Download The Top 6 June specials 2015

Focus on ‘specials’
Specials are unlicensed medicinal products manufactured in the UK for human use which have been specially
prepared to meet a prescription ordered for individual patients without the need for the manufacturer to hold
a marketing authorisation for the medicinal product concerned.”
Specials come with a number of considerations; Specials products will not have been assessed by the licensing
authority for safety, quality and efficacy. Depending on the manufacturer, may also vary in formulation and
hence efficacy, bioavailability and excipients. Special medicines can be very expensive (several hundred
pounds for one bottle) and may not represent a cost effective treatment. A special may have a short expiry
date e.g. seven days.
The GMC have produced some guidance on prescribing specials http://www.gmcuk.org/guidance/ethical_guidance/14327.asp/ which states, that wherever possible, licensed products should
be used in preference to unlicensed ‘specials’
The prescriber therefore, needs to decide whether the patient has special pharmaceutical needs which a
licensed product cannot meet, e.g. can a soluble tablet be prescribed instead of a liquid medicine? Indeed, in
many cases, a licensed tablet will disperse in water which is preferable to an unlicensed product.
Specials can be difficult to identify at the point of prescribing and prescribers may be unaware that they are
considering prescribing one. If a medicine is not in the British National Formulary (BNF) it could be a Special.
E.g. Dermatology products, eye drops and liquid preparations are more commonly formulated as Specials.
Electronic prescribing systems may not identify Specials however some systems may use the letter ‘U’ to
indicate an unlicensed medicine, or misleadingly highlight the cost of Specials as ‘zero’.
Prescribers and Community pharmacists should check and discuss alternatives if they think a prescribed
product is a Special.
If a “special” is unavoidable; check with your pharmacist for a cost effective choice.
TOP 6 SPECIALS
1.
PPI oral suspensions
Over the 3 months from January 2015 to March 2015 NH CCG spent £28,761 on lansoprazole and omeprazole
unlicensed liquid specials. This is an area where there may be a suitable licensed alternative product.
Omeprazole is available as dispersible tablets and lansoprazole as orodispersible tablets.
Omeprazole oral suspension (Drug Tariff Part VIIIB Special Prices Mar 15):1
Strength
Min volume
Supply at 5ml
Price per min
daily dose
volume
Cost of omeprazole
dispersible tablets
(Losec MUPs) for
equivalent length of
supply*
£4.15
10mg/5ml
75ml
15 days
£110.73
£12.43
20mg/5ml
150ml
30 days
£135.16
£16.57
40mg/5ml
100ml
20 days
£182.08
5mg/5ml
75ml
15 days
£114.63
No licensed
equivalent**
Lansoprazole oral suspension (Drug Tariff Part VIIIB Special Prices Mar 15)
Strength
Min volume
Supply at 5ml
Price per min
Cost of lansoprazole
daily dose
volume
orodispersible tablets
for equivalent length of
supply*
£2.26
15mg/5ml
100ml
20 days
£145.04
£3.88
30mg/5ml
100ml
20 days
£145.46
5mg/5ml
100ml
20 days
£145.33
No licensed
equivalent**
*Omeprazole capsules containing the granules can be opened and mixed with fruit juice or yoghurt. Please
switch to this formulation if appropriate.
**Please check dose and switch to alternative licenced formulation if appropriate.
For patients who are unable to swallow tablets, these formulations may provide a suitable alternative option.
Please seek advice from your Medicines Management Pharmacist or Technician if you are unsure about
changing formulations for patients who have enteral feeding tubes.
For all patients, ongoing need should be reviewed regularly and medicines that are no longer required should
be stopped.
There is a price in the Drug Tariff for the unlicensed oral suspension.
1
Acknowledgement to West Hampshire Clinical Commissioning Group
2.
Melatonin Preparations
Firstly, review the use as there is limited evidence to support the use of melatonin.
Circadin® 2mg MR is licensed and is indicated as monotherapy for the short-term treatment of primary
insomnia characterised by poor quality of sleep in patients who are aged 55 or over.
In preference to an unlicensed oral liquid, prescribe Circadin® 2mg MR. For children with difficulties
swallowing, the tablet can be crushed to a fine powder and mixed with water or given with cold soft food such
as a teaspoon of yoghurt or jam. Use a small amount of food to ensure the full dose is taken. The prescription
should state that the medication is to be crushed prior to administration.1 When crushed; the release
characteristics are similar to an immediate-release dosage form (an off- label use), or if halved using a tablet
cutter it will retain its slow release characteristics. The use of Circadin® 2mg MR in children is off- label.1
Special order liquid medicines and capsules are unlicensed and expensive and should ONLY be used where
absolutely necessary.
Prescribe licensed product Circadin® 2mg MR £15.39/ 30 tablets in preference to unlicensed oral solutions and
suspensions.
There are drug tariff prices for unlicensed melatonin oral suspensions (prices June 2015):
Melatonin Strength
Formulation
Minimum volume
Price per minimum
volume
Price for each extra ml/g
above the minimum
volume
Melatonin 10mg/5ml
oral solution
STD, SF, LF, CF,
NSF
100ml
£136.92
£0.05
Melatonin 10mg/5ml
oral suspension
STD, SF, LF, CF,
NSF
100ml
£239.13
£0.25
Melatonin 2mg/5ml
oral solution
STD, SF, LF, CF,
NSF, AF
100ml
£91.22
£0.04
Melatonin 2mg/5ml
oral suspension
STD, SF, LF, CF,
NSF, AF
100ml
£164.23
£0.23
Melatonin 2.5mg/5ml
oral solution
STD, SF, LF, CF,
NSF, AF, FF
100ml
£103.41
£0.05
Melatonin 2.5mg/5ml
oral suspension
STD, SF, LF, CF,
NSF, AF, FF
100ml
£260.25
£0.30
Melatonin 3mg/5ml
oral solution
STD, SF, LF, CF,
NSF, FF
100ml
£107.69
£0.09
Melatonin 3mg/5ml
oral suspension
STD, SF, LF, NSF
100ml
£198.15
£0.25
Melatonin 5mg/5ml
oral solution
STD, SF, LF, CF,
NSF, FF
200ml
£80.48
£0.10
Melatonin 5mg/5ml
oral suspension
STD, SF, LF, CF,
NSF, AF, FF
100ml
£108.17
£0.10
1
Basingstoke, Southampton & Winchester District Prescribing Committee Melatonin Shared Care Guidelines May 2015
STD Standard formulation including standard flavours, SF Sugar free, AF Alcohol free, CF Colour free, FF Flavour free, LF Lactose free, PF Preservative
free, NSF Non- standard flavours.
Melatonin immediate- release caps and tablets are not licensed preparations and not covered in the drug
tariff. The variation in price may be considerable even for the same item. The cost to the CCG >£100K per year.
Examples of variations in the cost of immediate- release melatonin (based on specials prescribed by the CCG
March 2015):
BNF Name
Variations in Total Act Cost
Quantity
£48.90- £101.53
28
£23.14- £285.71
60
£38.36- £210.64
60
Melatonin_Tab 3mg
£59.42- £94.44
60
Melatonin_Tab 1mg
£26.31- £66.70
60
Melatonin_Cap 5mg
Melatonin_Cap 3mg
Melatonin_Cap 2mg
3.
Midodrine Preparations
Midodrine does not have marketing authorisation in the UK for the treatment of postural hypotension or
for any other indication, therefore it is an unlicensed medicine in the UK. In the USA, midodrine is licensed
by the Food and Drug Administration (FDA) for the treatment of symptomatic postural hypotension.It is
also licensed for use in several EU countries, such as Germany, France, Ireland, Italy and Spain.
In line with guidance from the General Medical Council (GMC), it is the responsibility of the prescriber to
determine the clinical need of the patient and the suitability of using midodrine as an unlicensed
treatment for postural hypotension. No other drugs have UK marketing authorisation for postural
hypotension.
Two double-blinded randomised controlled trials (RCTs) provided some limited evidence that midodrine
may improve some patient-rated symptoms of postural hypotension, such as syncope (fainting) and low
energy levels.
The most common side effects seen with midodrine are piloerection (goose bumps), pruritus and
paraesthesia (particularly of the scalp), urinary retention or urgency, and supine hypertension.
The longer-term efficacy and safety of midodrine has not been assessed in the RCTs, nor has its effect on
activities of daily living.
Midodrine acts as an alpha adrenergic receptor agonist. It stimulates the sympathetic part of the
autonomic nervous system, resulting in an increase in the resistance of blood vessel walls and an increase
in blood pressure[8]. Midodrine is reported to only cross the blood–brain barrier poorly and so it is not
associated with effects on the central nervous system[9].
The evidence showed that 10 mg midodrine taken orally 3 times a day for 3 to 4 weeks increases standing
blood pressure 1 hour post-dose more than placebo in people with symptomatic postural hypotension
due to dysfunction in the autonomic nervous system. Midodrine also increases supine (lying) blood
pressure more than placebo. These results may only apply to people who can stay on the medication.
A number of drug and non-drug approaches have been used to treat postural hypotension. Non-drug
therapies include increasing water and salt intake, or using compression garments or bandages and
physical manoeuvres to counter the drop in blood pressure.
Many medicines have been considered or studied for potential use in postural hypotension, including
drugs that target the autonomic nervous system (such as phenylephrine, ephedrine, pseudoephedrine,
droxidopa and phenylpropanolamine), pyridostigmine, domperidone, non-steroidal anti-inflammatory
drugs, erythropoietin and fludrocortisone.
Some of these drugs, such as fludrocortisone, domperidone and pyridostigmine, have licenses for other
indications in the UK, therefore use in postural hypotension is off-label.
One systematic review concluded that many commonly used interventions for postural hypotension have
a limited evidence base supporting their use.
4.
Magnesium Glycerophos cap 48.6mg/Chble 97.2mg S/F
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5.
Magnesium-L-aspartate (Magnaspartate®) is the preferred choice for the treatment and prevention of
magnesium deficiency when clinically appropriate as it is the only UK licensed oral magnesium
preparation
If magnesium-L-aspartate (Magnaspartate®) is not effective in raising magnesium levels or if it is
poorly tolerated it is reasonable to try an alternative oral magnesium preparation, if the patient’s
condition allows
Robust evidence of the superiority of one oral magnesium preparation over another does not exist;
therefore it is not possible to recommend one particular preparation over another on the basis of
efficacy and safety
Large scale clinical outcome studies are needed to compare the different oral magnesium
preparations in patients with hypomagnesaemia
Information from the small studies available suggests there are differences in the bioavailability of
some magnesium salts
Factors affecting the choice of a second line preparation may include local availability, patient
tolerability, and price. Examples of oral magnesium preparations which are available in the UK are
given in Table 1
Caution should be exercised when switching between magnesium preparations. Swapping on a mmol
for mmol basis may not result in an equivalent therapeutic effect as magnesium preparations have
differing bioavailability. The new preparation needs to be titrated to the maximum tolerated dose
with monitoring of magnesium serum levels. Tolerability of a particular preparation may limit the
dosage.
The use of sustained-release preparations (e.g. Mag-Tab SR® containing Magnesium L-lactate
dihydrate) may allow the use of lower doses, which minimises the risk of diarrhoea
Levomepromazine 6mg
A phenothiazine used widely in palliative care to treat intractable nausea or vomiting, and for severe delirium/
agitation in the last days of life.
A licensed 25mg tablet (Nozinan®) is available and is scored, so may be cut in half or quarters; thus a
comparable dose of 6.25mg or 12.5mg is achievable.
In cases where a dose of less than 6mg is desired, or where it is uncertain that a patient is able to safely cut the
tablets in half or quarters, an unlicensed product, levomepromazine 6mg (Levinan®) is obtainable but is
significantly more expensive than its licensed counterpart.
6.
Topiramate 25mg/5ml suspension
Topamax® hard capsules 15mg/25mg/50mg may be swallowed whole or may be opened and sprinkled on a
teaspoon of soft food of any type. Examples are applesauce, custard, ice cream, porridge, pudding or yogurt. It
is also advisable to drink plenty of fluids after ingesting Topamax.
Only consider the unlicensed topiramate suspension in instances where the specified dose is not 15mg, 25mg,
30mg or 50mg.