Issue 5, May/June 2014
Halton CCG 1
Pan Mersey APC 2
Current Issues 3
Drug Tariff 4
Safety 6
National Institute for health and Care Excellence (NICE) 7
Halton CCG
Immunosuppressant prescribing for organ transplant patients
There is currently some prescribing of immunosuppressant drugs for organ transplant patients being carried out by practices.
Organ transplant services are now commissioned by NHS England and it has set out its intention to repatriate any prescribing of immunosuppressant drugs for organ transplant to specialist centres. These drugs are ciclosporin, sirolimus, tacrolimus, azathioprine, mycophenolate mofetil and corticosteroids. This only applies to prescribing of these drugs for prevention of transplanted organ rejection and not for other indications.
The Cheshire, Warrington and Wirral Area Team of NHS England are working with provider Trusts and CCGs across the North West to develop repatriation plans including the identification of appropriate budgets, to ensure transfer of prescribing occurs safely and that specialist services have capacity to manage these patients.
In the meantime prescribers in primary care should continue to prescribe immunosuppressant drugs for organ transplant patients under current arrangements until further details concerning repatriation are agreed. It is also recommended that prescribers in primary care should not agree to take on new prescribing for any patients starting on these drugs, in view of the fact this will be repatriated in due course.
Teriflunomide
Teriflunomide is a treatment for relapsing-remitting multiple sclerosis that has recently been recommended for use by a NICE technology appraisal http://guidance.nice.org.uk/TA303.
Multiple sclerosis is commissioned by NHS England and all teriflunomide prescribing is carried out by secondary care specialists.
Teriflunomide requires liver enzymes to be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter. The Walton Centre NHS Foundation Trust is aware that it is not appropriate for GPs to get involved with blood testing to monitor liver enzymes in patients prescribed teriflunomide. It is therefore recommended that any requests for liver enzyme monitoring for teriflunomide patients is declined, and responsibility for this monitoring passed back to the specialist.
Pan Mersey APC
RECOMMENDATIONS
AFLIBERCEPT (Eylea®▼) for macular oedema secondary to central retinal vein occlusion
The Pan Mersey Area Prescribing Committee recommends AFLIBERCEPT intravitreal injection (Eylea®▼) as a treatment option for treating visual impairment caused by macular oedema secondary to central retinal vein occlusion only by ophthalmologists in accordance with NICE TA305. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS45.pdf
TRIPTORELIN (Decapeptyl® SR)
The Pan Mersey Area Prescribing Committee recommends that TRIPTORELIN (Decapeptyl® SR 3mg, 11.25mg and 22.5mg) INTRAMUSCULAR INJECTION is first choice gonadorelin analogue for prostate cancer following specialist urologist / oncologist recommendation under shared care agreement or applicable local arrangement. http://www.panmerseyapc.nhs.uk/recommendations/documents/PS46.pdf
IBUPROFEN and NAPROXEN
The Pan Mersey Area Prescribing Committee recommends the prescribing of IBUPROFEN and NAPROXEN as the nonsteroidal antiinflammatory drugs of choice in accordance with the recommendation from the Medicines and Healthcare products Regulatory Authority (MHRA). http://www.panmerseyapc.nhs.uk/recommendations/documents/PS47.pdf
Update to Pan-Mersey Adult Diabetes Management Guidelines
http://www.panmerseyapc.nhs.uk/guidelines/documents/G5.pdf
Current Issues
NEWS
Tramadol reclassification to a schedule 3 controlled drug
Tramadol has now become a Schedule 3 controlled drug (CD No Register POM), but will be exempt from Safe Custody Regulation. This change came into effect on Tuesday 10th June 2014. From this date tramadol will need:
· The full CD prescription writing requirements including -
o The quantity in both words and figures.
o Dose – the dose must be clearly defined. i.e. the instructions: Take as directed, or When required will no longer be legally acceptable
· Prescriptions will only be valid for 28 days.
We would also remind prescribers it is good practice to limit the supply of tramadol on repeat prescriptions to 30 days in line with good practice on prescribing controlled drugs.
There are a number of implications for practices relating to this change, the Medicines Management Team have been in touch with practices to support any actions required of this change.
Pregabalin patent expiry
We are aware drug representatives have been talking to prescribers about the patent expiry for pregabalin. We would like to advise you the regulatory data protection (data exclusivity) for Lyrica® in the European Union expires in July 2014. At this point, generic companies may submit their applications for marketing authorisation for generic versions of pregabalin (we would anticipate generics would be available in the first half of 2015). However, we have been advised a supplementary patent protects Pfizer’s license for pain until 2017.
Whilst we consider the implications of this for the health economy we would advise prescribers continue to follow local guidance on the management of neuropathic pain.
The benefits and risks of statins
Following recent media coverage about side effects associated with statins, the Medicines and Healthcare products Regulatory Agency (MHRA) has published its position on their benefits and risks: http://www.mhra.gov.uk/NewsCentre/CON416702
Amoxicillin dose increase in children
The online BNF and BNF for Children (http://www.bnf.org/bnf/index.htm) now list higher doses of oral amoxicillin for use in children in line with changes to Health Protection Agency (HPA) guidance. The recommended oral doses of amoxicillin and ampicillin for children have been updated to take account of changes made to the amoxicillin product information across Europe, and to address concerns that children may have been receiving inadequate doses. N.B. The current edition of the paper BNF (67th edition, March 2014) which will be in circulation within practices does NOT list the new doses.
The new recommended doses are:
Child 1 month to 1 year - 125mg three times a day, increased if necessary up to 30mg/Kg three times a day
Child 1-5 years - 250mg three times a day, increased if necessary up to 30mg/Kg three times a day
Child 5-12 years - 500mg three times a day, increased if necessary to 30mg/Kg (max. 1g) three times a day
Child 12-18 years - 500mg three times a day; in severe infection 1g three times a day
The standard dose of oral amoxicillin for adults was increased to 500mg three times a day (doubled in severe infection) in September 2013 and this is reflected in the printed and online editions of the BNF.
New SPC: Fultium-D3® 3,200IU capsules
Fultium-D3® 3,200IU capsules are indicated for the treatment of vitamin D deficiency in adults and the elderly, at a dose of one capsule daily for up to 12 weeks, depending on disease severity and patient response. The capsules contain arachis (peanut) oil.
query corner
Now sildenafil tablets are available as generics at a much lower cost, can I prescribe them for erectile dysfunction on the NHS for all my patients?
There has been no change to the current Department of Health guidance. Treatment for erectile dysfunction on the NHS is limited to those men suffering erectile dysfunction with any of the following conditions:
· diabetes, multiple sclerosis, Parkinson's disease, poliomyelitis, prostate cancer, severe pelvic injury, single gene neurological disease, spina bifida, or spinal cord injury.
· are receiving dialysis for renal failure.
· have had radical pelvic surgery, prostatectomy, or kidney transplant.
· were receiving Caverject®, Erecnos®, MUSE®, Viagra® or Viridal® at the expense of the NHS on 14 September 1998.
· are suffering severe distress as a result of impotence (issued by specialist centres).
The Department of Health advises that one treatment a week will be appropriate for most patients treated for erectile dysfunction.
Note: generic sildenafil is now a fraction of the cost of Viagra® and a private prescription for 8 tablets of any strength should cost no more than an NHS prescription.
Drug Tariff
Prazosin tablets
Prazosin 2mg tablets are commonly prescribed as a special order product. However, a 1mg dose is readily available as a licensed formulation and is listed in Drug Tariff Part VIIIA.
price changes
Top ten monthly price reductions
Modafinil 200mg tablets [1 x 30] £78.75 (-£43.93)
Modafinil 100mg tablets [1 x 30] £15.51 (-£31.32)
Levetiracetam 100mg/ml oral solution sugar free [1 x 300] £27.64 (-£30.74)
Dapsone 50mg tablets [1 x 28] £46.69 (-£18.47)
Telmisartan 80mg tablets [1 x 28] £2.48 (-£14.52)
Memantine 20mg tablets [1 x 28] £28.85 (-£13.42)
Telmisartan 40mg tablets [1 x 28] £2.13 (-£11.48)
Riluzole 50mg tablets [1 x 56] £40.21 (-£11.14)
Telmisartan 20mg tablets [1 x 28] £1.85 (-£9.25)
Cilostazol 100mg tablets [1 x 56] £24.71 (-£8.33)
Top ten monthly price increases
Isradipine 2.5mg tablets [1 x 56] £114.75 (+£73.88)
Tranylcypromine 10mg tablets [1 x 28] £160.59 (+£32.12)
Pramipexole 3.15mg modified-release tablets [1 x 30] £389.87 (+£28.88)
Pramipexole 2.62mg modified-release tablets [1 x 30] £337.27 (+£24.98)
Pramipexole 2.1mg modified-release tablets [1 x 30] £259.91 (+£19.25)
Dicycloverine 20mg tablets [1 x 84] £55.20 (+£16.52)
Dicycloverine 10mg tablets [1 x 100] £51.50 (+£15.37)
Pramipexole 1.57mg modified-release tablets [1 x 30] £202.36 (+£14.99)
Dicycloverine 10mg/5ml oral solution [1 x 120] £56.05 (+£12.62)
Orphenadrine 50mg tablets [1 x 250] £231.73 (+£12.28)
Top 100 annual price reductions
http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201404.pdf
Top 100 annual price increases
http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201404.pdf
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 May 2014. Please consider the costs of the following drugs before prescribing (note: only drugs new to the list from April 2014 have been included):
· Amiloride 5mg tablets (28) – £19.10
· Cefalexin 500mg/5ml oral suspension(100ml) – £6.34
· Co-Amoxiclav 500/125 tablets (21) – £6.93
· Co-Amoxiclav 250/125 tablets (21) – £6.00
· Hydroxocobalamin 1mg/ml solution for injection ampoules (5) – £5.50
· Mebeverine 135mg tablets (100) – £16.80
· Naproxen 500mg gastro resistant tablets (56) -£13.59
· Nitrofurantoin 50mg capsules (30)- £13.92
Other drugs with long term supply issues
Description / Due Date / CommentAntabuse 200mg tablets / Manufacturer unable to confirm / A manufacturing issue is causing a delay in supply
Bactroban® Nasal ointment 3G / Supplier unable to confirm / On-going supply issue
Bumetanide 1mg tablets / Supplier unable to confirm / On-going supply issue
Caverject® Dual Chamber 20microgram / January 2016 / A manufacturing issue is causing a disruption in supply
Sumatriptan 50mg tablets / End of May, or June 2014 depending on manufacturer / A raw material issue is causing a delay in supply – Dexcel Pharma will supply directly to pharmacies, so trying other pharmacies is an option, consider prescribing by brand (Imigran 50mg £26.54 for 6), or switching to an alternative low cost generic triptan such as naratriptan 2.5mg tablets or zolmitriptan 2.5mg tablets
Valsartan capsules and tablets – all strengths / June 2014 (although some limited stocks available) / A raw material issue is causing a delay in supply
Note: this list has been complied using information obtained from AAH Pharmaceuticals and Alliance Pharmaceuticals, and that some generics are manufactured by several different companies, which may mean having to “shop around” for supplies.
Discontinuation of metformin sachets 500mg and 1gram.
Merck are discontinuing Metformin sachets (500mg and 1gram strength). These are currently included in the local formulary for patients with swallowing difficulties. There is a licensed liquid preparation available, Drug Tariff cost is £69.56/150ml. This is much more expensive than metformin plain and MR tablets; and the sachets which have been discontinued.
For patients currently taking metformin sachets, the first choice would be tablets if they are now able to swallow. If they do require a liquid formulation they will need to be switched to metformin oral solution sugar free 500mg/5ml at the same dose.
We have been informed that the 500mg sachets are now unavailable and that the 1gm strength will be discontinued soon.
For any further information regarding supply problems please contact your Practice Pharmacist or Technician or the Medicine Management Team.
Safety
Domperidone: risk of cardiac side effects - restricted indication, new contraindications, and reduced dose and duration of use.
Domperidone is linked to a small increased risk of serious cardiac side effects. Its use is now restricted to relief of nausea and vomiting and the dose and duration of use have been restricted as follows:
Adult dose: 10mg TDS up to a maximum of one week
It is now contra-indicated in those with sever hepatic impairment and underlying cardiac conditions such as:
· Congestive heart failure
· With conditions where the cardiac conduction is, or could be, impaired
· Receiving other medications known to prolong QT or potent CYP3A4 inhibitors
Patients should be reviewed at their next routine appointment and be switched to an alternative if required.
UKMi gives further advice on alternative steps:
http://www.midlandsmedicines.nhs.uk/filestore/domperidone%20GI%20restrictions%20May%202014.pdf
FDA drug safety communication warns of risk of rare but serious neurological problems linked to epidural corticosteroid injection
The FDA is warning that corticosteroid injections into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. It is requiring the addition of a warning to the drug labels to describe these risks.
http://www.fda.gov/Drugs/DrugSafety/ucm394280.htm
National Institute for health and Care Excellence (NICE)
clinical guidelines
Pressure ulcers: prevention and management of pressure ulcers
This guideline updates and replaces NICE clinical guideline 29 (published September 2005) and NICE clinical guideline 7 (published October 2003). It offers evidence-based advice on the prevention and management of pressure ulcers.
http://guidance.nice.org.uk/CG179
Lucy Reid (Halton) 01928 593 452
Danuta Kay (Warrington) 01925 843785
Sally McLaren (West Cheshire) 01244 650593
Vicky Vincent (Wirral) 0151 643 5319
Kieron Donlon (Pan Mersey) 0151 296 7076