Week 28 - adverse drug reactions and yellow card scheme Flashcards
MHRA
UK Government body responsible for medicines safety and licensing
YCC Wales (yellow card centre wales)
Funded by MHRA to promote
understanding, reporting and research of side effects to medicines
What is an adverse drug reaction?
-An ADR is a response to a medicinal product which is noxious and unintended
-ADRs may arise from the use of a product within or outside the terms of the marketing
authorisation, e.g. from off-label use, medication errors, overdose, misuse, or abuse
Adverse drug reactions vs. side effects?
->ADR – unpleasant or unwanted
->Side effect – may be beneficial as well as harmful
Why are ADRs important?
-Financial burden on NHS £466m
-Major clinical problem –
increase morbidity and mortality
-ADRs are related to 6.5%
hospital admissions in adults, and 2.1% in children
-6.7% hospitalised patients suffer ‘serious’ ADRs
-0.15% of hospital patients suffer fatal ADRs (= 5700 deaths per year)
-ADRs are 4th leading cause of death in the USA
ADRs can also..
-Adversely affect patient compliance
-Reduce available choice of drug treatment
-Reduce potential efficacy of drug treatment
-Reduce quality of life
-Cause diagnostic confusion
-Reduce a patient’s confidence in their healthcare professional
Classification of ADRs
Common ADRs – Approx. 80% of ADRs:
-Type A (‘Augmented’)
Predictable, dose related
Usually not severe
Uncommon but often well recognised ADRs:
-Type B (‘Bizarre’)
Unpredictable, not dose related
May be very severe / fatal
With new drugs ADRs not well recognised
Classification of ADRs
-Type C (Chronic treatment effects)
-Type D (Delayed effects)
-Type E (End of treatment effects)
-Type F (Failure of therapy) -> unexpected failure of therapy due to drug interaction
-Type G (Genetic or Genomic) -> irreversible genetic damage
Important factors in ADRs:
DoTS
3 factors: Dose, Time, Susceptibility
Dose
Dose at which the ADR can occur:
-At doses below therapeutic doses
-In the therapeutic dose range
-At high doses
Time
Time of onset can be characteristic:
-With the first or second dose
-Early, or after a time, or with long-term treatment
-On stopping treatment (withdrawal)
-Delayed
Susceptibility
Susceptibility of patients can be defined:
-Genetics
-Age
-Sex
-Physiological state
-Exogenous drugs or foods
-Disease
High risk populations
Younger children:
-Dose needs tailoring to age/ weight
-Not able to identify potential error
Older adults:
-Co-morbidities
-Polypharmacy
-Diminished reserves
-Reduced renal or hepatic function
Top 10 drugs/drug groups associated with ADRs
-NSAIDs
-Clopidogrel
-Diuretics
-Antidepressants
-Prednisolone
-Warfarin
-ACE inhibitors
-Opioids
-Beta-blockers
-Digoxin
What else may indicate an ADR?
-Abnormal clinical measurements while on drug therapy
-Abnormal laboratory results while on drug therapy
-New therapy started which could be used to treat ADR
-Reducing the dose or stopping the suspected drug alleviates
the symptoms -> (if drug reintroduced and symptoms recur - the drug is probably
responsible)
-Listen to patients own concerns
Are ADRs avoidable?
->70% ADRs are potentially avoidable
-Avoid unnecessary drug use
-Avoid/reduce drug interactions -> check the patient’s drug history before prescribing
-Consider risk factors for ADRs
-Avoid new (black triangle) drugs
-Patient counselling
-Monitor treatment & optimise dose
-Consider prophylactic therapy where appropriate
Pharmacovigilance
-The science of monitoring the safety of medicines, also known as drug safety - It involves collecting and analyzing data to detect and prevent adverse effects
Why report ADRs?
-Important role in patient
safety
-To detect rare adverse effects
-Allows continual safety monitoring of drugs – old & new
-New drugs - lack of experience on adverse effects
->Exposure in about 3-4,000 people only
->Short duration
->Unlikely to detect ADRs during clinical trials so is important to report them when used on market
->Less frequent than 1/4000
->With long latency
->Lack of experience in special patient groups ->elderly, children, pregnancy, multiple disease, polypharmacy
The Yellow Card Scheme
-Introduced in 1964 after the thalidomide tragedy
-Receives spontaneous reports of suspected adverse drug reactions
-Acts as an early warning system to identify ADRs and risk factors
-Over 1 million confidential reports received in UK
Who can report?
Anyone
What should I report?
-Report all suspected ADRs for new drugs (marked ▼) – even if not serious
-The black triangle ▼indicates a medicine is being intensively monitored
-It is assigned to:
-New drugs
-New combinations of drugs
-Novel routes or delivery systems for drugs
-Significant new indications for drugs
What should I report?
->Report all serious suspected adverse drug reactions to established drugs (adults and children):
-Fatal
-Life-threatening
-Disabling or incapacitating
-Result in or prolong hospitalisation
-Congenital abnormalities
-Medically significant
MHRA are particularly interested in suspected ADRs:
-In children
-In patients > 65 years
-Biological medicines
-Vaccines
-Delayed drug effects/ interactions
-Complimentary therapies e.g. herbal medicines
-Defective, counterfeit or fake medicines
How can I report?
By filling in a paper copy (“yellow card”) and returning to the FREEPOST address
-Found in the BNF
-Downloadable from
www.mhra.gov.uk/yellowcard
-Yellow Card information leaflets
Information to include in report:
->Adverse reactions to:
-A medicine
-Vaccine
-Herbal
-Homeopathic remedy
->Problems involving a medical device
->Adverse effect or safety concern for an e-cigarette
->Defective or falsified (fake) product
Looking for signals
“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”
Signal detection -> improved patient safety
- Signal detection
- Signal detection
meeting - Data gathering
- Signal evaluation
- Action
Actions
-No action, investigate, expert advice, or wait for further evidence, continue to monitor
-Change in legal status (P to POM)
-Restrict pack size
-Update patient leaflets and prescribing information to include new side effects
-Restrict indications, reduce dose or introduce new warnings for use
-Rarely - withdrawn from the market
Letting people know
-Central Alerting System
-Drug Safety Update (monthly)
-Dear Healthcare Professional letters (ad hoc)
-Updated product information (PIL and SPC)
-BNF safety warnings (CSM warnings)
-Targeted information for patients and working with stakeholders
-Social Media
-MHRA website
-Press releases/ campaigns
-iDAPs
