the professional Flashcards
what is an ADR
a response to a medicinal product which is noxious and unintended
who can get an ADR
anyone who takes a drug
are ADRs common
yes
major cause of hospital admissions
affect quality of life
cost to the MHS in hinders of millions
many are preventable
classifications of ADRs
rawlins and thompson
DoTS
what is rawlins and thompson
type A - dose related
common predictable
pharmacology related
low mortality
digoxin toxicity
constipation from morphine
type B - not dose related
uncommon and unpredictable
not related to pharmacology
high mortality
penicillin hypersensitivity
malignant
hyperthermia
ACE inhibitor induced angioedema
life threatening
rare
rawlins and thompson types C,F,E and F
C= long term
D = delayed
E = end of use
F = failure if treatment
what does DoTS stand for
Dose
Time
susceptibility
What are some issues with adverse drug reactions?
not enough information from clinical trials
Increased polypharmacy and comorbidities
Numbers of patients admitted to hospital with ADRs is increasing
what is meant by susceptibility in DoTS
genetic factors
Age
Sex
Physiology altered
Exogenous factors
Disease
what is pharmacovigilance?
New drug clinical trial to license drug
Product as license with a number of known side effects
Black triangle assessed
what are some disadvantages of pharmacovigilance?
New unknown side-effects
Can be difficult to link to the drug
Sharing of information can be slow
Lots of harm can occur
Why should we report adverse drug reactions?
important for patient safety
Continuous monitoring of old and new drugs
Provide data in special patient groups
What does the yellow card scheme collect reports of
suspect of problems or incidents involving side-effects/adverse drug reactions
medical device adverse incidents
Defence medicines
Counterfeit or fake medicines or medicinal devices
how to complete a yellow card
Online
Paper back of BNF
app
what do you report on a yellow card
serious reactions to established drugs
even if well recognised
report suspicion not proven casualty
What is a serious reaction?
allergy reaction which results in or prolongs hospitalisation
Fatal
Life-threatening
Disable
Incapacitating
Cause congenital abnormalities
Medically significant
What are black triangle drugs
they mean intensive monitoring
Contains a new active substance
Is a biological medicine
New indications
Has conditional approval
Company been asked for more data
Do you report a black triangle drug?
Yes
What should you do if you are unsure whether to report
You should report
Who can report?
doctors
Dentists
Hospital pharmacist
Community pharmacist
Nurse
Midwife
Health visitors
Pilot patient scheme
patients
Pharmaceutical companies
what is the aim of stockleys drug interactions
To provide concise accurate and clinically relevant information to healthcare professionals
how do you deal with household returns?
Disposal of medicines
advise patience to return, unwonted medication for safe disposal
Reduces environmental risk
what is the NWFD
Disposal of medicines
non-waste framework directive
There are some exemptions
One exemption in the law allows the temporary storage at a collection point, but the following conditions apply
Waste of different types should not be mixed
You can’t receive payment for collecting the waste
Can’t collect waste as your main business activity
This is an exemption
What did the environmental protection act 1990, introduce as a duty of care
Disposal of medicines
applies to all persons involved
Import
Produce
Carry
Keep
treat
Dispose of controlled waste
Ensures Transferred to authorised personnel
ensures records and audits
Make sure it is stored correctly
Make sure it’s a segregated/separated/not mixed
what does the hazardous waste regulations 2005 State?
Disposal of medicines
keep hazardous, waste and nonhazardous waste, separate
Cytotoxic and cytostatic waste, separate
tell me about emergency supply at the request of the prescriber
Emergency Supply - at the request of prescriber
• Relevant prescriber
GP, Dentist, NIP, PIP, Optometrist IP
• Emergency
- Genuine reason why a prescription cannot be provided immediately
• Prescription within 72 hours
• Directions
- In accordance with direction from prescriber
• Controlled drugs
Exemptions - Phenobarbitol for epilepsy
• Records
Must make record in POM register on day of supply or next day
ー
3 x Dates, 2 N+A, , details of medications supplied
• Labelling
Usual requirements
tell me about emergency supply at the request of the patient
Emergency Supply - request of patient
• Interview
- HMR regulation v RPS
- Professional judgement - carers/children
- Immediate need?
• Previous treatment and dose
• Controlled drugs
- Exemptions as previous
• Length of treatment
- If CD: Maximum 5 days
- If POM: Maximum 30 days
- 1 OP - insulin/creams/inhalers/contraception
• Records
- 1 x Date, 1 x N+A, details of medications supplied, Reason
