Guidance on Prescribing

Medicines should be prescribed only when they are necessary, and in all cases the benefit of administering the medicine should be considered in relation to the risk involved. This is particularly important during pregnancy, when the risk to both mother and fetus must be considered. It is important to discuss treatment options carefully with the patient to ensure that the patient is content to take the medicine as prescribed. In particular, the patient should be helped to distinguish the adverse effects of prescribed drugs from the effects of the medical disorder. When the beneficial effects of the medicine are likely to be delayed, the patient should be advised of this. For guidance on medicines optimisation, see Medicines optimisation p. 18.

Never Events Never events are serious and avoidable medical errors for which there should be preventative measures in place to stop their occurrence. The NHS Never Events policy and framework can be viewed at: improvement.nhs.uk/documents/2265/Revised_Never_Events_policy_and_framework_FINAL.pdf. For never events related to single drugs or drug classes, BNF Publications contain information within the monographs, in the important safety information section. Prescribing competency framework The Royal Pharmaceutical Society has published a Prescribing Competency Framework that includes a common set of competencies that form the basis for prescribing, regardless of professional background. The competencies have been developed to help healthcare professionals to be safe and effective prescribers, with the aim of supporting patients to get the best outcomes from their medicines. It is available at www.rpharms.com/resources/frameworks/prescriberscompetency-framework.

Biological medicines

Biological medicines are medicines that are made by or derived from a biological source using biotechnology processes, such as recombinant DNA technology. The size and complexity of biological medicines, as well as the way they are produced, may result in a degree of natural variability in molecules of the same active substance, particularly in different batches of the medicine. This variation is maintained within strict acceptable limits. Examples of biological medicines include insulins and monoclonal antibodies.g Biological medicines must be prescribed by brand name and the brand name specified onthe prescription should be dispensed in order to avoid inadvertent switching. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines. 

Biosimilar medicines

A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine that has already been authorised in the European Union (known as the reference biological medicine or originator medicine). The active substance of a biosimilar medicine is similar, but not identical, to the originator biological medicine. Once the patent for a biological medicine has expired, a biosimilar medicine may be authorised by the European Medicines Agency (EMA). A biosimilar medicine is not the same as a generic medicine, which contains a simpler molecular structure that is identical to the originator medicine.\

Therapeutic equivalence

Biosimilar medicines should be considered to be therapeutically equivalent to the originator biological medicine within their authorised indications. h Biosimilar medicines are usually licensed for all the indications of the originator biological medicine, but this depends on the evidence submitted to the EMA for authorisation and must be scientifically justified on the basis of demonstrated or extrapolated equivalence.

Prescribing and dispensing

The choice of whether to prescribe a biosimilar medicine or the originator biological medicine rests with the clinician in consultation with the patient.g Biological medicines (including biosimilar medicines) must be prescribed by brand name and the brand name specified on the prescription should be dispensed in order to avoid inadvertent switching. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.

Safety monitoring 

Biosimilar medicines are subject to a black triangle status (A) at the time of initial authorisation. It is important to report suspected adverse reactions using the Yellow Card Scheme (see Adverse reactions to drugs p. 12). For all biological medicines, adverse reaction reports should clearly state the brand name and the batch number of the suspected medicine. UK Medicines Information centres have developed a validated tool to determine potential safety issues associated with all new medicines. These ‘in-use product safety assessment reports’ will be published for new biosimilar medicines as they become available, see www.sps.nhs.uk/ home/medicines/.

National funding/access decisions 

The Department of Health has confirmed that, in England, NICE can decide to apply the same remit, and the resulting technology appraisal guidance, to relevant biosimilar medicines which appear on the market subsequent to their originator biological medicine. In other circumstances, where a review of the evidence for a particular biosimilar medicine is necessary,NICE will consider producing an evidence summary (see Evidence summary: new medicines,www.nice.org.uk/about/ what-we-do/our-programmes/nice-advice/evidence-summariesnew-medicines).

National information In England, see www.nice.org.uk/Media/ Default/About/what-we-do/NICE-guidance/NICE-technologyappraisals/biosimilars-statement.pdf. In Northern Ireland, see niformulary.hscni.net/managedentry/biosimilars/. In Scotland, see www.scottishmedicines.org.uk/About_SMC/Policy_statements/Biosimilar_Medicines. In Wales, see www.wales.nhs.uk/sites3/Documents/814/BIOSIMILARS-ABUHBpositionStatement%5BNov2015%5D.pdf. Availability The following drugs are available as a biosimilar medicine:

. Adalimumab 

. Bevacizumab 

. Enoxaparin sodium 

. Epoetin alfa 

. Epoetin zeta 

. Etanercept 

. Filgrastim 

. Follitropin alfa 

. Infliximab 

. Insulin glargine 

. Insulin lispro 

. Rituximab 

. Somatropin 

. Teriparatide 

. Trastuzumab 

Complementary and alternative medicine 

An increasing amount of information on complementary and alternative medicine is becoming available. The scope of the BNF is restricted to the discussion of conventional medicines but reference is made to complementary treatments if they affect conventional therapy (e.g. interactions with St John’s wort). Further information on herbal medicines is available at www.mhra.gov.uk.

Abbreviation of titles

In general, titles of drugs and preparations should be writte in full. Unofficial abbreviations should not be used as they may be misinterpreted.

Non-proprietary titles

Where non-proprietary (‘generic’) titles are given, they should be used in prescribing. This will enable any suitable product to be dispensed, thereby saving delay to the patient and sometimes expense to the health service. The only exception is where there is a demonstrable difference in clinical effect between each manufacturer’s version of the formulation, making it important that the patient should always receive the same brand; in such cases, the brand name or the manufacturer should be stated. Non-proprietary titles should not be invented for the purposes of prescribing generically since this can lead to confusion, particularly in the case of compound and modified-release preparations. Titles used as headings for monographs may be used freely in the United Kingdom but in other countries may be subject to restriction. Many of the non-proprietary titles used in this book are titles of monographs in the European Pharmacopoeia, British Pharmacopoeia, or British Pharmaceutical Codex 1973. In such cases the reparations must comply with the standard (if any) in the appropriate publication, as required by the Human Medicines Regulations 2012.

Proprietary titles

Names followed by the symbol ® are or have been used as proprietary names in the United Kingdom. These names may in general be applied only to products supplied by the owners of the trade marks.

Marketing authorization and BNF advice

In general the doses, indications, cautions, contra-indications, and side-effects in the BNF reflect those in the manufacturers’ data sheets or Summaries of Product Characteristics (SPCs) which, in turn, reflect those in the corresponding marketing authorizations (formerly known as Product Licences). The BNF does not generally include proprietary medicines that are not supported by a valid Summary of Product Characteristics or when the marketing authorisation holder has not been able to supply essential information. When a preparation is available from more than one manufacturer, the BNF reflects advice that is the most clinically relevant regardless of any variation in the marketing authorisations. Unlicensed products can be obtained from ‘special-order’ manufacturers or specialist importing companies.

Where an unlicensed drug is included in the BNF, this is indicated in the unlicensed use section of the drug monograph. When the BNF suggests a use that is outside the terms defined by the licence (‘off-label’ use), this too is indicated. Unlicensed or off-label use may be necessary if the clinical need cannot be met by licensed medicines; such use should be supported by appropriate evidence and experience. The doses stated in the BNF are intended for general guidance and represent, unless otherwise stated, the usual range of dose that are gererally regarded as being suitable for adults.

Prescribing unlicensed medicines 

Prescribing medicines outside the recommendations of their marketing authorisation alters (and probably increases) the prescriber’s professional responsibility and potential liability. The prescriber should be able to justify and feel competent in using such medicines, and also inform the patient or the patient’s carer that the prescribed medicine is unlicensed.

Oral syringes 

An oral syringe is supplied when oral liquid medicines are prescribed in doses other than multiples of 5 mL. The oral syringe is marked in 0.5 mL divisions from 1 to 5 mL to measure doses of less than 5 mL (other sizes of oral syringe may also be available). It is provided with an adaptor and an instruction leaflet. The 5–mL spoon is used for doses of 5 mL (or multiples thereof). Important To avoid inadvertent intravenous administration of oral liquid medicines, only an appropriate oral or enteral syringe should be used to measure an oral liquid medicine (if a medicine spoon or graduated measure cannot be used); these syringes should not be compatible with intravenous or other parenteral devices. Oral or enteral syringes should be clearly labelled ‘Oral’ or ‘Enteral’ in a large font size; it is the healthcare practitioner’s responsibility to label the syringe with this information if the manufacturer has not done so.

Excipients

Branded oral liquid preparations that do not contain fructose, glucose, or sucrose are described as ‘sugar-free’ in the BNF. Preparations containing hydrogenated glucose syrup, mannitol, maltitol, sorbitol, or xylitol are also marked ‘sugar-free’ since there is evidence that they do not cause dental caries. Patients receiving medicines containing cariogenic sugars should be advised of appropriate dental hygiene measures to prevent caries. Sugar-free preparations should be used whenever possible. Where information on the presence of aspartame, gluten, sulfites, tartrazine, arachis (peanut) oil or sesame oil is available, this is indicated in the BNF against the relevant preparation. Information is provided on selected excipients in skin preparations, in vaccines, and on selected preservatives and excipients in eye drops and injections. The presence of benzyl alcohol and polyoxyl castor oil (polyethoxylated castor oil) in injections is indicated in the BNF. Benzyl alcohol has been associated with a fatal toxic syndrome in preterm neonates, and therefore, parenteral preparations containing the preservative should not be used in neonates. Polyoxyl castor oils, used as vehicles in intravenous injections, have been associated with severe anaphylactoid reactions.

The presence of propylene glycol in oral or parenteral medicines is indicated in the BNF; it can cause adverse effects if its elimination is impaired, e.g. in renal failure, in neonates and young children, and in slow metabolisers of the substance. It may interact with disulfiram p. 517 and metronidazole p. 575. The lactose content in most medicines is too small to case problems in most lactose-intolerant patients. However in severe lactose intolerance, the lactose content should be determined before prescribing. The amount of lactose varies according to manufacturer, product, formulation, and strength.

Electrolytes

The sodium content of medicines should be considered for all patients, especially those with cardiovascular disease or on a reduced sodium diet, or those requiring long-term or regular medication. Some formulations of medicines, especially those that are effervescent, dispersible or soluble, can contain high levels of sodium as an excipient and this may be associated with an increased risk of cardiovascular events, including hypertension. 

The sodium content of a medicine is provided in the product literature for all medicines containing  1 mmo sodium per dose; below this level is considered essentially sodium-free. Medicines containing  17 mmol sodium in the total daily dose are considered to have a high sodium content and this is highlighted for medicines intended to be taken regularly (repeated use for more than 2 days every week) or long-term (continuous daily use for more than 1 month). 17 mmol sodium is approximately 20% of the WHO recommended maximum daily dietary intake of sodium for an adult. Important In the absence of information on excipients or electrolytes in the BNF and in the product literature (available at www.medicines.org.uk/emc), contact the manufacturer (see Index of Manufacturers) if it is essential to check details.

Extemporaneous preparation

A product should be dispensed extemporaneously only when no product with a marketing authorisation is available. The BP direction that a preparation must be freshly prepared indicates that it must be made not more than 24 hours before it is issued for use. The direction that a preparation should be recently prepared indicates that deterioration is likely if the preparation is stored for longer than about 4 weeks at 15–25° C. The term water used without qualification means either potable water freshly drawn direct from the public supply and suitable for drinking or freshly boiled and cooled purified water. The latter should be used if the public supply is from a local storage tank or if the potable water is unsuitable for a particular preparation (Water for injections).

Drugs and driving

Prescribers and other healthcare professionals should advise patients if treatment is likely to affect their ability to perform skilled tasks (e.g. driving). This applies especially to drugs with sedative effects; patients should be warned that these effects are increased by alcohol. General information about a patient’s fitness to drive is available from the Driver and Vehicle Licensing Agency at www.gov.uk/government/organisations/driver-and-vehicle-licensing-agency. A new offence of driving, attempting to drive, or being in charge of a vehicle, with certain specified controlled drugs in excess of specified limits, came into force on 2nd March 2015. This offence is an addition to the existing rules on drug impaired driving and fitness to drive, and applies to two groups of drugs—commonly abused drugs, including amfetamines, cannabis, cocaine, and ketamine p. 1399, and drugs used mainly for medical reasons, such as opioids and benzodiazepines. Anyone found to have any of the drugs (including related drugs, for example, apomorphine hydrochloride p. 438) above specified limits in their blood will be guilty of an offence, whether their driving was impaired or not. This also includes prescribed drugs which metabolise to those included in the offence, for example, selegiline hydrochloride p. 447. However, the legislation provides a statutory “medical defence” for patients taking drugs for medical reasons in accordance with instructions, if their driving was not impaired—it continues to be an offence to drive if actually impaired. Patients should therefore be advised to continue taking their medicines as prescribed, and when driving, to carry suitable evidence that the drug was prescribed, or sold, to treat a medical or dental problem, and that it was taken according to the instructions given by the prescriber, or information provided with the medicine (e.g. a repeat prescription form or the medicine’s patient information leaflet). Furter information is available from the Department for Transport at www.gov.uk/government/collections/drug-driving.

Patents

In the BNF, certain drugs have been included notwithstanding the existence of actual or potential patent rights. In so far as such substances are protected by Letters Patent, their inclusion in this Formulary neither conveys, nor implies, licence to manufacture.

Health and safety

When handling chemical or biological materials particular attention should be given to the possibility of allergy, fire, explosion, radiation, or poisoning. Substances such as corticosteroids, some antimicrobials, phenothiazines, and many cytotoxics, are irritant or very potent and should be handled with caution. Contact with the skin and inhalation of dust should be avoided.

Safety in the home

Patients must be warned to keep all medicines out of the reach of children. All solid dose and all oral and external liquid preparations must be dispensed in a reclosable childresistant container unless:

. the medicine is in an original pack or patient pack such as to make this inadvisable;

. the patient will have difficulty in opening a childresistant container;

. a specific request is made that the product shall not be dispensed in a child-resistant container;

. no suitable child-resistant container exists for a particular liquid preparation.

All patients should be advised to dispose of unwanted medicines by returning them to a supplier for destruction.

Labelling of prescribed medicines

There is a legal requirement for the following to appear on the label of any prescribed medicine:

. name of the patient;

. name and address of the supplying pharmacy;

. date of dispensing;

. name of the medicine;

. directions for use of the medicine;

. precautions relating to the use of the medicine. The Royal Pharmaceutical Society recommends that the following also appears on the label:

. the words ‘Keep out of the sight and reach of children’;

. where applicable, the words ‘Use this medicine only on your skin’.

A pharmacist can exercise professional skill and judgement to amend or include more appropriate wording for the name of the medicine, the directions for use, or the precautions relating to the use of the medicine.

Non-proprietary names of compound preparations

Non-proprietary names of compound preparations which appear in the BNF are those that have been compiled by the British Pharmacopoeia Commission or another recognised body; whenever possible they reflect the names of the active ingredients.

Prescribers should avoid creating their own compound names for the purposes of generic prescribing; such names do not have an approved definition and can be misinterpreted. Special care should be taken to avoid errors when prescribing compound preparations; in particular the hyphen in the prefix ‘co-’ should be retained.

Special care should also be taken to avoid creating generic names for modified-release preparations where the use of these names could lead to confusion between formulations with different lengths of action.

EEA and Swiss prescriptions 

Pharmacists can dispense prescriptions issued by doctors, dentists, and nurse prescribers from the European Economic Area (EEA) or Switzerland (except prescriptions for controlled drugs in Schedules 1, 2, or 3, or for drugs without a UK marketing authorisation). Prescriptions should be written in ink or otherwise so as to be indelible, should be dated, should state the name of the patient, should state the address of the prescriber, should contain particulars indicating whether the prescriber is a doctor, dentist, or nurse, and should be signed by the prescriber.

Security and validity of prescriptions The Councils of the British Medical Association and the Royal Pharmaceutical Society have issued a joint statement on the security and validity of prescriptions. In particular, prescription forms should:

. not be left unattended at reception desks; 

. not be left in a car where they may be visible; and

. when not in use, be kept in a locked drawer within the surgery and at home.

Where there is any doubt about the authenticity of a prescription, the pharmacist should contact the prescriber. If this is done by telephone, the number should be obtained from the directory rather than relying on the information on the prescription form, which may be false.

Patient group direction (PGD) 

In most cases, the most appropriate clinical care will be provided on an individual basis by a prescriber to a specific individual patient. However, a Patient Group Direction for supply and administration of medicines by other healthcare professionals can be used where it would benefit patient care without compromising safety.

A Patient Group Direction is a written direction relating to the supply and administration (or administration only) of a licensed prescription-only medicine (including some Controlled Drugs in specific circumstances) by certain classes of healthcare professionals; the Direction is signed by a doctor (or dentist) and by a pharmacist. Further information on Patient Group Directions is available in Health Service Circular HSC 2000/026 (England), HDL (2001) 7 (Scotland), and WHC (2000) 116 (Wales); see also the Human Medicines Regulations 2012. NICE, Scottish Medicines Consortium and All

Wales Medicines Strategy Group

Advice issued by the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG) is referenced in the BNF when relevant. Full details of this advice together with updates can be obtained from the funding body websites: www.nice.org.uk, www.scottishmedicines.org.uk and awmsg.nhs.wales/.

Specialized commissioning decisions

NHS England develops specialised commissioning policies that define access to specialised services for particular groups of patients to ensure consistency in access to treatments nationwide. For further information, see www.england.nhs.uk/specialised-commission

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