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Specialities > Clinical Pharmacology: The Use of Medicines > Flashcards

Clinical Pharmacology: The Use of Medicines Flashcards

1
Q

What is the name of the UK regulatory body?

A

MHRA

Medicines and Healthcare Products Regulatory Agency

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2
Q

What is the role of the MHRA?

A
  • Ensures that human medicines meet acceptable standards on safety, quality and efficacy.
  • Ensures that the sometimes difficult balance between safety and effectiveness is achieved.
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3
Q

What authorisations must take place before a product hits the marker?

A
  • Clinical trial authorisation for the product
  • Product license known as marketing authorisation
  • Company license, marketing and wholesaler dealer license
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4
Q

What are market authorisations?

A
  • Licenses granted for periods up to 5 years
  • They ensure the medicine meets the standards of safety, quality and efficacy
  • Variations to marketing authorisations are common
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5
Q

What doe the Scottish Medicines Consortium do?

A
  • 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.
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6
Q

What do the SMA look at when reviewing a new medicine?

A
  • How well the medicine works
  • Which patients could benefit from it
  • Whether is as good or better than medicines the NHS already uses to treat the particular condition
  • Whether it is good value for money
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7
Q

Off-label

A

Prescribed out with the terms of marketing authorisation

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8
Q

Unlicensed

A

No marketing authorisation

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9
Q

Specials

A

Special formulations of medicines made for clinical reasons when an existing formulation of an available licensed product is not suitable for a patient

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10
Q

What is the GMC guidance on the use of unlicensed medications?

A

“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.”

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11
Q

When using unlicensed medications what does the GMC expect you to do?

A
  • Carefully consider any treatment that you prescribe
  • Be able to justify your decisions and actions when prescribing, administering and managing medicines regardless of whether they are licensed or unlicensed.
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12
Q

What are the 3 classes of medications as described by the Human Medicines Regulations 2012?

A
  • Prescription-only medicines (POM)
  • Pharmacy (P) medicines (OTC)
  • General sales list (GSL) medicines (OTC)
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13
Q

General sale list medicines

A

Can be sold in registered pharmacies but also in other retail outlets
-e.g. paracetamol

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14
Q

Pharmacy (P) only medicines

A

Sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist

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15
Q

Prescription only medicine

A
  • 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.
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16
Q

Who can write a prescription for POM?

A
  • Doctor
  • Dentist
  • Supplementary prescriber
  • Nurse independent prescriber
  • Pharmacist independent prescriber
  • EEA and Swiss doctors (limited
  • Community practitioner nurses (limited)
  • Optometrist independent prescribers (limited)
17
Q

What are the general requirements for a prescription written in primary care?

A
  • 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
18
Q

How are controlled drugs prescribed?

A

-Misuse of Drugs Regulations 2001
-Separates drugs into 5 schedules based on who can prescribe them
Specifies import, export, production, supply, possession, prescribing, record keeping activities

19
Q

What are the requirements for a prescription of a controlled drug in particular?

A
  • 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
20
Q

How should doses be written in prescriptions?

A

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!

21
Q

What does a.c. mean?

A

Ante cibum (before food)

22
Q

What does b.d. mean?

A

Bis die (twice daily)

23
Q

What does o.d. mean?

A

Omni die (every day)

24
Q

What does o.m. mean?

A

Omni mane (every morning)

25
Q

What does o.n. mean?

A

Omni nocte (every night)

26
Q

What does p.c. mean?

A

Post cibum (after food)

27
Q

What does p.r.n mean?

A

Pro re nata (when required)

28
Q

What does q.d.s mean?

A

Quarter die sumendum (to be 4 times daily)

29
Q

What does q.q.h. mean?

A

Quarta quaque hora (every 4 hours)

30
Q

What does stat. mean?

A

Immediately

31
Q

What does t.d.s. mean?

A

Ter die sumendum (to be taken 3 times daily)

32
Q

What does t.i.d. mean?

A

Ter in die (3 times daily

33
Q

Where can you look for help with prescribing?

A
  • BNF

- NHS Grampian Joint Formulary

34
Q

What evidence based guidelines are there in the UK?

A
  • SIGN

- NICE

35
Q

What is a ‘PAR’?

A

Inpatient prescription administration record

36
Q

What should you do before prescribing anything?

A
  • Ensure good Medicine Reconciliation – accurate drug history taking.
  • 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.
37
Q

What are the general principles when prescribing?

A
  • 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 on chart
  • Generic prescribing unless clinically significant difference in bioavailability
  • BRANDED PRESCRIBING OF INSULIN
  • Keep all charts together
38
Q

How are doses of liquids prescribed?

A

Dose expressed as milligrams of the active ingredient not mL as many formulations may exist
e.g. 120mg/5mL

39
Q

Give examples of other prescription sheets you may come across in the hospital.

A
  • Diabetes Prescription sheet
  • Warfarin Chart
  • Fluid additive prescription sheet
  • Variable rate IV Infusion
  • Syringe volumetric Pump Record
  • Insulin infusion prescription sheet
  • Subcutaneous syringe pump recording chart

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