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Issue 13, March 2015
Wirral Drug & Therapeutics Committee UPDATE……………………………………………………………………………………………………………………..1
Current Issues............................................................................................................................................................................. 1
Topic of the month ..................................................................................................................................................................... 2
Drug Tariff .................................................................................................................................................................................. 4
Safety ......................................................................................................................................................................................... 7
Wirral Drug & Therapeutics Committee UPDATE
Alogliptin tablets (Vipidia®▼)
Alogliptin has been approved by the Drug & Therapeutics Committee (D&T) (January 2015) as the first line gliptin to
use for type 2 diabetic patients requiring gliptin therapy as per the Type 2 Diabetes Guidelines.
http://mm.wirral.nhs.uk/guidelines/
Once the black triangle status of alogliptin has been removed, a switch to alogliptin will be considered for patients
on other gliptins.
NOAC RAG Status Clarification
Following a review of the RAG status of NOACs at January D&T the following indications have these agreed RAG
statuses (within their NICE TAGs):
Indication
RAG status
For treatment of DVT and/or PE
AMBER
For prevention of recurrent DVT and/or PE
Anticoagulation in AF
GREEN
VTE prophylaxis post hip and knee surgery
RED
Current Issues
Supply of LMWH on discharge for VTE prophylaxis in orthopaedic patients
Joint Wirral Anticoagulant Guidelines currently state that up to 2 weeks’ supply of LMWH will be made by the
hospital at discharge for VTE prophylaxis in orthopaedic patients, and then this should be continued by the patient’s
GP. However, this has never been carried out in practice for orthopaedic patients that have undergone a fracture
and are in a cast, who may or may not have needed surgery, and WUTH have continued to supply up to 4 weeks of
enoxaparin on discharge.
1
From the beginning of March, WUTH will now be supplying 2 weeks of enoxaparin for these orthopaedic patients, in
line with the Joint Guidelines and the remainder of the course should be prescribed by the GP. Further guidance on
the prescribing and monitoring of LMWH can be found in the links below.
Joint Wirral Anticoagulant Guidelines
http://mm.wirral.nhs.uk/document_uploads/guidelines/LMWHprescribingandadministrationclinicalguidelinev1a141
013.pdf
Venothromboembolism prophylaxis: Trauma and Orthopaedics Guidelines
http://mm.wirral.nhs.uk/document_uploads/guidelines/VTEprophylaxisTraumaandorthopaedicsv2.pdf
The new naming system for NICE guidelines - say hello to NG
NICE has started to use a new way of numbering guidelines following the decision to use a single set of methods and
processes to develop all NICE guidelines. This applies to clinical, public health, social care, safe staffing and medicines
practice guidelines.
In January 2015, NICE published the first clinical guideline with the new numbering system, NG1 GORD in children
and young people.
Please note that other guidance products, i.e. technology appraisals, interventional procedures, medical
technologies and diagnostics guidance, as well as quality standards and advice products, will be unaffected by this
change.
Topic of the month
UNLICENSED MEDICATION – ‘SPECIALS’
Wirral CCG spent £268,082.77 on special-order medicines in the period April to November 20141.
Special-order products, also known as ‘Specials’, are unlicensed, premium-priced medicines. Reviewing and
preventing inappropriate use of unlicensed medicines is a regular piece of work for the Medicines Management
Team. The cost of unlicensed medicines can vary widely depending on where it is sourced by the Community
Pharmacy. The introduction of the Specials Tariff in Part VIIIB of the Drug Tariff has helped to reduce this variance in
cost for some products, but care needs to be taken when choosing between formulations, as shown in the table
below:
Specials in Part VIIIB
Cost2 for
Comments
150ml
Lorazepam oral solution
500mcg/5ml
Lorazepam oral suspension
500mcg/5ml
Zopiclone oral suspension
3.75mg/5ml
Zopiclone oral solution
3.75mg/5ml
£47.54
£98.17
£116.31
£40.01
Prescribing as solution is more cost effective,
although tablets can be crushed and mixed with
water or will disperse in water in 1-5 minutes.
Prescribing as solution is more cost effective.
Another option would be to consider changing to
zolpidem tablets which can be crushed and mixed
with water.
2
.Where the medicine is not listed in Part VIIIB of the Drug Tariff, the price depends on where the Dispenser sources
the product, and the Prescriber usually has no influence on this, as shown below:
Cost3
Comments
Midodrine 5mg tablets
£36.90/100 tablets from
Dispenser A
£58.49/100 tablets from
Dispenser B
This is a RED drug so should not
be issued in Primary Care
Phytomenadione 10mg tablets
£110.52/30 tablets from
Dispenser A
£64.34/30 tablets from
Dispenser B
£459 for 250g
This is an AMBER drug but price
depends on the supplier
Unlicensed specials not in Part
VIIIB
50% diprosone ointment 0.05%
with 50% diprobase ointment
Patients should be reviewed to
see if the ointment is still
clinically indicated and if a
licensed alternative could be
prescribed as an alternative.
As with any medicine, prescribers take full responsibility for their prescribing decision including any risks associated
with the use of unlicensed medicines. Another important consideration for prescribers is that specials have not been
assessed by the Medicine and Healthcare products Regulatory Agency (MHRA) for safety, quality and efficacy in the
same way as licensed medicines. Therefore, they have no Summary of Product Characteristics (SPC) outlining the
dose, contraindications, storage and side-effect profile. The MHRA recommends that an unlicensed medicinal
product should not be supplied where an equivalent licensed medicinal product can meet the “special needs” of the
patient.4
Advice to Prescribers
Prescribers should establish a ‘special clinical need’ before initiating or continuing a prescription for a ’special’.
A medication review prior to considering a ‘special’ may help to identify medicines which are no longer needed or
unsuitable for continuation.
If there is still a clinical need for the medicine, the following options could be considered instead of unlicensed
‘specials’:

Another licensed product in the same therapeutic class may be available in a suitable formulation for the
patient.

A different formulation of a licensed medicine may be available such as dispersible tablets, suppositories or
patches.

Using a UK licensed medicine outside the terms of its licence, e.g. outside defined indications, doses, routes of
administration. This is referred to as ‘off-label’ use, e.g. crushing tablets or opening capsules (where the
formulation allows). The NEWT Guidelines is a good source for advice. Although the MHRA does not recommend
’off label’ use of products, if the UK licensed product can meet the clinical need, even ‘off-label’, it should be
used instead of an unlicensed product. It should be understood that the prescriber’s responsibility and potential
liability are increased when prescribing ‘off-label’.4

If the UK licensed product cannot meet the special need, then another (imported) medicinal product should be
considered, which is licensed in the country of origin.4
3

If there is no licensed alternative that meets the patient’s clinical need, then an unlicensed UK manufactured
‘special’ can be considered.4
Where an unlicensed ‘special’ is prescribed then prescribers are advised to follow relevant professional guidance,
taking full responsibility for the decision. The patient (or those with authority to give consent on their behalf) should
provide informed consent, which should be documented in the patient notes.
The need for a ‘special’ should be reviewed regularly, as well as the need for the drug itself.
References:
1. ePACT. Medicines Management Financial Management Report. November 2014.
2. Drug Tariff price, March 2015.
3.ePACT.net. Drug Tariff Special Order Products and Special Order Products Prescribing data. November 2014.
4..MHRA. The supply of unlicensed medicinal products (‘specials’). 2014 (Article text).
Drug Tariff
PRICE CHANGES
Top ten monthly price reductions February 2015
Isosorbide mononitrate 50mg modified-release capsules [1 x 28] £3.69 (-£5.81)
Famotidine 20mg tablets [1 x 28] £17.87 (-£3.81)
Griseofulvin 500mg tablets [1 x 100] £93.31 (-£2.97)
Pentazocine 25mg tablets [1 x 28] £23.51 (-£2.68)
Famciclovir 500mg tablets [1 x 14] £161.00 (-£2.40)
Eplerenone 25mg tablets [1 x 28] £40.58 (-£2.14)
Eplerenone 50mg tablets [1 x 28] £40.58 (-£2.14)
Chlordiazepoxide 10mg capsules [1 x 100] £12.04 (-£0.79)
Glibenclamide 2.5mg tablets [1 x 28] £11.41 (-£0.76)
Irbesartan 300mg/Hydrochlorothiazide 25mg tablets [1 x 28] £8.85 (-£0.62)
Top ten monthly price increases February 2015
Glycopyrronium bromide 2mg tablets [1 x 30] £138.00 (+£23.00)
Glycopyrronium bromide 1mg tablets [1 x 30] £108.00 (+£18.00)
Ascorbic acid 500mg tablets [1 x 28] £25.58 (+£10.30)
Chloral hydrate 143.3mg/5ml oral solution BP [1 x 150] £148.20 (+£10.20)
Amantadine 100mg capsules [1 x 56] £29.80 (+£10.00)
Testosterone enantate 250mg/1ml solution for injection ampoules [1 x 3] £68.00 (+£9.14)
Disopyramide 150mg capsules [1 x 84] £27.58 (+£8.82)
Ascorbic acid 200mg tablets [1 x 28] £17.72 (+£7.14)
4
Temazepam 10mg/5ml oral solution sugar free [1 x 300] £77.61 (+£6.93)
Cloral betaine 707mg tablets [1 x 30] £83.98 (+£5.78)
Top 100 annual price reductions
http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201502.pdf
Top 100 annual price increases
http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201502.pdf
NHSBSA advice regarding payment for NeisVac-C® vaccine, Boostrix IPV® injection and Fluenz
Tetra®▼nasal spray suspension influenza vaccine
NHSBSA Prescription Services request that where vaccines have been centrally procured for the practice through
Public Health England, they should not make a claim under personal administration arrangements to the NHSBSA on
form FP34P/D Appendix or FP10.
NHSBSA Prescription Services has identified an increase in FP34P/D Appendix forms and FP10 forms claiming
payment for Fluenz Tetra®▼ nasal spray suspension Influenza vaccine, NeisVac-C® vaccine and Boostrix IPV®
injection where practices have later verified these have been centrally procured via a vaccine ordering facility, such
as ImmForm. Practices must not submit payment claims for vaccines or injections obtained in this way to the
NHSBSA.
An FP34P/D appendix or FP10 form should only be submitted for payment to cover the ‘dispensing’ of the vaccine
for personal administration where the vaccine has been purchased by the practice.
Practices who have incorrectly submitted centrally procured vaccines to NHSBSA Prescription Services should
contact [email protected] for a payment adjustment.
DRUG AVAILABILITY
Medication supply issues
The following generic drugs have supply issues and hence are incurring increased costs; they have been given a
NCSO (No Cheaper Stock Obtainable) status for February 2015. Please consider the costs of the following drugs
before prescribing.
Product
Quantity
Price concession
Clonidine 0.25mg tablets (new)
112
£6.99
Digoxin 125mcg tablets
28
£4.99
Digoxin 250mcg tablets
28
£4.36
Digoxin 62.5mcg tablets
28
£4.20
Exemestane 25mg tablets
30
£45.74
Haloperidol 5mg/ml solution for injection ampoules
5
£4.33
Lisinopril 20mg /Hydrochlorothiazide 12.5mg tablets
28
£9.50
5
Lofepramine 70mg tablets (new)
56
£15.00
Mebeverine 135mg tablets (new)
100
£13.50
Mefenamic Acid 500mg tablets (new)
28
£12.00
Olsalazine 250mg capsules (new)
112
£47.40
Olsalazine 500mg tablets (new)
60
£53.10
Pizotifen 0.5mg tablets
28
£6.90
Pizotifen 1.5mg tablets
28
£6.40
Tamoxifen 20mg tablets
30
£3.93
Trandolapril 2mg capsules
28
£7.20
Trimethoprim 100mg tablets
28
£7.55
Trimethoprim 200mg tablets
6
£3.10
Trimethoprim 200mg tablets
14
£7.25
The following drugs have long-term supply issues. The table below shows the reason for the supply issue, where
known and possible return to stock dates.
Description
Due date
Comment
Bisacodyl suppositories 10mg (12)
Supplier unable to confirm
Caverject® Dual Chamber
20 micrograms
Supplier unable to confirm
Co-Phenotrope tablets
2.5/0.025mg (100)
Fultium-D3® 800iu capsules (90)
June 2015
Manufacturing issue is causing
delay in supply.
Manufacturing issue is causing
delay in supply.
Medical Information Enquiries
0845 608 8866
Supplier issue is causing a delay
in supply.
Supplier issue is causing
delay in supply.
Supplier issue is causing
delay in supply
Ongoing supply issue.
Supplier issue is causing
delay in supply
Supplier issue is causing
delay in supply
Supplier issue is causing
delay in supply
Hormonin® tablets (84)
Mefenamic Acid tablets 500mg
Trimethoprim 100mg tablets
Trimethoprim 200mg tablets
Traxam® gel 3% 100g
Manufacturer unable to
confirm
Limited supplies ongoing
May 2015
Manufacturer unable to
confirm
May 2015
Manufacturer unable to
confirm
For any further information regarding supply problems please contact your Medicines Management Team.
Discontinued Products
Calcium-Sandoz® syrup (calcium glubionate 1.09g and calcium lactobionate 0.727g per 5ml) has been discontinued
by Alliance Pharmaceuticals and there is no remaining stock available.
6
Nivaquine® (chloroquine sulphate) 68mg/5ml syrup (equivalent to chloroquine base 50mg/5ml) has been
discontinued by Sanofi. There are no other chloroquine syrup preparations available in the UK. However,
chloroquine phosphate tablets are available as an alternative.
Dipentum® (olsalazine sodium) 250mg capsules and 500mg tablets have been discontinued by UCB Pharma.
Generic versions remain available.
Safety
Medicines Optimisation: Identifying medicines associated with serious medication errors.
A recent article ‘Identifying high-risk medication: a systematic literature review’, published in the European Journal
of Clinical Pharmacology http://www.ncbi.nlm.nih.gov/pubmed/24671697 identified those drugs reported to most
commonly cause serious adverse reactions because of medication errors.
Table 1: Top 10 medicines associated with fatal medication errors
Medicine or class
Methotrexate
Warfarin
Opioids
Digoxin
Theophylline
Number (%)
37 (26%)
13 (9%)
9 (6%)
8 (6%)
9 (6%)
Medicine or class
Other anticoagulants
Aspirin
NSAID
Beta-blockers
Antibiotics
Number (%)
7 (5%)
6 (4%)
6 (4%)
5 (4%)
4 (3%)
Table 2: Top 20 medicines associated with non fatal events (hospitalisations, prolonged hospitalisations, lifethreatening condition, and disability) due to medication errors
Medicine or
class
Methotrexate
Theophylline
NSAID
Opioids
Number
(%)
51 (11%)
51 (11%)
39 (8%)
32 (7%)
Medicine or class
Digoxin
28 (6%)
Aspirin
Diuretics
23 (5%)
22 (5%)
Potassium-sparing
diuretics
Antibiotics
Sulfonylureas
Antiepileptics
Beta-blockers
Warfarin
Other anticoagulants
Number
(%)
17 (4%)
17 (4%)
17 (4%)
15 (3%)
14 (3%)
13 (3%)
12 (3%)
Medicine or class
ACE inhibitors
Glucocorticoids
Antipsychotics
Calcium-channel
blockers
Insulin
Antidepressants
Number
(%)
11 (2%)
11 (2%)
10 (2%)
9 (2%)
7 (1%)
7 (1%)
Medication errors are not limited to Healthcare Professionals administering medication incorrectly, but can be
complex and multifactorial. They may take place at any stage from prescribing and monitoring to administration and
compliance. NICE are currently in the process of producing a ‘clinical guideline on medicines optimisation’ due to
published in march this year.
7
NHS England - Patient Safety Alert: Risk of death from asphyxiation by accidental ingestion of fluid/food
thickening powder
NHS England has received details of an incident where a Care Home resident died following the accidental ingestion
of thickening powder that had been left within their reach. Although this death remains under investigation, it
appears the powder formed a solid mass which caused fatal airway obstruction.
Whilst it is important that products remain accessible, all relevant staff need to be aware of potential risks to patient
safety. Appropriate storage and administration of thickening powder needs to be embedded within the wider
context of protocols, bedside documentation and training programmes, and access to expert advice is required to
safely manage all aspects of the care of individuals with dysphagia.
Individualised risk assessment and care planning is required to ensure that vulnerable people are identified and
protected.
For further information please go to:
http://www.england.nhs.uk/2015/02/06/psa-fluidfood-thickening-powder/
Unintentional overdose more likely with long-acting opioids
Results from a US cohort study published in the JAMA Internal Medicine suggest that long-acting opioids carry a
higher risk of unintentional overdose than short-acting formulations. Patients starting long-acting opioids to manage
chronic pain were more than twice as likely to overdose compared to starting treatment with short-acting opioids
with the highest risk being within the first two weeks of initiating treatment. The study suggests that clinicians
weighing the benefits and risks of initiating different opioid regimens should consider not only the daily dose
prescribed but also the duration of opioid action.
Common antibiotic taken with a diuretic linked to sudden death in older patients
Spironolactone, a diuretic used in heart failure, has been linked to sudden death when taken with co-trimoxazole, a
recent Canadian study has found. It is well documented that spironolactone cause hyperkalaemia but so can
trimethoprim.
A retrospective study in 2011 demonstrated the risk of hospital admission resulting from hyperkalaemia in elderly
patients taking spironolactone alongside trimethoprim–sulfamethoxazole (co-trimoxazole). This study used the
administrative health records, spanning 18 years, of more than 200,000 patients prescribed spironolactone.
The 2011 study did not establish whether the drug interaction was associated with an increased risk of death but
more recent analysis of the same data found that of the 11,968 patients who died of sudden death while receiving
potassium-elevating spironolactone, 328 died within 14 days of exposure to certain antibiotics: co-trimoxazole,
amoxicillin, ciprofloxacin, norfloxacin or nitrofurantoin. Most of the patients receiving spironolactone treatment who
died suddenly were 85 years of age or older.
The risk of sudden death was twice as likely with co-trimoxazole compared to those taking amoxicillin.
Hyperkalaemia is a common adverse effect of spironolactone and so the additive adverse effects should be expected
from any drug known to cause hyperkalaemia.
8
Hydroxyzine – new measures to minimise cardiac risks
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that hydroxyzine is associated with
a ‘small but definite’ risk of prolonged QT and torsade de pointes. PRAC has stated that hydroxyzine-containing
medicines can still be used but new recommendations should be followed to minimise risk.
These recommendations include:

Use the medicine at the lowest effective dose for as short a time as possible

Use is not recommended in the elderly

The maximum daily dose should be no more than 100 mg in adults (50 mg in the elderly if use cannot be
avoided), and 2 mg per kg body weight where used in children up to 40 kg in weight

Use must be avoided in patients who already have risk factors for heart rhythm disturbances or are taking
other medicines that increase the risk of QT prolongation

Care is also needed in patients taking medicines that slow the heart rate or decrease the level of potassium
in the blood, as these also increase the risk of problems with heart rhythm.
PRAC confirmed the known possibility of QT interval prolongation and torsade de pointes with hydroxyzine, and
noted that such events were most likely to occur in patients who had risk factors. The risk can therefore be
decreased by restricting hydroxyzine use in those most at risk of heart rhythm problems and reducing exposure to
the medicine. The PRAC recommendations will now be considered and a final position will be prepared; guidance for
patients and healthcare professionals will then follow.
Medicines Management Team contacts:
Victoria Vincent (Wirral)
[email protected]
For any feedback or suggestions on content, please email [email protected]
9
0151 643 5319