Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

4117 - h > ADRs and YCC > Flashcards

ADRs and YCC Flashcards

1
Q

What is the MHRA?

A

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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is the Yellow Card Scheme?

A

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.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What is an ADR?

A

A response to a medicinal product which is noxious and unintended

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

How may ADRs arise?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Why are ADRs bad?

A
  • 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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Type A Reaction

A

“Augmented”

  • predictable
  • related to pharmacology and dose of the drug
  • usually not severe

e.g. bradycardia with beta blockers and constipation with opioids

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Type B Reaction

A

“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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Type C Reaction

A

“Chronic Treatment Effects”
- tend to happen when the drug has been taking for a long period of time

e.g. osteoporosis with steroids

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Type D Reaction

A

“Delayed Effects”
- tend to happen months / years after a drug has been taken

e.g. drug induced cancers

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Type E Reaction

A

“End of treatment effects”
- tend to happen months / years after a drug has been taken

e.g. withdrawal syndromes with opiates

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

Type F Reaction

A

“Failure of therapy”
- unexpected failure of therapy as a result of a drug interaction

e.g. COC and rifampicin

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Type G Reaction

A

“Genetic or Genomic”
- cause irreversible genetic damage (carcinogens, teratogens)

e.g. when a medication is using during pregnancy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

Factors to consider whether an ADR has occurred..

A

Dose
Time
Susceptibility

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Dose at which ADR can occur

A

What is the dose?

  • below therapeutic dose
  • in the therapeutic dose range
  • at high doses (overdoses)
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

Time of onset

A

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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Susceptibility

A

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
17
Q

Why are younger children a high risk population for ADRs?

A
  • dose needs tailoring to age or weight

- rely on adults for medication administration - not able to identify potential error

18
Q

Why are older adults a high risk population for ADRs?

A
  • 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
19
Q

What may indicate an ADR?

A
  • 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
20
Q

How can an ADR be avoided?

A
  • 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
21
Q

What is Pharmacovigilance?

A

The study of the safety of medicines when they come onto the market. Relies on people volunteering info and reporting ADRs (YCC)

22
Q

What does Pharmacovigilance involve?

A

□ 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

23
Q

Why report ADRs?

A
  • patient safety
  • to detect rare adverse effects
  • allows continual safety monitoring of both old and new drugs
24
Q

Why are new drugs more susceptible to ADRs?

A
  • 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)
25
Q

What should I report?

A

Report all suspected ADRs for new drugs (▼)

26
Q

What is the black triangle assigned to?

A

The black triangle indicates a medicine is being intensively monitored. It is assigned to:

  • new drugs
  • new combination of drugs
  • novel routes of delivery systems for drugs
  • significant new indications for drugs
27
Q

For all other medications, report all serious ADRs. What is considered a serious ADR?

A
  • fatal
  • life threatening
  • disabling or incapacitating
  • prolonged hospitalisation
  • congenital abnormalities
  • medically significant
28
Q

What are MHRA particularly interested in suspected ADRs?

A
  • in children
  • elderly
  • biological meds
  • vaccines
  • delayed drug effects / interactions
  • complimentary therapies e.g. herbal medicines
  • encourage to report defective, counterfeit or fake medicines via the scheme
29
Q

What must appear on a Yellow Card Report?

A
  • scenario and symptoms
  • identifier (patient details)
  • medication details
30
Q

Journey of a Yellow Card

A

1) Submission of yellow card to MHRA
2) Uploaded on MHRA database, goes through quality assurance process
3) Acknowledgement is sent to reporter and to request any additional info if required
4) Committed from the database and made available for two different reasons: for any enquiries they receive and available on ADR summaries for different drugs and risk assessment / signal generation

31
Q

What is signal detection and the importance?

A

“A signal is reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending on the seriousness of the event and the quality of the information.”

  • importance: as not all signals will be true, so have to assess the signals before making any definite conclusions
32
Q

Signal detection process

A

1) MHRA is scanned regularly to detect any new signals
2) Discussed at a signal detection meeting with MHRA team, how severe symptoms are, any identifiable risk factors and prioritise how quickly action needs to be taken
3) Gather information - go back to reporter to find any additional info / discuss with manufacturer to see if they have any insight / received any direct reports
4) Team discusses all information and come up with conclusion
5) Action

33
Q

Actions as a result of YCC..

A
  • no action, investigate, expert advice or wait for further evidence, continue to monitor
  • change in legal status (P to POM)
  • restrict pack size e.g. paracetamol
  • update PIL and prescribing info to include new side effects
  • restrict indications, reduce dose or introduce new warnings
  • rarely - withdrawn from market (risk outweighs benefit)

4117 - h (3 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions