Clinical pharm - how to prescribe Flashcards
Who are the MHRA and what do they do?
MHRA - Medicines and Healthcare products Regulatory Agency
- Ensures that human medicines meet acceptable standards on safety, quality and efficacy.
- Ensures that the sometimes difficult balance between safety and effectiveness is achieved.
What is the role of the Scottsh Medicines Consortium (SMC)?
- Provide advice to NHS Scotland regarding all new licenced medicines, new formulations of existing medicines and new indications for established products.
- Review medicines that have received a licence from the MHRA or the EMA.
- Before a medicine can be routinely prescribed in Scotland it has to be accepted by SMC.
What does the SMC look at?
- How well the medicine works
- Which patients could benefit from i
- Whether is as good or better than medicines the NHS already uses to treat the particular condition
- Whether it is good value for money
What steps must occur for the licencing of meds?
- Clinical trial authorisation
- Product licence – marketing authorisation
What does the term ‘off label’ mean?
Prescribed out with the terms of marketing authorisation
What does the term unlicenced mean?
No marketing authorisation
When regarding drugs, what does ‘ specials’ mean?
Special formulations of medicines made for clinical reasons when an existing formulation of an available licensed product is not suitable for patient = unlicensed.
What is the GMC guidance on unlicenced medications?
“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.”
What are some examples of unlicenced use?
- ¨The patient needs a medicine in a formulation that is not specified in an applicable licence
- The patient is a child and a medicine licensed only for adult patients would meet the needs of the child
- A suitably licensed medicine that would meet the patient’s need is not available. This may arise where, for example, there is a temporary shortage in supply
How are drugs classified by the human medicines regulations 2012?
- Prescription only medicines (POM)
- Over the counter (OTC)
- Pharmacy medicines
- General sales list medicines: these can be sold for example in supermarkets etc
What are the rules regarding prescription only medicines?
- 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.
Give some examples of appropriate practitioners for POM?
- doctor
- dentist
- supplementary prescriber
- nurse independent prescriber
- pharmacist independent prescriber
What are the requirements on the prescription in primary care?
- Name and address of patient;
- Age of patient if under 12 years old;
- Details of drug name, formulation, dose, frequency and quantity to be dispensed;
- Signed in indelible ink by appropriate practitioner;
- Date on which is signed;
- Type of prescriber and address
What are some prescription requirements for prescribing controlled druggos?
- Schedules 2, 3, and 4 limited to supply of up to 30 days’ treatment.
- Specify formulation and strength.
- Specify dose
- Total amount in words and figures
Some general rules when writing prescriptions:
- Avoid decimal points…. eg 500mg not 0.5g
- If it is less than 1mg, write as micrograms
- Do not abbreviate micrograms and nanograms to mcg or ng or any other symbols
- Avoid the use of latin
