ADRs and YCC Flashcards
(33 cards)
What is the MHRA?
MHRA (Medicines and Health Care Products Regulatory Agency): UK Government body responsible for medicines safety and licensing. Regulates medicines and medical devices, ensuring they work and are acceptably safe, focuses on core activities of product licensing, inspection and enforcement, and pharmacovigilance.
What is the Yellow Card Scheme?
Funded by MHRA to promote understanding of ADRs, reporting and research of side effects to medicine. Acts as an early warning system to identify ADRs.
What is an ADR?
A response to a medicinal product which is noxious and unintended
How may ADRs arise?
ADRs may arise from the use of a product within or outside the terms of marketing authorisation, e.g. from off-label use, medication errors, misuse or abuse
Why are ADRs bad?
- reduce patient compliance
- reduce availability choice of drug (second line may have to be used instead of first)
- reduce potential efficacy of drug treatment
- reduce quality of life (ADR can be more bothersome than the disease itself)
- cause diagnostic confusion (is the ADR due to the drug or disease)
- reduce a patient’s confidence in their HC professional
- increase morbidity and mortality
- financial burden on NHS
Type A Reaction
“Augmented”
- predictable
- related to pharmacology and dose of the drug
- usually not severe
e.g. bradycardia with beta blockers and constipation with opioids
Type B Reaction
“Bizarre”
- unpredictable
- not obviously related to pharmacology of the drug or dose related
- uncommon but some individuals may be more susceptible to developing them
- may be severe / fatal
e.g. pts who have hypersensitivity are more likely to develop anaphylaxis with penicillins
Type C Reaction
“Chronic Treatment Effects”
- tend to happen when the drug has been taking for a long period of time
e.g. osteoporosis with steroids
Type D Reaction
“Delayed Effects”
- tend to happen months / years after a drug has been taken
e.g. drug induced cancers
Type E Reaction
“End of treatment effects”
- tend to happen months / years after a drug has been taken
e.g. withdrawal syndromes with opiates
Type F Reaction
“Failure of therapy”
- unexpected failure of therapy as a result of a drug interaction
e.g. COC and rifampicin
Type G Reaction
“Genetic or Genomic”
- cause irreversible genetic damage (carcinogens, teratogens)
e.g. when a medication is using during pregnancy
Factors to consider whether an ADR has occurred..
Dose
Time
Susceptibility
Dose at which ADR can occur
What is the dose?
- below therapeutic dose
- in the therapeutic dose range
- at high doses (overdoses)
Time of onset
Need to consider when the ADR began in relation to when the medication was started
- with the first or second dose
- early or after a time, or with long term treatment
- stopping treatment (withdrawal)
- delayed
Susceptibility
Consider if there is anything about the patient which means they are more likely to develop an ADR:
- Genetics
- Age
- Sex
- Physiological State
- Exogenous drugs or foods
- Disease
Why are younger children a high risk population for ADRs?
- dose needs tailoring to age or weight
- rely on adults for medication administration - not able to identify potential error
Why are older adults a high risk population for ADRs?
- co-morbidities
- polypharmacy, risk of drug interactions
- diminished reserves
- reduced renal or hepatic function = drug accumulation
- elderly brains are more susceptible to drugs which can cause confusion and tremor
What may indicate an ADR?
- abnormal clinical measurements while on drug
- abnormal laboratory results on drug
- new therapy started which could be used to treat ADR
- listen to patient own concerns
- reducing dose or stopping the suspected drug alleviates the symptoms
How can an ADR be avoided?
- avoid unnecessary drug use
- avoid / reduce drug interactions
- risk factors e.g. age extremes
- avoid new drugs (lack of experience)
- patient counselling
- monitor treatment & optimise dose
- consider prophylactic therapy e.g. prescribe PPI if long term NSAIDs
What is Pharmacovigilance?
The study of the safety of medicines when they come onto the market. Relies on people volunteering info and reporting ADRs (YCC)
What does Pharmacovigilance involve?
□ Monitoring use of medicines in everyday practice to identify previously unrecognised ADRs or changes in their patterns
□ Assessing the risks and benefits of medicines
□ Providing information to optimise safe and effective use of medicines
□ Monitoring the impact of any action taken
Why report ADRs?
- patient safety
- to detect rare adverse effects
- allows continual safety monitoring of both old and new drugs
Why are new drugs more susceptible to ADRs?
- lack of experience on adverse effects
- short duration of time
- some drugs have a long latency (long time to appear)
- exposure in a 3-4,000 people only
- lack of experience in special patient groups as they tend to be excluded from clinical trials (elderly, children, pregnancy)
