lec 4

Name one of the methods used for post-marketing surveillance of drugs.

Spontaneous adverse event reporting cards ("Yellow" cards)

What does ADR stand for?

Adverse drug reactions

According to Paracelsus, what differentiates a poison and a remedy?

The right dose

What is the purpose of post-marketing data?

To gather comprehensive safety data Signup and view all the answers

What is the term used for the study of the harmful effects of drugs?

Pharmacovigilance Signup and view all the answers

How can doctors and patients report adverse drug reactions?

Through dedicated hotlines or reporting cards Signup and view all the answers

What type of studies gather safety data on drugs after they are introduced to the general patient population?

Post-marketing studies Signup and view all the answers

Which phase of clinical trials focuses on the safety and effectiveness of a drug in a larger patient population?

Phase IV Signup and view all the answers

What is the main purpose of a systematic review in relation to drugs?

To evaluate the existing evidence on the effectiveness and safety of a drug Signup and view all the answers

What is the email address of Dr. Louise Rabbitt?

<a href="mailto:louise.rabbitt@nuigalway.ie">louise.rabbitt@nuigalway.ie</a> Signup and view all the answers

What aspects of renal function are reduced at birth?

All aspects of renal function are reduced at birth. Signup and view all the answers

What is the most common type of drug-induced skin reaction?

Erythematous eruptions: skin rash. Signup and view all the answers

What are the symptoms of anaphylactic shock?

Hypotension, urticaria and erythema of face and neck. Signup and view all the answers

How should anaphylactic shock be treated?

Treat with adrenaline, chlorpheniramine, corticosteroids. Signup and view all the answers

What is the timing of Type I drug allergy?

Type I drug allergy is IgE mediated. Signup and view all the answers

Which group of individuals have reduced plasma binding?

Plasma binding is reduced in neonates. Signup and view all the answers

Which drug may cause conjugation deficiency in some neonates?

Chloramphenicol. Signup and view all the answers

Which drugs are absolutely contraindicated while breastfeeding?

A number of drugs are absolutely contraindicated while the mother is breastfeeding. Signup and view all the answers

What may be the first sign of drug hypersensitivity?

Pruritus. Signup and view all the answers

What causes vasodilation, increased capillary permeability, and tissue edema in anaphylactic shock?

Histamine. Signup and view all the answers

What is an adverse drug reaction (ADR)?

An ADR is a harmful or unwanted effect of a drug. Signup and view all the answers

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

Type A ADRs are generally predictable and dose-related, while Type B ADRs are often unpredictable and unrelated to the known pharmacological action of the drug. Signup and view all the answers

What is the therapeutic index?

The therapeutic index is a measure of the relative safety of a drug, calculated as the ratio of the lethal dose in 50% of the population (LD50) to the effective dose in 50% of the population (ED50). Signup and view all the answers

What is the Number Needed to Treat (NNT)?

The NNT is the number of patients who need to be treated in order to show the desired effect. Signup and view all the answers

What is the Number Needed to Harm (NNH)?

The NNH is the number of patients who need to be treated in order to experience a harmful effect. Signup and view all the answers

What is the most common adverse effect of statins?

Muscle pain. Signup and view all the answers

What is rhabdomyolysis?

Rhabdomyolysis is a rare side effect of statins, characterized by the breakdown of muscle tissue. Signup and view all the answers

What is the FDA classification for drugs in pregnancy?

Category A: Controlled studies in humans show no risk, Category B: No evidence of risk in humans, Category C: Risk cannot be ruled out, Category D: Positive risk of evidence, Category X: Contraindicated in pregnancy. Signup and view all the answers

What is the potential risk of taking sodium valproate during pregnancy?

Taking sodium valproate during pregnancy can result in foetal valproate syndrome (FVS), which can include cognitive difficulties, learning disabilities, autism, and physical abnormalities. Signup and view all the answers

What are the clinical management principles for drug therapy in pregnancy?

Use medicines if the expected benefits are greater than the expected risks, avoid first trimester use, use drugs that have been extensively used in pregnancy, use monotherapy where possible, use the minimum dose required to achieve the desired therapeutic target, and remember that absence of data does not imply safety. Signup and view all the answers