PHRM 250 Unit 1 Past Paper PDF

PHRM 250: PHARMACOTHERAPEUTICS FOR HEALTH PROFESSIONALS Course Introduction & Unit 1.1 - Drug Legislation in Canada  INSTRUCTOR INTRODUCTION Amy Warren MN, RN Rural acute, continuing care, ER experience 10 years teaching at Portage Use my College emai...

PHRM 250: PHARMACOTHERAPEUTICS FOR HEALTH PROFESSIONALS Course Introduction & Unit 1.1 - Drug Legislation in Canada  INSTRUCTOR INTRODUCTION Amy Warren MN, RN Rural acute, continuing care, ER experience 10 years teaching at Portage Use my College email to contact me (and use yours as well) I will respond during business hours (so if it is important, email then)  COURSE FORMAT This week will be a traditional lecture week Before the end of this week you will receive links to lecture videos (they will be in your College email and I will post them on Moodle) You will be required to watch those videos before next week’s class During next week’s class you will have an opportunity to ask questions about the content and complete in-class activities ex: case studies, group discussions, interactive games etc… This flipped classroom format will continue for the remainder of the semester  COURSE OVERVIEW 10 Units divided by medications that affect a particular body system  PHRM 250 LEARNING GUIDE Make sure you use your PHRM 250 Learning Guide It has the following: All the readings All the learning outcomes Tips for success Additional Resources All necessary information to complete the group assignment Check the learning guide for an answer before emailing the instructor (chances are what you need is already in there) The learning guide is on your PHRM 250 Moodle site and has been emailed to your Portage College email ASSESSMENT VALUES EXAM BLUEPRINT  ASSESSMENT DUE DATES Midterm #1 on Units 1-4: February 4th @ 1200 Midterm #2 on Units 4-8: March 18th @ 1200 Part 1 of Group Assignment: February 25th @ 0900 Part 2 of Group Assignment: March 4th @ 0900 When everything is due and what we are covering in each class is listed in the PHRM 250 Course Calendar The Course Calendar is on the PHRM 250 Moodle site and has been emailed to your College email  ASSIGNMENT OVERVIEW Groups will be the same as your NURS 152 assignment groups Part 1 is an interview of a person on a particular medication on the approved list This gets written up as a short 2-page paper The medication chosen to focus on must be pre- approved by your instructor (no two groups can have the same medication) Interviewee cannot be an LPN student Part 2 is a research paper comparing the interview results with what the textbook and drug guide say 3 pages For full details on the assignment, please scroll to the end of the PHRM 250 Learning Guide Questions? Lesson 1.1: Drug Legislation in Canada  OVERVIEW Canadian drug legislation Food & Drug Act Controlled Drugs & Substances Act Patent Act Approval process for new medications Difference between prescription, controlled, over-the-counter, and herbal medications Where to find medication information  BEFORE WE GET STARTED, LETS BE CLEAR What is a drug? Chemical agent that produces physiological response in the body Effects may be: Desirable (therapeutic) Undesirable (adverse)  CANADIAN DRUG LEGISLATION Frameworks to provide safe administration of medications  CANADIAN FOOD & DRUGS ACT Primary piece of legislation governing foods, drugs, cosmetics, and medical devices in Canada The purpose of the act is to protect the consumer from contaminated or unsafe drugs, foods, cosmetics, and medical devices According to the Act, drugs must comply with official prescribed standards from recognized formularies Regulates information manufacturers can put on a drug label  CANADIAN FOOD & DRUGS ACT Made up of numerous schedules and parts Schedule A: Lists the diseases for which treatments may not be promoted to the public Section 3(1) and 3(2) prohibit any label claim or advertisement that is both directed to the general public and contains treatment, preventative, or cure claims for Schedule A diseases (life- threatening diseases such as cancer and acute forms of specific diseases)  CANADIAN FOOD & DRUGS ACT Schedule C: Radiopharmaceuticals Drugs in this schedule must list where the drug was manufactured and the process and conditions of manufacturing Schedule D: Includes allergenic substances, vaccines, insulin, anterior pituitary extracts, drugs obtained by recombinant DNA technology, and blood derivatives Like Schedule C, drugs in this schedule must list where the drug was manufactured and the process and conditions of manufacturing Schedule F: All drugs that require a prescription wit the exception of narcotics and controlled drugs Schedule F was replaced by a list of prescription drugs called the Prescription Drug List  CANADIAN FOOD & DRUGS ACT Part G: Requires a prescription Regulates controlled drugs that affect the central nervous system Labels on these drugs are marked C Controlled drugs are categorized into three parts: Part 1: designated controlled drugs with misuse potential that may be used for designated medical conditions outlined in Food and Drug Regulations Ex: amphetamines Part 2: controlled drugs with misuse potential prescribed for medical conditions Ex: barbiturates Part 3: controlled drugs with misuse potential Ex: anabolic steroids  CANADIAN FOOD & DRUGS ACT Part J: These are restricted drugs with high misuse potential, dangerous physiological and psychological adverse effects, and no recognized medical use Ex: LSD Food and Drug Regulations: an adjunct to the Food and Drugs Act, these regulations clarify terms used in the Act and state the processes that companies must carry out to comply with the Act in terms of importing, preparing, treating, processing, labelling, advertising, and selling foods, drugs, cosmetics, natural health products including herbal products, and medical devices  CONTROLLED DRUGS AND SUBSTANCES ACT (CDSA) A Health Canada act that makes it a criminal offence to possess, traffic, produce, import, or export controlled substances Controlled substances are any drug listed on one of the schedules of the CDSA Controlled substances and substances for medical treatment may be legally obtained only with a prescription from a licensed medical practitioner The CDSA provides requirements for the control and sale of narcotics, controlled drugs, and substances of misuse Comprised of 8 schedules based on potential for misuse or harm or how easy they are to manufacture into illicit substances RCMP is responsible for the enforcement of the CDSA  8 SCHEDULES OF THE CDSA Schedule I contains the most dangerous drugs, including opiates (opium, heroin, morphine, cocaine), fentanyls, and methamphetamine Schedule II contains synthetic cannabinoid receptor type 1 agonists (ccompounds that interact with and stimulate the activity of cannabinoid receptors) Ex: Dronabinol All other cannabis-related drugs are now regulated under the Cannabis Regulations and the Cannabis Act (since it’s now legal) Schedule III contains the more dangerous drugs, such as amphetamines and LSD  8 SCHEDULES OF THE CDSA Schedule IV contains drugs such as barbiturates and anabolic steroids, which are dangerous but have therapeutic uses (a prescription is required for possession) Schedules V and VI contains precursors required to produce controlled substances (ex: stuff to make meth or ecstasy) Schedules VII and VIII contain amounts of cannabis and cannabis resin required for charge and sentencing purposes Even though it’s legal, sellers must still be licensed by the federal government  CANADIAN PATENT ACT Allows the manufacturers of new drugs to market the new drug exclusively until the patent for the drug molecule expires (normally 20 years after discovery of the molecule and includes the 10-to-12-year period generally required to complete drug research) Essentially, they can exclusively sell the new drug they developed for about 8-10 years (after which, generic forms may become available) This allows them to recoup the costs of development, but also means new drugs tend to be very expensive  MEDICATION APPROVAL PROCESS Preclinical trial Lab research for usually 3-5 yrs, tests are done on human and microbial cells, then tested on animals to determine their harm to humans Four levels of testing are required for therapeutic drugs and biologics These progress from cellular and animal testing to use of the experimental drug in clients with the disease Clinical Phases 1: healthy volunteers (need informed consent) 2: individuals with a particular disorder (small group) 3: individuals with a particular disorder (large group) Double blind with use of a placebo 4: post-marketing studies conducted by drug companies once the drug is released in Canada  MEDICATION TYPES Prescription Drugs: require a script from a prescribing professional Over-the-Counter (OTC) Drugs: Medications that are legally available without a prescription Natural Health Products (NHPs): umbrella term for products that include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, and other products such as amino acids and essential fatty acids These may still interact with prescription medications C  OTC MEDICATIONS Regulated by the Food and Drug Regulations OTC medications classified as schedule II are restricted- access drugs available only from the pharmacist and are retained in an area behind the counter where there is no opportunity for consumer self-selection Ex: acetaminophen with codeine 8 mg This strategy ensures that the consumer is not self- medicating inappropriately and that the use of these drugs is subject to counselling by the pharmacist Schedule III OTC medications are ones the consumer has open access to in a pharmacy setting Ex: antihistamines like Benadryl Unscheduled OTC medications can be sold in any store ex: Tylenol  DRUG INFORMATION SOURCES Canadian Formulary (CF) Compendium of Pharmaceuticals and Specialities (CPS) Drug handbooks/guides (like the one you bought for this course) Each medication has an 8-digit identification number (DIN)  PHRM 250: PHARMACOTHERAPEUTICS FOR HEALTH PROFESSIONALS Unit 1.2: General Principles of Pharmacology  OVERVIEW Terms related generally to pharmacology The 4 processes of pharmacokinetics Half-life Therapeutic versus adverse drug reactions Drug toxicity and antidotes Idiosyncratic, carcinogenic, and teratogenic effects How age and health complications affect how our bodies respond to drugs Categories of risk for pregnant people  CHEMICAL VS. GENERIC VS. TRADE NAMES Chemical name: assigned due to properties Ex. (±)-2-(p- isobutylphenyl) propionic acid Generic name: is the universally accepted name of the drug ingredient or it’s common name on all drug labels, resource guides, and publications Ex. Ibuprofen Trade name: assigned by company marketing the drug Ex. Advil, Motrin  PHARMACOLOGICAL PRINCIPLES Pharmacology Pharmacokinetics Pharmacodynamics Pharmacotherapeutics Pharmacognosy  PHARMACOLOGICAL PRINCIPLES Pharmacology Broadest term for the study or science of drugs Pharmacokinetics The study of drug movement throughout the body Absorption Distribution Metabolism Excretion It is the study of what happens to the drug from the time it is put into the body until it leaves the body  PHARMACOLOGICAL PRINCIPLES Pharmacodynamics Study of the biochemical and physiological interactions of drugs at their sites of activity Pharmacotherapeutics The use of drugs and the clinical indications for drugs to prevent and treat diseases Pharmacognosy The study of natural (plant and animal) drug sources  PHARMACOKINETICS: ABSORPTION  Absorption determines the length of time required to produce a response  Absorption can be affected by many factors  The routes of absorption can be categorized into 3 basic routes Enteral (GI tract) Percutaneous (topical) Parenteral – any route other than enteral or percutaneous  ENTERAL ROUTE Drug is absorbed into the systemic circulation through the oral or gastric mucosa, the small intestine, or rectum Oral Sublingual Buccal Rectal  ENTERAL ROUTE Forms of oral meds Tablet Capsule Powder Liquid Enteric coated Gel cap Extended release Sustained release DRUG ABSORPTION ORALLY  TOPICAL ROUTE Skin (including transdermal patches) Eyes Ears Nose Lungs (inhalation) Vagina  PARENTERAL ROUTE Intravenous (fastest delivery into the blood circulation) Intramuscular Subcutaneous Intradermal (needle just under the skin) Intrathecal (needle in the spine) Intraarticular (needle in the joint) INTRATHECAL VS. EPIDURAL  FACTORS THAT AFFECT ABSORPTION Route of Status of the administration absorptive GI motility surface Health of tissue Food-Drug interactions Blood flow Ex. Grapefruit juice Surface area Drug-drug interactions pH Empty stomach Drug solubility (lipid) ( absorption) First pass effect… Bioavailability of drug  FIRST-PASS EFFECT The metabolism of a drug and its passage from the liver before entering the circulation A drug given via the oral route may be extensively metabolized by the liver before reaching the systemic circulation (high first- pass effect) The same drug—given IV—bypasses the liver, preventing the first-pass effect from taking place, and more drug reaches the circulation  DRUG ROUTES Non-First Pass First Pass Routes Routes Aural Hepatic artery Buccal Oral Inhalation Portal vein Intramuscular Rectal Intranasal Intra-ocular Intravaginal Intravenous Subcutaneous Sublingual IV IM SC  PHARMACOKINETICS: DISTRIBUTION Distribution is the transport of a drug through the bloodstream to the site of action Rate & extent varies Client physiology Body fat & water content Blood flow - Areas of ↑ blood supply receive drugs first (heart, liver, kidneys, brain) Lipid solubility Drug - Protein binding (drug-protein complexes)  PHARMACOKINETIC S: DISTRIBUTION Areas of rapid distribution Heart Liver Kidneys Brain Areas of slow distribution Muscle Skin Fat  PHARMACOKINETICS: DISTRIBUTION Drug-protein complex (protein binding) Only drug molecules that are not bound to plasma proteins (usually albumin) can freely distribute to extravascular tissue (outside the blood vessels) to reach their site of action If a drug binds to albumin only a limited amount of the drug is not bound. This unbound portion is pharmacologically active and is considered free drug whereas bound drug is pharmacologically inactive Low albumin levels (ex: burns) can lead to drug toxicity  PHARMACOKINETICS: DISTRIBUTION Drug-protein complex (protein binding) When an individual is taking 2 medications that are highly protein bound, these medications may compete for binding sites on the albumin protein. Because of this competition, there is more free, unbound drug. This can lead to a drug-drug interaction where the presence of one drug decreases or increases the action of another drug administered at the same time. Some drugs can have a high affinity to binding Example: Coumadin 99% bound Can remove/displace another drug from the protein, increasing levels of original drug  PHARMACOKINETICS : METABOLISM Metabolism is the biological transformation of a drug into a more or less active form that can be excreted (biotransformation) Metabolized drugs become more water soluble (excreted in urine) Sites of metabolism Liver (main organ) Kidneys Lungs Plasma Intestinal mucosa Exocrine glands  PHARMACOKINETICS : EXCRETION Excretion is the elimination of the drug from the body Sites Kidneys (main organ) Liver Bowel Lungs (gaseous substances) Exocrine glands Mammary (breast milk), sweat, salivary  PHARMACOKINETICS: EXCRETION Excreted through kidney via: Glomerular filtration Active tubular secretion The more water soluble the greater the chance of drug being excreted in urine Transforms during metabolism Body pH can also influence the rate of excretion  PHARMACODYNAMICS Therapeutic effect Onset, Peak, Duration Half Life Mechanism of action Receptor interactions Enzyme interactions  THERAPEUTIC EFFECT: ONSET, Onset PEAK & DURATION the point at which a drug elicits a therapeutic response Peak time it takes for drug to reach maximum therapeutic response absorption rate = elimination rate Duration time a drug concentration is sufficient to elicit a therapeutic response  ONSET, PEAK, DURATION The length of time until the onset and peak of action and the duration of action play an important part in determining the peak level (highest blood level) and trough level (lowest blood level) of a drug. If the peak blood level is too high, then drug toxicity may occur.  THERAPEUTIC EFFECT: HALF-LIFE (T½) Measures the rate in which drugs are removed from the body The time required for the body to eliminate 50% of the drug Can vary from person to person Affects dosing: Amount Frequency Difficulty in excreting a drug increase risk for toxicity  HALF-LIFE EXAMPLE t₀= time t₀=1200 furosemide administered 40mg t₁= 50% remains t₁= 50% remains@1300 t₂= 25% remains@1400 t₂= 25% remains t₃=12.5% t₃=12.5% remains remains@1500 t₄=6.25% remains t₄=6.25% t₅=3.13% remains remains@1600 t₅=3.13% remains@1700 97% of drug excreted at 1700 1.25mg remaining  MECHANISM OF ACTION: DRUG ACTION Local Effect of the drug is realized only locally (topical) Limited to one area Systemic Elicits a reaction throughout the whole body  RECEPTOR INTERACTIONS Drug-receptor interaction is the joining of the drug molecule with a reactive site on the surface of a cell or tissue Once a drug binds to an interacts with the receptor, a pharmacological response is produced Drugs interreact with receptors in different ways, by either eliciting or blocking a physiological response The drug with the strongest affinity for the receptor will elicit the greatest response from the cell  ENZYME INTERACTIONS Enzymes are substances that catalyze nearly every biochemical reaction in a cell For a drug to alter a physiological response, it may either inhibit (more common) or enhance (less common) the action of a specific enzyme (selective interaction) Ex: MAOIs  FACTORS INFLUENCING DRUG ACTION Body weight Culture Disease (pathology) Environment (lifestyle) Genetic differences Psychological factors Sex/gender Time of drug administration  MEDICATION ACTIONS Medications bind to cell receptors to elicit a response Enhance or inhibit the normal response Agonist: mimics the response of an endogenous substance Sometimes a greater or weaker response Antagonist: inhibits the response of an endogenous substance Compete for binding sites MECHANISM OF ACTION IN LIVING TISSUES…  MEDICATION INTERACTION EFFECTS Types: Additive effect: 1+ 1 = 2 Synergistic effect: 1 + 1 = greater than 2 Antagonistic effect: 1 + 1 = less than 2  PHARMACOTHERAPEUTIC TYPES OF DRUG THERAPY Palliative Acute Supportive Maintenance Supplemental Prophylactic Empirical  SECONDARY EFFECTS OF MEDICATIONS Adverse effects Carcinogenic Severe negative Idiosyncratic effect response Unpredictable Medication Over or under discontinued reacts Side effects Unintended Predictable  SECONDARY EFFECTS OF MEDICATIONS Toxicity Antidote (Antagonist Acute effect) Decreases the effects Chronic of toxicity Therapeutic No antidote then Index – diff charcoal is given between enterally to bind therapeutic level drug/toxins in GI to be and toxic level expelled in feces Prolonged intake Poison Control Accumulation Drug information 24 Antidotes hours/day Assist layperson & Lethal effects health professionals  ALLERGIC REACTION/ANAPHYLAXIS Allergic Anaphylactic reaction reactions Unintended Severe Unpredictable Life-threatening Release of Sudden onset antibodies Constriction of Medication bronchial airways allergy Emergency Medic alert bracelet  MORE POSSIBLE RESPONSES TO DRUG Tolerance: decreasing THERAPY response to repeated drug doses Dependence: physiological or psychological need for a drug Physical dependence: physiological need for a drug to avoid physical withdrawal symptoms Psychological dependence (addiction): obsessive desire for a drug  AN EXAMPLE OF THESE TERMS USING GRAVOL… Side effect – Gravol makes people sleepy Allergic rxn. – Gravol may give you hives Anaphylaxis – your throat closing off after taking Gravol Adverse effect – Gravol causing acute onset of liver failure Idiosyncratic effect – Gravol causing hyperactivity of agitation  DRUGS DURING PREGNANCY Risks for the fetus (cross placenta) Placenta contains enzymes that detoxify certain substances Teratogen – agents that cause fetal malformation No Rx, OTC or herbal should be taken without consulting a physician Pregnancy drug categories: A, B, C, D, X Fetal effects Benefits must outweigh risks  DRUGS DURING PREGNANCY PREGNANCY CATEGORY A No risk to the fetus PREGNANCY CATEGORY B Animal studies show risk, but human findings do not PREGNANCY CATEGORY C Risk cannot be ruled out Human studies are lacking and animal studies are either positive or lacking May be used during pregnancy if the potential benefits of the drug outweigh its possible risks  DRUGS DURING PREGNANCY CONT’D PREGNANCY CATEGORY D There is positive evidence of risk to the fetus Potential benefits may outweigh the risk to the fetus. In a life- threatening situation, the drug may be acceptable if safer drugs cannot be used or are ineffective PREGNANCY CATEGORY X Use of drug is contraindicated in pregnancy Studies show fetal risk that clearly outweighs any possible benefits to the patient  DRUGS AND PEDIATRICS Pediatric patients = immature organs Things to keep in mind when calculating pediatric doses Stomach lacks acid to kill bacteria Gastric emptying is slower Total body water high increasing the distribution and dilution of water soluble drugs Lower protein levels Immature blood-brain barrier Liver and kidneys immature = impaired metabolism and excretion  DRUGS & OLDER ADULTS Changes with age Degenerating organ systems Multiple & serious illness Unreliable compliance Polypharmacy Polypharmacy Taking multiple drugs concurrently Increases risk for drug interactions & side effects  DRUGS & OLDER ADULTS CONT’D Pharmacokinetics Lower dose, reduced frequency Absorption Slower ↓ motility, ↓ blood flow, ↓ gastric acidity Distribution ↑ body fat ↓ H₂O intake ↓ albumin (more free drug) ↓ Cardiac output  DRUGS & OLDER ADULTS CONT’D Metabolism ↓ Liver enzyme production ↓ Liver mass ↓ blood flow Excretion ↓ renal function ↓ GI motility