Adverse Drug Reactions

Flashcards about Adverse Drug Reactions based on lecture notes.

What is the definition of an Adverse Drug Reaction (ADR)?

A response to a medicine which is noxious and unintended, and which occurs at doses normally used in man.

According to Aronson and Ferner (2005), what is an Adverse Drug Reaction (ADR)?

An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product. It also predicts hazard from future administration and warrant prevention, or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.

According to the European Medicines Agency in 2012, what uses outside the terms of Marketing Authorisation (licence) are ADRs not limited to?

Misuse and abuse, medication error, overdose, and occupational exposure.

What factors increase the incidence of ADR?

Polypharmacy, Elderly, Children , Patient with multiple diseases, Pregnancy, Malnourished, Immunosuppression, Drug Abusers and addicts

What are two examples of important ADRs discussed?

Erythema Multiforme and Torsades de Pointes

What are the four grades of severity for Adverse Drug Reactions?

Minor, Moderate, Severe, and Lethal

What is the difference between Type A and Type B ADRs?

Type A reactions are dose-dependent and predictable based on the pharmacology of the drug, while Type B reactions are idiosyncratic and not predictable.

What does the 'DoTS' classification scheme for ADRs classify reactions dependent on?

Dose, Time course, and Relevant Susceptibility factors.

What are the simplified Naranjo questions used to identify if a drug caused an adverse effect?

Challenge, De-challenge, Re-challenge, and excluding alternative causes.

What four pieces of information are required for a Yellow Card report?

An identifiable source, An identifiable patient, An identifiable drug, and An identifiable suspect reaction.

In Nigeria, which agency coordinates Pharmacovigilance activities?

National Agency for Food and Drug Administration and Control (NAFDAC)

What is Pharmacovigilance?

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.

What can prevent adverse effects of drugs?

Avoid inappropriate use of drugs, ask for previous history of drug reactions and allergies, and always suspect ADR when new symptom arises after initiation of treatment.

What are the steps for dealing with ADRs?

STOP/PAUSE/REDUCE the suspect drug(s), consider why the drug therapy is prescribed, consider whether alternative treatment is available, and TREAT the symptoms.

What are some examples of agents used in the management of specific adverse drug reactions?

Naloxone for opioid toxicity, Icatibant for ACE inhibitor-induced angioedema, Idarucizumab for dabigatran reversal, and Intravenous lipid emulsion for local anesthetic toxicity.