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Medicines Management Newsletter
Number 10
October 2012
The newsletter is an independent, evidence-based collection of news items, including key clinical trials, Commission for Human
Medicines (CHM) and Medicines and Healthcare Products Regulatory Agency (MHRA) advice, safety information, local and
national issues and guidance and local prescribing initiatives and decisions, which the Medicines Management team believe are of
relevance to primary care prescribers, other healthcare professionals and their teams.
CONTENTS
EKPG Recommendations For Simvastatin Prescribing
Benzodiazepine Use and Risk of Dementia
Upper Gastrointestinal Bleeding – Re-Prescribing of Associated Drugs
Pertussis Vaccination for Pregnant Women
Department of Health Warns of Misuse of Methadone in Children
European Antibiotic Awareness Day
HPA Travel Advice for Hajj Pilgrims
Product Updates
Tamiflu Suspension - Change in Product Strength
Phenytoin Capsules - Product Name Change
Mesalazine MR Tablets - Brand Name Change
Dovobet (Calcipotriol / Betamethasone Dipropionate) Products
Slo-Drinks
NICE BNFC App
MHRA Drug Safety Update
NICE Publications
Vaccine Update
Feedback
EKPG RECOMMENDATIONS FOR SIMVASTATIN PRESCRIBING
The MHRA has recently highlighted changes to the prescribing information for simvastatin which has been
updated following the emergence of information from recent analysis of clinical trial data, spontaneously
reported cases and drug-drug interaction studies. These changes include contraindications to concomitant
use with certain medicines and maximum dose recommendations when simvastatin is taken with a number
of other medicines, as these interactions may increase plasma concentrations of simvastatin which is
associated with an increased risk of myopathy and / or rhabdomyolysis.
Key changes


Simvastatin is now contraindicated with ciclosporin, danazol and gemfibrozil
The maximum recommended dose for simvastatin in conjunction with amiodarone, amlodipine,
diltiazem or verapamil is now 20mg/day
Recommendations
Patients currently prescribed simvastatin 40mg and amiodarone, amlodipine, diltiazem or verapamil
Secondary Prevention
Switch to atorvastatin 10mg daily, increasing to atorvastatin 20mg daily if required to achieve
target lipid levels
Atorvastatin has also been reported to interact with amiodarone, amlodipine, diltiazem and verapamil to
increase the atorvastatin level but to a lesser extent than simvastatin.
Primary Prevention
Switch to pravastatin 40mg daily
Pravastatin does not interact with amiodarone, amlodipine, diltiazem or verapamil.
Prescribers are asked NOT to switch patients from simvastatin to rosuvastatin unless there is no clinically
acceptable alternative due to cost implications (atorvastatin 20mg £2.18, pravastatin 40mg £2.37,
simvastatin 20mg £0.73, atorvastatin 10mg £1.55, rosuvastatin 10mg £18.03 for 28 days treatment).
Prescribers are NOT advised to switch to an alternative calcium channel blocker as this is clinically less
desirable especially where patients are well controlled on their current calcium channel blocker.
Patients currently prescribed simvastatin and ciclosporin, danazol or gemfibrozil
Stop the simvastatin and switch to an alternative statin. Recommended alternative statins are:
• With ciclosporin: EITHER Atorvastatin at a maximum dose of 10mg (higher atorvastatin doses are
contraindicated with ciclosporin); OR pravastatin 20mg daily increasing to 40mg daily if required with
careful monitoring
• With danazol: EITHER Atorvastatin initiated at 10mg daily, increasing as required to control lipids, with
careful monitoring; OR pravastatin up to 40mg daily. Danazol is known to interact with artovastatin but to
a lesser extent than simvastatin
• With gemfibrozil: All statins interact with gemfibrozil. The combined use of gemfibrozil with a statin
should generally be avoided. Review all patients prescribed gemfibrozil and any statin. If the benefit of
this combination is still considered to outweigh the risk use EITHER Atorvastatin initiated at 10mg daily,
increasing as required to control lipids, with careful monitoring; OR pravastatin up to 40mg daily
The full recommendations are located on the NHS Eastern and Coastal Kent website:
http://www.easternandcoastalkent.nhs.uk/home/independent-contractors/medicines-management/drugformulary-and-prescribing-policies/cardiovascular-system/
BENZODIAZEPINE USE AND RISK OF DEMENTIA
The BMJ has reported a prospective, population based study which evaluated the association between the
use of benzodiazepines and incident dementia (PAQUID study, France).
The study participants were 1063 men and women (mean age 78.2 years) who were free of dementia and
did not start taking benzodiazepines until at least the third year of follow-up. The main outcome measure
was incident dementia, confirmed by a neurologist.
During a 15 year follow-up, 253 incident cases of dementia were confirmed. New use of benzodiazepines
was associated with an increased risk of dementia (multivariable adjusted hazard ratio 1.60, 95%
confidence interval 1.08 to 2.38). Sensitivity analysis considering the existence of depressive symptoms
showed a similar association (hazard ratio 1.62, 1.08 to 2.43). A secondary analysis pooled cohorts of
participants who started benzodiazepines during follow-up and evaluated the association with incident
dementia. The pooled hazard ratio across the five cohorts of new benzodiazepine users was 1.46 (1.10 to
1.94). Results of a complementary nested case-control study showed that ever use of benzodiazepines
was associated with an approximately 50% increase in the risk of dementia (adjusted odds ratio 1.55, 1.24
to 1.95) compared with never users. The results were similar in past users (odds ratio 1.56, 1.23 to 1.98)
and recent users (1.48, 0.83 to 2.63) but reached significance only for past users.
The authors concluded “In this prospective population based study, new use of benzodiazepines was
associated with increased risk of dementia. The result was robust in pooled analyses across cohorts of
new users of benzodiazepines throughout the study and in a complementary case-control study.
Considering the extent to which benzodiazepines are prescribed and the number of potential adverse
effects of this drug class in the general population, indiscriminate widespread use should be cautioned
against.”
http://www.bmj.com/content/345/bmj.e6231
UPPER GASTROINTESTINAL BLEEDING – RE-PRESCRIBING OF ASSOCIATED DRUGS
A study has found that, in the year after being discharged from hospital following a drug-related upper
gastrointestinal bleed, between 25% (for NSAIDs) and 82% (for SSRIs) of people redeemed a prescription
for the drug that was associated with that bleed. Proton pump inhibitors were generally, but by no means
always, co-prescribed.
Prescribers are advised to follow NICE guidance on the prevention of re-bleeding in patients on NSAIDs,
aspirin or clopidogrel and also take note of advice in the BNF on the risks of gastrointestinal bleeds with
SSRIS and other drugs.
http://www.ncbi.nlm.nih.gov/pubmed/22313346
PERTUSSIS (WHOOPING COUGH) VACCINATION FOR PREGNANT WOMEN
Following a sharp rise in cases of whooping cough with nine babies having died from the disease up to the
end of August the Chief Medical Officer has announced a programme of vaccination for expectant mothers
in weeks 28 to 38 of their pregnancy.
The Joint Committee on Vaccination and Immunisation (JCVI) has agreed that women in week 28 of their
pregnancy up to week 38 should be vaccinated with the whooping cough (pertussis) vaccine, as this is the
only way to protect their babies from birth from infection until they can be vaccinated at two months of age.
News item: http://www.dh.gov.uk/health/2012/09/whooping-cough/
Further information: http://www.dh.gov.uk/health/2012/09/whooping-cough-information/
Resources: http://www.dh.gov.uk/health/2012/09/whooping-cough-resources/
DEPARTMENT OF HEALTH WARNS OF MISUSE OF METHADONE IN CHILDREN
The Department of Health has received notification that some parents / carers have illicitly given part of
their prescribed methadone to their child(ren), to help treat an illness and / or to help aid their sleep,
sometimes with tragic consequences. The Department highlights to clinicians that when advising patients
about the risks of methadone to children, such as fatal overdose, and the importance of safe use and
storage, to consider reinforcing the message that even a small amount of methadone could have fatal
consequences if consumed by a child.
http://www.dh.gov.uk/health/2012/09/the-week-issue-265-14-20-september-2012/
http://www.nta.nhs.uk/uploads/clinical_guidelines_2007.pdf
EUROPEAN ANTIBIOTIC AWARENESS DAY
European Antibiotic Awareness Day (EAAD), which takes place on 18 November 2012, raises public and
professional awareness of the need for responsible prescribing to slow down the development of antibiotic
resistance and is part of a national programme to combat antimicrobial resistance. Antibiotic resistance is
driven by the over-use of antibiotics and inappropriate prescribing of antibiotics. The number of infections
due to antibiotic-resistant bacteria is growing and there is a lack of new antibiotics.
Activities will be launched from Friday 16th November. Materials have been produced centrally to prevent
duplication of effort and ensure consistency of message. The Department of Health is providing a range of
educational materials to help implement local campaigns and initiatives. These can be downloaded from
the DoH website at http://www.dh.gov.uk/health/tag/eaad/ and a limited number of hardcopy posters and
leaflets are available.
http://www.dh.gov.uk/health/2012/10/eaad-resources/
HPA TRAVEL ADVICE FOR HAJJ PILGRIMS
Around 25,000 people are expected to travel from the UK to Saudi Arabia for this year's Hajj, which is
taking place from 24-29 October. A large population from around the world confined to one area has
historically increased the risk of infectious disease outbreaks, in particular meningitis and respiratory
infections. The Health Protection Agency (HPA) and the National Travel Health Network and Centre
(NaTHNaC) want to remind people to seek health advice before making the journey to ensure a healthy
trip.
http://www.hpa.org.uk/NewsCentre/NationalPressReleases/2012PressReleases/121003TraveladviceforHajj
pilgrims/
PRODUCT UPDATES
Tamiflu Suspension - Change in Product Strength
Roche Products Limited has advised on new concentration and dosing instructions of Tamiflu® oral
suspension (oseltamivir phosphate).
The main points are:
 Concentration of TAMIFLU® for Oral Suspension will be changed from 12 mg/ml to 6 mg/ml
 The dispenser will be changed from milligrams (mgs) to millilitres (mLs)

The EU SPCs will be changed to include amended dosing tables to include a column for the volume
in millilitres based on the new 6 mg/ml formulation.
Prescriptions for Tamiflu® oral suspension should state the dose in millilitres and the new 6mg/ml
concentration should be used. Patients and parents / guardians of children should be carefully advised that
the carton packaging, dosing dispenser and packaging leaflet of the new oral suspension are different from
what they may have used in the past.
Tamiflu is indicated for treatment of influenza in patients one year of age and older who present with
symptoms typical of influenza, when influenza virus is circulating in the community within two days of first
onset of symptoms. It is also indicated for post-exposure prevention in individuals one year of age or older
following contact with a clinically diagnosed influenza case when influenza virus is circulating in the
community. During a pandemic influenza outbreak Tamiflu is also indicated for the treatment and postexposure prevention of influenza in infants below 12 months of age.
For full prescribing information please see the Summary of Product Characteristics which is available at
www.emc.medicines.org.uk.
Phenytoin Capsules Product Change
Flynn Pharma has taken over the manufacture and distribution of Epanutin capsules from 24 September
2012, with the product now marketed as Phenytoin Sodium Flynn hard capsules. Phenytoin sodium
Flynn hard capsules are bioequivalent to Epanutin and the capsules have markings and colourings exactly
like Epanutin capsules, including still having the marking ‘Epanutin’. The outer packaging will change. The
Epanutin brand will cease to be available once current stock has run out. Other Epanutin formulations
(Infatabs and suspension) will continue to be available as Epanutin brand. Patient free phone helpline
0800 077 8566.
Following this change in manufacturer, there will be a significant increase in cost. The list prices for
Phenytoin Sodium Flynn hard capsules, subject to the Drug Tariff, are as follows (previous Epanutin prices
for equivalent pack size in brackets):
•Phenytoin Sodium Flynn 25mg capsules x 28= £15.74 (Epanutin 25mg capsules x 28= £0.66)
•Phenytoin Sodium Flynn 50mg capsules x 28= £15.98 (£0.67)
•Phenytoin Sodium Flynn 100mg capsules x 84= £67.50 (£2.83)
•Phenytoin Sodium Flynn 300mg capsules x 28= £67.50 (£2.83)
NICE Clinical Guideline 137 The diagnosis and management of epilepsies in adults and children in primary
and secondary care recommends consistent supply of a particular manufacturer’s anti-epileptic drug
preparation unless the prescriber, in consultation with the patient, considers that this is not a concern.
http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con185674.pdf
Mesalazine MR Tablets Brand Name Change
Mesren brand will soon be discontinued and replaced by Octasa 400mg from 1st November. The only
thing changing is the name and the box; the tablets will be exactly the same as will the pack sizes and
price. Some Mesren is expected to be available until at least March next year. The manufacturer, Tillotts
Pharma UK, have produced a number of tools to support prescribers, pharmacist and patients with the
changeover process. These are expected to be available shortly.
Dovobet (Calcipotriol / Betamethasone Dipropionate) Products
From 1st November 2012, Dovobet Ointment 60g will be discontinued. Dovobet Ointment 120g, Dovobet
Gel 60g and Dovobet Gel 120g will continue to be available.
Slo-drinks
A number of care homes have contacted practices after receiving information from the manufacturer of Slodrinks. Slo-drinks are not currently recommended by the Speech and Language Team (SLT) team. Please
be reminded that thickeners should be initiated only by the speech and language team. Care homes
should not be asking prescribers to initiate thickeners. Prescribers are advised not to accept requests to
prescribe thickeners from care homes. Thickeners may not be appropriate for all patients. These patients
will require an assessment by SLT to determine appropriate treatment on an individual patient basis. If
there is a problem with a patient’s current thickener the SLT team should be contacted to discuss
alternatives.
The embedded Thickener Reference Sheet contains brief details of thickening agents used by Kent
Community Health Trust.
Thickener_reference
_sheet_for_PCT[1][1].pdf
NICE BRITISH NATIONAL FORMULARY FOR CHILDREN APP
NICE has launched a NICE British National Formulary for Children app for smartphone and tablet. The
BNFC app is available free to health and care professionals in England and can be downloaded via the
Apple App Store and Google Play Store. Users will need to enter their NHS Athens user name and
password to activate the app and download the content. Once downloaded and activated, the app does
not rely on a network connection and will provide direct offline access to the latest version of the BNF for
Children.
Healthcare professionals who do not have an NHS Athens account may register online at
www.evidence.nhs.uk.
The previously launched NICE BNF app launched in June is now available for Android and Apple tablets.
MHRA DRUG SAFETY UPDATE
Drug Safety Update September 2012; Volume 6, Issue 2
Paracetamol overdose: new guidance on treatment with intravenous acetylcysteine. New simplified
guidance on treating paracetamol overdose with intravenous acetylcysteine is now in place. This includes
an updated treatment nomogram.
Oseltamivir (Tamiflu): changed concentration and dosing dispenser of oral suspension from October 2012.
The strength of oseltamivir (Tamiflu) oral suspension will be 6 mg/mL. A new dosing dispenser, calibrated
in mL, will be introduced at the same time. (Please see article above for further information.)
Dipeptidylpeptidase-4 inhibitors (‘gliptins’): risk of acute pancreatitis. There have been reports of acute
pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents
(‘gliptins’). Patients should be informed of the characteristic symptoms of acute pancreatitis – persistent,
severe abdominal pain (sometimes radiating to the back) – and encouraged to tell their healthcare provider
if they have such symptoms. If pancreatitis is suspected, the DPP-4 inhibitor and other potentially suspect
medicinal products should be discontinued.
Panitumumab (Vectibix): risk of necrotising fasciitis. Severe skin reactions with panitumumab use are
known to be very common and may be followed by life-threatening and fatal infectious complications
including sepsis and cellulitis. In addition, five cases of necrotising fasciitis, three of which were fatal, have
now been reported in patients treated with panitumumab in combination with chemotherapy.
Levofloxacin: some indications restricted. Levofloxacin (a fluoroquinolone antibiotic) may only be
considered in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community
acquired pneumonia or complicated skin and soft tissue infections when other medicines cannot be
prescribed, or have been ineffective.
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/index.htm
NICE PUBLICATIONS
Technology Appraisals:
TA 264 Alteplase for treating acute ischaemic stroke (review of technology appraisal guidance 122). NICE
recommends alteplase as a possible treatment for people who have had an acute ischaemic stroke.
http://www.nice.org.uk/TA264
Clinical Guidelines:
CG150 Headaches: diagnosis and management of headaches in young people and adults. This guideline offers
evidence-based advice on the diagnosis and management of tension-type headache, migraine (including migraine
with aura and menstrual-related migraine), cluster headache and medication overuse headache in young people
(aged 12 years and older) and adults. http://guidance.nice.org.uk/CG150
CG151 Neutropenic sepsis: prevention and management of neutropenic sepsis in cancer patients. This guideline
offers evidence-based advice on the prevention, identification and management of neutropenic sepsis in patients
having anticancer treatment. http://guidance.nice.org.uk/CG151
CG152 Crohn's disease: Management in adults, children and young people. This clinical guideline (published October
2012) offers evidence-based advice on the management of Crohn’s disease in adults, children and young people.
http://publications.nice.org.uk/crohns-disease-cg152
Public Health Guidance:
PH39 Smokeless tobacco cessation: South Asian communities. This guidance aims to help people of South Asian
origin to stop using smokeless tobacco. The recommendations cover: assessing local need, working with local South
Asian communities, commissioning smokeless tobacco services, providing brief advice and referral: dentists, GPs,
pharmacists and other health professionals, specialist tobacco cessation services (including stop smoking services),
training for practitioners. http://publications.nice.org.uk/smokeless-tobacco-cessation-south-asian-communities-ph39
Quality Standards:
QS22 Antenatal care. This quality standard covers the antenatal care of all pregnant women up to 42 weeks of
pregnancy, in all settings that provide routine antenatal care, including primary, community and hospital-based care.
The quality standard addresses routine antenatal care, including screening tests for complications of pregnancy, but it
does not address the additional care needed to manage these complications if they arise in pregnancy (for example,
gestational diabetes, pre-eclampsia and venous thromboembolism).
http://www.nice.org.uk/guidance/index.jsp?action=byID&o=13898
Evidence Updates
Generalised anxiety disorder in adults. - Evidence Update September 2012
Management of stable angina - Evidence Update September 2012
http://www.evidence.nhs.uk/nhs-evidence-content/evidence-updates/evidence-updates-by-date
NICE Bites
September 2012; No. 45: Antibiotics for early-onset neonatal infection
October 2012, No.46: Diagnosis and management of headaches
http://www.nelm.nhs.uk/en/NeLM-Area/Health-In-Focus/
VACCINE UPDATE
September 2012
• Launch of the whooping cough vaccination programme for pregnant women
• The rise in whooping cough cases
• Clarification on contraindications and precautions for use of Repevax®
• National screening and immunisation programmes – roles and accountabilities from April 2013
• Migrant health guide – video
• Ordering vaccines through ImmForm
• ImmForm terms of use updated
https://www.wp.dh.gov.uk/immunisation/files/2012/10/8161_VaccineUpdate_Sept2012_193_10_accessible.pdf
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Email: [email protected] Phone: 01233 618158 Fax: 01233 618195
Post: NHS Kent and Medway, Kent House, 81 Station Road, Ashford. Kent TN23 1PP
Every effort is made to ensure that the information contained in the newsletter is accurate and up to date at the time of publication.
Please be aware that information about medicines and therapeutics will change over time, and that information may not be current
after the initial date of publication. Please take note of the publication date and seek further advice if in any doubt about the
currency of the information.