Toxic Effects of Drugs INTRODUCTION All drugs are potentially dangerous, even though chemicals are carefully screened and tested in animals and in people before they are release as drugs. Drug products often cause unexpected or unacceptable reaction when they are administered. Drugs are chemical and the human body operates by vast series of chemical reaction, consequently many effects can be seen when just one chemical factor is altered. Today’s potent and amazing drugs can cause a great variety of reactions, many of which are more severe than those you seen before. Paracelsus (Grandfather of Toxicology) “All substance are poisons; there is none which is not poison. The right dose differentiate a poison and a remedy” Flow of Slide Presentation Adverse Drug Reaction Drug Allergy Drug induced tissue and organ damage Adverse Drug Reaction Expected Therapeutic Response: Drugs desired effect. Adverse Drug Reaction (Side effect or Adverse Effect) Undesired effects to drug administration that maybe unpleasant or even dangerous. Harmful , undesirable response. It can range from mild one that disappear when the drug is discontinued to debilitating diseases that become chronic. It can appear shortly after starting a new medication but may become less severe with time. All drugs have adverse effects associated with them. Adverse effects can be an extension of the primary action or secondary effects that are not necessarily desirable but are unavoidable. Reason for Adverse Effect The drugs may have other effects on the body besides therapeutic effect. The patient may be sensitive to the drug being given. The drug’s action on the body may cause other responses that are undesirable or unpleasant. The patient maybe taking too much or too little of the drug, leading to adverse effects. Adverse Drug Reaction Adverse effects can be one of the several types: Primary Action Secondary Action Hypersensitivity All drugs have effects other than the desired therapeutic response. Primary action of the drug can be extension of the desired effect. Secondary action of the drugs are effects that the drug causes in the body that are not related to the therapeutic effect. Hypersensitivity reaction to a drug are individual reactions that maybe cause by increased sensitivity to the drug’s therapeutic or adverse effects. Examples of Adverse Drug Reaction Primary Actions: Anticoagulant are medicines that help prevent blood clots. They're given to people at a high risk of getting clots, to reduce their chances of developing serious conditions such as strokes and heart attacks. A blood clot is a seal created by the blood to stop bleeding from wounds. Example: An anticoagulant may act so effectively that the patient experiences excessive and spontaneous bleeding. This type of adverse effect can be avoided by monitoring the patient carefully and adjusting the prescribed dose to fit that particular patient’s need. Antihypertensives are a class of drugs that are used to treat hypertension (high blood pressure) Example: A patient taking an antihypertensive drug may become dizzy and weak, or faint when taking the “recommended dose” but will be able to adjust to the drug therapy with a reduced dose. Secondary Action: Antihistamines reduce or block histamines, so they stop allergy symptoms. These medicines work well to relieve symptoms of different types of allergies, including seasonal (hay fever), indoor, and food allergies. But they can't relieve every symptom. To treat nasal congestion, your doctor may recommend a decongestant. Example: Many antihistamines are very effective in drying up secretion and helping breathing, but they cause drowsiness. Nursing responsibility: Instruct patient not to drive a car or operate power tool or machinery while taking antihistamine because the drowsiness could pose a serious problem. Hypersensitivity: Some patients are excessively sensitive to either the primary or secondary effect of a drug. It may result from pathological or underlying condition. Example: A patient who has kidney problem may not be able to excrete the drug and may accumulate the drug in the body, causing toxic effects. The patient will exhibit exaggerated adverse effects from standard dose of medication because of the accumulation of drugs . DRUG ALLERGY DRUG ALLERGY Drug allergies occur when a patient develops antibodies to a drug after exposure to the drug. A patient cannot be allergic to a drug that has never been taken. Assess patient understanding regarding drug allergy. Ask additional question to verify patient’s knowledge of drug allergy. Four Main Classification of Drug Allergies Anaphylactic Reaction Cytotoxic Reaction Serum Sickness Delayed Reaction Drug Induced Tissue and Organ Damage Drugs can act (directly and indirectly) to cause many types of adverse effects in various tissues, structures and organs. These effects occur frequently enough that the nurse should be knowledgeable enough about the presentation of the drug induced damage about appropriate intervention to be used should they occur. Dermatological Reaction Rashes, Hives Stomatitis Superinfection Blood Dyscrasia Toxicity Liver injury Renal injury Poisoning Tissue damage can include: skin problem mucous membrane inflammation blood dyscrasia Superinfection liver or renal toxicity poisoning hypoglycemia or hyperglycemia, electrolyte disturbances various CNS problem (ocular damage, auditory damage, atropine-like effects, parkison’s-like syndrome, NMS) teratogenicity Dermatological Reaction Meprobanate Symptoms: Provide (Anxiolytics) Hives and frequent rashes skin care It is important to and other Instruct determine dermatolo the whether a rash is gical patient to a commonly lesion avoid associated maybe rubbing , adverse effect of seen. wearing the drug. Severe tight or reaction rough may clothing, include using exfoliative harsh dermatitis soap or characteri perfumed ze by rash lotion. and Administe scaling r Fever antihista Enlarged mine, as nodes appropria Enlarged te. liver In severe Potentially cases, fatal discontin erythema ue the multiform drug . e Topical exudativu corticoste m (Steven riods, – Johnson antihista Syndrome mine, ) emolient. Antineoplasti c can cause Stomatitis. Stomatitis – inflammation of mucous membrane Many drugs are known to cause stomatitis. Superinfection Infections caused by organism that are usually controlled by the normal flora. Symptoms: Swollen gums inflamed gums, swollen and red tongue. (Glossitis) Other symptoms difficulty swallowin g bad breath pain the mouth and throat. Superinfection Symptoms : ₒ Fever ₒ Diarrhea ₒ black or hairy tongue (glossitis) ₒ mucous membrane lesions vaginal ₒ discharge with or without itching. Frequent mouth care frequent small meals If necessary , arrange for dental consultati on. NOTE : Antifungal agent and /or local anesthetics are sometimes used ₒ ₒ ₒ Blooddyscrasia is bone marrow suppression caused by drug effects. ₒ Occurs when drugs that can cause Blood Dyscrasia Symptoms: Fever, chills, sore throat, weakness, back pain, dark urine decrease hematocrit (anemia) low platelet count(thrombo Provide supportive measures frequent mouth care skin care access to bathroom facilities small frequent meals. Antifungal therapy as appropriat e. Discontinue the drug (in severe cases) *Monitor blood counts *Provide supportive measures *Discontinu e the drug or Stop administrat cell death are used. DRUGS: ₒ Antineopl astics ₒ Antibiotics cytopenia) low white blood cell count (leukopenia) reduction of cellular elements of the complete blood count (pancytopenia) ion until the bone marrow recovers to a safe level. Toxicity Refers to the level of damage that a compound can cause to an organism. These are not acceptable adverse effect but are a potentially serious reaction to drugs. Known toxic effect- the benefits of the drug must be weighed against the possibility of toxic effect – harm to the patient . Liver Injury (Hepatotoxicitity Liver injury : Symptoms : Discontinu Metabolites that Fever, e the drug are irritating or Malaise Offer toxic will also Nausea supportive affect liver Vomiting measures integrity. *Small frequent Jaundice change in meals Hepatotoxic color of *Skin care Drugs: urine or *Cool *Acetaminophe stools environment n *Rest periods Abdomin *Erythromycin al pain or *Iron overdose colic *Isoniazid Elevated *Rifampicin liver *Sulfonamides enzymes Alteration in bilirubin levels Changes in clotting factors. Renal Injury (Nephrotoxicity) Nephrotoxicity Symptoms: ₒ Discontin is define as ₒ Elevated ue the drug rapid blood ₒ Offer deterioration in urea supportive the kidney nitrogen measure: function due to ₒ Elevated *Positioning toxic effect of creatinin *Diet and fluid medications e restriction and chemicals. concent *Skin care ration *Electrolyte Decreas therapy ₒ Nephrotoxic Drugs: *Acetaminoph en *Acyclovir *Aminoglycosid es *Amphotericin B *Ciprofloxacin *Rifampicin *Sulfonamides *Tetracycline *Contrast medium ₒ ₒ ₒ ₒ ₒ ₒ e hemato crit Electroly te imbalan ces Fatigue Malaise Edema Irritability Skin rash *Rest periods *Controlled environment Dialysis – severe cases Poisoning Poisoning occurs when an overdose of drug damages multiple body system leading to the potential for fatal reaction. Assessment parameters vary with the particular drug. Treatment of drug poisoning also varies depending on the drug. Teratogenicity Teratogenicity Many drugs that reach the developing fetus or embryo can cause death or congenital (birth) defects which can include: Skeletal and limb abnormalities CNS alteration Heart defects Teratogenic drugs Fluoroquinolones Aminoglycosides Tetracyclines ACE inhibitors Lithium Oral hypoglycemic agents 10 RIGHTS of Drug Administration 1. Right drug 2. Right patient 3. Right Dose 4. Right route 5. Right time and frequency 6. Right documentation 7. Right history and assessment 8. Drug approach right to refuse 9. Right drug- drug interaction and evaluation 10. Right education and information Be Familiar with the Medication The reason it is being administered. Side effects and adverse effects. Typical dose and range of safety, if applicable. Specific safety regulation before administration. Check compatibility of medication with the other drugs and infusion the patient is receiving . Do not administer any medication that you did not prepare. Asses the Patient Food and drugs allergies. e.g. eggs, milk, peanuts, fish, shellfish, wheat, soy, penicillin, anticonvulsant, aspirin, ibuprofen and chemotherapy drugs. Past medical history and present condition. Knowledge deficits and teaching needed. Evaluate Responses Evaluate the patient for his or her response to the medication, and document if appropriate Report and unfavorable of unexpected response. Testing and Clinical Trials of Drugs Testing process begins with animal studies. Next step involves food and Drug administration (FDA) to review the data obtained in animal studies. Types of Clinical Trials Different types of clinical trials have specific goals. For example: Treatment trials to test the effectiveness of a new drug or procedure. Screening trials to test new ways of detecting cancer or other health conditions in people before they have any symptoms. PHASES PHASE-I Treatment Trials Trials are the first step in testing a new approach in people trial tests an experimental treatment on a small group of often healthy people (20 to 80) to judge its safety and side effects and to find the correct drug dosage. PHASE-II PHASE-III PHASE-IV trial uses more people (100 to 300). While the emphasis in Phase I is on safety, the emphasis in Phase II is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase can last several years. trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device. trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time. Screening Trials The methods of detecting disease, often called screening tests, can include: imaging tests that produce pictures of areas inside the body. laboratory tests that check blood, urine, and other body fluids and tissues. genetic tests that look for inherited genetic markers linked to disease. A genetic marker is a specific gene or other identifiable portion of DNA that can be used to identify an individual disease or trait. Drug Concepts Generally, the client should not take antacid with the medication or with milk because antacid will affect the absorption of the drug. Enteric coated and sustained-release tablet should not be crushed Capsules should not be opened Never adjust or change medication dose or abruptly stop taking the medication without consulting the physician or without Doctor’s order. Generally, the client should not take antacid with the medication or with milk because antacid will affect the absorption of the drug. Don’t rush to crush! Enteric coated and sustained-release tablet should not be crushed Drug Concepts cont’d Avoid taking OTC any or any herbal. preparation unless they are approved. Avoid smoking and drinking alcohol beverages while taking specific drug. Never administer medication if the order is difficult to read or dose that is not even within the therapeutic range Drugs That can Cause Staining Macrodantine Iron Lugol’s solution Tetracycline