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CHAPTER5 Medicines andprescribing
Writingprescriptions
• Legal responsibility for writing prescriptions lies with the person who
signs the prescription form.
British National Formulary (BNF) Contains a list of all drugs that a
registered medical practitioner can prescribe on NHS prescription. It does not
include homeopathic drugs, nor aids and appliances. There is a separate but
linked BNF concerned with prescribing for children. Dentists and nurses have
their own limited formulary. Further information:M https:// bnf.nice.org.uk/
Claiming for items dispensed by a non- dispensing GP All GPs
may claim payment for dispensing certain items that are supplied and personally administered by the GP or practice sta on behalf of the GP. Claims
are made on form FP10 (GP10) to the NHS Business Services Authority and
must state the name of the patient, item dispensed, and manufacturer of
the item. Claimable items include:
• Vaccines • Sutures • Contraceptive caps/ diaphragms
• Anaesthetics • Skin closing strips
• Injections • IUCDs
• Pessaries that are appliances (e.g. ring pessary)
0 Dierent arrangements apply for high- volume vaccines, e.g. inuenza.
Prescription writing NHS prescriptions are written on form FP10
(GP10 in Scotland). They should be legible and in indelible ink. They are
valid for 13wk from the date written on them. Include:
• Patient details— full name, address, and age/ date of birth if <12y
• Date
• Full name of the drug (not abbreviated), with quantity to be supplied
and dose interval (avoid the use of decimal points, e.g. for quantities
<1g, write in mg). If you want a description of the drug included on the
label, then write it on the prescription (e.g. ‘for asthma’)
• Deletion of any unused space (e.g. by striking through)
• Name and address of the prescriber
• Must be signed in ink by an authorized prescriber
0 Special rules apply for controlled drugs— E p. 125.
Computer- issued prescriptions (form FP10(C)) Should contain the
same information as their handwritten equivalents.
Electronic Prescription Service (EPS) Removes the need for
paper prescriptions. The prescription is generated by the prescriber in the
same way as a computer- issued prescription but the prescriber’s electronic
signature is added (using the user’s NHS Smartcard and password) and the
prescription is sent electronically directly to a pharmacy of the patient’s
choice, where it is dispensed in the normal way.
Prescribing forpeople goingabroad
• Do not provide NHS prescriptions for conditions that might arise while
a patient is away, e.g. traveller’s diarrhoea
• Diagnostic reagents
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WRITINGPRESCRIPTIONS
• Prescribing interval for repeat medication should be related to the next
time that medication would normally be reviewed (generally <13wk).
The prescriber retains medicolegal responsibility for the duration of
the prescription. If a prescription is issued for the patient’s stay abroad
(e.g. if repeat supplies cannot be obtained at the destination or narrow
therapeutic index), warn the patient to consult a doctor for regular
monitoring or for unforeseen medical problems while away
Non- NHS prescriptions The same rules apply to the writing of pri-
vate prescriptions as NHS prescriptions but private prescriptions should not
be written on FP10 forms. Hand- written private prescriptions are usually
written on headed notepaper. Computer- generated private prescriptions
are often printed on the counterfoil of the FP10 form. Electronically transmitted prescriptions can be electronically marked as ‘private prescriptions’.
Private prescriptions for controlled drugs Controlled drugs in Schedules 2 and
3 (including temazepam) presented for dispensing in the community (but
not in hospitals) must be written on specially designated forms available
from local PCOs. These forms must include the prescriber’s unique 6- digit
identication number issued for their private prescribing activity.
Dentists (BNF— Appendix DPF) Can prescribe medication for dental
conditions to their NHS patients on form FP10(D) (GP14 in Scotland).
Other healthcare practitioners with prescribing rights Awide
range of healthcare practitioners can undertake supplementary training to
become independent prescribers, including nurses, paramedics, community
pharmacists, optometrists, physiotherapists, and podiatrists.
Emergency supply of medicines by pharmacists In emergency
situations any pharmacist can dispense prescription- only medicines (POM).
In general ≤5d supply can be dispensed.
Patient information All newly licensed/ relicensed medicines dis-
pensed in an original pack must be accompanied by a patient information
leaet (PiL). Even though most drugs are now supplied with PiLs, prescribers
should make patients aware of ‘substantial or special risks’. Information regarded as important by patients includes:name of drug; what to do if a dose
is missed; purpose of treatment; precautions (e.g. eect on driving); when/
how to take the medicine; problems with alcohol/ other drugs; unwanted
eects and what to do about them.
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Security of prescriptions NHS prescription fraud is common and
wastes valuable NHS resources. GP surgeries have a responsibility to:
• Keep paper prescriptions secure
• Ensure that Smartcards are not left unattended or passwords shared
• Be alert to irregularities associated with prescriptions/ prescribing, e.g.
requests for repeat prescriptions not ordered by patients or excessive
quantities of drugs, altered paper prescriptions, patients who have
multiply registered to obtain prescription drugs
Report suspected fraudulent use of NHS prescriptions to the NHS
Counter Fraud Authority: F 0800 0284060 M www.cfa.nhs.uk/
reportfraud
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CHAPTER5 Medicines andprescribing
Medicinesmanagement
Dened as ‘facilitating the maximum benet and minimum risk for medicines for individual patients’. Encompasses the way medicines are selected,
procured, delivered, prescribed, administered, and reviewed.
Generic prescribing Use of generic, rather than brand name, when
prescribing is one of the simplest ways to d cost of drugs to the NHS
without compromising patient care. As long as the drug’s patent is valid,
the company that developed the drug will derive income from prescription whatever the name on the prescription. Once the patent has expired,
competitors can manufacture the drug and market it under its generic or
an alternative brand name. If prescribed generically, the pharmacist decides
which brand to supply and market forces drive price d.
Reasons not toprescribegenerically
• Drugs with a low therapeutic index e.g. lithium, carbamazepine,
phenytoin, ciclosporin— small dierences in plasma concentrations can
be clinically signicant
• Modied- release formulations e.g. diltiazem, or theophylline products.
Composition/ pharmacokinetic properties are dicult to standardize
• Formulations containing ≥2 drugs Some do have generic names (e.g.
co- amilofruse 5/ 40, co- codamol)— others do not. Do not make up a
generic name if the combination drug does not have one
Practice and locality formularies An agreed practice or locality for-
mulary is an eective way to promote best practice in prescribing, and limit
costs. Those compiling formularies should consider:evidence of ecacy;
safety; cost- eectiveness; national guidelines and local policies.
Concordance A process of prescribing and medicine- taking based on
partnership. Patient concordance (or rather lack of it) is a major challenge
in general practice. For drugs to be optimally eective they should be taken
as directed by the prescriber. Concordance sucient to attain therapeutic
objectives occurs about 50% of the time— 1 in 6 patients take medication
exactly as directed; 1 in 3 take medication as directed 80– 90% of the time; 1
in 3 take medication as directed 40– 80% of the time; the remaining 16– 17%
take medication as directed <40% of the time.
‘White- coat concordance’ Phenomenon in which 90% of patients take
regular medication as directed for a period before a check- up— may mask
eects of non- concordance.
Consequences ofnon- concordance
• Failure to attain therapeutic targets, e.g. not taking antihypertensive
medication, results in increased risk of stroke
• Wastage of precious resources. ~£250million worth of medicines
are returned to pharmacies each year for disposal— the true quantity
wasted is many times that
Ways toimproveconcordance
• Use simple language and avoid medical terms; discuss reasons for
treatment and consequences of not treating in terms the patient can
understand; seek the patient’s views on his/ her condition and agree a
course of action before prescribing
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MEDICINESMANAGEMENT
• Explain what the drug is, its function, and (if known and not too
complex) its mechanism of action
• Keep the drug regimen as simple as possible— od or bd dosing is
preferable, especially long term; discuss how the patient will manage
the regimen within his/ her daily schedule and try to tie in with daily
routine (e.g. take one in the morning when you get up). Give clear verbal
instructions and reinforce with written instructions if a complex regimen,
the patient is elderly, or the understanding of the patient is in doubt
• Discuss possible side eects
• Respond to any questions the patient has
• If necessary arrange review within a short time of starting medicine to
discuss progress or queries, or arrange follow- up by another member
of the primary healthcare team (e.g. asthma nurse to check inhaler
technique 2– 3wk after starting inhaler)
• Monitor repeat prescriptions
Medication errors The PRACtICe Study (2012) showed that 1 in 20
prescriptions issued in general practice contain an error:42% are minor,
54% moderate, and 4% severe. Common errors include incomplete information on prescriptions; dose, strength, or dose timing errors; and monitoring errors (where necessary monitoring was not requested).
Minimizing medicationerrors
• Prescriber actions Read aloud prescriptions to patients to check for
errors and ensure patient understanding; if unfamiliar with a drug
initiated in secondary care, clarify before prescribing; review patients on
new drugs after <6wk and do not put medication on repeat until stable;
conrm important information (e.g. drug allergies) with patients even if
you know them well; become familiar with prescribing safety features on
practice IT systems and use them
• Practice actions Appoint a prescribing lead; use a practice/ locality
formulary; discuss adverse prescribing events and learn from mistakes;
update medical records as soon as possible after notication of
medication alterations by other services; use call– recall systems
to ensure regular monitoring tests are done and results available
before prescription requests are due; train dedicated sta to manage
prescription requests; highlight queries to GPs; ensure ‘dicult’ patients
(e.g. those on many drugs) have a named GP to manage their medication
• IT solutions Use alerts, warnings, and other safety features built into
practice computer software to highlight potential pitfalls; perform
regular prescribing audits for high- risk situations, e.g. drug monitoring
for potentially dangerous drugs such as methotrexate
Further information
Aver y T, etal. (2012) The PRACtICe Study. M http:// www.gmc- uk.org/
about/ research/ 12996.asp
GMC (2013) Good practice in prescribing and managing medicines and devices. M www.gmc- uk.org/ ethical- guidance/ ethical- guidance- for- doctors/
prescribing- and- managing- medicines- and- devices
NICE (2009) Medicines adherence. M https:// www.nice.org.uk/ guid-
ance/ cg76
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CHAPTER5 Medicines andprescribing
Repeatprescribing
80% of NHS prescriptions are for repeat medication. Good practice is essential to ensure wastage (>10% of total prescribing costs) is kept to a
minimum. Essential elements are:
• Written explanation of the repeat prescribing process for patients
and carers
• Practice personnel with dedicated responsibility ensure patient recall
and regular medication review
• Agreed practice policies for repeat prescriptions, e.g. duration of supply;
procedure if someone ‘runs out’ but is not authorized to have more
• Authorization check each time a prescription is signed
• Compliance check for under- or overuse (prescription frequency)
• Equivalence check that all regular prescriptions are for the same
duration of treatment so that prescription requests can be synchronized
• Regular housekeeping keeps records of medication up to date (including
dosage instructions)— particular care is needed after hospital discharge
when medication could have been substantially changed
• Training of practice sta
Review process Invite the patient ± carer. Areas to cover:
• Explain what you want to do in the review and the reasons for it
• Compile a list of all medicines being taken/ used including:prescribed
medication; OTC drugs; herbal/ homeopathic medicines; illicit drugs;
and medicines borrowed from others. Compare the list of drugs
generated with the prescription record
• Concordance. Find out whether and how medication is taken
• Explore understanding of the purpose of the medication and
consequences of not taking it and how much, how often, when
• Discuss misconceptions/ queries
• Ask about side eects
• Review relevant monitoring tests, e.g. lithium level; TFTs; INR; HbA1c
• Review practical aspects. Problems ordering/ receiving repeat
prescriptions; using medicines, e.g. problems opening containers; with
formulations, e.g. diculty swallowing tablets; reading labels— can
request large print; remembering to take medication— consider
reminder chart, multi- compartment compliance aid, altering times of
doses to t in better with daily schedule
• Check necessity and appropriateness of all prescriptions (Figure 5.1)
Comparative practice data PCO prescribing teams can provide
comparative prescribing data for practices within their area. Comparing
practice data against that of other local practices can highlight over- or
under- prescribing and expensive drugs being used for which there are
cheaper, equally eective alternatives.
Further information
BNF M https:// bnf.nice.org.uk/
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Check the patient
Is the drug still needed?
Consider—duplication; whether the
condition is still present;
age/circumstances of the patient
Check the BNF
Is this use a recognized indication for
the drug?
Does the BNF support that the drug is
of value for the condition it is
prescribed for?
Is total daily dosage, dose frequency,
and treatment duration in line with
that described in the BNF?
Check evidence-based guidelines/
local policies
Is use in line with up-to-date evidencebased guidelines ( p. 70)?
Is use in accordance with local
prescribing policies?
Cost
Is it the cheapest drug in its
therapeutic class?
Is the generic version prescribed
( p. 116)?
Hazards: weigh risks vs benets
Is the patient getting side eects?
What are the potential hazards
(e.g. GI bleeding with NSAIDs)?
Is there a potentially hazardous drugdrug combination?
Risk < benet
REPEATPRESCRIBING
NO
NONOIs a valid reason for
YES
NO
YES
NO
YES
Risk >
benet
Stop prescribing
prescribing in this
instance given?
Stop prescribing/
consider alternative
Is a valid reason for
prescribing in this
instance given?
Is a valid reason for
prescribing in this
instance given?
Stop prescribing/
consider alternative
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NO
NO
Consider omissions
Are there any prescriptions the patient should be on but isn’t?, e.g. aspirin?
Figure5.1 Deciding whether a prescribed drug is appropriate
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CHAPTER5 Medicines andprescribing
Adverse drugreactions
‘I don’t want two diseases— one nature- made and one doctor- made’
An adverse drug reaction is an unwanted or harmful reaction which occurs
after administration of a drug or drugs and is suspected or known to be
due to the drug(s). Any drug may produce unwanted or unexpected effects. Common side eects are listed in the BNF or drug data sheet but any
patient can have an allergic reaction or idiosyncratic response to any drug.
Napoleon Bonaparte, St Helena (1820)
Types ofadversereaction
• Type A (‘Augmented’) drug reactions are related to the normal
pharmacological action of the drug. As such, they are common,
predictable, and usually dose dependent. Examples include:constipation
with opioids; dry mouth with amitriptyline; cough with ACE inhibitors.
Usually managed by reducing the dose or withholding the drug
• Type B (‘Bizarre’) reactions are not related to the usual pharmacological
action of the drug. They are uncommon, not predictable, and may
not be dose dependent. Examples include:anaphylaxis with penicillin;
cholestatic jaundice with co- amoxiclav
Management ofsuspected adverse drugreactions
• Severe reactions (e.g. anaphylaxis, respiratory depression, Stevens–
Johnson syndrome)— take emergency action
• If less severe, assess the patient— take a history of the presenting
symptoms and a detailed drug history. Has the patient ever had a similar
reaction before? Atemporal relationship between starting or i the dose
of a drug may suggest a drug reaction. Examine the patient as directed
by the history and arrange any tests needed (e.g. blood test if lithium or
digoxin toxicity is suspected)
• Check the drug literature— is this a recorded side eect of any
implicated medication(s)?
• Consider whether the reaction may be due to another cause, e.g.
another medical condition, drug interaction, or OTC medication
• Consider whether to stop the drug or reduce the dose. If the drug
is stopped, monitor to see if the adverse reaction resolves. Treat
symptoms if needed (e.g. antihistamine for itching)
• Record any adverse drug eects in the patient’s medical record
• Consider reporting the adverse reaction via the Yellow Card Scheme
Reporting adverse drug events In the UK, the ‘Yellow Card Scheme’
allows both healthcare professionals and patients to report adverse drug
events to the Medicines and Healthcare products Regulatory Agency
(MRHA). Reports can be led online via M www.yellowcard.mhra.gov.uk.
The scheme covers:
• Adverse reactions associated with medicines and vaccines (including
blood products and complementary medicines)
• Adverse incidents associated with medical devices
• Defective or counterfeit medicines
• Side eects or safety concerns with e- cigarettes
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ADVERSE DRUGREACTIONS
~25,000 Yellow Card reports are submitted to the MHRA each year. By
collating adverse events, product data sheets can be updated as side effects are recognized and warnings issued and/ or drugs withdrawn if serious
safety concerns emerge.
Report
• Serious suspected adverse drug reactions to established drugs and
vaccines (including OTC, herbal, and unlicensed or o- label medicines)
• All suspected adverse drug reactions (including those not deemed
serious) to newly licensed medicines identied by the ▼ symbol in
the BNF
Prevention ofadversereactions
• Never use a drug unless there is a good indication
• Always ask patients if they have had reactions previously to a drug
before prescribing
• Ask about other drugs patients are taking (including self- medication);
consider interactions
• Consider the eects of age and hepatic or renal impairment
• Prescribe as few drugs as possible— the more drugs, the more
likelihood of interactions
• Give clear instructions about how to take the drug
• Wherever possible use drugs you are familiar with; if using a new
drug, be alert to side eects
• Warn patients about potentially serious side eects (e.g. risk of GI
bleeding with NSAIDs)
Defective medicines A medicine which does not conform to its speci-
cation is deemed defective. Report suspected defective medicines, with as
much detail as possible via the Yellow Card Scheme.
Consumer Protection Act (1987) If a patient is damaged by a de-
fective product, liability falls on the producer unless outside the EC when
it falls on the importer. If the importer cannot be identied, liability falls on
the supplier. This is important for GPs. Those who dispense are at greatest
risk but all GPs occasionally supply drugs in an emergency or for procedures
within the surgery (vaccinations, minor surgery, contraception). Always
record manufacturer, batch number, and expiry date when using such drugs
and keep records of storage of drugs and maintenance of equipment.
Sources ofdruginformation
• British National Formulary (BNF) M https:// bnf.nice.org.uk/
• Electronic Medicines Compendium M www.medicines.org.uk
• Interactive Drug Analysis Proles (iDAPs)— summary of adverse events
reported to the MHRA for individual drugs M https:// yellowcard.mhra.
gov.uk/ idap
• Regional and district medicine information services
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CHAPTER5 Medicines andprescribing
Licensing ofmedicines
In the UK, the Medicines Act (1968) makes it essential for anyone who
manufactures or markets a drug for which therapeutic claims are made to
hold a licence. The Licensing Authority, working through the Medicines
and Healthcare products Regulatory Agency (MHRA), can grant both
Manufacturer’s Licence and Marketing Authorization (which allows a company to market and supply a product for specied indications). Although
doctors usually prescribe according to the licensed indications, they are not
obliged to.
Unlicensed and o- label drugs Unlicensed drugs are drugs that do
not have a product licence for use in the UK. ‘O- label’ drugs are drugs that
have a product licence but are being used for indications not covered by
that product licence.
Prescribing outside licence There may be occasions when a doctor
feels it is necessary to prescribe outside a drug’s licence.
• Generic formulations for which indications are not described. The
prescriber has to assume the indications are the same as for branded
formulations
• Use of well- established licensed drugs for proven indications not
covered by the product licence, e.g. amitriptyline for neuropathic pain
• Use of drugs for conditions where there are no other treatments, even
if the evidence of their eectiveness is not well proven. This often
occurs in secondary care when new treatments become accepted.
GPs may become involved if a patient is discharged to the community
and the GP is asked to continue prescribing. 0 The person signing the
prescription is legally responsible
• Use of drugs for individuals not covered by their licensed indications—
frequently occurs in paediatrics
• Before prescribing any medication (whether within or outside the licence) weigh risks against benets. The more dangerous the medicine
and the imsier the evidence base for treatment, the more dicult it is to
justify the decision to prescribe.
When prescribing licensed drugs for unlicensed indications, it is important
to inform patients and carers of what you are doing and why. Explain that
the patient information leaet (PiL) will not have information about the
use of the drug in these circumstances. Record in the patient’s notes your
reasons for prescribing outside the licensed indications for the drug.
Clinical trials Drug discovery and development is a protracted process
(>10y) costing huge sums of money (~£100million). Clinical testing is conventionally divided into ve stages:
• Phase Itrials Clinical pharmacology in normal volunteers
• Phase II trials Preliminary small- scale studies
• Phase III trials Large- scale trials (several thousands of patients often).
Once complete, application is made for a licence to sell the drug
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LICENSING OFMEDICINES
• Phase IV trials Post- marketing surveillance— large- scale follow- up of
patients using the drug to establish evidence of long- term ecacy
and safety
• Phase V trials Further trials to compare ecacy and safety with other
marketed compounds and explore new indications
GPs are unlikely to be involved before phase III. Taking part in trials can
benet both patients and the practice but consider proposals carefully before embarking on a project.
Research in general practice E p. 55
Questions toask beforeagreeing totake part ina
clinicaltrial
• Are the aims and objectives of the study dened?
• What is the design?
• Which drug is to be tested?
• What are the end points?
• Are the criteria for identifying patients clear and explicit?
• Are the numbers to be recruited specied and feasible?
• Are the observations to be made clearly and vigorously dened?
• Are the arrangements for providing information to patients and for
obtaining informed consent satisfactory?
• Has ethical approval of the study been obtained?
• Are the nancial arrangements clearly set out (minimum—
reimbursement of patients’ expenses and reimbursement of practice
expenses)?
• Has adequate provision been made for compensation in the event of
injury to patients in the course of the study?
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