Adverse reactions and yellow cards Flashcards
What is a side effect ?
Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is related to the pharmacological properties of the drug.
E.g. diarrhoea after antibiotic or doxazosin for prostatism lowering BP
What is an adverse drug reaction?
“An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended, where a causal relationship between the medicinal product and adverse event is either known or strongly suspected.”
What factors can influence the chance of a patient experiencing an ADR ?
- Impaired renal function (increased risk toxicity)
- Impaired liver function – Lack of metabolism
- Extremes of age
- Multiple drug therapy
- Gender
- Disease states
- Ethnicity
What is a Type A drug reaction? Give an example
- 80% of all ADRs
- an exaggeration of a drug’s normal pharmacological actions
- dose-dependent
- readily reversible on reducing the dose or stopping drug
- Often recognised before marketing
- Concomitant use of anti-hypertensives leading to hypotension
E.g. ACE Inhibitor and diuretic for hypertension - NSAIDs and opioid analgesia for pain control
Increased potency when used together - Bradycardia with beta-adrenergic blockers (BB)
- Headache with glyceryl trinitrate (GTN)
What is a type B reaction ?
- unusual and can’t be predicted from the drug’s pharmacology
- Immunological or pharmaco-genetic mechanisms
- Often unrelated to dose
- More serious
- Comparatively rare
- Not often seen prior to marketing
What is a type C reaction ?
- Result from long term drug use
- Usually associated with treatment for chronic disease
- Examples
- Hypothalamic-pituitary-adrenal axis suppression with long term corticosteroid use
- Tolerance to nicotine
What is a type D reaction ?
- Can occur many years after therapy has stopped
- Example
- Stilboestrol and vaginal cancer
What is a type E reaction ?
- Occur as a result of abrupt cessation of some therapies
- Examples
- Examples
- Abrupt withdrawal of systemic corticosteroids can lead to acute adrenal insufficiency, hypotension or death.
- Withdrawal effects when stopping some anti-depressants or Alcohol
What happens if someone has a ADR?
- Admit if serious or life threatening.
- Seek advice from your GP/Consultant & Pharmacist as to likelihood & best management.
- Report what’s happened on the yellow card system
What is pharmacovigiliance ?
-The detection, assessment, understanding and prevention of adverse effects of drugs.
- monitoring the use of medicines to identify adverse effects .
- assessing the risks and benefits of medicines in order to determine saftey of drugs.
- providing information to healthcare professionals and patients to optimise safe and effective use of medicines.
When do you use the yellow card scheme ?
Who regulates it ?
What process is it important for ?
- for all suspected severe, significant or harmful or minor ADRs
- In Black Triangle products
- Established products.
- Serious ADRs include Fatal; Life threatening; Disabling, Incapacitating; ADRs resulting in or prolonging hospitalisation
- All Paediatric reactions
- The Medicines and Healthcare products Regulatory Agency (MHRA) are responsible for monitoring the safety of all medicines in the UK
- Yellow Card Scheme is an important source of information for them.
- It supports the process of pharmacovigilance.
What is a black triangle drug?
Any drug or vaccine which is:
* a new active substance or a biosimilar medicine
* a new combination of medicines or active substances
* a new route of administration
* a new drug-delivery system
* an established medicine which is to be used in a new patient population
What is an allergy ?
What is a type F ADR ?
Effect Failure
What are the 6 types of ADR ? ABCDEF
A- Agumented
B - Bizzare
C- Chronic
D - Delayed
E - End of use effects
F - Effect Failure
