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 is off-label prescribing?
licensed but prescribed outwith the terms of marketing authorisation
what is specials prescribing?
special formulations of medicines made for clinical reasons when an existing formulation of an available licensed product is not suitable for patient = unlicensed
So, on these circumstances, when using an unlicensed/off-label medicine, the prescriber takes ____ ____________ for product
full responsibility
Examples:
A patient needs a medicine in a formulation that is not specified in an applicable licence:
= Liquid formulation of ethambutol for a patient with tuberculosis and with an enteral tube
The patient is a child and a medicine licensed only for adult patients would meet the needs of the child:
= Use of captopril in a neonate with hypertension
GMC guidance – what is their guidance for Unlicensed medicines?
“You should usually prescribe licensed medicines in accordance with the terms of their licence. However, you may prescribe unlicensed medicines where, on the basis of an assessment of the individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific needs of the patient.”
We expect you to carefully consider any treatment that you prescribe, and we expect you to be able to justify your decisions and actions when prescribing, administering and managing medicines regardless of whether they are licensed or unlicensed
what are the classifications of medications?
Prescription-only medicines (POM)
Pharmacy (P) medicines
General Sales List (GSL) medicines
Over the counter (OTC)
GSL and P medicines are collectively known as over-the-counter (OTC) or non-prescription medicines
general sale list medicaitons can be sold where?
Can be sold in registered pharmacies but also in other retail outlets.
E.g. Paracetamol (pack sizes 16 or 32)
Supermarkets, petrol stations. E.g.
how are Pharmacy (P) Only medicaitons sold?
Sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist
“P” medicines - not for public self-selection
Additional legal/professional considerations
The Pharmacists involved in the sale P medicines needs to check for any contra-indications or problems before the sale of the P medicine
Prescription Only Medicine:
Written by an appropriate ___________ before it can be sold or supplied
Some medicines - more than one category of ____________ (formulation, strength, quantity, indication or marketing authorisation).
Increasing number reclassified from ___ to _ – improved access to medicines with safety net of Pharmacists.
Written by an appropriate practitioner before it can be sold or supplied.
Some medicines - more than one category of classification (formulation, strength, quantity, indication or marketing authorisation).
Increasing number reclassified from POM to P – improved access to medicines with safety net of Pharmacists.
POM’s - what are some appropriate Practitioners?
doctor
dentist
supplementary prescriber
nurse independent prescriber
pharmacist independent prescriber
EEA and Swiss doctors and dentists (limited)
community practitioner nurses (limited)
optometrist independent prescribers (limited)
what are the General Prescription Requirements –
in Primary Care
what are the prescription requirements for contorlled drugs?
- Schedules 2, 3, and 4 limited to supply of up to 30 days’ treatment. (cant supply more than that)
- Specify formulation and strength.
- Specify dose
- Total amount in words and figures
For hospital discharges, even for electronic prescriptions, the prescriber must send a signed paper copy down to the pharmacy dispensary before the pharmacy can release the CD’s
Controlled drug – have to specific amount you want supplied in both words and figures
when writing doses, how should this be done?
Less than 1 g – write as mg, E.g. 500mg not 0.5g
Less than 1 mg – write as micrograms, E.g. 500 micrograms not 0.5mg
Note: Do not abbreviate micrograms and nanograms to mcg or ng or other symbols!
should you use latin?
no
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.
before prescribing anything, what needs to be done and checked?
Ensure good Medicine Reconciliation – accurate drug history taking (Know what medications the patient is taking at point of admission)
Decide/discuss with seniors if the medicine is to continue, change dose/ frequency, be with-held or stopped – record on medicine reconciliation form
Check the BNF if unsure of drug/dose/frequency
what are the general principles of prescribing?
All patients must have a PAR (“kardex”)
Use permanent black ink
Legible!
In BLOCK letters
Maximum of 2 PARs at a time
Use 24 hour clock
Don’t use dittos “ – can be confused with 11
Sign for each medicine AND PRINT NAME!
All routes of administration go onto this chart
Generic prescribing unless clinically significant differences in bioavailability between brands – e.g. beclometasone dipropionate inhalers, ciclosporin (immunosuppressants for organ transplant).
*Branded prescribing of insulins*
Keep all charts together
No bracketing meds together - causes misinterpretation when prescriptions are cancelled
All medicines, e.g. oral and injectables, should be written together
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”
how would you prescribe liquids?
Dose expressed as e.g. milligrams of the active ingredient, not mL as many formulations may exist
PARACETAMOL ORAL SUSPENSION:
- 120mg/5mL
- 250mg/5mL
- 500mg/5mL
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
