ADVERSE DRUG REACTIONS

SUBMITTED TO: DR. SUMIT GULLAIYA MENTOR & ASSISTANT PROFESSOR AMITY INSTITUTE OF PHARMACY

SUBMITTED BY:YOGENDER SINGH A4513310006 B.PHARMA (2010-14)

ACKNOWLEDGEMENT
I owe great many thanks to many people who helped me and supported me during
the writing of this term paper.

My deepest thanks to my mentor Dr. Sumit Gullaiya, the guide of

the project for guiding and correcting various documents of mine with attention and care. She has taken pain to go through the project and make necessary corrections as and when needed. I express my thanks to the principal of Amity Institute of Pharmacy for extending his support and all my faculty members without whom project would have been distant reality.

CONTENTS
Abstract.... .4 Introduction................5 What is an adverse drug reaction......................................................................5 Definitions..............................................................................................................6 The prevalence of ADRs.......................................................................................6 Etiology....8 Reasons by which ADRs occurs..........8 Drug-Drug Interactions.....9 Drug-Food Interactions.........................................................................................9 Signs/ Symptoms of ADRs...11 Impacts of ADRs...................................................................................................11 Classification of ADRs..........13 Reporting of ADRs.....16 Methods of reporting ADRs...17 The MedWatch Card Scheme....19 Why are reporting of ADRs important....... 20 Diagnosis.....21 Treatment............22 Prevention...22 Conclusion...22 References........................23
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ABSTRACT
Since time immemorial medicine, drugs and their active compounds have played a very important role in the life of humans being as in the treatment, diagnosis, prophylaxis of various diseases and illnesses that are prone to human body. But along with the healing properties of the drugs side wise side some side effects/ reactions also start take placing. In this term paper we discuss about the adverse drug reactions (ADRs) definitions, reasons or complications that arises ADRs, Signs or symptoms, impacts and classifications of ADRs. How to minimize the various drug reactions and what precautions should be taken while using these drugs. The various organizations which monitor the drugs from time to time for reducing the impacts of Adverse drug reactions. Thus, help in maintaining the safety and efficacy of human population in this world.

INTRODUCTION
What is an adverse drug reaction? An adverse drug reactions (ADRs) is an expression that describes harm associated with the use of given medications at a normal dosage during normal use. ADR may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. Before starting the topic, we should firstly know the meaning of each word of this topic. So, the meanings of each word are as follows:Adverse: - It means Unfavorable/ opposite. Drug: - Medicine (a chemical compound in suitable form of medication used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being). Reactions: - It means the Responses. If we join the meanings of these words we get a short term mean of ADRs i.e., unfavorable/ opposite responses by medicine. And, the definition in medical science or pharmacy of ADRs by W.H.O. is an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product. In medical science or pharmacy, Adverse Drug Reactions (ADRs) also has known as Adverse Drug Events (ADEs) and Toxicity.

Definitions:The ADRs is defined as an unwanted or harmful reaction occurs under normal conditions following the administration of a drug or combinations of drugs are known as Adverse Drug Reaction (ADRs). Any substance that is capable of producing a therapeutic effect can also produce unwanted or adverse effects. The risk of such effects ranges from near zero to high. For example: - Zero effects: nystatin & hydroxocobalamin and High effects: immunosuppressive or anti-neoplastic drugs. An adverse drug reaction is a response to a drug that is noxious and unintended and occurs at normal doses used in man for the prophylaxis, diagnosis or therapy of disease, or for modification of physiological function. In this definition use of the word noxious (mean as injurious/harmful). The prevalence of ADRs: Definition of ADRs specifically excludes minor unwanted reactions (e.g., a slight dryness of the mouth): A harmful or significantly unpleasant effect caused by a drug at doses intended for therapeutic effect (or prophylaxis or diagnosis) which warrants reduction of dose or withdrawal of the drug from future administration. However, these definitions exclude error as a source of adverse effects. Moreover, they exclude reactions due to contaminants (e.g., in herbal medicines) or supposedly inactive excipients in a formulation. Indeed, there is a case for talking about adverse reactions to medicines or medicaments, rather than adverse drug reactions, since medicinal products contain ingredients other than active principles. Others, in the context of adverse events, have used the definition of an injury resulting from medical intervention related to a drug. But other problems arise from this definition for instance, the words injury and medical are ambiguous and there is no reason why an intervention should necessarily be medical to cause an adverse effect. We therefore propose the following definition of an adverse drug reaction: An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen or withdrawal of the product. The term adverse effect is preferable to other terms such as toxic effect or side effect.
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A toxic effect is one that occurs as an exaggeration of the desired therapeutic effect and which is not common at normal doses. For example, a headache due to a calcium antagonist is a toxic effect. It occurs by the same mechanism as the therapeutic effect (vasodilatation). A toxic effect is always dose-related. On the other hand, a side effect is an unwanted effect occurs via some other mechanism and may be dose-related or not. For example, the dose-related anti-cholinergic effect of a tricycle antidepressant is a side effect. Since this action is not associated with the therapeutic effect. Similarly, non-dose-related anaphylaxis with penicillin is a side effect. A WHO definition says ambiguously that a side effect is related to the pharmacological properties of the drug. However, this definition was formulated to include side effects that, although not the main aim of therapy, may be beneficial rather than harmful. Such an effect may or may not occur through the pharmacological action for which the drug is being used. For example, treating hypertension with a beta-blocker may also relieve the patients angina, a beneficial side effect. Alternatively, a depressed patient with irritable bowel syndrome may incidentally benefit from the anti-cholinergic side effect of a tricycle antidepressant as well as from its antidepressant action. The term adverse effect encompasses all unwanted effect. It makes no assumptions about mechanism, evokes no ambiguity and avoids the risk of misclassification. The terms adverse reaction and adverse effect are interchangeable, except that an adverse effect is seen from the point of view of the drug, whereas an adverse reaction is seen from the point of view of the patient. However, the terms adverse effect and adverse reaction must be distinguished from adverse event. An adverse effect is an adverse outcome that can be attributed to some action of a drug. An adverse event is an adverse outcome that occurs while a patient is taking a drug but is not or not necessarily attributable to it. This distinction is important, for example, in clinical trials, in which not all events are necessarily drug-related. In describing adverse outcomes as events rather than (drug-related) effects, investigators acknowledge that it is not always possible to describe causality.

Etiology:Most ADRs are dose-related; others are allergic or idiosyncratic. Dose-related ADRs are usually predictable; ADRs unrelated to dose are usually unpredictable. Dose-related ADRs are particularly a concern when drugs have a narrow therapeutic index (eg, hemorrhage with oral anticoagulants). ADRs may result from decreased drug clearance in patients with impaired renal or hepatic function or from drug-drug interactions. Allergic ADRs are not dose-related and require prior exposure. Allergies develop when a drug acts as an antigen or allergen. After a patient is sensitized, subsequent exposure to the drug produces one of several different types of allergic reaction. Clinical history and appropriate skin tests can sometimes help predict allergic ADRs. Idiosyncrasy is an imprecise term used to classify unexpected ADRs that are not doserelated or allergic. They occur in a small percentage of patients given a drug. Idiosyncrasy has been defined as a genetically determined abnormal response to a drug, but not all idiosyncratic reactions have a pharmacogenetic cause. The term may become obsolete as specific mechanisms of ADRs become known. Reasons by which ADRs occurs:An Adverse drug reaction includes allergic to a drug or by the drug. No drugs are harmful or definitely cause allergy until they are not used properly. The drugs which are considered to be the most dangerous drugs have the greatest potential for benefit. Example: - Insulin. Some reasons or complications by which ADRs are generally caused or allergy by drug occurred are as follows: 1. If drug is not used properly: It means that if the patient is not administrating the drug properly or is being discontinued i.e., discontinuation of therapy. 2. Concentration of drug: If the concentration of the drug is taken high. 3. The liver or kidneys are unable to remove the drug from the bloodstream. 4. Discontinuation of drug therapy. 5. Drug-drug interactions, Drug food interactions.

6. Medications error. e.g.: prescribing, transcribing, dispensing, or monitoring a drug. 7. On Missing dose. Drug-Drug Interactions: A drug interaction is a situation in which a substance (usually another drug) affects the activity of a drug when both are administered together. This action can be synergistic (when the drugs effect is increased) or antagonistic (when the drugs effect is decreased) or a new effect can be produced that neither produces on its own. Typically, interactions between drugs come to mind (drug-drug interaction). It is defined as the phenomenon that occurs when the effect of pharmacokinetics of the drugs are altered by prior administration or co-administration of second drug. It is a particularly important type of adverse drug event. It is a complex pathway, involving either increasing or decreasing the activity of a given cyto-chrome pathway, or preferentially using the pathway rather than other drugs. Drug-Food Interactions: Drug-food interaction: It is the result of the action between a drug and a nutrient (food) that would not happen with the nutrient or the drug alone. It is a broad term that includes drug-nutrient interactions and the effect of a medication on nutritional status Monoamine oxidised inhibitors can cause fatal hypertension in patients who have also consumed food containing high concentrations of tyramine. The suspect foods form an odd assortment. Examples: Chianti wine, some smoked fish and aged cheese.

Signs/ Symptoms of ADRs:Adverse drug reactions (ADRs) are caused by many drugs but there are three main drugs which cause major effects like coma, seizures and even death. These drugs are Insulin, Digoxin. Warfarin. These drugs are 35 times more dangerous than the other drugs. But the drugs which are most dangerous drugs have the greatest potential for benefit. When adverse drug reactions takes place in the body, following signs/ symptoms are included. It can be classified as mild adverse drug reaction and serious adverse drug reaction. If the drug causes Mild Adverse drug reaction following symptoms are commonly observed like Drowsiness, Dry mouth, Dizziness, Skin rashes, Diarrhea, Loss of appetite and weigh and if the drug causes Serious Adverse drug reaction then following symptoms are observed Kidney damage, Breathing, Fever, Joint pain, Stomach pain, Swelling of
the eyes and lips(Anaphylactic shock).

Anaphylactic shock or anaphylaxis is an allergic reaction to a substance that severely affects body functions. Some of the most common symptoms of anaphylactic shock include swelling of the eyes and lips and difficulty breathing, confusion and even fainting. Anaphylaxis is a life-threatening reaction; emergency care is imperative. Symptoms and signs may manifest soon after the first dose or only after chronic use. They may obviously result from drug use or be too subtle to identify as drug-related. In the elderly, ADRs can cause functional deterioration, changes in mental status, failure to thrive, loss of appetite, confusion, and depression. Allergic ADRs typically occur soon after a drug is taken but generally do not occur after the first dose. Typically, they occur when the drug is given after an initial exposure. Symptoms include itching, rash, fixed-drug eruption, upper or lower airway edema with difficulty breathing, and hypotension. Idiosyncratic ADRs can produce almost any symptom or sign and usually cannot be predicted.

Impact of ADRs: The Impacts of ADRs on the life of patients in such following ways:1. Increased risk of death: - A study in the UK showed that the occurrence of ADRs in patients doubled the chances of death. 2. Prolongation of hospital stay: - This is particularly significant now with the shortage of hospital beds. An American study showed that ADRs prolonged hospital stay by 1.9 days. 3. Increased costs of drugs related to morbidity: - In the US; the annual cost of drugrelated morbidity and mortality is 76 billion. 4. Non-compliance: - In the elderly, only one-third would be compliant with their treatment. Lack of compliance might be due to ADRs and could lead to a resurgence of the disease for which the treatment was intended. Non-compliance might also lead to a life-threatening disease, for example, cerebral malaria in travelers who avoided taking mefloquine because of its tendency to cause depression.

5. Reducing quality of life: - ADRs have a negative impact on patients' quality of life, such as when using alpha interferon in treating hepatitis C.

In the above graph we observe the number of deaths (y-axis) which occurred due to Medical errors (shown in blue) and the number of deaths due to Unforeseen Adverse Effects of Drugs (shown in red) in the years 1990 to 2000(x-axis).

Classification of adverse drug reactions: Adverse drug reactions can be categorized in a number of ways (e.g. by severity, by body systems affected). Rawlins and Thompson devised a classification scheme in 1991, which continues to be the most frequently used. Adverse drug reactions are classified into six types are as follows: 1. Type A: Dose-related (Augmented) 2. Type B: Non-dose-related (Bizarre) 3. Type C: Dose-related and time-related (Chronic) 4. Type D: Time-related (Delayed) 5. Type E: Withdrawal (End of use) 6. Type F: Failure of therapy (failure) Type A: This reaction is dose related and it can be predict pharmacologically (study of drug action).In a study of older adults, this type was the most common with the most common offending drugs being warfarin, insulin, and digoxin. Examples: Toxicity of overdose (e.g. Hepatic failure with high dose of Paracetamol). Side effects (e.g. sedation with antihistamines). Secondary effects (e.g. development of diarrhea with antibiotic therapy), Drug interaction (e.g. Theophylline toxicity in the presence of erythromycin therapy). Type B: This reaction is non dose related so cannot be predicting pharmacologically (study of drug action) and in this reaction unwanted causes are seen. Examples: Intolerance (e.g. tinnitus with use of Aspirin). Immune related such as hypersensitivity reactions (e.g. Anaphylaxis with penicillin administration).

 Non-immune reactions such as porphyries, narcoleptic malignant syndrome, or malignant hyperthermia. Idiosyncratic reaction (e.g. development of anemia with the use of anti-oxidant drugs in the presence of glucose-6 phosphate dehydrogenises deficiency). Type C: This reaction is dose-related as well as time-related. This is actually related to duration and dosage of exposure. These reactions are associated with long-term drug therapy. Example: Hypothalamic-pituitary-adrenal suppression from glucocorticoid therapy. Benzodiazepine dependence and Analgesic nephropathy. Type D: These reactions refer to carcinogenic and teratogenic effects. These reactions are delayed in onset and are very rare since extensive mutagencity and carcinogenicity studies are done before drug is licensed. Type E: Withdrawal; end of dose reaction. An example is narcotic or beta-blocker withdrawal.

Type F: Unexpected failure of therapy. This may be caused by drug interactions. An example is failure of oral contraceptives due to induction of enzymes by a second drug.

Types A and B were proposed in the 1970s, and the other types were proposed subsequently when the first two proved insufficient to classify ADRs. About 80% of all adverse drug reactions are type A and for most prescription this type of reaction is described in handbooks such as the physicians desk reference.

The forerunner of the modern pharmacological classification of adverse drug reactions distinguished dose-related and non-dose-related reactions, which were first called type A and type B, respectively. Later, for mnemonic purposes, they were labeled Augmented and Bizarre. Subsequently, two further types of reaction were added: reactions related to both dose and time, and delayed reactions. Later labeled it as type C and D. The last of these categories can be split into two: time-related reactions and withdrawal effects. More recently, a sixth category has been proposed: unexpected failure of therapy. This classification is shown in table as follow, with examples of adverse drug reactions in each category and notes on their management.

Type of Mnemonic Features reaction A: Dose-related Augmented Common Predictable Low mortality

Examples Toxic effects: Digoxin toxicity Side effects: Antidepressants

Management Reduce dose or withhold. Consider effects of therapy.

B: Non-doserelated C: Dose-related and time-related

Bizarre

Chronic

uncommon unpredictable High mortality Uncommon Related to the cumulative dose Uncommon Occurs or becomes apparent some time after the use of the drug Uncommon. Occurs soon after withdrawal of the drug. Common Dose-related Often caused by drug interactions

Immunological reactions: Penicillin hypersensitivity Pseudo allergy Hypothalamic-pituitaryadrenal axis suppression by corticosteroids Carcinogenesis

Withhold and avoid in future Reduce dose or withhold; withdrawal may have to be prolonged Often intractable

D: Time-related

Delayed

E: Withdrawal

End of use

Myocardial ischemia

Reintroduce and withdraw slowly Consider effects of concomitant therapy Increase dosage

F: Unexpected failure of therapy

Failure

Inadequate dosage of an oral contraceptive particularly when used with specific enzyme inducers

In addition to definitions of these general terms, specific definitions of adverse effects themselves have been formulated in a series of papers by the Council for International Organizations of Medical Sciences, starting in 1992 and have been used in computerized databases. Reporting of ADRs The currently accepted international terminology for reporting of adverse drug reactions is WHO Adverse Reaction Terminology (WHO-ART). This terminology is hierarchical and links system or organ classes to three types of terms: broad high-level terms; more specific and disease-related or symptom-related preferred terms; and finally the frequently reported alternative included term and true synonyms. This terminology is intended for use alongside the general disease terminologythe International Classification of Diseases (ICD). Work is being undertaken to link these classifications, so that WHO-ART will become a subset of ICD. Another initiative is the medical terminology for drug regulatory authorities (MedDRA). This terminology includes historical terms from WHO-ART, ICD and COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms used in the past by the US Food and Drug Administration). MedDRA is currently being promoted commercially and is accepted by the European Union, the USA, and Japan. The cases of adverse drug reactions were documented or handle by the Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO), Medical experts, Drug regulatory authorities, the pharmaceutical industry. The main aims of these organizations/authorities on the Adverse drug reactions are as follows: Identify the suspected drug. Identify factors that contributed to the occurrence of the ADRs such as drug-drug interactions, Drug food interactions. Identify unlabeled, rare, delayed adverse reactions and abuse potential. Increase information on use in at-risk population Make changes to product information based on new findings.

Methods of reporting ADRs Spontaneous reporting The most common way that regulatory bodies collect ADR information for medicines once they are on the market is through voluntary, spontaneous reporting structures. The MedWatch card Scheme is run by the MHRA and the Commission on Human Medicines (CHM) and is used to collect information on ADRs from healthcare professionals and members of the public. The original CHM, known as the Committee on Safety of Drugs, was established in 1964 following the thalidomide tragedy and since then, over half a million reports have been collected. When this was introduced, only doctors and dentists could submit reports. Gradually this has been extended and now all healthcare professionals, including coroners, pharmacists and nurses are able to report ADRs via the scheme. Available data indicate that the introduction of nurse and pharmacist reporting is proving to be very useful. The extension of reporting to other professionals should not, however, lead to complacency by doctors, who should continue to use this Card Scheme and take responsibility for reporting suspected ADRs to the regulatory authorities. It is important to appreciate that the database used by the MHRA can detect duplicate reports. Therefore a doctor deems it necessary to submit a Card. They should do so even if there is a possibility that someone else might have done the same. Secondly, different people will include different information when they complete a Card, all of which is useful in creating a full picture of the reaction that has taken place. MedWatch Cards should be submitted to either the MHRA directly or to one of ve regional monitoring centres (RMC). Cards are available by writing to either the MHRA or one of the RMCs, and can also be found in copies of the BNF, the Nurse Prescribers Formulary (NPF), and the Monthly Index of Medical Specialties (MIMS) Companion and from the Association of the British Pharmaceutical Industry (ABPI) Compendium of Data Sheets and Summaries of Product Characteristics. The MHRA also receives ADR reports from pharmaceutical companies, which have a statutory obligation to report suspected serious ADRs. If a doctor passes

details of an ADR on to the pharmaceutical rm which markets the drug, this information will subsequently be passed on to the MHRA.

What should be reported via the MedWatch Card Scheme? If it is suspected that a patient has experienced an ADR it should be reported using a card. ADRs resulting from prescription medicines, herbal remedies and OTC medications can all be reported. If there is any doubt about whether or not an ADR has occurred and should be reported it is always best practice to submit a report. Causality does not need to have been established.

Why are reporting of ADRs important? The limitations of clinical trials mean that when a drug is rst marketed, much may be known about its efficacy while relatively little may be known about its safety. For example, at least 30,000 people need to use a medication in order to identify, with 95 per cent power, an adverse reaction with an incidence of one in 10,000. A relative lack of widespread clinical trials for medicines to treat children means that many drugs are initially only licensed for use in adults, which can leave no alternative to the prescriber than to use off-label and unauthorized products in this population. Thus, the need for ADRs can be seen as a means to identify drug safety problems not picked up by pre-marketing tests and promulgate any necessary advice and/or regulatory action to prescribers and users. Pharmacovigilance through, for example, spontaneous ADR reporting or large scale databases, is used to generate hypotheses and signals about potential hazards of marketed drugs that require further investigation. Spontaneous reporting of suspected ADRs is particularly useful in identifying rare or delayed reactions as such a system enables medicines to be monitored throughout their lifetime. In addition to contributing to the safety proles of existing drugs, pharmacovigilance activities help to improve the knowledge set and contribute to the breadth of epidemiological data. Pharmacovigilance is, therefore, vital for the advancement of future research, medical understanding, drug development and epidemiological studies. Large-scale databases containing longitudinal patient or prescription data reect routine usage of medications in the general population and provide denominator data which can be used to identify trends. Any improvements in drug safety or understanding will ultimately lead to improvements in patient care and thus the benets of effective pharmacovigilance should be appreciated and pursued by all healthcare professionals. Effective spontaneous reporting of suspected ADRs also relies on good communication between healthcare professionals and patients, which in turn should assist good relationships and can improve patient care.

The importance of pharmacovigilance and reporting ADRs is reected in the General Medical Councils (GMC) core guidance Good medical practice, which states that in providing care, doctors have a duty to report adverse drug reactions as required under the relevant reporting scheme, and cooperate with requests for information from organizations monitoring the public health. Diagnosis Consideration of rechallenge Reporting of suspected ADRs to MedWatch Symptoms that occur soon after a drug is taken are often easily connected with use of a drug. However, diagnosing symptoms due to chronic drug use requires a significant level of suspicion and is often complicated. Stopping a drug is sometimes necessary but is difficult if the drug is essential and does not have an acceptable substitute. When proof of the relationship between drug and symptoms is important, rechallenge should be considered, except in the case of serious allergic reactions.

The problem is to find out whether a patient is taking a medicinal product including: over-the-counter formulations, products that may not be thought of as medicines (such as herbal or traditional remedies, recreational drugs, or drugs of abuse) and long-term treatments that the patient may forget (such as oral contraceptives). The next step is to find out whether the effect could be due to a medicine. If the patient is taking several medicines, the problem is to distinguish which, if any, is causative. This problem is complex, because some of the patients complaints might be due to other diseases or to one or more of the drugs. There are many formal methods for assigning probability of causation to a suspected adverse drug reaction. Physicians should report most suspected ADRs to MedWatch. Only through such reporting can unexpected ADRs be identified and investigated. Nurses, pharmacists, and other health care practitioners should also report ADRs. The incidence of severe or fatal ADRs is very low (typically < 1 in 1000) and may not be apparent during clinical trials, which are typically not powered to detect low-incidence ADRs. Thus, these ADRs may not be detected until after a drug is released to the general public and is in widespread use. Clinicians should not assume that because a drug is on the market that all ADRs are known. Post marketing surveillance is extremely important for tracking low-incidence ADRs. Management includes withdrawal of the drug if possible and specific treatment of its effects. Suspected adverse drug reactions should be reported. Surveillance methods can detect reactions and prove associations. Treatment

 Modification of dosage Discontinuation of drug if necessary Switching to a different drug For dose-related ADRs, modifying the dose or eliminating or reducing precipitating factors may suffice. Increasing the rate of drug elimination is rarely necessary. For allergic and idiosyncratic ADRs, the drug usually should be discontinued and not tried again. Switching to a different drug class is often required for allergic ADRs and sometimes required for doserelated ADRs. The process of treatment will likely include acquiring a patient history, a physical examination and the use of laboratory tests on blood and vomit. Any physician will advise you to stop using the medication that is causing such an adverse reaction, unless the need far outweighs the side-effects. Then, if necessary, treatment may involve the application of adrenaline, an intravenous drip or even the use of a stomach pump to remove elements of the harmful poison. Adverse drug reactions can happen to anybody. Prevention Prevention of ADRs requires familiarity with the drug and potential reactions to it. Computer-based analysis should be used to check for potential drug interactions, analysis should be repeated whenever drugs are changed or added. The steps we can normally take to prevent ADRs are as follows: Keep a careful record of what drugs you are taking. Inform the doctors you see of every medication you are taking and be aware of what the dosage is. Also list supplements, herbs or other OTC medicine you are taking. If blood tests do not bring your doctor to a diagnosis, ask him to do a specific test for drug toxicity. Eliminate or reduce the dose of a suspected medication under doctors care.

 Prescribe the drugs of known ADR only when there is no choice left. Obtain history of the patient. Educate the patient about the early symptoms of ADRs. Always discourage self medication.

CONCLUSION: Adverse drug reactions have implications not only for the patient, but for the entire health care system. Reporting of ADRs and ADEs provides clinicians and health care companies valuable insight into the toxicity profile of an agent. Many ADRs and ADEs are preventable, although some effects cannot be avoided (e.g. nausea in chemo treatment for cancer). Better research and greater understanding of disease processes will lead to more effective, and hopefully, safer drug products.

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http://www.ehow.com/about_5097695_signs-symptoms-adverse-drugreactions.html http://www.cioms.ch/publications/reporting_adverse_drug.pdf http://www.pbm.va.gov/vamedsafe/Adverse%20Drug%20Reaction.pdf http://www.authorstream.com/Presentation/arsh29-1214712-adversedrug-reactions-by-armaan/ http://www.authorstream.com/Presentation/zafariqbaljafri-396091adverse-drug-reactions-meri-apni-presentation-education-ppt-powerpoint/ http://nursing411.org/Courses/MD0575_Integumentar_System/503_Integum_Syst.html