Adverse, drug reactions

Adverse drug reaction is an undesired or unintended effect of the drug, occurs at dose normally used by human being. The adverse drug reaction requires treatment or decrease in dose if it is due to poisoning or overdose. 

Adverse drug reaction may be defined as any response to a drug which is noxious (injurious) and unintended, and which occurs at doses of an appropriately given drug used in man for prophylaxis, diagnosis or therapy excluding therapeutic failures.  

Adverse drugs reactions are not rare and have increased in number, which may be due to irrational use of multiple drug therapy, availability of most of the drugs as OTC (over the counter) i.e. without prescription and self medication by the patients. 

Adverse effects can be based on the pharmacodynamics of the drug i.e. side effects (occur at therapeutic dose of the drug), toxic effects (occurs at overdose or poisoning) and drug withdrawal symptoms (i.e. 

There are undesirable and unavoidable pharmacological effect of the drug, which occur at therapeutic dose. These unwanted effects of many drugs are based on their pharmacological actions. Some important examples are  

The occurrence of any drug effect that is not of therapeutic, diagnostic or prophylactic benefit to the patient. 

The WHO definition encompasses six groups, which need not be memorized but which are included for completeness. 

Group 1 Dose-related reactions Group 2 Non-dose-related reactions Group 3 Dose- and time-related reactions Group 4 Time-related reactions Group 5 Withdrawal reactions Group 6 Treatment failure. 

The most important type to the anaesthetist is type B, which encompasses both anaphylactic and anaphylactoid reactions. 

A response to a substance to which an individual has been previously sensitized via the formation of a specific IgE antibody. It is characterized by the release of vasoactive substances and the presence of systemic symptoms. 

Microsomes Can be frozen and used on demand Contains major drug metabolizing enzymes Straighforward to use Limited enzyme complement Closed system so may not be representative of in vivo situation 

Hepatocytes Culture methods available Full enzyme complement - contain enzymes and enzyme cofactors not present in subcellular fractions Full enzyme complement - contain enzymes and enzyme cofactors not present in subcellular fractions Can be used quantitatively Useful for prediction of Phase 1 and 11 metabolism Require fresh tissue No cell-cell contact Need collagenase digestion Handling difficult Closed system so may not be representative of in vivo situation 

Liver slices Easy to prepare Cell-cell contact No use of proteolytic enzymes All cell types present Phase 1 and 11 metabolic processes accessible Require fresh tissue Necrosis of slice centre Long-term culture difficult Quantitative studies variable 

Whilst the only tme measure of the disposition of metabolites in humans is to measure excreted and circulating drug-related material, many systems exist enable the prediction of metabolic pathways in vitro, in vivo or in silico. The advantages and disadvantages of some typical in vitro metabolism systems are shown in Table 7.1. 

Standard, internationally agreed definitions of side-effect, ADR and adverse event may be paraphrased as follows  

the three terms defined above should be applied in the following contexts  

Use ADR to mean that it is now generally accepted that drug X may cause effect y rather than in relation to individual cases. Qualify the term with possible if there is doubt. 

Use suspected ADR when a health professional or investigator indicates that a drug may have been responsible for an event in an individual case. A vahd case submitted as a spontaneous report to a company or regulatory authority is a suspected ADR by definition. 

Use AE only in the context of systematic data collection when no element of judgement is involved in determining whether or not a case is counted. 

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In general, the detection of adverse drug reactions early in the drug discovery process is becoming commonplace. So-called liability panels of receptors, hERG channel activity, and cytochrome enzymes are utilized to identify... 

Drug reactions are potentially serious. The nurse should observe all patients for adverse drug reactions, drug idiosyncrasy, and evidence of drug tolerance (when applicable). It is important to report all drug reactions or any unusual drug effect to the primary health care provider. 

The nurse must use judgment about when adverse drug reactions are reported to the primary health care provider. Accurate observation and evaluation of the circumstances are essential the nurse should record all observations in the patient s record. If there is any question regarding the events that are occurring, the nurse can withhold the drug but must contact the primary health care provider. 

Risk for Impaired Skin Integrity related to adverse drug reaction of the sulfonamides... 

Monitoring and Managing Adverse Drug Reactions The nurse must observe the patient for adverse reactions, especially an allergic reaction (see Chap. 1). If one or more adverse reactions should occur, the nurse withholds Hie next dose of Hie drag and notifies Hie primaiy healtii care provider. 

Monitoring and Managing Adverse Drug Reactions Treatment of minor hypersensitivity reactions may include administration of an antihistamine such as Benadryl (for a rash or itching). Major hypersensitivity reactions, such as bronchospasm, laryngospasm,... 

The expected outcomes for the patient depend on the reason for administration but may include an optimal response to therapy (infectious process controlled), management of adverse drug reactions, and an understanding of and compliance with the prescribed treatment regimen. 

The nurse observes the patient closely for any adverse drug reactions, particularly signs and symptoms of a hypersensitivity reaction. It is important to report a... 

Diarrhea related to superinfedion secondary to antibiotic therapy, adverse drug reaction... 

Monitoring and Managing Adverse Drug Reactions The nurse observes the patient at frequent intervals, especially during the first 48 hours of therapy. It is important to report to the primary health care provider the occurrence of any adverse reaction before the next dose of the drug is due The nurse should report serious adverse reactions, such as a severe hypersensitivity reaction, respiratory difficulty, severe diarrhea, or a decided drop in blood pressure, to the primary health care provider immediately because a serious adverse reaction may require emergency intervention. 

The nurse always listens, evaluates, and reports any complaints die patient may have certain complaints may be an early sign of an adverse drug reaction. The nurse should report all changes in die patient s condition and any new problems that occur (eg, nausea or diarrhea) as soon as possible. It is tiien up to the primary health care provider to decide if tiiese changes or... 

Monitoring and Managing Adverse Drug Reactions Fluoroquinolones... 

The ongoing assessment involves careful observation of the patient every 2 to 4 hours for adverse drug reactions when the antifungal drug is given by the oral or parenteral route. When these dru are applied topically to the skin, the nurse inspects the area at the time of each application for localized skin reactions. When these dm i are administered vaginally, the nurse questions the patient regarding any discomfort or other sensations... 

Unless ordered otherwise, the nurse should save all stools that are passed after the drug is given. It is important to visually inspect each stool for passage of the helminth. If stool specimens are to be saved for laboratory examination, the nurse follows hospital procedure for saving the stool and transporting it to the laboratory. If the patient is acutely ill or has a massive infection, it is important to monitor vital signs every 4 hours and measure and record fluid intake and output. The nurse observes the patient for adverse drug reactions, as well as severe episodes of diarrhea. It is important to notify the primary health care provider if these occur. 

Risk for Imbalanced Nutrition Less Than Body Requirements related to adverse drug reactions or disease process (malaria)... 

Disturbed Sensory Perception Visual related to adverse drug reactions... 

SALICYLATES The nurse observes the patient for adverse drug reactions. When high doses of salicylates are administered (eg, to those with severe arthritic disorders), the nurse observes the patient for signs of salicylism. Should signs of salicylism occur, the nurse should notify the pri-rnary health care provider before the next dose is given because a reduction in dose or determination of the plasma salicylate level may be necessary. Therapeutic salicylate levels are between 100 and 300 meg/ mL. Symptoms associated with certain salicylate levels are ... 

As part of the ongoing assessment during the administration of naloxone, the nurse monitors the blood pressure, pulse, and respiratory rate at frequent intervals, usually every 5 minutes, until the patient responds. After the patient has shown response to the drug, the nurse monitors vital signs every 5 to 15 minutes. The nurse should notify tlie primary healdi care provider if any adverse drug reactions occur because additional medical treatment may be needed. The nurse monitors die respiratory rate, rhydun, and depdi pulse blood pressure and level of consciousness until the effects of die narcotics wear off. 

Notify the primary health care provider promptly if adverse drug reactions occur. 

MYASTHENIA GRAVIS. Once dierapy is under way, the nurse must document any increase in the symptoms of die disease or adverse drug reactions before giving each dose of the drug. The nurse assesses the patient for the presence or absence of die symptoms of myasdienia gravis before each drug dose In patients witii severe... 

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