Substance Act (CDSA) SCHEDULES Schedule I – drugs with highest potential for abuse Schedule II- synthetic cannabinoid receptor type 1 agonists (other cannabis related products fall under Cannabis Act) Schedule III – drugs with a high potential for abuse Schedule IV – drugs with potential for abuse that have therapeutic uses  Control of Narcotics in a Health Care Agency ▪Narcotic and non-narcotic medications that have potential for abuse. ▪Special record keeping ▪Stored in a locked cupboard ▪Nurses carry the key in old systems, all nurses have a code in the new systems  Control of Narcotics in a Health Care Agency ▪ Pass the keys in person to another LPN or RN ▪ If you take the keys home, you must bring them back ▪ Use is accounted for (according to physicians’ orders) what patient receives how much of what medication at what time given by whom and waste witnessed by whom  Narcotic recording ▪ There is a recording system - narcotic drugs are accounted for on a narcotic drug count sheet ▪ Each use is recorded and subtracted; this count is done at the end of each shift and by each nurse each time a narcotic is given.  If there is an error in the count Unused portion is wasted, and wastage ▪ Find out where the is witnessed (as per narcotic was used i.e.. agency policy) review meds given since last count and find it; or fill out an incident report Health Professions Act Legislation in Alberta that provides framework for governance, registration, restricted activities, discipline and continuing competence. LPNs fall under this act as regulated health care practitioners. (Health Professions Act, RSA 2024, c H-7.) CLPNA Competencies The College of Licensed Practical Nurses of Alberta is the governing body for all LPNs in Alberta. (CLPNA, 2020)  Institute for Safe Medication Practices Devoted to preventing medication errors Publish lists of error prone medications Instituted the TALLman letters to distinguish different drugs such as: DimenhyDRINATE vs diphenhydramine Safety issues with medications Recalls Storing medications- colour coding different types of medications and ensuring long-acting vs short-acting are clearly labelled to prevent med errors. (Institution for Safe Medication Practices, n.d.). Case study Jane, a new LPN in a long-term care facility, has been assigned to administer medications to her assigned residents. She prepares the medications according to the MAR and administers them to the residents. Later in the day, one of the residents complains of feeling dizzy and nauseous, which prompts Jane to review the medications administered. She realizes that she inadvertently gave the resident another resident's medication due to a similar-sounding name. 1. What measures could Mary have taken to avoid this error? 2. What immediate actions should Mary take to address the situation now?  Review Content Chemical, brand and generic name How is the name assigned? What is it based on? Can drug have more than one of each names? Which names are commonly used by the healthcare providers? Between the brand name and generic name, which name is commonly written in lower case, and which is capitalized? What are some other key points to remember?  REFERENCES College of Licensed Practical Nurses of Alberta. (2020, February 1). Competency Profile for LPNs. CLPNA. https://www.clpna.com/lpn/lpns/competency-profile-for-lpns/​ Lilley, L. L., Collins, S. R., Snyder, J. S., Sealock, K., & Seneviratne, C. (Cdn. Eds.). (2021). Lilley's pharmacology for Canadian health care practice (4th ed.). Elsevier. (Health Professions Act, RSA 2024, c H-7.) https://kings- printer.alberta.ca/1266.cfm?page=H07.cfm&leg_type=Acts&isbncln=9780779740772&CFID=198618670&CFT OKEN=a1654e8fd09d3613-42EF0171-9E69-7795-581C58BD633E88C7 Institute for Safe Medication Practices. (n.d.). Tools and support. https://ismpcanada.ca/resource/ltc/tools- and-support/#launch Newfoundland and Labrador Pharmacy Board, (n.d.). Drug scheduling in Canada. [image]. NAPRA. https://www.napra.ca/national-drug-schedules/national-drug-schedules-program/ Potter, P. A., Stockert, P., Perry, A. G., & Hall, A. (Eds.), & Astle, B. J., & Duggleby, W. (Cdn. Eds.). (2024). Potter and Perry's Canadian fundamentals of nursing (7th ed.). Elsevier. National Association of Pharmacy Regulatory Authorities. (2024). What are the national drug schedules? https://www.napra.ca/national-drug-schedules/what-are-the-national-drug-schedules/ Thanks! CREDITS: This presentation template was created by Slidesgo, and includes icons by Flaticon Slidesgo Flaticon, and Freepik infographics & images by Freepik Please keep this slide for attribution