Wirral Drug & Therapeutics Committee · Oral Methocarbamol (Robaxin®) Oral Methocarbamol is licensed only for use as a short-term adjunct to the symptomatic treatment of acute musculoskeletal

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Issue 11, Dec/Jan 2015

Wirral Drug & Therapeutics Committee ..................................................................................................................................... 1 Current Issues ............................................................................................................................................................................. 1 Topic of the month ..................................................................................................................................................................... 6 Drug Tariff .................................................................................................................................................................................. 7 Safety ......................................................................................................................................................................................... 9 Public Health England ............................................................................................................................................................... 13

Wirral Drug & Therapeutics Committee

RECOMMENDATIONS

Medicines Clinical Guidance Sub-Team of Wirral Drug & Therapeutics Panel

This group met recently and the following guidelines were approved and should soon be available on the Wirral

Medicines Management website at http://mm.wirral.nhs.uk/guidelines/

• COPD Guideline

This now places DuoResp Spiromax® and Fostair® MDI as the first line ICS/LABA combination inhalers.

• Asthma Guideline

Fostair® MDI and DuoResp Spiromax® are now first line ICS/LABA combination therapies.

• Anticoagulation for Stroke Prevention in Atrial Fibrillation Quick Reference Guide

This follows the NICE Guideline CG180 Atrial Fibrillation.

• Dyspepsia Guideline

• Erectile Dysfunction Guidelines

This has been updated to reflect changes in prescribing generic sildenafil.

• Shared Care Protocol - Azathioprine and Mercaptopurine for IBD

Mercaptopurine has been included in this Shared Care Protocol along with azathioprine.

Current Issues Important information regarding flu vaccinations

The NHS Business Services Authority (NHSBSA) has requested that CCGs make practices aware that where Fluenz®

Tetra vaccine nasal suspension or Influenza vaccine (live attenuated) nasal suspension 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.

An FP34P/D Appendix should only be submitted for payment where the vaccine has been purchased by the practice

specifically for personal administration.

http://mm.wirral.nhs.uk/guidelines/

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Compliance Aids

In response to several requests for information regarding supplying prescriptions for issue into patient compliance

aids we have referred to the several Pharmaceutical Services Negotiating Committee (PSNC) factsheets which

provide a useful reference.

In summary the key points are:

The funding agreed for the pharmacy contractual framework included a sum towards the pharmacist’s

compliance with the Disability Discrimination Act 1995 (now the Equality Act 2010). This sum is not distributed

specifically for any adjustments made, but is distributed on a flat rate basis, towards any adjustments that the

pharmacist makes. It is therefore towards the funding for easy open containers, large print labels, reminder

charts, compliance aids etc.

It is the pharmacist’s decision as to whether compliance aids are appropriate for the patient, and which would

best suit the patient’s needs. The legislation does not require a formal assessment to be carried out, only that a

reasonable adjustment is made to help a disabled person overcome the obstacles to the use of the service. A

pharmacy could provide compliance aids (such as easy open containers, reminder charts) that will assist the

patient to use the service.

If a patient requires a compliance aid because they have a disability, and a compliance aid is the only reasonable

means of overcoming the obstacles to them using the dispensed medicines, then that will be funded by the

Equality Act 2010 element of the practice payment. It will not cover compliance aids provided for convenience,

or where it is being used for a purpose other than to comply with the Equality Act 2010.

The final decision whether or not to use a compliance aid for a patient with a disability in order to comply with

the obligations in the Equality Act 2010 is for the pharmacist to assess. GPs cannot insist that compliance aids

are used. However, if a GP identifies a patient who may require support overcoming the obstacles to using

dispensed medicines they may discuss this with the pharmacy.

Once a medicine has been dispensed, the NHS pharmacy terms of service do not require the pharmacy to make

any further adjustments. Therefore, if the patient’s therapy is changed, unless the GP has instructed the patient

to ignore any of the discontinued medicines from the prepared pack, and is confident that the patient will do

this and be able to take the separately dispensed replacements, the whole compliance aid container should be

discarded, and a new one produced. As the decision to dispense in a compliance pack was on disability grounds,

it is possible that the patient will not be able to handle a separately dispensed item, and if this is the case, there

is no alternative but for the GP to issue a new prescription for all current medicines, so that they can be

dispensed together in a replacement pack.

28 day prescriptions are appropriate for those patients that the pharmacist has assessed as requiring a

compliance aid because they have a disability, and the compliance pack is the only reasonable means of

overcoming the obstacles to using the dispensed medicines. The pharmacy may supply 4 x 7 day compliance aids

or 1 x 28 day compliance aid, issued to the patient on one occasion.

Practices may decide 7 day prescriptions would be appropriate for a patient whose medication regime is

unstable (to reduce waste generated from the need to replace the whole of the remaining cycle of packs

required from changing one item), or may be at risk if the patient had access to more than 7 days at a time e.g.

risk of self harm or severe compliance issues.

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For further information see:

http://psnc.org.uk/contract-it/psnc-briefings-pharmacy-contract-and-it/psnc-briefing-08413-the-equality-act-2010-

august-2013/

http://psnc.org.uk/contract-it/pharmacy-regulation/dda/the-equality-act-2010-28-day-prescribing/

Medical Exemption Certificates- renewal required every five years.

People with certain medical conditions can get free NHS prescriptions if they hold a valid medical exemption

certificate. Medical Exemption Certificates last for five years or until the patients 60th birthday, whichever is sooner.

The certificates are renewed by asking the GP to complete and submit a new FP92A application form. The patient

will be sent a reminder letter approximately one month before their certificate is due to expire.

A proportion of prescription forms are checked to verify the circumstances in which a patient has claimed exemption

or remission. If patients are found to have claimed entitlement incorrectly, such as a patient who has claimed free

NHS prescriptions but whose medical exemption certificate has expired, they will be asked to pay the full amount of

any unpaid NHS costs. Patients are now also liable to pay a penalty charge in addition to the original charge. The

penalty is five times the amount wrongly claimed, up to a maximum of £100. A further surcharge will be imposed if

the total is not paid within a specified period. Failure to respond to a Penalty Notice may result in civil recovery

action being taken through the County Court and the patient may be liable for additional court costs.

There does not need to be any proof of criminal intent; liability is normally incurred simply by an incorrect claim to

exemption. Penalties may therefore be imposed on any patient.

Patients have responsibilities towards the NHS as well as rights. It is the patient’s responsibility to ensure that they

claim exemption from or remission of NHS charges correctly. A person will be liable for a penalty charge if they have

acted wrongfully, or carelessly, in relation to the original charge. Ignorance of the rules relating to NHS health costs

is not a valid defence.

Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new legal offence

The Department for Transport has introduced a new offence of driving with certain controlled drugs above specified

limits in the blood; this is likely to come into force on 2nd March 2015. The list of drugs includes some licensed

medicines. Anyone found to have any of these drugs in their blood above the specified limits will be guilty of an

offence, whether driving was impaired or not.

The legislation provides a statutory “medical defence” for people taking the drugs for medical reasons, if their

driving was not impaired. The conditions of the medical defence state that the individual is not guilty of an offence

if:

the medicine was prescribed, supplied, or sold to treat a medical or dental problem, and

it was taken according to the instructions given by the prescriber or the information provided with the medicine.

Drugs included in the new offence that might be used for medicinal purposes are: cannabis (tetrahydrocannabinol,

THC), cocaine, morphine, diamorphine, methadone, ketamine, amphetamine, flunitrazepam (not currently licensed

in the UK), clonazepam, diazepam, lorazepam, temazepam and oxazepam.

http://psnc.org.uk/contract-it/psnc-briefings-pharmacy-contract-and-it/psnc-briefing-08413-the-equality-act-2010-august-2013/http://psnc.org.uk/contract-it/psnc-briefings-pharmacy-contract-and-it/psnc-briefing-08413-the-equality-act-2010-august-2013/http://psnc.org.uk/contract-it/pharmacy-regulation/dda/the-equality-act-2010-28-day-prescribing/

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Advice for healthcare professionals: Any condition that requires medicinal treatment may itself pose a risk to driving

ability if left untreated. Therefore it is important to advise patients to continue their treatment.

For further information see: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON432898

Tiotropium in asthma

As described in last month’s newsletter, The British Thoracic Society has updated their latest asthma guidance and at

step 4, the guidance states that there appears to be benefit in adding tiotropium to ICS and salmeterol in patients

who remain symptomatic despite these medications (p67 of full guidance document).

However, clinicians are reminded that tiotropium (Respimat®) has not been to Wirral Drug &Therapeutics Panel

(WDTP) for use in asthma yet and patients should be referred to secondary care if they are uncontrolled at step 4 as

per Wirral Asthma Guidelines. An application will be submitted to WDTP shortly and clinicians will be informed of

the outcome.

BTS Guidance: https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-

guideline-2014/

Wirral Guidelines: http://mm.wirral.nhs.uk/document_uploads/guidelines/asthmaguidelinesv2.pdf

Oral Methocarbamol (Robaxin®)

Oral Methocarbamol is licensed only for use as a short-term adjunct to the symptomatic treatment of acute

musculoskeletal disorders associated with painful muscle spasms.1,2

The Joint Formulary Committee considers the drug 'less suitable for prescribing' as indicated by the ‘ ‘ symbol.1

The limited available clinical trial evidence for methocarbamol suffers from poor design, making evaluation of place

in therapy difficult. It is better than placebo, but not superior to analgesics, sedatives, or other commercially

available muscle relaxants.2

Mechanism of action in humans has not been established, but is thought to be due to general central nervous

system depression. It may potentiate the effects of other central nervous system depressants, stimulants and

anticholinergics. Little is known about the possibility of interactions with other drugs.2

The following side effects and adverse reactions have been reported2,3 :

Body as a whole: Angioneurotic oedema, anaphylactic reaction, fever, headache.

Cardiovascular system: Bradycardia, flushing, hypotension, syncope.

Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting.

Blood and lymphatic system: Leucopenia.

Nervous system: Restlessness, anxiety, tremor, amnesia, confusion, diplopia, dizziness or light-headedness, vertigo,

drowsiness, insomnia, mild muscular incoordination, nystagmus, seizures (including grand mal).

Skin and special senses: Blurred vision, conjunctivitis with nasal congestion, metallic taste, pruritus, rash, urticaria.

GPs may wish to review patients prescribed methocarbamol at their next routine medication review, and give

consideration to prescribing a suitable alternative where appropriate.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON432898https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2014/https://www.brit-thoracic.org.uk/document-library/clinical-information/asthma/btssign-asthma-guideline-2014/http://mm.wirral.nhs.uk/document_uploads/guidelines/asthmaguidelinesv2.pdf

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References:

1. eBNF Available at: https://www.medicinescomplete.com/mc/bnf/current/

2. Micromedex® Available at: http://www.micromedexsolutions.com/

3. SPC Robaxin available at: http://www.medicines.org.uk/emc/medicine/22599

QUERY CORNER

Can clopidogrel be prescribed post MI for aspirin intolerance?

NICE defines aspirin intolerance as proven hypersensitivity to aspirin-containing medicines or history of severe

dyspepsia caused by low-dose aspirin.

For secondary prevention of cardiovascular disease, which includes myocardial infarction as an indication, long-

term clopidogrel 75 mg tablets, once daily, can be prescribed as an alternative if aspirin is contraindicated or not

tolerated.1

If taking clopidogrel alone or in combination with aspirin, then avoid co-prescribing omeprazole or esomeprazole

with clopidogrel, or use an alternative PPI or consider prescribing an H2-receptor antagonist for 1 month (for

example, ranitidine [avoid cimetidine]).1

Reference:

1. NICE CKS ( http://cks.nice.org.uk/antiplatelet-treatment#!scenariorecommendation:4)

What dose of low molecular weight heparin (LMWH) could be used for air travel VTE prophylaxis?

A UKMI medicines Q&A (426.2, July 2014) discussed the evidence for use of LMWH for prophylaxis of travel-related

thrombosis:

http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=789669

It outlines that there is no clear guidance on prescribing of LMWH for air travel VTE prophylaxis (e.g. choice of

preparation, dosage, time of administration and duration of treatment). Clinicians should assess the risk of patients

developing travel-related VTE on a case by case and, if it is out their scope of practice, to seek specialist advice from

a haematologist before prescribing LMWH. If a LMWH is indicated, a pragmatic approach would be to use the

recommended LMWH dose for prophylaxis in high risk settings (e.g. enoxaparin 40mg).

Should my patient buy that “miraculous cure” advertised on the internet or in a magazine?

UKMI have produced a Medicines Q&A which provides some questions and thoughts to help structure discussions

with a patient if he or she asks about buying a medicine that may be of dubious worth or quality. The document can

be accessed through the link below:

http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=793622

Can Midodrine be prescribed for hypotension?

Midodrine is not currently listed within Wirral Drug Formulary or RAG list. Midodrine is an unlicensed product.

The BNF lists midodrine as a possible option for the treatment of neuropathic postural hypotension. They advise the

following: increased salt intake and the use of the licensed mineralocorticoid fludrocortisone 100–400 micrograms

https://www.medicinescomplete.com/mc/bnf/current/http://www.micromedexsolutions.com/http://www.medicines.org.uk/emc/medicine/22599http://cks.nice.org.uk/antiplatelet-treatment#!scenariorecommendation:4http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=789669http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=793622

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daily [an unlicensed use] may help by increasing plasma volume, but uncomfortable oedema is a common side-

effect. Fludrocortisone can also be combined with flurbiprofen and ephedrine hydrochloride [both unlicensed].

GPs are advised to discuss alternative treatments with specialists or to contact Wirral Medicines Information Service

to discuss options.

Topic of the month

NATIONAL OBESITY AWARENESS WEEK (12TH-18TH JAN 2015)

The NHS spends £6bn on the medical costs of conditions related to being overweight and obese, and a further

£10bn on diabetes, every year.

Eight out of ten men and seven out of ten women are likely to be obese in the UK by 2020.

January 12th to 18th 2015 will be ‘National Obesity Awareness Week’ (NOAW)

The aim of NOAW is to promote the ways in which government, business and individuals can improve their health

and to provide the information and resources that will allow meaningful and long-term change. It is not about

making a huge commitment or an incredible challenge, but manageable and sustainable change – this could include

eating more healthily or increasing physically activity.

NOAW have launched a website http://www.noaw.org.uk/. The website includes information to help individuals and

organisations tackle obesity, including information about health and fitness, eating well, weight loss and how to get

involved.

NICE have issued new guidelines on obesity identification, assessment and management (CG189)

The guidelines advise on interventions to prevent obesity in all age groups including advice on how to keep track of

weight, behaviours to maintain a healthy weight and where to get advice and help with losing weight. There are

lifestyle and weight management programmes for both adults and children.

For obese patients, the emphasis is on assessing lifestyle, co-morbidities and a willingness to change. Then the

guidelines cover managing weight through lifestyle changes.

NICE suggest considering drug treatment for people who have not reached their target weight loss or who have

reached a plateau on dietary, activity and behavioural changes.

Orlistat is the only treatment available on prescription in the UK for adults with a BMI of ≥30 kg/m2 or ≥28 kg/m2

with associated risk factors. It should be prescribed as part of an overall plan for managing obesity. Making the

decision to start should be done after discussing the potential benefits and limitations with the person, including the

mode of action, adverse effects, monitoring requirements and the potential impact on the person's motivation.

Ensure that appropriate healthcare professionals can offer information, support and counselling on additional diet,

physical activity and behavioral strategies when drug treatment is prescribed. Information about patient support

programmes should also be provided.

Orlistat should ONLY be continued beyond 3 months if the person has lost at least 5% of their initial body weight

since starting drug treatment. The decision to use drug treatment for longer than 12 months (usually for weight

maintenance) should be made after discussing potential benefits and limitations with the person. The co-prescribing

of orlistat with other drugs aimed at weight reduction is not recommended.

http://pathways.nice.org.uk/pathways/obesity

http://www.noaw.org.uk/http://pathways.nice.org.uk/pathways/obesity

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Drug Tariff

PRICE CHANGES Top ten monthly price reductions December 2014 Famciclovir 500mg tablets [1 x 14] £167.14 (-£11.23) Clobetasol 500micrograms/g shampoo [1 x 125] £10.29 (-£5.70) Ciprofibrate 100mg tablets [1 x 28] £104.56 (-£2.08) Chlordiazepoxide 10mg capsules [1 x 100] £13.66 (-£1.66) Chlordiazepoxide 5mg capsules [1 x 100] £7.03 (-£1.59) Dipyridamole 25mg tablets [1 x 84] £7.22 (-£1.34) Co-amilofruse 10mg/80mg tablets [1 x 28] £16.11 (-£1.19) Levofloxacin 250mg tablets [1 x 10] £9.55 (-£1.13) Glibenclamide 2.5mg tablets [1 x 28] £13.12 (-£0.95) Olanzapine 20mg orodispersible tablets sugar free [1 x 28] £9.20 (-£0.60) Top ten monthly price increases December 2014 Co-danthramer 25mg/200mg/5ml oral suspension sugar free [1 x 300] £120.02 (+£10.87) Chloramphenicol 5% ear drops [1 x 10] £50.13 (+£9.21) Disopyramide 150mg capsules [1 x 84] £27.58 (+£8.82) Carbimazole 20mg tablets [1 x 100] £168.45 (+£8.36) Chlordiazepoxide 10mg tablets [1 x 100] £33.00 (+£7.80) Cloral betaine 707mg tablets [1 x 30] £74.80 (+£6.80) Dicycloverine 20mg tablets [1 x 84] £86.77 (+£6.62) Dicycloverine 10mg/5ml oral solution [1 x 120] £81.44 (+£6.31) Dicycloverine 10mg tablets [1 x 100] £82.18 (+£6.25) Prochlorperazine 3mg buccal tablets [1 x 50] £18.22 (+£6.24) Top 100 annual price reductions December 2014 http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201412.pdf Top 100 annual price increases December 2014 http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201412.pdf

COST EFFECTIVE PRESCRIBING

Here are some quick ways to reduce costs:

Arimidex® 1mg tablets x 28 changed to anastrazole 1mg tablets saves £66.53 per pack or £864.89 per annum.

Imigran® 50mg tablets changed to sumatriptan 50mg tablets x 6 saves £30.20 per pack

Imigran® 100mg tablets changed to sumatriptan 100mg tablets x 6 saves £49.52 per pack

Imigran Radis® 50mg tablets changed to sumatriptan 50mg tablets x 6 saves £22.25 per pack

Imigran Radis® 100mg tablets changed to sumatriptan 100mg tablets x 6 saves £40.94 per pack

Singular® 4mg chewable tablets x 28 changed to montelukast 4mg chewable tablets x 28 saves = £23.58 per

pack or £306.54 per annum.

Singulair® 10mg tablets x 28 changed to montelukast 10mg tablet x 28 saves = £24.55 per pack or £319.15 per

annum.

http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201412.pdfhttp://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_increases_201412.pdf

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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 December 2014. Please consider the costs of the following drugs

before prescribing.

Product Pack Size Price concession

Amantadine 100mg capsules 56 £19.80

Amiloride 5mg tablets 28 £14.05

Co-amilofruse 2.5/20 tablets 28 £4.32

Co-amilofruse 5/40 tablets 28 £4.80

Co-Tenidone 50/12.5mg tablets 28 £3.36

Co-Tenidone 100/25mg tablets 28 £3.55

Estriol 0.01% cream 80g £16.04

Exemestane 25mg tablets 30 £42.20

Fenofibrate micronised 200mg capsules 28 £12.00

Naftidrofuryl 100mg capsules 84 £8.10

Pizotifen 0.5mg tablets 28 £5.78

Pizotifen 1.5mg tablets 28 £5.45

Tamoxifen 20mg tablets 30 £4.15

Trandolapril 2mg capsules 28 £7.50

Omega-3-acid (Prestylon®)

Unfortunately, due to global supply issues affecting the availability of the active pharmaceutical

ingredient, Prestylon® is likely to go out of stock during January and at other points during 2015. We have therefore

removed this recommendation to switch from ScriptSwitch and we advise that patients are switched to the generic

formulation when community pharmacies indicate that stocks of Prestylon® are no longer available.

Product Pack Size Price

Omega-3-acid Ester (Prestylon®) 1 g cap Pack of 28 caps £10.68

Omega-3-acid Ester (Omacor®) 1 g cap Pack of 28 caps £14.24

Omega-3-acid (EPA/DHA) 460 mg / 380mg caps Pack of 28 £14.24

Prices Drug Tariff/ MIMS December 2014

Demeclocycline Capsules

There is currently a shortage of licensed demeclocycline capsules. They will not be available until June 2015. After

exploring all available options, it was agreed at Wirral CCG Medicines Management QIPP group that the most

suitable option would be to prescribe unlicensed demeclocycline tablets in primary care for these patients until the

licensed version becomes available.

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There are six Wirral patients, at the time if writing, who are currently prescribed demeclocycline. The relevant

practices have been contacted directly.

Community pharmacies have been advised that they will need to obtain unlicensed demeclocycline as a ‘Special’. If

there are any queries then please contact the Medicines Management Team on 0151 643 5338.

Other drugs with long-term supply issues

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

Bactroban cream 15g Supplier unable to confirm GSK Enquiries Call 0800 221 441

Betnovate cream 30g/100g

Betnovate oint 30g/100g

Betnovate RD ointment/ cream 100g

End of February 2015 GSK Enquiries Call 0800 221 441

Dermovate cream and ointment End of February 2015 GSK Enquiries Call 0800 221 441

Eumovate cream End of February 2015 GSK Enquiries Call 0800 221 441

Ezetrol tablets 10mg No date given Contact MSD/AAH

Gentisone HC ear drops Manufacturer unable to confirm

Temporary supply issue

Glucophage SR tablets 500mg Limited supplies ongoing Stock in transit to Alliance Healthcare.

Mefenamic acid tablets 500mg Supplier unable to confirm Ongoing supply issue

Synalar cream 1:4 dilution 50g Manufacturer unable to confirm

A manufacturing issue is causing a delay in supply

Trimovate cream End of January 2015 Medical Information Enquiries - 0800 221 441

For any further information regarding supply problems please contact your Practice Pharmacist/Technician or the

Medicines Management Team.

Safety

Minimising Dosing Errors

A recent incident highlighted the need for prescribers and pharmacists to be extra vigilant when prescribing and

dispensing extremely small doses for very young children. Whilst no harm came to the patient it highlighted how a

decimal point in the wrong place can lead to a dose ten times the intended being prescribed and dispensed.

Dosing errors are the most frequently reported type of medication error. In the reports to the National Reporting

and Learning System (NRLS), the greatest number of reported incidents of deaths and severe harms from dosing

errors related to opioids, anticoagulants and insulin products. Children and older people are more commonly

involved in dosing errors than other patients.

In the fourth report from the Patient Safety Observatory, “Safety in doses: medication safety incidents in the NHS”,

the NPSA made the following recommendations for healthcare professionals:

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• Ensure that when prescribing, dispensing, preparing, administering or monitoring medicines you are fully aware

of, and have easy access to essential information regarding medicine dosing. In particular, help minimise dosing

errors in children by making full use of the BNF for Children.

• Always undertake the required checks on dosage. Do not assume that some other member of staff will have

undertaken the safety check.

• If dosage calculations are required, where possible, ask another healthcare professional to also calculate the

dosage independently.

• Ensure arrangements are in place for all the required clinical monitoring and dosage adjustments to be made as

required.

• When prescribing, dispensing or administering medicines ensure that you are aware of the previous dose, any

change in the patient’s clinical condition and any laboratory data that may indicate a change is required in the

dose of the medicine.

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=61392

Low-dose methotrexate and alcohol

Long term use of methotrexate at low doses (up to 25mg weekly) is associated with an increased risk of liver

cirrhosis and fibrosis. Previous studies have suggested that patients who drink alcohol whilst taking methotrexate

have a greater likelihood of developing liver damage. This led to the recommendation that alcohol should be

avoided. However recent evidence has shown that the risk of liver toxicity is dependent on a number of factors such

as previous and current alcohol use as well as whether it is being used to treat psoriasis or rheumatoid arthritis.

Patients who have psoriasis are advised to limit their alcohol intake to 4 to 6 units a week and those who take

methotrexate for rheumatoid arthritis are advised to consume no more than the national recommended limits of 2

to 3 units for women and 3 to 4 units for men. Methotrexate should not be given to patients who have significantly

impaired liver function, patients with a history of liver disease or those patients suspected of alcohol abuse.

http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=509825

Safer Use of Sharps EU Directive (Insulin)

The Directive highlights that it is a breach of Health and Safety law for Healthcare Staff to use a ‘non-safe’ sharp in

cases where there is a version of a ‘safe sharp’.

When patients are self-administering insulin there is no need for safer sharps to be used or prescribed. However,

when healthcare professionals are administering insulin (either withdrawing from a vial or using insulin pens) then

the EU Directive states that any equipment used must be compliant.

Wirral Community Trust have arranged that Community Nursing Teams carry a stock of the safer sharp devices for

situations in which they encounter the need to administer insulin with needles without safety technology. They will

then make a request to GPs to prescribe safer sharps for these patients only for as long as third-party healthcare

staff are handling and administering insulin to these patients.

Wirral Community Trust has made the decision to use the following safer sharps when their Community Nurses are

administering insulin to patients:

http://www.nrls.npsa.nhs.uk/EasySiteWeb/getresource.axd?AssetID=61392http://www.medicinesresources.nhs.uk/GetDocument.aspx?pageId=509825

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For Syringes:

Kendall Magellan insulin safety syringes £6.60 for 50

These come in the following dimensions: 0.3ml syringe and needle (0.3mm/30g), 0.5ml syringe and needle

(0.3mm/30g) and 1.0ml syringe and needle (0.3mm/30g)

For Pen Devices:

Novofine Autocover 8mm/30 gauge £22.28 for 100

Prices from the Drug tariff online December 2014

Community Nurses will request that GPs prescribe the safety devices for syringes or pen devices for those patients

administered insulin under their care. They will also highlight to GPs any patients under their care on insulin pens, as

there may be the option of directly transferring some patients to the same insulin in a vial formulation. This would

be a cost saving and would also be safer in terms of administration for the Community Nurse. Where the insulin is

not available in a vial, the GP should decide if patients are to remain on the same insulin (thus remaining on the pen

device) or if the insulin could be changed to an alternative insulin (in a vial) without compromising the patients’

therapy. This may involve highlighting the patient to be considered for a change in insulin therapy to a vial

formulation at any routine secondary care review.

Reminder - From July 2014, Metoject® syringe changed to Metoject®Pen

The previously available licensed syringes (Metoject®) have now been replaced by Metoject® Pen, a pre-filled

methotrexate auto injector. This has affected how patients administer the product. Information regarding the

switch, including patient administration guides and a video regarding administration is available at:

http://metoject.co.uk/patient/metoject-is-switching/

All GP Practices should check that their prescribing systems have been updated with this change and that if the

syringe is marked as discontinued it has the correct link to the new product. There have been several incidents of

patients not receiving treatment, delayed treatment or worse still receiving unlicensed syringes of methotrexate in

the wrong concentration. Repeat prescriptions for these patients need to be changed to Metoject® Pen to ensure

patients are able to obtain their prescribed medication. If methotrexate prefilled injections are prescribed

generically then the word PEN should be added manually to the prescription and initialed by the prescriber as the

generic description has been reported as confusing to pharmacies and could cause dispensing errors.

GPs should prescribe the usual 1L sharps bin on a monthly basis as only four Metoject® Pens can fit in the bin.

Patient safety alert – Risk of death or serious harm from accidental ingestion of potassium permanganate

preparations

NHS England has issued a Stage One patient safety alert on the risk of death or serious harm from accidental

ingestion of potassium permanganate preparations. The alert reminds healthcare professionals that though this

preparation is supplied as a tablet, it is to be used topically and not ingested. The alert has been issued in response

to a recent death of a patient after ingesting potassium permanganate orally. Whilst this death remains under

investigation, analysis of the National Reporting and Learning System (NRLS) has identified 43 incidents in the past

three and a half years where potassium permanganate tablets have been ingested orally by patients.

http://metoject.co.uk/patient/metoject-is-switching/

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Although packaging clearly states potassium permanganate should not be swallowed, it is very unusual for a topical

preparation to come in a tablet form, and therefore some staff, patients and carers may accidentally treat it as an

oral preparation. The risk of error appears to increase when the term ‘potassium permanganate tablets’ is used

rather than a term such as ‘potassium permanganate soak’. The risk of accidental ingestion also increased where

receptacles that implied oral ingestion were used, such as plastic cups or jugs. Other incidents involved potassium

permanganate being directly dispensed to vulnerable patients in their own homes and the patient misunderstanding

that the tablets were not for oral ingestion.

Where accidental ingestion had occurred, staff did not always appear aware of the need to treat this as a medical

emergency and that analysis of the NRLS reports suggested that arrangements for supply, storage and preparation

varied greatly among healthcare providers.

Clinicians should ensure that patients and their carers are aware of the risks and ensure that appropriate counselling

is given.

Further information can be found through the link below and also on the Wirral Medicines Management website:

http://www.england.nhs.uk/2014/12/22/psa-potassium/

http://mm.wirral.nhs.uk/OtherTopics/

MHRA DRUG SAFETY UPDATE DECEMBER 2014

Ivabradine (Procoralan) in the symptomatic treatment of angina: risk of cardiac side effects—new advice to

minimise risk

Ivabradine may be associated with the risks of bradycardia, atrial fibrillation, and other cardiovascular risks. Only

start ivabradine if the resting heart rate is at least 70 beats per minute.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491129

Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders—warn patients and family; monitor

patients for signs of depression

The MHRA has issued safety advice to remind patients and family of the possible risk of psychiatric disorders.

Patients and their family should be warned that isotretinoin may cause psychiatric disorders and they should

monitor for signs of depression. If patients have a history of depression the balance of benefits of treatment should

be considered against the risk of psychiatric disorders.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491130

Hydroxyethyl starch intravenous infusions to be used only in patients with acute blood loss and when crystalloids

alone are not sufficient

The licences of all hydroxyethyl starch (HES) products were suspended in the UK in June 2013. A European regulatory

review of the benefits and risks of HES has since been completed.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491131

http://www.england.nhs.uk/2014/12/22/psa-potassium/http://mm.wirral.nhs.uk/OtherTopics/http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491129http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491130http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491131

13

Hydrogen peroxide: reminder of risk of gas embolism when used in surgery–do not use in closed body cavities or

on deep or large wounds

There have been life threatening and fatal cases of gas embolism with use of hydrogen peroxide during surgery. We

remind you that hydrogen peroxide must not be used during surgery

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491132

Veletri (epoprostenol) powder for solution for infusion: incompatibilities with some models of administration

devices

There have been reports of reconstituted solution leaking from some models of extension sets and pumps. The

administration accessories listed below have been shown to be compatible with Veletri.

http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON491133

Public Health England

PUBLIC HEALTH RESOURCES

Pregabalin and gabapentin: Risk of misuse

Public Health England and NHS England have jointly issued guidance on the risk of misuse of pregabalin and

gabapentin.

In summary, clinicians are reminded of the potential benefits of these drugs to patients, but also that the drugs can

lead to dependence and may be misused or diverted. Practitioners should prescribe pregabalin and gabapentin

appropriately to minimise the risks of misuse and dependence, and should be able to identify and manage problems

of misuse if they arise. Most patients who are given these drugs will use their medicines appropriately without

misuse.

Prescribing for patients with a known or suspected propensity to misuse, divert or become dependent on these

drugs may place these people at greater risks from their use. Prescribers must make a careful assessment to balance

the potential benefits against the risks. However, it should be noted that such patients may also have a higher

prevalence of the indicated conditions for these drugs and some may benefit from their use.

Patients who are offered these drugs need to have sufficient information to consent to the treatment plan. Patients

should be aware of the likely efficacy of the drugs for management of their symptoms and also about the risk of

harms, including dependence.

This information can be read in full through the link below:

https://www.gov.uk/government/publications/pregabalin-and-gabapentin-advice-for-prescribers-on-the-risk-of-misuse

Medicines Management Team contacts:

Victoria Vincent (Wirral) [email protected] 0151 643 5319

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