Clinical Pharmacology - The Use of Medicines

Question 1

who is the licensing of medicines done by?

Answer 1

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.

Question 2

MHRA - Medicines and Healthcare products Regulatory Agency:

what do they ensure?

Answer 2

Ensures that human medicines meet acceptable standards on safety, quality and efficacy

Ensures that the sometimes difficult balance between safety and effectiveness is achieved

Question 3

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.

Answer 3

clinical trials

‘marketing authorisation’

manufacture

distribution

supply

Question 4

Licensing of medicines - what is needed for the product? and what is needed for the company?

Answer 4

Product:

• Clinical trial authorisation
• Product licence – marketing authorisation

Company:

• Company licences – manufacturing and wholesaler dealer licences

Question 5

what is Pharmacovigilance?

Answer 5

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

Question 6

The main aim of pharmacovigilance is to what?

Answer 6

optimise drug therapy and minimise morbidity, hospitalisation and mortality

Question 7

what is the main method for post-marketing surveillance of ADRs in the UK?

Answer 7

Yellow Card scheme

Question 8

MHRA Yellow card scheme:

The Scheme collects information on suspected problems or incidents involving what?

Answer 8

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)

Question 9

MHRA – Yellow card scheme:

________ scheme

Both healthcare professionals and members of the public can file a _______ ____ ________

Answer 9

Voluntary

yellow card report

Question 10

Healthcare professionals should report all suspected adverse reactions to what?

Answer 10

1. new drug on market and black triangle drug
2. children (Mostly off license)
3. Serious ADRs for established drugs and vaccines, e.g. anaphylaxis, events that have led to significant harm, those which are fatal
4. 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.
5. ADRs involving children.
6. 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.

Question 11

what information hould be included in a yellow card report?

Answer 11

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

Question 12

a yellow card report can be done using different methods, what are they?

Answer 12

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

Question 13

New vaccine :
vomiting following administration of new vaccine

A) Report

B) Dont report

Answer 13

A

New vaccine and still don’t have much information following their trials

Question 14

Well-established drug and formulation:
Neutropenia following two weeks’ treatment. (already mentioned in BNF as a side-effect)

A) Report

B) Dont report

Answer 14

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

Question 15

Well-established drug and formulation:
Sleep disturbance following two weeks administration (already mentioned in BNF)

A) Report

B) Dont report

Answer 15

B

Question 16

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?

Answer 16

no marketing authorisation

Question 17

what is off-label prescribing?

Answer 17

licensed but prescribed outwith the terms of marketing authorisation

Question 18

what is specials prescribing?

Answer 18

special formulations of medicines made for clinical reasons when an existing formulation of an available licensed product is not suitable for patient = unlicensed

Question 19

So, on these circumstances, when using an unlicensed/off-label medicine, the prescriber takes ____ ____________ for product

Answer 19

full responsibility

Question 20

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

Answer 20

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

Question 21

GMC guidance – what is their guidance for Unlicensed medicines?

Answer 21

“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

Question 22

what are the classifications of medications?

Answer 22

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

Question 23

general sale list medicaitons can be sold where?

Answer 23

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.

Question 24

how are Pharmacy (P) Only medicaitons sold?

Answer 24

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

Question 25

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.

Answer 25

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.

Question 26

POM’s - what are some appropriate Practitioners?

Answer 26

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)

Question 27

what are the General Prescription Requirements – in Primary Care

Answer 27

Question 28

what are the prescription requirements for contorlled drugs?

Answer 28

* 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

Question 29

when writing doses, how should this be done?

Answer 29

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!

Question 30

should you use latin?

Answer 30

no

Question 31

Inpatient Prescription and Administration Record (“PAR”) - what are they?

Answer 31

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.

Question 32

before prescribing anything, what needs to be done and checked?

Answer 32

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

Question 33

what are the general principles of prescribing?

Answer 33

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

Question 34

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?

Answer 34

e.g. Medicine/form = CO-AMILOFRUSE 2.5/20 Dose = “ONE TABLET” Circle times = 08:00

Question 35

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?

Answer 35

e.g. Medicine/form = Seretide 500 Dose = One inhalation/ puff Circle times = 08:00 and 22:00 Additional instructions – “Accuhaler”

Question 36

how would you prescribe liquids?

Answer 36

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

Question 37

what is wrong here?

Answer 37

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

Question 38

what is incorrect here?

Answer 38

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

Question 39

what is incorrect here?

Answer 39

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

Question 40

what is the problem here?

Answer 40

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