wirral medicines clinical guidelines sub group of d&t...
TRANSCRIPT
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Issue 15, May 2015
Wirral Clinical Guidelines Group ................................................................................................................................................. 1 Current Issues ............................................................................................................................................................................. 1 Query Corner .............................................................................................................................................................................. 4 Topic of the month ..................................................................................................................................................................... 5 Drug Tariff .................................................................................................................................................................................. 8 Safety ....................................................................................................................................................................................... 11 Public Health England ............................................................................................................................................................... 14
Wirral Medicines Clinical Guidelines sub group of D&T (April 2015)
The following guidelines were approved at the April committee:
Checklist for the initial medical and surgical management of patients with Parkinson's disease.
Guidelines for the treatment and care of children and young adults with ADHD.
Antiplatelet and anticoagulant in stroke guidelines – quick reference guide.
The following shared-care guidelines were approved:
Lisdexamfetamine shared-care in children and adolescents.
Methotrexate (oral and subcutaneous) for psoriasis and other dermatological conditions.
Mycophenolate mofetil for pemphigus and other dermatological disease (adults).
Hydroxycarbamide for psoriasis (adults).
These will shortly be available on the Medicines Management Website at http://mm.wirral.nhs.uk/guidelines/.
Current Issues GP Reporting of Hospital Prescribing Issues
The most recent report for hospital prescribing issues can be found via the following link:
http://mm.wirral.nhs.uk/document_uploads/hospital-concerns/InterfaceReportQ4201415.pdf
There were only three issues reported in Q4 of 2014-15, which is very low compared to the usual numbers.
Taking the time to report concerns will ensure the Medicines Management Team are aware of problems with
hospital prescribing. They can then be addressed to prevent further occurrences and so improve patient care.
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Trends can be monitored and similar incidents for a particular Prescriber escalated in a formal manner.
Reporters are reminded to ensure the immediate clinical need of the patient is addressed before reporting the issue,
to ensure no patient is left without medication.
The following issues should be raised using the GP Reporting Forms for Hospital Prescribing Issues:
Non-Formulary prescribing
Requests to prescribe Hospital-Only Medicines
Lack of information for shared-care prescribing
Inappropriate changes to medication
Medication supply problems
Prescribing errors.
Other non-prescribing issues such as lack of discharge information or handwriting concerns should be submitted to
the CCG via their Primary Care Incident Reporting Form on the CCG website:
https://www.wirralccg.nhs.uk/About%20Us/primary-care-incident-reporting.htm
The GP Reporting Forms for Hospital Prescribing Issues and the process flow chart are available from the Wirral
Medicines Management website: http://mm.wirral.nhs.uk/hospitalconcerns/.
The form is also available as a Word document from Practice Pharmacists, so Practices should be able to make it a
template on their clinical system if they wish.
Please raise any queries with the Practice Pharmacist or with Wirral Medicines Information on 0151 643 5338.
Ketoprofen gel: risk of photosensitivity reactions
Information has been sent to Healthcare Professionals as a reminder about the risk of photosensitivity reactions with
the use of topical ketoprofen.
http://www.tillomed.com/wp-content/uploads/2015/04/Ketoprofen-Reminder_of_Risk_Minimisation_Measures.pdf
The letter contains a checklist for Prescribers to counsel patients, and also an information sheet for patients on how
to minimise the risk of skin reactions with topical ketoprofen.
13 items were issued in Wirral in January 2015. Prescribers are reminded that this is a non-formulary item in Wirral,
and a review of prescribing is recommended in the light of these safety concerns. Ibuprofen gel (prescribed as
Fenbid®gel) is the topical NSAID of choice, with the 100g pack size being the most cost-effective presentation.
Sun Awareness Campaign
During May and June 2015, Community Pharmacies will be supporting the British Association of Dermatologists’
(BAD) national campaign around skin cancer, called ‘Sun Awareness’, which includes National Sun Awareness Week
in May.
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The Advisory Committee on Borderline Substances (ACBS) states that specified sun creams can be prescribed, but
only for the following conditions:
Abnormal cutaneous photosensitivity resulting from genetic disorders
Photodermatoses, including vitiligo and those resulting from radiotherapy
Chronic or recurrent herpes simplex labialis
Patients requesting prescriptions for sun cream for other conditions such as eczema, following surgery for skin
cancers or who experience allergies to regular sun cream should be advised to purchase these products, which are
readily available over the counter.
A recent article in the Daily Mail highlighted the fact that the NHS gave out 404,500 prescriptions for suncream at a
cost of £13m in 2014.
Read more: http://www.dailymail.co.uk/news/article-3031124/13million-NHS-bill-suncream-Millions-wasted-
prescriptions-toothpaste-Yakult-Calpol.html#ixzz3Y7hG5mIN
The Antibiotic Quality Premium
The Quality Premium for 2015/ 2016 has been launched by NHS England and includes a premium for improved
antibiotic prescribing. There are two targets for primary care:
A reduction of 1% in the number of antibiotics prescribed in primary care.
A reduction in the proportion of broad-spectrum antibiotics prescribed in primary care.
CCGs will be rewarded for quality improvement and this will be paid in the following financial year for reinvestment
in quality or health outcome improvement.
This supports the 5 year UK Antimicrobial Resistance Strategy and aims to help tackle the problems with antibiotic
resistance.
Evidence suggests that antibiotic resistance is driven by over-using antibiotics and prescribing them inappropriately.
Keeping levels of antibacterial prescribing low, by only prescribing antibiotics when appropriate, will help reduce the
spread of the antibacterial resistance that can be a serious threat to patients who have infections that do not
respond to antimicrobial drugs.
Broad spectrum antibiotics, such as co-amoxiclav, cephalosporins and quinolones, need to be reserved to treat
resistant disease and should generally be used only when standard antibiotics are ineffective.
A tool kit for prescribers is available:
“TARGET” (Treat Antibiotics Responsibly, Guidance, Education, Tools,) which is hosted on the Royal College of
General Practitioners website at: http://www.rcgp.org.uk/targetantibiotics/
It has a range of resources to support the appropriate prescribing of antibiotics including:
Patient information leaflets
Audit toolkits with indicators of responsible antimicrobial use
National antibiotic management guidance
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Training resources including links to online clinical modules
Resources for practices including videos that can be shown in the waiting room
A self assessment checklist for GPs and Commissioners
Query Corner
WHICH DRUGS CAN BE PRESCRIBED TO DELAY MENSTRUATION IN PATIENTS AT RISK OF DVT?
Norethisterone 5mg tablets are licensed for postponement of menstruation. The manufacturers of the three
norethisterone 5mg products have been contacted and none are aware of any imminent changes to the licence(1-3)
In contrast, medroxyprogesterone tablets are not licensed to postpone menstruation(4)
The Faculty of Sexual & Reproductive Healthcare (FSRH) (5) recently issued a statement which noted that:
“Norethisterone and norethisterone acetate have been shown to be partly metabolised to ethinylestradiol. At an oral
dose of 5mg a conversion ratio of about +0.4/-0.4 was found. This approximated to equate to an oral dose equivalent
of 4μg of ethinylestradiol per 1mg of norethisterone, although the authors noted that they could not rule out
individual variations. While therapeutic doses of norethisterone used for gynaecological treatment should perhaps be
prescribed with care in women with risk factors or contraindications to estrogen, POPs in the UK only contain 350μg
of norethisterone, and therefore this conversion is not likely to be clinically significant”.
In another document(6), the FSRH states:
“One consideration of note is that a recent review article has highlighted that norethisterone is partly metabolised to
ethinylestradiol. This article suggested that therapeutic doses of norethisterone should be viewed like a combination
type product and called for health professionals to consider reassessing prescribing treatment in women at higher
risk of VTE. It suggested that concern does not apply to use of the norethisterone POP on its own, as the preparation
available in the UK contains only 350μg norethisterone.”
The relevant references are:
Mansour D. Safer prescribing of therapeutic norethisterone for women at risk of venous thromboembolism. Journal of
Family Planning and Reproductive Health Care 2012.
Chu MC, Zhang X, Gentzschein E, Stanczyk FZ, Lobo RA. Formation of ethinyl estradiol in women during treatment
with norethindrone acetate. J Clin Endocrinol Metab 2007;92(6):2205-7.
Kuhnz W, Heuner A, Humpel M, Seifert W, Michaelis K. In vivo conversion of norethisterone and norethisterone
acetate to ethinyl estradiol in postmenopausal women. Contraception 1997;56(6):379-85.
Summary
At the dose recommended for postponement of menstruation (norethisterone 5mg three times daily), this
conversion may be clinically significant, so it should be prescribed with care in women with risk factors or
contraindications to estrogen. For most women, the risks of venous thromboembolism following a short (two-week)
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course of norethisterone 5mg three times daily are unlikely to be high. However, prescribers should use
progestogens with caution in those susceptible to thromboembolism – this is reflected in some, but not all,
norethisterone SPCs.
References
1. Actavis medical information. Contacted 13/1/15
2. Wockhardt medical information. Contacted 13/1/15
3. Pfizer medical information. Contacted 13/1/15
4. SPC Provera tablets. Available via www.medicines.org.uk
5. Faculty of Sexual & Reproductive Healthcare. Venous Thromboembolism (VTE) and Hormonal Contraception
Statement. November 2014.
Available at: http://www.fsrh.org/pdfs/FSRHStatementVTEandHormonalContraception.pdf
6. Faculty of Sexual & Reproductive Healthcare. Can women use norethisterone 5mg three times daily alongside
progestogen-only pills to control irregular bleeding and still maintain contraceptive cover? 201.3
Available at: www.fsrh.org/pdfs/No%204195.pdf
Acknowledgements to NW Medicines Information for their valuable contribution to this query.
Topic of the month
MENTAL HEALTH AWARENESS WEEK 11TH - 17TH MAY 2015
Founded in 1949 the Mental Health Foundation is the UKs leading mental health research, policy and service
improvement charity.
The Foundation are working for an end to mental ill health and the inequalities that face people experiencing mental
distress, living with learning disabilities or reduced mental capacity.
The first Mental Health Awareness Week (MHAW) took place in 2000 with the aim of raising awareness of mental
health and wellbeing issues. Since then, MHAWs have generated public debates around how anxiety, sleep
deprivation and exercise can impact mental health.
Monday 11th to Sunday 17th May 2015 is MHAW and the focus is ‘Mindfulness’
http://www.mentalhealth.org.uk/our-work/mentalhealthawarenessweek/ Twitter: #mhaw15
What is mindfulness?
Mindfulness is paying attention to the present moment, without getting stuck in the past or worrying about the
future.
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How can mindfulness help?
Contrary to popular belief, mindfulness isn’t about emptying the mind of thoughts and ‘zoning out’. It can mean
different things to different people. At the heart of it, mindfulness helps people observe the way they think and feel
about their experiences, whether good or bad. This can change the way people manage and react to stressful
situations, giving them a valuable tool to stay mentally healthy, and a growing body of evidence shows that it works.
Mindfulness is already known to be successful in helping people with mental and physical health problems, from
stress, depression and anxiety, to chronic pain, eating disorders and concentration. It can boost productivity at work
and give people a greater enjoyment of life.
How can I find out more?
The website (above) signposts a number of resources, including access to on-line courses at;
http://www.bemindfulonline.com/ and http://bemindful.co.uk/
Additionally, information resource packs to assist with the hosting of local events is available.
Other developments in Mental Health
NICE have recently published a number of clinical guidelines and quality standards relating to mental health.
Bipolar disorder: the assessment and management of bipolar disorder in adults, children and young people in
primary and secondary care (updates and replaces CG38). CG185 September 2014
http://www.nice.org.uk/guidance/cg185
Relevant sections have been amended regarding the use of valproate, including a new recommendation on
withdrawal of valproate in women of childbearing potential. These changes are in line with the revised Medicines
and Healthcare Products Regulatory Agency (MHRA) warning on valproate - https://www.gov.uk/drug-safety-
update/medicines-related-to-valproate-risk-of-abnormal-pregnancy-outcomes
Antenatal and postnatal mental health: clinical management and service guidance (updates and replaces CG45 and
section 1.5.6 in CG62). CG192 December 2014
http://www.nice.org.uk/guidance/cg192
Quality Standards for psychosis and schizophrenia in adults. QS80 February 2015
http://www.nice.org.uk/guidance/qs80
This quality standard covers the treatment and management of psychosis and schizophrenia (including related
psychotic disorders such as schizoaffective disorder, schizophreniform disorder and delusional disorder) in adults (18
years and older) with onset before the age of 60 years in Primary, Secondary and Community Care. It will not cover
adults with transient psychotic symptoms. For more information see the psychosis and schizophrenia in adults topic
overview http://www.nice.org.uk/Guidance/QS80/Documents
Improvements in the following outcomes are expected:
Severe mental illness premature mortality
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Employment and vocational rates
Hospital admissions
Referral to crisis resolution and home treatment teams
Service user experience of mental health services
Detention rates under the Mental Health Act.
This quality standard, in conjunction with the guidance on which it is based, should contribute to the improvements
outlined in the following 3 outcomes frameworks published by the Department of Health:
NHS Outcomes Framework 2015–16 (Department of Health, December 2014)
https://www.gov.uk/government/publications/nhs-outcomes-framework-2015-to-2016
The Adult Social Care Outcomes Framework 2015–16 (Department of Health, November 2014)
https://www.gov.uk/government/publications/adult-social-care-outcomes-framework-ascof-2015-to-2016
Improving outcomes and supporting transparency: a public health outcomes framework for England 2013–
2016, Parts 1 and 1A (Department of Health, November 2013)
https://www.gov.uk/government/publications/healthy-lives-healthy-people-improving-outcomes-and-supporting-
transparency
Depression in children and young people: Identification and management in Primary, Community and Secondary Care CG28 March 2015 http://www.nice.org.uk/guidance/cg28
Prescribing data for Mental Health (BNF Sections 4.1-4.4)
Items / Astro PUs Cost / Astro PUs Total actual cost
Locality Current
12
Months
Previous
12
Months
Locality Current
12
Months
Previous Mar 14 – Feb 15
12
Months
WIRRAL CCG 149.38 129.80 WIRRAL CCG £3,280.69 £3,204.08 £4,125,000
This prescribing data shows that for mental health drugs overall there has not been an increase in cost growth, and
only a very small increase in prescribing volume, when comparing March 2014-February 2015 with March 2013-
February 2014. Overall spend for mental health drugs is just over £4,125,000 for Wirral CCG for the last 12 months
with over 680,000 prescriptions issued.
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Drug Tariff
PRICE CHANGES
Top 10 monthly price reductions April 2015
Modafinil 200mg tablets [1 x 30] £24.71 (-£22.94) Celecoxib 200mg capsules [1 x 30] £3.86 (-£17.69) Celecoxib 100mg capsules [1 x 60] £4.20 (-£17.35) Rivastigmine 9.5mg/24hours transdermal patches [1 x 30] £31.69 (-£10.70) Dapsone 50mg tablets [1 x 28] £29.55 (-£9.04) Aripiprazole 30mg tablets [1 x 28] £184.08 (-£8.00) Isradipine 2.5mg tablets [1 x 56] £190.53 (-£6.52) Valsartan 160mg capsules [1 x 28] £6.01 (-£5.83) Levetiracetam 100mg/ml oral solution sugar free [1 x 300] £11.31 (-£5.61) Fluoxetine 60mg capsules [1 x 30] £20.17 (-£4.60)
Top 10 monthly price increases April 2015
Liothyronine 20microgram tablets [1 x 28] £152.18 (+£49.88) Carbimazole 20mg tablets [1 x 100] £188.31 (+£19.86) Exemestane 25mg tablets [1 x 30] £22.48 (+£17.56) Chloral hydrate 143.3mg/5ml oral solution BP [1 x 150] £172.93 (+£16.03) Naftidrofuryl 100mg capsules [1 x 84] £28.18 (+£14.84) Prednisolone 5mg soluble tablets [1 x 30] £53.48 (+£10.70) Cloral betaine 707mg tablets [1 x 30] £97.99 (+£9.08) Disopyramide 150mg capsules [1 x 84] £27.58 (+£8.82) Carbimazole 5mg tablets [1 x 100] £76.49 (+£8.32) Dipyridamole 100mg tablets [1 x 84] £12.14 (+£8.16)
Top 100 annual price reductions
http://www.panmerseyapc.nhs.uk/home/tariff_watch/partviiia_reductions_201504.pdf
Top 100 annual price increases
http://www.panmerseyapc.nhs.uk/home//tariff_watch/partviiia_increases_201504.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 April 2015. Please consider the costs of the following drugs
before prescribing.
Product Quantity Price
concession
Baclofen 10mg tablets 84 £7.20
Clonidine 25microgram tablets 112 £7.50
Digoxin 125mcg tablets 28 £4.89
Digoxin 250mcg tablets 28 £4.62
Digoxin 62.5mcg tablets 28 £4.75
Exemestane 25mg tablets 30 £33.00
Fosinopril 10mg tablets 28 £15.35
Fosinopril 20mg tablets 28 £15.49
Lisinopril 20mg/Hydrochlorothiazide 12.5mg tablets 28 £8.99
Lofepramine 70mg tablets (new) 56 £24.50
Mebeverine 135mg tablets (new) 100 £18.50
Mefenamic Acid 250mg capsules 100 £12.75
Mefenamic Acid 500mg tablets 28 £14.95
Olsalazine 250mg capsule (new) 112 £75.00
Olsalazine 500mg tablets (new) 60 £85.00
Trimethoprim 100mg tablets 28 £6.99
Trimethoprim 200mg tablets 14 £6.50
Trimethoprim 200mg tablets 6 £2.79
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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
Anusol® suppositories x12 and 24 Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Bisacodyl suppositories 10mg Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Caverject® Dual Chamber (Pfizer) January 2016 A manufacturing issue is causing a delay
in supply. Medical Information Enquiries
- 0845 608 8866
Colofac® tablets 135mg x 100
(Bgp Products)
June 2015 A manufacturing issue is causing a delay
in supply
Co-Phenotrope tablets
2.5/0.025mg x 100 (Amco Rwa /
Mercury Pharma)
June 2015 A supplier issue is causing a delay in
supply.
Diclofenac EC 50mg tablets
(different brands)
Limited supplies ongoing A supplier issue is causing a delay in
supply.
Ferrous Fumerate tablets 210mg
x 84 (Amco Rwa / Mercury
Pharma)
June 2015 A manufacturing issue is causing a delay
in supply.
Glucophage® SR tablets 750mg x
56 (Merck Serono)
Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Hormonin® tablets x 84 (Amco
Rwa / Mercury Pharma)
Limited supplies ongoing A supplier issue is causing a delay in
supply
Modrasone® cream 50g (Teva) Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Securon® SR tablets 240mg x 28
(Bgp Products)
Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Sno Tears® 10ml (Bausch&Lomb) Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
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Tegretol® Chewtab 100mg x 56
(Novartis Pharma)
Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Traxam® gel 3% 100g (Amco Rwa
/ Mercury Pharma)
Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Unistik® 3 Comfort Lancet 28G x
1. 8mm x 100 (Owen Mumford)
Limited supplies ongoing A supplier issue is causing a delay in
supply
Unistik® 3 Comfort Lancet 28G x
1.8mm x 50 (Owen Mumford)
Limited supplies ongoing A supplier issue is causing a delay in
supply
Zacin® cream 0.025% 45g (Teva) Supplier unable to
confirm
A manufacturing issue is causing a delay
in supply
Zoton® Fastab® 15mg x 28
(Pfizer)
Supplier unable to
confirm
Product awaiting QC/QA approval
For any further information regarding supply problems please contact your Practice Pharmacist/Technician or the
Medicines Management Team.
Safety
Revised Summary of Product Characteristics (SPC) for Tildiem®
SPC for Tildiem® (diltiazem) products have been revised to include a new warning regarding the potential for
interaction between the combination of grapefruit juice and diltiazem. This is within the current SPC in the Electronic
Medicines Compendium under Interactions (section 4.5).
This section states that grapefruit juice exposure may increase diltiazem exposure (1.2 fold) and advises that patients
who consume grapefruit juice should be monitored for increased adverse effects.
European Medicines Agency (EMA) recommends avoiding the concomitant use of certain hepatitis C medicines
and amiodarone together
Hepatitis C medicines Harvoni® (sofosbuvir with ledipasvir) or a combination of Sovaldi® (sofosbuvir) and Daklinza®
(daclatasvir) have been confirmed by the EMA to cause severe bradycardia or heart block when used in patients
taking amiodarone. A total of eight cases have been reviewed up to April 2015, one of which resulted in a fatal
cardiac arrest and a further two needed pacemaker intervention.
The advice from the EMA is to only use amiodarone in patients taking these hepatitis C medicines if other
antiarrhythmics cannot be used or are contra-indicated. In these circumstances, close monitoring is recommended
and, as amiodarone has a long half-life, monitoring is also required if the hepatitis C drugs mentioned above are
given within a few months of stopping amiodarone. Patients who have no alternative but to take amiodarone with
these hepatitis C drugs should be monitored in a clinical setting for at least 48 hours, and should be told to inform
their doctor immediately if they experience symptoms such as dizziness, slow heart beat, faintness, unusual
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tiredness, shortness of breath or chest pain during treatment. The exact mechanism of action with this interaction is
unknown and further investigations with Sovaldi® and other hepatitis C medicines are taking place. Harvoni®,
Sovaldi® and Daklinza® product information will be updated to highlight avoiding their use with amiodarone. These
hepatitis C treatments are novel agents, which have allowed a more simplified management of the disease and also
have the prospect of curing the infection.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) warn of increased cardiovascular risks with high doses of ibuprofen
The EMA’s PRAC carried out a review which confirmed that a small increase in cardiovascular risk such as stroke or
heart attacks can occur with high doses of ibuprofen (at or above the maximum 2400 mg daily dose). The review
highlights that the risk with high-dose ibuprofen is similar to the risks with other non-steroidal anti-inflammatory
drugs (NSAID) and COX-2 inhibitors.
The highest dose used over-the-counter (OTC) is 1200 mg per day and no increase in cardiovascular risk was seen at
this dose. The conclusion by PRAC was that the benefits of ibuprofen do outweigh the risks but advice should be
updated on the use of high-dose ibuprofen in order to minimise cardiovascular risk. High-doses of ibuprofen (2400
mg a day or higher) should not be used in patients who have heart failure, heart disease, previous heart attack or
stroke, or underlying circulatory conditions.
The advice for Prescribers is to assess the risk factors for a patient before initiating long-term treatment with
ibuprofen, particularly when higher doses may be needed. Risk factors such as smoking, diabetes, high blood
cholesterol and high blood pressure should be considered. Similar recommendations should also be applied to
dexibuprofen, a medicine similar to ibuprofen. A high dose of dexibuprofen is considered to be a dose at or above
1200 mg per day (equivalent to 2400mg of ibuprofen). This review only considers ibuprofen and dexibuprofen for
systemic use and so excludes other formulations such as gels and sprays. A warning for NSAIDs is already in place for
this group of medicines to be used at the lowest effective dose and for the shortest time possible needed to control
symptoms.
Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/04/news_detail_002306.js
p&mid=WC0b01ac058004d5c1
FDA Committee recommends label update for saxagliptin tablets (Onglyza®)
Saxagliptin (Onglyza®) has an acceptable cardiovascular risk safety profile, but the FDA has concluded that the label
should state the increased risk of heart failure. The SAVOR study, which reviewed use in type 2 diabetes, showed it
had ‘an acceptable cardiovascular risk profile’. Astra Zeneca has stated that they will investigate further the heart
failure risks found from the SAVOR trial.
Available at: http://www.pharmatimes.com/Article/15-04-
14/FDA_Committee_recommends_label_update_for_AZ_Onglyza.aspx
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FDA Alert - Illnesses and deaths in pets exposed to prescription topical pain medication
The FDA has warned that flurbiprofen containing topical medication can be linked to illness and death in pets that
are exposed. There have been incidences in the US with cats in two different households who became ill or died
following exposure to the topical NSAID drug flurbiprofen. The pet owners applied the cream or gel to their own
neck or feet and not directly to the pet. How much exposure these cats had to the cream or gel is unknown but
evidence from the cat autopsies found that the cats had kidney failure similar to that found with NSAID toxicity. The
FDA recommends people who use flurbiprofen containing topical preparations should avoid exposure to pets.
Available at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm443386.htm
MHRA DRUG SAFETY UPDATE
Tiotropium delivered via Respimat® compared with Handihaler®: no significant difference in mortality in TIOSPIR
trial
Consider the risk of cardiovascular side effects when prescribing tiotropium delivered via Respimat® or Handihaler®
to patients with certain cardiac conditions, who were excluded from clinical trials of tiotropium (including TIOSPIR).
When using tiotropium delivered via Respimat® or Handihaler® to treat chronic obstructive pulmonary disease
(COPD):
Take the risk of cardiovascular side effects into account for patients with conditions that may be affected by
the anticholinergic action of tiotropium including:
myocardial infarction in the last 6 months
unstable or life-threatening cardiac arrhythmia
cardiac arrhythmia requiring intervention or a change in drug therapy in the past year
hospitalisation for heart failure (NYHA Class III or IV) within the past year
Tell these patients to report any worsening of cardiac symptoms after starting tiotropium (patients with
these conditions were excluded from clinical trials of tiotropium, including TIOSPIR)
Review the treatment of all patients already taking tiotropium as part of the comprehensive management
plan to ensure that it remains appropriate for them; regularly review treatment of patients at high risk of
cardiovascular events
Remind patients not to exceed the recommended once-daily dose
Continue to report suspected side effects to tiotropium via the Yellow Card Reporting Scheme
Available at: www.gov.uk/drug-safety-update/tiotropium-delivered-via-respimat-compared-with-handihaler-no-
significant-difference-in-mortality-in-tiospir-trial
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Public Health England Risk Assessment of avian influenza (H5N1) - first update from Public Health England
Public Health England has provided an initial risk assessment carried out by the World Health Organisation regarding
increasing number of cases of human avian influenza in Egypt. There have been 116 reported cases in Egypt since
the beginning of 2015. For UK residents travelling to Egypt, the risk of influenza A (H5N1) infection remains very low
and the risk remains very low for UK residents within the UK. With good compliance to infection control measures,
the risk to health care professionals caring for patients with influenza A (H5N1) remains very low too. However
health care workers who have a severe respiratory illness, caring for patients with influenza A (H5N1) will require
testing. Clinicians need to keep a high alert for travellers from Egypt who develop signs and symptoms of influenza
within seven days of their return.
Available at:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/420965/H5N1_RA_2015_v3.pdf
Medicines Management Team contacts:
Victoria Vincent (Wirral) [email protected] 0151 643 5319
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