Clinical Pharmacology - The Use of Medicines Flashcards
who is the licensing of medicines done by?
Drug companies can apply for a licence to the EMEA (European medicines agency) which will result in a single marketing authorisation valid for the whole of the EU or for a licence in a specific country to the country’s licensing authority. In the UK that licensing authority is the MHRA.
MHRA - Medicines and Healthcare products Regulatory Agency:
what do they ensure?
Ensures that human medicines meet acceptable standards on safety, quality and efficacy
Ensures that the sometimes difficult balance between safety and effectiveness is achieved
A license from the MHRA is required before any medicine can be used to treat people in the UK. If a trial is to be conducted in the UK, companies and/or researchers must apply to the MHRA for permission to test drugs through ________ ______ – clinical trial authorisation. This will be granted once all the strict safety criteria have been met.
all the test results are then sent to the MHRA for detailed assessment. Once the MHRA is satisfied that the medicine works as it should, and that it is acceptably safe it is given a _____________ _________________ (formerly called a ‘product licence’).
The pharmaceutical company and any wholesalers must also be able to satisfy the MHRA that the __________, _________ and ______ of the medicine meet the required safety and quality standards. If satisfied the MHRA will issue a manufacturer’s and/or wholesale dealer’s licences.
clinical trials
‘marketing authorisation’
manufacture
distribution
supply
Licensing of medicines - what is needed for the product? and what is needed for the company?
Product:
- Clinical trial authorisation
- Product licence – marketing authorisation
Company:
- Company licences – manufacturing and wholesaler dealer licences
what is Pharmacovigilance?
The process involving detection, assessment, understanding and prevention of adverse drug reactions (ADRs)
Provides continual assessment of the risks and benefits of each drug resulting in the best drug therapy for the patient
After licensing, the MHRA continues to collect information. This information is about how well the drug works and about the side effects. So they continue to check the safety and effectiveness of the drug – Pharmacovigilance
children and the elderly are frequently excluded from trial protocols so there is limited safety data about these patients
The main aim of pharmacovigilance is to what?
optimise drug therapy and minimise morbidity, hospitalisation and mortality
what is the main method for post-marketing surveillance of ADRs in the UK?
Yellow Card scheme
MHRA Yellow card scheme:
The Scheme collects information on suspected problems or incidents involving what?
side effects (also known as adverse drug reactions or ADRs);
medical device adverse incidents;
defective medicines (those that are not of an acceptable quality);
counterfeit or fake medicines or medical devices;
safety concerns, e.g. for e-cigarettes or their refill containers (e-liquids)
MHRA – Yellow card scheme:
________ scheme
Both healthcare professionals and members of the public can file a _______ ____ ________
Voluntary
yellow card report
Healthcare professionals should report all suspected adverse reactions to what?
- new drug on market and black triangle drug
- children (Mostly off license)
- Serious ADRs for established drugs and vaccines, e.g. anaphylaxis, events that have led to significant harm, those which are fatal
- All suspected ADRs to new drugs and vaccines which are still under intensive surveillance (black triangle). This not only helps to identify unknown ADRs but can also confirm the safety of a new product.
- ADRs involving children.
- Report serious ADRs for established drugs and vaccines (e.g. fatal, life-threatening, disabling, incapacitating, or which result in or prolonged hospitalisation). They should be reported even if well recognised.
what information hould be included in a yellow card report?
When reporting ADRs using the yellow card scheme, there are four pieces of information that need to be included:
Side-effects; information about the person experiencing the side-effect; the name of the medicine; your name and full address.
4 pieces of information you have to include
a yellow card report can be done using different methods, what are they?
Using the forms in the picture, which are found at the end of a BNF
or you can report it online
or you cna download the yellow card app and do it on there
New vaccine :
vomiting following administration of new vaccine
A) Report
B) Dont report
A
New vaccine and still don’t have much information following their trials
Well-established drug and formulation:
Neutropenia following two weeks’ treatment. (already mentioned in BNF as a side-effect)
A) Report
B) Dont report
A
Although it is already a known drug and known side effect, it is a very serious adverse reaction and could lead to death and be fatal
Well-established drug and formulation:
Sleep disturbance following two weeks administration (already mentioned in BNF)
A) Report
B) Dont report
B
the authorisation does not limit what that medicine can be used for. If a prescriber wants to use an unlicensed or off-label or non-formulary medicine they can and there is guidance given locally
what is unlicensed prescribing?
no marketing authorisation
what are the General Prescription Requirements –
in Primary Care
Inpatient Prescription and Administration Record (“PAR”) - what are they?
The Prescription and Administration Record is available in three formats to accommodate patients on varying numbers of medicines and lengths of stay in hospital: 2-page; standard; long stay.
All Prescription and Administration Records must be filed in the patient’s medical records on completion/discharge whether or not any entries have been made.
Prescription and Administration Records belonging to patients transferred within NHS Grampian may continue to be used in the receiving ward/hospital if staff are confident and familiar with the system.
A new record must be used for readmitted patients regardless of the amount of time that has elapsed.
Prescribing combination medicines:
e. g. Co-amilofruse – 3 strengths available
- 2.5/20 – amiloride 2.5mg + furosemide 20mg
- 5/40 – amiloride 5mg + furosemide 40mg
- 10/80 – amiloride 10mg + furosemide 80mg
how is it done?
e.g. Medicine/form = CO-AMILOFRUSE 2.5/20
Dose = “ONE TABLET”
Circle times = 08:00
Prescribing combination inhalers:
e. g. Seretide = Fluticasone + Salmeterol
- 5 different dose combinations – “50”, “100”, “125”, “250”, “500” related to steroid component
- 2 different formulations – dry powder (Accuhaler) and aerosol (Evohaler)
how is it done?
e.g. Medicine/form = Seretide 500
Dose = One inhalation/ puff
Circle times = 08:00 and 22:00
Additional instructions – “Accuhaler”
what is wrong here?
These are not acceptable and can compromise patient safety.
Warfarin – 3/4mg – what does this mean? 3 or 4 or three quarters, and how does the nurse decide? Also warfarin should be prescribed on a separate warfarin prescription sheet, which should be referred to from the main drug kardex. It is prescribed on a daily basis in hospital.
Warfarin is an anticoagulant and the dose varies depending on the patients INR so often patients take different doses on different days and because of this warfarin should be given on a different prescription chart, this is in hospital, dose will vary and you have to prescribe it every day
Levothyroxine – 50 micrograms should be written out in full, no “mu” symbol.
Fludrocortisone – not signed, and dose is less than 1mg, so should be prescribed as 100 micrograms (NB. not 100mcg).
Amoxicillin – wrong dose, but otherwise written OK.
Paracetamol – route should not be written at “O” – write out as “oral”, and gram as “g” is fine
If not signed then its not legal and you cant give it
Frequency box has not been filled in
Amoxicillin – dose incorrect and normally given 8 hourly so 3 times a day
what is incorrect here?
Hydroxocobalamin – given every 3 months so prescriber should score through the days not required
Digoxin – 250mcg not acceptable write out as “micrograms”.
Gliclazide – this is diabetes medication so should be prescribed on diabetes chart – at the moment! There will be a change in the diabetes prescription sheet in the future, when oral diabetes meds MAY be prescribed on the main drug kardex, but until then, refer to the separate prescription sheet from the main kardex.
Senna – not discontinued properly, and note no times circled.
Picture shows how you should score of a medicine – score the name, score the day it has been stopped, and the blank space and always sign and date it when stopping a medication so if someone wants to know why a meidcaiton has been stopped you can find the person
what is incorrect here?
Paracetamol looks OK, but write gram as “g”.
Dihydrocodeine – no frequency or indication, and no maximum dose in 24 hours
Need to have a max dose
The BNF will tell you if not sure
Make sure to specify how often it can be given and what for
what is the problem here?
Minimum of 3 different HC professionals thought this was acceptable
Poor hand writing
No frequency
Write in block capital
Normal sailine
Some prescribers hand writing is very poor
Important of using block capitals
Other people need to be able to read it
