PNC 304-PND 401-PN 303 Drug Information Lecture 1 PDF

PNC 304-PND 401-PN 303 Drug Information PNC 304 Drug Information Lecture 1 September Lecture –29 1 Fall, 2024-2025 February 19-24, 2022 Ming Ming Wen, Ph.D. Dept. of C...

PNC 304-PND 401-PN 303 Drug Information PNC 304 Drug Information Lecture 1 September Lecture –29 1 Fall, 2024-2025 February 19-24, 2022 Ming Ming Wen, Ph.D. Dept. of Clinical Pharmacy & Pharmacy Practice Faculty of Pharmacy Categorization of drug information questions 17  What can I There are so many eat to help My son’s doctor different lower my recommended a osteoporosis cholesterol? treatment that isn’t medications. I covered by insurance. don’t know which Is this the standard one is the best. treatment for his condition? My father takes so many different My father is going to medications. I’m have a pacemaker worried about the put in. I want to side effects & any know more about drug interactions. the procedure. What are the What is triamcinolone treatment options acetonide cream used for ? for prostate cancer? 18  Types of question asked can be categorized as follows: – Drug availability –Drug Therapy (comparison between – Drug identification different drug for the same indications) – Drug dosing and administration – Disease state/Treatment – Indications – Herbal medicines/Dietary – Contraindications/Warnings supplements – Side effects/Adverse drug – Generic bioequivalence reactions – Pharmacokinetics – Drug interactions – Compounding – Drug use during pregnancy – Investigational drugs/ and lactation Experimental drugs – OTC products – Toxicology – IV compatibility and Drug – Cost stability – Others 19 Drug use during pregnancy and lactation Trimesters of pregnancy Molecular size pH 20 Since 1975, the FDA has required drug labeling to include a subsection on a drug's ability to cause birth defects and other effects on reproduction and pregnancy. Products also must be classified under one of five letter categories--A, B, C, D, and X for pregnancy (see thechart below) CATEGORY INTERPRETATION Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal A abnormalities to the fetus in any trimester of pregnancy. Animal studies have shown no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. B OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. C OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For D example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective. Adequate well-controlled or observational studies in animals or pregnant women have X demonstrated positive evidence of fetal abnormalities or risks. The use of the product is contraindicated in women who are or may become pregnant. 21 The gold standard book for checking IV compatibility is: Trissel handbook on injectable drugs IV Compatibility Information includes 4 types: 1) Y-site Compatibility - A single drug that is administered simultaneously at a Y-site connection with another drug in a solution 2) Solution Compatibility - A single drug in a solution 3) Admixture Compatibility - Two drugs in a solution 4) Syringe Compatibility - Two drugs in a syringe  IV compatibility and Drug stability Many injectable drugs cannot be mixed together in syringes or infusions. Some cannot be diluted in infusion bags. Incompatibility includes precipitation, ionic reactions, evolution of gas and denaturation of biological molecules. To know the information of drug compatibility is needed before mixing injectable drugs. If drugs are mixed together, the mixture should be inspected for precipitates, turbidity or changes in color, however not all incompatibilities are visible. 22  Off-label use (Unlicenced Use) When a medicine is used as intended, it is known as a licensed use. If a licensed product is prescribed for use in a way that differs from the condition’s licensed terms, it is said to be an off-label use. For example, medicines used for a different indication, age group and dose other than approved indications. 23  Drug availability This category includes the availability of drug product, dose strength, dosage forms and prescription/OTC drugs. Someone told me that a vaccine containing human stem cells could prevent bowel cancer. Do we have this vaccine here in Egypt? 1 1  Drug identification Drug identification can be searched by the  imprint code  color,  shape and scoring If the question is to identify a foreign drug, make sure the spelling of drug (brand/generic name) is correct. Other questions such as country of origin? indication? appearance of the medication? I found this pill in my son's bedroom. It’s round white pill, scored on one side with the markings "TEC 143" on the other. Should I be concerned? 1 2  Drug dosing and administration Dosing requirements should be adjusted in different patient populations, such as  neonates  pediatrics  patient with renal impairment or hepatic impairment For Example, Fentanyl is available in various dosage forms for different administration sites according to the need of patients : transmucosal lozenges Effervescent buccal tablet Transdermal patch Injection (lollipops) Oral transmucosal lozenges and effervescent buccal tablets are used for the management of cancer pain in patients who are already receiving opioid medication for their persistent pain. Transdermal patches are used in the management of chronic pain in patients who require continuous opioid analgesia for pain. Fentanyl citrate injections are administered intravenously, intramuscularly, spinally or epidurally for potent analgesia and anesthesia. 10  Indications This category includes FDA approved and not official approved uses. (The non-official approved indication is called off-labeled OR unlicenced). An off-labeled use of a drug is a use that is not included as an indication on the drug's label as approved by the FDA. Physicians sometimes use medications to treat diseases that are not stated as FDA approved indication if the use is determined to be medically acceptable and safe. Off-labeled medicines also include extemporaneously compounded medicines. Sometimes suitable dosage forms are not always available for specific patient populations and must be extemporaneously compounded. They are also off- labeled medicines. P & T committee in the hospital asks you to evaluate the use of epoetin alpha to reduce the blood transfusion in the ICUs because of the non-FDA-approved status for this indication. 11  Contraindications/Warnings should include the known hazards (not theoretical possibilities),such as  Observed adverse reactions which outweigh any potential benefit to the patient. Expected adverse reactions which may occur when a drug is used in a specific clinical situation. Likely clinical situations, such as coexistent physiological state (existing hepatic disease, renal disease, pregnancy ) or other demographic risk factor (age, sex , race). is used to alert prescribers for the following situation:  The adverse reaction is very serious compared to the potential benefit from the drug There is a serious adverse reaction that can be prevented or reduced severity by appropriate use of the drug FDA approved the drug, but with restrictions, to assure safe use of the medicine. I have heart problem for several years. Can I take Vioxx? Contraindication of Vioxx: Vioxx is contraindicated in patients Warning Statement of Vioxx: concurrently taking blood pressure Vioxx increased risk of serious cardiovascular medications, and/or patients with a events, including heart attacks and strokes, 12 history of heart problems. blood clots, and pulmonary embolism.  Side effects/Adverse drug reactions  Side effect is often used to refer to a drug's unintended effects that occur within the therapeutic range.  Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. What are the possible risks and side effects of taking potassium iodide (KI)? 13  Drug interactions It is very important to know also the Drug Interactions include: mechanism of each drug interaction  drug-drug interaction the level of significance of the  drug-disease interaction interaction (major, moderate or minor)  drug-food interaction the recommended course of action to manage the interaction  drug-laboratory test interaction  drug-herbal interaction  drug-dietary supplement interaction Should I take the thyroid hormone with food or an empty stomach? Do oranges and other citrus fruits cause the same interaction as grapefruit juice with felodipine ? 14 Example:  Drug-Drug interactions may involve prescription or OTC drugs.  Types of drug-drug interactions include duplication, opposition (antagonism), and alteration of what the body does to one or both drugs. Both medicines contain diphenhydramine. +  Drug-Disease Interactions Sometimes, drugs that are helpful in one disease are harmful in another disorder. Beta-blockers help in hypertension But worsen the asthma  Drug-Laboratory test Interactions Mefenamic Acid may prolong prothrombin time. Therefore, when the drug is administered to patients receiving oral anticoagulant drugs, frequent monitoring of prothrombin time is necessary. 15  OTC products  Some common nonprescription medicines include: antacids laxatives, and stool softeners antidiarrheals Cold and allergy remedies Pain relievers Weight control These drugs can be very helpful when used properly but can cause serious problems if used incorrectly or may interact with other medications. Whether Actifed can help with allergy and not making me sleepy? 18  Drug therapy This category includes questions related to the mechanism of action and pharmacologic effect of a drug OR comparison between different drugs with the same indication. My doctor asked me to take Zocor for my high lipid level. Can you tell me how Zocor works in my body? Answer: Zocor is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL). It is used to lower cholesterol and triglycerides in the blood and lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors. 21  Disease state/Treatment I had asthma attack during training session. I’m an athlete in track and field. Doctor told me it’s exercise-induced asthma. Is it possible that exercise can trigger asthma attack? Can it be prevented? Answer: Proper warm-up and cool- down may prevent or reduce the incidence of exercise- induced asthma. 22  Herbal medicines/Dietary supplements Are there any dietary supplements that prevent water retention? Medicinal herbs and botanicals are not required to prove the safety and efficacy prior to marketing them. It is possible that these substances might be ineffective, potential for causing drug interaction and the risk of product contamination. I need your advice on herbal slimming tea. 23  Generic Bioequivalence Bioequivalence is a term used when comparing brand name and generic drugs. Generic bioequivalent drugs should have the same strength as the brand name medication, and provide the same therapeutic effects. What is the equivalent dose of Lipitor (atorvastatin) to Zocor (simvastatin)? 24  Pharmacokinetics Pharmacokinetics is the study of rate of movement of drugs within biological systems, as affected by the absorption, distribution, metabolism, and elimination of medications (ADME). The biological, physiological, and physicochemical factors may influence the transfer processes of drugs and the rate and extent of ADME of the drugs in the body. Can psyllium affect the absorption of dietary supplements? 25  Compounding Does liothyronine compounding powder require refrigeration? I recently had gastric bypass surgery. Doctor asked me to take Wellbutrin for the depression. But I cannot absorb everything taking orally, especially the tablet. Can you make it as liquid for me? 26  Investigational Drugs/Experimental drugs Investigational or experimental drugs are new drugs that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use, and are in the process of being tested for safety and effectiveness. I’m 40 years old. I have been diagnosed with osteoarthritis of the knee for more than 6 months. My problem is having knee joint pain on most of the days. Current medications are not really helpful. Am I eligible to enroll in a clinical trial that are testing new drugs for osteoarthritis? 27  Toxicology  Poisoning may occur accidentally or intentionally (self-poisoning).  This category may include:  Drug overdose  Carbonmonoxide poisoning  Caustic ingestion  Fish and shellfish sting  plant/mushroom poisoning  Insects bite  Heavy metal My eight-year old boy just took a bottle of Ferrofol tablets in the kitchen. I think that he took 40 or 50 of them. What should I do? 28  Cost Is Gaviscon the same price here as in USA? 29 Thank You