Download Brand-name Prescribing in Primary Care

Medicines Q&As
Q&A 247.3
Which medicines should be considered for brand-name prescribing in
primary care?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date prepared: July 2013 (partial update December 2013)
Summary
Prescribing medicines by generic rather than brand name can improve cost-effectiveness and is
encouraged. However, there are some circumstances in which continuity of the same brand is
important for patient safety and brand-name prescribing preferred. These include:
 Where there is a difference in bioavailability between brands of the same medicine, particularly if
the medicine has a narrow therapeutic index.
 Where modified release preparations are not interchangeable.
 Where products contain multiple ingredients and brand name prescribing aids identification.
 Where there are important differences in formulation between brands of the same medicine.
 Where administration devices (e.g. inhaler or self-injection) have different instructions for use and
patient familiarity with one product is important.
 Where the product is a biological rather than chemical entity.
Background
Medicines may be prescribed by ‘brand’ (proprietary) or ‘generic’ (recommended International Nonproprietary Name, rINN) name.
In primary care, if a medicine is prescribed by brand name, the pharmacist may dispense only the
specified brand and is reimbursed for doing so. If a medicine is prescribed by generic name, the
pharmacist may dispense any suitable generic or branded product and is reimbursed at a set price,
listed in the Drug Tariff. Proposals for ‘generic substitution’ whereby community pharmacists would be
allowed to supply a generic preparation even if a branded product were prescribed have been rejected
in England [1]. Legislation has recently been passed allowing generic substitution in Ireland for
medicines on an ‘interchangeable list’ maintained by the Irish Medicines Board [2].
Advantages of generic prescribing are that it is generally more cost-effective than prescribing by brand
name and, because it allows any suitable product to be dispensed, can reduce delays in supplying
medicines to the patient [3, 4]. Increasing the level of generic prescribing in the UK has long been
encouraged. A measure of generic prescribing in primary care (‘potential generic savings’) in England
is reported as a prescribing comparator [5].
Although generic prescribing is encouraged there are some circumstances in which it is preferable to
prescribe by brand name. Broadly these circumstances are where continuity of the same brand is
important due to differences in bioavailability, where patient training differs between products and to
aid identification where products have multiple ingredients. The NHS Dictionary of Medicines and
Devices (dm+d) and NHS Prescription Service Common Drug Reference database annotate
medicines not recommended for generic prescribing [6, 7]. Prescribing software systems may also
indicate medicines for which brand name prescribing is preferred. Specific circumstances are
described below:

Where there is a difference in bioavailability between brands of the same medicine, particularly if
the medicine has a narrow therapeutic index. In these circumstances, lack of clarity over which
preparation is intended when prescribing can lead to the patient receiving a sub-therapeutic or toxic
dose. Examples include ciclosporin, lithium, CFC-free beclometasone metered dose inhalers and
some antiepileptic medicines.
Available through NICE Evidence Search at www.evidence.nhs.uk

Where modified release preparations are not interchangeable, particularly if the medicine has a
narrow therapeutic index. This avoids confusion between formulations with different release
characteristics. Examples include aminophylline, diltiazem and morphine.

Where there are important differences in formulation between brands of the same medicine. For
example, fentanyl patches are available as matrix formulations and reservoir formulations.
Reservoir patches must not be cut because damage to the rate-limiting membrane can lead to a
rapid release of fentanyl resulting in overdose. If the prescriber intends the patch to be cut
(although this is unlicensed and not recommended by the MHRA) then the prescription must
specify a brand of matrix formulation patch.

Where products contain more than one ingredient and brand name prescribing aids identification.
This is useful when prescribing products with multiple ingredients (e.g. pancreatin supplements,
skin and scalp preparations) and to differentiate between similar products where patient familiarity
with a brand is important (e.g. hormone replacement therapy and oral contraceptives).

Where administration devices have different instructions for use and patient familiarity with one
product is important. For example salbutamol dry powder inhalers and adrenaline pre-filled
syringes.

Where the product is a biological rather than chemical entity. Such agents are licensed as
‘biosimilar’ medicines. Examples include erythropoietin and somatropin (growth hormone)
preparations.
Answer
The following table lists medicines that might be considered for brand-name prescribing. This table
has been compiled using a number of sources. Specific references for individual medicines are
included where appropriate.
BNF
Drug or drug class
Reason for considering brand-name
prescribing
Specific
references
Chapter 1
1.1.1
Antacids preparations containing
simeticone
To aid identification. Products contain
multiple ingredients.
BNF
1.1.2
Compound alginates and
proprietary indigestion preparations
To aid identification. Products contain
multiple ingredients.
BNF
1.5.1
Mesalazine oral preparations
The delivery characteristics of oral
mesalazine preparations may vary and
should not be considered
interchangeable.
BNF
1.6.1
Bulk forming laxatives
To aid identification. Products contain
multiple ingredients.
-
1.6.4
Macrogols (polyethylene glycols)
To aid identification. Products contain
multiple ingredients.
-
1.7.2
Compound haemorrhoid
preparations
To aid identification. Products contain
multiple ingredients.
-
1.9.4
Pancreatin supplements
To aid identification. Products contain
multiple ingredients.
-
Chapter 2
2.6.2
Diltiazem modified release (MR)
preparations
MR preparations have different release
characteristics and are not
interchangeable.
Available through NICE Evidence Search at www.evidence.nhs.uk
BNF
dm+d
BNF
2.6.2
Drug or drug class
Nifedipine modified release
preparations
Reason for considering brand-name
prescribing
Specific
references
MR preparations have different release
characteristics and are not
interchangeable.
BNF
dm+d
Chapter 3
3.1.1
Formoterol dry powder inhalers
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
dm+d
3.1.1
Salbutamol dry powder inhalers
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
dm+d
3.1.3
Theophylline modified release
preparations
MR preparations have different release
characteristics and are not
interchangeable. Theophylline has a
narrow therapeutic index.
BNF
3.1.3
Aminophylline modified release
preparations
MR preparations have different release
characteristics and are not
interchangeable. Aminophyline has a
narrow therapeutic index.
BNF
dm+d
3.2
Beclometasone dipropionate CFCfree pressurised metered dose
inhalers
Qvar and Clenil Modulite are not
interchangeable. Qvar has extra-fine
particles and is approximately twice as
potent as Clenil Modulite and CFCcontaining beclometasone inhalers. The
MHRA has advised that CFC-free
beclometasone inhalers should be
prescribed by brand name. This applies
also to combination products.
BNF
dm+d
MHRA [8]
3.2
Beclometasone dry powder inhalers
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
3.2
Beclometasone and formoterol
CFC-free metered dose inhalers
See beclometasone CFC-free metered
dose inhalers, above.
3.2
Budesonide dry powder inhalers
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
-
3.4.3
Adrenaline (epinephrine) pre-filled
syringes
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
BNF
dm+d
dm+d
BNF
MHRA [8]
Chapter 4
4.2.3
Lithium preparations
Preparations vary widely in bioavailability.
Changing the preparation requires the
same precautions as initiation of
treatment. Lithium has a narrow
therapeutic index.
BNF
dm+d
4.4
Methylphenidate modified release
preparations
MR preparations contain different
proportions of immediate-release and
modified-release methylphenidate.
BNF
dm+d
Available through NICE Evidence Search at www.evidence.nhs.uk
BNF
Drug or drug class
Reason for considering brand-name
prescribing
Specific
references
4.7.2
Morphine oral modified release
preparations
MR preparations have different release
characteristics; Patient familiarity with one
brand is important.
PCF4 [9]
4.7.2
Fentanyl patches
Patches are available as matrix and
reservoir formulations; Patient familiarity
with one brand is important. Reservoir
patches must not be cut because damage
to the rate-limiting membrane can lead to
a rapid release of fentanyl resulting in
overdose. If the prescriber intends the
patch to be cut (NB: unlicensed and not
recommended by the MHRA) then the
prescription must specify a brand of
matrix formulation patch.
PCF4 [9]
4.7.4
Botulinum toxin type A
Preparations are not interchangeable due
to differences in potency.
BNF
dm+d
4.8.1
Antiepileptic drugs
The MHRA has classified antiepileptic
drugs (AEDs) into three categories of risk,
based primarily on their therapeutic index
and physiochemical characteristics (in
particular solubility and permeability
across membranes) indicative of potential
differences between formulations.
MRHA
[10,11]
Category 1:
Specific measures are necessary to
ensure consistent supply of a particular
product (which could be either a branded
product or a specified manufacturer’s
generic product).
Category 2:
NB: By default, this category includes all
AEDs not listed in categories 1 or 3.
The need for continued supply of a
particular manufacturer’s product should
be based on clinical judgement and
consultation with patient and/or carer.
Category 3:
No specific measures are normally
required and these AEDs can be
prescribed generically and without
specifying a specific manufacturer’s
product:
NICE recommends continuity of the same
brand, or the same generic preparation,
for patients with seizure disorders, unless
the prescriber (in consultation with the
patient and their family or carers)
considers this not to be a concern.
(For individual antiepileptic agents, see
below.)
Available through NICE Evidence Search at www.evidence.nhs.uk
NICE [12]
BNF
Drug or drug class
Reason for considering brand-name
prescribing
Specific
references
4.8.1
Carbamazepine
MHRA Category 1 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Ethosuxamide
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Gabapentin
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Lacosamide
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Levetiracetam
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Phenobarbital
MHRA Category 1 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Phenytoin
MHRA Category 1 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Pregabalin
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Primidone
MHRA Category 1 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Tiagabine
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.8.1
Vigabatrin
MHRA Category 3 (see ‘Antiepileptic
drugs’ above).
MRHA [11]
4.9.1
Apomorphine pre-filled syringe
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
dm+d
4.9.3
Botulinum toxin type A
Preparations are not interchangeable due
to differences in potency.
BNF
dm+d
dm+d
Chapter 6
6.1.1
Insulins
Patient familiarity with the same brand is
important; training is required in the use of
specific devices for self-injection.
6.4.1
Hormone replacement therapy oral
preparations
Different brands of the same formulation
are available. Patient familiarity with one
brand is important.
-
6.4.1
Estradiol transdermal patches
Different brands of the same formulation
are available. Patient familiarity with one
brand is important.
-
6.5.1
Somatropin injection cartridges
Patient familiarity with the same brand is
important and training is required in the
use of specific devices for self-injection.
Some somatropin preparations are
licensed as ‘biosimilar’ medicines.
BNF
dm+d
Different brands of the same formulation
are available. Patient familiarity with one
brand is important.
-
Chapter 7
7.3.1
Combined oral contraceptives
Available through NICE Evidence Search at www.evidence.nhs.uk
BNF
Drug or drug class
Reason for considering brand-name
prescribing
7.3.2
Progestogen only oral
contraceptives
Different brands of the same formulation
are available. Patient familiarity with one
brand is important.
7.4.5
Alprostadil injection
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
Specific
references
-
dm+d
Chapter 8
8.2.1
Azathioprine
Different formulations may vary in
bioavailability; to avoid reduced effect or
excessive side effects, it is important not
to change formulation except on the
advice of a transplant specialist.
BNF
Eur Soc
Org Trans
[12]
8.2.1
Mycophenolate
Generic and branded preparations are
considered bioequivalent but it may be
prudent not to change formulation except
on the advice of a transplant specialist.
Mycophenolate mofetil and mycophenolic
acid preparations are not
interchangeable.
BNF
Eur Soc
Org Trans
[12]
PJ [13]
8.2.2
Ciclosporin
Preparations are not interchangeable and
should be prescribed by brand-name to
avoid inadvertent switching. It is important
not to change formulation except on the
advice of a transplant specialist.
Ciclosporin has a narrow therapeutic
index.
BNF
dm+d
Eur Soc
Org Trans
[12]
MHRA [14]
8.2.2
Tacrolimus
Preparations are not interchangeable;
care should be taken to ensure the
correct preparation is prescribed and
dispensed. It is important not to change
formulation except on the advice of a
transplant specialist. Tacrolimus has a
narrow therapeutic index.
BNF
dm+d
MHRA [15]
8.2.4
Interferon pre-filled disposable
injection devices
Patient familiarity with one brand is
important; instructions for use vary
between preparations.
dm+d
Peginterferon pre-filled disposable
injection devices
Chapter 9
9.1.3
Erythropoietins
Patient familiarity with the same brand is
important and training is required in the
use of specific devices for self-injection.
Some epoetin preparations are licensed
as ‘biosimilar’ medicines.
BNF
dm+d
9.1.6
Granulocyte-colony stimulating
factors
Patient familiarity with the same brand is
important and training is required in the
use of specific devices for self-injection.
Filgrastim preparations have been
approved as ‘biosimilar’.
dm+d
BNF
Available through NICE Evidence Search at www.evidence.nhs.uk
BNF
Drug or drug class
Reason for considering brand-name
prescribing
Specific
references
9.2.1
Oral rehydration salts
To aid identification. Products contain
multiple ingredients.
-
9.5.1
Calcium salts
To aid identification. Products contain
multiple ingredients.
-
To aid identification. Products contain
multiple ingredients.
-
To aid identification. Products contain
multiple ingredients. Also, potency of
topical corticosteroid preparations is a
result of the formulation as well as the
corticosteroid.
-
Chapter 12
12.3.5
Saliva replacement products
Chapter 13
13.113.10
Preparations for skin and scalp
conditions containing multiple
ingredients
Chapter 14
14.4
Human papillomavirus vaccine
Cervarix (bivalent vaccine) and Gardasil
(quadravalent vaccine) are not considered
interchangeable.
BNF
Limitations

This list of medicines may not be comprehensive.
References
1. Department of Health. Press release: No plans to implement generic substitution of medicines. 14
October 2010. Accessed at
http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/MediaCentre/Pressreleases/DH_1
20502 on 4/9/2013.
2. Irish Medicines Board. Generic and interchangeable medicines. Accessed at
www.imb.ie/EN/Human-Medicines/Generic-and-Interchangeable-Medicines.aspx on 4/9/2013.
3. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and
Pharmaceutical Press. Accessed via www.medicinescomplete.com on 4/9/2013.
4. NHS Choices. Medicines information – brand names and generics. Reviewed 24/10/2012.
Accessed at www.nhs.uk/Conditions/Medicinesinfo/Pages/Brandnamesandgenerics.aspx on
3/9/2013.
5. NHS Business Services Authority. Prescribing comparators. Accessed at
www.nhsbsa.nhs.uk/PrescriptionServices/3634.aspx on 4/9/2013.
6. NHS Business Services Authority. NHS Dictionary of Medicines and Devices (dm+d) Editorial
Policy. Release 2.3. August 2013. Accessed via http://195.59.176.218/dmd_download.htm on
4/9/2013.
7. Information Services, NHS Business Services Authority Prescription Services. Items indicated as
not being suitable for generic prescribing, from the NHS Prescription Service Common Drug
Reference database. Personal communication on 2/7/2013 (data produced 25/6/2013).
8. Medicines and Healthcare products Regulatory Agency. Inhaled products that contain
corticosteroids. Drug Safety Update 2008; 12(1):8. Accessed at
www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON085179 on 4/9/2013.
9. Twycross R, Wilcock A (eds). Palliative Care Formulary. 4th Edition. Nottingham:
Palliativedrugs.com Ltd: 2011 pp362, 392.
Available through NICE Evidence Search at www.evidence.nhs.uk
10. Medicines and Healthcare products Regulatory Agency. Antiepileptic drugs: new advice on
switching between different manufacturers’ products for a particular drug. Drug Safety Update
November 2013; 7 (4): A1. Accessed at:
www.mhra.gov.uk/home/groups/dsu/documents/publication/con336729.pdf on 3/12/2013.
11. Medicines and Healthcare products Regulatory Agency. Formulation switching of antiepileptic
drugs: A report on the recommendations of the Commission on Human Medicines from July 2013.
Accessed at http://www.mhra.gov.uk/home/groups/commsic/documents/websiteresources/con341226.pdf on 3/12/2013.
12. National Institute for Health and Clinical Excellence. Clinical guideline 137: The epilepsies – the
diagnosis and management of the epilepsies in adults and children in primary and secondary care.
January 2012. Accessed at www.nice.org.uk/nicemedia/live/13635/57779/57779.pdf on 4/9/2013.
13. European Society for Organ Transplantation Advisory Committee. Generic substitution of
immunosuppressive drugs. Transpl Int 2011; 24 (12): 1135-1141. Accessed at
http://onlinelibrary.wiley.com/doi/10.1111/j.1432-2277.2011.01378.x/pdf on 4/9/2013.
14. Tynan S and Jerram P. Generic or branded mycophenolate – what strategy should the NHS
adopt? Pharm J 2010; 285 (7630): 659-660.
15. Medicines and Healthcare products Regulatory Agency. Ciclosporin must be prescribed and
dispensed by brand name. Drug Safety Update Dec 2009; 3 (5): 2. Accessed at
www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON087726 on 4/9/2013
16. Medicines and Healthcare products Regulatory Agency. Oral tacrolimus products: prescribe and
dispense by brand name only, to minimise the risk of inadvertent switching between products,
which has been associated with reports of toxicity and graft rejection. Drug Safety Update 2012; 5
(11): A1. Accessed at www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON155756 on
4/9/2013.
Quality Assurance
Prepared by
Karoline Brennan, North West Medicines Information Centre
Date Prepared
February 2009 (partial revision May 2011)
Update prepared September 2013 (partial update December 2013)
Checked by
Simone Henderson, North West Medicines Information Centre
Christine Proudlove, North West Medicines Information Centre
Date of check
February 2009 (partial revision May 2011)
Update checked September 2013 (partial update December 2013)
Search strategy
In-house enquiries [Search terms: “generic prescribing”, “therapeutic equivalency”]
BNF online [Search terms: “brand”, “bioavailability”, “interchangeable”]
NICE Evidence Search [Search terms: generic prescribing, individual drug names]
NHS Choices [generic medicines]
Irish Medicines Board
BNF 65 paper copy
NHS Business Services Authority
General internet searches [Search terms included nhs generic medicines, QIPP generic prescribing,
NHS England generic medicines]
Available through NICE Evidence Search at www.evidence.nhs.uk